[Title 40 CFR ]
[Code of Federal Regulations (annual edition) - July 1, 2013 Edition]
[From the U.S. Government Printing Office]



[[Page i]]

          

          Title 40

Protection of Environment


________________________

Parts 150 to 189

                         Revised as of July 1, 2013

          Containing a codification of documents of general 
          applicability and future effect

          As of July 1, 2013
                    Published by the Office of the Federal Register 
                    National Archives and Records Administration as a 
                    Special Edition of the Federal Register

[[Page ii]]

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                            Table of Contents



                                                                    Page
  Explanation.................................................       v

  Title 40:
          Chapter I--Environmental Protection Agency 
          (Continued)                                                3
  Finding Aids:
      Table of CFR Titles and Chapters........................     771
      Alphabetical List of Agencies Appearing in the CFR......     791
      List of CFR Sections Affected...........................     801

[[Page iv]]





                     ----------------------------

                     Cite this Code: CFR
                     To cite the regulations in 
                       this volume use title, 
                       part and section number. 
                       Thus, 40 CFR 150.17 refers 
                       to title 40, part 150, 
                       section 17.

                     ----------------------------

[[Page v]]



                               EXPLANATION

    The Code of Federal Regulations is a codification of the general and 
permanent rules published in the Federal Register by the Executive 
departments and agencies of the Federal Government. The Code is divided 
into 50 titles which represent broad areas subject to Federal 
regulation. Each title is divided into chapters which usually bear the 
name of the issuing agency. Each chapter is further subdivided into 
parts covering specific regulatory areas.
    Each volume of the Code is revised at least once each calendar year 
and issued on a quarterly basis approximately as follows:

Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1

    The appropriate revision date is printed on the cover of each 
volume.

LEGAL STATUS

    The contents of the Federal Register are required to be judicially 
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie 
evidence of the text of the original documents (44 U.S.C. 1510).

HOW TO USE THE CODE OF FEDERAL REGULATIONS

    The Code of Federal Regulations is kept up to date by the individual 
issues of the Federal Register. These two publications must be used 
together to determine the latest version of any given rule.
    To determine whether a Code volume has been amended since its 
revision date (in this case, July 1, 2013), consult the ``List of CFR 
Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative 
List of Parts Affected,'' which appears in the Reader Aids section of 
the daily Federal Register. These two lists will identify the Federal 
Register page number of the latest amendment of any given rule.

EFFECTIVE AND EXPIRATION DATES

    Each volume of the Code contains amendments published in the Federal 
Register since the last revision of that volume of the Code. Source 
citations for the regulations are referred to by volume number and page 
number of the Federal Register and date of publication. Publication 
dates and effective dates are usually not the same and care must be 
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instances where the effective date is beyond the cut-off date for the 
Code a note has been inserted to reflect the future effective date. In 
those instances where a regulation published in the Federal Register 
states a date certain for expiration, an appropriate note will be 
inserted following the text.

OMB CONTROL NUMBERS

    The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires 
Federal agencies to display an OMB control number with their information 
collection request.

[[Page vi]]

Many agencies have begun publishing numerous OMB control numbers as 
amendments to existing regulations in the CFR. These OMB numbers are 
placed as close as possible to the applicable recordkeeping or reporting 
requirements.

PAST PROVISIONS OF THE CODE

    Provisions of the Code that are no longer in force and effect as of 
the revision date stated on the cover of each volume are not carried. 
Code users may find the text of provisions in effect on any given date 
in the past by using the appropriate List of CFR Sections Affected 
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Affected'' is published at the end of each CFR volume. For changes to 
the Code prior to the LSA listings at the end of the volume, consult 
previous annual editions of the LSA. For changes to the Code prior to 
2001, consult the List of CFR Sections Affected compilations, published 
for 1949-1963, 1964-1972, 1973-1985, and 1986-2000.

``[RESERVED]'' TERMINOLOGY

    The term ``[Reserved]'' is used as a place holder within the Code of 
Federal Regulations. An agency may add regulatory information at a 
``[Reserved]'' location at any time. Occasionally ``[Reserved]'' is used 
editorially to indicate that a portion of the CFR was left vacant and 
not accidentally dropped due to a printing or computer error.

INCORPORATION BY REFERENCE

    What is incorporation by reference? Incorporation by reference was 
established by statute and allows Federal agencies to meet the 
requirement to publish regulations in the Federal Register by referring 
to materials already published elsewhere. For an incorporation to be 
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This material, like any other properly issued regulation, has the force 
of law.
    What is a proper incorporation by reference? The Director of the 
Federal Register will approve an incorporation by reference only when 
the requirements of 1 CFR part 51 are met. Some of the elements on which 
approval is based are:
    (a) The incorporation will substantially reduce the volume of 
material published in the Federal Register.
    (b) The matter incorporated is in fact available to the extent 
necessary to afford fairness and uniformity in the administrative 
process.
    (c) The incorporating document is drafted and submitted for 
publication in accordance with 1 CFR part 51.
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CFR INDEXES AND TABULAR GUIDES

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alphabetical list of agencies publishing in the CFR are also included in 
this volume.

[[Page vii]]

    An index to the text of ``Title 3--The President'' is carried within 
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the revision dates of the 50 CFR titles.

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INQUIRIES

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or write to the Director, Office of the Federal Register, National 
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    Charles A. Barth,
    Director,
    Office of the Federal Register.
    July 1, 2013.







[[Page ix]]



                               THIS TITLE

    Title 40--Protection of Environment is composed of thirty-four 
volumes. The parts in these volumes are arranged in the following order: 
Parts 1-49, parts 50-51, part 52 (52.01-52.1018), part 52 (52.1019-
52.2019), part 52 (52.2020-end of part 52), parts 53-59, part 60 (60.1-
end of part 60, sections), part 60 (Appendices), parts 61-62, part 63 
(63.1-63.599), part 63 (63.600-63.1199), part 63 (63.1200-63.1439), part 
63 (63.1440-63.6175), part 63 (63.6580-63.8830), part 63 (63.8980-end of 
part 63) parts 64-71, parts 72-80, parts 81-84, part 85-Sec.  86.599-99, 
part 86 (86.600-1-end of part 86), parts 87-95, parts 96-99, parts 100-
135, parts 136-149, parts 150-189, parts 190-259, parts 260-265, parts 
266-299, parts 300-399, parts 400-424, parts 425-699, parts 700-789, 
parts 790-999, and part 1000 to end. The contents of these volumes 
represent all current regulations codified under this title of the CFR 
as of July 1, 2013.

    Chapter I--Environmental Protection Agency appears in all thirty-
four volumes. Regulations issued by the Council on Environmental 
Quality, including an Index to Parts 1500 through 1508, appear in the 
volume containing part 1000 to end. The OMB control numbers for title 40 
appear in Sec.  9.1 of this chapter.

    For this volume, Cheryl E. Sirofchuck was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of 
Michael L. White, assisted by Ann Worley.


[[Page 1]]



                   TITLE 40--PROTECTION OF ENVIRONMENT




                  (This book contains parts 150 to 189)

  --------------------------------------------------------------------
                                                                    Part

chapter i--Environmental Protection Agency (Continued)......         150

[[Page 3]]



         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)




  --------------------------------------------------------------------


  Editorial Note: Nomenclature changes to chapter I appear at 65 FR 
47324, 47325, Aug. 2, 2000, and at 66 FR 34375, 34376, June 28, 2001.

                    SUBCHAPTER E--PESTICIDE PROGRAMS
Part                                                                Page
150             General.....................................           5
151             [Reserved]

152             Pesticide registration and classification 
                    procedures..............................           5
153             Registration policies and interpretations...          44
154             Special review procedures...................          45
155             Registration standards and registration 
                    review..................................          53
156             Labeling requirements for pesticides and 
                    devices.................................          62
157             Packaging requirements for pesticides and 
                    devices.................................          84
158             Data requirements for pesticides............          88
159             Statements of policies and interpretations..         196
160             Good laboratory practice standards..........         210
161             Data requirements for registration of 
                    antimicrobial pesticides................         222
162             State registration of pesticide products....         263
164             Rules of practice governing hearings, under 
                    the Federal Insecticide, Fungicide, and 
                    Rodenticide Act, arising from refusals 
                    to register, cancellations of 
                    registrations, changes of 
                    classifications, suspensions of 
                    registrations and other hearings called 
                    pursuant to section 6 of the Act........         271
165             Pesticide management and disposal...........         289
166             Exemption of Federal and State agencies for 
                    use of pesticides under emergency 
                    conditions..............................         315
167             Registration of pesticide and active 
                    ingredient producing establishments, 
                    submission of pesticide reports.........         325
168             Statements of enforcement policies and 
                    interpretations.........................         328
169             Books and records of pesticide production 
                    and distribution........................         337

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170             Worker protection standard..................         340
171             Certification of pesticide applicators......         367
172             Experimental use permits....................         383
173             Procedures governing the rescission of State 
                    primary enforcement responsibility for 
                    pesticide use violations................         400
174             Procedures and requirements for plant-
                    incorporated protectants................         402
176             Time-limited tolerances for emergency 
                    exemptions..............................         411
178             Objections and requests for hearings........         413
179             Formal evidentiary public hearing...........         417
180             Tolerances and exemptions for pesticide 
                    chemical residues in food...............         428
181-189         [Reserved]

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                     SUBCHAPTER E_PESTICIDE PROGRAMS



PART 150_GENERAL--Table of Contents



    Authority: Reorganization Plan No. 3 of 1970 (5 U.S.C. App.).



Sec. 150.17  Addresses for the Office of Pesticide Programs.

    The official addresses, unless otherwise noted, are as follows:
    (a) Applications, correspondence, and non-docket materials--(1) 
United States Postal Service mailing address. Office of Pesticide 
Programs (7510P), Environmental Protection Agency, 1200 Pennsylvania 
Ave. NW., Washington, DC 20460-0001.
    (2) Hand/courier delivery address. Office of Pesticide Programs, 
Environmental Protection Agency, 2777 S. Crystal Dr., Arlington, VA 
22202-4501. This is not a mailing address. You must make arrangements 
with the person receiving your delivery.
    (b) Office of Pesticide Programs Regulatory Public Docket (OPP 
Docket)--(1) Electronic docket address. Publicly available docket 
materials are available in the electronic docket at http://
www.regulations.gov. Although listed in the docket index at 
regulations.gov, some information is not publicly available, e.g., 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Certain other material, such as 
copyrighted material, will be publicly available only at the OPP Docket.
    (2) Physical location. Environmental Protection Agency Docket Center 
(EPA/DC), Environmental Protection Agency, EPA West Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. This is not a 
mailing address. For instructions on visiting the docket, go to http://
www.epa.gov/dockets/contacts.htm.
    (3) United States Postal Service mailing address. Office of 
Pesticide Programs Regulatory Public Docket, Environmental Protection 
Agency Docket Center (EPA/DC), (28221T), Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
    (4) Hand/courier delivery. For hand/courier delivery or to make 
special arrangements for deliveries of boxed information, please follow 
the instructions at http://www.epa.gov/dockets/contacts.htm.

[77 FR 46291, Aug. 3, 2012]

                           PART 151 [RESERVED]



PART 152_PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES--Table of 

Contents



                      Subpart A_General Provisions

Sec.
152.1 Scope.
152.3 Definitions.
152.5 Pests.
152.6 Substances excluded from regulation by FIFRA.
152.8 Products that are not pesticides because they are not for use 
          against pests.
152.10 Products that are not pesticides because they are not intended 
          for a pesticidal purpose.
152.15 Pesticide products required to be registered.

                          Subpart B_Exemptions

152.20 Exemptions for pesticides adequately regulated by another Federal 
          agency.
152.25 Exemptions for pesticides of a character not requiring FIFRA 
          regulation.
152.30 Pesticides that may be transferred, sold, or distributed without 
          registration.

                    Subpart C_Registration Procedures

152.40 Who may apply.
152.42 Application for new registration.
152.43 Alternate formulations.
152.44 Application for amended registration.
152.46 Notification and non-notification changes to registrations.
152.50 Contents of application.
152.55 Where to send applications and correspondence.

Subpart D [Reserved]

  Subpart E_Procedures To Ensure Protection of Data Submitters' Rights

152.80 General.
152.81 Applicability.
152.83 Definitions.
152.84 When materials must be submitted to the Agency.
152.85 Formulators' exemption.
152.86 The cite-all method.

[[Page 6]]

152.90 The selective method.
152.91 Waiver of a data requirement.
152.92 Submission of a new valid study.
152.93 Citation of a previously submitted valid study.
152.94 Citation of a public literature study or study generated at 
          government expense.
152.95 Citation of all studies in the Agency's files pertinent to a 
          specific data requirement.
152.96 Documentation of a data gap.
152.97 Rights and obligations of data submitters.
152.98 Procedures for transfer of exclusive use or compensation rights 
          to another person.
152.99 Petitions to cancel registration.

                 Subpart F_Agency Review of Applications

152.100 Scope.
152.102 Publication.
152.104 Completeness of applications.
152.105 Incomplete applications.
152.107 Review of data.
152.108 Review of labeling.
152.110 Time for agency review.
152.111 Choice of standards for review of applications.
152.112 Approval of registration under FIFRA sec. 3(c)(5).
152.113 Approval of registration under FIFRA sec. 3(c)(7)--Products that 
          do not contain a new active ingredient.
152.114 Approval of registration under FIFRA sec. 3(c)(7)--Products that 
          contain a new active ingredient.
152.115 Conditions of registration.
152.116 Notice of intent to register to original submitters of exclusive 
          use data.
152.117 Notification to applicant.
152.118 Denial of application.
152.119 Availability of material submitted in support of registration.

             Subpart G_Obligations and Rights of Registrants

152.122 Currency of address of record and authorized agent.
152.125 Submission of information pertaining to adverse effects.
152.130 Distribution under approved labeling.
152.132 Supplemental distribution.
152.135 Transfer of registration.

Subpart H [Reserved]

                 Subpart I_Classification of Pesticides

152.160 Scope.
152.161 Definitions.
152.164 Classification procedures.
152.166 Labeling of restricted use products.
152.167 Distribution and sale of restricted use products.
152.168 Advertising of restricted use products.
152.170 Criteria for restriction to use by certified applicators.
152.171 Restrictions other than those relating to use by certified 
          applicators.
152.175 Pesticides classified for restricted use.

Subparts J-T [Reserved]

                       Subpart U_Registration Fees

152.400 Purpose.
152.401 Inapplicability of fee provisions to applications filed prior to 
          October 1, 1997.
152.403 Definitions of fee categories.
152.404 Fee amounts.
152.406 Submission of supplementary data.
152.408 Special considerations.
152.410 Adjustment of fees.
152.412 Waivers and refunds.
152.414 Procedures.

Subparts V-Y [Reserved]

                            Subpart Z_Devices

152.500 Requirements for devices.

    Authority: 7 U.S.C. 136-136y; Subpart U is also issued under 31 
U.S.C. 9701.



                      Subpart A_General Provisions

    Source: 53 FR 15975, May 4, 1988, unless otherwise noted.



Sec. 152.1  Scope.

    (a) Part 152 sets forth procedures, requirements and criteria 
concerning the registration of pesticide products under FIFRA section 3, 
including plant-incorporated protectants (PIPs). Unless specifically 
superseded by part 174, the regulations in part 152 apply to PIPs.
    (b) Part 152 also describes associated regulatory activities 
affecting registration, as described in this paragraph.
    (1) Data compensation and exclusive use of data in support of 
registration. Refer to subpart E of this part.
    (2) Rights and obligations of registrants. Refer to subpart G of 
this part.
    (3) Classification of pesticide uses. Refer to subpart I of this 
part.
    (4) Fees. Refer to subpart U of this part.
    (5) Requirements pertaining to pesticide devices. Refer to subpart Z 
of this part.

[73 FR 75594, Dec. 12, 2008]

[[Page 7]]



Sec. 152.3  Definitions.

    Terms used in this part have the same meaning as in the Act. In 
addition, the following terms have the meanings set forth in this 
section.
    Act or FIFRA means the Federal Insecticide, Fungicide, and 
Rodenticide Act, as amended (7 U.S.C. 136-136y).
    Active ingredient means any substance (or group of structurally 
similar substances if specified by the Agency) that will prevent, 
destroy, repel or mitigate any pest, or that functions as a plant 
regulator, desiccant, or defoliant within the meaning of FIFRA sec. 
2(a), except as provided in Sec. 174.3 of this chapter.
    Acute dermal LD50 means a statistically derived estimate 
of the single dermal dose of a substance that would cause 50 percent 
mortality to the test population under specified conditions.
    Acute inhalation LC50 means a statistically derived 
estimate of the concentration of a substance that would cause 50 percent 
mortality to the test population under specified conditions.
    Acute oral LD50 means a statistically derived estimate of 
the single oral dose of a substance that would cause 50 percent 
mortality to the test population under specified conditions.
    Administrator means the Administrator of the United States 
Environmental Protection Agency or his delegate.
    Agency means the United States Environmental Protection Agency 
(EPA), unless otherwise specified.
    Applicant means a person who applies for a registration or amended 
registration under FIFRA sec. 3.
    Biological control agent means any living organism applied to or 
introduced into the environment that is intended to function as a 
pesticide against another organism declared to be a pest by the 
Administrator.
    Distribute or sell and other grammatical variations of the term such 
as ``distributed or sold'' and ``distribution or sale,'' means the acts 
of distributing, selling, offering for sale, holding for sale, shipping, 
holding for shipment, delivering for shipment, or receiving and (having 
so received) delivering or offering to deliver, or releasing for 
shipment to any person in any State.
    End use product means a pesticide product whose labeling
    (1) Includes directions for use of the product (as distributed or 
sold, or after combination by the user with other substances) for 
controlling pests or defoliating, desiccating, or regulating the growth 
of plants, and
    (2) Does not state that the product may be used to manufacture or 
formulate other pesticide products.
    Final printed labeling means the label or labeling of the product 
when distributed or sold. Final printed labeling does not include the 
package of the product, unless the labeling is an integral part of the 
package.
    Inert ingredient means any substance (or group of structurally 
similar substances if designated by the Agency), other than an active 
ingredient, which is intentionally included in a pesticide product, 
except as provided by Sec. 174.3 of this chapter.
    Institutional use means any application of a pesticide in or around 
any property or facility that functions to provide a service to the 
general public or to public or private organizations, including but not 
limited to:
    (1) Hospitals and nursing homes.
    (2) Schools other than preschools and day care facilities.
    (3) Museums and libraries.
    (4) Sports facilities.
    (5) Office buildings.
    Living plant means a plant, plant organ, or plant part that is 
alive, viable, or dormant. Examples of plant parts include, but are not 
limited to, seeds, fruits, leaves, roots, stems, flowers, and pollen.
    Manufacturing use product means any pesticide product that is not an 
end-use product.
    New use, when used with respect to a product containing a particular 
active ingredient, means:
    (1) Any proposed use pattern that would require the establishment 
of, the increase in, or the exemption from the requirement of a 
tolerance or food additive regulation under section 408 of the Federal 
Food, Drug and Cosmetic Act;
    (2) Any aquatic, terrestrial, outdoor, or forestry use pattern, if 
no product

[[Page 8]]

containing the active ingredient is currently registered for that use 
pattern; or
    (3) Any additional use pattern that would result in a significant 
increase in the level of exposure, or a change in the route of exposure, 
to the active ingredient of man or other organisms.
    Operated by the same producer, when used with respect to two 
establishments, means that each such establishment is either owned by, 
or leased for operation by and under the control of, the same person. 
The term does not include establishments owned or operated by different 
persons, regardless of contractural agreement between such persons.
    Package or packaging means the immediate container or wrapping, 
including any attached closure(s), in which the pesticide is contained 
for distribution, sale, consumption, use, or storage. The term does not 
include any shipping or bulk container used for transporting or 
delivering the pesticide unless it is the only such package.
    Pesticide means any substance or mixture of substances intended for 
preventing, destroying, repelling, or mitigating any pest, or intended 
for use as a plant regulator, defoliant, or desiccant, other than any 
article that:
    (1) Is a new animal drug under FFDCA sec. 201(w), or
    (2) Is an animal drug that has been determined by regulation of the 
Secretary of Health and Human Services not to be a new animal drug, or
    (3) Is an animal feed under FFDCA sec. 201(x) that bears or contains 
any substances described by paragraph (s) (1) or (2) of this section.
    Pesticide product means a pesticide in the particular form 
(including composition, packaging, and labeling) in which the pesticide 
is, or is intended to be, distributed or sold. The term includes any 
physical apparatus used to deliver or apply the pesticide if distributed 
or sold with the pesticide.
    Plant-incorporated protectant means a pesticidal substance that is 
intended to be produced and used in a living plant, or in the produce 
thereof, and the genetic material necessary for production of such a 
pesticidal substance. It also includes any inert ingredient contained in 
the plant, or produce thereof.
    Released for shipment. A product becomes released for shipment when 
the producer has packaged and labeled it in the manner in which it will 
be distributed or sold, or has stored it in an area where finished 
products are ordinarily held for shipment. Products stored in an area 
where finished products are ordinarily held for shipment, but which are 
not intended to be released for shipment must be physically separated 
and marked as not yet released for shipment. Once a product becomes 
released for shipment, the product remains in the condition of being 
released for shipment unless subsequent activities, such as relabeling 
or repackaging, constitute production.
    Residential use means use of a pesticide directly:
    (1) On humans or pets,
    (2) In, on, or around any structure, vehicle, article, surface, or 
area associated with the household, including but not limited to areas 
such as non-agricultural outbuildings, non-commercial greenhouses, 
pleasure boats and recreational vehicles, or
    (3) In any preschool or day care facility.

[53 FR 15975, May 4, 1988, as amended at 66 FR 37814, July 19, 2001; 73 
FR 64224, Oct. 29, 2008; 73 FR 75594, Dec. 12, 2008]



Sec. 152.5  Pests.

    An organism is declared to be a pest under circumstances that make 
it deleterious to man or the environment, if it is:
    (a) Any vertebrate animal other than man;
    (b) Any invertebrate animal, including but not limited to, any 
insect, other arthropod, nematode, or mollusk such as a slug and snail, 
but excluding any internal parasite of living man or other living 
animals;
    (c) Any plant growing where not wanted, including any moss, alga, 
liverwort, or other plant of any higher order, and any plant part such 
as a root; or
    (d) Any fungus, bacterium, virus, prion, or other microorganism, 
except for those on or in living man or other living animals and those 
on or in processed food or processed animal feed, beverages, drugs (as 
defined in FFDCA

[[Page 9]]

section 201(g)(1)) and cosmetics (as defined in FFDCA section 201(i)).

[53 FR 15975, May 4, 1988, as amended at 78 FR 13507, Feb. 28, 2013]



Sec. 152.6  Substances excluded from regulation by FIFRA.

    Products and substances listed in this section are excluded from 
FIFRA regulation if they meet the specified conditions or criteria.
    (a) Liquid chemical sterilants. A liquid chemical sterilant product 
is not a pesticide under section 2(u) of FIFRA if it meets all of the 
following criteria. Excluded products are regulated by the Food and Drug 
Administration (FDA). Products excluded are those meeting all of the 
following criteria:
    (1) Composition. The product must be in liquid form as sold or 
distributed. Pressurized gases or products in dry or semi-solid form are 
not excluded by this provision. Ethylene oxide products are not liquid 
products and are not excluded by this provision.
    (2) Claims. The product must bear a sterilant claim, or a sterilant 
plus subordinate level disinfection claim. Products that bear 
antimicrobial claims solely at a level less than ``sterilant'' are not 
excluded and are jointly regulated by EPA and FDA.
    (3) Use site. (i) The product must be intended and labeled only for 
use on ``critical or semi-critical devices.'' A ``critical device'' is 
any device which is introduced directly into the human body, either into 
or in contact with the bloodstream or normally sterile areas of the 
body. A semi-critical device is any device which contacts intact mucous 
membranes but which does not ordinarily penetrate the blood barrier or 
otherwise enter normally sterile areas of the body.
    (ii) Liquid chemical sterilants that bear claims solely for use on 
non-critical medical devices are jointly regulated by EPA and FDA.
    (iii) Liquid chemical sterilants that bear claims solely for use on 
sites that are not medical devices, such as veterinary equipment, are 
not excluded and are regulated solely by EPA.
    (b) Nitrogen stabilizers. A nitrogen stabilizer is excluded from 
regulation under FIFRA if it is a substance (or mixture of substances), 
meeting all of the following criteria:
    (1) The substance prevents or hinders the process of nitrification, 
denitrification, ammonia volatilization, or urease production through 
action affecting soil bacteria and is distributed and sold solely for 
those purposes and no other pesticidal purposes. For purposes of this 
section, living organisms are not considered to be substances, and the 
actions of living organisms are not relevant to whether a substance is 
deemed to be a nitrogen stabilizer.
    (2) The substance was in ``commercial agronomic use'' in the United 
States before January 1, 1992. EPA considers a substance to be in 
commercial agronomic use if it is available for sale or distribution to 
users for direct agronomic benefit, as opposed to limited research, 
experimental or demonstration use.
    (3) The substance was not registered under FIFRA before January 1, 
1992.
    (4) Since January 1, 1992, the distributor or seller has made no 
claim that the product prevents or hinders the process of nitrification, 
denitrification, ammonia volatilization or urease production. EPA 
considers any of the following claims (or their equivalents) to be a 
claim that the product prevents or hinders nitrification, 
denitrification, ammonia volatilization or urease production:
    (i) Improves crop utilization of applied nitrogen.
    (ii) Reduces leaching of applied nitrogen or reduces groundwater 
nitrogen contamination.
    (iii) Prevents nitrogen loss.
    (iv) Prolongs availability of nitrogen.
    (v) Increases nitrogen uptake, availability, usage, or efficiency.
    (5) A product will be considered to have met the criterion of 
paragraph (b)(4) of this section that no nitrogen stabilization claim 
has been made if:
    (i) The nitrogen stabilization claim, in whatever terms expressed, 
is made solely in compliance with a State requirement to include the 
claim in materials required to be submitted to a State legislative or 
regulatory authority, or in the labeling or other literature 
accompanying the product; and

[[Page 10]]

    (ii) The State requirement to include the claim was in effect both 
before the product bearing the claim was introduced into commercial 
agronomic use, and before the effective date of this rule.
    (6) A product that meets all of the criteria of this paragraph with 
respect to one State is not thereby excluded from FIFRA regulation if 
distributed and sold in another State whose nitrogen stabilization 
statement requirement does not meet the requirements of paragraph 
(b)(5)(ii) of this section.
    (c) Human drugs. Fungi, bacteria, viruses or other microorganisms in 
or on living man are not ``pests'' as defined in section 2(t) of FIFRA. 
Products intended and labeled for use against such organisms are human 
drugs subject to regulation by the FDA under the FFDCA.
    (d) Animal drugs. (1) Fungi, viruses, bacteria or other 
microorganisms on or in living animals are not ``pests'' under section 
2(t) of FIFRA. Products intended for use against such organisms are 
``animal drugs'' regulated by the FDA under the FFDCA.
    (2) A ``new animal drug'' as defined in section 201(w) of the FFDCA, 
or an animal drug that FDA has determined is not a ``new animal drug'' 
is not a pesticide under section 2(u) of FIFRA. Animal drugs are 
regulated by the FDA under the FFDCA.
    (e) Animal feeds. An animal feed containing a new animal drug is not 
a pesticide under section 2(u) of FIFRA. An animal feed containing a new 
animal drug is subject to regulation by the FDA under the FFDCA.
    (f) Vitamin hormone products. A product consisting of a mixture of 
plant hormones, plant nutrients, inoculants, or soil amendments is not a 
``plant regulator'' under section 2(v) of FIFRA, provided it meets the 
following criteria:
    (1) The product, in the undiluted package concentration at which it 
is distributed or sold, meets the criteria of Sec. 156.62 of this 
chapter for Toxicity Category III or IV; and
    (2) The product is not intended for use on food crop sites, and is 
labeled accordingly.
    (g) Products intended to aid the growth of desirable plants. A 
product of any of the following types, intended only to aid the growth 
of desirable plants, is not a ``plant regulator'' under section 2(v) of 
FIFRA, and therefore is not a pesticide:
    (1) A plant nutrient product, consisting of one or more 
macronutrients or micronutrient trace elements necessary to normal 
growth of plants and in a form readily usable by plants.
    (2) A plant inoculant product consisting of microorganisms to be 
applied to the plant or soil for the purpose of enhancing the 
availability or uptake of plant nutrients through the root system.
    (3) A soil amendment product containing a substance or substances 
intended for the purpose of improving soil characteristics favorable for 
plant growth.

[66 FR 64763, Dec. 14, 2001, as amended at 73 FR 75594, Dec. 12, 2008]



Sec. 152.8  Products that are not pesticides because they are not for use 

against pests.

    A substance or article is not a pesticide, because it is not 
intended for use against ``pests'' as defined in Sec. 152.5, if it is:
    (a) A fertilizer product not containing a pesticide.
    (b) A product intended to force bees from hives for the collection 
of honey crops.

[53 FR 15975, May 4, 1988, as amended at 66 FR 64764, Dec. 14, 2001]



Sec. 152.10  Products that are not pesticides because they are not intended 

for a pesticidal purpose.

    A product that is not intended to prevent, destroy, repel, or 
mitigate a pest, or to defoliate, desiccate or regulate the growth of 
plants, is not considered to be a pesticide. The following types of 
products or articles are not considered to be pesticides unless a 
pesticidal claim is made on their labeling or in connection with their 
sale and distribution:
    (a) Deodorizers, bleaches, and cleaning agents;
    (b) Products not containing toxicants, intended only to attract 
pests for survey or detection purposes, and labeled accordingly;

[[Page 11]]

    (c) Products that are intended to exclude pests only by providing a 
physical barrier against pest access, and which contain no toxicants, 
such as certain pruning paints to trees.



Sec. 152.15  Pesticide products required to be registered.

    No person may distribute or sell any pesticide product that is not 
registered under the Act, except as provided in Sec. Sec. 152.20, 
152.25, and 152.30. A pesticide is any substance (or mixture of 
substances) intended for a pesticidal purpose, i.e., use for the purpose 
of preventing, destroying, repelling, or mitigating any pest or use as a 
plant regulator, defoliant, or desiccant. A substance is considered to 
be intended for a pesticidal purpose, and thus to be a pesticide 
requiring registration, if:
    (a) The person who distributes or sells the substance claims, 
states, or implies (by labeling or otherwise):
    (1) That the substance (either by itself or in combination with any 
other substance) can or should be used as a pesticide; or
    (2) That the substance consists of or contains an active ingredient 
and that it can be used to manufacture a pesticide; or
    (b) The substance consists of or contains one or more active 
ingredients and has no significant commercially valuable use as 
distributed or sold other than (1) use for pesticidal purpose (by itself 
or in combination with any other substance), (2) use for manufacture of 
a pesticide; or
    (c) The person who distributes or sells the substance has actual or 
constructive knowledge that the substance will be used, or is intended 
to be used, for a pesticidal purpose.



                          Subpart B_Exemptions

    Source: 53 FR 15977, May 4, 1988, unless otherwise noted.



Sec. 152.20  Exemptions for pesticides adequately regulated by another Federal 

agency.

    The pesticides or classes of pesticide listed in this section are 
exempt from all requirements of FIFRA. The Agency has determined, in 
accordance with FIFRA sec. 25(b)(1), that they are adequately regulated 
by another Federal agency.
    (a) Certain biological control agents. (1) Except as provided by 
paragraphs (a)(3) and (a)(4) of this section, all biological control 
agents are exempt from FIFRA requirements.
    (2) If the Agency determines that an individual biological control 
agent or class of biological control agents is no longer adequately 
regulated by another Federal agency, and that it should not otherwise be 
exempted from the requirements of FIFRA, the Agency will revoke this 
exemption by amending paragraph (a)(3) of this section.
    (3) The following biological control agents are not exempt from 
FIFRA requirements:
    (i) A eucaryotic microorganism including, but not limited to, 
protozoa, algae and fungi;
    (ii) A procaryotic microorganism including, but not limited to, 
Eubacteria and Archaebacteria; or
    (iii) A parasitically-replicating microscopic element, including, 
but not limited to, viruses.
    (4) All living plants intended for use as biological control agents 
are exempt from the requirements of FIFRA. However, plant-incorporated 
protectants are not exempt pursuant to this section. Regulations, 
including exemptions, for plant-incorporated protectants are addressed 
in part 174 of this chapter.
    (b) Non-liquid chemical sterilants. A non-liquid chemical sterilant, 
except ethylene oxide, that meets the criteria of Sec. 152.6(a)(2) with 
respect to its claims and Sec. 152.6(a)(3) with respect to its use 
sites is exempted from regulation under FIFRA.

[53 FR 15977, May 4, 1988, as amended at 66 FR 37814, July 19, 2001; 66 
FR 64764, Dec. 14, 2001; 72 FR 61027, Oct. 26, 2007]



Sec. 152.25  Exemptions for pesticides of a character not requiring FIFRA 

regulation.

    The pesticides or classes of pesticides listed in this section have 
been determined to be of a character not requiring regulation under 
FIFRA, and are therefore exempt from all provisions of FIFRA when 
intended for use, and used, only in the manner specified.

[[Page 12]]

    (a) Treated articles or substances. An article or substance treated 
with, or containing, a pesticide to protect the article or substance 
itself (for example, paint treated with a pesticide to protect the paint 
coating, or wood products treated to protect the wood against insect or 
fungus infestation), if the pesticide is registered for such use.
    (b) Pheromones and pheromone traps. Pheromones and identical or 
substantially similar compounds labeled for use only in pheromone traps 
(or labeled for use in a manner which the Administrator determines poses 
no greater risk of adverse effects on the environment than use in 
pheromone traps), and pheromone traps in which those compounds are the 
sole active ingredient(s).
    (1) For the purposes of this paragraph, a pheromone is a compound 
produced by an arthropod which, alone or in combination with other such 
compounds, modifies the behavior of other individuals of the same 
species.
    (2) For the purposes of this paragraph, a synthetically produced 
compound is identical to a pheromone only when their molecular 
structures are identical, or when the only differences between the 
molecular structures are between the stereochemical isomer ratios of the 
two compounds, except that a synthetic compound found to have 
toxicological properties significantly different from a pheromone is not 
identical.
    (3) When a compound possesses many characteristics of a pheromone 
but does not meet the criteria in paragraph (a)(2) of this section, it 
may, after review by the Agency, be deemed a substantially similar 
compound.
    (4) For the purposes of this paragraph, a pheromone trap is a device 
containing a pheromone or an identical or substantially similar compound 
used for the sole purpose of attracting, and trapping or killing, target 
arthropods. Pheromone traps are intended to achieve pest control by 
removal of target organisms from their natural environment and do not 
result in increased levels of pheromones or identical or substantially 
similar compounds over a significant fraction of the treated area.
    (c) Preservatives for biological specimens. (1) Embalming fluids.
    (2) Products used to preserve animal or animal organ specimens, in 
mortuaries, laboratories, hospitals, museums and institutions of 
learning.
    (3) Products used to preserve the integrity of milk, urine, blood, 
or other body fluids for laboratory analysis.
    (d) Foods. Products consisting of foods and containing no active 
ingredients, which are used to attract pests.
    (e) Natural cedar. (1) Natural cedar blocks, chips, shavings, balls, 
chests, drawer liners, paneling, and needles that meet all of the 
following criteria:
    (i) The product consists totally of cedarwood or natural cedar.
    (ii) The product is not treated, combined, or impregnated with any 
additional substance(s).
    (iii) The product bears claims or directions for use solely to repel 
arthropods other than ticks or to retard mildew, and no additional 
claims are made in sale or distribution. The labeling must be limited to 
specific arthropods, or must exclude ticks if any general term such as 
``arthropods,'' ``insects,'' ``bugs,'' or any other broad inclusive 
term, is used. The exemption does not apply to natural cedar products 
claimed to repel ticks.
    (2) The exemption does not apply to cedar oil, or formulated 
products which contain cedar oil, other cedar extracts, or ground cedar 
wood as part of a mixture.
    (f) Minimum risk pesticides--(1) Exempted products. Products 
containing the following active ingredients are exempt from the 
requirements of FIFRA, alone or in combination with other substances 
listed in this paragraph, provided that all of the criteria of this 
section are met.

Castor oil (U.S.P. or equivalent)
Cedar oil
Cinnamon and cinnamon oil
Citric acid
Citronella and citronella oil
Cloves and clove oil
Corn gluten meal
Corn oil
Cottonseed oil
Dried blood
Eugenol
Garlic and garlic oil
Geraniol
Geranium oil
Lauryl sulfate
Lemongrass oil
Linseed oil

[[Page 13]]

Malic acid
Mint and mint oil
Peppermint and peppermint oil
2-Phenethyl propionate (2-phenylethyl propionate)
Potassium sorbate
Putrescent whole egg solids
Rosemary and rosemary oil
Sesame (includes ground sesame plant) and sesame oil
Sodium chloride (common salt)
Sodium lauryl sulfate
Soybean oil
Thyme and thyme oil
White pepper
Zinc metal strips (consisting solely of zinc metal and impurities)

    (2) Permitted inerts. A pesticide product exempt under paragraph 
(f)(1) of this section may only include inert ingredients listed in the 
most current List 4A. This list is updated periodically. The most 
current list may be obtained by contacting the Registration Division at 
the appropriate address as set forth in 40 CFR 150.17(a) or (b).
    (3) Other conditions of exemption. All of the following conditions 
must be met for products to be exempted under this section:
    (i) Each product containing the substance must bear a label 
identifying the name and percentage (by weight) of each active 
ingredient and the name of each inert ingredient.
    (ii) The product must not bear claims either to control or mitigate 
microorganisms that pose a threat to human health, including but not 
limited to disease transmitting bacteria or viruses, or claims to 
control insects or rodents carrying specific diseases, including, but 
not limited to ticks that carry Lyme disease.
    (iii) The product must not include any false and misleading labeling 
statements, including those listed in 40 CFR 156.10(a)(5)(i) through 
(viii).

[53 FR 15977, May 4, 1988, as amended at 59 FR 2751, Jan. 19, 1994; 61 
FR 8878, Mar. 6, 1996; 66 FR 64764, Dec. 14, 2001; 71 FR 35545, June 21, 
2006]



Sec. 152.30  Pesticides that may be transferred, sold, or distributed without 

registration.

    An unregistered pesticide, or a pesticide whose registration has 
been cancelled or suspended, may be dis-tributed or sold, or otherwise 
transferred, to the extent described by this section.
    (a) A pesticide transferred between registered establishments 
operated by the same producer. An unregistered pesticide may be 
transferred between registered establishments operated by the same 
producer. The pesticide as transferred must be labeled in accordance 
with part 156 of this chapter.
    (b) A pesticide transferred between registered establishments not 
operated by the same producer. An unregistered pesticide may be 
transferred between registered establishments not operated by the same 
producer if:
    (1) The transfer is solely for the purpose of further formulation, 
packaging, or labeling into a product that is registered;
    (2) Each active ingredient in the pesticide, at the time of 
transfer, is present as a result of incorporation into the pesticide of 
either:
    (i) A registered product; or
    (ii) A pesticide that is produced by the registrant of the final 
product; and
    (3) The product as transferred is labeled in accordance with part 
156 of this chapter.
    (c) A pesticide distributed or sold under an experimental use 
permit. (1) An unregistered pesticide may be distributed or sold in 
accordance with the terms of an experimental use permit issued under 
FIFRA sec. 5, if the product is labeled in accordance with Sec. 172.6 
of this chapter.
    (2) An unregistered pesticide may be distributed or sold in 
accordance with the provisions of Sec. 172.3 of this chapter, 
pertaining to use of a pesticide for which an experimental use permit is 
not required, provided the product is labeled in accordance with part 
156 of this chapter.
    (d) A pesticide transferred solely for export. An unregistered 
pesticide may be transferred within the United States solely for export 
if it meets the following conditions:
    (1) The product is prepared and packaged according to the 
specifications of the foreign purchaser; and
    (2) The product is labeled in accordance with part 156 of this 
chapter.
    (e) A pesticide distributed or sold under an emergency exemption. An 
unregistered pesticide may be distributed or

[[Page 14]]

sold in accordance with the terms of an emergency exemption under FIFRA 
sec. 18, if the product is labeled in accordance with part 156 of this 
chapter.
    (f) A pesticide transferred for purposes of disposal. An 
unregistered, suspended, or cancelled pesticide may be transferred 
solely for disposal in accordance with FIFRA sec. 19 or an applicable 
Administrator's order. The product must be labeled in accordance with 
part 156 of this chapter.
    (g) Existing stocks of a formerly registered product. A cancelled or 
suspended pesticide may be distributed or sold to the extent and in the 
manner specified in an order issued by the Administrator concerning 
existing stocks of the pecticide.



                    Subpart C_Registration Procedures

    Source: 53 FR 15978, May 4, 1988, unless otherwise noted.



Sec. 152.40  Who may apply.

    Any person may apply for new registration of a pesticide product. 
Any registrant may apply for amendment of the registration of his 
product.



Sec. 152.42  Application for new registration.

    Any person seeking to obtain a registration for a new pesticide 
product must submit an application for registration, containing the 
information specified in Sec. 152.50. An application for new 
registration must be approved by the Agency before the product may 
legally be distributed or sold, except as provided by Sec. 152.30.



Sec. 152.43  Alternate formulations.

    (a) A product proposed for registration must have a single, defined 
composition, except that EPA may approve a basic formulation and one or 
more alternate formulations for a single product.
    (b) An alternate formulation must meet the criteria listed in 
paragraph (b) (1) through (4) of this section. The Agency may require 
the submission of data to determine whether the criteria have been met.
    (1) The alternate formulation must have the same certified limits 
for each active ingredient as the basic formulation.
    (2) If the alternate formulation contains an inert ingredient or 
impurity of toxicological signficance, the formulation must have the 
same upper certified limit for that substance as the basic formulation;
    (3) The label text of the alternate formulation product must be 
identical to that of the basic formulation.
    (4) The analytical method required under Sec. 158.355 of this 
chapter must be suitable for use on both the basic formulation and the 
alternate formulation.
    (c) Notwithstanding the criteria in this section, the Agency may 
determine that an alternate formulation must be separately registered. 
If EPA makes this determination, the Agency will notify the applicant of 
its determination and its reasons. Thereafter the application for an 
alternate formulation will be treated as an application for new 
registration, and the alternate formulation will be assigned a new 
registration number.

[53 FR 15978, May 4, 1988, as amended at 72 FR 61027, Oct. 26, 2007]



Sec. 152.44  Application for amended registration.

    (a) Except as provided by Sec. 152.46, any modification in the 
composition, labeling, or packaging of a registered product must be 
submitted with an application for amended registration. The applicant 
must submit the information required by Sec. 152.50, as applicable to 
the change requested. If an application for amended registration is 
required, the application must be approved by the Agency before the 
product, as modified, may legally be distributed or sold.
    (b) In its discretion, the Agency may:
    (1) Waive the requirement for submission of an application for 
amended registration;
    (2) Require that the applicant certify to the Agency that he has 
complied with an Agency directive rather than submit an application for 
amended registration; or
    (3) Permit an applicant to modify a registration by notification or 
non-notification in accordance with Sec. 152.46.

[[Page 15]]

    (c) A registrant may at any time submit identical minor labeling 
amendments affecting a number of products as a single application if no 
data are required for EPA to approve the amendment (for example, a 
change in the wording of a storage statement for designated residential 
use products). A consolidated application must clearly identify the 
labeling modification(s) to be made (which must be identical for all 
products included in the application), list the registration number of 
each product for which the modification is requested, and provide 
required supporting materials (for example, labeling) for each affected 
product.

[53 FR 15978, May 4, 1988, as amended at 61 FR 33041, June 26, 1996; 66 
FR 64764, Dec. 14, 2001]



Sec. 152.46  Notification and non-notification changes to registrations.

    (a) Changes permitted by notification. (1) EPA may determine that 
certain minor modifications to registration having no potential to cause 
unreasonable adverse effects to the environment may be accomplished by 
notification to the Agency, without requiring that the registrant obtain 
Agency approval. If EPA so determines, it will issue procedures 
following an opportunity for public comment describing the types of 
modifications permitted by notification and any conditions and 
procedures for submitting notifications.
    (2) A registrant may modify a registration consistent with paragraph 
(a)(1) of this section and any procedures issued thereunder and 
distribute or sell the modified product as soon as the Agency has 
received the notification. Based upon the notification, the Agency may 
require that the registrant submit an application for amended 
registration. If it does so, the Agency will notify the registrant and 
state its reasons for requiring an application for amended registration. 
Thereafter, if the registrant fails to submit an application the Agency 
may determine that the product is not in compliance with the 
requirements of the Act. Notification under this paragraph is considered 
a report filed under the Act for the purposes of FIFRA section 
12(a)(2)(M).
    (b) Changes permitted without notification. EPA may determine that 
certain minor modifications to registration having no potential to cause 
unreasonable adverse effects to the environment may be accomplished 
without notification to or approval by the Agency. If EPA so determines, 
it will issue procedures following an opportunity for public comment 
describing the types of amendments permitted without notification (also 
known as non-notification). A registrant may distribute or sell a 
product changed in a manner consistent with such procedures without 
notification to or approval by the Agency.
    (c) Effect of non-compliance. Notwithstanding any other provision of 
this section, if the Agency determines that a product has been modified 
through notification or without notification in a manner inconsistent 
with paragraphs (a) or (b) of this section and any procedures issued 
thereunder, the Agency may initiate regulatory and/or enforcement action 
without first providing the registrant with an opportunity to submit an 
application for amended registration.

[61 FR 33041, June 26, 1996]



Sec. 152.50  Contents of application.

    Each application for registration or amended registration must 
include the following information, as applicable:
    (a) Application form. An application form must be completed and 
submitted to the Agency. Application forms are provided by the Agency, 
with instructions as to the number of copies required and proper 
completion.
    (b) Identity of the applicant--(1) Name. The applicant must identify 
himself. An applicant not residing in the United States must also 
designate an agent in accordance with paragraph (b)(3) of this section 
to act on behalf of the applicant on all registration matters.
    (2) Address of record. The applicant must provide an address in the 
United States for correspondence purposes. The U.S. address provided 
will be considered the applicant's address of record, and EPA will send 
all correspondence concerning the application and any subsequent 
registration to that address. It is the responsibility of the applicant 
and any registrant under

[[Page 16]]

Sec. 152.122 to ensure that the Agency has a current and accurate 
address.
    (3) Authorized agent. An applicant may designate a person residing 
in the United States to act as his agent. If an applicant wishes to 
designate an agent, he must send the Agency a letter stating the name 
and United States address of his agent. The applicant must notify the 
Agency if he changes his designated agent. This relationship may be 
terminated at any time by the applicant by notifying the Agency in 
writing.
    (4) Company number. If an applicant has been assigned a company 
number by the Agency, the application must reference that number.
    (c) Summary of the application. Each application must include a list 
of the data submitted with the application, together with a brief 
description of the results of the studies. The list of data submitted 
may be the same as the list required by Sec. 158.32 or Sec. 161.32, as 
applicable, of this chapter. The summary must state that it is 
releasable to the public after registration in accordance with Sec. 
152.119.
    (d) Identity of the product. The product for which application is 
being submitted must be identified. The following information is 
required:
    (1) The product name;
    (2) The trade name(s) (if different); and
    (3) The EPA Registration Number, if currently registered.
    (e) Draft labeling. Each application for new registration must be 
accompanied by five legible copies of draft labeling (typescript or 
mock-up). Each application for amended registration that proposes to 
make any changes in the product labeling must be accompanied by five 
legible copies of draft labeling incorporating the proposed labeling 
changes. If the proposed labeling change affects only a portion of the 
labeling, such as the use directions, the applicant may submit five 
copies of that portion of the label which is the subject of the 
amendment. Upon request, an applicant for amended registration must 
submit a complete label to consolidate amendments.
    (f) Registration data requirements. (1) An applicant must submit 
materials to demonstrate that he has complied with the FIFRA sec. 
3(c)(1)(F) and subpart E of this part with respect to satisfaction of 
data requirements, to enable the Agency to make the determination 
required by FIFRA sec. 3(c)(5)(B). Required items are described in 
subpart E of this part.
    (2) An applicant must furnish any data specified in part 158 or part 
161 of this chapter, as applicable, of this chapter which are required 
by the Agency to determine that the product meets the registration 
standards of FIFRA sec. 3(c)(5) or (7). Each study must comply with:
    (i) Section 158.32 of this chapter, with respect to format of data 
submission.
    (ii) Section 158.33 of this chapter, with respect to studies for 
which a claim of trade secret or confidential business information is 
made.
    (iii) Section 158.34 of this chapter, with respect to flagging for 
potential adverse effects.
    (iv) Section 160.12 of this chapter, with respect to a statement 
whether studies were conducted in accordance with Good Laboratory 
Practices of part 160.
    (3) An applicant shall furnish with his application any factual 
information of which he is aware regarding unreasonable adverse effects 
of the pesticide on man or the environment, which would be required to 
be reported under FIFRA sec. 6(a)(2) if the product were registered.
    (g) Certification relating to child-resistant packaging. If the 
product meets the criteria for child-resistant packaging, the applicant 
must submit a certification that the product will be distributed or sold 
only in child-resistant packaging. Refer to part 157 of this chapter for 
the criteria and certification requirements.
    (h) Request for classification. If an applicant wishes to request a 
classification different from that established by the Agency, he must 
submit a request for such classification and information supporting the 
request.
    (i) Statement concerning tolerances. (1) If the proposed labeling 
bears instructions for use of the pesticide on food or feed crops, or if 
the intended use of the pesticide results or may be expected to result, 
directly or indirectly, in pesticide chemical residues in or on food

[[Page 17]]

or feed (including residues of any active ingredient, inert ingredient, 
metabolite, or degradation product), the applicant must submit a 
statement indicating whether such residues are authorized by a tolerance 
or exemption from the requirement of a tolerance issued under section 
408 of the Federal Food, Drug and Cosmetic Act (FFDCA).
    (2) If such residues have not been authorized, the application must 
be accompanied by a petition for establishment of appropriate tolerances 
or exemptions from the requirement of a tolerance, in accordance with 
part 180 of this chapter.
    (j) Fees. (1) The applicant shall identify the appropriate fee 
category in the schedule provided for by FIFRA sec. 33, and shall submit 
the fee for that category as prescribed by the latest EPA notice of 
section 33 fees.
    (2) If FIFRA sec. 33 is not in effect, the applicant shall submit 
any fees required by subpart U of this part, if applicable.

[53 FR 15978, May 4, 1988, as amended at 58 FR 34203, June 23, 1993; 60 
FR 32096, June 19, 1995; 72 FR 61027, Oct, 26 2007; 73 FR 75594, Dec. 
12, 2008]



Sec. 152.55  Where to send applications and correspondence.

    Applications and correspondence relating to registration should be 
sent to the Office of Pesticide Programs' Document Processing Desk at 
the appropriate address as set forth in 40 CFR 150.17(a) or (b).

[71 FR 35545, June 21, 2006]

Subpart D [Reserved]



  Subpart E_Procedures To Ensure Protection of Data Submitters' Rights

    Source: 49 FR 30903, Aug. 1, 1984, unless otherwise noted.



Sec. 152.80  General.

    This subpart E describes the information that an applicant must 
submit with his application for registration or amended registration to 
comply (and for the Agency to determine compliance) with the provisions 
of FIFRA sec. 3(c)(1)(F). This subpart also describes the procedures by 
which data submitters may challenge registration actions which allegedly 
failed to comply with these procedures. If the Agency determines that an 
applicant has failed to comply with the requirements and procedures in 
this subpart, the application may be denied. If the Agency determines, 
after registration has been issued, that an applicant failed to comply 
with these procedures and requirements, the Agency may issue a notice of 
intent to cancel the product's registration.

[73 FR 75594, Dec. 12, 2008]



Sec. 152.81  Applicability.

    (a) Except as provided in paragraph (b) of this section, Sec. Sec. 
152.83 through 152.119 apply to:
    (1) Each application for registration of a new product;
    (2) Each application for an amendment of a registration; and
    (3) Each application for reregistration under FIFRA section 3(g).
    (b) This subpart E does not apply to:
    (1) Applications for registration submitted to States under FIFRA 
section 24(c);
    (2) Applications for experimental use permits under FIFRA section 5;
    (3) Applications for emergency exemptions under FIFRA section 18;
    (4) Applications to make only one or more of the following types of 
amendments to existing registrations, unless the Administrator or his 
designee finds that Agency consideration of scientific data would be 
necessary in order to approve the amendment under FIFRA section 3(c)(5):
    (i) An increase or decrease in the percentage in the product of one 
or more of its active ingredients or deliberately added inert 
ingredients;
    (ii) A revision of the identity or amount of impurities present in 
the product;
    (iii) The addition or deletion of one or more deliberately added 
inert ingredients;
    (iv) The deletion of one or more active ingredients;
    (v) A change in the source of supply of one or more of the active 
ingredients used in the product, if the new source of the active 
ingredient is a product

[[Page 18]]

which is registered under FIFRA section 3;
    (vi) Deletion of approved uses of claims;
    (vii) Redesign of the label format involving no substantive changes, 
express or implied, in the directions for use, claims, representations, 
or precautionary statements;
    (viii) Change in the product name or addition of an additional brand 
name, if no additional claims, representations, or uses are expressed or 
implied by the changes;
    (ix) Clarification of directions for use;
    (x) Correction of typographical errors;
    (xi) Changes in the registrant's name or address;
    (xii) Adding or deleting supplemental registrants;
    (xiii) Changes in the package or container size;
    (xiv) Changes in warranty, warranty disclaimer, or liability 
limitation statements, or addition to or deletion of such statements;
    (xv) ``Splitting'' a label for the sole purpose of facilitating the 
marketing of a product in different geographic regions with appropriate 
labels, where each amended label will contain previously approved use 
instructions (and related label statements) appropriate to a particular 
geographic region;
    (xvi) Any other type of amendment, if the Administrator or his 
designee determines, by written finding, that the Agency consideration 
of scientific data would not be necessary in order to approve the 
amendment under FIFRA section 3(c)(5); and
    (xvii) Compliance with Agency Regulations, adjudicatory hearing 
decisions, notices, or other Agency announcements that unless the 
registration is amended in the manner the Agency proposes, the product's 
registration will be suspended or cancelled, or that a hearing will be 
held under FIFRA section 6. (However, this paragraph does not apply to 
amendments designed to avoid cancellation or suspension threatened under 
FIFRA section 3(c)(2)(B) or because of failure to submit data.)



Sec. 152.83  Definitions.

    As used in this subpart, the following terms shall have the meanings 
set forth in this section:
    Data gap means the absence of any valid study or studies in the 
Agency's files which would satisfy a specific data requirement for a 
particular pesticide product.
    Data Submitters List means the current Agency list, entitled 
``Pesticide Data Submitters by Chemical,'' of persons who have submitted 
data to the Agency.
    Exclusive use study means a study that meets each of the following 
requirements:
    (1) The study pertains to a new active ingredient (new chemical) or 
new combination of active ingredients (new combination) first registered 
after September 30, 1978;
    (2) The study was submitted in support of, or as a condition of 
approval of, the application resulting in the first registration of a 
product containing such new chemical or new combination (first 
registration), or an application to amend such registration to add a new 
use; and
    (3) The study was not submitted to satisfy a data requirement 
imposed under FIFRA section 3(c)(2)(B);
    Provided that, a study is an exclusive use study only during the 10-
year period following the date of the first registration.
    Original data submitter means the person who possesses all rights to 
exclusive use or compensation under FIFRA section 3(c)(1)(F) in a study 
originally submitted in support of an application for registration, 
amended registration, reregistration, or experimental use permit, or to 
maintain an existing registration in effect. The term includes the 
person who originally submitted the study, any person to whom the rights 
under FIFRA section 3(c)(1)(F) have been transferred, or the authorized 
representative of a group of joint data developers.
    Valid study means a study that has been conducted in accordance with 
the Good Laboratory Practice standards of 40 CFR part 160 or generally 
accepted

[[Page 19]]

scientific methodology and that EPA has not determined to be invalid.

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008]



Sec. 152.84  When materials must be submitted to the Agency.

    All information required by this subpart should be submitted with 
the application, but may be submitted at any later time prior to EPA's 
approval of the application. The Agency will not approve any application 
until it determines either that the application is not subject to these 
requirements or that all required materials have been submitted and are 
acceptable.



Sec. 152.85  Formulators' exemption.

    (a) Statutory provision. FIFRA section 3(c)(2)(D) excuses an 
applicant from the requirement to submit or cite data pertaining to any 
pesticide contained in his product that is derived solely from one or 
more EPA-registered products which the applicant purchases from another 
person. This provision is commonly referred to as the formulators' 
exemption.
    (b) Applicability of the formulators' exemption. (1) The 
formulators' exemption applies only to data concerning the purchased 
product or its ingredients. These data may include, but are not limited 
to, product chemistry, toxicology, residue chemistry, exposure, 
environmental fate, and ecological effects.
    (2) The data to which the formulators' exemption applies usually 
will concern the safety of one or more of the product's active 
ingredients, specifically, those active ingredients which are contained 
in the purchased product. In general, data for which the required test 
substance is the technical grade of the active ingredient, the pure 
active ingredient, the radiolabeled pure active ingredient, or a typical 
end-use product are eligible for the formulators' exemption.
    (3) The formulators' exemption generally does not apply to data on 
the applicant's product itself, including the safety or efficacy of the 
product, unless the composition of the product is identical to the 
purchased product. In general, data for which the required test 
substance is the product proposed for registration are not eligible for 
the formulators' exemption.
    (c) Limitation of the formulators' exemption. EPA interprets FIFRA 
section 3(c)(2)(D) as allowing an applicant to use the formulators' 
exemption with respect to data concerning an ingredient of his product 
only if:
    (1) The application indicates that the ingredient's presence in the 
product is attributable solely to the purchase from another person of an 
identified, registered product containing that ingredient and the use of 
the purchased product in formulating the product; and
    (2) The purchased product is a registered manufacturing-use product 
whose label does not prohibit its use for making an end-use product 
labeled for any use for which the applicant's product will be labeled; 
or
    (3) The purchased product is a registered end-use product labeled 
for each use for which the applicant's product will be labeled.
    (d) Claiming eligibility for the exemption. (1) If the product 
contains one or more ingredients eligible for the formulators' 
exemption, the applicant need not comply with the requirements of 
Sec. Sec. 152.90 through 152.96 with respect to any data requirement 
pertaining to such ingredient, provided that he submits to the Agency a 
certification statement containing the following information (a form for 
this purpose is available from the Agency):
    (i) Identification of the applicant, and of the product by EPA 
registration number or file symbol.
    (ii) Identification of each ingredient in the pesticide that is 
eligible for the formulators' exemption, and the EPA registration number 
of the product that is the source of that ingredient.
    (iii) A statement that the listed ingredients meet the requirements 
for the formulators' exemption.
    (iv) A statement that the applicant has submitted (either previously 
or with the current application) a complete, accurate and current 
Confidential Statement of Formula.
    (v) The name, title and signature of the applicant or his authorized 
representative and the date of signature.
    (2) An applicant for amended registration is not required to submit 
a

[[Page 20]]

new formulators' exemption statement, if the current statement in Agency 
files is complete and accurate.
    (e) Approval of registration. Notwithstanding FIFRA section 
3(c)(2)(D), EPA will not approve an application unless there are 
available to EPA for its review all data that are necessary to make the 
required risk/benefit finding under FIFRA section 3(c)(5) or section 
3(c)(7).

[72 FR 61027, Oct. 26, 2007]



Sec. 152.86  The cite-all method.

    An applicant may comply with this subpart by citing all data in 
Agency files that are pertinent to its consideration of the requested 
registration under FIFRA section 3(c)(5), in accordance with the 
procedures in this section, as applicable.
    (a) Exclusive use studies. The applicant must certify to the Agency 
that he has obtained, from each person listed on the Data Submitters 
List as an exclusive use data submitter for the chemical in question, a 
written authorization that contains at least the following information:
    (1) Identification of the applicant to whom the authorization is 
granted;
    (2) Authorization to the applicant to use all pertinent studies in 
satisfaction of data requirements for the application in question; and
    (3) The signature and title of the original data submitter or his 
authorized representative and date of the authorization.

If the Agency identifies any exclusive use data submitter not on the 
Data Submitters List, the applicant will be required prior to 
registration to obtain the necessary written authorization from such 
person.
    (b) Other studies. The applicant must certify to the Agency that, 
with respect to each other person on the Data Submitters List for the 
chemical in question:
    (1) He has obtained from that person a written authorization that 
contains the information required by paragraphs (a) (1) through (3) of 
this section; or
    (2) He has furnished to that person:
    (i) A notification of his intent to apply for registration, 
including the name of the proposed product, and a list of the product's 
active ingredients;
    (ii) An offer to pay the person compensation to the extent required 
by FIFRA section 3(c)(1)(F) for any data on which the application 
relies;
    (iii) An offer to commence negotiations to determine the amount and 
terms of compensation, if any, to be paid for the use of any study; and
    (iv) His name, address and telephone number.
    (c) General offer to pay statement. The applicant must submit to the 
Agency the following general offer to pay statement:

    [Name of applicant] hereby offers and agrees to pay compensation to 
other persons, with regard to the approval of this application, to the 
extent required by FIFRA section 3(c)(1)(F) of the Federal Insecticide, 
Fungicide and Rodenticide Act.

    (d) Acknowledgement of reliance on data. Each application filed 
under this section shall include an acknowledgement that for purposes of 
FIFRA section 3(c)(1)(F) the application relies on the following data:
    (1) All data submitted with or specifically cited in the 
application; and
    (2) Each other item of data in the Agency's files which:
    (i) Concerns the properties or effects of the applicant's product, 
of any product which is identical or substantially similar to the 
applicant's product, or of one or more of the active ingredients in the 
applicant's product; and
    (ii) Is one of the types of data that EPA would require to be 
submitted if the application sought the initial registration under FIFRA 
section 3(c)(5) of a product with composition and intended uses 
identical or substantially similar to the applicant's product, under the 
data requirements in effect on the date EPA approves the applicant's 
present application.

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008]



Sec. 152.90  The selective method.

    An applicant may comply with this subpart by listing the specific 
data requirements that apply to his product, its active ingredients, and 
use patterns, and demonstrating his compliance for each data requirement 
by submitting or citing individual studies, or by demonstrating that no 
study has

[[Page 21]]

previously been submitted to the Agency. This section summarizes the 
procedures that an applicant must follow if he chooses the selective 
method of demonstrating compliance. Sections 152.91 through 152.96 
contain specific procedures for citing or submitting a study or 
demonstrating a data gap.
    (a) List of data requirements. Each applicant must submit a list of 
the data requirements that would apply to his pesticide, its active 
ingredients, and its use patterns, if the product were being proposed 
for registration under FIFRA section 3(c)(5) for the first time. The 
applicant need not list data requirements pertaining to any ingredient 
which qualifies for the formulator's exemption.
    (1) If a Registration Standard has been issued for any active 
ingredient, the applicant must list the applicable data requirements 
enumerated in that Standard for the active ingredient and, if end use 
products are covered by the Registration Standard, for such products 
containing that active ingredient.
    (2) If a Registration Standard has not been issued, or if an issued 
Registration Standard does not cover all data requirements for products 
containing the active ingredient in question, the applicant must list 
the applicable requirements as prescribed by 40 CFR part 158 or part 
161, as applicable. All required (R) studies, and any studies that could 
be conditionally required (CR) based upon composition, use pattern, or 
the results of required studies, are to be listed. The applicant may 
demonstrate via the data gap procedures in Sec. 152.96 that a 
conditional requirement need not be satisfied by the submission or 
citation of data at the time of application.
    (b) Methods of demonstrating compliance. The applicant must state 
for each data requirement on the list required by paragraph (a) of this 
section which of the following methods of compliance with the 
requirement he is using, and shall provide the supporting documentation 
specified in the referenced section.
    (1) Existence of or granting of a data waiver. Refer to Sec. 
152.91.
    (2) Submission of a new valid study. Refer to Sec. 152.92.
    (3) Citation of a specific valid study previously submitted to the 
Agency by the applicant or another person, with any necessary written 
authorizations or offers to pay. Refer to Sec. 152.93.
    (4) Citation of a public literature study. Refer to Sec. 152.94.
    (5) Citation of all pertinent studies previously submitted to the 
Agency, with any necessary written authorizations or offers to pay. 
Refer to Sec. 152.95.
    (6) Documentation of a data gap. Refer to Sec. 152.96.

[49 FR 30903, Aug. 1, 1984, as amended at 72 FR 61028, Oct. 26, 2007]



Sec. 152.91  Waiver of a data requirement.

    The applicant may demonstrate compliance for a data requirement by 
documenting the existence of a waiver in accordance with paragraph (a) 
of this section, or by being granted a new waiver requested in 
accordance with paragraph (b) of this section.
    (a) Request for extension of an existing waiver. An applicant may 
claim that a waiver previously granted by the Agency also applies to a 
data requirement for his product. To document this claim, the applicant 
must provide a reference to the Agency record that describes the 
previously granted waiver, such as an Agency list of waivers or an 
applicable Registration Standard, and must explain why that waiver 
should apply to his product.
    (b) Request for a new waiver. An applicant who requests a waiver to 
satisfy a data requirement must submit the information specified in 40 
CFR 158.45 or 40 CFR 161.45.
    (c) Effect of denial of waiver request. If the request for a new 
waiver or extension of an existing waiver is denied by the Agency, the 
applicant must choose another method of satisfying the data requirement.

[49 FR 30903, Aug. 1, 1984, as amended at 72 FR 61028, Oct. 26, 2007]



Sec. 152.92  Submission of a new valid study.

    An applicant may demonstrate compliance for a data requirement by 
submitting a valid study that has not previously been submitted to the 
Agency. A study previously submitted to the Agency should not be 
resubmitted but

[[Page 22]]

should be cited in accordance with Sec. 152.93.



Sec. 152.93  Citation of a previously submitted valid study.

    An applicant may demonstrate compliance for a data requirement by 
citing a valid study previously submitted to the Agency. The study is 
not to be submitted to the Agency with the application.
    (a) Study originally submitted by the applicant. If the applicant 
certifies that he is the original data submitter, no documentation other 
than the citation is necessary.
    (b) Study previously submitted by another person. If the applicant 
is not the original data submitter, the applicant may cite the study 
only in accordance with paragraphs (b) (1) through (3) of this section.
    (1) Citation with authorization of original data submitter. The 
applicant may cite any valid study for which he has obtained the written 
authorization of the original data submitter. The applicant must obtain 
written authorization to cite any study that is an exclusive use study. 
The applicant must certify that he has obtained from the original data 
submitter a written authorization that contains at least the following 
information:
    (i) Identification of the applicant to whom the authorization is 
granted;
    (ii) Identification by title, EPA Accession Number or Master Record 
Identification Number, and date of submission, of the study or studies 
for which the authorization is granted;
    (iii) Authorization to the applicant to use the specified study in 
satisfaction of the data requirement for the application in question; 
and
    (iv) The signature and title of the original data submitter or his 
authorized representative, and date of the authorization.
    (2) Citation with offer to pay compensation to the original data 
submitter. The applicant may cite any valid study that is not subject to 
the exclusive use provisions of FIFRA section 3(c)(1)(F)(i) without 
written authorization from the original data submitter if the applicant 
certifies to the Agency that he has furnished to the original data 
submitter:
    (i) A notification of the applicant's intent to apply for 
registration, including the proposed product name and a list of the 
product's active ingredients;
    (ii) Identification of the specific data requirement involved and of 
the study for which the offer to pay is made (by title, EPA Accession 
Number or Master Record Identification Number, and date of submission, 
if possible);
    (iii) An offer to pay the person compensation to the extent required 
by FIFRA section 3(c)(1)(F);
    (iv) An offer to commence negotiations to determine the amount and 
terms of compensation, if any, to be paid for the use of the study; and
    (v) The applicant's name, address and telephone number.
    (3) Citation without authorization or offer to pay. The applicant 
may cite any valid study without written authorization from, or offer to 
pay to, the original data submitter if the study was originally 
submitted to the Agency on or before the date that is 15 years before 
the date of the application for which it is cited, and the study is not 
an exclusive use study, as defined in Sec. 152.83(c).

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008]



Sec. 152.94  Citation of a public literature study or study generated at 

government expense.

    (a) An applicant may demonstrate compliance for a data requirement 
by citing, and submitting to the Agency, one of the following:
    (1) A valid study from the public literature.
    (2) A valid study generated by, or at the expense of, any government 
(Federal, State, or local) agency.
    (b) In no circumstances does submission of a public literature study 
or government-generated study confer any rights on the data submitter to 
exclusive use of data or compensation under FIFRA section 3(c)(1)(F).

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008]

[[Page 23]]



Sec. 152.95  Citation of all studies in the Agency's files pertinent to a 

specific data requirement.

    An applicant normally may demonstrate compliance for a data 
requirement by citation of all studies in the Agency's files pertinent 
of that data requirement. The applicant who selects this cite-all option 
must submit to the Agency:
    (a) A general offer to pay statement having the same wording as that 
specified in Sec. 152.86(c) except that the offer to pay may be limited 
to apply only to data pertinent to the specific data requirement(s) for 
which the cite-all method of support has been selected;
    (b) A certification that:
    (1) For each person who is included on the Data Submitters List as 
an original data submitter of exclusive use data for the active 
ingredient in question, the applicant has obtained a written 
authorization containing the information required by Sec. 152.86(a) for 
the use the any exclusive use study that would be pertinent to the 
applicant's product; and
    (2) For each person included on the current Data Submitters List as 
an original data submitter of data that are not exclusive use for the 
active ingredient in question, the applicant has furnished:
    (i) A notification of the applicant's intent to apply for 
registration, including the name of the proposed product, and a list of 
the product's active ingredients;
    (ii) Identification of the specific data requirement(s) for which 
the offer to pay for data is being made;
    (iii) An offer to pay the person compensation to the extent required 
by FIFRA section 3(c)(1)(F);
    (iv) An offer to commence negotiations to determine the amount and 
terms of compensation, if any, to be paid for use of any study; and
    (v) The applicant's name, address and telephone number; and
    (c) An acknowledgment having the same wording as that specified in 
Sec. 152.86(d), except that it may be limited to apply only to data 
pertinent to the specific data requirement(s) for which the cite-all 
method of support has been selected.

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008]



Sec. 152.96  Documentation of a data gap.

    Except as provided in paragraph (a) of this section, an applicant 
may defer his obligation to satisfy an applicable data requirement until 
the Agency requests the data if he can demonstrate, by the procedure in 
this section, that no other person has previously submitted to the 
Agency a study that would satisfy the data requirement in question.
    (a) When data gap procedures may not be used. (1) An applicant for 
registration of a product containing a new chemical may not defer his 
obligation by the procedure in this section, unless he can demonstrate 
to the Agency's satisfaction that the data requirement was imposed so 
recently that insufficient time has elapsed for the study to have been 
completed and that, in the public interest, the product should be 
registered during the limited period of time required to complete the 
study. Refer to FIFRA section 3(c)(7)(C).
    (2) An applicant for registration of a product under FIFRA section 
3(c)(7) (A) or (B) may not defer his obligation by the procedure in this 
section if the Agency requires the data to determine:
    (i) Whether the product is identical or substantially similar to 
another currently registered product or differs only in ways that would 
not substantially increase the risk of unreasonable adverse effects on 
the environment;
    (ii) If efficacy data are required, whether the product is 
efficacious; or
    (iii) Whether the new use would substantially increase the risk of 
unreasonable adverse effects on the environment, usually required when 
the application involves a new use of a product which is identical or 
substantially similar to a currently registered product.
    (b) Data gap listed in a Registration Standard. The applicant may 
rely on a data gap that is documented by a Registration Standard without 
submitting the certification required by paragraph (c) of this section. 
If the data gap listed in the Registration Standard has been

[[Page 24]]

filled since the issuance of the Standard, the Agency will notify the 
applicant and require him to choose another method of demonstrating 
compliance.
    (c) Certification of a data gap. Except as provided by paragraph (b) 
of this section, an applicant who wishes to claim that a data gap exists 
must certify to the Agency that:
    (1) The applicant has furnished, by certified mail, to each original 
data submitter on the current Data Submitters List for the active 
ingredient in question, a notice containing the following information:
    (i) The name and address of the applicant;
    (ii) The name of the product, and a statement that the applicant 
intends to apply for registration of that product;
    (iii) The name(s) of the active ingredient(s) in the procuct;
    (iv) A list of the data requirements for which the applicant intends 
to claim under this section that a data gap exists; and
    (v) A request that the data submitter identify, within 60 days of 
receipt of the notice, any valid study which he has submitted to the 
Agency that would fulfill any of the data requirement(s) listed.
    (2) The applicant has, within that 60-day period, received no 
response, or has received a negative response, from each person 
notified; and
    (3) The applicant has no basis to believe that any data have been 
submitted to the Agency that would fulfill the data requirement, and is 
entitled to claim that a data gap exists.
    (d) Requirement to obtain permission or make offer to pay. In 
responding to a data gap letter, the original data submitter is not 
deemed to have given his authorization for the applicant to cite any 
study which the data submitter identifies in his response. The applicant 
must seek and obtain specific written authorization from, or make an 
offer to pay to, the original data submitter to cite the identified 
study in order to demonstrate compliance for the data requirement. 
Nothing, however, precludes the applicant from requesting written 
authorization or making an offer to pay at the same time that he 
requests confirmation of a data gap.



Sec. 152.97  Rights and obligations of data submitters.

    (a) Right to be listed on Data Submitters List. (1) Each original 
data submitter shall have the right to be included on the Agency's Data 
Submitters List.
    (2) Each original data submitter who wishes to have his name added 
to the current Data Submitters List must submit to the Agency the 
following information:
    (i) Name and current address;
    (ii) Chemical name and common name (if any) of the active 
ingredient(s), with respect to which he is an original data submitter;
    (iii) For each such active ingredient, the type(s) of study he has 
previously submitted (corresponding to Guidelines reference numbers 
given in tables in 40 CFR part 158 or part 161, as applicable), the date 
of submission, and the EPA registration number, file symbol, or other 
identifying reference for which it was submitted.
    (3) Each applicant not already included on the Data Submitters List 
for a particular active ingredient must inform the Agency at the time of 
submission of a relevant study whether he wishes to be included on the 
Data Submitters List for that pesticide.
    (b) Obligation to respond to data gap letters. An applicant who 
chooses to defer his obligation by demonstrating the existence of a data 
gap must write to each original data submitter for confirmation that the 
data submitter has not submitted a valid study that would satisfy the 
requirement. The original data submitter is not required to respond to 
such letters. However, if he fails to respond, the applicant is entitled 
to assume (and the Agency will act on the assumption) that the original 
data submitter has not submitted a study to satisfy the requirement. The 
data submitter may thereby limit his right to later challenge the 
applicant's claim if he fails respond in writing delivered to the 
applicant within 60 days of receipt of the applicant's data gap letter.

[49 FR 30903, Aug. 1, 1984, as amended at 72 FR 61028, Oct. 26, 2007]

[[Page 25]]



Sec. 152.98  Procedures for transfer of exclusive use or compensation rights 

to another person.

    A person who possesses rights to exclusive use or compensation under 
FIFRA section 3(c)(1)(F) may transfer such rights to another person in 
accordance with this section.
    (a) The original data submitter must submit to the Agency a transfer 
document that contains the following information:
    (1) The name, address and state of incorporation (if any) of the 
original data submitter (the transferor);
    (2) The name, address and state of incorporation (if any) of the 
person to whom the data rights are being transferred (the transferee);
    (3) Identification of each item of data transferred including:
    (i) The name of the study or item of data;
    (ii) Whether the study is an exclusive use study, and, if so, when 
the period of exclusive use protection expires;
    (iii) The name of the person or laboratory that conducted the study;
    (iv) The date the study was submitted to the Agency;
    (v) The EPA document number assigned to the item of data (the Master 
Record Identification Number or Accession Number), if known. If not 
known, the EPA administrative number (such as the EPA Registration 
Number, petition number, file symbol, or permit number) with which the 
item of data was submitted, such that the Agency can identify the item 
of data.
    (vi) A statement that the transferor transfers irrevocably to the 
transferee all rights, titles, and interest in the items of data named;
    (vii) A statement that the transferor and transferee understand that 
any false statement may be punishable under 18 U.S.C. 1001; and
    (viii) The names, signatures and titles of the transferor and 
transferee, and the date signed.
    (b) In addition, the original data submitter must submit to the 
Agency a notarized statement affirming that:
    (1) The person signing the transfer agreement is authorized by the 
original data submitter to bind the data submitter;
    (2) No court order prohibits the transfer, and any required court 
approvals have been obtained; and
    (3) The transfer is authorized under Federal, State, and local law 
and relevant corporate charters, bylaws or partnership agreements.
    (c) The Agency will acknowledge the transfer of the data by 
notifying both transferor and transferee, and will state the effective 
date of the transfer. Thereafter the transferee will be considered to be 
the original data submitter of the items of data transferred for all 
purposes under FIFRA section 3(c)(1)(F), unless a new transfer agreement 
is submitted to the Agency.

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008]



Sec. 152.99  Petitions to cancel registration.

    An original data submitter may petition the Agency to deny or cancel 
the registration of a product in accordance with this section if he has 
submitted to the Agency a valid study which, he claims, satisfies a data 
requirement that an applicant purportedly has failed to satisfy.
    (a) Grounds for petition. (1) If an applicant has offered to pay 
compensation to an original data submitter of a study (either 
specifically or by filing a general offer to pay statement), the 
original data submitter may petition the Agency to deny or cancel the 
registration to which the offer related on any of the following grounds:
    (i) The applicant has failed to participate in an agreed-upon 
procedure for reaching an agreement on the amount and terms of 
compensation. The petitioner shall submit a copy of the agreed-upon 
procedure and describe the applicant's failure to participate in the 
procedure.
    (ii) The applicant has failed to comply with the terms of an 
agreement on compensation. The petitioner shall submit a copy of the 
agreement, and shall describe how the applicant has failed to comply 
with the agreement.
    (iii) The applicant has failed to participate in an arbitration 
proceeding. The petitioner shall submit evidence of such failure.

[[Page 26]]

    (iv) The applicant has failed to comply with the terms of an 
arbitration decision. The petitioner shall submit a copy of the 
arbitration decision, and describe how the applicant has failed to 
comply with the decision.
    (2) When no offer to pay has been made, the petitioner shall state 
in his petition the basis for the challenge, and describe how the 
failure of the applicant to comply with the procedures of this subpart 
has deprived him of the rights accorded him under FIFRA section 
3(c)(1)(F). Possible grounds for challenge include, but are not limited 
to, the following:
    (i) The applicant has failed to list a data requirement applicable 
to his product, or has failed to demonstrate compliance with all 
applicable data requirements.
    (ii) The applicant has submitted or cited a study that is not valid.
    (iii) The applicant has submitted or cited a study that does not 
satisfy the data requirement for which it was submitted or cited.
    (iv) The applicant has failed to comply with the procedure for 
showing that a data gap exists.
    (v) The applicant has improperly certified that a data gap exists. 
An original data submitter who has failed without good cause to respond 
to an applicant's request for confirmation of a data gap may not 
petition the Agency for review on this basis.
    (vi) The applicant has submitted or cited a study originally 
submitted by the petitioner, without the required authorization or offer 
to pay.
    (b) Procedure for petition to the Agency--(1) Time for filing. A 
petition under paragraph (a)(1) of this section may be filed at any time 
that the circumstances warrant. A petition under paragraph (a)(2) of 
this section must be filed within one year after the Agency makes public 
the issuance of the registration.
    (2) Notice to affected registrant. At the same time that the 
petitioner files his petition with the Agency, he shall send a copy by 
certified mail to the affected applicant or registrant. The applicant or 
registrant shall have 60 days from the date of his receipt of the 
petition to submit written comments to the Agency.
    (c) Disposition of petitions. The Agency will consider the material 
submitted by the petitioner and the response, if any, by the affected 
applicant or registrant.
    (1) If the Agency determines that the petition is without merit, it 
will inform the petitioner and the affected applicant or registrant that 
the petition is denied. Denial of a petition is a final Agency action.
    (2) If the Agency determines that an applicant has acted in any way 
described by paragraph (a)(1) of this section, the Agency will notify 
the petitioner and the affected applicant or registrant that it intends 
to deny or cancel the registration of the product in support of which 
the data were cited. The affected applicant or registrant will have 15 
days from the date of delivery of this notice to respond. If the Agency 
determines, after considering any response, that the affected applicant 
or registrant has acted in the ways described by paragraph (a)(1) of 
this section, the Agency will deny or cancel the registration without 
further hearing. Refer to FIFRA section 3(c)(1)(F)(ii). Denial or 
cancellation of a registration is a final Agency action.
    (3) Except as provided in paragraph (c)(2) of this section, if the 
Agency determines that an applicant for registration of a product has 
acted in any way that deprives an original data submitter of rights 
under FIFRA section 3(c)(1)(F), the Agency will take steps to deny the 
application or cancel the registration, as appropriate. The procedures 
in FIFRA section 3(c)(6) or section 6(b) shall be followed. Denial or 
cancellation is a final Agency action.
    (d) Hearing. Any hearing will be conducted in accordance with the 
procedures in 40 CFR part 164. The only matter for resolution at the 
hearing shall be whether the registrant failed to comply with the 
requirements and procedures of FIFRA section 3(c)(1)(F) or of this 
subpart, in the manner described by the petitioner. A decision following 
a hearing shall be final.

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008]

[[Page 27]]



                 Subpart F_Agency Review of Applications

    Source: 53 FR 15980, May 4, 1988, unless otherwise noted.



Sec. 152.100  Scope.

    (a) The Agency will follow the procedures in this subpart for all 
applications for registration, except an application for registration of 
a pesticide that has been the subject of a previous Agency cancellation 
or suspension notice under FIFRA sec. 6.
    (b) The Agency will follow the procedures of subpart D of part 164 
of this chapter in evaluating any application for registration of a 
pesticide involving use of the pesticide in a manner that is prohibited 
by a suspension or cancellation order, to the extent required by subpart 
D of part 164.



Sec. 152.102  Publication.

    The Agency will issue in the Federal Register a notice of receipt of 
each application for registration of a product that contains a new 
active ingredient or that proposes a new use. After registration of the 
product, the Agency will issue in the Federal Register a notice of 
issuance. The notice of issuance will describe the new chemical or new 
use, summarize the Agency's regulatory conclusions, list missing data 
and the conditions for their submission, and respond to comments 
received on the notice of application.



Sec. 152.104  Completeness of applications.

    The applicant is responsible for the accuracy and completeness of 
all information submitted in connection with the application. The Agency 
will review each application to determine whether it is complete. An 
application is incomplete if any pertinent item specified in Sec. 
152.50 has not been submitted, or has been incorrectly submitted (for 
example, data required by part 158, or part 161 of this chapter, as 
applicable, and not submitted in accordance with the requirements for 
format, claims of confidential business information, or flagging).

[72 FR 61028, Oct. 26, 2007]



Sec. 152.105  Incomplete applications.

    The Agency will not begin or continue the review of an application 
that is incomplete. If the Agency determines that an application is 
incomplete or that further information is needed in order to complete 
the Agency's review, the Agency will notify the applicant of the 
deficiencies and allow the applicant 75 days to make corrections or 
additions to complete the application. If the applicant believes that 
the deficiencies cannot be corrected within 75 days, he must notify the 
Agency within those 75 days of the date on which he expects to complete 
the application. If, after 75 days, the applicant has not responded, or 
if the applicant subsequently fails to complete the application within 
the time scheduled for completion, the Agency will terminate any action 
on such application, and will treat the application as if it had been 
withdrawn by the applicant. Any subsequent submission relating to the 
same product must be submitted as a new application.



Sec. 152.107  Review of data.

    (a) The Agency normally will review data submitted with an 
application that have not previously been submitted to the Agency.
    (b) The Agency normally will review other data submitted or cited by 
an applicant only:
    (1) As part of the process of reregistering currently registered 
products;
    (2) When acting on an application for registration of a product 
containing a new active ingredient;
    (3) If such data have been flagged in accordance with Sec. 158.34 
or 161.34 of this chapter; or
    (4) When the Agency determines that it would otherwise serve the 
public interest.
    (c) If the Agency finds that it needs additional data in order to 
determine whether the product may be registered, it will notify the 
applicant as early as possible in the review process.

[53 FR 15980, May 4, 1988, as amended at 72 FR 61028, Oct. 26, 2007]



Sec. 152.108  Review of labeling.

    The Agency will review all draft labeling submitted with the 
application.

[[Page 28]]

If an applicant for amended registration submits only that portion of 
the labeling proposed for amendment, the Agency may review the entire 
label, as revised by the proposed changes, in deciding whether to 
approve the amendment. The Agency will not approve final printed 
labeling, but will selectively review it for compliance.



Sec. 152.110  Time for agency review.

    The Agency will complete its review of applications as expeditiously 
as possible. Applications subject to specific timeframes under the fee 
schedule established by FIFRA section 33 will be reviewed within the 
timeframes established for the application or action type.

[73 FR 75595, Dec. 12, 2008]



Sec. 152.111  Choice of standards for review of applications.

    The Agency has discretion to review applications under either the 
unconditional registration criteria of FIFRA sec. 3(c)(5) or the 
conditional registration criteria of FIFRA sec. 3(c)(7). The type of 
review chosen depends primarily on the extent to which the relevant data 
base has been reviewed for completeness and scientific validity. EPA 
conducts data reviews needed to support unconditional registrations on a 
chemical-by-chemical basis, according to an established priority list. 
Except for applications for registration of a new active ingredient or 
in special cases where it finds immediate review to be warranted, the 
Agency will not commence a complete review of the existing data base on 
a given chemical in response to receipt of an application for 
registration. Instead the Agency will review the application using the 
criteria for conditional registration in FIFRA sec. 3(c)(7) (A) and (B).



Sec. 152.112  Approval of registration under FIFRA sec. 3(c)(5).

    EPA will approve an application under the criteria of FIFRA sec. 
3(c)(5) only if:
    (a) The Agency has determined that the application is complete and 
is accompanied by all materials required by the Act and this part, 
including, but not limited to, evidence of compliance with subpart E of 
this part;
    (b) The Agency has reviewed all relevant data in the possession of 
the Agency (see Sec. Sec. 152.107 and 152.111);
    (c) The Agency has determined that no additional data are necessary 
to make the determinations required by FIFRA sec. 3(c)(5) with respect 
to the pesticide product which is the subject of the application;
    (d) The Agency has determined that the composition of the product is 
such as to warrant the proposed efficacy claims for it, if efficacy data 
are required to be submitted for the product by part 158 or part 161 of 
this chapter, as applicable.
    (e) The Agency has determined that the product will perform its 
intended function without unreasonable adverse effects on the 
environment, and that, when used in accordance with widespread and 
commonly recognized practice, the product will not generally cause 
unreasonable adverse effects on the environment;
    (f) The Agency has determined that the product is not misbranded as 
that term is defined in FIFRA sec. 2(q) and part 156 of this chapter, 
and its labeling and packaging comply with the applicable requirements 
of the Act, this part, and parts 156 and 157 of this chapter;
    (g) If the proposed labeling bears directions for use on food, 
animal feed, or food or feed crops, or if the intended use of the 
pesticide results or may reasonably be expected to result, directly or 
indirectly, in pesticide residues (including residues of any active or 
inert ingredient of the product, or of any metabolite or degradation 
product thereof) in or on food or animal feed, all necessary tolerances, 
exemptions from the requirement of a tolerance, and food additive 
regulations have been issued under FFDCA sec. 408, and
    (h) If the product, in addition to being a pesticide, is a drug 
within the meaning of FFDCA sec. 201(q), the Agency has been notified by 
the Food and Drug Administration (FDA) that the product complies with 
any requirements imposed by FDA.

[53 FR 15980, May 4, 1988, as amended at 72 FR 61028, Oct. 26, 2007; 73 
FR 75595, Dec. 12, 2008]

[[Page 29]]



Sec. 152.113  Approval of registration under FIFRA sec. 3(c)(7)--Products that 

do not contain a new active ingredient.

    (a) Except as provided in paragraph (b) of this section, the Agency 
may approve an application for registration or amended registration of a 
pesticide product, each of whose active ingredients is contained in one 
or more other registered peticide products, only if the Agency has 
determined that:
    (1) It possesses all data necessary to make the determinations 
required by FIFRA sec. 3(c)(7)(A) or (B) with respect to the pesticide 
product which is the subject of the application (including, at a 
minimum, data needed to characterize any incremental risk that would 
result from approval of the application);
    (2) Approval of the application would not significantly increase the 
risk of any unreasonable adverse effect on the environment; and
    (3) The criteria of Sec. 152.112(a), (d), and (f) through (h) have 
been satisfied.
    (b) Notwithstanding the provisions of paragraph (a) of this section, 
the Agency will not approve the conditional registration of any 
pesticide under FIFRA sec. 3(c)(7)(A) unless the Agency has determined 
that the applicant's product and its proposed use are identical or 
substantially similar to a currently registered pesticide and use, or 
that the pesticide and its proposed use differ only in ways that would 
not significantly increase the risk of unreasonable adverse effects on 
the environment.
    (c) Notwithstanding the provisions of paragraph (a) of this section, 
the Agency will not approve the conditional registration of any 
pesticide product for a new use under FIFRA sec. 3(c)(7)(B) if:
    (1) The pesticide is the subject of a special review, based on a use 
of the product that results in human dietary exposure; and
    (2) The proposed new use involves use on a major food or feed crop, 
or involves use on a minor food or feed crop for which there is 
available an effective alternative registered pesticide which does not 
meet the risk criteria associated with human dietary exposure. The 
determination of available and effective alternatives shall be made with 
the concurrence of the Secretary of Agriculture.



Sec. 152.114  Approval of registration under FIFRA sec. 3(c)(7)--Products that 

contain a new active ingredient.

    An application for registration of a pesticide containing an active 
ingredient not in any currently registered product may be conditionally 
approved for a period of time sufficient for the generation and 
submission of certain of the data necessary for a finding of 
registrability under FIFRA sec. 3(c)(5) if the Agency determines that:
    (a) Insufficient time has elapsed since the imposition of the data 
requirement for those data to have been developed;
    (b) All other required test data and materials have been submitted 
to the Agency;
    (c) The criteria in Sec. 152.112(a), (b), (d), and (f) through (h) 
have been satisfied;
    (d) The use of the pesticide product during the period of the 
conditional registration will not cause any unreasonable adverse effect 
on the environment; and
    (e) The registration of the pesticide product and its subsequent use 
during the period of the conditional registration are in the public 
interest.



Sec. 152.115  Conditions of registration.

    (a) Substantially similar products and new uses. Each registration 
issued under Sec. 152.113 shall be conditioned upon the submission or 
citation by the registrant of all data which are required for 
unconditional registration of his product under FIFRA sec. 3(c)(5), but 
which have not yet been submitted, no later than the time such data are 
required to be submitted for similar pesticide products already 
registered. If a notice requiring submission of such data has been 
issued under FIFRA sec. 3(c)(2)(B) prior to the date of approval of the 
application, the applicant must submit or cite the data described by 
that notice at the time specified by that notice. The applicant must 
agree to these conditions before the application may be approved.
    (b) New active ingredients. Each registration issued under Sec. 
152.114 shall be

[[Page 30]]

conditioned upon the applicant's agreement to each of the following 
conditions:
    (1) The applicant will submit remaining required data (and interim 
reports if required) in accordance with a schedule approved by the 
Agency.
    (2) The registration will expire upon a date established by the 
Agency, if the registrant fails to submit data as required by the 
Agency. The expiration date will be established based upon the length of 
time necessary to generate and submit the required data. If the studies 
are submitted in a timely manner, the registration will be cancelled if 
the Agency determines, based on the data (alone, or in conjuction with 
other data), that the product or one or more of its uses meets or 
exceeds any of the risk criteria established by the Agency to initiate a 
special review. If the Agency so determines, it will issue to the 
registrant a Notice of Intent to Cancel under FIFRA sec. 6(e), and will 
specify any provisions for sale and distribution of existing stocks of 
the pesticide product.
    (3) The applicant will submit an annual report of the production of 
the product.
    (c) Other conditions. The Agency may establish, on a case-by-case 
basis, other conditions applicable to registrations to be issued under 
FIFRA sec. 3(c)(7).
    (d) Cancellation if condition is not satisfied. If any condition of 
the registration of the product is not satisfied, or if the Agency 
determines that the registrant has failed to initiate or pursue 
appropriate action towards fulfillment of any condition, the Agency will 
issue a notice of intent to cancel under FIFRA sec. 6(e).

[53 FR 15980, May 4, 1988, as amended at 60 FR 32096, June 19, 1995]



Sec. 152.116  Notice of intent to register to original submitters of exclusive 

use data.

    (a) Except as provided in paragraph (c) of this section, at least 30 
days before registration of a product containing an active ingredient 
for which a previously submitted study is eligible for exclusive use 
under FIFRA sec. 3(c)(1)(F)(i), the Agency will notify the original 
submitter of the exclusive use study of the intended registration of the 
product. If requested by the exclusive use data submitter within 30 
days, the Agency will also provide the applicant's list of data 
requirements and method of demonstrating compliance with each data 
requirement.
    (b) Within 30 days after receipt of the Agency's notice, or of the 
applicant's list of data requirements, whichever is later, the exclusive 
use data submitter may challenge the issuance of the registration in 
accordance with the procedures in Sec. 152.99 (b) and (c). If the 
Agency finds that the challenge has merit, it will issue a notice of 
denial of the application. The applicant may then avail himself of the 
hearing procedures provided by FIFRA sec. 3(c)(6). If the Agency finds 
that the challenge is without merit, it will deny the petition and 
register the applicant's product. Denial of the petition is a final 
Agency action.
    (c) If an applicant has submitted to the Agency a certification from 
an exclusive use data submitter that he is aware of the applicant's 
application for registration, and does not object to the issuance of the 
registration, the Agency will not provide the 30-day notification 
described in paragraph (a) of this section to that exclusive use data 
submitter.

[53 FR 15980, May 4, 1988, as amended at 73 FR 75595, Dec. 12, 2008]



Sec. 152.117  Notification to applicant.

    The Agency will notify the applicant of the approval of his 
application by a Notice of Registration for new registration, or by a 
letter in the case of an amended registration.



Sec. 152.118  Denial of application.

    (a) Basis for denial. The Agency may deny an application for 
registration if the Agency determines that the pesticide product does 
not meet the criteria for registration under either FIFRA sec. 3(c)(5) 
or (7), as specified in Sec. Sec. 152.112 through 152.114.
    (b) Notification of applicant. If the Agency determines that an 
application should be denied, it will notify the applicant by certified 
letter. The letter will set forth the reasons and factual basis for the 
determination with conditions, if any, which must be fulfilled in

[[Page 31]]

order for the registration to be approved.
    (c) Opportunity for remedy by the applicant. The applicant will have 
30 days from the date of receipt of the certified letter to take the 
specified corrective action. During this time the applicant may request 
that his application be withdrawn.
    (d) Notice of denial. If the applicant fails to correct the 
deficiencies within the 30-day period, the Agency may issue a notice of 
denial, which will be published in the Federal Register, and which will 
set forth the reasons and the factual basis for the denial.
    (e) Hearing rights. Within 30 days following the publication of the 
notice of denial, an applicant, or any interested person with written 
authorization of the applicant, may request a hearing in accordance with 
FIFRA sec. 6(b). Hearings will be conducted in accordance with part 164 
of this chapter.



Sec. 152.119  Availability of material in support of registration.

    (a) The information submitted to support a registration application 
shall be part of the official Agency file for that registration.
    (b) Within 30 days after registration, the Agency will make 
available for public inspection, upon request, the materials required by 
subpart E to be submitted with an application. Materials that will be 
publicly available include an applicant's list of data requirements, the 
method used by the applicant to demonstrate compliance for each data 
requirement, and the applicant's citations of specific studies in the 
Agency's possession if applicable.
    (c) Except as provided by FIFRA sec. 10, within 30 days after 
registration, the data on which the Agency based its decision to 
register the product will be made available for public inspection, upon 
request, in accordance with the procedures in 40 CFR part 2.



             Subpart G_Obligations and Rights of Registrants

    Source: 53 FR 15983, May 4, 1988, unless otherwise noted.



Sec. 152.122  Currency of address of record and authorized agent.

    (a) The registrant must keep the Agency informed of his current name 
and address of record. If the Agency's good faith attempts to contact 
the registrant are not successful, the Agency will issue in the Federal 
Register a notice of intent to cancel all products of the registrant 
under FIFRA sec. 6(b). The registrant must respond within 30 days 
requesting that the registrations be maintained in effect, and providing 
his name and address of record. If no response is received, the 
cancellations will become effective at the end of 30 days without 
further notice to the registrant. The Agency may make provision for the 
sale and distribution of existing stocks of such products after the 
effective date of cancellation.
    (b) The registrant must also notify the Agency if he changes his 
authorized agent.



Sec. 152.125  Submission of information pertaining to adverse effects.

    If at any time the registrant receives or becomes aware of any 
factual information regarding unreasonable adverse effects of the 
pesticide on the environment that has not previously been submitted to 
the Agency, the registrant shall, in accordance with FIFRA section 
6(a)(2) and the requirements of part 159, subpart D of this chapter, 
provide such information to the Agency, clearly identified as FIFRA 
6(a)(2) data.

[73 FR 75595, Dec. 12, 2008]



Sec. 152.130  Distribution under approved labeling.

    (a) A registrant may distribute or sell a registered product with 
the composition, packaging and labeling currently approved by the 
Agency.
    (b) A registrant may distribute or sell a product under labeling 
bearing any subset of the approved directions for use, provided that in 
limiting the uses listed on the label, no changes would be necessary in 
precautionary statements, use classification, or packaging of the 
product.

[[Page 32]]

    (c) Normally, if the product labeling is amended on the initiative 
of the registrant, by submission of an application for amended 
registration, the registrant may distribute or sell under the previously 
approved labeling for a period of 18 months after approval of the 
revision, unless an order subsequently issued by the Agency under FIFRA 
sec. 6 or 13 provides otherwise. However, if paragraph (d) of this 
section applies to the registrant's product, the time frames established 
by the Agency in accordance with that paragraph shall take precedence.
    (d) If a product's labeling is required to be revised as a result of 
the issuance of a Registration Standard, a Label Improvement Program 
notice, or a notice concluding a special review process, the Agency will 
specify in the notice to the registrant the period of time that 
previously approved labeling may be used. In all cases, supplemental or 
sticker labeling may be used as an interim compliance measure for a 
reasonable period of time. The Agency may establish dates as follows 
governing when label changes must appear on labels:
    (1) The Agency may establish a date after which all product 
distributed or sold by the registrant must bear revised labeling.
    (2) The Agency may also establish a date after which no product may 
be distributed or sold by any person unless it bears revised labeling. 
This date will provide sufficient time for product in channels of trade 
to be distributed or sold to users or otherwise disposed of.



Sec. 152.132  Supplemental distribution.

    The registrant may distribute or sell his registered product under 
another person's name and address instead of (or in addition to) his 
own. Such distribution and sale is termed ``supplemental distribution'' 
and the product is referred to as a ``distributor product.'' The 
distributor is considered an agent of the registrant for all intents and 
purposes under the Act, and both the registrant and the distributor may 
be held liable for violations pertaining to the distributor product. 
Supplemental distribution is permitted upon notification to the Agency 
if all the following conditions are met:
    (a) The registrant has submitted to the Agency for each distributor 
product a statement signed by both the registrant and the distributor 
listing the names and addresses of the registrant and the distributor, 
the distributor's company number, the additional brand name(s) to be 
used, and the registration number of the registered product.
    (b) The distributor product is produced, packaged and labeled in a 
registered establishment operated by the same producer (or under 
contract in accordance with Sec. 152.30) who produces, packages, and 
labels the registered product.
    (c) The distributor product is not repackaged (remains in the 
producer's unopened container).
    (d) The label of the distributor product is the same as that of the 
registered product, except that:
    (1) The product name of the distributor product may be different 
(but may not be misleading);
    (2) The name and address of the distributor may appear instead of 
that of the registrant;
    (3) The registration number of the registered product must be 
followed by a dash, followed by the distributor's company number 
(obtainable from the Agency upon request);
    (4) The establishment number must be that of the final establishment 
at which the product was produced; and
    (5) Specific claims may be deleted, provided that no other changes 
are necessary.
    (e) Voluntary cancellation of a product applies to the registered 
product and all distributor products distributed or sold under that 
registration number. The registrant is responsible for ensuring that 
distributors under his cancelled registration are notified and comply 
with the terms of the cancellation.

[53 FR 15975, May 4, 1988, as amended at 60 FR 32096, June 19, 1995]



Sec. 152.135  Transfer of registration.

    (a) A registrant may transfer the registration of a product to 
another person, and the registered product may be

[[Page 33]]

distributed and sold without the requirement of a new application for 
registration by that other person, if the parties submit to the Agency 
the documents listed in paragraphs (b) and (c) of this section, and 
receive Agency approval as described in paragraph (d) of this section.
    (b) Persons seeking approval of a transfer of registration must 
provide a document signed by the authorized representative of the 
registrant (the transferor) and of the person to whom the registration 
is transferred (the transferee) that contains the following information:
    (1) The name, address and State of incorporation (if any) of the 
transferor;
    (2) The name, address and State of incorporation of the transferee;
    (3) The name(s) and EPA registration number(s) of the product(s) 
being transferred;
    (4) A statement that the transferor transfers irrevocably to the 
transferee all right, title, and interest in the EPA registration(s) 
listed in the document;
    (5) A statement that the transferred registration(s) shall not serve 
as collateral or otherwise secure any loan or other payment arrangement 
or executory promise, and that the registration(s) shall not revert to 
the transferor unless a new transfer agreement is submitted to and 
approved by the Agency;
    (6) A description of the general nature of the underlying 
transaction, e.g., merger, spinoff, bankruptcy transfer (no financial 
information need be disclosed);
    (7) A statement that the transferor and transferee understand that 
any false statement may be punishable under 18 U.S.C. 1001; and
    (8) An acknowledgment by the transferee that his rights and duties 
concerning the registration under FIFRA and this chapter will be deemed 
by EPA to be the same as those of the transferor at the time the 
transfer is approved.
    (c) In addition, the transferor must submit to the Agency a 
notarized statement affirming that:
    (1) The person signing the transfer agreement is authorized by the 
registrant to bind the transferor;
    (2) No court order prohibits the transfer, and that any required 
court approvals have been obtained; and
    (3) The transfer is authorized under all relevant Federal, State and 
local laws and all relevant corporate charters, bylaws, partnerships, or 
other agreements.
    (d) If the required documents are submitted, and no information 
available to the Agency indicates that the information is incorrect, the 
Agency will approve the transfer without requiring that the transferee 
obtain a new registration. The Agency will notify the transferor and 
transferee of its approval.
    (e) The transfer will be effective on the date of Agency approval. 
Thereafter the transferee will be regarded as the registrant for all 
purposes under FIFRA.
    (f) Rights to exclusive use of data or compensation under FIFRA 
section 3(c)(1)(F) are separate from the registration itself and may be 
retained by the transferor, or may be transferred independently in 
accordance with the provisions of Sec. 152.98. If the registrant as the 
original data submitter wishes to transfer data rights at the same time 
as he transfers the registration, he may submit a single transfer 
document containing the information required by this section for both 
the registration and the data.

[53 FR 15983, May 4, 1988, as amended at 58 FR 34203, June 23, 1993; 73 
FR 75595, Dec. 12, 2008]

Subpart H [Reserved]



                 Subpart I_Classification of Pesticides

    Source: 53 FR 15986, May 4, 1988, unless otherwise noted.



Sec. 152.160  Scope.

    (a) Types of classification. A pesticide product may be 
unclassified, or it may be classified for restricted use or for general 
use. The Agency does not normally classify products for general use; 
products that are not restricted remain unclassified.
    (b) Kinds of restrictions. The Agency may restrict a product or its 
uses to

[[Page 34]]

use by a certified applicator, or by or under the direct supervision of 
a certified applicator, as described in FIFRA sec. 3(d)(1)(C). The 
Agency may also, by regulation, prescribe restrictions relating to the 
product's composition, labeling, packaging, uses, or distribution and 
sale, or to the status or qualifications of the user.



Sec. 152.161  Definitions.

    In addition to the definitions in Sec. 152.3, the following terms 
are defined for the purposes of this subpart:
    (a) Dietary LC50 means a statistically derived estimate 
of the concentration of a test substance in the diet that would cause 50 
percent mortality to the test population under specified conditions.
    (b) Outdoor use means any pesticide application that occurs outside 
enclosed manmade structures or the consequences of which extend beyond 
enclosed manmade structures, including, but not limited to, pulp and 
paper mill water treatments and industrial cooling water treatments.



Sec. 152.164  Classification procedures.

    (a) Grouping of products for classification purposes. In its 
discretion, the Agency may identify a group of products having common 
characteristics or uses and may classify for restricted use same or all 
of the products or uses included in that group. Such a group may be 
comprised of, but is not limited to, products that:
    (1) Contain the same active ingredients.
    (2) Contain the same active ingredients in a particular 
concentration range, formulation type, or combination of concentration 
range and formulation type.
    (3) Have uses in common.
    (4) Have other characteristics, such as toxicity, flammability, or 
physical properties, in common.
    (b) Classification reviews. The Agency may conduct classification 
reviews and classify products at any time, if it determines that a 
restriction on the use of a pesticide product is necessary to avoid 
unreasonable adverse effects on the environment. However, classification 
reviews normally will be conducted and products classified only in the 
following circumstances:
    (1) As part of the review of an application for new registration of 
a product containing an active ingredient not contained in any currently 
registered product.
    (2) As part of the review of an application for a new use of a 
product, if existing uses of that product previously have been 
classified for restricted use. Review of a restricted use product at 
this time is for the purpose of determining whether the new use should 
also be classified for restricted use. Normally the Agency will not 
conduct initial classification reviews for existing uses of individual 
products in conjunction with an application for amended registration.
    (3) As part of the process of developing or amending a registration 
standard for a pesticide. The Agency normally will conduct 
classification reviews of all uses of a currently registered pesticide 
at this time.
    (4) As part of any special review of a pesticide, in accordance with 
the procedures of 40 CFR part 154.
    (c) Classification procedures. (1) If the Agency determines that a 
product or one or more of its uses should be classified for restricted 
use, the Agency initially may classify the product by regulation. In 
this case, within 60 days after the effective date of a final rule, each 
registrant of a product subject to the rule must submit to the Agency 
one of the following, as directed in the final rule:
    (i) A copy of the amended label and any supplemental labeling to be 
used as an interim compliance measure.
    (ii) A statement, which the Agency considers a report under the Act, 
that the registrant will comply with the labeling requirements 
prescribed by the Agency within the timeframes prescribed by the 
regulation.
    (iii) An application for amended registration to delete the uses 
which have been restricted, or to ``split'' the registration into two 
registrations, one including only restricted or all uses, and the other 
including only uses that have not been classified.
    (2) Alternatively, EPA may notify the applicant or registrant of the 
classification decision and require that he

[[Page 35]]

submit the information required by paragraph (c)(1) of this section. The 
Agency may deny registration or initiate cancellation proceedings if the 
registrant fails to comply within the timeframes established by the 
Agency in its notification.



Sec. 152.166  Labeling of restricted use products.

    (a) Products intended for end use. A product whose labeling bears 
directions for end use and that has been classified for restricted use 
must be labeled in accordance with the requirements of Sec. 156.10 of 
this chapter or other Agency instructions. The Agency will permit the 
use of stickers or supplemental labeling as an interim alternative to 
the use of an approved amended label, in accordance with Sec. 152.167.
    (b) Products intended only for formulation. A product whose labeling 
does not bear directions for end use (a product that is intended and 
labeled solely for further formulation into other pesticide products) is 
not subject to the labeling requirements of this subpart.



Sec. 152.167  Distribution and sale of restricted use products.

    Unless modified by the Agency, the compliance dates in this section 
shall apply to restricted use products.
    (a) Sale by registrant or producer. (1) No product with a use 
classified for restricted use may be distributed or sold by the 
registrant or producer after the 120th day after the effective date of 
such classification unless the product:
    (i) Bears an approved amended label which contains the terms of 
restricted use imposed by the Agency and otherwise complies with part 
156 of this chapter;
    (ii) Bears a sticker containing the product name, EPA registration 
number, and any terms of restricted use imposed by the Agency; or
    (iii) Is accompanied by supplemental labeling bearing the 
information listed in paragraph (a)(1)(ii) of this section.
    (2) If the registrant chooses to delete the restricted uses from his 
product label, that product may not be distributed or sold after the 
180th day after the effective date of classification unless the product 
bears amended labeling with the restricted uses deleted.
    (3) Notwithstanding paragraphs (a) (1) and (2) of this section, 
after the 270th day after the effective date of classification, no 
registrant or producer may distribute or sell a product that does not 
bear the approved amended label. After that date, stickers and 
supplemental labeling described in paragraph (a)(1) (ii) and (iii) are 
no longer acceptable.
    (b) Sale by retailer. No product with a use classified for 
restricted use by a regulation may be distributed or sold by a retailer 
or other person after the 270th day after the effective date of the 
final rule unless the product bears a label or labeling which complies 
with paragraph (a)(1) of this section.



Sec. 152.168  Advertising of restricted use products.

    (a) Any product classified for restricted use shall not be 
advertised unless the advertisement contains a statement of its 
restricted use classification.
    (b) The requirement in paragraph (a) of this section applies to all 
advertisements of the product, including, but not limited, to:
    (1) Brochures, pamphlets, circulars and similar material offered to 
purchasers at the point of sale or by direct mail.
    (2) Newspapers, magazines, newsletters and other material in 
circulation or available to the public.
    (3) Broadcast media such as radio and television.
    (4) Telephone advertising.
    (5) Billboards and posters.
    (c) The requirement may be satisfied for printed material by 
inclusion of the statement ``Restricted Use Pesticide,'' or the terms of 
restriction, prominently in the advertisement. The requirement may be 
satisfied with respect to broadcast or telephone advertising by 
inclusion in the broadcast of the spoken words ``Restricted use 
pesticide,'' or a statement of the terms of restriction.
    (d) The requirements of this section shall be effective:
    (1) After 270 days after the effective date of restriction of a 
product that is currently registered, unless the Agency specifies a 
shorter time period;

[[Page 36]]

    (2) Upon the effective date of registration of a product not 
currently registered.



Sec. 152.170  Criteria for restriction to use by certified applicators.

    (a) General criteria. An end-use product will be restricted to use 
by certified applicators (or persons under their direct supervision) if 
the Agency determines that:
    (1) Its toxicity exceeds one or more of the specific hazard criteria 
in paragraph (b) or (c) of this section, or evidence described in 
paragraph (d) of this section substantiates that the product or use 
poses a serious hazard that may be mitigated by restricting its use;
    (2) Its labeling, when considered according to the factors in 
paragraph (e)(2) of this section, is not adequate to mitigate these 
hazard(s);
    (3) Restriction of the product would decrease the risk of adverse 
effects; and
    (4) The decrease in risks of the pesticide as a result of 
restriction would exceed the decrease in benefits.
    (b) Criteria for human hazard--(1) Residential and institutional 
uses. A pesticide product intended for residential or institutional use 
will be considered for restricted use classification if:
    (i) The pesticide, as diluted for use, has an acute oral 
LD50 of 1.5 g/kg or less;
    (ii) The pesticide, as formulated, has an acute dermal 
LD50 of 2000 mg/kg or less;
    (iii) The pesticide, as formulated, has an acute inhalation 
LC50 of 0.5 mg/liter or less, based upon a 4-hour exposure 
period;
    (iv) The pesticide, as formulated, is corrosive to the eye (causes 
irreversible destruction of ocular tissue) or results in corneal 
involvement or irritation persisting for more than 7 days;
    (v) The pesticide, as formulated, is corrosive to the skin (causes 
tissue destruction into the dermis and/or scarring) or causes severe 
irritation (severe erythema or edema) at 72 hours; or
    (vi) When used in accordance with label directions, or widespread 
and commonly recognized practice, the pesticide may cause significant 
subchronic, chronic or delayed toxic effects on man as a result of 
single or multiple exposures to the product ingredients or residues.
    (2) All other uses. A pesticide product intended for uses other than 
residential or institutional use will be considered for restricted use 
classification if:
    (i) The pesticide, as formulated, has an acute oral LD50 
of 50 mg/kg or less;
    (ii) The pesticide, as formulated, has an acute dermal 
LD50 of 200 mg/kg or less;
    (iii) The pesticide, as diluted for use, has an acute dermal 
LD50 of 16 g/kg or less;
    (iv) The pesticide, as formulated, has an acute inhalation 
LC50 of 0.05 mg/liter or less, based upon a 4-hour exposure 
period;
    (v) The pesticide, as formulated, is corrosive to the eye or causes 
corneal involvement or irritation persisting for more than 21 days;
    (vi) The pesticide, as formulated, is corrosive to the skin (causes 
tissue destruction into the dermis and/or scarring); or
    (vii) When used in accordance with label directions, or widespread 
and commonly recognized practice, the pesticide may cause significant 
subchronic toxicity, chronic toxicity, or delayed toxic effects on man, 
as a result of single or multiple exposures to the product ingredients 
or residues.
    (c) Criteria for hazard to non-target species--(1) All products. A 
pesticide product intended for outdoor use will be considered for 
restricted use classification if:
    (i) When used according to label directions, application results in 
residues of the pesticide, its metabolites, or its degradation products, 
in the diet of exposed mammalian wildlife, immediately after 
application, such that:
    (A) The level of such residues equals or exceeds one-fifth of the 
acute dietary LC50; or
    (B) The amount of pesticide consumed in one feeding day (mg/kg/day) 
equals or exceeds one-fifth of the mammalian acute oral LD50;
    (ii) When used according to label directions, application results, 
immediately after application, in residues of the pesticide, its 
metabolites or its

[[Page 37]]

degradation products, in the diet of exposed birds at levels that equal 
or exceed one-fifth of the avian subacute dietary LC50;
    (iii) When used according to label directions, application results 
in residues of the pesticide, its metabolites or its degradation 
products, in water that equal or exceed one-tenth of the acute 
LC50 for non-target aquatic organisms likely to be exposed; 
or
    (iv) Under conditions of label use or widespread and commonly 
recognized practice, the pesticide may cause discernible adverse effects 
on non-target organisms, such as significant mortality or effects on the 
physiology, growth, population levels or reproduction rates of such 
organisms, resulting from direct or indirect exposure to the pesticide, 
its metabolites or its degradation products.
    (2) Granular products. In addition to the criteria of paragraph 
(c)(1) of this section, a pesticide intended for outdoor use and 
formulated as a granular product will be considered for restricted use 
classification if:
    (i) The formulated product has an acute avian or mammalian oral 
LD50 of 50 mg/kg or less as determined by extrapolation from 
tests conducted with technical material or directly with the formulated 
product; and
    (ii) It is intended to be applied in such a manner that significant 
exposure to birds or mammals may occur.
    (d) Other evidence. The Agency may also consider evidence such as 
field studies, use history, accident data, monitoring data, or other 
pertinent evidence in deciding whether the product or use may pose a 
serious hazard to man or the environment that can reasonably be 
mitigated by restricted use classification.
    (e) Alternative labeling language. (1) If the Agency determines that 
a product meets one or more of the criteria of paragraphs (b) or (c) of 
this section, or if other evidence identified in paragraph (d) of this 
section leads the Agency to conclude that the product should be 
considered for restricted use classification, the Agency will then 
determine if additional labeling language would be adequate to mitigate 
the identified hazard(s) without restricted use classification. If the 
labeling language meets all the criteria specified in paragraph (e)(2) 
of this section, the product will not be classified for restricted use.
    (2) The labeling will be judged adequate if it meets all the 
following criteria:
    (i) The user, in order to follow label directions, would not be 
required to perform complex operations or procedures requiring 
specialized training and/or experience.
    (ii) The label directions do not call for specialized apparatus, 
protective equipment, or materials that reasonably would not be 
available to the general public.
    (iii) Failure to follow label directions in a minor way would result 
in few or no significant adverse effects.
    (iv) Following directions for use would result in few or no 
significant adverse effects of a delayed or indirect nature through 
bioaccumulation, persistence, or pesticide movement from the original 
application site.
    (v) Widespread and commonly recognized practices of use would not 
nullify or detract from label directions such that unreasonable adverse 
effects on the environment might occur.



Sec. 152.171  Restrictions other than those relating to use by certified 

applicators.

    The Agency may by regulation impose restrictions on a product or 
class of products if it determines that:
    (a) Without such restrictions, the product when used in accordance 
with warnings, cautions and directions for use or in accordance with 
widespread and commonly recognized practices of use may cause 
unreasonable adverse effects on the environment; and
    (b) The decrease in risks as a result of restricted use would exceed 
the decrease in benefits as a result of restricted use.

[[Page 38]]



Sec. 152.175  Pesticides classified for restricted use.

    The following uses of pesticide products containing the active 
ingredients specified below have been classified for restricted use and 
are limited to use by or under the direct supervision of a certified 
applicator.

----------------------------------------------------------------------------------------------------------------
                                                                                                    Criteria
       Active ingredient              Formulation           Use pattern       Classification      influencing
                                                                                   \1\            restriction
----------------------------------------------------------------------------------------------------------------
Acrolein.......................  As sole active         All uses..........  Restricted.......  Inhalation hazard
                                  ingredient. No                                                to humans.
                                  mixtures registered.                                          Residue effects
                                                                                                on avian species
                                                                                                and aquatic
                                                                                                organisms.
Aldicarb.......................  As sole active         Ornamental uses     ......do.........  Other hazards--
                                  ingredient.            (indoor and                            accident
                                                         outdoor).                              history.
                                 No mixtures            Agricultural crop   Under further
                                  registered.            uses.               evaluation.
Aluminum phosphide.............  As sole active         ......do..........  ......do.........  Inhalation hazard
                                  ingredient. No                                                to humans.
                                  mixtures registered.
Azinphos methyl................  All liquids with a     ......do..........  ......do.........   Do.
                                  concentration
                                  greater than 13.5
                                  pct.
                                 All other              ......do..........  Under futher
                                  formulations.                              evaluation..
Carbofuran.....................  All concentrate        ......do..........  ......do.........  Acute inhalation
                                  suspensions and                                               toxicity.
                                  wettable powders 40%
                                  and greater.
                                 All granular           Rice..............  Under evaluation.
                                  formulations.
                                 All granular and       All uses except     ......do.........
                                  fertilizer             rice.
                                  formulations.
Chloropicrin...................  All formulations       All uses..........  ......do.........  Acute inhalation
                                  greater than 2%.                                              toxicity.
                                 All formulations.....  Rodent control....  ......do.........  Hazard to non-
                                                                                                target
                                                                                                organisms.
                                 All formulations 2%    Outdoor uses        Unclassified.....
                                  and less.              (other than
                                                         rodent control).
Clonitralid....................  All wettable powders   All uses..........  Restricted.......  Acute inhalation
                                  70% and greater.                                              toxicity.
                                 All granulars and      Molluscide uses...  Restricted.......  Effects on
                                  wettable powders.                                             aquatic
                                                                                                organisms.
                                 Pressurized sprays     Hospital            Unclassified.....
                                  0.55% and less.        antiseptics.
Dicrotophos....................  All liquid             All uses..........  Restricted.......  Acute dermal
                                  formulations 8% and                                           toxicity;
                                  greater.                                                      residue effects
                                                                                                on avian species
                                                                                                (except for tree
                                                                                                injections).
Disulfoton.....................  All emulsifiable       ......do..........  Restricted.......   Do.
                                  concentrates 65% and                                         Acute inhalation
                                  greater, all                                                  toxicity.
                                  emulsifiable
                                  concentrates and
                                  concentrate
                                  solutions 21% and
                                  greater with
                                  fensulfothion 43%
                                  and greater, all
                                  emulsifiable
                                  concentrates 32% and
                                  greater in
                                  combination with 32%
                                  fensulfothion and
                                  greater.
                                 Non-aqueous solution   Commercial seed     Restricted.......  Acute dermal
                                  95% and greater.       treatment.                             toxicity.
                                 Granular formulations  Indoor uses         ......do.........  Acute inhalation
                                  10% and greater.       (greenhouse).                          toxicity.
Ethoprop.......................  Emulsifiable           Aquatic uses......  ......do.........  Acute dermal
                                  concentrates 40% and                                          toxicity.
                                  greater.
                                 All granular and       All uses..........  Under evaluation.
                                  fertilizer
                                  formulations.
Ethyl parathion................  All granular and dust  ......do..........  Restricted.......  Inhalation hazard
                                  formulations greater                                          to humans. Acute
                                  than 2 pct,                                                   dermal toxicity.
                                  fertilizer                                                    Residue effects
                                  formulations,                                                 on mammalian,
                                  wettable powders,                                             aquatic, avian
                                  emulsifiable                                                  species.
                                  concentrates,
                                  concentrated
                                  suspensions,
                                  concentrated
                                  solutions.
                                 Smoke fumigants......  ......do..........  ......do.........  Inhalation hazard
                                                                                                to humans.
                                 Dust and granular      ......do..........  ......do.........  Other hazards--
                                  formulations 2 pct                                            accident
                                  and below.                                                    history.
Fenamiphos.....................  Emulsifiable           ......do..........  ......do.........  Acute dermal
                                  concentrates 35% and                                          toxicity.
                                  greater.
Fonofos........................  Emulsifiable           ......do..........  ......do.........  Acute dermal
                                  concentrates 44% and                                          toxicity.
                                  greater.

[[Page 39]]

 
                                 Emulsifiable           Tobacco...........  Unclassified.....
                                  concentrates 12.6%
                                  and less with
                                  pebulate 50.3% and
                                  less.
Methamidophos..................  Liquid formulations    ......do..........  Restricted.......  Acute dermal
                                  40% and greater.                                              toxicity;
                                                                                                residue effects
                                                                                                on avian
                                                                                                species.
                                 Dust formulations      ......do..........  ......do.........  Residue effects
                                  2.5% and greater.                                             on avian
                                                                                                species.
Methidathion...................  All formulations.....  All uses except     ......do.........   Do.
                                                         nursery stock,
                                                         safflower and
                                                         sunflower.
                                 All formulations.....  Nursery stock,      Unclassified.....
                                                         safflower and
                                                         sunflower.
Methomyl.......................  As sole active         Nondomestic         Restricted.......  Residue effects
                                  ingredient in 1 pct    outdoors-                              on mammalian
                                  to 2.5 baits (except   agricultural                           species.
                                  1 pct fly bait).       crops, ornamental
                                                         and turf. All
                                                         other registered
                                                         uses.
                                 All concentrated       ......do..........  ......do.........  Other hazards-
                                  solution                                                      accident
                                  formulations.                                                 history.
                                 90 pct wettable        ......do..........  ......do.........   Do.
                                  powder formulations
                                  (not in water
                                  soluble bags).
                                 90 pct wettable        ......do..........  Unclassified.....
                                  powder formulation
                                  in water soluble
                                  bags.
                                 All granular           ......do..........  ......do.........
                                  formulations.
                                 25 pct wettable        ......do..........  ......do.........
                                  powder formulations.
                                 In 1.24 pct to 2.5     ......do..........  ......do.........
                                  pct dusts as sole
                                  active ingredient
                                  and in mixtures with
                                  fungicides and
                                  chlorinated
                                  hydrocarbon,
                                  inorganic phosphate
                                  and biological
                                  insecticides.
Methyl bromide.................  All formulations in    All uses..........  Restricted.......   Do.
                                  containers greater
                                  than 1.5 lb.
                                 Containers with not    Single              Unclassified.....
                                  more than 1.5 lb of    applications
                                  methyl bromide with    (nondomestic use)
                                  0.25 pct to 2.0 pct    for soil
                                  chloropicrin as an     treatment in
                                  indicator.             closed systems.
                                 Container with not     All uses..........  Restricted.......   Do.
                                  more than 1.5 lb
                                  having no indicator.
Methyl parathion...............  All dust and granular  ......do..........  ......do.........  Other hazards-
                                  formulations less                                             accident
                                  than 5 pct.                                                   history. All
                                                                                                foliar
                                                                                                applications
                                                                                                restricted based
                                                                                                on residue
                                                                                                effects on
                                                                                                mammalian and
                                                                                                avian species.
                                 Microencapsulated....  ......do..........  ......do.........  Residue effects
                                                                                                on avian
                                                                                                species. Hazard
                                                                                                to bees.
                                 All dust and granular  ......do..........  ......do.........  Acute dermal
                                  formulations 5 pct                                            toxicity.
                                  and greater and all                                           Residue effects
                                  wettable powders and                                          on mammalian and
                                  liquids.                                                      avian species.
Nicotine (alkaloid)............  Liquid and dry         Indoor              ......do.........  Acute inhalation
                                  formulations 14% and   (greenhouse).                          toxicity.
                                  above.
                                 All formulations.....  Applications to     ......do.........  Effects on
                                                         cranberries.                           aquatic
                                                                                                organisms.
                                 Liquid and dry         All uses (domestic  Unclassified.....
                                  formulations 1.5%      and nondomestic).
                                  and less.
Paraquat (dichloride) and        All formulations and   All uses..........  Restricted.......  Other hazards.
 paraquat bis(methyl sulfate).    concentrations                                                Use and accident
                                  except those listed                                           history, human
                                  below.                                                        toxicological
                                                                                                data.
                                 Pressurized spray      Spot weed and       ......do.........
                                  formulations           grass control.
                                  containing 0.44 pct
                                  Paraquat bis(methyl
                                  sulfate) and 15 pct
                                  petroleum
                                  distillates as
                                  active ingredients.

[[Page 40]]

 
                                 Liquid fertilizers     All uses..........  Unclassified.....
                                  containing
                                  concentrations of
                                  0.025 pct paraquat
                                  dichloride and 0.03
                                  percent atrazine;
                                  0.03 pct paraquat
                                  dichloride and 0.37
                                  pct atrazine, 0.04
                                  pct paraquat
                                  dichloride and 0.49
                                  pct atrazine.
Phorate........................  Liquid formulations    ......do..........  Restricted.......  Acute dermal
                                  65% and greater.                                              toxicity.
                                                                                               Residue effects
                                                                                                on avian species
                                                                                                (applies to
                                                                                                foliar
                                                                                                applications
                                                                                                only).
                                                                                               Residue effects
                                                                                                on mammalian
                                                                                                species (applies
                                                                                                to foliar
                                                                                                application
                                                                                                only).
                                 All granular           Rice..............  ......do.........  Effects on
                                  formulations.                                                 aquatic
                                                                                                organisms.
Phosphamidon...................  Liquid formulations    ......do..........  ......do.........  Acute dermal
                                  75% and greater.                                              toxicity.
                                                                                               Residue effects
                                                                                                on mammalian
                                                                                                species.
                                                                                               Residue effects
                                                                                                on avian
                                                                                                species.
                                 Dust formulations      ......do..........  ......do.........   Do.
                                  1.5% and greater.                                            Residue effects
                                                                                                on mammalian
                                                                                                species.
Picloram.......................  All formulations and   ......do..........  ......do.........  Hazard to
                                  concentrations                                                nontarget
                                  except tordon 101 R.                                          organisms
                                                                                                (specifically
                                                                                                nontarget plants
                                                                                                both crop and
                                                                                                noncrop).
                                 Tordon 101 R forestry  Control of          Unclassified.....
                                  herbicide containing   unwanted trees by
                                  5.4 pct picloram and   cut surface
                                  20.9 pct 2.4-D.        treatment.
Sodium cyanide \3\.............  All capsules and ball  All uses..........  Restricted.......  Inhalation hazard
                                  formulations.                                                 to humans.
Sodium fluoroacetate...........  All solutions and dry  ......do..........  ......do.........  Acute oral
                                  baits.                                                        toxicity. Hazard
                                                                                                to nontarget
                                                                                                organisms. Use
                                                                                                and accident
                                                                                                history.
Strychnine.....................  All dry baits,         ......do..........  ......do.........  Acute oral
                                  pellets and powder                                            toxicity. Hazard
                                  formulations greater                                          to nontarget
                                  than 0.5 pct.                                                 avain species.
                                                                                                Use and accident
                                                                                                history.
                                 All dry baits,         All uses calling    ......do.........  Hazard to
                                  pellets and powder     for burrow                             nontarget
                                  formulations.          builders.                              organisms.
                                 All dry baits,         All uses except     ......do.........   Do.
                                  pellets and powder     subsoil.
                                  formulations 0.5 pct
                                  and below.
                                 ......do.............  All subsoil uses..  Unclassified.....
Sulfotepp......................  Sprays and smoke       All uses..........  Restricted.......  Inhalation hazard
                                  generators.                                                   to humans.
Zinc Phosphide.................  All formulations 2%    All domestic uses   Unclassified.....
                                  and less.              and non-domestic
                                                         uses in and
                                                         around buildings.
                                 All dry formulations
                                  60% and greater..
                                                        All uses..........  Restricted.......  Acute inhalation
                                                                                                toxicity.
                                 All bait formulations  Non-domestic        ......do.........  Hazard to non-
                                                         outdoor uses                           target
                                                         (other than                            organisms.
                                                         around buildings).
                                 All dry formulations   Domestic uses.....  ......do.........  Acute oral
                                  10% and greater.                                              toxicity.
----------------------------------------------------------------------------------------------------------------
\1\ ``Under evaluation'' means no classification decision has been made and the use/formulation in question is
  still under active review within EPA.
\2\ Percentages given are the total of dioxathion plus related compounds.
\3\ (Note--M-44 sodium cyanide capsules may only be used by certified applicators who have also taken the
  required additional training.)


[43 FR 5790, Feb. 9, 1978, as amended at 44 FR 45132, Aug. 1, 1979; 46 
FR 5698, Jan. 19, 1981. Redesignated and amended at 53 FR 15988, May 4, 
1988; 60 FR 32096, June 19, 1995]

[[Page 41]]

Subparts J-T [Reserved]



                       Subpart U_Registration Fees

    Source: 53 FR 19114, May 26, 1988, unless otherwise noted.



Sec. 152.400  Purpose.

    Subpart U prescribes fees to be charged for the pesticide regulatory 
activities set forth in Sec. 152.403 as performed by the Environmental 
Protection Agency (as authorized by 31 U.S.C. 9701 and Pub. L. 100-202) 
and provisions regarding their payment.



Sec. 152.401  Inapplicability of fee provisions to applications filed prior to 

October 1, 1997.

    No fee required by this subpart U shall be levied with respect to 
any application filed during the period beginning on October 25, 1988, 
and ending on September 30, 1997. See FIFRA section 4(i)(7) (added to 
FIFRA by Pub. L. 100-532, October 25, 1988, 102 Stat. 2654).

[53 FR 11923, Mar. 22, 1989]



Sec. 152.403  Definitions of fee categories.

    (a) New chemical registration review means review of an application 
for registration of a pesticide product containing a chemical active 
ingredient which is not contained as an active ingredient in any other 
pesticide product that is registered under FIFRA at the time the 
application is made.
    (b) New biochemical and microbial registration review means review 
of an application for registration of a biochemical or microbial 
pesticide product containing a biochemical or microbial active 
ingredient not contained in any other pesticide product that is 
registered under FIFRA at the time the application is made. For purposes 
of this subpart, the definitions of biochemical and microbial pesticides 
contained in Sec. 158.2000 and Sec. 158.2100, respectively, shall 
apply.
    (c) New use pattern registration review means review of an 
application for registration, or for amendment of a registration 
entailing a major change to the use pattern of an active ingredient 
contained in a product registered under FIFRA or pending Agency decision 
on a prior application at the time of application. For purposes of this 
paragraph, examples of major changes include but are not limited to, 
changes from non-food to food use, outdoor to indoor use, ground to 
aerial application, terrestrial to aquatic use, and non-residential to 
residential use.
    (d) Old chemical registration review means review of an application 
for registration of a new product containing active ingredients and uses 
which are substantially similar or identical to those currently 
registered or for which an application is pending Agency decision.
    (e) Amendment review means review of any application requiring 
Agency approval to amend the registration of a currently registered 
product, or for which an application is pending Agency decision, not 
entailing a major change to the use pattern of an active ingredient.
    (f) Experimental use permit review means review of an application 
for a permit pursuant to section 5 of FIFRA to apply a limited quantity 
of a pesticide in order to accumulate information necessary to register 
the pesticide. The application may be for a new chemical or for a new 
use of an old chemical. The fee applies to such experimental uses of a 
single unregistered active ingredient (no limit on the number of other 
active ingredients, in a tank mix, already registered for the crops 
involved) and no more than three crops. This fee does not apply to 
experimental use permits required for small-scale field testing of 
microbial pest control agents (40 CFR 172.3).

[53 FR 19114, May 26, 1988, as amended at 72 FR 61028, Oct. 26, 2007]



Sec. 152.404  Fee amounts.

    The fee prescribed by the following table must be submitted with 
each application for registration, amended registration or experimental 
use permit. Fees will be adjusted annually in accordance with Sec. 
152.410. The Agency may waive or refund fees in accordance with Sec. 
152.412.

                        Table--Registration Fees
------------------------------------------------------------------------
                        Type of review                            Fee
------------------------------------------------------------------------
New chemical.................................................   $184,500
New biochemical or microbial.................................     64,000

[[Page 42]]

 
New use pattern..............................................     33,800
Experimental use permit......................................      4,500
Old chemical.................................................      4,000
Amendment....................................................        700
------------------------------------------------------------------------


[53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993]



Sec. 152.406  Submission of supplementary data.

    Applicants may submit data to supplement pending applications 
without incurring additional charges if the proper fee was paid with 
submission of the original application and subsequent submissions of 
supplementary data do not constitute a change in the type of 
registration action requested.

[53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993]



Sec. 152.408  Special considerations.

    (a) If two or more applicants apply for a new chemical registration 
for products having the same active ingredient and each applicant 
provides a set of data in support of the registration developed 
independently of the other applicants' data, then each applicant 
submitting an independent set of data shall be charged the full new 
chemical registration review fee.
    (b) If two or more applicants apply for a new chemical registration 
for products having the same active ingredient and the applicants have 
jointly developed or paid for the joint development of a common set of 
data to support their applications for registration, then each applicant 
shall be charged an equal share of the total fee for review of the 
applications for all of the subject products. The total fee will include 
the sum of the new chemical registration review fee for one product and 
one old chemical registration review fee for each additional product.
    (c) If an application is received for registration of a product that 
contains two or more new chemical active ingredients and a different set 
of generic data is required by the Agency for each new chemical for the 
purpose of registration, the applicant will be required to pay the full 
new chemical registration review fee for each active ingredient.



Sec. 152.410  Adjustment of fees.

    (a) The fee schedule will be adjusted annually by the same 
percentage as the percent change in the Federal General Schedule (GS) 
pay scale. Such adjustments will be published in the Federal Register as 
a final rule and will be effective 30 days or more after promulgation.
    (b) Processing costs and fees will be reviewed periodically and 
changes will be made to the schedule as necessary. Such adjustments will 
be published for notice and comment in the Federal Register.



Sec. 152.412  Waivers and refunds.

    (a) Refunds. If an application is not accepted for processing 
because it is incomplete, the fee, less $1,200 for handling and initial 
review (or the amount of the fee, whichever is less), shall be returned. 
If an application is withdrawn by the applicant before significant 
Agency scientific review has begun, the fee, less $1,200, shall be 
returned. If an unacceptable or withdrawn petition is resubmitted, it 
shall be accompanied by the fee that would be required if it were 
submitted for the first time.
    (b) Waiver of fees for activities initiated by the Agency. The 
Agency may waive fees for amended registrations where the amendment has 
been initiated solely by the Agency. The Agency retains sole discretion 
in determining when this fee will be waived. The announcement of the fee 
waiver will accompany the EPA request for an amendment. The Agency will 
not approve any individual requests for waivers of EPA-initiated 
activity fees.
    (c) Waiver of fees for activities initiated by applicants. Upon 
request by an applicant, together with the supporting documentation or 
justification described in this paragraph, the Agency may waive or 
refund fees in whole or in part. A request for waiver must be submitted 
in accordance with Sec. 152.414(a). An application for which a waiver 
of fees has been requested will not be accepted for review until the 
waiver has been granted, or until the waiver has

[[Page 43]]

been denied and thereafter the proper fee has been submitted.
    (1) Minor use. Fees may be waived for applications limited to minor 
uses that lack commercial feasibility for the pesticide applicant. An 
applicant requesting a waiver on this basis must provide supporting 
information that demonstrates that anticipated revenues from the uses 
that are the subject of the application would be insufficient to pay 
back the cost of the fee. The burden of proof of the reasonableness of 
this estimate rests with the applicant.
    (2) IR-4. Fees will be waived for registration actions that are 
determined to be specifically associated with tolerance petitions 
submitted by the Inter-Regional Research Project Number 4 (IR-4 program) 
when such waiver is deemed by the Agency to be in the public interest.
    (3) Severe economic impact. The Agency may waive two-thirds of any 
cumulative registration fee payment in a 12-month period following 
completion of the applicant's most recent fiscal year that exceeds 3 
percent of the applicant's pesticide sales in its most recently 
completed fiscal year. An applicant requesting a waiver on this basis 
must provide documentation (e.g. copy of an annual report, or income tax 
forms filed with the Internal Revenue Service, or if needed, a notarized 
statement signed by a corporate officer regarding annual pesticide 
sales) demonstrating that:
    (i) The company applying had less than $40 million in gross revenue 
(including all revenue sources) in the most recently concluded fiscal 
year of operation, and a single fee would constitute more than 3 percent 
of the applicant's gross revenue from pesticide sales in the most 
recently completed fiscal year of operation, or
    (ii) The company applying had less than $40 million in gross revenue 
(including all revenue sources) in the most recently concluded fiscal 
year of operation, and the cumulative registration fees paid during the 
12 months following the applicant's most recently completed fiscal year, 
including any registration fees paid for the applicant for which a 
waiver is requested, constitute more than 3 percent of the applicant's 
gross revenue from pesticide sales in the most recently concluded fiscal 
year of operation.
    (iii) The Agency will not grant such a waiver if it determines that 
the entity submitting the application has been formed or manipulated to 
qualify for such a waiver.
    (4) Public interest. The Agency, in its discretion, may waive in 
whole or in part any of the fees established herein in the public 
interest. Examples include, but are not limited to, pesticides offering 
unique advantages for reducing public health risks, those that 
significantly reduce a current environmental risk, or a product with 
extraordinary utility for use in Integrated Pest Management (IPM).

[53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993]



Sec. 152.414  Procedures.

    (a) Procedures for requesting a waiver. (1) A request for a waiver 
must be submitted in writing at the time the application is submitted to 
the Office of Pesticide Programs' Document Processing Desk at the 
appropriate address as set forth in 40 CFR 150.17(a) or (b).
    (2) A payment of $1,200 for processing the waiver or the amount of 
the actual fee, whichever is less, must be submitted simultaneously to 
the address set forth in paragraph (b) of this section. This fee will be 
refunded (or applied to any resulting partial fee) if the waiver is 
granted. Payment of fees for the registration activities, in contrast to 
the waiver fee, shall not be required until the Agency makes a 
determination on the waiver request. Since the actual fee is submitted 
to an address different than the one to which the waiver request is 
submitted, a copy of the payment document must be submitted with the 
waiver request that is submitted to the Office of Pesticide Programs' 
Document Processing Desk as described in paragraph (a)(1) of this 
section. No fee is required from a person who has no financial interest 
in the application.
    (b) Procedures for payment of fees. All fees required by this 
section must be paid by money order, bank draft, or certified check 
drawn to the order of the Environmental Protection Agency. All payment 
of fees must be forwarded

[[Page 44]]

to the Environmental Protection Agency, Headquarters Accounting 
Operations Branch, Office of Pesticide Programs (Registration Fees), 
P.O. Box 360277M, Pittsburgh, PA 15251. The payments should be 
specifically labeled ``Registration Fees'' and should be accompanied 
only by a copy of the registration application form or the experimental 
use permit application form, as appropriate. An application will not be 
accepted for processing until the required fees have been submitted.
    (c) Procedures for submitting application and supporting data. The 
application, along with supporting data, shall be forwarded within 30 
days of payment to the Washington DC address set forth in paragraph 
(a)(1) of this section.

[53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993; 69 
FR 39864, July 1, 2004; 71 FR 35545, June 21, 2006]

Subparts V-Y [Reserved]



                            Subpart Z_Devices



Sec. 152.500  Requirements for devices.

    (a) A device is defined as any instrument or contrivance (other than 
a firearm) intended for trapping, destroying, repelling, or mitigating 
any pest or any other form of plant or animal life (other than man and 
other than a bacterium, virus, or other microorganism on or in living 
man or living animals) but not including equipment used for the 
application of pesticides (such as tamper-resistant bait boxes for 
rodenticides) when sold separately therefrom.
    (b) A device is not required to be registered under FIFRA sec. 3. 
The Agency has issued a policy statement concerning its authority and 
activities with respect to devices, which was published in the Federal 
Register of November 19, 1976 (41 FR 51065). A device is subject to the 
requirements set forth in:
    (1) FIFRA sec. 2(q)(1) and part 156 of this chapter, with respect to 
labeling;
    (2) FIFRA sec. 7 and part 167 of this chapter, with respect to 
establishment registration and reporting;
    (3) FIFRA sec. 8 and part 169 of this chapter, with respect to books 
and records;
    (4) FIFRA sec. 9, with respect to inspection of establishments;
    (5) FIFRA sec. 12, 13, and 14, with respect to violations, 
enforcement activities, and penalties;
    (6) FIFRA sec. 17, with respect to import and export of devices;
    (7) FIFRA sec. 25(c)(3), with respect to child-resistant packaging; 
and
    (8) FIFRA sec. 25(c)(4), with respect to the Agency's authority to 
declare devices subject to certain provisions of the Act.

[53 FR 15990, May 4, 1988. Redesignated at 60 FR 32096, June 19, 1995]



PART 153_REGISTRATION POLICIES AND INTERPRETATIONS--Table of Contents



Subparts A-F [Reserved]

         Subpart G_Determination of Active and Inert Ingredients

Sec.
153.125 Criteria for determination of pesticidal activity.

          Subpart H_Coloration and Discoloration of Pesticides

153.140 General.
153.155 Seed treatment products.

Subparts I-M [Reserved]

    Authority: 7 U.S.C. 136w.

Subparts A-F [Reserved]



         Subpart G_Determination of Active and Inert Ingredients

    Source: 53 FR 15989, May 4, 1988, unless otherwise noted.



Sec. 153.125  Criteria for determination of pesticidal activity.

    (a) An ingredient will be considered an active ingredient if it is 
contained in a pesticide product and:
    (1) The ingredient has the capability by itself, and when used as 
directed at the proposed use dilution, to function as a pesticide; or
    (2) The ingredient has the ability to elicit or enhance a pesticidal 
effect in another compound whose pesticidal activity is substantially 
increased due to the interaction of the compounds.

[[Page 45]]

Compounds which function simply to enhance or prolong the activity of an 
active ingredient by physical action, such as stickers and other 
adjuvants, are not generally considered to be active ingredients.
    (b) Normally the applicant will determine and state in his 
application whether an ingredient is active or inert with respect to 
pesticidal activity. The Agency, as part of its review of an application 
for registration, or in conjunction with the Registration Standard or 
Special Review process, may require any ingredient, to be designated as 
an active ingredient if the Agency finds that it meets the criteria in 
paragraph (a) of this section. Conversely, the Agency may determine that 
any ingredient designated as active by an applicant is an inert 
ingredient if it fails to meet those criteria.
    (c) If an ingredient is designated as an active ingredient, it must 
be identified in the label ingredients statement. If an ingredient is 
designated as an inert ingredient, it must be included as part of the 
total inert ingredients in the label ingredients statement.
    (d) Designation of a substance as a pesticidally inert ingredient 
does not relieve the applicant or registrant of other requirements of 
FIFRA with respect to labeling of inert ingredients or submission of 
data, or from the requirements of the Federal Food, Drug, and Cosmetic 
Act with respect to tolerances or other clearance of ingredients.

[53 FR 15989, May 4, 1988, as amended at 60 FR 32096, June 19, 1995]



          Subpart H_Coloration and Discoloration of Pesticides

    Source: 53 FR 15990, May 4, 1988, unless otherwise noted.



Sec. 153.140  General.

    Section 25(c)(5) of the Act authorizes the Administrator to 
prescribe regulations requiring coloration or discoloration of any 
pesticide if the Administrator determines that such requirements are 
feasible and necessary for the protection of health and the environment. 
This subpart describes those pesticide products which must be colored or 
discolored.

[60 FR 32096, June 19, 1995]



Sec. 153.155  Seed treatment products.

    (a) Pesticide products intended for use in treating seeds must 
contain an EPA-approved dye to impart an unnatural color to the seed, 
unless appropriate tolerances or other clearances have been established 
under the Federal Food, Drug and Cosmetic Act for residues of the 
pesticide.
    (b) The following products are exempt from the requirement of 
paragraph (a) of this section:
    (1) Products intended and labeled for use solely by commercial seed 
treaters, provided that the label bears a statement requiring the user 
to add an EPA-approved dye with the pesticide during the seed treatment 
process.
    (2) Products intended and labeled for use solely as at-planting or 
hopper box treatments.
    (3) Products which are gaseous in form or are used as fumigants.
    (c) EPA-approved dyes for seed treatment are listed in:
    (1) Sections 180.910, 180.920, and 180.950 if an exemption from the 
requirement of a tolerance has been established.
    (2) Section 180.2010 if EPA has determined that residues of the dye 
will be present, if at all, at levels that are below the threshold of 
regulation.
    (3) Section 180.2020 if it has been determined that no tolerance or 
exemption from the requirement of a tolerance is needed as a result of a 
determination by EPA that the use is unlikely to result in residues in 
food/feed.

[53 FR 15990, May 4, 1988, as amended at 66 FR 66772, Dec. 27, 2001; 69 
FR 23117, Apr. 28, 2004]

Subparts I-M [Reserved]



PART 154_SPECIAL REVIEW PROCEDURES--Table of Contents



                      Subpart A_General Provisions

Sec.
154.1 Purpose and scope.
154.3 Definitions.
154.5 Burden of persuasion in determinations under this part.

[[Page 46]]

154.7 Criteria for initiation of Special Review.
154.10 Petitions to begin the Special Review process.
154.15 Docket for the Special Review.

                          Subpart B_Procedures

154.21 Preliminary notification to registrants and applicants for 
          registration.
154.23 Proposed decision not to initiate a Special Review.
154.25 Public announcement of final decision whether to initiate a 
          Special Review.
154.26 Comment opportunity.
154.27 Meetings with interested persons.
154.29 Informal public hearings.
154.31 Notices of Preliminary Determination.
154.33 Notice of Final Determination.
154.34 Expedited procedures.
154.35 Finality of determinations.

    Authority: 7 U.S.C. 136a, d, and w.

    Source: 50 FR 49015, Nov. 27, 1985, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 154.1  Purpose and scope.

    (a) Purpose. The purpose of the Special Review process is to help 
the Agency determine whether to initiate procedures to cancel, deny, or 
reclassify registration of a pesticide product because uses of that 
product may cause unreasonable adverse effects on the environment, in 
accordance with sections 3(c)(6) and 6 of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA). The process is intended to 
ensure that the Agency assesses risks that may be posed by pesticides, 
and the benefits of use of those pesticides, in an open and responsive 
manner. The issuance of a Notice of Special Review means that the Agency 
has determined that one or more uses of a pesticide may pose significant 
risks and that, following completion of the Special Review process, the 
Agency expects to initiate formal proceedings seeking to cancel, deny, 
reclassify, or require modifications to the registration of the 
product(s) in question unless it has been shown during the Special 
Review that the Agency's initial determination was erroneous, that the 
risks can be reduced to acceptable levels without the need for formal 
proceedings, or that the benefits of the pesticide's use outweigh the 
risks. Following completion of the Special Review process, a pesticide 
in question may be returned to the registration process.
    (b) Scope. This part sets forth the substantive standards for 
initiating a Special Review of a pesticide product and the procedures 
for initiating and conducting the Special Review.



Sec. 154.3  Definitions.

    Terms used in this part have the same meaning as in the Act. In 
addition, as used in this part, the following terms shall apply:
    Act or FIFRA means the Federal Insecticide, Fungicide, and 
Rodenticide Act, as amended.
    Administrator means the Administrator of the Environmental 
Protection Agency or any officer or employee thereof to whom authority 
has been delegated to act for the Administrator.
    Confidential business information means trade secrets or 
confidential commercial or financial information under FIFRA section 
10(b) or 5 U.S.C. 552(b)(3) or (4).
    Other significant evidence means factually significant information 
that relates to the uses of the pesticide and its adverse risk to man or 
to the environment but does not include evidence based only on misuse of 
the pesticide unless such misuse is widespread and commonly recognized 
practice.
    Person means an applicant, registrant, manufacturer, pesticide user, 
environmental group, labor union, or other individual or group of 
individuals interested in pesticide regulation.
    Pesticide use means a use of a pesticide (described in terms of the 
application site and other applicable identifying factors) that is 
included in the labeling of a pesticide product which is registered, or 
for which an application for registration is pending, and the terms and 
conditions (or proposed terms and conditions) of registration for the 
use.
    Terms and conditions of registration means the terms and conditions 
governing lawful sale, distribution, and use approved in conjunction 
with registration, including labeling, use classification, composition, 
and packaging.

[[Page 47]]

    Validated test means a test determined by the Agency to have been 
conducted and evaluated in a manner consistent with accepted scientific 
procedures.

[73 FR 75595, Dec. 12, 2008]



Sec. 154.5  Burden of persuasion in determinations under this part.

    In making determinations under this part the Administrator shall be 
guided by the principle that the burden of persuasion that a pesticide 
product is entitled to registration or continued registration for any 
particular use or under any particular set of terms and conditions of 
registration is always on the proponent(s) of registration.



Sec. 154.7  Criteria for initiation of Special Review.

    (a) The Administrator may conduct a Special Review of a pesticide 
use if he determines, based on a validated test or other significant 
evidence, that the use of the pesticide (taking into account the 
ingredients, impurities, metabolites, and degradation products of the 
pesticide):
    (1) May pose a risk of serious acute injury to humans or domestic 
animals.
    (2) May pose a risk of inducing in humans an oncogenic, heritable 
genetic, teratogenic, fetotoxic, reproductive effect, or a chronic or 
delayed toxic effect, which risk is of concern in terms of either the 
degree of risk to individual humans or the number of humans at some 
risk, based upon:
    (i) Effects demonstrated in humans or experimental animals.
    (ii) Known or predicted levels of exposure of various groups of 
humans.
    (iii) The use of appropriate methods of evaluating data and relating 
such data to human risk.
    (3) May result in residues in the environment of nontarget organisms 
at levels which equal or exceed concentrations acutely or chronically 
toxic to such organisms, or at levels which produce adverse reproductive 
effects in such organisms, as determined from tests conducted on 
representative species or from other appropriate data.
    (4) May pose a risk to the continued existence of any endangered or 
threatened species designated by the Secretary of the Interior or the 
Secretary of Commerce under the Endangered Species Act of 1973, as 
amended.
    (5) May result in the destruction or other adverse modification of 
any habitat designated by the Secretary of the Interior or the Secretary 
of Commerce under the Endangered Species Act as a critical habitat for 
any endangered or threatened species.
    (6) May otherwise pose a risk to humans or to the environment which 
is of sufficient magnitude to merit a determination whether the use of 
the pesticide product offers offsetting social, economic, and 
environmental benefits that justify initial or continued registration.
    (b) In making any determination that a pesticide use satisfies one 
of the criteria for issuance of a Special Review specified by paragraph 
(a) of this section, the Administrator shall consider available evidence 
concerning both the adverse effect in question and the magnitude and 
scope of exposure of humans and nontarget organisms associated with use 
of the pesticide.



Sec. 154.10  Petitions to begin the Special Review process.

    The Administrator may evaluate a pesticide use under the criteria of 
Sec. 154.7 either on his own initiative, or at the suggestion of any 
interested person.



Sec. 154.15  Docket for the Special Review.

    (a) Establishment of the docket. When the Agency first notifies 
registrants privately that it is considering issuance of a Notice of 
Special Review for a pesticide, it shall establish a docket concerning 
that particular pesticide.
    (b) Contents of the docket. For each pre-Special Review or Special 
Review, the docket shall contain:
    (1) The Notice of Special Review, any Notice of Preliminary 
Determination, and any Notice of Final Determination.
    (2) Any notice issued under Sec. 154.21 or Sec. 154.23.
    (3) Any documents (other than information claimed to be confidential 
business information) referred to by the Agency in those notices as 
relied upon by the Agency in reaching its determination.

[[Page 48]]

    (4) Copies of all written comments or materials (other than 
information claimed to be confidential business information) responding 
to any notice furnished under Sec. 154.21 or Sec. 154.23 or submitted 
at any time during the Special Review process by any person outside of 
government.
    (5) Any written response to the Notice of Preliminary Determination 
from the Secretary of Agriculture or the Scientific Advisory Panel.
    (6) A transcript of all public meetings held by the Scientific 
Advisory Panel or conducted by the Agency for the purpose of gathering 
information.
    (7) A memorandum describing each meeting between Agency personnel 
and any person or party outside of government which concerns a pending 
pre-Special Review or Special Review decision. Each such memorandum 
shall be based on notes taken at the meeting and shall specify the date 
and time of the meeting, the participants and their affiliations, who 
requested the meeting, the subject matter of the meeting, and the person 
who prepared the memorandum. Except for information claimed to be 
confidential business information, each memorandum shall describe fully 
and accurately all significant positions taken, arguments made, and 
facts presented by each participant in the meeting, and shall identify 
all documents, proposals, or other materials distributed or exchanged at 
the meeting. Any discussion of claimed confidential business information 
shall be identified in meeting notes and referenced in the memorandum.
    (8) All comments, correspondence, or other materials concerning a 
pending pre-Special Review or Special Review decision provided to the 
Agency by a person or party outside of government (other than 
information claimed to be confidential business information).
    (9) All documents, proposals, or other materials concerning a 
pending pre-Special Review or Special Review decision, provided by the 
Agency to any person or party outside of government (other than 
information claimed to be confidential business information).
    (c) Assertion of confidential business information claims. (1) 
Information, comments, data, or other written material submitted to the 
Agency concerning a Special Review may be claimed by the submitter to be 
confidential business information. The burden of identifying claimed 
confidential business information rests with the submitter, or, in 
meetings, with the participants who wish to assert a claim of 
confidentiality.
    (2) To assert a claim of confidentiality for all or any part of a 
written submission concerning a Special Review, the submitter must 
furnish three copies of the material. Two copies must be complete, with 
claimed confidential business information clearly marked in the text. 
Items in the document that are claimed confidential should be numbered 
consecutively throughout the text. The third copy must have the claimed 
confidential business information excised from the text without closing 
up or paraphrasing the remaining text. The deletions should be 
consecutively numbered to correspond to the numbering of the complete 
copies. Each copy must be marked on the cover as to whether it contains 
claimed confidential business information.
    (3) Any written material concerning a Special Review received by the 
Agency that is not marked as confidential will be deemed to be 
nonconfidential, and may be made available through the public docket or 
otherwise disclosed without prior notice to the submitter.
    (d) Placement of materials in the docket. Any memorandum identified 
under paragraph (b)(7) of this section shall be placed in the docket 
within 10 working days of the subject meeting. Materials identified 
under paragraph (b)(8) of this section shall be placed in the docket 
within 10 working days of receipt by the Office of Pesticide Programs, 
or within 15 working days of receipt by the Office of Pesticide Programs 
if the submitter has asserted a confidential business information claim 
concerning the submittal. Materials identified under paragraph (b)(9) of 
this section shall be placed in the docket within 15 working days of 
transmittal to such person or party outside of government.
    (e) Index. The Agency shall prepare and maintain a current index of 
all materials included in the docket. The index will include a list 
identifying, for

[[Page 49]]

each meeting between Agency personnel and a person or party outside of 
government for which a memorandum has been prepared, the date, the 
subject, participants, and person who requested the meeting. The index 
will also list any document included in the docket by its title, its 
source, its recipient, and the date it was received or provided by the 
Agency.
    (f) Access to the docket. (1)(i) For each chemical in Special 
Review, the docket shall be available for public inspection and copying 
and its index kept current and made available to the public on request. 
The docket and index for any pesticide for which the Agency has issued a 
pre-Special Review notification under Sec. 154.21 will only be made 
available for public inspection and copying following issuance of a 
proposed decision not to start a Special Review under Sec. 154.23, a 
Notice of Special Review under Sec. 154.25(c), or as otherwise 
specified in Sec. 154.34.
    (ii) The docket and index will be available at the OPP Regulatory 
Public Docket located as set forth in 40 CFR 150.17(c).
    (2) Information contained in the docket shall not be disclosed to 
the public to the extent that FIFRA or any other statute or regulation 
(including, but not limited to, 5 U.S.C. 552(b)(3) or (4)) prohibits its 
disclosure.
    (3) The Agency will distribute a compendium of indices for new 
materials in the public docket by mail, on a monthly basis, to those 
members of the public who have specifically requested such material. The 
Agency will announce the availability of docket indices both annually in 
the Federal Register and in each Federal Register Notice concerning pre-
Special Review or Special Review for specific pesticides. The Agency may 
also periodically require parties on the mailing list to renew their 
previous request for such materials.

[50 FR 49015, Nov. 27, 1985, as amended at 69 FR 39864, July 1, 2004; 71 
FR 35545, June 21, 2006]



                          Subpart B_Procedures



Sec. 154.21  Preliminary notification to registrants and applicants for 

registration.

    (a) Preliminary notification. If the Administrator decides that he 
may initiate a Special Review of a pesticide use, he shall send written 
notice by certified mail to the affected registrant(s) and applicant(s) 
setting forth his decision and a general description of the information 
which supports it.
    (b) Comment opportunity. Registrant(s) and applicant(s) will be 
allowed 30 days from the receipt of notification to respond in writing 
to dispute the validity of the Agency's conclusions or to present 
information in response to the notification.



Sec. 154.23  Proposed decision not to initiate a Special Review.

    If the Administrator proposes not to initiate a Special Review after 
having given notice under Sec. 154.21, he shall issue a proposed 
decision for publication in the Federal Register. The proposal shall 
include a description of the concerns which were the original basis for 
placement of the pesticide in pre-Special Review status and the Agency's 
rationale for its proposed decision, announce the availability of a 
public docket, and provide a period generally not less than 30 days for 
submission of comments. A notice under Sec. 154.25(b) may not be 
published unless it has been preceded by a notice under this section. A 
proposal under this section shall not be based on the benefits of use of 
a pesticide product.



Sec. 154.25  Public announcement of final decision whether to initiate a 

Special Review.

    (a) The Administrator shall evaluate the available information and 
the comments received in response to the notice under Sec. 154.21 and 
any notice issued under Sec. 154.23, and shall issue for publication in 
the Federal Register a notice under paragraph (b) or (c) of this 
section.
    (b) If the Administrator determines after having given notice under 
Sec. 154.21 not to initiate a Special Review, he shall issue his 
decision for publication

[[Page 50]]

in the Federal Register with a statement of reasons.
    (c) If the Administrator determines after having given notice under 
Sec. 154.21 that one or more of the risk criteria set forth in Sec. 
154.7 have been satisfied, the Agency shall issue a notice for 
publication in the Federal Register which shall include:
    (1) Identification of the pesticide uses for which a Special Review 
has been initiated and an identification of the criteria which have been 
satisfied.
    (2) A brief discussion of the Agency's reasons for determining that 
the criteria have been satisfied.
    (3) A statement indicating that EPA has established a docket for the 
Special Review, the contents of the docket, the location of the docket, 
and the times during which the docket will be available for inspection 
and copying.
    (4) An invitation to all interested persons to submit further 
information concerning the risks and benefits associated with each use 
of the pesticide subject to the Special Review.
    (5) A brief description of the Special Review process and a 
statement that registrants and applicants bear an affirmative burden of 
supporting registration of a pesticide product.
    (6) A date by which information in response to the Agency's request 
for further information must be submitted.
    (d) In his discretion, the Administrator may request that the 
Scientific Advisory Panel hold a public meeting to review the scientific 
issues related to the Special Review.



Sec. 154.26  Comment opportunity.

    After issuance of a Notice of Special Review that applies to a use 
of a pesticide product (or category of products), any person may submit 
to the Agency any information, argument, or both, pertinent to:
    (a) Whether the use of a pesticide product satisfies any of the 
Sec. 154.7 risk criteria, with respect to the composition, labeling, 
packaging, and restrictions on use of the product as currently 
registered.
    (b) Whether the use of a pesticide product would satisfy any of the 
Sec. 154.7 risk criteria if its composition, labeling, packaging, and 
restrictions on use were approved in accordance with an application for 
registration or amended registration pending before the Agency. For 
further information see Sec. 154.27(b).
    (c) Whether any risks posed by the use or proposed use of the 
product that satisfy the Sec. 154.7 risk criteria are unreasonable, 
taking into account the economic, social, and environmental costs and 
benefits of the use of the product.
    (d) What regulatory action, if any, the Agency should take with 
respect to the use of the product.



Sec. 154.27  Meetings with interested persons.

    (a) In the Special Review process, to assure openness and 
responsiveness, no person or party outside of government will be 
afforded special or preferential access to Agency Special Review 
decisionmakers or to the Agency's Special Review process. At the same 
time, however, Agency personnel are free to meet and otherwise 
communicate with persons or parties outside of government, including 
registrants and manufacturers, users, trade unions, environmental groups 
and other interested persons, to obtain information, exchange views, 
explore factual and substantive positions, or discuss regulatory options 
concerning Special Review decisions.
    (b) Meetings between EPA and any person or party outside of 
government will not result in undue delay in reaching Special Review 
decisions. During such meetings, the Agency will not commit to take any 
particular action concerning a pending decision. The Agency may receive 
and consider information and recommendations from persons or parties 
outside of government; however, the Agency will make the final 
administrative decision on a wholly independent basis and in accordance 
with law.
    (c) Any interested person may ask to meet with Agency officials to 
discuss factual information available to the Agency, to present any 
factual information, to respond to presentations by other persons, or to 
discuss what regulatory actions should be taken regarding a pesticide 
which is or may be the subject of a Special Review. If, at its

[[Page 51]]

discretion, the Agency holds such meetings with any person outside of 
government concerning a use of a pesticide product, the Agency will 
prepare and file in the docket a memorandum of such meeting, meeting the 
requirements specified in Sec. 154.15(b)(7).
    (d) Meetings described in this section may include meetings held 
after issuance of a Notice of Special Review with any registrant who 
proposes to change voluntarily the composition, packaging, and labeling, 
or other terms and conditions of registration of his pesticide product 
in a way which he believes would reduce the risks of use of the product 
so that it would no longer meet or exceed the risk criteria of Sec. 
154.7. Meetings for this purpose will be most helpful and productive for 
both registrants and the Agency if they are requested by registrants 
shortly after the issuance of the Notice of Special Review.
    (e) If the Agency meets with any person or party outside of 
government concerning a pending Special Review decision, the Agency will 
not issue a final Special Review decision until 30 days after inclusion 
of a memorandum concerning that meeting in the public docket. During 
those 30 days, any person or party may submit written comments to the 
Agency regarding the subject matter of the meeting in question. The 
Agency may issue a final Special Review decision without allowing this 
30-day period if expedited action is necessary to protect public health 
or the environment, or if the Agency has invited other parties with 
potentially opposing viewpoints to the meeting in question (e.g., 
registrants, users, labor, and environmental groups).
    (f) The Agency may decline to meet subsequently with any person or 
party who asserts unreasonable confidential business information claims 
pursuant to Sec. 154.15(c) for the purpose of circumventing the 
docketing procedures described in Sec. 154.15(b).



Sec. 154.29  Informal public hearings.

    (a) Timing. At any time after issuance of a Notice of Special Review 
and prior to issuance of a Notice of Final Determination, the 
Administrator may conduct an informal public hearing to gather relevant 
information or otherwise assist Agency decisionmaking.
    (b) Federal Register notice. The Administrator shall issue a notice 
for publication in the Federal Register of any informal public hearing 
to be held under this section. The notice shall contain the following 
information:
    (1) The time, date, and place of the hearing.
    (2) A brief description of the procedures governing participation in 
the hearing by interested persons.
    (3) The issues to be considered at the hearing.
    (c) Transcript. A verbatim transcript of the hearing shall be 
prepared and filed in the public docket.



Sec. 154.31  Notices of Preliminary Determination.

    The Administrator shall prepare a Notice of Preliminary 
Determination after the close of the comment period on a Notice of 
Special Review.
    (a) Contents of notice. The Notice of Preliminary Determination 
shall respond to all significant comments submitted in response to the 
Notice of Special Review. For each use of a pesticide product that was 
the subject of the Notice of Special Review, the Notice of Preliminary 
Determination shall also include, as appropriate:
    (1) A determination whether the use satisfies any of the risk 
criteria set forth in Sec. 154.7, and a discussion of the reasons for 
the determination.
    (2) A determination of whether any changes in the composition, 
packaging, labeling, or restrictions on use of a pesticide product that 
were proposed in an application for new or amended registration 
submitted after issuance of the Notice of Special Review would reduce 
the risk so that the use no longer would satisfy any of the risk 
criteria in Sec. 154.7.
    (3) If the use satisfies any of the risk criteria set forth in Sec. 
154.7, a determination of whether the adverse effects posed by the use 
are unreasonable, taking into account the economic, social, and 
environmental costs and benefits of the use of the product, and a 
discussion of reasons for the determination.

[[Page 52]]

    (4) If the use is determined to pose an unreasonable adverse effect, 
a statement of the regulatory action, if any, which the Agency intends 
to initiate with respect to the use, and a discussion of the reasons for 
initiating that regulatory action.
    (5) A statement that the Administrator is requesting comments from 
the Secretary of Agriculture and the Scientific Advisory Panel on the 
notices and analysis specified in paragraph (b) of this section, and 
that the notices and analysis are available on request.
    (6) Instructions to interested persons on how to submit comments 
(including the deadline for submission of comments).
    (7) The location of the docket under Sec. 154.15 and the times 
during which the docket will be available for inspection and copying.
    (b) Referral to Secretary of Agriculture and Scientific Advisory 
Panel. If the Administrator proposes to cancel, deny, or change the 
classification of the registration of a pesticide product which is the 
subject of a Special Review, or to hold a hearing under FIFRA section 
6(b)(2) on whether to take any of those actions, he shall:
    (1) Prepare a proposed form of a Notice of Intent to Cancel, a 
Notice of Intent to Deny Registration, a Notice of Intent to Hold a 
Hearing, and/or a Notice of Intent to Change Classification, as 
appropriate.
    (2) Prepare an Agricultural Impact Analysis, analyzing the impact of 
the proposed action on production and prices of agricultural 
commodities, retail food prices, and otherwise on the agricultural 
economy.
    (3) Send the proposed notices and analysis to the Secretary of 
Agriculture and the Scientific Advisory Panel for comment, as provided 
by the Act.
    (4) Send the Notice of Preliminary Determination and the other 
notices and analysis prepared under this section to all registrants and 
applicants for registration of products that are subject to the Special 
Review.
    (c) Publication. The Agency shall issue the Notice of Preliminary 
Determination for publication in the Federal Register.



Sec. 154.33  Notice of Final Determination.

    (a) Publication and notice to registrants and applicants. The 
Administrator shall prepare a Notice of Final Determination after the 
close of the comment period on a Notice of Preliminary Determination. As 
necessary, the Administrator shall also prepare Notices of Intent to 
Cancel, Notices of Denial, Notices of Intent to Hold a Hearing under 
FIFRA section 6(b)(2), or Notices of Intent to Change Classification.
    (b) Contents. The Notice of Final Determination shall include:
    (1) For each pesticide use subject to the Notice of Preliminary 
Determination, the Agency's final determination with respect to each 
use, along with a discussion of the reasons for the determination.
    (2) Any comments submitted by the Secretary of Agriculture or the 
Scientific Advisory Panel, and the responses of the Administrator to 
these comments.
    (3) The response of the Administrator to any significant public 
comments submitted on the Notice of Preliminary Determination.
    (4) Instructions to registrants, applicants for registration, and 
other interested persons concerning the procedures which will be used to 
implement any regulatory action which the Administrator has decided 
upon, including instructions concerning how to request hearings, if 
hearings are available as of right under the Act or have been made 
available by the Administrator under the Act.
    (5) The location of the docket under Sec. 154.15 and the times 
during which the docket will be available for inspection and copying.
    (c) Publication and notification of registrants and applicants. The 
Notice of Final Determination and any Notice of Intent to Cancel, Notice 
of Denial, Notice of Intent to Hold a Hearing, or Notice of Intent to 
Change Classification shall be published in the Federal Register. If the 
Administrator issues a Notice of Intent to Cancel, Notice of Denial, 
Notice of Intent to Hold a Hearing, or Notice of Intent to Change 
Classification, such notice, along with the Notice of Final 
Determination, also shall be sent by certified mail to all affected 
registrants and applicants.

[[Page 53]]



Sec. 154.34  Expedited procedures.

    (a) The Agency may elect to issue a Notice of Special Review and a 
Notice of Preliminary Determination simultaneously; or, to initiate 
cancellation, suspension, or denial proceedings concerning a pesticide 
or any of its uses without first conducting a Special Review or issuing 
a Notice of Preliminary Determination.
    (b) If the Agency elects to issue a simultaneous Notice of Special 
Review and Notice of Preliminary Determination, the Agency will make the 
docket for that decision available for public inspection no more than 3 
months after the Agency privately notifies the registrant of its risk 
concerns pursuant to Sec. 154.21(a).



Sec. 154.35  Finality of determinations.

    (a) The Administrator will not approve an application for 
registration or amended registration of a pesticide product except by 
use of the procedures specified in paragraph (c) of this section, if:
    (1) The application proposes registration of a product for a use 
which earlier had been the subject of a notice under Sec. 154.21(a);
    (2) After the Administrator issued the notice, he determined not to 
initiate a Special Review, because of a proposal by an applicant for 
registration or amended registration to change the terms and conditions 
of registration of the product in a way which would reduce the risk 
sufficiently to eliminate the need for a Special Review; and
    (3) The application for registration or amended registration now 
proposes that the terms and conditions which served as the basis of the 
earlier determination be eliminated, or be modified in a way which might 
increase the risk which was the subject of the notice under Sec. 
154.21(a).
    (b) The Administrator will not approve an application for 
registration or amended registration of a pesticide product except by 
use of the procedures specified in paragraph (c) of this section, if:
    (1) The application proposed registration of a product for a use 
which earlier had been the subject of a Notice of Special Review issued 
under Sec. 154.25;
    (2) After the Administrator issued that Notice, he determined not to 
issue a notice under FIFRA section 3(c)(6) or 6(b) because of a proposal 
by an applicant for registration or amended registration to change the 
terms and conditions of registration of the product in a way which would 
reduce the risk sufficiently to eliminate the need for issuance of a 
notice under FIFRA section 3(c)(6) or 6(b); and
    (3) The application for registration or amended registration now 
proposes that the terms and conditions of registration which served as 
the basis for the earlier determination now be eliminated or be modified 
in a way which might increase the risk which was the subject of the 
Notice of Special Review.
    (c) An application to which paragraph (a) or (b) of this section 
applies may not be approved until:
    (1) The Administrator issues a notice for publication in the Federal 
Register which describes why the application is subject to the 
provisions of this section, states that the Administrator proposes to 
approve the application and his reasons, solicits public comment on 
whether the application should be approved, and provides a period not 
less than 30 days for comments to be submitted; and
    (2) If any substantive comments are submitted in response to the 
notice, the Administrator issues a second notice for publication in the 
Federal Register responding to the comments.



PART 155_REGISTRATION STANDARDS AND REGISTRATION REVIEW--Table of Contents



Subpart A [Reserved]

         Subpart B_Docketing and Public Participation Procedures

Sec.
155.23 Definitions.
155.25 Schedule.
155.27 Agency review of data.
155.30 Meetings and communications.
155.32 Public docket.
155.34 Notice of availability.

                Subpart C_Registration Review Procedures

155.40 General.

[[Page 54]]

155.42 Registration review cases.
155.44 Establish schedules for registration review.
155.46 Deciding that a registration review is complete and additional 
          review is not needed.
155.48 Data Call-In.
155.50 Initiate a pesticide's registration review.
155.52 Stakeholder engagement.
155.53 Conduct of a pesticide's registration review.
155.56 Interim registration review decision.
155.57 Registration review decision.
155.58 Procedures for issuing a decision on a registration review case.

    Authority: 7 U.S.C. 136a and 136w.

    Source: 50 FR 49001, Nov. 27, 1985, unless otherwise noted.

Subpart A [Reserved]



         Subpart B_Docketing and Public Participation Procedures



Sec. 155.23  Definitions.

    For the purposes of this part, confidential business information 
means trade secrets or confidential commercial or financial information 
under FIFRA sec. 10(b) or 5 U.S.C. 552(b) (3) or (4).



Sec. 155.25  Schedule.

    EPA will issue annually in the Federal Register a notice listing the 
pesticides (or groups of pesticides) for which Registration Standards 
are currently being developed. The list will include pesticides for 
which a Registration Standard is scheduled for issuance within the next 
year, and the approximate sequence of issuance. The list may also 
include pesticides for which a Registration Standard will be under 
development during the upcoming year, but which are not scheduled for 
issuance until the succeeding year. The notice will invite comment and 
submission of information on the individual pesticides on the list.



Sec. 155.27  Agency review of data.

    EPA will independently (or using the services of disinterested 
contractors or consultants) review available data in preparation for the 
development of a Registration Standard, and will be responsible for the 
drafting of the Registration Standard based on such data reviews. The 
Agency will not permit registrants to prepare, or assist in the 
preparation of, data reviews or other Registration Standard documents. 
The Agency may, however, meet with registrants to discuss its pending 
reviews, decisions, or documents, in accordance with the meeting 
procedures in Sec. 155.30, and the docketing procedures in Sec. 
155.32.



Sec. 155.30  Meetings and communications.

    EPA personnel may, upon their own initiative or upon request of any 
interested person or party, meet or communicate with persons or parties 
outside of government concerning a Registration Standard under 
development. Such meetings or communications will conform to the 
following policies and procedures:
    (a) Purpose. Meetings and communications may be for the purpose of 
receiving and considering information, exchanging views, exploring 
factual and substantive positions, discussing regulatory options or for 
any other purpose deemed appropriate by the Agency in its deliberations 
concerning development of a Registration Standard. The Agency will not 
commit to take any particular action concerning a Registration Standard 
under development during discussions with any person or party outside of 
government. The Agency will make its final administrative decision on a 
wholly independent basis, and in accordance with law.
    (b) Meetings with persons or parties outside of government. Requests 
by responsible persons or parties outside of government to meet with 
Agency personnel concerning a Registration Standard under development 
should be directed in writing to the Registration Division. Reasonable 
requests will ordinarily be granted on a timely basis. EPA will decide 
the time and place of such meetings, and the Agency personnel who will 
attend. EPA may decline to meet with persons or parties who assert 
unreasonable claims of confidential business information for the purpose 
of circumventing the docketing procedures in Sec. 155.32. EPA may also 
decline to meet if the number or

[[Page 55]]

frequency of meetings would delay unduly the issuance of the 
Registration Standard. Further, no person or party outside government 
will be accorded special or preferential access to Agency pesticide 
decisionmaking or to the Agency's decisional process.
    (c) Information submitted to the Agency concerning a Registration 
Standard under development. (1) Information, comments, data, or other 
written material submitted to the Agency at any time concerning a 
Registration Standard under development may be claimed by the submitter 
to be confidential business information. The burden of identifying 
claimed confidential business information rests with the submitter, or, 
in meetings, with the participants from outside of government who wish 
to assert a claim of confidentiality.
    (2) To assert a claim of confidentiality for all or any part of a 
written submission concerning a Registration Standard under development, 
the submitter must furnish three copies of the material. Two copies must 
be complete, with claimed confidential business information clearly 
marked in the text. Items in the document that are claimed confidential 
should be numbered consecutively throughout the document. The third copy 
must have the claimed confidential business information excised from the 
text without closing up or paraphrasing the remaining text. The 
deletions should be consecutively numbered to correspond to the 
numbering of the complete copies. Each copy must be marked on the cover 
as to whether it contains claimed confidential business information.
    (3) Any written material received by the Agency that is not marked 
as confidential will be deemed to be nonconfidential, and may be made 
available through the public docket or otherwise disclosed without prior 
notice to the submitter.
    (d) Memorandum of meeting. For each meeting with a person or party 
outside of government, the Agency will prepare, based on notes taken at 
the meeting, a memorandum of the meeting. The memorandum will be 
prepared within 10 working days of the meeting and will include all of 
the following information:
    (1) The date and time of the meeting.
    (2) The name of the person who requested the meeting.
    (3) The names and affiliations of the participants.
    (4) The subject matter of the meeting.
    (5) A full and accurate description of all significant positions 
taken, facts presented, and arguments made by each participant (except 
that any discussion of claimed confidential business information will be 
identified in meeting notes, and referenced in the memorandum).
    (6) Identification of all documents, proposals, or other materials 
(other than information claimed to be confidential business information) 
distributed or exchanged at the meeting.
    (7) The name of the person who prepared the memorandum.

[50 FR 49001, Nov. 27, 1985, as amended at 58 FR 34203, June 23, 1993]



Sec. 155.32  Public docket.

    (a) When created. (1) A docket will be created for each Registration 
Standard under development when the Agency begins review of data for the 
Registration Standard or upon publication of the notice described in 
Sec. 155.25 setting out the list and sequence of Registration 
Standards, whichever is earlier. The Agency will announce in its annual 
schedule notice the dockets that are available for Registration 
Standards under development.
    (2) If the Agency notifies registrants privately in accordance with 
40 CFR 154.21 that one or more risk criteria set forth in 40 CFR 154.7 
(leading to a special review) may have been exceeded, that notification 
and any subsequent communications concerning that notification will be 
placed in a separate docket pertaining to possible special review in 
accordance with the provisions of Sec. 154.15.
    (b) Contents of docket. The docket will contain, within the time 
frames indicated, all of the following documents and information (except 
that information claimed to be confidential business information will 
not be included):
    (1) An index of its contents (refer to paragraph (c) of this 
section).
    (2) A copy of each comment received in response to the notice 
described in Sec. 155.25 that pertains to a pesticide for

[[Page 56]]

which the notice indicated a Registration Standard was under development 
(within 10 working days after receipt by the Agency, or 15 working days 
if the submitter has asserted a confidential business information claim 
concerning the material).
    (3) A copy of each memorandum of a meeting between the Agency and 
persons or parties outside of government, prepared in accordance with 
Sec. 155.30(d) (within 10 working days after the meeting).
    (4) A copy of each document, comment, item of correspondence or 
other written material concerning the Registration Standard submitted to 
the Agency by any person or party outside of government, whether in a 
meeting or separately (within 10 working days after receipt, or 15 
working days if the submitter has asserted a confidential business 
information claim concerning the material).
    (5) A copy of each document, proposal, or other item of written 
material concerning the Registration Standard provided by the Agency to 
any person or party outside of government (within 15 working days after 
the item is made available to such person or party).
    (6) A copy of the Registration Standard;
    (7) With respect to a Registration Standard for which the Agency has 
determined that a substantially complete chronic health and teratology 
data base exists, a copy of the Federal Register notice concerning 
availability of a proposed Registration Standard, and a copy of each 
comment received in response to that notice (within 10 working days 
after receipt by the Agency, or 15 working days if the submitter has 
asserted a confidential business information claim concerning the 
material).
    (8) A copy of the Federal Register notice announcing the issuance of 
the Registration Standard (within 10 working days after the publication 
of the notice).
    (c) Index of the docket. The Agency will establish and keep current 
an index to the docket for each Registration Standard. The index will 
include, but is not limited to:
    (1) A list of each meeting between the Agency and any person or 
party outside of government, containing the date and subject of the 
meeting, the names of participants and the name of the person requesting 
the meeting.
    (2) A list of each document in the docket by title, source or 
recipient(s), and the date the document was received or provided by the 
Agency.
    (d) Availability of docket and indices. (1) The Agency will make 
available to the public for inspection and copying the docket and index 
for any Registration Standard.
    (2) The Agency will establish and maintain a mailing list of persons 
who have specifically requested that they receive indices for 
Registration Standard dockets. On a quarterly basis, EPA will distribute 
the indices of new materials placed in the public docket to these 
persons. Annually, EPA will require that persons on the list renew their 
requests for inclusion on the list.
    (3) The Agency will issue annually in the Federal Register (in 
conjunction with the annual schedule notice specified in Sec. 155.25) a 
notice announcing the availability of docket indices.
    (4) Each Federal Register notice of availability of a Registration 
Standard will announce the availability of the docket index for that 
Standard.



Sec. 155.34  Notice of availability.

    (a) The Agency will issue in the Federal Register a notice 
announcing the issuance and availability of Registration Standard which:
    (1) Concerns a previously unregistered active ingredient; or
    (2) Concerns a previously registered active ingredient, and the 
Registration Standard states that registrants will be required (under 
FIFRA section 3(c)(2)(B)) to submit chronic health (including, but not 
limited to, chronic feeding, oncogenicity and reproduction) or 
teratology studies.
    (b) Interested persons may submit comments concerning any 
Registration Standard described by paragraph (a) of this section at any 
time.
    (c) The Agency will issue in the Federal Register a notice 
announcing the availability of, and providing opportunity for comment 
on, each proposed Registration Standard which concerns

[[Page 57]]

a previously registered active ingredient for which the Agency has 
determined that a substantially complete chronic health and teratology 
data base exists. Following the comment period and issuance of the 
Registration Standard, the Agency will issue in the Federal Register a 
notice of availability of the Registration Standard.



                Subpart C_Registration Review Procedures

    Source: 71 FR 45732, Aug. 9, 2006, unless otherwise noted.



Sec. 155.40  General.

    (a) Purpose. These regulations establish procedures for the 
registration review program required in FIFRA section 3(g). Registration 
review is the periodic review of a pesticide's registration to ensure 
that each pesticide registration continues to satisfy the FIFRA standard 
for registration. Under FIFRA section 3(g), each pesticide is required 
to be reviewed every 15 years.
    (1) Among other things, FIFRA requires that a pesticide generally 
will not cause unreasonable adverse effects on the environment. 
Registration review is intended to ensure that each pesticide's 
registration is based on current scientific and other knowledge 
regarding the pesticide, including its effects on human health and the 
environment.
    (2) If a product fails to satisfy the FIFRA standard for 
registration, the product's registration may be subject to cancellation 
or other remedies under FIFRA.
    (b) Applicability. This subpart applies to every pesticide product 
registered under FIFRA section 3 as well as all pesticide products 
registered under FIFRA section 24(c). It does not apply to products 
whose sale or distribution is authorized under FIFRA section 5 or 
section 18.
    (c) Limitations. (1) At any time, the Agency may undertake any other 
review of a pesticide under FIFRA, irrespective of the pesticide's past, 
ongoing, scheduled, or not yet scheduled registration review.
    (2) When the Agency determines that new data or information are 
necessary for a pesticide's registration review, it will require such 
data under FIFRA section 3(c)(2)(B).

[71 FR 45732, Aug. 9, 2006, as amended at 73 FR 75595, Dec. 12, 2008]



Sec. 155.42  Registration review cases.

    (a) Establishing registration review cases. A registration review 
case will be composed of one or more active ingredients and all the 
products containing such ingredient(s). The Agency may group related 
active ingredients into a registration review case when the active 
ingredients are so closely related in chemical structure and 
toxicological profile as to allow common use of some or all required 
data for hazard assessment.
    (1) Existing pesticides. The Agency will assign each pesticide 
registered on or before the effective date of this regulation to a 
registration review case.
    (2) New pesticides. The Agency will assign each pesticide registered 
after the effective date of this regulation to an existing registration 
review case or to a new registration review case.
    (3) A pesticide product that contains multiple active ingredients 
will belong to the registration review cases for each of its active 
ingredients.
    (b) Modifying registration review cases. New data or information may 
suggest that a registration review case should be modified. The Agency 
may modify a registration review case in the following ways:
    (1) Add a new active ingredient to a registration review case. The 
Agency may determine that a new active ingredient is chemically and 
toxicologically similar to active ingredients in an existing 
registration review case and should be grouped with the ingredients in 
the existing registration review case.
    (2) Split a registration review case into two or more registration 
review cases. For example, new data or information may suggest that 
active ingredients in a registration review case are not as similar as 
previously believed and that they belong in two or more separate 
registration review cases.
    (3) Move an ingredient from one registration review case to another. 
For example, new data or information might suggest that an ingredient

[[Page 58]]

should not be grouped with the other ingredients in the registration 
review case and that it belongs in a different registration review case.
    (4) Merge two or more registration review cases into a single 
registration review case. For example, new data or information might 
suggest that the active ingredients in two or more registration review 
cases should be grouped together for registration review.
    (5) Delete an active ingredient from a registration review case. For 
example, the Agency will remove the ingredient from the case if the 
registrations of all products containing an active ingredient in a 
registration review case are canceled.
    (c) Closing a registration review case. The Agency will close a 
registration review case if all products in the case are canceled.
    (d) Establishing a baseline date for a registration review case. For 
the purpose of scheduling registration reviews, the Agency will 
establish a baseline date for each registration review case. In general, 
the baseline date will be the date of initial registration of the oldest 
pesticide product in the case or the date of reregistration, whichever 
is later. For the purpose of these procedures, the date of 
reregistration is the date on which the Reregistration Eligibility 
Decision or Interim Reregistration Decision was signed, whichever date 
the Agency determines to be more appropriate based on the 
comprehensiveness of the review.
    (1) The Agency generally will not change the baseline date for a 
registration review case when it modifies a case by adding or deleting 
ingredients or products.
    (2) When the Agency splits a registration review case into two or 
more cases, the new case(s) generally will have the baseline date of the 
original registration review case.
    (3) When the Agency merges two or more registration review cases 
into a single case, the Agency generally will use the earliest baseline 
date as the baseline date for the new case.
    (e) Announcing registration review cases and baseline dates. The 
Agency will maintain a list of registration review cases, including 
baseline dates, on its website.



Sec. 155.44  Establish schedules for registration review.

    The Agency will develop schedules for registration review that are 
generally based on the baseline date of the registration review case or 
on the date of the latest registration review of the registration review 
case. The Agency may also take into account other factors, such as 
achieving process efficiencies by reviewing related cases together, when 
developing schedules for registration review. The Agency will maintain 
schedules for the current year and at least two subsequent years on its 
website.



Sec. 155.46  Deciding that a registration review is complete and additional 

review is not needed.

    The Agency may determine that there is no need to reconsider a 
previous decision that a pesticide satisfies the standard of 
registration in FIFRA. In such cases, instead of establishing a 
pesticide registration review case docket as described in Sec. 155.50, 
the Agency may propose that, based on its determination that a pesticide 
meets the FIFRA standard for registration, no further review will be 
necessary. In such circumstances, the Agency will publish a notice in 
the Federal Register announcing the availability of the proposed 
decision and provide a comment period of at least 60 calendar days. The 
Agency will publish a notice in the Federal Register announcing the 
availability of a final version of the decision, an explanation of any 
changes to the proposed decision and its response to any comments. The 
date of the final notice of availability would be used as the date of 
the latest registration review for the purpose of scheduling subsequent 
registration reviews.



Sec. 155.48  Data Call-In.

    The Agency may issue a Data Call-In notice under FIFRA section 
3(c)(2)(B) at any time if the Agency believes that the data are needed 
to conduct the registration review. The provisions in FIFRA section 
3(c)(1), (c)(2)(B), and

[[Page 59]]

(c)(2)(D) apply to the submission, compensation, and exemption of data 
required to conduct a registration review.



Sec. 155.50  Initiate a pesticide's registration review.

    The Agency will initiate a pesticide's registration review by 
establishing a docket for each registration review case, except for 
cases covered under Sec. 155.46, and opening it for public review.
    (a) Contents of the registration review case docket. The Agency will 
place in this docket information that will assist the public in 
understanding the types of information and issues that the Agency may 
consider in the course of the registration review. The Agency may 
include information from its files including, but not limited to, the 
following information:
    (1) An overview of registration review case status;
    (2) A list of current registrations and registrants, any Federal 
Register notices regarding pending registration actions, and current or 
pending tolerances;
    (3) Risk assessment documents;
    (4) Bibliographies concerning current registrations;
    (5) Summaries of incident data; and
    (6) Any other pertinent data or information.
    (b) Public review of the registration review case docket. The Agency 
will publish a notice in the Federal Register announcing the 
availability for public review of the information described in paragraph 
(a) of this section and establishing a comment period of at least 60 
days. During this comment period, interested persons may identify any 
additional information they believe the Agency should consider in the 
course of the registration review.
    (c) Submission of data and other information during the comment 
period. The Agency may identify, either in the notice published under 
paragraph (b) of this section, or at any other time, data or information 
that it does not have but which may be useful, if available, for 
consideration in the registration review. Any person may submit data or 
information in response to such identification. In order to be 
considered during a pesticide's registration review, the submitted data 
or information must meet the requirements listed below.
    (1) In order to ensure that the Agency will consider data or 
information in the conduct of a registration review, interested persons 
must submit the data or information during the comment period 
established in the notice described in paragraph (b) of this section. 
The Agency may, at its discretion, consider data or information 
submitted at a later date.
    (2) The data or information must be presented in a legible and 
useable form. For example, an English translation must accompany any 
material that is not in English and a written transcript must accompany 
any information submitted as an audiographic or videographic record. 
Written material may be submitted in paper or electronic form.
    (3) Submitters must clearly identify the source of any submitted 
data or information.
    (4) Submitters may request the Agency to reconsider data or 
information that the Agency rejected in a previous review. However, 
submitters must explain why they believe the Agency should reconsider 
the data or information in the pesticide's registration review.
    (d) For the purposes of this subpart, the provisions of subpart B do 
not apply.



Sec. 155.52  Stakeholder engagement.

    In addition to the public participation opportunities described in 
Sec. 155.50 and Sec. 155.53(c), the Agency may meet with stakeholders 
regarding a forthcoming or ongoing registration review. For example, 
before conducting a pesticide's registration review, the Agency may 
consult with registrants or pesticide users regarding the use and usage 
of the pesticide. The Agency may consult with registrants, pesticide 
users, or other persons during a pesticide's registration review with 
regard to developing risk management options for a pesticide. The Agency 
may informally consult with officials of Federal, State or Tribal 
agencies regarding a forthcoming or ongoing registration review.

[[Page 60]]

    (a) Minutes of meetings with persons outside of government. Subject 
to paragraph (c) of this section, if the Agency meets with one or more 
individuals that are not government employees to discuss matters 
relating to a registration review, the Agency will place in the docket a 
list of meeting attendees, minutes of the meeting, and any documents 
exchanged at the meeting, not later than the earlier of:
    (1) 45 days after the meeting; or
    (2) The date of issuance of the registration review decision.
    (b) Exchange of documents or other written material. In the course 
of a meeting with a person outside of government, the Agency or that 
person may provide the other with a copy of a document or other written 
material that has not yet been released to the public. The Agency will 
place a copy of any such document or other written material in the 
docket along with the minutes of the meeting where the materials were 
exchanged.
    (c) Confidential business information. The Agency will identify, but 
not include in the docket, any confidential business information whose 
disclosure is prohibited by FIFRA section 10.

[71 FR 45732, Aug. 9, 2006, as amended at 73 FR 75596, Dec. 12, 2008]



Sec. 155.53  Conduct of a pesticide's registration review.

    The Agency will review data and information described in Sec. 
155.50(a), (b), and (c) or submitted in response to a Data Call-In 
notice that it believes should be considered in the pesticide's 
registration review.
    (a) Assess changes since a pesticide's last review. The Agency will 
assess any changes that may have occurred since the Agency's last 
registration decision in order to determine the significance of such 
changes and whether the pesticide still satisfies the FIFRA standard for 
registration. The Agency will consider whether to conduct a new risk 
assessment to take into account, among other things, any changes in 
statutes or regulations, policy, risk assessment procedures or methods, 
or data requirements. The Agency will consider whether any new data or 
information on the pesticide, including any data or information 
submitted under Sec. 155.50 or in response to a Data Call-In notice, 
warrant conducting a new risk assessment or a new risk/benefit 
assessment. The Agency will also consider whether any new data or 
information regarding an individual pesticide product, including any 
data or information submitted under Sec. 155.50 or in response to a 
Data Call-In notice, such as data or information about an inert 
ingredient in the pesticide product or other information or data 
relating to the composition, labeling or use of the pesticide product, 
warrant additional review of a pesticide product's registration.
    (b) Conduct new assessments as needed. (1) Active ingredient(s) in 
the registration review case. If the Agency finds that a new assessment 
of the pesticide is needed, it will determine whether it can base the 
new assessment on available data or information, including data or 
information submitted under Sec. 155.50 or in response to a Data Call-
In notice. If sufficient data or information are available, the Agency 
will conduct the new risk assessment or risk/benefit assessment. If the 
Agency determines that additional data or information are needed to 
conduct the review, the Agency will issue a Data Call-In notice under 
FIFRA section 3(c)(2)(B).
    (2) Individual product registrations. If the Agency finds that 
additional review of an individual product's registration is needed, it 
will review the pesticide product label, confidential statement of 
formula, product-specific data, or other pertinent data or information, 
as appropriate, to determine whether the registration of the individual 
product meets the FIFRA standard for registration. If the Agency 
determines that additional data or information are needed to conduct the 
review, the Agency will issue a Data Call-In notice under FIFRA section 
3(c)(2)(B).
    (c) Public participation during a pesticide's registration review. 
The Agency will generally make available for public review and comment a 
draft risk assessment for a pesticide if a new risk assessment has been 
conducted. The Agency will publish a notice in the Federal Register 
announcing the

[[Page 61]]

availability of the draft risk assessment and provide a comment period 
of at least 30 calendar days. The Agency will publish a notice in the 
Federal Register announcing the availability of a revised risk 
assessment, an explanation of any changes to the proposed document, and 
its response to comments. If the revised risk assessment indicates risks 
of concern, the Agency may, in the notice announcing the availability of 
the revised risk assessment, provide a comment period of at least 30 
calendar days for the public to submit suggestions for mitigating the 
risk identified in the revised risk assessment.
    (1) The Agency might not request comments on a draft risk assessment 
in cases where the Agency's initial screening of a pesticide indicates 
that it has low use/usage, affects few if any stakeholders or members of 
the public, poses low risk, and/or requires little or no risk 
mitigation. In such cases, the Agency will make a draft risk assessment 
available for public review and comment when it issues a proposed 
decision on the registration review case.
    (2) If the Agency finds that it is not necessary to conduct a new 
risk assessment, it will issue a proposed decision on the registration 
review case as described in Sec. 155.58.



Sec. 155.56  Interim registration review decision.

    The Agency may issue, when it determines it to be appropriate, an 
interim registration review decision before completing a registration 
review. Among other things, the interim registration review decision may 
require new risk mitigation measures, impose interim risk mitigation 
measures, identify data or information required to complete the review, 
and include schedules for submitting the required data, conducting the 
new risk assessment and completing the registration review. A FIFRA 
3(c)(2)(B) notice requiring the needed data or information may precede, 
accompany, or follow issuance of the interim registration review 
decision. The Agency will follow procedures in Sec. 155.58 when issuing 
an interim registration review decision.



Sec. 155.57  Registration review decision.

    A registration review decision is the Agency's determination whether 
a pesticide meets, or does not meet, the standard for registration in 
FIFRA.



Sec. 155.58  Procedures for issuing a decision on a registration review case.

    (a) The Agency will publish a notice in the Federal Register 
announcing the availability of a proposed registration review decision 
or a proposed interim registration review decision. At that time, the 
Agency will place in the pesticide's registration review docket the 
Agency's proposed decision and the bases for the decision. There will be 
a comment period of at least 60 calendar days on the proposed decision.
    (b) In its proposed decision, the Agency will, among other things:
    (1) State its proposed findings with respect to the FIFRA standard 
for registration and describe the basis for such proposed findings.
    (2) Identify proposed risk mitigation measures or other remedies as 
needed and describe the basis for such proposed requirements.
    (3) State whether it believes that additional data are needed and, 
if so, describe what is needed. A FIFRA 3(c)(2)(B) notice requiring such 
data may be issued in conjunction with a proposed or final decision on 
the registration review case or a proposed or final interim decision on 
a registration review case.
    (4) Specify proposed labeling changes; and
    (5) Identify deadlines that it intends to set for completing any 
required actions.
    (c) After considering any comments on the proposed decision, the 
Agency will issue a registration review decision or interim registration 
review decision. This decision will include an explanation of any 
changes to the proposed decision and the Agency's response to 
significant comments. The Agency will publish a notice in the Federal 
Register announcing the availability of a registration review decision 
or interim registration review decision. The registration review case 
docket will remain open until all actions required in the final decision 
on

[[Page 62]]

the registration review case have been completed.
    (d) If the registrant fails to take the action required in a 
registration review decision or interim registration review decision, 
the Agency may take appropriate action under FIFRA.



PART 156_LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES--Table of Contents



                      Subpart A_General Provisions

Sec.
156.3 Definitions.
156.10 Labeling requirements.

Subparts B-C [Reserved]

           Subpart D_Human Hazard and Precautionary Statements

156.60 General.
156.62 Toxicity Category.
156.64 Signal word.
156.66 Child hazard warning.
156.68 First aid statement.
156.70 Precautionary statements for human hazards.
156.78 Precautionary statements for physical or chemical hazards.

       Subpart E_Environmental Hazard and Precautionary Statements

156.80 General.
156.85 Non-target organisms.

Subparts F-G [Reserved]

                      Subpart H_Container Labeling

156.140 Identification of container types.
156.144 Residue removal instructions--general.
156.146 Residue removal instructions for nonrefillable containers--rigid 
          containers with dilutable pesticides.
156.156 Residue removal instructions for refillable containers.
156.159 Compliance date.

Subparts I-J [Reserved]

                 Subpart K_Worker Protection Statements

156.200 Scope and applicability.
156.203 Definitions.
156.204 Modification and waiver of requirements.
156.206 General statements.
156.208 Restricted-entry statements.
156.210 Notification-to-workers statements.
156.212 Personal protective equipment statements.

    Authority: 7 U.S.C. 136-136y.



                      Subpart A_General Provisions



Sec. 156.3  Definitions.

    Terms used in this part have the same meaning as in the Act and part 
152 of this chapter. In addition, as used in this part, the following 
terms shall have the meanings set forth below.
    Dilutable means that the pesticide product's labeling allows or 
requires the pesticide product to be mixed with a liquid diluent prior 
to application or use.
    Transport vehicle means a cargo-carrying vehicle such as an 
automobile, van, tractor, truck, semitrailer, tank car or rail car used 
for the transportation of cargo by any mode.

[73 FR 64224, Oct. 29, 2008]



Sec. 156.10  Labeling requirements.

    (a) General--(1) Contents of the label. Every pesticide product 
shall bear a label containing the information specified by the Act and 
the regulations in this part. The contents of a label must show clearly 
and prominently the following:
    (i) The name, brand, or trademark under which the product is sold as 
prescribed in paragraph (b) of this section;
    (ii) The name and address of the producer, registrant, or person for 
whom produced as prescribed in paragraph (c) of this section;
    (iii) The net contents as prescribed in paragraph (d) of this 
section;
    (iv) The product registration number as prescribed in paragraph (e) 
of this section;
    (v) The producing establishment number as prescribed in paragraph 
(f) of this section;
    (vi) An ingredient statement as prescribed in paragraph (g) of this 
section;
    (vii) Hazard and precautionary statements as prescribed in subpart D 
of this part for human and domestic animal hazards and subpart E of this 
part for environmental hazards.
    (viii) The directions for use as prescribed in paragraph (i) of this 
section; and
    (ix) The use classification(s) as prescribed in paragraph (j) of 
this section.

[[Page 63]]

    (2) Prominence and legibility. (i) All words, statements, graphic 
representations, designs or other information required on the labeling 
by the Act or the regulations in this part must be clearly legible to a 
person with normal vision, and must be placed with such conspicuousness 
(as compared with other words, statements, designs, or graphic matter on 
the labeling) and expressed in such terms as to render it likely to be 
read and understood by the ordinary individual under customary 
conditions of purchase and use.
    (ii) All required label text must:
    (A) Be set in 6-point or larger type;
    (B) Appear on a clear contrasting background; and
    (C) Not be obscured or crowded.
    (3) Language to be used. All required label or labeling text shall 
appear in the English language. However, the Agency may require or the 
applicant may propose additional text in other languages as is 
considered necessary to protect the public. When additional text in 
another language is necessary, all labeling requirements will be applied 
equally to both the English and other-language versions of the labeling.
    (4) Placement of Label--(i) General. The label shall appear on or be 
securely attached to the immediate container of the pesticide product. 
For purposes of this section, and the misbranding provisions of the Act, 
``securely attached'' shall mean that a label can reasonably be expected 
to remain affixed during the foreseeable conditions and period of use. 
If the immediate container is enclosed within a wrapper or outside 
container through which the label cannot be clearly read, the label must 
also be securely attached to such outside wrapper or container, if it is 
a part of the package as customarily distributed or sold.
    (ii) Tank cars and other bulk containers--(A) Transportation. While 
a pesticide product is in transit, the appropriate provisions of 49 CFR 
parts 170-189, concerning the transportation of hazardous materials, and 
specifically those provisions concerning the labeling, marking and 
placarding of hazardous materials and the vehicles carrying them, define 
the basic Federal requirements. In addition, when any registered 
pesticide product is transported in a tank car, tank truck or other 
mobile or portable bulk container, a copy of the accepted label must be 
attached to the shipping papers, and left with the consignee at the time 
of delivery.
    (B) Storage. When pesticide products are stored in bulk containers, 
whether mobile or stationary, which remain in the custody of the user, a 
copy of the label of labeling, including all appropriate directions for 
use, shall be securely attached to the container in the immediate 
vicinity of the discharge control valve.
    (5) False or misleading statements. Pursuant to section 2(q)(1)(A) 
of the Act, a pesticide or a device declared subject to the Act pursuant 
to Sec. 152.500, is misbranded if its labeling is false or misleading 
in any particular including both pesticidal and non-pesticidal claims. 
Examples of statements or representations in the labeling which 
constitute misbranding include:
    (i) A false or misleading statement concerning the composition of 
the product;
    (ii) A false or misleading statement concerning the effectiveness of 
the product as a pesticide or device;
    (iii) A false or misleading statement about the value of the product 
for purposes other than as a pesticide or device;
    (iv) A false or misleading comparison with other pesticides or 
devices;
    (v) Any statement directly or indirectly implying that the pesticide 
or device is recommended or endorsed by any agency of the Federal 
Government;
    (vi) The name of a pesticide which contains two or more principal 
active ingredients if the name suggests one or more but not all such 
principal active ingredients even though the names of the other 
ingredients are stated elsewhere in the labeling;
    (vii) A true statement used in such a way as to give a false or 
misleading impression to the purchaser;
    (viii) Label disclaimers which negate or detract from labeling 
statements required under the Act and these regulations;
    (ix) Claims as to the safety of the pesticide or its ingredients, 
including

[[Page 64]]

statements such as ``safe,'' ``nonpoisonous,'' ``noninjurious,'' 
``harmless'' or ``nontoxic to humans and pets'' with or without such a 
qualifying phrase as ``when used as directed''; and
    (x) Non-numerical and/or comparative statements on the safety of the 
product, including but not limited to:
    (A) ``Contains all natural ingredients'';
    (B) ``Among the least toxic chemicals known''
    (C) ``Pollution approved''
    (6) Final printed labeling. (i) Except as provided in paragraph 
(a)(6)(ii) of this section, final printed labeling must be submitted and 
accepted prior to registration. However, final printed labeling need not 
be submitted until draft label texts have been provisionally accepted by 
the Agency.
    (ii) Clearly legible reproductions or photo reductions will be 
accepted for unusual labels such as those silk-screened directly onto 
glass or metal containers or large bag or drum labels. Such 
reproductions must be of microfilm reproduction quality.
    (b) Name, brand, or trademark. (1) The name, brand, or trademark 
under which the pesticide product is sold shall appear on the front 
panel of the label.
    (2) No name, brand, or trademark may appear on the label which:
    (i) Is false or misleading, or
    (ii) Has not been approved by the Administrator through registration 
or supplemental registration as an additional name pursuant to Sec. 
152.132.
    (c) Name and address of producer, registrant, or person for whom 
produced. An unqualified name and address given on the label shall be 
considered as the name and address of the producer. If the registrant's 
name appears on the label and the registrant is not the producer, or if 
the name of the person for whom the pesticide was produced appears on 
the label, it must be qualified by appropriate wording such as ``Packed 
for * * *,'' ``Distributed by * * *,'' or ``Sold by * * *'' to show that 
the name is not that of the producer.
    (d) Net weight or measure of contents. (1) The net weight or measure 
of content shall be exclusive of wrappers or other materials and shall 
be the average content unless explicitly stated as a minimum quantity.
    (2) If the pesticide is a liquid, the net content statement shall be 
in terms of liquid measure at 68 [deg]F (20 [deg]C) and shall be 
expressed in conventional American units of fluid ounces, pints, quarts, 
and gallons.
    (3) If the pesticide is solid or semisolid, viscous or pressurized, 
or is a mixture of liquid and solid, the net content statement shall be 
in terms of weight expressed as avoirdupois pounds and ounces.
    (4) In all cases, net content shall be stated in terms of the 
largest suitable units, i.e., ``1 pound 10 ounces'' rather than ``26 
ounces.''
    (5) In addition to the required units specified, net content may be 
expressed in metric units.
    (6) Variation above minimum content or around an average is 
permissible only to the extent that it represents deviation unavoidable 
in good manufacturing practice. Variation below a stated minimum is not 
permitted. In no case shall the average content of the packages in a 
shipment fall below the stated average content.
    (7) For a pesticide product packaged in a refillable container, an 
appropriately sized area on the label may be left blank to allow the net 
weight or measure of content to be marked in by the refiller according 
to 40 CFR 165.65(h) or 165.70(i) prior to distribution or sale of the 
pesticide. As required in paragraph (a)(1)(iii) of this section, the net 
contents must be shown clearly and prominently on the label.
    (e) Product registration number. The registration number assigned to 
the pesticide product at the time of registration shall appear on the 
label, preceded by the phrase ``EPA Registration No.,'' or the phrase 
``EPA Reg. No.'' The registration number shall be set in type of a size 
and style similar to other print on that part of the label on which it 
appears and shall run parallel to it. The registration number and the 
required identifying phrase shall not appear in such a manner as to 
suggest or imply recommendation or endorsement of the product by the 
Agency.

[[Page 65]]

    (f) Producing establishment's registration number. The producing 
establishment registration number preceded by the phrase ``EPA Est.'', 
of the final establishment at which the product was produced may appear 
in any suitable location on the label or immediate container. It must 
appear on the wrapper or outside container of the package if the EPA 
establishment registration number on the immediate container cannot be 
clearly read through such wrapper or container. For a pesticide product 
packaged in a refillable container, an appropriately sized area on the 
label may be left blank after the phrase ``EPA Est.'' to allow the EPA 
establishment registration number to be marked in by the refiller 
according to 40 CFR 165.65(h) or 165.70(i) prior to distribution or sale 
of the pesticide.
    (g) Ingredient statement--(1) General. The label of each pesticide 
product must bear a statement which contains the name and percentage by 
weight of each active ingredient, the total percentage by weight of all 
inert ingredients; and if the pesticide contains arsenic in any form, a 
statement of the percentages of total and water-soluble arsenic 
calculated as elemental arsenic. The active ingredients must be 
designated by the term ``active ingredients'' and the inert ingredients 
by the term ``inert ingredients,'' or the singular forms of these terms 
when appropriate. Both terms shall be in the same type size, be aligned 
to the same margin and be equally prominent. The statement ``Inert 
Ingredients, none'' is not required for pesticides which contain 100 
percent active ingredients. Unless the ingredient statement is a 
complete analysis of the pesticide, the term ``analysis'' shall not be 
used as a heading for the ingredient statement.
    (2) Position of ingredient statement. (i) The ingredient statement 
is normally required on the front panel of the label. If there is an 
outside container or wrapper through which the ingredient statement 
cannot be clearly read, the ingredient statement must also appear on 
such outside container or wrapper. If the size or form of the package 
makes it impracticable to place the ingredient statement on the front 
panel of the label, permission may be granted for the ingredient 
statement to appear elsewhere.
    (ii) The text of the ingredient statement must run parallel with 
other text on the panel on which it appears, and must be clearly 
distinguishable from and must not be placed in the body of other text.
    (3) Names to be used in ingredient statement. The name used for each 
ingredient shall be the accepted common name, if there is one, followed 
by the chemical name. The common name may be used alone only if it is 
well known. If no common name has been established, the chemical name 
alone shall be used. In no case will the use of a trademark or 
proprietary name be permitted unless such name has been accepted as a 
common name by the Administrator under the authority of section 
25(c)(6).
    (4) Statements of percentages. The percentages of ingredients shall 
be stated in terms of weight-to-weight. The sum of percentages of the 
active and the inert ingredients shall be 100. Percentages shall not be 
expressed by a range of values such as ``22-25%.'' If the uses of the 
pesticide product are expressed as weight of active ingredient per unit 
area, a statement of the weight of active ingredient per unit volume of 
the pesticide formulation shall also appear in the ingredient statement.
    (5) Accuracy of stated percentages. The percentages given shall be 
as precise as possible reflecting good manufacturing practice. If there 
may be unavoidable variation between manufacturing batches, the value 
stated for each active ingredient shall be the lowest percentage which 
may be present.
    (6) Deterioration. Pesticides which change in chemical composition 
significantly must meet the following labeling requirements:
    (i) In cases where it is determined that a pesticide formulation 
changes chemical composition significantly, the product must bear the 
following statement in a prominent position on the label: ``Not for sale 
or use after [date].''
    (ii) The product must meet all label claims up to the expiration 
time indicated on the label.
    (7) Inert ingredients. The Administrator may require the name of any

[[Page 66]]

inert ingredient(s) to be listed in the ingredient statement if he 
determines that such ingredient(s) may pose a hazard to man or the 
environment.
    (h) [Reserved]
    (i) Directions for Use--(1) General requirements--(i) Adequacy and 
clarity of directions. Directions for use must be stated in terms which 
can be easily read and understood by the average person likely to use or 
to supervise the use of the pesticide. When followed, directions must be 
adequate to protect the public from fraud and from personal injury and 
to prevent unreasonable adverse effects on the environment.
    (ii) Placement of directions for use. Directions may appear on any 
portion of the label provided that they are conspicuous enough to be 
easily read by the user of the pesticide product. Directions for use may 
appear on printed or graphic matter which accompanies the pesticide 
provided that:
    (A) If required by the Agency, such printed or graphic matter is 
securely attached to each package of the pesticide, or placed within the 
outside wrapper or bag;
    (B) The label bears a reference to the directions for use in 
accompanying leaflets or circulars, such as ``See directions in the 
enclosed circular:'' and
    (C) The Administrator determines that it is not necessary for such 
directions to appear on the label.
    (iii) Exceptions to requirement for direction for use. (A) Detailed 
directions for use may be omitted from labeling of pesticides which are 
intended for use only by manufacturers of products other than pesticide 
products in their regular manufacturing processes, provided that:
    (1) The label clearly shows that the product is intended for use 
only in manufacturing processes and specifies the type(s) of products 
involved.
    (2) Adequate information such as technical data sheets or bulletins, 
is available to the trade specifying the type of product involved and 
its proper use in manufacturing processes;
    (3) The product will not come into the hands of the general public 
except after incorporation into finished products; and
    (4) The Administrator determines that such directions are not 
necessary to prevent unreasonable adverse effects on man or the 
environment.
    (B) Detailed directions for use may be omitted from the labeling of 
pesticide products for which sale is limited to physicians, 
veterinarians, or druggists, provided that:
    (1) The label clearly states that the product is for use only by 
physicians or veterinarians;
    (2) The Administrator determines that such directions are not 
necessary to prevent unreasonable adverse effects on man or the 
environment; and
    (3) The product is also a drug and regulated under the provisions of 
the Federal Food, Drug and Cosmetic Act.
    (C) Detailed directions for use may be omitted from the labeling of 
pesticide products which are intended for use only by formulators in 
preparing pesticides for sale to the public, provided that:
    (1) There is information readily available to the formulators on the 
composition, toxicity, methods of use, applicable restrictions or 
limitations, and effectiveness of the product for pesticide purposes;
    (2) The label clearly states that the product is intended for use 
only in manufacturing, formulating, mixing, or repacking for use as a 
pesticide and specifies the type(s) of pesticide products involved;
    (3) The product as finally manufactured, formulated, mixed, or 
repackaged is registered; and
    (4) The Administrator determines that such directions are not 
necessary to prevent unreasonable adverse effects on man or the 
environment.
    (2) Contents of Directions for Use. The directions for use shall 
include the following, under the headings ``Directions for Use'':
    (i) The statement of use classification as prescribed in paragraph 
(j) of this section immediately under the heading ``Directions for 
Use.''
    (ii) Immediately below the statement of use classification, the 
statement ``It is a violation of Federal law to use this product in a 
manner inconsistent with its labeling.''

[[Page 67]]

    (iii) The site(s) of application, as for example the crops, animals, 
areas, or objects to be treated.
    (iv) The target pest(s) associated with each site.
    (v) The dosage rate associated with each site and pest.
    (vi) The method of application, including instructions for dilution, 
if required, and type(s) of application apparatus or equipment required.
    (vii) The frequency and timing of applications necessary to obtain 
effective results without causing unreasonable adverse effects on the 
environment.
    (viii) Worker protection statements meeting the requirements of 
subpart K of this part.
    (ix) Specific directions concerning the storage, residue removal and 
disposal of the pesticide and its container, in accordance with subpart 
H of this part. These instructions must be grouped and appear under the 
heading, ``Storage and Disposal.'' This heading must be set in type of 
the same minimum sizes as required for the child hazard warning. (See 
table in Sec. 156.60(b))
    (x) Any limitations or restrictions on use required to prevent 
unreasonable adverse effects, such as:
    (A) Required intervals between application and harvest of food or 
feed crops.
    (B) Rotational crop restrictions.
    (C) Warnings as required against use on certain crops, animals, 
objects, or in or adjacent to certain areas.
    (D) For total release foggers as defined in Sec. 156.78(d)(1), the 
following statements must be included in the ``Directions for Use.''

    DO NOT use more than one fogger per room. DO NOT use in small, 
enclosed spaces such as closets, cabinets, or under counters or tables. 
Do not use in a room 5 ft.x5 ft. or smaller; instead, allow fog to enter 
from other rooms. Turn off ALL ignition sources such as pilot lights 
(shut off gas valves), other open flames, or running electrical 
appliances that cycle off and on (i.e., refrigerators, thermostats, 
etc.). Call your gas utility or management company if you need 
assistance with your pilot lights.''

    (E) For restricted use pesticides, a statement that the pesticide 
may be applied under the direct supervision of a certified applicator 
who is not physically present at the site of application but nonetheless 
available to the person applying the pesticide, unless the Agency has 
determined that the pesticide may only be applied under the direct 
supervision of a certified applicator who is physically present.
    (F) Other pertinent information which the Administrator determines 
to be necessary for the protection of man and the environment.
    (j) Statement of use classification. Any pesticide product for which 
some uses are classified for general use and others for restricted use 
shall be separately labeled according to the labeling standards set 
forth in this subsection, and shall be marketed as separate products 
with different registration numbers, one bearing directions only for 
general use(s) and the other bearing directions for restricted use(s) 
except that, if a product has both restricted use(s) and general use(s), 
both of these uses may appear on a product labeled for restricted use. 
Such products shall be subject to the provisions of paragraph (j)(2) of 
this section.
    (1) General Use Classification. Pesticide products bearing 
directions for use(s) classified general shall be labeled with the exact 
words ``General Classification'' immediately below the heading 
``Directions for Use.'' And reference to the general classification that 
suggests or implies that the general utility of the pesticide extends 
beyond those purposes and uses contained in the Directions for Use will 
be considered a false or misleading statement under the statutory 
definitions of misbranding.
    (2) Restricted Use Classification. Pesticide products bearing 
direction for use(s) classified restricted shall bear statements of 
restricted use classification on the front panel as described below:
    (i) Front panel statement of restricted use classification. (A) At 
the top of the front panel of the label, set in type of the same minimum 
sizes as required for human hazard signal words (see table in paragraph 
(h)(1)(iv) of this section), and appearing with sufficient prominence 
relative to other text and graphic material on the front panel to make 
it unlikely to be overlooked

[[Page 68]]

under customary conditions of purchase and use, the statement 
``Restricted Use Pesticide'' shall appear.
    (B) Directly below this statement on the front panel, a summary 
statement of the terms of restriction imposed as a precondition to 
registration shall appear. If use is restricted to certified 
applicators, the following statement is required: ``For retail sale to 
and use only by Certified Applicators or persons under their direct 
supervision and only for those uses covered by the Certified 
Applicator's certification.'' If, however, other regulatory restrictions 
are imposed, the Administrator will define the appropriate wording for 
the terms of restriction by regulation.

[40 FR 28268, July 3, 1975; 40 FR 32329, Aug. 1, 1975; 40 FR 36571, Aug. 
21, 1975, as amended at 43 FR 5786, Feb. 9, 1978. Redesignated and 
amended at 53 FR 15991, 15999, May 4, 1988; 57 FR 38146, Aug. 21, 1992; 
60 FR 32096, June 19, 1995; 63 FR 9082, Feb. 23, 1998; 66 FR 64764, Dec. 
14, 2001; 71 FR 47420, Aug. 16, 2006; 73 FR 75596, Dec. 12, 2008]

Subparts B-C [Reserved]



           Subpart D_Human Hazard and Precautionary Statements

    Source: 66 FR 64764, Dec. 14, 2001, unless otherwise noted.



Sec. 156.60  General.

    Each product label is required to bear hazard and precautionary 
statements for humans and domestic animals (if applicable) as prescribed 
in this subpart. Hazard statements describe the type of hazard that may 
occur, while precautionary statements will either direct or inform the 
user of actions to take to avoid the hazard or mitigate its effects.
    (a) Location of statements--(1) Front panel statements. The signal 
word, child hazard warning, and, in certain cases, the first aid 
statement are required to appear on the front panel of the label, and 
also in any supplemental labeling intended to accompany the product in 
distribution or sale.
    (2) Statements elsewhere on label. Hazard and precautionary 
statements not required on the front panel may appear on other panels of 
the label, and may be required also in supplemental labeling. These 
include, but are not limited to, the human hazard and precautionary 
statements, domestic animal statements if applicable, a Note to 
Physician, and physical or chemical hazard statements.
    (b) Placement and prominence--(1) Front panel statements. All 
required front panel warning statements shall be grouped together on the 
label, and shall appear with sufficient prominence relative to other 
front panel text and graphic material to make them unlikely to be 
overlooked under customary conditions of purchase and use. The table 
below shows the minimum type size requirements for the front panel 
warning statements for various front panel sizes.

              Type Sizes for Front Panel Warning Statements
------------------------------------------------------------------------
                                                           Point Size
                                                      ------------------
                                                        Signal
      Size of Label Front Panel (Square Inches)          Word     Child
                                                         (All     Hazard
                                                        Capital  Warning
                                                       Letters)
------------------------------------------------------------------------
5 and under..........................................         6        6
Over 5 to 10.........................................        10        6
Over 10 to 15........................................        12        8
Over 15 to 30........................................        14       10
Over 30..............................................        18       12
------------------------------------------------------------------------

    (2) Other required statements. All other hazard and precautionary 
statements must be at least 6 point type.



Sec. 156.62  Toxicity Category.

    This section establishes four Toxicity Categories for acute hazards 
of pesticide products, Category I being the highest toxicity category. 
Most human hazard, precautionary statements, and human personal 
protective equipment statements are based upon the Toxicity Category of 
the pesticide product as sold or distributed. In addition, toxicity 
categories may be used for regulatory purposes other than labeling, such 
as classification for restricted use and requirements for child-
resistant packaging. In certain cases, statements based upon the 
Toxicity Category of the product as diluted for use are also permitted. 
A Toxicity Category is assigned for each of five types of acute 
exposure, as specified in the table in this paragraph.

[[Page 69]]



                                Acute Toxicity Categories for Pesticide Products
----------------------------------------------------------------------------------------------------------------
        Hazard Indicators                  I                  II                  III                 IV
----------------------------------------------------------------------------------------------------------------
Oral LD50.......................  Up to and           50 thru  500      5,000
                                   including 50 mg/    500 mg/kg           thru 5,000 mg/kg    mg/kg
                                   kg
Dermal LD50.....................  Up to and           200      2000     20,000
                                   including 200 mg/   thru 2000 mg/kg     thru 20,000 mg/kg   mg/kg
                                   kg
Inhalation LC50.................  Up to and           0.2      2 thru   20 mg/
                                   including 0.2 mg/   thru 2 mg/liter     20 mg/liter         liter
                                   liter
Eye irritation..................  Corrosive; corneal  Corneal opacity     No corneal          No irritation
                                   opacity not         reversible within   opacity;
                                   reversible within   7 days;             irritation
                                   7 days              irritation          reversible within
                                                       persisting for 7    7 days
                                                       days
Skin irritation.................  Corrosive           Severe irritation   Moderate            Mild or slight
                                                       at 72 hours         irritation at 72    irritation at 72
                                                                           hours               hours
----------------------------------------------------------------------------------------------------------------



Sec. 156.64  Signal word.

    (a) Requirement. Except as provided in paragraph (a)(4), each 
pesticide product must bear on the front panel a signal word, reflecting 
the highest Toxicity Category (Category I is the highest toxicity 
category) to which the product is assigned by any of the five routes of 
exposure in Sec. 156.62. The signal word must also appear together with 
the heading for the human precautionary statement section of the 
labeling (see Sec. 156.70).
    (1) Toxicity Category I. Any pesticide product meeting the criteria 
of Toxicity Category I for any route of exposure must bear on the front 
panel the signal word ``DANGER.'' In addition, if the product is 
assigned to Toxicity Category I on the basis of its oral, inhalation or 
dermal toxicity (as distinct from skin and eye irritation), the word 
``Poison'' must appear in red on a background of distinctly contrasting 
color, and the skull and crossbones symbol must appear in immediate 
proximity to the word ``Poison.''
    (2) Toxicity Category II. Any pesticide product meeting the criteria 
of Toxicity Category II as the highest category by any route of exposure 
must bear on the front panel the signal word ``WARNING.''
    (3) Toxicity Category III. Any pesticide product meeting the 
criteria of Toxicity Category III as the highest category by any route 
of exposure must bear on the front panel the signal word ``CAUTION.''
    (4) Toxicity Category IV. A pesticide product meeting the criteria 
of Toxicity Category IV by all routes of exposure is not required to 
bear a signal word. If a signal word is used, it must be ``CAUTION.''
    (b) Use of signal words. In no case may a product:
    (1) Bear a signal word reflecting a higher Toxicity Category than 
indicated by the route of exposure of highest toxicity, unless the 
Agency determines that such labeling is necessary to prevent 
unreasonable adverse effects on man or the environment;
    (2) Bear a signal word reflecting a lesser Toxicity Category 
associated with a diluted product. Although precautionary statements for 
use dilutions may be included on label, the signal word must reflect the 
toxicity of the product as distributed or sold; or
    (3) Bear different signal words on different parts of the label.



Sec. 156.66  Child hazard warning.

    (a) Each pesticide product must bear on the front panel of the label 
the statement ``Keep Out of Reach of Children.'' That statement, or any 
alternative statement approved by EPA, must appear on a separate line in 
close proximity to the signal word, if required. The statement is 
required on Toxicity Category IV products that do not otherwise require 
a signal word.
    (b) In its discretion, EPA may waive the requirement, or require or 
permit an alternative child hazard warning, if:
    (1) The applicant can demonstrate that the likelihood of exposure of 
children to the pesticide during distribution, marketing, storage or use 
is remote (for example, an industrial use product); or
    (2) The pesticide is approved for use on children (for example, an 
insect repellent).

[[Page 70]]

    (c) EPA may approve an alternative child hazard warning that more 
appropriately reflects the nature of the pesticide product to which 
children may be exposed (for example, an impregnated pet collar). In 
this case, EPA may also approve placement on other than the front panel.



Sec. 156.68  First aid statement.

    (a) Product as sold and distributed. Each product must bear a first 
aid statement if the product has systemic effects in Category I, II, or 
III, or skin or eye irritation effects in Category I or II.
    (b) Product as diluted for use. If the product labeling bears 
directions for dilution with water prior to use, the label may also 
include a statement describing how the first aid measures may be 
modified for the diluted product. Such a statement must reflect the 
Toxicity Category(ies) of the diluted product, based upon data for the 
route of exposure (or calculations if appropriate). If the labeling 
provides for a range of use dilutions, only that use dilution 
representing the highest concentration allowed by labeling may be used 
as the basis for a statement pertaining to the diluted product. The 
statement for a diluted product may not substitute for the statement for 
the concentrate, but augments the information provided for the 
concentrate.
    (c) Heading. The heading of the statement may be ``First Aid'' or 
``Statement of Practical Treatment.''
    (d) Location of first aid statement. The first aid statement must 
appear on the front panel of the label of all products assigned to 
Toxicity Category I by any route of exposure. Upon review, the Agency 
may permit reasonable variations in the placement of the first aid 
statement if a reference such as ``See first aid statement on back 
panel'' appears on the front panel. The first aid statement for products 
assigned to Toxicity Categories II or III may appear on any panel of the 
label.



Sec. 156.70  Precautionary statements for human hazards.

    (a) Requirement. Human hazard and precautionary statements as 
required must appear together on the label or labeling under the general 
heading ``Precautionary Statements'' and under appropriate subheadings 
similar to ``Humans and Domestic Animals,'' ``Environmental Hazards'' 
(see subpart E of this part) and ``Physical or Chemical Hazards.'' The 
phrase ``and Domestic Animals'' may be omitted from the heading if 
domestic animals will not be exposed to the product.
    (b) Content of statements. When data or other information show that 
an acute hazard may exist to humans or domestic animals, the label must 
bear precautionary statements describing the particular hazard, the 
route(s) of exposure and the precautions to be taken to avoid accident, 
injury or toxic effect or to mitigate the effect. The precautionary 
paragraph must be immediately preceded by the appropriate signal word.
    (c) Typical precautionary statements. The table below presents 
typical hazard and precautionary statements. Specific statements 
pertaining to the hazards of the product and its uses must be approved 
by the Agency. With Agency approval, statements may be augmented to 
reflect the hazards and precautions associated with the product as 
diluted for use. Refer to Sec. 156.68(b) for requirements for use 
dilution statements.

                                Typical Human Hazard and Precautionary Statements
----------------------------------------------------------------------------------------------------------------
                                       Systemic effects (oral,                            Sensitizer (There are
          Toxicity Category               dermal, inhalation       Irritation effects        no categories of
                                              toxicity)              (skin and eye)          sensitization.)
----------------------------------------------------------------------------------------------------------------
I                                      Fatal (poisonous) if     Corrosive, causes eye    If product is a
                                        swallowed [inhaled or    and skin damage [or      sensitizer: Prolonged
                                        absorbed through         skin irritation]. Do     or frequently repeated
                                        skin]. Do not breathe    not get in eyes on       skin contact may cause
                                        vapor [dust or spray     skin, or on clothing.    allergic reactions in
                                        mist]. Do not get in     Wear goggles or face     some individuals.
                                        eyes, on skin, or on     shield and rubber
                                        clothing. [Front panel   gloves when handling.
                                        first aid statement      Harmful or fatal if
                                        required.]               swallowed. [Front
                                                                 panel first aid
                                                                 statement required.]
----------------------------------------------------------------------------------------

[[Page 71]]

 
II                                     May be fatal if          Causes eye [and skin]
                                        swallowed, [inhaled or   irritation. Do not get
                                        absorbed through the     in eyes, on skin, or
                                        skin]. Do not breathe    on clothing. Harmful
                                        vapors [dust or spray    if swallowed.
                                        mist]. Do not get in     [Appropriate first aid
                                        eyes, on skin, or on     statement required.]
                                        clothing. [Appropriate
                                        first aid statement
                                        required.]
----------------------------------------------------------------------------------------
III                                    Harmful if swallowed     Avoid contact with
                                        [inhaled or absorbed     skin, eyes or
                                        through the skin].       clothing.
                                        Avoid breathing vapors
                                        [dust or spray mist].
                                        Avoid contact with
                                        skin [eyes or
                                        clothing].
                                        [Appropriate first aid
                                        statement required.]
----------------------------------------------------------------------------------------
IV                                     No precautionary         No precautionary
                                        statements required      statements required.
----------------------------------------------------------------------------------------------------------------



Sec. 156.78  Precautionary statements for physical or chemical hazards.

    (a) Requirement. Warning statements on the flammability or explosive 
characteristics of the pesticide product are required if a product meets 
the criteria in this section. Warning statements pertaining to other 
physical/chemical hazards (e.g., oxidizing potential, conductivity, 
chemical reactions leading to production of toxic substances) may be 
required on a case-by-case basis.
    (b) Pressurized products. The table below sets out the required 
flammability label statements for pressurized products.

            Flammability Statements for Pressurized Products
------------------------------------------------------------------------
  Flash point/flame extension of product     Required labeling statement
------------------------------------------------------------------------
--Flash point at or below 20 [deg]F         Extremely flammable.
                                             Contents under pressure.
                                             Keep away from fire,
                                             sparks, and heated
                                             surfaces. Do not puncture
                                             or incinerate container.
                                             Exposure to temperatures
                                             above 130 [deg]F may cause
                                             bursting.
 OR
 
--Flashback at any valve opening
------------------------------------------------------------------------
--Flash point 20 [deg]F to 80    Flammable. Contents under
 [deg]F                                      pressure. Keep away from
                                             heat, sparks and open
                                             flame. Do not puncture or
                                             incinerate container.
                                             Exposure to temperatures
                                             above 130 [deg]F may cause
                                             bursting.
 OR
 
--Flame extension more than 18 in. long at
 a distance of 6 in from the flame
------------------------------------------------------------------------
All other pressurized products              Contents under pressure. Do
                                             not use or store near heat
                                             or open flame. Do not
                                             puncture or incinerate
                                             container. Exposure to
                                             temperatures above 130
                                             [deg]F may cause bursting.
------------------------------------------------------------------------

    (c) Non-pressurized products. The table below sets out the required 
flammability label statements for non-pressurized products.

          Flammability Statements for Non-Pressurized Products
------------------------------------------------------------------------
                Flash point                  Required labeling statement
------------------------------------------------------------------------
At or below 20 [deg]F                       Extremely flammable. Keep
                                             away from fire, sparks and
                                             heated surfaces.
------------------------------------------------------------------------
Greater than 20 [deg]F to 80 [deg]F         Flammable. Keep away from
                                             heat and open flame.
------------------------------------------------------------------------
Greater than 80 [deg]F to 150 [deg]F        Combustible. Do not use or
                                             store near heat or open
                                             flame.
------------------------------------------------------------------------

    (d) Total release fogger products. (1) A total release fogger is 
defined as a pesticide product in a pressurized container designed to 
automatically release the total contents in one operation, for the 
purpose of creating a permeating fog within a confined space to

[[Page 72]]

deliver the pesticide throughout the space.
    (2) If a pesticide product is a total release fogger containing a 
propellant with a flash point at or below 20 [deg]F, then the following 
special instructions must be added to the ``Physical and Chemical 
Hazards'' warning statement, in addition to any flammability statement 
required by paragraph (b) of this section:

This product contains a highly flammable ingredient. It may cause a fire 
or explosion if not used properly. Follow the Directions for Use on this 
label very carefully.
    (3) A graphic symbol depicting fire, such as illustrated in this 
paragraph, or an equivalent symbol, must be displayed along with the 
required language adjoining the ``Physical and Chemical Hazards'' 
warning statement. The graphic symbol must be no smaller than twice the 
size of the first character of the human hazard signal word.
[GRAPHIC] [TIFF OMITTED] TR14DE01.011


Highly Flammable Ingredient

Ingrediente Altamente Inflamable



       Subpart E_Environmental Hazard and Precautionary Statements

    Source: 66 FR 64767, Dec. 14, 2001, unless otherwise noted.



Sec. 156.80  General.

    (a) Requirement. Each product is required to bear hazard and 
precautionary statements for environmental hazards, including hazards to 
non-target organisms, as prescribed in this subpart. Hazard statements 
describe the type of hazard that may be present, while precautionary 
statements direct or inform the user of actions to take to avoid the 
hazard or mitigate its effects.
    (b) Location of statements. Environmental hazard and precautionary 
statements may appear on any panel of the label and may be required also 
in supplemental labeling. The environmental hazard statements must 
appear together under the heading ``Environmental Hazards.'' Typically 
the statements are grouped as a sub-category within the ``Precautionary 
Statements'' section of the labeling.
    (c) Type size. All environmental hazard and precautionary statements 
must be at least 6 point type.



Sec. 156.85  Non-target organisms.

    (a) Requirement. Where a hazard exists to non-target organisms, EPA 
may require precautionary statements of the nature of the hazard and the 
appropriate precautions to avoid potential accident, injury, or damage.
    (b) Examples. The statements in this paragraph illustrate the types 
of hazard statements that EPA may require and the circumstances under 
which they are typically required. These statements are not 
comprehensive; other statements may be required if more appropriate to 
the formulation or use.
    (1) If a pesticide intended for outdoor use contains an active 
ingredient with a mammalian acute oral LD50 of 100 mg/kg or 
less, the statement, ``This pesticide is toxic to wildlife'' is 
required.
    (2) If a pesticide intended for outdoor use contains an active 
ingredient with a fish acute LC50 of 1 ppm or less, the 
statement, ``This pesticide is toxic to fish'' is required.
    (3) If a pesticide intended for outdoor use contains an active 
ingredient with an avian acute oral LD50 of 100 mg/kg or 
less, or a subacute dietary LC50 of 500 ppm or less, the 
statement, ``This pesticide is toxic to wildlife'' is required.
    (4) If either accident history or field studies demonstrate that the 
use of the pesticide may result in fatality to birds, fish or mammals, 
the statement, ``This pesticide is extremely toxic to wildlife (fish)'' 
is required.
    (5) If a product is intended for or involves foliar application to 
agricultural crops, forests or shade trees, or mosquito abatement 
treatments, and contains a pesticide toxic to pollinating insects, the 
label must bear appropriate label cautions.

[[Page 73]]

    (6) If a product is intended for outdoor use other than aquatic 
applications, the label must bear the caution, ``Keep out of lakes, 
ponds or streams. Do not contaminate water by cleaning of equipment or 
disposal of wastes.''

Subparts F-G [Reserved]



                      Subpart H_Container Labeling

    Source: 71 FR 47420, Aug. 16, 2006, unless otherwise noted.



Sec. 156.140  Identification of container types.

    For products other than plant-incorporated protectants, the 
following statements, as applicable, must be placed on the label or 
container. The information may be located on any part of the container 
except the closure. If the statements are placed on the container, they 
must be durably marked on the container. Durable marking includes, but 
is not limited to etching, embossing, ink jetting, stamping, heat 
stamping, mechanically attaching a plate, molding, or marking with 
durable ink.
    (a) Nonrefillable container. For nonrefillable containers, the 
statements in paragraphs (a)(1) through (a)(4) of this section are 
required except as provided in paragraphs (a)(5), (c), (d), and (e) of 
this section. If placed on the label, the statements in paragraphs 
(a)(1) through (a)(3) of this section must be under an appropriate 
heading under the heading ``Storage and Disposal.'' If any of the 
statements in paragraphs (a)(1) through (a)(3) of this section are 
placed on the container, an appropriate referral statement such as ``See 
container for recycling [or other descriptive word] information.'' must 
be placed on the label under the heading ``Storage and Disposal.''
    (1) Statement identifying a nonrefillable container. The following 
phrase is required: ``Nonrefillable container.''
    (2) Reuse statement. One of the following statements is required. 
Products with labels that allow household/residential use must use the 
statement in paragraph (a)(2)(i) or (a)(2)(iii) of this section. All 
other products must use the statement in paragraph (a)(2)(i), 
(a)(2)(ii), or (a)(2)(iii) of this section.
    (i) ``Do not reuse or refill this container.''
    (ii) ``Do not reuse this container to hold materials other than 
pesticides or dilute pesticides (rinsate). After emptying and cleaning, 
it may be allowable to temporarily hold rinsate or other pesticide-
related materials in the container. Contact your state regulatory agency 
to determine allowable practices in your state.''
    (iii) The following statement may be used if a product is ``ready-
to-use'' and its directions for use allow a different product (that is a 
similar, but concentrated formulation) to be poured into the container 
and diluted by the end user: ``Do not reuse or refill this container 
unless the directions for use allow a different (concentrated) product 
to be diluted in the container.''
    (3) Recycling or reconditioning statement. One of the following 
statements is required:
    (i) ``Offer for recycling if available.''
    (ii) ``Once cleaned, some agricultural plastic pesticide containers 
can be taken to a container collection site or picked up for recycling. 
To find the nearest site, contact your chemical dealer or manufacturer 
or contact [a pesticide container recycling organization] at [phone 
number] or [web site]. For example, this statement could be ``Once 
cleaned, some agricultural plastic pesticide containers can be taken to 
a container collection site or picked up for recycling. To find the 
nearest site, contact your chemical dealer or manufacturer or contact 
the Ag Container Recycling Council (ACRC) at 1-877-952-2272 (toll-free) 
or www.acrecycle.org.''
    (iii) A recycling statement approved by EPA and published in an EPA 
document, such as a Pesticide Registration Notice.
    (iv) An alternative recycling statement that has been reviewed and 
approved by EPA.
    (v) ``Offer for reconditioning if appropriate.''
    (4) Batch code. A lot number, or other code used by the registrant 
or producer to identify the batch of the pesticide product which is 
distributed and sold is required.

[[Page 74]]

    (5) Exemptions. Pesticide products in the following types of 
nonrefillable containers, and their packaging, are exempt from the 
requirements in paragraphs (a)(1) and (a)(2) of this section:
    (i) Aerosol cans.
    (ii) Devices as defined in Sec. 152.500 of this chapter.
    (iii) One-time use caulking tubes and other one-time use squeezable 
tube containers for paste, gel, or other similar substances.
    (iv) Foil packets for water soluble packaging, repellent wipes, and 
other one-time use products.
    (v) One-time use portion control packets, such as polyethylene 
sleeve packages, or rodenticide placepacks.
    (vi) One-time use bait stations.
    (vii) One-time use cages for repellent or trapping strips.
    (viii) Pet collars or animal ear tags, such as cattle ear tags.
    (ix) One-time use semiochemical dispersion devices.
    (x) Any container that is destroyed by the use of the product 
contained.
    (xi) Any container that would be destroyed if reuse of the container 
were attempted.
    (b) Refillable container. For refillable containers, one of the 
following statements is required, except as provided in paragraphs (c), 
(d), and (e) of this section. If placed on the label, the statement must 
be under the heading ``Storage and Disposal.'' If the statement is 
placed on the container, an appropriate referral statement, such as 
``Refilling limitations are on the container.'' must be placed under the 
heading ``Storage and Disposal.''
    (1) ``Refillable Container. Refill this container with pesticide 
only. Do not reuse this container for any other purpose.''
    (2) ``Refillable Container. Refill this container with [common 
chemical name] only. Do not reuse this container for any other 
purpose.''
    (c) Modification. EPA may, on its own initiative or based on data or 
information submitted by any person, modify or waive the requirements of 
this section or permit or require alternative labeling statements.
    (d) Exemption for articles. Pesticidal articles that are not 
exempted from FIFRA regulation by Sec. 152.25(a) of this chapter are 
exempt from the requirements of this section.
    (e) Exemption for transport vehicles. Transport vehicles are exempt 
from the requirements of this section.

[71 FR 47420, Aug. 16, 2006, as amended at 73 FR 64224, Oct. 29, 2008]



Sec. 156.144  Residue removal instructions--general.

    (a) General. Except as provided by paragraphs (c) through (g) of 
this section, the label of each pesticide product must include the 
applicable instructions for removing pesticide residues from the 
container prior to container disposal that are specified in Sec. 
156.146 and Sec. 156.156. The residue removal instructions are required 
for both nonrefillable and refillable containers.
    (b) Placement of residue removal statements. All residue removal 
instructions must be placed under the heading ``Storage and Disposal.''
    (c) Exemption for residential/household use products. Residential/
household use pesticide products are exempt from the residue removal 
instruction requirements in this section through Sec. 156.156.
    (d) Modification. EPA may, on its own initiative or based on data 
submitted by any person, modify or waive the requirements of this 
section through Sec. 156.156, or permit or require alternative labeling 
statements.
    (e) Exemption for gases. Pesticide products that are gaseous at 
atmospheric temperature and pressure are exempt from the residue removal 
instruction requirements in this section through Sec. 156.156.
    (f) Exemption for articles. Pesticidal articles that are not 
exempted from FIFRA regulation by Sec. 152.25(a) of this chapter are 
exempt from the residue removal instruction requirements in this section 
through Sec. 156.156.
    (g) Exemption for transport vehicles. Transport vehicles are exempt 
from the requirements in this section through Sec. 156.156.

[71 FR 47420, Aug. 16, 2006, as amended at 73 FR 64224, Oct. 29, 2008]

[[Page 75]]



Sec. 156.146  Residue removal instructions for nonrefillable containers--rigid 

containers with dilutable pesticides.

    The label of each dilutable (liquid or solid) pesticide product 
packaged in a rigid nonrefillable container must include the following 
residue removal instructions as appropriate.
    (a) Timing of the residue removal procedure. One of the following 
statements must immediately precede the instructions required in 
paragraph (b) of this section and must be consistent with the 
instructions in paragraphs (b) and (c) of this section:
    (1) ``Clean container promptly after emptying.''
    (2) ``Triple rinse or pressure rinse container (or equivalent) 
promptly after emptying.''
    (3) ``Triple rinse container (or equivalent) promptly after 
emptying.''
    (b) Triple rinse instructions. The label of each dilutable pesticide 
product packaged in rigid nonrefillable containers must include one of 
the following sets of instructions.
    (1) For liquid dilutable pesticide products in containers small 
enough to shake, use the following instructions: ``Triple rinse as 
follows: Empty the remaining contents into application equipment or a 
mix tank and drain for 10 seconds after the flow begins to drip. Fill 
the container \1/4\ full with water and recap. Shake for 10 seconds. 
Pour rinsate into application equipment or a mix tank or store rinsate 
for later use or disposal. Drain for 10 seconds after the flow begins to 
drip. Repeat this procedure two more times.''
    (2) For solid dilutable pesticide products in containers small 
enough to shake, use the following instructions: ``Triple rinse as 
follows: Empty the remaining contents into application equipment or a 
mix tank. Fill the container \1/4\ full with water and recap. Shake for 
10 seconds. Pour rinsate into application equipment or a mix tank or 
store rinsate for later use or disposal. Drain for 10 seconds after the 
flow begins to drip. Repeat this procedure two more times.''
    (3) For containers that are too large to shake, use the following 
instructions: ``Triple rinse as follows: Empty remaining contents into 
application equipment or a mix tank. Fill the container \1/4\ full with 
water. Replace and tighten closures. Tip container on its side and roll 
it back and forth, ensuring at least one complete revolution, for 30 
seconds. Stand the container on its end and tip it back and forth 
several times. Turn the container over onto its other end and tip it 
back and forth several times. Empty the rinsate into application 
equipment or a mix tank or store rinsate for later use or disposal. 
Repeat this procedure two more times.''
    (c) Pressure rinse instructions. The label of each dilutable 
pesticide product packaged in rigid nonrefillable containers may include 
one of the following sets of instructions, and one of them must be used 
if the statement in paragraph (a)(2) of this section is used. If one of 
these statements is included on the label, it must immediately follow 
the triple rinse instructions specified in paragraph (b) of this 
section.
    (1) For liquid dilutable pesticide products, use the following label 
instruction: ``Pressure rinse as follows: Empty the remaining contents 
into application equipment or a mix tank and continue to drain for 10 
seconds after the flow begins to drip. Hold container upside down over 
application equipment or mix tank or collect rinsate for later use or 
disposal. Insert pressure rinsing nozzle in the side of the container, 
and rinse at about 40 PSI for at least 30 seconds. Drain for 10 seconds 
after the flow begins to drip.''
    (2) For solid dilutable pesticide products, use the following label 
instruction: ``Pressure rinse as follows: Empty the remaining contents 
into application equipment or a mix tank. Hold container upside down 
over application equipment or mix tank or collect rinsate for later use 
or disposal. Insert pressure rinsing nozzle in the side of the 
container, and rinse at about 40 PSI for at least 30 seconds. Drain for 
10 seconds after the flow begins to drip.''
    (d) Non-water diluent. (1) A registrant who wishes to require users 
to clean a container with a diluent other than water (e.g., solvents) 
must submit to EPA a written request to modify the residue removal 
instructions of this section. The registrant may not distribute or sell 
the pesticide with the

[[Page 76]]

modified residue removal instructions until EPA approves the request in 
writing.
    (2) The registrant must indicate why a non-water diluent is 
necessary for efficient residue removal, and must propose residue 
removal instructions and disposal instructions that are appropriate for 
the characteristics and formulation of the pesticide product and non-
water diluent. The proposed residue removal instructions must identify 
the diluent. If the Directions for Use permit the application of a 
mixture of the pesticide and the non-water diluent, the instructions may 
allow the rinsate to be added to the application equipment or mix tank. 
If the Directions for Use do not identify the non-water diluent as an 
allowable addition to the pesticide, the instructions must require 
collection and storage of the rinsate in a rinsate collection system.
    (3) EPA may approve the request if EPA finds that the proposed 
instructions are necessary and appropriate.



Sec. 156.156  Residue removal instructions for refillable containers.

    The label of each pesticide product packaged in a refillable 
container must include the residue removal instructions in this section. 
Instructions must be given for all pesticide products that are 
distributed or sold in refillable containers, including those that do 
not require dilution prior to application.
    (a) Timing of the residue removal procedure. One of the following 
statements must immediately precede the instructions required in 
paragraph (b) of this section and must be consistent with the 
instructions in paragraph (b) of this section:
    (1) ``Cleaning the container before final disposal is the 
responsibility of the person disposing of the container. Cleaning before 
refilling is the responsibility of the refiller.''
    (2) ``Pressure rinsing the container before final disposal is the 
responsibility of the person disposing of the container. Cleaning before 
refilling is the responsibility of the refiller.''
    (b) Residue removal instructions prior to container disposal. (1) 
Instructions for cleaning each refillable container prior to disposal 
are required. The residue removal instructions must be appropriate for 
the characteristics and formulation of the pesticide product and must be 
adequate to protect human health and the environment.
    (2) Subject to meeting the standard in paragraph (b)(1) of this 
section, the statement on residue removal instructions could include any 
one of the following:
    (i) The refilling residue removal procedure developed by the 
registrant for the pesticide product.
    (ii) Standard industry practices for cleaning refillable containers.
    (iii) For pesticides that require dilution prior to application, the 
following statement: ``To clean the container before final disposal, 
empty the remaining contents from this container into application 
equipment or a mix tank. Fill the container about 10 percent full with 
water. Agitate vigorously or recirculate water with the pump for 2 
minutes. Pour or pump rinsate into application equipment or rinsate 
collection system. Repeat this rinsing procedure two more times.''
    (iv) Any other statement the registrant considers appropriate.



Sec. 156.159  Compliance date.

    Any pesticide product released for shipment by a registrant after 
August 16, 2011 must bear a label that complies with Sec. Sec. 
156.10(d)(7), 156.10(f), 156.10(i)(2)(ix), 156.140, 156.144, 156.146 and 
156.156.

[75 FR 62326, Oct. 8, 2010]

Subparts I-J [Reserved]



                 Subpart K_Worker Protection Statements

    Source: 57 FR 38146, Aug. 21, 1992, unless otherwise noted.



Sec. 156.200  Scope and applicability.

    (a) Scope. (1) This subpart prescribes statements that must be 
placed on the pesticide label and in pesticide labeling. These 
statements incorporate by reference the Worker Protection Standard, part 
170 of this chapter. The requirements addressed in these statements are 
designed to reduce the risk of illness or injury resulting from

[[Page 77]]

workers' and pesticide handlers' occupational exposures to pesticides 
used in the production of agricultural plants on agricultural 
establishments as defined in Sec. 170.3 of this chapter. These 
statements refer to specific workplace practices designed to reduce or 
eliminate exposure and to respond to emergencies that may arise from the 
exposures that may occur.
    (2) This subpart prescribes interim requirements that must be placed 
on the pesticide label and in pesticide labeling. These interim 
requirements pertain to restricted-entry intervals, personal protective 
equipment, and notification. On a case-by-case basis, these interim 
requirements will be reviewed and may be revised during reregistration 
or other agency review processes.
    (b) Applicability. (1) The requirements of this subpart apply to 
each pesticide product that bears directions for use in the production 
of any agricultural plant on any agricultural establishment as defined 
in Sec. 170.3 of this chapter, or whose labeling reasonably permits 
such use.
    (2) The requirements of this subpart do not apply to a product that 
bears directions solely for uses excepted by Sec. 170.202(b) of this 
chapter.
    (c) Effective dates. No product to which this subpart applies shall 
be distributed or sold without amended labeling by any registrant after 
April 21, 1994, or by any person after October 23, 1995.

[57 FR 38146, Aug. 21, 1992, as amended at 73 FR 75596, Dec. 12, 2008]



Sec. 156.203  Definitions.

    Terms in this subpart have the same meanings as they do in the 
Federal Insecticide, Fungicide, and Rodenticide Act, as amended. In 
addition, the following terms, as used in this subpart, shall have the 
meanings stated below:
    Fumigant means any pesticide product that is a vapor or gas or forms 
a vapor or gas on application and whose method of pesticidal action is 
through the gaseous state.
    Restricted-entry interval or REI means the time after the end of a 
pesticide application during which entry to the treated area is 
restricted.

[57 FR 38146, Aug. 21, 1992, as amended at 73 FR 75596, Dec. 12, 2008]



Sec. 156.204  Modification and waiver of requirements.

    (a) Modification on Special Review. If the Agency concludes in 
accordance with Sec. 154.25(c) of this chapter that a pesticide should 
be placed in Special Review because the pesticide meets or exceeds the 
criteria for human health effects of Sec. 154.7(a)(1)(2) or (6) of this 
chapter, the Agency may modify the personal protective equipment 
required for handlers or early-entry workers or both, the restricted-
entry intervals, or the notification to workers requirements.
    (b) Other modifications. The Agency, pursuant to this subpart and 
authorities granted in FIFRA sections 3, 6, and 12, may, on its 
initiative or based on data submitted by any person, modify or waive the 
requirements of this subpart, or permit or require alternative labeling 
statements. Supporting data may be either data conducted according to 
Subdivisions U or K of the Pesticide Assessments guidelines or data from 
medical, epidemiological, or health effects studies. A registrant who 
wishes to modify any of the statements required in Sec. 156.206, Sec. 
156.208, Sec. 156.210, or Sec. 156.212 must submit an application for 
amended registration unless specifically directed otherwise by the 
Agency.

[57 FR 38146, Aug. 21, 1992, as amended at 73 FR 75596, Dec. 12, 2008]



Sec. 156.206  General statements.

    (a) Application restrictions. Each product shall bear the statement: 
``Do not apply this product in a way that will contact workers or other 
persons, either directly or through drift. Only protected handlers may 
be in the area during application.'' This statement shall be near the 
beginning of the DIRECTIONS FOR USE section of the labeling under the 
heading AGRICULTURAL USE REQUIREMENTS.
    (b) 40 CFR part 170 reference statement. (1) Each product shall bear 
the reference statement: ``Use this product only in accordance with its 
labeling

[[Page 78]]

and with the Worker Protection Standard, 40 CFR part 170.'' This 
statement shall be placed on the product label under the heading 
AGRICULTURAL USE REQUIREMENTS.
    (2) Each product shall bear the statement: ``This standard contains 
requirements for the protection of agricultural workers on farms, 
forests, nurseries, and greenhouses, and handlers of agricultural 
pesticides. It contains requirements for training, decontamination, 
notification, and emergency assistance. It also contains specific 
instructions and exceptions pertaining to the statements on this label 
[in this labeling] about [use any of the following that are applicable] 
personal protective equipment, restricted-entry interval, and 
notification to workers.'' These statements shall be placed immediately 
following the reference statement required by paragraph (b)(1) of this 
section, or they shall be placed in the supplemental product labeling 
under the heading AGRICULTURAL USE REQUIREMENTS.
    (3) If the statements in paragraph (b)(2) of this section are 
included in supplemental labeling rather than on the label of the 
pesticide container, the container label must contain this statement 
immediately following the statement required in paragraph (b)(1) of this 
section: ``Refer to supplemental labeling entitled AGRICULTURAL USE 
REQUIREMENTS in the DIRECTIONS FOR USE section of the labeling for 
information about this standard.''
    (4) If the statements in paragraph (b)(2) of this section are 
included in supplemental labeling, they must be preceded immediately by 
the statement in paragraph (b)(1) of this section under the heading 
AGRICULTURAL USE REQUIREMENTS in the labeling.
    (c) Product-type identification. (1) If the product contains an 
organophosphate (i.e., an organophosphorus ester that inhibits 
cholinesterase) or an N-methyl carbamate (i.e., an N-methyl carbamic 
acid ester that inhibits cholinesterase), the label shall so state. The 
statement shall be associated with the product name or product-type 
identification or shall be in the STATEMENT OF PRACTICAL TREATMENT or 
FIRST AID section of the label.
    (2) If the product is a fumigant, the label shall so state. The 
identification shall appear:
    (i) As part of the product name; or
    (ii) Close to the product name, as part of the product-type 
identification or as a separate phrase or sentence.
    (d) State restrictions. Each product shall bear the statement: ``For 
any requirements specific to your State, consult the agency in your 
State responsible for pesticide regulation.'' This statement shall be 
under the heading AGRICULTURAL USE REQUIREMENTS in the labeling.
    (e) Spanish warning statements. If the product is classified as 
toxicity category I or toxicity category II according to the criteria in 
Sec. 156.62, the signal word shall appear in Spanish in addition to 
English followed by the statement, ``Si Usted no entiende la etiqueta, 
busque a alguien para que se la explique a Usted en detalle. (If you do 
not understand the label, find some one to explain it to you in 
detail.)'' The Spanish signal word ``PELIGRO'' shall be used for 
products in toxicity category I, and the Spanish signal word ``AVISO'' 
shall be used for products in toxicity category II. These statements 
shall appear on the label close to the English signal word.

[57 FR 38146, Aug. 21, 1992, as amended at 58 FR 34203, June 23, 1993; 
73 FR 75596, Dec. 12, 2008]



Sec. 156.208  Restricted-entry statements.

    (a) Requirement. Each product with a restricted-entry interval shall 
bear the following statement: ``Do not enter or allow worker entry into 
treated areas during the restricted-entry interval (REI).'' This 
statement shall be under the heading AGRICULTURAL USE REQUIREMENTS in 
the labeling.
    (b) Location of specific restricted-entry interval statements. (1) 
If a product has one specific restricted-entry interval applicable to 
all registered uses of the product on agricultural plants, the 
restricted-entry interval for the product shall appear as a continuation 
of the statement required in paragraph (a) of this section and shall 
appear as follows: ``of X hours'' or ``of X days'' or

[[Page 79]]

``until the acceptable exposure level of X ppm or mg/m\3\ is reached.''
    (2) If different restricted-entry intervals have been established 
for some crops or some uses of a product, the restricted-entry statement 
in paragraph (b)(1) of this section shall be associated on the labeling 
of the product with the directions for use for each crop each use to 
which it applies, immediately preceded or immediately followed by the 
words ``Restricted-entry interval'' (or the letters ``REI'').
    (c) Restricted-entry interval based on toxicity of active 
ingredient--(1) Determination of toxicity category. A restricted-entry 
interval shall be established based on the acute toxicity of the active 
ingredients in the product. For the purpose of setting the restricted-
entry interval, the toxicity category of each active ingredient in the 
product shall be determined by comparing the obtainable data on the 
acute dermal toxicity, eye irritation effects, and skin irritation 
effects of the ingredient to the criteria of Sec. 156.62. The most 
toxic of the applicable toxicity categories that are obtainable for each 
active ingredient shall be used to determine the restricted-entry 
interval for that product. If no acute dermal toxicity data are 
obtainable, data on acute oral toxicity also shall be considered in this 
comparison. If no applicable acute toxicity data are obtainable on the 
active ingredient, the toxicity category corresponding to the signal 
word of any registered manufacturing-use product that is the source of 
the active ingredient in the end-use product shall be used. If no acute 
toxicity data are obtainable on the active ingredients and no toxicity 
category of a registered manufacturing-use product is obtainable, the 
toxicity category of the end-use product (corresponding to the signal 
word on its labeling) shall be used.
    (2) Restricted-entry interval for sole active ingredient products. 
(i) If the product contains only one active ingredient and it is in 
toxicity category I by the criteria in paragraph (c)(1) of this section, 
the restricted-entry interval shall be 48 hours. If, in addition, the 
active ingredient is an organophosphorus ester that inhibits 
cholinesterase and that may be applied outdoors in an area where the 
average annual rainfall for the application site is less than 25 inches 
per year, the following statement shall be added to the restricted-entry 
interval statement: ``(72 hours in outdoor areas where average annual 
rainfall is less than 25 inches a year).''
    (ii) If the product contains only one active ingredient and it is in 
toxicity category II by the criteria in paragraph (c)(1) of this 
section, the restricted-entry interval shall be 24 hours.
    (iii) If the product contains only active ingredients that are in 
toxicity category III or IV by the criteria in paragraph (c)(1) of this 
section, the restricted-entry interval shall be 12 hours.
    (3) Restricted-entry interval for multiple active ingredient 
products. If the product contains more than one active ingredient, the 
restricted-entry interval (including any associated statement concerning 
use in arid areas under paragraph (c)(2)(i) of this section) shall be 
based on the active ingredient that requires the longest restricted-
entry interval as determined by the criteria in this section.
    (d) Exception for fumigants. The criteria for determining 
restricted-entry intervals in paragraph (c) of this section shall not 
apply to any product that is a fumigant. For fumigants, any existing 
restricted-entry interval (hours, days, or acceptable exposure level) 
shall be retained. Entry restrictions for fumigants have been or shall 
be established on a case-by-case basis at the time of registration, 
reregistration, or other Agency review process.
    (e) Existing product-specific restricted-entry intervals. (1) A 
product-specific restricted-entry interval, based on data collected in 
accordance with Sec. 158.1070 or Sec. 161.390 of this chapter and 
Subdivision K of the Pesticide Assessment Guidelines, shall supersede 
any restricted-entry interval applicable to the product under paragraph 
(c) of this section.
    (2) Product-specific restricted-entry intervals established for 
pesticide products or pesticide uses that are not covered by part 170 of 
this chapter shall remain in effect and shall not be placed under the 
heading AGRICULTURAL USE REQUIREMENTS in the labeling.

[[Page 80]]

    (f) Existing interim restricted-entry intervals. (1) An interim 
restricted-entry interval established by the Agency before the effective 
date of this subpart will continue to apply unless a longer restricted-
entry interval is required by paragraph (c) of this section.
    (2) Existing interim restricted-entry intervals established by the 
Agency for pesticide products or pesticide uses not covered by part 170 
of this chapter shall remain in effect and shall not be placed under the 
heading AGRICULTURAL USE REQUIREMENTS in the labeling.

[57 FR 38146, Aug. 21, 1992, as amended at 58 FR 34203, June 23, 1993; 
72 FR 61028, Oct. 26, 2007; 73 FR 75596, Dec. 12, 2008]



Sec. 156.210  Notification-to-workers statements.

    (a) Requirement. Each product that meets the requirements of 
paragraph (b) of this section shall bear the posting and oral 
notification statements prescribed below. The statements shall be in the 
DIRECTIONS FOR USE section of the labeling under the heading 
AGRICULTURAL USE REQUIREMENTS.
    (b) Notification to workers of pesticide application. (1) Each 
product that contains any active ingredient classified as toxicity 
category I for either acute dermal toxicity or skin irritation potential 
under the criteria in Sec. 156.62 shall bear the statement: ``Notify 
workers of the application by warning them orally and by posting warning 
signs at entrances to treated areas.'' If no acute dermal toxicity data 
are obtainable, data on acute oral toxicity of the active ingredient 
shall be considered instead. If no data on acute dermal toxicity, skin 
irritation potential, or acute oral toxicity are obtainable on the 
active ingredient, the toxicity category corresponding to the signal 
word of any registered manufacturing-use product that is the source of 
the active ingredient in the end-use product shall be used. If none of 
the applicable acute toxicity data are obtainable on the active 
ingredient and no toxicity category of the registered manufacturing-use 
product is obtainable, the toxicity category of the end-use product 
corresponding to the product's signal word shall be used.
    (2) Each product that is a fumigant and is registered for use in a 
greenhouse (or whose labeling allows use in a greenhouse) shall bear the 
statement: ``For greenhouse applications, notify workers of the 
application by warning them orally and by posting warning signs outside 
all entrances to the greenhouse.''

[57 FR 38146, Aug. 21, 1992, as amended at 58 FR 34203, June 23, 1993; 
73 FR 75596, Dec. 12, 2008]



Sec. 156.212  Personal protective equipment statements.

    (a) Requirement. Each product shall bear the personal protective 
equipment statements prescribed in paragraphs (d) through (j) of this 
section.
    (b) Exceptions. (1) If personal protective equipment were required 
for a product before the effective date of this subpart, the existing 
requirements shall be retained on the labeling wherever they are more 
specific or more protective (as specified in EPA guidance materials) 
than the requirements in the table in paragraph (e) of this section.
    (2) Any existing labeling statement that prohibits the use of gloves 
or boots overrides the corresponding requirement in paragraph (e) of 
this section and must be retained on the labeling.
    (3) If the product labeling contains uses that are not covered by 
part 170 of this chapter, the registrant may adopt the personal 
protective equipment required in this section for those uses. However, 
if the personal protective equipment required in this section would not 
be sufficiently protective or would be onerously overprotective for uses 
not covered by part 170 of this chapter, the registrant must continue to 
apply the existing personal protective equipment requirements to those 
uses. The labeling must indicate which personal protective equipment 
requirements apply to uses covered by part 170 of this chapter and which 
personal protective equipment requirements apply to other uses.
    (c) Location of personal protective equipment statements--(1) 
Personal protective equipment statements for pesticide handlers. 
Personal protective equipment statements for pesticide handlers

[[Page 81]]

shall be in the HAZARDS TO HUMANS (AND DOMESTIC ANIMALS) section of the 
labeling. The required statements may be combined to avoid redundancy as 
long as the requirements and conditions under which they apply are 
identified.
    (2) Personal protective equipment statements for early-entry 
workers. Personal protective equipment statements for early-entry 
workers shall be placed in the DIRECTIONS FOR USE section of the 
labeling under the heading AGRICULTURAL USE REQUIREMENTS and immediately 
after the restricted-entry statement required in Sec. 156.208(a).
    (d) Personal protective equipment statements for pesticide handlers. 
(1) The table in paragraph (e) of this section specifies minimum 
requirements for personal protective equipment (as defined in Sec. 
170.240 of this chapter) and work clothing for pesticide handlers. This 
personal protective equipment requirement applies to any product that 
presents a hazard through any route of exposure identified in the table 
(acute dermal toxicity, skin irritation potential, acute inhalation 
toxicity, and eye irritation potential).
    (2) The requirement for personal protective equipment is based on 
the acute toxicity category of the end-use product for each route of 
exposure as defined by Sec. 156.62. If data to determine the acute 
dermal toxicity or the acute inhalation toxicity are not obtainable, the 
acute oral toxicity shall be used as a surrogate to determine the 
personal protective equipment requirements for that route of exposure. 
If data to determine the acute toxicity of the product by a specific 
route of exposure (including acute oral toxicity in lieu of acute dermal 
or acute inhalation toxicity) are not obtainable, the toxicity category 
corresponding to the signal word of the end-use product shall be used to 
determine personal protective equipment requirements for that route of 
exposure. If the signal word is ``CAUTION,'' toxicity category III will 
be used.
    (3) The minimum personal protective equipment and work clothing 
requirements specified in this section shall be included in a statement 
such as the following: ``Applicators and other handlers must wear: (body 
protection statement); (glove statement, if applicable); (footwear 
statement, if applicable); (protective eyewear statement, if 
applicable); (respirator statement, if applicable).'' The format of 
statements given in this paragraph is optional, but it is recommended 
for clarity.
    (e) Summary of personal protective equipment requirements. The 
following table 1 summarizes the personal protective equipment 
requirements by route of exposure and toxicity category:

         Table 1--Minimum Personal Protective Equipment (PPE) and Work Clothing for Handling Activities
----------------------------------------------------------------------------------------------------------------
                                                       Toxicity Category of End-Use Product
        Route of Exposure        -------------------------------------------------------------------------------
                                           I                  II                  III                 IV
----------------------------------------------------------------------------------------------------------------
Dermal Toxicity or Skin           Coveralls worn      Coveralls worn      Long-sleeved shirt  Long-sleeved shirt
 Irritation Potential \1\          over long-sleeved   over short-         and long pants      and long pants
                                   shirt and long      sleeved shirt and
                                   pants               short pants
                                  Socks               Socks               Socks               Socks
                                  Chemical-resistant  Chemical-resistant  Shoes               Shoes
                                   footwear            footwear
                                  Chemical-resistant  Chemical-resistant  Chemical-resistant  No minimum \4\
                                   gloves \2\          gloves \2\          gloves \2\
 
Inhalation Toxicity               Respiratory         Respiratory         No minimum \4\      No minimum \4\
                                   protection device   protection device
                                   \3\                 \3\
 
Eye Irritation Potential          Protective eyewear  Protective eyewear  No minimum \4\      No minimum \4\
----------------------------------------------------------------------------------------------------------------
\1\ If dermal toxicity and skin irritation potential are in different toxicity categories, protection shall be
  based on the more toxic (lower numbered) category.
\2\ For labeling language for chemical-resistant gloves, see paragraph (f) of this section.
\3\ For labeling language for respiratory protection device, see paragraphs (g) and (h) of this section.
\4\ Although no minimum PPE is required by this section for this toxicity category and route of exposure, the
  Agency may require PPE on a product-specific basis.


[[Page 82]]

    (f) Chemical-resistant gloves labeling statements for pesticide 
handlers. If the table in paragraph (e) of this section indicates that 
chemical-resistant gloves are required, the glove statement shall be as 
specified in paragraph (f)(2), (3), (4), or (5) of this section.
    (1) Exception. The registrant shall specify a glove type other than 
that selected through the criteria in paragraphs (f)(2) through (5) of 
this section if information available to the registrant indicates that 
such a glove type is more appropriate or more protective than the glove 
type specified in this section. The statement must specify the 
particular types of chemical-resistant glove (such as nitrile, butyl, 
neoprene, and/or barrier-laminate).
    (2) Solid formulations. For products formulated and applied as 
solids or formulated as solids and diluted solely with water for 
application, the glove statement shall specify: ``waterproof gloves.''
    (3) Aqueous-based formulations. For products formulated and applied 
as a water-based liquid or formulated as a water-based liquid and 
diluted solely with water for application, the glove statement may 
specify: ``waterproof gloves'' instead of the statement in paragraph 
(f)(4) of this section.
    (4) Other liquid formulations. For products formulated or diluted 
with liquids other than water, the glove statement shall specify: 
``chemical-resistant (such as nitrile or butyl) gloves.''
    (5) Gaseous formulations and applications. For products formulated 
or applied as gases, any existing glove statement established before the 
effective date of this subpart, including any glove prohibition 
statement, will continue to apply. If no glove statement or glove 
prohibition now exists, the glove statement shall specify ``chemical-
resistant (such as nitrile or butyl) gloves.''
    (g) Existing respirator requirement for pesticide handlers on 
product labeling--(1) General requirement. If a statement placed on a 
product's labeling before the effective date of this subpart indicates 
that respiratory protection is required, that requirement for protection 
shall be retained. The statement must specify, or be amended to specify, 
one of the following respirator types and the appropriate MSHA/NIOSH 
approval number prefix:
    (i) Dust/mist filtering respirator with MSHA/NIOSH/ approval number 
prefix TC-21C; or
    (ii) Respirator with an organic-vapor-removing cartridge and a 
prefilter approved for pesticides with MSHA/NIOSH approval number prefix 
TC-23C or with a canister approved for pesticides with MSHA/NIOSH 
approval number prefix TC-14G; or
    (iii) Supplied-air respirator with MSHA/NIOSH approval number prefix 
TC-19C or self-contained breathing apparatus (SCBA) with MSHA/NIOSH 
approval number TC-13F.
    (2) Respirator type already specified on labeling. If the existing 
respiratory protection requirement specifies a respirator type, it shall 
be retained. The respirator statement must be revised, if necessary, to 
conform to the wording in paragraph (g)(1) of this section.
    (3) Respirator type not already specified on labeling. If the 
existing respiratory protection requirement on product labeling does not 
specify a respirator type as listed in paragraph (g)(1) of this section, 
the specific respirator type shall be that required in the criteria in 
paragraphs (g)(3)(ii) through (vi) of this section.
    (i) Exception. The registrant shall specify a different type of 
respiratory protection device if information, such as vapor pressure 
value, is available to the registrant to indicate that the type of 
respiratory protection device selected through the criteria in 
paragraphs (g)(3)(ii) through (vi) of this section would not be 
adequately protective, or might increase risks to the user 
unnecessarily.
    (ii) Gases applied outdoors. For products that are formulated or 
applied as a gas (space and soil fumigants) and that may be used 
outdoors, the respiratory protection statement shall be: ``For handling 
activities outdoors, use either a respirator with an organic-vapor-
removing cartridge with a prefilter approved for pesticides (MSHA/NIOSH 
approval number prefix TC-23C), or a canister approved for pesticides 
(MSHA/NIOSH approval number prefix TC-14G).''
    (iii) Gases used in enclosed areas. For products that are formulated 
or applied

[[Page 83]]

as a gas (space and soil fumigants) and that may be used in greenhouses 
or other enclosed areas, the respiratory protection statement shall 
specify: ``For handling activities in enclosed areas, use either a 
supplied-air respirator with MSHA/NIOSH approval number prefix TC-19C, 
or a self-contained breathing apparatus (SCBA) with MSHA/NIOSH approval 
number TC-13F.''
    (iv) Solids. For products that are formulated and applied as solids, 
the respiratory protection statement shall specify: ``dust/mist 
filtering respirator (MSHA/NIOSH approval number prefix TC-21C).''
    (v) Liquids in toxicity category I. For products that are formulated 
or applied as liquids, and, as formulated, have an acute inhalation 
toxicity (or its surrogate as specified in paragraph (d)(2) of this 
section) in category I, the respiratory protection statement shall 
specify: ``either a respirator with an organic-vapor-removing cartridge 
with a prefilter approved for pesticides (MSHA/NIOSH approval number 
prefix TC-23C), or a canister approved for pesticides (MSHA/NIOSH 
approval number prefix 14G).''
    (vi) Liquids in toxicity category II. For products that are 
formulated or applied as liquids, and, as formulated, have an acute 
inhalation toxicity (or its surrogate as specified in paragraph (d)(2) 
of this section) in category II, the respiratory protection statement 
shall specify: ``For handling activities during (select uses applicable 
to the product: airblast, mistblower, pressure greater than 40 p.s.i. 
with fine droplets, smoke, mist, fog, aerosol or direct overhead) 
exposures, wear either a respirator with an organic-vapor-removing 
cartridge with a prefilter approved for pesticides (MSHA/NIOSH approval 
number prefix TC-23C), or a canister approved for pesticides (MSHA/NIOSH 
approval number prefix 14G). For all other exposures, wear a dust/mist 
filtering respirator (MSHA/NIOSH approval number prefix TC-21C).''
    (h) New respirator requirement established for pesticide handlers in 
this part--(1) General requirement. If the table in paragraph (e) of 
this section indicates a respiratory protection device is required, and 
existing product labeling has no respiratory protection requirement, the 
registrant shall add a respiratory protection statement that specifies 
a: ``dust/mist filtering respirator (MSHA/NIOSH approval number prefix 
TC-21C).''
    (2) Exception. The registrant shall specify a different type of 
respiratory protection device if information, such as vapor pressure 
value, is available to the registrant to indicate that the type of 
respiratory protection device required in paragraph (h)(1) of this 
section would not be adequately protective or might increase risks to 
the user unnecessarily.
    (i) Additional personal protective equipment requirements for 
pesticide handlers. In addition to the minimum personal protective 
equipment and work clothing requirements given in the table in paragraph 
(e) of this section, the labeling statement for any product in toxicity 
category I or II on the basis of dermal toxicity or skin irritation 
potential (or their surrogate as specified in paragraph (d)(2) of this 
section), shall include the following personal protective equipment 
instructions, additions, or substitutions as applicable:
    (1) If the product is not ready-to-use and there is no existing 
requirement for a chemical-resistant suit, the following statement shall 
be included: ``Mixers/Loaders: add a chemical-resistant apron.''
    (2) If the application of the product may result in overhead 
exposure to any handler (for example, applicator exposure during 
airblast spraying of orchards or flagger exposure during aerial 
application), the following statement shall be included: ``Overhead 
Exposure: wear chemical-resistant headgear.''
    (3) If any type of equipment other than the product container may be 
used to mix, load, or apply the product, and there is no requirement for 
a chemical-resistant protective suit, the following statement shall be 
included: ``For Cleaning Equipment: add a chemical-resistant apron.''
    (j) Personal protective equipment for early-entry workers. This 
paragraph specifies minimum requirements for personal protective 
equipment (as defined in Sec. 170.240 of this chapter) and work 
clothing for early-entry workers.

[[Page 84]]

    (1) For all pesticide products, add the statement: ``For early entry 
to treated areas that is permitted under the Worker Protection Standard 
and that involves contact with anything that has been treated, such as 
plants, soil, or water, wear: (list the body protection, glove, 
footwear, protective eyewear, and protective headgear, if applicable, 
statements specified for applicators and other handlers, but omit any 
respiratory protection statement).''
    (2) If the body protection statement in the personal protective 
equipment requirement for handlers specifies a long-sleeved shirt and 
long pants, ``coveralls'' must be specified in the statement of personal 
protective equipment for early-entry workers.
    (3) If there is no statement requiring gloves and no prohibition 
against gloves for applicators and other handlers under the heading 
HAZARDS TO HUMANS (AND DOMESTIC ANIMALS) in the labeling, add a 
requirement for ``waterproof gloves'' in the statement of personal 
protective equipment for early-entry workers.

[57 FR 38146, Aug. 21, 1992, as amended at 58 FR 34203, June 23, 1993; 
73 FR 75596, Dec. 12, 2008]



PART 157_PACKAGING REQUIREMENTS FOR PESTICIDES AND DEVICES--Table of Contents



Subpart A [Reserved]

                   Subpart B_Child-Resistant Packaging

Sec.
157.20 General.
157.21 Definitions.
157.22 When required.
157.24 Exemptions.
157.27 Unit packaging.
157.30 Voluntary use of child-resistant packaging.
157.32 Standards.
157.34 Certification.
157.36 Recordkeeping.

    Authority: 7 U.S.C. 136w.

    Source: 51 FR 21286, June 11, 1986; 51 FR 36692, Oct. 15, 1986, 
unless otherwise noted.

Subpart A [Reserved]



                   Subpart B_Child-Resistant Packaging



Sec. 157.20  General.

    This subpart prescribes requirements for child-resistant packaging 
of pesticide products and devices. The requirements are established 
under the authority of FIFRA section 25(a)(1), which authorizes the 
Administrator to issue regulations to carry out the purposes of the Act, 
and FIFRA section 25(c)(3), which authorizes the Administrator to 
establish standards with respect to the package, container or wrapping 
in which a pesticide or device is enclosed in order to protect children 
and adults from serious injury or illness resulting from accidental 
ingestion or contact with pesticides or devices regulated under the Act.



Sec. 157.21  Definitions.

    Terms used in this subpart shall have the following meanings:
    Appropriate, when used with respect to child-resistant packaging, 
means that the packaging is chemically compatible with the pesticide 
contained therein.
    Child-resistant packaging means packaging that is designed and 
constructed to be significantly difficult for children under 5 years of 
age to open or obtain a toxic or harmful amount of the substance 
contained therein within a reasonable time, and that is not difficult 
for normal adults to use properly.
    Package or packaging means the immediate container or wrapping, 
including any attached closure(s), in which the pesticide is contained 
for distribution, sale, consumption, use or storage. The term does not 
include any shipping or bulk container used for transporting or 
delivering the pesticide unless it is the only such package.
    Practicable, when used with respect to child-resistant packaging, 
means that the packaging can be mass produced and can be used in 
assembly line production.
    Residential use means use of a pesticide or device:
    (1) Directly on humans or pets;
    (2) In, on, or around any structure, vehicle, article, surface or 
area associated with the household, including but

[[Page 85]]

not limited to areas such as non-agricultural outbuildings, non-
commercial greenhouses, pleasure boats and recreational vehicles; or
    (3) In or around any preschool or day care facility.
    Technically feasible, when applied to child-resistant packaging, 
means that the technology exists to produce the child-resistant 
packaging for a particular pesticide.
    Unit packaging means a package that is labeled with directions to 
use the entire contents of the package in a single application.

[51 FR 21286, June 11, 1986, as amended at 73 FR 75596, Dec. 12, 2008]



Sec. 157.22  When required.

    Unless exempted under Sec. 157.24, a pesticide product must be 
distributed and sold in child-resistant packaging complying with Sec. 
157.32 if it meets both of the following criteria:
    (a) Toxicity criterion. Based upon testing with an appropriate test 
species, the product meets any of the following toxicity criteria:
    (1) The pesticide has an acute oral LD50 of 1.5 g/kg or 
less;
    (2) The pesticide has an acute dermal LD50 of 2000 mg/kg 
or less;
    (3) The pesticide has an acute inhalation LC50 of 2 mg/
liter or less;
    (4) The pesticide is corrosive to the eye (causes irreversible 
destruction of ocular tissue) or causes corneal involvement or 
irritation persisting for 21 days or more;
    (5) The pesticide is corrosive to the skin (causes tissue 
destruction into the dermis and/or scarring) or causes severe skin 
irritation (severe erythema or edema) at 72 hours; or
    (6) The pesticide or device has such characteristics that, based 
upon human toxicological data, use history, accident data or such other 
evidence as is available, the Agency determines there is serious hazard 
of accidental injury or illness which child-resistant packaging could 
reduce; and
    (b) Use criterion. The product's labeling either directly recommends 
residential use or reasonably can be interpreted to permit residential 
use.



Sec. 157.24  Exemptions.

    (a) General exemptions. The Agency hereby exempts from the 
requirement for child-resistant packaging the following classes of 
products:
    (1) Products classified for restricted use. (i) A product restricted 
to use by or under the supervision of a certified applicator is not 
required to be distributed and sold in child-resistant packaging.
    (ii) Notwithstanding the exemption in paragraph (a)(1)(i) of this 
section, the Agency may require the use of child-resistant packaging for 
a product classified for restricted use by or under the direct 
supervision of a certified applicator if the Agency determines that the 
product poses a risk of serious accidental injury or illness which 
child-resistant packaging could reduce. If the Agency makes such a 
determination, it will notify the registrant in writing and provide a 
short statement of the basis of its determination. The registrant will 
then have 30 days to request a hearing on the Agency's determination. 
Thereafter the Agency will decide whether to require the product to be 
distributed only in child-resistant packaging and will notify the 
registrant of its decision.
    (2) Products packaged in large sizes. (i) Except as provided by 
paragraph (a)(2)(ii) of this section, a product is not required to be in 
child-resistant packaging if distributed and sold in the following 
sizes:
    (A) If the product is a solid product, regardless of pesticide type, 
a size of 50 pounds or greater;
    (B) If the product is a liquid product intended for use in swimming 
pools, a size greater than 7.5 gallons by volume;
    (C) If the product is a liquid product intended for any other 
pesticide use, a size of 5 gallons or greater by volume;
    (D) If the product is packaged as an aerosol (measured by weight), 
regardless of pesticide type, a weight of 2 pounds or greater.
    (ii) The Agency may require that a product packaged in a size 
exceeding that listed in paragraphs (a)(2)(i) (A) through (D) of this 
section be distributed and sold only in child-resistant packaging if the 
Agency determines that the product is, or is intended to be, distributed 
or sold to homeowners

[[Page 86]]

or other members of the general public. If the Agency makes such a 
determination, it will notify the registrant in writing and provide a 
short statement of the basis of its determination. The registrant will 
then have 30 days to request a hearing on the Agency's determination. 
Thereafter the Agency will decide whether to require the product to be 
distributed only in child-resistant packaging and will notify the 
registrant of its decision.
    (b) Exemptions requiring Agency approval. The Agency may, in 
accordance with paragraphs (b) (1) through (3) of this section, grant an 
exemption from the requirements of this subpart. An exemption may be 
withdrawn in accordance with paragraph (b)(4) of this section.
    (1) Requesting an exemption. A request for an exemption must be 
submitted to the Agency, and must be accompanied by two copies of the 
following information:
    (i) The name, address, and telephone number of the requester;
    (ii) The name and registration number (or file symbol) of the 
product(s) for which the exemption is requested;
    (iii) A description of the package and the size(s) for which the 
exemption is requested; and
    (iv) Documentation supporting the request for exemption, including 
the length of time for which the exemption is requested.
    (2) Exemption based upon lack of toxicity. The Agency may grant an 
exemption from the requirements of this subpart if the registrant or 
applicant demonstrates to the Agency's satisfaction that the hazards 
indicated by the toxicity criteria in Sec. 157.22(a) are not indicative 
of the hazards to man. If granted, an exemption shall apply to other 
products of substantially similar composition. A notice will be issued 
in the Federal Register stating the nature of and reasons for the 
exemption.
    (3) Exemption based upon technical factors. The Agency may grant an 
exemption from the requirements of this subpart based upon technical 
considerations. If granted, the exemption will be for a specified length 
of time, and will apply to other products of substantially similar 
composition and intended uses. A notice of the granting of an exemption 
will be issued in the Federal Register. In considering whether to grant 
an exemption, the Agency will consider, among other things, the 
following:
    (i) Whether the toxicity of the product is such that it should not 
be allowed to be distributed or sold except in child-resistant 
packaging.
    (ii) Whether child-resistant packaging is technically feasible, 
practicable, or appropriate. An exemption may be granted if the Agency 
determines that any one of these criteria has not been met.
    (iii) Whether the composition or use pattern of the product 
necessitates a particular form of packaging for proper use.
    (iv) Whether child-resistant packaging that is technically feasible, 
practicable, and appropriate is available for the product or can 
reasonably be made available to the registrant in sufficient quantities 
to meet his packaging needs. This determination does not include a 
consideration of whether the packaging would be adaptable to a 
registrant's existing package type or packaging equipment.
    (v) Whether the registrant has made a timely and good faith effort 
to obtain child-resistant packaging for the product.
    (vi) If child-resistant packaging which is technically feasible, 
practicable, and appropriate is not yet available, when such packaging 
is likely to be available.
    (4) An exemption may be withdrawn by the Agency at any time if the 
lack of child-resistant packaging results in serious illnesses or 
injuries to children. If the Agency determines that an exemption should 
be withdrawn, it will notify the registrant, stating the basis for its 
determination. The registrant will then have 30 days to request a 
hearing on the Agency's determination. Thereafter the Agency will decide 
whether to withdraw the exemption, and will notify the registrant of its 
decision.



Sec. 157.27  Unit packaging.

    Pesticide products distributed or sold as an aggregate of one or 
more unit packages and meeting the criteria of Sec. 157.22 must be 
distributed or sold in

[[Page 87]]

child-resistant packaging either for each unit package or for the outer 
retail container which contains the unit packages. Child-resistant 
packaging is not required for both the outer package and the unit 
packages unless the Agency determines, on a case-by-case basis, that it 
is necessary for risk reduction.



Sec. 157.30  Voluntary use of child-resistant packaging.

    A registrant whose product is not required to be in child-resistant 
packaging may distribute or sell his pesticide product in child-
resistant packaging. If he does so, that packaging must meet the 
standards for child-resistant packaging stated in Sec. 157.32. The 
registrant must certify to this effect in accordance with Sec. 157.34, 
and must retain the records required by Sec. 157.36.



Sec. 157.32  Standards.

    (a) Effectiveness standard. The child-resistant packaging, when 
tested by the protocol specified in 16 CFR 1700.20, shall meet the 
effectiveness specifications in 16 CFR 1700.15(b).
    (b) Compatibility standard. The child-resistant packaging must 
continue to meet the effectiveness specifications of paragraph (a) of 
this section when in actual use as a pesticide container. This 
requirement may be satisfied by appropriate scientific evaluation of the 
compatibility of the substance with the child-resistant packaging to 
determine that the chemical and physical characteristics of the 
pesticide will not compromise or interfere with the proper functioning 
of the child-resistant packaging and that the packaging will not be 
detrimental to the integrity of the product during storage and use.
    (c) Durability standard. The child-resistant packaging must continue 
to meet the effectiveness and compatibility standards of paragraphs (a) 
and (b) of this section for the reasonably expected lifetime of the 
package, taking into account the number of times the package is 
customarily opened and closed. This requirement may be satisfied by 
appropriate technical evaluation based on physical wear and stress 
factors of packaging, the force required for activation, and other 
relevant factors.



Sec. 157.34  Certification.

    (a) General. (1) The registrant of a pesticide product required to 
be in child-resistant packaging shall certify to the Agency that the 
package meets the standards of Sec. 157.32.
    (2) Certification must be submitted with each application for new 
registration, if applicable. If the Agency determines, in accordance 
with Sec. 157.24(a)(1)(ii), (2)(ii), or (b)(4), that a currently 
registered product is required to be packaged in child-resistant 
packaging, a certification must be submitted within 6 months after the 
Agency finally notifies the registrant of the requirement.
    (b) Contents of certification. The certification must contain the 
following information:
    (1) The name and EPA registration number of the product to which the 
certification applies, the registrant's name and address, the date, and 
the name, title and signature of the company official making the 
certification.
    (2) A statement that the packaging that is being used for the 
product will meet the standards of Sec. 157.32. The statement, ``I 
certify that the packaging that will be used for this product meets the 
standards of 40 CFR 157.32,'' will suffice for this purpose.



Sec. 157.36  Recordkeeping.

    For as long as the registration of a pesticide product required to 
be in child-resistant packaging is in effect, the registrant must retain 
the records listed in this section. The registrant must, upon request by 
the Agency, make them available to Agency representatives for inspection 
and copying, or must submit them to the Agency.
    (a) A description of the package, including a description of:
    (1) The container and its dimensions and composition.
    (2) The closure or child-resistant mechanism, including the name of 
its manufacturer and the manufacturer's designation for the closure or 
the physical working of the child-resistant packaging mechanism.
    (b) A copy of the certification statement required by Sec. 157.34.

[[Page 88]]

    (c) One of the following types of records verifying that each 
package for the product is child-resistant:
    (1) Test data on the package based on the Consumer Product Safety 
Commission protocol in 16 CFR 1700.20.
    (2) Test data, not conforming to the protocol in 16 CFR 1700.20, or 
a set of measurements on the package, together with an explanation as to 
why such data or measurements demonstrate that the package is child-
resistant.
    (3) Test data, whether or not conforming to the protocol in 16 CFR 
1700.20, on a different package, together with an explanation of why 
such data demonstrate that the package being used is child-resistant.
    (4) Written evidence that verifies that testing on the package has 
been conducted according to the protocol in 16 CFR 1700.20. Written 
evidence may be one of the following:
    (i) A letter or literature from the packaging supplier;
    (ii) A letter from the facility that conducted the testing; or
    (iii) A specification in the contract between the registrant or 
applicant and the packaging supplier;
    (5) When the container and closure are purchased separately by the 
registrant:
    (i) Information of the kinds described in paragraphs (c) (1) through 
(4) of this section showing that the closure is child-resistant; and
    (ii) A written explanation of why the container is child-resistant; 
and
    (iii) Information showing that the closure and container are 
compatible with each other, and a written explanation of why the 
resulting package is child-resistant.
    (6) A combination of the records listed in paragraphs (c) (1) 
through (5).
    (d) Records verifying that the package meets the compatibility and 
durability standards of Sec. 157.32(b) and (c).

[51 FR 21286, June 11, 1986; 51 FR 36692, Oct. 15, 1986, as amended at 
65 FR 39304, June 26, 2000]



PART 158_DATA REQUIREMENTS FOR PESTICIDES--Table of Contents



                      Subpart A_General Provisions

Sec.
158.1 Purpose and scope.
158.3 Definitions.
158.5 Applicability.
158.30 Flexibility.
158.32 Format of data submissions.
158.33 Confidential data.
158.34 Flagging of studies for potential adverse effects.
158.45 Waivers.
158.60 Minor use data policies.
158.70 Satisfying data requirements.
158.75 Requirements for additional data.
158.80 Use of other data.

                    Subpart B_How To Use Data Tables

158.100 Pesticide use patterns.
158.110 Required and conditionally required data.
158.120 Determining data requirements.
158.130 Purposes of the registration data requirements.

                   Subpart C_Experimental Use Permits

158.200 Experimental use permit data requirements tables.
158.210 Experimental use permit data requirements for product chemistry
158.220 Experimental use permit data requirements for product 
          performance.
158.230 Experimental use permit data requirements for toxicology.
158.240 Experimental use permit data requirements for ecological 
          effects.
158.243 Experimental use permit data requirements for terrestrial and 
          aquatic nontarget organisms.
158.250 Experimental use permit data requirements for human exposure.
158.260 Experimental use permit data requirements for environmental 
          fate.
158.270 Experimental use permit data requirements for residue chemistry.
158.280-158.290 [Reserved]

                       Subpart D_Product Chemistry

158.300 Definitions.
158.310 Product chemistry data requirements table.
158.320 Product identity and composition.
158.325 Description of materials used to produce the product.
158.330 Description of production process.
158.335 Description of formulation process.
158.340 Discussion of formation of impurities.
158.345 Preliminary analysis.
158.350 Certified limits.
158.355 Enforcement analytical method.

[[Page 89]]

                      Subpart E_Product Performance

158.400 Product performance data requirements.

                          Subpart F_Toxicology

158.500 Toxicology data requirements table.
158.510 Tiered testing options for nonfood pesticides.

                      Subpart G_Ecological Effects

158.630 Terrestrial and aquatic nontarget organisms data requirements 
          table.
158.660 Nontarget plant protection data requirements table.

                         Subparts H	J [Reserved]

158.700-158.900 [Reserved]

                        Subpart K_Human Exposure

158.1000 Applicator exposure--general requirements.
158.1010 Applicator exposure--criteria for testing.
158.1020 Applicator exposure data requirements table.
158.1050 Post-application exposure--general requirements.
158.1060 Post-application exposure--criteria for testing.
158.1070 Post-application exposure data requirements table.

                          Subpart L_Spray Drift

158.1100 Spray drift data requirements table.

                          Subpart M [Reserved]

158.1200-158.1299 [Reserved]

                      Subpart N_Environmental Fate

158.1300 Environmental fate data requirements table.

                       Subpart O_Residue Chemistry

158.1400 Definitions.
158.1410 Residue chemistry data requirements table.

                         Subparts P	T [Reserved]

158.1500-158.1900 [Reserved]

                    Subpart U_Biochemical Pesticides

158.2000 Biochemical pesticides definition and applicability.
158.2010 Biochemical pesticides data requirements.
158.2030 Biochemical pesticides product chemistry data requirements 
          table.
158.2040 Biochemical pesticides residue data requirements table.
158.2050 Biochemical pesticides human health assessment data 
          requirements table.
158.2060 Biochemical pesticides nontarget organisms and environmental 
          fate data requirements table.
158.2070 Biochemical pesticides product performance data requirements.
158.2080 Experimental use permit data requirements--biochemical 
          pesticides.
158.2081 Experimental use permit biochemical pesticides product 
          chemistry data requirements table.
158.2082 Experimental use permit biochemical pesticides residue data 
          requirements table.
158.2083 Experimental use permit biochemical pesticides human health 
          assessment data requirements table.
158.2084 Experimental use permit biochemical pesticides nontarget 
          organisms and environmental fate data requirements table.

                     Subpart V_ Microbial Pesticides

158.2100 Microbial pesticides definition and applicability.
158.2110 Microbial pesticides data requirements.
158.2120 Microbial pesticides product analysis data requirements table.
158.2130 Microbial pesticides residue data requirements table.
158.2140 Microbial pesticides toxicology data requirements table.
158.2150 Microbial pesticides nontarget organisms and environmental fate 
          data requirements table.
158.2160 Microbial pesticides product performance data requirements.
158.2170 Experimental use permit data requirements--microbial 
          pesticides.
158.2171 Experimental use permit microbial pesticides product analysis 
          data requirements table.
158.2172 Experimental use permit microbial pesticides residue data 
          requirements table.
158.2173 Experimental use permit microbial pesticides toxicology data 
          requirements table.
158.2174 Experimental use permit microbial pesticides nontarget 
          organisms and environmental fate data requirements table.

           Subpart W_Antimicrobial Pesticide Data Requirements

158.2200 Applicability.
158.2201 Antimicrobial use patterns.
158.2203 Definitions.
158.2204 Public health and nonpublic health claims.
158.2210 Product chemistry.

[[Page 90]]

158.2220 Product performance.
158.2230 Toxicology.
158.2240 Nontarget organisms.
158.2250 Nontarget plant protection.
158.2260 Applicator exposure.
158.2270 Post-application exposure.
158.2280 Environmental fate.
158.2290 Residue chemistry.

                         Subpart X	Z [Reserved]

158.2300-158.2500 [Reserved]

    Authority: 7 U.S.C. 136-136y; 21 U.S.C. 346a.

    Source: 72 FR 60957, Oct. 26, 2007, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 158.1  Purpose and scope.

    (a) Purpose. The purpose of this part is to specify the kinds of 
data and information EPA requires in order to make regulatory judgments 
under FIFRA secs. 3, 4, and 5 about the risks and benefits of pesticide 
products. Further, this part specifies the data and information needed 
to determine the safety of pesticide chemical residues under FFDCA sec. 
408.
    (b) Scope. (1) This part describes the minimum data and information 
EPA typically requires to support an application for pesticide 
registration or amendment; support the reregistration of a pesticide 
product; support the maintenance of a pesticide registration by means of 
the data call-in process, e.g., as used in the registration review 
program; or establish or maintain a tolerance or exemption from the 
requirements of a tolerance for a pesticide chemical residue.
    (2) This part establishes general policies and procedures associated 
with the submission of data in support of a pesticide regulatory action.
    (3) This part does not include study protocols, methodology, or 
standards for conducting or reporting test results; nor does this part 
describe how the Agency uses or evaluates the data and information in 
its risk assessment and risk management decisions, or the regulatory 
determinations that may be based upon the data.
    (c) Scope of individual subparts. (1) Conventional pesticides. 
Subparts A, B, C, D, F, G, K, L, N, and O apply to conventional 
pesticides.
    (2) Biochemical pesticides. Subparts A, B and U apply to biochemical 
pesticides.
    (3) Microbial pesticides. Subparts A, B and V apply to microbial 
pesticides.
    (4) Antimicrobial pesticides. [Reserved]

    Effective Date Note: At 78 FR 26978, May 8, 2013, Sec. 158.1 was 
amended by revising paragraph (c)(4), effective July 8, 2013. For the 
convenience of the user, the revised text is set forth as follows:



Sec. 158.1  Purpose and scope.

                                * * * * *

    (c) * * *
    (4) Antimicrobial pesticides. Subparts A, B, C, D, and W of this 
part apply to antimicrobial pesticides.



Sec. 158.3  Definitions.

    All terms defined in sec. 2 of the Federal Insecticide, Fungicide, 
and Rodenticide Act apply to this part and are used with the meaning 
given in the Act. Applicable terms from the Federal Food, Drug, and 
Cosmetic Act also apply to this part. Individual subparts may contain 
definitions that pertain solely to that subpart. The following 
additional terms apply to this part:
    Applicant means any person or entity, including for the purposes of 
this part a registrant, who submits, or is required to submit, to the 
Agency any application, petition, or submission intended to persuade EPA 
to grant, modify, or leave unmodified a registration or other approval 
required as a condition of sale or distribution of a pesticide. Such 
submissions may include, but are not limited to, the following:
    (1) An application for registration or amended registration of a 
pesticide product under FIFRA sec. 3 or 24.
    (2) A submission of data required in conjunction with reregistration 
of a currently registered product under FIFRA sec. 4.
    (3) An application for an experimental use permit under FIFRA sec. 
5.
    (4) A submission of data in response to a notice issued by EPA under 
FIFRA sec. 3(c)(2)(B).
    (5) A petition to establish or modify a tolerance or an exemption 
from the requirement of a tolerance for a pesticide chemical residue 
under FFDCA sec. 408.

[[Page 91]]

    Registration includes a new registration, amended registration and 
reregistration, unless stated otherwise.



Sec. 158.5  Applicability.

    (a) The requirements of this part apply to the following 
submissions:
    (1) An application for new or amended registration under FIFRA sec. 
3 or 24.
    (2) An application for experimental use permit under FIFRA sec. 5.
    (3) A submission of data or information to support the continuation 
of a registration under FIFRA sec. 3, 4, or 24.
    (4) A petition to establish, modify or revoke a tolerance or 
exemption from a tolerance under FFDCA sec. 408.
    (b) The information specified in this part must be furnished with 
each submission described in paragraph (a) of this section if it has not 
been submitted previously, or if any previous submission is not accurate 
or complete.



Sec. 158.30  Flexibility.

    (a) FIFRA provides EPA flexibility to require, or not require, data 
and information for the purposes of making regulatory judgments for 
pesticide products. EPA has the authority to establish or modify data 
needs for individual pesticide chemicals. The actual data required may 
be modified on an individual basis to fully characterize the use and 
properties, characteristics, or effects of specific pesticide products 
under review. The Agency encourages each applicant to consult with EPA 
to discuss the data requirements particular to its product prior to and 
during the registration process.
    (b) The Agency cautions applicants that the data routinely required 
in this part may not be sufficient to permit EPA to evaluate the 
potential of the product to cause unreasonable adverse effects to man or 
the environment. EPA may require the submission of additional data or 
information beyond that specified in this part if such data or 
information are needed to appropriately evaluate a pesticide product.
    (c) This part will be updated as needed to reflect evolving program 
needs and advances in science.



Sec. 158.32  Format of data submissions.

    (a) General. (1) All data submitted under this part must be 
formatted in accordance with this section.
    (2) The requirements of this section do not apply to administrative 
materials accompanying a data submission, including forms, labeling, and 
correspondence.
    (b) Transmittal document. Each submission in support of a regulatory 
action must be accompanied by a transmittal document, which includes:
    (1) Identity of the submitter.
    (2) The transmittal date.
    (3) Identification of the regulatory action with which the 
submission is associated, e.g., the registration or petition number.
    (4) A list of the individual documents included in the submission.
    (c) Individual documents. Unless otherwise specified by the Agency, 
each submission must be in the form of individual documents or studies. 
Previously submitted documents should not be resubmitted unless 
specifically requested by the Agency, but should be cited with adequate 
information to identify the previously submitted document. Each study or 
document should include the following:
    (1) A title page including the following information:
    (i) The title of the study, including identification of the 
substance(s) tested and the test name or data requirement addressed.
    (ii) The author(s) of the study.
    (iii) The date the study was completed.
    (iv) If the study was performed in a laboratory, the name and 
address of the laboratory, project numbers or other identifying codes.
    (v) If the study is a commentary on or supplement to another 
previously submitted study, full identification of the other study with 
which it should be associated in review.
    (vi) If the study is a reprint of a published document, all relevant 
facts of publication, such as the journal title, volume, issue, 
inclusive page numbers, and date of publication.
    (2) The appropriate statement(s) regarding any data confidentiality 
claims as described in Sec. 158.33.

[[Page 92]]

    (3) A statement of compliance or non-compliance with respect to Good 
Laboratory Practice Standards as required by 40 CFR 160.12, if 
applicable.
    (4) A complete and accurate English translation must be included for 
any information that is not in English.
    (5) A flagging statement as prescribed by Sec. 158.34, if 
applicable.



Sec. 158.33  Confidential data.

    (a) Definitions. For the purposes of this section:
    (1) Registered or previously registered pesticide means any 
pesticide containing an active ingredient contained in a product that 
is, or has ever been, an active ingredient in a product registered under 
sec. 3 of FIFRA. A registered pesticide that is the subject of an 
application for a new use falls within the category of ``registered or 
previously registered pesticide.''
    (2) Safety and efficacy information means information concerning the 
objectives, methodology, results, or significance of any test or 
experiment performed on or with a registered or previously registered 
pesticide or its separate ingredients, impurities, or degradation 
products, and any information concerning the effects of such pesticide 
on any organism or the behavior of such pesticide in the environment, 
including, but not limited to, data on safety to fish and wildlife, 
humans and other mammals, plants, animals, and soil, and studies on 
persistence, translocation and fate in the environment, and metabolism.
    (b) Applicability. (1) This section applies to information submitted 
pursuant to this part. It supplements the general confidentiality 
procedures in 40 CFR part 2, subpart B, including FIFRA confidentiality 
procedures at 40 CFR 2.307. To the extent that provisions in this 
section conflict with those in 40 CFR part 2, subpart B, the provisions 
in this section take precedence. The provisions of 40 CFR 2.308 do not 
apply to information to which this section applies. In addition to 
complying with the requirements of this section, any confidentiality 
claims for information subject to 40 CFR part 174 (plant-incorporated 
protectants) must be substantiated at the time of submission as 
described in Sec. 174.9 of this chapter.
    (2) FFDCA sec. 408(i) protects confidential information submitted in 
connection with an application for a tolerance or exemption to the same 
extent as FIFRA sec. 10. References in this section to FIFRA sec. 10 are 
deemed to apply equally to information submitted pursuant to FFDCA sec. 
408, pursuant to the authority in sec. 408(i).
    (c) Method of asserting business confidentiality claims--(1) Claim 
required. Information to which this section applies (and which is 
submitted on or after the effective date of this regulation) will be 
deemed as not subject to a confidentiality claim unless a claim for that 
information is made in accordance with the procedures specified in this 
paragraph. Information not subject to a confidentiality claim may be 
made available to the public without further notice, subject to the 
requirements of FIFRA sec. 10(g).
    (2) Statement required. Upon submission to EPA, each document must 
be accompanied by a signed and dated document containing either the 
statements in paragraph (c)(2)(i) or (ii) of this section. No claims or 
markings on the document or any attachments, other than these statements 
and attachments submitted in accordance with paragraph (c)(3) of this 
section, will be recognized as asserting a claim of confidentiality. The 
format of data submissions is set forth in Sec. 158.32.
    (i) No claim of confidentiality.
    No claim of confidentiality, on any basis whatsoever, is made for 
any information contained in this document. I acknowledge that 
information not designated as within the scope of FIFRA sec. 
10(d)(1)(A), (B), or (C) and which pertains to a registered or 
previously registered pesticide is not entitled to confidential 
treatment and may be released to the public, subject to the provisions 
regarding disclosure to multinational entities under FIFRA sec. 10(g).
    (ii) Claim of confidentiality.
    Information claimed as confidential has been removed to a 
confidential attachment.
    (3) Confidential attachment. (i) All information claimed as 
confidential must be submitted in a separate confidential attachment to 
the document and cross referenced to the specific location in the 
document from which it was removed. The confidential attachment must 
have its own title page and be

[[Page 93]]

paginated separately from the non-confidential document.
    (ii) All information in the confidential attachment that consists of 
(or whose disclosure would in turn disclose) manufacturing or quality 
control processes must be individually identified in the confidential 
attachment as a claim for information within the scope of FIFRA sec. 
10(d)(1)(A).
    (iii) All information in the confidential attachment that consists 
of (or whose disclosure would in turn disclose) the details of any 
methods for testing, detecting, or measuring the quantity of any 
deliberately added inert ingredient of a pesticide, must be individually 
identified in the confidential attachment as a claim for information 
within the scope of FIFRA sec. 10(d)(1)(B).
    (iv) All information in the confidential attachment that consists of 
(or whose disclosure would in turn disclose) the identity or percentage 
quantity of any deliberately added inert ingredient of a pesticide must 
be individually identified in the confidential attachment as a claim for 
information within the scope of FIFRA sec. 10(d)(1)(C).
    (v) Information in the confidential attachment that is designated in 
accordance with paragraphs (c)(3)(ii) - (iv) of this section must be on 
a separate page from information that is not so designated.
    (4) Voluntary release of information to States and foreign 
governments. (i) Submitters are encouraged to include with the statement 
required under paragraph (c)(2) of this section an additional statement 
to allow EPA to share information with State and foreign governments. 
EPA will not consider such a statement to be a waiver of confidentiality 
or proprietary claims for the information. The statement is as follows:
    I authorize the Environmental Protection Agency to release any 
information contained in this document to State or foreign governments, 
without relinquishing proprietary rights or any confidentiality claims 
asserted above.
    (ii) Information designated as releasable to state or foreign 
governments in accordance with this section may be released to such a 
government without further notice to the submitter. EPA will inform the 
State or foreign government of any of the confidentiality claims 
associated with the information.
    (d) Release of information. (1) Safety and efficacy information that 
was submitted to EPA on or after May 4, 1988 and that has not been 
designated by the submitter as FIFRA sec. 10(d)(1)(A), (B), or (C) 
information in accordance with the applicable requirements of this 
section is not entitled to confidential treatment and may be disclosed 
to the public without further notice to the submitter, in accordance 
with paragraph (d)(2) of this section. Safety and efficacy information 
which has been designated by the submitter as FIFRA sec. 10(d)(1) (A), 
(B), or (C) information is entitled to confidential treatment only to 
the extent provided by FIFRA sec. 10(b), this section, and 40 CFR 2.208.
    (2) Information that is not entitled to be protected as confidential 
in accordance with FIFRA sec. 10(b), this section and with EPA 
confidentiality regulations at 40 CFR part 2, subpart B, may be released 
to the public without the affirmation of non-multinational status 
provided under FIFRA sec. 10(g), provided that the information does not 
contain or consist of any complete unpublished report submitted to EPA, 
or excerpts or restatements of any such report which reveal the full 
methodology and complete results of the study, test, or experiment, and 
all explanatory information necessary to understand the methodology or 
interpret the results.



Sec. 158.34  Flagging of studies for potential adverse effects.

    (a) Any applicant who submits a study of a type listed in paragraph 
(b) of this section must submit with the study a statement in accordance 
with paragraph (c) of this section.
    (b) The following table indicates the study types and the criteria 
to be applied to each. Column 1 lists the study types by name. Column 2 
lists the associated Pesticide Assessment Guideline number. Column 3 
lists the criteria applicable to each type of study. Column 4 lists the 
reporting code to be included in the statement specified in paragraph

[[Page 94]]

(c) of this section when any criterion is met or exceeded.

                                            Table--Flagging Criteria
----------------------------------------------------------------------------------------------------------------
                                                                    Criteria: Treated animals show     Criteria
                 Study Type(s)                    Guideline No.         any of the following:            No.
----------------------------------------------------------------------------------------------------------------
Carcinogenicity or combined carcinogenicity/           870.4200   An incidence of neoplasms in                 1
 chronic feeding study                                 870.4300    males or females which increases
                                                                   with dose (positive trend
                                                                   p<=0.05); or
 
                                                                  A statistically significant                  2
                                                                   (pairwise p<=0.05) increase of
                                                                   any type of neoplasm in any test
                                                                   group, males or females at any
                                                                   dose level, compared to
                                                                   concurrent control animals of
                                                                   the same sex; or
 
                                                                  An increase in any type of                   3
                                                                   uncommon or rare neoplasms in
                                                                   any test group, males or females
                                                                   animals at any dose level,
                                                                   compared to concurrent controls
                                                                   of the same sex; or
 
                                                                  A decrease in the time to                    4
                                                                   development of any type of
                                                                   neoplasms in any test group,
                                                                   males or females at any dose
                                                                   level, compared to concurrent
                                                                   controls of the same sex.
----------------------------------------------------------------------------------------------------------------
Prenatal developmental toxicity                        870.3700   When compared to concurrent                  5
Reproduction and fertility.....................        870.3800    controls, treated offspring show
Developmental neurotoxicity....................        870.6300    a dose-related increase in
                                                                   malformations, pre- or post-
                                                                   natal deaths, or persistent
                                                                   functional or behavioral changes
                                                                   on a litter basis in the absence
                                                                   of significant maternal toxicity
                                                                   at the same dose level.
----------------------------------------------------------------------------------------------------------------
Neurotoxicity                                          870.6100   When compared to concurrent                  6
                                                       870.6200    controls, treated animals show a
                                                                   statistically or biologically
                                                                   significant increase in
                                                                   neuropathological lesions or
                                                                   persistent functional or
                                                                   behavioral changes.
----------------------------------------------------------------------------------------------------------------
Chronic feeding                                        870.4100   The no observed adverse effect               7
Carcinogenicity................................        870.4200    level (NOAEL) from one of these
Reproduction and fertility.....................        870.3800    studies is less than the NOAEL
Prenatal developmental toxicity................        870.3700    currently used by the Agency as
Developmental neurotoxicity....................        870.6300    the basis for either the acute
Acute or 90-day neurotoxicity..................        870.6200    or chronic reference dose.
----------------------------------------------------------------------------------------------------------------

    (c) Identification of studies. For each study of a type identified 
in paragraph (b) of this section, the applicant shall include the 
appropriate one of the following two statements, together with the 
signature of the authorized representative of the company, and the date 
of signature:
    (1) Study does not meet or exceed criteria.
    I have applied the criteria of 40 CFR 158.34 for flagging studies 
for potential adverse effects to the results of the attached study. This 
study neither meets nor exceeds any of the applicable criteria.

    (2) Study meets or exceeds criteria.
    I have applied the criteria of 40 CFR 158.34 for flagging studies 
for potential adverse effects to the results of the attached study. This 
study meets or exceeds the criteria numbered [insert all applicable 
reporting codes].



Sec. 158.45  Waivers.

    (a) The data requirements specified in this part as applicable to a 
category of products will not always be appropriate for every product in 
that category. Some products may have unusual physical, chemical, or 
biological properties or atypical use patterns which would make 
particular data requirements inappropriate, either because it would not 
be possible to generate the required data or because the data would not 
be useful in the Agency's evaluation of the risks or benefits of the 
product. The Agency will waive data requirements it finds are 
inappropriate, but will ensure that sufficient data are available to 
make the determinations required by the applicable statutory standards.
    (b)(1) Applicants are encouraged to discuss a data waiver request 
with the

[[Page 95]]

Agency before developing and submitting supporting data, information, or 
other materials.
    (2) All waiver requests must be submitted to the Agency in writing. 
The request must clearly identify the data requirement(s) for which a 
waiver is sought along with an explanation and supporting rationale why 
the applicant believes the data requirement should be waived. In 
addition, the applicant must describe any unsuccessful attempts to 
generate the required data, furnish any other information which the 
applicant(s) believe(s) would support the request, and when appropriate, 
suggest alternative means of obtaining data to address the concern which 
underlies the data requirement.
    (c) The Agency will review each waiver request and subsequently 
inform the applicant in writing of its decision. If the decision could 
apply to more than the requested product, the Agency, in its discretion, 
may choose to send a notice to all registrants or publish a notice in 
the Federal Register announcing the decision. An Agency decision denying 
a written request to waive a data requirement is a final Agency action.



Sec. 158.60  Minor use data policies.

    FIFRA sec. 2(ll) defines the term ``minor use''and FIFRA provides a 
number of statutory provisions concerning minor uses. In addition, EPA 
has established policies with respect to minor uses of pesticides, 
including, but not limited to, the following:
    (a) A new data requirement pertinent to both an unregistered minor 
use and a registered major use will not be applied to a minor use 
applicant until it is applied to the major use registration.
    (b) EPA will accept appropriate and adequate extrapolations and 
regional data to support establishment of individual minor use 
tolerances.



Sec. 158.70  Satisfying data requirements.

    (a) General policy. The Agency will determine whether the data 
submitted or cited to fulfill the data requirements specified in this 
part are acceptable. This determination will be based on the design and 
conduct of the experiment from which the data were derived, and an 
evaluation of whether the data fulfill the purpose(s) of the data 
requirement. In evaluating experimental design, the Agency will consider 
whether generally accepted methods were used, sufficient numbers of 
measurements were made to achieve statistical reliability, and 
sufficient controls were built into all phases of the experiment. The 
Agency will evaluate the conduct of each experiment in terms of whether 
the study was conducted in conformance with the design, good laboratory 
practices were observed, and results were reproducible. The Agency will 
not reject data merely because they were derived from studies which, 
when initiated, were in accordance with an Agency-recommended protocol, 
even if the Agency subsequently recommends a different protocol, as long 
as the data fulfill the purposes of the requirements as described in 
this paragraph.
    (1) The provisions in this part 158 should be read in conjunction 
with the provisions in Sec. 152.85 to claim eligibility for the 
formulators' exemption.
    (2) [Reserved]
    (b) Good laboratory practices. Applicants must adhere to the good 
laboratory practice (GLP) standards described in 40 CFR part 160 when 
conducting studies. Applicants must also adhere to GLP standards when 
conducting a study in support of a waiver request of any data 
requirement which is within the scope of the GLP requirements.
    (c) Agency guidelines. EPA has published Test Guidelines that 
contain standards for conducting acceptable tests, guidance on the 
evaluation and reporting of data, definition of terms, and suggested 
study protocols. Copies of the Test Guidelines may be obtained by 
visiting the agency's website at www.epa.gov/pesticides.
    (d) Study protocols--(1) General. Any appropriate protocol may be 
used to generate the data required by this part, provided that it meets 
the purpose of the test standards specified in the pesticide assessment 
guidelines, and provides data of suitable quality and completeness as 
typified by the protocols cited in the guidelines. Applicants should use 
the test procedure which is

[[Page 96]]

most suitable for evaluation of the particular ingredient, mixture, or 
product. Accordingly, failure to follow a suggested protocol will not 
invalidate a test if another appropriate methodology is used.
    (2) Organization for Economic Co-Operation and Development (OECD) 
protocols. Tests conducted in accordance with the requirements and 
recommendations of the applicable OECD protocols can be used to develop 
data necessary to meet the requirements specified in this part. 
Applicants should note, however, that certain of the OECD recommended 
test standards, such as test duration and selection of test species, are 
less restrictive than those recommended by EPA. Therefore, when using 
OECD protocols, care should be taken to observe the test standards in a 
manner such that the data generated by the study will satisfy the 
requirements of this part.
    (e) Combining studies. Certain toxicology studies may be combined to 
satisfy data requirements. For example, carcinogenicity studies in rats 
may be combined with the rat chronic toxicity study. Combining 
appropriate studies may be expected to reduce usage of test animals as 
well as reduce the cost of studies. EPA encourages this practice by 
including standards for acceptable combined tests in the Pesticide 
Assessment Guidelines. Registrants and applicants are encouraged to 
consider combining other tests when practical and likely to produce 
scientifically acceptable results. Registrants and applicants, however, 
must consult with the EPA before initiating combined studies.



Sec. 158.75  Requirements for additional data.

    The data routinely required by this part may not be sufficient to 
permit EPA to evaluate every pesticide product. If the information 
required under this part is not sufficient to evaluate the potential of 
the product to cause unreasonable adverse effects on man or the 
environment, additional data requirements will be imposed. However, EPA 
expects that the information required by this part will be adequate in 
most cases for an assessment of the properties and effects of the 
pesticide.



Sec. 158.80  Use of other data.

    (a) Data developed in foreign countries. With certain exceptions, 
laboratory and field study data developed outside the United States may 
be submitted in support of a pesticide registration. Data generated in a 
foreign country which the Agency will not consider include, but are not 
limited to, data from tests which involved field test sites or a test 
material, such as a native soil, plant, or animal, that is not 
characteristic of the United States. Applicants submitting foreign data 
must take steps to ensure that U.S. materials are used, or be prepared 
to supply data or information to demonstrate the lack of substantial or 
relevant differences between the selected material or test site and the 
U.S. material or test site. Once submitted, the Agency will determine 
whether or not the data meet the data requirements.
    (b) Data generated for other purposes. Data developed for purposes 
other than satisfaction of FIFRA data requirements, such as monitoring 
studies, may also satisfy data requirements in this part. Consultation 
with the Agency should be arranged if applicants are unsure about 
suitability of such data.



                    Subpart B_How To Use Data Tables



Sec. 158.100  Pesticide use patterns.

    (a) General use patterns. There are six broad use categories used in 
the data tables. The six broad categories include terrestrial outdoor 
uses, aquatic outdoor uses, greenhouse uses, forestry uses, residential 
outdoor uses, and indoor uses of all types. The 6 broad use categories 
are further subdivided into 12 general use patterns which are the bases 
for data requirements established by use pattern. Within the data 
tables, general use patterns have been combined into single columns when 
the data requirements are the same for the combined uses. If there are 
no data requirements for a specific use, the column for that use is not 
included in the table. The 12 general use pattern groups used in the 
data table in this part are:
    (1) Terrestrial food crop use.
    (2) Terrestrial feed crop use.

[[Page 97]]

    (3) Terrestrial nonfood crop use.
    (4) Aquatic food crop use.
    (5) Aquatic nonfood use.
    (6) Greenhouse food crop use.
    (7) Greenhouse nonfood crop use.
    (8) Forestry use.
    (9) Residential outdoor use.
    (10) Residential indoor use.
    (11) Indoor food use.
    (12) Indoor nonfood use.
    (b) Pesticide use site index. The Pesticide Use Site Index is a 
comprehensive list of specific pesticide use sites. The index is 
alphabetized separately by site for all agricultural and all 
nonagricultural uses. The Pesticide Use Site Index associates each 
pesticide use site with one or more of the 12 general use patterns. It 
may be used in conjunction with the data tables to determine the 
applicability of data requirements to specific uses. The Pesticide Use 
Site Index, which will be updated periodically, is available from the 
Agency or may be obtained from the Agency's website at http://
www.epa.gov/pesticides.
    (c) Applicants unsure of the correct use pattern for their 
particular product should consult the Agency.

    Effective Date Note: At 78 FR 26978, May 8, 2013, Sec. 158.100 was 
amended by revising the heading of paragraph (a); revising paragraph 
(b); redesignating paragraph (c) as paragraph (e); revising newly 
redesignated paragraph (e); and adding new paragraphs (c) and (d), 
effective July 8, 2013. For the convenience of the user, the added and 
revised text is set forth as follows:



Sec. 158.100  Pesticide use patterns.

    (a) General use patterns for conventional, biochemical, and 
microbial pesticides. * * *
    (b) Pesticide use site index for conventional, biochemical, and 
microbial pesticides. The Pesticide Use Site Index for Conventional, 
Biochemical, and Microbial Pesticides is a comprehensive list of 
specific pesticide use sites. The index is alphabetized separately by 
site for all agricultural and all nonagricultural uses. The Pesticide 
Use Site Index associates each pesticide use site with one or more of 
the 12 general use patterns. It may be used in conjunction with the data 
tables to determine the applicability of data requirements to specific 
uses. The Pesticide Use Site Index for Conventional, Biochemical, and 
Microbial Pesticides will be updated periodically, and is available from 
the Agency or may be obtained from the Agency's Web site at http://
www.epa.gov/pesticides.
    (c) Antimicrobial pesticide use patterns. The general use patterns 
for antimicrobial pesticides are described in Sec. 158.2201.
    (d) Pesticide use site index for antimicrobial pesticides. The 
Pesticide Use Site Index for Antimicrobial Pesticides is a comprehensive 
list of specific antimicrobial use sites. The index is alphabetized by 
antimicrobial use sites, and associates each antimicrobial use site with 
one or more of the antimicrobial use patterns. It may be used in 
conjunction with the data tables to determine the applicability of data 
requirements to specific uses. The Pesticide Use Site Index for 
Antimicrobial Pesticides will be updated periodically, and is available 
from the Agency or may be obtained from the Agency's Web site at http://
www.epa.gov/pesticides.
    (e) Determination of use pattern. Applicants unsure of the correct 
use pattern for their particular product should consult the Agency.



Sec. 158.110  Required and conditionally required data.

    The tables in this part use the descriptors R (required), CR 
(conditionally required), and NR (not required) as a general indication 
of the applicability of a data requirement. In all cases, the test notes 
referred to in the table must be consulted to determine the actual 
applicability of the data requirement.
    (a) EPA requires data designated as ``required''(R) for products 
with a given use pattern in order to evaluate the risks or benefits of a 
product having that use pattern under any conditions established by the 
test notes.
    (b) Data designated as ``conditionally required'' (CR) for products 
with a given use pattern are required by EPA to evaluate the risks or 
benefits of a product having that use pattern if the product meets the 
conditions specified in the notes accompanying the requirement. The 
determination of whether the data must be submitted is based on the 
product's use pattern, physical or chemical properties, expected 
exposure of nontarget organisms, and/or results of previous testing (for 
example, tier testing). Applicants must evaluate each applicable test 
note for the conditions and criteria to be considered in determining 
whether conditionally required data must be submitted.

[[Page 98]]

    (c) Data not required for the Agency's assessment of the risks and 
benefits of a particular use pattern are designated ``not required'' 
(NR) in data tables.



Sec. 158.120  Determining data requirements.

    As with current practice, the actual data and studies required may 
be modified on an individual basis to fully characterize the use and 
properties of specific pesticide products under review. While EPA is 
attempting to assist the applicant in this subpart, it is important to 
emphasize that it is the applicant's obligation under FIFRA to 
demonstrate that an individual product meets the standard under FIFRA 
and/or FFDCA. Accordingly, applicants are encouraged to consult with the 
Agency on the appropriate data requirements as set forth here as they 
relate to their specific product prior to and during the registration 
process.
    (a) Finding the appropriate data table. (1) Pesticide data 
requirements for conventional chemical active ingredients and related 
substances are presented in subparts D, E, F, G, K, L, N, and O of this 
part in the form of a series of data tables, each addressing a 
particular scientific discipline or data topic. Data requirements for 
biochemical and microbial pest control agents are contained and are 
described separately within subparts U and V of this part, respectively.
    (2) Key to table notations. R = required data; CR = conditionally 
required data; NR = Not required; MP = manufacturing-use product; EP = 
end-use product; TEP = typical end-use product; TGAI = technical grade 
of the active ingredient; PAI = pure active ingredient; PAIRA = pure 
active ingredient, radiolabeled; Choice = choice of several test 
substances depending on studies required.
    (b) Identifying required studies. To determine the specific kinds of 
data needed to support the registration use of each pesticide product, 
the applicant may:
    (1) Refer to the applicable subpart(s) of this part. These subparts 
describe the data requirements including data tables for each subject 
area.
    (2) Select the general use pattern(s) that best cover the use 
pattern(s) specified on the pesticide product label as explained in 
Sec. 158.100. All applicable use patterns must be included.
    (3) Proceed down the appropriate general use pattern column in the 
table and note which tests are required (R), conditionally required 
(CR), or not required (NR). Required and conditionally required studies 
are described in Sec. 158.110.
    (4) Review the notes for each requirement to determine its 
applicability to the specific product proposed for registration.
    (5)(i) Proceed down the Test substance columns and determine the 
appropriate test substance needed for that study. If the data are 
intended to support a manufacturing-use product, use the MP column. If 
the data are intended to support an end-use product, use the EP column.
    (ii) The test substances columns specify which substance is to be 
used for testing. Applicants should note that the substance that must be 
used when performing the study may or may not be the product itself. For 
example, the data from a certain study may be required to support the 
registration of an end-use product, but the test substance column may 
state that the particular test shall be performed using the technical 
grade of the active ingredient(s) in the end-use product.
    (iii) Manufacturing-use products (MP) and end-use products (EP) 
containing a single active ingredient and no intentionally added inert 
ingredients are considered identical in composition to each other, and 
to the technical grade of the active ingredient (TGAI) from which they 
were derived. Therefore, the data from a test conducted using any one of 
these as the test substance is also suitable to meet the requirement (if 
any) for the same test to be conducted using either of the other 
substances.
    (6) Refer to the Pesticide Assessment Guideline reference number for 
each study located in the first column. See Sec. 158.70(c) for 
information pertaining to the guidelines and how to obtain copies.

[[Page 99]]



Sec. 158.130  Purposes of the registration data requirements.

    (a) General. The data requirements for registration are intended to 
generate data and information necessary to address concerns pertaining 
to the identity, composition, potential adverse effects and 
environmental fate of each pesticide.
    (b) Product chemistry--(1) Product composition. Data on product 
composition are needed:
    (i) To support the conclusions expressed in the statement of 
formula;
    (ii) To compare to the composition of materials used in required 
testing under this part; and
    (iii) To determine whether a product is ``identical or substantially 
similar''to another product, a determination that involves the 
comparison of product composition.
    (2) Nominal concentration and certified limits. The nominal 
concentration of a product, defined as that concentration that is 
expected to be present in a product as a result of the production or 
formulation process, is used to gauge the acceptability of the certified 
limits, which define the outer limits of the range of the product's 
ingredients. The certified limits are used to enforce the composition of 
the product and to ensure the accuracy of hazard assessments.
    (3) Physical and chemical characteristics. The physical and chemical 
characteristics of an active ingredient or product are used:
    (i) To confirm or provide supportive information on the identity and 
composition of the product;
    (ii) To assess the hazards of the ingredient or product; and
    (iii) To trigger or evaluate certain other studies required by this 
part.
    (c) Product performance. Requirements to develop data on product 
performance provide a mechanism to ensure that pesticide products will 
perform as intended and that unnecessary pesticide exposure to the 
environment will not occur as a result of the use of ineffective 
products. Specific performance standards are used to validate the 
efficacy data in the public health areas, including disinfectants used 
to control microorganisms infectious to man in any area of the inanimate 
environment and those pesticides used to control vertebrates (such as 
rodents, birds, bats and skunks) that may directly or indirectly 
transmit diseases to humans.
    (d) Toxicology-humans and domestic animals. Data required to assess 
hazards to humans and domestic animals are derived from a variety of 
acute, subchronic and chronic toxicity tests, and tests to assess 
mutagenicity and pesticide metabolism.
    (1) Acute studies. Determination of acute oral, dermal and 
inhalation toxicity is usually the initial step in the assessment and 
evaluation of the toxic characteristics of a pesticide. These data 
provide information on health hazards likely to arise soon after, and as 
a result of, short-term exposure. Data from acute studies serve as a 
basis for classification and precautionary labeling. For example, acute 
toxicity data are used to calculate farmworker reentry intervals and to 
develop precautionary label statements pertaining to protective clothing 
requirements for applicators. They also provide information used in 
establishing the appropriate dose levels in subchronic and other 
studies; provide initial information on the mode of toxic action(s) of a 
substance; and determine the need for child resistant packaging. 
Information derived from primary eye and primary dermal irritation 
studies serves to identify possible hazards from exposure of the eyes, 
associated mucous membranes and skin.
    (2) Subchronic studies. Subchronic tests provide information on 
health hazards that may arise from repeated exposures over a limited 
period of time. They provide information on target organs and 
accumulation potential. The resulting data are also useful in selecting 
dose levels for chronic studies and for establishing safety criteria for 
human exposure. These tests are not capable of detecting those effects 
that have a long latency period for expression (e.g., carcinogenicity).
    (3) Chronic studies. Chronic toxicity studies (usually conducted by 
feeding the test substance to the test species) are intended to 
determine the effects of a substance in a mammalian species following 
prolonged and repeated exposure. Under the conditions of this test,

[[Page 100]]

effects which have a long latency period or are cumulative should be 
detected. The purpose of long-term carcinogenicity studies is to observe 
test animals over most of their life span for the development of 
neoplastic lesions during or after exposure to various doses of a test 
substance by an appropriate route of administration.
    (4) Developmental toxicity and reproduction studies. The 
developmental toxicity study is designed to determine the potential of 
the test substance to induce structural and/or other abnormalities to 
the fetus as the result of exposure of the mother during pregnancy. Two-
generation reproduction testing is designed to provide information 
concerning the general effects of a test substance on gonadal function, 
estrus cycles, mating behavior, conception, parturition, lactation, 
weaning, and the growth and development of the offspring. The study may 
also provide information about the effects of the test substance on 
neonatal morbidity, mortality, and preliminary data on prenatal 
developmental toxicity and serve as a guide for subsequent tests.
    (5) Mutagenicity studies. For each test substance a battery of tests 
is required to assess the potential to affect the mammalian cell's 
genetic components. The objectives underlying the selection of a battery 
of tests for mutagenicity assessment are:
    (i) To detect, with sensitive assay methods, the capacity of a 
chemical to alter genetic material in cells.
    (ii) To determine the relevance of these mutagenic changes to 
mammals.
    (iii) When mutagenic potential is demonstrated, to incorporate these 
findings in the assessment of heritable effects, carcinogenicity, and, 
possibly, other health effects.
    (6) Metabolism studies. Data from studies on the absorption, 
distribution, metabolism, and excretion of a pesticide aid in the 
valuation of test results from other toxicity studies and in the 
extrapolation of data from animals to man. The main purpose of 
metabolism studies is to produce data which increases the Agency's 
understanding of the behavior of the chemical when considering the human 
exposure anticipated from intended uses of the pesticide.
    (e) Hazards to nontarget organisms--(1) General. The information 
required to assess hazards to nontarget organisms is derived from tests 
to determine pesticidal effects on birds, mammals, fish, terrestrial and 
aquatic invertebrates and plants. These tests include short-term acute, 
subacute, reproduction, simulated field, and full field studies arranged 
in a hierarchical or tier system which progresses from the basic 
laboratory tests to the applied field tests. The results of each tier of 
testing must be evaluated to determine the potential of the pesticide to 
cause adverse effects, and to determine whether further testing is 
required. A purpose common to all data requirements is to provide data 
which determine the need for (and appropriate wording for) precautionary 
label statements to minimize the potential adverse effects to nontarget 
organisms.
    (2) Short-term studies. The short-term acute and subchronic 
laboratory studies provide basic toxicity information which serves as a 
starting point for the hazard assessment. These data are used: To 
establish acute toxicity levels of the active ingredient to the test 
organisms; to compare toxicity information with measured or estimated 
pesticide residues in the environment in order to assess potential 
impacts on fish, wildlife and other nontarget organisms; and to indicate 
whether further laboratory and/or field studies are needed.
    (3) Long-term and field studies. Additional studies (i.e., avian, 
fish, and invertebrate reproduction, life cycle studies and plant field 
studies) may be required when basic data and environmental conditions 
suggest possible problems. Data from these studies are used to: Estimate 
the potential for chronic effects, taking into account the measured or 
estimated residues in the environment; and to determine if additional 
field or laboratory data are necessary to further evaluate hazards. 
Simulated field and/or field data are used to examine acute and chronic 
adverse effects on captive or monitored fish and wildlife populations 
under natural or near-natural environments. Such studies are required 
only when predictions as to possible adverse effects in less extensive 
studies cannot

[[Page 101]]

be made, or when the potential for adverse effects is high.
    (f) Applicator and post-application exposure. Data are used to 
evaluate exposures to persons in occupational and non-occupational 
settings, including agricultural, residential, commercial, institutional 
and recreational sites. Data include oral, dermal and inhalation 
exposure data, post-application residue data, post-application 
monitoring data, use information, and human activity information. These 
data, together with toxicology data, are used to determine whether 
application or post-application risks are of concern, and, where 
appropriate, to develop post-application restrictions such as reentry 
restrictions.
    (g) Pesticide spray drift evaluation. Data required to evaluate 
pesticide spray drift are derived from studies of droplet size spectrum 
and spray drift field evaluations. These data contribute to the 
development of the overall exposure estimate and, along with data on 
toxicity for humans, fish and wildlife, or plants, are used to assess 
the potential hazard of pesticides to these organisms. A purpose common 
to all these tests is to provide data which will be used to determine 
the need for (and appropriate wording for) precautionary labeling to 
minimize the potential adverse effect to nontarget organisms.
    (h) Environmental fate--(1) General. The data generated by 
environmental fate studies are used to: Assess the toxicity to man 
through exposure of humans to pesticide residues remaining after 
application, either upon reentering treated areas or from consuming 
inadvertantly-contaminated food; assess the presence of widely 
distributed and persistent pesticides in the environment which may 
result in loss of usable land, surface water, ground water, and wildlife 
resources; and, assess the potential environmental exposure of other 
nontarget organisms, such as fish and wildlife, to pesticides. Another 
specific purpose of the environmental fate data requirements is to help 
applicants and the Agency estimate expected environmental concentrations 
of pesticides in specific habitats where threatened or endangered 
species or other wildlife populations at risk are found.
    (2) Degradation studies. The data from hydrolysis and photolysis 
studies are used to determine the rate of pesticide degradation and to 
identify pesticides that may adversely affect nontarget organisms.
    (3) Metabolism studies. Data generated from aerobic and anaerobic 
metabolism studies are used to determine the nature and availability of 
pesticides to rotational crops and to aid in the evaluation of the 
persistence of a pesticide.
    (4) Mobility studies. These data requirements pertain to leaching, 
adsorption/desorption, and volatility of pesticides. They provide 
information on the mode of transport and eventual destination of the 
pesticide in the environment. This information is used to assess 
potential environmental hazards related to: Contamination of human and 
animal food; loss of usable land and water resources to man through 
contamination of water (including ground water); and habitat loss of 
wildlife resulting from pesticide residue movement or transport in the 
environment.
    (5) Dissipation studies. The data generated from dissipation studies 
are used to assess potential environmental hazards (under actual field 
use conditions) related to: Reentry into treated areas; hazards from 
residues in rotational crops and other food sources; and the loss of 
land as well as surface and ground water resources.
    (i) Residue chemistry. (1) Residue chemistry data are used by the 
Agency to estimate the exposure of the general population to pesticide 
residues in food and for setting and enforcing tolerances for pesticide 
residues in food or feed.
    (2) Information on the chemical identity and composition of the 
pesticide product, the amounts, frequency and time of the pesticide 
application, and results of tests on the amount of residues remaining on 
or in the treated food or feed, are needed to support a finding as to 
the magnitude and identity of residues which result in food or animal 
feed as a consequence of a proposed pesticide usage.
    (3) Residue chemistry data are also needed to support the adequacy 
of one

[[Page 102]]

or more methods for the enforcement of the tolerance, and to support 
practicable methods for removing residues that exceed any proposed 
tolerance.
    (4) Accumulation studies. Accumulation studies indicate pesticide 
residue levels in food supplies that originate from wild sources or from 
rotational crops. Rotational crop studies are necessary to establish 
realistic crop rotation restrictions and to determine if tolerances may 
be needed for residues on rotational crops. Data from irrigated crop 
studies are used to determine the amount of pesticide residues that 
could be taken up by representative crops irrigated with water 
containing pesticide residues. These studies allow the Agency to 
establish label restrictions regarding application of pesticides on 
sites where the residues can be taken up by irrigated crops. These data 
also provide information that aids the Agency in establishing any 
corresponding tolerances that would be needed for residues on such 
crops. Data from pesticide accumulation studies in fish are used to 
establish label restrictions to prevent applications in certain sites so 
that there will be minimal residues entering edible fish or shellfish. 
These residue data are also used to determine if a tolerance or action 
level is needed for residues in aquatic animals eaten by humans.



                   Subpart C_Experimental Use Permits



Sec. 158.200  Experimental use permit data requirements tables.

    Sections 158.200 through 158.270 describe how to use these tables to 
determine the experimental use permit data requirements for a particular 
pesticide product. Notes that apply to an individual test and include 
specific conditions, qualifications, or exceptions to the designated 
test are listed at the end of each table. Refer to 40 CFR part 172 for 
further information on experimental use permits.



Sec. 158.210  Experimental use permit data requirements for product chemistry.

    All product chemistry data, as described in Sec. 158.310, must be 
submitted to support a request for an experimental use permit.



Sec. 158.220  Experimental use permit data requirements for product 

performance.

    All product performance data, as described in paragraph (c) of this 
section, must be submitted to support a request for an experimental use 
permit.
    (a) Use patterns. (1) The terrestrial use pattern includes products 
classified under the general use patterns of terrestrial food crop and 
terrestrial nonfood crop. The aquatic use pattern includes products 
classified under the general use patterns of aquatic food crop and 
aquatic nonfood crop. The greenhouse use pattern includes products 
classified under the general use patterns of greenhouse food crop and 
greenhouse nonfood crop. The indoor use pattern includes products 
classified under the general use patterns of indoor food and indoor 
nonfood use.
    (2) Data are also required for forestry and residential outdoor 
uses.
    (b) Key. CR=Conditionally required; NR=Not required; R=Required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product.
    (c) Table. The following table shows the experimental use data 
requirements for product performance. The test notes are shown in 
paragraph (d) of this section.

[[Page 103]]



                                                                                                    Table--Experimental Use Permit Data Requirements for Product Performance
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                            Use Pattern                                                                                          Test substance to
                                                      ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------         support
          Guideline No.             Data Requirement                  Terrestrial                                Aquatic                                Greenhouse                                                                           ------------------------  Test Note
                                                      ---------------------------------------------------------------------------------------------------------------------------      Forestry           Residential           Indoor                                    No.
                                                            Food Crop           Nonfood Crop          Food Crop          Nonfood Crop          Food Crop         Nonfood Crop                              Outdoors                               MP          EP
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy of antimicrobial agents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  91-8                            Products for         NR                   NR                   CR                   NR                  NR                  NR                  NR                  NR                  NR                         NR          EP           1
                                   treating water
                                   systems
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy of fungicides and nematicides
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  93-16                           Products for         CR                   NR                   CR                   NR                  CR                  NR                  NR                  NR                  NR                         NR          EP           1
                                   control of
                                   organisms
                                   producing
                                   mycotoxins
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy of vertebrate control agents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  96-5                            Avian toxicants      R                    R                    NR                   NR                  NR                  NR                  NR                  R                   R                          NR          EP           1
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  96-6                            Avian repellents     R                    R                    NR                   NR                  NR                  NR                  NR                  R                   NR                         NR          EP           1
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  96-7                            Avian frightening    R                    R                    NR                   NR                  NR                  NR                  NR                  R                   NR                         NR          EP           1
                                   agents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  96-9                            Bat toxicants and    NR                   NR                   NR                   NR                  NR                  NR                  NR                  NR                  R                          NR          EP           1
                                   repellents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  96-10                           Commensal            R                    R                    NR                   NR                  NR                  NR                  NR                  R                   R                         TEP          EP           1
                                   rodenticides
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  96-12                           Rodenticides on      R                    R                    NR                   NR                  NR                  NR                  NR                  R                   NR                         NR          EP           1
                                   farm and
                                   rangelands
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  95-13                           Rodent fumigants     R                    R                    NR                   NR                  NR                  NR                  NR                  R                   R                          NR          EP           1
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  95-16                           Rodent reproductive  R                    R                    NR                   NR                  NR                  NR                  NR                  R                   R                          NR          EP           1
                                   inhibitors
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  95-17                           Mammalian            R                    R                    NR                   NR                  NR                  NR                  NR                  R                   NR                         NR          EP           1
                                   predacides
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 104]]

    (d) Test notes. The following test notes apply to the data 
requirements in the table to paragraph (c) of this section.
    1. The Agency has waived the requirement to submit efficacy data 
unless the pesticide product bears a claim to control pest 
microorganisms that pose a threat to human health and whose presence 
cannot readily be observed by the user including, but not limited to, 
microorganisms infectious to man in any area of the inanimate 
environment, or a claim to control vertebrates (such as rodents, birds, 
bats, canids, and skunks) that may directly or indirectly transmit 
diseases to humans. However each registrant must ensure through testing 
that his product is efficacious when used in accordance with label 
directions and commonly accepted pest control practices. The Agency 
reserves the right to require, on a case-by-case basis, submission of 
efficacy data for any pesticide product registered or proposed for 
registration.
    2. [Reserved]

[72 FR 60957, Oct. 26, 2007, as amended at 73 FR 75596, Dec. 12, 2008]



Sec. 158.230  Experimental use permit data requirements for toxicology.

    All toxicology data, as described in paragraph (c) of this section, 
must be submitted to support a request for an experimental use permit.
    (a) Use patterns. (1) Food use patterns include products classified 
under the general use patterns of terrestrial food crop use, terrestrial 
feed crop use, aquatic food crop use, greenhouse food crop use, and 
indoor food use.
    (2) Nonfood use patterns include products classified under the 
general use patterns of terrestrial nonfood crop use, aquatic nonfood 
crop use, aquatic nonfood outdoor use, greenhouse nonfood crop use, 
forestry use, residential outdoor use, indoor nonfood use, and indoor 
residential use.
    (b) Key. CR=Conditionally required; NR=Not required; R=Required; 
EP=End-use product; MP=Manufacturing-use product; PAIRA=Pure active 
ingredient radio-labeled; TGAI=Technical grade of the active ingredient.
    (c) Table. The following table shows the experimental use data 
requirements for toxicology. The test notes are shown in paragraph (d) 
of this section.

                                                Table--Experimental Use Permit Toxicity Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Use Pattern                      Test substance to support
        Guideline Number           Data Requirement  --------------------------------------------------------------------------------    Test Note No.
                                                             Food               Nonfood               MP                  EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.1100                        Acute oral          R                   R                   MP and TGAI         TGAI, EP            1
                                   toxicity - rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.1200                        Acute dermal        R                   R                   MP and TGAI         TGAI, EP            1, 2
                                   toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.1300                        Acute inhalation    R                   R                   MP and TGAI         TGAI and EP         3
                                   toxicity - rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.2400                        Primary eye         R                   R                   MP                  TGAI and EP         2
                                   irritation -
                                   rabbit
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.2500                        Primary dermal      R                   R                   MP                  TGAI and EP         1, 2
                                   irritation
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.2600                        Dermal              R                   R                   MP                  TGAI and EP         2, 4
                                   sensitization
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.6100                        Delayed             CR                  CR                  TGAI                TGAI                5
                                   neurotoxicity
                                   (acute) - hen
--------------------------------------------------------------------------------------------------------------------------------------------------------
Subchronic Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.3100                        90-day Oral -       R                   NR                  TGAI                TGAI                --
                                   rodent
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.3150                        90-day Oral - non-  R                   NR                  TGAI                TGAI                --
                                   rodent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chronic Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 105]]

 
  870.4100                        Chronic oral -      R                   NR                  TGAI                TGAI                6
                                   rodent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Developmental Toxicity and Reproduction
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.3700                        Prenatal            R                   NR                  TGAI                TGAI                7, 8
                                   Developmental
                                   toxicity - rat
                                   and rabbit,
                                   preferred
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.3800                        Reproduction        R                   NR                  TGAI                TGAI                6
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mutagenicity Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.5100                        Bacterial reverse   R                   NR                  TGAI                TGAI                9
                                   mutation assay
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.5300                        In vitro mammalian  R                   NR                  TGAI                TGAI                9, 10
  870.5375......................   cell assay
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.5385                        In vivo             R                   NR                  TGAI                TGAI                9, 11
  870.5395......................   cytogenetics
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test notes apply to the data 
requirements in the table to paragraph (c) of this section.
    1. Not required if test material is a gas or a highly volatile 
liquid.
    2. Not required if test material is corrosive to skin or has a pH of 
less than 2 or greater than 11.5.
    3. Required if the product consists of, or under conditions of use 
will result in, a respirable material (e.g., gas, vapor, aerosol, or 
particulate).
    4. Required if repeated dermal exposure is likely to occur under 
conditions of use.
    5. Required if the test material is an organophosphorus substance, 
which includes uncharged organophosphorus esters, thioesters, or 
anhydrides of organophosphoric, organophosphonic, or 
organophosphoramidic acids, or of related phosphorothioic, 
phosponothioic, or phosphorothioamidic acids, or is structurally related 
to other substances that may cause the delayed neurotoxicity sometimes 
seen in this class of chemicals.
    6. These studies are seldom required to support EUPs. They may be 
required if the dietary exposure for these EUPs occupies a large part, 
e.g., greater than 50%, of the reference dose.
    7. The oral route, by oral intubation, is preferred unless the 
chemical or physical properties of the test substance or the pattern of 
exposure suggests a more appropriate route of exposure.
    8. May be combined with the 2-generation reproduction study in 
rodents by utilizing a second mating of the parental animals in either 
generation.
    9. At a minimum, an initial battery of mutagenicity tests with 
possible confirmatory testing is required. Other relevant mutagenicity 
tests that may have been performed, plus a complete reference list must 
also be submitted.
    10. Choice of assay using either:
    i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, 
maximizing assay conditions for small colony expression or detection;
    ii. Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast 
(V79) cells, hypoxanthine-guanine phosphoribosyl transferase (hgprt) 
gene locus, accompanied by an appropriate in vitro test for 
clastogenicity; or
    iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl 
transferase (xprt) gene locus.
    11. The micronucleus rodent bone marrow assay is preferred; however, 
rodent bone marrow assays using metaphase analysis (aberrations) are 
acceptable.

[72 FR 60957, Oct. 26, 2007, as amended at 73 FR 75596, Dec. 12, 2008]



Sec. 158.240  Experimental use permit data requirements for ecological 

effects.

    All data for terrestrial nontarget organisms and aquatic nontarget 
organisms as described in Sec. 158.243 must be submitted to support a 
request for an experimental use permit. No data for nontarget plant 
protection must be submitted to support a request for an experimental 
use permit.

[[Page 106]]



Sec. 158.243  Experimental use permit data requirements for terrestrial and 

aquatic nontarget organisms.

    All terrestrial and aquatic nontarget organism data, as described in 
paragraph (c) of this section, must be submitted to support a request 
for an experimental use permit.
    (a) Use patterns. (1) The terrestrial use pattern includes products 
classified under the general use patterns of terrestrial food crop, 
terrestrial feed crop, and terrestrial nonfood crop. The aquatic use 
pattern includes products classified under the general use patterns of 
aquatic food crop and aquatic nonfood. The greenhouse use pattern 
includes products classified under the general use patterns of 
greenhouse food crop and greenhouse nonfood crop. The indoor use pattern 
includes products classified under the general use patterns of indoor 
food and indoor nonfood use.
    (2) Data are also required for the general use patterns of forestry 
and residential outdoor use.
    (b) Key. CR=Conditionally required; NR=Not required; R=Required; 
TEP=Typical end-use product; TGAI=Technical grade of the active 
ingredient; commas between the test substances (e.g. TGAI, TEP) indicate 
that data may be required on the TGAI or TEP depending on the conditions 
set forth in the test note.
    (c) Table. The following table shows the experimental use data 
requirements for terrestrial and aquatic nontarget organisms. The test 
notes are shown in paragraph (d) of this section.

                                                   Table--Experimental Use Permit Terrestrial and Aquatic Nontarget Organism Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                  Use Pattern
                                                 ------------------------------------------------------------------------------------------------------------
         Guideline No.          Data Requirement                                                           Residential                                         Test substance     Test Note No.
                                                     Terrestrial         Aquatic          Forestry           Outdoor         Greenhouse          Indoor
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Avian and Mammalian Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.2100                      Avian oral        R                 R                 R                 R                 CR                CR                TGAI              1, 2, 3
                                 toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.2200                      Avian dietary     R                 R                 R                 R                 NR                NR                TGAI              1, 4
                                 toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Aquatic Organisms Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1075                      Freshwater fish   R                 R                 R                 NR                NR                NR                TGAI, TEP         1, 2, 5, 6, 11
                                 toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1010                      Acute toxicity    R                 R                 R                 NR                NR                NR                TGAI, TEP         1, 2, 6, 7, 11
                                 freshwater
                                 invertebrates
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1300                      Aquatic           NR                R                 R                 NR                NR                NR                TGAI              1, 7, 8
                                 invertebrate
                                 life cycle
                                 (freshwater)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1400                      Fish early-life   NR                R                 R                 NR                NR                NR                TGAI              1, 8, 9
                                 stage
                                 (freshwater)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Accumulation Study
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1730                      Fish              CR                CR                CR                NR                NR                NR                TGAI or PAIRA     10
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Insect Pollinator Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.3020                      Honeybee acute    R                 R                 R                 NR                NR                NR                TGAI              1
                                 contact
                                 toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test notes apply to the data 
requirements in the table to paragraph (c) of this section.
    1. Data using the TGAI are required to support all outdoor end-use 
product uses including, but not limited to, turf. Data are generally not 
required to support end-use products in the form of a gas, a highly 
volatile

[[Page 107]]

liquid, a highly reactive solid, or a highly corrosive material.
    2. For greenhouse and indoor end-use products, data using the TGAI 
are required to support manufacturing-use products to be reformulated 
into these same end-use products or to support end-use products when 
there is no registered manufacturing-use product. Avian acute oral data 
are not required for liquid formulations for greenhouse and indoor uses. 
The study is not required if there is no potential for environmental 
exposure.
    3. Data are required on one passerine species and either one 
waterfowl species or one upland game bird species for terrestrial, 
aquatic, forestry, and residential outdoor uses. Data are preferred on 
waterfowl or upland game bird species for indoor and greenhouse uses.
    4. Data are required on waterfowl and upland game bird species.
    5. Data are required on one coldwater fish and one warmwater fish 
for terrestrial, aquatic, forestry, and residential outdoor uses. For 
indoor and greenhouse uses, testing with only one of either fish species 
is required.
    6. EP or TEP testing is required for any product which meets any of 
the following conditions:
    i. The end-use pesticide will be introduced directly into an aquatic 
environment (e.g., aquatic herbicides and mosquito larvicides) when used 
as directed.
    ii. The maximum expected environmental concentration (MEEC) or the 
estimated environmental concentration (EEC) in the aquatic environment 
is = one-half the LC50 or EC50 of the 
TGAI when the EP is used as directed.
    iii. An ingredient in the end-use formulation other than the active 
ingredient is expected to enhance the toxicity of the active ingredient 
or to cause toxicity to aquatic organisms.
    7. Data are required on one freshwater aquatic invertebrate species.
    8. Data are generally not required for outdoor residential uses, 
other than turf, unless data indicate that pesticide residues from the 
proposed use(s) can potentially enter waterways.
    9. Data are required on one freshwater fish species. If the test 
species is different from the two species used for the freshwater fish 
acute toxicity tests, a 96 hour LC50 on that species must 
also be provided.
    10. Not required when:
    i. The octanol/water partition coefficients of the pesticide and its 
major degradates are <1,000; or
    ii. There are no potential exposures to fish and other nontarget 
aquatic organisms; or
    iii. The hydrolytic half-life is <5 days at pH 5, 7 and 9.
    11. The freshwater fish test species for the TEP testing is the most 
sensitive of the species tested with the TGAI. A freshwater invertebrate 
must also be tested with the EP or TEP using the same species tested 
with the TGAI.

[72 FR 60957, Oct. 26, 2007, as amended at 73 FR 75596, Dec. 12, 2008]



Sec. 158.250  Experimental use permit data requirements for human exposure.

    No data for applicator exposure and post-application exposure must 
be submitted to support a request for an experimental use permit.



Sec. 158.260  Experimental use permit data requirements for environmental 

fate.

    All environmental fate data, as described in paragraph (c) of this 
section, must be submitted to support a request for an experimental use 
permit.
    (a) Use patterns. (1) The terrestrial use pattern includes products 
classified under the general use patterns of terrestrial food crop, 
terrestrial feed crop, and terrestrial nonfood. The aquatic use pattern 
includes the general use patterns of aquatic food crop, aquatic nonfood 
residential, and aquatic nonfood outdoors. The greenhouse use pattern 
includes both food and nonfood uses. The indoor use pattern includes 
food, nonfood, and residential indoor uses.
    (2) Data are also required for the general use patterns of forestry 
use and residential outdoor use.
    (b) Key. CR=Conditionally required; NR=Not required; R=Required; 
PAIRA=Pure active ingredient radio-labeled; TGAI=Technical grade of the 
active ingredient.
    (c) Table. The following table shows the experimental use data 
requirements for environmental fate. The test notes are shown in 
paragraph (d) of this section.

[[Page 108]]



                                                               Table--Experimental Use Permit Environmental Fate Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Use Pattern
                                                   -------------------------------------------------------------------------------------------------------------                      Test Note
         Guideline No.            Data Requirement                                                                                               Residential       Test substance        No.
                                                       Terrestrial        Aquatic        Greenhouse          Indoors            Forestry           Outdoors
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Degradation Study - Laboratory
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.2120                       Hydrolysis         R                            R   R                  NR                 R                  R                  TGAI or PAIRA                1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Metabolism Studies - Laboratory
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.4100                       Aerobic soil       R                             CR NR                 NR                 R                  NR                 TGAI or PAIRA                2
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.4300                       Aerobic aquatic    NR                           R   NR                 NR                 NR                 NR                 TGAI or PAIRA               --
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Mobility Study
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.1230                       Leaching and       R                           NR   NR                 NR                 R                  NR                 TGAI or PAIRA                3
  835.1240.....................   adsorption/
                                  desorption
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test notes apply to the data 
requirements in the table to paragraph (c) of this section.
    1. Study is required for indoor uses in cases where environmental 
exposure is likely to occur. Such sites include, but are not limited to, 
agricultural premises, in or around farm buildings, barnyards, and 
beehives.
    2. Required for aquatic uses for aquatic sites that are 
intermittently dry. Such sites include, but are not limited to cranberry 
bogs and rice paddies.
    3. Adsorption and desorption using a batch equilibrium method is 
preferred. However, in some cases, for example, where the pesticide 
degrades rapidly, soil column leaching with unaged or aged columns may 
be more appropriate to fully characterize the potential mobility of the 
parent compound and major transformation products.

[72 FR 60957, Oct. 26, 2007, as amended at 73 FR 75596, Dec. 12, 2008]



Sec. 158.270  Experimental use permit data requirements for residue chemistry.

    All residue chemistry data, as described in Sec. 158.1410, are 
required for an experimental use permit for which a temporary tolerance 
under FFDCA section 408(r) is sought. Residue chemistry data are not 
required for an experimental use permit issued on a crop-destruct basis.



Sec. Sec. 158.280-158.290  [Reserved]



                       Subpart D_Product Chemistry



Sec. 158.300  Definitions.

    The following terms are defined for the purposes of this subpart:
    Active ingredient means any substance (or group of structurally 
similar substances, if specified by the Agency) that will prevent, 
destroy, repel or mitigate any pest, or that functions as a plant 
regulator, desiccant, defoliant, or nitrogen stabilizer, within the 
meaning of FIFRA sec. 2(b).
    End-use product means a pesticide product whose labeling:
    (1) Includes directions for use of the product (as distributed or 
sold, or after combination by the user with other substances) for 
controlling pests or defoliating, desiccating or regulating growth of 
plants, or as a nitrogen stabilizer, and
    (2) does not state that the product may be used to manufacture or 
formulate other pesticide products.
    Formulation means:
    (1) The process of mixing, blending, or dilution of one or more 
active ingredients with one or more other active or inert ingredients, 
without an intended

[[Page 109]]

chemical reaction, to obtain a manufacturing-use product or an end-use 
product, or
    (2) The repackaging of any registered product.
    Impurity means any substance (or group of structurally similar 
substances if specified by the Agency), in a pesticide product other 
than an active ingredient or an inert ingredient, including unreacted 
starting materials, side reaction products, contaminants, and 
degradation products.
    Impurity associated with an active ingredient means:
    (1) Any impurity present in the technical grade of active 
ingredient; and
    (2) Any impurity which forms in the pesticide product through 
reactions between the active ingredient and any other component of the 
product or packaging of the product.
    Inert ingredient means any substance (or group of structurally 
similar substances if designated by the Agency), other than the active 
ingredient, which is intentionally included in a pesticide product.
    Integrated system means a process for producing a pesticide product 
that:
    (1) Contains any active ingredient derived from a source that is not 
an EPA-registered product; or
    (2) Contains any active ingredient that was produced or acquired in 
a manner that does not permit its inspection by the Agency under FIFRA 
sec. 9(a) prior to its use in the process.
    Manufacturing-use product means any pesticide product other than an 
end-use product. A product may consist of the technical grade of active 
ingredient only, or may contain inert ingredients, such as stabilizers 
or solvents.
    Nominal concentration means the amount of an ingredient which is 
expected to be present in a typical sample of a pesticide product at the 
time the product is produced, expressed as a percentage by weight.
    Starting material means a substance used to synthesize or purify a 
technical grade of active ingredient (or the practical equivalent of the 
technical grade ingredient if the technical grade cannot be isolated) by 
chemical reaction.
    Technical grade of active ingredient means a material containing an 
active ingredient:
    (1) Which contains no inert ingredient, other than one used for 
purification of the active ingredient; and
    (2) Which is produced on a commercial or pilot plant production 
scale (whether or not it is ever held for sale).



Sec. 158.310  Product chemistry data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the product chemistry data requirements for a 
particular pesticide product. Notes that apply to an individual test and 
include specific conditions, qualifications, or exceptions to the 
designated test are listed in paragraph (f) of the section.
    (b) Use patterns. Product chemistry data are required for all 
pesticide products and are not use-specific.
    (c) Test substance. Data requirements that list only the 
manufacturing-use product as the test substance apply to products 
containing solely the technical grade of the active ingredient and 
manufacturing-use products to which other ingredients have been 
intentionally added.
    (d) Key. R=Required; CR=Conditionally required; MP=Manufacturing-use 
product; NR=Not required; EP=End-use product; TGAI=Technical grade of 
the active ingredient; PAI=Pure active ingredient.
    (e) Table. The following table shows the data requirements for 
product chemistry. The table notes are shown in paragraph (f) of this 
section.

                                       Product Chemistry Data Requirements
----------------------------------------------------------------------------------------------------------------
                                                   Use Pattern       Test substance to support
       Guideline Number         Data Requirement --------------------------------------------------   Test Note
                                                       All             MP                EP              No.
----------------------------------------------------------------------------------------------------------------
Product Identity and Composition................................................................................
----------------------------------------------------------------------------------------------------------------
  830.1550                      Product identity            R   MP                EP                          1
                                 and composition
----------------------------------------------------------------------------------------------------------------

[[Page 110]]

 
  830.1600                      Description of              R   MP                EP                          2
                                 materials used
                                 to produce the
                                 product
----------------------------------------------------------------------------------------------------------------
  830.1620                      Description of              R   MP                EP                          3
                                 production
                                 process
----------------------------------------------------------------------------------------------------------------
  830.1650                      Description of              R   MP                EP                          4
                                 formulation
                                 process
----------------------------------------------------------------------------------------------------------------
  830.1670                      Discussion of               R   MP, and possibly  EP, and possibly            5
                                 formulation of                  TGAI              TGAI
                                 impurities
----------------------------------------------------------------------------------------------------------------
  830.1700                      Preliminary                  CR MP, and possibly  EP, and possibly     6, 9, 10
                                 analysis                        TGAI              TGAI
----------------------------------------------------------------------------------------------------------------
  830.1750                      Certified limits            R   MP                EP                          7
----------------------------------------------------------------------------------------------------------------
  830.1800                      Enforcement                 R   MP                EP                          8
                                 analytical
                                 method
----------------------------------------------------------------------------------------------------------------
  830.1900                      Submittal of                 CR MP, PAI and TGAI  EP, PAI, TGAI           9, 11
                                 samples
----------------------------------------------------------------------------------------------------------------
Physical and Chemical Properties................................................................................
----------------------------------------------------------------------------------------------------------------
  830.6302                      Color                       R   MP and TGAI       EP                          9
----------------------------------------------------------------------------------------------------------------
  830.6303                      Physical state              R   MP and TGAI       EP and TGAI                 9
----------------------------------------------------------------------------------------------------------------
  830.6304                      Odor                        R   MP and TGAI       EP                          9
----------------------------------------------------------------------------------------------------------------
  830.6313                      Stability to                R   MP and TGAI       EP                  9, 12, 26
                                 normal and
                                 elevated
                                 temperatures,
                                 metals, and
                                 metal ions
----------------------------------------------------------------------------------------------------------------
  830.6314                      Oxidation/                   CR MP                EP                         13
                                 reduction:
                                 chemical
                                 incompatibility
----------------------------------------------------------------------------------------------------------------
  830.6315                      Flammability                 CR MP                EP                         14
----------------------------------------------------------------------------------------------------------------
  830.6316                      Explodability                CR MP                EP                         15
----------------------------------------------------------------------------------------------------------------
  830.6317                      Storage                     R   MP                EP
                                 stability
----------------------------------------------------------------------------------------------------------------
  830.6319                      Miscibility                  CR MP                EP                         16
----------------------------------------------------------------------------------------------------------------
  830.6320                      Corrosion                   R   MP                EP
                                 characteristics
----------------------------------------------------------------------------------------------------------------
  830.6321                      Dielectric                   CR NR                EP                         17
                                 breakdown
                                 voltage
----------------------------------------------------------------------------------------------------------------
  830.7000                      pH                           CR MP and TGAI       EP and TGAI             9, 18
----------------------------------------------------------------------------------------------------------------
  830.7050                      UV/visible light            R   TGAI or PAI       NR                         --
                                 absorption
----------------------------------------------------------------------------------------------------------------
  830.7100                      Viscosity                    CR MP                EP                         19
----------------------------------------------------------------------------------------------------------------
  830.7200                      Melting point/              R   TGAI or PAI       TGAI or PAI             9, 20
                                 melting range
----------------------------------------------------------------------------------------------------------------
  830.7220                      Boiling point/              R   TGAI or PAI       TGAI or PA              9, 21
                                 boiling range
----------------------------------------------------------------------------------------------------------------
  830.7300                      Density/relative            R   MP and TGAI       EP and TGAI                 9
                                 density/bulk
                                 density
----------------------------------------------------------------------------------------------------------------
  830.7370                      Dissociation                R   TGAI or PAI       TGAI or PAI             9, 22
                                 constants in
                                 water
----------------------------------------------------------------------------------------------------------------
  830.7520                      Particle size,               CR TGAI or PAI       EP                         23
                                 fiber length,
                                 and diameter
                                 distribution
----------------------------------------------------------------------------------------------------------------
  830.7550                      Partition                   R   TGAI or PAI       TGAI or PAI                24
  830.7560....................   coefficient (n-
  830.7570....................   octanol/water)
----------------------------------------------------------------------------------------------------------------
  830.7840                      Water solubility            R   TGAI or PAI       TGAI or PAI                 9
  830.7860....................
----------------------------------------------------------------------------------------------------------------
  830.7950                      Vapor pressure              R   TGAI or PAI       TGAI or PAI             9, 25
----------------------------------------------------------------------------------------------------------------


[[Page 111]]

    (f) Test notes. The following test notes are applicable to the 
product chemistry data requirements in the table to paragraph (e) of 
this section:
    1. Data must be provided in accordance with Sec. 158.320.
    2. Data must be provided in accordance with Sec. 158.325.
    3. Data must be provided in accordance with Sec. 158.330.
    4. Data must be provided in accordance with Sec. 158.335.
    5. Data must be provided in accordance with Sec. 158.340.
    6. Data must be provided in accordance with Sec. 158.345.
    7. Data must be provided in accordance with Sec. 158.350.
    8. Data must be provided in accordance with Sec. 158.355.
    9. If the TGAI cannot be isolated, data are required on the 
practical equivalent of the TGAI.
    10. Data are required if the product is produced by an integrated 
system.
    11. Basic manufacturers are required to provide the Agency with a 
sample of each TGAI used to formulate a product produced by an 
integrated system when the new TGAI is first used as a formulating 
ingredient in products registered under FIFRA. A sample of the active 
ingredient (PAI) suitable for use as an analytical standard is also 
required at this time. Samples of end-use products produced by an 
integrated system must be submitted on a case-by-case basis.
    12. Data on the stability to metals and metal ions are required only 
if the TGAI is expected to come into contact with either material.
    13. Required when the product contains an oxidizing or reducing 
agent.
    14. Required when the product contains combustible liquids.
    15. Required when the product is potentially explosive.
    16. Required when the product is an emulsifiable liquid and is to be 
diluted with petroleum solvent.
    17. Required when the EP is a liquid and is to be used around 
electrical equipment.
    18. Required when the test substance is soluble or dispersible in 
water.
    19. Required when the product is a liquid.
    20. Required when the TGAI is solid at room temperature.
    21. Required when the TGAI is liquid at room temperature.
    22. Required when the test substance contains an acid or base 
functionality (organic or inorganic) or an alcoholic functionality 
(organic).
    23. Required for water insoluble test substances 
(10-6 g/l) and fibrous test substances with 
diameter of =0.1 [micro]m.
    24. Required if technical chemical is organic and non-polar.
    25. Not required for salts.
    26. Data on stability of the MP and TGAI to storage at normal 
temperatures are required. Data on the stability of the TGAI to high 
temperatures are required if the TGAI is expected to be subjected to 
temperatures 50 [deg]C (122 [deg]F) during production or 
storage.



Sec. 158.320  Product identity and composition.

    Information on the composition of the pesticide product must be 
furnished. The information required by paragraphs (a), (b), and (f) of 
this section must be provided for each product. In addition, if the 
product is produced by an integrated system, the information on 
impurities required by paragraphs (c) and (d) of this section must be 
provided.
    (a) Active ingredient. The following information is required for 
each active ingredient in the product:
    (1) If the source of any active ingredient in the product is an EPA-
registered product:
    (i) The chemical and common name (if any) of the active ingredient, 
as listed on the source product.
    (ii) The nominal concentration of the active ingredient in the 
product, based upon the nominal concentration of active ingredient in 
the source product.
    (iii) Upper and lower certified limits of the active ingredient in 
the product, in accordance with Sec. 158.350.
    (2) If the source of any active ingredient in the product is not an 
EPA-registered product:
    (i) The chemical name according to Chemical Abstracts Society (CAS) 
nomenclature, the CAS Registry Number, and any common names.
    (ii) The molecular, structural, and empirical formulae and the 
molecular weight or weight range.
    (iii) The nominal concentration.
    (iv) Upper and lower certified limits of the active ingredient in 
accordance with Sec. 158.350.
    (v) The purpose of the ingredient in the formulation.
    (b) Inert ingredients. The following information is required for 
each inert ingredient (if any) in the product:
    (1) The chemical name of the ingredient according to Chemical 
Abstracts

[[Page 112]]

Society nomenclature, the CAS Registry Number, and any common names (if 
known). If the chemical identity or chemical composition of an 
ingredient is not known to the applicant because it is proprietary or 
trade secret information, the applicant must ensure that the supplier or 
producer of the ingredient submits to the Agency (or has on file with 
the Agency) information on the identity or chemical composition of the 
ingredient. Generally, it is not required that an applicant know the 
identity of each ingredient in a mixture that he uses in his product. 
However, in certain circumstances, the Agency may require that the 
applicant know the identity of a specific ingredient in such a mixture. 
If the Agency requires specific knowledge of an ingredient, it will 
notify the applicant in writing.
    (2) The nominal concentration.
    (3) Upper and lower certified limits in accordance with Sec. 
158.350.
    (4) The purpose of the ingredient in the formulation.
    (c) Impurities of toxicological significance associated with the 
active ingredient. For each impurity associated with the active 
ingredient that is determined by EPA to be toxicologically significant, 
the following information is required:
    (1) Identification of the ingredient as an impurity.
    (2) The chemical name of the impurity.
    (3) The nominal concentration of the impurity in the product.
    (4) A certified upper limit, in accordance with Sec. 158.350.
    (d) Other impurities associated with the active ingredient. For each 
other impurity associated with an active ingredient that was found to be 
present in any sample at a level =0.1 percent by weight of 
the technical grade active ingredient the following information is 
required:
    (1) Identification of the ingredient as an impurity.
    (2) The chemical name of the impurity.
    (3) The nominal concentration of the impurity in the final product.
    (e) Impurities associated with an inert ingredient. [Reserved]
    (f) Ingredients that cannot be characterized. If the identity of any 
ingredient or impurity cannot be specified as a discrete chemical 
substance (such as mixtures that cannot be characterized or isomer 
mixtures), the applicant must provide sufficient information to enable 
EPA to identify its source and qualitative composition.



Sec. 158.325  Description of materials used to produce the product.

    The following information must be submitted on the materials used to 
produce the product:
    (a) Products not produced by an integrated system. (1) For each 
active ingredient that is derived from an EPA-registered product:
    (i) The name of the EPA-registered product.
    (ii) The EPA registration number of that product.
    (2) For each inert ingredient:
    (i) Each brand name, trade name, common name, or other commercial 
designation of the ingredient.
    (ii) All information that the applicant knows (or that is reasonably 
available to him) concerning the composition (and, if requested by the 
Agency, chemical and physical properties) of the ingredient, including a 
copy of technical specifications, data sheets, or other documents 
describing the ingredient.
    (iii) If requested by the Agency, the name and address of the 
producer of the ingredient or, if that information is not known to the 
applicant, the name and address of the supplier of the ingredient.
    (b) Products produced by an integrated system. (1) The information 
required by paragraph (a)(1) of this section concerning each active 
ingredient that is derived from an EPA-registered product (if any).
    (2) The following information concerning each active ingredient that 
is not derived from an EPA-registered product:
    (i) The name and address of the producer of the ingredient (if 
different from the applicant).
    (ii) Information about each starting material used to produce the 
active ingredient, as follows:

[[Page 113]]

    (A) Each brand name, trade name, or other commercial designation of 
the starting material.
    (B) The name and address of the person who produces the starting 
material or, if that information is not known to the applicant, the name 
and address of each person who supplies the starting material.
    (C) All information that the applicant knows (or that is reasonably 
available to him), concerning the composition (and if requested by the 
Agency, chemical or physical properties) of the starting material, 
including a copy of all technical specifications, data sheets, or other 
documents describing it.
    (3) The information required by paragraph (a)(2) of this section 
concerning each inert ingredient.
    (c) Additional information. On a case-by-case basis, the Agency may 
require additional information on substances used in the production of 
the product.



Sec. 158.330  Description of production process.

    If the product is produced by an integrated system, the applicant 
must submit information on the production (reaction) processes used to 
produce the active ingredients in the product. The applicant must also 
submit information about the formulation process, in accordance with 
Sec. 158.335.
    (a) Information must be submitted for the current production process 
for each active ingredient that is not derived from an EPA-registered 
product. If the production process is not continuous (a single reaction 
process from starting materials to active ingredient), but is 
accomplished in stages or by different producers, the information must 
be provided for each such production process.
    (b) The following information must be provided for each process 
resulting in a separately isolated substance:
    (1) The name and address of the producer who uses the process, if 
not the same as the applicant.
    (2) A general characterization of the process (e.g., whether it is a 
batch or continuous process).
    (3) A flow chart of the chemical equations of each intended reaction 
occurring at each step of the process, and of the duration of each step 
and of the entire process.
    (4) The identity of the materials used to produce the product, their 
relative amounts, and the order in which they are added.
    (5) A description of the equipment used that may influence the 
composition of the substance produced.
    (6) A description of the conditions (e.g., temperature, pressure, 
pH, humidity) that are controlled during each step of the process to 
affect the composition of the substance produced, and the limits that 
are maintained.
    (7) A description of any purification procedures (including 
procedures to recover or recycle starting materials, intermediates or 
the substance produced).
    (8) A description of the procedures used to assure consistent 
composition of the substance produced, e.g., calibration of equipment, 
sampling regimens, analytical methods, and other quality control 
methods.



Sec. 158.335  Description of formulation process.

    The applicant must provide information on the formulation process of 
the product (unless the product consists solely of a technical grade of 
active ingredient) as required by the following sections:
    (a) Section 158.330(b)(2), pertaining to characterization of the 
process.
    (b) Section 158.330(b)(4), pertaining to ingredients used in the 
process.
    (c) Section 158.330(b)(5), pertaining to process equipment.
    (d) Section 158.330(b)(6), pertaining to the conditions of the 
process.
    (e) Section 158.330(b)(8), pertaining to quality control measures.



Sec. 158.340  Discussion of formation of impurities.

    The applicant must provide a discussion of the impurities that may 
be present in the product, and why they may be present. The discussion 
should be based on established chemical theory and on what the applicant 
knows about the starting materials, technical grade of active 
ingredient, inert ingredients, and production or formulation process. If 
the applicant has reason to believe that an impurity that EPA

[[Page 114]]

would consider toxicologically significant may be present, the 
discussion must include an expanded discussion of the possible formation 
of the impurity and the amounts at which it might be present. The 
impurities which must also be discussed are the following, as 
applicable:
    (a) Technical grade active ingredients and products produced by an 
integrated system. (1) Each impurity associated with the active 
ingredient which was found to be present in any analysis of the product 
conducted by or for the applicant.
    (2) Each other impurity which the registrant or applicant has reason 
to believe may be present in his product at any time before use at a 
level =0.1 percent (1,000 ppm) by weight of the technical 
grade of the active ingredient, based on what he knows about the 
following:
    (i) The composition (or composition range) of each starting material 
used to produce his product.
    (ii) The impurities which the applicant knows are present (or 
believes are likely to be present) in the starting materials, and the 
known or presumed level (or range of levels) of these impurities.
    (iii) The intended reactions and side reactions which may occur in 
the production of the product, and the relative amounts of byproduct 
impurities produced by such reactions.
    (iv) The possible degradation of the ingredients in the product 
after its production but prior to its use.
    (v) Post-production reactions between the ingredients in the 
product.
    (vi) The possible migration of components of packaging materials 
into the pesticide.
    (vii) The possible carryover of contaminants from use of production 
equipment previously used to produce other products or substances.
    (viii) The process control, purification and quality control 
measures used to produce the product.
    (b) Products not produced by an integrated system. Each impurity 
associated with the active ingredient which the applicant has reason to 
believe may be present in the product at any time before use at a level 
=0.1 percent (1,000 ppm) by weight of the product based on 
what he knows about the following:
    (1) The possible carryover of impurities present in any registered 
product which serves as the source of any of the product's active 
ingredients. The identity and level of impurities in the registered 
source need not be discussed or quantified unless known to the 
formulator.
    (2) The possible carryover of impurities present in the inert 
ingredients in the product.
    (3) Possible reactions occurring during the formulation of the 
product between any of its active ingredients, between the active 
ingredients and inert ingredients, or between the active ingredient and 
the production equipment.
    (4) Post-production reactions between any of the product's active 
ingredients and any other component of the product or its packaging.
    (5) Possible migration of packaging materials into the product.
    (6) Possible contaminants resulting from earlier use of equipment to 
produce other products.
    (c) Expanded discussion. On a case-by-case basis, the Agency may 
require an expanded discussion of information on impurities:
    (1) From other possible chemical reactions.
    (2) Involving other ingredients.
    (3) At additional points in the production or formulation process.



Sec. 158.345  Preliminary analysis.

    (a) If the product is produced by an integrated system, the 
applicant must provide a preliminary analysis of each technical grade of 
active ingredient contained in the product to identify all impurities 
present at 0. 1 percent or greater of the technical grade of the active 
ingredient. The preliminary analysis should be conducted at the point in 
the production process after which no further chemical reactions 
designed to produce or purify the substances are intended.
    (b) Based on the preliminary analysis, a statement of the 
composition of the technical grade of the active ingredient must be 
provided. If the technical grade of the active ingredient cannot

[[Page 115]]

be isolated, a statement of the composition of the practical equivalent 
of the technical grade of the active ingredient must be submitted.



Sec. 158.350  Certified limits.

    The applicant must propose certified limits for the ingredients in 
the product. Certified limits become legally binding limits upon 
approval of the application. Certified limits will apply to the product 
from the date of production to date of use. If the product label bears a 
statement prohibiting use after a certain date, the certified limits 
will apply only until that date.
    (a) Ingredients for which certified limits are required. Certified 
limits are required on the following ingredients of a pesticide product:
    (1) An upper and lower limit for each active ingredient.
    (2) An upper and lower limit for each inert ingredient.
    (3) If the product is a technical grade of active ingredient or is 
produced by an integrated system, an upper limit for each impurity of 
toxicological significance associated with the active ingredient and 
found to be present in any sample of the product.
    (4) On a case-by-case basis, certified limits for other ingredients 
or impurities as specified by EPA.
    (b) EPA determination of standard certified limits for active and 
inert ingredients. (1) Unless the applicant proposes different limits as 
provided in paragraph (c) of this section, the upper and lower certified 
limits for active and inert ingredients will be determined by EPA. EPA 
will calculate the certified limits on the basis of the nominal 
concentration of the ingredient in the product, according to the table 
in paragraph (b)(2) of this section.
    (2) Table of standard certified limits.

                        Standard Certified Limits
------------------------------------------------------------------------
If the nominal concentration (N)       The certified limits for that
     for the ingredient and           ingredient will be as follows:
  percentage by weight for the   ---------------------------------------
         ingredient is:               Upper Limit         Lower Limit
------------------------------------------------------------------------
N <=1.0%                          N + 10%N            N - 10%N
------------------------------------------------------------------------
1.0% <= N <=20.0%                 N + 5%N             N - 5%N
------------------------------------------------------------------------
20.0% <=N <=100.0%                N + 3%N             N - 3%N
------------------------------------------------------------------------

    (c) Applicant proposed limits. (1) The applicant may propose a 
certified limit for an active or inert ingredient that differs from the 
standard certified limit calculated according to paragraph (b)(2) of 
this section.
    (2) If certified limits are required for impurities, the applicants 
must propose a certified limit. The standard certified limits may not be 
used for such substances.
    (3) Certified limits should:
    (i) Be based on a consideration of the variability of the 
concentration of the ingredient in the product when good manufacturing 
practices and normal quality control procedures are used.
    (ii) Allow for all sources of variability likely to be encountered 
in the production process.
    (iii) Take into account the stability of the ingredient in the 
product and the possible formation of impurities between production and 
sale or distribution.
    (4) The applicant may include an explanation of the basis of his 
proposed certified limits, including how the certified limits were 
arrived at (e.g., sample analysis, quantitative estimate based on 
production process), and its accuracy and precision. This will be 
particularly useful if the range of the certified limit for an active or 
inert ingredient is greater than the standard certified limits.
    (d) Special cases. If the Agency finds unacceptable any certified 
limit (either standard, or applicant proposed), the Agency will inform 
the registrant or applicant of its determination and will provide 
supporting reasons. The Agency may also recommend alternative limits to 
the applicant. The Agency may require, on a case-by-case basis, any or 
all of the following:
    (1) More precise limits.

[[Page 116]]

    (2) More thorough explanation of how the certified limits were 
determined.
    (3) A narrower range between the upper and lower certified limits 
than that proposed.
    (e) Certification statement. The applicant must certify the accuracy 
of the information presented, and that the certified limits of the 
ingredients will be maintained. The following statement, signed by the 
authorized representative of the company, is acceptable:
    I hereby certify that, for purposes of FIFRA sec. 12(a)(1)(C), the 
description of the composition of [insert product name], EPA Reg. No. 
[insert registration number], refers to the composition set forth on the 
Statement of Formula and supporting materials. This description includes 
the representations that: (1) no ingredient will be present in the 
product in an amount greater than the upper certified limit or in an 
amount less than the lower certified limit (if required) specified for 
that ingredient in a currently approved Statement of Formula (or as 
calculated by the Agency); and (2) if the Agency requires that the 
source of supply of an ingredient be specified, that all quantities of 
such ingredient will be obtained from the source specified in the 
Statement of Formula.



Sec. 158.355  Enforcement analytical method.

    An analytical method suitable for enforcement purposes must be 
provided for each active ingredient in the product and for each other 
ingredient or impurity that the Agency determines to be toxicologically 
significant.



                      Subpart E_Product Performance



Sec. 158.400  Product performance data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the product performance data requirements for a 
particular pesticide product. Notes that apply to an individual test, 
including specific conditions, qualifications, or exceptions to the 
designated test are listed in paragraph (e) of this section.
    (b) Use patterns. The terrestrial use pattern includes products 
classified under the general use patterns of terrestrial food crop and 
terrestrial nonfood crop. The aquatic use pattern includes products 
classified under the general use patterns of aquatic food crop and 
aquatic nonfood. The greenhouse use pattern includes products classified 
under the general use patterns of greenhouse food crop and greenhouse 
nonfood crop. Data are also required for the general use patterns of 
forestry use, residential outdoor use, and indoor use, which includes 
both food and nonfood uses.
    (c) Key. CR=Conditionally required; NR=Not required; R=Required; 
EP=End-use product; MP=Manufacturing-use product; TEP=Typical end-use 
product.
    (d) Table. The following table lists the data requirements that 
pertain to product performance. The table notes are shown in paragraph 
(e) of this section.

[[Page 117]]



                                                                                                                  Table--Product Performance Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                            Use Pattern                                                                                          Test substance to
                                                      ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------         support
        Guideline Number            Data Requirement                  Terrestrial                                Aquatic                                Greenhouse                                                                           ------------------------  Test Note
                                                      ---------------------------------------------------------------------------------------------------------------------------      Forestry           Residential           Indoor                                    No.
                                                            Food Crop           Nonfood Crop             Food               Nonfood            Food Crop         Nonfood Crop                               Outdoor                               MP          EP
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy of antimicrobial agents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  91-2                            Products for use on  NR                   NR                   NR                   NR                  NR                  NR                  NR                  NR                  CR                         NR          EP           1
                                   hard surfaces
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  91-3                            Products requiring   NR                   NR                   NR                   NR                  NR                  NR                  NR                  NR                  CR                         NR          EP           1
                                   confirmatory data
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  91-4                            Products for use on  NR                   NR                   NR                   NR                  NR                  NR                  NR                  NR                  CR                         NR          EP           1
                                   fabrics and
                                   textiles
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  91-5                            Air sanitizers       NR                   NR                   NR                   NR                  NR                  NR                  NR                  NR                  CR                         NR          EP           1
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  91-7                            Products for         NR                   NR                   NR                   NR                  NR                  NR                  NR                  NR                  CR                         NR          EP           1
                                   control of
                                   microbial pests
                                   associated with
                                   human and animal
                                   wastes
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  91-8                            Products for         NR                   NR                   CR                   NR                  NR                  NR                  NR                  NR                  CR                         NR          EP           1
                                   treating water
                                   systems
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  810.2700                        Products with prion- NR                   NR                   NR                   NR                  NR                  NR                  NR                  NR                  R                          NR          EP           1
                                   related claims
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy of fungicides and nematicides
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  93-16                           Products for         CR                   NR                   CR                   NR                  CR                  NR                  NR                  NR                  NR                         NR          EP           1
                                   control of
                                   organisms
                                   producing
                                   mycotoxins
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy of vertebrate control agents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  96-5                            Avian toxicants      R                    R                    NR                   NR                  NR                  NR                  NR                  R                   R                          NR          EP           1
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  96-6                            Avian repellents     R                    R                    NR                   NR                  NR                  NR                  NR                  R                   NR                         NR          EP           1
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  96-7                            Avian frightening    R                    R                    NR                   NR                  NR                  NR                  NR                  R                   NR                         NR          EP           1
                                   agents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  96-9                            Bat toxicants and    NR                   NR                   NR                   NR                  NR                  NR                  NR                  NR                  R                          NR          EP           1
                                   repellents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  96-10                           Commensal            R                    R                    NR                   NR                  NR                  NR                  NR                  R                   R                         TEP          EP           1
                                   rodenticides
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 118]]

 
  96-12                           Rodenticides on      R                    R                    NR                   NR                  NR                  NR                  NR                  R                   NR                         NR          EP           1
                                   farm and
                                   rangelands
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  95-13                           Rodent fumigants     R                    R                    NR                   NR                  NR                  NR                  NR                  R                   R                          NR          EP           1
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  95-16                           Rodent reproductive  R                    R                    NR                   NR                  NR                  NR                  NR                  R                   R                          NR          EP           1
                                   inhibitors
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  95-17                           Mammalian            R                    R                    NR                   NR                  NR                  NR                  NR                  R                   NR                         NR          EP           1
                                   predacides
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 119]]

    (e) Test notes. The following notes appy to the data requirements 
table in paragraph (d) of this section.
    1. The Agency has waived the requirement to submit product 
performance data unless the pesticide product bears a claim to control 
pest microorganisms that pose a threat to human health and whose 
presence cannot readily be observed by the user including, but not 
limited to, microorganisms infectious to man in any area of the 
inanimate environment, or a claim to control vertebrates (such as 
rodents, birds, bats, canids, and skunks) that may directly or 
indirectly transmit diseases to humans. However each registrant must 
ensure through testing that his product is efficacious when used in 
accordance with label directions and commonly accepted pest control 
practices. The Agency reserves the right to require, on a case-by-case 
basis, submission of product performance data for any pesticide product 
registered or proposed for registration.
    2. [Reserved]

[72 FR 60957, Oct. 26, 2007, as amended at 78 FR 13507, Feb. 28, 2013]

    Effective Date Note: At 78 FR 26978, May 8, 2013, Sec. 158.400 was 
amended in paragraph (d) by removing the heading ``Efficacy of 
Antimicrobial Agents,'' and the entries 91-2 through 91-8 under that 
category, effective July 8, 2013.



                          Subpart F_Toxicology



Sec. 158.500  Toxicology data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
the data table in paragraph (d) of this section to determine the 
toxicology data requirements for a particular pesticide product. Notes 
that apply to an individual test and include specific conditions, 
qualifications, or exceptions to the designated test in the table are 
listed in paragraph (e) of this section.
    (b) Use patterns. (1) Food use patterns include products classified 
under the general use patterns of terrestrial food crop use, terrestrial 
feed crop use, aquatic food crop use, greenhouse food crop use, and 
indoor food use.
    (2) Nonfood use patterns include products classified under the 
general use patterns of terrestrial nonfood crop use, aquatic nonfood 
use, greenhouse nonfood crop use, forestry use, residential outdoor use, 
and indoor nonfood use.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TGAI=Technical grade 
of the active ingredient; PAI=Pure active ingredient; PAIRA=Pure active 
ingredient radio-labeled; Choice=Choice of several test substances 
depending on study required.
    (d) Table. The following table lists the toxicology data 
requirements. The table notes are shown in paragraph (e) of this 
section.

                                                           Table--Toxicology Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Use Pattern                      Test substance to support
        Guideline Number           Data Requirements --------------------------------------------------------------------------------    Test Note No.
                                                             Food               Nonfood               MP                  EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.1100                        Acute oral          R                   R                   TGAI and MP         TGAI, EP, and       1, 2
                                   toxicity - rat                                                                  possibly diluted
                                                                                                                   EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.1200                        Acute dermal        R                   R                   TGAI and MP         TGAI, EP            1, 2, 3
                                   toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.1300                        Acute inhalation    R                   R                   TGAI and MP         TGAI and EP         4
                                   toxicity - rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.2400                        Primary eye         R                   R                   TGAI and MP         TGAI and EP         3
                                   irritation -
                                   rabbit
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.2500                        Primary dermal      R                   R                   TGAI and MP         TGAI and EP         1, 3
                                   irritation
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 120]]

 
  870.2600                        Dermal              R                   R                   TGAI and MP         TGAI and EP         3, 5
                                   sensitization
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.6100                        Delayed             CR                  CR                  TGAI                TGAI                6
                                   neurotoxicity
                                   (acute) - hen
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.6200                        Acute               R                   R                   TGAI                TGAI                7
                                   neurotoxicity -
                                   rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
Subchronic Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.3100                        90-day Oral -       R                   CR                  TGAI                TGAI                8, 9
                                   rodent
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.3150                        90-day Oral - non-  R                   CR                  TGAI                TGAI                36
                                   rodent
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.3200                        21/28-day Dermal    R                   NR                  TGAI                TGAI and EP         10, 11
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.3250                        90-day Dermal       CR                  R                   TGAI                TGAI and EP         11, 12
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.3465                        90-day Inhalation - CR                  CR                  TGAI                TGAI                13, 14
                                    rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.6100                        28-day Delayed      CR                  CR                  TGAI                TGAI                6, 15
                                   neurotoxicity-hen
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.6200                        90-day              R                   R                   TGAI                TGAI                7, 16
                                   Neurotoxicity -
                                   rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chronic Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.4100                        Chronic oral -      R                   CR                  TGAI                TGAI                17, 18, 19
                                   rodent
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.4200                        Carcinogenicity -   R                   CR                  TGAI                TGAI                9, 17, 18, 19, 20,
                                   two rodent                                                                                          21
                                   species - rat and
                                   mouse preferred
--------------------------------------------------------------------------------------------------------------------------------------------------------
Developmental Toxicity and Reproduction
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.3700                        Prenatal            R                   R                   TGAI                TGAI                22, 23, 24, 25, 26
                                   Developmental
                                   toxicity - rat
                                   and rabbit,
                                   preferred
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.3800                        Reproduction and    R                   R                   TGAI                TGAI                26, 27, 29
                                   fertility effects
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.6300                        Developmental       CR                  CR                  TGAI                TGAI                27, 28, 29
                                   neurotoxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mutagenicity Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.5100                        Bacterial reverse   R                   R                   TGAI                TGAI                30
                                   mutation assay
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.5300                        In vitro mammalian  R                   R                   TGAI                TGAI                30, 31
  870.5375......................   cell assay
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.5385                        In vivo             R                   R                   TGAI                TGAI                30, 32
  870.5395......................   cytogenetics
--------------------------------------------------------------------------------------------------------------------------------------------------------
Special Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.7485                        Metabolism and      R                   CR                  PAI or PAIRA        PAI or PAIRA        33
                                   pharmacokinetics
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.7200                        Companion animal    CR                  CR                  NR                  TGAI or EP          34
                                   safety
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.7600                        Dermal penetration  CR                  CR                  Choice              Choice              35
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.7800                        Immunotoxicity      R                   R                   TGAI                TGAI
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes apply to the requirements 
in the table to paragraph (d) of this section:
    1. Not required if test material is a gas or a highly volatile 
liquid.

[[Page 121]]

    2. Diluted EP testing is required to support the end product 
registration if results using the EP meet the criteria for restricted 
use classification under Sec. 152.170(b) or special review 
consideration under Sec. 154.7(a)(1).
    3. Not required if the test material is corrosive to skin or has a 
pH of less than 2 or greater than 11.5.
    4. Required if the product consists of, or under conditions of use 
will result in, a respirable material (e.g., gas, vapor, aerosol, or 
particulate).
    5. Required if repeated dermal exposure is likely to occur under 
conditions of use.
    6. Required if the test material is an organophosphorus substance, 
which includes uncharged organophosphorus esters; thioesters or 
anhydrides of organophosphoric, organophosphonic, or 
organophosphoramidic acids; or of related phosphorothioic, 
phosponothioic, or phosphorothioamidic acids; or is structurally related 
to other substances that may cause the delayed neurotoxicity sometimes 
seen in this class of chemicals.
    7. As determined by the Agency, additional measurements may also be 
required, such as cholinesterase activity for certain pesticides, e.g., 
organophosphates and some carbamates. The route of exposure must 
correspond with the primary route of exposure.
    8. Required for nonfood use pesticides if oral exposure could occur.
    9. The 90-day study is required in the rat for hazard 
characterization (possibly endpoint selection) and dose-setting for the 
chronic/carcinogenicity study. It is not required in the mouse, but the 
Agency would strongly encourage the registrant to conduct a 90-day range 
finding for the purposes of dose selection for the mouse carcinogenicity 
study to achieve adequate dosing and an acceptable study. The registrant 
is also encouraged to consult with the Agency on the results of the 90-
day mouse study prior to conducting the carcinogenicity study.
    10. Required for agricultural uses or if repeated human dermal 
exposure may occur. Not required if an acceptable 90-day dermal toxicity 
study is performed and submitted.
    11. EP testing is required if the product, or any component of it, 
may increase dermal absorption of the active ingredient(s) as determined 
by testing using the TGAI, or increase toxic or pharmacologic effects.
    12. Required for food uses if either of the following criteria is 
met:
    (i) The use pattern is such that the dermal route would be the 
primary route of exposure; or
    (ii) The active ingredient is known or expected to be metabolized 
differently by the dermal route of exposure than by the oral route, and 
a metabolite is the toxic moiety.
    13. Required if there is the likelihood of significant repeated 
inhalation exposure to the pesticide as a gas, vapor, or aerosol.
    14. Based on estimates of the magnitude and duration of human 
exposure, studies of shorter duration, e.g., 21- or 28-days, may be 
sufficient to satisfy this requirement. Registrants should consult with 
the Agency to determine whether studies of shorter duration would meet 
this requirement.
    15. Required if results of acute neurotoxicity study indicate 
significant statistical or biological effects, or if other available 
data indicate the potential for this type of delayed neurotoxicity, as 
determined by the Agency.
    16. All 90-day subchronic studies in rats can be designed to 
simultaneously fulfill the requirements of the 90-day neurotoxicity 
study using separate groups of animals for testing. Although the 
subchronic guidelines include the measurement of neurological endpoints, 
they do not meet the requirement of the 90-day neurotoxicity study.
    17. Required if either of the following are met:
    (i) The use of the pesticide is likely to result in repeated human 
exposure over a considerable portion of the human lifespan, as 
determined by the Agency;
    (ii) The use requires a tolerance or an exemption from the 
requirement of a tolerance.
    18. Based on the results of the acute and subchronic neurotoxicity 
studies, or other available data, a combined chronic toxicity and 
neurotoxicity study may be required.
    19. Studies which are designed to simultaneously fulfill the 
requirements of both the chronic oral and carcinogenicity studies (i.e., 
a combined study) may be conducted. Minimum acceptable study durations 
are:
    (i) Chronic rodent feeding study (food use) - 24 months.
    (ii) Chronic rodent feeding study (nonfood use) - 12 months.
    (iii) Mouse carcinogenicity study - 18 months.
    (iv) Rat carcinogenicity study - 24 months.
    20. Required if any of the following, as determined by the Agency, 
are met:
    (i) The use of the pesticide is likely to result in significant 
human exposure over a considerable portion of the human life span which 
is significant in terms of either frequency, duration, or magnitude of 
exposure;
    (ii) The use requires a tolerance or an exemption from the 
requirement of a tolerance; or
    (iii) The active ingredient, metabolite, degradate, or impurity (a) 
is structurally related to a recognized carcinogen, (b) causes mutagenic 
effects as demonstrated by in vitro or in vivo testing, or (c) produces 
a morphologic effect in any organ (e.g., hyperplasia, metaplasia) in 
subchronic studies that may lead to a neoplastic change.
    21. If this study is modified or waived, a subchronic 90-day oral 
study conducted in the same species may be required.

[[Page 122]]

    22. Testing in two species is required for all uses.
    23. The oral route, by oral intubation, is preferred unless the 
chemical or physical properties of the test substance or the pattern of 
exposure suggests a more appropriate route of exposure.
    24. Additional testing by other routes may be required if the 
pesticide is determined to be a prenatal developmental toxicant after 
oral dosing.
    25. May be combined with the 2-generation reproduction study in 
rodents by utilizing a second mating of the parental animals in either 
generation.
    26. Required to support products intended for food uses and to 
support products intended for nonfood uses if use of the product is 
likely to result in significant human exposure over a portion of the 
human life span in terms of frequency, magnitude or duration of 
exposure.
    27. An information-based approach to testing is preferred, which 
utilizes the best available knowledge on the chemical (hazard, 
pharmacokinetic, or mechanistic data) to determine whether a standard 
guideline study, an enhanced guideline study, or an alternative study 
should be conducted to assess potential hazard to the developing animal, 
or in some cases to support a waiver for such testing. Registrants 
should submit any alternative proposed testing protocols and supporting 
scientific rationale to the Agency prior to study initiation.
    28. Study required using a weight-of-evidence approach considering:
    (i) The pesticide causes treatment-related neurological effects in 
adult animal studies (i.e., clinical signs of neurotoxicity, 
neuropathology, functional or behavioral effects).
    (ii) The pesticide causes treatment-related neurological effects in 
developing animals, following pre- and postnatal exposure (i.e., nervous 
system malformations or neuropathy, brain weight changes in offspring, 
functional or behavioral changes in the offspring).
    (iii) The pesticide elicits a causative association between 
exposures and adverse neurological effects in human epidemiological 
studies.
    (iv) The pesticide evokes a mechanism that is associated with 
adverse effects on the development of the nervous system (e.g., SAR 
relationship to known neurotoxicants, altered neuroreceptor or 
neurotransmitter responses).
    29. The use of a combined study that utilizes the 2-generation 
reproduction study in rodents as a basic protocol for the addition of 
other endpoints or functional assessments in the immature animal is 
encouraged.
    30. At a minimum, an initial battery of mutagenicity tests with 
possible confirmatory testing is required. Other relevant mutagenicity 
tests that may have been performed, plus a complete reference list must 
also be submitted.
    31. Choice of assay using either:
    (i) Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, 
maximizing assay conditions for small colony expression or detection;
    (ii) Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast 
(V79) cells, hypoxanthine-guanine phosphoribosyl transferase (hgprt) 
gene locus, accompanied by an appropriate in vitro test for 
clastogenicity; or
    (iii) CHO cells strains AS52, xanthine-guanine phosphoribosyl 
transferase (xprt) gene locus.
    32. The micronucleus rodent bone marrow assay is preferred; however, 
rodent bone marrow assays using metaphase analysis (aberrations) are 
acceptable.
    33. Required when chronic or carcinogenicity studies are required. 
May be required if significant adverse effects are seen in available 
toxicology studies and these effects can be further elucidated by 
metabolism studies.
    34. May be required if the product's use will result in exposure to 
domestic animals through, but not limited to, direct application.
    35. A risk assessment assuming that dermal absorption is equal to 
oral absorption must be performed to determine if the study is required, 
and to identify the doses and duration of exposure for which dermal 
absorption is to be quantified.
    36. A 1-year non-rodent study (i.e., 1-year dog study) would be 
required if the Agency finds that a pesticide chemical is highly 
bioaccumulating and is eliminated so slowly that it does not achieve 
steady state or sufficient tissue concentrations to elicit an effect 
during a 90-day study. EPA would require the appropriate tier II 
metabolism and pharmacokinetic studies to evaluate more precisely 
bioavailability, half-life, and steady state to determine if a longer 
duration dog toxicity study is needed.



Sec. 158.510  Tiered testing options for nonfood pesticides.

    For nonfood use pesticides only, applicants have two options for 
generating and submitting required toxicology (Sec. 158.500) and human 
exposure (Sec. 158.1020, Sec. 158.1070, and Sec. 158.1410) studies. 
Applicants are to select one of the following:
    (a) Acute, subchronic, chronic, and other toxicological studies on 
the active ingredient must be submitted together. The specific makeup of 
the set of toxicology study requirements is based on the anticipated 
exposure to the pesticide as determined by the

[[Page 123]]

Agency. If hazards are identified based upon review of these studies, 
specific exposure data will be required to evaluate risk.
    (b) Certain toxicological and exposure studies must be submitted 
simultaneously with the toxicology data submitted in a tiered system. 
Exposure data must be submitted along with first tier toxicology data. 
The requirement for additional second and third level toxicology testing 
will be determined by the Agency based on the results of the first 
tiered studies.
    (1) The required first-tier toxicology studies consist of:
    (i) Battery of acute studies.
    (ii) A subchronic 90-day dermal study or a subchronic 90-day 
inhalation study.
    (iii) An acute and subchronic neurotoxicity screening battery in the 
rat.
    (iv) Prenatal developmental toxicity studies in both the rat and 
rabbit.
    (v) Reproduction and fertility studies in rats.
    (vi) Battery of mutagenicity studies.
    (vii) Immunotoxicity study.
    (2) The conditionally required second-tier studies include:
    (i) Subchronic 90-day feeding studies in both the rodent and 
nonrodent.
    (ii) Dermal penetration study.
    (3) The conditionally required third-tier studies include:
    (i) Chronic feeding studies in the rodent.
    (ii) Carcinogenicity.
    (iii) Metabolism study.
    (iv) Additional mutagenicity testing.



                      Subpart G_ Ecological Effects



Sec. 158.630  Terrestrial and aquatic nontarget organisms data requirements 

table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the terrestrial and aquatic nontarget data 
requirements for a particular pesticide product. Notes that apply to an 
individual test including specific conditions, qualifications, or 
exceptions to the designated test are listed in paragraph (e) of this 
section.
    (b) Use patterns. (1) The terrestrial use pattern includes products 
classified under the general use patterns of terrestrial food crop, 
terrestrial feed crop, and terrestrial nonfood crop. The aquatic use 
pattern includes products classified under the general use patterns of 
aquatic food crop and aquatic nonfood use patterns. The greenhouse use 
pattern includes products classified under the general use patterns of 
greenhouse food crop and greenhouse nonfood crop. The indoor use pattern 
includes products classified under the general use patterns of indoor 
food and indoor nonfood use.
    (2) Data are also required for the general use patterns of forestry 
and residential outdoor use.
    (3) In general, for all outdoor end-uses, including turf, the 
following studies are required: Two avian oral LD50, two 
avian dietary LC50, two avian reproduction studies, two 
freshwater fish LC50, one freshwater invertebrate 
EC50, one honeybee acute contact LD50, one 
freshwater fish early-life stage, one freshwater invertebrate life 
cycle, and three estuarine acute LC50/EC50 studies 
-- fish, mollusk and invertebrate. All other outdoor residential uses, 
i.e., gardens and ornamental will not usually require the freshwater 
fish early-life stage, the freshwater invertebrate life-cycle, and the 
acute estuarine tests.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
TGAI=Technical grade of the active ingredient; TEP=Typical end-use 
product; PAI=Pure active ingredient; EP=end-use product. Commas between 
the test substances (i.e., TGAI, TEP) indicate that data may be required 
on the TGAI or the TEP depending on the conditions set forth in the test 
note.
    (d) Table. The following table shows the data requirements for 
nontarget terrestrial and aquatic organism. The table notes are shown in 
paragraph (e) of this section.

[[Page 124]]



                                                                  Terrestrial and Aquatic Nontarget Organism Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                  Use Pattern
                                                 ------------------------------------------------------------------------------------------------------------
       Guideline Number         Data Requirement                                                           Residential                                         Test substance     Test Note No.
                                                     Terrestrial         Aquatic          Forestry           Outdoor         Greenhouse          Indoor
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Avian and Mammalian Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.2100                      Avian oral        R                 R                 R                 R                 CR                CR                TGAI              1, 2, 3
                                 toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.2200                      Avian dietary     R                 R                 R                 R                 NR                NR                TGAI              1, 4
                                 toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.2400                      Wild mammal       CR                CR                CR                CR                NR                NR                TGAI              5
                                 toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.2300                      Avian             R                 R                 R                 R                 NR                NR                TGAI              1, 4
                                 reproduction
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.2500                      Simulated or      CR                CR                CR                CR                NR                NR                TEP               6, 7
                                 actual field
                                 testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Aquatic Organisms Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1075                      Freshwater fish   R                 R                 R                 R                 CR                CR                TGAI, TEP         1, 2, 8, 9, 26
                                 toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1010                      Acute toxicity    R                 R                 R                 R                 CR                CR                TGAI, TEP         1, 2, 9, 10, 26
                                 freshwater
                                 invertebrates
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1025                      Acute toxicity    R                 R                 R                 R                 NR                NR                TGAI, TEP         1, 9, 11, 12, 26
  850.1035....................   estuarine and
  850.1045....................   marine
  850.1055....................   organisms
  850.1075....................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1300                      Aquatic           R                 R                 R                 R                 NR                NR                TGAI              1, 10, 12
                                 invertebrate
                                 life cycle
                                 (freshwater)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1350                      Aquatic           CR                CR                CR                CR                NR                NR                TGAI              12, 14, 15
                                 invertebrate
                                 life cycle
                                 (saltwater)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1400                      Fish early-life   R                 R                 R                 R                 NR                NR                TGAI              1, 12, 13
                                 stage
                                 (freshwater)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1400                      Fish early-life   CR                CR                CR                CR                NR                NR                TGAI              12, 15, 16
                                 stage
                                 (saltwater)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1500                      Fish life cycle   CR                CR                CR                CR                NR                NR                TGAI              17, 18
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1710                      Aquatic           CR                CR                CR                CR                NR                NR                TGAI, PAI,        19
  850.1730....................   organisms                                                                                                                     degradate
  850.1850....................   bioavailability
                                 ,
                                 biomagnificatio
                                 n, toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1950                      Simulated or      CR                CR                CR                CR                NR                NR                TEP               7, 20
                                 actual field
                                 testing for
                                 aquatic
                                 organisms
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Sediment Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1735                      Whole sediment:   CR                CR                CR                CR                NR                NR                TGAI              21
                                 acute
                                 freshwater
                                 invertebrates
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 125]]

 
  850.1740                      Whole sediment:   CR                CR                CR                CR                NR                NR                TGAI              21, 23
                                 acute marine
                                 invertebrates
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                Whole sediment:   CR                CR                CR                CR                NR                NR                TGAI              22, 23
                                 chronic
                                 invertebrates
                                 freshwater and
                                 marine
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Insect Pollinator Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.3020                      Honeybee acute    R                 CR                R                 R                 NR                NR                TGAI              1
                                 contact
                                 toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.3030                      Honey bee         CR                CR                CR                CR                NR                NR                TEP               24
                                 toxicity of
                                 residues on
                                 foliage
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.3040                      Field testing     CR                CR                CR                CR                NR                NR                TEP               25
                                 for pollinators
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes apply to terrestrial and 
aquatic nontarget organisms data requirements in the table to paragraph 
(d) of this section:
    1. Data using the TGAI are required to support all outdoor end-use 
product uses including, but not limited to turf. Data are generally not 
required to support end-use products in the form of a gas, a highly 
volatile liquid, a highly reactive solid, or a highly corrosive 
material.
    2. For greenhouse and indoor end-use products, data using the TGAI 
are required to support manufacturing-use products to be reformulated 
into these same end-use products or to support end-use products when 
there is no registered manufacturing-use product. Avian acute oral data 
are not required for liquid formulations for greenhouse and indoor uses. 
The study is not required if there is no potential for environmental 
exposure.
    3. Data are required on one passerine species and either one 
waterfowl species or one upland game bird species for terrestrial, 
aquatic, forestry, and residential outdoor uses. Data are preferred on 
waterfowl or upland game bird species for indoor and greenhouse uses.
    4. Data are required on waterfowl and upland game bird species.
    5. Tests are required based on the results of lower tier toxicology 
studies, such as the acute and subacute testing, intended use pattern, 
and environmental fate characteristics that indicate potential exposure.
    6. Higher tier testing may be required for a specific use pattern 
when a refined risk assessment indicates a concern based on laboratory 
toxicity endpoints and refined exposure assessments.
    7. Environmental chemistry methods used to generate data associated 
with this study must include results of a successful confirmatory method 
trial by an independent laboratory. Test standards and procedures for 
independent laboratory validation are available as addenda to the 
guideline for this test requirement.
    8. Data are required on one coldwater fish and one warmwater fish 
for terrestrial, aquatic, forestry, and residential outdoor uses. For 
indoor and greenhouse uses, testing with only one of either fish species 
is required.
    9. EP or TEP testing is required for any product which meets any of 
the following conditions:
    i. The end-use pesticide will be introduced directly into an aquatic 
environment (e.g., aquatic herbicides and mosquito larvicides) when used 
as directed.
    ii. The maximum expected environmental concentration (MEEC) or the 
estimated environmental concentration (EEC) in the aquatic environment 
is = one-half the LC50 or EC50 of the 
TGAI when the EP is used as directed.
    iii. An ingredient in the end-use formulation other than the active 
ingredient is expected to enhance the toxicity of the active ingredient 
or to cause toxicity to aquatic organisms.
    10. Data are required on one freshwater aquatic invertebrate 
species.
    11. Data are required on one estuarine/marine mollusk, one 
estuarine/marine invertebrate and one estuarine/marine fish species.

[[Page 126]]

    12. Data are generally not required for outdoor residential uses, 
other than turf, unless data indicate that pesticide residues from the 
proposed use(s) can potentially enter waterways.
    13. Data are required on one freshwater fish species. If the test 
species is different from the two species used for the freshwater fish 
acute toxicity tests, a 96-hour LC50 on that species must 
also be provided.
    14. Data are required on one estuarine/marine invertebrate species.
    15. Data are required on estuarine/marine species if the product 
meets any of the following conditions:
    i. Intended for direct application to the estuarine or marine 
environment.
    ii. Expected to enter this environment in significant concentrations 
because of its expected use or mobility patterns.
    iii. If the acute LC50 or EC50 <1 milligram/
liter (mg/l).
    iv. If the estimated environmental concentration (EEC) in water is 
=0.01 of the acute EC50 or LC50 or if 
any of the following conditions exist:
    A. Studies of other organisms indicate the reproductive physiology 
of fish and/or invertebrates may be affected.
    B. Physicochemical properties indicate bioaccumulation of the 
pesticide.
    C. The pesticide is persistent in water (e.g., half-life in water 
4 days).
    16. Data are required on one estuarine/marine fish species.
    17. Data are required on estuarine/marine species if the product is 
intended for direct application to the estuarine or marine environment, 
or the product is expected to enter this environment in significant 
concentrations because of its expected use or mobility patterns.
    18. Data are required on freshwater species if the end-use product 
is intended to be applied directly to water, or is expected to be 
transported to water from the intended use site, and when any of the 
following conditions apply:
    i. If the estimated environmental concentration (EEC) is 
=0.1 of the no-observed-effect level in the fish early-life 
stage or invertebrate life cycle test;
    ii. If studies of other organisms indicate that the reproductive 
physiology of fish may be affected.
    19. Not required when:
    i. The octanol/water partition coefficients of the pesticide and its 
major degradates are <1,000; or
    ii. There are no potential exposures to fish and other nontarget 
aquatic organisms; or
    iii. The hydrolytic half-life is <5 days at pH 5, 7 and 9.
    20. Data are required based on the results of lower tier studies 
such as acute and chronic aquatic organism testing, intended use 
pattern, and environmental fate characteristics that indicate 
significant potential exposure.
    21. Data are required if:
    i. The half-life of the pesticide in the sediment is <=10 days in 
either the aerobic soil or aquatic metabolism studies and if any of the 
following conditions exist:
    A. The soil partition coefficient (Kd) is =50.
    B. The log Kow is =3.
    C. The Koc =1,000.
    ii. Registrants must consult with the Agency on appropriate test 
protocols prior to designing the study.
    22. Data are required if:
    i. The estimated environmental concentration (EEC) in sediment is 
0.1 of the acute LC50/EC50 values and
    ii. The half-life of the pesticide in the sediment is 10 
days in either the aerobic soil or aquatic metabolism studies and if any 
of the following conditions exist:
    A. The soil partition coefficient (Kd) is =50.
    B. The log Kow is =3.
    C. The Koc =1,000.
    iii. Registrants must consult with the Agency on appropriate test 
protocols prior to designing the study.
    23. Sediment testing with estuarine/marine test species is required 
if the product is intended for direct application to the estuarine or 
marine environment or the product is expected to enter this environment 
in concentrations which the Agency believes to be significant, either by 
runoff or erosion, because of its expected use or mobility pattern.
    24. Data are required only when the formulation contains one or more 
active ingredients having an acute LD50 of <11 micrograms per 
bee as determined in the honey bee acute contact study and the use 
pattern(s) indicate(s) that honey bees may be exposed to the pesticide.
    25. Required if any of the following conditions are met:
    i. Data from other sources (Experimental Use Permit program, 
university research, registrant submittals, etc.) indicate potential 
adverse effects on colonies, especially effects other than acute 
mortality (reproductive, behavioral, etc.);
    ii. Data from residual toxicity studies indicate extended residual 
toxicity.
    iii. Data derived from studies with terrestrial arthropods other 
than bees indicate potential chronic, reproductive or behavioral 
effects.
    26. The freshwater fish test species for the TEP testing is the most 
sensitive of the species tested with the TGAI. Freshwater invertebrate 
and acute estuarine and marine organisms must also be tested with the EP 
or TEP using the same species tested with the TGAI.

[[Page 127]]



Sec. 158.660  Nontarget plant protection data requirements table.

    (a) General. Sections 158.100 through158.130 describe how to use 
this table to determine the nontarget plant data requirements for a 
particular pesticide product. Notes that apply to an individual test and 
include specific conditions, qualifications, or exceptions to the 
designated test are listed in paragraph (e) of this section.
    (b) Use patterns. (1) The terrestrial use pattern includes products 
classified under the general use patterns of terrestrial food crop, 
terrestrial feed crop, and terrestrial nonfood. The aquatic use pattern 
includes only the general use patterns of aquatic food crops and aquatic 
nonfood.
    (2) Data are also required for the general use patterns of forestry 
use and residential outdoor use.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
TGAI=Technical grade of the active ingredient; TEP=Typical end-use 
product.
    (d) Table. The following table shows the nontarget plant protection 
data requirements. The table notes are shown in paragraph (e) of this 
section.

                                                   Table--Nontarget Plant Protection Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Use Pattern
                                                     ------------------------------------------------------------
        Guideline Number           Data Requirement                                              Forestry and       Test substance       Test Note No.
                                                          Terrestrial           Aquatic           Residential
                                                                                                    Outdoor
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nontarget Area Phytotoxicity - Tier I
--------------------------------------------------------------------------------------------------------------------------------------------------------
  850.4100                        Seedling emergence  R                   R                   R                   TEP                 1, 2, 7
--------------------------------------------------------------------------------------------------------------------------------------------------------
  850.4150                        Vegetative vigor    R                   R                   R                   TEP                 1, 2, 3, 7
--------------------------------------------------------------------------------------------------------------------------------------------------------
  850.4400                        Aquatic plant       R                   R                   R                   TEP or TGAI         1, 2, 7
  850.5400......................   growth (algal and
                                   aquatic vascular
                                   plant toxicity)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nontarget Area Phytotoxicity - Tier II
--------------------------------------------------------------------------------------------------------------------------------------------------------
  850.4100                        Seedling emergence  CR                  CR                  CR                  TEP                 1, 4, 5, 7
--------------------------------------------------------------------------------------------------------------------------------------------------------
  850.4150                        Vegetative vigor    CR                  CR                  CR                  TEP                 1, 3, 4, 5, 7
--------------------------------------------------------------------------------------------------------------------------------------------------------
  850.4400                        Aquatic plant       CR                  CR                  CR                  TEP or TGAI         1, 4, 6, 7
  850.5400......................   growth (algal and
                                   aquatic vascular
                                   plant toxicity)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nontarget Area Phytotoxicity - Tier III
--------------------------------------------------------------------------------------------------------------------------------------------------------
  850.4300                        Terrestrial field   CR                  CR                  CR                  TEP                 1, 7, 8, 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
  850.4450                        Aquatic field       CR                  CR                  CR                  TEP                 1, 7, 8, 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
Target Area Phytotoxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
  850.4025                        Target area         CR                  CR                  CR                  TEP                 1, 7, 9, 10
                                   phytotoxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes apply to the table in 
paragraph (d) of this section.
    1. Not required for contained pesticide treatments such as bait 
boxes and pheromone traps unless adverse effects reports are received by 
the Agency.
    2. Not required for known phytotoxicants.
    3. Generally not required for granular formulations. May be 
requested on a case-by-case basis.
    4. Required for known phytotoxicants such as herbicides, desiccants 
and defoliants.
    5. Required if a tested terrestrial species exhibits a 25 percent or 
greater detrimental effect in the Tier I study. When Tier II testing is 
required, the test species should be the species that showed detrimental 
effects in the Tier I testing.
    6. Required if the tested aquatic species exhibits a 50 percent or 
greater detrimental effect in the Tier I study. When Tier II testing is 
required, the test species should be the species that showed detrimental 
effects in the tier I testing.
    7. Not required for aquatic residential uses.

[[Page 128]]

    8. Environmental chemistry methods used to generate data must 
include the results of a successful confirmatory method trial by an 
independent laboratory.
    9. Tests are required on a case-by-case basis based on the results 
of lower tier phytotoxicity studies, adverse incident reports, intended 
use pattern, and environmental fate characteristics that indicate 
potential exposure.
    10. Registrants must consult with the Agency on appropriate test 
protocols prior to designing the study.



                         Subparts H-J [Reserved]



Sec. Sec. 158.700-158.900  [Reserved]



                        Subpart K_Human Exposure



Sec. 158.1000  Applicator exposure--general requirements.

    (a) If EPA determines that industrial standards, such as the 
workplace standards set by the Occupational Safety and Health 
Administration (OSHA), provide adequate protection from risk under FIFRA 
for a particular pesticide use pattern, exposure data may not be 
required for that use pattern. Applicants should consult with the Agency 
on appropriate testing prior to the initiation of studies.
    (b) The Agency may accept surrogate exposure data estimations from 
other sources to satisfy applicator exposure data requirements if the 
data meet the basic quality assurance, quality control, good laboratory 
practice, and other scientific requirements set by EPA. In order to be 
acceptable, the Agency must find that the surrogate exposure data 
estimations have adequate information to address applicator exposure 
data requirements and contain adequate replicates of acceptable quality 
data to reflect the specific use prescribed on the label and the 
applicator activity of concern, including formulation type, application 
methods and rates, type of activity, and other pertinent information. 
The Agency will consider using such surrogate data for evaluating human 
exposure on a case-by-case basis.



Sec. 158.1010  Applicator exposure--criteria for testing.

    Applicator exposure data described in paragraph (d) of this section 
are required based on toxicity and exposure criteria. Data are required 
if a product meets, as determined by the Agency, at least one of the 
toxicity criteria in paragraph (a) of this section and either or both of 
the exposure criteria in paragraph (b) of this section.
    (a) Toxicity criteria. (1) Evidence of potentially significant 
adverse effects have been observed in any applicable toxicity study.
    (2) Scientifically sound epidemiological or poisoning incident data 
indicate that adverse health effects may have resulted from handling of 
the pesticide.
    (b) Exposure criteria. (1) Dermal exposure may occur during the 
prescribed use.
    (2) Respiratory exposure may occur during the prescribed use.



Sec. 158.1020  Applicator exposure data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the applicator exposure data requirements for a 
particular pesticide product. Notes that apply to an individual test and 
include specific conditions, qualifications, or exceptions to the 
designated test are listed in paragraph (e) of this section.
    (b) Use patterns. (1) Occupational use patterns include products 
classified under the general use patterns of terrestrial food crop, 
terrestrial feed crop, terrestrial nonfood crop, aquatic food, aquatic 
nonfood use, forestry, greenhouse food, greenhouse nonfood, indoor food 
use, and indoor nonfood use. Occupational use patterns also include 
commercial (``for hire'') applications to residential outdoor and indoor 
sites.
    (2) Residential use patterns include residential outdoor use and 
residential indoor use. These use patterns are limited to 
nonoccupational, i.e., nonprofessional, pesticide applications.
    (c) Key. R=Required; CR=Conditionally required; TEP=Typical end-use 
product.
    (d) Table. The data requirements listed pertain to pesticide 
products that meet the testing criteria outlined in Sec. 158.1010. The 
table notes are shown in paragraph (e) of this section.

[[Page 129]]



                                                      Table--Applicator Exposure Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Use pattern
          Guideline Number              Data requirement    -----------------------------------------------     Test substance         Test Note No.
                                                                  Occupational            Residential
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1100                             Dermal outdoor          R                       R                      TEP                    1, 2, 3
                                      exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1200                             Dermal indoor exposure  R                       R                      TEP                    1, 2, 4
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1300                             Inhalation outdoor      R                       R                      TEP                    1, 2, 3
                                      exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1400                             Inhalation indoor       R                       R                      TEP                    1, 2, 4
                                      exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1500                             Biological monitoring   CR                      CR                     TEP                    1, 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1600                             Data reporting and      R                       R                      TEP                    5
                                      calculations
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1700                             Product use             R                       R                      TEP                    --
                                      information
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following notes apply to the data requirements 
in the table to paragraph (d) of this section:
    1. Protocols must be submitted for approval prior to the initiation 
of the study. Details for developing protocols are available from the 
Agency.
    2. Biological monitoring data may be submitted in addition to, or in 
lieu of, dermal and inhalation exposure data, provided the human 
pharmacokinetics of the pesticide and/or metabolite/analog compounds 
(i.e., whichever method is selected as an indicator of body burden or 
internal dose) allow for the back calculation to actual dose.
    3. Data are required if the product is applied outdoors.
    4. Data are required if the product is applied indoors.
    5. Data reporting and calculations are required when handler 
exposure data are submitted.



Sec. 158.1050  Post-application exposure--general requirements.

    (a) If EPA determines that industrial standards, such as the 
workplace standards set by the Occupational Safety and Health 
Administration, provide adequate protection for a particular pesticide 
use pattern, post-application exposure data may not be required for that 
use pattern. Applicants should consult with the Agency on appropriate 
testing before the initiation of studies.
    (b) The Agency may accept surrogate exposure data from other sources 
to satisfy post-application exposure data requirements if the data meet 
the basic quality assurance, quality control, good laboratory practice, 
and other scientific needs of EPA. In order to be acceptable, among 
other things, the Agency must find that the surrogate exposure data have 
adequate information to address post-application exposure data 
requirements and contain adequate replicates of acceptable quality data 
to reflect the specific use prescribed on the label and the post-
application activity of concern, including formulation type, application 
methods and rates, type of activity, and other pertinent information. 
The Agency will consider using such surrogate data for evaluating human 
exposure on a case-by-case basis.



Sec. 158.1060  Post-application exposure--criteria for testing.

    Exposure data described in Sec. 158.1070(d) are required based upon 
toxicity and exposure criteria. Data are required if a product meets, as 
determined by the Agency, either or both of the toxicity criteria in 
paragraph (a) of this section and either or both of the exposure 
criteria in paragraph (b) of this section.
    (a) Toxicity criteria. (1) Evidence of potentially significant 
adverse health effects have been observed in any applicable toxicity 
study.
    (2) Scientifically sound epidemiological or poisoning incident data 
indicate that adverse health effects may have resulted from post-
application exposure to the pesticide.
    (b) Exposure criteria. The need for data from potential exposure 
resulting from situations not covered by this paragraph should be 
discussed with the Agency.
    (1) For outdoor uses. (i) Occupational human post-application 
exposure to

[[Page 130]]

pesticide residues on plants or in soil could occur as the result of 
cultivation, pruning, harvesting, mowing or other work-related activity. 
Such uses include agricultural food, feed, and fiber commodities, forest 
trees, ornamental plants, and turf grass.
    (ii) Residential human post-application exposure to pesticide 
residues on plants or in soil could occur. Such uses may include turf 
grass, fruits, vegetables, and ornamentals grown at sites, including, 
but not limited to, homes, parks, and recreation areas.
    (2) For indoor uses. (i) Occupational human post-application 
exposure to pesticide residues could occur following the application of 
the pesticide to indoor spaces or surfaces at agricultural or commercial 
sites, such as, but not limited to, agricultural animal facilities and 
industrial or manufacturing facilities.
    (ii) Residential human post-application exposure to pesticide 
residues could occur following the application of the pesticide to 
indoor spaces or surfaces at residential sites, such as, but not limited 
to homes, daycare centers, hospitals, schools, and other public 
buildings.



Sec. 158.1070  Post-application exposure data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the post-application data requirements for a 
particular pesticide product. Notes that apply to an individual test and 
include specific conditions, qualifications, or exceptions to the 
designated test are listed in paragraph (e) of this section.
    (b) Use patterns. (1) Occupational use patterns include products 
classified under the general use patterns of terrestrial food crop, 
terrestrial feed crop, terrestrial nonfood use, aquatic food, aquatic 
nonfood use, forestry, greenhouse food, greenhouse nonfood, indoor food, 
and indoor nonfood. Occupational use patterns also include commercial 
(``for hire'') applications to residential outdoor and indoor sites.
    (2) Residential use patterns include residential outdoor use and 
indoor residential use. These use patterns are limited to 
nonoccupational, i.e., nonprofessional, pesticide applications.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
TEP=Typical end-use product.
    (d) Table. The data requirements listed in the following table 
pertain to pesticide products that meet the testing criteria outlined in 
Sec. 158.1060. The table notes are shown in paragraph (e) of this 
section.

                                                   Table--Post-Application Exposure Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Use Pattern
          Guideline Number              Data Requirement    -----------------------------------------------     Test Substance         Test Note No.
                                                                  Occupational            Residential
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.2100                             Dislodgeable foliar     R                       R                      TEP                    1, 2, 3, 4, 5
                                      residue and turf
                                      transferable residues
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.2200                             Soil residue            R                       CR                     TEP                    1, 2, 6, 7
                                      dissipation
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.2300                             Indoor surface residue  R                       R                      TEP                    1, 2, 8, 9
                                      dissipation
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.2400                             Dermal exposure         R                       R                      TEP                    1, 2, 10, 11, 12
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.2500                             Inhalation exposure     R                       R                      TEP                    1, 10, 11, 12
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.2600                             Biological monitoring   CR                      CR                     TEP                    1, 12, 13
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.2700                             Product use             R                       R                      TEP                    --
                                      information
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.2800                             Description of human    R                       R                      TEP                    --
                                      activity
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.2900                             Data reporting and      R                       R                      TEP                    14
                                      calculations
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.3000                             Nondietary ingestion    NR                      R                      TEP                    1, 11, 15
                                      exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 131]]

    (e) Test notes. The following test notes apply to the data 
requirements in the table to paragraph (d) of this section:
    1. Protocols must be submitted for approval prior to the initiation 
of the study. Details for developing protocols are available from the 
Agency.
    2. Bridging applicable residue dissipation data to dermal exposure 
data is required.
    3. Turf grass transferable residue dissipation data are required 
when pesticides are applied to turf grass. Dislodgeable foliar residue 
dissipation data are required when pesticides are applied to the foliage 
of plants other than turf grass.
    4. Data are required for occupational sites if (i) there are uses on 
turf grass or other plant foliage, and (ii) the human activity data 
indicate that workers are likely to have post-application dermal contact 
with treated foliage while participating in typical activities.
    5. Data are required for residential sites if there are uses on turf 
grass or other plant foliage.
    6. Data are required for occupational sites, if (i) there are 
outdoor or greenhouse uses to or around soil or other planting media, 
and (ii) the human activity data indicate that workers are likely to 
have post-application dermal contact with treated soil or planting media 
while participating in typical activities.
    7. Data are required for residential sites if the pesticide is 
applied to or around soil or other planting media both outdoors and 
indoors, e.g., residential greenhouse or houseplant uses.
    8. Data are required for occupational sites if the pesticide is 
applied to or around on non-plant surfaces, e.g., flooring or 
countertops, and if the human activity data indicate that workers are 
likely to have post-application dermal contact with treated indoor 
surfaces while participating in typical activities.
    9. Data are required for residential sites if the pesticide is 
applied to or around non-plant surfaces, e.g., flooring and countertops.
    10. Data are required for occupational sites if the human activity 
data indicate that workers are likely to have post-application exposures 
while participating in typical activities.
    11. Data are required for residential sites if post-application 
exposures are likely.
    12. Biological monitoring data may be submitted in addition to, or 
in lieu of, dermal and inhalation exposure data provided the human 
pharmocokinetics of the pesticide and/or metabolite/analog compounds 
(i.e., whichever method is selected as an indicator of body burden or 
internal dose) allow for a back-calculation to the total internal dose.
    13. Data are required when passive dosimetry techniques are not 
applicable for a particular exposure scenario, such as a swimmer 
exposure to pesticides.
    14. Data reporting and calculations are required when any post-
application exposure monitoring data are submitted.
    15. The selection of a sampling method will depend on the nondietary 
pathway(s) of interest. Data must be generated to consider all potential 
pathways of nondietary ingestion exposure that are applicable (e.g., 
soil ingestion, hand-to-mouth transfer, and object-to-mouth transfer of 
surface residues).



                          Subpart L_Spray Drift



Sec. 158.1100  Spray drift data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the spray drift data requirements for a 
particular pesticide product. Notes that apply to an individual test, 
including specific conditions, qualifications, or exceptions to the 
designated test are listed in paragraph (e) of this section.
    (b) Use patterns. The terrestrial use pattern includes products 
classified under the general use patterns of terrestrial food crop and 
terrestrial nonfood crop. The aquatic use pattern includes products 
classified under the general use patterns of aquatic food crop and 
aquatic nonfood. The greenhouse use pattern includes products classified 
under the general use patterns of greenhouse food crop and greenhouse 
nonfood crop. Data are also required for the general use patterns of 
forestry use, residential outdoor use, and indoor use.
    (c) Key. CR=Conditionally required; NR=Not required; TEP=Typical 
end-use product; MP=Manufacturing use product; EP=End-use product.
    (d) Table. The following table lists the data requirements that 
pertain to spray drift. The table notes are shown in paragraph (e) of 
this section.

[[Page 132]]



                                                                                                                      Table--Spray Drift Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                            Use Pattern                                                                                           Test substance
                                                      ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
        Guideline Number            Data Requirement                  Terrestrial                                Aquatic                                Greenhouse                                                                                                     Test Note
                                                      ---------------------------------------------------------------------------------------------------------------------------      Forestry           Residential           Indoor            MP          EP          No.
                                                            Food Crop           Nonfood Crop             Food               Nonfood            Food Crop         Nonfood Crop                               Outdoor
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  201-1                           Droplet size         CR                   CR                   CR                   CR                  NR                  NR                  CR                  NR                  NR                        TEP         TEP           1
                                   spectrum
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  202-1                           Droplet size         CR                   CR                   CR                   CR                  NR                  NR                  CR                  NR                  NR                        TEP         TEP           1
                                   spectrum
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 133]]

    (e) Test notes. The following notes apply to the requirements in the 
table to paragraph (d) of this section:
    1. This study is required when aerial applications (rotary and fixed 
winged) and mist blower or other methods of ground application are 
proposed and it is estimated that the detrimental effect level of those 
nontarget organisms expected to be present would be exceeded. The 
nontarget organisms include humans, domestic animals, fish and wildlife, 
and nontarget plants.
    2. [Reserved]



                          Subpart M [Reserved]



Sec. Sec. 158.1200 -158.1299  [Reserved]



                      Subpart N_Environmental Fate



Sec. 158.1300  Environmental fate data requirements table.

    (a) General. All environmental fate data, as described in paragraph 
(c) of this section, must be submitted to support a request for 
registration.
    (b) Use patterns. (1) The terrestrial use pattern includes products 
classified under the general use patterns of terrestrial food crop, 
terrestrial feed crop, and terrestrial nonfood. The aquatic use pattern 
includes the general use patterns of aquatic food crop, and aquatic 
nonfood. The greenhouse use pattern includes both food and nonfood uses. 
The indoor use pattern includes food, nonfood, and residential indoor 
uses.
    (2) Data are also required for the general use patterns of forestry 
use and residential outdoor use.
    (c) Key. CR=Conditionally required; NR=Not required; R=Required; 
PAIRA=Pure active ingredient radio-labeled; TGAI=Technical grade of the 
active ingredient; TEP=Typical end-use product.
    (d) Table. The following table shows the data requirements for 
environmental fate. The test notes are shown in paragraph (e) of this 
section.

                                                                           Table--Environmental Fate Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                  Use Pattern
                                                 ------------------------------------------------------------------------------------------------------------
       Guideline Number         Data Requirement                                                                                               Residential     Test substance     Test Note No.
                                                     Terrestrial         Aquatic         Greenhouse          Indoor           Forestry           Outdoor
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Degradation Studies - Laboratory
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.2120                      Hydrolysis        R                 R                 R                 CR                R                 R                 TGAI or PAIRA     1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.2240                      Photodegradation  R                 R                 NR                NR                R                 NR                TGAI or PAIRA     2
                                 in water
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.2410                      Photodegradation  R                 NR                NR                NR                R                 NR                TGAI or PAIRA     3
                                 on soil
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.2370                      Photodegradation  CR                NR                CR                NR                CR                CR                TGAI or PAIRA     4
                                 in air
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Metabolism Studies - Laboratory
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.4100                      Aerobic soil      R                 CR                R                 NR                R                 R                 TGAI or PAIRA     5
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.4200                      Anaerobic soil    R                 NR                NR                NR                NR                NR                TGAI or PAIRA     --
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.4300                      Aerobic aquatic   R                 R                 NR                NR                R                 NR                TGAI or PAIRA     --
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.4400                      Anaerobic         R                 R                 NR                NR                R                 NR                TGAI or PAIRA     --
                                 aquatic
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Mobility Studies
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.1230                      Leaching and      R                 R                 R                 NR                R                 R                 TGAI or PAIRA     6
  835.1240....................   adsorption/
                                 desorption
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 134]]

 
  835.1410                      Volatility -      CR                NR                CR                NR                NR                NR                TEP               4
                                 laboratory
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.8100                      Volatility -      CR                NR                CR                NR                NR                NR                TEP               --
                                 field
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Dissipation Studies - Field
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.6100                      Terrestrial       R                 CR                NR                NR                CR                R                 TEP               5, 7, 12
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.6200                      Aquatic           CR                R                 NR                NR                NR                NR                TEP               7, 8
                                 (sediment)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.6300                      Forestry          NR                NR                NR                NR                CR                NR                TEP               7, 9, 12
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.6400                      Combination and   CR                CR                NR                NR                NR                NR                TEP               10
                                 tank mixes
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Ground Water Monitoring
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.7100                      Ground water      CR                NR                NR                NR                CR                CR                TEP               7, 9, 11
                                 monitoring
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes apply to the requirements 
in the table to paragraph (d) of this section:
    1. Study is required for indoor uses in cases where environmental 
exposure is likely to occur. Such sites include, but are not limited to, 
agricultural premises, in or around farm buildings, barnyards, and 
beehives.
    2. Not required when the electronic absorption spectra, measured at 
pHs 5, 7, and 9, of the chemical and its hydrolytic products, if any, 
show no absorption or tailing between 290 and 800 nm.
    3. Not required when the chemical is to be applied only by soil 
injection or is incorporated in the soil.
    4. Requirement based on use patterns and other pertinent factors 
including, but not limited to, the Henry's Law Constant of the chemical. 
In view of methodological difficulties with the study of 
photodegradation in air, prior consultation with the Agency regarding 
the protocol is recommended before the test is performed.
    5. Required for aquatic food and nonfood crop uses for aquatic sites 
that are intermittently dry. Such sites include, but are not limited to, 
cranberry bogs and rice paddies.
    6. Adsorption and desorption using a batch equilibrium method is 
preferred. However in some cases, for example, where the pesticide 
degrades rapidly, soil column leaching with unaged or aged columns may 
be more appropriate to fully characterize the potential mobility of the 
parent compound and major transformation products.
    7. Environmental chemistry methods used to generate data associated 
with this study must include results of a successful confirmatory method 
trial by an independent laboratory. Test standards and procedures for 
independent laboratory validation are available as addenda to the 
guideline for this test requirement.
    8. Requirement for terrestrial uses is based on potential for 
aquatic exposure and if pesticide residues have the potential for 
persistence, mobility, nontarget aquatic toxicity or bioaccumulation. 
Not required for aquatic residential uses. Field testing under the 
terrestrial field dissipation requirement may be more appropriate for 
some aquatic food crops, such as rice and cranberry uses, that are 
managed to have a dry-land period for production. The registrant is 
encouraged to consult with the Agency on protocols.
    9. Agency approval of a protocol is necessary prior to initiation of 
the study.
    10. This study may be triggered if there is specific evidence that 
the presence of one pesticide can affect the dissipation characteristics 
of another pesticide when applied simultaneously or serially.
    11. Required if the weight-of-evidence indicates that the pesticide 
and/or its degradates is likely to leach to ground water, taking into 
account other factors such as the toxicity of the chemicals(s), 
available monitoring data, and the vulnerability of ground water 
resources in the pesticide use area.
    12. If the terrestrial dissipation study cannot assess all of the 
major routes of dissipation, the forestry study will be required.

[[Page 135]]



                       Subpart O_Residue Chemistry



Sec. 158.1400  Definitions.

    The following terms are defined for the purposes of this subpart:
    Livestock, for the purposes of this section, includes all domestic 
animals that are bred for human consumption, including, but not limited 
to, cattle, swine, sheep, and poultry.
    Plant or animal metabolite means a pesticide chemical residue that 
is the result of biological breakdown of the parent pesticide within the 
plant or animal.
    Residue of concern means the parent pesticidal compound and its 
metabolites, degradates, and impurities of toxicological concern.
    Tolerance, for the purposes of this section, includes the 
establishment of a new tolerance or tolerance exemption, or amended 
tolerance or tolerance exemption.



Sec. 158.1410  Residue chemistry data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the residue chemistry data requirements for a 
particular pesticide product. Notes that apply to an individual test and 
include specific conditions, qualifications, or exceptions to the 
designated test are listed in paragraph (e) of this section.
    (b) Use patterns. (1) Data are required or conditionally required 
for all pesticides used in or on food and for residential outdoor uses 
where food crops are grown. Food use patterns include products 
classified under the general use patterns of terrestrial food crop use, 
terrestrial feed crop use, aquatic food crop use, greenhouse food crop 
use, and indoor food use.
    (2) Data may be required for nonfood uses if pesticide residues may 
occur in food or feed as a result of the use. Data requirements for 
these nonfood uses will be determined on a case-by-case basis. For 
example, most products used in or near kitchens require residue data for 
risk assessment purposes even though tolerances may not be necessary in 
all cases.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
TGAI=Technical grade of the active ingredient; PAI=Pure active 
ingredient; PAIRA=Pure active ingredient radio-labeled; Residue of 
concern= the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; TEP=Typical end-use product.
    (d) Table. The following table list the data requirements for 
residue chemistry related to food uses. The table notes are shown in 
paragraph (e) of this section.

                                                                    Table--Residue Chemistry Data Requirements for Food Uses
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                  Use Pattern
                                                     ----------------------------------------------------------------------------------------------------
        Guideline Number           Data Requirement    Terrestrial Food                                                                   Residential       Test substance       Test Note No.
                                                            or Feed          Aquatic Food       Greenhouse Food       Indoor Food           Outdoor
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Supporting Information
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1100                        Chemical identity   R                   R                   R                   R                   R                   TGAI                --
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1200                        Directions for use  R                   R                   R                   R                   R                   --                  --
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1550                        Proposed tolerance  R                   R                   R                   CR                  NR                  --                  1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1560                        Reasonable grounds  R                   R                   R                   CR                  NR                  --                  1
                                   in support of
                                   petition
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1650                        Submittal of        R                   R                   R                   CR                  NR                  PAI and residue of  1, 2, 25
                                   analytical                                                                                                              concern
                                   reference
                                   standards
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Nature of the residue
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1300                        Nature of the       R                   R                   R                   CR                  CR                  PAIRA               3, 4, 25
                                   residue in plants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 136]]

 
  860.1300                        Nature of the       CR                  CR                  CR                  CR                  NR                  PAIRA or            1, 6, 25
                                   residue in                                                                                                              radiolabeled
                                   livestock                                                                                                               plant metabolite
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1850                        Confined            CR                  CR                  NR                  NR                  NR                  PAIRA               7
                                   rotational crops
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Analytical methods
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1340                        Residue analytical  R                   R                   R                   CR                  CR                  Residue of concern  1, 3, 8, 9, 10, 25
                                   methods
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1360                        Multiresidue        R                   R                   R                   CR                  NR                  Residue of concern  1, 11, 25
                                   method
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Magnitude of the residue
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1380                        Storage stability   R                   R                   R                   CR                  CR                  TEP or residue of   1, 3, 10, 12, 25
                                                                                                                                                           concern
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1500                        Crop field trials   R                   R                   R                   CR                  CR                  TEP                 3, 10, 14, 24, 25
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1520                        Processed food or   CR                  CR                  CR                  CR                  NR                  TEP                 1, 15, 25
                                   feed
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1480                        Meat/milk/poultry/  CR                  CR                  CR                  CR                  NR                  TGAI or plant       1, 16, 17, 18, 25
                                   eggs                                                                                                                    metabolite
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                        Potable water       NR                  R                   NR                  NR                  NR                  TEP                 19, 25
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                        Fish                NR                  R                   NR                  NR                  NR                  TEP                 5, 25
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                        Irrigated crops     NR                  CR                  NR                  NR                  NR                  TEP                 20, 25
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1460                        Food handling       NR                  NR                  NR                  CR                  NR                  TEP                 1, 21, 25
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1540                        Anticipated         CR                  CR                  CR                  CR                  NR                  Residue of concern  1, 13, 22, 26
                                   residues
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1900                        Field rotational    CR                  CR                  NR                  NR                  NR                  TEP                 23, 25
                                   crops
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes apply to the data 
requirements in the table to paragraph (d) of this section.
    1. Required if indoor use could result in pesticide residues in or 
on food or feed.
    2. Material safety data sheets must accompany standards as specified 
by OSHA in 29 CFR 1910.1200.
    3. Required for residential outdoor uses on food crops if the 
corresponding agricultural use is not approved or the residential use is 
expected to produce higher residues based on the label directions.
    4. Required for indoor uses where the pesticide is applied directly 
to food, in order to determine metabolites and/or degradates. Not 
required when only indirect contact with food would occur (e.g., crack 
and crevice treatments).
    5. Data for fish are required for all pesticides applied directly to 
water inhabited, or which will be inhabited, by fish that may be caught 
or harvested for human consumption.

[[Page 137]]

    6. Required when a pesticide is to be applied directly to livestock, 
to livestock premises, to livestock drinking water, or to crops used for 
livestock feed. If results from the plant metabolism study show 
differing metabolites in plants from those found in animals, an 
additional livestock metabolism study involving dosing with the plant 
metabolite(s) may also be required.
    7. Required when the Agency determines that it is reasonably 
foreseeable that a food or feed crop could be subsequently planted on 
the site of pesticide application after harvest or failure of the 
treated crop. Typically not required for pesticide uses in permanent 
food crops (e.g., various tree crops, vines) or semi-permanent crops 
(e.g., asparagus, pineapples).
    8. A residue analytical method suitable for enforcement purposes is 
required whenever a numeric tolerance (including temporary and time-
limited tolerances) is proposed.
    9. New analytical methods to be used for enforcement purposes must 
include results from an independent laboratory validation.
    10. A residue method, storage stability data, and crop field trials 
are required for the nonfood crop tobacco (green, freshly harvested). 
Depending on the level of residues found on the green tobacco, 
additional data may be required on cured/dried tobacco and pyrolysis 
products.
    11. Data are required to determine whether FDA/USDA multiresidue 
methodology would detect and identify the pesticides and any 
metabolites.
    12. Data are required for any magnitude of the residue study unless 
analytical samples are stored frozen for 30 days or less, and the active 
ingredient is not known to be volatile or labile.
    13. Studies using single serving samples of a raw agricultural 
commodity may be needed for acutely toxic pesticides and/or their 
metabolites. These residue studies must be conducted using a statistical 
design accepted by the Agency.
    14. Required for indoor uses which are direct postharvest treatments 
of raw agricultural commodities (e.g., fungicidal waxes or stored grain 
fumigants).
    15. Data on the nature and level of residues in processed food/feed 
are required if residues could potentially concentrate on processing 
thus requiring the establishment of a separate tolerance higher than 
that of the raw agricultural commodity.
    16. Required when the pesticide use is a direct application to 
livestock.
    17. Data are required if pesticide residues are present in or on 
livestock feed items or intentionally added to drinking water. These 
studies, however, may not be required in cases where the livestock 
metabolism studies indicate negligible transfer of the pesticide's 
residues of concern to tissues, milk, and eggs at the maximum expected 
exposure level for the animals.
    18. If results from the plant metabolism study show differing 
metabolites in plants from those found in animals, an additional 
livestock feeding study involving dosing with the plant metabolite(s) 
may also be required.
    19. Data are required whenever a pesticide may be applied directly 
to water, unless it can be demonstrated that the treated water would not 
be available for human or livestock consumption.
    20. Data are required when a pesticide is to be applied directly to 
water that could be used for irrigation or to irrigation facilities such 
as irrigation ditches.
    21. Data are required whenever a pesticide may be used in a food 
handling or feed handling establishment.
    22. Required when residues at the tolerance level may result in a 
risk of concern. These data may include washing, cooking, processing or 
degradation studies as well as market basket surveys for a more precise 
residue determination.
    23. Typically required if pesticide residues of concern greater than 
0.01 ppm are found in crops at the appropriate plant back intervals 
(taking into account plant back restrictions on product labels) in the 
confined rotational crop study. If residues of concern in the confined 
study are greater than 0.01 ppm but less than the limit of quantitation 
of the analytical method to be used on field trial samples, the Agency 
will consider not requiring, on a case-by-case basis, the limited field 
trials. If there are particular toxicological concerns with the parent 
pesticide or any metabolites, limited field studies may be needed if 
such residues are identified at levels below 0.01 ppm in the confined 
study.
    24. Crop field trials are required to establish tolerances on 
rotational crops when quantifiable residues of concern are observed in 
the field rotational crops study.
    25. Not required for an exemption from a tolerance provided that 
dietary exposure estimates are not needed due to low toxicity or that 
theoretical estimates of exposure are adequate to assess dietary risk.
    26. Not required for an exemption from a tolerance.



                         Subparts P-T [Reserved]



Sec. Sec. 158.1500-158.1900  [Reserved]



                    Subpart U_Biochemical Pesticides

    Source: 72 FR 61002, Oct. 26, 2007, unless otherwise noted.

[[Page 138]]



Sec. 158.2000  Biochemical pesticides definition and applicability.

    This subpart applies to all biochemical pesticides as defined in 
paragraphs (a), (b), and (c) of this section.
    (a) Definitions. The following terms are defined for the purposes of 
subpart U of this part.
    (1) A biochemical pesticide is a pesticide that:
    (i) Is a naturally-occurring substance or structurally-similar and 
functionally identical to a naturally-occurring substance;
    (ii) Has a history of exposure to humans and the environment 
demonstrating minimal toxicity, or in the case of a synthetically-
derived biochemical pesticides, is equivalent to a naturally-occurring 
substance that has such a history; and
    (iii) Has a non-toxic mode of action to the target pest(s).
    (2) A Pheromone is a compound produced by a living organism or is a 
synthetically derived substance that is structurally similar and 
functionally identical to a naturally-occurring pheromone, which, alone 
or in combination with other such compounds, modifies the behavior of 
other individuals of the same species.
    (i) An Arthropod Pheromone is a pheromone produced by a member of 
the taxonomic phylum Arthropoda.
    (ii) A Lepidopteran Pheromone is an arthropod pheromone produced by 
a member of the insect order Lepidoptera.
    (iii) A Straight Chain Lepidopteran Pheromone is a lepidopteran 
pheromone consisting of an unbranched aliphatic chain (between 9 and 18 
carbons) ending in an alcohol, aldehyde, or acetate functional group and 
containing up to three double bonds in the aliphatic backbone.
    (b) Examples. Biochemical pesticides include, but are not limited 
to:
    (1) Semiochemicals (insect pheromones and kairomones),
    (2) Natural plant and insect regulators,
    (3) Naturally-occurring repellents and attractants, and
    (4) Enzymes.
    (c) Applicability. The Agency may review, on a case-by-case basis, 
naturally-occurring pesticides that do not clearly meet the definition 
of a biochemical pesticide in an effort to ensure, to the greatest 
extent possible, that only the minimum testing sufficient to make 
scientifically sound regulatory decisions would be conducted. The Agency 
will review applications for registration of naturally-occurring 
pesticides to determine whether to review the pesticide under this 
subpart U.



Sec. 158.2010  Biochemical pesticides data requirements.

    (a) Sections 158.2030 through 158.2070 identify the data 
requirements that are required to support registration of biochemical 
pesticides. Sections 158.2080 through 158.2084 identify the data 
requirements that are required to support Experimental Use Permits 
(EUPs). Variations in the test conditions are identified within the test 
notes. Definitions that apply to all biochemical data requirements can 
be found in Sec. 158.2000.
    (b) Each data table includes ``use patterns'' under which the 
individual data are required, with variations including food and nonfood 
uses for terrestrial and aquatic applications, greenhouse, indoor, 
forestry, and residential outdoor applications under certain 
circumstances.
    (c) The categories for each data requirement are ``R'', which stands 
for required, and ``CR'' which stands for conditionally required. 
Generally, ``R'' indicates that the data are more likely required than 
for those data requirements with ``CR.'' However, in each case, the 
regulatory text preceding the data table and the test notes following 
the data table must be used to determine whether the data requirement 
must be satisfied.
    (d) Each table identifies the test substance that is required to be 
tested to satisfy the data requirement. Test substances may include: 
technical grade active ingredient (TGAI), manufacturing-use product 
(MP), end-use product (EP), typical end-use product (TEP), residue of 
concern, and pure active ingredient (PAI) or all of the above (All). 
Commas between the test substances (i.e., TGAI, EP) indicate that data 
may be required on the TGAI or

[[Page 139]]

EP or both depending on the conditions set forth in the test note.
    (e) The data requirements are organized into a tier-testing system 
with specified additional studies at higher tiers being required if 
warranted by adverse effects observed in lower tier studies. The lower 
tier studies are a subset of those required for conventional pesticides, 
and the studies overall are generally selected from those required for 
conventional pesticides.
    (f) Two sets of guideline numbers are provided for some of the 
environmental fate data requirements. For ease of understanding, the 
current guidelines will be used as an interim measure until the new 
guidelines (in parentheses) are finalized.



Sec. 158.2030  Biochemical pesticides product chemistry data requirements 

table.

    (a) General. (1) Sections 158.100 through 158.130 describe how to 
use this table to determine the product chemistry data requirements for 
a particular pesticide product. Notes that apply to an individual test 
and include specific conditions, qualifications, or exceptions to the 
designated test are listed in paragraph (e) of the section.
    (2) Definitions in Sec. 158.300 apply to data requirements in this 
section.
    (b) Use patterns. Product chemistry data are required for all 
pesticide products and are not use specific.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; Residue of 
concern=the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; All=All of the above.
    (d) Table. The following table shows the data requirements for 
biochemical pesticides product chemistry. The test notes are shown in 
paragraph (e) of this section.

                                            Table--Biochemical Pesticides Product Chemistry Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Test Substance
          Guideline Number              Data Requirement        All Use Patterns    ----------------------------------------------       Test Notes
                                                                                               MP                     EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product Identity and Composition
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.1100                             Product identity and    R                       TGAI, MP               TGAI, EP               1, 2
                                      composition
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.1200                             Description of          R                       TGAI, MP               TGAI, EP               2, 3
                                      starting materials,
                                      production and
                                      formulation process
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.1400                             Discussion of           R                       TGAI and MP            TGAI and EP            4
                                      formation of
                                      impurities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Analysis and Certified Limits
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.1700                             Preliminary analysis    CR                      TGAI and MP            TGAI and EP            5, 8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.1750                             Certified limits        R                       MP                     EP                     6
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.1800                             Enforcement analytical  R                       MP                     EP                     7
                                      method
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physical and Chemical Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6302                             Color                   R                       TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6303                             Physical state          R                       TGAI and MP            TGAI and EP            8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6304                             Odor                    R                       TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6313                             Stability to normal     R                       TGAI                   TGAI                   8, 17
                                      and elevated
                                      temperatures, metals
                                      and metal ions
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6315                             Flammability            CR                      MP                     EP                     9
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6317                             Storage stability       R                       MP                     EP                     --
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 140]]

 
830.6319                             Miscibility             CR                      MP                     EP                     10
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6320                             Corrosion               R                       MP                     EP                     --
                                      characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7000                             pH                      CR                      TGAI and MP            TGAI and EP            8, 11
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7050                             UV/Visible light        R                       TGAI                   TGAI                   --
                                      absorption
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7100                             Viscosity               CR                      MP                     EP                     12
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7200                             Melting point/melting   CR                      TGAI                   TGAI                   8, 13
                                      range
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7220                             Boiling point/boiling   CR                      TGAI                   TGAI                   8, 14
                                      range
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7300                             Density/relative        R                       TGAI and MP            TGAI and EP            8, 18
                                      density/bulk density
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7520                             Particle size, fiber    CR                      TGAI                   TGAI                   8, 15
                                      length, and diameter
                                      distribution
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7550                             Partition coefficient   CR                      TGAI                   TGAI                   16
830.7560...........................   (n-Octanol /Water)
830.7570...........................
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7840                             Water solubility        R                       TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7950                             Vapor pressure          R                       TGAI                   TGAI                   8, 19
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for biochemical pesticides product chemistry and are 
referenced in the last column of the table in paragraph (d) of this 
section.
    1. Data must be provided in accordance with Sec. 158.320.
    2. If the MP and EP are produced by an integrated formulation system 
(non-registered source), these data are also required on TGAI.
    3. Data must be provided in accordance with Sec. Sec. 158.325, 
158.330, and Sec. 158.335.
    4. Data must be provided in accordance with Sec. 158.340.
    5. Data must be provided in accordance with Sec. 158.345. Also, 
required to support the registration of each manufacturing-use product 
(including registered TGAIs) and end-use products produced by an 
integrated formulation system. Data on other end-use products would be 
required on a case-by-case basis.
    6. Data must be provided in accordance with Sec. 158.350.
    7. Data must be provided in accordance with Sec. 158.355.
    8. If the TGAI cannot be isolated, data are required on the 
practical equivalent of the TGAI. EP testing may also be appropriate.
    9. Required if the product contains combustible liquids.
    10. Required if the product is an emulsifiable liquid and is to be 
diluted with petroleum solvents.
    11. Required if the test substance is soluble or dispersible in 
water.
    12. Required if the product is a liquid.
    13. Required when the technical chemical is a solid at room 
temperature.
    14. Required when the technical chemical is a liquid at room 
temperature.
    15. Required for water insoluble test substances 
(10-6g/l) and fibrous test substances with 
diameter =0.1 [micro]m.
    16. Required for organic chemicals unless they dissociate in water 
or are partially or completely soluble in water.
    17. Data on the stability to metals and metal ions is required only 
if the active ingredient is expected to come in contact with either 
material during storage.
    18. True density or specific density are required for all test 
substances. Data on bulk density is required for MPs or EPs that are 
solid at room temperature.
    19. Not required for salts.



Sec. 158.2040  Biochemical pesticides residue data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the biochemical pesticides residue data 
requirements for a particular pesticide product and the substance that 
needs to be tested. These data requirements apply to all biochemical 
pesticides, i.e., naturally occurring insect repellents and

[[Page 141]]

attractants, semiochemicals (e.g., insect pheromones), natural and plant 
growth regulators. Notes that apply to an individual test and include 
specific conditions, qualifications, or exceptions to the designated 
test are listed in paragraph (e) of this section.
    (b) Use patterns. (1) Data are required or conditionally required 
for all pesticides used in or on food and for residential outdoor uses 
where food crops are grown. Food use patterns include products 
classified under the general use patterns of terrestrial food crop use, 
terrestrial feed crop use, aquatic food crop use, greenhouse food crop 
use, and indoor food use. Data are also conditionally required for 
aquatic nonfood use if there is direct application to water that could 
subsequently result in exposure to food.
    (2) Data are conditionally required for nonfood uses if pesticide 
residues may occur in food or feed as a result of the use. Data 
requirements for these nonfood uses would be determined on a case-by-
case basis. For example, most products used in or near kitchens require 
residue data for risk assessment purposes even though tolerances may not 
be necessary in all cases.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing end-use product; EP=End-use product; TEP=Typical end-
use product; TGAI=Technical grade of the active ingredient; Residue of 
concern=the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; All=All of the above. Specific 
conditions, qualifications, or exceptions to the designated test 
procedures appear in paragraph (e) of this section, and apply to the 
individual tests in the following table:
    (d) Data requirements table. The following table shows the data 
requirements for biochemical pesticides residue. The test notes are 
shown in paragraph (e) of this section.

                                             Table--Biochemical Residue Data Requirements for Specific Uses
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Use Patterns
                                                -----------------------------------------------------------------------
       Guideline Number        Data Requirement     Terrestrial         Aquatic                                          Test Substance     Test Notes
                                                ------------------------------------  Greenhouse Food    Indoor Food
                                                     Food/Feed           Food
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supporting Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1100                     Chemical          CR                CR                CR                CR               TGAI             1, 2, 4
                                identity
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1200                     Directions for    CR                CR                CR                CR               --               1, 3, 4
                                use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nature of the Residue
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1300                     Nature of the     CR                CR                CR                CR               TGAI             1, 4, 5, 6
                                residue in
                                plants
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1300                     Nature of the     CR                CR                CR                CR               TGAI or plant    1, 7, 8, 10, 13
                                residue in                                                                               metabolite
                                livestock
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1340                     Residue           CR                CR                R                 CR               Residue of       4, 9, 10
                                analytical                                                                               concern
                                method
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1360                     Multiresidue      CR                CR                R                 CR               Residue of       10, 11
                                method                                                                                   concern
--------------------------------------------------------------------------------------------------------------------------------------------------------
Magnitude of the Residue
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                     Potable water     NR                CR                NR                NR               TGAI             1, 12
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                     Fish              NR                CR                NR                NR               TGAI             1, 13
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                     Irrigated crops   NR                CR                NR                NR               TGAI             1, 14
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1460                     Food handling     NR                NR                NR                CR               TGAI             1, 15
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 142]]

 
  860.1480                     Meat/milk/        CR                CR                CR                CR               TGAI or plant    1, 7, 8, 10
                                poultry/eggs                                                                             metabolites
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1500                     Crop field        CR                CR                CR                CR               TEP              1, 3, 4
                                trials
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1520                     Processed food/   CR                CR                CR                CR               TEP              1, 16
                                feed
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1540                     Anticipated       CR                CR                CR                CR               Residue of       1, 10, 17
                                residues                                                                                 concern
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1550                     Proposed          CR                CR                CR                CR               --               1, 18
                                tolerances
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1560                     Reasonable        CR                CR                CR                CR               --               1, 10
                                grounds in
                                support of the
                                petition
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1650                     Submittal of      CR                CR                CR                CR               TGAI and         10, 19
                                analytical                                                                               residue of
                                reference                                                                                concern
                                standards
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for biochemical pesticides product chemistry and are in the 
last column of the table contained in paragraph (d) of this section.
    1. Residue chemistry data requirements apply to biochemical 
pesticide products when Tier II or Tier III toxicology data are 
required, as specified for biochemical agents in the biochemical human 
health assessment data requirements, Sec. 158.2050.
    2. The same chemical identity data are required for biochemical 
product chemistry data requirements, Sec. 158.2030, with an emphasis on 
impurities.
    3. Required information includes crops to be treated, rate of 
application, number and timing of applications, preharvest intervals, 
and relevant restrictions.
    4. Required for residential outdoor uses on food crops if the 
corresponding agricultural use is not approved or the residential use is 
expected to produce higher residues based on the label directions.
    5. Required unless it is an arthropod pheromone applied at a rate 
less than or equal to 150 grams active ingredient per acre.
    6. Required for indoor uses where the pesticide is applied directly 
to food, in order to determine metabolites and/or degradates. Not 
required when only indirect contact with food would occur (e.g., crack 
and crevice treatments).
    7. Required when a pesticide is to be applied directly to livestock, 
to livestock premises, to livestock drinking water, or to crops used for 
livestock feed.
    8. If results from the plant metabolism study show differing 
metabolites in plants from those found in animals, an additional 
livestock metabolism study involving dosing with the plant metabolite(s) 
may also be required.
    9. A residue analytical method suitable for enforcement of 
tolerances is required whenever a numeric tolerance (including temporary 
and time-limited tolerances) is proposed.
    10. Required if indoor use could result in pesticide residues in or 
on food or feed.
    11. Data are required to determine whether FDA/USDA multiresidue 
methodology would detect and identify the pesticides and any 
metabolites.
    12. Data are required whenever a pesticide may be applied directly 
to water, unless it can be demonstrated that the treated water would not 
be available for human or livestock consumption.
    13. Data on fish are required for all pesticides applied directly to 
water inhabited, or which will be inhabited by fish that may be caught 
or harvested for human consumption.
    14. Data are required when a pesticide is to be applied directly to 
water that could be used for irrigation or to irrigation facilities such 
as irrigation ditches.
    15. Data are required whenever a pesticide may be used in food/feed 
handling establishments.
    16. Data on the nature and level of residue in processed food/feed 
are required when detectible residues could potentially concentrate on 
processing thus requiring the establishment of a separate tolerance 
higher

[[Page 143]]

than that of the raw agricultural commodity.
    17. Required when residues at the tolerance level may result in risk 
of concern. These data may include washing, cooking, processing, or 
degradation studies as well as market basket surveys for a more precise 
residue determination.
    18. The proposed tolerance must reflect the maximum residue likely 
to occur in crops, in meat, milk, poultry, or eggs.
    19. Required when a residue analytical method is required.



Sec. 158.2050  Biochemical pesticides human health assessment data 

requirements table.

    (a) General. (1) Sections 158.100 through 158.130 describe how to 
use this table to determine the biochemical human health assessment data 
requirements for a particular biochemical pesticide product.
    (2) The data in this section are not required for straight chain 
lepidopteran pheromones when applied up to a maximum use rate of 150 
grams active ingredient/acre/year.
    (b) Use patterns. (1) Food use patterns, in general, include 
products classified under the following general uses: terrestrial food 
crop use; terrestrial feed crop use; aquatic food crop use; greenhouse 
food crop use.
    (2) Nonfood use patterns include products classified under the 
general use patterns of terrestrial nonfood crop use; aquatic nonfood 
residential use; aquatic nonfood outdoor use; aquatic nonfood industrial 
use; greenhouse nonfood crop use; forestry use; residential outdoor use; 
residential indoor use; indoor food use; indoor nonfood use; indoor 
medical use.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; Residue of 
concern=the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; All=All of the above. Specific 
conditions, qualifications, or exceptions to the designated test 
procedures appear in paragraph (e) of this section, and apply to the 
individual tests in the following table:
    (d) Table. The following table shows the data requirements for 
biochemical pesticides human health assessment. The test notes are shown 
in paragraph (e) of this section.

                                         Table--Biochemical Pesticides Human Health Assessment Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Use Patterns                           Test Substance
        Guideline Number           Data Requirement  --------------------------------------------------------------------------------     Test Notes
                                                             Food               Nonfood               MP                  EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Acute Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1100                          Acute oral          R                   R                   TGAI and MP         TGAI and EP         1
                                   toxicity - rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1200                          Acute dermal        R                   R                   TGAI and MP         TGAI and EP         1, 2
                                   toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1300                          Acute inhalation    R                   R                   TGAI and MP         TGAI and EP         3
                                   toxicity - rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2400                          Primary eye         R                   R                   TGAI and MP         TGAI and EP         2
                                   irritation -
                                   rabbit
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2500                          Primary dermal      R                   R                   TGAI and MP         TGAI and EP         1, 2
                                   irritation
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2600                          Dermal              R                   R                   TGAI and MP         TGAI and EP         2, 4
                                   sensitization
--------------------------------------------------------------------------------------------------------------------------------------------------------
none                              Hypersensitivity    R                   R                   All                 All                 5
                                   incidents
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Subchronic Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3100                          90-day oral (one    R                   CR                  TGAI                TGAI                6
                                   species)
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 144]]

 
870.3250                          90-day dermal -     CR                  CR                  TGAI                TGAI                7
                                   rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3465                          90-day inhalation - CR                  CR                  TGAI                TGAI                8
                                    rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Developmental Toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3700                          Prenatal            R                   CR                  TGAI                TGAI                9
                                   developmental -
                                   rat preferably
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Mutagenicity Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5100                          Bacterial reverse   R                   CR                  TGAI                TGAI                10
                                   mutation test
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5300                          In vitro mammalian  R                   CR                  TGAI                TGAI                10, 11
870.5375........................   cell assay
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier II
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Mutagenicity Testing (In vivo cytogenetics)
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5385                          In vivo Mammalian   CR                  CR                  TGAI                TGAI                13
870.5895........................   Cytogenetics
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Developmental Toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3700                          Prenatal            CR                  CR                  TGAI                TGAI                9
                                   developmental
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Special Tests
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.3550                          Immunotoxicity      CR                  CR                  TGAI                TGAI                12, 13
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Applicator/User Exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1100                          Dermal outdoor      CR                  CR                  TGAI                TGAI                15
                                   exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1200                          Dermal indoor       CR                  CR                  TGAI                TGAI                15
                                   exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1300                          Inhalation outdoor  CR                  CR                  TGAI                TGAI                15
                                   exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1400                          Inhalation indoor   CR                  CR                  TGAI                TGAI                15
                                   exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1500                          Biological          CR                  CR                  TGAI                TGAI                15
                                   monitoring
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier III
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Chronic Testing/Special Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.3800                          Immune response     CR                  CR                  TGAI                TGAI                14
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3800                          Reproduction and    CR                  CR                  TGAI                TGAI                16
                                   fertility effects
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.4100                          Chronic oral -      CR                  CR                  TGAI                TGAI                17
                                   rodent and
                                   nonrodent
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.4200                          Carcinogenicity -   CR                  CR                  TGAI                TGAI                18
                                   two species - rat
                                   and mouse
                                   preferred
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5380                          Mammalian           CR                  CR                  TGAI                TGAI                19
                                   spermatogonial
                                   chromosome
                                   aberration test
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Special Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.7200                          Companion animal    CR                  CR                  NR                  TGAI or EP          20
                                   safety
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for biochemical pesticides human health assessment as 
referenced in the last column of the table in paragraph (d) of this 
section.

    1. Required unless the test material is a gas or highly volatile 
(vapor pressure 10-4torr (mm/Hg)).

[[Page 145]]

    2. Required unless the test material is corrosive to skin or has pH 
<2 or 11.5.
    3. Required when the pesticide, under conditions of use, would 
result in respirable material (e.g., gas, volatile substance or aerosol/
particulate), unless it is a straight chain lepidopteran pheromone.
    4. Required if repeated contact with human skin is likely to occur 
under conditions of use.
    5. Hypersensitivity incidents must be reported as adverse effects 
data.
    6. Required for non-food uses that are likely to result in repeated 
oral exposure to humans.
    7. Required to support uses involving purposeful application to the 
human skin or which would result in comparable prolonged human exposure 
to the product (e.g., insect repellents) and if any of the following 
criteria are met:
    i. Data from a 90-day oral study are not required.
    ii. The active ingredient is known or expected to be metabolized 
differently by the dermal route of exposure than by the oral route and 
the metabolite is of toxicological concern.
    iii. The use pattern is such that the dermal route would be the 
primary route of exposure.
    8. Required if there is a likelihood of significant levels of 
repeated inhalation exposure to the pesticide as a gas, vapor, or 
aerosol.
    9. Required if the use of the product under widespread and commonly 
recognized practice may reasonably be expected to result in significant 
exposure to female humans (e.g., occupational exposure or repeated 
application of insect repellents directly to the skin). Tier II data is 
required on a different test species from Tier I data when developmental 
effects are observed in the first study and information on species-to-
species extrapolation is needed.
    10. Required to support nonfood uses if either:
    i. The use is likely to result in significant human exposure; or
    ii. The active ingredient (or its metabolites) is structurally 
related to a known mutagen or belongs to any chemical class of compounds 
containing a known mutagen. Additional mutagenicity tests that may have 
been performed plus a complete reference list must also be submitted. 
Subsequent testing may be required based on the available evidence.
    11. Choice of assay using either:
    i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, 
maximizing assay conditions for small colony expression or detection;
    ii. Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast 
(V79) cells, hypoxanthine-guanine phosphoribosyl transferase (hgprt) 
gene locus, accompanied by an appropriate in vitro test for 
clastogenicity; or
    iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl 
transferase (xprt) gene locus.
    12. Required if there are effects on hematology, clinical chemistry, 
lymphoid organ weights, and histopathology are observed in the 90-day 
studies.
    13. The micronucleus rodent bone marrow assay is preferred; however, 
rodent bone marrow assays using metaphase analysis (aberrations) are 
acceptable.
    14. Required if adverse effects are observed in the Tier II 
immunotoxicity study. The protocol for evaluating adverse effects to the 
immune response should be developed after evaluating the effects noted 
in the immunotoxicity study.
    15. These data are required when the data used for the human health 
assessment indicates that the biochemical may pose a potential hazard to 
the applicator/user.
    16. Required if there is evidence of:
    i. Endocrinological effects from the subchronic toxicity studies.
    ii. Developmental effects in the prenatal developmental toxicity 
study(s), or
    iii. Genotoxicity to mammals based on results from the mutagenicity 
tests.
The use of a combined study that utilizes the two-generation 
reproduction study in rodents (guideline 870.3800) as a basic protocol 
for the addition of other endpoints or functional assessments in the 
immature animal is encouraged.
    17. Required if the potential for adverse chronic effects is 
indicated based on any of the following:
    i. The subchronic effect level established in the following Tier I 
studies: 90-day oral toxicity study, 90-day dermal toxicity study, or 
90-day inhalation toxicity study.
    ii. The pesticide use pattern (e.g., rate, frequency, and site of 
application).
    iii. The frequency and level of repeated human exposure that is 
expected.
    18. Required if the product meets either of the following criteria:
    i. The active ingredient (or any of its metabolites, degradation 
products, or impurities) produce(s) in Tier I subchronic studies a 
morphologic effect (e.g., hyperplasia or metaplasia) in any organ that 
potentially could lead to neoplastic change.
    ii. Adverse cellular effects suggesting carcinogenic potential are 
observed in Tier II immunotoxicity and Tier III immune response study or 
in Tier II mammalian mutagenicity assays.
    In addition, a 90-day range finding study in both rats and mice is 
required to determine the dose levels if carcinogenicity studies are 
required. If the mouse carcinogenicity study is not required, the 90-day 
mouse subchronic study is likewise not required.

[[Page 146]]

    19. Required if results from lower tiered mutation or reproductive 
studies indicate there is potential for chromosomal aberration to occur.
    20. May be required if the product's use will result in exposure to 
domestic animals through, but not limited to, direct application or 
consumption of treated feed.



Sec. 158.2060  Biochemical pesticides nontarget organisms and environmental 

fate data requirements table.

    (a) General. (1) Sections 158.100 through 158.130 describe how to 
use this table to determine the terrestrial and aquatic nontarget 
organisms and fate data requirements for a particular biochemical 
pesticide product. Notes that apply to an individual test including 
specific conditions, qualifications, or exceptions to the designated 
test are listed in paragraph (e) of this section. In general, for all 
outdoor end-use products including turf, the following studies are 
required: one avian acute oral, one avian dietary, one acute freshwater 
fish, one acute freshwater invertebrate study, plant toxicity testing, 
and a honeybee acute contact study.
    (2) The data in this section are not required for arthropod 
pheromones when applied at up to a maximum use rate of 150 grams active 
ingredient/acre/year except when the product is expected to be available 
to avian species (i.e., granular formulation).
    (b) Use patterns. The terrestrial use pattern includes products 
classified under the general use patterns of terrestrial food crop, 
terrestrial feed crop, and terrestrial nonfood/nonfeed crop. The 
greenhouse use pattern includes products classified under the general 
use patterns of greenhouse food crop and greenhouse nonfood crop. The 
indoor use pattern includes products classified under the general use 
patterns of indoor food and nonfood use. The remaining terrestrial uses 
include: forestry and residential outdoor use. Data are also required 
for the general use patterns of aquatic food and nonfood crop use.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; Residue of 
concern=the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; All=All of the above. Specific 
conditions, qualifications, or exceptions to the designated test 
procedures appear in paragraph (e) of this section, and apply to the 
individual tests in the following table:
    (d) Table. The following table shows the data requirements for 
biochemical pesticides nontarget organisms and environmental fate. The 
test notes are shown in paragraph (e) of this section.

                                                   Table--Biochemical Pesticides Nontarget Organisms and Environmental Fate Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                     Use Patterns
                                                      ---------------------------------------------------------------------------------------------------------
        Guideline Number            Data Requirement       Terrestrial            Aquatic             Greenhouse                                  Indoor          Test Substance     Test Notes
                                                      ---------------------------------------------------------------      Forestry,      ---------------------
                                                        Food/Feed/Nonfood       Food/Nonfood         Food/Nonfood     Residential Outdoor      Food/Nonfood
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Avian Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2100                          Avian acute oral     R..................  R..................  CR.................  R..................  CR.................  TGAI, EP..........   1, 2, 3, 4
                                   toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2200                          Avian dietary        R..................  R..................  CR.................  R..................  CR.................  TGAI, EP..........   1, 2, 3, 4
                                   toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Aquatic Organism Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1075                          Fish acute           R..................  R..................  CR.................  R..................  CR.................  TGAI, EP..........   2, 3, 4, 5
                                   toxicity,
                                   freshwater
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 147]]

 
850.1010                          Aquatic              R..................  R..................  CR.................  R..................  CR.................  TGAI, EP..........      2, 3, 5
                                   invertebrate acute
                                   toxicity,
                                   freshwater
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Nontarget Plant Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4100                          Terrestrial Plant    R..................  R..................  NR.................  R..................  NR.................  TGAI, EP..........            5
                                   Toxicity, Seedling
                                   emergence
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4150                          Terrestrial Plant    R..................  R..................  NR.................  R..................  NR.................  TGAI, EP..........            5
                                   Toxicity,
                                   Vegetative vigor
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Insect Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
880.4350                          Nontarget Insect     R..................  R..................  R..................  R..................  NR.................  TGAI..............           14
                                   Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier II
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Environmental Fate Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
163-1 (835.1230)                  Sediment and soil    CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   adsorption/
                                   desorption for
                                   parent and
                                   degradates
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
163-1 (835.1240)                  Soil column          CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   leaching
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
163-2 (835.1410)                  Laboratory           CR.................  NR.................  CR.................  CR.................  NR.................  TEP...............            7
                                   volatilization
                                   from soil
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
161-1 (835.2120)                  Hydrolysis           CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
161-1 (835.4100)                  Aerobic soil         CR.................  NR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   metabolism
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
161-2 (835.2240)                  Photodegradation in  CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   water
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
161-3 (835.2410)                  Photodegradation on  CR.................  NR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   soil
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
162-2 (835.4200)                  Anaerobic soil       CR.................  NR.................  NR.................  NR.................  NR.................  TGAI..............            6
                                   metabolism
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
162-4 (835.4300)                  Aerobic aquatic      CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   metabolism
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
162-3 (835.4400)                  Anaerobic aquatic    CR.................  CR.................  NR.................  NR.................  NR.................  TGAI..............            6
                                   metabolism
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
880.4425                          Dispenser - water    CR.................  NR.................  CR.................  CR.................  NR.................  EP................            8
                                   leaching
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Nontarget Plant
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4225                          Seedling emergence   R..................  R..................  NR.................  R..................  NR.................  TGAI..............            9
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4250                          Vegetative vigor     R..................  R..................  NR.................  R..................  NR.................  TGAI..............            9
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier III
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Aquatic Fauna Chronic, Life Cycle, and Field Studies
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1300                          Freshwater fish/     CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           10
850.1400........................   invertebrate
850.1500........................   testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 148]]

 
850.1025                          Marine/Estuarine     CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           10
850.1035........................   fish/invertebrate
850.1045........................   animal testing
850.1055........................
850.1350........................
850.1400........................
850.1500........................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1950                          Aquatic field fish/  CR.................  CR.................  NR.................  CR.................  NR.................  EP................           10
                                   invertebrate
                                   testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Terrestrial Wildlife
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2300                          Avian Reproduction   CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           11
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2400                          Wild mammal acute    CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           11
                                   toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2500                          Terrestrial field    CR.................  CR.................  NR.................  CR.................  NR.................  EP................           11
                                   testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Beneficial Insects
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.3040                          Field testing for    CR.................  CR.................  NR.................  CR.................  NR.................  TEP...............           12
                                   Pollinators
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Nontarget Plants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4225                          Nontarget plant      CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           13
850.4250........................
850.4300........................
850.4450........................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for biochemical pesticides nontarget organisms and 
environmental fate as referenced in the last column of the table 
contained in paragraph (d) of this section.
    1. Required for the EP when any end-use formulation may contain 
other ingredients that may be toxic to nontarget organisms or to support 
arthropod pheromones that would be available to avian wildlife, (e.g., a 
granular product).
    2. Tests for pesticides intended solely for indoor application would 
be required on a case-by-case basis, depending on use pattern, physical/
chemical properties, production volume, and other pertinent factors.
    3. Not required for any use groups if the pesticide is highly 
volatile (estimated volatility 5 x10-5atm m\3\/
mol).
    4. Preferred test species are Upland game, waterfowl, or passerine 
for avian acute oral toxicity studies; Upland game and waterfowl for 
avian dietary studies; and coldwater fish species for acute freshwater 
fish studies.
    5. Required for the EP when the end-use formulation may contain 
other ingredients that may be toxic to nontarget organisms.
    6. Required on a case-by-case basis when results from Tier I studies 
indicate adverse effects.
    7. Required when results of any one or more of the nontarget 
organism studies in Tier I indicate potential adverse effects on 
nontarget organisms and the pesticide is to be applied on land. In view 
of methdological difficulties with the study of photodegradation in air, 
prior consultation with the Agency regarding the protocol is recommended 
before the test is performed.
    8. Required when results of any one or more of the nontarget 
organism studies in Tier I indicate potential adverse effects on 
nontarget organisms and the pesticide is to be applied in a passive 
dispenser.
    9. Required to support registration of known phytotoxicants, i.e., 
herbicides, desiccants, defoliants, and plant growth regulators.
    10. Required if environmental fate characteristics indicate that the 
estimated environmental concentration of the pesticide in the aquatic 
environment is 0.01 of any EC50

[[Page 149]]

or LC50 determined in the aquatic nontarget organism testing.
    11. Required if either of the following criteria are met:
    i. Environmental fate characteristics indicate that the estimated 
concentration of the pesticide in the terrestrial environment is 
0.20 the avian dietary LC50 or equal to 
0.20 the avian oral single dose LD50 (converted to 
ppm).
    ii. The pesticide or any of its metabolites or degradation products 
are stable in the environment to the extent that potentially toxic 
amounts may persist in the avian or mammalian feed.
    12. Required when results of Tier I nontarget organism studies 
indicate potential adverse effects on nontarget insects and results of 
Tier II tests indicate exposure of nontarget insects. Additional insect 
species may have to be tested if necessary to address issues raised by 
use patterns and potential exposure of important nontarget insect 
species, (e.g., threatened or endangered species).
    13. Required if the product is expected to be transported from the 
site of application by air, soil, or water. The extent of movement would 
be determined by the results of the Tier II environmental fate studies.
    14. Required depending on pesticide mode of action, method and 
timing of application, and results of any available efficacy data. 
Typically the honeybee acute toxicity guideline (guideline 850.3020) 
satisfies this requirement, however, additional nontarget insect species 
may have to be tested if necessary to address issues raised by use 
patterns and potential exposure of important nontarget insect species, 
(e.g., endangered species.)



Sec. 158.2070  Biochemical pesticides product performance data requirements.

    Product performance data must be developed for all biochemical 
pesticides. However, the Agency typically does not require applicants to 
submit such efficacy data unless the pesticide product bears a claim to 
control public health pests, such as pest microorganisms infectious to 
man in any area of the inanimate environment or a claim to control 
vertebrates (including but not limited to: rodents, birds, bats, canids, 
and skunks) or invertebrates (including but not limited to: mosquitoes 
and ticks) that may directly or indirectly transmit diseases to humans. 
However, each registrant must ensure through testing that his products 
are efficacious when used in accordance with label directions and 
commonly accepted pest control practices. The Agency reserves the right 
to require, on a case-by-case basis, submission of efficacy data for any 
pesticide product registered or proposed for registration.



Sec. 158.2080  Experimental use permit data requirements--biochemical 

pesticides.

    (a) Sections 158.2081 through 158.2084 describe the experimental use 
permit (EUP) data requirements for biochemical pesticides. Variations in 
the test conditions are identified within the test notes. Definitions 
that apply to all biochemical data requirements can be found in Sec. 
158.2000.
    (b) For general information on the data requirement tables, see 
Sec. 158.2010(b)-(f).



Sec. 158.2081  Experimental use permit biochemical pesticides product 

chemistry data requirements table.

    (a) General. (1) Sections 158.100 through 158.130 describe how to 
use this table to determine the product chemistry data requirements for 
a particular biochemical pesticide product. Notes that apply to an 
individual test and include specific conditions, qualifications, or 
exceptions to the designated test are listed in paragraph (e) of the 
section.
    (2) Depending on the results of the required product chemistry 
studies, appropriate use restrictions, labeling requirements, or special 
packaging requirements may be imposed.
    (b) Use patterns. Product chemistry data are required for all 
pesticide products and are not use specific.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; Residue of 
concern=the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; All=All of the above. Specific 
conditions, qualifications, or exceptions to the designated test 
procedures appear in paragraph (e) of this section, and apply to the 
individual tests in the following table:
    (d) Table. The following table shows the data requirements for 
experimental

[[Page 150]]

use permit biochemical pesticides product chemistry. The test notes are 
shown in paragraph (e) of this section.

                                          Table--EUP Biochemical Pesticides Product Chemistry Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Test Substance
          Guideline Number              Data Requirement        All Use Patterns    ----------------------------------------------       Test Notes
                                                                                               MP                     EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product Identity and Composition
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.1100                             Product identity and    R                       TGAI, MP               TGAI, EP               1, 2
                                      composition
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.1200                             Description of          R                       TGAI, MP               TGAI, EP               2, 3
                                      starting materials,
                                      production and
                                      formulation process
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.1400                             Discussion of           R                       TGAI and MP            TGAI and EP            4
                                      formation of
                                      impurities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Analysis and Certified Limits
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.1700                             Preliminary analysis    CR                      TGAI and MP            TGAI and EP            5, 8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.1750                             Certified limits        R                       MP                     EP                     6
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.1800                             Enforcement analytical  R                       MP                     EP                     7
                                      method
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physical and Chemical Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6302                             Color                   R                       TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6303                             Physical state          R                       TGAI and MP            TGAI and EP            8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6304                             Odor                    R                       TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6313                             Stability to normal     R                       TGAI                   TGAI                   8, 17
                                      and elevated
                                      temperatures, metals
                                      and metal ions
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6315                             Flammability            CR                      MP                     EP                     9
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6317                             Storage stability       R                       MP                     EP                     --
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6319                             Miscibility             CR                      MP                     EP                     10
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6320                             Corrosion               R                       MP                     EP                     --
                                      characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7000                             pH                      CR                      TGAI and MP            TGAI and EP            8, 11
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7050                             UV/Visible light        R                       TGAI                   TGAI                   --
                                      absorption
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7100                             Viscosity               CR                      MP                     EP                     12
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7200                             Melting point/melting   CR                      TGAI                   TGAI                   8, 13
                                      range
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7220                             Boiling point/boiling   CR                      TGAI                   TGAI                   8, 14
                                      range
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7300                             Density/relative        R                       TGAI and MP            TGAI and EP            8, 18
                                      density/bulk density
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7520                             Particle size, fiber    CR                      TGAI                   TGAI                   8, 15
                                      length, and diameter
                                      distribution
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7550                             Partition coefficient   CR                      TGAI                   TGAI                   16
830.7560...........................   (n-Octanol /Water)
830.7570...........................
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7840                             Water solubility        R                       TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7950                             Vapor pressure          R                       TGAI                   TGAI                   8, 19
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for experimental use permit biochemical pesticides product 
chemistry and are referenced in the last column of the table in 
paragraph (d) of this section.

[[Page 151]]

    1. Data must be provided in accordance with Sec. 158.320.
    2. If the MP and EP are produced by an integrated formulation system 
(non-registered source), these data are also required on TGAI.
    3. Data must be provided in accordance with Sec. 158.325, Sec. 
158.330, and Sec. 158.335.
    4. Data must be provided in accordance with Sec. 158.340.
    5. Data must be provided in accordance with Sec. 158.345. Also, 
required to support the registration of each manufacturing-use product 
(including registered TGAIs) and end-use products produced by an 
integrated formulation system. Data on other end-use products would be 
required on a case-by-case basis. For pesticides in the production 
stage, a preliminary product analytical method and data would suffice to 
support an experimental use permit.
    6. Data must be provided in accordance with Sec. 158.350.
    7. Data must be provided in accordance with Sec. 158.355.
    8. If the TGAI cannot be isolated, data are required on the 
practical equivalent of the TGAI. EP testing may also be appropriate.
    9. Required if the product contains combustible liquids.
    10. Required if the product is an emulsifiable liquid and is to be 
diluted with petroleum solvents.
    11. Required if the test substance is soluble or dispersible in 
water.
    12. Required if the product is a liquid.
    13. Required when the technical chemical is a solid at room 
temperature.
    14. Required when the technical chemical is a liquid at room 
temperature.
    15. Required for water insoluble test substances 
(10-6g/l) and fibrous test substances with 
diameter =0.1 [micro]m.
    16. Required for organic chemicals unless they dissociate in water 
or are partially or completely soluble in water.
    17. Data on the stability to metals and metal ions is required only 
if the active ingredient is expected to come in contact with either 
material during storage.
    18. True density or specific density are required for all test 
substances. Data on bulk density is required for MPs or EPs that are 
solid at room temperature.
    19. Not required for salts.



Sec. 158.2082  Experimental use permit biochemical pesticides residue data 

requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the biochemical pesticides residue data 
requirements for a particular pesticide product and the substance that 
needs to be tested. These data requirements apply to all biochemical 
pesticides, i.e., naturally occurring insect repellents and attractants, 
semiochemicals (e.g., insect pheromones), natural and plant growth 
regulators. Notes that apply to an individual test and include specific 
conditions, qualifications, or exceptions to the designated test are 
listed in paragraph (e) of this section.
    (b) Use patterns. (1) Data are required or conditionally required 
for all pesticides used in or on food and for residential outdoor uses 
where food crops are grown. Food use patterns include products 
classified under the general use patterns of terrestrial food crop use, 
terrestrial feed crop use, aquatic food crop use, greenhouse food crop 
use, and indoor food use. Data are also conditionally required for 
aquatic nonfood use if there is direct application to water that could 
subsequently result in exposure to food.
    (2) Data are conditionally required for nonfood uses if pesticide 
residues may occur in food or feed as a result of the use. Data 
requirements for these nonfood uses would be determined on a case-by-
case basis. For example, most products used in or near kitchens require 
residue data for risk assessment purposes even though tolerances may not 
be necessary in all cases.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing end-use product; EP=End-use product; TEP=Typical end-
use product; TGAI=Technical grade of the active ingredient; Residue of 
concern=the active ingredient and its metabolites, degradates,and 
impurities of toxicological concern. All=All of the above. Specific 
conditions, qualifications, or exceptions to the designated test 
procedures appear in paragraph (e) of this section, and apply to the 
individual tests in the following table:
    (d) Data table. The following table shows the data requirements for 
biochemical pesticides residue. The test notes are shown in paragraph 
(e) of this section.

[[Page 152]]



                                               Table--EUP Biochemical Pesticides Residue Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Use Patterns
                                                -----------------------------------------------------------------------
       Guideline Number        Data Requirement     Terrestrial         Aquatic                                          Test Substance     Test Notes
                                                ------------------------------------  Greenhouse Food    Indoor Food
                                                     Food/Feed           Food
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supporting Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1100                     Chemical          CR                CR                CR                CR               TGAI             1, 2, 4
                                identity
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1200                     Directions for    CR                CR                CR                CR               --               1, 3, 4
                                use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nature of Residue
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1300                     Nature of the     CR                CR                CR                CR               TGAI             1, 4, 5, 6
                                residue in
                                plants
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1300                     Nature of the     CR                CR                CR                CR               TGAI or plant    1, 7, 8, 9, 13
                                residue in                                                                               metabolite
                                livestock
--------------------------------------------------------------------------------------------------------------------------------------------------------
Magnitude of the Residue
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                     Potable water     NR                CR                NR                NR               TGAI             1, 11
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                     Fish              NR                CR                NR                NR               TGAI             1, 12
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                     Irrigated crops   NR                CR                NR                NR               TGAI             1, 13
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1460                     Food handling     NR                NR                NR                CR               TGAI             1, 14
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1480                     Meat/milk/        CR                CR                CR                CR               TGAI or plant    1, 7, 8, 9
                                poultry/eggs                                                                             metabolites
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1500                     Crop field        CR                CR                CR                CR               TEP              1, 3, 4
                                trials
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1520                     Processed food/   CR                CR                CR                CR               TEP              1, 15
                                feed
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1540                     Anticipated       CR                CR                CR                CR               Residue of       1, 9, 16
                                residues                                                                                 concern
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1550                     Proposed          CR                CR                CR                CR               --               1, 17
                                tolerances
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1560                     Reasonable        CR                CR                CR                CR               --               1, 9
                                grounds in
                                support of the
                                petition
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1650                     Submittal of      CR                CR                CR                CR               TGAI and         9, 18
                                analytical                                                                               residue of
                                reference                                                                                concern
                                standards
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for biochemical pesticides product chemistry and are 
referenced referenced in the last column of the table contained in 
paragraph (d) of this section.
    1. Residue chemistry data requirements apply to biochemical 
pesticide products when Tier II or Tier III toxicology data are 
required, as specified for biochemical agents in the biochemical human 
health assessment data requirements, Sec. 158.2050.
    2. The same chemical identity data are required for biochemical 
product chemistry data requirements,Sec. 158.2030 with an emphasis on 
impurities.
    3. Required information includes crops to be treated, rate of 
application, number and timing of applications, preharvest intervals, 
and relevant restrictions.
    4. Required for residential outdoor uses on food crops if the 
corresponding agricultural use is not approved or the residential use is 
expected to produce higher residues based on the label directions.
    5. Required unless it is an arthropod pheromone applied at a rate 
less than or equal to 150 grams active ingredient per acre.
    6. Required for indoor uses where the pesticide is applied directly 
to food, in order to determine metabolites and/or degradates. Not 
required when only indirect contact with food would occur (e.g., crack 
and crevice treatments).
    7. Required when a pesticide is to be applied directly to livestock, 
to livestock premises, to livestock drinking water, or to crops used for 
livestock feed. If results from

[[Page 153]]

the plant metabolism study show differing metabolites in plants form 
those found in animals, an additional livestock metabolism study 
involving dosing with the plant metabolite(s) may also be required.
    8. Livestock feeding studies are required whenever a pesticide 
residue is present in livestock feed or when direct application to 
livestock uses occurs.
    9. Required if indoor use could result in pesticide residues in or 
on food or feed.
    10. Data are required to determine whether FDA/USDA multiresidue 
methodology would detect and identify the pesticides and any 
metabolites.
    11. Data are required whenever a pesticide may be applied directly 
to water, unless it can be demonstrated that the treated water would not 
be available for human or livestock consumption.
    12. Data on fish are required for all pesticides applied directly to 
water inhabited, or which will be inhabited, by fish that may be caught 
or harvested for human consumption.
    13. Data are required when a pesticide is to be applied directly to 
water that could be used for irrigation or to irrigation facilities such 
as irrigation ditches.
    14. Data are required whenever a pesticide may be used in food/feed 
handling establishments.
    15. Data on the nature and level of residue in processed food/feed 
are required when detectible residues could potentially concentrate on 
processing thus requiring the establishment of a separate tolerance 
higher than that of the raw agricultural commodity.
    16 Anticipated residue data are required when the assumption of 
tolerance level residues would result in predicted exposure at an unsafe 
level of exposure. Data, using single serving samples of a raw 
agricultural commodity, on the level or residue in food as consumed 
would be used to obtain a more precise estimate of potential dietary 
exposure. These data may also include washing, cooking, processing or 
degradation studies as well as market basket surveys for a more precise 
residue determination.
    17. The proposed tolerance must reflect the maximum residue likely 
to occur in crops, in meat, milk, poultry, or eggs.
    18. Required when a residue analytical method is required.



Sec. 158.2083  Experimental use permit biochemical pesticides human health 

assessment data requirements table.

    (a) General. (1) Sections 158.100 through 158.130 describe how to 
use this table to determine the human health assessment data 
requirements for a particular biochemical pesticide product.
    (2) The data in this section are not required for straight chain 
lepidopteran pheromones when applied up to a maximum use rate of 150 
grams active ingredient/acre/year.
    (b) Use patterns. (1) Food use patterns, in general, include 
products classified under the following general uses: terrestrial food 
crop use; terrestrial feed crop use; aquatic food crop use; greenhouse 
food crop use.
    (2) Nonfood use patterns include products classified under the 
general use patterns of terrestrial nonfood crop use; aquatic nonfood 
residential use; aquatic nonfood outdoor use; aquatic nonfood industrial 
use; greenhouse nonfood crop use; forestry use; residential outdoor use; 
residential indoor use; indoor food use; indoor nonfood use; indoor 
medical use.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; Residue of 
concern=the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; All=All of the above. Specific 
conditions, qualifications, or exceptions to the designated test 
procedures appear in paragraph (e) of this section, and apply to the 
individual tests in the following table:
    (d) Table. The following table shows the data requirements for 
experimental use permit biochemical pesticides human health assessment. 
The test notes are shown in paragraph (e) of this section.

                                       Table--EUP Biochemical Pesticides Human Health Assessment Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Use Patterns                           Test Substance
        Guideline Number           Data Requirement  --------------------------------------------------------------------------------     Test Notes
                                                             Food               Nonfood               MP                  EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 154]]

 
  Acute Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1100                          Acute oral          R                   R                   TGAI and MP         TGAI and EP         1
                                   toxicity - rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1200                          Acute dermal        R                   R                   TGAI and MP         TGAI and EP         1, 2
                                   toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1300                          Acute inhalation    R                   R                   TGAI and MP         TGAI and EP         3
                                   toxicity - rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2400                          Primary eye         R                   R                   TGAI and MP         TGAI and EP         2
                                   irritation -
                                   rabbit
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2500                          Primary dermal      R                   R                   TGAI and MP         TGAI and EP         1, 2
                                   irritation
--------------------------------------------------------------------------------------------------------------------------------------------------------
none                              Hypersensitivity    R                   R                   All                 All                 4
                                   incidents
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Subchronic Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3100                          90-day oral (one    R                   NR                  TGAI                TGAI                --
                                   species)
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Developmental Toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3700                          Prenatal            R                   CR                  TGAI                TGAI                5
                                   developmental -
                                   rat preferably
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Mutagenicity Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5100                          Bacterial reverse   R                   CR                  TGAI                TGAI                6
                                   mutation test
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5300                          In vivo mammalian   R                   CR                  TGAI                TGAI                6, 7
                                   cell assay
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier II
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Developmental Toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3700                          Prenatal            CR                  CR                  TGAI                TGAI                5
                                   developmental
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for experimental use permit biochemical pesticides human 
health assessment as referenced in the last column of the table in 
paragraph (d) of this section.
    1. Required unless the test material is a gas or highly volatile 
(vapor pressure 10-4torr (mm/Hg)).
    2. Required unless the test material is corrosive to skin or has pH 
<2 or 11.5.
    3. Required when the pesticide, under conditions of use, would 
result in respirable material (e.g., gas, volatile substance or aerosol/
particulate), unless it is a straight chain lepidopteran pheromone.
    4. Hypersensitivity incidents must be reported as adverse effects 
data.
    5. Required if the use of the product under widespread and commonly 
recognized practice may reasonably be expected to result in significant 
exposure to female humans (e.g., occupational exposure or repeated 
application of insect repellents directly to the skin). Tier II data is 
required on a different test species from Tier I data when developmental 
effects are observed in the first study and information on species-to-
species extrapolation is needed.
    6. Required to support nonfood uses if either:
    i. The use is likely to result in significant human exposure; or
    ii. The active ingredient (or its metabolites) is structurally 
related to a known mutagen or belongs to any chemical class of compounds 
containing a known mutagen.

    Additional mutagenicity tests that may have been performed plus a 
complete reference list must also be submitted. Subsequent testing may 
be required based on the available evidence.
    7. Choice of assay using either:
    i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, 
maximizing

[[Page 155]]

assay conditions for small colony expression or detection;
    ii. Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast 
(V79) cells, hypoxanthine-guanine phosphoribosyl transferase (hgprt) 
gene locus, accompanied by an appropriate in vivo test for 
clastogenicity; or
    iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl 
transferase (xprt) gene locus.



Sec. 158.2084  Experimental use permit biochemical pesticides nontarget 

organisms and environmental fate data requirements table.

    (a) General. (1) Sections 158.100 through 158.130 describe how to 
use this table to determine the terrestrial and aquatic nontarget 
organisms and fate data requirements for a particular biochemical 
pesticide product. Notes that apply to an individual test including 
specific conditions, qualifications, or exceptions to the designated 
test are listed in paragraph (e) of this section. In general, for all 
outdoor end-use products including turf, the following studies are 
required: one avian acute oral, one avian dietary, one acute freshwater 
fish, and one acute freshwater invertebrate study.
    (2) The data in this section are not required for arthropod 
pheromones when applied at up to a maximum use rate of 150 grams active 
ingredient/acre/year except when the product is expected to be available 
to avian species (i.e., granular formulation).
    (b) Use patterns. The terrestrial use pattern includes products 
classified under the general use patterns of terrestrial food crop, 
terrestrial feed crop, and terrestrial nonfood/nonfeed crop. The 
greenhouse use pattern includes products classified under the general 
use patterns of greenhouse food crop and greenhouse nonfood crop. The 
indoor use pattern includes products classified under the general use 
patterns of indoor food and nonfood use. The remaining terrestrial uses 
include forestry and residential outdoor use. Data are also required for 
the general use patterns of aquatic food and nonfood crop use.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; Residue of 
concern=the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; All=All of the above. Specific 
conditions, qualifications, or exceptions to the designated test 
procedures appear in paragraph (e) of this section, and apply to the 
individual tests in the following table:
    (d) Table. The following table shows the data requirements for 
experimental use permit biochemical pesticides nontarget organisms and 
environmental fate. The test notes are shown in paragraph (e) of this 
section.

                                                 Table--EUP Biochemical Pesticides Nontarget Organisms and Environmental Fate Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                     Use Patterns
                                                      ---------------------------------------------------------------------------------------------------------
        Guideline Number            Data Requirement       Terrestrial            Aquatic             Greenhouse                                  Indoor          Test Substance     Test Notes
                                                      ---------------------------------------------------------------      Forestry,      ---------------------
                                                        Food/Feed/Nonfood       Food/Nonfood         Food/Nonfood     Residential Outdoor      Food/Nonfood
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Avian Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2100                          Avian acute oral     R..................  R..................  NR.................  R..................  NR.................  TGAI, EP..........      1, 2, 3
                                   toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2200                          Avian dietary        R..................  R..................  NR.................  R..................  NR.................  TGAI, EP..........      1, 2, 3
                                   toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Aquatic Organism Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1075                          Fish acute           R..................  R..................  NR.................  R..................  NR.................  TGAI, EP..........      2, 3, 4
                                   toxicity,
                                   freshwater
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 156]]

 
850.1010                          Aquatic              R..................  R..................  NR.................  R..................  NR.................  TGAI, EP..........         2, 4
                                   invertebrate acute
                                   toxicity,
                                   freshwater
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for experimental use permit biochemical pesticides 
nontarget organisms and environmental fate as referenced in the last 
column of the table contained in paragraph (d) of this section.
    1. Required for the EP when any end-use formulation may contain 
other ingredients that may be toxic to nontarget organisms or to support 
arthropod pheromones that would be available to avian wildlife, (e.g., a 
granular product).
    2. Not required for any use groups if the pesticide is highly 
volatile (estimated volatility 5x10-5atm m\3\/
mol).
    3. Preferred test species are: upland game, waterfowl, or passerine 
for avian acute oral toxicity studies; upland game or waterfowl for 
avian dietary studies; and coldwater fish for acute freshwater fish 
studies.
    4. Required for the EP when the end-use formulation may contain 
other ingredients that may be toxic to nontarget organisms.



                     Subpart V_Microbial Pesticides

    Source: 72 FR 61002, Oct. 26, 2007, unless otherwise noted.



Sec. 158.2100  Microbial pesticides definition and applicability.

    (a) This subpart applies to all living or dead microbial pesticides 
as described in paragraphs (b) and (c) of this section.
    (b) Definition. Microbial pesticide is a microbial agent intended 
for preventing, destroying, repelling, or mitigating any pest, or 
intended for use as a plant regulator, defoliant, or desiccant, that:
    (1) Is a eucaryotic microorganism including, but not limited to, 
protozoa, algae, and fungi;
    (2) Is a procaryotic microorganism, including, but not limited to, 
Eubacteria and Archaebacteria; or
    (3) Is a parasitically replicating microscopic element, including, 
but not limited to, viruses.
    (c) Applicability. (1) This subpart applies to microbial pesticides 
as specified in paragraphs (c)(2), (c)(3), and (c)(4) of this section.
    (2) Each new isolate of a microbial pesticide is a new active 
ingredient and must be registered independently of any similarly 
designated and already registered microbial pesticide active ingredient. 
Each new isolate for which registration is sought must have a unique 
identifier following the taxonomic name of the microorganism, and the 
registration application must be supported by data required in this 
subpart. This does not preclude the possibility of using data from 
another isolate, provided sufficient similarity is established, to 
support registration.
    (3) Genetically modified microbial pesticides may be subject to 
additional data or information requirements on a case-by-case basis 
depending on the particular microbial agent and/or its parental strains, 
the proposed pesticide use pattern, and the manner and extent to which 
the organism has been genetically modified.
    (4) Pest control organisms such as insect predators, nematodes, and 
macroscopic parasites are exempt from the requirements of FIFRA as 
authorized by section 25(b) of FIFRA and specified in Sec. 152.20 (a) 
of this chapter.

[72 FR 61002, Oct. 26, 2007, as amended at 77 FR 52612, Aug. 30, 2012]

[[Page 157]]



Sec. 158.2110  Microbial pesticides data requirements.

    (a) For all microbial pesticides. (1) The following Sec. 158.2120 
through Sec. 158.2150 identify the data requirements that are required 
to support registration of microbial pesticides. The variations in the 
test conditions are identified within the test notes.
    (2) Each data table includes ``use patterns'' under which the 
individual data are required, with variations including all use 
patterns, food and nonfood uses for terrestrial and aquatic 
applications, greenhouse, indoor, forestry, and residential outdoor 
applications under certain circumstances.
    (3) The categories for each data requirement are ``R,'' which stands 
for required, and ``CR'' which stands for conditionally required. If a 
bracket appears around the ``R'' or ``CR,'' the data are required for 
both the registration and experimental use permit requests. Generally, 
``R'' indicates that the data are more likely required than for those 
data requirements with ``CR.'' However, in each case, the regulatory 
text preceding the data table and the test notes following the data 
table must be used to determine whether the data requirement must be 
satisfied.
    (4) Each table identifies the test substance that is required to be 
tested to satisfy the data requirement. Test substances may include: 
technical grade active ingredient (TGAI), manufacturing-use product 
(MP), end-use product (EP), typical end-use product (TEP), residue of 
concern, and pure active ingredient (PAI) or all of the above (All). 
Commas between the test substances (i.e., TGAI, EP) indicate that data 
may be required on the TGAI or EP or both depending on the conditions 
set forth in the test note. Data requirements which list two test 
substances (i.e., TGAI and EP) indicate that both are required to be 
tested. Data requirements that list only MP as the test substance apply 
to products containing solely the technical grade of the active 
ingredient and manufacturing-use products to which other ingredients 
have been intentionally added. Data requirements listing the EP as the 
test substance apply to any EP with an ingredient in the end-use 
formulation other than the active ingredient that is expected to enhance 
the toxicity of the product.
    (b) Additional data requirements for genetically modified microbial 
pesticides. Additional requirements for genetically modified microbial 
pesticides may include but are not limited to: genetic engineering 
techniques used; the identity of the inserted or deleted gene segment 
(base sequence data or enzyme restriction map of the gene); information 
on the control region of the gene in question; a description of the 
``new'' traits or characteristics that are intended to be expressed; 
tests to evaluate genetic stability and exchange; and selected Tier II 
environmental expression and toxicology tests.



Sec. 158.2120  Microbial pesticides product analysis data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the product analysis data requirements and the 
substance to be tested for a particular microbial pesticide. Notes that 
apply to an individual test and include specific conditions, 
qualifications, or exceptions to the designated test are identified in 
paragraph (d) of this section.
    (b) Key. R = Required; CR = Conditionally required; NR = Not 
required; MP = Manufacturing-use product; EP = End-use product; TEP = 
Typical end-use product; TGAI = Technical grade of the active 
ingredient; All = All of the above.
    (c) Table. The table in this paragraph shows the data requirements 
for microbial pesticides product analysis. The test notes are shown in 
paragraph (d) of this section.

[[Page 158]]



                         Table--Microbial Pesticides Product Analysis Data Requirements
----------------------------------------------------------------------------------------------------------------
                                                                             Test substance
 Test guideline No.       Data requirement          All use     ----------------------------------------   Test
                                                   patterns              MP                  EP           notes
----------------------------------------------------------------------------------------------------------------
                                        Product Chemistry and Composition
----------------------------------------------------------------------------------------------------------------
885.1100............  Product identity.......  R                 MP................  EP................
885.1200............  Manufacturing process..  R                 TGAI and MP.......  TGAI and EP.......
885.1250............  Deposition of a sample   R                 TGAI..............  TGAI..............        1
                       in a nationally
                       recognized culture
                       collection.
885.1300............  Discussion of formation  R                 TGAI and MP.......  TGAI and EP.......
                       of unintentional
                       ingredients.
----------------------------------------------------------------------------------------------------------------
                                          Analysis and Certified Limits
----------------------------------------------------------------------------------------------------------------
885.1400............  Analysis of samples....  R                 TGAI and MP.......  TGAI and EP.......        2
885.1500............  Certification of limits  R                 MP................  EP................
----------------------------------------------------------------------------------------------------------------
                                      Physical and Chemical Characteristics
----------------------------------------------------------------------------------------------------------------
830.6302............  Color..................  R                 TGAI..............  TGAI..............
830.6303............  Physical state.........  R                 TGAI..............  TGAI..............
830.6304............  Odor...................  R                 TGAI..............  TGAI..............
830.6313............  Stability to normal and  R                 TGAI..............  TGAI..............
                       elevated temperatures,
                       metals, and metal ions.
830.6317............  Storage stability......  R                 TGAI and MP.......  TGAI and EP.......
830.6319............  Miscibility............  R                 MP................  EP................        3
830.6320............  Corrosion                R                 MP................  EP................        4
                       characteristics.
830.7000............  pH.....................  R                 TGAI..............  TGAI..............
830.7100............  Viscosity..............  R                 MP................  EP................        5
830.7300............  Density/relative         R                 TGAI..............  TGAI..............  .......
                       density/bulk density
                       (specific gravity).
----------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test notes are applicable to the data 
requirements for microbial pesticides product analysis as referenced in 
the last column of the table contained in paragraph (c) of this section.
    1. Required for each isolate of a microbial pesticide. Isolates must 
be deposited with an agreement to ensure that the sample will be 
maintained and will not be discarded for the duration of the associated 
registration(s).
    2. Required to support registration of each manufacturing-use 
product and end-use product. This analysis must be conducted at the 
point in the production process after which there would be no potential 
for microbial contamination or microbial regrowth. For full 
registration, generally an analysis of samples is a compilation of 
batches, over a period of time, depending on the frequency of 
manufacturing.
    3. Only required for emulsifiable liquid forms of microbial 
pesticides.
    4. Required when microbial pesticides are packaged in metal, 
plastic, or paper containers.
    5. Only required for liquid forms of microbial pesticides.

[72 FR 61002, Oct. 26, 2007, as amended at 77 FR 52612, Aug. 30, 2012]



Sec. 158.2130  Microbial pesticides residue data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the residue chemistry data requirements and the 
substance to be tested for a particular microbial pesticide. Specific 
conditions, qualifications, or exceptions to the designated test appear 
in paragraph (d) of this section, and the procedures appear in paragraph 
(e) of this section.
    (b) Key. R=required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; All=All of the 
above. Specific conditions, qualifications, or exceptions to the 
designated test procedures appear in paragraph (d) of this section, and 
apply to the individual tests in the following table:
    (c) Table. The following table shows the data requirements for 
microbial pesticides residue. The test notes are shown in paragraph (d) 
of this section.

[[Page 159]]



                              Table--Microbial Pesticides Residue Data Requirements
----------------------------------------------------------------------------------------------------------------
                                                                            Test Substance
        Guideline Number           Data Requirement    All Use Patterns   Data to Support MP      Test Notes
                                                                                 or EP
----------------------------------------------------------------------------------------------------------------
885.2100                          Chemical Identity   CR                  EP                  1
----------------------------------------------------------------------------------------------------------------
885.2200                          Nature of the       CR                  EP                  1
                                   Residue in plants
----------------------------------------------------------------------------------------------------------------
885.2250                          Nature of the       CR                  EP                  1
                                   Residue in
                                   animals
----------------------------------------------------------------------------------------------------------------
885.2300                          Analytical methods  CR                  TGAI                1
                                   - plants
----------------------------------------------------------------------------------------------------------------
885.2350                          Analytical methods  CR                  TGAI                1
                                   - animals
----------------------------------------------------------------------------------------------------------------
885.2400                          Storage Stability   CR                  EP                  1
----------------------------------------------------------------------------------------------------------------
885.2500                          Magnitude of        CR                  EP                  1
                                   residue in plants
----------------------------------------------------------------------------------------------------------------
885.2550                          Magnitude of        CR                  EP                  1
                                   residues in meat,
                                   milk, poultry,
                                   eggs
----------------------------------------------------------------------------------------------------------------
885.2600                          Magnitude of        CR                  EP                  1
                                   residues in
                                   potable water,
                                   fish, and
                                   irrigated crops
----------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test note is applicable to the data 
requirements for microbial pesticides residue as referenced in the last 
column of the table contained in paragraph (c) of this section.
    1. Required when the results of testing:
    i. Indicate the potential to cause adverse human health effects or 
the product characterization indicates the microbial pesticide has a 
significant potential to produce a mammalian toxin; and
    ii. The use pattern is such that residues may be present in or on 
food or feed crops.



Sec. 158.2140  Microbial pesticides toxicology data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the toxicology data requirements for a 
particular pesticide product. Notes that apply to an individual test and 
include specific conditions, qualifications, or exceptions to the 
designated test are listed in paragraph (d) of this section.
    (b) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; All=All of the 
above. Specific conditions, qualifications, or exceptions to the 
designated test procedures appear in paragraph (d) of this section, and 
apply to the individual tests in the following table:
    (c) Table. The following table shows the data requirements for 
microbial pesticides toxicology. The test notes are shown in paragraph 
(d) of this section.

                            Table--Microbial Pesticides Toxicology Data Requirements
----------------------------------------------------------------------------------------------------------------
        Guideline Number           Data Requirement    All Use Patterns     Test Substance        Test Notes
----------------------------------------------------------------------------------------------------------------
Tier I
----------------------------------------------------------------------------------------------------------------
885.3050                          Acute oral          R                   TGAI                1
                                   toxicity/
                                   pathogenicity
----------------------------------------------------------------------------------------------------------------
885.3150                          Acute pulmonary     R                   TGAI                --
                                   toxicity/
                                   pathogenicity
----------------------------------------------------------------------------------------------------------------
885.3200                          Acute injection     R                   TGAI                2
                                   toxicity/
                                   pathogenicity/
                                   (intravenous)
                                  Acute injection
                                   toxicity/
                                   pathogenicity/
                                   (intraperitoneal).
----------------------------------------------------------------------------------------------------------------
885.3400                          Hypersensitivity    R                   All                 3
                                   incidents
----------------------------------------------------------------------------------------------------------------
885.3500                          Cell culture        R                   TGAI                4
----------------------------------------------------------------------------------------------------------------
870.1100                          Acute oral          R                   MP , EP             1, 5
                                   toxicity
----------------------------------------------------------------------------------------------------------------
870.1200                          Acute dermal        R                   MP , EP             5
                                   toxicity
----------------------------------------------------------------------------------------------------------------
870.1300                          Acute inhalation    R                   MP , EP             5, 6
                                   toxicity
----------------------------------------------------------------------------------------------------------------
870.2400                          Acute eye           R                   MP , EP             5
                                   irritation
----------------------------------------------------------------------------------------------------------------

[[Page 160]]

 
870.2500                          Primary dermal      R                   MP , EP             5
                                   irritation
----------------------------------------------------------------------------------------------------------------
Tier II
----------------------------------------------------------------------------------------------------------------
885.3550                          Acute toxicology    CR                  TGAI                7
----------------------------------------------------------------------------------------------------------------
885.3600                          Subchronic          CR                  TGAI                8
                                   toxicity/
                                   pathogenicity
----------------------------------------------------------------------------------------------------------------
Tier III
----------------------------------------------------------------------------------------------------------------
885.3650                          Reproductive        CR                  TGAI                9, 13
                                   fertility effects
----------------------------------------------------------------------------------------------------------------
870.4200                          Carcinogenicity     CR                  TGAI                10, 13
----------------------------------------------------------------------------------------------------------------
870.7800                          Immunotoxicity      CR                  TGAI                11, 13
----------------------------------------------------------------------------------------------------------------
885.3000                          Infectivity/        CR                  TGAI                12, 13
                                   pathogenicity
                                   analysis
----------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test notes are applicable to the data 
requirements for microbial pesticides toxicology as referenced in the 
last column of the table contained in paragraph (c) of this section:
    1. The acute oral toxicity/pathogenicity study is required to 
support the TGAI. However, it can be combined with the unit dose portion 
of the acute oral toxicity study, with an EP or MP test material to 
fulfill the requirement for the TGAI and the MP or EP in a single study, 
if the new protocol is designed to address the endpoints of concern.
    2. Data not required for products whose active ingredient is a 
virus. For test materials whose size or consistency may prevent use of 
an intravenous injection, the intraperitoneal injection procedure may be 
employed.
    3. Hypersensitivity incidents, including immediate type and delayed-
type reactions of humans or domestic animals, occur during the testing 
or production of the TGAI, MP, or EP, or are otherwise known to the 
applicant must be reported if they occur.
    4. Data must be submitted only for products whose active ingredient 
is a virus.
    5. The 870 series studies for the MP and EP are intended to provide 
data on the acute toxicity of the product. Waivers for any or all of 
these studies may be granted when the applicant can demonstrate that the 
combination of inert ingredients is not likely to pose any significant 
human health risks. Where appropriate, the limit dose approach to 
testing is recommended.
    6. Required when the product consists of, or under conditions of use 
would result in, an inhalable material (e.g., gas, volatile substances, 
or aerosol particulate).
    7. Data required when significant toxicity, in the absence of 
pathogenicity and significant infectivity, is observed in acute oral, 
injection, or pulmonary studies (Tier I). Route(s) of exposure 
correspond to route(s) where toxicity was observed in Tier I studies. 
The toxic component of the TGAI is to be tested.
    8. Data required when significant infectivity and/or unusual 
persistence is observed in the absence of pathogenicity or toxicity in 
Tier I studies. Routes of exposure (oral and/or pulmonary) correspond to 
routes in Tier I studies where adverse effects were noted. Data may also 
be required to evaluate adverse effects due to microbial contaminants or 
to toxic byproducts.
    9. Data are required when one or more of the following criteria are 
met:
    i. Significant infectivity of the microbial pest control agent 
(MPCA) was observed in test animals in the Tier II subchronic study and 
in which no significant signs of toxicity or pathogenicity were 
observed.
    ii. The microbial pesticide is a virus which can persist or 
replicate in mammalian cell culture lines.
    iii. The microbial pesticide is not amenable to thorough taxonomic 
classification, and is related to organisms known to be parasitic for 
mammalian cells.
    iv. The microbial pesticide preparation is not well purified, and 
may contain contaminants which are parasitic for mammals.
    10. Data may be required for products known to contain or suspected 
to contain carcinogenic viruses or for microbial components that are 
identified as having significant toxicity in Tier II testing.
    11. Data may be required for products known to contain or suspected 
to contain viruses that can interact in an adverse manner with 
components of the mammalian immune system.
    12. An analysis of human infectivity/pathogenicity potential using 
scientific literature, genomic analysis, and/or actual specific cell 
culture/animal data may be required for products known to contain or 
suspected of containing intracellular parasites of mammalian cells for 
products that exhibit pathogenic characteristics in Tier I and/or Tier 
II, for products which are closely related to known human pathogens 
based on the product analysis data, or for known human pathogens that 
have been ``disarmed'' or rendered non-pathogenic for humans.
    13. Test standards may have to be modified depending on the 
characteristics of the microorganism. Requirements may vary for these 
studies depending on the active ingredient being tested. Consultation 
with the Agency is advised before performing these Tier III studies.

[[Page 161]]



Sec. 158.2150  Microbial pesticides nontarget organisms and environmental fate 

data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the terrestrial and aquatic nontarget organisms 
data requirements for a particular microbial pesticide product. Notes 
that apply to an individual test including specific conditions, 
qualifications, or exceptions to the designated test are listed in 
paragraph (e) of this section.
    (b) Use patterns. Aquatic uses include: food and feed, nonfood uses 
(e.g., outdoor, residential, and industrial). Terrestrial uses include: 
Food, Feed, Non-Food, Forestry, Residential outdoor, greenhouse (food 
and food), Indoor (food and nonfood), and Industrial.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; All=All of the 
above. Specific conditions, qualifications, or exceptions to the 
designated test procedures appear in paragraph (e) of this section, and 
apply to the individual tests in the following table:
    (d) Table. The following table shows the data requirements for 
microbial pesticides nontarget organisms and environmental fate. The 
test notes are shown in paragraph (e) of this section.

                                                                        Table--Microbial Pesticides Nontarget Organisms and Environmental Fate Data Requirements
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                      Use Patterns
                                                  ---------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Aquatic                                                                Terrestrial
       Guideline Number          Data Requirement ---------------------------------------------------------------------------------------------------------------------------------------------------  Test Substance      Test Notes
                                                                                                                                 Residential       Greenhouse          Indoor
                                                       Food/Feed           Nonfood       Food/Feed/Nonfood      Forestry     ------------------------------------------------------    Industrial
                                                                                                                                   Outdoor        Food/Nonfood      Food/Nonfood
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4050                        Avian oral         R                  R                  R                  R                 R                 CR                CR                CR                TGAI              1, 2
                                 toxicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4100                        Avian inhalation   CR                 CR                 CR                 CR                CR                CR                CR                CR                TGAI              1, 2, 3
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4150                        Wild mammal        CR                 CR                 CR                 CR                CR                NR                NR                CR                TGAI              1, 4
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4200                        Freshwater fish    R                  R                  R                  R                 CR                CR                CR                CR                TGAI or TEP       1, 2, 5
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4240                        Freshwater         R                  R                  R                  R                 CR                CR                CR                CR                TGAI or TEP       1, 2, 5
                                 invertebrate
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4280                        Estuarine/Marine   CR                 CR                 CR                 CR                CR                NR                NR                CR                TGAI              1, 6
                                 fish testing
                                Estuarine and
                                 marine
                                 invertebrate
                                 testing.
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4300                        Nontarget plant    CR                 CR                 CR                 R                 CR                NR                CR                CR                TEP               1, 7
                                testing..........
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4340                        Nontarget insect   R                  R                  R                  R                 R                 CR                NR                CR                TGAI              1, 8
                                 testing
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4380                        Honey bee testing  R                  R                  R                  R                 R                 CR                NR                CR                TGAI              1
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier II
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.5200                        Terrestrial        CR                 CR                 CR                 CR                CR                NR                NR                CR                TGAI or TEP       9
                                 environmental
                                 expression tests
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 162]]

 
885.5300                        Freshwater         CR                 CR                 CR                 CR                CR                NR                NR                CR                TGAI or TEP       10
                                 environmental
                                 expression tests
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.5400                        Marine or          CR                 CR                 CR                 CR                CR                NR                NR                CR                TGAI or TEP       11, 12
                                 estuarine
                                 environmental
                                 expression tests
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier III
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4600                        Avian chronic      CR                 CR                 CR                 CR                CR                NR                NR                CR                TGAI              12, 13
                                 pathogenicity
                                 and reproduction
                                 test
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4650                        Aquatic            CR                 CR                 CR                 CR                CR                NR                NR                CR                TGAI              12, 14
                                 invertebrate
                                 range testing
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4700                        Fish life cycle    CR                 CR                 CR                 CR                CR                NR                NR                CR                TGAI              12, 14
                                 studies
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4750                        Aquatic ecosystem  CR                 CR                 CR                 CR                CR                NR                NR                CR                TGAI              15
                                 test
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier IV
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2500                        Field testing for  CR                 CR                 CR                 CR                CR                NR                NR                CR                TGAI or TEP       11, 16
850.1950......................   terrestrial
                                 wildlife and
                                 Field testing
                                 for aquatic
                                 organisms
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2500                        Simulated or       CR                 CR                 CR                 CR                CR                NR                NR                CR                TEP               16, 17, 20
                                 actual field
                                 tests (birds,
                                 mammals)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1950                        Simulated or       CR                 CR                 CR                 CR                CR                NR                NR                CR                TEP               16, 18, 19, 20
                                 actual field
                                 test (aquatic
                                 organisms)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2500                        Simulated or       CR                 CR                 CR                 CR                CR                NR                NR                CR                TEP               16, 18, 19, 20
                                 actual field
                                 tests (insect
                                 predators,
                                 parasites)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.3040                        Simulated or       CR                 CR                 CR                 CR                CR                NR                NR                CR                TEP               16, 18, 19, 20
                                 actual field
                                 tests (insect
                                 pollinators)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4300                        Simulated or       CR                 CR                 CR                 CR                CR                NR                NR                CR                TEP               16, 18, 19, 20
                                 actual field
                                 tests (plants)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for microbial pesticides nontarget organism and 
environmental fate as referenced in the last column of the table 
contained in paragraph (d) of this section.
    1. Tests for pesticides intended solely for indoor application would 
be required on a case-by-case basis, depending on use pattern,

[[Page 163]]

production volume, and other pertinent factors.
    2. The preferred species for the avian oral study is either the 
upland game or waterfowl. The preferred species for the avian inhalation 
toxicity/pathogenicity study and the avian chronic toxicity/
pathogenicity study is the upland game. There is also the option to test 
the passerine if there is a concern. The coldwater fish is preferred for 
freshwater fish testing. However, two species (coldwater and warmwater 
fish species are the preferred species) must be tested for uses 
involving direct freshwater exposure. Freshwater invertebrate testing is 
also required.
    3. Data required when the nature of the microbial pesticide and/or 
its toxins indicates potential pathogenicity to birds.
    4. Required on a case-by-case basis if results of tests required by 
Sec. 158.2140 are inadequate or inappropriate for assessment of hazards 
to wild mammals.
    5. Required when there will be significant exposure to aquatic 
organisms (fish and invertebrates).
    6. Required if the product is intended for direct application into 
the estuarine or marine environment or expected to enter this 
environment in significant concentrations because of expected use or 
mobility pattern.
    7. Required if the microbial pesticide is taxonomically related to a 
known plant pathogen.
    8. Data are not required unless an active microbial ingredient 
controls the target insect pest by a mechanism of infectivity; i.e., may 
create an epizootic condition in nontarget insects.
    9. Required if toxic or pathogenic effects are observed in one or 
more of the following tests for microbial pesticides:
    i. Avian acute oral or avian inhalation studies.
    ii. Wild mammal studies.
    iii. Nontarget plant studies (terrestrial).
    iv. Honey bee studies.
    v. Nontarget insect studies.
    10. Required when toxic or pathogenic effects are observed in any of 
the following Tier I tests for microbial pest control agents:
    i. Freshwater fish studies.
    ii. Freshwater invertebrate studies.
    iii. Nontarget plant studies (aquatic).
    11. Required if product is applied on land or in fresh water or 
marine/estuarine environments and toxic or pathogenic effects are 
observed in any of the following Tier I tests for microbial pesticides:
    i. Estuarine and marine animal toxicity and pathogenicity.
    ii. Plant studies - estuarine or marine species.
    12. An appropriate dose-response toxicity test is required when 
toxic effects on nontarget terrestrial wildlife or aquatic organisms 
(including plants) are reported in one or more Tier I tests and results 
of Tier II tests indicate exposure of the microbial agent to the 
affected nontarget terrestrial wildlife or aquatic organisms. The 
protocols for these tests may have to be modified in accordance with 
results from the nontarget organism and environmental expression 
studies.
    13. Required when one or more of the following are present:
    i. Pathogenic effects are observed in Tier I avian studies.
    ii. Tier II environmental expression testing indicate that long-term 
exposure of terrestrial animals is likely.
    14. Required when product is intended for use in water or expected 
to be transported to water from the intended use site, and when 
pathogenicity or infectivity was observed in Tier I aquatic studies.
    15. Required if, after an analysis of the microbial pesticide's 
ability to survive and multiply in the environment and what ecological 
habitat it would occupy, the intended use patterns, and the results of 
previous nontarget organisms and environmental expression tests, it is 
determined that use of the microbial agent may result in adverse effects 
on the nontarget organisms in aquatic environments. Testing is to 
determine if applications of the microbial pest control would be 
expected to disrupt the balance of populations in the target ecosystem.
    16. Tier IV studies may be conducted as a condition of registration 
as post-registration monitoring if the potential for unreasonable 
adverse effects appears to be minimal during that period of use due to 
implementation of mitigation measures.
    17. Required when both of the following conditions occur:
    i. Pathogenic effects observed at actual or expected field residue 
exposure levels are reported in Tier III; and
    ii. The Agency determines that quarantine methods would not prevent 
the microbial pesticide from contaminating areas adjacent to the test 
area.
    18. Short term simulated or actual field studies are required when 
it is determined that the product is likely to cause adverse short-term 
or acute effects, based on consideration of available laboratory data, 
use patterns, and exposure rates.
    19. Data from a long-term simulated field test (e.g., where 
reproduction and growth of confined populations are observed) and/or an 
actual field test (e.g., where reproduction and growth of natural 
populations are observed) are required if laboratory data indicate that 
adverse long-term, cumulative, or life-cycle effects may result from 
intended use.
    20. Since test standards would be developed on a case-by-case basis, 
consultation with the Agency and development of a protocol is advised 
before performing these Tier IV studies.

[[Page 164]]



Sec. 158.2160  Microbial pesticides product performance data requirements.

    Product performance data must be developed for all microbial 
pesticides. However, the Agency has waived all requirements to submit 
efficacy data unless the pesticide product bears a claim to control 
public health pests, such as pest microorganisms infectious to man in 
any area of the inanimate environment or a claim to control vertebrates 
(including but not limited to: rodents, birds, bats, canids, and skunks) 
or invertebrates (including but not limited to: mosquitoes and ticks) 
that may directly or indirectly transmit diseases to humans. However, 
each registrant must ensure through testing that his products are 
efficacious when used in accordance with label directions and commonly 
accepted pest control practices. The Agency reserves the right to 
require, on a case-by-case basis, submission of efficacy data for any 
pesticide product registered or proposed for registration.



Sec. 158.2170  Experimental use permit data requirements--microbial 

pesticides.

    (a) For all microbial pesticides. (1) The following Sec. 158.2171 
through Sec. 158.2174 identify the data requirements that are required 
to support experimental use permits for microbial pesticides. The 
variations in the test conditions are identified within the test notes.
    (2) For general information on the data requirement tables, see 
Sec. 158.2110(a)(2)-(4).
    (b) Additional data requirements for genetically modified microbial 
pesticides. Additional requirements for genetically modified microbial 
pesticides may include but are not limited to: genetic engineering 
techniques used; the identity of the inserted or deleted gene segment 
(base sequence data or enzyme restriction map of the gene); information 
on the control region of the gene in question; a description of the 
``new'' traits or characteristics that are intended to be expressed; 
tests to evaluate genetic stability and exchange; and selected Tier II 
environmental expression and toxicology tests.



Sec. 158.2171  Experimental use permit microbial pesticides product analysis 

data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the product analysis data requirements and the 
substance to be tested for a particular microbial pesticide. Notes that 
apply to an individual test and include specific conditions, 
qualifications, or exceptions to the designated test are identified in 
paragraph (d) of this section.
    (b) Key. R = Required; CR = Conditionally required; NR = Not 
required; MP = Manufacturing-use product; EP = End-use product; TEP = 
Typical end-use product; TGAI = Technical grade of the active 
ingredient; All = All of the above.
    (c) Table. The table in this paragraph shows the data requirements 
for experimental use permit microbial pesticides product analysis. The 
test notes are shown in paragraph (d) of this section.

                       Table--EUP Microbial Pesticides Product Analysis Data Requirements
----------------------------------------------------------------------------------------------------------------
                                                                             Test substance
 Test guideline No.       Data requirement     All use patterns ----------------------------------------   Test
                                                                         MP                  EP           notes
----------------------------------------------------------------------------------------------------------------
                                        Product Chemistry and Composition
----------------------------------------------------------------------------------------------------------------
885.1100............  Product identity.......  R                 MP................  EP................
885.1200............  Manufacturing process..  R                 TGAI and MP.......  TGAI and EP.......     1, 2
885.1250............  Deposition of a sample   R                 TGAI..............  TGAI..............        3
                       in a nationally
                       recognized culture
                       collection.
885.1300............  Discussion of formation  R                 TGAI and MP.......  TGAI and EP.......        2
                       of unintentional
                       ingredients.
----------------------------------------------------------------------------------------------------------------
                                          Analysis and Certified Limits
----------------------------------------------------------------------------------------------------------------
885.1400............  Analysis of samples....  R                 TGAI and MP.......  TGAI and EP.......     2, 4
885.1500............  Certification of limits  R                 MP................  EP................
----------------------------------------------------------------------------------------------------------------

[[Page 165]]

 
                                      Physical and Chemical Characteristics
----------------------------------------------------------------------------------------------------------------
830.6302............  Color..................  R                 TGAI..............  TGAI..............
830.6303............  Physical state.........  R                 TGAI..............  TGAI..............
830.6304............  Odor...................  R                 TGAI..............  TGAI..............
830.6313............  Stability to normal and  R                 TGAI..............  TGAI..............
                       elevated temperatures,
                       metals, and metal ions.
830.6317............  Storage stability......  R                 TGAI and MP.......  TGAI and EP.......
830.6319............  Miscibility............  R                 MP................  EP................        5
830.6320............  Corrosion                R                 MP................  EP................        6
                       characteristics.
830.7000............  pH.....................  R                 TGAI..............  TGAI..............
830.7100............  Viscosity..............  R                 MP................  EP................        7
830.7300............  Density/relative         R                 TGAI..............  TGAI..............  .......
                       density/bulk density
                       (specific gravity).
----------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test notes are applicable to the data 
requirements for experimental use permit microbial pesticides product 
analysis as referenced in the last column of the table contained in 
paragraph (c) of this section.
    1. If an experimental use permit is being sought, and if the 
pesticide is not already under full-scale production, a schematic 
diagram and/or description of the manufacturing process suffices.
    2. If an experimental use permit is being sought, and if the product 
is not already under full-scale production, a discussion of 
unintentional ingredients is required to be submitted to the extent this 
information is available.
    3. Required for each isolate of a microbial pesticide. Isolates must 
be deposited with an agreement to ensure that the sample will be 
maintained and will not be discarded for the duration of the associated 
experimental use permit(s).
    4. Required to support registration of each manufacturing-use 
product and end-use product. This analysis must be conducted at the 
point in the production process after which there would be no potential 
for microbial contamination or microbial regrowth. For pesticides in the 
production stage, a preliminary product analytical method and data would 
suffice to support an experimental use permit. For full registration, 
generally an analysis of samples is a compilation of batches, over a 
period of time, depending on the frequency of manufacturing.
    5. Only required for emulsifiable liquid forms of microbial 
pesticides.
    6. Required when microbial pesticides are packaged in metal, 
plastic, or paper containers.
    7. Only required for liquid forms of microbial pesticides.

[72 FR 61002, Oct. 26, 2007, as amended at 77 FR 52613, Aug. 30, 2012]



Sec. 158.2172  Experimental use permit microbial pesticides residue data 

requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the residue chemistry data requirements and the 
substance to be tested for a particular microbial pesticide. Specific 
conditions, qualifications, or exceptions to the designated test appear 
in (d) of this section, and the procedures appear in paragraph (e) of 
this section.
    (b) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; All=All of the 
above. Specific conditions, qualifications, or exceptions to the 
designated test procedures appear in paragraph (d) of this section, and 
apply to the individual tests in the following table:
    (c) Table. The following table shows the data requirements for 
experimental use permit microbial pesticides residue. The test notes are 
shown in paragraph (d) of this section.

[[Page 166]]



                            Table--EUP Microbial Pesticides Residue Data Requirements
----------------------------------------------------------------------------------------------------------------
                                                                            Test Substance
        Guideline Number           Data Requirement    All Use Patterns   Data to Support MP      Test Notes
                                                                                 or EP
----------------------------------------------------------------------------------------------------------------
885.2100                          Chemical Identity   CR                  EP                  1
----------------------------------------------------------------------------------------------------------------
885.2200                          Nature of the       CR                  EP                  1
                                   Residue in plants
----------------------------------------------------------------------------------------------------------------
885.2250                          Nature of the       CR                  EP                  1
                                   Residue in
                                   animals
----------------------------------------------------------------------------------------------------------------
885.2300                          Analytical methods  CR                  TGAI                1
                                   - plants
----------------------------------------------------------------------------------------------------------------
885.2350                          Analytical methods- CR                  TGAI                1
                                   animals
----------------------------------------------------------------------------------------------------------------
885.2400                          Storage Stability   CR                  EP                  1
----------------------------------------------------------------------------------------------------------------
885.2500                          Magnitude of        CR                  EP                  1
                                   residue in plants
----------------------------------------------------------------------------------------------------------------
885.2550                          Magnitude of        CR                  EP                  1
                                   residues in meat,
                                   milk, poultry,
                                   eggs
----------------------------------------------------------------------------------------------------------------
885.2600                          Magnitude of        CR                  EP                  1
                                   residues in
                                   potable water,
                                   fish, and
                                   irrigated crops
----------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test note is applicable to the data 
requirements for experimental use permit microbial pesticides residue as 
referenced in the last column of the table contained in paragraph (c) of 
this section.
    1. Required when the results of testing:
    i. Indicate the potential to cause adverse human health effects or 
the product characterization indicates the microbial pesticide has a 
significant potential to produce a mammalian toxin; and
    ii. The use pattern is such that residues may be present in or on 
food or feed crops.



Sec. 158.2173  Experimental use permit microbial pesticides toxicology data 

requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the toxicology data requirements for a 
particular microbial pesticide product. Notes that apply to an 
individual test and include specific conditions, qualifications, or 
exceptions to the designated test are listed in paragraph (d) of this 
section.
    (b) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; All=All of the 
above. Specific conditions, qualifications, or exceptions to the 
designated test procedures appear in paragraph (d) of this section, and 
apply to the individual tests in the following table:
    (c) Table. The following table shows the data requirements for 
microbial pesticide toxicology. The test notes are shown in paragraph 
(d) of this section.

                          Table--EUP Microbial Pesticides Toxicology Data Requirements
----------------------------------------------------------------------------------------------------------------
        Guideline Number           Data Requirement    All Use Patterns     Test Substance        Test Notes
----------------------------------------------------------------------------------------------------------------
885.3050                          Acute oral          R                   TGAI                1
                                   toxicity/
                                   pathogenicity
----------------------------------------------------------------------------------------------------------------
885.3150                          Acute pulmonary     R                   TGAI                --
                                   toxicity/
                                   pathogenicity
----------------------------------------------------------------------------------------------------------------
885.3200                          Acute injection     R                   TGAI                2
                                   toxicity/
                                   pathogenicity/
                                   (intravenous)
                                  Acute injection
                                   toxicity/
                                   pathogenicity/
                                   (intraperitoneal).
----------------------------------------------------------------------------------------------------------------
885.3400                          Hypersensitivity    R                   All                 3
                                   incidents
----------------------------------------------------------------------------------------------------------------
885.3500                          Cell culture        R                   TGAI                4
----------------------------------------------------------------------------------------------------------------
870.1100                          Acute oral          R                   MP, EP              1, 5
                                   toxicity
----------------------------------------------------------------------------------------------------------------
870.1200                          Acute dermal        R                   MP, EP              5
                                   toxicity
----------------------------------------------------------------------------------------------------------------
870.1300                          Acute inhalation    R                   MP, EP              5, 6
                                   toxicity
----------------------------------------------------------------------------------------------------------------
870.2400                          Acute eye           R                   MP, EP              5
                                   irritation
----------------------------------------------------------------------------------------------------------------
870.2500                          Primary dermal      CR                  MP, EP              5
                                   irritation
----------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test notes are applicable to the data 
requirements for experimental use permit microbial pesticides toxicology 
as referenced in the last column of the table contained in paragraph (c) 
of this section:
    1. The acute oral toxicity/pathogenicity study is required to 
support the TGAI. However, it can be combined with the unit dose portion 
of the acute oral toxicity study, with an EP or MP test material to 
fulfill the requirement for the TGAI and the MP or EP in a single study, 
if the new protocol is designed to address the endpoints of concern.

[[Page 167]]

    2. Data not required for products whose active ingredient is a 
virus. For test materials whose size or consistency may prevent use of 
an intravenous injection, the intraperitoneal injection procedure may be 
employed.
    3. Hypersensitivity incidents, including immediate type and delayed 
type reactions of humans or domestic animals occur during the testing or 
production of the TGAI, MP, or EP, or are otherwise known to the 
applicant must be reported if they occur.
    4. Data must be submitted only for products whose active ingredient 
is a virus.
    5. The 870 series studies for the MP and EP are intended to provide 
data on the acute toxicity of the product. Waivers for any or all of 
these studies may be granted when the applicant can demonstrate that the 
combination of inert ingredients is not likely to pose any significant 
human health risks. Where appropriate, the limit dose approach to 
testing is recommended.
    6. Required when the product consists of, or under conditions of use 
that would result in an inhalable material (e.g., gas, volatile 
substances, or aerosol particulate).



Sec. 158.2174  Experimental use permit microbial pesticides nontarget 

organisms and environmental fate data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the terrestrial and aquatic nontarget organisms 
data requirements for a particular microbial pesticide product. Notes 
that apply to an individual test including specific conditions, 
qualifications, or exceptions to the designated test are listed in 
paragraph (e) of this section.
    (b) Use patterns. Aquatic uses include: food and feed, nonfood uses 
(e.g., outdoor, residential, and industrial). Terrestrial uses include: 
Food, Feed, Non-Food, Forestry, Residential outdoor, greenhouse (food 
and food), Indoor (food and nonfood), and Industrial.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; All=All of the 
above. Specific conditions, qualifications, or exceptions to the 
designated test procedures appear in paragraph (e) of this section, and 
apply to the individual tests in the following table:
    (d) Table. The following table shows the data requirements for 
experimental use permit microbial pesticides nontarget organisms and 
environmental fate. The test notes are shown in paragraph (e) of this 
section.

                                                                      Table--EUP Microbial Pesticides Nontarget Organisms and Environmental Fate Data Requirements
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                      Use Patterns
                                                  ---------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Aquatic                                                                Terrestrial
       Guideline Number          Data Requirement ---------------------------------------------------------------------------------------------------------------------------------------------------  Test Substance      Test Notes
                                                                                                                                 Residential       Greenhouse          Indoor
                                                       Food/Feed           Nonfood       Food/Feed/Nonfood      Forestry     ------------------------------------------------------    Industrial
                                                                                                                                   Outdoor        Food/Nonfood      Food/Nonfood
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4050                        Avian oral         NR                 R                  R                  R                 R                 NR                NR                NR                TGAI              1, 2
                                toxicity.........
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4200                        Freshwater fish    NR                 R                  R                  R                 NR                NR                NR                NR                TGAI              1, 2, 3
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4240                        Freshwater         NR                 R                  R                  R                 NR                NR                NR                NR                TGAI              1, 2, 3
                                 invertebrate
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4300                        Nontarget plant    NR                 NR                 NR                 R                 NR                NR                NR                NR                TEP               1, 4
                                testing..........
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4340                        Nontarget insect   R                  R                  R                  R                 NR                NR                NR                NR                TGAI              1, 5
                                 testing
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4380                        Honey bee testing  R                  R                  R                  R                 NR                NR                NR                NR                TGAI              1
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 168]]

    (e) Test notes. The following test notes are applicable to the data 
requirements for microbial pesticides nontarget organism and 
environmental fate as referenced in the last column of the table 
contained in paragraph (d) of this section.
    1. Tests for pesticides intended solely for indoor application would 
be required on a case-by-case basis, depending on use pattern, 
production volume, and other pertinent factors. Tests to support EUP's 
are based on the application timing and acreage.
    2. The preferred species for the avian oral study is either the 
upland game or waterfowl. The preferred species for the avian inhalation 
toxicity/pathogenicity study and the avian chronic toxicity/
pathogenicity study is the upland game. There is also the option to test 
a passerine species if there is a concern. The coldwater fish is 
preferred for freshwater fish testing. However, two species (coldwater 
and warmwater fish are the preferred species) must be tested for uses 
involving direct freshwater exposure. Freshwater invertebrates are 
preferred for invertebrate testing.
    3. Required when there will be significant exposure to aquatic 
organisms (fish and invertebrates).
    4. Required if the microbial pesticide is taxonomically related to a 
known plant pathogen.
    5. Data are not required unless an active microbial ingredient 
controls the target insect pest by a mechanism of infectivity; i.e., may 
create an epizootic condition in nontarget insects.



           Subpart W_Antimicrobial Pesticide Data Requirements

    Source: 78 FR 26978, May 8, 2013, unless otherwise noted.

    Effective Date Note: At 78 FR 26978, May 8, 2013, subpart W, 
consisting of Sec. Sec. 158.2200 through 158.2290 was added, effective 
July 8, 2013.



Sec. 158.2200  Applicability.

    Part 158, subpart W establishes data requirements for any pesticide 
product that is:
    (a) A pesticide that is intended for use as an ``antimicrobial 
pesticide'' within the meaning of FIFRA sec. 2(mm)(1)(A), regardless of 
whether it also meets the criterion of FIFRA sec. 2(mm)(1)(B). That 
criterion excludes from the definition any antimicrobial product that is 
intended for a food-use requiring a tolerance or exemption under FFDCA 
sec. 408 or a food additive regulation or clearance under FFDCA sec. 
409. EPA will apply this subpart to all products intended for an 
antimicrobial use, purpose or function; the exclusion in FIFRA sec. 
2(mm)(1)(B) does not exclude products from the data requirements of this 
subpart.
    (b) A product that bears both antimicrobial and non-antimicrobial 
uses or claims. Such a product is subject to the data requirements for 
pesticides in subparts C through O, and U or V of this part with respect 
to its non-antimicrobial uses and claims, and to the requirements of 
this subpart with respect to its antimicrobial uses and claims.
    (c) A wood preservative, including a product that is intended to 
prevent wood degradation problems due to fungal rot or decay, sapstain, 
or molds.
    (d) An antifoulant, including a product that is intended to kill or 
repel organisms that can attach to underwater surfaces, such as boat 
bottoms.



Sec. 158.2201  Antimicrobial use patterns.

    (a) Antimicrobial use patterns. The 12 general use patterns used in 
the data tables in this subpart are:
    (1) Agricultural premises and equipment.
    (2) Food-handling/storage establishments, premises and equipment.
    (3) Commercial, institutional and industrial premises and equipment.
    (4) Residential and public access premises.
    (5) Medical premises and equipment.
    (6) Human drinking water systems.
    (7) Materials preservatives.
    (8) Industrial processes and water systems.
    (9) Antifoulant paints and coatings.
    (10) Wood preservatives.
    (11) Swimming pools.
    (12) Aquatic areas.
    (b) Use site index. The Pesticide Use Site Index for Antimicrobial 
Pesticides is a comprehensive list of specific antimicrobial use sites. 
The Index associates antimicrobial use sites with one or more of the 12 
antimicrobial use patterns. It is to be used in conjunction with the 
data tables in this subpart to

[[Page 169]]

determine the applicability of data requirements to specific uses. The 
Antimicrobial Pesticide Use Site Index, which will be updated 
periodically, is available from the Agency or may be obtained from the 
Agency's Web site at http://www.epa.gov/pesticides.



Sec. 158.2203  Definitions.

    The following terms are defined for the purposes of this subpart:
    Disinfectant means a substance, or mixture of substances, that 
destroys or irreversibly inactivates bacteria, fungi and viruses, but 
not necessarily bacterial spores, in the inanimate environment.
    Fungicide means a substance, or mixture of substances, that destroys 
fungi (including yeasts) and fungal spores pathogenic to man or other 
animals in the inanimate environment.
    Microbiological water purifier means any unit, water treatment 
product or system that removes, kills or inactivates all types of 
disease-causing microorganisms from the water, including bacteria, 
viruses and protozoan cysts, so as to render the treated water safe for 
drinking.
    Sanitizer means a substance, or mixture of substances, that reduces 
the bacteria population in the inanimate environment by significant 
numbers, but does not destroy or eliminate all bacteria. Sanitizers 
meeting Public Health Ordinances are generally used on food contact 
surfaces and are termed sanitizing rinses.
    Sterilant means a substance, or mixture of substances, that destroys 
or eliminates all forms of microbial life in the inanimate environment, 
including all forms of vegetative bacteria, bacterial spores, fungi, 
fungal spores, and viruses.
    Tuberculocide means a substance, or mixture of substances, that 
destroys or irreversibly inactivates tubercle bacilli in the inanimate 
environment.
    Virucide means a substance, or mixture of substances, that destroys 
or irreversibly inactivates viruses in the inanimate environment.



Sec. 158.2204  Public health and nonpublic health claims.

    (a) Public health claim. An antimicrobial pesticide is considered to 
make a public health claim if the pesticide product bears a claim to 
control pest microorganisms that pose a threat to human health, and 
whose presence cannot readily be observed by the user, including but not 
limited to, microorganisms infectious to man in any area of the 
inanimate environment. A product makes a public health claim if one or 
more of the following apply:
    (1) A claim is made for control of specific microorganisms that are 
directly or indirectly infectious or pathogenic to man (or both man and 
animals). Examples of specific microorganisms include, but are not 
limited to: Mycobacterium tuberculosis, Pseudomonas aeruginosa, 
Escherichia coli (E. coli), human immunodeficiency virus (HIV), 
Streptococcus, and Staphylococcus aureus. Claims for control of 
microorganisms infectious or pathogenic only to animals (such as canine 
distemper virus or hog cholera virus) are not considered public health 
claims.
    (2) A claim is made for the pesticide product as a sterilant, 
disinfectant, virucide, sanitizer, or tuberculocide against 
microorganisms that are infectious or pathogenic to man.
    (3) A claim is made for the pesticide product as a fungicide against 
fungi infectious or pathogenic to man, or the product does not clearly 
state that it is intended for use only against nonpublic health fungi.
    (4) A claim is made for the pesticide product as a microbiological 
water purifier or microbial purification system.
    (5) A non-specific claim is made that the pesticide product will 
beneficially impact or affect public health at the site of use or in the 
environment in which it is applied, and:
    (i) The pesticide product contains one or more ingredients that, 
under the criteria in 40 CFR 153.125(a), is an active ingredient with 
respect to a public health microorganism and there is no other 
functional purpose for the ingredient in the product; or
    (ii) The pesticide product is similar in composition to a registered 
pesticide product that makes antimicrobial public health claims.
    (b) Nonpublic health claim. An antimicrobial pesticide is considered 
to make a nonpublic health claim if the

[[Page 170]]

pesticide product bears a claim to control microorganisms of economic or 
aesthetic significance, where the presence of the microorganism would 
not normally lead to infection or disease in humans. Examples of 
nonpublic health claims include, but are not limited to: Algaecides, 
slimicides, preservatives and products for which a pesticidal claim with 
respect to odor sources is made.



Sec. 158.2210  Product chemistry.

    The product chemistry data requirements of subpart D of this part 
apply to antimicrobial products covered by this subpart.



Sec. 158.2220  Product performance.

    (a) General--(1) Product performance requirement for all 
antimicrobial pesticides. Each applicant must ensure through testing 
that his product is efficacious when used in accordance with label 
directions and commonly accepted pest control practices. The Agency may 
require, on a case-by-case basis, submission of product performance data 
for any pesticide product registered or proposed for registration or 
amendment.
    (2) Product performance data for each product that bears a public 
health claim. Each product that bears a public health claim, as 
described in Sec. 158.2204(a), must be supported by product performance 
data, as listed in the table in paragraph (c) of this section. Product 
performance data must be submitted with any application for registration 
or amended registration.
    (3) Product performance data for each product that bears a nonpublic 
health claim. Each product that bears a nonpublic health claim, as 
described in Sec. 158.2204(b), must be supported by product performance 
data. Each registrant must ensure through testing that his product is 
efficacious when used in accordance with label directions and commonly 
accepted practices. The Agency reserves the right to require, on a case-
by-case basis, submission of product performance data for any pesticide 
product registered or proposed for registration or amendment.
    (4) Determination of data requirements. Subpart B of this part and 
Sec. 158.2201 describe how to use the table in paragraph (c) of this 
section to determine the product performance data requirements for 
antimicrobial pesticide products.
    (b) Key. R = Required; EP = End-use product.
    (c) Antimicrobial product performance data requirements table. The 
following table shows the data requirements for antimicrobial product 
performance.

                           Table--Antimicrobial Product Performance Data Requirements
----------------------------------------------------------------------------------------------------------------
         Guideline No.               Data requirement          All use patterns             Test substance
----------------------------------------------------------------------------------------------------------------
810.2100.......................  Sterilants--Efficacy     R.........................  EP
                                  Data Recommendations.
810.2200.......................  Disinfectants for Use    R.........................  EP
                                  on Hard Surfaces--
                                  Efficacy Data
                                  Recommendations.
810.2300.......................  Sanitizers for Use on    R.........................  EP
                                  Hard Surfaces--
                                  Efficacy Data
                                  Recommendations.
810.2400.......................  Disinfectants and        R.........................  EP
                                  Sanitizers for Use on
                                  Fabrics and Textiles--
                                  Efficacy Data
                                  Recommendations.
810.2500.......................  Air Sanitizers--         R.........................  EP
                                  Efficacy Data
                                  Recommendations.
810.2600.......................  Disinfectants for Use    R.........................  EP
                                  in Water--Efficacy
                                  Data Recommendations.
----------------------------------------------------------------------------------------------------------------



Sec. 158.2230  Toxicology.

    (a) General. Subpart B of this part and Sec. 158.2201 describe how 
to use the table in paragraph (g) of this section to determine the 
toxicology data requirements for an antimicrobial pesticide product. 
Notes that apply to an individual test, including specific conditions, 
qualifications, or exceptions are listed in paragraph (h) of this 
section.
    (b) Uses. The applicant for registration must first determine 
whether the use is likely to result in pesticide residues in food or 
water and therefore consult the ``Food Use'' columns of the table in 
paragraph (g) of this section. Generally, if the residues of the 
antimicrobial result from an application to

[[Page 171]]

a surface or if incorporated into a material that may come into contact 
with food or feed, and residues may be expected to transfer to such food 
or feed, then the ``Indirect Food Uses'' columns is to be consulted.
    (c) Tiering of data requirements. Applicants for registration of 
antimicrobials may perform tests in a tiered fashion. After the 
initially required tests are conducted, additional testing may be 
required if results of the initial tests trigger the need for additional 
data. Conditions that trigger the need for additional data are given in 
the test notes in paragraph (h) of this section.
    (d) 200 parts per billion (ppb). The 200 ppb level was originally 
used by the Food and Drug Administration with respect to the 
concentration of residues in or on food for tiering of data requirements 
for indirect food use biocides. The Agency has also adopted this same 
residue level for determining toxicology data requirements for indirect 
food uses of antimicrobial pesticides. The 200 ppb level is the 
concentration of antimicrobial residues in or on the food item.
    (e) Use of OSHA standards. If EPA determines that industrial 
standards, such as the workplace standards set by the Occupational 
Safety and Health Administration (OSHA standards), provide adequate 
protection for a particular pesticide or a particular use pattern, 
additional toxicity data may not be required for that pesticide or the 
use pattern.
    (f) Key. R = Required; CR = Conditionally required; NR = Not 
required; MP = Manufacturing-use product; EP = End-use product; TGAI = 
Technical grade of the active ingredient; TEP = Typical end-use product; 
PAI = Pure active ingredient; PAIRA = Pure active ingredient, 
radiolabeled; Choice = choice of several test substances depending on 
studies required.
    (g) Antimicrobial toxicology data requirements table. The following 
table shows the data requirements for toxicology. The test notes 
applicable to the data requirements in this table appear in paragraph 
(h) of this section.

[[Page 172]]



                                                                        Table--Antimicrobial Toxicology Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Food uses                                          Nonfood uses                         Test substance
                                      -------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                        Swimming pools,
  Guideline  No.    Data  requirement                        Indirect food uses                          aquatic areas,                                                            Test note No.
                                         Direct food uses     (200     Indirect food uses  wood preservatives,   All other nonfood          MP               EP
                                                                    ppb)             (<=200 ppb)         metal working             uses
                                                                                                             fluids
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                          Acute Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
870.1100.........  Acute oral          R..................  R..................  R..................  R..................  R..................  MP and TGAI....  EP and TGAI....            1, 2
                    toxicity--rat.
870.1200.........  Acute dermal        R..................  R..................  R..................  R..................  R..................  MP and TGAI....  EP and TGAI....         1, 2, 3
                    toxicity.
870.1300.........  Acute inhalation    R..................  R..................  R..................  R..................  R..................  MP and TGAI....  EP and TGAI....            2, 4
                    toxicity--rat.
870.2400.........  Primary eye         R..................  R..................  R..................  R..................  R..................  MP and TGAI....  EP and TGAI....         1, 2, 3
                    irritation--rabbi
                    t.
870.2500.........  Primary dermal      R..................  R..................  R..................  R..................  R..................  MP and TGAI....  EP and TGAI....         1, 2, 3
                    irritation.
870.2600.........  Dermal              R..................  R..................  R..................  R..................  R..................  MP and TGAI....  EP and TGAI....      1, 2, 3, 5
                    sensitization.
870.2600.........  Acute               R..................  R..................  CR.................  R..................  CR.................  TGAI...........  TGAI...........           6, 11
                    neurotoxicity--ra
                    t.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Subchronic Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
870.3100.........  90-Day oral         R..................  R..................  R..................  R..................  CR.................  TGAI...........  TGAI...........    8, 9, 15, 38
                    toxicity--rodent.
870.3150.........  90-Day oral         R..................  R..................  CR.................  R..................  CR.................  TGAI...........  TGAI...........          10, 15
                    toxicity--nonrode
                    nt.
870.3200.........  21/28-Day dermal    CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  EP and TGAI....          12, 13
                    toxicity.
870.3250.........  90-Day dermal       CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  EP and TGAI....   7, 13, 14, 15
                    toxicity.
870.3465.........  90-Day inhalation   CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........   7, 15, 16, 17
                    toxicity--rat.
870.6200.........  90-Day              R..................  R..................  CR.................  R..................  CR.................  TGAI...........  TGAI...........            6, 8
                    neurotoxicity--ra
                    t.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Chronic Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
870.4100.........  Chronic oral        R..................  R..................  CR.................  R..................  CR.................  TGAI...........  TGAI...........      18, 19, 20
                    toxicity--rodent.
870.4200.........  Carcinogenicity--t  R..................  R..................  CR.................  R..................  CR.................  TGAI...........  TGAI...........      19, 21, 22
                    wo rodent
                    species--rat and
                    mouse preferred.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 173]]

 
                                                                             Developmental Toxicity and Reproduction
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
870.3700.........  Prenatal            R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........  23, 24, 25, 26
                    developmental
                    toxicity--rat and
                    rabbit preferred.
870.3800.........  Reproduction and    R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........  26, 27, 28, 29
                    fertility effects.
870.6300.........  Developmental       CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........      28, 29, 30
                    neurotoxicity.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                          Mutagenicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
870.5100.........  Reverse mutation    R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........          31, 32
                    assay.
870.5300.........  In vitro mammalian  R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........          31, 33
870.5375.........   gene mutation.
870.5385.........  In vivo             R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........          31, 34
870.5395.........   cytogenetics.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Special Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
870.7485.........  Metabolism and      R..................  R..................  CR.................  R..................  CR.................  PAI or PAIRA...  PAI or PAIRA...          35, 39
                    pharmacokinetics.
870.7200.........  Companion animal    CR.................  CR.................  CR.................  CR.................  CR.................  NR.............  Choice.........              36
                    safety.
870.7600.........  Dermal penetration  CR.................  CR.................  CR.................  CR.................  CR.................  Choice.........  Choice.........           3, 37
870.7800.........  Immunotoxicity....  R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........               8
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 174]]

    (h) Test notes. The following test notes apply to the data 
requirements in the table to paragraph (g) of this section:
    1. Not required if test material is a gas or highly volatile liquid.
    2. The six end-use product (EP) acute toxicity studies are required 
using the product as formulated for sale and distribution. In addition, 
if the EP label has directions for diluting the product, then, the 
applicant may also need to conduct certain of the acute toxicity studies 
using the highest concentration labeled for dilution (i.e., the least 
diluted product). The end-use dilution testing is in addition to the 
testing conducted on the EP.
    3. Not required if test material is corrosive to skin or has pH less 
than 2 or greater than 11.5.
    4. Data are required when the product consists of, or under 
conditions of use will result in, a respirable material (e.g., gas, 
vapor, aerosol or particulates).
    5. Data are required if repeated dermal exposure is likely to occur 
under conditions of use.
    6. For indirect food uses <= 200 ppb, and all other nonfood uses, 
data are required if the neurotoxicity screen in the 90-day oral rodent 
study or other data indicate neurotoxicity.
    7. The 90-day dermal toxicity study and/or 90-day inhalation 
toxicity study are required if the Agency determines that dermal and/or 
inhalation exposure is the primary route of exposure.
    8. All 90-day subchronic studies in the rodent can be designed to 
simultaneously fulfill the requirements of the 90-day neurotoxicity and/
or immunotoxicity studies by adding separate groups of animals for 
testing of neurotoxicity and/or immunotoxicity parameters.
    9. The 90-day study is required in the rodent for hazard 
characterization (possibly endpoint selection) and dose-setting for the 
chronic/carcinogenicity study. It is not required in the mouse, but the 
Agency would encourage the applicant to conduct a 90-day range finding 
study for the purposes of dose selection for the mouse carcinogenicity 
study to achieve adequate dosing and an acceptable study.
    10. A 1-year non-rodent study (i.e., 1-year dog study) may be 
required if the Agency finds that a pesticide chemical is highly 
bioaccumulative and slowly eliminated. EPA may also require the 
appropriate metabolism and pharmacokinetic studies to evaluate more 
precisely bioavailability, half life, and steady state to determine if a 
longer duration dog toxicity study is needed.
    11. Although the subchronic toxicity testing guidelines include 
measurement of neurological endpoints, such screens do not meet the 
requirement of the 90-day neurotoxicity study. For nonfood uses, if the 
90-day study does not include a neurotoxicity screen, then the acute 
neurotoxicity study will be required.
    12. Data are required if all of the following criteria are met:
    i. The intended use of the antimicrobial pesticide product is 
expected to result in repeated dermal human exposure to the product.
    ii. Data from a 90-day dermal toxicity study are not available.
    iii. The 90-day dermal toxicity study has not been triggered.
    13. EP testing is required if the product or any component of the 
product may increase dermal absorption of the active ingredient(s) or 
increases its toxic or pharmacologic effects, as determined by testing 
using the TGAI or based on available information about the toxic effects 
of the product or its components.
    14. Data are required if the active ingredient in the product is 
known or expected to be metabolized differently by the dermal route of 
exposure than by the oral route, and a metabolite of the active 
ingredient is the toxic moiety.
    15. A 90-day oral toxicity test is not required for heating, 
ventilation, air conditioning, and refrigeration systems (collectively 
referred to as HVAC&R). Instead, two 90-day toxicity tests, one by the 
dermal route and one by the inhalation route are required.
    16. Data are required if there is the likelihood of significant 
repeated inhalation exposure to the pesticide as a gas, vapor, or 
aerosol.
    17. Based on estimates of the magnitude and duration of human 
exposure, studies of shorter duration, e.g.,

[[Page 175]]

21- or 28-days, may be sufficient to satisfy this requirement. The prime 
consideration in determining the appropriateness of a shorter duration 
study is the likely period of time for which humans will be exposed.
    18. Based on the positive results of the acute or 90-day 
neurotoxicity studies, or on other data indicating neurotoxicity, a 
chronic neurotoxicity study (i.e., a chronic study with additional 
neurotoxicity evaluations) may be required to provide information about 
potential neurotoxic effects from long-term exposures.
    19. Studies which are designed to simultaneously fulfill the 
requirements of both the chronic oral and carcinogenicity studies (i.e., 
a combined study) may be conducted.
    20. For indirect food uses <= 200 ppb, and all other nonfood uses, 
data are required if either of the following criteria are met:
    i. The use of the pesticide is likely to result in repeated human 
exposure over a considerable portion of the human lifespan; or
    ii. The use requires that a tolerance, tolerance exemption, or food 
additive regulation or clearance be established.
    21. For indirect food uses <= 200 ppb, and all other nonfood uses, 
data are required if any of the following criteria, are met:
    i. The use of the pesticide is likely to result in significant human 
exposure over a considerable portion of the human life span which is 
significant in terms of frequency, time, duration, and/or magnitude of 
exposure.
    ii. The use requires that a tolerance, tolerance exemption, or food 
additive regulation or clearance be established.
    iii. The active ingredient, metabolite, degradate, or impurity:
    A. Is structurally related to a recognized carcinogen;
    B. Causes mutagenic effects as demonstrated by in vitro or in vivo 
testing; or
    C. Produces a morphologic effect in any organ (e.g., hyperplasia, 
metaplasia) in subchronic studies that may lead to a neoplastic change.
    22. If the requirement for a carcinogenicity study in any species is 
modified or waived for any reason, then a subchronic 90-day oral study 
in the same species may be required.
    23. Testing in two species is required for all uses.
    24. The oral route, by oral intubation, is preferred, unless the 
chemical or physical properties of the test substance, or the pattern of 
human exposure, suggest a more appropriate route of exposure.
    25. Additional testing by other routes of exposure may be required 
if the pesticide is determined to be a prenatal developmental toxicant 
after oral dosing.
    26. The developmental toxicity study in rodents may be combined with 
the two-generation reproduction study in rodents by using a second 
mating of the parental animals in either generation. Protocols must be 
approved by the Agency prior to the initiation of the study.
    27. A two-generation reproduction study is required.
    28. An information-based approach to testing is preferred, which 
utilizes the best available knowledge on the chemical (hazard, 
pharmacokinetic, or mechanistic data) to determine whether a standard 
guideline study, an enhanced guideline study, or an alternative study 
should be conducted to assess potential hazard to the developing animal. 
Applicants must submit any alternative proposed testing protocols and 
supporting scientific rationale to the Agency. Protocols must be 
approved by the Agency prior to the initiation of the study.
    29. The use of a combined two-generation reproduction/developmental 
neurotoxicity study that utilizes the two-generation reproduction study 
in rodents as a basic protocol for the addition of other endpoints or 
functional assessments in the immature animal is encouraged.
    30. A DNT study is required using a weight-of-evidence approach 
when:
    i. The pesticide causes treatment-related neurological effects in 
adult animal studies (i.e., clinical signs of neurotoxicity, 
neuropathology, functional or behavioral effects).
    ii. The pesticide causes treatment-related neurological effects in 
developing animals, following pre- or post-natal

[[Page 176]]

exposure (i.e., nervous system malformations or neuropathy, brain weight 
changes in offspring, functional or behavioral changes in the 
offspring).
    iii. The pesticide elicits a causative association between exposures 
and adverse neurological effects in human epidemiological studies.
    iv. The pesticide evokes a mechanism that is associated with adverse 
effects on the development of the nervous system (i.e., structure-
activity-relationship (SAR) to known neurotoxicants, altered 
neuroreceptor or neurotransmitter responses).
    31. To facilitate the weight-of-evidence determination for the 
pesticide's mutagenicity, in addition to those specifically listed in 
this table, the Agency requires submission of other mutagenicity test 
results that may have been performed. A reference list of all studies 
and papers known to the applicant concerning the mutagenicity of the 
test chemical must be submitted with the required studies.
    32. Due to the nature of antimicrobials, if testing with bacterial 
strains has not been conducted, then testing using a mammalian cell 
assay such as the mouse lymphoma TK  assay is 
preferred. If reverse mutation assay testing with bacterial strains has 
already been conducted, and the testing was conducted at levels that did 
not cause toxicity to the bacterial strains tested, then the applicant 
may submit the study to fulfill this data requirement.
    33. For the in vitro mammalian gene mutation study, there is a 
choice of assays using either mouse lymphoma L5178Y cell thymidine 
kinase (tk) gene locus, maximizing assay conditions for small colony 
expression and detection; Chinese hamster ovary (CHO) or Chinese hamster 
lung fibroblast (v79) cells, hypoxanthine-guanine phosphoribosyl 
transferase (hgprt) gene locus, accompanied by an appropriate in vitro 
test for clastogenicity; or CHO cells strains AS52, xanthine-guanine 
phosphoribosyl transferase (xprt) gene locus.
    34. There is a choice of assays, but the micronucleus rodent bone 
marrow assay is preferred; the rodent bone marrow assays using metaphase 
analysis (aberrations) are acceptable.
    35. Data are required when chronic toxicity or carcinogenicity 
studies are also required.
    36. Data is required if the product label directs that it be applied 
to domestic animals, such as cats, dogs, cattle, pigs, and horses.
    37. In the absence of dermal absorption data or a repeated dose 
dermal toxicity study, the assumption of 100 percent dermal absorption 
would be used in a risk assessment to determine if a dermal penetration 
study is required, and to identify the doses and duration of exposure 
for which dermal absorption is to be quantified.
    38. Required for nonfood uses, if oral exposure could occur.
    39. Data may be required if significant adverse effects are seen in 
available toxicology studies and these effects can be further elucidated 
by metabolism and pharmacokinetics studies.



Sec. 158.2240  Nontarget organisms.

    (a) General. Subpart B of this part and Sec. 158.2201 describe how 
to use the table in paragraph (c) of this section to determine the 
terrestrial and aquatic nontarget organisms data requirements for a 
particular antimicrobial pesticide product. Notes that apply to an 
individual test, including specific conditions, qualifications, or 
exceptions are listed in paragraph (d) of this section.
    (1) Terrestrial and aquatic nontarget organism data are required to 
support the registration of most end-use and manufacturing-use 
antimicrobial products.
    (2) Data are generally not required to support end-use products of a 
gas, highly volatile liquid, highly reactive solid, or a highly 
corrosive material.
    (3) Data on transformation/degradation products or leachate residues 
of the parent compound are also required to support registration, if the 
transformation/degradation/degradation products or leachate residues 
meet one of the following criteria:
    (i) More toxic, persistent, or bioaccumulative than the parent;
    (ii) Have been shown to cause adverse effects in mammalian or 
aquatic reproductive studies; or

[[Page 177]]

    (iii) The moiety of concern (i.e., functional group in the parent 
chemical molecule that imparts adverse effects) remains intact.
    (4) If an antimicrobial may be applied to a field crop, 
horticultural crop, or turf, then the data requirements in Sec. 158.630 
apply.
    (5) For the purpose of determining data requirements, the all other 
use patterns category includes the following use patterns:
    (i) Agricultural premises and equipment.
    (ii) Food-handling/storage establishments, premises, and equipment.
    (iii) Commercial, institutional and industrial premises and 
equipment.
    (iv) Residential and public access premises.
    (v) Medical premises and equipment.
    (vi) Human drinking water systems.
    (vii) Materials preservatives.
    (viii) Swimming pools.
    (b) Key. MP = Manufacturing use product; EP = End-use product; R = 
Required; CR = Conditionally required; NR = Not required; TGAI = 
Technical grade of the active ingredient; TEP = Typical end-use product; 
PAIRA = Pure active ingredient radiolabeled; a.i. = active ingredient.
    (c) Antimicrobial nontarget organism data requirements table. The 
following table shows the data requirements for nontarget organisms. The 
test notes appear in paragraph (d) of this section.

[[Page 178]]



                                                                    Table--Antimicrobial Nontarget Organism Data Requirements
                                                                                        Tier One Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2100.........  Acute avian oral    R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........               1
                    toxicity.
850.1010.........  Acute freshwater    R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........               2
                    invertebrates
                    toxicity.
850.1075.........  Acute freshwater    R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........               3
                    fish toxicity.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Higher Tier Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Avian Testing...................................................................................................................................................................................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2200.........  Avian dietary       CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........               4
                    toxicity.
850.2300.........  Avian reproduction  CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........            1, 6
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    Aquatic Organisms Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1010.........  Acute freshwater    CR.................  CR.................  CR.................  CR.................  CR.................  ...............  TEP............         2, 5, 7
                    invertebrates
                    toxicity.
850.1075.........  Acute freshwater    CR.................  CR.................  CR.................  CR.................  CR.................  ...............  TEP............         3, 5, 7
                    fish toxicity.
850.1025.........  Acute estuarine     CR.................  R..................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........            8, 9
                    and marine
                    organisms
                    toxicity.
850.1035
850.1045
850.1055.........  Acute estuarine     CR.................  CR.................  CR.................  CR.................  CR.................  ...............  TEP............         5, 7, 8
                    and marine
                    organisms
                    toxicity.
850.1075
850.1400.........  Fish early-life     R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........              10
                    stage.
850.1300.........  Aquatic             R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........              10
                    invertebrate life-
                    cycle.
850.1350
850.1500.........  Fish life-cycle...  CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........          11, 12
850.1710.........  Aquatic organisms,  CR.................  CR.................  CR.................  CR.................  CR.................  TGAI, PAI,       TGAI, PAI,                   13
                    bioavailability,                                                                                                             degradate.       degradate.
                    biomagnification,
                    toxicity tests.
850.1730
850.1850
850.1950.........  Simulated or        CR.................  CR.................  CR.................  CR.................  CR.................  TEP............  TEP............      14, 15, 16
                    actual field
                    testing for
                    aquatic organisms.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 179]]

 
                                                                                        Sediment Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1735.........  Whole sediment;     CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........          15, 17
                    acute freshwater
                    invertebrates.
850.1740.........  Whole sediment;     CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........      15, 17, 19
                    acute marine
                    invertebrates.
None.............  Whole sediment;     CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........      15, 18, 19
                    chronic
                    invertebrates
                    fresh-water and
                    marine.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    Insect Pollinator Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.3020.........  Honeybee acute      NR.................  NR.................  R..................  NR.................  CR.................  TGAI...........  TGAI...........              20
                    contact.
850.3030.........  Toxicity of         NR.................  NR.................  R..................  NR.................  CR.................  TGAI...........  TEP or treated           20, 21
                    residues to                                                                                                                                   wood.
                    honeybees.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 180]]

    (d) Test notes. The following test notes apply to the data 
requirements in the table to paragraph (c) of this section:
    1. For industrial processes and water systems, antifoulant paints 
and coatings, wood preservatives, and aquatic areas, data are required 
for two avian species: one waterfowl species and one upland game bird 
species. For the all other use patterns category (as specified in Sec. 
158.2240(a)(5)), data are required for one avian species.
    2. Data are required on one freshwater aquatic invertebrate species.
    3. For the industrial processes and water systems, antifoulant 
paints and coatings, wood preservatives, and aquatic use pattern areas, 
data are required on two species of fish, one cold water species and one 
warm water species. For the all other use patterns category (as 
specified in Sec. 158.2240(a)(5)), data are required on one species of 
fish, either one cold water species or one warm water species. Testing 
on a second species is required if the active ingredient or principal 
transformation products are stable in the environment and the 
LC50 in the first species is less than or equal to 1 ppm or 1 
mg/L.
    4. Data are required on one avian species, either one waterfowl 
species or one upland game bird species, if the avian acute oral 
LD50 (TGAI testing) is less than or equal to 100 mg/a.i./kg 
and a.i. residues or its principal transformation products are likely to 
occur in avian feed items. Data on the second species are required if 
the avian dietary LC50 in the first species tested is less 
than or equal to 500 ppm a.i. in the diet.
    5. If TEP testing cannot be conducted due to the physical 
characteristics of the test substance (for example, a paint), then the 
applicant should request a waiver.
    6. Data are required if one or more of the following criteria are 
met:
    i. Birds may be subjected to repeated or continued exposure to the 
pesticide or any of its transformation products, especially preceding or 
during the breeding season.
    ii. The pesticide or any of its major metabolites or degradation 
products are stable in the environment to the extent that a potentially 
toxic amount may persist in avian feed.
    iii. The pesticide or any of its major metabolites or degradation 
products are stored or accumulated in plant or animal tissues, as 
indicated by the octanol/water partition coefficient (Kow is 
greater than or equal to 1,000), accumulation studies, metabolic release 
and retention studies, or as indicated by structural similarity to known 
bioaccumulative chemicals.
    iv. Any other information, such as that derived from mammalian 
reproduction studies, indicates that reproduction in terrestrial 
vertebrates may be adversely affected by the anticipated use of the 
pesticide product.
    7. TEP testing is required for any product which meets one or more 
of the following conditions:
    i. When based on deterministic modeling results: If the Estimated 
Environmental Concentration (EEC) in the aquatic environment is equal to 
or greater than one-half the LC50/EC50 of the 
TGAI.
    ii. When based on probabilistic modeling results: If the estimated 
10th percentile 7Q10 Surface Water Concentration exceeds the acute 
concentration of concern (i.e., one-half the LC50/
EC50).
    iii. If an ingredient in the end-use product other than the active 
ingredient is expected to enhance the toxicity of the active ingredient 
or to cause toxicity to aquatic organisms.
    iv. The end-use antimicrobial product will be applied directly into 
an aquatic environment.
    8. Data are required on one estuarine/marine mollusk, one other 
estuarine/marine invertebrate, and one estuarine/marine fish species.
    9. For the all other use patterns category (as specified in Sec. 
158.2240(a)(5)), industrial processes and water systems, wood 
preservatives, and aquatic areas, data are required if the pesticide 
residues from the parent compound and/or transformation products are 
likely to enter the estuarine/marine environment.
    10. Testing must be conducted with the most sensitive organism 
(either freshwater or estuarine/marine vertebrates, or freshwater or 
estuarine/marine invertebrates), as determined from the results of the 
acute toxicity

[[Page 181]]

tests (acute EC50 freshwater invertebrates; acute 
LC50/EC50 estuarine and marine organisms; acute 
freshwater fish LC50).
    11. Data are required on estuarine/marine species if the product is 
intended for direct application to the estuarine or marine environment, 
or the product is expected to enter this environment in significant 
concentrations because of its expected use or mobility patterns.
    12. Data are required on freshwater species if the end-use product 
is intended to be applied directly to water, or is expected to be 
transported to water from the intended use site, and when one or more of 
the following conditions apply:
    i. When based on deterministic modeling results: If the Estimated 
Environmental Concentration (EEC) in water is equal to or greater than 
0.1 of the no-observed-adverse-effect concentration or no-observed-
adverse-effect level (NOAEC/NOAEL) in the fish early-life stage or 
invertebrate life cycle tests.
    ii. When based on probabilistic modeling results: If the estimated 
10th percentile 7Q10 Surface Water Concentration based on probabilistic 
modeling exceeds for 20 days or more the chronic concentration of 
concern (i.e., one-tenth the NOAEC or NOAEL) determined in the fish 
early-life stage or invertebrate life cycle tests.
    iii. If studies of other organisms indicate that the reproductive 
physiology of fish may be affected.
    13. Not required when:
    i. The octanol/water partition coefficients of the pesticide and its 
major degradates are less than 1,000;
    ii. There are no potential exposures to fish and other nontarget 
aquatic organisms; or
    iii. The hydrolytic half-life is less than 5 days at pH 5, 7, and 9.
    14. Environmental chemistry methods used to generate data associated 
with this study must include results of a successful confirmatory method 
trial by an independent laboratory. Test standards and procedures for 
independent laboratory validation are available as addenda to the 
guideline for this test requirement.
    15. Protocols must be approved by the Agency prior to the initiation 
of the study.
    16. Data are required if the intended use pattern, and the physical/
chemical properties and environmental fate characteristics of the 
antimicrobial indicate significant potential exposure, and, based on the 
results of the acute and chronic aquatic organism testing, significant 
impairment of nontarget aquatic organisms could result.
    17. Data are required if the half-life of the pesticide in the 
sediment is equal to or less than 10 days in either the aerobic soil or 
aquatic metabolism studies, and if one or more of the following 
conditions are met:
    i. The soil partition coefficient (Kd) is equal to or 
greater than 50 L/kg.
    ii. The log Kow is equal to or greater than 3.
    iii. The Koc is equal to or greater than 1,000.
    18. Data are required if the EEC in sediment is greater than 0.1 of 
the acute LC50/EC50 values and if one or more of 
the following conditions are met:
    i. The soil partition coefficient (Kd) is equal to or 
greater than 50 L/kg.
    ii. The log Kow is equal to or greater than 3.
    iii. The Koc is equal to or greater than 1,000.
    19. Sediment testing with estuarine/marine test species is required 
if the product is intended for direct application to the estuarine or 
marine environment or the product is expected to enter this environment 
in significant concentrations either by runoff or erosion, because of 
its expected use or mobility pattern.
    20. For the all other use patterns category (as specified in Sec. 
158.2240(a)(5)), data are required only for beehive applications when 
the beehive (empty or occupied) may be treated.
    21. A study similar to ``Honey Bee Toxicity of Residues on Foliage'' 
is required using treated wood instead of the foliage. Protocols must be 
approved by the Agency prior to the initiation of the study.



Sec. 158.2250  Nontarget plant protection.

    (a) Subpart B of this part and Sec. 158.2201 describe how to use 
the table

[[Page 182]]

in paragraph (f) of this section to determine the nontarget plant 
protection data requirements for a particular antimicrobial pesticide 
product. Notes that apply to an individual test including specific 
conditions, qualifications, or exceptions are listed in paragraph (g) of 
this section.
    (b) Data on transformation/degradation products or leachate residues 
of the parent compound are also required to support registration, if the 
transformation/degradation products or leachate residues meet one of the 
following criteria:
    (1) More toxic, persistent, or bioaccumulative than the parent;
    (2) Have been shown to cause adverse effects in mammalian or aquatic 
reproductive studies; or
    (3) The moiety of concern (i.e., functional group in the parent 
chemical molecule that imparts adverse effects) remains intact.
    (c) For the purpose of determining data requirements, the all other 
use patterns category includes the following use patterns:
    (1) Agricultural premises and equipment.
    (2) Food-handling/storage establishments, premises, and equipment.
    (3) Commercial, institutional and industrial premises and equipment.
    (4) Residential and public access premises.
    (5) Medical premises and equipment.
    (6) Human drinking water systems.
    (7) Materials preservatives.
    (8) Swimming pools.
    (d) If an antimicrobial may be applied to a field crop, 
horticultural crop, or turf, then the data requirements in Sec. 158.660 
apply.
    (e) Key. MP = Manufacturing use product; EP = End-use product; R = 
Required; CR = Conditionally required; NR = Not required; TGAI = 
Technical grade of the active ingredient; TEP = Typical end-use product.
    (f) Nontarget plant protection data requirements table. The 
following table shows the data requirements for nontarget plant 
protection. The test notes appear in paragraph (g) of this section.

[[Page 183]]



                                                                       Table--Nontarget Plant Protection Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                     Use pattern                                                         Test substance
                                      -------------------------------------------------------------------------------------------------------------------------------------------
  Guideline No.     Data  requirement       Industrial                                                                                                                             Test note No.
                                       processes and water      Antifoulant       Wood preservatives     Aquatic areas        All other use            MP               EP
                                             systems        coatings and paints                                             patterns  category
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4225.........  Seedling            CR.................  CR.................  CR.................  CR.................  CR.................  TEP............  TEP............            1, 2
                    emergence, Tier
                    II--dose response.
850.4250.........  Vegetative vigor,   CR.................  NR.................  CR.................  CR.................  CR.................  TEP............  TEP............            1, 3
                    Tier II--dose
                    response.
850.4400.........  Aquatic plant       R..................  R..................  R..................  R..................  CR.................  TGAI, TEP......  TGAI, TEP......           4, 10
                    growth (aquatic
                    vascular plant)
                    Tier II--dose
                    response.
850.5400.........  Aquatic plant       R..................  R..................  R..................  R..................  R..................  TGAI, TEP......  TGAI, TEP......         4, 5, 6
                    growth (algal)
                    Tier II (dose
                    response).
850.4300.........  Terrestrial field.  CR.................  CR.................  CR.................  CR.................  CR.................  TEP............  TEP............         7, 8, 9
850.4450.........  Aquatic field.....  CR.................  CR.................  CR.................  CR.................  CR.................  TEP............  TEP............         7, 8, 9
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 184]]

    (g) Test notes. The following test notes apply to the data 
requirements in the table to paragraph (f) of this section:
    1. Data on only one plant species (rice, Oryza sativa) are required.
    2. Data are required if the risk quotient from any aquatic plant 
growth Tier II study exceeds a level of concern for aquatic plants.
    3. Not required when:
    i. There are no potential exposures to plants;
    ii. The hydrolytic half-life is less than 5 days at pH 5, 7, and 9; 
or
    iii. The results of a biodegradation study indicate that the active 
ingredient or principal degradation products are not biodegradable in 28 
days, i.e., the biodegradation curve has not reached a plateau for at 
least three determinations within the 28 days.
    4. For TEP testing, data are required for the applicant's end-use 
product if an ingredient in the end-use product, other than the active 
ingredient, is expected to enhance the toxicity of the active 
ingredient.
    5. One Tier II (dose response) study, conducted with Selenastrum 
capricornutum, is required for the all other use patterns category (as 
specified in Sec. 158.2250(c)). If the results of this study exhibit 
detrimental effects (EC50 less than 1.0 ppm or mg/L), then 
additional Tier II (dose response) studies are required on three species 
(Anabaena flos-aquae, Navicula pelliculosa, and Skeletonema costatum).
    6. For industrial processes and water systems, antifoulant coatings 
and paints, wood preservatives, and aquatic areas, Tier II (dose 
response) studies are required on four species (Anabaena flos-aquae, 
Navicula pelliculosa, Skeletonema costatum, and Selenastrum 
capricornutum).
    7. Environmental chemistry methods used to generate data must 
include the results of a successful confirmatory method trial by an 
independent laboratory.
    8. Tests are required on a case-by-case basis based on the results 
of lower tier plant protection studies, adverse incident reports, 
intended use pattern, and environmental fate characteristics that 
indicate potential exposure.
    9. Protocols must be approved by the Agency prior to the initiation 
of the study.
    10. For the all other use patterns category (as specified in Sec. 
158.2250(c)), data are required if the aquatic (algal) plant growth Tier 
II study demonstrates detrimental effects at less than 1.0 ppm or mg/L.



Sec. 158.2260  Applicator exposure.

    (a) General. Subpart B of this part and Sec. 158.2201 describe how 
to use the table in paragraph (d) of this section to determine the 
applicator exposure data requirements for antimicrobial pesticide 
products. Notes that apply to an individual test including specific 
conditions, qualifications, or exceptions are listed in paragraph (e) of 
this section.
    (1) The Agency may accept surrogate exposure data estimations and/or 
modeling estimations from other sources to satisfy exposure data 
requirements. The surrogate data must meet the basic quality assurance, 
quality control, good laboratory practice, and other scientific 
requirements set by EPA. To be acceptable, the Agency must find that the 
surrogate exposure data estimations have adequate information to address 
the applicable exposure data requirements and contain adequate 
monitoring events of acceptable quality. The data must reflect the 
specific use prescribed on the label and the activity of concern, 
including formulation type, application methods and rates, type of 
activity, and other pertinent information.
    (2) Occupational uses include not only handlers, mixers, loaders, 
and applicators, but also commercial applications to residential sites. 
Residential uses are limited to non-occupational, i.e., non-
professional, antimicrobial applications. Both occupational and 
residential applicator data may be required for the same product.
    (b) Criteria for testing. Applicator exposure data described in the 
table to paragraph (d) of this section are required based on toxicity 
and exposure criteria. Data are required if at least one of the toxicity 
criteria in paragraph (b)(1) of this section, and at least one of the 
exposure criteria in paragraph (b)(2) of this section are met.

[[Page 185]]

    (1) Toxicity criteria. (i) Evidence of potentially significant 
adverse effects have been observed in any applicable toxicity studies.
    (ii) Scientifically sound epidemiological or poisoning incident data 
with a clear cause-effect relationship indicating that adverse health 
effects may have resulted from exposure to the pesticide.
    (2) Exposure criteria. (i) Dermal exposure may occur during product 
use.
    (ii) Respiratory exposure may occur during product use.
    (c) Key. R = Required; CR = Conditionally required; TEP = Typical 
end-use product.
    (d) Antimicrobial applicator exposure data requirements table. The 
following table shows the data requirements for applicator exposure. The 
test notes appear in paragraph (e) of this section.

                                               Table--Antimicrobial Applicator Exposure Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Use sites
           Guideline No.                  Data requirements      --------------------------------------------------     Test  substance       Test note
                                                                        Occupational             Residential                                     No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1100...........................  Dermal exposure............  R......................  R......................  TEP....................   1, 2, 3, 4
875.1200
875.1300...........................  Inhalation exposure........  R......................  R......................  TEP....................   1, 2, 3, 4
875.1400
875.1500...........................  Biological monitoring......  CR.....................  CR.....................  TEP....................      1, 2, 3
875.1600...........................  Data reporting and           R......................  R......................  TEP....................            5
                                      calculations.
875.1700...........................  Product use information....  R......................  R......................  TEP....................  ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes apply to the data 
requirements in the table to paragraph (d) of this section:
    1. Prior to initiation of the study, protocols involving intentional 
exposure of human subjects must be submitted for review by EPA and then 
the Human Studies Review Board (HSRB) according to 40 CFR 26.1125. 
Examples of proposed human study research can be found in various 
reviews provided by the Human Studies Review Board (http://www.epa.gov/
osa/hsrb/index.htm).
    2. Biological monitoring data may be submitted in addition to, or in 
lieu of, dermal and inhalation passive dosimetry exposure data, provided 
the human pharmacokinetics of the pesticide or metabolite/analog 
compounds (i.e., whichever method is selected as an indicator of body 
burden or internal dose) allow for the back calculation to the total 
internal dose.
    3. For products with both indoor and outdoor uses, and similar 
conditions of use, data are generally required for the indoor 
applications only. However, data for outdoor uses are required if the 
Agency expects outdoor uses to result in greater exposure than indoor 
uses (e.g., higher use rates and application frequency, or longer 
exposure duration, or application methods/equipment create potential for 
increased dermal or inhalation exposure in outdoor versus indoor use 
sites). In certain cases, when a pesticide may be used both indoors and 
outdoors under dissimilar conditions of use, the Agency may require 
submission of applicator exposure data for both use patterns.
    4. EPA will consider waiving this data requirement for 
antimicrobials applied via closed loading systems if the antimicrobial 
has a low vapor pressure.
    5. Data reporting and calculations are required only if handler 
exposure data are required.



Sec. 158.2270  Post-application exposure.

    (a) General. Subpart B of this part and Sec. 158.2201 describe how 
to use the table in paragraph (d) of this section to determine the post-
application exposure data requirements for antimicrobial pesticide 
products. The data generated during these studies are used to determine 
the quantity of pesticide to which people may be exposed after 
application. Notes that apply to an individual test, including specific 
conditions, qualifications, or exceptions to the designated test, are 
listed in paragraph (e) of this section.

[[Page 186]]

    (1) Post-application exposure data are required when certain 
toxicity criteria are met and the human activities associated with the 
pesticide's use pattern can lead to potential adverse exposures.
    (2) The Agency may accept surrogate exposure data estimations and/or 
modeling estimations from other sources to satisfy exposure data 
requirements. The surrogate data must meet the basic quality assurance, 
quality control, good laboratory practice, and other scientific 
requirements set by EPA. To be acceptable, the Agency must find that the 
surrogate exposure data estimations have adequate information to address 
the applicable exposure data requirements and contain adequate 
monitoring events of acceptable quality. The data must reflect the 
specific use prescribed on the label and the activity of concern, 
including formulation type, application methods and rates, type of 
activity, and other pertinent information.
    (b) Criteria for testing. Post-application exposure data described 
in the table to paragraph (d) of this section are required based on 
toxicity and exposure criteria. Data are required if at least one of the 
toxicity criteria in paragraph (b)(1) of this section, and at least one 
of the exposure criteria in paragraph (b)(2) of this section are met.
    (1) Toxicity criteria. (i) Evidence of potentially significant 
adverse effects have been observed in any applicable toxicity studies.
    (ii) Scientifically sound epidemiological or poisoning incident data 
with a clear cause-effect relationship indicating that adverse health 
effects may have resulted from exposure to the pesticide.
    (2) Exposure criteria--(i) Outdoor uses. (A) Occupational human 
post-application or bystander exposure to residues of antimicrobial 
pesticides could occur as the result of, but is not limited to, worker 
reentry into treatment sites, clean-up and equipment maintenance tasks, 
handling wood preservative-treated wood, or other work-related activity.
    (B) Residential human post-application or bystander exposure to 
residues of antimicrobial pesticides could occur following the 
application of antimicrobial pesticides to outdoor areas and spaces at 
residential sites, such as, but not limited to homes, daycare centers, 
and other public buildings.
    (ii) Indoor uses. (A) Occupational human post-application or 
bystander exposure to pesticide residues could occur following the 
application of the antimicrobial pesticide to indoor spaces or surfaces.
    (B) Residential human post-application or bystander exposure to 
pesticide residues could occur following the application of the 
antimicrobial pesticide to indoor spaces or surfaces at residential 
sites, such as, but not limited to homes, daycare centers, hospitals, 
schools, and other public buildings.
    (c) Key. R = Required; CR = Conditionally required; NR = Not 
required; TEP = Typical end-use product.
    (d) Antimicrobial post-application exposure data requirements table. 
The following table shows the data requirements for post-application 
exposure. The test notes appear in paragraph (e) of this section.

                                            Table--Antimicrobial Post-Application Exposure Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Use sites
           Guideline No.                   Data requirement      --------------------------------------------------     Test  substance       Test note
                                                                        Occupational             Residential                                     No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.2200...........................  Soil residue dissipation...  CR.....................  CR.....................  TEP....................         2, 3
875.2300...........................  Indoor surface residue       CR.....................  R......................  TEP....................   3, 4, 5, 6
                                      dissipation.
875.2400...........................  Dermal exposure............  CR.....................  CR.....................  TEP....................      1, 7, 8
875.2500...........................  Inhalation exposure........  CR.....................  CR.....................  TEP....................    1,7, 8, 9
875.2600...........................  Biological monitoring......  CR.....................  CR.....................  TEP....................         1, 8
875.2700...........................  Product use information....  R......................  R......................  TEP....................
875.2800...........................  Description of human         R......................  R......................  TEP....................
                                      activity.
875.2900...........................  Data reporting and           R......................  R......................  TEP....................           10
                                      calculations.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes apply to the data 
requirements in the table to paragraph (d) of this section:

[[Page 187]]

    1. Prior to initiation of the study, protocols involving intentional 
exposure of human subjects must be submitted for review by EPA and then 
the Human Studies Review Board (HSRB) according to 40 CFR 26.1125. 
Examples of proposed human study research can be found in various 
reviews provided by the Human Studies Review Board (HSRB) (http://
www.epa.gov/osa/hsrb/index.htm).
    2. For residential wood preservative uses, data may be required if 
soil has the potential to be an important exposure pathway, and soil is 
in contact with or adjacent to treated wood, including but not limited 
to decks, play sets, and gazebos,
    3. Protocols must be approved by the Agency prior to the initiation 
of the study.
    4. For wood preservatives, data are required for treated wood 
surfaces where post-application contact with treated wood is 
anticipated.
    5. For occupational uses, data are required if the pesticide may be 
applied to or around surfaces, and if the human activity data indicate 
that workers are likely to have post-application dermal contact with 
treated surfaces while participating in typical activities.
    6. Data are required for residential use sites, schools, and daycare 
institutions. This includes but is not limited to the following: 
Residential and public access premises; material preservatives 
(including those used in residential products, including but not limited 
to clothing and plastic toys) and wood preservatives (when contact with 
treated wood is likely to occur).
    7. Data are required for occupational and residential uses if the 
human activity data indicate the potential for post-application dermal 
and/or inhalation exposures while participating in typical activities 
and no acceptable modeling options are available.
    8. Biological monitoring data may be submitted in addition to, or in 
lieu of, dermal and inhalation passive dosimetry exposure data provided 
the human pharmacokinetics of the pesticide or metabolite/analog 
compounds (i.e., whichever method is selected as an indicator of body 
burden or internal dose) allow for a back-calculation to the total 
internal dose.
    9. Data are required for occupational and residential uses if there 
is the potential for bystander exposure and the pesticide use could 
result in respirable and/or inhalable material (e.g., gas, vapor, 
aerosol, or particulates).
    10. Data reporting and calculations are required only if post-
application exposure data are required.



Sec. 158.2280  Environmental fate.

    (a) General. Subpart B of this part and Sec. 158.2201 describe how 
to use the table in paragraph (c) of this section to determine the 
environmental fate data requirements for antimicrobial pesticide 
products. Notes that apply to an individual test including specific 
conditions, qualifications, or exceptions are listed in paragraph (d) of 
this section.
    (1) Environmental fate data are required to support the 
registrations of all end-use and manufacturing-use antimicrobial 
products.
    (2) Data on transformation/degradation products or leachate residues 
of the parent compound are also required to support registration, if the 
transformation/degradation products or leachate residues meet one of the 
following criteria:
    (i) More toxic, persistent, or bioaccumulative than the parent;
    (ii) Have been shown to cause adverse effects in mammalian or 
aquatic reproductive studies; or
    (iii) The moiety of concern (i.e., functional group in the parent 
chemical molecule that imparts adverse effects) remains intact.
    (3) For the purpose of determining data requirements, the all other 
use patterns category includes the following use patterns:
    (i) Agricultural premises and equipment.
    (ii) Food-handling/storage establishments, premises, and equipment.
    (iii) Commercial, institutional and industrial premises and 
equipment.
    (iv) Residential and public access premises.
    (v) Medical premises and equipment.
    (vi) Human drinking water systems.
    (vii) Materials preservatives.
    (viii) Swimming pools.
    (b) Key. MP = Manufacturing use product; EP = End-use product; R = 
Required; CR = Conditionally required;

[[Page 188]]

NR = Not required; TGAI = Technical grade of the active ingredient; TEP 
= Typical end-use product; PAIRA = Pure active ingredient radiolabeled; 
ROC = residue of concern.
    (c) Antimicrobial environmental fate data requirements table. The 
following table shows the data requirements for environmental fate. The 
test notes appear in paragraph (d) of this section.

[[Page 189]]



                                                                    Table--Antimicrobial Environmental Fate Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Use pattern                                                        Test substance
                                       ------------------------------------------------------------------------------------------------------------------------------------------
  Guideline No.     Data  requirement        Industrial                                                                                                                            Test note No.
                                        processes and  water  Antifoulant coatings         Wood            Aquatic areas       All other use           MP               EP
                                               systems             and paints          preservatives                        patterns  category
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                 Degradation Studies--Laboratory
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.2120.........  Hydrolysis.........  R...................  R...................  R.................  R.................  R.................  TGAI or PAIRA..  TGAI or PAIRA..               1
835.2240.........  Photodegradation in  R...................  R...................  R.................  R.................  R.................  TGAI or PAIRA..  TGAI or PAIRA..               2
                    water.
835.2410.........  Photodegradation in  NR..................  NR..................  R.................  NR................  NR................  TGAI or PAIRA..  TGAI or PAIRA..              10
                    soil.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Toxicity and Fate in Wastewater Systems
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.6800.........  Activated Sludge,    R...................  R...................  R.................  NR................  R.................  TGAI...........  TGAI...........              21
                    Respiration
                    Inhibition Test.
                   OECD 209...........
835.1110.........  Activated Sludge     CR..................  CR..................  CR................  NR................  CR................  TGAI...........  TGAI...........          19, 20
                    Sorption Isotherm.
835.3110.........  Ready                CR..................  CR..................  CR................  NR................  CR................  TGAI...........  TGAI...........        3, 4, 18
                    Biodegradability.
835.3220.........  Porous Pot Study...  CR..................  CR..................  CR................  NR................  CR................  TGAI...........  TGAI...........           3, 18
835.3280.........  Simulation Tests to  CR..................  CR..................  CR................  NR................  CR................  TGAI...........  TGAI...........           3, 18
                    Assess the
                    Biodegradability
                    of Chemicals
                    Discharged in
                    Wastewater.
835.3240.........  Simulation Test--    CR..................  CR..................  CR................  NR................  CR................  TGAI...........  TGAI...........           3, 18
                    Aerobic Sewage
                    Treatment: A.
                    Activated Sludge
                    Units.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                        Mobility Studies
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.1230.........  Leaching and         R...................  R...................  R.................  R.................  CR................  TGAI or PAIRA..  TGAI or PAIRA..            5, 6
                    adsorption/de-
                    sorption.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.1240
                                                                                 Metabolism Studies--Laboratory
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.4100.........  Aerobic soil         CR..................  NR..................  R.................  CR................  CR................  TGAI or PAIRA..  TGAI or PAIRA..         7, 8, 9
                    metabolism.
835.4200.........  Anaerobic soil       NR..................  NR..................  R.................  NR................  CR................  TGAI or PAIRA..  TGAI or PAIRA..            5, 8
                    metabolism.

[[Page 190]]

 
835.4300.........  Aerobic aquatic      R...................  R...................  R.................  R.................  CR................  TGAI or PAIRA..  TGAI or PAIRA..            5, 8
                    metabolism.
835.4400.........  Anaerobic aquatic    R...................  R...................  R.................  R.................  CR................  TGAI or PAIRA..  TGAI or PAIRA..            5, 8
                    metabolism.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                   Dissipation Studies--Field
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.6200.........  Aquatic (sediment).  CR..................  R...................  CR................  R.................  CR................  TEP............  TEP............      11, 12, 13
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               Ground and Surface Water Monitoring
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
None.............  Monitoring of        CR..................  CR..................  CR................  CR................  CR................  ROC............  ROC............      11, 14, 17
                    representative
                    U.S. waters.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Special Studies
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
None.............  Special leaching...  NR..................  R...................  R.................  NR................  NR................  TGAI...........  TEP............          15, 16
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 191]]

    (d) Test notes. The following test notes apply to the data 
requirements in the table in paragraph (c) of this section:
    1. For testing antifoulant paints and coatings, testing is to be 
performed separately with both sterile buffered distilled water and 
sterile synthetic seawater at pHs 5, 7, and 9.
    2. Not required if:
    i. The electronic absorption spectra, measured at pHs 5, 7 and 9, of 
the chemical and its hydrolytic products, if any, show no absorption or 
tailing between 290 and 800 nm, inclusive; or
    ii. The results of the hydrolysis study at all three pHs (5, 7, and 
9) demonstrates a half-life of less than 30 days.
    3. The results of the activated sludge, respiration inhibition 
(ASRI) test determine which of the following tests are required: Ready 
biodegradability, porous pot, the biodegradation in activated sludge 
study as described in the ``Simulation Tests to Assess the 
Biodegradability of Chemicals Discharged in Wastewater,'' or simulation 
test--aerobic sewage treatment: A. activated sludge units.
    i. If the ASRI test EC50 is equal to or less than 20 mg/
L, then the applicant must choose either to:
    A. Conduct the biodegradation in activated sludge study as described 
in the ``Simulation Tests to Assess the Biodegradability of Chemicals 
Discharged in Wastewater'';
    B. Conduct the porous pot test; or
    C. Conduct the simulation test--aerobic sewage treatment: A. 
activated sludge units.
    ii. If the ASRI test EC50 is greater than 20 mg/L, then 
the applicant must choose either to:
    A. Conduct a ready biodegradability study; or
    B. Conduct one of the following studies: The biodegradation in 
activated sludge study as described in the ``Simulation Tests to Assess 
the Biodegradability of Chemicals Discharged in Wastewater,'' the porous 
pot test, or the simulation test--aerobic sewage treatment: A. activated 
sludge units.
    4. Pass criteria for the ready biodegradability study are: 70 
percent removal of dissolved organic carbon (DOC) and 60 percent removal 
of theoretical oxygen demand (ThOD) or theoretical carbon dioxide 
(ThCO2) production for respirometric methods. These pass 
levels must be reached in a 10-day window within the 28-day period of 
the test. If the antimicrobial passes the ready biodegradability study, 
then no further testing is required. If the antimicrobial fails the 
ready biodegradability study, then the applicant must conduct one of the 
following studies: The biodegradation in activated sludge study as 
described in the ``Simulation Tests to Assess the Biodegradability of 
Chemicals Discharged in Wastewater,'' the porous pot test, or the 
simulation test--aerobic sewage treatment: A. activated sludge units.
    5. For the all other use patterns category (as specified in Sec. 
158.2280(a)(3)), data are required based on a weight-of-evidence 
evaluation of the results of the hydrolysis, photodegradation in water, 
activated sludge sorption isotherm, biodegradability, and activated 
sludge, respiration inhibition tests.
    6. Adsorption and desorption using a batch equilibrium method is 
preferred. In some cases, as when the antimicrobial pesticide degrades 
rapidly, soil column leaching with unaged or aged columns may be more 
appropriate to fully characterize the potential mobility of the parent 
compound and major transformation products.
    7. For industrial processes and water systems, aquatic areas, and 
the all other use patterns category (as specified in Sec. 
158.2280(a)(3)), data are required based on a weight-of-evidence 
evaluation of the results of the hydrolysis, photodegradation in water, 
activated sludge sorption isotherm, biodegradability, and activated 
sludge, respiration inhibition tests.
    8. The environmental media (soil, water, hydrosoil, and biota) to be 
utilized in these studies must be collected from areas representative of 
potential use sites.
    9. For industrial processes and water systems, and aquatic areas, 
data are required for use sites that are intermittently dry.
    10. Data are not required if the antimicrobial is an inorganic 
substance or a metal salt; or if the standardized soil

[[Page 192]]

profiles demonstrate that the antimicrobial is likely to readily degrade 
either microbially or via redox reactions (chemically) and no 
transformation/degradate/leachate products of concern (as described 
under Sec. 158.2280(a)(2)) are produced.
    11. Analytical methods used to generate data associated with this 
study must include results of a successful confirmatory method trial by 
an independent laboratory.
    12. Protocols must be approved by the Agency prior to the initiation 
of the study.
    13. For industrial processes and water systems, wood preservatives, 
and the all other use patterns category (as specified in Sec. 
158.2280(a)(3)), data are required based on the potential for aquatic 
exposure and if the weight-of-evidence indicates that the active 
ingredient or principal transformation products are likely to have the 
potential for persistence, mobility, nontarget aquatic toxicity, or 
bioaccumulation.
    14. Data are required if the weight-of-evidence indicates that the 
active ingredient or principal transformation products are likely to 
occur in nontarget freshwater, estuarine, or marine waters such that 
human or environmental exposures are likely to occur. In making that 
determination, the Agency takes into account other factors such as the 
toxicity of the chemical(s), available monitoring data and the 
vulnerability of the freshwater, estuarine, or marine water resources in 
the antimicrobial use area.
    15. For wood preservatives, an aquatic leaching study is required. A 
soil leaching study is required if human or environmental exposures are 
likely to occur from leachates that contain the active ingredient or 
principal transformation products from wood treated with a preservative 
product. Protocols must be approved by the Agency prior to the 
initiation of the study.
    16. For antifoulant paints and coatings, a leaching study is 
required. Protocols must be approved by the Agency prior to the 
initiation of the study.
    17. Protocols, which include the residues of concern (such as 
parent, degradate/transformation product, and/or leachate residues) that 
would be monitored, must be approved by the Agency prior to the 
initiation of the study.
    18. A biodegradation study is not required if the antimicrobial 
meets one or more of the following criteria:
    i. Classified as a metal,
    ii. Relatively volatile, but not hydrophobic,
    iii. Highly reactive,
    iv. Both the parent and all transformation/degradate products (as 
described under Sec. 158.2280(a)(2)) have half-lives of less than 3 
hours,
    v. None of the registered or proposed product uses would result in 
transport of the parent and its transformation/degradate products (as 
described under Sec. 158.2280(a)(2)) to a wastewater treatment plant.
    19. The activated sludge sorption isotherm test is not required if 
the antimicrobial is:
    i. Relatively volatile, but not hydrophobic;
    ii. Highly reactive; or
    iii. The log Kow is less than 3.0.
    20. If the criteria of test note 19 of this paragraph are not met, 
then the activated sludge sorption isotherm test is required if one or 
more of the following criteria are also met:
    i. The antimicrobial is a metal,
    ii. The log Kow is greater than or equal to 3.0,
    iii. The antimicrobial is positively charged or polycationic,
    iv. The EC50 in the activated sludge, respiration 
inhibition test is less than or equal to 20 mg/L,
    v. The EC50 in the activated sludge, respiration 
inhibition test is greater than 20 mg/L, and the antimicrobial fails the 
ready biodegradability study.
    21. The activated sludge respiration inhibition study is not 
required if none of the registered or proposed product uses would result 
in transport of the parent and its transformation/degradate products (as 
described under Sec. 158.2280(a)(2)) to a wastewater treatment plant.



Sec. 158.2290  Residue chemistry.

    (a) General. Subpart B of this part and Sec. 158.2201 describe how 
to use the table in paragraph (h) of this section to determine the 
residue chemistry data

[[Page 193]]

requirements for antimicrobial pesticide products. Notes that apply to 
an individual test including specific conditions, qualifications, or 
exceptions are listed in paragraph (i) of this section.
    (b) Residue chemistry data are required for:
    (1) Antimicrobial end-use products with uses that may result in 
residues in or on food, including but not limited to:
    (i) Products that require a tolerance, tolerance exemption, or food 
additive regulation or clearance.
    (ii) Products that may be used to treat livestock or poultry 
drinking water, for food egg washing, or for fruit and vegetable rinses.
    (iii) Products that may be applied to a surface or incorporated into 
a material that may contact food or feed. Data are required regardless 
of whether the antimicrobial is applied or impregnated for the purpose 
of imparting antimicrobial protection to external surfaces of the 
substance or article, or for the purpose of protecting the substance or 
article itself.
    (iv) Products that may be applied to water that have the potential 
to result in residues in potable water, or in water used for livestock 
and poultry drinking water, irrigation of crops, or water containing 
fish that may be used for human food.
    (v) Wood preservative or antifoulant products intended for treating 
submerged materials that may result in food contact (e.g., lobster pots, 
fish cages on fish farms).
    (2) Each manufacturing-use product bearing directions for 
formulation into an end-use product bearing uses described in paragraph 
(b)(1) of this section.
    (c) Residue chemistry data are not required under paragraph (b) of 
this section if no adverse effects (no toxicity endpoints) are 
associated with dietary exposure to the active ingredient or if 
theoretical (high-end) dietary exposure estimates combined with the 
applicable toxicity endpoint result in acute and chronic dietary risks 
that are below the Agency levels of concern.
    (d) For purposes of this section, Magnitude of the Residue Studies 
include the following: Food-handling, migration studies, potable water, 
fish, irrigated crops, meat/milk/poultry/eggs, crop field trails, 
processed food or feed, and anticipated residues.
    (e) If the antimicrobial chemical may be applied to a field crop, 
then the residue chemistry data requirements of Sec. 158.1410 apply.
    (f) The following term is defined for the purposes of this 
section:Residue of concern means the parent pesticidal compound and its 
metabolites, degradates, and impurities of toxicological concern.
    (g) Key. R = Required; CR = Conditionally required; NR = Not 
required; TGAI = Technical grade of the active ingredient; TEP = Typical 
end-use product; PAI = Pure active ingredient; PAIRA = Pure active 
ingredient radiolabeled; ROC = Residue of concern.
    (h) Antimicrobial residue chemistry data requirements table. The 
following table shows the data requirements for residue chemistry. The 
test notes appear in paragraph (i) of this section.

[[Page 194]]



                                                Table--Antimicrobial Residue Chemistry Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Uses
                                     ------------------------------------------------------------------------------------                     Test note
  Guideline No.    Data requirement       Agricultural                                                                     Test  substance       No.
                                            premise           Indirect food         Direct food            Aquatic
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Supporting Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1100........  Chemical identity.  R..................  R..................  R..................  R..................  TGAI.............
860.1200........  Directions for use  R..................  R..................  R..................  R..................  .................
860.1550........  Proposed tolerance/ R..................  R..................  R..................  R..................  .................            1
                   tolerance
                   exemption.
860.1560........  Reasonable grounds  R..................  R..................  R..................  R..................  .................            1
                   in support of
                   petition.
860.1650........  Submittal of        R..................  R..................  R..................  R..................  PAI/ROC..........            2
                   analytical
                   reference
                   standards.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     Food-Contact Surfaces or Impregnated Materials
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1460........  Food-handling.....  CR.................  CR.................  CR.................  CR.................  TEP..............            3
None............  Nature of residue   CR.................  CR.................  CR.................  CR.................  PAIRA or TGAI....            4
                   on surfaces.
None............  Migration studies.  CR.................  CR.................  CR.................  CR.................  TEP..............            5
860.1340........  Residue analytical  CR.................  CR.................  CR.................  CR.................  ROC..............            6
                   method for data
                   collection.
860.1380........  Storage stability.  R..................  R..................  R..................  R..................  TEP or ROC.......            7
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Higher tiered
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1300........  Nature of the       CR.................  CR.................  CR.................  CR.................  PAIRA............            8
                   residue in plants.
860.1300........  Nature of the       CR.................  CR.................  CR.................  CR.................  PAIRA............            9
                   residue in
                   livestock.
860.1340........  Residue analytical  CR.................  CR.................  CR.................  CR.................  ROC..............           10
                   methods for
                   tolerance/
                   tolerance
                   exemption
                   enforcement.
860.1360........  Multiresidue        CR.................  CR.................  CR.................  CR.................  ROC..............           11
                   method testing.
860.1400........  Potable water.....  CR.................  CR.................  CR.................  CR.................  TEP..............           12
860.1400........  Fish..............  CR.................  CR.................  CR.................  CR.................  TEP..............           13
860.1400........  Irrigated crops...  CR.................  CR.................  CR.................  CR.................  TEP..............           14
860.1480........  Meat/milk/poultry/  CR.................  CR.................  CR.................  CR.................  TGAI or ROC......           15
                   eggs.
860.1500........  Crop field trials.  CR.................  CR.................  CR.................  CR.................  TEP..............           16
860.1520........  Processed food or   CR.................  CR.................  CR.................  CR.................  TEP..............           17
                   feed.
None............  Anticipated         CR.................  CR.................  CR.................  CR.................  ROC..............           18
                   residues.
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 195]]

    (i) Test notes. The following test notes apply to the data 
requirements in the table to paragraph (h) of this section:
    1. A petition proposing a numerical tolerance or a tolerance 
exemption is required for any food or feed use subject to section 408 of 
FFDCA if the use is not covered by an existing tolerance or tolerance 
exemption. If the use is subject to FFDCA section 409, the applicant 
must identify to EPA an applicable section 409 food additive regulation 
or clearance, or submit a copy of a petition to FDA requesting a section 
409 food additive regulation or clearance for the food or feed use.
    2. An analytical reference standard is required for any food or feed 
use requiring a numeric tolerance or exemption. Material safety data 
sheets as specified by the Occupational Safety and Health Administration 
in 29 CFR 1910.1200 must accompany analytical standards.
    3. Data are required if a pesticide may be used in a food-handling 
establishment unless data including, but not limited to, theoretical 
(high-end) estimates, radiolabeled laboratory data, or the nature of the 
residue on surfaces study show that residues will not occur in food or 
feed.
    4. If an antimicrobial pesticide may be applied to a food-contact 
surface or impregnated into a food-contact material and if theoretical 
(high-end) estimates of exposure exceed EPA's risk level of concern, 
then the nature of the residue on surfaces study is required. Protocols 
must be approved by the Agency prior to the initiation of the study.
    5. Based on the results of the nature of the residue on surfaces 
study, if residues of concern are identified, then the migration study 
will be required. Protocols must be approved by the Agency prior to the 
initiation of the study.
    6. If a magnitude of the residue study, as specified in Sec. 
158.2290(d), is required, then a residue analytical method suitable for 
collecting data is also required. The method must be capable of 
determining all residues of concern, to permit calculation of dietary 
risk or to establish a tolerance or tolerance exemption.
    7. If a magnitude of the residue study, as specified in Sec. 
158.2290(d), is required, then storage stability data are also required, 
unless analytical samples are stored for 30 days or less. If, during 
hazard characterization, a residue has been identified as ``of concern'' 
and is known to be volatile or labile, then storage stability data are 
required regardless of sample storage time.
    8. If crop plants or metabolically active raw agricultural 
commodities of food crops may be directly or indirectly exposed to an 
antimicrobial, plant metabolism studies are required to determine the 
transformation products that may enter the human diet. Such exposure 
could include, but is not limited to:
    i. Treatment of storage or shipping containers,
    ii. Postharvest fruit and vegetable treatment prior to shipping or 
storage,
    iii. Use of antimicrobial-treated water for irrigation, and
    iv. Any direct food contact use.
    9. If livestock may be exposed to an antimicrobial, then hen and 
ruminant metabolism studies are required to determine the identities of 
residues of concern that may enter the human diet from consumption of 
livestock commodities. Livestock may be exposed via the oral, dermal, or 
inhalation route following treatment or contamination of sites 
including, but not limited to, livestock premises, feed, and drinking 
water. Shell eggs and other metabolically active livestock products may 
also be treated. If livestock may be exposed to one or more residues of 
concern differing from those found in animals, then one or more 
additional livestock metabolism studies involving dosing with these 
residues may be required.
    10. If there is a numerical tolerance or tolerance exemption level 
to enforce, then a residue analytical method suitable for enforcement 
purposes is required. The method must be supported by an independent 
laboratory validation.
    11. If there is a numerical tolerance or tolerance exemption level 
to enforce, then testing is required to determine whether the Food and 
Drug Administration/United States Department of Agriculture multiresidue 
methodology would detect and identify

[[Page 196]]

the antimicrobial and its residues of concern, as part of programs to 
monitor pesticides in the U.S. food supply.
    12. Data are required if an antimicrobial may be applied directly to 
water or if there is the potential that the antimicrobial-treated water 
could be used directly for drinking water purposes by humans or animals 
or that contaminated water could run-off, leach, or be discharged from 
treated sites or materials and make its way into potable water.
    13. Data are required if an antimicrobial may be applied directly to 
water inhabited by fish or that will be inhabited by fish or if 
contaminated water could run-off, leach, or be discharged from treated 
sites or materials and make its way into bodies of water containing fish 
that may be used for human consumption.
    14. Data are required if an antimicrobial may be applied directly to 
water used for irrigation of food crops or such that contaminated water 
could run-off, leach, or be discharged from treated sites or materials 
to make its way into water used for irrigation of food crops.
    15. If the antimicrobial may be applied directly to livestock, 
metabolically-active livestock commodities (e.g., eggs), livestock feed 
or drinking water, or livestock premises, or a livestock metabolism 
study indicates that residues of the antimicrobial may result in 
livestock commodities, studies are required to determine the magnitude 
of the residues of concern in fat, meat, meat by-products, milk, 
poultry, and eggs that may be consumed by humans. These studies, 
however, may not be required in cases where the livestock metabolism 
studies indicate that transfer of pesticide residues of concern to 
tissues, milk, and eggs is not expected to occur at the maximum expected 
exposure level for the animals.
    16. If food crops or raw agricultural commodities of food crops may 
be exposed to an antimicrobial, then residue studies are required to 
determine the magnitude of the residues of concern that may enter the 
human diet. Such exposures include, but are not limited to, postharvest 
fruit and vegetable treatments and application of antimicrobial 
chemicals to field crops, mushroom houses, empty or occupied beehives, 
or wood used to construct beehives.
    17. Data on the nature and magnitude of residues in processed food 
or feed are required if antimicrobial residues could potentially 
concentrate on processing. If so, the establishment of a separate 
tolerance higher than that in the raw agricultural commodity may be 
required.
    18. Data are required when dietary exposure values at the tolerance 
level or screening-level (high-end) result in estimates of dietary or 
aggregate risk that meet or exceed the Agency's level of concern. These 
data may include, but are not limited to, washing, cooking, processing, 
or degradation studies as well as market basket surveys for a more 
realistic residue determination. Protocols must be approved by the 
Agency prior to the initiation of the study.



                         Subparts X-Z [Reserved]



Sec. Sec. 158.2300-158.2500  [Reserved]



PART 159_STATEMENTS OF POLICIES AND INTERPRETATIONS--Table of Contents



Subparts A-C [Reserved]

      Subpart D_Reporting Requirements for Risk/Benefit Information

Sec.
159.152 What the law requires of registrants.
159.153 Definitions.
159.155 When information must be submitted.
159.156 How information must be submitted.
159.158 What information must be submitted.
159.159 Information obtained before promulgation of the rule.
159.160 Obligations of former registrants.
159.165 Toxicological and ecological studies.
159.167 Discontinued studies.
159.170 Human epidemiological and exposure studies.
159.178 Information on pesticides in or on food, feed, or water.
159.179 Metabolites, degradates, contaminants, and impurities.
159.184 Toxic or adverse effect incident reports.
159.188 Failure of performance information.
159.195 Reporting of other information.

    Authority: 7 U.S.C. 136-136y.

[[Page 197]]


    Source: 63 FR 49388, Sept. 19, 1997, unless otherwise noted.

Subparts A-C [Reserved]



      Subpart D_Reporting Requirements for Risk/Benefit Information



Sec. 159.152  What the law requires of registrants.

    (a) Section 6(a)(2) of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) states: ``If at any time after the registration 
of a pesticide the registrant has additional factual information 
regarding unreasonable adverse effects on the environment of the 
pesticide, he shall submit such information to the Administrator.''
    (b) Section 152.50(f)(3) of this chapter requires applicants to 
submit, as part of an application for registration, any factual 
information of which he is aware regarding unreasonable adverse effects 
of the pesticide on humans or the environment, which would be required 
to be reported under section 6(a)(2) if the product were registered.
    (c) Compliance with this part will satisfy a registrant's 
obligations to submit additional information pursuant to section 6(a)(2) 
and will satisfy an applicant's obligation to submit additional 
information pursuant to Sec. 152.50(f)(3) of this chapter.



Sec. 159.153  Definitions.

    (a) For the purposes of reporting information pursuant to FIFRA 
section 6(a)(2), the definitions set forth in FIFRA section 2 and in 40 
CFR part 152 apply to this part unless superseded by a definition in 
paragraph (b) of this section.
    (b) For purposes of reporting information pursuant to FIFRA section 
6(a)(2), the following definitions apply only to this subpart:
    Established level means a tolerance, temporary tolerance, food 
additive regulation, action level, or other limitation on pesticide 
residues imposed by law, regulation, or other authority.
    Formal Review means Special Review, Rebuttable Presumption Against 
Registration (RPAR), FIFRA section 6(c) suspension proceeding, or FIFRA 
section 6(b) cancellation proceeding, whether completed or not.
    Hospitalization means admission for treatment to a hospital, clinic 
or other health care facility. Treatment as an out-patient is not 
considered to be hospitalization.
    Maximum contaminant level (MCL) means the maximum permissible level, 
established by EPA, for a contaminant in water which is delivered to any 
user of a public water system.
    Non-target organism means any organism for which pesticidal control 
was either not intended or not legally permitted by application of a 
pesticide.
    Pesticide means a pesticide product which is or was registered by 
EPA, and each active ingredient, inert ingredient, impurity, metabolite, 
contaminant or degradate contained in, or derived from, such pesticide 
product.
    Qualified expert means one who, by virtue of his or her knowledge, 
skill, experience, training, or education, could be qualified by a court 
as an expert to testify on issues related to the subject matter on which 
he or she renders a conclusion or opinion. Under Rule 702 of the Federal 
Rules of Evidence, a person may be qualified as an expert on a 
particular matter by virtue of ``knowledge, skill, experience, training, 
or education.'' In general, EPA wants registrants to report information 
when a person has relevant expert credentials, e.g., a medical doctor 
giving a medical opinion, a plant pathologist giving an opinion on plant 
pathology, etc.
    Registrant includes any person who holds, or ever held, a 
registration for a pesticide product issued under FIFRA section 3 or 
24(c).
    Similar species means two or more species belonging to the same 
general taxonomic groups: The general taxonomic groups for purposes of 
this requirement are: mammals, birds, reptiles, amphibians, fish, 
aquatic invertebrates, insects, arachnids, aquatic plants (including 
macrophyte, floating, and submerged plants), and terrestrial (all non-
aquatic) plants.
    Water reference level means the level specified in paragraph (1) or 
(2) of this definition, whichever is lower.
    (1) Ten percent of the maximum contaminant level (MCL) established 
by

[[Page 198]]

EPA, or if no MCL has been established by EPA, 10 percent of the most 
recent draft or final long-term health advisory level (HAL) established 
by EPA, or if EPA has not published or proposed an MCL or HAL, the 
lowest detectable amount of the pesticide.
    (2) The ambient water quality criteria for the protection of aquatic 
life, established by EPA pursuant to section 304(a) of the Clean Water 
Act.

[62 FR 49388, Sept. 19, 1997, as amended at 63 FR 33582, June 19, 1998; 
73 FR 75596, Dec. 12, 2008]



Sec. 159.155  When information must be submitted.

    (a) The following reportable information must be received by EPA not 
later than the 30th calendar day after the registrant first possesses or 
knows of the information:
    (1) Scientific studies described in Sec. 159.165.
    (2) Information about discontinued studies described in Sec. 
159.167.
    (3) Human epidemiological and exposure studies described in Sec. 
159.170.
    (4) Detection of a pesticide in or on food or feed described in 
Sec. 159.178(a).
    (5) Detection of metabolites, degradates, contaminates, impurities 
described in Sec. 159.179.
    (6) Failure of performance studies described in Sec. 159.188(a)(2), 
(b)(2), and (c).
    (7) Other information described in Sec. 159.195.
    (b) Reportable information concerning detections of pesticides in 
water described in Sec. 159.178(b), adverse effects incidents described 
in Sec. 159.184(a), and efficacy failure incidents described in Sec. 
159.188(a)(1) and (b)(1) must be reported according to the time frames 
set forth in Sec. 159.184(d).
    (c) EPA may, in its discretion, notify a registrant in writing of a 
different reporting period that will apply to specific types of 
reportable information or eliminate reporting requirements entirely. 
Such notification supersedes otherwise applicable reporting requirements 
set forth in this part.
    (d) For purposes of this part, a registrant possesses or knows of 
information at the time any officer, employee, agent, or other person 
acting for the registrant first comes into possession of, or knows of, 
such information; provided that, such person performs any activities for 
the registrant related to the development, testing, sale or registration 
of a pesticide or the person could be reasonably expected to come into 
possession of information otherwise reportable under this part. In the 
case of information known to or possessed by an agent or other person 
acting for the registrant, a registrant is responsible for such 
information only if the agent or other person acquired such information 
while acting for the registrant.

[63 FR 33582, June 19, 1998]



Sec. 159.156  How information must be submitted.

    A submission under FIFRA section 6(a)(2) must be delivered to the 
Office of Pesticide Programs' Document Processing Desk at the 
appropriate address as set forth in 40 CFR 150.17(a) or (b).
    (a) Include a cover letter which contains the information requested 
in paragraphs (d) and (e) of this section, and a prominent statement 
that the information is being submitted in accordance with FIFRA section 
6(a)(2).
    (b) Contain the name of the submitter, registrant name and 
registration number, date of transmittal to EPA, the type of study or 
incident being reported under Sec. Sec. 159.165 through 159.195, and a 
statement of why the information is considered reportable under this 
part.
    (c) Identify the substance tested or otherwise covered by the 
information (including, if known, the EPA registration number(s) to 
which the information pertains, and if known, the CAS Registry Number).
    (d) In reporting incidents, provide the data listed in Sec. 
159.184, to the extent such information is available.
    (e) In submitting scientific studies, follow the procedures set 
forth in Sec. 158.32 or Sec. 161.32 of this chapter, as applicable.
    (f) If the information is part of a larger package being submitted 
in order to comply with another provision of FIFRA (e.g., sections 
3(c)(2)(B), 4(e)(1)(E)), identify in the transmittal the individual 
studies being submitted under this part.

[[Page 199]]

    (g) If a claim of confidentiality is made under FIFRA section 10 for 
information relating to any part of a study or incident report contained 
in the submission, follow the procedures set forth in Sec. 158.33 or 
Sec. 161.33 of this chapter, as applicable regarding the identification 
and segregation of information claimed to be confidential.
    (h) If a submission includes a study subject to the flagging 
requirements of Sec. 158.34 or Sec. 161.34 of this chapter, as 
applicable, comply with the requirements of that section, and, if the 
flagging statement is positive, identify it as 6(a)(2) information in 
the transmittal.
    (i) If a submission is a follow-up to an earlier study or incident 
report submitted to EPA, the transmittal must state that fact, and must 
cite the earlier submission, as follows:
    (1) If the earlier submission was a study to which EPA assigned a 
Master Record Identifier number (MRID), cite the MRID.
    (2) If the previous submission was an incident report to which no 
MRID number was assigned, cite the date of the initial submission of the 
incident information or report.

[63 FR 49388, Sept. 19, 1997, as amended at 69 FR 39864, July 1, 2004; 
71 FR 35545, June 21, 2006; 72 FR 61028, Oct. 26, 2007]



Sec. 159.158  What information must be submitted.

    (a) General. Information which is reportable under this part must be 
submitted if the registrant possesses or receives the information, and 
the information is relevant to the assessment of the risks or benefits 
of one or more specific pesticide registrations currently or formerly 
held by the registrant. Information relevant to the assessment of the 
risks or benefits also includes conclusion(s) or opinion(s) rendered by 
a person who meets any of the following:
    (1) Who was employed or retained (directly or indirectly) by the 
registrant, and was likely to receive such information.
    (2) From whom the registrant requested the opinion(s) or 
conclusion(s) in question.
    (3) Who is a qualified expert as described in Sec. 159.153(b).
    (b) Exceptions--(1) Clearly erroneous information. Information need 
not be submitted if before that date on which the registrant must submit 
such information if all of the following conditions are met:
    (i) The registrant discovers that any analysis, conclusion, or 
opinion was predicated on data that were erroneously generated, 
recorded, or transmitted, or on computational errors.
    (ii) Every author of each such analysis, conclusion, or opinion, or 
as many authors as can be contacted through the use of reasonable 
diligence, has acknowledged in writing that the analysis, conclusion, or 
opinion was improper and has either corrected the original analysis, 
conclusion, or opinion accordingly, or provided an explanation as to why 
it cannot be corrected.
    (iii) As a result of the correction, the information is no longer 
required to be reported under FIFRA section 6(a)(2), or if no correction 
was possible, the authors agree that the original analysis, conclusion 
or opinion has no scientific validity.
    (2) Previously submitted information. Information regarding an 
incident, study, or other occurrence need not be submitted if before the 
date on which the registrant must submit such information, the 
registrant is aware that the reportable information concerning that 
incident, study, or other occurrence is contained completely in one of 
the following:
    (i) Documents officially logged in by the EPA Office of Pesticide 
Programs.
    (ii) EPA publications, EPA hearing records, or publications cited in 
EPA Federal Register notices.
    (iii) Any other documents which are contained in the official files 
and records of the EPA Office of Pesticide Programs.
    (iv) Any documents officially logged in by the EPA Office of 
Pollution Prevention and Toxics under the provisions of section 8(e) of 
the Toxic Substances Control Act, provided that if the information 
pertains to a chemical compound which, subsequent to the submission of 
data under section 8(e), becomes the subject of an application for 
registration as a pesticide active ingredient, information is submitted 
to

[[Page 200]]

the Office of Pesticide Programs as required by 40 CFR 152.50(f)(3).
    (3) Publications. A published article or report containing 
information otherwise reportable under this part need not be submitted 
if it fits into either of the following categories:
    (i) Any scientific article or publication which has been abstracted 
in a recognized database of scientific and medical literature, such as 
Medline, ENBASE, Toxline or Index Medicus, if the abstract in question 
clearly identified the active ingredient or the registered pesticide(s) 
to which the information pertains. Otherwise reportable information 
received by or known to the registrant prior to publication of an 
abstract concerning the information must be reported and may not be 
withheld pending such publication.
    (ii) Reports or publications which have been made available to the 
public by any of the following Federal agencies: Centers for Disease 
Control and Prevention, Consumer Products Safety Commission, Department 
of Agriculture, Department of the Interior, Food and Drug Administration 
or any other agency or institute affiliated with the Department of 
Health and Human Services. Otherwise reportable information concerning 
research which was performed, sponsored, or funded by the registrant 
which may also appear in forthcoming Government reports or publications 
must be reported and may not be withheld pending publication.
    (4) Information concerning former inerts, contaminants or 
impurities. Notwithstanding any other provisions of this part, a 
registrant need not report information concerning a chemical compound 
that was at one time an inert ingredient or a contaminant or impurity of 
a pesticide product, and would otherwise be reportable under this part, 
if both of the following conditions are met:
    (i) The compound has been eliminated from its registered product due 
to changes in manufacturing processes, product formulation or by other 
means.
    (ii) The registrant has informed the appropriate product manager in 
the Office of Pesticide Programs in writing of the presence previously 
of the inert, contaminant or impurity in the product and its subsequent 
elimination from the product.

[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998]



Sec. 159.159  Information obtained before promulgation of the rule.

    (a) Notwithstanding any other provision of this part, information 
held by registrants on August 17, 1998 which has not been previously 
submitted to the Agency, but which is reportable under the terms of this 
part, must be submitted to the Agency if it meets any of the following 
criteria:
    (1) Information is otherwise reportable under Sec. 159.184, and 
pertains to an incident that is alleged to have occurred on or after 
January 1, 1994, and to have involved any of the following:
    (i) A fatality or hospitalization of a human being.
    (ii) A fatality of a domestic animal.
    (iii) A fatality or fatalities to fish or wildlife, if the incident 
meets the criteria for the exposure type and severity category 
designation ``W-A'' set forth in Sec. 159.184(c)(5)(iii).
    (2) Submission of the information is requested by the Agency 
pursuant to Sec. 159.195(c).
    (b) If a registrant possesses information required to be submitted 
by paragraph (a)(1) of this section, the registrant must submit on or 
before June 16, 1999 in accordance with Sec. 159.156(c), (d), and (e) 
an inventory of the incidents that meet the requirements of paragraphs 
(a)(1) of this section. Such an inventory must include the separate 
number of incidents that meet the requirements of paragraphs (a)(1)(i), 
(a)(1)(ii), and (a)(1)(iii) of this section, and for each type of 
incident, the total numbers of fatalities or hospitalizations involved.
    (c) If a registrant possesses information required to be submitted 
by paragraph (a)(2) of this section, the information must be submitted 
in accordance with any schedule contained in the Agency's request for 
the information.

[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998, as amended at 
63 FR 41193, Aug. 3, 1998]

[[Page 201]]



Sec. 159.160  Obligations of former registrants.

    (a) General. A former registrant is obliged to continue to submit 
information concerning the registration of a pesticide product 
previously held by the registrant and otherwise reportable under the 
provisions of this part for a period of 5 years after the registration 
of the pesticide product has been canceled or transferred to another 
registrant, with the exceptions provided by paragraph (b) of this 
section.
    (b) Exceptions. Notwithstanding the provisions of paragraph (a) of 
this section, a former registrant is not obligated to report information 
pursuant to this part if any of the following conditions are applicable:
    (1) The information is first obtained by the person more than 1 year 
after the date on which the person ceased to hold the registration of 
the product to which the information pertains, and the person holds no 
active pesticide registrations, or for some other reason cannot 
reasonably be expected to receive information concerning the formerly 
registered product.
    (2) The information is associated solely with an inert ingredient, 
contaminant, impurity, metabolite, or degradate contained in a product, 
and the information is first obtained by the person more than 1 year 
after the date upon which the person ceased to hold the registration of 
the product.
    (3) The information is associated with an active ingredient or a 
formerly registered product, and the active ingredient or every active 
ingredient contained in the formerly registered product has not been 
contained in any pesticide product registered in the United States for 
any part of the 3-year period preceding the date on which the person 
first obtained the information.
    (4) The information pertains solely to a formerly registered product 
that no longer meets the definition of ``pesticide'' in section 2(u) of 
FIFRA.
    (c) Information arising from litigation. Notwithstanding any other 
provisions of this section, a former registrant is obliged to submit 
information otherwise reportable under this part concerning formerly-
registered pesticide products which arises in the course of litigation 
concerning the effects of such products, regardless of when the 
information is first acquired, provided that neither of the provisions 
of paragraphs (b)(3) or (b)(4) of this section are met. Such information 
shall be submitted in the same manner and according to the same 
schedules as it would have to be submitted by a current registrant of a 
pesticide product to which the information pertained.

[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998, as amended at 
73 FR 75596, Dec. 12, 2008]



Sec. 159.165  Toxicological and ecological studies.

    Adverse effects information must be submitted as follows:
    (a) Toxicological studies. (1) The results of a study of the 
toxicity of a pesticide to humans or other non-target domestic organisms 
if, relative to all previously submitted studies, they show an adverse 
effect under any of the following conditions:
    (i) That is in a different organ or tissue of the test organism.
    (ii) At a lower dosage, or after a shorter exposure period, or after 
a shorter latency period.
    (iii) At a higher incidence or frequency.
    (iv) In a different species, strain, sex, or generation of test 
organism.
    (v) By a different route of exposure.
    (2) Acute oral, acute dermal, acute inhalation or skin and eye 
irritation studies in which the only change in toxicity is a numerical 
decrease in the median lethal dose (LD50), median lethal 
concentration (LC50) or irritation indices, are not 
reportable under this part unless the results indicate a more 
restrictive toxicity category for labeling under the criteria of 40 CFR 
156.62.
    (b) Ecological studies. The results of a study of the toxicity of a 
pesticide to terrestrial or aquatic wildlife or plants if, relative to 
all previously submitted studies, they show an adverse effect under any 
of the following conditions:
    (1) At levels 50 percent or more lower than previous acute toxicity 
studies with similar species, including determinations of the median 
lethal dose (LD50), median lethal concentration 
(LC50), or median effective concentration (EC50).

[[Page 202]]

    (2) At lower levels in a chronic study than previous studies with 
similar species.
    (3) In a study with a previously untested species the results 
indicate the chronic no observed effect level (NOEL) is 10 percent or 
less of the lowest LC50 or LD50 for a similar 
species.
    (4) For plants when tested at the maximum label application rate or 
less, if either of the following conditions is met:
    (i) More than 25 percent of terrestrial plants show adverse effects 
on plant life cycle functions and growth such as germination, emergence, 
plant vigor, reproduction and yields.
    (ii) More than 50 percent of aquatic plants show adverse effects on 
plant life cycle functions and growth such as germination, emergence, 
plant vigor, reproduction and yields.
    (c) Results from a study that demonstrates any toxic effect (even if 
corroborative of information already known to the Agency), must be 
submitted if the pesticide is or has been the subject of a Formal Review 
based on that effect within 5 years of the time the results are 
received. Within 30 calendar days of the publication of a Notice of 
Commencement of a Formal Review in the Federal Register, all information 
which has become reportable due to the commencement of the Formal Review 
must be submitted.
    (d) Incomplete studies. Information from an incomplete study of the 
toxicity to any organism of a registered pesticide product or any of its 
ingredients, impurities, metabolites, or degradation products which 
would otherwise be reportable under paragraphs (a), (b) or (c) of this 
section must be submitted if the information meets any one of the 
folowing three sets of criteria:
    (1) Short-term studies. A study using a test regimen lasting 90 
calendar days or less, and all of the following conditions are met:
    (i) All testing has been completed.
    (ii) A preliminary data analysis or gross pathological analysis has 
been conducted.
    (iii) Final analysis has not been completed.
    (iv) A reasonable period for completion of the final analysis not 
longer than 90 calendar days following completion of testing has 
elapsed.
    (v) Comparable information concerning the results of a completed 
study would be reportable.
    (2) Long-term studies. A study using a test regimen lasting more 
than 90 calendar days, and all of the following conditions are met:
    (i) All testing has been completed.
    (ii) A preliminary data analysis or gross pathological analysis has 
been conducted.
    (iii) Final analysis has not been completed.
    (iv) A reasonable period of completion of final analysis (not longer 
that 1 year following completion of testing) has elapsed.
    (v) Comparable information concerning the results of a completed 
study would be reportable.
    (3) Serious adverse effects. Any study in which testing or analysis 
of results is not yet complete but in which serious adverse effects have 
already been observed which may reasonably be attributed to exposure to 
the substances tested, because the effects observed in exposed organisms 
differ from effects observed in control organisms, are atypical in view 
of historical experience with the organism tested, or otherwise support 
a reasonable inference of causation, and 30 days have passed from the 
date the registrant first has the information.

[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998; 73 FR 75597, 
Dec. 12, 2008]



Sec. 159.167  Discontinued studies.

    The fact that a study has been discontinued before the planned 
termination must be reported to EPA, with the reason for termination, if 
submission of information concerning the study is, or would have been, 
required under this part.



Sec. 159.170  Human epidemiological and exposure studies.

    Information must be submitted which concerns any study that a person 
described in Sec. 159.158(a) has concluded, or might reasonably 
conclude, shows that a correlation may exist between exposure to a 
pesticide and observed adverse effects in humans. Information must also 
be submitted which concerns

[[Page 203]]

exposure monitoring studies that indicate higher levels of risk or 
exposure than would be expected based on previously available reports, 
data, or exposure estimates. Such information must be submitted 
regardless of whether the registrant considers any observed correlation 
or association to be significant.



Sec. 159.178  Information on pesticides in or on food, feed or water.

    (a) Food and feed. Information must be submitted if it shows that 
the pesticide is present in or on food or feed at a level in excess of 
established levels, except that information on excess residues resulting 
solely from studies conducted under authority of FIFRA section 5 or 
under other controlled research studies conducted to test a pesticide 
product need not be submitted, provided that the treated crop is not 
marketed as a food or feed commodity. The information to be submitted is 
the same as that required in Sec. 159.184(c)(1), (2), (3), and 
(4)(iv)(E), (F), (G), and (H).
    (b) Water. (1) Information must be submitted if it shows that a 
pesticide is present above the water reference level in any of the 
following instances:
    (i) Waters of the United States, as defined in Sec. 122.2 of this 
chapter, except paragraph (d) of Sec. 122.2.
    (ii) Ground water.
    (iii) Finished drinking water.
    (2) If the lowest detectable amount of the pesticide is reported, 
the detection limit must also be reported.
    (3) Information need not be submitted regarding the detection of a 
pesticide in waters of the United States or finished drinking water if 
the pesticide is registered for use in finished drinking water or 
surface water and the amount detected does not exceed the amounts 
reported by a registrant in its application for registration, as 
resulting in those waters from legal applications of the pesticide.
    (4) Information need not be submitted concerning detections of 
pesticides in waters of the United States, ground water or finished 
drinking water if the substance detected is an inert ingredient, or a 
metabolite, degradate, contaminant or impurity of a pesticide product, 
unless EPA has established or proposed a maximum contaminant level (MCL) 
or health advisory level (HAL) for that substance, or has estimated a 
health advisory level based on an established reference dose (RfD) for 
that substance, and notified registrants of that level.
    (5) Information to be submitted is the same as that required in 
Sec. 159.184(c)(1), (2), (3), (4)(iv) and (v), and (5)(vi).

[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998]



Sec. 159.179  Metabolites, degradates, contaminants, and impurities.

    (a) Metabolites and degradates. Information which shows the 
existence of any metabolite or degradate of a pesticide product must be 
submitted if either of the following conditions is met:
    (1) The metabolite or degradate may occur or be present under 
conditions of use of the pesticide product, and the existence of the 
metabolite or degradate or the association of the metabolite or 
degradate with the pesticide product has not been previously reported to 
EPA.
    (2) The metabolite or degradate has been previously reported, but it 
is detected at levels higher than any previously reported; and either of 
the following conditions is met:
    (i) Any person described in Sec. 159.158(a) has concluded that the 
metabolite or degradate may pose a toxicological or ecological risk 
based on any one or more of the following:
    (A) The physical or chemical properties of the metabolite or 
degradate.
    (B) Data regarding structurally analogous chemicals.
    (C) Data regarding chemical reactivity of the metabolite or 
degradate and structurally analogous substances.
    (D) Data on the metabolite or degradate.
    (ii) The registrant has concluded, or has been advised by any person 
described in Sec. 159.158(a) that the metabolite or degradate, or 
analogous chemicals, may have any experimentally determined half-life 
greater than 3 weeks as shown from laboratory aerobic soil metabolism 
studies or field dissipation studies, or may have any experimentally 
determined resistance to hydrolytic degradation, or photolytic 
degradation on soil or in water, under

[[Page 204]]

any conditions, resulting in degradation of less than 10 percent in a 
30-day period.
    (b) Contaminants and impurities. The presence in any pesticide 
product of a contaminant or impurity not previously identified by the 
registrant as part of the pesticide product's approved composition must 
be reported pursuant to this part if the contaminant or impurity is 
present in the product in any of the following quantities:
    (1) Quantities greater than 0.1 percent by weight (1,000 parts per 
million).
    (2) Quantities that EPA considers, and so informs registrants, to be 
of toxicological significance.
    (3) Quantities that the registrant considers to be of toxicological 
significance.
    (4) Quantities above a level for which the registrant has 
information indicating that the presence of the contaminant or impurity 
may pose a risk to health or the environment.
    (5) Quantities that a person described in Sec. 159.158(a) has 
informed the registrant is likely to be of toxicological significance.

[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998]



Sec. 159.184  Toxic or adverse effect incident reports.

    (a) General. Information about incidents affecting humans or other 
non-target organisms must be submitted if the following three conditions 
are met:
    (1) The registrant is aware, or has been informed that a person or 
non-target organism may have been exposed to a pesticide.
    (2) The registrant is aware, or has been informed that the person or 
non-target organism suffered a toxic or adverse effect, or may suffer a 
delayed or chronic adverse effect in the future.
    (3) The registrant has or could obtain information concerning where 
the incident occurred, the pesticide or product involved, and the name 
of a person to contact regarding the incident.
    (b) Exceptions. Information regarding an incident need not be 
submitted if any of the following conditions are met:
    (1) The registrant is aware of facts which clearly establish that 
the reported toxic effect, or reported exposure, did not or will not 
occur.
    (2) The registrant has been notified in writing by the Agency that 
the reporting requirement has been waived for this incident or category 
of incidents, and the registrant has not been notified in writing by the 
Agency that the waiver is rescinded.
    (3) It concerns a toxic effect to non-target plants, which were at 
the use site at the time the pesticide was applied, if the label 
provides adequate notice of such a risk.
    (4) It concerns non-lethal phytotoxicity to the treated crop if the 
label provides an adequate notice of such a risk.
    (5) It concerns a toxic effect to pests not specified on the label, 
provided that such pests are similar to pests specified on the label.
    (6) It concerns minor skin or eye irritation effects warned of on 
the label of a product which is registered for use in residential use 
sites, and the effects occurred as a result of use in a residential 
site.
    (c) Required information on individual incidents. To the extent that 
the registrant has any of the information listed in paragraphs (c)(1) 
through (c)(4) of this section, the registrant must supply the 
information on each pesticide incident that meets the requirements 
outlined in paragraph (a) of this section. If the registrant acquires 
additional information concerning an incident previously reported to the 
Agency under this part, such information shall be reported if it meets 
the criteria set forth in paragraph (f) of this section. In the future, 
the Agency may by notice specify a format for such submissions. The 
Administrative, Pesticide, Circumstance and Exposure Type(s) of 
information must be reported for individual incidents, except where the 
provisions of paragraph (e) of this section allow for aggregated summary 
forms of reporting, or if EPA in the future grants permission in writing 
for alternative reporting formats. The registrant must also provide one 
or more Exposure Type and Severity categories and their designations for 
each incident as set forth in paragraph (c)(5) of this section, 
depending on the applicability of the criteria listed below. The

[[Page 205]]

criteria listed should be used in assigning a category. For example, an 
incident which allegedly caused serious but non-fatal effects to human 
beings and domestic animals might be designated ``H-B: D-B.'' When a 
single incident involves multiple pesticides, the registrant need only 
report on their specific product. However, if a single incident involves 
more than one type of non-target organism--for example, both humans and 
domestic animals are involved--all appropriate available information 
dealing with each of the victims must also be reported. The 
informational items below are grouped by sections for ease in reporting 
pesticide incidents.
    (1) Administrative. Pesticide incident reports must be submitted if 
the registrant possesses or receives any of the following information, 
and the incident meets the minimum requirements set forth in paragraph 
(a) of this section:
    (i) Name of reporter, address, and telephone number.
    (ii) Name, address, and telephone number of contact person (if 
different than reporter).
    (iii) Incident report status (e.g., new or update); if update, 
include the date of original submission.
    (iv) Date registrant became aware of the incident.
    (v) Date of incident (if appropriate, list start and end dates).
    (vi) Location of incident (city, county and state).
    (vii) Is incident part of a larger study.
    (viii) Source if different from reporting registrant.
    (2) Pesticide. Pesticide incident reports must be submitted for each 
pesticide that may have contributed to the incident, if the registrant 
possesses or receives any of the following information, and the incident 
meets the minimum requirements set forth in paragraph (a) of this 
section:
    (i) Product name.
    (ii) Active ingredient(s).
    (iii) EPA Registration Number.
    (iv) Diluted for use, or concentrate.
    (v) Formulation, if known.
    (3) Circumstance. Pesticide incident reports must be submitted if 
the registrant possesses or receives any of the following information, 
and the incident meets the minimum requirements set forth in paragraph 
(a) of this section:
    (i) Evidence the label directions were not followed (e.g., yes, no, 
unknown).
    (ii) How exposed (e.g., spill, drift, equipment failure, container 
failure, mislabeling, runoff, etc.).
    (iii) Situation (e.g., household use, mixing/loading, application, 
reentry, disposal, transportation, other (describe)).
    (iv) Use site (e.g., home, yard, commercial turf, agricultural 
(specify crop), industrial, building/office, school, nursery, 
greenhouse, pond/lake/stream, well, forest/woods, other.
    (v) Applicator certified (yes, no, unknown).
    (vi) A brief description of the circumstances of the incident.
    (4) Other incident specific information. Pesticide incident reports 
must be submitted if the registrant possesses or receives any of the 
following information, and the incident meets the minimum requirements 
set forth in paragraph (a) of this section:
    (i) If the incident involves humans:
    (A) Route of exposure (skin, eye, respiratory, oral).
    (B) List signs/symptoms/adverse effects.
    (C) If laboratory tests were performed, list name of test(s) and 
results.
    (D) If available, submit laboratory report(s).
    (E) Time between exposure and onset of symptoms.
    (F) Was adverse effect the result of suicide/homicide or attempted 
suicide/homicide.
    (G) Type of medical care sought, (e.g., none, Poison Control Center, 
hospital emergency department, hospital inpatient, private physician, 
clinic, other).
    (H) Demographics (sex, age, occupation).
    (I) If female, pregnant?
    (J) Exposure data: amount of pesticide; duration of exposure; weight 
of victim.
    (K) Was exposure occupational; days lost due to illness.
    (L) Was protective clothing worn (specify).
    (ii) If domestic animal:

[[Page 206]]

    (A) Type of animal (e.g., livestock, poultry, bird, fish, household 
pet e.g., dog/cat etc.).
    (B) List signs/symptoms/adverse effects.
    (C) Breed/species (name and number affected, per adverse effect).
    (D) Route of exposure (e.g., skin, eye, respiratory, oral).
    (E) Time between exposure and onset of symptoms.
    (F) If laboratory test(s) performed, list name of tests and results.
    (G) If available, submit laboratory report(s).
    (iii) If fish, wildlife, plants or other non-target organisms:
    (A) List species affected, and number of individuals per species.
    (B) List symptoms or adverse effects.
    (C) Magnitude of the effect (e.g., miles of streams, square area of 
terrestrial habitat).
    (D) Pesticide application rate, intended use site (e.g., corn, 
turf), and method of application.
    (E) Description of the habitat and the circumstances under which the 
incident occurred.
    (F) If plant, type of plant life (i.e., crop, forest, orchard, home 
garden, ornamental, forage).
    (G) Formulation of pesticide if not indicated by brand name 
(granular, flowable).
    (H) Distance from treatment site.
    (I) If laboratory test(s) performed, list name of test(s) and 
results.
    (J) If available, submit laboratory report(s).
    (iv) If surface water:
    (A) If raw water samples, water bodies sampled and approximate 
locations in each water body.
    (B) If raw water samples, proximity of sampling locations to 
drinking water supply intakes and identities of systems supplied.
    (C) If finished water samples, water supply systems sampled.
    (D) If finished water samples, percent surface water source by 
specific surface water sources to water supply system(s).
    (E) Sample type (grab, composite).
    (F) Sampling times/frequency.
    (G) Pesticides and degredates analyzed for, the detection limits, 
and the amount detected.
    (H) Method of analysis.
    (v) If ground water:
    (A) Pesticides and degredates analyzed for, the analytical method 
used, the detection limits, and the amount detected.
    (B) Sample date.
    (C) Amount pesticide applied (lbs-ai/acre).
    (D) Date of last application.
    (E) Depth to water.
    (F) Latitude/longitude.
    (G) Soil series and texture (sand/silt/clay).
    (H) Frequency of applications per year.
    (I) Aquifer description (confined/unconfined).
    (J) Method of application.
    (K) Years pesticide used.
    (L) Well use and well identifier.
    (M) Screened interval.
    (N) Annual cumulative rainfall (inches).
    (O) Maximum rainfall and date.
    (P) Cumulative irrigation (inches).
    (Q) Hydrologic group.
    (R) Hydraulic conductivity.
    (S) pH.
    (T) Organic matter or organic carbon (percent).
    (vi) If property damage.
    (A) Provide description.
    (B) [Reserved]
    (5) Exposure types and severity category designations--(i) Humans. 
If an effect involves a human, provide the appropriate 2-letter exposure 
types and severity categories and their designations, based upon the 
following categories:
    (A) H-A: If the person died.
    (B) H-B: If the person alleged or exhibited symptoms which may have 
been life-threatening, or resulted in adverse reproductive effects or in 
residual disability.
    (C) H-C: If the person alleged or exhibited symptoms more 
pronounced, more prolonged or of a more systemic nature than minor 
symptoms. Usually some form of treatment of the person would have been 
Indicated. Symptoms were not life threatening and the person has 
returned to his/her pre-exposure state of health with no additional 
residual disability.
    (D) H-D: If the person alleged or exhibited some symptoms, but they 
were

[[Page 207]]

minimally traumatic. The symptoms resolved rapidly and usually involve 
skin, eye or respiratory irritation.
    (E) H-E: If symptoms are unknown, unspecified or are alleged to be 
of a delayed or chronic nature that may appear in the future.
    (ii) Domestic animals. If an effect involves a domestic animal, 
provide the appropriate 2-letter notation based upon the following 
categories:
    (A) D-A: If the domestic animal died or was euthanized.
    (B) D-B: If the domestic animal exhibited or was alleged to have 
exhibited symptoms which may have been life-threatening or resulted in 
residual disability.
    (C) D-C: If the domestic animal exhibited or was alleged to have 
exhibited symptoms which are more pronounced, more prolonged or of a 
more systemic nature than minor symptoms. Usually some form of treatment 
would have been indicated to treat the animal. Symptoms were not life 
threatening and the animal has returned to its pre-exposure state of 
health with no additional residual disability.
    (D) D-D: If the domestic animal was alleged to have exhibited 
symptoms, but they were minimally bothersome. The symptoms resolved 
rapidly and usually involve skin, eye or respirator irritation.
    (E) D-E: If symptoms are unknown or not specified.
    (iii) Fish or wildlife. If an alleged effect involves fish or 
wildlife, label the incident W-A if any of the following criteria are 
met, or W-B if none of the criteria are met:
    (A) Involves any incident caused by a pesticide currently in Formal 
Review forecological concerns.
    (B) Fish: Affected 1,000 or more individuals of a schooling species 
or 50 or more individuals of a non-schooling species.
    (C) Birds: Affected 200 or more individuals of a flocking species, 
or 50 or moreindividuals of a songbird species, or 5 or more individuals 
of a predatory species.
    (D) Mammals, reptiles, amphibians: Affected 50 or more individuals 
of a relatively common or herding species or 5 or more individuals of a 
rare or solitary species.
    (E) Involves effects to, or illegal pesticide treatment (misuse) of 
a substantial tract of habitat (greater than or equal to 10 acres, 
terrestrial or aquatic).
    (F) Involves a major spill or discharge (greater than or equal to 
5,000 gallons) of a pesticide.
    (G) Involves adverse effects caused by a pesticide, to federally 
listed endangered or threatened species.
    (iv) Plants. If an alleged effect involves damage to plants, label 
the incident P-A if the following criterion is met, or P-B if the 
criterion is not met:
    (A) The effect is alleged to have occurred on more than 45 percent 
of the acreage exposed to the pesticide.
    (B) [Reserved]
    (v) Other non-target organisms. If an alleged effect involves damage 
to non-target organisms other than fish, wildlife or plants (for 
example, beneficial insects), label the incident ONT.
    (vi) Water contamination. If a pesticide is alleged to have been 
detected in groundwater, surface water or finished drinking water, label 
the incident in accordance with the following criteria:
    (A) G-A: If the pesticide was detected at levels greater than the 
maximum contaminant level (MCL) or health advisory level (HAL) or an 
applicable criterion for ambient water quality.
    (B) G-B: If the pesticide was detected at levels greater than 10 
percent of the MCL, HAL or a criterion for ambient water quality but 
does not exceed the MCL or other applicable level.
    (C) G-C: If the pesticide was detected at levels less than 10 
percent of the MCL, HAL, or other applicable level, or there is no 
established level of concern.
    (vii) Property damage. If an incident involves alleged property 
damage the applicable term(s) shall be included along with any other 
applicable effect category label; for example, ``H-B: property damage.'' 
Label the incident in accordance with the following criteria:
    (A) PD-A: The product is alleged to have caused damage in a manner 
that could have caused direct human injury, such as fire or explosion.
    (B) PD-B: The product is alleged to have caused damage in excess of 
$5,000.

[[Page 208]]

    (C) PD-C: Any allegation of property damage that does not meet the 
criteria of paragraphs (c)(5)(vii)(A) or (B) of this section, including 
cases in which the level of damages is not specified.
    (d) Time requirements for submitting incident information. 
Information concerning incidents reportable under this section must be 
submitted within the time frames listed for different exposure and 
severity categories, as follows:
    (1) For allegations involving human fatality (H-A), registrants must 
submit the required information, to the extent it is available, no later 
than 15 days after learning of an allegation.
    (2) Information concerning incidents which meet the criteria for the 
following exposure and severity category labels described in paragraph 
(c)(5) of this section, reports of detections of pesticides in water, 
and efficacy failure incidents may be described in Sec. 159.188(a)(1) 
and (b)(1), may be accumulated for a 30-day period, and submitted to the 
Agency within 30 days after the end of each 30-day accumulation period 
for: Humans, H-B, and H-C; Wildlife, W-A; Plants, P-A; Water, G-A; 
Property Damage, PD-A.
    (3) Incidents or reports of detections of pesticides in water 
meeting all other exposure and severity label categories, information 
may be accumulated by registrants for 90 days and submitted within 60 
days after the end of each 90-day accumulation period.
    (e) Aggregated reports. For incidents that are reportable under the 
schedule requirements of paragraph (d)(3) of this section, in lieu of 
individual reports containing the information listed in paragraphs 
(c)(1) through (c)(4) of this section, registrants must provide an 
aggregated report listing:
    (1) The time period covered by the report.
    (2) For each exposure and severity label category, a count of the 
number of incidents, listed by product registration number (if known) or 
active ingredient.
    (3) A count of domestic animal incidents in categories, other than 
D-A or D-B, which can be added together and reported as a single number.
    (f) Reporting additional information. If, after the submission of an 
incident report to the Agency, a registrant acquires additional 
information concerning that incident, the information should be 
submitted within the same time frame as applied to the original incident 
report, if any of the following conditions apply:
    (1) The information concerns an alleged human fatality (H-A), and 
the information consists of any of the elements listed in paragraphs 
(c)(1) through (c)(4) of this section.
    (2) The information concerns an incident originally reported as 
alleging a major human illness or injury (H-B), or fatality to a 
domestic animal (D-A), or wildlife (W-A), and the additional information 
consists of pesticide or circumstance information listed in paragraphs 
(c)(2) or (c)(3) of this section, or is a laboratory report concerning 
persons or animals involved in the incident.
    (3) The information concerns any incident not originally reported 
with one of the exposure and severity labels H-A, or H-B for human 
incidents, or at the ``A'' level of severity for any other exposure or 
incident type, and the new information would result in labeling the 
incident H-A or H-B for a human incident, or at the ``A'' level of 
severity for any other exposure or incident type listed in paragraph 
(c)(5) of this section.

[62 FR 49388, Sept. 19, 1997; 63 FR 33583, June 19, 1998]



Sec. 159.188  Failure of performance information.

    (a) Microorganisms that pose a risk to human health. Information 
must be submitted which concerns either incidents described in paragraph 
(a)(1) of this section or a study described in paragraph (a)(2) of this 
section:
    (1) Information which concerns an incident which meets all of the 
following conditions:
    (i) The registrant has been informed that a pesticide product may 
not have performed as claimed against target microorganisms.
    (ii) The possible failures of the pesticide to perform as claimed 
involved the use against microorganisms which may pose a risk to human 
health.
    (iii) The pesticide product's use site is other than residential.

[[Page 209]]

    (iv) The registrant has or could obtain information concerning where 
the incident occurred, the pesticide or product involved, and the name 
of a person to contact regarding the incident.
    (2) A study which indicates that the pesticide may not perform in 
accordance with one or more claims made by the registrant regarding uses 
intended for control of microorganisms tha may pose a risk to human 
health, including any of the public health antimicrobials identified in 
part 161 of this chapter.
    (b) Animals that pose a risk to human health. For the purposes of 
this section, any animal (including insects) poses a risk to human 
health if it may cause disease in humans, either directly or as a 
disease vector; produce toxins that are harmful to humans; or cause 
direct physical harm to humans. Information must be submitted which 
concerns either incidents described in paragraph (b)(1) of this section 
or a study described in paragraph (b)(2) of this section.
    (1) Information which concerns an incident which meets all of the 
following conditions:
    (i) The registrant has been informed by municipal, State, or Federal 
public health officials that a pesticide product may not have performed 
as claimed against target animals.
    (ii) The possible failures of the pesticide to perform as claimed 
involved the use against animals that pose a risk to human health.
    (iii) The registrant has or could obtain information concerning 
where the incident occurred, the pesticide or product involved, and the 
name of a person to contact regarding the incident.
    (2) A study which indicates that the pesticide may not perform in 
accordance with one or more claims by the registrant regarding uses 
intended for control of animals that pose a risk to human health, 
including any of the public health pesticides identified in part 158 of 
this chapter.
    (c) Development of pesticide resistance. Information must be 
submitted concerning substantiation of any incident of a pest having 
developed resistance to any pesticide (both public health and non-public 
health) that occurred under conditions of use, application rates and 
methods specified on the label if either of the following conditions is 
met:
    (1) The survival of the suspected pesticide-resistant pest was 
significantly higher than that of a known susceptible pest when both the 
suspected resistant and susceptible pests were treated with the 
pesticide under controlled conditions.
    (2) Biochemical tests or DNA sequencing indicate that the pest is 
resistant to the pesticide.

[63 FR 49388, Sept. 19, 1997, as amended at 72 FR 61029, Oct. 26, 2007]



Sec. 159.195  Reporting of other information.

    (a) The registrant shall submit to the Administrator information 
other than that described in Sec. Sec. 159.165 through 159.188 if the 
registrant knows, or reasonably should know, that if the information 
should prove to be correct, EPA might regard the information alone or in 
conjunction with other information about the pesticide as raising 
concerns about the continued registration of a product or about the 
appropriate terms and conditions of registration of a product. Examples 
of the types of information which must be provided if not already 
reportable under some other provision of this part include but are not 
limited to information showing:
    (1) Previously unknown or unexpected bioaccumulation of a pesticide 
by various life forms.
    (2) Greater than anticipated drift of pesticides to non-target 
areas.
    (3) Use of a pesticide may pose any greater risk than previously 
believed or reported to the Agency.
    (4) Use of a pesticide promotes or creates secondary pest 
infestations.
    (5) Any information which might tend to invalidate a study submitted 
to the Agency to support a pesticide registration.
    (b) A registrant is not obligated under paragraph (a) of this 
section to provide information to the Administrator if the registrant is 
aware of facts which establish that otherwise reportable information is 
not correct.
    (c) The registrant shall submit to the Administrator information 
other than that described in Sec. Sec. 159.165 through

[[Page 210]]

159.188 if the registrant has been informed by EPA that such additional 
information has the potential to raise questions about the continued 
registration of a product or about the appropriate terms and conditions 
of registration of a product.

[62 FR 49388, Sept. 19, 1997; 63 FR 33583, June 19, 1998]



PART 160_GOOD LABORATORY PRACTICE STANDARDS--Table of Contents



                      Subpart A_General Provisions

Sec.
160.1 Scope and applicability.
160.3 Definitions.
160.10 Applicability to studies performed under grants and contracts.
160.12 Statement of compliance or non-compliance.
160.15 Inspection of a testing facility.
160.17 Effects of non-compliance.

                  Subpart B_Organization and Personnel

160.29 Personnel.
160.31 Testing facility management.
160.33 Study director.
160.35 Quality assurance unit.

                          Subpart C_Facilities

160.41 General.
160.43 Test system care facilities.
160.45 Test system supply facilities.
160.47 Facilities for handling test, control, and reference substances.
160.49 Laboratory operation areas.
160.51 Specimen and data storage facilities.

                           Subpart D_Equipment

160.61 Equipment design.
160.63 Maintenance and calibration of equipment.

                 Subpart E_Testing Facilities Operation

160.81 Standard operating procedures.
160.83 Reagents and solutions.
160.90 Animal and other test system care.

            Subpart F_Test, Control, and Reference Substances

160.105 Test, control, and reference substance characterization.
160.107 Test, control, and reference substance handling.
160.113 Mixtures of substances with carriers.

              Subpart G_Protocol for and Conduct of a Study

160.120 Protocol.
160.130 Conduct of a study.
160.135 Physical and chemical characterization studies.

Subparts H-I [Reserved]

                      Subpart J_Records and Reports

160.185 Reporting of study results.
160.190 Storage and retrieval of records and data.
160.195 Retention of records.

    Authority: 7 U.S.C. 136a, 136c, 136d, 136f, 136j, 136t, 136v, 136w; 
21 U.S.C. 346a, 371, Reorganization Plan No. 3 of 1970.

    Source: 54 FR 34067, Aug. 17, 1989, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 160.1  Scope and applicability.

    (a) This part prescribes good laboratory practices for conducting 
studies that support or are intended to support applications for 
research or marketing permits for pesticide products regulated by the 
EPA. This part is intended to assure the quality and integrity of data 
submitted pursuant to sections 3, 4, 5, 8, 18 and 24(c) of the Federal 
Insecticide, Fungicide, and Rodenticide Act, as amended, and section 408 
or 409 of the Federal Food, Drug and Cosmetic Act.
    (b) This part applies to any study described by paragraph (a) of 
this section which any person conducts, initiates, or supports on or 
after October 16, 1989.

[73 FR 75597, Dec. 12, 2008]



Sec. 160.3  Definitions.

    As used in this part the following terms shall have the meanings 
specified:
    Application for research or marketing permit means any of the 
following:
    (1) An application for registration, amended registration, or 
reregistration of a pesticide product under FIFRA sections 3, 4 or 
24(c).
    (2) An application for an experimental use permit under FIFRA 
section 5.
    (3) An application for an exemption under FIFRA section 18.

[[Page 211]]

    (4) A petition or other request for establishment or modification of 
a tolerance, for an exemption for the need for a tolerance, or for other 
clearance under FFDCA section 408.
    (5) A petition or other request for establishment or modification of 
a food additive regulation or other clearance by EPA under FFDCA section 
409 that was submitted prior to August 3, 1996.
    (6) A submission of data in response to a notice issued by EPA under 
FIFRA section 3(c)(2)(B).
    (7) Any other application, petition, or submission sent to EPA 
intended to persuade EPA to grant, modify, or leave unmodified a 
registration or other approval required as a condition of sale or 
distribution of a pesticide.
    Batch means a specific quantity or lot of a test, control, or 
reference substance that has been characterized according to Sec. 
160.105(a).
    Carrier means any material, including but not limited to feed, 
water, soil, nutrient media, with which the test substance is combined 
for administration to a test system.
    Control substance means any chemical substance or mixture, or any 
other material other than a test substance, feed, or water, that is 
administered to the test system in the course of a study for the purpose 
of establishing a basis for comparison with the test substance for known 
chemical or biological measurements.
    EPA means the U.S. Environmental Protection Agency.
    Experimental start date means the first date the test substance is 
applied to the test system.
    Experimental termination date means the last date on which data are 
collected directly from the study.
    FDA means the U.S. Food and Drug Administration.
    FFDCA means the Federal Food, Drug and Cosmetic Act, as amended (21 
U.S.C. 321 et seq).
    FIFRA means the Federal Insecticide, Fungicide and Rodenticide Act 
as amended (7 U.S.C. 136 et seq).
    Person means an individual, partnership, corporation, association, 
scientific or academic establishment, government agency or 
organizational unit thereof, or any other legal entity.
    Quality assurance unit means any person or organizational element, 
except the study director, designated by testing facility management to 
perform the duties relating to quality assurance of the studies.
    Raw data means any laboratory worksheets, records, memoranda, notes, 
or exact copies thereof, that are the result of original observations 
and activities of a study and are necessary for the reconstruction and 
evaluation of the report of that study. In the event that exact 
transcripts of raw data have been prepared (e.g., tapes which have been 
transcribed verbatim, dated, and verified accurate by signature), the 
exact copy or exact transcript may be substituted for the original 
source as raw data. ``Raw data'' may include photographs, microfilm or 
microfiche copies, computer printouts, magnetic media, including 
dictated observations, and recorded data from automated instruments.
    Reference substance means any chemical substance or mixture, or 
analytical standard, or material other than a test substance, feed, or 
water, that is administered to or used in analyzing the test system in 
the course of a study for the purposes of establishing a basis for 
comparison with the test substance for known chemical or biological 
measurements.
    Specimen means any material derived from a test system for 
examination or analysis.
    Sponsor means:
    (1) A person who initiates and supports, by provision of financial 
or other resources, a study;
    (2) A person who submits a study to the EPA in support of an 
application for a research or marketing permit; or
    (3) A testing facility, if it both initiates and actually conducts 
the study.
    Study means any experiment at one of more test sites, in which a 
test substance is studied in a test system under laboratory conditions 
or in the environment to determine or help predict its effects, 
metabolism, product performance (efficacy studies only as required by 40 
CFR 158.400 or 161.640, as applicable), environmental and chemical fate, 
persistence and residue, or other characteristics in humans, other 
living organisms, or media. The term

[[Page 212]]

``study''does not include basic exploratory studies carried out to 
determine whether a test substance or a test method has any potential 
utility.
    Study completion date means the date the final report is signed by 
the study director.
    Study director means the individual responsible for the overall 
conduct of a study.
    Study initiation date means the date the protocol is signed by the 
study director.
    Test substance means a substance or mixture administered or added to 
a test system in a study, which substance or mixture:
    (1) Is the subject of an application for a research or marketing 
permit supported by the study, or is the contemplated subject of such an 
application; or
    (2) Is an ingredient, impurity, degradation product, metabolite, or 
radioactive isotope of a substance described by paragraph (1) of this 
definition, or some other substance related to a substance described by 
that paragraph, which is used in the study to assist in characterizing 
the toxicity, metabolism, or other characteristics of a substance 
described by that paragraph.
    Test system means any animal, plant, microorganism, chemical or 
physical matrix, including but not limited to soil or water, or subparts 
thereof, to which the test, control, or reference substance is 
administered or added for study. ``Test system'' also includes 
appropriate groups or components of the system not treated with the 
test, control, or reference substance.
    Testing facility means a person who actually conducts a study, i.e., 
actually uses the test substance in a test system. ``Testing facility'' 
encompasses only those operational units that are being or have been 
used to conduct studies.
    Vehicle means any agent which facilitates the mixture, dispersion, 
or solubilization of a test substance with a carrier.

[54 FR 34067, Aug. 17, 1989, as amended at 72 FR 61029, Oct. 26, 2007; 
73 FR 75597, Dec. 12, 2008]



Sec. 160.10  Applicability to studies performed under grants and contracts.

    When a sponsor or other person utilizes the services of a consulting 
laboratory, contractor, or grantee to perform all or a part of a study 
to which this part applies, it shall notify the consulting laboratory, 
contractor, or grantee that the service is, or is part of, a study that 
must be conducted in compliance with the provisions of this part.



Sec. 160.12  Statement of compliance or non-compliance.

    Any person who submits to EPA an application for a research or 
marketing permit and who, in connection with the application, submits 
data from a study to which this part applies shall include in the 
application a true and correct statement, signed by the applicant, the 
sponsor, and the study director, of one of the following types:
    (a) A statement that the study was conducted in accordance with this 
part; or
    (b) A statement describing in detail all differences between the 
practices used in the study and those required by this part; or
    (c) A statement that the person was not a sponsor of the study, did 
not conduct the study, and does not know whether the study was conducted 
in accordance with this part.



Sec. 160.15  Inspection of a testing facility.

    (a) A testing facility shall permit an authorized employee or duly 
designated representative of EPA or FDA, at reasonable times and in a 
reasonable manner, to inspect the facility and to inspect (and in the 
case of records also to copy) all records and specimens required to be 
maintained regarding studies to which this part applies. The records 
inspection and copying requirements should not apply to quality 
assurance unit records of findings and problems, or to actions 
recommended and taken, except that EPA may seek production of these 
records in litigation or formal adjudicatory hearings.
    (b) EPA will not consider reliable for purposes of supporting an 
application for a research or marketing permit any data developed by a 
testing facility or

[[Page 213]]

sponsor that refuses to permit inspection in accordance with this part. 
The determination that a study will not be considered in support of an 
application for a research or marketing permit does not, however, 
relieve the applicant for such a permit of any obligation under any 
applicable statute or regulation to submit the results of the study to 
EPA.



Sec. 160.17  Effects of non-compliance.

    (a) EPA may refuse to consider reliable for purposes of supporting 
an application for a research or marketing permit any data from a study 
which was not conducted in accordance with this part.
    (b) Submission of a statement required by Sec. 160.12 which is 
false may form the basis for cancellation, suspension, or modification 
of the research or marketing permit, or denial or disapproval of an 
application for such a permit, under FIFRA section 3, 5, 6, 18, or 24 or 
FFDCA section 406 or 409, or for criminal prosecution under 18 U.S.C. 2 
or 1001 or FIFRA section 14, or for imposition of civil penalties under 
FIFRA section 14.



                  Subpart B_Organization and Personnel



Sec. 160.29  Personnel.

    (a) Each individual engaged in the conduct of or responsible for the 
supervision of a study shall have education, training, and experience, 
or combination thereof, to enable that individual to perform the 
assigned functions.
    (b) Each testing facility shall maintain a current summary of 
training and experience and job description for each individual engaged 
in or supervising the conduct of a study.
    (c) There shall be a sufficient number of personnel for the timely 
and proper conduct of the study according to the protocol.
    (d) Personnel shall take necessary personal sanitation and health 
precautions designed to avoid contamination of test, control, and 
reference substances and test systems.
    (e) Personnel engaged in a study shall wear clothing appropriate for 
the duties they perform. Such clothing shall be changed as often as 
necessary to prevent microbiological, radiological, or chemical 
contamination of test systems and test, control, and reference 
substances.
    (f) Any individual found at any time to have an illness that may 
adversely affect the quality and integrity of the study shall be 
excluded from direct contact with test systems, and test, control, and 
reference substances, and any other operation or function that may 
adversely affect the study until the condition is corrected. All 
personnel shall be instructed to report to their immediate supervisors 
any health or medical conditions that may reasonably be considered to 
have an adverse effect on a study.



Sec. 160.31  Testing facility management.

    For each study, testing facility management shall:
    (a) Designate a study director as described in Sec. 160.33 before 
the study is initiated.
    (b) Replace the study director promptly if it becomes necessary to 
do so during the conduct of a study.
    (c) Assure that there is a quality assurance unit as described in 
Sec. 160.35.
    (d) Assure that test, control, and reference substances or mixtures 
have been appropriately tested for identity, strength, purity, 
stability, and uniformity, as applicable.
    (e) Assure that personnel, resources, facilities, equipment, 
materials and methodologies are available as scheduled.
    (f) Assure that personnel clearly understand the functions they are 
to perform.
    (g) Assure that any deviations from these regulations reported by 
the quality assurance unit are communicated to the study director and 
corrective actions are taken and documented.



Sec. 160.33  Study director.

    For each study, a scientist or other professional of appropriate 
education, training, and experience, or combination thereof, shall be 
identified as the study director. The study director has overall 
responsibility for the technical conduct of the study, as well as for 
the

[[Page 214]]

interpretation, analysis, documentation, and reporting of results, and 
represents the single point of study control. The study director shall 
assure that:
    (a) The protocol, including any change, is approved as provided by 
Sec. 160.120 and is followed.
    (b) All experimental data, including observations of unanticipated 
responses of the test system are accurately recorded and verified.
    (c) Unforseen circumstances that may affect the quality and 
integrity of the study are noted when they occur, and corrective action 
is taken and documented.
    (d) Test systems are as specified in the protocol.
    (e) All applicable good laboratory practice regulations are 
followed.
    (f) All raw data, documentation, protocols, specimens, and final 
reports are transferred to the archives during or at the close of the 
study.



Sec. 160.35  Quality assurance unit.

    (a) A testing facility shall have a quality assurance unit which 
shall be responsible for monitoring each study to assure management that 
the facilities, equipment, personnel, methods, practices, records, and 
controls are in conformance with the regulations in this part. For any 
given study, the quality assurance unit shall be entirely separate from 
and independent of the personnel engaged in the direction and conduct of 
that study. The quality assurance unit shall conduct inspections and 
maintain records appropriate to the study.
    (b) The quality assurance unit shall:
    (1) Maintain a copy of a master schedule sheet of all studies 
conducted at the testing facility indexed by test substance, and 
containing the test system, nature of study, date study was initiated, 
current status of each study, identity of the sponsor, and name of the 
study director.
    (2) Maintain copies of all protocols pertaining to all studies for 
which the unit is responsible.
    (3) Inspect each study at intervals adequate to ensure the integrity 
of the study and maintain written and properly signed records of each 
periodic inspection showing the date of the inspection, the study 
inspected, the phase or segment of the study inspected, the person 
performing the inspection, findings and problems, action recommended and 
taken to resolve existing problems, and any scheduled date for 
reinspection. Any problems which are likely to affect study integrity 
found during the course of an inspection shall be brought to the 
attention of the study director and management immediately.
    (4) Periodically submit to management and the study director written 
status reports on each study, noting any problems and the corrective 
actions taken.
    (5) Determine that no deviations from approved protocols or standard 
operating procedures were made without proper authorization and 
documentation.
    (6) Review the final study report to assure that such report 
accurately describes the methods and standard operating procedures, and 
that the reported results accurately reflect the raw data of the study.
    (7) Prepare and sign a statement to be included with the final study 
report which shall specify the dates inspections were made and findings 
reported to management and to the study director.
    (c) The responsibilities and procedures applicable to the quality 
assurance unit, the records maintained by the quality assurance unit, 
and the method of indexing such records shall be in writing and shall be 
maintained. These items including inspection dates, the study inspected, 
the phase or segment of the study inspected, and the name of the 
individual performing the inspection shall be made available for 
inspection to authorized employees or duly designated representatives of 
EPA or FDA.
    (d) An authorized employee or a duly designated representative of 
EPA or FDA shall have access to the written procedures established for 
the inspection and may request testing facility management to certify 
that inspections are being implemented, performed, documented, and 
followed up in accordance with this paragraph.

[[Page 215]]



                          Subpart C_Facilities



Sec. 160.41  General.

    Each testing facility shall be of suitable size and construction to 
facilitate the proper conduct of studies. Testing facilities which are 
not located within an indoor controlled environment shall be of suitable 
location to facilitate the proper conduct of studies. Testing facilities 
shall be designed so that there is a degree of separation that will 
prevent any function or activity from having an adverse effect on the 
study.



Sec. 160.43  Test system care facilities.

    (a) A testing facility shall have a sufficient number of animal 
rooms or other test system areas, as needed, to ensure: proper 
separation of species or test systems, isolation of individual projects, 
quarantine or isolation of animals or other test systems, and routine or 
specialized housing of animals or other test systems.
    (1) In tests with plants or aquatic animals, proper separation of 
species can be accomplished within a room or area by housing them 
separately in different chambers or aquaria. Separation of species is 
unnecessary where the protocol specifies the simultaneous exposure of 
two or more species in the same chamber, aquarium, or housing unit.
    (2) Aquatic toxicity tests for individual projects shall be isolated 
to the extent necessary to prevent cross-contamination of different 
chemicals used in different tests.
    (b) A testing facility shall have a number of animal rooms or other 
test system areas separate from those described in paragraph (a) of this 
section to ensure isolation of studies being done with test systems or 
test, control, and reference substances known to be biohazardous, 
including volatile substances, aerosols, radioactive materials, and 
infectious agents.
    (c) Separate areas shall be provided, as appropriate, for the 
diagnosis, treatment, and control of laboratory test system diseases. 
These areas shall provide effective isolation for the housing of test 
systems either known or suspected of being diseased, or of being 
carriers of disease, from other test systems.
    (d) Facilities shall have proper provisions for collection and 
disposal of contaminated water, soil, or other spent materials. When 
animals are housed, facilities shall exist for the collection and 
disposal of all animal waste and refuse or for safe sanitary storage of 
waste before removal from the testing facility. Disposal facilities 
shall be so provided and operated as to minimize vermin infestation, 
odors, disease hazards, and environmental contamination.
    (e) Facilities shall have provisions to regulate environmental 
conditions (e.g., temperature, humidity, photoperiod) as specified in 
the protocol.
    (f) For marine test organisms, an adequate supply of clean sea water 
or artificial sea water (prepared from deionized or distilled water and 
sea salt mixture) shall be available. The ranges of composition shall be 
as specified in the protocol.
    (g) For freshwater organisms, an adequate supply of clean water of 
the appropriate hardness, pH, and temperature, and which is free of 
contaminants capable of interfering with the study, shall be available 
as specified in the protocol.
    (h) For plants, an adequate supply of soil of the appropriate 
composition, as specified in the protocol, shall be available as needed.



Sec. 160.45  Test system supply facilities.

    (a) There shall be storage areas, as needed, for feed, nutrients, 
soils, bedding, supplies, and equipment. Storage areas for feed 
nutrients, soils, and bedding shall be separated from areas where the 
test systems are located and shall be protected against infestation or 
contamination. Perishable supplies shall be preserved by appropriate 
means.
    (b) When appropriate, plant supply facilities shall be provided. As 
specified in the protocol, these include:
    (1) Facilities for holding, culturing, and maintaining algae and 
aquatic plants.
    (2) Facilities for plant growth, including, but not limited to 
greenhouses, growth chambers, light banks, and fields.

[[Page 216]]

    (c) When appropriate, facilities for aquatic animal tests shall be 
provided. These include, but are not limited to, aquaria, holding tanks, 
ponds, and ancillary equipment, as specified in the protocol.



Sec. 160.47  Facilities for handling test, control, and reference substances.

    (a) As necessary to prevent contamination or mixups, there shall be 
separate areas for:
    (1) Receipt and storage of the test, control, and reference 
substances.
    (2) Mixing of the test, control, and reference substances with a 
carrier, e.g., feed.
    (3) Storage of the test, control, and reference substance mixtures.
    (b) Storage areas for test, control, and/or reference substance and 
for test, control, and/or reference mixtures shall be separate from 
areas housing the test systems and shall be adequate to preserve the 
identity, strength, purity, and stability of the substances and 
mixtures.



Sec. 160.49  Laboratory operation areas.

    Separate laboratory space and other space shall be provided, as 
needed, for the performance of the routine and specialized procedures 
required by studies.



Sec. 160.51  Specimen and data storage facilities.

    Space shall be provided for archives, limited to access by 
authorized personnel only, for the storage and retrieval of all raw data 
and specimens from completed studies.



                           Subpart D_Equipment



Sec. 160.61  Equipment design.

    Equipment used in the generation, measurement, or assessment of data 
and equipment used for facility environmental control shall be of 
appropriate design and adequate capacity to function according to the 
protocol and shall be suitably located for operation, inspection, 
cleaning, and maintenance.



Sec. 160.63  Maintenance and calibration of equipment.

    (a) Equipment shall be adequately inspected, cleaned, and 
maintained. Equipment used for the generation, measurement, or 
assessment of data shall be adequately tested, calibrated, and/or 
standardized.
    (b) The written standard operating procedures required under Sec. 
160.81(b)(11) shall set forth in sufficient detail the methods, 
materials, and schedules to be used in the routine inspection, cleaning, 
maintenance, testing, calibration, and/ or standardization of equipment, 
and shall specify, when appropriate, remedial action to be taken in the 
event of failure or malfunction of equipment. The written standard 
operating procedures shall designate the person responsible for the 
performance of each operation.
    (c) Written records shall be maintained of all inspection, 
maintenance, testing, calibrating, and/or standardizing operations. 
These records, containing the dates of the operations, shall describe 
whether the maintenance operations were routine and followed the written 
standard operating procedures. Written records shall be kept of 
nonroutine repairs performed on equipment as a result of failure and 
malfunction. Such records shall document the nature of the defect, how 
and when the defect was discovered, and any remedial action taken in 
response to the defect.



                 Subpart E_Testing Facilities Operation



Sec. 160.81  Standard operating procedures.

    (a) A testing facility shall have standard operating procedures in 
writing setting forth study methods that management is satisfied are 
adequate to insure the quality and integrity of the data generated in 
the course of a study. All deviations in a study from standard operating 
procedures shall be authorized by the study director and shall be 
documented in the raw data. Significant changes in established standard 
operating procedures shall be properly authorized in writing by 
management.
    (b) Standard operating procedures shall be established for, but not 
limited to, the following:
    (1) Test system area preparation.
    (2) Test system care.

[[Page 217]]

    (3) Receipt, identification, storage, handling, mixing, and method 
of sampling of the test, control, and reference substances.
    (4) Test system observations.
    (5) Laboratory or other tests.
    (6) Handling of test systems found moribund or dead during study.
    (7) Necropsy of test systems or postmortem examination of test 
systems.
    (8) Collection and identification of specimens.
    (9) Histopathology.
    (10) Data handling, storage and retrieval.
    (11) Maintenance and calibration of equipment.
    (12) Transfer, proper placement, and identification of test systems.
    (c) Each laboratory or other study area shall have immediately 
available manuals and standard operating procedures relative to the 
laboratory or field procedures being performed. Published literature may 
be used as a supplement to standard operating procedures.
    (d) A historical file of standard operating procedures, and all 
revisions thereof, including the dates of such revisions, shall be 
maintained.



Sec. 160.83  Reagents and solutions.

    All reagents and solutions in the laboratory areas shall be labeled 
to indicate identity, titer or concentration, storage requirements, and 
expiration date. Deteriorated or outdated reagents and solutions shall 
not be used.



Sec. 160.90  Animal and other test system care.

    (a) There shall be standard operating procedures for the housing, 
feeding, handling, and care of animals and other test systems.
    (b) All newly received test systems from outside sources shall be 
isolated and their health status or appropriateness for the study shall 
be evaluated. This evaluation shall be in accordance with acceptable 
veterinary medical practice or scientific methods.
    (c) At the initiation of a study, test systems shall be free of any 
disease or condition that might interfere with the purpose or conduct of 
the study. If during the course of the study, the test systems contract 
such a disease or condition, the diseased test systems should be 
isolated, if necessary. These test systems may be treated for disease or 
signs of disease provided that such treatment does not interfere with 
the study. The diagnosis, authorization of treatment, description of 
treatment, and each date of treatment shall be documented and shall be 
retained.
    (d) Warm-blooded animals, adult reptiles, and adult terrestrial 
amphibians used in laboratory procedures that require manipulations and 
observations over an extended period of time or in studies that require 
these test systems to be removed from and returned to their test system-
housing units for any reason (e.g., cage cleaning, treatment, etc.), 
shall receive appropriate identification (e.g., tattoo, color code, ear 
tag, ear punch, etc.). All information needed to specifically identify 
each test system within the test system-housing unit shall appear on the 
outside of that unit. Suckling mammals and juvenile birds are excluded 
from the requirement of individual identification unless otherwise 
specified in the protocol.
    (e) Except as specified in paragraph (e)(1) of this section, test 
systems of different species shall be housed in separate rooms when 
necessary. Test systems of the same species, but used in different 
studies, should not ordinarily be housed in the same room when 
inadvertent exposure to test, control, or reference substances or test 
system mixup could affect the outcome of either study. If such mixed 
housing is necessary, adequate differentiation by space and 
identification shall be made.
    (1) Plants, invertebrate animals, aquatic vertebrate animals, and 
organisms that may be used in multispecies tests need not be housed in 
separate rooms, provided that they are adequately segregated to avoid 
mixup and cross contamination.
    (2) [Reserved]
    (f) Cages, racks, pens, enclosures, aquaria, holding tanks, ponds, 
growth chambers, and other holding, rearing and breeding areas, and 
accessory equipment, shall be cleaned and sanitized at appropriate 
intervals.
    (g) Feed, soil, and water used for the test systems shall be 
analyzed periodically to ensure that contaminants known to be capable of 
interfering with

[[Page 218]]

the study and reasonably expected to be present in such feed, soil, or 
water are not present at levels above those specified in the protocol. 
Documentation of such analyses shall be maintained as raw data.
    (h) Bedding used in animal cages or pens shall not interfere with 
the purpose or conduct of the study and shall be changed as often as 
necessary to keep the animals dry and clean.
    (i) If any pest control materials are used, the use shall be 
documented. Cleaning and pest control materials that interfere with the 
study shall not be used.
    (j) All plant and animal test systems shall be acclimatized to the 
environmental conditions of the test, prior to their use in a study.



            Subpart F_Test, Control, and Reference Substances



Sec. 160.105  Test, control, and reference substance characterization.

    (a) The identity, strength, purity, and composition, or other 
characteristics which will appropriately define the test, control, or 
reference substance shal1 be determined for each batch and shall be 
documented before its use in a study. Methods of synthesis, fabrication, 
or derivation of the test, control, or reference substance shall be 
documented by the sponsor or the testing facility, and the location of 
such documentation shall be specified.
    (b) When relevant to the conduct of the study the solubility of each 
test, control, or reference substance shall be determined by the testing 
facility or the sponsor before the experimental start date. The 
stability of the test, control, or reference substance shall be 
determined before the experimental start date or concomitantly according 
to written standard operating procedures, which provide for periodic 
analysis of each batch.
    (c) Each storage container for a test, control, or reference 
substance shall be labeled by name, chemical abstracts service number 
(CAS) or code number, batch number, expiration date, if any, and, where 
appropriate, storage conditions necessary to maintain the identity, 
strength, purity, and composition of the test, control, or reference 
substance. Storage containers shall be assigned to a particular test 
substance for the duration of the study.
    (d) For studies of more than 4 weeks experimental duration, reserve 
samples from each batch of test, control, and reference substances shall 
be retained for the period of time provided by Sec. 160.195.
    (e) The stability of test, control, and reference substances under 
storage conditions at the test site shall be known for all studies.



Sec. 160.107  Test, control, and reference substance handling.

    Procedures shall be established for a system for the handling of the 
test, control, and reference substances to ensure that:
    (a) There is proper storage.
    (b) Distribution is made in a manner designed to preclude the 
possibility of contamination, deterioration, or damage.
    (c) Proper identification is maintained throughout the distribution 
process.
    (d) The receipt and distribution of each batch is documented. Such 
documentation shall include the date and quantity of each batch 
distributed or returned.



Sec. 160.113  Mixtures of substances with carriers.

    (a) For each test, control, or reference substance that is mixed 
with a carrier, tests by appropriate analytical methods shall be 
conducted:
    (1) To determine the uniformity of the mixture and to determine, 
periodically, the concentration of the test, control, or reference 
substance in the mixture.
    (2) When relevant to the conduct of the study, to determine the 
solubility of each test, control, or reference substance in the mixture 
by the testing facility or the sponsor before the experimental start 
date.
    (3) To determine the stability of the test, control, or reference 
substance in the mixture before the experimental start date or 
concomitantly according to written standard operating procedures, which 
provide for periodic analysis of each batch.

[[Page 219]]

    (b) Where any of the components of the test, control, or reference 
substance carrier mixture has an expiration date, that date shall be 
clearly shown on the container. If more than one component has an 
expiration date, the earliest date shall be shown.
    (c) If a vehicle is used to facilitate the mixing of a test 
substance with a carrier, assurance shall be provided that the vehicle 
does not interfere with the integrity of the test.



              Subpart G_Protocol for and Conduct of a Study



Sec. 160.120  Protocol.

    (a) Each study shall have an approved written protocol that clearly 
indicates the objectives and all methods for the conduct of the study. 
The protocol shall contain but shall not necessarily be limited to the 
following information:
    (1) A descriptive title and statement of the purpose of the study.
    (2) Identification of the test, control, and reference substance by 
name, chemical abstracts service (CAS) number or code number.
    (3) The name and address of the sponsor and the name and address of 
the testing facility at which the study is being conducted.
    (4) The proposed experimental start and termination dates.
    (5) Justification for selection of the test system.
    (6) Where applicable, the number, body weight range, sex, source of 
supply, species, strain, substrain, and age of the test system.
    (7) The procedure for identification of the test system.
    (8) A description of the experimental design, including methods for 
the control of bias.
    (9) Where applicable, a description and/or identification of the 
diet used in the study as well as solvents, emulsifiers and/or other 
materials used to solubilize or suspend the test, control, or reference 
substances before mixing with the carrier. The description shall include 
specifications for acceptable levels of contaminants that are reasonably 
expected to be present in the dietary materials and are known to be 
capable of interfering with the purpose or conduct of the study if 
present at levels greater than established by the specifications.
    (10) The route of administration and the reason for its choice.
    (11) Each dosage level, expressed in milligrams per kilogram of body 
or test system weight or other appropriate units, of the test, control, 
or reference substance to be administered and the method and frequency 
of administration.
    (12) The type and frequency of tests, analyses, and measurements to 
be made.
    (13) The records to be maintained.
    (14) The date of approval of the protocol by the sponsor and the 
dated signature of the study director.
    (15) A statement of the proposed statistical method to be used.
    (b) All changes in or revisions of an approved protocol and the 
reasons therefore shall be documented, signed by the study director, 
dated, and maintained with the protocol.



Sec. 160.130  Conduct of a study.

    (a) The study shall be conducted in accordance with the protocol.
    (b) The test systems shall be monitored in conformity with the 
protocol.
    (c) Specimens shall be identified by test system, study, nature, and 
date of collection. This information shall be located on the specimen 
container or shall accompany the specimen in a manner that precludes 
error in the recording and storage of data.
    (d) In animal studies where histopathology is required, records of 
gross findings for a specimen from postmortem observations shall be 
available to a pathologist when examining that specimen 
histopathologically.
    (e) All data generated during the conduct of a study, except those 
that are generated by automated data collection systems, shall be 
recorded directly, promptly, and legibly in ink. All data entries shall 
be dated on the day of entry and signed or initialed by the person 
entering the data. Any change in entries shall be made so as not to 
obscure the original entry, shall indicate the reason for such change,

[[Page 220]]

and shall be dated and signed or identified at the time of the change. 
In automated data collection systems, the individual responsible for 
direct data input shall be identified at the time of data input. Any 
change in automated data entries shall be made so as not to obscure the 
original entry, shall indicate the reason for change, shall be dated, 
and the responsible individual shall be identified.



Sec. 160.135  Physical and chemical characterization studies.

    (a) All provisions of the GLP standards shall apply to physical and 
chemical characterization studies designed to determine stability, 
solubility, octanol water partition coefficient, volatility, and 
persistence (such as biodegradation, photodegradation, and chemical 
degradation studies) of test, control, or reference substances.
    (b) The following GLP standards shall not apply to studies, other 
than those designated in paragraph (a) of this section, designed to 
determine physical and chemical characteristics of a test, control, or 
reference substance:

Sec. 160.31 (c), (d), and (g)
Sec. 160.35 (b) and (c)
Sec. 160.43
Sec. 160.45
Sec. 160.47
Sec. 160.49
Sec. 160.81(b) (1), (2), (6) through (9), and (12)
Sec. 160.90
Sec. 160.105 (a) through (d)
Sec. 160.113
Sec. 160.120(a) (5) through (12), and (15)
Sec. 160.185(a) (5) through (8), (10), (12), and (14)
Sec. 160.195 (c) and (d)

Subparts H-I [Reserved]



                      Subpart J_Records and Reports



Sec. 160.185  Reporting of study results.

    (a) A final report shall be prepared for each study and shall 
include, but not necessarily be limited to, the following:
    (1) Name and address of the facility performing the study and the 
dates on which the study was initiated and was completed, terminated, or 
discontinued.
    (2) Objectives and procedures stated in the approved protocol, 
including any changes in the original protocol.
    (3) Statistical methods employed for analyzing the data.
    (4) The test, control, and reference substances identified by name, 
chemical abstracts service (CAS) number or code number, strength, 
purity, and composition, or other appropriate characteristics.
    (5) Stability and, when relevant to the conduct of the study the 
solubility of the test, control, and reference substances under the 
conditions of administration.
    (6) A description of the methods used.
    (7) A description of the test system used. Where applicable, the 
final report shall include the number of animals used, sex, body weight 
range, source of supply, species, strain and substrain, age, and 
procedure used for identification.
    (8) A description of the dosage, dosage regimen, route of 
administration, and duration.
    (9) A description of all circumstances that may have affected the 
quality or integrity of the data.
    (10) The name of the study director, the names of other scientists 
or professionals and the names of all supervisory personnel, involved in 
the study.
    (11) A description of the transformations, calculations, or 
operations performed on the data, a summary and analysis of the data, 
and a statement of the conclusions drawn from the analysis.
    (12) The signed and dated reports of each of the individual 
scientists or other professionals involved in the study, including each 
person who, at the request or direction of the testing facility or 
sponsor, conducted an analysis or evaluation of data or specimens from 
the study after data generation was completed.
    (13) The locations where all specimens, raw data, and the final 
report are to be stored.
    (14) The statement prepared and signed by the quality assurance unit 
as described in Sec. 160.35(b)(7).
    (b) The final report shall be signed and dated by the study 
director.
    (c) Corrections or additions to a final report shall be in the form 
of an

[[Page 221]]

amendment by the study director. The amendment shall clearly identify 
that part of the final report that is being added to or corrected and 
the reasons for the correction or addition, and shall be signed and 
dated by the person responsible. Modification of a final report to 
comply with the submission requirements of EPA does not constitute a 
correction, addition, or amendment to a final report.
    (d) A copy of the final report and of any amendment to it shall be 
maintained by the sponsor and the test facility.



Sec. 160.190  Storage and retrieval of records and data.

    (a) All raw data, documentation, records, protocols, specimens, and 
final reports generated as a result of a study shall be retained. 
Specimens obtained from mutagenicity tests, specimens of soil, water, 
and plants, and wet specimens of blood, urine, feces, and biological 
fluids, do not need to be retained after quality assurance verification. 
Correspondence and other documents relating to interpretation and 
evaluation of data, other than those documents contained in the final 
report, also shall be retained.
    (b) There shall be archives for orderly storage and expedient 
retrieval of all raw data, documentation, protocols, specimens, and 
interim and final reports. Conditions of storage shall minimize 
deterioration of the documents or specimens in accordance with the 
requirements for the time period of their retention and the nature of 
the documents of specimens. A testing facility may contract with 
commercial archives to provide a repository for all material to be 
retained. Raw data and specimens may be retained elsewhere provided that 
the archives have specific reference to those other locations.
    (c) An individual shall be identified as responsible for the 
archives.
    (d) Only authorized personnel shall enter the archives.
    (e) Material retained or referred to in the archives shall be 
indexed to permit expedient retrieval.



Sec. 160.195  Retention of records.

    (a) Record retention requirements set forth in this section do not 
supersede the record retention requirements of any other regulations in 
this subchapter.
    (b) Except as provided in paragraph (c) of this section, 
documentation records, raw data, and specimens pertaining to a study and 
required to be retained by this part shall be retained in the archive(s) 
for whichever of the following periods is longest:
    (1) In the case of any study used to support an application for a 
research or marketing permit approved by EPA, the period during which 
the sponsor holds any research or marketing permit to which the study is 
pertinent.
    (2) A period of at least 5 years following the date on which the 
results of the study are submitted to the EPA in support of an 
application for a research or marketing permit.
    (3) In other situations (e.g., where the study does not result in 
the submission of the study in support of an application for a research 
or marketing permit), a period of at least 2 years following the date on 
which the study is completed, terminated, or discontinued.
    (c) Wet specimens, samples of test, control, or reference 
substances, and specially prepared material which are relatively fragile 
and differ markedly in stability and quality during storage, shall be 
retained only as long as the quality of the preparation affords 
evaluation. Specimens obtained from mutagenicity tests, specimens of 
soil, water, and plants, and wet specimens of blood, urine, feces, and 
biological fluids, do not need to be retained after quality assurance 
verification. In no case shall retention be required for longer periods 
than those set forth in paragraph (b) of this section.
    (d) The master schedule sheet, copies of protocols, and records of 
quality assurance inspections, as required by Sec. 160.35(c) shall be 
maintained by the quality assurance unit as an easily accessible system 
of records for the period of time specified in paragraph (b) of this 
section.
    (e) Summaries of training and experience and job descriptions 
required to be maintained by Sec. 160.29(b) may be retained along with 
all other testing facility employment records for the

[[Page 222]]

length of time specified in paragraph (b) of this section.
    (f) Records and reports of the maintenance and calibration and 
inspection of equipment, as required by Sec. 160.63 (b) and (c), shall 
be retained for the length of time specified in paragraph (b) of this 
section.
    (g) If a facility conducting testing or an archive contracting 
facility goes out of business, all raw data, documentation, and other 
material specified in this section shall be transferred to the archives 
of the sponsor of the study. The EPA shall be notified in writing of 
such a transfer.
    (h) Specimens, samples, or other non-documentary materials need not 
be retained after EPA has notified in writing the sponsor or testing 
facility holding the materials that retention is no longer required by 
EPA. Such notification normally will be furnished upon request after EPA 
or FDA has completed an audit of the particular study to which the 
materials relate and EPA has concluded that the study was conducted in 
accordance with this part.
    (i) Records required by this part may be retained either as original 
records or as true copies such as photocopies, microfilm, microfiche, or 
other accurate reproductions of the original records.



PART 161_DATA REQUIREMENTS FOR REGISTRATION OF ANTIMICROBIAL PESTICIDES--Table 

of Contents



                      Subpart A_General Provisions

Sec.
161.20 Overview.
161.25 Applicability of data requirements.
161.30 Timing of the imposition of data requirements.
161.32 Format of data submission.
161.33 Procedures for claims of confidentiality of data.
161.34 Flagging of studies for potential adverse effects.
161.35 Flexibility of the data requirements.
161.40 Consultation with the Agency.
161.45 Waivers.
161.55 Agricultural vs. non-agricultural pesticides.
161.60 Minor uses.
161.70 Acceptable protocols.
161.75 Requirements for additional data.
161.80 Acceptability of data.
161.85 Revision of data requirements and guidelines.

                    Subpart B_How To Use Data Tables

161.100 How to determine registration data requirements.
161.101 Required vs. conditionally required data.
161.102 Distinguishing between what data are required and what substance 
          is to be tested.
161.108 Relationship of Pesticide Assessment Guidelines to data 
          requirements.

              Subpart C_Product Chemistry Data Requirements

161.150 General.
161.153 Definitions.
161.155 Product composition.
161.160 Description of materials used to produce the product.
161.162 Description of production process.
161.165 Description of formulation process.
161.167 Discussion of formation of impurities.
161.170 Preliminary analysis.
161.175 Certified limits.
161.180 Enforcement analytical method.
161.190 Physical and chemical characteristics.

                    Subpart D_Data Requirement Tables

161.202 Purposes of the registration data requirements.
161.240 Residue chemistry data requirements.
161.290 Environmental fate data requirements.
161.340 Toxicology data requirements.
161.390 Reentry protection data requirements.
161.440 Spray drift data requirements.
161.490 Wildlife and aquatic organisms data requirements.
161.540 Plant protection data requirements.
161.590 Nontarget insect data requirements.
161.640 Product performance data requirements table.

Appendix A to Part 161--Data Requirements for Registration: Use Pattern 
          Index.

    Authority: 7 U.S.C. 136-136y.

    Source: 49 FR 42881, Oct. 24, 1984, unless otherwise noted. 
Redesignated at 72 FR 60253, Oct. 24, 2007.

    Effective Date Note: At 78 FR 26993, May 8, 2013, part 161 was 
removed, effective July 8, 2013.



                      Subpart A_General Provisions

    Source: 49 FR 42881, Oct. 24, 1984, unless otherwise noted. 
Redesignated and amended at 72 FR 60253, 60254, Oct. 24, 2007.

[[Page 223]]



Sec. 161.20  Overview.

    (a) Legal authority. These requirements are promulgated under the 
authority of sections 3, 5, 12, and 25 of the Federal Insecticide, 
Fungicide and Rodenticide Act, as amended (FIFRA) (7 U.S.C. 136-136y).
    (b) Purposes of this part. (1) The primary purpose of this part is 
to specify the types and minimum amounts of data and information the 
Agency requires in order to make regulatory judgments about the risks 
and benefits of various kinds of pesticide products under the criteria 
set forth in FIFRA sections 3(c)(5) (C) and (D) and 3(c)(7).
    (2) This part also specifies the types and minimum amounts of data 
and information the Agency requires to decide whether to approve 
applications for experimental use permits under FIFRA section 5.
    (3) Finally, this part specifies the types and minimum amounts of 
data and information that an applicant for registration, amended 
registration, or reregistration must submit or cite in support of an 
application in order to satisfy the requirements of FIFRA section 
3(c)(1)(D) and sections 3(c)(5)(B) or 3(c)(7). Use of the term 
``registration'' in this part will pertain to new registrations and 
amended registrations as well as reregistration accomplished under 
section 3(g), unless stated otherwise.
    (c) Availability of related guidelines. The data requirements for 
pesticide registration specified in this part pertain to product 
chemistry, residue chemistry, environmental fate, toxicology, reentry 
protection, aerial drift evaluation, wildlife and aquatic organisms, 
plant protection, nontarget insects, product performance, and 
biochemical and microbial pesticides. The standards for conducting 
acceptable tests, guidance on evaluation and reporting of data, further 
guidance on when data are required, definition of most terms, and 
examples of protocols are not specified in this part. This information 
is available in advisory documents (collectively referred to as 
Pesticide Assessment Guidelines) through the National Technical 
Information Service, 5285 Port Royal Road, Springfield, VA 22161 
(telephone: 703-487-4650).



Sec. 161.25  Applicability of data requirements.

    (a) Some kinds of data and information are specified in subparts C 
and D of this part as ``required'' (``R'') for the evaluation of some or 
all types of products. Other kinds of data and information are specified 
in those sections as ``conditionally required'' (``CR''), that is, they 
are required if the product's proposed pattern of use, results of other 
tests, or other pertinent factors meet the criteria specified in those 
sections. The terms ``required'' and ``conditionally required'' are 
further discussed in Sec. Sec. 161.100 and 161.101.
    (b) The Agency recognizes that certain data requirements may not be 
applicable to (or should be waived for) some products, and has made 
provisions for such cases in this part as specified in Sec. 161.35 
Flexibility of the data requirements, Sec. 161.40 Consultation with the 
Agency, Sec. 161.45 Waivers, and Sec. 161.60 Minor uses.

[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988]



Sec. 161.30  Timing of the imposition of data requirements.

    This part establishes requirements for the types of data which are 
necessary to support the unconditional registration of a pesticide 
product under section 3(c)(5) of the Act. While every registered 
pesticide product must eventually be supported by the data required by 
part 161, when an applicant or registrant must initially satisfy these 
data requirements depends on the factors listed below in this section.
    (a) Existing Registrations. A registrant of a currently registered 
pesticide product is not obligated to satisfy any data requirement in 
part 161 with respect to that product until he receives a notice under 
section 3(c)(2)(B) of the Act that additional data are required to 
support the continued registration of the product, until he applies for 
an amendment to the registration, or until the product is subject to 
reregistration.
    (b) Applications. The amount of data required by the Agency to 
evaluate an application for initial or amended registration depends on 
whether the product is being reviewed under section

[[Page 224]]

3(c)(5) of the Act (unconditional registration) or section 3(c)(7) of 
the Act (conditional registration). Refer to Sec. 152.111 of this 
chapter or consult with the appropriate EPA Product Manager to determine 
under which section of the Act the application will be reviewed. The 
following paragraphs identify, for each different type of application, 
the minimum amount of data that must be available for EPA review to 
permit EPA to make the statutory risk-benefit determinations required by 
section 3(c)(5) or 3(c)(7) of the Act. In addition to satisfying these 
minimum data requirements, applicants may be required to submit or cite 
additional data, either to permit EPA to assess the safety or efficacy 
of the product (refer to Sec. 161.75) or to comply with the statutory 
requirements of section 3(c)(1)(D) of the Act, or both.
    (1) Applications for unconditional registration under section 
3(c)(5) of the Act. EPA will not approve an application for 
unconditional registration unless all data required by this part which 
have not been waived are available for EPA to review.
    (2) Applications for conditional registration of a new chemical 
under section 3(c)(7)(C) of the Act. EPA will not approve an application 
for conditional registration of a pesticide containing an active 
ingredient not contained in any currently registered product unless data 
required by this part are available for EPA to review except for:
    (i) Those data for which the requirement has been waived.
    (ii) Those data for which the requirement was imposed so recently 
that the applicant has not had sufficient time to produce the data.
    (3) Applications for conditional registration of products which are 
identical or substantially similar to currently registered products 
under section 3(c)(7)(A) of the Act. EPA will not approve an application 
for conditional registration of a pecticide product which is identical 
or substantially similar to a currently registered pesticide unless the 
following data are available for EPA to review:
    (i) Product chemistry data, as required by subpart C of this part.
    (ii) Product performance data, to the extent required by Sec. 
161.160.
    (4) Applications for conditional registration of new uses of 
currently registered products under section 3(c)(7)(B) of the Act. EPA 
will not approve an application for registration of a pesticide for a 
new use of a currently registered pesticide product unless the following 
data are available for EPA to review:
    (i) Product chemistry data, as required by subpart C of this part.
    (ii) Product performance data, to the extent required by Sec. 
161.160.
    (iii) Other data pertaining solely to the new use. The applicant may 
generally determine which data pertain solely to the new use by 
comparing the data requirements for all existing uses of all currently 
registered products containing the same active ingredient(s) with those 
for all uses including the new use. Any differences are attributable to 
the new use and must be submitted with the application.

[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988; 58 
FR 34203, June 23, 1993]



Sec. 161.32  Format of data submission.

    (a) Transmittal document. All data submitted at the same time and 
for review in support of a single administrative action (e.g., an 
application for registration, reregistration, experimental use permit, 
or in response to a requirement for data under the authority of FIFRA 
sec. 3(c)(2)(B), must be accompanied by a single transmittal document 
including the following information:
    (1) The identity of the submitter, or the identity of each joint 
submitter and of the agent for joint submitters;
    (2) The date of the submission;
    (3) The identification of the Agency action in support of which the 
data are being submitted, such as the registration number or file 
symbol, petition number, experimental use permit number, or registration 
standard review; and
    (4) A bibliography of all specific documents included in the 
submission and covered by the transmittal.
    (b) Individual studies. (1) All data must be submitted in the form 
of individual studies. Unless otherwise specified by the Agency, each 
study should address a single data requirement, and

[[Page 225]]

be listed separately in the bibliography.
    (2) Each study must include the following elements in addition to 
the study itself:
    (i) A title page, as described in paragraph (c) of this section;
    (ii) A Statement of Data Confidentiality Claims and, if desired, a 
Supplemental Statement of Data Confidentiality Claims, in accordance 
with Sec. 161.33;
    (iii) A certification with respect to Good Laboratory Practice 
standards, if required by Sec. 160.12 of this chapter;
    (iv) If the original study is not in the English language, a 
complete and accurate English translation under the same cover; and
    (v) If the study is of a type listed in Sec. 161.34(b), the 
statement prescribed by paragraph (c) of that section.
    (3) Three identical copies of each study must be submitted. If the 
study is submitted in conjunction with a pending Special Review or 
Registration Standard under development, four copies must be submitted. 
Three copies must be identical and must conform to the requirements of 
Sec. 161.33 with respect to claims of confidentiality. The fourth copy 
will be placed in the public docket and must conform to the requirements 
of Sec. 154.15(c) of this chapter or Sec. 155.30(c) of this chapter 
with respect to claimed confidential business information.
    (4) All copies must be in black ink on uniform pages of white, 8\1/
2\ x 11 inch paper. Copies must have high contrast and good resolution 
for microfilming. Frayed or oversize pages and glued bindings are not 
acceptable.
    (c) Contents of title page. Each individual study must have a title 
page bearing the following identifying information:
    (1) The title of the study, including identification of the 
substance(s) tested and the test name or data requirement addressed;
    (2) The author(s) of the study;
    (3) The date the study was completed;
    (4) If the study was performed in a laboratory, the name and address 
of the laboratory and any laboratory project numbers or other 
identifying codes;
    (5) If the study is a commentary on or supplement to another 
previously submitted study, full identification of the other study with 
which it should be associated in review; and
    (6) If the study is a reprint of a published document, all relevant 
facts of publication, such as the journal title, volume, issue, 
inclusive page numbers, and date of publication.
    (d) EPA identification number. EPA will assign each study an EPA 
Master Record Identification (MRID) number, and will promptly notify the 
submitter of the number assigned. This number should be used in all 
further communications with the Agency about the study.
    (e) Reference to previously submitted data. Data which previously 
have been submitted need not be resubmitted unless resubmission is 
specifically requested by the Agency. If an applicant or registrant 
wishes the Agency to consider such data in the review of an Agency 
action, he should cite the data by providing:
    (1) The title or adequate description of the study;
    (2) The transmittal information required by paragraph (a) (1), (2), 
and (3) of this section; and
    (3) The MRID number assigned in accordance with paragraph (d) of 
this section.

[53 FR 15991, May 4, 1988]



Sec. 161.33  Procedures for claims of confidentiality of data.

    (a) General. A data submitter must clearly identify any information 
which he claims is entitled to confidential treatment under FIFRA sec. 
10. The procedures in this section must be followed to assert a claim of 
confidentiality.
    (b) Claims of confidentiality for information described by FIFRA 
sec. 10(d)(1) (A), (B), and (C). Any information claimed to be 
confidential under FIFRA sec. 10(d)(1) (A) through (C) must be submitted 
in accordance with the following procedures:
    (1) The information must be contained in a separate attachment to 
the study. If any information is included in the body of the study 
rather than in

[[Page 226]]

the confidential attachment, the submitter waives a claim of 
confidentiality for such information under FIFRA sec. 10(d)(1) (A), (B), 
or (C).
    (2) The attachment must have a cover page which is clearly marked to 
indicate that the material contained in the attachment falls within the 
scope of FIFRA sec. 10(d)(1) (A), (B), or (C).
    (3) Each item in the attachment must be numbered. For each item, the 
submitter must cite the applicable portion of FIFRA sec. 10(d)(1) (A), 
(B), or (C) on which the claim of confidentiality is based. In addition, 
for each item, the submitter must provide a list of page numbers in the 
study where the item is cited (i.e., identified by number).
    (4) Each item in the attachment must be referenced in the body of 
the study by its number in the attachment.
    (5) The following statement must appear on the Statement of Data 
Confidentiality Claims:

    Information claimed confidential on the basis of its falling within 
the scope of FIFRA sec. 10(d)(1)(A), (B), or (C) has been removed to a 
confidential appendix, and is cited by cross-reference number in the 
body of the study.


The statement must bear the name, title, and signature of the submitter 
or his properly designated agent, and the date of signature.
    (c) No claim of confidentiality under FIFRA sec. 10(d)(1)(A), (B), 
or (C). If no claim of confidentiality is being made for information 
described by FIFRA sec. 10(d)(1)(A), (B), or (C), or if such information 
is not contained in the body of the study, the Statement of Data 
Confidentiality Claims must include the following statement:

    No claim of confidentiality is made for any information contained in 
this study on the basis of its falling within the scope of FIFRA sec. 
10(d)(1)(A), (B), or (C).


This statement must bear the name, title and signature of the submitter 
or his properly designated agent, and the date of signature.
    (d) Claim of confidentiality for information not described by FIFRA 
sec. 10(d)(1) (A), (B), or (C). Any information not described by FIFRA 
sec. 10(d)(1) (A), (B), or (C) for which a claim of confidentiality is 
made must be submitted in accordance with the following procedures:
    (1) The information must be clearly marked in the body of the study 
as being claimed confidential.
    (2) A separate Supplemental Statement of Data Confidentiality Claims 
must be submitted identifying by page and line number the location 
within the study of each item claimed confidential, and stating the 
basis for the claim.
    (3) The Supplemental Statement of Data Confidentiality Claims must 
bear the name, title, and signature of the submitter or his properly 
designated agent, and the date of signature.

[53 FR 15991, May 4, 1988]



Sec. 161.34  Flagging of studies for potential adverse effects.

    (a) Any person who submits a study of a type listed in paragraph (b) 
of this section to support an application for new or amended 
registration, or to satisfy a requirement imposed under FIFRA sec. 
3(c)(2)(B), must submit with the study a statement in accordance with 
paragraph (c) of this section.
    (b) The following table indicates that study types and the criteria 
to be applied to each. Column 1 lists the study types by name. Column 2 
lists the associated Pesticide Assessment Guideline number. Column 3 
lists the criteria applicable to each type of study. Column 4 lists the 
reporting code to be included in the statement specified in paragraph 
(c) of this section when any criterion is met or exceeded.

                                            Table--Flagging Criteria
----------------------------------------------------------------------------------------------------------------
                                            Pesticide
                                            assessment                                                Reporting
             Toxicity studies               guidelines                    Criteria                       code
                                               No.
----------------------------------------------------------------------------------------------------------------
Oncogenicity [or combined oncogenicity/           83-2  Treated animals show any of the following:
 chronic feeding study]

[[Page 227]]

 
 or
Subchronic feeding study.................         82-1  An incidence of neoplasms in male or female            1
                                                         animals which increases with dose;
                                           ...........   or
                                           ...........  A statistically significant (p <=0.05)                 2
                                                         incidence of any type of neoplasm in any
                                                         test group (male or female animals at any
                                                         dose level) compared to concurrent control
                                                         animals of the same sex;
                                           ...........   or
                                           ...........  An increase in any type of uncommon or rare            3
                                                         neoplasms in any test group (male or
                                                         female animals at any dose level) compared
                                                         to concurrent control animals
                                           ...........   or
                                           ...........  A decrease in the time to development of               4
                                                         any type of neoplasms in any test group
                                                         (male or female animals at any dose level)
                                                         compared to concurrent control animals
----------------------------------------------------------------------------------------------------------------
Teratogenicity...........................         83-3  When compared with concurrent controls,                5
                                                         treated animals show a dose-related
                                                         increase in malformations (or deaths) on a
                                                         litter basis in the absence of significant
                                                         maternal toxicity at the same dose levels
----------------------------------------------------------------------------------------------------------------
Neurotoxicity............................         81-7  When compared with controls, treated                   6
                                                         animals show a response indicative of
                                                         acute delayed neurotoxicity
----------------------------------------------------------------------------------------------------------------
Chronic feeding study or combined chronic         83-1  Cholinesterase inhibition NOEL less than 10            7
 feeding/oncogenicity study                              times the current existing ADI.
                                           ...........   or
                                           ...........  General (systemic) toxicity NOEL less than             8
                                                         100 times the current existing ADI.
----------------------------------------------------------------------------------------------------------------
Reproduction study.......................         83-4  Reproductive effects NOEL less than 100                9
                                                         times the current ADI.
----------------------------------------------------------------------------------------------------------------
Subchronic feeding study.................         82-1  Cholinesterase inhibition NOEL less than              10
                                                         100 times the current existing ADI.
                                           ...........   or
                                           ...........  General (systemic) toxicity NOEL less than            11
                                                         1000 times the current existing ADI.
----------------------------------------------------------------------------------------------------------------

    (c) Identification of studies. For each study of a type identified 
in paragraph (b) of this section, the applicant (or registrant in the 
case of information submitted under FIFRA sec. 3(c)(2)(B)) shall include 
the appropriate one of the following two statements, together with the 
signature of the authorized representative of the company, and the date 
of signature:
    (1) ``I have applied the criteria of 40 CFR 161.34 for flagging 
studies for potential adverse effects to the results of the attached 
study. This study neither meets nor exceeds any of the applicable 
criteria.''
    (2) ``I have applied the criteria of 40 CFR 161.34 for flagging 
studies for potential adverse effects to the results of the attached 
study. This study meets or exceeds the criteria numbered [insert all 
applicable reporting codes.]''

[53 FR 15992, May 4, 1988, as amended at 58 FR 34203, June 23, 1993]



Sec. 161.35  Flexibility of the data requirements.

    Several provisions of this part provide EPA flexibility in requiring 
(or not requiring) data and information for the purposes specified in 
Sec. 161.20(b). These provisions are summarized in this section and 
discussed elsewhere in this part.
    (a) The Agency encourages each applicant, particularly a person 
applying for registration for the first time, to consult with the 
Product Manager for

[[Page 228]]

his product to resolve questions relating to the protocols or the data 
requirements before undertaking extensive testing under Sec. 161.40.
    (b) Any applicant who believes that a data requirement is 
inapplicable to a specific pesticide product may request a waiver of a 
data requirement under Sec. 161.45.
    (c) The Agency may require an applicant to provide additional data 
or information beyond that specified in subparts C and D of this part 
when these data are not sufficient to permit EPA to evaluate the 
applicant's product under Sec. 161.75.
    (d) Several policies are in effect that govern the data requirements 
for registration of products having minor uses. These policies reduce 
substantially the data requirements that need to be met on the basis of 
limited exposures and economic equity, and allow case-by-case decision 
making to determine the specific needs for each kind of use under Sec. 
161.60.
    (e) The data requirements and guidelines are not static documents. 
Section 3(c)(2) of FIFRA states that the administrator ``shall revise 
such guidelines from time to time.'' Therefore, the data requirements 
and guidelines will be revised periodically to reflect new scientific 
knowledge, new trends in pesticide development, and new Agency policies 
under Sec. 161.80.

[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988]



Sec. 161.40  Consultation with the Agency.

    This part establishes data requirements applicable to various 
general use patterns of pesticide products, but some unique or 
unanticipated aspect of a proposed product's use pattern or composition 
may result in the need for conferences between registration applicants 
and the Agency. Such conferences may be initiated by the Agency or by 
registration applicants. Applicants are expected to contact their 
respective Product Managers to arrange discussions. The Agency welcomes 
suggestions for changes to improve the clarity, accuracy, or some other 
aspect of the data requirements set forth in this part. Specific 
suggestions should be forwarded to the Director of the Hazard Evaluation 
Division.



Sec. 161.45  Waivers.

    (a) Rationale and policy. (1) The data requirements specified in 
this part as applicable to a category of products will not always be 
appropriate for every product in that category. Some products may have 
unusual physical, chemical, or biological properties or atypical use 
patterns which would make particular data requirements inappropriate, 
either because it would not be possible to generate the required data or 
because the data would not be useful in the Agency's evaluation of the 
risks or benefits of the product. The Agency will waive data 
requirements it finds are inappropriate, but will ensure that sufficient 
data are available to make the determinations required by the applicable 
statutory standards.
    (2) The Agency will waive data requirements on a case-by-case basis 
in response to specific written requests by applicants. Because of the 
wide variety of types and use patterns of pesticides, it is impossible 
to spell out all of the circumstances which might serve as a basis for 
waiving data requirements. The Agency, however, will take into account, 
as appropriate, the factors enumerated in sections 3(c)(2)(A) and 
25(a)(1) of FIFRA.
    (b) Procedure for requesting waiver. (1) An applicant should discuss 
his plans to request a waiver with the EPA Product Manager responsible 
for his product before developing and submitting extensive support 
information for the request.
    (2) To request a waiver, an applicant must submit a written request 
to the appropriate Product Manager. The request must specifically 
identify the data requirement for which a waiver is requested, explain 
why he thinks data requirement(s) should be waived, describe any 
unsuccessful attempts to generate the required data, furnish any other 
information which he believes would support the request, and when 
appropriate, suggest alternative means of obtaining data to address the 
concern which underlies the data requirement.
    (c) Notification of waiver decision. The Agency will review each 
waiver request and inform the applicant in writing of its decision. In 
addition, for decisions

[[Page 229]]

that could apply to more than a specific product, the Agency may choose 
to send a notice to all registrants or to publish a notice in the 
Federal Register announcing its decision. An Agency decision denying a 
written request to waive a data requirement shall constitute final 
Agency action for purposes of FIFRA section 16(a).
    (d) Availability of waiver decisions. Agency decisions under this 
section granting waiver requests will be available to the public at the 
OPP Regulatory Public Docket located as set forth in 40 CFR 150.17(c). 
Any person may obtain a copy of any waiver decision by written request 
in the manner set forth in 40 CFR part 2.

[49 FR 42881, Oct. 24, 1984, as amended at 69 FR 39864, July 1, 2004; 71 
FR 35545, June 21, 2006]



Sec. 161.55  Agricultural vs. non-agricultural pesticides.

    Section 25(a)(1) of FIFRA instructs the Administrator to ``take into 
account the difference in concept and usage between various classes of 
pesticides and differences in environmental risk and the appropriate 
data for evaluating such risk between agricultural and non-agricultural 
pesticides.'' This part distinguishes the various classes of pesticide 
use (e.g., crop vs. non-crop) and the corresponding data necessary to 
support registration under FIFRA. This information is present in each 
data requirement table. In addition, the Use Pattern Index (appendix A) 
is a comprehensive list of pesticide use patterns, cross-referenced to 
the general use patterns appearing in the tables; the index will further 
assist the reader in distinguishing agricultural versus non-agricultural 
uses of pesticides.

[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988]



Sec. 161.60  Minor uses.

    (a) Minor use policy. A minor use of a pesticide is a use on a 
``minor crop'' (a crop which is planted on a small total amount of 
acreage) or a use which is otherwise limited such that the potential 
market volume of the product for that use is inherently small. EPA's 
policy concerning data requirements for minor uses of pesticides 
includes the following elements:
    (1) Since the market volume for a minor use of a pesticide is 
intrinsically low, and the risk associated with the use often is also 
correspondingly low, EPA will adjust the data requirements concerning 
the minor use appropriately.
    (2) A new data requirement pertinent to both an unregistered minor 
use and a registered major use will not be applied to a minor use 
applicant until it is applied to the major use registrations.
    (3) EPA will accept extrapolations and regional data to support 
establishment of individual minor use tolerances.
    (4) Group tolerances will be established to assist applicants for 
registration of products for minor uses as described in 40 CFR 180.34.
    (b) Advice on data requirements to support minor uses. Applicants 
for registration are advised to contact the appropriate EPA Product 
Manager of the Minor Use Officer for advice on developing data to 
support new applications for minor uses of pesticides.



Sec. 161.70  Acceptable protocols.

    The Agency has published Pesticide Assessment Guidelines, as 
indicated in Sec. 161.20(d), which contain suggested protocols for 
conducting tests to develop the data required by this part.
    (a) General policy. Any appropriate protocol may be used provided 
that it meets the purpose of the test standards specified in the 
guidelines and provides data of suitable quality and completeness as 
typified by the protocols cited in the guidelines. Applicants should use 
the test procedure which is most suitable for evaluation of the 
particular ingredient, mixture, or product. Accordingly, failure to 
follow a suggested protocol will not invalidate a test if another 
appropriate methodology is used.
    (b) Organization for Economic Cooperation and Development (OECD) 
Protocols. Tests conducted in accordance with the requirements and 
recommendations of the applicable OECD protocols can be used to develop 
data necessary to meet the requirements specified in this part.

[[Page 230]]

Readers should note, however, that certain of the OECD recommended test 
standards, such as test duration and selection of test species, are less 
restrictive than those recommended by EPA. Therefore, when using the 
OECD protocols, care should be taken to observe the test standards in a 
manner such that the data generated by the study will satisfy the 
requirements of this part.
    (c) Procedures for requesting advice on protocols. Normally, all 
contact between the Agency and applicants or registrants is handled by 
the assigned Product Manager in the Registration Division of the Office 
of Pesticide Programs. Accordingly, questions concerning protocols 
should be directed, preferably in writing, to the Product Manager 
responsible for the registration or application which would be affected.



Sec. 161.75  Requirements for additional data.

    (a) General policy. The data routinely required by part 161 may not 
be sufficient to permit EPA to evaluate every pesticide product. If the 
information required under this part is not sufficient to evaluate the 
potential of the product to cause unreasonable adverse effects on man or 
the environment, additional data requirements will be imposed. However, 
EPA expects that the information required by this part will be adequate 
in most cases for an assessment of the properties of pesticide.
    (b) Policy on test substance. In general, where the technical grade 
of the active ingredient is specified as the substance to be tested, 
tests may be performed using a technical grade which is substantially 
similar to the technical grade used in the product for which 
registration is sought. In addition to or in lieu of the testing 
required in subparts C and D of this part the Administrator will, on a 
case-by-case basis, require testing to be conducted with:
    (1) An analytical pure grade of an active ingredient, with or 
without radioactive tagging.
    (2) The technical grade of an active ingredient.
    (3) The representative technical grade of an active ingredient.
    (4) An intentionally added inert ingredient in a pesticide product.
    (5) A contaminant or impurity of an active or inert ingredient.
    (6) A plant or animal metabolite or degradation product of an active 
or inert ingredient.
    (7) The end-use pesticide product.
    (8) The end-use pesticide product plus any recommended vehicles and 
adjuvants.
    (9) Any additional substance which could act as a synergist to the 
product for which registration is sought.
    (10) Any combination of substances in paragraphs (b) (1) through (9) 
of this section.

[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988; 58 
FR 34203, June 23, 1993]



Sec. 161.80  Acceptability of data.

    (a) General policy. The Agency will determine whether the data 
submitted to fulfill the data requirements specified in this part are 
acceptable. This determination will be based on the design and conduct 
of the experiment from which the data were derived, and an evaluation of 
whether the data fulfill the purpose(s) of the data requirement. In 
evaluating experimental design, the Agency will consider whether 
generally accepted methods were used, sufficient numbers of measurements 
were made to achieve statistical reliability, and sufficient controls 
were built into all phases of the experiment. The Agency will evaluate 
the conduct of each experiment in terms of whether the study was 
conducted in conformance with the design, good laboratory practices were 
observed, and results were reproducible. The Agency will not reject data 
merely because they were derived from studies which, when initiated were 
in accordance with an Agency-recommended protocol, even if the Agency 
subsequently recommends a different protocol, as long as the data 
fulfill the purposes of the requirements as described in this paragraph.
    (b) Previously developed data. The Agency will consider that data 
developed prior to the effective date of this part would be satisfactory 
to support applications provided good laboratory practices were 
followed, the data meet the purposes of this part, and the data

[[Page 231]]

permit sound scientific judgments to be made. Such data will not be 
rejected merely because they were not developed in accordance with 
suggested protocols.
    (c) Data developed in foreign countries. The Agency considers all 
applicable data developed from laboratory and field studies anywhere to 
be suitable to support pesticide registrations except for data from 
tests which involved field test sites or a test material, such as a 
native soil, plant, or animal, that is not characteristic of the United 
States. When studies at test sites or with materials of this type are 
anticipated, applicants should take steps to assure that United States 
materials are used or be prepared to supply data or information to 
demonstrate the lack of substantial or relevant differences between the 
selected material or test site and the United States material or test 
site. Once comparability has been established, the Agency will assess 
the acceptability of the data as described in paragraph (a) of this 
section.
    (d) Data from monitoring studies. Certain data are developed to meet 
the monitoring requirements of FIFRA sections 5, 8 or 20. Applicants may 
wish to determine whether some of these data may meet the requirements 
of this part. In addition, data developed independently of FIFRA 
regulations or requirements may also satisfy data requirements in this 
part. Consultation with appropriate EPA Product Managers would be 
helpful if applicants are unsure about suitability of such data.



Sec. 161.85  Revision of data requirements and guidelines.

    (a) Data requirements will be revised from time to time to keep up 
with policy changes and technology. Revisions to this part will be made 
in accordance with the Administrative Procedure Act (5 U.S.C. 551 et 
seq.). Changes having a significant impact on the registration process, 
applicants, testers, or other parties, or on the outcome and evaluation 
of studies, will be made only after public notice and opportunity for 
comment. Until final rules reflecting a change have been promulgated, 
the Agency can implement changes in the data requirements on a case-by-
case basis.
    (b) The Agency invites registration applicants, registrants, and the 
general public to suggest changes in the data requirements or the 
Pesticide Assessment Guidelines. Suggestions may be submitted at any 
time. Those making suggestions are requested to contact, in writing, the 
Director of the Hazard Evaluation Division. When suggestions consist of 
new suggested methods, representative test results should accompany the 
submittals.



                    Subpart B_How To Use Data Tables

    Source: 49 FR 42881, Oct. 24, 1984, unless otherwise noted. 
Redesignated and amended at 72 FR 60253-60255, Oct. 24, 2007.



Sec. 161.100  How to determine registration data requirements.

    To determine the specific kinds of data needed to support the 
registration of each pesticide product, the registration applicant 
should:
    (a) Refer to subparts C and D (Sec. Sec. 161.150 through 161.640). 
These subparts describe the data requirements, including data tables for 
each subject area. The corresponding subdivisions in the Pesticide 
Assessment Guidelines are listed in Sec. 161.108.
    (b) Select the general use pattern(s) that best covers the use 
pattern(s) specified on the pesticide product label. Selection of the 
appropriate general use pattern(s) will usually be obvious. However, 
unique or ambiguous cases will arise occasionally. These situations may 
be clarified by reference to the Use Pattern Index presented in the 
appendix to the Data Requirements for Registration. The applicant can 
look up a specific use pattern in appendix A and it will be cross 
referenced to the appropriate general use patterns to be used in each 
Data Requirement table.
    (c) Proceed down the appropriate general use pattern column in the 
table and note which tests (listed along the left hand side of the 
table) are required (``R''), conditionally required (``CR'') or usually 
not required (``--''). After reading through each data requirement 
table, the applicant will have a complete list of required and 
conditionally required data for the pesticide product

[[Page 232]]

and the substance to be tested in developing data to meet each 
requirement. The data EPA must have available to review the registration 
of a specific product consists of all the data designated as required 
for that product and all the applicable data designated as conditionally 
required for that product.

[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15993, May 4, 1988]



Sec. 161.101  Required vs. conditionally required data.

    (a) Data designated as ``required'' (``R'') for products with a 
given general use pattern are needed by EPA to evaluate the risks or 
benefits of a product having that use pattern unless the data 
requirement has been waived under Sec. 161.45 for that particular 
product or unless the product is covered by a specific exception set 
forth in a note accompanying the requirement.
    (b) Data designated as ``conditionally required'' (``CR'') for 
products with a given general use pattern are needed by EPA to evaluate 
the risks or benefits of a product having that use pattern if the 
product meets the conditions specified in the corresponding notes 
accompanying the data requirements table. As indicated in the notes, the 
determination of whether the data must be submitted is based on the 
product's use pattern, physical or chemical properties, expected 
exposure of nontarget organisms, and/or results of previous testing 
(e.g., tier testing). Applicants must evaluate each applicable note to 
determine whether or not conditionally required data must be submitted 
as indicated by the conditions and criteria specified in the 
accompanying notes unless the Agency has granted a waiver request 
submitted by the registrant in accordance with Sec. 161.45.
    (c) For certain of the required or conditionally required data, the 
``R'' or ``CR'' designations and are enclosed in brackets (i.e., [R], 
[CR]). The brackets designate those data that are required or 
conditionally required to support a product when an experimental use 
permit is being sought. In all other situations (i.e., other than 
support of an experimental use permit), the brackets have no meaning and 
the designations R and CR are equivalent to [R] and [CR], respectively.

[49 FR 42881, Oct. 24, 1984, as amended at 58 FR 34203, June 23, 1993]



Sec. 161.102  Distinguishing between what data are required and what substance 

is to be tested.

    (a) Readers should be careful to distinguish between what data are 
required and what substance is to be tested, as specified in this part 
and in each corresponding section of the guidelines. Each data 
requirement table specifies whether a particular data requirement is 
required to support the registration of manufacturing-use products, end-
use products, or both. The test substance column specifies which 
substance is to be subjected to testing. Thus, the data from a certain 
kind of study may be required to support the registration of each end-
use product, but the test substance column may state that the particular 
test shall be performed using, for example, the technical grade of the 
active ingredient(s) in the end-use product.
    (b) Manufacturing-use products (MP) and end-use products (EP) 
containing a single active ingredient and no inert ingredients are 
identical in composition to each other and to the technical grade of the 
active ingredient (TGAI) from which they were derived, and therefore, 
the data from a test conducted using any one of these as the test 
substance (e.g., TGAI) is also suitable to meet the requirement (if any) 
for the same test to be conducted using either of the other substances 
(i.e., MP or EP).

[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988]



Sec. 161.108  Relationship of Pesticide Assessment Guidelines to data 

requirements.

    The Pesticide Assessment Guidelines contain the standards for 
conducting acceptable tests, guidance on evaluation and reporting of 
data, definition of terms, further guidance on when data are required, 
and examples of acceptable protocols. They are available through the 
National Technical Information Service, 5285 Port Royal Road, 
Springfield, VA 22161 (703-605-6000). The following Subdivisions of the 
Pesticide

[[Page 233]]

Assessment Guidelines, referenced to the appropriate sections of this 
part, are currently available:

----------------------------------------------------------------------------------------------------------------
                                                                                    Corresponding section(s) in
            Subdivision                      Title              NTIS order no.               this part
----------------------------------------------------------------------------------------------------------------
D                                    Product Chemistry      PB83-153890                       161.150 - 161.190
----------------------------------------------------------------------------------------------------------------
E                                    Hazard Evaluation:     PB83-153908                                 161.490
                                      Wildlife and Aquatic
                                      Organisms
----------------------------------------------------------------------------------------------------------------
F                                    Hazard Evaluation:     PB83-153916                                 161.340
                                      Humans and Domestic
                                      Animals
----------------------------------------------------------------------------------------------------------------
G                                    Product Performance    PB83-153924                                 161.640
----------------------------------------------------------------------------------------------------------------
I                                    Experimental Use       PB83-153932                        161.20 - 161.640
                                      Permits
----------------------------------------------------------------------------------------------------------------
J                                    Hazard Evaluation:     PB83-153940                                 161.540
                                      Nontarget Plants
----------------------------------------------------------------------------------------------------------------
K                                    Reentry Protection     PB85-120962                                 161.390
----------------------------------------------------------------------------------------------------------------
L                                    Hazard Evaulation:     PB83-153957                                 161.590
                                      Nontarget Insect
----------------------------------------------------------------------------------------------------------------
N                                    Environmental Fate     PB83-153973                                 161.290
----------------------------------------------------------------------------------------------------------------
O                                    Residue Chemistry      PB83-153961                                 161.240
----------------------------------------------------------------------------------------------------------------
R                                    Spray Drift            PB84-189216                                 161.440
                                      Evaluation
----------------------------------------------------------------------------------------------------------------


[72 FR 60255, Oct. 24, 2007]



              Subpart C_Product Chemistry Data Requirements

    Source: 53 FR 15993, May 4, 1988, unless otherwise noted. 
Redesignated and amended at 72 FR 60253-60255, Oct. 24, 2007.



Sec. 161.150  General.

    (a) Applicability. This subpart describes the product chemistry data 
that are required to support the registration of each pesticide product. 
The information specified in this subpart must be submitted with each 
application for new or amended registration or for reregistration, if it 
has not been submitted previously or if the previously submitted 
information is not complete and accurate. References in this subpart to 
the ``applicant'' include the registrant if the information is required 
for a registered product.
    (b) Purpose--(1) Product composition. (i) Data on product 
composition are needed to support the conclusions expressed in the 
statement of formula. These data include information on the starting 
materials, production or formulating process, possible formation of 
impurities, results of preliminary analysis of product samples, a 
description of analytical methods to identify and quantify ingredients 
and validation data for such methods. In addition, an applicant is 
required to certify the limits for ingredients of his product.
    (ii) Product composition data are compared to the composition of 
materials used in required testing under subpart D of this part. This 
comparison indicates which components of a pesticide product have been 
evaluated by a particular study, and might lead to a conclusion that 
another study is needed. Based on conclusions concerning the product's 
composition and its toxic properties, appropriate use restrictions, 
labeling requirements, or special packaging requirements may be imposed.
    (iii) Product composition data, including certified limits of 
components, are used to determine whether a product is ``identical or 
substantially similar'' to another product or ``differs only in ways 
that do not significantly increase the risk of unreasonable adverse 
effects on the environment'' (FIFRA sec. 3(c)(7)(A)). In nearly every 
case,

[[Page 234]]

this determination involves a comparison of the composition of an 
applicant's product with that of currently registered products.
    (2) Certified limits. Certified limits required by Sec. 161.175 are 
used in two ways. First, the Agency considers the certified limits in 
making the registration determination required by sections 3(c)(5), 
3(c)(7) and 3(d) of the Act and making other regulatory decisions 
required by the Act. Second, the Agency may collect commercial samples 
of the registered products and analyze them for the active 
ingredient(s), inert ingredients, or impurities determined by the Agency 
to be toxicologically significant. If, upon analysis the composition of 
such a sample is found to differ from that certified, the results may be 
used by the Agency in regulatory actions under FIFRA sec. 12(a)(1)(C) 
and other pertinent sections.
    (3) Nominal concentration. The nominal concentration required by 
Sec. 161.155 is the amount of active ingredient that is most likely to 
be present in the product when produced. Unlike the certified limits, 
which are the outer limits of the range of the product's ingredients and 
thus are present only in a small proportion of the products, the nominal 
concentration is the amount that typically is expected to result from 
the applicant's production or formulating process. The nominal 
concentration together with production process information is used to 
gauge the acceptability of the certified limits presented by the 
applicant. The nominal concentration is used by the Agency as the basis 
for enforceable certified limits if the applicant has chosen not to 
specify certified limits of his own (thereby agreeing to abide by the 
standard limits in Sec. 161.175).
    (4) Physical and chemical characteristics. (i) Data on the physical 
and chemical characteristics of pesticide active ingredients and 
products are used to confirm or provide supportive information on their 
identity. Such data are also used in reviewing the production or 
formulating process used to produce the pesticide or product. For 
example, data that indicate significant changes in production or 
formulation might indicate the need for additional information on 
product composition.
    (ii) Certain information (e.g., color, odor, physical state) is 
needed for the Agency to respond to emergency requests for 
identification of unlabeled pesticides involved in accidents or spills. 
Physicians, hospitals, and poison control centers also request this 
information to aid in their identification of materials implicated in 
poisoning episodes.
    (iii) Certain physical and chemical data are used directly in the 
hazard assessment. These include stability, oxidizing and reducing 
action, flammability, explodability, storage stability, corrosion, and 
dielectric breakdown voltage. For example, a study of the corrosion 
characteristics of a pesticide is needed to evaluate effects of the 
product formulation on its container. If the pesticide is highly 
corrosive, measures can be taken to ensure that lids, liners, seams or 
container sides will not be damaged and cause the contents to leak 
during storage, transport, handling, or use. The storage stability study 
provides data on change (or lack of change) in product composition over 
time. If certain ingredients decompose, other new chemicals are formed 
whose toxicity and other characteristics must be considered.
    (iv) Certain data are needed as basic or supportive evidence in 
initiating or evaluating other studies. For example, the octanol/water 
partition coefficient is used as one of the criteria to determine 
whether certain fish and wildlife toxicity or accumulation studies must 
be conducted. Vapor pressure data are needed, among other things, to 
determine suitable reentry intervals and other label cautions pertaining 
to worker protection. Data on viscosity and miscibility provide 
necessary information to support acceptable labeling for tank mix and 
spray applications.



Sec. 161.153  Definitions.

    The following terms are defined for the purposes of this subpart:
    (a) Active ingredient means any substance (or group of structurally 
similar substances, if specified by the Agency) that will prevent, 
destroy, repel or mitigate any pest, or that functions as

[[Page 235]]

a plant regulator, desiccant, or defoliant within the meaning of FIFRA 
sec. 2(a).
    (b) End use product means a pesticide product whose labeling
    (1) Includes directions for use of the product (as distributed or 
sold, or after combination by the user with other substances) for 
controlling pests or defoliating, desiccating or regulating growth of 
plants, and
    (2) Does not state that the product may be used to manufacture or 
formulate other pesticide products.
    (c) Formulation means
    (1) The process of mixing, blending, or dilution of one or more 
active ingredients with one or more other active or inert ingredients, 
without an intended chemical reaction, to obtain a manufacturing use 
product or an end use product, or
    (2) The repackaging of any registered product.
    (d) Impurity means any substance (or group of structurally similar 
substances if specified by the Agency) in a pesticide product other than 
an active ingredient or an inert ingredient, including unreacted 
starting materials, side reaction products, contaminants, and 
degradation products.
    (e) Impurity associated with an active ingredient means:
    (1) Any impurity present in the technical grade of active 
ingredient; and
    (2) Any impurity which forms in the pesticide product through 
reactions between the active ingredient and any other component of the 
product or packaging of the product.
    (f) Inert ingredient means any substance (or group of structurally 
similar substances if designated by the Agency), other than an active 
ingredient, which is intentionally included in a pesticide product.
    (g) Integrated system means a process for producing a pesticide 
product that:
    (1) Contains any active ingredient derived from a source that is not 
an EPA-registered product; or
    (2) Contains any active ingredient that was produced or acquired in 
a manner that does not permit its inspection by the Agency under FIFRA 
sec. 9(a) prior to its use in the process.
    (h) Manufacturing use product means any pesticide product other than 
an end use product. A product may consist of the technical grade of 
active ingredient only, or may contain inert ingredients, such as 
stabilizers or solvents.
    (i) Nominal concentration means the amount of an ingredient which is 
expected to be present in a typical sample of a pesticide product at the 
time the product is produced, expressed as a percentage by weight.
    (j) Starting material means a substance used to synthesize or purify 
a technical grade of active ingredient (or the practical equivalent of 
the technical grade ingredient if the technical grade cannot be 
isolated) by chemical reaction.
    (k) Technical grade of active ingredient means a material containing 
an active ingredient:
    (1) Which contains no inert ingredient, other than one used for 
purification of the active ingredient; and
    (2) Which is produced on a commercial or pilot-plant production 
scale (whether or not it is ever held for sale).



Sec. 161.155  Product composition.

    Information on the composition of the pesticide product must be 
furnished. The information required by paragraphs (a), (b) and (f) of 
this section must be provided for each product. In addition, if the 
product is produced by an integrated system, the information on 
impurities required by paragraphs (c) and (d) must be provided.
    (a) Active ingredient. The following information is required for 
each active ingredient in the product:
    (1) If the source of any active ingredient in the product is an EPA-
registered product:
    (i) The chemical and common name (if any) of the active ingredient, 
as listed on the source product.
    (ii) The nominal concentration of the active ingredient in the 
product, based upon the nominal concentration of active ingredient in 
the source product.
    (iii) Upper and lower certified limits of the active ingredient in 
the product, in accordance with Sec. 161.175.
    (2) If the source of any active ingredient in the product is not an 
EPA-registered product:

[[Page 236]]

    (i) The chemical name according to Chemical Abstracts Society 
nomenclature, the CAS Registry Number, and any common names.
    (ii) The molecular, structural, and empirical formulae, and the 
molecular weight or weight range.
    (iii) The nominal concentration.
    (iv) Upper and lower certified limits in accordance with Sec. 
161.175.
    (v) The purpose of the ingredient in the formulation.
    (b) Inert ingredients. The following information is required for 
each inert ingredient (if any) in the product:
    (1) The chemical name of the ingredient according to Chemical 
Abstracts Society nomenclature, the CAS Registry Number, and any common 
names (if known). If the chemical identity or chemical composition of an 
ingredient is not known to the applicant because it is proprietary or 
trade secret information, the applicant must ensure that the supplier or 
producer of the ingredient submits to the Agency (or has on file with 
the Agency) information on the identity or chemical composition of the 
ingredient. Generally, it is not required that an applicant know the 
identity of each ingredient in a mixture that he uses in his product. 
However, in certain circumstances, the Agency may require that the 
applicant know the identity of a specific ingredient in such a mixture. 
If the Agency requires specific knowledge of an ingredient, it will 
notify the applicant in writing.
    (2) The nominal concentration in the product.
    (3) Upper and lower certified limits in accordance with Sec. 
161.175.
    (4) The purpose of the ingredient in the formulation.
    (c) Impurities of toxicological significance associated with the 
active ingredient. For each impurity associated with the active 
ingredient that is determined to be toxicologically significant, the 
following information is required:
    (1) Identification of the ingredient as an impurity.
    (2) The chemical name of the impurity.
    (3) The nominal concentration of the impurity in the product.
    (4) A certified upper limit, in accordance with Sec. 161.175.
    (d) Other impurities associated with the active ingredient. For each 
other impurity associated with an active ingredient that was found to be 
present in any sample at a level equal to or greater than 0.1 percent by 
weight of the technical grade active ingredient, the following 
information is required:
    (1) Identification of the ingredient as an impurity.
    (2) Chemical name of the impurity.
    (3) The nominal concentration of the impurity in the final product.
    (e) Impurities associated with an inert ingredient. [Reserved]
    (f) Ingredients that cannot be characterized. If the identity of any 
ingredient or impurity cannot be specified as a discrete chemical 
substance (such as mixtures that cannot be characterized or isomer 
mixtures), the applicant must provide sufficient information to enable 
EPA to identify its source and qualitative composition.



Sec. 161.160  Description of materials used to produce the product.

    The following information must be submitted on the materials used to 
produce the product:
    (a) Products not produced by an integrated system. (1) For each 
active ingredient that is derived from an EPA-registered product:
    (i) The name of the EPA-registered product.
    (ii) The EPA registration number of that product.
    (2) For each inert ingredient:
    (i) Each brand name, trade name, or other commercial designation of 
the ingredient.
    (ii) All information that the applicant knows (or that is reasonably 
available to him) concerning the composition (and, if requested by the 
Agency, chemical and physical properties) of the ingredient, including a 
copy of technical specifications, data sheets, or other documents 
describing the ingredient.
    (iii) If requested by the Agency, the name and address of the 
producer of the ingredient or, if that information is not known to the 
applicant, the name and address of the supplier of the ingredient.

[[Page 237]]

    (b) Products produced by an integrated system. (1) The information 
required by paragraph (a)(1) of this section concerning each active 
ingredient that is derived from an EPA-registered product (if any).
    (2) The following information concerning each active ingredient that 
is not derived from an EPA-registered product:
    (i) The name and address of the producer of the ingredient (if 
different from the applicant).
    (ii) Information on each starting material used to produce the 
active ingredient, as follows:
    (A) Each brand name, trade name, or other commercial designation of 
the starting material.
    (B) The name and address of the person who produces the starting 
material or, if that information is not known to the applicant, the name 
and address of each person who supplies the starting material.
    (C) All information that the applicant knows (or that is reasonably 
available to him) concerning the composition (and if requested by the 
Agency, chemical or physical properties) of the starting material, 
including a copy of all technical specifications, data sheets, or other 
documents describing it.
    (3) The information required by paragraph (a)(2) of this section 
concerning each inert ingredient.
    (c) Additional information. On a case-by-case basis, the Agency may 
require additional information on substances used in the production of 
the product.



Sec. 161.162  Description of production process.

    If the product is produced by an integrated system, the applicant 
must submit information on the production (reaction) processes used to 
produce the active ingredients in the product. The applicant must also 
submit information on the formulation process, in accordance with Sec. 
161.165.
    (a) Information must be submitted for the current production process 
for each active ingredient that is not derived from an EPA-registered 
product. If the production process is not continuous (a single reaction 
process from starting materials to active ingredient), but is 
accomplished in stages or by different producers, the information must 
be provided for each such production process.
    (b) The following information must be provided for each process 
resulting in a separately isolated substance:
    (1) the name and address of the producer who uses the process, if 
not the same as the applicant.
    (2) A general characterization of the process (e.g., whether it is a 
batch or continuous process).
    (3) A flow chart of the chemical equations of each intended reaction 
occurring at each step of the process, the necessary reaction 
conditions, and the duration of each step and of the entire process.
    (4) The identity of the materials used to produce the product, their 
relative amounts, and the order in which they are added.
    (5) A description of the equipment used that may influence the 
composition of the substance produced.
    (6) A description of the conditions (e.g., temperature, pressure, 
pH, humidity) that are controlled during each step of the process to 
affect the composition of the substance produced, and the limits that 
are maintained.
    (7) A description of any purification procedures (including 
procedures to recover or recycle starting materials, intermediates or 
the substance produced).
    (8) A description of the procedures used to assure consistent 
composition of the substance produced, e.g., calibration of equipment, 
sampling regimens, analytical methods, and other quality control 
methods.



Sec. 161.165  Description of formulation process.

    The applicant must provide information on the formulation process of 
the product (unless the product consists solely of a technical grade of 
active ingredient), as required by the following sections:
    (a) Section 161.162(b)(2), pertaining to characterization of the 
process.
    (b) Section 161.162(b)(4), pertaining to ingredients used in the 
process.
    (c) Section 161.162(b)(5), pertaining to process equipment.

[[Page 238]]

    (d) Section 161.162(b)(6), pertaining to the conditions of the 
process.
    (e) Section 161.162(b)(8), pertaining to quality control measures.



Sec. 161.167  Discussion of formation of impurities.

    The applicant must provide a discussion of the impurities that may 
be present in the product, and why they may be present. The discussion 
should be based on established chemical theory and on what the applicant 
knows about the starting materials, technical grade of active 
ingredient, inert ingredients, and production or formulation process. If 
the applicant has reason to believe that an impurity that EPA would 
consider toxicologically significant may be present, the discussion must 
include an expanded discussion of the possible formation of the impurity 
and the amounts at which it might be present. The impurities which must 
be discussed are the following, as applicable:
    (a) Technical grade active ingredients and products produced by an 
integrated system. (1) Each impurity associated with the active 
ingredient which was found to be present in any analysis of the product 
conducted by or for the applicant.
    (2) Each other impurity which the applicant has reason to believe 
may be present in his product at any time before use at a level equal to 
or greater than 0.1 percent (1000 ppm) by weight of the technical grade 
of the active ingredient, based on what he knows about the following:
    (i) The composition (or composition range) of each starting material 
used to produce his product.
    (ii) The impurities which he knows are present (or believes are 
likely to be present) in the starting materials, and the known or 
presumed level (or range of levels) of those impurities.
    (iii) The intended reactions and side reactions which may occur in 
the production of the product, and the relative amounts of byproduct 
impurities produced by such reactions.
    (iv) The possible degradation of the ingredients in the product 
after its production but prior to its use.
    (v) Post-production reactions between the ingredients in the 
product.
    (vi) The possible migration of components of packaging materials 
into the pesticide.
    (vii) The possible carryover of contaminants from use of production 
equipment previously used to produce other products or substances.
    (viii) The process control, purification and quality control 
measures used to produce the product.
    (b) Products not produced by an integrated system. Each impurity 
associated with the active ingredient which the applicant has reason to 
believe may be present in the product at any time before use at a level 
equal to or greater than 0.1 percent (1000 ppm) by weight of the product 
based on what he knows about the following:
    (1) The possible carryover of impurities present in any registered 
product which serves as the source of any of the product's active 
ingredients. The identity and level of impurities in the registered 
source need not be discussed or quantified unless known to the 
formulator.
    (2) The possible carryover of impurities present in the inert 
ingredients in the product.
    (3) Possible reactions occurring during the formulation of the 
product between any of its active ingredients, between the active 
ingredients and inert ingredients, or between the active ingredients and 
the production equipment.
    (4) Post-production reactions between any of the product's active 
ingredients and any other component of the product or its packaging.
    (5) Possible migration of packaging materials into the product.
    (6) Possible contaminants resulting from earlier use of equipment to 
produce other products.
    (c) Expanded discussion. On a case-by-case basis, the Agency may 
require an expanded discussion of information of impurities:
    (1) From other possible chemical reactions;
    (2) Involving other ingredients; or
    (3) At additional points in the production or formulation process.



Sec. 161.170  Preliminary analysis.

    (a) If the product is produced by an integrated system, the 
applicant must

[[Page 239]]

provide a preliminary analysis of each technical grade of active 
ingredient contained in the product to identify all impurities present 
at 0.1 percent or greater of the TGAI. The preliminary analysis should 
be conducted at the point in the production process after which no 
further chemical reactions designed to produce or purify the substance 
are intended.
    (b) Based on the preliminary analysis, a statement of the 
composition of the technical grade of active ingredient must be 
provided. If the technical grade of active ingredient cannot be 
isolated, a statement of the composition of the practical equivalent of 
the technical grade of active ingredient must be submitted.



Sec. 161.175  Certified limits.

    The applicant must propose certified limits for the ingredients in 
the product. Certified limits become legally binding limits upon 
approval of the application. Certified limits will apply to the product 
from the date of production to date of use, unless the product label 
bears a statement prohibiting use after a certain date, in which case 
the certified limits will apply only until that date.
    (a) Ingredients for which certified limits are required. Certified 
limits are required on the following ingredients of a pesticide product:
    (1) An upper and lower limit for each active ingredient.
    (2) An upper and lower limit for each inert ingredient.
    (3) If the product is a technical grade of active ingredient or is 
produced by an integrated system, an upper limit for each impurity of 
toxicological significance associated with the active ingredient and 
found to be present in any sample of the product.
    (4) On a case-by-case basis, certified limits for other ingredients 
or impurities as specified by EPA.
    (b) EPA determination of certified limits for active and inert 
ingredients. (1) Unless the applicant proposes different limits as 
provided in paragraph (c) of this section, the upper and lower certified 
limits for active and inert ingredients will be determined by EPA. EPA 
will calculate the certified limits on the basis of the nominal 
concentration of the ingredient in the product, according to the table 
in paragraph (b)(2) of this section.
    (2) Table of standard certified limits.

------------------------------------------------------------------------
                                      The certified limits for that
  If the nominal concentration        ingredient will be as follows:
   (N) for the ingredient is:   ----------------------------------------
                                     Upper limit          Lower limit
------------------------------------------------------------------------
N <= 1.0%......................  N + 10%N             N - 10%N
1.0% < N <= 20.0%..............  N + 5%N              N - 5%N
20.0% < N <= 100.0%............  N + 3%N              N - 3%N
------------------------------------------------------------------------

    (c) Applicant proposed limits. (1) The applicant may propose a 
certified limit for an active or inert ingredient that differs from the 
standard certified limit calculated according to paragraph (b)(2) of 
this section.
    (2) If certified limits are required for impurities, the applicant 
must propose a certified limit. The standard certified limits may not be 
used for such substances.
    (3) Certified limits should:
    (i) Be based on a consideration of the variability of the 
concentration of the ingredient in the product when good manufacturing 
practices and normal quality control procedures are used.
    (ii) Allow for all sources of variability likely to be encountered 
in the production process.
    (iii) Take into account the stability of the ingredient in the 
product and the possible formation of impurities between production and 
sale of distribution.
    (4) The applicant may include an explanation of the basis of his 
proposed certified limits, including how the certified limits were 
arrived at (e.g., sample analysis, quantitative estimate based on 
production process), and its accuracy and precision. This will be 
particularly useful if the range of the certified limit for an active or 
inert ingredient is greater than the standard certified limits.
    (d) Special cases. If the Agency finds unacceptable any certified 
limit (either standard or applicant-proposed), the Agency will inform 
the applicant of its determination and will provide supporting reasons. 
EPA may also recommend alternative limits to the applicant. The Agency 
may require, on a case-by-case basis, any or all of the following:
    (1) More precise limits.

[[Page 240]]

    (2) More thorough explanation of how the certified limits were 
determined.
    (3) A narrower range between the upper and lower certified limits 
than that proposed.
    (e) Certification statement. The applicant must certify the accuracy 
of the information presented, and that the certified limits of the 
ingredients will be maintained. The following statement, signed by the 
authorized representative of the company, is acceptable:

    I hereby certify that, for purposes of FIFRA sec. 12(a)(1)(C), the 
description of the composition of [product name], EPA Reg. No. [insert 
registration number], refers to the composition set forth on the 
Statement of Formula and supporting materials. This description includes 
the representations that: (1) no ingredient will be present in the 
product in an amount greater than the upper certified limit or in an 
amount less than the lower certified limit (if required) specified for 
that ingredient in a currently approved Statement of Formula (or as 
calculated by the Agency); and (2) if the Agency requires that the 
source of supply of an ingredient be specified, that all quantities of 
such ingredient will be obtained from the source specified in the 
Statement of Formula.



Sec. 161.180  Enforcement analytical method.

    An analytical method suitable for enforcement purposes must be 
provided for each active ingredient in the product and for each other 
ingredient or impurity that is determined to be toxicologically 
significant.



Sec. 161.190  Physical and chemical characteristics.

    (a) Table. Sections 161.100 through 161.102 describe how to use this 
table to determine the physical and chemical characteristics data 
requirements and the substance to be tested.

----------------------------------------------------------------------------------------------------------------
                                            All general use               Test substance
                                               patterns      ---------------------------------------- Guidelines
     Kind of data required         (b)     (requirements are                                           reference
                                  Notes   the same for every  Data to support MP  Data to support EP      No.
                                             use pattern)
----------------------------------------------------------------------------------------------------------------
Color..........................  .......  [R]...............  MP and TGAI.......  EP* and TGAI......     63-2
Physical state.................  .......  [R]...............  MP and TGAI.......  EP* and TGAI......     63-3
Odor...........................  .......  [R]...............  MP and TGAI.......  EP* and TGAI......     63-4
Melting point..................  (\1\)    [R]...............  TGAI..............  TGAI..............     63-5
Boiling point..................  (\2\)    [R]...............  TGAI..............  TGAI..............     63-6
Density, bulk density, or        .......  [R]...............  MP and TGAI.......  EP* and TGAI......     63-7
 specific gravity.
Solubility.....................  .......  [R]...............  TGAI or PAI.......  TGAI or PAI.......     63-8
Vapor pressure.................  .......  [R]...............  TGAI or PAI.......  TGAI or PAI.......     63-9
Dissociation constant..........  .......  [R]...............  TGAI or PAI.......  TGAI or PAI.......    63-10
Octanol/water partition          (\3\)    [CR]..............  PAI...............  PAI...............    63-11
 coefficient.
pH.............................  (\4\)    [CR]..............  MP and TGAI.......  EP* and TGAI......    63-12
Stability......................  .......  [R]...............  TGAI..............  TGAI..............    63-13
Oxidizing or reducing action...  (\5\)    [CR]..............  ..................  ..................  ..........
Flammability...................  (\6\)    [CR]..............  MP................  EP*...............    63-15
Explodability..................  (\7\)    [R]...............  MP................  EP*...............    63-16
Storage stability..............  .......  [R]...............  MP................  EP*...............    63-17
Viscosity......................  (\8\)    [CR]..............  MP................  EP*...............    63-18
Miscibility....................  (\9\)    [CR]..............  MP................  EP*...............    63-19
Corrosion characteristics......  .......  [R]...............  MP................  EP*...............    63-20
Dielectric breakdown voltage...  (\10\)   [CR]..............  ..................  EP*...............    63-21
Other requirements: Submittal    (\11\)   [CR]..............  MP, TGAI, PAI.....  EP*, TGAI, PAI....     64-1
 of samples.
----------------------------------------------------------------------------------------------------------------
Key: R = Required; CR = Conditionally Required; [ ] = Brackets (i.e., [R],[CR]) indicate data requirements that
  apply when an experimental use permit is being sought; MP = Manufacturing Use Product, EP* = End Use Product;
  asterisk indicates those registrants that end-use applicants (i.e., formulators) need not satisfy, if their
  active ingredient(s) is (are) purchased from a registered source; TGAI = Technical Grade of the Active
  Ingredient; PAI = Pure Active Ingredient.
(b) Notes. The following notes are referenced in column two of the table contained in paragraph (a) of this
  section.
(\1\) Required if technical chemical is a solid at room temperature.
(\2\) Required if technical chemical is a liquid at room temparature.
(\3\) Required if technical chemical is organic and non-polar.
(\4\) Required if test substance is dispersible with water.
(\5\) Required if product contains an oxidizing or reducing agent.
(\6\) Required if product contains combustible liquids.
(\7\) Required if product is potentially explosive.
(\8\) Required if product is a liquid.
(\9\) Required if product is a emulsifiable liquid and is to be diluted with petroleum solvents.
(\10\) Required if end-use product is a liquid and is to be used around electrical equipment.
(\11\) Basic manufacturers are required to provide the Agency with a sample of each TGAI used to formulate a
  product produced by an integrated system when the new TGAI is first used as a formulating ingredient in
  products registered under FIFRA. A sample of the active ingredient (PAI) suitable for use as an analytical
  standard is also required at this time. Samples of end use products produced by an integrated system must be
  submitted on a case-by-case basis.


[[Page 241]]


[49 FR 42881, Oct. 24, 1984, as amended at 58 FR 34203, June 23, 1993]



                    Subpart D_Data Requirement Tables

    Source: 49 FR 42881, Oct. 24, 1984, unless otherwise noted. 
Redesignated and amended at 72 FR 60253-60255, Oct. 24, 2007.



Sec. 161.202  Purposes of the registration data requirements.

    (a) General. The data requirements for registration are intended to 
generate data and information necessary to address concerns pertaining 
to the identity, composition, potential adverse effects and 
environmental fate of each pesticide.
    (b) [Reserved]
    (c) Residue chemistry. (1) Residue Chemistry Data are used by the 
Agency to estimate the exposure of the general population to pesticide 
residues in food and for setting and enforcing tolerances for pesticide 
residues in food or feed.
    (2) Information on the chemical identity and composition of the 
pesticide product, the amounts, frequency and time of pesticide 
application, and results of test on the amount of residues remaining on 
or in the treated food or feed, are needed to support a finding as to 
the magnitude and identity of residues which result in food or animal 
feed as a consequence of a proposed pesticide usage.
    (3) Residue chemistry data are also needed to support the adequacy 
of one or more methods for the enforcement of the tolerance, and to 
support practicable methods for removing residues that exceed any 
proposed tolerance.
    (d) Environmental fate--(1) General. The data generated by 
environmental fate studies are used to: assess the toxicity to man 
through exposure of humans to pesticide residues remaining after 
application, either upon reentering treated areas or from consuming 
inadvertently-contaminated food; assess the presence of widely 
distributed and persistent pesticides in the environment which may 
result in loss of usable land, surface water, ground water, and wildlife 
resources; and, assess the potential environmental exposure of other 
nontarget organisms, such as fish and wildlife, to pesticides. Another 
specific purpose of the environmental fate data requirements is to help 
applicants and the Agency estimate expected environmental concentrations 
of pesticides in specific habitats where threatened or endangered 
species or other wildlife populations at risk are found.
    (2) Degradation studies. The data from hydrolysis and photolysis 
studies are used to determine the rate of pesticide degradation and to 
identify pesticides that may adversely affect nontarget organisms.
    (3) Metabolism studies. Data generated from aerobic and anaerobic 
metabolism studies are used to determine the nature and availability of 
pesticides to rotational crops and to aid in the evaluation of the 
persistence of a pesticide.
    (4) Mobility studies. These data requirements pertain to leaching, 
adsorption/desorption, and volatility of pesticides. They provide 
information on the mode of transport and eventual destination of the 
pesticide in the environment. This information is used to assess 
potential environmental hazards related to: contamination of human and 
animal food; loss of usable land and water resources to man through 
contamination of water (including ground water); and habitat loss of 
wildlife resulting from pesticide residue movement or transport in the 
environment.
    (5) Dissipation studies. The data generated from dissipation studies 
are used to assess potential environmental hazards (under actual field 
use conditions) related to: reentry into treated areas; hazards from 
residues in rotational crop and other food sources; and the loss of land 
as well as surface and ground water resources.
    (6) Accumulation studies. Accumulation studies indicate pesticide 
residue levels in food supplies that originate from wild sources or from 
rotational crops. Rotational crop studies are necessary to establish 
realistic crop rotation restrictions and to determine if tolerances may 
be needed for residues

[[Page 242]]

on rotational crops. Data from irrigated crop studies are used to 
determine the amount of pesticide residues that could be taken up by 
representative crops irrigated with water containing pesticide residues. 
These studies allow the Agency to establish label restrictions regarding 
application of pesticides on sites where the residues can be taken up by 
irrigated crops. These data also provide information that aids the 
Agency in establishing any corresponding tolerances that would be needed 
for residues on such crops. Data from pesticides accumulation studies in 
fish are used to establish label restrictions to prevent applications in 
certain sites so that there will be minimal residues entering edible 
fish or shell fish. These residue data are also used to determine if a 
tolerance or action level is needed for residues in aquatic animals 
eaten by humans.
    (e) Hazard to humans and domestic animals. Data required to assess 
hazards to humans and domestic animals are derived from a variety of 
acute, subchronic and chronic toxicity tests, and tests to assess 
mutagenicity and pesticide metabolism.
    (1) Acute studies. Determination of acute oral, dermal and 
inhalation toxicity is usually the initial step in the assessment and 
evaluation of the toxic characteristics of a pesticide. These data 
provide information on health hazards likely to arise soon after, and as 
a result of, short-term exposure. Data from acute studies serve as a 
basis for classification and precautionary labeling. For example, acute 
toxicity data are used to calculate farmworker reentry intervals and to 
develop precautionary label statements pertaining to protective clothing 
requirements for applicators. They also: provide information used in 
establishing the appropriate dose levels in subchronic and other 
studies; provide initial information on the mode of toxic action(s) of a 
substance; and determine the need for child resistant packaging. 
Information derived from primary eye and primary dermal irritation 
studies serves to identify possible hazards from exposure of the eyes, 
associated mucous membranes and skin.
    (2) Subchronic studies. Subchronic tests provide information on 
health hazards that may arise from repeated exposures over a limited 
period of time. They provide information on target organs and 
accumulation potential. The resulting data are also useful in selecting 
dose levels for chronic studies and for establishing safety criteria for 
human exposure. These tests are not capable of detecting those effects 
that have a long latency period for expression (e.g., carcinogenicity).
    (3) Chronic studies. Chronic toxicity (usually conducted by feeding 
the test substance to the test species) studies are intended to 
determine the effects of a substance in a mammalian species following 
prolonged and repeated exposure. Under the conditions of this test, 
effects which have a long latency period or are cumulative should be 
detected. The purpose of long-term oncogenicity studies is to observe 
test animals over most of their life span for the development of 
neoplastic lesions during or after exposure to various doses of a test 
substance by an appropriate route of administration.
    (4) Teratogenicity and reproduction studies. The teratogenicity 
study is designed to determine the potential of the test substance to 
induce structural and/or other abnormalities to the fetus as the result 
of exposure of the mother during pregnancy. Two-generation reproduction 
testing is designed to provide information concerning the general 
effects of a test substance on gonadal function, estrus cycles, mating 
behavior, conception, parturition, lactation, weaning, and the growth 
and development of the offspring. The study may also provide information 
about the effects of the test substance on neonatal morbidity, 
mortality, and preliminary data on teratogenesis and serve as a guide 
for subsequent tests.
    (5) Mutagenicity studies. For each test substance a battery of tests 
are required to assess potential to affect the mammalian cell's genetic 
components. The objectives underlying the selection of a battery of 
tests for mutagenicity assessment are:
    (i) To detect, with sensitive assay methods, the capacity of a 
chemical to alter genetic material in cells.

[[Page 243]]

    (ii) To determine the relevance of these mutagenic changes to 
mammals.
    (iii) When mutagenic potential is demonstrated, to incorporate these 
findings in the assessment of heritable effects, oncogenicity, and 
possibly, other health effects.
    (6) Metabolism studies. Data from studies on the absorption, 
distribution, excretion, and metabolism of a pesticide aid in the 
valuation of test results from other toxicity studies and in the 
extrapolation of data from animals to man. The main purpose of 
metabolism studies is to produce data which increase the Agency's 
understanding of the behavior of the chemical in its consideration of 
the human exposure anticipated from intended uses of the pesticide.
    (f) Reentry Protection. Data required to assess hazard to farm 
employees resulting from reentry into areas treated with pesticides are 
derived from studies on toxicity, residue dissipation, and human 
exposure. Monitoring data generated during exposure studies are used to 
determine the quantity of pesticide to which people may be exposed after 
application and to develop reentry intervals.
    (g) Pesticide Spray Drift Evaluation. Data required to evaluate 
pesticide spray drift are derived from studies of droplet size spectrum 
and spray drift field evaluations. These data contribute to development 
of the overall exposure estimate and along with data on toxicity for 
humans, fish and wildlife, or plants are used to assess the potential 
hazard of pesticides to these organisms. A purpose common to all these 
tests is to provide data which will be used to determine the need for 
(and appropriate wording for) precautionary labeling to minimize the 
potential adverse effect to nontarget organisms.
    (h) Hazard to nontarget organisms--(1) General. The information 
required to assess hazards to nontarget organisms are derived from tests 
to determine pesticidal effects on birds, mammals, fish, terrestrial and 
aquatic invertebrates, and plants. These tests include short-term acute, 
subacute, reproduction, simulated field, and full field studies arranged 
in a hierarchial or tier system which progresses from the basic 
laboratory tests to the applied field tests. The results of each tier of 
tests must be evaluated to determine the potential of the pesticide to 
cause adverse effects, and to determine whether further testing is 
required. A purpose common to all data requirements is to provide data 
which determines the need for (and appropriate wording for) 
precautionary label statements to minimize the potential adverse effects 
to nontarget organisms.
    (2) Short term studies. The short-term acute and subchronic 
laboratory studies provide basic toxicity information which serves as a 
starting point for the hazard assessment. These data are used: to 
establish acute toxicity levels of the active ingredient to the test 
organisms; to compare toxicity information with measured or estimated 
pesticide residues in the environment in order to assess potential 
impacts on fish, wildlife and other nontarget organisms; and to indicate 
whether further laboratory and/or field studies are needed.
    (3) Long term and field studies. Additional studies (i.e., avian, 
fish, and invertebrate reproduction, lifecycle studies and plant field 
studies) may be required when basic data and environmental conditions 
suggest possible problems. Data from these studies are used to: estimate 
the potential for chronic effects, taking into account the measured or 
estimated residues in the environment; and to determine if additional 
field or laboratory data are necessary to further evaluate hazards. 
Simulated field and/or field data are used to examine acute and chronic 
adverse effects on captive or monitored fish and wildlife populations 
under natural or near-natural environments. Such studies are required 
only when predictions as to possible adverse effects in less extensive 
studies cannot be made, or when the potential for adverse effects is 
high.
    (i) Product performance. Requirements to develop data on product 
performance provide a mechanism to ensure that pesticide products will 
control the pests listed on the label and that unnecessary pesticide 
exposure to the environment will not occur as a result of the use of 
ineffective products. Specific

[[Page 244]]

performance standards are used to validate the efficacy data in the 
public health areas, including disinfectants used to control 
microorganisms infectious to man in any area of the inanimate 
environment and those pesticides used to control vertebrates (such as 
rodents, birds, bats and skunks) that may directly or indirectly 
transmit diseases to humans.

[49 FR 42881, Oct. 24, 1984. Redesignated and amended at 53 FR 15993, 
May 4, 1988]

[[Page 245]]



Sec. 161.240  Residue chemistry data requirements.

    (a) Table. Sections 161.100 through 161.102 describe how to use this 
table to determine the residue chemistry data requirements and the 
substances to be tested.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (b) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food corp    Nonfood   Food corp   Nonfood               outdoor                     MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Chemical identity.............        (1)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        TGAI............  TGAI............       171-2
Directions for use............        (2)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        ................  ................       171-3
Nature of the residue:
    Plants....................      (13),  [R]         ..........  [R]         ..........  [R]        .........  .........  [CR]       [CR]       PAIRA...........  PAIRA...........       171-4
                                     (14)
    Livestock.................       (3),  [CR]        ..........  [CR]        ..........  [CR]       .........  .........  [CR]       [CR]       PAIRA and plant   PAIRA and plant        171-4
                                    (13),                                                                                                          metabloites.      metabolites.
                                     (14)
Residue analytical method.....       (4),  [R]         ..........  [R]         ..........  [R]        .........  .........  [CR]       [CR]       TGAI and          TGAI and               171-4
                                    (13),                                                                                                          metabolites.      metabolites.
                                    (14),
                                     (15)
Magnitude of the residue:
    Crop field trials.........      (13),  [R]         ..........  [R]         ..........  [R]        .........  .........  [CR]       [CR]       TEP.............  TEP.............       171-4
                                     (14)
    Processed food/feed.......  (5), (14)  [CR]        ..........  [CR]        ..........  [CR]       .........  .........  .........  [CR]       EP..............  EP..............       171-4
    Meat/milk/poultry/eggs....  (6), (14)  [CR]        ..........  [CR]        ..........  [CR]       .........  .........  .........  [CR]       TGAI or plant     TGAI or plant          171-4
                                                                                                                                                   metabolites.      metabolites.
    Potable water.............        (7)  ..........  ..........  [R]         [R]         .........  .........  .........  .........  .........  EP..............  EP..............       171-4
    Fish......................        (8)  ..........  ..........  [R]         [R]         .........  .........  .........  .........  .........  EP..............  EP..............       171-4
    Irrigated crops...........        (9)  ..........  ..........  [CR]        [CR]        .........  .........  .........  .........  .........  EP..............  EP..............       171-4
    Food handling.............      (10),  ..........  ..........  ..........  ..........  .........  .........  .........  .........  [CR]       EP..............  EP..............       171-4
                                     (14)
Reduction of residue..........      (11),  [CR]        ..........  [CR]        ..........  [CR]       .........  .........  .........  [CR]       Residue of        Residue of             171-5
                                     (14)                                                                                                          concern.          concern.
Proposed tolerance............      (12),  [R]         ..........  [R]         ..........  [R]        .........  .........  .........  [CR]       Residue of        Residue of             171-6
                                     (14)                                                                                                          concern.          concern.
Reasonable grounds in support        (14)  [R]         ..........  [R]         ..........  [R]        .........  .........  .........  [CR]       ................  ................       171-7
 of the petition.
Submittal of analytical              (14)  [R]         ..........  [R]         ..........  [R]        .........  .........  .........  [CR]       PAIRA...........  PAIRA...........      171-13
 reference standards.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required data; CR=Conditionally required data; TGAI=Technical grade of the active ingredient; PAIRA=Pure active ingredient, radio labeled; EP=End-use product; TEP=Typical end-use
  product; MP=Manufacturing-use product; [ ]=Brackets (i.e., [R], [CR]) indicate data requirements that apply when an experimental use permit is being sought.
(b) Notes. The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) The same chemical identity data as required under subpart C of this part are required, with emphasis on impurities that could constitute a residue problem.
(2) Required information includes crops to be treated, rate of application, number and timing of applications, preharvest intervals, and relevant restrictions.
(3) Data on metabolism in livestock are required when residues occur on a livestock feed, or the pesticide is to be applied directly to livestock.

[[Page 246]]

 
(4) A residue method for enforcement of tolerances is needed whenever a numeric tolerance is proposed. Exemptions from the requirement of a tolerance will also usually require an analytical
  method. Analytical methods used to enforce residue limits for emergency exemptions, temporary tolerances and permanent tolerances must be available for use by enforcement agencies and thus
  may not be claimed as confidential business information.
(5) Data on the nature and level of residue in processed food/feed are required when detectable residues could concentrate on processing and thus require establishment of a food additive
  tolerance.
(6) Livestock feeding studies are required whenever a pesticide occurs as a residue in a livestock feed. Use involving direct application to livestock, including poultry, will require animal
  treatment residue studies.
(7) Data on residues in potable water are required whenever a pesticide is to be applied directly to water, unless it can be determined that the treated water would not be used (eventually)
  for drinking purpose, by man or animals.
(8) Data on residue in fish are required whenever a pesticide is to be applied directly to water inhabited by fish.
(9) Data on residues in irrigated crops are required when a pesticide is to be applied directly to water that could be used for irrigation or to irrigation facilities such as irrigation
  ditches.
(10) Data on residues in food/feed in food handling establishments are required whenever a pesticide is to be used in food/feed handling establishments. Disinfectants and sanitizers used in
  food or feed handling establishment are exempt from this requirement if their residues are regulated by the Food and Drug Administration at 21 CFR 178.1010.
(11) Reduction of residue data are required when the assumption of tolerance level residues would result in predicted exposure at an unsafe level. Data on the level of residue in food as
  consumed will be used to obtain a more precise estimate of potential dietary exposure. The Agency recommends that such data be generated to support all pesticides requiring a tolerance in
  case new data are revealed which indicates the pesticide is more toxic than initially determined.
(12) The proposed tolerance must reflect the maximum residue likely to occur in crops and meat/milk/poultry eggs.
(13) Residue data for outdoor domestic uses are required if home gardens are to be treated and the home garden use pattern is different from the use pattern on which the tolerance was
  established.
(14) Required to support registration of an indoor use pesticide if such a use could result in residues in food or feed.
(15) For all food uses, data on whether the FDA/USDA multiresidue methodology would detect and identify the pesticide are required.


[49 FR 42881, Oct. 24, 1984. Redesignated and amended at 53 FR 15993, 
15999, May 4, 1988; 58 FR 34203, June 23, 1993]



Sec. 161.290  Environmental fate data requirements.

    (a) Table. Sections 161.100 through 161.102 describe how to use this 
table to determine the environmental fate data requirements and the 
substance to be tested.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (b) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor                     MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
    Degradation studies-lab
 
Hydrolysis....................  .........  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        .........  TGAI or PAIRA...  TGAI or PAIRA...       161-1
Photodegradation:
    In water..................  .........  R           R           R           R           .........  .........  R          .........  .........  TGAI or PAIRA...  TGAI or PAIRA...       161-2
    On soil...................        (1)  CR          ..........  ..........  ..........  .........  .........  CR         .........  .........  TGAI or PAIRA...  TGAI or PAIRA...       161-3
    In air....................        (2)  CR          ..........  ..........  ..........  .........  .........  .........  .........  .........  TGAI or PAIRA...  TGAI or PAIRA...       161-4
 
    Metabolism studies-lab
 
    Aerobic soil..............  .........  [R]         [R]         ..........  ..........  R          R          [R]        R          .........  TGAI or PAIRA...  TGAI or PAIRA...       162-1
    Anaerobic aquatic.........  .........  ..........  ..........  R           R           .........  .........  R          .........  .........  TGAI or PAIRA...  TGAI or PAIRA...       162-3

[[Page 247]]

 
    Aerobic aquatic...........  .........  ..........  ..........  [R]         [R]         .........  .........  .........  .........  .........  TGAI or PAIRA...  TGAI or PAIRA...       162-4
 
       Mobility studies
 
Leaching and adsorption/        .........  [R]         [R]         R           R           R          R          [R]        R          .........  TGAI or PAIRA...  TGAI or PAIRA...       163-1
 desorption.
Volatility:
    (Lab).....................        (2)  CR          ..........  ..........  ..........  CR         CR         .........  .........  .........  TEP.............  TEP.............       163-2
    (Field)...................        (2)  CR          ..........  ..........  ..........  CR         CR         .........  .........  .........  TEP.............  TEP.............       163-3
 
   Dissipation studies-field
 
Soil..........................  .........  R           R           ..........  ..........  .........  .........  .........  R          .........  TEP.............  TEP.............       164-1
Aquatic (sediment)............  .........  ..........  ..........  R           R           .........  .........  .........  .........  .........  TEP.............  TEP.............       164-2
Forestry......................  .........  ..........  ..........  ..........  ..........  .........  .........  R          .........  .........  TEP.............  TEP.............       164-3
Combination and tank mixes....        (2)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  .........  ................  ................       164-4
Soil, long-term...............        (4)  CR          ..........  CR          ..........  .........  .........  .........  .........  .........  TEP.............  TEP.............       164-5
 
     Accumulation studies
 
Rotational crops:
    (Confined)................        (5)  [CR]        ..........  [CR]        ..........  .........  .........  .........  .........  .........  PAIRA...........  PAIRA...........       165-1
    (Field)...................        (6)  CR          ..........  CR          ..........  .........  .........  .........  .........  .........  TEP.............  TEP.............       165-2
Irrigated crops...............        (7)  ..........  ..........  [CR]        CR          .........  .........  .........  .........  .........  TEP.............  TEP.............       165-3
In fish.......................        (8)  [CR]        [CR]        [CR]        [CR]        .........  .........  [CR]       .........  .........  TGAI or PAIRA...  TGAI or PAIRA...       165-4
In aquatic non-target            (8), (9)  ..........  ..........  ..........  CR          .........  .........  CR         .........  .........  TEP.............  TEP.............       165-5
 organisms.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required: CR=Conditionally required; [ ]=Brackets (ie. [R], [CR], indicate data requirements that apply when an experimental use permit is being sought; TGAI=Technical grade of the
  active ingredient, PAIRA=``Pure'' active ingredient-radio labeled; TEP=typical end use product; EP =End use product.
(b) Notes. The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) Not required if use involves application to soils solely by injection of the product into the soil or by incorporation of the product into the soil upon application.
 AAA(2) Required on case by case basis depending on product use pattern and other pertinent factors.
 AAA(3) Not required if anaerobic aquatic metabolism study has been conducted.
 AAA(4) Required if pesticide residues do not readily dissipate in soil.
 AAA(5) Confined accumulation study is required when it is reasonably foreseeable that any food or feed crop may be subsequently planted on the site of pesticide application.
 AAA(6) Field accumulation study is required if significant pesticide residue is likely to be present in soil at time of plant crop, as evidenced by residue data obtained from confined
  accumulation study.
 AAA(7) Required if it is reasonably foreseeable that water at treated site may be used for irrigation purposes.
 AAA(8) Required if significant concentrations of the active ingredient and/or its principal degradation products are likely to occur in aquatic environments and may accumulate in aquatic
  organisms.
 AAA(9) Required unless tolerance or action level for fish has been granted.


[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988]



Sec. 161.340  Toxicology data requirements.

    (a) Table. Sections 161.100 through 161.102 describe how to use this 
table to determine the toxicology data requirements and the substance to 
be tested.

[[Page 248]]



------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (b) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor                     MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
         Acute testing
 
Acute oral toxicity--rat......        (1)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* or EP               81-1
                                                                                                                                                                     dilution* and
                                                                                                                                                                     TGAI.
Acute dermal toxicity.........   (1), (2)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* or EP               81-2
                                                                                                                                                                     dilution* and
                                                                                                                                                                     TGAI.
Acute inhalation toxicity--rat       (16)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* and TGAI....        81-3
Primary eye irritation--rabbit        (2)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP..............  EP*.............        81-4
Primary dermal irritation.....   (1), (2)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP..............  EP*.............        81-5
Dermal sensitization..........        (3)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP..............  EP*.............        81-6
Acute delayed neurotoxicity--         (4)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        TGAI............  TGAI............        81-7
 hen.
 
      Subchronic testing
 
90-day feeding studies--rodent       (17)  [R]         CR          [R]         CR          [R]        CR         CR         CR         CR         TGAI............  TGAI............        82-1
 and nonrodent.
21-day dermal.................       (18)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI and EP*....        82-2
90-day dermal.................  (5), (19)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............        82-3
90-day inhalation--rat                (6)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............        82-4
90-day neurotoxicity:
  Hen.........................        (7)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............        82-5
  Mammal......................        (8)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............        82-5
 
        Chronic testing
 
Chronic feeding--2 spp. rodent       (9),  [R]         CR          [R]         CR          [R]        CR         CR         CR         CR         TGAI............  TGAI............        83-1
 and nonrodent.                     (13),
                                     (20)
Oncogenicity study--2 Spp. rat  (9), (21)  R           CR          R           CR          R          CR         CR         CR         CR         TGAI............  TGAI............        83-2
 and mouse preferred.
Teratogenicity--2 species.....      (10),  [R]         CR          [R]         CR          [R]        CR         CR         CR         CR         TGAI............  TGAI............        83-3
                                     (15)
Reproduction, 2-generation....      (11),  [R]         CR          [R]         CR          [R]        CR         CR         CR         CR         TGAI............  TGAI............        83-4
                                     (14)
 
     Mutagenicity testing
 
Gene mutation.................       (22)  [R]         R           [R]         R           [R]        R          R          R          R          TGAI............  TGAI............        84-2
Structural chromosomal               (22)  [R]         R           [R]         R           [R]        R          R          R          R          TGAI............  TGAI............        84-2
 aberration.
Other genotoxic effects.......       (22)  [R]         R           [R]         R           [R]        R          R          R          R          TGAI............  TGAI............        84-4
 

[[Page 249]]

 
        Special testing
 
General metabolism............       (23)  R           CR          R           CR          R          CR         CR         CR         CR         PAI or PAIRA....  PAI or PAIRA....        85-1
Dermal penetration............       (24)  CR          CR          CR          CR          CR         CR         CR         CR         CR         Choice..........  Choice..........        85-2
Domestic animal safety........       (12)  CR          CR          CR          CR          .........  .........  CR         CR         .........  Choice..........  Choice..........        86-1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 AAAKey: R=Required data; CR=Conditionally required; [ ]=Brackets (ie [R], [CR] indicate data requirements that apply when an experimental use permit is being sought; MP=manufacturing-use
  product; EP*=End-Use Product; (asterisk identifies those data requirements that end-use applicants (i.e., ``formulators'') must satisfy, provided that their active ingredient(s) is (are)
  purchased from a registered source); TGAI=Technical grade of the active ingredient; PAI=``Pure'' active ingredient; PAIRA=``Pure'' active ingredient, radio-labeled; Choice=choice of several
  test substances, depending on studies required.
(b) Notes. The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) Not required if test material is a gas or highly volatile.
(2) Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.5; such a product will be classified as toxicity category I on the basis of potential eye and
  dermal irritation effects.
(3) Required unless repeated dermal exposure does not occur under conditions of use.
(4) Not required unless test material, is an organophosphate, or a metabolite or degradation product thereof which causes acetyl cholinesterase depression or is structurally related to a
  substance that causes delayed neurotoxicity.
(5) Required if use involves purposeful dermal application to, or prolonged exposure of, human skin.
(6) Required if use may result in repeated inhalation exposure at a concentration likely to be toxic. A test with duration of 21 days is required if pesticide is used on tobacco.
(7) Required if acute delayed neurotoxicity test showed neuropathy or neurotoxicity or if closely related structural to a compound which can induce these effects.
(8) Required if acute oral, dermal, or inhalation studies showed neuropathy or neurotoxicity.
(9)(i) Studies designed to simultaneously meet the requirements of both the chronic feeding and oncogenicity studies (i.e., a combined study) can be conducted.
(ii) Minimum acceptable test durations for chronic feeding and oncogenicity studies are as follows:
(A) Chronic rodent feeding study (food use pesticides)--24 months.
(B) Chronic rodent feeding study (non-food pesticides)--12 months is usually sufficient.
(C) Chronic nonrodent (i.e., dog) feeding study--12 months.
(D) Mouse oncogenicity study--18 months.
(E) Rat oncogenicity study--24 months.
(10) Required to support products intended for food uses and to supoort products intended for non-food uses if significant exposure of human females of child bearing age may reasonably be
  expected.
(11) Required to support products intended for food uses and to support products intended for non-food uses if use of the product is likely to result in human exposure over a portion of the
  human lifespan which is significant in terms of the frequency of exposure, magnitude of exposure, or the duration of exposure (for example; pesticides used in treated fabrics for wearing
  apparel, diapers, or bedding; insect repellents applied directly to human skin; swimming pool additives; constant-release indoor pesticides which are used in aerosol form).
(12) Required on a case by case basis.
(13) In most cases, where theoretical maximum residue contribution (TMRC) exceeds 50 percent of the maximum permitted intake (MPI), a one year (or longer) interim report on a chronic feed
  study is required to support a temporary tolerance.
(14) In most cases, where theoretical maxium residue contribution (TMRC) exceeds 50 percent of the maxium permitted intake (MPI), a first generation (or longer) interim report on a
  multigeneration reproduction study is required to support a temporary tolerance.
(15) A teratology study in one species is required to support a temporary tolerance.
(16) Required if the product consists of, or under conditions of use will result in, an inhalable material (e.g., gas volatile substances, or aerosol/particulate).
(17) Required if intended use(s) of the pesticide product is expected to result in human exposure to the product, under the following conditions:
(i) Human exposure is via the oral route.
(ii) Expected human exposure is over a limited portion of the human lifespan, yet is significant in terms of the frequency of exposure, magnitude of exposure, or the duration of exposure (for
  example, products requiring a temporary tolerance to support an experimental use permit or emergency exemption).
(18) Required if intended use(s) of the pesticide product is expected to result in human exposure to the product, under the following conditions:
(i) Human exposure is via skin contact.
(ii) Expected human skin contact is not purposeful, and such exposure is of limited frequence and duration (for example, such exposure could result from use of certain disinfectant, liquid
  fumigant or agricultural or home/garden pesticide products, and other circumstances where the Agency determines that more than acute dermal exposure is involved).
(iii) Data from a subchronic 90-day dermal toxicity study are not required.
(19) Required if pesticidal use will involve purposeful application to the human skin or will result in comparable human exposure to the product, (e.g., swimming pool algaecides, pesticides
  for impregnating clothing), and if either of the following criteria are met:
(i) Data from a subchronic oral study are not required.
(ii) The active ingredient of the product is known or expected to be metabolized differently by the dermal route of exposure than by the oral route, and a metabolite of the active ingredient
  is the toxic moiety.
(20) Required if either of the following criteria are met:
(i) Use of the pesticide product is likely to result in repeated human exposure to the product, over a significant portion of the human life-span (for example, products intended for use in and
  around residences, swimming pools, and enclosed working spaces or their immediate vicinity).
(ii) The use requires a tolerance for the pesticide or an exemption from the requirement to obtain a tolerance, or requires issuance of a food additive regulation.
(21) Required if any of the following criteria are met:

[[Page 250]]

 
(i) The active ingredient(s) or any of its (their) metabolites, degradation products, or impurities:
(A) Is structually related to a recognized carcinogen.
(B) Is a substance that cause mutagenic effect as demonstrated by in vitro or in vivo testing.
(C) Produces in subchronic studies a morphologic effect (e.g., hyperplasia, metaplasia) in any organ that may lead to neoplastic change.
(ii) The use requires a tolerance for the pesticide or exemption from the requirement to obtain a tolerance, or requires the issuance of a food additive regulation.
(iii) Use of the pesticide product is likely to result in human exposure over a portion of the human lifespan which is significant in terms of either the time the exposure occurs or the
  duration of exposure (for example; pesticides used in treated fabrics for wearing apparel, diapers, or bedding; insect repellents applied directly to human skin; swimming pool additives;
  constant-release indoor pesticides which are used in aerosol form).
(22)(i) The required battery of mutagenicity tests must include tests appropriate to address the following three categories in accordance with the objectives set forth in Sec.  161.202:
(A) Gene mutations.
(B) Structural chromosomal aberrations.
(C) Other genotoxic effects as appropriate for the test substance, e.g., numerical chromosome abberations, direct DNA damage and repair, mammalian cells transformation, target organ/cell
  analysis.
(ii) Currently recognized tests for each of these categories are listed with the National Technical Information Service (NTIS). Applicants shall explain their reasons for selecting specific
  tests from the battery of currently recognized tests. Because of the rapid improvements in this field, applicants are encouraged to discuss with the Agency: test selection, protocol design
  and results of preliminary testing.
(iii) Not required if the pesticide use pattern precludes human exposure (e.g., nonvolatile pesticides packaged and used in enclosed bait boxes).
(23) Required if chronic feeding or oncogenicity studies are required.
(24) Dermal absorption studies required for compounds having a serious toxic effect as identified by oral or inhalation studies, for which a significant route of human exposure is dermal and
  for which the assumption of 100 percent absorption does not produce an adequate margin of safety. Registrants should work closely with the Agency in developing an acceptable protocol and
  performing dermal absorption studies.


[49 FR 42881, Oct. 24, 1984. Redesignated and amended at 53 FR 15993, 
15999, May 4, 1988; 58 FR 34203, June 23, 1993]



Sec. 161.390  Reentry protection data requirements.

    (a) Table. Sections 161.100 through 161.102 describe how to use this 
table to determine the reentry protection data requirements and the 
substance to be tested.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                     Test substance
                                          -------------------------------------------------------------------------------------------------------------------------------------------- Guideline
     Kind of data required      (b) Notes        Terrestrial               Aquatic               Greenhouse                                                                            reference
                                          -----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support     No.
                                            Food crop    Nonfood    Food crop    Nonfood    Food crop   Nonfood               outdoor                     MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Foliar dissipation............        (1)  CR          CR          CR          CR          ..........  .........  CR         .........  .........  TEP.............  TEP.............      132-1
Soil dissipation..............   (1), (4)  CR          CR          CR          CR          ..........  .........  CR         .........  .........  TEP.............  TEP.............      132-1
Dermal exposure...............  (1), (2),  CR          CR          CR          CR          ..........  .........  CR         .........  .........  TEP.............  TEP.............      133-3
                                      (3)
Inhalation exposure...........  (1), (2),  CR          CR          CR          CR          ..........  .........  CR         .........  .........  TEP.............  TEP.............      133-4
                                      (3)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: CR=Conditionally required; TEP=Typical end-use product.
(b) Notes. The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) Data are required if the following conditions are met:
(i)(A) The acute dermal toxicity of the technical grade of active ingredient is less than 200 mg/kg (body weight); or
(B) The acute inhalation toxicity of the technical grade of active ingredient is less than 200 mg/m \3\ (for a one-hour exposure); or
(C) The acute oral toxicity of the technical grade of active ingredient is less than 50 mg/kg (body weight); or
(D) Neurotoxic, teratogenic, or oncogenic effects or other adverse effects as evidenced by subchronic, chronic, and reproduction studies would be expected from entry of persons into treated
  sites; or
(E) The Agency receives other scientifically validated toxicological or epidemiological evidence that a pesticide or residue of a pesticide could cause adverse effects on persons entering
  treated sites. In the last situation, reentry intervals and supporting data may be required on a case-by-case basis.
(ii) And if: end-use product is to be registered for:
(A) Application to growing crops, such as to or around horticultural and agronomic crops that are field- or orchard-grown.

[[Page 251]]

 
(B) Application to outdoor tree nursery and forestry operations.
(C) Application to turf crops and commercial applications to turf.
(D) Application to parks and arboretums; or (E) application to aquatic crops.
(iii) And if: human exposure to residues of the pesticide can be reasonably foreseen. This applies primarily to pesticides that will be used on crops where human tasks will involve substantial
  exposure to residues of the pesticide.
(2) Data required if appropriate surrogate data are not available.
(3) Data required if the applicant chooses to use the allowable exposure level method for proposal of a reentry interval.
(4) Soil dissipation data required if agricultural practice involves human tasks that would cause substantial exposure to residues sorbed to soil.


[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988, 
as amended at 58 FR 34203, June 23, 1993]



Sec. 161.440  Spray drift data requirements.

    (a) Table. Sections 161.100 through 161.102 describe how to use this 
table to determine the aerial spray drift data requirements and the 
substance to be tested.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (b) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor                     MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Droplet size spectrum.........        (1)  CR          CR          CR          CR          .........  .........  CR         .........  .........  TEP.............  TEP.............       201-1
Drift field evaluation........        (1)  CR          CR          CR          CR          .........  .........  CR         .........  .........  TEP.............  TEP.............       202-1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: CR=Conditionally required; TEP=Typical end use product.
(b) Notes. The following are referenced in column two of the table contained in paragraph (a) of this section.
(1) This study is required when aerial applications (rotary and fixed winged) and mist blower or other methods of ground application are proposed and it is estimated that the detrimental
  effect level of those nontarget organisms expected to be present would be exceeded. The nontarget organisms include humans, domestic animals, fish and wildlife, and nontarget plants. This
  requirement may be satisfied by submittal of published or unpublished information regarding spray drift patterns that would be expected to be similar to the proposed product.
(2) [Reserved]


[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988, 
as amended at 58 FR 34203, June 23, 1993]



Sec. 161.490  Wildlife and aquatic organisms data requirements.

    (a) Table. Sections 161.100 through 161.102 describe how to use this 
table to determine the wildlife and aquatic organisms data requirements 
and the substance to be tested.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (b) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food Crop    Nonfood   Food crop   Nonfood               outdoor      use            MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Avian and mammalian testing
 
Avian oral LD50 (preferably           (1)  [R]         [R]         [R]         [R]         CR         CR         [R]        [R]        CR         TGAI............  TGAI............        71-1
 mallard or bobwhite).

[[Page 252]]

 
Avian dietary LC50 (preferably        (1)  [R]         [R]         [R]         [R]         CR         CR         [R]        [R]        CR         TGAI............  TGAI............        71-2
 mallard and bobwhite).
Wild mammal toxicity..........        (2)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............        71-3
Avian reproduction (preferably        (3)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............        71-4
 mallard and bobwhite).
Simulated and actual field            (2)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TEP.............  TEP.............        71-5
 testing--mammals and birds.
 
   Aquatic organism testing
 
Freshwater fish LC50             (1), (7)  [R]         [R]         [R]         [R]         CR         CR         [R]        [R]        CR         TGAI............  TGAI............        72-1
 (preferably rainbow and
 bluegill).
Acute LC50 freshwater            (1), (7)  [R]         [R]         [R]         [R]         CR         CR         [R]        [R]        CR         TGAI............  TGAI............        72-2
 invertebrates (preferably
 Daphnia).
Acute LC50 estuarine and         (4), (7)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............        72-3
 marine organisms.
Fish early life stage and             (5)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............        72-4
 aquatic invertebrate life-
 cycle.
Fish--life-cycle..............        (6)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............        72-5
Aquatic organism accumulation.        (8)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI, PAI, or     TGAI, PAI, or           72-6
                                                                                                                                                   degradation       degradation
                                                                                                                                                   product.          product.
Simulated or actual field             (2)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TEP               TEP                     72-7
 testing--aquatic organisms.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required; CR=Conditonally required; [ ]=Brackets (ie. [R], [CR]) indicate data requirements that apply when an experimental use permit is being sought; TGAI=Techical grade of the active
  ingredient; TEP=Typical end-use product; PAI=``Pure'' active ingredient.
(b) Notes. The following notes are referenced in column two of the table contained in paragraph (a) of this section.

[[Page 253]]

 
(1)(i) Data are required as follows to support manufacturing use products and those end-use products for indoor use for which there is no registered manufacturing use product:
(A) Solid formulation indoor use products require avian oral LD50 (bobwhite), avian dietary LC50 (bobwhite), freshwater fish LC50 (rainbow trout) and acute LC50 freshwater invertebrate
  (Daphnia).
(B) Liquid formulation indoors use products require all tests listed under (b)(1)(i) of this section except the avian oral LD50.
(ii) Data are not required to support:
(A) Indoor end-use products consisting of a gas/highly volatile liquid or a highly reactive solid.
(B) Indoor end-use products for which there is a manufacturing use product registration.
(2) Tests required on a case-by-case basis depending on the results of lower tier studies such as acute and subacute testing, intended use pattern, and pertinent environmental fate
  characteristics.
(3) Data required if one or more of the following criteria are met:
(i) Birds may be subjected to repeated or continued exposure to the pesticide or any of its major metabolite degradation products, especially preceding or during the breeding season.
(ii) The pesticide or any of its major metabolites or degradation products are stable in the environment to the extent that potentially toxic amounts may persist in avian feed.
(iii) The pesticide or any of its major metalolites or degradation products is stored or accumulated in plant animal tissues, as indicated by its octanol/water partition coefficient,
  accumulation studies, metabolic release and retention studies, or as indicated by structural similarity to known bioaccumulative chemicals.
(iv) Any other information, such as that derived from mammalian reproduction studies that indicates the reproduction in terrestrial vertebrates may be adversely affected by the anticipated use
  of the pesticide product.
Note: Prior to conducting this test to support the registration of an avicide, the applicant should consult the Agency.
(4) Data required if the product is intended for direct application to the estuarine or marine environment, or the product is expected to enter this environment in significant concentrations
  because of its expected use or mobility pattern.
(5) Data from fish early life-stage tests or life-cycle tests with aquatic invertebrates (on whichever species is most sensitive to the pesticide as determined from the results of the acute
  toxicity tests) are required if the product is applied directly to water or expected to be transported to water from the intended use site, and when any one or more of the following
  conditions apply:
(i) If the pesticide is intended for use such that its presence in water is likely to be continuous or recurrent regardless of toxicity.
(ii) If any LC 50 or EC 50 value determined in acute toxicity testing is less than 1 mg/l; or
(iii) If the estimated environmental concentration in water is equal to or greater than 0.01 of any EC 50 or LC 50 determined in acute toxicity testing.
(iv) If the actual or estimated environmental concentration in water resulting from use is less than 0.01 of any EC50 or LC50 determined in acute toxicity testing and any of the following
  conditions exist:
(A) Studies of other organisms indicate the reproductive physiology of fish and/or invertebrates may be affected.
(B) Physiochemical properties indicate cumulative effects.
(C) The pesticide is persistent in water (e.g., half-life in water greater than 4 days).
(6) Data are required if end-use product is intended to be applied directly to water or expected to transport to water from the intended use site, and when any of the following conditions
  apply:
(i) if the estimated environmental concentration is equal to or greater than one-tenth of the no-effect level in the fish early life-stage or invertebrate life-cycle test.
(ii) If studies of other organisms indicate the reproductive physiology of fish may be affected. NOTE: The applicant should consult the Agency prior to these tests to support the registration
  of a pesticide.
(7) Data from testing with the applicant's end-use product or a typical end-use product is required to support the registration of each end-use product which meets any one of the following
  conditions:
(i) The end-use pesticide will be introduced directly not an aquatic environment when used as directed.
(ii) The LC50 or EC50 of the technical grade of active ingredient is equal to or less than the maximum expected environmental concentration (MEEC) or the estimated environmental concentration
  (EEC) in the aquatic environment when the end-use pesticide is used as directed.
(iii) An ingredient in the end-use formulation other than the active ingredient is expected to enhance the toxicity of the active ingredient or to cause toxicity to aquatic organisms.
(8) Required if significant concentrations of the active ingredient and/or its principal degradation products are likely to occur in aquatic environments and may accumulate in aquatic
  organisms.


[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988, 
as amended at 58 FR 34203, June 23, 1993]



Sec. 161.540  Plant protection data requirements.

    (a) Table. Sections 161.100 through 161.102 describe how to use this 
table to determine the plant protection data requirements and the 
substance to be tested.

[[Page 254]]



------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (b) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor                     MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Target area phytotoxicity.....        (1)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  .........  EP..............  EP..............       121-1
Nontarget area phytotoxicity..
Tier I:
    Seed germination/seedling         (2)  ..........  R           ..........  R           .........  .........  R          .........  .........  TGAI............  TGAI............       122-1
     emergence.
    Vegetative vigor..........        (2)  ..........  R           ..........  R           .........  .........  R          .........  .........  TGAI............  TGAI............       122-1
    Aquatic plant growth......        (2)  ..........  R           ..........  R           .........  .........  R          .........  .........  TGAI............  TGAI............       122-2
Tier II:
    Seed germination/seedling         (3)  ..........  CR          ..........  CR          .........  .........  CR         .........  .........  TGAI............  TGAI............       123-1
     emergence.
    Vegetative vigor..........        (3)  ..........  CR          ..........  CR          .........  .........  CR         .........  .........  TGAI............  TGAI............       123-1
    Aquatic plant growth......        (4)  ..........  CR          ..........  CR          .........  .........  CR         .........  .........  TGAI............  TGAI............       123-2
Tier III:
    Terrestrial field.........        (3)  ..........  CR          ..........  CR          .........  .........  CR         .........  .........  TEP.............  TEP.............       124-1
    Aquatic field.............        (4)  ..........  CR          ..........  CR          .........  .........  CR         .........  .........  TEP.............  TEP.............       124-2
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: CR=Conditionally required; TGAI=Technical grade of the active ingredient; EP=End-use product; TEP=Typical end-use product.
(b) Notes. The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) Data are required for Special Review and certain public health situations.
(2) Data are required for pesticides to be used in forests and natural grasslands. For herbicide used in forest site preparation; the acquatic plant growth tests will be required. Data are
  required to support products to be used in other locations when any of the following conditions are met:
(i) Phytotoxicity problems concerning the product arise and open literature data are not available to address the problems.
(ii) The product may pose hazards to endangered or threatened species.
(iii) Special Review has been initiated on the product.
(3) Required if a 25 percent or greater detrimental effect was found in 1 or more plant species in the corresponding test of the previous tier.
(4) Required if a 50 percent or greater detrimental effect was found on any plant species in the corresponding test of the previous tier.


[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988, 
as amended at 58 FR 34203, June 23, 1993]



Sec. 161.590  Nontarget insect data requirements.

    (a) Table. Sections 161.100 through 161.102 describe how to use this 
table to determine the nontarget insect data requirements and the 
substance to be tested.

[[Page 255]]



------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use pattern                                                     Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (b) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor      use            MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Nontarget insect testing--
          pollinators
 
Honey bee acute contact LD50..        (1)  [CR]        [CR]        [CR]        [CR]        .........  .........  [CR]       [CR]       .........  TGAI............  TGAI............       141-1
Honey bee--toxicity of           (1), (2)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TEP.............  TEP.............       141-2
 residues on foliage.
Honey bee subacute feeding            (3)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  .........  ................  ................       141-4
 study.
Field testing for pollinators.        (4)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TEP.............  TEP.............       141-5
 
  Nontarget insect testing--
        aquatic insects
Acute toxicity to aquatic             (5)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  .........  ................  ................       142-1
 insects.
Aquatic insect life-cycle             (5)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  .........  ................  ................       142-1
 study.
Simulated or actual field             (5)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  .........  ................  ................       142-3
 testing for aquatic insects.
Nontarget insect testing--            (5)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  .........  ................  ................       143-1
 predators and parasites.                                                                                                                                                                   thru
                                                                                                                                                                                           143-3
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: CR=Conditionally required; [ ]=Brackets (ie, [CR]) indicate data requirements that apply to products for which an experimental use permit is being sought; TGAI=Technical grade of the
  active ingredient; TEP=Typical end-use product.
(b) Notes. The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) Required only if proposed use will result in honey bee exposure.
(2) Required only when formulation contains one or more active ingredients having an acute LD50 of less than 1 microgram/bee.
(3) This requirement is reserved pending development of test methodology.
(4) May be required under the following conditions:
(i) Data from the honey bee subacute feeding study indicate adverse effects on colonies, especially effects other than acute mortality (reproductive, behavioral, etc.).
(ii) Data from residual toxicity studies indicate extended residual toxicity.
(iii) Data derived from studies with organisms other than bees indicate properties of the pesticide beyond acute toxicity, such as the ability to cause reproductive or chronic effects.
(5) This requirement is reserved pending further evaluation to determine what and when data should be required, and to develop appropriate test methods.


[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988, 
as amended at 58 FR 34203, June 23, 1993]



Sec. 161.640  Product performance data requirements table.

    (a) Table. Sections 161.100 through 161.102 describe how to use this 
table to determine the product performance data requirements and the 
substance to be tested.

[[Page 256]]



------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (b) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor                     MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
   Efficacy of antimicrobial
            agents
 
Products for use on hard              (1)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  CR         ................  EP*.............        91-2
 surfaces.
Products requiring                    (1)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  CR         ................  EP*.............        91-3
 confirmatory data.
Products for use on fabrics           (1)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  CR         ................  EP*.............        91-4
 and textiles.
Air sanitizers................        (1)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  CR         ................  EP*.............        91-5
Products for control of               (1)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  CR         ................  EP*.............        91-7
 microbial pests associated
 with human and animal wastes.
Products for treating water           (1)  ..........  ..........  [CR]        ..........  .........  .........  .........  .........  CR         ................  EP*.............        91-8
 systems.
 
  Efficacy of fungicides and
          nematicides
 
Products for control of               (1)  [CR]        ..........  [CR]        ..........  [CR]       .........  .........  .........  .........  ................  EP*.............       93-16
 organisms producing
 mycotoxins.
 
Efficacy of Vertebrate Control
            Agents
 
Avian toxicants...............        (1)  (R).......  (R).......  ..........  ..........  .........  .........  .........  (R)......  (R)......  ................  EP*.............        96-5
Avian repellents..............        (1)  (R).......  (R).......  ..........  ..........  .........  .........  .........  (R)......  .........  ................  EP*.............        96-6
Avian frightening agents......        (1)  (R).......  (R).......  ..........  ..........  .........  .........  .........  (R)......  .........  ................  EP*.............        96-7
Bat toxicants and repellents..        (1)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  (R)......  ................  EP*.............        96-9
Commensal rodenticides........        (1)  (R).......  (R).......  ..........  ..........  .........  .........  .........  (R)......  (R)......  TEP.............  EP*.............       96-10
Rodenticides on farm and              (1)  (R).......  (R).......  ..........  ..........  .........  .........  .........  (R)......  .........  ................  EP*.............       96-12
 rangelands.
Rodent fumigants..............        (1)  (R).......  (R).......  ..........  ..........  .........  .........  .........  (R)......  (R)......  ................  EP*.............       96-13
Rodent reproductive inhibitors        (1)  (R).......  (R).......  ..........  ..........  .........  .........  .........  (R)......  (R)......  ................  EP*.............       96-16
Mammalian predacides..........        (1)  (R).......  (R).......  ..........  ..........  .........  .........  .........  (R)......  .........  ................  EP*.............       96-17
Products with prion-related             *  ..........  ..........  ..........  ..........  .........  .........  .........  R........  .........  EP *............  810.2700........
 claims.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required; CR=Conditionally required; [ ]=Brackets (i.e., [R], [CR]) indicate data requirements that apply to products for which an experimental use permit is being sought; EP=End-use
  product* (asterisk identifies those data requirements that end-use applicants (i.e., ``formulators'') must satisfy, provided that their active ingredient(s) is (are) purchased from a
  registered source); MP=Manufacturing use product; TEP=Typical end-use product.
(b) Notes: The following notes are referenced in column two of the table contained in paragraph (a) of this section.

[[Page 257]]

 
(1) The Agency has waived all requirements to submit efficacy data unless the pesticide product bears a claim to control pest microorganisms that pose a threat to human health and whose
  presence cannot readily be observed by the user including, but not limited to, microorganisms infectious to man in any area of the inanimate environment or a claim to control vertebrates
  (such as rodents, birds, bats, canids, and skunks) that may directly or indirectly transmit diseases to humans. However, each registrant must ensure through testing that his products are
  efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency reserves the right to require, on a case-by-case basis, submission of
  efficacy data for any pesticide product registered or proposed for registration.
(2) [Reserved]


[49 FR 42881, Oct. 24, 1984, as amended at 50 FR 46766, Nov. 13, 1985. 
Redesignated at 53 FR 15993, May 4, 1988, as amended at 58 FR 34203, 
June 23, 1993; 78 FR 13507, Feb. 28, 2013]

[[Page 258]]



  Sec. Appendix A to Part 161--Data Requirements for Registration: Use 

                              Pattern Index

How to use this Index:
    1. Identify the Pesticide Use Site Group listed below (e.g., 
agricultural crops, forests, ornamental plants) that covers the specific 
use pattern of interest to you.
    2. Find your specific use pattern under the appropriate Pesticide 
Use Site Group.
    3. Identify the general use pattern that corresponds to your 
specific use pattern.
    4. Use the general use pattern in determining applicable data 
requirements on the Data Requirements tables presented in Sec. Sec. 
161.155 through 161.640.
Pesticide use site group
    1. Agricultural Crops.
    2. Ornamental Plants and Forest Trees.
    3. General Soil Treatment and Composting.
    4. Processed or Manufactured Products, and food or feed containers 
or dispensers.
    5. Pets and Domestic Animals.
    6. Agricultural Premises and Equipment.
    7. Household.
    8. Wood or Wood Structure Protection Treatments.
    9. Aquatic sites.
    10. Noncrop, wide area, and general indoor/outdoor treatments.
    11. Antifouling treatments.
    12. Commercial and Industrial Uses.
    13. Domestic and Human Use.
    14. Miscellaneous Indoor Uses.

------------------------------------------------------------------------
 Specific use patterns--listed according to    Corresponding general use
               use site group                           pattern
------------------------------------------------------------------------
            1. Agricultural crops
Small fruits                                  Terrestrial food crop
  Caneberries (e.g., raspberry, dewberry)
  Bushberries (e.g., blueberry, currant)
  Vine fruits (e.g., grape, kiwi fruit)
  Strawberry
  Cranberry
  Pome fruits (e.g., apple, quince)
  Stone fruits (e.g., peach, cherry)
  Nut crops--tree & shrub (e.g., pecan,
   filbert)
  Other temperate fruits (e.g., persimmon,
   pawpaw)
Tropical and subtropical fruits
  Citrus
  Banana and plantain
  Palm fruits and nuts (e.g., date, coconut)
  Pineapple
  Other fruits and nuts
Beverage crops
  Woody--cocoa, coffee, tea
  Herbaceous--chicory, mint
Flavoring and spice crops
  Woody--leaf/stem, root, seed and pod
  Herbacleaf/stem, root, seed and pod
Vegetables--leaf/stem, root, seed and pod,
 fruiting vegetables, cucurbits
  Commercial annual (e.g., tomato, bean)
  Commercial perennial (e.g., asparagus,
   rhubarb)
Greenhouse (commercial)                       Greenhouse food crop
  Mushrooms
  Nursery/seed crop/medical crop/tobacco      Greenhouse non-food crop
Fiber crops                                   Terrestrial food crop
  Cotton
  Others--(e.g., flax)
Forage crops
  Typical grasses--annual (e.g., sudan
   grass)
  Typical grasses--perennial (e.g.,
   bromegrass)
  Corn and sorghum
  Small grains for forage (e.g., rye)
  Perennial legumes (e.g., white clover)
Annual legumes (e.g., crotalaria, soybean)
Crop harvest residue (peanut vines, beet
 tops, etc.)
Grain and edible seed crops
  Corn
  Rice                                        Aquatic food crop
  Wheat, barley, rye, oats                    Terrestrial food crop
  Sorghum
  Alfalfa
  Other grains
  Other nongrains (e.g., squash, pumpkin)
  Buckwheat
  Sesame
  Peanut
  Sunflower
Seed sprout crops
  Mung bean, red clover, soybean, alfalfa,
   etc.
  Nonlegume crops (e.g., wheat, radish,
   black mustard)
Crops grown exclusively for seed for
 planting
Sugar crops
Stored raw agricultural commodities           Indoor
  Honey (principal nectar-producing crops)
  Sugar beet
  Sugarcane
  Sugar maple
  Sorghum (for sugar)
Crops for smoking and chewing                 Terrestrial nonfood crop
    --field
    --shade
    --storage
    --greenhouses
  Sapodilla (for chewing gum)                 Terrestrial food crop
Oil crops
  Annual herbaceous crops
  Perennial herbaceous crops
  Tropical/subtropical woody crops
Drug and medicinal crops                      Terrestrial nonfood crop
  Annual herbaceous crops
  Perennial herbaceous crops
  Temperate woody crops
  Tropical/subtropical wood crops

[[Page 259]]

 
    2. Ornamental plants and forest trees
Ornamental plants                             Terrestrial nonfood crop
  Annual garden plants
  Temperate perennial nonfood garden herbs
  Commercial greenhouse crops                 Greenhouse nonfood crop
  Houseplants                                 Indoor
  Home and retail greenhouse and
   conservatory plants
  Public display plantings                    Terrestrial nonfood crop
  Bulb, corm, and tuber ornamentals
  Subtropical/tropical garden evergreen
   plants (dry--e.g., agave)
  Subtropical/tropical garden evergreen
   plants (moist--e.g., ferns)
  Groundcovers
  Aquatic plants (e.g., waterlilies)          Aquatic nonfood use
Ornamental trees, shrubs, and vines (woody)   Terrestrial nonfood crop
  Deciduous temperate broadleaf
  Evergreen temperate broadleaf
  Deciduous temperate conifer
  Evergreen temperate conifer
  Tropical/subtropical broadleaf
  Tropical/subtropical conifer
  Tropical/subtropical miscellaneous (e.g.,
   cycad, tree fern, bamboo)
Lawn and turf grasses--ornamental             Terrestrial nonfood crop
                                               or domestic outdoor
  Cool season Winter grasses (bent,
   bluegrass, fescue, etc.)
  Summer grasses (zoysia, bermudagrass,
   etc.)
  Ornamental bunch grasses (pampasgrass,
   blue fescue)
Forest trees--nonornamental--trees forests,   Forestry
 plantings
  Deciduous temperate (broadleaf)
  Evergreen temperate (broadleaf)
  Deciduous and evergreen conifers
  Tropical/subtropical broadleaf
  Tropical/subtropical conifer
Forest tree nurseries--Temperate broadleaf
 trees
  Temperate conifer trees
Forest trees: dead trees/logs/stumps in the
 forest or in plantings
  3. General soil treatment and composting
General soil treatments                       Terrestrial nonfood crop
  Soil application with no mention of crops
   to be grown (potting soil, top soil).
  Manure
  Composts
  Cull piles
  Mulches
 4. Processed or manufactured products, and
    food or feed containers or dispensers
Processed vegetables, fruits, and nuts        Indoor
  Fruits
  Leafy vegetables
  Root vegetables
  Fruited vegetables
  Nuts
  Peanuts
  Seeds (sesame, sunflower)
Dried processed
  Fruits
  Vegetables
  Tobacco
  Beverages (tea, coffee)
  Herbs and spices
Animal Feeds
  Cattle (beef)
  Cattle (dairy)
  Goat (nondairy)
  Goat (dairy)
  Horse, mule, donkey
  Poultry (chicken, turkey, etc.)
  Sheep (meat)
  Sheep (wool)
  Swine
  Dog
  Cat
  Other pets (including birds)
  Fur-bearing stock
  Other meat-producing stock (e.g., rabbit)
  Fish food (commercial)
  Fish food (pet)
  Birdseed
Processed grain products for human
 consumption
  Corn
  Soybean
  Wheat
  Other grains (rice, barley, etc.)
  Cereal foods
  Flour
  Baked goods
  Farinaceous products
  Processed animal products for human
   consumption
  Cheese
  Egg yolks
  Meats, including fish and poultry
  Milk
Processed plant products for human
 consumption
  Chocolate
  Candy
  Sugar
  Yeast
  Citrus pulp
  Chewing gum
  Cigarettes, etc.
  Herbs and spices
  Pickles
  Glazed fruits
  Jellies
  Seed oils
  Fruit syrups (e.g., cola)
  Fruit juices
  Fermentation beverages (wine, beer,
   whiskey, vinegar)
  Processed or manufactured nonfood plant
   and animal products
  Textiles, fabrics, fibers
  Fur and hair products
  Leather products
Food and feed containers, dispensers, and
 processing equipment
  Airtight storages--large (empty/full)
  Airtight storages--small (empty/full)
  Fumigation chambers
  Bins
  Elevators

[[Page 260]]

 
  Storage areas--(empty/full)
  Processing or handling equipment and
   machinery (other than food processing)
  5. Pets and domestic animals--animals and
           their man-made premises
Dairy cattle--lactating                       Indoor
Dairy cattle--nonlactating
Dairy cattle--heifers, calves
Goats--lactating
Goats--nonlactating
Goats--young (kids)
Fur- and wool-bearing animals
  Goats
  Sheep
  Mink
  Chinchilla
  Rabbit
  Fox
  Nutria
Meat animals (mammals)
  Cattle (and calves)
  Goats (and kids)
  Horses
  Rabbits
  Sheep (and lambs)
  Swine
  Bison
  Reindeer
Poultry (meat, eggs)
  Chickens
  Turkeys
  Ducks, geese
  Guineas, pheasants, quail, etc.
Honey production
  Bees
  Beehives
  Honeycombs
Fish and shellfish production                 Aquatic food use
  Hatchery buildings
  Culture ponds, containers
Animals for labor, display, riding, racing,   Indoor
 lab use, etc.
  Dogs
  Horses, donkeys, mules
  Guinea pigs
  Mice
  Rats
  Gerbils
  Hamsters
  Monkeys
  Cats
  Chickens, birds
  Wild rodents
  Alfalfa leafcutting bee (pollinator)
  Alkaline bee (pollinator)
  Zoo ruminants
  Zoo ungulates
  Zoo canines
  Zoo felines
  Zoo primates
  Zoo reptiles
  Zoo amphibians
  Zoo birds
  Zoo--others
  Aquarium fish
Animals for pets, including their cages,
 bedding, nests, etc.
  Dogs
  Cats
  Birds
  Rodents
  Lagomorphs
  Fish
  Amphibians
  Reptiles
  Primates
  Other vertebrates
   6. Agricultural premises and equipment
Egg handling facilities and equipment         Indoor
  Egg washers
  Egg rooms
  Hatching egg treatments
  Hatching egg rooms
  Hatching egg equipment
  Egg packing plants and hatcheries
Milk handling facilities and equipment
  Milk storage rooms
  Milking stalls and parlors
  Milking machines, milk tanks, etc.
  Teat cups, liners, etc.
  Milk processing equipment
                7. Household
Non-food area and sites                       Indoor
  Closets, storage areas
  Basements, cellars
  Bedrooms
  Attics
  Recreation rooms
  Living rooms
  Baseboards, window sills, etc.
  Plumbing fixtures
  Sickrooms
Food-handling and food storage areas
  Kitchens
  Dining rooms
  Pantry and food storage shelving
Household contents and space
  Air
  Beds
  Rugs
  Book cases
  Furs, fabrics, blankets
  Play pens
  Sickroom utensils
  Filters for air vents, air conditioners,
   furnaces, etc.
Outdoor areas (Noncommercial homeowner use)   Domestic outdoor or
                                               terrestrial food crop
  Home garden, orchards
  Porches                                     Domestic outdoor
  Patios
  Foundations
  Steps
  Eaves
  Yards, lawn, turf
  Domestic ornamental plantings
    8. Wood or Wood Structure Protection
                 Treatments
Buildings (for termite, powderdust beetle     Domestic outdoor or indoor
 controls, etc.)
Unseasoned forest products
Seasoned forest products
Finished wood products
Wood pressure treatments
Plant-growing wood structures and containers
Wood containers for nonfood, nonfeed uses
              9. Aquatic sites
Food processing water systems                 Aquatic food crop
Poultry and livestock drinking water
Pulp and papermill systems                    Aquatic noncrop
Swimming pool water
Industrial disposal systems

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Industrial ponds
Human drinking water                          Aquatic food crop
Cooling water towers                          Aquatic noncrop
Agricultural irrigation water, and ditches    Aquatic food crop
Agricultural drainage water and ditches
Sewage systems and drainfields                Aquatic noncrop
Dishwashing water                             Indoor
Domestic and commercial nonpotable water      Aquatic noncrop
Lakes, ponds, impounded water
Streams, rivers, canals
Swamps, marshes, wetlands
Air conditioner water
  Humidifier water
Air washer water systems
Secondary oil recovery injection water
Heat exchange water system
Polluted water
Bait boards (floating--for vertebrate
 control)
Catch basins, puddles, tree holes
Estuaries, tidal marshes
Commercial and sport fish-bearing waters      Aquatic food crop
 10. Noncrop, wide area, and general indoor/
             outdoor treatments
Uncultivated agricultural areas (nonfood      Terrestrial noncrop
 producing)
  Farmyards
  Fuel storage areas
  Fence rows
  Rights-of-way
  Fallow land                                 Terrestrial food crop
  Soil bank land                              Terrestrial noncrop
  Barrier strips
Uncultivated nonagricultural areas (outdoor)
  Airports
Recreation areas, fairgrounds, race tracks,
 tennis courts, etc.
  Campgrounds
  Recreation area structures
  Highway rights-of-way
  Railroad rights-of-way
  Utility rights-of-way
  Sewage disposal areas
Industrial sites (lumberyards, tank farms,
 etc.)
Paved areas
  Private roads and walks
  Fencerows and hedgerows (nonagricultural)
Directed Pest Control to Pests' Nests, etc.,  Terrestrial noncrop or
 and for Traps                                 indoor
  Diseased beehives
  Nuisance bee nests
  Ant mounds, hills, dens
  Termite mounds
  Insect traps (chemical lures)
  Repellents and irritants to pests (when
   not covered by other sites)
Wide area and general indoor/outdoor
 treatments
  Rural areas (unspecified)
  Urban areas (unspecified)
  Public buildings and structures
  Animal burrow entrances, dens, tunnels
  Animal nests
  Animal trails
  Mammal feeding areas
  Nonagricultural areas for public health
   treatments
  Bird roosting, nesting areas
  Bird feeding areas
         11. Antifouling Treatments
Sites for marine exposures                    Aquatic noncrop
  Boat bottoms and other submersed
   structures
    Steel
    Fiberglass
    Aluminum
    Wood
    Plastic
    Other substances and materials
  Crab pots and lobster pots
Sites for fresh water exposures
Cooling tower influent conduits
     12. Commercial and Industrial Uses
Transportation Facilities                     Indoor
  Bus
  Truck and Trailer
  Containerized units
  Railroad cars
  Aircraft
  Ships/barges
  Auto, taxis
  Recreational vehicles
  Shipping containers
Food and feed processing plants
  Bakeries
  Bottlers
  Canneries
  Dairies, creameries, milk processing
   plants
  Feed mills, feed stores
  Fresh fruit packing and processing
  Meat processing
  Poultry processing
  Wineries, wine cellars
  Flour mills, machinery, warehouses, bins,
   elevators
  Egg processing
  Candy and confectionary plants
  Sugar processing, cane mills, etc.
  Cider mills
  Dry food products plants
  Tobacco processing
  Air treatment for processing and
   transportation of foods
  Beverage processing
  Nut processing
  Cereal processing
  Seafood processing
  Vegetable oil processing
  Spice mills
  Vinegar processing
  Farinaceous processing (noodles, etc.)
  Mushroom processing
  Dried fruit processing
  Pickle processing
  Ice plants
  Chocolate processing
  Fruit juice processing
Eating establishments (all)
  Food handling areas
  Food serving areas
  Eating establishment nonfood areas
  Air treatment for eating establishments
  Food storage equipment (coolers,
   refrigerators, etc.)

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  Eating and serving utensils (spoons, etc.)
Food marketing, storage, and distribution
  Food dispensing and vending equipment
  Food stores, markets, stands
  Meat and fish markets
  Food catering facilities
  Food marketing, storage, and distribution
   equipment and utensils
Hospitals and related institutions and
 facilities
  Critical premises (e.g., burn wards, etc.)
  Hospital patient premises (wards,
   emergency rooms, etc.)
  Noncritical premises (labs, lounges,
   lobbies, storage)
  Critical items (hypodermic needles, dental
   instruments, catheters, etc.)
  Noncritical items (bedpans, carpets,
   furniture, etc.)
  Air treatment (also to ambulances)
Janitorial equipment
Barber and beauty shop instruments and
 equipment
Morgues, mortuaries, and funeral homes
  Premises (embalming rooms, etc.)
  Equipment (tables, etc.)
  Instruments
  Burial vaults, mausoleums
  Air treatment
Commercial, institutional, and industrial
Maintenance, Buildings, and Structures
  Locker rooms, equipment
  Gyms, bowling alleys, and equipment
  Telephones and booths
  Shower rooms, mats, and equipment
  Cotton mill premises and equipment
  Auditoriums and stadiums
  Factories
  Rendering plants
  Loading areas, ramps
  School buildings and equipment
  Office buildings
  Laundries
Fuels from Crops (alcohol, methane)
  Fossil fuels (e.g., oils, jet fuel)
  Seed oils
  Paper
Pesticide materials preservation and
 protection
  Rodenticide baits (protection against
   insects)
  Dried plant parts (pyrethrum, red squill,
   rotenone, sabadilla)
  Paints
Preservatives and protectants
  Grains
  Hay, silage
  Adhesives
  Coatings (asphalt and lacquer)
  Fuels
  Leather and leather products
  Leather processing liquors
  Metalworking cutting fluids
  Oil recovery drilling muds and packer
   fluids
  Paints (latex)
  Paper and paper products
  Plastic products
  Resin emulsions
  Rubber (natural) products
  Specialty products (polishes, cleansers,
   dyes, etc.)
  Textiles, textile fibers, and cordage
  Wet-end additives, etc. (pulp sizing,
   alum, casein, printing pastes)
  Disposable diapers
  Wool, hair, mohair, furs, felt, feathers,
   etc.
  Electrical supplies, cables, and equipment
         13. Domestic and Human Use
Human Body and Hair                           Indoor
Fiber product protection (Moth,
    mildew-proofing)
  Clothing
  Upholstery
  Ornamental fabrics (draperies, tapestries)
  Ropes
  Sail cloth
Human articles and materials
  Bedding, blankets, mattresses
  (Treatments to) hair, body, clothing
   (while being worn)
  Clothing
  Face gear (goggles, face masks, etc.)
  Headgear (safety helmets, headphones,
   etc.)
  Wigs
  Contact lenses
  Dentures, toothbrushes, mouthpieces to
   musical instruments, etc.
  Brick, asbestos, etc.
  Wood surfaces
  Leather surfaces
  Fabric surfaces
  Paper/paperboard surfaces
Specialty uses
  Museum collectors (preserved animal and
   plant specimens)
  Military uses--not specified
  Quarantine uses--not specified
  DHHS/FDA uses--not specified
  Filters (air conditioning, air, and
   furnace)
  Biological specimens
  Underground cables
  Cuspidors, spittoons
  Vomitus
  Human wastes
  Air sanitizers
  Diapers
  Laundry equipment (carts, chutes, tables,
   etc.)
  Dust control--products and equipment
   (mops, etc.)
  Dry cleaning
  Carpets
  Upholstery
Bathrooms, toilets bowls, and related sites
  Bathroom premises
  Toilet bowls and urinals
  Toilet tanks
  Portable toilets, chemical toilets

[[Page 263]]

 
  Vehicular holding tanks
  Bathroom air treatment
  Diaper pails
Refuse and soild waste
  Refuse and solid waste containers
  Refuse and solid waste transportation and
   handling equipment
  Garbage dumps
  Household trash compactors
  Garbage disposal units, food disposals
  Incinerators
        14. Miscellaneous Indoor Uses
Surface Treatments                            Indoor
  Hard nonporous surfaces (painted, tile,
   plastic, metal, glass, etc.)
  Hard porous surfaces (cement, plaster)
  Camping equipment and gear
  Grooming instruments (brushes, clippers,
   razors, etc.)
Laundry, cleaning, and dry cleaning
------------------------------------------------------------------------


[40 FR 42881, Oct. 24, 1984. Redesignated and amended at 72 FR 60253-
60255, Oct. 24, 2007]



PART 162_STATE REGISTRATION OF PESTICIDE PRODUCTS--Table of Contents



Subparts A-C [Reserved]

Subpart D_Regulations Pertaining to State Registration of Pesticides To 
                        Meet Special Local Needs

Sec.
162.150 General.
162.151 Definitions.
162.152 State registration authority.
162.153 State registration procedures.
162.154 Disapproval of State registrations.
162.155 Suspension of State registration authority.
162.156 General requirements.

Subpart E [Reserved]

Subparts A-C [Reserved]



Subpart D_Regulations Pertaining to State Registration of Pesticides To 

                        Meet Special Local Needs

    Authority: 7 U.S.C. 136v, 136w.

    Source: 46 FR 2014, Jan. 7, 1981, unless otherwise noted.



Sec. 162.150  General.

    (a) Scope. This subpart sets forth regulations governing the 
registration by any State of pesticide products, or uses thereof, 
formulated for distribution and use within the State to meet special 
local needs under sec. 24(c) of the Act. It also sets forth regulations 
governing the exercise by the Administrator of the power to disapprove 
specific State registrations and to suspend a State's registration 
authority under sec. 24(c). Unless otherwise indicated, any reference 
herein to registrations issued by a State includes amendments of 
registrations issued by States.
    (b) Applicability. This subpart applies only to State registration 
authority granted by sec. 24(c) of FIFRA. It does not apply to any 
authority granted, or procedures established, by State law with respect 
to registration, licensing, or approval required for use within the 
State of federally registered pesticide products.

[46 FR 2014, Jan. 7, 1981, as amended at 53 FR 15999, May 4, 1988; 60 FR 
32097, June 19, 1995]



Sec. 162.151  Definitions.

    Terms used in this part have the same meaning as in the Act and part 
152 of this chapter. In addition, as used in this subpart, the following 
terms shall apply:
    Federally registered means currently registered under section 3 of 
the Act, after having been initially registered under the Federal 
Insecticide, Fungicide, and Rodenticide Act of 1947 by the Secretary of 
Agriculture or under FIFRA by the Administrator.
    Manufacturing-use product means any pesticide product other than a 
product to be labeled with directions for end use. This term includes 
any product intended for use as a pesticide after reformulation or 
repackaging.
    New product means a pesticide product which is not a federally 
registered product.
    Pest problem means:
    (1) A pest infestation and its consequences, or
    (2) Any condition for which the use of plant regulators, defoliants, 
or desiccants would be appropriate.
    Product or pesticide product means a pesticide offered for 
distribution and use, and includes any labeled container and any 
supplemental labeling.
    Similar composition means a pesticide product which contains only 
the same active ingredient(s), or combinations of

[[Page 264]]

active ingredients, and which is in the same toxicity category, as 
defined in Sec. 156.62 of this chapter, as a federally registered 
pesticide product.
    Similar product means a pesticide product which, when compared to a 
federally registered product, has a similar composition and a similar 
use pattern.
    Similar use pattern means a use of a pesticide product which, when 
compared to a federally registered use of a product with a similar 
composition, does not require a change in precautionary labeling under 
part 156 of this chapter, and which is substantially the same as the 
federally registered use. Registrations involving changed use patterns 
are not included in this term.
    Special local need means an existing or imminent pest problem within 
a State for which the State lead agency, based upon satisfactory 
supporting information, has determined that an appropriate federally 
registered pesticide product is not sufficiently available.
    State or State lead agency means the State agency designated by the 
State to be responsible for registering pesticides to meet special local 
needs under section 24(c) of the Act.

[73 FR 75597, Dec. 12, 2008]



Sec. 162.152  State registration authority.

    (a) Statutory limitations. In accordance with sec. 24(c) of the Act, 
each State is authorized to register a new end use product for any use, 
or an additional use of a federally registered pesticide product, if the 
following conditions exist:
    (1) There is a special local need for the use within the State;
    (2) The use is covered by necessary tolerances, exemptions or other 
clearances under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 346 
et seq.), if the use is a food or feed use;
    (3) Registration for the same use has not previously been denied, 
disapproved, suspended or cancelled by the Administrator, or voluntarily 
cancelled by the registrant subsequent to issuance by the Administrator 
of a notice of intent to cancel that registration, because of health or 
environmental concerns about an ingredient contained in the pesticide 
product, unless such denial, disapproval, suspension or cancellation has 
been superseded by subsequent action of the Administrator; and
    (4) The registration is in accord with the purposes of FIFRA.
    (b) Types of registrations--(1) Amendments to federal registrations. 
(i) Subject to the provisions of paragraphs (a) and (b)(1)(ii) through 
(iv) of this section, States may register any new use of a federally 
registered pesticide product.
    (ii) A State may register any use of a federally registered product 
for which registration of other uses of the product was denied, 
disapproved, suspended, or cancelled by the Administrator, provided that 
the State may register a use not considered by the Administrator in 
reaching such a determination only after the State consults with 
appropriate EPA personnel.
    (iii) Except as provided in paragraph (a)(3) of this section, a 
State may register any use of a federally registered product for which 
registration of some or all uses has been voluntarily cancelled by the 
registrant, provided that a State may register such a use only after the 
State has consulted with appropriate EPA personnel.
    (iv) A State may not register an amendment to a federally registered 
manufacturing-use product.
    (2) New products. (i) Subject to the provisions of paragraph (a) and 
subparagraphs (b)(2) (ii) and (iii) of this section, a State may issue 
registrations to meet special local needs for the following types of new 
end-use products:
    (A) A product which is identical in composition to a federally 
registered product, but which has differences in packaging, or in the 
identity of the formulator.
    (B) A product which contains the same active and inert ingredients 
as a federally registered product, but in different percentages.
    (C) Subject to the requirements of paragraph (b)(2)(ii) of this 
section, a product containing a new combination of active, or active and 
inert, ingredients.

[[Page 265]]

    (ii) A State may register a new product only if each of the active 
ingredients in the new product is present because of the use of one or 
more federally registered products and if each of the inert ingredients 
in the new product is contained in a federally registered product.
    (iii) A State may not register a new manufacturing-use product.
    (iv) A State may register any use of a new product containing an 
ingredient described in paragraph (a)(3) of this section, if the new 
product registration is for a formulation or a use not included in the 
denial, disapproval, suspension, or cancellation, or if the federally 
registered use was voluntarily cancelled without a prior notice of 
intent to cancel by the Administrator. However, a formulation or use of 
such a new product which was not considered by the Administrator during 
such proceedings, or which was not the subject of a notice of intent to 
cancel, may be registered by a State only after the State consults with 
appropriate EPA personnel regarding the registration application.
    (c) Effect of State registration. (1) A State registration issued 
under FIFRA sec. 24(c) which meets the conditions described in 
paragraphs (a) and (b) of this section, and which is not disapproved by 
the Administrator under Sec. 162.154, shall be considered a federal 
registration, but shall authorize distribution and use only within that 
State. Accordingly, such registrations are subject to all provisions of 
FIFRA which apply to currently registered products, including provisions 
for cancellation and suspension of registrations, and reregistration of 
products.
    (2) A State may require, as a condition of distribution or use of a 
pesticide product within the State, that the pesticide product be 
registered under State law as well as under FIFRA. Neither FIFRA sec. 
24(c) nor Sec. Sec. 162.150-162.156 affects a State's right under its 
own law to revoke, suspend, cancel, or otherwise affect such a 
registration issued under State law. However, the federal registration, 
whether issued under FIFRA sec. 3 or 24(c), is not affected by such a 
State action.

[46 FR 2014, Jan. 7, 1981, as amended at 73 FR 75597, Dec. 12, 2008]



Sec. 162.153  State registration procedures.

    (a) Application for registration. States shall require all 
applicants for registration to submit the following information:
    (1) Name and address of the applicant and any other person whose 
name will appear on the labeling or in the directions for use.
    (2) The name of the pesticide product, and, if the application is 
for an amendment to a federally registered product, the EPA registration 
number of that product.
    (3) A copy of proposed labeling, including all claims made for the 
product as well as directions for its use to meet the special local 
need, consisting of:
    (i) For a new product, a copy of the complete proposed labeling; or,
    (ii) For an additional use of a federally registered product, a copy 
of proposed supplemental labeling and a copy of the labeling for the 
federally registered product.
    (4) The complete formula of the product, if the application is for a 
new product registration.
    (5) Any other information which is required to be reviewed prior to 
registration under this section.
    (b) Special local need determination. In reviewing any application 
for registration, the State shall determine whether there is a special 
local need for the registration. Situations which a State may consider 
as not involving a special local need may include, but are not limited 
to, applications for registrations to control a pest problem present on 
a nationwide basis, or for use of a pesticide product registered by 
other States on an interregional or nationwide basis.
    (c) Unreasonable adverse effects determination. (1) Prior to issuing 
a registration in the following cases, the State shall determine that 
use of the product for which registration is sought will not cause 
unreasonable adverse effects on man or the environment, when used in 
accordance with labeling directions or widespread and commonly 
recognized practices:
    (i) For use of a product which has a composition not similar to any 
federally registered product.

[[Page 266]]

    (ii) For use of a project involving a use pattern not similar to any 
federally registered use of the same product or of a product with a 
similar composition.
    (iii) For use of a product for which other uses of the same product, 
or of a product with a similar composition, have had registration 
denied, disapproved, suspended, or cancelled by the Administrator.
    (2) Determinations required by paragraph (c)(1) of this section 
shall be based on data and criteria consistent with those sections of 
part 152 of this chapter, applicable to the type of product or use under 
consideration. Such determinations may also involve consideration of the 
effect of the anticipated classification of the product or use under 
paragraph (g) of this section.
    (d) Efficacy determination. Prior to registration of any use of a 
product for public health purposes--that is, a use which could result in 
substantial harm to the public health if the product does not perform 
its intended function, the State shall determine that the product 
warrants the claims made for it in the registration application. Such 
determinations shall be based on criteria specified in applicable 
sections of part 152 of this chapter and on any additional criteria 
established by the State.
    (e) Labeling requirements. (1) Prior to issuing any registration, 
the State shall review the proposed labeling submitted with the 
application to determine compliance with this paragraph. In addition, 
the State shall review a copy of the final printed labeling as soon as 
practical after a registration is issued in order to verify compliance 
with this paragraph.
    (2) For a new product, the State must, as a condition of the 
registration, require that the product be accompanied from the time it 
enters the stream of commerce by labeling meeting all applicable 
criteria of Sec. 156.10 of this chapter. New product labeling must all 
contain:
    (i) A statement identifying the State where registration is to be 
valid.
    (ii) The special local need registration number assigned by the 
State.
    (3) Except as provided in paragraph (e)(4) of this section, as a 
condition for a registration of an additional use of a federally 
registered product, the State must require that at the time of sale to 
users, labeling from the federally registered product be accompanied by 
supplemental labeling which contains:
    (i) A statement identifying the State where registration is valid.
    (ii) Directions for use to meet the special local need which satisfy 
the criteria of Sec. 156.10(i) of this chapter.
    (iii) The trade name of the product.
    (iv) The name and address of the section 24(c) registrant.
    (v) The EPA registration number of the federally registered product.
    (vi) The special local need registration number assigned by the 
State.
    (vii) A statement prohibiting use of the product in a manner 
inconsistent with all applicable directions, restrictions, and 
precautions found in the labeling of the federally registered product 
and accompanying supplemental labeling.
    (4) When a federally registered product is already in the stream of 
commerce at the time the State issues a registration for an additional 
use of that product, the State must ensure that supplemental labeling 
for the additional use, meeting the criteria of paragraph (e)(3) of this 
section, is made available to purchasers and users of the product within 
45 days of the date on which the State approves the final printed 
supplemental labeling.
    (5) If a State classifies for restricted use a product or use 
registered by the State, which is not required to be so classified by 
paragraph (g) of this section, then the State may require supplemental 
labeling for the product or use containing additional appropriate 
precautions, and a statement that the product or use is for restricted 
use within that State.
    (f) Packaging and coloration standards. All products registered by a 
State must meet all appropriate packaging standards prescribed by the 
Administrator under sec. 25(c)(3) of FIFRA. State registered products 
must also meet all appropriate standards for coloration, or 
discoloration, established by regulation under sec. 25(c) of FIFRA, 
including the standards contained in subpart H of part 153 of this 
chapter. Prior to issuing any registration, the State

[[Page 267]]

shall determine that the product will conform to these requirements.
    (g) Classification. (1) As part of the registration of any product 
or use, a State shall classify the product or use as a restricted use 
pesticide if:
    (i) The product is identical or similar in composition to a 
federally registered product:
    (A) For which all federally registered uses have been classified as 
restricted by the Administrator; or
    (B) For which a use similar to the State registered use has been 
classified as restricted by the Administrator; or
    (ii) The State registered product or use meets the criteria for 
classification as a restricted use pesticide under the applicable 
provisions of Sec. 152.170 of this chapter.
    (2) [Reserved]
    (h) Notification and submission of data. (1) Within ten working days 
from the date a State issues, amends, or revokes a registration, the 
State shall notify EPA, in writing, of the action. Notification of State 
registrations, or amendments thereto, shall include the effective date 
of the registration or amendment, a confidential statement of the 
formula of any new product, and a copy of the draft labeling reviewed 
and approved by the State, provided that labeling previously approved by 
the Administrator as part of a federal registration need not be 
submitted.
    (2) Notification of State registrations or amendments shall be 
supplemented by the State sending to EPA a copy of the final printed 
labeling approved by the State within 60 days after the effective date 
of the registration or amendment.
    (3) Notification of revocation of a registration by a State shall 
indicate the effective date of revocation, and shall state the reasons 
for revocation.
    (4) The Administrator or his designee may request, when appropriate, 
that a State submit to EPA any data used by the State to determine that 
unreasonable adverse effects will not be caused when the State registers 
any use described in paragraph (c)(1) of this section. Within 15 working 
days of receipt of such a request from EPA, the State shall submit two 
copies of the requested data.
    (i) Federal Register publication. The Administrator shall publish in 
the Federal Register, on a regular basis, a summary of all State 
registrations made under sec. 24(c) during a previous reporting period 
established by the Administrator. For each product or use registered, 
the notice shall indicate:
    (1) The name of the product.
    (2) The name of the registrant.
    (3) The registered use(s) of the product.
    (4) The effective date of the State registration.
    (5) If the registration is for an additional use of a federally 
registered product, whether the State registration involves a changed 
use pattern.
    (j) Electronic reporting under State registration of pesticide 
products for special local needs. States that choose to receive 
electronic documents under the regulations pertaining to state 
registration of pesticides to meet special local needs, must ensure that 
the requirements of 40 CFR Part 3--(Electronic reporting) are satisfied 
by their state procedures for such registrations.

[46 FR 2014, Jan. 7, 1981, as amended at 53 FR 15999, May 4, 1988; 60 FR 
32097, June 19, 1995; 70 FR 59888, Oct. 13, 2005; 73 FR 75597, Dec. 12, 
2008]



Sec. 162.154  Disapproval of State registrations.

    (a) General disapprovals. (1) Except as provided in paragraph (b) of 
this section, the Administrator may disapprove, on any reasonable 
grounds, any state registration which, when compared to a federally 
registered product, does not have both a similar composition and a 
similar use pattern; provided that the Administrator may not disapprove 
such a registration solely because of a lack of essentiality. Grounds 
for disapproval of State registrations not involving similar products 
may include, but are not limited to:
    (i) Probable creation of unreasonable adverse effects on man or the 
environment by the registered use.
    (ii) Refusal of the registering State to submit information 
supporting the registration as required by Sec. 162.153(h).

[[Page 268]]

    (iii) Failure of information submitted by the State to support the 
State's decision to issue the registration under standards established 
by Sec. 162.153.
    (2) Prior to disapproval of any State registration under this 
paragraph, the Administrator shall notify the registering State, in 
writing, of the Administrator's intent to disapprove, and of the reasons 
for disapproval. The notice of intent will provide a reasonable time, 
not less than ten days from the date the notice is received by the 
State, for the State to respond, and will invite the State to consult 
with the Administrator or his designee. If the grounds for disapproval 
are based on actions or omissions by the State, the notice will, if 
possible, also provide the State with a reasonable amount of time in 
which to take corrective action, not to exceed the time allowed for 
disapproval under paragraph (c) of this section.
    (3) The registering State may, within ten days of receipt of a 
notice of intent to disapprove, request that the Administrator, or his 
designee, consult with appropriate State officials prior to the 
Administrator's final decision on disapproval. The Administrator will 
consider any relevant information presented at such a consultation, or 
in any other timely and appropriate fashion, in deciding whether to 
withdraw the notice of intent to disapprove.
    (b) Special disapprovals. (1) The Administrator may disapprove any 
State registration, including a registration for a similar product, at 
any time, if the Administrator determines that use of the product under 
the State registration:
    (i) Would constitute an imminent hazard.
    (ii) May result in a residue on food or feed exceeding, or not 
covered by, a tolerance, exemption, or other clearance under the Federal 
Food, Drug and Cosmetic Act (21 U.S.C. 346a et seq.).
    (2) If the Administrator disapproves a registration under this 
paragraph, the Administrator shall provide the registering State with 
written notification of disapproval, in accordance with paragraph (c) of 
this section, as soon thereafter as practicable. Such notification will 
specify the grounds for disapproval and invite the State to comment on 
the decision.
    (3) If requested by the State within ten days of its receipt of a 
notice of disapproval, the Administrator, or his designee, will consult 
with appropriate State officials. The Administrator may consider any 
information presented at such a consultation, or in any other 
appropriate fashion, in determining whether the disapproval should be 
rescinded.
    (c) Decision and notification of disapproval. Except as provided in 
paragraph (b)(1) of this section, the Administrator will make a final 
decision on disapproval of a State registration, and provide written 
notification thereof to the State, within 90 days of the effective date 
of the registration; provided that, if the State does not notify the 
Agency of a registration within ten days of its effective date, then the 
Administrator will make a final decision on disapproval within 90 days 
of the date on which EPA receives notification of the State 
registration. The notice of disapproval will specify an appropriate date 
on which the disapproval will become effective. Disapproval may become 
effective immediately, or at anytime within the period allowed for the 
Administrator to make a final decision on disapproval. The notice of 
disapproval will also, when appropriate, give instructions for use or 
disposal of the pesticide. Each notice of disapproval will be published 
in the Federal Register.
    (d) Effect of disapproval. If a registration issued by a State is 
disapproved by the Administrator, that registration will not be valid 
for any purpose under FIFRA, as of the date the disapproval becomes 
effective. Thereafter, distribution or sale of the pesticide, in either 
interstate or intrastate commerce, for uses subject to the disapproval 
will be a violation of sec. 12(a)(1) of FIFRA.
    (e) Rescission of disapproval. If the Administrator determines, 
after consultation with the State lead agency, that a registration, 
previously issued by the State and disapproved by the Administrator, 
should not have been disapproved under FIFRA, then the Administrator 
shall rescind the disapproval. The Administrator shall send written 
notification of the rescission to

[[Page 269]]

the State. In addition, the Administrator shall publish notice of any 
rescission of disapproval in the Federal Register.
    (f) Notification of registrants. Any State that issues a 
registration which has been disapproved, or which is subject to a notice 
of intent to disapprove, shall be responsible for notifying the affected 
registrant of any such notice of intent or disapproval, and of any 
recession of disapproval by the Administrator.



Sec. 162.155  Suspension of State registration authority.

    (a) General. (1) If the Administrator finds that a State is not 
capable of exercising, or has failed to exercise, adequate control over 
its registration program, so that the State cannot ensure that 
registrations issued by it will be in accord with the purposes of FIFRA, 
then the Administrator may suspend the State's authority to register 
pesticides under sec. 24(c) of the Act. Registrations issued by the 
State after suspension of its authority will not be considered valid 
under FIFRA. Registrations issued by the State prior to suspension will 
not be affected by the suspension.
    (2) The Administrator may suspend all or any part of a State's 
registration authority, as appropriate.
    (b) Grounds for suspension. (1) The Administrator may suspend a 
State's registration authority due to lack of, or failure to exercise, 
adequate control by the State over its sec. 24(c) registration program. 
Adequate control includes, but is not limited to, all of the following:
    (i) Access to appropriate scientific and technical personnel to 
review data and make determinations as required by Sec. 162.153.
    (ii) Registration procedures satisfying Sec. 162.153.
    (iii) Complete and accurate records of State registrations.
    (iv) Adequate legal authority. (A) To deny, suspend, revoke, or 
amend a State registration when the registration is not in compliance 
with FIFRA, this subpart, or State law, or when necessary to prevent 
unreasonable adverse effects on the environment.
    (B) To enter, at reasonable times, by consent, warrant, or other 
legal means, any establishment where pesticides are produced or held for 
distribution or sale, to inspect, sample, and observe whether pesticides 
are being produced or distributed in compliance with FIFRA, this 
subpart, State law, and the terms of any State registration.
    (2) The Administrator may suspend a State's registration authority 
if the State fails to exercise the controls specified in paragraph 
(b)(1) of this section, or if the State refuses to correct within a 
reasonable time any other significant deficiencies in its regulatory 
program, as specified by the Administrator in a notice of intent to 
suspend.
    (c) Procedures for suspension. (1) Prior to suspending the 
registration authority of any State, the Administrator will notify the 
State lead agency, in writing, of the Administrator's intent to suspend, 
and of the specific grounds for suspension. The notice of intent will 
specify whether the suspension will be complete or partial, and will 
provide the State an opportunity to respond and a reasonable amount of 
time, not less than 30 days from the date the notice is received, in 
which to correct the deficiencies specified in the notice. If the State 
does not correct the specified deficiencies within the reasonable time 
allowed by the notice, or if the Administrator has not withdrawn the 
notice of intent before that time, the notice of intent will be 
published in the Federal Register, and the public given an opportunity 
to comment thereon.
    (2) If requested by the affected State lead agency within 30 days of 
receipt of the notice of intent to suspend, an informal consultation 
between appropriate State and EPA officials will be held to discuss the 
proposed suspension. In such a case, the Administrator shall not make a 
final decision on the proposed suspension until after the consultation. 
The Administrator shall consider all relevant information presented at 
the consultation, or in any other appropriate manner, in determining 
whether to suspend the State's authority. If the Administrator 
determines, on the basis of such information, that the deficiencies 
listed in the notice of intent no longer exist, or will

[[Page 270]]

be corrected in a reasonable time, then the Administrator will withdraw, 
in writing, the notice of intent to suspend.
    (3) Within ten days of the date a notice of intent to suspend is 
published in the Federal Register, a State may request a public hearing 
to consider the proposed suspension. If a hearing is requested, the 
Administrator will:
    (i) Schedule a public hearing to be held in that State.
    (ii) Publish in the Federal Register a notice announcing the date, 
time, and location of the hearing.
    (iii) Appoint a presiding officer who shall preside over the 
hearing.
    (iv) Prescribe additional, appropriate procedures for the conduct of 
the hearing, including procedures for the presentation of relevant 
material evidence from the State, EPA, or members of the public who 
would be affected by the outcome of the hearing. Evidence may be 
presented in either oral or written form, at the discretion of the 
Administrator.
    (4) Following the close of any hearing held under paragraph (c)(3) 
of this section, the presiding officer shall make a recommended decision 
that the State's authority to register pesticides under sec. 24(c) of 
FIFRA be suspended, in whole or in part, or that the State's authority 
not be suspended and that the notice of intent to suspend be withdrawn.
    (5) Any recommended decision made by a presiding officer under 
paragraph (c)(4) of this section may be appealed to the Administrator 
within 30 days after its issuance by the State or by EPA. Any 
recommended decision which is not appealed, or which the Administrator 
does not review on his own initiative, will become a final Agency action 
30 days after its issuance.
    (6) If no hearing is requested under paragraph (c)(3) of this 
section, or if a recommended decision is appealed to the Administrator 
under paragraph (c)(5) of this section, the Administrator shall issue a 
final order either suspending the State's authority to register 
pesticides under section 24(c) of FIFRA, in whole or in part, or 
withdrawing the notice of intent to suspend.
    (7) Any final order suspending State registration authority, issued 
under paragraph (c) (5) or (6) of this section, will specify the grounds 
therefor and an effective date for the suspension. If the suspension is 
merely partial, the notice of suspension will specify the types of 
registrations which will not be recognized as valid under sec. 24(c). 
All final orders issued under paragraph (c) (5) or (6) will be published 
in the Federal Register.
    (d) Termination of suspension. Suspension of a State's authority 
will be effective for the period specified in the notice of suspension, 
or if no period was specified, until such time as the Administrator is 
satisfied that the State can and will exercise adequate control over its 
program. In the latter case, the Administrator will notify the State 
that the suspension is terminated, or that it will be terminated on a 
specific date. In either case, the Administrator will publish a notice 
of the termination of suspension in the Federal Register.
    (e) Judicial review. Any State whose authority to register 
pesticides has been finally suspended by the Administrator may seek 
judicial review of the Administrator's decision under sec. 16 of FIFRA, 
at any time prior to termination of the suspension. Such suspension 
shall remain in effect during the period of judicial review unless 
otherwise ordered by the Administrator.



Sec. 162.156  General requirements.

    (a) Requirements for distribution and use. (1) Any product whose 
State registration has been issued in accordance with Sec. Sec. 162.152 
and 162.153 may be distributed and used in that State, subject to the 
following provisions of the Act and the regulations promulgated 
thereunder:
    (i) Sec. 12(a)(1) (A) through (E), in accordance with:
    (A) Sec. 2(q)(1) (A) through (G).
    (B) Sec. 2(q)(2) (A) through (D).
    (ii) Sec. 12(a)(2) (A) through (G) and (I) through (P).
    (2) A product or use classified by a State for restricted use under 
Sec. 162.153(g) may be used only by, or

[[Page 271]]

under the direct supervision of, an applicator certified under a plan 
approved by EPA in accordance with sec. 4 of FIFRA.
    (3) State registrations which are not issued in accordance with 
Sec. 162.152 (a) and (b)(2) (i), (ii) and (iii) are not authorized by 
section 24(c) and are not considered valid for any purposes under FIFRA. 
When the Administrator determines that a registration is invalid, the 
Administrator shall notify the registering State that the registration 
is invalid, and may specify the reason for the invalidity.
    (b) Establishment registration requirements. No person may produce 
any pesticide, including any pesticide registered by a State under 
section 24(c), unless the establishment in which it is produced is 
registered by the Administrator in accordance with sec. 7 of FIFRA and 
40 CFR part 167.
    (c) Books and records requirements. All producers of pesticides, 
including those producers of pesticides registered by States under sec. 
24(c), must maintain records in accordance with the requirements imposed 
under sec. 8 of FIFRA and 40 CFR part 169.

Subpart E [Reserved]



PART 164_RULES OF PRACTICE GOVERNING HEARINGS, UNDER THE FEDERAL INSECTICIDE, 

FUNGICIDE, AND RODENTICIDE ACT, ARISING FROM REFUSALS TO REGISTER, 

CANCELLATIONS OF REGISTRATIONS, CHANGES OF CLASSIFICATIONS, SUSPENSIONS OF 

REGISTRATIONS AND OTHER HEARINGS CALLED PURSUANT TO SECTION 6 OF THE ACT--

Table of Contents



                            Subpart A_General

Sec.
164.1 Number of words.
164.2 Definitions.
164.3 Scope and applicability of this part.
164.4 Arrangements for examining Agency records, transcripts, orders, 
          and decisions.
164.5 Filing and service.
164.6 Time.
164.7 Ex parte discussion of proceeding.
164.8 Publication.

 Subpart B_General Rules of Practice Concerning Proceedings (Other Than 
                           Expedited Hearings)

                       Commencement of Proceeding

164.20 Commencement of proceeding.
164.21 Contents of a denial of registration, notice of intent to cancel 
          a registration, or notice of intent to change a 
          classification.
164.22 Contents of document setting forth objections.
164.23 Contents of the statement of issues to accompany notice of intent 
          to hold a hearing.
164.24 Response to the Administrator's notice of intention to hold a 
          hearing.
164.25 Filing copies of notification of intent to cancel registration or 
          change classification or refusal to register, and statement of 
          issues.

              Appearances, Intervention, and Consolidation

164.30 Appearances.
164.31 Intervention.
164.32 Consolidation.

                        Administrative Law Judge

164.40 Qualifications and duties of Administrative Law Judge.

                   Prehearing Procedures and Discovery

164.50 Prehearing conference and primary discovery.
164.51 Other discovery.

                                 Motions

164.60 Motions.

                       Subpoenas and Witness Fees

164.70 Subpoenas.
164.71 Fees of witnesses.

                              The Hearings

164.80 Order of proceeding and burden of proof.
164.81 Evidence.
164.82 Transcripts.

                     Initial or Accelerated Decision

164.90 Initial decision.
164.91 Accelerated decision.

                                 Appeals

164.100 Appeals from or review of interlocutory orders or rulings.
164.101 Appeals from or review of initial decisions.
164.102 Appeals from accelerated decisions.
164.103 Final decision or order on appeal or review.

[[Page 272]]

164.110 Motion for reopening hearings; for rehearing; for reargument of 
          any proceeding; or for reconsideration of order.
164.111 Procedure for disposition of motions.

       Subpart C_General Rules of Practice for Expedited Hearings

164.120 Notification.
164.121 Expedited hearing.
164.122 Final order and order of suspension.
164.123 Emergency order.

Subpart D_Rules of Practice for Applications Under Sections 3 and 18 To 
            Modify Previous Cancellation or Suspension Orders

164.130 General.
164.131 Review by Administrator.
164.132 Procedures governing hearing.
164.133 Emergency waiver of hearing.

    Authority: 7 U.S.C. 136d.

    Source: 38 FR 19371, July 20, 1973, unless otherwise noted.



                            Subpart A_General



Sec. 164.1  Number of words.

    As used in this part, a word in the singular form shall be deemed to 
import the plural, and vice versa, as the case may require.



Sec. 164.2  Definitions.

    For the purposes of this part, the following terms shall be defined, 
as listed below:
    (a) The term Act means the Federal Insecticide, Fungicide, and 
Rodenticide Act, as amended (86 Stat. 973) and other legislation 
supplementary thereto and amendatory thereof.
    (b) The term Administrative Law Judge means an Administrative Law 
Judge appointed pursuant to 5 U.S.C. 3105 (see also 5 CFR part 930, as 
amended), and such term is synonymous with the term ``Hearing Examiner'' 
as used in the Act or in the United States Code.
    (c) The term Administrator means the Administrator of the United 
States Environmental Protection Agency.
    (d) The term Agency, unless otherwise specified, means the United 
States Environmental Protection Agency.
    (e) The term Applicant means any person who has made application to 
have a pesticide registered or classified pursuant to the provisions of 
the Act.
    (f) The term Committee means a group of qualified scientists 
designated by the National Academy of Sciences according to agreement 
under the Act to submit an independent report to the Administrative Law 
Judge on questions of scientific fact referred from a hearing under 
subpart B of this part.
    (g) Environmental Appeals Board shall mean the Board within the 
Agency described in Sec. 1.25 of this title. The Administrator 
delegates authority to the Environmental Appeals Board to issue final 
decisions in appeals filed under subparts B and C of this part. An 
appeal directed to the Administrator, rather than to the Environmental 
Appeals Board, will not be considered. This delegation does not preclude 
the Environmental Appeals Board from referring an appeal or a motion 
under subparts B and C to the Administrator when the Environmental 
Appeals Board, in its discretion, deems it appropriate to do so. When an 
appeal or motion is referred to the Administrator, all of the parties 
shall be so notified and the rules in subparts B and C referring to the 
Environmental Appeals Board shall be interpreted as referring to the 
Administrator.
    (h) The term Expedited Hearing means a hearing commenced as the 
result of the issuance of a notice of intention to suspend or the 
suspension of a registration of a pesticide by an emergency order, and 
is limited to a consideration as to whether a pesticide presents an 
imminent hazard which justifies such suspension.
    (i) The term Hearing means a public hearing which is conducted 
pursuant to the provisions of chapter 5, subchapter II of title 5 of the 
United States Code and the regulations of this part.
    (j) The term Hearing Clerk means the Hearing Clerk, Environmental 
Protection Agency, Washington, DC 20460.
    (k) The term Initial Decision means the decision of the 
Administrative Law Judge supported by findings of fact and conclusions 
regarding all material issues of law, fact, or discretion, as well as 
reasons therefor. Such decision shall become the final decision and 
order of the Administrator without further proceedings unless an appeal

[[Page 273]]

therefrom is taken or the Administrator orders review thereof as herein 
provided.
    (l) The term Judicial Officer means an officer or employee of the 
Agency designated as a judicial officer, pursuant to these rules, who 
shall meet the qualifications and perform functions as herein provided.
    (1) Office. There may be designated for the Agency one or more 
judicial officers, one of whom may be Chief Judicial Officer. As work 
requires, there may be a judicial officer designated to act for the 
purpose of a particular case. All prior designations of judicial officer 
shall stay in force until further notice.
    (2) Qualification. A judicial officer shall be a permanent or 
temporary employee or officer of the Agency who may perform other duties 
for the Agency. Such judicial officer shall not be employed by the 
Office of Chemical Safety and Pollution Prevention or have any 
connection with the preparation or presentation of evidence for a 
hearing.
    (3) Functions. The Administrator may delegate any or part of his 
authority to act in a given case under subparts B and C of this part to 
a judicial officer. The Administrator can separately delegate his 
authority to rule on interlocutory orders and motions, and may also 
delegate his authority to make findings of fact and draw conclusions of 
law in a particular proceeding, providing that this delegation shall not 
preclude the Judicial Officer from referring any motion or case to the 
Administrator when the Judicial Officer determines such referral to be 
appropriate. The Administrator, in deciding a case himself, may consult 
with and assign the preliminary drafting of conclusions of law and 
findings of fact to any judicial officer.
    (m) The term Party means any person, group, organization, or Federal 
agency or department that participates in a hearing.
    (n) The term Person includes any individual, partnership, 
association, corporation, and any organized group of persons, whether 
incorporated or not.
    (o) The term Petitioner means any person adversely affected by a 
notice of the Administrator who requests a public hearing.
    (p) The term Presiding Officer means any person designated by the 
Administrator to conduct an expedited hearing.
    (q) The term Recommended Decision means the recommended findings and 
conclusions of the Presiding Officer in an expedited hearing.
    (r) The term Registrant means any person who has registered a 
pesticide pursuant to the provisions of the Act.
    (s) The term Respondent means the Assistant Administrator of the 
Office of Chemical Safety and Pollution Prevention.

Terms defined in the act and not explicitly defined herein are used 
herein with the meanings given in the act.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5342, Feb. 13, 1992; 57 
FR 30657, July 10, 1992; 73 FR 75597, Dec. 12, 2008; 77 FR 46292, Aug. 
3, 2012]



Sec. 164.3  Scope and applicability of this part.

    The provisions of subpart B of this part shall govern proceedings, 
conducted pursuant to the provisions of the Act, concerning refusals to 
register, cancellations of registration, changes of classifications or 
hearings called by the Administrator; the provisions of subpart C of 
this part shall govern suspension proceedings conducted pursuant to the 
provisions of the Act.



Sec. 164.4  Arrangements for examining Agency records, transcripts, orders, 

and decisions.

    (a) Reporting of orders, decisions, and other signed documents. All 
orders, decisions, or other signed documents required by the rules in 
this part, whether issued by the Environmental Appeals Board or the 
Presiding Officer shall be made available to the public.
    (b) Establishment of an Agency repository. In addition, all 
transcripts and docket entries shall become part of the official docket 
and shall be retained by the hearing clerk. At least two copies of all 
final orders, decisions and a notification of any appeals taken 
therefrom shall be retained by the hearing clerk and filed 
chronologically and shall be periodically bound and indexed. All the 
above documents shall

[[Page 274]]

be made available to the public for reasonable inspections during Agency 
business hours.
    (c) Whenever any information or data is required to be produced or 
examined and any party to the proceeding claims that such information is 
a trade secret or commercial or financial information, other than 
information relating to the formulas of a pesticide, the Administrative 
Law Judge, the Presiding Officer, or the Environmental Appeals Board may 
require production or testimony in camera and sealed to all but the 
parties.
    (d) All orders, decisions, or other documents made or signed by the 
Administrative Law Judge, the Presiding Officer, or the Environmental 
Appeals Board shall be filed with the hearing clerk. The hearing clerk 
shall immediately serve all parties with a copy of such order, decision, 
or other document.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5342, Feb. 13, 1992]



Sec. 164.5  Filing and service.

    (a) All documents or papers required or authorized to be filed, 
shall be filed with the hearing clerk, except as provided otherwise in 
this part. At the same time that a party files documents or papers with 
the clerk, it shall serve upon all other parties copies thereof, with a 
certificate of service on each document or paper, including those filed 
with the hearing clerk. If filing is accomplished by mail addressed to 
the clerk, filing shall be deemed timely if the papers are postmarked on 
the due date except as to initial filings requesting a public hearing or 
responding to a notice of intent to hold a hearing, in which case such 
filings must be received by the hearing clerk either within the time 
required by statute or by the notice of intent to hold a hearing.
    (b) Each document filed, other than papers commencing a proceeding, 
shall contain the FIFRA docket number and, if the document affects less 
than all of the registrations included under that docket number, the 
registration number or file symbol of each product which is the subject 
of the document.
    (c) In addition to copies served on all other parties, each party 
shall file an original and two copies of all papers with the hearing 
clerk.



Sec. 164.6  Time.

    (a) Computation. In computing any period of time prescribed or 
allowed by these rules, except as otherwise provided, the day of the 
act, event, or default from which the designated period of time begins 
to run shall not be included. Saturdays, Sundays, and legal holidays 
shall be included in computing the time allowed for the filing of any 
document or paper, except that when such time expires on a Saturday, 
Sunday, or legal holiday, such period shall be extended to include the 
next following business day.
    (b) Enlargement. When by these rules or by order of the 
Administrative Law Judge, the Presiding Officer, or the Environmental 
Appeals Board, an act is required or allowed to be done at or within a 
specified time, the Administrative Law Judge (before his initial 
decision is filed), or the Presiding Officer (before his recommended 
decision is filed), or the Environmental Appeals Board (after the 
Administrative Law Judge's initial decision or the presiding officer's 
recommended decision is filed), for cause shown may at any time in their 
discretion: with or without motion or notice, order the period enlarged 
if request therefor, which may be made ex parte, is made before the 
expiration of the period originally prescribed or as extended by a 
previous order; or on motion made after the expiration of the specified 
period, permit the act to be done where the failure to act was the 
result of excusable neglect. In this connection, consideration shall be 
given to the fact that, under the provisions of the act, the 
Administrator must issue his order not later than 90 days after the 
completion of the hearing, unless all parties agree by stipulation to 
extend this period of time pursuant to Sec. 164.103.
    (c) Additional time after service by mail. A prescribed period of 
time within which a party is required or permitted to do an act shall be 
computed from the time of service, except that when the service is made 
by mail, 3 days shall be added to the prescribed period. Such addition 
for service by mail shall not apply in the case of filing initial

[[Page 275]]

requests for hearings or responding to a notice of intent to hold a 
hearing, in which cases statutory filing times will run from the date of 
the return receipt pursuant to Sec. 164.8.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5342, Feb. 13, 1992]



Sec. 164.7  Ex parte discussion of proceeding.

    At no stage of a proceeding shall the Administrator, the members of 
the Environmental Appeals Board, the Presiding Officer, or the 
Administrative Law Judge discuss ex parte the merits of the proceeding 
with any party or with any person who has been connected with the 
preparation or presentation of the proceeding as an advocate, or in an 
investigative or expert capacity, or with any representative of such 
person, Provided, That the Environmental Appeals Board, the Presiding 
Officer, or the Administrative Law Judge may discuss the merits of the 
case with any such person if all parties to the proceeding, or their 
representatives, have been given reasonable notice and opportunity to be 
present. Any memorandum or other communication addressed to the 
Administrator, the Environmental Appeals Board, the Presiding Officer, 
or the Administrative Law Judge during the pendency of the proceeding, 
and relating to the merits thereof, by or on behalf of any party, shall 
be regarded as an argument made in the proceeding. The Administrator, 
the Environmental Appeals Board, the Presiding Officer, or the 
Administrative Law Judge shall cause any such communication to be filed 
with the hearing clerk and served upon all other parties to the 
proceeding who will be given the opportunity to file an answer thereto.

[57 FR 5342, Feb. 13, 1992]



Sec. 164.8  Publication.

    All notices of intention to cancel a registration, all notices of 
intention to change a classification, and all denials of registrations, 
all together with the reasons (including the factual basis therefor), 
and all notices of intention by the Administrator to hold a hearing, 
together with the statement of issues as provided by Sec. 164.20(b) 
shall be sent to the registrant or applicant by registered or certified 
mail (return receipt requested), and published by appropriate 
announcement in the Federal Register by the Administrator. The 
Administrative Law Judge shall cause to be published in the Federal 
Register by appropriate announcement, a notice of the filing of any 
objections, pursuant to Sec. 164.20(b) or responses pursuant to Sec. 
164.24, and a notice of the public hearing as provided by Sec. 164.80 
et seq. Said notice of public hearing shall designate the place where 
the hearing will be held and specify the time when the hearing will 
commence. The hearing shall convene at the place and time announced in 
the notice, unless amended by subsequent notice published in the Federal 
Register, but thereafter it may be moved to a different place and may be 
continued from day to day or recessed to a later day without other 
notice than announcement thereof at the hearing.



 Subpart B_General Rules of Practice Concerning Proceedings (Other Than 

                           Expedited Hearings)

                       Commencement of Proceeding



Sec. 164.20  Commencement of proceeding.

    (a) A proceeding shall be commenced whenever a hearing is requested 
by any person adversely affected by a notice of the Administrator of his 
refusal to register or of his intent to cancel the registration or to 
change the classification of a pesticide. A proceeding shall likewise be 
commenced whenever the Administrator decides to call a hearing to 
determine whether or not the registration of a pesticide should be 
canceled or its classification changed. Such request or notice of intent 
to hold a hearing shall be timely filed with the hearing clerk, and the 
matter shall be docketed and assigned a FIFRA docket number.
    (b) If a request for a hearing is filed, the person filing the 
request shall, at the same time, file a document stating his objections 
to the Administrator's refusal to register or his intent to cancel the 
registration or to change the classification of a pesticide. If a notice 
of intent to hold a hearing is filed by

[[Page 276]]

the Administrator, he shall, at the same time, file a statement of 
issues.
    (c) Upon the filing of any objections or notice of intent to hold a 
hearing, the proceeding shall be referred to the Chief Administrative 
Law Judge by the hearing clerk. The Chief Administrative Law Judge shall 
refer the proceeding to himself or another Administrative Law Judge who 
shall thereafter be in charge of all further matters concerning the 
proceedings, except as otherwise provided for by order of the Chief 
Administrative Law Judge, the Administrator, or the Environmental 
Appeals Board.

[38 FR 19371, July 20, 1973, as amended at 38 FR 34117, Dec. 11, 1973; 
57 FR 5342, Feb. 13, 1992]



Sec. 164.21  Contents of a denial of registration, notice of intent to cancel 

a registration, or notice of intent to change a classification.

    (a) Contents. The denial of registration or a notice of intent to 
cancel a registration or to change a classification shall be accompanied 
by the reasons (including the factual basis) for the action.
    (b) Amendments to contents of denials and notices. Such documents 
under this section may be amended or enlarged by the Administrator at 
any time prior to the commencement of the public hearing. If the 
Administrative Law Judge determines that additional time is necessary to 
permit a party to prepare for matters raised by such amendments, the 
commencement of the hearing shall be delayed for an appropriate period.



Sec. 164.22  Contents of document setting forth objections.

    (a) Concise statement required. Any document containing objections 
to an order of the Administrator of his refusal to register, or his 
intent to cancel the registration, or change the classification of a 
pesticide, shall clearly and concisely set forth such objections and the 
basis for each objection, including relevant allegations of fact 
concerning the pesticide under consideration. The document shall 
indicate the registration number of the pesticide, if applicable, a copy 
of the currently accepted and/or proposed labeling and a list of the 
currently registered or proposed uses of said pesticide.
    (b) Amendments to objections byleave. Objections may be amended at 
any time prior to the commencement of the public hearing by leave of the 
Administrative Law Judge or by written consent of all parties. The 
Administrative Law Judge shall freely grant such leave when justice so 
requires. If the Administrative Law Judge determines that additional 
time is necessary to permit a party to prepare for matters raised by 
amendments to objections, the commencement of the hearing shall be 
delayed for an appropriate period. This subsection shall not permit the 
addition, beyond the statutory deadline, of registered pesticides which 
are not included in the objections filed pursuant to paragraph (a) of 
this section.
    (c) Amendments to objections as a matter of right. Objections may be 
amended as a matter of right within 30 days, or in such time as the 
Administrator shall designate, after the Administrator amends his notice 
of intent to cancel a registration, change a classification, or his 
refusal to register a pesticide.



Sec. 164.23  Contents of the statement of issues to accompany notice of intent 

to hold a hearing.

    (a) Concise statement required. The statement of issues by the 
Administrator shall set a time in which any person wishing to 
participate in the hearing shall file a written response to the 
statement of issues as provided by Sec. 164.24. The statement of issues 
shall include questions as to which evidence shall be taken at the 
hearing. Those questions may include questions concerning whether a 
pesticide's registration should be canceled or its classification 
changed, whether its composition is such as to warrant the claims for 
it, whether its labeling and other material submitted comply with the 
requirements of the Act, whether it will perform its intended function 
without unreasonable adverse effects on the environment, and whether, 
when used in accordance with widespread and commonly recognized 
practice, it will or will not generally cause unreasonable adverse 
effects on the environment.

[[Page 277]]

    (b) Amendment to statement of issues. The statement of issues may be 
amended or enlarged by the Administrator at any time prior to the 
commencement of the public hearing. If the Administrative Law Judge 
determines that additional time is necessary to permit a party to 
prepare for matters raised by amendments or enlargements to the 
statement of issues, the commencement of the hearing shall be delayed 
for an appropriate period.



Sec. 164.24  Response to the Administrator's notice of intention to hold a 

hearing.

    Any person wishing to participate in any proceeding commenced 
pursuant to any notice by the Administrator of intention to hold a 
hearing, shall file with the hearing clerk, within the time set by the 
Administrator in the notice (in no case less than 30 days from the date 
of the notice), a written response to the statement of issues which 
shall include the position and interest of such person with respect 
thereto. If any such person is a registrant or an applicant for 
registration, he shall also file the registration number of the 
pesticide, if applicable, a copy of the currently accepted and/or 
proposed labeling and a list of the currently registered or proposed 
uses of said pesticide.



Sec. 164.25  Filing copies of notification of intent to cancel registration or 

change classification or refusal to register, and statement of issues.

    After a copy of the document setting forth the objections and 
requesting a public hearing is filed with the hearing clerk or a 
response to the statement of issues is filed, the hearing clerk shall 
serve a copy of the document upon Respondent and the Office of the 
General Counsel of the Agency, Respondent shall, by counsel, thereupon 
file with the hearing clerk a copy of the appropriate notice of 
intention to cancel, the notice of intention to change the 
classification or the registration refusal order.

              Appearances, Intervention, and Consolidation



Sec. 164.30  Appearances.

    Representatives. Parties may appear in person or by counsel or other 
representative. Persons who appear as counsel or in a representative 
capacity must conform to the standards of ethical conduct required of 
practitioners before the courts of the United States.



Sec. 164.31  Intervention.

    (a) Motion. Any person may file a motion for leave to intervene in a 
hearing conducted under this subpart. A motion must set forth the 
grounds for the proposed intervention, the position and interest of the 
movant in the proceeding and the documents proposed to be filed pursuant 
to either Sec. 164.22 or Sec. 164.24.
    (b) When filed. A motion for leave to intervene in a hearing must 
ordinarily be filed prior to the commencement of the first prehearing 
conference. Any motion filed after that time must contain, in addition 
to the information set forth in paragraph (a) of this section, a 
statement of good cause for the failure to file the motion prior to the 
commencement of the first prehearing conference, and shall be granted 
only upon a finding (1) that extraordinary circumstances justify the 
granting of the motion, or (2) that the intervenor shall be bound by 
agreements, arrangements, and other matters previously made in the 
proceeding.
    (c) Disposition. Leave to intervene will be freely granted but only 
insofar as such leave raises matters which are pertinent to and do not 
unreasonably broaden the issues already presented. If leave is granted, 
the movant shall thereby become a party with the full status of the 
original parties to the proceedings. If leave is denied, the movant may 
request that the ruling be certified to the Environmental Appeals Board, 
pursuant to Sec. 164.100 for a speedy appeal.
    (d) Amicus curiae. Persons not parties to the proceedings wishing to 
file briefs may do so by leave of the Administrative Law Judge granted 
on motion. A motion for leave shall identify the interest of the 
applicant and shall state the reasons why the proposed amicus

[[Page 278]]

brief is desirable. Unless all parties otherwise consent, an amicus 
curiae shall file its brief within the time allowed the party whose 
position the brief will support. Upon a showing of good cause, the 
Administrator or Administrative Law Judge may grant permission for later 
filing.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5342, Feb. 13, 1992]



Sec. 164.32  Consolidation.

    The Chief Administrative Law Judge, by motion or sua sponte, may 
consolidate two or more proceedings whenever it appears that this will 
expedite or simplify consideration of the issues. Consolidation shall 
not affect the right of any party to raise issues that could have been 
raised if consolidation had not occurred. At the conclusion of 
proceedings consolidated under this section, the Administrative Law 
Judge shall issue one decision under Sec. 164.90 unless one or more of 
the consolidated proceedings have been dismissed pursuant to Sec. 
164.91.

                        Administrative Law Judge



Sec. 164.40  Qualifications and duties of Administrative Law Judge.

    (a) Qualifications. The Administrative Law Judge shall have the 
qualifications required by statute. He shall not decide any matter in 
connection with a proceeding where he has a financial interest in any of 
the parties or a relationship with a party that would make it otherwise 
inappropriate for him to act.
    (b) Disqualification of the Administrative Law Judge. (1) Any party 
may, by motion made to the Administrative Law Judge, as soon as 
practicable, request that he disqualify himself and withdraw from the 
proceeding. The Administrative Law Judge shall then rule upon the motion 
and, upon request of the movant, shall certify an adverse ruling for 
appeal.
    (2) Withdrawal sua sponte. The Administrative Law Judge may at any 
time withdraw from any proceedings in which he deems himself 
disqualified for any reason.
    (c) Conduct. The Administrative Law Judge shall conduct the 
proceeding in a fair and impartial manner subject to the precepts of the 
Canons of Judicial Ethics of the American Bar Association.
    (d) Power. Subject to review, as provided elsewhere in this part, 
the Administrative Law Judge shall have power to take actions and 
decisions in conformity with statute or in the interests of justice. The 
Administrative Law Judge shall not interrupt the recording of the 
proceedings on the record over the objection of any party.
    (e) Absence or change of the Administrative Law Judge. In the case 
of the absence or unavailability of the Administrative Law Judge, or his 
inability to act, or his removal by disqualification or withdrawal, the 
powers and duties to be performed by him under this part in connection 
with a hearing assigned to him may, unless otherwise directed by the 
Administrator, be assigned to another Administrative Law Judge so 
designated to act by the Chief Administrative Law Judge, the 
Administrator or the Environmental Appeals Board.

[38 FR 19371, July 20, 1973, as amended at 38 FR 34117, Dec. 11, 1973; 
57 FR 5342, Feb. 13, 1992]

                   Prehearing Procedures and Discovery



Sec. 164.50  Prehearing conference and primary discovery.

    (a) Purpose of the prehearing conference. Except as otherwise 
provided in paragraph (d) of this section, the Administrative Law Judge 
shall, prior to the commencement of the hearing and for the purpose of 
expediting the hearing, file with the hearing clerk an order for a 
prehearing conference. More than one such conference may be held. Such 
order or orders shall direct the parties or their counsel to appear at a 
specified time and place to consider:
    (1) The simplification of issues including listing of specific uses 
to be contested;
    (2) The necessity or desirability of amendments to the objections or 
statement of issues, or any document filed in response thereto;
    (3) The possibility of obtaining stipulations of fact and documents 
which will avoid unnecessary delay;
    (4) Matters of which official notice may be taken;

[[Page 279]]

    (5) The limitation of the number of expert and other witnesses;
    (6) Procedure at the hearing except as so provided in Sec. 
164.80(a);
    (7) The use of verified written statements in lieu of oral direct 
testimony;
    (8) The intent of any party to request a scientific advisory 
committee as defined in Sec. 164.2(f);
    (9) The issuance of subpoenas and subpoenas duces tecum for 
discovery and hearing purposes;
    (10) A setting of a time and place for the public hearing, after 
giving careful consideration to the convenience of all the parties, the 
witnesses, the public interest and the necessity for notice in the 
Federal Register as provided by Sec. 164.8; and
    (11) Any other matter that may expedite the hearing or aid in the 
disposition of the proceeding.
    (b) Primary discovery (Exchange of witness lists and documents). At 
a prehearing conference or within some reasonable time set by the 
Administrative Law Judge prior to the hearing, each party shall make 
available to the other parties the names of the expert and other 
witnesses the party expects to call, together with a brief narrative 
summary of their expected testimony and a list of all documents and 
exhibits which the party expects to introduce into evidence. Thereafter, 
witnesses, documents, or exhibits may be added and narrative summaries 
of expected testimony amended upon motion by a party.
    (c) Record of the prehearing conference. No transcript of any 
prehearing conference shall be made unless a request therefor by one of 
the parties is granted by the Administrative Law Judge. Such party shall 
bear the cost of the taking of the transcript unless otherwise ordered 
by the Administrative Law Judge. The Administrative Law Judge shall 
prepare and file for the record a written report of the action taken at 
each conference, which shall incorporate any stipulations or agreements 
made by the parties at or as a result of such conference, all rulings 
upon matters considered at such conference and appropriate orders.
    (d) Unavailability of a prehearing conference. Upon a finding that 
circumstances render a prehearing conference unnecessary, or 
impracticable, or upon a finding that a prehearing conference would 
serve primarily to delay the proceedings rather than to expedite them, 
the Administrative Law Judge, on motion or sua sponte, may order that 
the prehearing conference not be held. In these circumstances he may 
request the parties to correspond with him for the purpose of 
accomplishing any of the objectives set forth in this section. Such 
correspondence shall not be made a part of the record, but the 
Administrative Law Judge shall submit a written summary for the record 
if any action is taken.
    (e) Submission of questions to an advisory committee--(1) General. 
At any prehearing conference, or if none is held prior to the public 
hearing, except as herein provided, the Administrative Law Judge shall 
determine whether any party desires that questions of scientific fact be 
referred to a committee designated by the National Academy of Sciences.
    (2) Preparation of questions. On determining an affirmative intent, 
the Administrative Law Judge shall direct all parties to file and serve, 
within a time period subject to his discretion, proposed questions of 
scientific fact accompanied by reasons supporting their submission to 
said committee. Within 10 days of the service of such proposed 
questions, together with their supporting reasons, any party may respond 
in writing to the proposed submission of the questions to the said 
committee. The Administrative Law Judge shall determine whether or not a 
reference of questions of scientific fact to said committee is necessary 
or desirable. In the event he decides such reference is necessary or 
desirable, he shall so inform the National Academy in writing, and shall 
prepare in his discretion appropriate questions. If any of the questions 
prepared are not in substance based upon the submissions of the parties, 
the Administrative Law Judge shall permit any party 10 days after their 
preparation to respond in writing to the proposed submission of said 
question or questions. He shall then determine whether such questions 
should be referred to the committee.

[[Page 280]]

    (3) Reference and report. Not less than 30 days after he has 
informed the National Academy that questions of scientific fact will be 
referred to it, the Administrative Law Judge shall refer the questions 
of scientific fact as prepared. The committee shall report in writing to 
the Administrative Law Judge within 60 days after such referral on these 
questions of scientific fact and the report, its record and any other 
matter transmitted as provided for by the Administrator's agreement with 
the National Academy of Sciences shall be made public and considered as 
part of the hearing record.
    (4) Request and submission subsequent to prehearing conference. At 
any time before the hearing is closed, the Administrative Law Judge or a 
party by motion may request that questions of scientific fact not 
previously referred be referred, or that questions previously referred 
be amended or expanded. The Administrative Law Judge may refer such 
questions if he finds that good cause exists and that reference of such 
questions is necessary or desirable.

[38 FR 19371, July 20, 1973, as amended at 39 FR 11884, Apr. 1, 1974]



Sec. 164.51  Other discovery.

    (a) General. Except as so provided by Sec. 164.50(b) supra, further 
discovery, under this subpart, shall be permitted only upon 
determination by the Administrative Law Judge (1) that such discovery 
shall not in any way unreasonably delay the proceeding, (2) that the 
information to be obtained is not otherwise obtainable and (3) that such 
information has significant probative value. The Administrative Law 
Judge shall be guided by the procedures set forth in the Federal Rules 
of Civil Procedure, where practicable, and the precedents thereunder, 
except that no discovery shall be undertaken except upon order of the 
Administrative Law Judge or upon agreement of the parties.
    (b) Depositions upon oral questions. The Administrative Law Judge 
shall order depositions upon oral questions only upon a showing of good 
cause and upon a finding that (1) the information sought cannot be 
obtained by alternative methods, or (2) there is a substantial reason to 
believe that relevant and probative evidence may otherwise not be 
preserved for presentation by a witness at the hearing.
    (c) Procedure. (1) Any party to the proceeding desiring discovery 
shall make a motion or motions therefor. Such a motion shall set forth 
(i) the circumstances warranting the taking of the discovery, (ii) the 
nature of the information expected to be discovered and (iii) the 
proposed time and place where it will be taken.
    (2) If the Administrative Law Judge determines the motion should be 
granted, he shall issue an order and appropriate subpoenas, if 
necessary, for the taking of such discovery together with the conditions 
and terms thereof.

                                 Motions



Sec. 164.60  Motions.

    (a) General. All motions, except those made orally during the course 
of a public hearing or as otherwise provided by this part, shall be in 
writing and shall state with particularity the grounds therefor, shall 
set forth the relief or order sought, and shall be filed with the 
hearing clerk and served on all parties.
    (b) Response to motions. Within 10 days after service of any motion 
filed pursuant to this part, or within such other time as may be fixed 
by the Administrator, his designee, or the Administrative Law Judge, any 
party may serve and file an answer to the motion. The movant shall, if 
requested by the Administrator, his designee, or the Administrative Law 
Judge, serve and file reply papers within the time set by the request.
    (c) Decision. The Administrative Law Judge shall rule upon all 
motions filed or made prior to the filing of his initial or accelerated 
decision at the time of filing on ex parte motions or where the movant 
has stated that no party objects to the granting of such motion. 
Otherwise, such decision shall await the answering papers and reply 
papers if permitted. The Environmental Appeals Board shall rule upon all 
motions filed after the filing of the initial or accelerated decision. 
Oral argument of motions will be permitted only if the

[[Page 281]]

Administrative Law Judge or the Environmental Appeals Board deems it 
necessary.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5343, Feb. 13, 1992]

                       Subpoenas and Witness Fees



Sec. 164.70  Subpoenas.

    (a) The attendance of witnesses or the production of documentary 
evidence may, by subpoena, be required at any designated place of 
hearing or place of discovery. Subpoenas may be issued by the 
Administrative Law Judge sua sponte or upon a showing by an applicant 
that evidence sought for hearing is relevant and material to the issues 
involved in the hearing or that the sought discovery pursuant to Sec. 
164.51 meets the standards set forth therein. The Administrative Law 
Judge shall be guided by the principles of the Federal Rules of Civil 
Procedure in making any order for the protection of a witness or the 
content of the documents produced.
    (b) Motion for subpoena duces tecum. Subpoenas for the production of 
documentary evidence, unless issued by the Administrative Law Judge sua 
sponte, shall be issued only upon a written motion. Such motion shall 
specify, as exactly as possible, the documents desired.
    (c) Service of subpoenas. Subpoenas shall be served as provided by 
the Federal Rules of Civil Procedure.



Sec. 164.71  Fees of witnesses.

    Witnesses summoned before the Administrative Law Judge shall be paid 
the same fees and mileage that are paid witnesses in the courts of the 
United States, and persons whose depositions are taken, and the persons 
taking the same, shall be entitled to the same fees as are paid for like 
services in the courts of the United States. Fees shall be paid by the 
party at whose instance the witness appears or the deposition is taken.

                              The Hearings



Sec. 164.80  Order of proceeding and burden of proof.

    (a) At the hearing, the proponent of cancellation or change in 
classification has the burden of going forward to present an affirmative 
case for the cancellation or change in classification of the 
registration. In the case of the denial of an application for 
registration, the applicant shall have the burden of going forward. In 
the case of a hearing called by the Administrator, the Respondent has 
the burden of going forward to present an affirmative case as to the 
statement of issues. The party having the burden of going forward shall 
have the opportunity to submit evidence on rebuttal.
    (b) On all issues arising in connection with the hearing, the 
ultimate burden of persuasion shall rest with the proponent of the 
registration.
    (c) If any party, other than Respondent, after being duly notified, 
fails to appear at the hearing, he shall be deemed to have authorized 
the Administrative Law Judge to dismiss the proceeding with or without 
prejudice, as the Administrative Law Judge may determine, unless a 
motion excusing the failure to appear has been made and granted. In the 
event that a party appears at the hearing and no representative of the 
Agency appears, the Administrative Law Judge shall proceed ex parte to 
hear the evidence of the party: Provided, That failure on the part of 
Respondent to appear at a hearing shall not be deemed to be a waiver of 
Respondent's right to file proposed findings of fact, conclusions of law 
and orders, to be served with a copy of the Administrative Law Judge's 
initial or accelerated decision, and to file exceptions with and to 
submit argument before the Administrator with respect thereto.



Sec. 164.81  Evidence.

    (a) General. The Administrative Law Judge shall admit all relevant, 
competent and material evidence, except evidence that is unduly 
repetitious. Relevant, competent and material evidence may be received 
at any hearing even though inadmissible under the rules of evidence 
applicable to judicial proceedings. The weight to be given evidence 
shall be determined by its reliability and probative value. In all 
hearings the testimony of witnesses shall be taken orally, except as 
otherwise provided by these rules or by the

[[Page 282]]

Administrative Law Judge. Parties, however, shall have the right to 
cross-examine a witness who appears at the hearing, provided that such 
cross examination is not unduly repetitious.
    (b) Report of a committee of the National Academy of Sciences. If 
questions have been submitted to a committee designated by the National 
Academy pursuant to Sec. 164.50(e), the report of the committee, other 
material that may be required by the Administrator and a list of 
witnesses and evidence relied upon shall be received into evidence and 
made part of the record of the hearing. Objections to the report may 
also be made part of the record and go to the weight of its evidentiary 
value.
    (c) Objections. If a party objects to the admission or rejection of 
any evidence or the limitation of the scope of any examination or cross-
examination, he shall state briefly the grounds for such objection. The 
transcript shall include any argument or debate thereon, unless the 
Administrative Law Judge, with the consent of all parties, orders that 
such argument not be transcribed. The ruling and the reasons given 
therefor by the Administrative Law Judge on any objection shall be a 
part of the transcript. An automatic exception to that ruling will 
follow.
    (d) Exhibits. Except where the Administrative Law Judge finds that 
the furnishing of copies is impracticable, a copy of each exhibit filed 
with the Administrative Law Judge shall be furnished to each other 
party. A true copy of an exhibit may, in the discretion of the 
Administrative Law Judge, be substituted for the original.
    (e) Official Notice. Official notice may be taken of Agency 
proceedings, any matter judicially noticed in the Federal courts, and of 
other facts within the specialized knowledge and experience of the 
Agency. Any active party shall be given adequate opportunity to show 
that such facts are erroneously noticed by presenting evidence to the 
contrary.
    (f) Offer of proof. Whenever evidence is deemed inadmissible, the 
party offering such evidence may make an offer of proof, which shall be 
included in the transcript. The offer of proof for excluded oral 
testimony shall consist of a brief statement describing the nature of 
the evidence excluded. If the evidence consists of a document or 
exhibit, it shall be inserted in the record in total. In the event the 
Environmental Appeals Board decides that the Administrative Law Judge's 
ruling in excluding the evidence was erroneous and prejudicial, the 
hearings may be reopened to permit the taking of such evidence, or where 
appropriate, the Environmental Appeals Board may evaluate the evidence 
and proceed to a final decision.
    (g) Verified statements. With the approval of the Administrative Law 
Judge, a witness may insert into the record, as his testimony, 
statements of fact or opinion prepared by him or written answers to 
interrogatories of counsel, or may submit as an exhibit his prepared 
statement, provided that such statements or answers must not include 
legal argument. Before any such statement or answer is read or admitted 
into evidence the witness shall deliver to the Administrative Law Judge, 
the reporter, and opposing counsel a copy of such. The admissibility of 
the evidence contained in such statement shall be subject to the same 
rules as if such testimony were produced in the usual manner and the 
witness shall be subject to oral cross-examination on the contents of 
such statements. Approval for such a procedure may be denied when it 
appears to the Administrative Law Judge that the memory or the demeanor 
of the witness is of importance.

[38 FR 19371, July 20, 1973, as amended at 40 FR 25815, June 19, 1975; 
57 FR 5343, Feb. 13, 1992]



Sec. 164.82  Transcripts.

    (a) Filing and certification. Hearings shall be stenographically 
reported, transcribed and made available to the public as required by 
statute or Agency regulations. As soon as practicable after the taking 
of the last evidence, the Administrative Law Judge shall certify (1) 
that the original transcript is a true transcript of the testimony 
offered or received at the hearing, except in such particulars as he 
shall specify and (2) that the exhibits accompanying the transcript are 
all the exhibits introduced at the hearing, with such exceptions as he 
shall specify. A copy of

[[Page 283]]

such certificate shall be attached to each of the copies of the 
transcript.
    (b) [Reserved]

                     Initial or Accelerated Decision



Sec. 164.90  Initial decision.

    (a) Proposed findings of fact, conclusions, and order. Within 20 
days after the last evidence is taken in a hearing, each party may file 
with the hearing clerk proposed orders, findings of fact, and 
conclusions of law based solely on the record, and a brief in support 
thereof. Within 10 days thereafter, each party may file a reply brief. 
The Administrative Law Judge may, in his discretion, extend the total 
time period for filing any proposed findings, conclusions, orders or 
briefs for an additional 30 days. In such instances, briefs and replies 
shall be due at such time as the Administrative Law Judge may fix by 
order. The hearing shall be deemed closed at the conclusion of the 
briefing period.
    (b) Initial decision. The Administrative Law Judge, within 25 days 
after the close of the hearing, shall evaluate the record before him, 
and prepare and file his initial decision with the hearing clerk. A copy 
of the initial decision shall be served upon each of the parties, and 
the hearing clerk shall immediately transmit a copy to the Environmental 
Appeals Board. The initial decision shall become the decision of the 
Environmental Appeals Board without further proceedings unless an appeal 
is taken from it or the Environmental Appeals Board orders review of it, 
pursuant to Sec. 164.101.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5343, Feb. 13, 1992]



Sec. 164.91  Accelerated decision.

    (a) General. The Administrative Law Judge, in his discretion, may at 
any time render an accelerated decision in favor of Respondent as to all 
or any portion of the proceeding, including dismissal without further 
hearing or upon such limited additional evidence such as affidavits as 
he may receive, under any of the following conditions:
    (1) Untimely or insufficient objections filed pursuant to Sec. 
164.20;
    (2) Failure to comply with discovery orders;
    (3) Failure to comply with prehearing orders;
    (4) Failure to appear or to proceed at prehearing conferences;
    (5) Failure to appear at the hearing;
    (6) Failure to state a claim upon which relief can be granted, or 
direct or collateral estoppel.
    (7) Theat there is no genuine issue of any material fact and that 
the respondent is entitled to judgment as a matter of law; or
    (8) Such other and further reasons as are just.
    (b) Effect. A decision rendered under this section shall have the 
same force and effect as an initial decision entered under Sec. 164.90.

                                 Appeals



Sec. 164.100  Appeals from or review of interlocutory orders or rulings.

    Except as provided herein, appeals as a matter of right shall lie to 
the Environmental Appeals Board only from an initial or accelerated 
decision of the Administrative Law Judge. Appeals from other orders or 
rulings shall, except as provided in this section, lie only if the 
Administrative Law Judge certifies such orders or rulings for appeal, or 
otherwise as provided. The Administrative Law Judge may certify an order 
or ruling for appeal to the Environmental Appeals Board when: (a) The 
order or ruling involves an important question of law or policy about 
which there is substantial ground for difference of opinion; and (b) 
either (1) an immediate appeal from the order and ruling will materially 
advance the ultimate termination of the proceeding or (2) review after 
the final judgment is issued will be inadequate or ineffective. The 
Administrative Law Judge shall certify orders or rulings for appeal only 
upon the request of a party. If the Environmental Appeals Board 
determines that certification was improvidently granted, or takes no 
action within thirty (30) days of the certification, the appeal shall be 
deemed dismissed. When an order or ruling is not certified by the 
Administrative Law Judge, it shall be reviewed by the Environmental 
Appeals Board only upon appeal from the initial or accelerated decision 
except when the Environmental Appeals

[[Page 284]]

Board determines, upon request of a party and in exceptional 
circumstances, that delaying review would be deleterious to vital public 
or private interests. Except in extraordinary circumstances proceedings 
will not be stayed pending an interlocutory appeal; where a stay is 
granted, a stay of more than 30 days must be approved by the 
Environmental Appeals Board. Ordinarily, the interlocutory appeal will 
be decided on the basis of the submission made to the Administrative Law 
Judge, but the Environmental Appeals Board may allow further briefs and 
oral argument.

[57 FR 5343, Feb. 13, 1992]



Sec. 164.101  Appeals from or review of initial decisions.

    (a) Exceptions and request for oral argument. (1) Within 20 days 
after the filing of the Administrative Law Judge's initial decision, 
each party may take exception to any matter set forth in such decision 
or to any adverse order or ruling to which he objected during the 
hearing and may appeal such exceptions to the Environmental Appeals 
Board for decision by filing them in writing with the hearing clerk, 
including a section containing proposed findings of fact, conclusions, 
orders, or rulings. Within the same period of time each party filing 
exceptions and amicus curiae shall file with the hearing clerk a brief 
concerning each of the exceptions being appealed. The party shall 
include, in its brief, page references to the relevant portions of the 
record and to the Administrative Law Judge's initial decision.
    (2) Within 7 days of the service of exceptions, and of a brief under 
paragraph (a)(1) of this section, any other party or amicus curiae may 
file and serve a brief responding to exceptions or arguments raised by 
any other party. Such brief shall include references to the relevant 
portions of the record. Such brief shall not, however, raise additional 
exceptions.
    (3) Five copies of all material filed under this section shall be 
filed with the hearing clerk.
    (b) Review by Administrator when no exceptions are filed. If no 
exceptions are filed within the time provided, the hearing clerk shall 
notify the Administrator 30 days from the date of filing of the 
Administrative Law Judge's initial decision. Within 10 days after said 
notification, the Environmental Appeals Board shall issue an order 
either declining review of the initial decision or expressing its intent 
to review said initial decision. Such order may include a statement of 
issues to be briefed by the parties and a time schedule concerning 
service and filing of briefs adequate to allow the Environmental Appeals 
Board to issue a final order within 90 days from the close of the 
hearing.
    (c) Argument before the Environmental Appeals Board. (1) A party, if 
he files exceptions and a brief, shall state in writing whether he 
desires to make an oral argument thereon before the Environmental 
Appeals Board; otherwise, he shall be deemed to have waived such oral 
argument. The Environmental Appeals Board shall, however, on its own 
initiative, have the right to set an appeal for oral argument.
    (2) If the Environmental Appeals Board determines that additional 
exceptions should be argued, counsel for the parties shall be given 
reasonable written notice of such determination so as to permit 
preparation of adequate argument on all of the exceptions to be argued.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5343, Feb. 13, 1992]



Sec. 164.102  Appeals from accelerated decisions.

    (a) Within 20 days after filing of an accelerated decision by the 
Administrative Law Judge, any party may file exceptions and a supporting 
brief with the hearing clerk, stating with particularity the grounds 
upon which he asserts that the decision is incorrect. The party shall 
include in its brief page references to the relevant portions of the 
record, if applicable.
    (b) Within 7 days of the service of exceptions and brief under 
paragraph (a) of this section, any other party or amicus curiae may file 
and serve a brief responding thereto, with appropriate page references 
to the relevant portions of the record, if applicable.
    (c) Ordinarily, the appeal from an accelerated decision will be 
decided on the basis of the submission of briefs, but the Environmental 
Appeals Board

[[Page 285]]

may allow additional briefs and oral argument.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5343, Feb. 13, 1992]



Sec. 164.103  Final decision or order on appeal or review.

    Within 90 days after the close of the hearing or within 90 days from 
the filing of an accelerated decision, unless otherwise stipulated by 
the parties, the Environmental Appeals Board shall, on appeal or review 
from an initial or accelerated order of the Administrative Law Judge, 
issue its final decision and order, including its rulings on any 
exceptions filed by the parties; such final order may accept or reject 
all or part of the initial or accelerated decision of the Administrative 
Law Judge even if acceptable to the parties.

[57 FR 5343, Feb. 13, 1992]



Sec. 164.110  Motion for reopening hearings; for rehearing; for reargument of 

any proceeding; or for reconsideration of order.

    (a) Filing; service. A motion for reopening the hearing to take 
further evidence, or for rehearing or reargument of any proceeding or 
for reconsideration of the order, must be made by motion to the 
Environmental Appeals Board filed with the hearing clerk. Every such 
motion must state specifically the grounds relied upon.
    (b) Motion to reopen hearings. A motion to reopen a hearing to take 
further evidence may be filed at any time prior to the issuance of the 
Administrator's final order. Every such motion shall state briefly the 
nature and purpose of the evidence to be adduced, shall show that such 
evidence is not merely cumulative, and shall set forth good reason why 
such evidence was not adduced at a hearing.
    (c) Motions to rehear or reargue proceedings, or to reconsider final 
orders. A motion to rehear or reargue the proceeding or to reconsider 
the final order shall be filed within 10 days after the date of service 
of the final order. Every such motion must state specifically the 
matters claimed to have been erroneously decided, and alleged errors 
must be briefly stated. Motions to rehear or reargue proceedings or to 
reconsider final orders shall be directed to, and heard by, the 
Environmental Appeals Board. Motions under this section directed to the 
Administrator will not be considered, except in cases that the 
Environmental Appeals Board has referred to the Administrator pursuant 
to Sec. 164.2(g) and in which the Administrator has issued the final 
order. A motion for reconsideration shall not stay the effective date of 
the final order unless specifically so ordered by the Environmental 
Appeals Board.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5343, Feb. 13, 1992]



Sec. 164.111  Procedure for disposition of motions.

    Within 7 days following the service of any motion provided for in 
Sec. 164.110, any other party to the proceeding may file with the 
hearing clerk an answer thereto. As soon as practicable thereafter, the 
Environmental Appeals Board shall announce its decision whether to grant 
or to deny the motion. Unless the Environmental Appeals Board shall 
determine otherwise, operation of the order shall not be stayed pending 
the decision to grant or to deny the motion. In the event that any such 
motion is granted by the Environmental Appeals Board, the applicable 
rules of practice, as set out elsewhere herein, shall be followed.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5344, Feb. 13, 1992]



       Subpart C_General Rules of Practice for Expedited Hearings



Sec. 164.120  Notification.

    (a) Whenever the Administrator determines that action is necessary 
to prevent an imminent hazard during the time required for cancellation 
or change in classification proceedings, but that the hazard does not 
constitute an emergency, he shall notify the registrant of his intention 
to suspend registration of the pesticide at issue.
    (b) Such notice shall include findings pertaining to the question of 
imminent hazard and shall either be personally served on the registrant 
or be sent to the registrant by registered or certified mail, return 
receipt requested, and filed with the hearing clerk.

[[Page 286]]



Sec. 164.121  Expedited hearing.

    (a) Request. (1) An expedited hearing shall be held whenever the 
Administrator has received from the registrant a timely request for such 
hearing in response to the Administrator's notice of intention to 
suspend.
    (2) A request for an expedited hearing is timely if made in writing 
or by telegram and filed with the office of the hearing clerk within 5 
days of the registrant's receipt of the notice of intention to suspend.
    (3) At the time of filing a request for an expedited hearing, the 
registrant shall also file a document setting forth objections to the 
Administrator's notice of intention to suspend and its findings 
pertaining to the question of imminent hazard. Such objections shall 
conform to the requirements of Sec. 164.21.
    (b) Presiding officer. (1) An expedited hearing shall be conducted 
by a presiding officer appointed by the Administrator, and such officer 
need not be an Administrative Law Judge.
    (2) The presiding officer shall not have the authority to make an 
initial decision on the merits but shall make a recommended decision 
only.
    (c) The issue. The expedited hearing shall address only the issue of 
whether an imminent hazard exists.
    (d) Time of hearing. The hearing shall commence within 5 days after 
the filing of the request with the office of the hearing clerk unless 
the registrant and respondent agree that it shall commence at a later 
time. As soon as possible, the presiding officer shall publish in the 
Federal Register notice of such hearing.
    (e) Intervention. Any person adversely affected by the 
Administrator's notice may move to intervene within 5 days after the 
receipt by the registrant of said notice or at any time prior to the 
conclusion of the presentation of the evidence, upon good cause found, 
except
    (1) Leave to intervene will be granted only if the motion to 
intervene meets the standards of Sec. 164.31 and, in addition, 
indicates that the movant would raise matters or introduce evidence 
pertinent to the issue of imminent hazard which would substantially 
assist in its resolution.
    (2) A movant denied permission to intervene under this section but 
who otherwise meets the standards of Sec. 164.31 and who is adversely 
affected may file proposed findings and conclusions and briefs in 
support thereof pursuant to paragraph (j) of this section. Any person 
filing under this subsection shall be deemed to have been a party to the 
proceeding, for all purposes of its further review.
    (3) When an ``emergency order'' is issued pursuant to Sec. 164.123, 
no person other than the respondent and the registrant shall participate 
in the hearing except that any person adversely affected may file 
proposed findings and conclusions and briefs in support thereof pursuant 
to paragraph (j) of this section. Any person filing under this 
subsection shall be deemed to have been a party to the proceeding for 
all purposes of its further review.
    (f) Appearances and consolidation. The provisions of Sec. Sec. 
164.30 and 164.32 apply to an expedited hearing insofar as may be 
practicable.
    (g) Order of proceeding and burden of proof. At the hearing, the 
proponent of suspension shall have the burden of going forward to 
present an affirmative case for the suspension. However, the ultimate 
burden of persuasion shall rest with the proponent of the registration.
    (h) Evidence. The provisions of Sec. 164.81, where applicable, 
apply to an expedited hearing.
    (i) Transcripts. The presiding officer shall make provision for 
daily transcripts and otherwise comply with the provisions of Sec. 
164.82.
    (j) Proposed findings or conclusions; recommended decision. (1) 
Within 4 days of the conclusion of the presentation of evidence, the 
parties may propose findings and conclusions to the Presiding Officer. 
Such proposed findings and conclusions shall be accompanied by a brief 
with supporting reasons.
    (2) Within 8 days of the conclusion of the presentation of evidence, 
the Presiding Officer shall submit to the parties his proposed 
recommended findings and conclusions and a statement of the reasons on 
which they are based.

[[Page 287]]

    (3) Within 10 days of the conclusion of the presentation of evidence 
the Presiding Officer shall submit to the Environmental Appeals Board 
his recommended findings and conclusions, together with the record.
    (4) Within 12 days of the conclusion of the presentation of evidence 
the parties shall submit to the Environmental Appeals Board their 
objections to the Presiding Officer's recommended findings and 
conclusions and written briefs in support thereof.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5344, Feb. 13, 1992]



Sec. 164.122  Final order and order of suspension.

    (a) Final order. Within 7 days of receipt of the record and of the 
Presiding Officer's recommended findings and conclusions, the 
Environmental Appeals Board shall issue a final decision and order. Such 
final order may accept or reject in whole or in part the recommendations 
of the Presiding Officer.
    (b) Order of suspension. No final order of suspension shall be 
issued unless the Environmental Appeals Board has issued or at the same 
time issues a notice of its intention to cancel the registration or 
change the classification of the pesticide. Such notice shall be given 
as provided in Sec. 164.8.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5344, Feb. 13, 1992]



Sec. 164.123  Emergency order.

    (a) Whenever the Environmental Appeals Board determines that an 
emergency exists that does not permit him to hold a hearing before 
suspension, the Environmental Appeals Board may issue a suspension order 
in advance of notification to the registrant.
    (b) The Environmental Appeals Board shall immediately notify the 
registrant of the suspension order. The registrant may then request a 
hearing in accordance with Sec. Sec. 164.121 and 164.122, but the 
suspension order shall remain in effect during the hearing pending the 
issuance of a final order on suspension.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5344, Feb. 13, 1992]



Subpart D_Rules of Practice for Applications Under Sections 3 and 18 To 

            Modify Previous Cancellation or Suspension Orders

    Authority: Sec. 25(a) and 6 of the Federal Insecticide, Fungicide, 
and Rodenticide Act, as amended by the Federal Environmental Pesticide 
Control Act of 1972 (86 Stat. 997).

    Source: 40 FR 12265, Mar. 18, 1975, unless otherwise noted.



Sec. 164.130  General.

    EPA has determined that any application under section 3 or section 
18 of the Act to allow use of a pesticide at a site and on a pest for 
which registration has been finally cancelled or suspended by the 
Administrator constitutes a petition for reconsideration of such order. 
Because of the extensive notice and hearing opportunities mandated by 
FIFRA and the Administrative Procedures Act before a final cancellation 
or suspension order may be issued, EPA has determined that such orders 
may not be reversed or modified without affording interested parties--
who may in fact have participated in lengthy cancellation proceedings--
similar notice and hearing opportunities. The procedures set forth in 
this subpart D shall govern all such applications.



Sec. 164.131  Review by Administrator.

    (a) The Administrator will review applications subject to this 
subpart D and supporting data submitted by the applicant to determine 
whether reconsideration of the Administrator's prior cancellation or 
suspension order is warranted. The Administrator shall determine that 
such reconsideration is warranted when he finds that: (1) The applicant 
has presented substantial new evidence which may materially affect the 
prior cancellation or suspension order and which was not available to 
the Administrator at the time he made his final cancellation or 
suspension determination and (2) such evidence could not, through the 
exercise of due diligence, have been discovered by the parties to the 
cancellation or suspension proceeding prior to the issuance of the final 
order.

[[Page 288]]

    (b) If after review of the application and other supporting data 
submitted by the applicant, the Administrator determines, in accordance 
with paragraph (a) of this section, that reconsideration of his prior 
order is not warranted, then the application will be denied without 
requirement for an administrative hearing. The Administrator shall 
publish notice in the Federal Register of the denial briefly describing 
the basis for his determination as soon as practicable. Such denial 
shall constitute final agency action.
    (c) If after review of the application and other supporting data 
submitted by the applicant, the Administrator determines, in accordance 
with paragraph (a) of this section, that reconsideration of his prior 
order is warranted, he will then publish notice in the Federal Register 
setting forth his determination and briefly describing the basis for the 
determination. Such notice shall announce that a formal public hearing 
will be held in accordance with 5 U.S.C. section 554. The notice shall 
specify: (1) The date on which the hearing will begin and end, (2) the 
issues of fact and law to be adjudicated at the hearing, (3) the date on 
which the presiding officer shall submit his recommendations, including 
findings of fact and conclusions, to the Administrator, and (4) the date 
on which a decision by the Administrator is anticipated.



Sec. 164.132  Procedures governing hearing.

    (a) The burden of proof in the hearing convened pursuant to Sec. 
164.131 shall be on the applicant and he shall proceed first. The issues 
in the hearing shall be whether: (1) Substantial new evidence exists and 
(2) such substantial new evidence requires reversal or modification of 
the existing cancellation or suspension order. The determination of 
these issues shall be made taking into account the human and 
environmental risks found by the Administrator in his cancellation or 
suspension determination and the cumulative effect of all past and 
present uses, including the requested use, and uses which may reasonably 
be anticipated to occur in the future as a result of granting the 
requested reversal or modification. The granting of a particular 
petition for use may not in itself pose a significant risk to man or the 
environment, but the cumulative impact of each additional use of the 
cancelled or suspended pesticide may re-establish, or serve to maintain, 
the significant risks previously found by the Administrator.
    (b) The presiding officer shall make recommendations, including 
findings of fact and conclusions and to the extent feasible, as 
determined by the presiding officer, the procedures at the hearing shall 
follow the Rules of Practice, set forth in subparts A and B of this part 
164.



Sec. 164.133  Emergency waiver of hearing.

    (a) In the case of an application subject to this subpart D which is 
filed under section 18 of FIFRA, and regulations thereunder, and for 
which a hearing is required pursuant to Sec. 164.131, the Administrator 
may dispense with the requirement of convening such a hearing in any 
case in which he determines:
    (1) That the application presents a situation involving need to use 
the pesticide to prevent an unacceptable risk: (i) To human health, or 
(ii) to fish or wildlife populations when such use would not pose a 
human health hazard; and
    (2) That there is no other feasible solution to such risk; and
    (3) That the time available to avert the risk to human health or 
fish and wildlife is insufficient to permit convening a hearing as 
required by Sec. 164.131; and
    (4) That the public interest requires the granting of the requested 
use as soon as possible.
    (b) Notice of any determination made by the Administrator pursuant 
to paragraph (a) of this section shall be published in the Federal 
Register as soon as practicable after granting the requested use and 
shall set forth the basis for the Administrator's determination.

[[Page 289]]



PART 165_PESTICIDE MANAGEMENT AND DISPOSAL--Table of Contents



                            Subpart A_General

Sec.
165.1 Scope.
165.3 Definitions.
165.4-165.19 [Reserved]

   Subpart B_Nonrefillable Container Standards: Container Design and 
                             Residue Removal

165.20 General provisions.
165.23 Scope of pesticide products included.
165.25 Nonrefillable container standards.
165.27 Reporting and recordkeeping.
165.28-165.39 [Reserved]

       Subpart C_Refillable Container Standards: Container Design

165.40 General provisions.
165.43 Scope of pesticide products included.
165.45 Refillable container standards.
165.47 What information must I report about my refillable containers?
165.48-165.59 [Reserved]

 Subpart D_Standards for Repackaging Pesticide Products into Refillable 
                               Containers

165.60 General provisions.
165.63 Scope of pesticide products included.
165.65 Registrants who distribute or sell pesticide products in 
          refillable containers.
165.67 Registrants who distribute or sell pesticide products to 
          refillers for repackaging.
165.70 Refillers who are not registrants.
165.71-165.79 [Reserved]

        Subpart E_Standards for Pesticide Containment Structures

165.80 General provisions.
165.81 Scope of stationary pesticide containers included.
165.82 Scope of pesticide dispensing areas included.
165.83 Definition of new and existing structures.
165.85 Design and capacity requirements for new structures.
165.87 Design and capacity requirements for existing structures.
165.90 Operational, inspection and maintenance requirements for all new 
          and existing containment structures.
165.92 What if I need both a containment pad and a secondary containment 
          unit?
165.95 What recordkeeping do I have to do as a facility owner or 
          operator?
165.97 States with existing containment programs.

    Authority: 7 U.S.C. 136 through 136y.

    Source: 71 FR 47422, Aug. 16, 2006, unless otherwise noted.



                            Subpart A_General



Sec. 165.1  Scope.

    The part 165 regulations establish standards and requirements for 
pesticide containers, repackaging pesticides, and pesticide containment 
structures.



Sec. 165.3  Definitions.

    Terms used in this part have the same meaning as in the Act and part 
152 of this chapter. In addition, as used in this part, the following 
terms shall have the meanings set forth below.
    Act means the Federal Insecticide, Fungicide, and Rodenticide Act.
    Agricultural pesticide means any pesticide product labeled for use 
in or on a farm, forest, nursery, or greenhouse.
    Appurtenance means any equipment or device which is used for the 
purpose of transferring a pesticide from a stationary pesticide 
container or to any refillable container, including but not limited to, 
hoses, fittings, plumbing, valves, gauges, pumps and metering devices.
    Capacity means, as applied to containers, the rated capacity of the 
container.
    Container means any package, can, bottle, bag, barrel, drum, tank, 
or other containing-device (excluding any application tanks) used to 
enclose a pesticide. Containers that are used to sell or distribute a 
pesticide product and that also function in applying the product (such 
as spray bottles, aerosol cans and containers that become part of a 
direct injection system) are considered to be containers for the 
purposes of this part.
    Containment pad means any structure that is designed and constructed 
to intercept and contain pesticides, rinsates, and equipment wash water 
at a pesticide dispensing area.
    Containment structure means either a secondary containment unit or a 
containment pad.

[[Page 290]]

    Custom blending means the service of mixing pesticides to a 
customer's specifications, usually a pesticide(s)-fertilizer(s), 
pesticide-pesticide, or a pesticide-animal feed mixture, when:
    (1) The blend is prepared to the order of the customer and is not 
held in inventory by the blender;
    (2) The blend is to be used on the customer's property (including 
leased or rented property);
    (3) The pesticide(s) used in the blend bears end-use labeling 
directions which do not prohibit use of the product in such a blend;
    (4) The blend is prepared from registered pesticides; and
    (5) The blend is delivered to the end-user along with a copy of the 
end-use labeling of each pesticide used in the blend and a statement 
specifying the composition of the mixture.
    Dilutable means that the pesticide product's labeling allows or 
requires the pesticide product to be mixed with a liquid diluent prior 
to application or use.
    Dry pesticide means any pesticide that is in solid form and that has 
not been combined with liquids; this includes formulations such as 
dusts, wettable powders, dry flowables, water-soluble powders, granules, 
and dry baits.
    Establishment means any site where a pesticidal product, active 
ingredient, or device is produced, regardless of whether such site is 
independently owned or operated, and regardless of whether such site is 
domestic and producing a pesticidal product for export only, or whether 
the site is foreign and producing any pesticidal product for import into 
the United States.
    Facility means all buildings, equipment, structures, and other 
stationary items which are located on a single site or on contiguous or 
adjacent sites and which are owned or operated by the same person (or by 
any person who controls, who is controlled by, or who is under common 
control with such person).
    Nonrefillable container means a container that is not a refillable 
container and that is designed and constructed for one-time use and is 
not intended to be filled again with a pesticide for sale or 
distribution. Reconditioned containers are considered to be 
nonrefillable containers.
    One-way valve means a valve that is designed and constructed to 
allow virtually unrestricted flow in one direction and no flow in the 
opposite direction, thus allowing the withdrawal of material from, but 
not the introduction of material into, a container.
    Operator means any person in control of, or having responsibility 
for, the daily operation of a facility at which a containment structure 
is located.
    Owner means any person who owns a facility at which a containment 
structure is required.
    Pesticide compatible as applied to containers means that the 
container construction materials will not chemically react with the 
formulation. A container is not compatible with the formulation if, for 
example, the formulation:
    (1) Is corrosive to the container;
    (2) Causes softening, premature aging, or embrittlement of the 
container;
    (3) Otherwise causes the container to weaken or to create the risk 
of discharge;
    (4) Reacts in a significant chemical, electrolytic, or galvanic 
manner with the container, or
    (5) Interacts in a way, such as the active ingredient permeating the 
container wall, that would cause the formulation to differ from its 
composition as described in the statement required in connection with 
its registration under FIFRA section 3.
    Pesticide compatible as applied to containment means that the 
containment construction materials are able to withstand anticipated 
exposure to stored or transferred substances without losing the 
capability to provide the required containment of the same or other 
substances within the containment area.
    Pesticide dispensing area means an area in which pesticide is 
transferred out of or into a container.
    Portable pesticide container means a refillable container that is 
not a stationary pesticide container.
    Produce means to manufacture, prepare, propagate, compound, or 
process any pesticide, including any pesticide produced pursuant to 
section 5 of the

[[Page 291]]

Act, and any active ingredient or device, or to package, repackage, 
label, relabel, or otherwise change the container of any pesticide or 
device.
    Producer means any person, as defined by the Act, who produces any 
pesticide, active ingredient, or device (including packaging, 
repackaging, labeling and relabeling).
    Refillable container means a container that is intended to be filled 
with pesticide more than once for sale or distribution.
    Refiller means a person who engages in the activity of repackaging 
pesticide product into refillable containers. This could include a 
registrant or a person operating under contract to a registrant.
    Refilling establishment means an establishment where the activity of 
repackaging pesticide product into refillable containers occurs.
    Repackage means, for the purposes of this part, to transfer a 
pesticide formulation from one container to another without a change in 
the composition of the formulation, the labeling content, or the 
product's EPA registration number, for sale or distribution.
    Rinsate means the liquid resulting from the rinsing of the interior 
of any equipment or container that has come in direct contact with any 
pesticide.
    Runoff means surface water leaving the target site.
    Secondary containment unit means any structure, including rigid 
diking, that is designed and constructed to intercept and contain 
pesticide spills and leaks and to prevent runoff and leaching from 
stationary pesticide containers.
    Stationary pesticide container means a refillable container that is 
fixed at a single facility or establishment or, if not fixed, remains at 
the facility or establishment for at least 30 consecutive days, and that 
holds pesticide during the entire time.
    Suspension concentrate means a stable suspension of solid 
particulate active ingredients in a liquid intended for dilution with 
water before use.
    Tamper-evident device means a device which can be visually inspected 
to determine if a container has been opened.
    Transport vehicle means a cargo-carrying vehicle such as an 
automobile, van, tractor, truck, semitrailer, tank car or rail car used 
for the transportation of cargo by any mode.
    Washwater means the liquid resulting from the rinsing of the 
exterior of any equipment or containers that have or may have come in 
direct contact with any pesticide or system maintenance compound, such 
as oil or antifreeze.

[71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64224, Oct. 29, 2008]



Sec. Sec. 165.4-165.19  [Reserved]



   Subpart B_Nonrefillable Container Standards: Container Design and 

                             Residue Removal



Sec. 165.20  General provisions.

    (a) What is the purpose of the regulations in this subpart? The 
regulations in this subpart establish design and construction 
requirements for nonrefillable containers used for the distribution or 
sale of some pesticide products.
    (b) Do I have to comply with the regulations in this subpart? You 
must comply with the regulations in this subpart if you are a registrant 
who distributes or sells a pesticide product in nonrefillable 
containers. If your pesticide product is subject to the regulations in 
this subpart as set out in Sec. 165.23, your pesticide product must be 
distributed or sold in a nonrefillable container that meets the 
standards of these regulations.
    (c) When do I have to comply? Any pesticide product packaged in a 
nonrefillable container and released for shipment by you after August 
16, 2009 must be packaged in a nonrefillable container that complies 
with the regulations of this subpart.

[71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64225, Oct. 29, 2008]



Sec. 165.23  Scope of pesticide products included.

    (a) Are manufacturing use products subject to the regulations in 
this subpart? No, the regulations in this subpart do not apply to 
manufacturing use products, as defined in Sec. 158.153(h) of this 
chapter.
    (b) Are plant-incorporated protectants subject to the regulations in 
this subpart? No, the regulations in this subpart do

[[Page 292]]

not apply to plant-incorporated protectants, as defined in Sec. 174.3 
of this chapter.
    (c) Which antimicrobial pesticide products are not subject to the 
regulations in this subpart? The regulations in this subpart do not 
apply to a pesticide product if it satisfies all of the following 
conditions:
    (1) The pesticide product meets one of the following two criteria:
    (i) The pesticide product is an antimicrobial pesticide as defined 
in FIFRA section 2(mm); or
    (ii) The pesticide product: (A) Is intended to: disinfect, sanitize, 
reduce or mitigate growth or development of microbiological organisms; 
or protect inanimate objects, industrial processes or systems, surfaces, 
water, or other chemical substances from contamination, fouling, or 
deterioration caused by bacteria, viruses, fungi, protozoa, algae, or 
slime; and
    (B) In the intended use is subject to a tolerance under section 408 
of the Federal Food, Drug, and Cosmetic Act or a food additive 
regulation under section 409 of such Act.
    (2) The labeling of the pesticide product includes directions for 
use on a site in at least one of the following antimicrobial product use 
categories: food handling/storage establishments premises and equipment; 
commercial, institutional, and industrial premises and equipment; 
residential and public access premises; medical premises and equipment; 
human drinking water systems; materials preservatives; industrial 
processes and water systems; antifouling coatings; wood preservatives; 
or swimming pools.
    (3) The pesticide product is not a hazardous waste as set out in 
part 261 of this chapter when the pesticide product is intended to be 
disposed.
    (4) EPA has not specifically determined that the pesticide product 
must be subject to the regulations in this subpart to prevent an 
unreasonable adverse effect on the environment according to the 
provisions of paragraph (d) of this section.
    (d) How will EPA determine if an antimicrobial pesticide product 
otherwise exempted must be subject to the regulations in this subpart to 
prevent an unreasonable adverse effect on the environment? (1) EPA may 
determine that an antimicrobial pesticide product otherwise exempted by 
paragraph (c) of this section must be subject to the nonrefillable 
container regulations in this subpart to prevent an unreasonable adverse 
effect on the environment if all of the following conditions exist:
    (i) EPA obtains information, data or other evidence of a problem 
with the containers of a certain pesticide product or related group of 
products.
    (ii) The information, data or other evidence is reliable and 
factual.
    (iii) The problem causes or could reasonably be expected to cause an 
unreasonable adverse effect on the environment.
    (iv) Complying with the container regulations could reasonably be 
expected to eliminate the problem.
    (2) If EPA determines that an antimicrobial pesticide product 
otherwise exempted by paragraph (c) of this section must be subject to 
the nonrefillable container regulations in this subpart to prevent an 
unreasonable adverse effect on the environment, EPA may require, by 
rule, that the product be distributed or sold in nonrefillable 
containers that comply with all or some of the requirements in this 
subpart. Alternatively, EPA may notify the applicant or registrant of 
its intent to make such a determination. After allowing the applicant or 
registrant a reasonable amount of time to reply, EPA may require, by 
notification and as a condition of registration, that the product be 
distributed or sold in nonrefillable containers that comply with all or 
some of the requirements in this subpart. For the purpose of the 
previous sentence, 60 days would be a reasonable amount of time to 
reply, although EPA may, in its discretion, provide more time. EPA may 
deny registration or initiate cancellation proceedings if the registrant 
fails to comply with the nonrefillable container regulations within the 
time frames established by EPA in the rule or in its notification.
    (e) What other pesticide products are subject to the regulations in 
this subpart? (1) Except for manufacturing use products, plant-
incorporated protectants,

[[Page 293]]

and antimicrobial products that are exempt under paragraph (c) of this 
section, all of the regulations in this subpart apply to a pesticide 
product if it satisfies at least one of the following criteria:
    (i) The pesticide product meets the criteria of Toxicity Category I 
as set out in Sec. 156.62 of this chapter.
    (ii) The pesticide product meets the criteria of Toxicity Category 
II as set out in Sec. 156.62 of this chapter.
    (iii) The pesticide product is classified for restricted use as set 
out in Sec. Sec. 152.160 - 152.175 of this chapter.
    (2) Except for manufacturing use products, plant-incorporated 
protectants, antimicrobial products that are exempt under (c) of this 
section, and other pesticide products that are regulated under paragraph 
(e)(1) of this section, a pesticide product must be packaged in 
compliance with 49 CFR 173.24. If the pesticide product meets the 
definition of a hazardous material in 49 CFR 171.8, the Department of 
Transportation requires it to be packaged according to 49 CFR parts 171-
180.
    (f) What does ``pesticide product'' or ``pesticide'' mean in the 
rest of this subpart? In Sec. Sec. 165.25 through 165.27, the term 
``pesticide product'' or ``pesticide'' refers only to a pesticide 
product or a pesticide that is subject to the regulations in this 
subpart as described in paragraphs (a) through (e) of this section.

[71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64225, Oct. 29, 2008]



Sec. 165.25  Nonrefillable container standards.

    (a) What Department of Transportation (DOT) standards do my 
nonrefillable containers have to meet under this part if my pesticide 
product is not a DOT hazardous material? A pesticide product that does 
not meet the definition of a hazardous material in 49 CFR 171.8 must be 
packaged in a nonrefillable container that, if portable, is designed, 
constructed, and marked to comply with the requirements of 49 CFR 173.4, 
173.5, 173.6, 173.24, 173.24a, 173.24b, 173.28, 173.155, 173.203, 
173.213, 173.240(c), 173.240(d), 173.241(c), 173.241(d), part 178, and 
part 180 that are applicable to a Packing Group III material, or, if 
subject to a special permit, according to the applicable requirements of 
49 CFR part 107 subpart B. The requirements in this paragraph apply to 
the pesticide product as it is packaged for transportation in commerce.
    (b) What DOT standards do my nonrefillable containers have to meet 
under this part if my pesticide product is a DOT hazardous material? (1) 
If your pesticide product meets the definition of a hazardous material 
in 49 CFR 171.8, the DOT requires your pesticide product to be packaged 
according to 49 CFR parts 171-180 or, if subject to a special permit, 
according to the applicable requirements of 49 CFR part 107 subpart B.
    (2) For the purposes of these regulations, a pesticide product that 
meets the definition of a hazardous material in 49 CFR 171.8 must be 
packaged in a nonrefillable container that, if portable, is designed, 
constructed, and marked to comply with the requirements of 49 CFR parts 
171-180 or, if subject to a special permit, according to the applicable 
requirements of 49 CFR part 107 subpart B. The requirements in this 
paragraph apply to the pesticide product as it is packaged for 
transportation in commerce.
    (c) What will EPA do if DOT proposes to change any of the cross-
referenced regulations? If the DOT proposes to change any of the 
regulations that are incorporated in paragraphs (a) and (b) of this 
section, EPA will provide notice of the proposed changes and an 
opportunity to comment in the Federal Register. Following notice and 
comment, EPA will take final action regarding whether or not to revise 
its rules, and the extent to which any such revision will correspond 
with revised DOT regulations.
    (d) What standards for closures do my nonrefillable containers have 
to meet? If your nonrefillable container is a rigid container with a 
capacity equal to or greater than 3.0 liters (0.79 gallons), if the 
container is not an aerosol container or a pressurized container, and if 
the container is used to distribute or sell a liquid agricultural 
pesticide, each nonrefillable container must have at least one of the 
following standard closures:
    (1) Bung, 2 inch pipe size (2.375 inches in diameter), external 
threading, 11.5

[[Page 294]]

threads per inch, National Pipe Straight (NPS) standard.
    (2) Bung, 2 inch pipe size (2.375 inches in diameter), external 
threading, 5 threads per inch, buttress threads.
    (3) Screw cap, 63 millimeters, at least one thread revolution at 6 
threads per inch.
    (4) Screw cap, 38 millimeters, at least one thread revolution at 6 
threads per inch. The cap may fit on a separate rigid spout or on a 
flexible pull-out plastic spout.
    (e) What standards for dispensing do my nonrefillable containers 
have to meet? If your nonrefillable container has a capacity of 5 
gallons (18.9 liters) or less, if the container is not an aerosol 
container, a pressurized container, or a spray bottle, and if the 
container holds a liquid pesticide, your nonrefillable container must do 
both of the following:
    (1) Allow the contents of the nonrefillable container to pour in a 
continuous, coherent stream.
    (2) Allow the contents of the nonrefillable container to be poured 
with a minimum amount of dripping down the outside of the container.
    (f) What standards for residue removal do my nonrefillable 
containers have to meet? Each nonrefillable container and pesticide 
formulation combination must meet the applicable residue removal 
standard of this section.
    (1) If the nonrefillable container is rigid and has a capacity less 
than or equal to 5 gallons (18.9 liters) for liquid formulations or 50 
pounds (22.7 kilograms) for solid formulations and if the pesticide 
product's labeling allows or requires the pesticide product to be mixed 
with a liquid diluent prior to application (that is, if the pesticide is 
dilutable), each container/formulation combination must be capable of 
attaining at least 99.99 percent removal of each active ingredient when 
tested using the EPA test procedure ``Rinsing Procedures for Dilutable 
Pesticide Products in Rigid Containers.''
    (2) The test must be conducted only if the pesticide product is a 
suspension concentrate or if EPA specifically requests the records on a 
case by case basis.
    (3) For the rigid container/dilutable product standard in paragraph 
(f)(1) of this section, percent removal represents the percent of the 
original concentration of the active ingredient in the pesticide product 
when compared to the concentration of that active ingredient in the 
fourth rinse. Percent removal is calculated by the formula:

percent removal = [1.0 - RR] x 100.0, where

    RR = rinsate ratio = Active ingredient concentration in fourth 
rinsate/Original concentration of active ingredient in the product

    (g) Can I obtain a waiver from or a modification to any of the 
nonrefillable container standards? Yes, it is possible for you to obtain 
a waiver from or a modification to the nonrefillable container 
standards, as follows:
    (1) EPA may waive or modify the requirements of paragraph (a) of 
this section regarding the DOT standards for pesticide products that are 
not DOT hazardous materials if EPA determines that an alternative 
(partial or modified) set of standards or pre-existing requirements 
achieves a level of safety that is at least equal to that specified in 
the requirements of paragraph (a) of this section.
    (2) EPA may waive or modify the requirements of paragraph (b) of 
this section regarding the DOT standards for pesticide products that are 
DOT hazardous materials if EPA determines that an alternative (partial 
or modified) set of standards or pre-existing requirements achieves a 
level of safety that is at least equal to that specified in the 
requirements of paragraph (b) of this section. EPA will modify or waive 
the requirements of paragraph (b) of this section only after consulting 
with DOT to ensure consistency with DOT regulations and exemptions.
    (3) EPA may approve a non-standard closure (that is, a closure not 
listed in paragraph (d) of this section) if EPA determines that both of 
the following conditions are satisfied:
    (i) The non-standard closure is necessary for the proper mixing, 
loading, or application of the pesticide product.
    (ii) The non-standard closure offers exposure protection to handlers 
during mixing and loading that is the same or greater than that provided 
by the standard closures.

[[Page 295]]

    (4) EPA may waive or modify the container dispensing capability 
standards in paragraph (e) of this section if EPA determines that at 
least one of the following conditions is satisfied:
    (i) The product is typically removed from the container by a method 
other than pouring.
    (ii) Compliance with the container dispensing capability standards 
would increase exposure to the pesticide container handler.
    (5) EPA may waive or modify the requirements of paragraph (f) of 
this section regarding the residue removal standard if EPA determines 
that both of the following conditions are satisfied:
    (i) The residue remaining in the container would not cause an 
unreasonable adverse effect on the environment; and
    (ii) The product offers significant benefits and cannot be 
economically reformulated or repackaged.
    (h) How do I obtain a waiver from or a modification to any of the 
nonrefillable container standards? To obtain a waiver from or a 
modification to any of the nonrefillable container standards, you must 
submit a written request for a waiver or a modification to the EPA to 
the following address: Office of Pesticide Programs (7504P); U.S. 
Environmental Protection Agency; Ariel Rios Building; 1200 Pennsylvania 
Avenue, N.W., Washington, DC 20460. You cannot distribute or sell the 
pesticide product in a nonrefillable container that does not comply with 
all of the nonrefillable container standards unless and until EPA 
approves the request for the waiver or modification in writing. You must 
include two copies of the following information (which may be part of an 
application for registration or amended registration) with your written 
request:
    (1) The name and address of the registrant; the date; and the name, 
title, signature, and phone number of the company official making the 
request.
    (2) The name and EPA registration number of the pesticide product 
for which the waiver or modification is requested.
    (3) A statement specifying the requirement or requirements from 
which you are requesting a waiver or a modification.
    (4) A description of the nonrefillable container or containers for 
which the waiver or modification is requested.
    (5) Documentation or justification to demonstrate that the 
applicable waiver or modification criteria in paragraph (g) of this 
section are satisfied.

[71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64225, Oct. 29, 2008]



Sec. 165.27  Reporting and recordkeeping.

    (a) What information must I report about my nonrefillable 
containers? You are not required to report to EPA with information about 
your nonrefillable containers under the regulations in this subpart. You 
should refer to the reporting standards in part 159 of this chapter to 
determine if information on container failures or other incidents 
involving pesticide containers must be reported to EPA under FIFRA 
section 6(a)(2) (7 U.S.C. 136d(a)(2)).
    (b) What recordkeeping do I have to do for my nonrefillable 
containers? For each pesticide product that is subject to Sec. Sec. 
165.25 through 165.27 and is distributed or sold in nonrefillable 
containers, you must maintain the records listed in this section for as 
long as a nonrefillable container is used to distribute or sell the 
pesticide product and for 3 years after that. You must furnish these 
records for inspection and copying upon request by an employee of EPA or 
any entity designated by EPA, such as a State, another political 
subdivision or a Tribe. You must keep the following records:
    (1) The name and EPA registration number of the pesticide product.
    (2) A description of the nonrefillable container(s) in which the 
pesticide product is distributed or sold.
    (3) At least one of the following records to document compliance 
with the requirement for closures in Sec. 165.25(d) for each 
nonrefillable container used to distribute or sell the pesticide product 
that must comply with Sec. 165.25(d):
    (i) A letter or document from the container supplier that describes 
the closure.
    (ii) A specification about the closure in the contract between the 
registrant or applicant and the container supplier.

[[Page 296]]

    (iii) A copy of EPA's approval of any non-standard closure.
    (4) At least one of the following records pertaining to the 
container dispensing capability requirements in Sec. 165.25(e) for each 
nonrefillable container used to distribute or sell the pesticide product 
that must comply with Sec. 165.25(e):
    (i) Test data or documentation demonstrating that the nonrefillable 
container meets the standards in Sec. 165.25(e) when it contains the 
pesticide product.
    (ii) Test data or documentation demonstrating that a different 
nonrefillable container meets the standards in Sec. 165.25(e) when it 
contains the pesticide product or even a different pesticide product and 
a written explanation of why such data or documentation demonstrates 
that the container meets the standards in Sec. 165.25(e) for the 
pesticide product.
    (iii) A copy of EPA's approval of a request for a waiver from the 
container dispensing requirement.
    (5) At least one of the following records pertaining to the 
nonrefillable container residue removal requirement in Sec. 165.25(f) 
if the pesticide product is a suspension concentrate or if EPA 
specifically requests the records on a case-by-case basis:
    (i) Test data showing that the nonrefillable container and pesticide 
formulation meet the standard in Sec. 165.25(f) .
    (ii) Test data showing that a different nonrefillable container with 
the same or a different pesticide formulation meets the standard in 
Sec. 165.25(f), together with a written explanation of why such data 
demonstrate that the nonrefillable container and pesticide formulation 
meet the standard in Sec. 165.25(f).
    (iii) A copy of EPA's approval of a request for a waiver from the 
residue removal standard requirement.

[71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64225, Oct. 29, 2008]



Sec. Sec. 165.28-165.39  [Reserved]



       Subpart C_Refillable Container Standards: Container Design



Sec. 165.40  General provisions.

    (a) What is the purpose of the regulations in this subpart? The 
regulations in this subpart establish design and construction 
requirements for refillable containers used for the distribution or sale 
of some pesticide products.
    (b) Do I have to comply with the regulations in this subpart? (1) 
You must comply with all of the regulations in this subpart if you are a 
registrant who distributes or sells a pesticide product in refillable 
containers. If your pesticide product is subject to the regulations in 
this subpart as set out in Sec. 165.43, your pesticide product must be 
distributed or sold in a refillable container that meets the standards 
of these regulations. This includes your pesticide products that are 
repackaged according to subpart D of this part.
    (2) You must comply with the regulations in Sec. 165.45(f) for 
stationary pesticide containers if you are a refiller of a pesticide 
product and you are not the registrant of the pesticide product. If the 
pesticide product is subject to the regulations in this subpart as set 
out in Sec. 165.43, the stationary pesticide containers used to 
distribute or sell the product must meet the standards of Sec. 
165.45(f).
    (3) If you are a refiller of a pesticide product and you are not a 
registrant of the pesticide product, Sec. 165.45(a)(2) provides an 
exemption from some of the requirements in Sec. 165.45(a)(1) .
    (c) When do I have to comply? Any pesticide product packaged in a 
refillable container and released for shipment by you after August 16, 
2011 must be packaged in a refillable container that complies with the 
regulations of this subpart.

[71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64226, Oct. 29, 2008]



Sec. 165.43  Scope of pesticide products included.

    (a) Are manufacturing use products subject to the regulations in 
this subpart? No, the regulations in this subpart do

[[Page 297]]

not apply to manufacturing use products, as defined in Sec. 158.153(h) 
of this chapter.
    (b) Are plant-incorporated protectants subject to the regulations in 
this subpart? No, the regulations in this subpart do not apply to plant-
incorporated protectants, as defined in Sec. 174.3 of this chapter.
    (c) Which antimicrobial pesticide products are not subject to the 
regulations in this subpart? The regulations in this subpart do not 
apply to a pesticide product if it satisfies all of the following 
conditions:
    (1) The pesticide product meets one of the following two criteria:
    (i) The pesticide product is an antimicrobial pesticide as defined 
in FIFRA section 2(mm); or
    (ii) The pesticide product: (A) Is intended to: disinfect, sanitize, 
reduce or mitigate growth or development of microbiological organisms; 
or protect inanimate objects, industrial processes or systems, surfaces, 
water, or other chemical substances from contamination, fouling, or 
deterioration caused by bacteria, viruses, fungi, protozoa, algae, or 
slime; and
    (B) In the intended use is subject to a tolerance under section 408 
of the Federal Food, Drug, and Cosmetic Act or a food additive 
regulation under section 409 of such Act.
    (2) The labeling of the pesticide product includes directions for 
use on a site in at least one of the following antimicrobial product use 
categories: food handling/storage establishments premises and equipment; 
commercial, institutional, and industrial premises and equipment; 
residential and public access premises; medical premises and equipment; 
human drinking water systems; materials preservatives; industrial 
processes and water systems; antifouling coatings; wood preservatives; 
or swimming pools.
    (3) The pesticide product is not a hazardous waste as set out in 
part 261 of this chapter when the pesticide product is intended to be 
disposed.
    (4) EPA has not specifically determined that the pesticide product 
must be subject to the regulations in this subpart to prevent an 
unreasonable adverse effect on the environment according to the 
provisions of paragraph (e) of this section.
    (d) Which requirements must an antimicrobial swimming pool product 
comply with if it is not exempt from these regulations? An antimicrobial 
swimming pool product that is not exempt by paragraph (a), (b), or (c) 
of this section must comply with all of the regulations in this subpart 
except Sec. 165.45(d) regarding marking and Sec. 165.45(e) regarding 
openings. For the purposes of this subpart, an antimicrobial swimming 
pool product is a pesticide product that satisfies both of the following 
conditions:
    (1) The pesticide product is intended to: disinfect, sanitize, 
reduce or mitigate growth or development of microbiological organisms; 
or protect inanimate objects, industrial processes or systems, surfaces, 
water, or other chemical substances from contamination, fouling, or 
deterioration caused by bacteria, viruses, fungi, protozoa, algae, or 
slime.
    (2) The labeling of the pesticide product includes directions for 
use on only a site or sites in the antimicrobial product use category of 
swimming pools.
    (e) How will EPA determine if an antimicrobial pesticide product 
otherwise exempted must be subject to the regulations in this subpart to 
prevent an unreasonable adverse effect on the environment? (1) EPA may 
determine that an antimicrobial pesticide product otherwise exempted by 
paragraph (c) of this section must be subject to the refillable 
container regulations in this subpart to prevent an unreasonable adverse 
effect on the environment if all of the following conditions exist:
    (i) EPA obtains information, data or other evidence of a problem 
with the containers of a certain pesticide product or related group of 
products.
    (ii) The information, data or other evidence is reliable and 
factual.
    (iii) The problem causes or could reasonably be expected to cause an 
unreasonable adverse effect on the environment.
    (iv) Complying with the container regulations could reasonably be 
expected to eliminate the problem.
    (2) If EPA determines that an antimicrobial pesticide product 
otherwise

[[Page 298]]

exempted by paragraph (c) of this section must be subject to the 
refillable container regulations in this subpart to prevent an 
unreasonable adverse effect on the environment, EPA may require, by 
rule, that the product be distributed or sold in refillable containers 
that comply with all or some of the requirements in this subpart. 
Alternatively, EPA may notify the applicant or registrant of its intent 
to make such a determination. After allowing the applicant or registrant 
a reasonable amount of time to reply, EPA may require, by notification 
and as a condition of registration, that the product be distributed or 
sold in refillable containers that comply with all or some of the 
requirements in this subpart. For the purpose of the previous sentence, 
60 days would be a reasonable amount of time to reply, although EPA may, 
in its discretion, provide more time. EPA may deny registration or 
initiate cancellation proceedings if the registrant fails to comply with 
the refillable container regulations within the time frames established 
by EPA in the rule or in its notification.
    (f) What other pesticide products are subject to the regulations in 
this subpart? The regulations in this subpart apply to all pesticide 
products other than manufacturing use products, plant-incorporated 
protectants, and antimicrobial products that are exempt by paragraph (c) 
of this section. Antimicrobial products covered under paragraph (d) of 
this section are subject to the regulations indicated in paragraph (d) 
of this section.
    (g) What does ``pesticide product'' or ``pesticide'' mean in the 
rest of this subpart? In Sec. 165.43(h) through Sec. 165.47, the term 
``pesticide product'' or ``pesticide'' refers only to a pesticide 
product or a pesticide that is subject to the regulations in this 
subpart as described in paragraphs (a) through (f) of this section.
    (h) Are there any other exceptions? (1) The regulations in this 
subpart do not apply to transport vehicles that contain pesticide in 
pesticide-holding tanks that are an integral part of the transport 
vehicle and that are the primary containment for the pesticide.
    (2) The regulations in this subpart do not apply to containers that 
hold pesticides that are gaseous at atmospheric temperature and 
pressure.

[71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64226, Oct. 29, 2008]



Sec. 165.45  Refillable container standards.

    (a) What Department of Transportation (DOT) standards do my 
refillable containers have to meet under this part if my pesticide 
product is not a DOT hazardous material? (1) A pesticide product that 
does not meet the definition of a hazardous material in 49 CFR 171.8 
must be packaged in a refillable container that, if portable, is 
designed, constructed, and marked to comply with the requirements of 49 
CFR 173.4, 173.5, 173.6, 173.24, 173.24a, 173.24b, 173.28, 173.155, 
173.203, 173.213, 173.240(c), 173.240(d), 173.241(c), 173.241(d), part 
178, and part 180 that are applicable to a Packing Group III material, 
or, if subject to a special permit, according to the applicable 
requirements of 49 CFR part 107 subpart B. The requirements in this 
paragraph apply to the pesticide product as it is packaged for 
transportation in commerce.
    (2) A refiller is not required to comply with 49 CFR 173.28(b)(2) 
for pesticide products that are not DOT hazardous materials if the 
refillable container to be reused complies with the refillable container 
regulations in this subpart and the refilling is done in compliance with 
the repackaging regulations in subpart D of this part.
    (b) What DOT standards do my refillable containers have to meet 
under this part if my pesticide product is a DOT hazardous material? (1) 
If your pesticide product meets the definition of a hazardous material 
in 49 CFR 171.8, the DOT requires your pesticide product to be packaged 
according to 49 CFR parts 171-180 or, if subject to a special permit, 
according to the applicable requirements of 49 CFR part 107 subpart B.
    (2) For the purposes of these regulations, a pesticide product that 
meets the definition of a hazardous material in 49 CFR 171.8 must be 
packaged in a refillable container that, if portable, is designed, 
constructed, and marked to comply with the requirements of 49 CFR parts 
171-180 or, if subject to a special permit, according to the applicable

[[Page 299]]

requirements of 49 CFR part 107 subpart B. The requirements in this 
paragraph apply to the pesticide product as it is packaged for 
transportation in commerce.
    (c) What will EPA do if DOT proposes to change any of the cross-
referenced regulations? If the DOT proposes to change any of the 
regulations that are incorporated in paragraphs (a) and (b) of this 
section, EPA will provide notice of the proposed changes and an 
opportunity to comment in the Federal Register. Following notice and 
comment, EPA will take final action regarding whether or not to revise 
its rules, and the extent to which any such revision will correspond 
with revised DOT regulations.
    (d) What standards for marking do my refillable containers have to 
meet? Each refillable container must be marked in a durable and clearly 
visible manner with a serial number or other identifying code that will 
distinguish the individual container from all other containers. Durable 
marking includes, but is not limited to, etching, embossing, ink 
jetting, stamping, heat stamping, mechanically attaching a plate, 
molding, and marking with durable ink. The serial number or other 
identifying code must be located on the outside part of the container 
except on a closure. Placement on the label or labeling is not 
sufficient unless the label is an integral, permanent part of or 
permanently stamped on the container.
    (e) What standards for openings do my refillable containers have to 
meet? If your refillable container is a portable pesticide container 
that is designed to hold liquid pesticide formulations and is not a 
cylinder that complies with the DOT Hazardous Materials Regulations in 
49 CFR parts 171-180, each opening of the container other than a vent 
must have a one-way valve, a tamper-evident device or both. A one-way 
valve may be located in a device or system separate from the container 
if the device or system is the only reasonably foreseeable way to 
withdraw pesticide from the container. A vent must be designed to 
minimize the amount of material that could be introduced into the 
container through it.
    (f) What standards do my stationary pesticide containers have to 
meet? If a stationary pesticide container designed to hold undivided 
quantities of pesticides equal to or greater than 500 gallons (1,890 
liters) of liquid pesticide or equal to or greater than 4,000 pounds 
(1,818 kilograms) of dry pesticide is located at the refilling 
establishment of a refiller operating under written contract to you, the 
stationary pesticide container must meet the following standards:
    (1) Except during a civil emergency or any unanticipated grave 
natural disaster or other natural phenomenon of an exceptional, 
inevitable and irresistible character, the effects of which could not 
have been prevented or avoided by the exercise of due care or foresight, 
each stationary pesticide container (for liquid and dry pesticides) and 
its appurtenances must meet both of the following standards:
    (i) Each stationary pesticide container and its appurtenances must 
be resistant to extreme changes in temperature and constructed of 
materials that are adequately thick to not fail and that are resistant 
to corrosion, puncture, or cracking.
    (ii) Each stationary pesticide container must be capable of 
withstanding all operating stresses, taking into account static heat, 
pressure buildup from pumps and compressors, and any other foreseeable 
mechanical stresses to which the container may be subjected in the 
course of operations.
    (2) Each stationary container of liquid pesticides must meet all of 
the following standards:
    (i) Each stationary container of liquid pesticides must be equipped 
with a vent or other device designed to relieve excess pressure, prevent 
losses by evaporation, and exclude precipitation.
    (ii) External sight gauges, which are pesticide-containing hoses or 
tubes that run vertically along the exterior of the container from the 
top to the bottom, are prohibited on stationary containers of liquid 
pesticides.
    (iii) Each connection on a stationary container of liquid pesticides 
that is below the normal liquid level must be equipped with a shutoff 
valve which is capable of being locked closed. A shutoff valve must be 
located within a secondary containment unit if one is required by 
subpart E of this part.

[[Page 300]]

    (g) Can I obtain a waiver from or a modification to any of the 
refillable container standards? Yes, it is possible for you to obtain a 
waiver from or a modification to some of the refillable container 
standards, as follows:
    (1) EPA may waive or modify the requirements of paragraph (a) of 
this section regarding the DOT standards for pesticide products that are 
not DOT hazardous materials if EPA determines that an alternative 
(partial or modified) set of standards or pre-existing requirements 
achieves a level of safety that is at least equal to that specified in 
the requirements of paragraph (a) of this section.
    (2) EPA may waive or modify the requirements of paragraph (b) of 
this section regarding the DOT standards for pesticide products that are 
DOT hazardous materials if EPA determines that an alternative (partial 
or modified) set of standards or pre-existing requirements achieves a 
level of safety that is at least equal to that specified in the 
requirements of paragraph (b) of this section. EPA will modify or waive 
the requirements of paragraph (b) of this section only after consulting 
with DOT to ensure consistency with DOT regulations and exemptions.
    (h) How do I obtain a waiver from or a modification to any of the 
refillable container standards? To obtain a waiver from or a 
modification to any of the refillable container standards, you must 
submit a written request for a waiver or a modification to the EPA to 
the following address: Office of Pesticide Programs (7504P); U.S. 
Environmental Protection Agency; Ariel Rios Building; 1200 Pennsylvania 
Avenue, N.W., Washington, DC 20460. You cannot distribute or sell the 
pesticide product in a refillable container that does not comply with 
all of the refillable container standards unless and until EPA approves 
the request for the waiver or modification in writing. You must include 
two copies of the following information (which may be part of an 
application for registration or amended registration) with your written 
request:
    (1) The name and address of the registrant; the date; and the name, 
title, signature, and phone number of the company official making the 
request.
    (2) The name and EPA registration number of the pesticide product 
for which the waiver or modification is requested.
    (3) A statement specifying the requirement or requirements from 
which you are requesting a waiver or a modification.
    (4) A description of the refillable container or containers for 
which the waiver or modification is requested.
    (5) Documentation or justification to demonstrate that the 
applicable waiver or modification criteria in paragraph (g) of this 
section are satisfied.

[71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64226, Oct. 29, 2008]



Sec. 165.47  What information must I report about my refillable containers?

    You are not required to report to EPA with information about your 
refillable containers under the regulations in this subpart. You should 
refer to the reporting standards in part 159 of this chapter to 
determine if information on container failures or other incidents 
involving pesticide containers must be reported to EPA under FIFRA 
section 6(a)(2) (7 U.S.C. 136d(a)(2)).



Sec. Sec. 165.48-165.59  [Reserved]



 Subpart D_Standards for Repackaging Pesticide Products into Refillable 

                               Containers



Sec. 165.60  General provisions.

    (a) What is the purpose of the regulations in this subpart? The 
regulations in this subpart establish requirements for repackaging some 
pesticide products into refillable containers for distribution or sale.
    (b) Do I have to comply with the regulations in this subpart? You 
must comply with the regulations in this subpart if you are a registrant 
who distributes or sells a pesticide product in refillable containers, 
if you are a registrant who distributes or sells pesticide products to a 
refiller (that is not part of your company) for repackaging into 
refillable containers, or if you are a refiller of a pesticide product 
and you are not the registrant of the pesticide product. Each pesticide 
product that is subject to the regulations in this subpart as set out in 
Sec. 165.63 and that is distributed or

[[Page 301]]

sold in a refillable container must be distributed or sold in compliance 
with the standards of these regulations.
    (c) When do I have to comply? Any pesticide product repackaged into 
a refillable container and released for shipment by you after August 16, 
2011 must be repackaged in compliance with the regulations of this 
subpart.

[71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64227, Oct. 29, 2008]



Sec. 165.63  Scope of pesticide products included.

    (a) Are manufacturing use products subject to the regulations in 
this subpart? No, the regulations in this subpart do not apply to 
manufacturing use products, as defined in Sec. 158.153(h) of this 
chapter.
    (b) Are plant-incorporated protectants subject to the regulations in 
this subpart? No, the regulations in this subpart do not apply to plant-
incorporated protectants, as defined in Sec. 174.3 of this chapter.
    (c) Which antimicrobial pesticide products are not subject to the 
regulations in this subpart? The regulations in this subpart do not 
apply to a pesticide product if it satisfies all of the following 
conditions:
    (1) The pesticide product meets one of the following two criteria:
    (i) The pesticide product is an antimicrobial pesticide as defined 
in FIFRA section 2(mm); or
    (ii) The pesticide product: (A) Is intended to: disinfect, sanitize, 
reduce or mitigate growth or development of microbiological organisms; 
or protect inanimate objects, industrial processes or systems, surfaces, 
water, or other chemical substances from contamination, fouling, or 
deterioration caused by bacteria, viruses, fungi, protozoa, algae, or 
slime; and
    (B) In the intended use is subject to a tolerance under section 408 
of the Federal Food, Drug, and Cosmetic Act or a food additive 
regulation under section 409 of such Act.
    (2) The labeling of the pesticide product includes directions for 
use on a site in at least one of the following antimicrobial product use 
categories: food handling/storage establishments premises and equipment; 
commercial, institutional, and industrial premises and equipment; 
residential and public access premises; medical premises and equipment; 
human drinking water systems; materials preservatives; industrial 
processes and water systems; antifouling coatings; wood preservatives; 
or swimming pools.
    (3) The pesticide product is not a hazardous waste as set out in 
part 261 of this chapter when the pesticide product is intended to be 
disposed.
    (4) EPA has not specifically determined that the pesticide product 
must be subject to the regulations in this subpart to prevent an 
unreasonable adverse effect on the environment according to the 
provisions of paragraph (e) of this section.
    (d) Which requirements must an antimicrobial swimming pool product 
comply with if it is not exempt from these regulations? (1) An 
antimicrobial swimming pool product that is not exempt by paragraph (a), 
(b), or (c) of this section must comply with all of the regulations in 
this subpart except for the following requirements:

----------------------------------------------------------------------------------------------------------------
                                                       Requirement for registrants
                                                         who distribute or sell       Requirement for refillers
                     Requirement                         directly in refillable        who are not registrants
                                                               containers
----------------------------------------------------------------------------------------------------------------
Recordkeeping specific to each instance of                     Sec.  165.65(i)(2)           Sec.  165.70(j)(2)
 repackaging
----------------------------------------------------------------------------------------------------------------
Container inspection: criteria regarding a serial              Sec.  165.65(e)(2)           Sec.  165.70(f)(2)
 number or other identifying code
----------------------------------------------------------------------------------------------------------------
Container inspection: criteria regarding one-way               Sec.  165.65(e)(3)           Sec.  165.70(f)(3)
 valve or tamper-evident device
----------------------------------------------------------------------------------------------------------------
Cleaning requirement: criteria regarding one-way               Sec.  165.65(f)(1)           Sec.  165.70(g)(1)
 valve or tamper-evident device
----------------------------------------------------------------------------------------------------------------
Cleaning if the one-way valve or tamper-evident                   Sec.  165.65(g)              Sec.  165.70(h)
 device is not intact
----------------------------------------------------------------------------------------------------------------


[[Page 302]]

    (2) For the purposes of this subpart, an antimicrobial swimming pool 
product is a pesticide product that satisfies both of the following 
conditions:
    (i) The pesticide product is intended to: disinfect, sanitize, 
reduce or mitigate growth or development of microbiological organisms; 
or protect inanimate objects, industrial processes or systems, surfaces, 
water, or other chemical substances from contamination, fouling, or 
deterioration caused by bacteria, viruses, fungi, protozoa, algae, or 
slime.
    (ii) The labeling of the pesticide product includes directions for 
use on only a site or sites in the antimicrobial product use category of 
swimming pools.
    (e) How will EPA determine if an antimicrobial pesticide product 
otherwise exempted must be subject to the regulations in this subpart to 
prevent an unreasonable adverse effect on the environment? (1) EPA may 
determine that an antimicrobial pesticide product otherwise exempted by 
paragraph (c) of this section must be subject to the repackaging 
regulations in this subpart to prevent an unreasonable adverse effect on 
the environment if all of the following conditions exist:
    (i) EPA obtains information, data or other evidence of a problem 
with the containers of a certain pesticide product or related group of 
products.
    (ii) The information, data or other evidence is reliable and 
factual.
    (iii) The problem causes or could reasonably be expected to cause an 
unreasonable adverse effect on the environment.
    (iv) Complying with the container regulations could reasonably be 
expected to eliminate the problem.
    (2) If EPA determines that an antimicrobial pesticide product 
otherwise exempted by paragraph (c) of this section must be subject to 
the repackaging regulations in this subpart to prevent an unreasonable 
adverse effect on the environment, EPA may require, by rule, that the 
product be repackaged in compliance with all or some of the requirements 
in this subpart. Alternatively, EPA may notify the applicant or 
registrant of its intent to make such a determination. After allowing 
the applicant or registrant a reasonable amount of time to reply, EPA 
may require, by notification and as a condition of registration, that 
the product be repackaged in compliance with all or some of the 
requirements in this subpart. For the purpose of the previous sentence, 
60 days would be a reasonable amount of time to reply, although EPA may, 
in its discretion, provide more time. EPA may deny registration or 
initiate cancellation proceedings if the registrant fails to comply with 
the repackaging regulations within the time frames established by EPA in 
the rule or in its notification.
    (f) What other pesticide products are subject to the regulations in 
this subpart? The regulations in this subpart apply to all pesticide 
products other than manufacturing use products, plant-incorporated 
protectants, and antimicrobial products that are exempt paragraph (c) of 
this section. Antimicrobial products covered under paragraph (d) of this 
section are subject to the regulations indicated in that section.
    (g) What does ``pesticide product'' or ``pesticide'' mean in the 
rest of this subpart? In Sec. Sec. 165.63(h) through 165.70, the term 
``pesticide product'' or ``pesticide'' refers only to a pesticide 
product or a pesticide that is subject to the regulations in this 
subpart as described in paragraphs (a) through (f) of this section.
    (h) Are there any other exceptions? (1) The regulations in this 
subpart do not apply to transport vehicles that contain pesticide in 
pesticide-holding tanks that are an integral part of the transport 
vehicle and that are the primary containment for the pesticide.
    (2) Custom blending is not subject to the regulations in this 
subpart.
    (3) The regulations in this subpart do not apply to containers that 
hold pesticides that are gaseous at atmospheric temperature and 
pressure.

[71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64227, Oct. 29, 2008]



Sec. 165.65  Registrants who distribute or sell pesticide products in 

refillable containers.

    (a) Must I comply with the standards in this section? You must 
comply with the standards in this section if you are a

[[Page 303]]

registrant who distributes or sells pesticide products in refillable 
containers. This means that you conduct all of the repackaging for a 
pesticide product and that you do not distribute or sell the pesticide 
product to a refiller that is not part of your company for repackaging 
into refillable containers. If you are a registrant that repackages a 
product directly into refillable containers for sale or distribution and 
you also sell or distribute other quantities of that product to an 
independent refiller for repackaging, then you must meet the 
requirements in this section for those quantities you distribute or sell 
directly and the requirements in Sec. 165.67 for those quantities that 
you distribute or sell to an independent refiller.
    (b) Am I responsible for product integrity? Yes, you are responsible 
for the pesticide product that you distribute or sell in refillable 
containers not being adulterated or different from the composition 
described in its confidential statement of formula that is required 
under FIFRA section 3.
    (c) What information must I develop? For each pesticide product 
distributed or sold in refillable containers, you must develop both of 
the following documents in writing.
    (1) You must develop a refilling residue removal procedure that 
describes how to remove pesticide residue from a refillable container 
(portable or stationary pesticide container) before it is refilled.
    (i) The refilling residue removal procedure must be adequate to 
ensure that the composition of the pesticide product does not differ at 
the time of its distribution or sale from the composition described in 
its confidential statement of formula that is required under FIFRA 
section 3.
    (ii) If the refilling residue removal procedure requires the use of 
a solvent other than the diluent used for applying the pesticide as 
specified on the labeling under ``Directions for Use,'' or if there is 
no diluent used for application, the refilling residue removal procedure 
must describe how to manage any rinsate resulting from the procedure in 
accordance with applicable Federal and State regulations.
    (2) You must develop a description of acceptable refillable 
containers (portable or stationary pesticide containers) that can be 
used for distributing or selling that pesticide product.
    (i) An acceptable container is one that you have determined meets 
the standards in subpart C of this part and is compatible with the 
pesticide formulation intended to be distributed and sold using the 
refillable container.
    (ii) You must identify the containers by specifying the container 
materials of construction that are compatible with the pesticide 
formulation and specifying information necessary to confirm compliance 
with the refillable container requirements in subpart C of this part.
    (d) What requirements must my individual establishments follow 
regarding repackaging a pesticide product into refillable containers? A 
refiller at your individual establishment that repackages a pesticide 
product into refillable containers for distribution or sale must comply 
with all of the following provisions.
    (1) The establishment must be registered with EPA as a producing 
establishment as required by Sec. 167.20 of this chapter.
    (2) The refiller must not change the pesticide formulation unless 
the refiller has a registration for the new formulation.
    (3) The refiller must repackage a pesticide product only into a 
refillable container that is identified on your description of 
acceptable containers for that pesticide product.
    (4) The refiller may repackage any quantity of a pesticide product 
into a refillable container up to the rated capacity of the container. 
In addition, there are no general limits on the size of the refillable 
containers that the refiller can use.
    (5) The refiller must have all of the following items at the 
establishment before repackaging a pesticide product into any refillable 
container for distribution or sale:
    (i) The pesticide product's label and labeling.
    (ii) The written refilling residue removal procedure for the 
pesticide product.

[[Page 304]]

    (iii) The written description of acceptable containers for the 
pesticide product.
    (6) Before repackaging a pesticide product into any refillable 
container for distribution or sale, the refiller must identify the 
pesticide product previously contained in the refillable container to 
determine whether a residue removal procedure must be conducted in 
accordance with paragraph (f) of this section. The refiller may identify 
the previous pesticide product by referring to the label or labeling.
    (7) The refiller must inspect each refillable container according to 
paragraph (e) of this section.
    (8) The refiller must clean each refillable container according to 
paragraph (f) or (g) of this section, if required by either paragraph.
    (9) The refiller must ensure that each refillable container is 
properly labeled according to paragraph (h) of this section.
    (10) The establishment must maintain records in accordance with 
paragraph (i) of this section.
    (11) The establishment must maintain records as required by part 169 
of this chapter.
    (12) The establishment must report as required by part 167 of this 
chapter.
    (e) How must my individual establishments inspect refillable 
containers? Before repackaging a pesticide product into any refillable 
container, a refiller at your establishment must visually inspect the 
exterior and (if possible) the interior of the container and the 
exterior of appurtenances. The purpose of the inspection is to determine 
whether the container meets the necessary criteria with respect to 
continued container integrity, required markings, and openings. If the 
condition in paragraph (e)(1) of this section exists, the container 
fails the inspection and must not be refilled unless the container is 
repaired, reconditioned, or remanufactured in compliance with the 
relevant DOT requirement. If the condition in paragraph (e)(2) or (e)(3) 
of this section exists (or both), the container fails the inspection and 
must not be refilled until the container meets the standards specified 
in subpart C of this part. The conditions are:
    (1) The integrity of the container is compromised in at least one of 
the following ways:
    (i) The container shows signs of rupture or other damage which 
reduces its structural integrity.
    (ii) The container has visible pitting, significant reduction in 
material thickness, metal fatigue, damaged threads or closures, or other 
significant defects.
    (iii) The container has cracks, warpage, corrosion or any other 
damage which might render it unsafe for transportation.
    (iv) There is damage to the fittings, valves, tamper-evident devices 
or other appurtenances that may cause failure of the container.
    (2) The container does not bear the markings required by Sec. 
165.45(a), (b) and (d), or such markings are not legible.
    (3) The container does not have an intact and functioning one-way 
valve or tamper-evident device on each opening other than a vent, if 
required.
    (f) How must my individual establishments clean refillable 
containers? A refiller at your establishment must clean each refillable 
container by conducting the pesticide product's refilling residue 
removal procedure before repackaging the pesticide product into the 
refillable container, unless the conditions in paragraph (f)(1) of this 
section and either paragraph (f)(2) or (f)(3) of this section are 
satisfied:
    (1) If required, each tamper-evident device and one-way valve is 
intact.
    (2) The refillable container is being refilled with the same 
pesticide product.
    (3) Both of the following conditions are satisfied:
    (i) The container previously held a pesticide product with a single 
active ingredient and is being used to repackage a pesticide product 
with the same single active ingredient.
    (ii) There is no change that would cause the composition of the 
product being repackaged to differ from the composition described in its 
confidential statement of formula that is required under FIFRA section 
3. Examples of unallowable changes include the active ingredient 
concentration increasing or decreasing beyond the limits established by 
the confidential

[[Page 305]]

statement of formula or a reaction or interaction between the pesticide 
product being repackaged and the residue remaining in the container.
    (g) How must my individual establishments clean a refillable 
container that has a broken (non-intact) tamper-evident device or one-
way valve? As required in paragraph (f) of this section, a refiller at 
your establishment must clean each refillable container that has a 
tamper-evident device or one-way valve that is not intact by conducting 
the pesticide product's refilling residue removal procedure before 
repackaging the pesticide product into the refillable container. In 
addition, other procedures may be necessary to assure that product 
integrity is maintained in such cases.
    (h) How must my individual establishments label refillable 
containers? Before distributing or selling a pesticide product in a 
refillable container, a refiller at your establishment must ensure that 
the label of the pesticide product is securely attached to the 
refillable container such that the label can reasonably be expected to 
remain affixed during the foreseeable conditions and period of use. The 
label and labeling must comply in all respects with the requirements of 
part 156 of this chapter. In particular, the refiller at your 
establishment must ensure that the net contents statement and EPA 
establishment number appear on the label.
    (i) What recordkeeping must my individual establishments do? Each of 
your individual establishments that repackages a pesticide product into 
refillable containers for distribution or sale must maintain all of the 
records listed in this section in addition to the applicable records 
identified in parts 167 and 169 of this chapter. The establishment must 
furnish these records for inspection and copying upon request by an 
employee of EPA or any entity designated by EPA, such as a State, 
another political subdivision or a Tribe.
    (1) For each pesticide product distributed or sold in refillable 
containers, both of the following records must be maintained for the 
current operating year and for 3 years after that:
    (i) The written refilling residue removal procedure for the 
pesticide product.
    (ii) The written description of acceptable containers for the 
pesticide product.
    (2) Each time a refiller at your establishment repackages a 
pesticide product into a refillable container and distributes or sells 
the product, the following records must be generated and maintained for 
at least 3 years after the date of repackaging:
    (i) The EPA registration number of the pesticide product distributed 
or sold in the refillable container.
    (ii) The date of the repackaging.
    (iii) The serial number or other identifying code of the refillable 
container.

[71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64227, Oct. 29, 2008]



Sec. 165.67  Registrants who distribute or sell pesticide products to 

refillers for repackaging.

    (a) Must I comply with the standards in this section? You must 
comply with the standards in this section if you are a registrant who 
distributes or sells pesticide products to a refiller that is not part 
of your company for repackaging into refillable containers.
    (b) Under what conditions can I allow a refiller to repackage my 
pesticide product into refillable containers? You may allow a refiller 
to repackage your pesticide product into refillable containers and to 
distribute or sell such repackaged product under your existing 
registration if all of the following conditions are satisfied:
    (1) The repackaging results in no change to the pesticide 
formulation.
    (2) One of the following conditions regarding a registered refilling 
establishment is satisfied:
    (i) The pesticide product is repackaged at a refilling establishment 
registered with EPA as required by Sec. 167.20 of this chapter.
    (ii) The pesticide product is repackaged by a refilling 
establishment registered with EPA as required by Sec. 167.20 of this 
chapter at the site of a user who intends to use or apply the product.
    (3) You have entered into a written contract with the refiller to 
repackage the pesticide product and to use the label of your pesticide 
product.
    (4) The pesticide product is repackaged only into refillable 
containers

[[Page 306]]

that meet the standards of subpart C of this part.
    (5) The pesticide product is labeled with the product's label with 
no changes except the addition of an appropriate net contents statement 
and the refiller's EPA establishment number.
    (c) What violations are applicable to illegal repackaging? 
Repackaging a pesticide product for distribution or sale without either 
obtaining a registration or meeting all of the conditions in paragraph 
(b) of this section is a violation of section 12 of the Act. Both you 
and the refiller that is repackaging your pesticide product under 
written contract with you may be liable for violations pertaining to the 
repackaged product.
    (d) When must I provide the written contract to the refiller? If you 
allow a refiller to repackage your product as specified in paragraph (b) 
of this section you must provide the written contract referred to in 
paragraph (b)(3) of this section to the refiller before you distribute 
or sell the pesticide product to the refiller.
    (e) Am I responsible for product integrity? Yes, for a product that 
you distribute or sell to a refiller that is not part of your company 
for repackaging into refillable containers, you are responsible for the 
pesticide product not being adulterated or different from the 
composition described in its confidential statement of formula that is 
required under FIFRA section 3.
    (f) What information must I develop? For each pesticide product 
distributed or sold in refillable containers, you must develop both of 
the following documents in writing.
    (1) You must develop a refilling residue removal procedure that 
describes how to remove pesticide residue from a refillable container 
(portable or stationary pesticide container) before it is refilled.
    (i) The refilling residue removal procedure must be adequate to 
ensure that the composition of the pesticide product does not differ at 
the time of its distribution or sale from the composition described in 
its confidential statement of formula that is required under FIFRA 
section 3.
    (ii) If the refilling residue removal procedure requires the use of 
a solvent other than the diluent used for applying the pesticide as 
specified on the labeling under ``Directions for Use,'' or if there is 
no diluent used for application, the refilling residue removal procedure 
must describe how to manage any rinsate resulting from the procedure in 
accordance with applicable Federal and State regulations.
    (2) You must develop a description of acceptable refillable 
containers (portable or stationary pesticide containers) that can be 
used for distributing or selling that pesticide product.
    (i) An acceptable container is one that you have determined meets 
the standards in subpart C of this part and is compatible with the 
pesticide formulation intended to be distributed and sold using the 
refillable container.
    (ii) You must identify the containers by specifying the container 
materials of construction that are compatible with the pesticide 
formulation and specifying information necessary to confirm compliance 
with the refillable container requirements in subpart C of this part.
    (g) When must I provide the information to the refiller? You must 
provide the refiller with all of the following information and 
documentation before or at the time of distribution or sale of your 
pesticide product to the refiller:
    (1) Your written refilling residue removal procedure for the 
pesticide product.
    (2) Your written description of acceptable containers for the 
pesticide product.
    (3) The pesticide product's label and labeling.
    (h) What recordkeeping must I do? You must maintain all of the 
records listed in this section for the current operating year and for 3 
years after that. You must furnish these records for inspection and 
copying upon request by an employee of EPA or any entity designated by 
EPA, such as a State, another political subdivision or a Tribe:
    (1) Each written contract entered into with a refiller for 
repackaging your pesticide product into refillable containers.

[[Page 307]]

    (2) Your written refilling residue removal procedure for the 
pesticide product.
    (3) Your written description of acceptable containers for the 
pesticide product.

[71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64227, Oct. 29, 2008]



Sec. 165.70  Refillers who are not registrants.

    (a) Must I comply with the standards in this section? You must 
comply with the standards in this section if you are a refiller of a 
pesticide product and you are not the registrant of the pesticide 
product.
    (b) Under what conditions can I repackage a registrant's pesticide 
product into refillable containers? A registrant may allow you to 
repackage the registrant's pesticide product into refillable containers 
and to distribute or sell such repackaged product under the registrant's 
existing registration if all of the following conditions are satisfied:
    (1) The repackaging results in no change to the pesticide 
formulation.
    (2) One of the following conditions regarding a registered refilling 
establishment is satisfied:
    (i) The pesticide product is repackaged at a refilling establishment 
registered with EPA as required by Sec. 167.20 of this chapter.
    (ii) The pesticide product is repackaged by a refilling 
establishment registered with EPA as required by Sec. 167.20 of this 
chapter at the site of a user who intends to use or apply the product.
    (3) The registrant has entered into a written contract with you to 
repackage the pesticide product and to use the label of the registrant's 
pesticide product.
    (4) The pesticide product is repackaged only into refillable 
containers that meet the standards of subpart C of this part.
    (5) The pesticide product is labeled with the product's label with 
no changes except the addition of an appropriate net contents statement 
and the refillers EPA establishment number.
    (c) What violations are applicable to illegal repackaging? 
Repackaging a pesticide product for distribution or sale without either 
obtaining a registration or meeting all of the conditions in paragraph 
(b) of this section is a violation of section 12 of the Act. Both you 
and the pesticide product's registrant may be liable for violations 
pertaining to the repackaged product.
    (d) Am I responsible for product integrity? Yes, you are responsible 
for the pesticide product that you distribute or sell in refillable 
containers not being adulterated or different from the composition 
described in its confidential statement of formula that is required 
under FIFRA section 3.
    (e) What requirements must I follow regarding repackaging a 
pesticide product into refillable containers? You must comply with all 
of the following provisions.
    (1) Your establishment must be registered with EPA as a producing 
establishment as required by Sec. 167.20 of this chapter.
    (2) You must not change the pesticide formulation unless you have a 
registration for the new formulation.
    (3) You must repackage a pesticide product only into a refillable 
container that is identified on the description of acceptable containers 
for that pesticide product provided by the registrant.
    (4) You may repackage any quantity of a pesticide product into a 
refillable container up to the rated capacity of the container. In 
addition, there are no general limits on the size of the refillable 
containers that you can use.
    (5) You must have all of the following items at your establishment 
before repackaging a pesticide product into any refillable container for 
distribution or sale:
    (i) The written contract referred to in paragraph (b)(3) of this 
section from the pesticide product's registrant.
    (ii) The pesticide product's label and labeling.
    (iii) The registrant's written refilling residue removal procedure 
for the pesticide product.
    (iv) The registrant's written description of acceptable containers 
for the pesticide product.
    (6) Before repackaging a pesticide product into any refillable 
container for distribution or sale, you must identify the pesticide 
product previously contained in the refillable container to determine 
whether a residue removal

[[Page 308]]

procedure must be conducted in accordance with paragraph (g) of this 
section. You may identify the previous pesticide product by referring to 
the label or labeling.
    (7) You must inspect each refillable container according to 
paragraph (f) of this section.
    (8) You must clean each refillable container according to paragraph 
(g) or (h) of this section, if required by either paragraph.
    (9) You must ensure that each refillable container is properly 
labeled according to paragraph (i) of this section.
    (10) You must maintain records in accordance with paragraph (j) of 
this section.
    (11) You must maintain records as required by part 169 of this 
chapter.
    (12) You must report as required by part 167 of this chapter.
    (13) The stationary pesticide containers at your establishment must 
meet the standards in Sec. 165.45(f).
    (14) You may be required to comply with the containment standards in 
subpart E of this part.
    (f) How must I inspect refillable containers? Before repackaging a 
pesticide product into any refillable container, you must visually 
inspect the exterior and (if possible) the interior of the container and 
the exterior of appurtenances. The purpose of the inspection is to 
determine whether the container meets the necessary criteria with 
respect to continued container integrity, required markings, and 
openings. If the condition in paragraph (f)(1) of this section exists, 
the container fails the inspection and must not be refilled unless the 
container is repaired, reconditioned, or remanufactured in compliance 
with the relevant DOT requirement. If the condition in paragraph (f)(2) 
or (f)(3) of this section exists (or both), the container fails the 
inspection and must not be refilled until the container meets the 
standards specified in subpart C of this part. The conditions are:
    (1) The integrity of the container is compromised in at least one of 
the following ways:
    (i) The container shows signs of rupture or other damage which 
reduces its structural integrity.
    (ii) The container has visible pitting, significant reduction in 
material thickness, metal fatigue, damaged threads or closures, or other 
significant defects.
    (iii) The container has cracks, warpage, corrosion or any other 
damage which might render it unsafe for transportation.
    (iv) There is damage to the fittings, valves, tamper-evident devices 
or other appurtenances that may cause failure of the container.
    (2) The container does not bear the markings required by Sec. 
165.45(a), (b) and (d), or such markings are not legible.
    (3) The container does not have an intact and functioning one-way 
valve or tamper-evident device on each opening other than a vent, if 
required.
    (g) How must I clean refillable containers? You must clean each 
refillable container by conducting the pesticide product's refilling 
residue removal procedure before repackaging the pesticide product into 
the refillable container, unless the conditions in paragraph (g)(1) of 
this section and either paragraph (g)(2) or (g)(3) of this section are 
satisfied:
    (1) If required, each tamper-evident device and one-way valve is 
intact.
    (2) The refillable container is being refilled with the same 
pesticide product.
    (3) Both of the following conditions are satisfied.
    (i) The container previously held a pesticide product with a single 
active ingredient and is being used to repackage a pesticide product 
with the same single active ingredient.
    (ii) There is no change that would cause the composition of the 
product being repackaged to differ from the composition described in its 
confidential statement of formula that is required under FIFRA section 
3. Examples of unallowable changes include the active ingredient 
concentration increasing or decreasing beyond the limits established by 
the confidential statement of formula or a reaction or interaction 
between the pesticide product being repackaged and the residue remaining 
in the container.
    (h) How must I clean a refillable container that has a broken (non-
intact) tamper-evident device or one-way valve? As

[[Page 309]]

required in paragraph (g) of this section, you must clean each 
refillable container that has a tamper-evident device or one-way valve 
that is not intact by conducting the pesticide product's refilling 
residue removal procedure before repackaging the pesticide product into 
the refillable container. In addition, other procedures may be necessary 
to assure that product integrity is maintained in such cases.
    (i) How must I label refillable containers? Before distributing or 
selling a pesticide product in a refillable container, you must ensure 
that the label of the pesticide product is securely attached to the 
refillable container such that the label can reasonably be expected to 
remain affixed during the foreseeable conditions and period of use. The 
label and labeling must comply in all respects with the requirements of 
part 156 of this chapter. In particular, you must ensure that the net 
contents statement and EPA establishment number appear on the label.
    (j) What recordkeeping must I do? You must maintain all of the 
records listed in this section in addition to the applicable records 
identified in parts 167 and 169 of this chapter. You must furnish these 
records for inspection and copying upon request by an employee of EPA or 
any entity designated by EPA, such as a State, another political 
subdivision or a Tribe.
    (1) For each pesticide product distributed or sold in refillable 
containers, all of the following records must be maintained for the 
current operating year and for 3 years after that:
    (i) The written contract from the pesticide product's registrant for 
the pesticide product.
    (ii) The written refilling residue removal procedure for the 
pesticide product.
    (iii) The written description of acceptable containers for the 
pesticide product.
    (2) Each time you repackage a pesticide product into a refillable 
container and distribute or sell the product, the following records must 
be generated and maintained for at least 3 years after the date of 
repackaging:
    (i) The EPA registration number of the pesticide product distributed 
or sold in the refillable container.
    (ii) The date of the repackaging.
    (iii) The serial number or other identifying code of the refillable 
container.

[71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64227, Oct. 29, 2008]



Sec. Sec. 165.71-165.79  [Reserved]



        Subpart E_Standards for Pesticide Containment Structures



Sec. 165.80  General provisions.

    (a) What is the purpose of the regulations in this subpart? The 
purpose of the containment regulations in this subpart is to protect 
human health and the environment from exposure to agricultural 
pesticides which may spill or leak from stationary pesticide containers. 
This protection is achieved by the construction of secondary containment 
units or pads at certain facilities handling agricultural pesticides. 
These regulations will also reduce waste generation associated with:
    (1) Storage and handling of large quantities of pesticide products.
    (2) Pesticide dispensing and container-refilling operations.
    (b) Do I have to comply with the regulations in this subpart? You 
must comply with the regulations in this subpart if you are an owner or 
operator of one of the following businesses and if you also have a 
stationary pesticide container or a pesticide dispensing (including 
container refilling) area:
    (1) Refilling establishments who repackage agricultural pesticides 
and whose principal business is retail sale (i.e., more than 50% of 
total annual revenue comes from retail operations).
    (2) Custom blenders of agricultural pesticides.
    (3) Businesses which apply an agricultural pesticide for 
compensation (other than trading of personal services between 
agricultural producers).
    (c) When do I have to comply? You must comply with all applicable 
containment regulations for new and existing structures as of August 17, 
2009.

[71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64227, Oct. 29, 2008]

[[Page 310]]



Sec. 165.81  Scope of stationary pesticide containers included.

    (a) What is a stationary pesticide container? A stationary pesticide 
container is a refillable container that is fixed at a single facility 
or establishment, or, if not fixed, remains at the facility or 
establishment for at least 30 consecutive days, and that holds pesticide 
during the entire time.
    (b) What stationary pesticide containers are subject to the 
regulations in this subpart? Stationary pesticide containers designed to 
hold undivided quantities of agricultural pesticides equal to or greater 
than 500 gallons (1,890 liters) of liquid pesticide or equal to or 
greater than 4,000 pounds (1,818 kilograms) of dry pesticide are subject 
to the regulations in this subpart and must have a secondary containment 
unit that complies with the provisions of this subpart unless any of the 
following conditions exists:
    (1) The container is empty, that is, all pesticide that can be 
removed by methods such as draining, pumping or aspirating has been 
removed (whether or not the container has been rinsed or washed).
    (2) The container holds only pesticide rinsates or wash waters, and 
is labeled accordingly.
    (3) The container holds only pesticides which would be gaseous when 
released at atmospheric temperature and pressure.
    (4) The container is dedicated to non-pesticide use, and is labeled 
accordingly.



Sec. 165.82  Scope of pesticide dispensing areas included.

    (a) What pesticide dispensing areas are subject to the regulations 
in this subpart? A pesticide dispensing area is subject to the 
containment regulations in this subpart and must have a containment pad 
that complies with the requirements of this subpart if any of the 
following activities occur:
    (1) Refillable containers of agricultural pesticide are emptied, 
cleaned or rinsed.
    (2) Agricultural pesticides are dispensed from a stationary 
pesticide container designed to hold undivided quantities of 
agricultural pesticides equal to or greater than 500 gallons (1,890 
liters) of liquid pesticide or equal to or greater than 4,000 pounds 
(1,818 kilograms) of dry pesticide for any purpose, including refilling 
or emptying for cleaning. This applies when pesticide is dispensed from 
the container into any vessel, including, but not limited to:
    (i) Refillable containers;
    (ii) Service containers;
    (iii) Transport vehicles;
    (iv) Application equipment.
    (3) Agricultural pesticides are dispensed from a transport vehicle 
for purposes of filling a refillable container.
    (4) Agricultural pesticides are dispensed from any other container 
for the purpose of refilling a refillable container for sale or 
distribution. Containment requirements do not apply if the agricultural 
pesticide is dispensed from such a container for use, application or 
purposes other than refilling for sale or distribution.
    (b) What pesticide dispensing areas are exempt from the regulations 
in this subpart? A pesticide dispensing area is exempt from the 
regulations in this subpart if any of the following conditions exist:
    (1) The only pesticides in the dispensing area would be gaseous when 
released at atmospheric temperature and pressure.
    (2) The only pesticide containers refilled or emptied within the 
dispensing area are stationary pesticide containers which are already 
protected by a secondary containment unit that complies with the 
provisions of this subpart.
    (3) The pesticide dispensing area is used solely for dispensing 
pesticide from a rail car which does not remain at a facility long 
enough to meet the definition of a stationary pesticide container; that 
is, 30 days.



Sec. 165.83  Definition of new and existing structures.

    (a) What is a new containment structure? A new containment structure 
is one whose installation began after November 16, 2006. Installation is 
considered to have begun if:
    (1) You, as the owner or operator, have obtained all Federal, State, 
and local approvals or permits necessary to

[[Page 311]]

begin physical construction of the containment structure; AND
    (2) You have either begun a continuous on-site physical construction 
or installation program OR you have entered into contractual 
obligations. The contract must be such that it cannot be canceled or 
modified without substantial loss, and must be for the physical 
construction or installation of the containment structure within a 
specific and reasonable time frame.
    (b) What is an existing containment structure? An existing 
containment structure is defined as one whose installation began on or 
before November 16, 2006.



Sec. 165.85  Design and capacity requirements for new structures.

    (a) For all new containment structures, what construction materials 
must I use? These are the material specifications for a new containment 
structure:
    (1) The containment structure must be constructed of steel, 
reinforced concrete or other rigid material capable of withstanding the 
full hydrostatic head, load and impact of any pesticides, precipitation, 
other substances, equipment and appurtenances placed within the 
structure. The structure must be liquid-tight with cracks, seams and 
joints appropriately sealed.
    (2) The structure must not be constructed of natural earthen 
material, unfired clay, or asphalt.
    (3) The containment structure must be made of materials compatible 
with the pesticides stored. In this case, compatible means able to 
withstand anticipated exposure to stored or transferred substances and 
still provide containment of those same or other substances within the 
containment area.
    (b) For all new containment structures, what are the general design 
requirements? These are the general design requirements for new 
containment structures:
    (1) You must protect appurtenances and pesticide containers against 
damage from operating personnel and moving equipment. Means of 
protection include, but are not limited to, supports to prevent sagging, 
flexible connections, the use of guard rails, barriers, and protective 
cages.
    (2) Appurtenances, discharge outlets or gravity drains must not be 
configured through the base or wall of the containment structure, except 
for direct interconnections between adjacent containment structures 
which meet the requirements of this subpart. Appurtenances must be 
configured in such a way that spills or leaks are easy to see.
    (3) The containment structure must be constructed with sufficient 
freeboard to contain precipitation and prevent water and other liquids 
from seeping into or flowing onto it from adjacent land or structures.
    (4) Multiple stationary pesticide containers may be protected within 
a single secondary containment unit.
    (c) For new secondary containment units for stationary containers of 
liquid pesticides and new containment pads in pesticide dispensing 
areas, what are the capacity requirements? These are the capacity 
requirements:
    (1) New secondary containment units for stationary containers of 
liquid pesticides, if protected from precipitation, must have a capacity 
of at least 100 percent of the volume of the largest stationary 
pesticide container plus the volume displaced by other containers and 
appurtenances within the unit.
    (2) New secondary containment units for stationary containers of 
liquid pesticides, if exposed to or unprotected from precipitation, must 
have a capacity of at least 110 percent of the volume of the largest 
stationary pesticide container plus the volume displaced by other 
containers and appurtenances within the unit.
    (3) New containment pads in pesticide dispensing areas which have a 
pesticide container or pesticide-holding equipment with a volume of 750 
gallons or greater must have a holding capacity of at least 750 gallons.
    (4) New containment pads in pesticide dispensing areas which do not 
have a pesticide container or pesticide-holding equipment with a volume 
of at least 750 gallons must have a holding capacity of at least 100 
percent of the volume of the largest pesticide container or pesticide-
holding equipment used on the pad.
    (d) For new secondary containment units for stationary containers of 
liquid pesticides, what are the specific design requirements? You must 
either anchor or

[[Page 312]]

elevate each stationary container of liquid pesticides protected by a 
new secondary containment unit to prevent flotation in the event that 
the secondary containment unit fills with liquid.
    (e) For new containment pads in pesticide dispensing areas, what are 
the specific design requirements? Each new containment pad in a 
pesticide dispensing area must:
    (1) Be designed and constructed to intercept leaks and spills of 
pesticides which may occur in the pesticide dispensing area.
    (2) Have enough surface area to extend completely beneath any 
container on it, with the exception of transport vehicles dispensing 
pesticide for sale or distribution to a stationary pesticide container. 
For such vehicles, the surface area of the containment pad must 
accommodate at least the portion of the vehicle where the delivery hose 
or device couples to the vehicle. This exception does not apply to 
transport vehicles that are used for prolonged storage or repeated on-
site dispensing of pesticides.
    (3) Allow, in conjunction with its sump, for removal and recovery of 
spilled, leaked, or discharged material and rainfall, such as by a 
manually activated pump. Automatically-activated pumps which lack 
automatic overflow cutoff switches for the receiving container are 
prohibited.
    (4) Have its surface sloped toward an area where liquids can be 
collected for removal, such as a liquid-tight sump or a depression, in 
the case of a single-pour concrete pad.
    (f) For new secondary containment units for stationary containers of 
dry pesticides, what are the specific design requirements? These are the 
specific design requirements for new secondary containment units for 
stationary containers of dry pesticides:
    (1) The stationary containers of dry pesticides within the 
containment unit must be protected from wind and precipitation.
    (2) Stationary containers of dry pesticides must be placed on 
pallets or a raised concrete platform to prevent the accumulation of 
water in or under the pesticide.
    (3) The storage area for stationary containers of dry pesticides 
must include a floor that extends completely beneath the pallets or 
raised concrete platforms on which the stationary containers of dry 
pesticides must be stored.
    (4) The storage area for stationary containers of dry pesticides 
must be enclosed by a curb a minimum of 6 inches high that extends at 
least 2 feet beyond the perimeter of the container.

[71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64227, Oct. 29, 2008]



Sec. 165.87  Design and capacity requirements for existing structures.

    (a) For all existing containment structures, what construction 
materials must I use? These are the material specifications for an 
existing containment structure:
    (1) The containment structure must be constructed of steel, 
reinforced concrete or other rigid material capable of withstanding the 
full hydrostatic head, load and impact of any pesticides, precipitation, 
other substances, equipment and appurtenances placed within the 
structure. The structure must be liquid-tight with cracks, seams and 
joints appropriately sealed.
    (2) The structure must not be constructed of natural earthen 
material, unfired clay, or asphalt.
    (3) The containment structure must be made of materials compatible 
with the pesticides stored. In this case, compatible means able to 
withstand anticipated exposure to stored or transferred substances and 
still provide containment of those same or other substances within the 
containment area.
    (b) For all existing containment structures, what are the general 
design requirements? These are the general design requirements for 
existing containment structures:
    (1) You must protect appurtenances and pesticide containers against 
damage from operating personnel and moving equipment. Means of 
protection include, but are not limited to, supports to prevent sagging, 
flexible connections, the use of guard rails, barriers, and protective 
cages.
    (2) You must seal all appurtenances, discharge outlets and gravity 
drains

[[Page 313]]

through the base or wall of the containment structure, except for direct 
interconnections between adjacent containment structures which meet the 
requirements of this subpart.
    (3) The containment structure must be constructed with sufficient 
freeboard to contain precipitation and prevent water and other liquids 
from seeping into or flowing onto it from adjacent land or structures.
    (4) Multiple stationary pesticide containers may be protected within 
a single secondary containment unit.
    (c) For existing secondary containment units for stationary 
containers of liquid pesticides and existing containment pads in 
pesticide dispensing areas, what are the capacity requirements? These 
are the capacity requirements:
    (1) Existing secondary containment units for stationary containers 
of liquid pesticides must have a capacity of at least 100 percent of the 
volume of the largest stationary pesticide container plus the volume 
displaced by other containers and appurtenances within the unit.
    (2) Existing containment pads in pesticide dispensing areas which 
have a pesticide container or pesticide-holding equipment with a volume 
of 750 gallons or greater must have a holding capacity of at least 750 
gallons.
    (3) Existing containment pads in pesticide dispensing areas which do 
not have a pesticide container or pesticide-holding equipment with a 
volume of at least 750 gallons must have a holding capacity of at least 
100 percent of the volume of the largest pesticide container or 
pesticide-holding equipment used on the pad.
    (d) For existing secondary containment units for stationary 
containers of liquid pesticides, what are the specific design 
requirements? You must either anchor or elevate each stationary 
container of liquid pesticides protected by an existing secondary 
containment unit to prevent flotation in the event that the secondary 
containment unit fills with liquid.
    (e) For existing containment pads in pesticide dispensing areas, 
what are the specific design requirements? Each existing containment pad 
in a pesticide dispensing area must:
    (1) Be designed and constructed to intercept leaks and spills of 
pesticides which may occur in the pesticide dispensing area.
    (2) Have enough surface area to extend completely beneath any 
container on it, with the exception of transport vehicles dispensing 
pesticide for sale or distribution to a stationary pesticide container. 
For such vehicles, the surface area of the containment pad must 
accommodate at least the portion of the vehicle where the delivery hose 
or device couples to the vehicle. This exception does not apply to 
transport vehicles that are used for prolonged storage or repeated on-
site dispensing of pesticides.
    (3) Allow, in conjunction with its sump, for removal and recovery of 
spilled, leaked, or discharged material and rainfall, such as by a 
manually activated pump. Automatically-activated pumps which lack 
automatic overflow cutoff switches for the receiving container are 
prohibited.
    (f) For existing secondary containment units for stationary 
containers of dry pesticides, what are the specific design requirements? 
These are the specific design requirements for existing secondary 
containment units for stationary containers of dry pesticides:
    (1) The stationary containers of dry pesticides within the 
containment unit must be protected from wind and precipitation.
    (2) Stationary containers of dry pesticides must be placed on 
pallets or a raised concrete platform to prevent the accumulation of 
water in or under the pesticide.
    (3) The storage area for stationary containers of dry pesticides 
must include a floor that extends completely beneath the pallets or 
raised concrete platforms on which the stationary containers of dry 
pesticides must be stored.
    (4) The storage area for stationary containers of dry pesticides 
must be enclosed by a curb a minimum of 6 inches high that extends at 
least 2 feet beyond the perimeter of the container.

[71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64228, Oct. 29, 2008]

[[Page 314]]



Sec. 165.90  Operational, inspection and maintenance requirements for all new 

and existing containment structures.

    (a) What are the operating procedures required for all new and 
existing containment structures? As the owner or operator of a new or 
existing pesticide containment structure, you must:
    (1) Manage the structure in a manner that prevents pesticides or 
materials containing pesticides from escaping from the containment 
structure (including, but not limited to, pesticide residues washed off 
the containment structure by rainfall or cleaning liquids used within 
the structure.)
    (2) Ensure that pesticide spills and leaks on or in any containment 
structure are collected and recovered in a manner that ensures 
protection of human health and the environment (including surface water 
and groundwater) and maximum practicable recovery of the pesticide 
spilled or leaked. Cleanup must occur no later than the end of the day 
on which pesticides have been spilled or leaked except in circumstances 
where a reasonable delay would significantly reduce the likelihood or 
severity of adverse effects to human health or the environment.
    (3) Ensure that all materials resulting from spills and leaks and 
any materials containing pesticide residue are managed according to 
label instructions and applicable Federal, State and local laws and 
regulations.
    (4) Ensure that transfers of pesticides between containers, or 
between containers and transport vehicles are attended at all times.
    (5) Ensure that each lockable valve on a stationary pesticide 
container, if it is required by Sec. 165.45(f), is closed and locked, 
or that the facility is locked, whenever the facility is unattended.
    (b) What are the inspection and maintenance requirements for all new 
and existing containment structures? As owner or operator of a new or 
existing pesticide containment structure, you must:
    (1) Inspect each stationary pesticide container and its 
appurtenances and each containment structure at least monthly during 
periods when pesticides are being stored or dispensed on the containment 
structure. Your inspection must look for visible signs of wetting, 
discoloration, blistering, bulging, corrosion, cracks or other signs of 
damage or leakage.
    (2) Initiate repair to any areas showing visible signs of damage and 
seal any cracks and gaps in the containment structure or appurtenances 
with material compatible with the pesticide being stored or dispensed no 
later than the end of the day on which damage is noticed and complete 
repairs within a time frame that is reasonable, taking into account 
factors such as the weather, and the availability of cleanup materials, 
trained staff, and equipment.
    (3) Not store any additional pesticide on a containment structure if 
the structure fails to meet the requirements of this subpart until 
suitable repairs have been made.

[71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64228, Oct. 29, 2008]



Sec. 165.92  What if I need both a containment pad and a secondary containment 

unit?

    You may combine containment pads and secondary containment units as 
an integrated system provided the requirements set out in this subpart 
for containment pads and secondary containment units in Sec. Sec. 
165.85(a) and (b), 165.87(a) and (b) and Sec. 165.90, and as 
applicable, Sec. Sec. 165.85(c)-(f) and 165.87(c)-(f) are satisfied 
separately.



Sec. 165.95  What recordkeeping do I have to do as a facility owner or 

operator?

    As a facility owner or operator subject to the requirements of this 
subpart, you must maintain the following records, and you must furnish 
these records for inspection and copying upon request by an employee of 
EPA or any entity designated by EPA, such as a State, another political 
subdivision or a Tribe:
    (a) Records of inspection and maintenance for each containment 
structure and for each stationary pesticide container and its 
appurtenances must be kept for 3 years and must include the following 
information:
    (1) Name of the person conducting the inspection or maintenance;
    (2) Date the inspection or maintenance was conducted;

[[Page 315]]

    (3) Conditions noted;
    (4) Specific maintenance performed.
    (b) Records for any non-stationary pesticide container designed to 
hold undivided quantities of agricultural pesticides equal to or greater 
than 500 gallons (1,890 liters) of liquid pesticide or equal to or 
greater than 4,000 pounds (1,818 kilograms) of dry pesticide that holds 
pesticide but is not protected by a secondary containment unit meeting 
these regulations must be kept for 3 years. Records on these non-
stationary pesticide containers must include the time period that the 
container remains at the same location.
    (c) Records of the construction date of the containment structure 
must be kept for as long as the pesticide containment structure is in 
use, and for 3 years afterwards.



Sec. 165.97  States with existing containment programs.

    (a) What options are available to States that already have 
containment regulations? States that have promulgated containment 
regulations effective prior to August 16, 2006, and which also have 
primary enforcement responsibility and/or certification programs, have 
the option of continuing to implement their own programs in lieu of 
these Federal regulations.
    (b) How may a State request authority to continue implementing its 
State containment regulations? A State with pesticide containment 
regulations may request the authority to continue implementing State 
containment regulations by August 16, 2007 in the following manner:
    (1) The State must submit a letter and any supporting documentation 
to EPA. Supporting documentation must demonstrate that the State's 
program is providing environmental protection equivalent to or more 
protective than that expected to be provided by the Federal regulations 
in this subpart.
    (2) The State must identify any significant changes to State 
regulations which would be necessary in order to provide environmental 
protection equivalent to the EPA regulations, and develop an estimated 
timetable to effect these changes. The letter must be signed by the 
designated State Lead Agency.
    (c) How will EPA notify the State if its request is granted? EPA's 
Office of Pesticide Programs will review the State's correspondence and 
determine whether the State program is adequate to provide environmental 
protection equivalent to or more protective than these Federal 
regulations for new and existing containment structures. EPA's Office of 
Pesticide Programs will inform the State of its determination through a 
letter authorizing or declining to authorize the State to continue 
implementing its containment regulations and will detail any reasons for 
declining authorization.
    (d) How must a State inform EPA of revisions to its containment 
regulations? Any state that has received authorization to continue 
implementing its state containment regulations must inform EPA by letter 
signed by the designated State Lead Agency within 6 months of any 
revision to the State's containment regulations. EPA will inform the 
state by letter if it determines that the State's containment 
regulations are no longer adequate based on the revisions. The State's 
containment regulations will remain in effect, unless and until EPA 
sends the state a letter making this determination.

[71 FR 47422, Aug. 16, 2006, as amended at 73 FR 64228, Oct. 29, 2008]



PART 166_EXEMPTION OF FEDERAL AND STATE AGENCIES FOR USE OF PESTICIDES UNDER 

EMERGENCY CONDITIONS--Table of Contents



                      Subpart A_General Provisions

Sec.
166.1 Purpose and organization.
166.2 Types of exemptions.
166.3 Definitions.
166.7 User notification; advertising.

      Subpart B_Specific, Quarantine, and Public Health Exemptions

166.20 Application for a specific, quarantine, or public health 
          exemption.
166.22 Consultation with the Secretary of Agriculture and Governors of 
          the States.
166.24 Public notice of receipt of application and opportunity for 
          public comment.
166.25 Agency review.
166.28 Duration of exemption.
166.30 Notice of Agency decision.

[[Page 316]]

166.32 Reporting and recordkeeping requirements for specific, 
          quarantine, and public health exemptions.
166.34 EPA review of information obtained in connection with emergency 
          exemptions.
166.35 Revocation or modification of exemptions.

                       Subpart C_Crisis Exemptions

166.40 Authorization.
166.41 Limitations.
166.43 Notice to EPA and registrants or basic manufacturers.
166.45 Duration of crisis exemption.
166.49 Public notice of crisis exemptions.
166.50 Reporting and recordkeeping requirements for crisis exemption.
166.53 EPA review of crisis exemption and revocation of authority.

    Authority: 7 U.S.C. 136p, and 136w.

    Source: 51 FR 1902, Jan. 15, 1986, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 166.1  Purpose and organization.

    (a) Purpose and scope. Section 18 of the Act authorizes the 
Administrator to exempt State and Federal agencies from any provision of 
the Act, if he determines that emergency conditions exist which require 
an exemption. The regulations in this part establish procedures whereby 
the Administrator may exempt a Federal or State agency from the 
provisions of the Act which regulate the manner in which a pesticide is 
made available for use or is used.
    (b) Organization. (1) The provisions in subpart A of this part 
describe the four types of emergency exemptions authorized by the Agency 
and define terms used in this part.
    (2) Subpart B of this part establishes procedures and criteria for 
specific, quarantine, and public health exemptions.
    (3) Subpart C of this part establishes procedures and criteria for 
crisis exemptions.



Sec. 166.2  Types of exemptions.

    There are four types of emergency exemptions which may be 
authorized: specific, quarantine, public health, and crisis exemptions.
    (a) Specific exemption. A specific exemption may be authorized in an 
emergency condition to avert:
    (1) A significant economic loss; or
    (2) A significant risk to:
    (i) Endangered species,
    (ii) Threatened species,
    (iii) Beneficial organisms, or
    (iv) The environment.
    (b) Quarantine exemption. A quarantine exemption may be authorized 
in an emergency condition to control the introduction or spread of any 
pest that is an invasive species, or is otherwise new to or not 
theretofore known to be widely prevalent or distributed within and 
throughout the United States and its territories.
    (c) Public health exemption. A public health exemption may be 
authorized in an emergency condition to control a pest that will cause a 
significant risk to human health.
    (d) Crisis exemption. A crisis exemption may be utilized in an 
emergency condition when the time from discovery of the emergency to the 
time when the pesticide use is needed is insufficient to allow for the 
authorization of a specific, quarantine, or public health exemption.

[51 FR 1902, Jan. 15, 1986, as amended at 71 FR 4510, Jan. 27, 2006]



Sec. 166.3  Definitions.

    Terms used in this part have the same meaning as in the Act. In 
addition, as used in this part, the following terms shall apply:
    Act means the Federal Insecticide, Fungicide, and Rodenticide Act, 
as amended.
    Agency and EPA mean the U. S. Environmental Protection Agency.
    Beneficial organism means any pollinating insect, or any pest 
predator, parasite, pathogen or other biological control agent which 
functions naturally or as part of an integrated pest management program 
to control another pest.
    Emergency condition means an urgent, non-routine situation that 
requires the use of a pesticide(s) and shall be deemed to exist when:
    (1) No effective pesticides are available under the Act that have 
labeled uses registered for control of the pest

[[Page 317]]

under the conditions of the emergency; and
    (2) No economically or environmentally feasible alternative 
practices which provide adequate control are available; and
    (3) The situation:
    (i) Involves the introduction or dissemination of an invasive 
species or a pesticide new to or not theretofore known to be widely 
prevalent or distributed within or throughout the United States and its 
territories; or
    (ii) Will present significant risks to human health; or
    (iii) Will present significant risks to threatened or endangered 
species, beneficial organisms, or the environment; or
    (iv) Will cause significant economic loss due to:
    (A) An outbreak or an expected outbreak of a pest; or
    (B) A change in plant growth or development caused by unusual 
environmental conditions where such change can be rectified by the use 
of a pesticide(s).
    First food use means the use of a pesticide on a food or in a manner 
which otherwise would be expected to result in residues in a food, if no 
tolerance or exemption from the requirements of a tolerance for residues 
of the pesticide on any food has been established for the pesticide 
under section 408 of the Federal Food, Drug, and Cosmetic Act.
    Food means any article used for food or drink for man or animals.
    Invasive species means, with respect to a particular ecosystem, any 
species that is not native to that ecosystem, and whose introduction 
does or is likely to cause economic or environmental harm or harm to 
human health.
    IR-4 means the Interregional Research Project No. 4, a cooperative 
effort of the state land grant universities, the U.S. Department of 
Agriculture and EPA, to address the chronic shortage of pest control 
options for minor crops, which are generally of too small an acreage to 
provide economic incentive for registration by the crop protection 
industry.
    New chemical means an active ingredient not contained in any 
currently registered pesticide.
    Significant economic loss means that, compared to the situation 
without the pest emergency and despite the best efforts of the affected 
persons, the emergency conditions at the specific use site identified in 
the application are reasonably expected to cause losses meeting any of 
the following criteria:
    (1) For pest activity that primarily affects the current crop or 
other output, one or more of the following:
    (i) Yield loss greater than or equal to 20%.
    (ii) Economic loss, including revenue losses and cost increases, 
greater than or equal to 20% of gross revenues.
    (iii) Economic loss, including revenue losses and cost increases 
greater than or equal to 50% of net revenues.
    (2) For any pest activity where EPA determines that the criteria in 
paragraph (1) of this definition would not adequately describe the 
expected loss, substantial loss or impairment of capital assets, or a 
loss that would affect the long-term financial viability expected from 
the productive activity.
    Special Review means any interim administrative review of the risks 
and benefits of the use of a pesticide conducted pursuant to the 
provisions of part 154 of this chapter, or Sec. 162.11 of this chapter 
prior to November 27, 1985, or any subsequent version of those rules.
    Unreasonable adverse effects on the environment means any 
unreasonable risk to man or the environment, taking into account the 
economic, social, and environmental costs and benefits of the use of any 
pesticide.

[73 FR 75597, Dec. 12, 2008]



Sec. 166.7  User notification; advertising.

    (a) A State or Federal agency that obtains an exemption may notify 
eligible users of the availability of the exempted pesticide(s) through 
user groups, retail dealers, and other means. Notification may include 
distributing copies of the section 18 approval letter, labeling, or 
other information to eligible persons.
    (b) As set forth more fully in Sec. 168.22 of this chapter, EPA 
interprets FIFRA sections 12(a)(1) (A) and (B) as making it unlawful for 
any person who distributes, sells, offers for sale, holds for

[[Page 318]]

sale, ships, delivers for shipment, or receives and (having so received) 
delivers or offers to deliver any pesticide, to advertise the pesticide 
for any use authorized by an emergency exemption, except for 
advertisements that are placed in media that address only persons in the 
geographical area to which the exemption applies, state the name and 
address of one or more retail dealers where users may buy the pesticide, 
and contain a prominent notice of the limitations on use under the 
emergency exemption. EPA may withdraw an exemption if the use of the 
pesticide covered by the exemption is advertised unlawfully.

[54 FR 1125, Jan. 11, 1989]



      Subpart B_Specific, Quarantine, and Public Health Exemptions



Sec. 166.20  Application for a specific, quarantine, or public health 

exemption.

    (a) General information required in an application for a specific, 
quarantine or public health exemption. An application must be submitted 
in writing by the head of the Federal or State agency, the Governor of 
the State involved, or their official designee. If a designee has been 
delegated authority to request exemptions, written authorization of such 
delegation must accompany the request or be on file with the Agency. In 
addition, the application must contain all applicable information 
specified in paragraphs (a) (1) through (11) of this section.
    (1) Identity of contact persons. (i) Unless otherwise specified, the 
person who submits the application will be considered the contact person 
for all matters relating to administration of the emergency exemption.
    (ii) Requests should identify by name and telephone number one or 
more qualified experts who may be contacted in case any questions arise 
concerning the application.
    (2) Description of the pesticide. The application shall contain a 
description of the pesticide(s) proposed for use under the exemption. 
Such information shall include:
    (i) For a federally registered pesticide product:
    (A) A copy of the label(s) if a specific product(s) is/are 
requested; or the formulation(s) requested if a specific product is not 
requested; and
    (B) A copy of any additional labeling proposed for the emergency 
exemption; or
    (ii) For any other pesticide products:
    (A) A confidential statement of formula or reference to one already 
submitted to the Agency; and
    (B) Complete labeling to be used in connection with the proposed 
exemption use.
    (3) Description of the proposed use. The application shall identify 
all of the following:
    (i) Sites to be treated, including their locations within the State;
    (ii) The method of application;
    (iii) The rate of application in terms of active ingredient and 
product;
    (iv) The maximum number of applications;
    (v) The total acreage or other appropriate unit proposed to be 
treated;
    (vi) The total amount of pesticide proposed to be used in terms of 
both active ingredient and product;
    (vii) All applicable restrictions and requirements concerning the 
proposed use which may not appear on labeling;
    (viii) The duration of the proposed use; and
    (ix) Earliest possible harvest dates.
    (4) Alternative methods of control. The application shall contain:
    (i) A detailed explanation of why the pesticide(s) currently 
registered for the particular use proposed in the application is not 
available in adequate supplies and/or effective to the degree needed to 
control the emergency. If the applicant states that an available 
registered pesticide is ineffective for the given situation, the 
statement must be supported by field data which demonstrate 
ineffectiveness of registered pesticides, or, if such data are 
unavailable, statements by qualified agricultural experts, extension 
personnel, university personnel or other persons similarly qualified in 
the field of pest control; and
    (ii) A detailed explanation of why alternative practices, if 
available, either would not provide adequate control or would not be 
economically or environmentally feasible.

[[Page 319]]

    (5) Effectiveness of proposed use. The application shall contain 
data, a discussion of field trials, or other evidence which provide the 
basis for the conclusion that the proposed pesticide treatment will be 
effective in dealing with the emergency.
    (6) Discussion of residues for food uses. If the proposed use is 
expected to result in residues of the pesticide in or on food, the 
application shall list the food likely to contain such residues and 
shall contain an estimate of the maximum amount of the residue likely to 
result from the proposed use, together with the information on which 
such estimates are based.
    (7) Discussion of risk information. The application shall address 
the potential risks to human health, endangered or threatened species, 
beneficial organisms, and the environment expected to result from the 
proposed use, together with references to data and other supporting 
information.
    (8) Coordination with other affected State or Federal agencies. If 
the proposed use of the pesticide is likely to be of concern to other 
Federal or State agencies, the application shall indicate that such 
agencies have been contacted prior to submission of the application, and 
any comments received from such agencies shall be submitted to EPA.
    (9) Acknowledgment by registrant. The application shall contain a 
statement by the registrants of all pesticide products proposed for use 
acknowledging that a request has been made to the Agency for use of the 
pesticide under this section. This acknowledgment shall include a 
statement of support for the requested use, including the expected 
availability of adequate quantities of the requested product under the 
use scenario proposed by the applicant(s); and the status of the 
registration in regard to the requested use including appropriate 
petition numbers, or of the registrant's intentions regarding the 
registration of the use.
    (10) Description of proposed enforcement program. Prior to approval, 
the applicant shall provide an explanation of the authority of the 
applicant or related State or Federal agencies for ensuring that use of 
the pesticide under the proposed exemption would comply with any special 
requirements imposed by the Agency and a description of the program and 
procedures for assuring such compliance.
    (11) Repeated uses. Applications for the use of a pesticide at a 
site for which the applicant has previously been exempted under section 
18 shall contain an interim report summarizing the results of the 
specific, quarantine, or public health exemption previously issued, if 
the application is submitted prior to the time the final report for the 
previous exemption is due. The interim report shall contain that 
information specified in Sec. 166.32 to the extent available at the 
time the application is made.
    (b) Information required for a specific exemption. An application 
for a specific exemption shall provide all of the following information, 
as appropriate, concerning the nature of the emergency:
    (1) The scientific and common name of the pest or pest complex;
    (2) A discussion of the events which brought about the emergency 
condition;
    (3) A discussion of the anticipated risks to endangered or 
threatened species, beneficial organisms, or the environment that would 
be remedied by the proposed use of the pesticide; and
    (4) A discussion of the anticipated significant economic loss, 
together with data and other information supporting the discussion, that 
addresses one or more of the following, as appropriate:
    (i) Yield or utilized yield reasonably anticipated in the absence of 
the emergency and expected losses in quantity due to the emergency;
    (ii) The information in paragraph (b)(4)(i) of this section plus 
prices reasonably anticipated in the absence of the emergency and 
changes in prices and/or production costs due to the emergency;
    (iii) The information in paragraph (b)(4)(ii) of this section plus 
operating costs reasonably anticipated in the absence of the emergency;
    (iv) Any other information explaining the economic consequences of 
the emergency.
    (5) Re-certification of an emergency condition. Applicants for 
specific exemptions may submit re-certification

[[Page 320]]

applications relying on previously submitted information to satisfy the 
information requirements of paragraphs (a)(1) through (a)(10) of this 
section, and of paragraphs (b)(1) through (b)(4) of this section, where 
all of the following conditions are met:
    (i) An exemption was granted for the same pesticide at the same site 
to the same applicant the previous year;
    (ii) The emergency condition could reasonably be expected to 
continue for longer than 1 year;
    (iii) EPA has not declared the use ineligible for re-certification;
    (iv) The use is not subject to public notice pursuant to Sec. 
166.24(a)(1) through (a)(6);
    (v) The applicant certifies that all of the following are true:
    (A) The emergency condition described in the preceding year's 
application continues to exist;
    (B) Except as expressly identified, all information submitted in the 
preceding year's application is still accurate;
    (C) Except as expressly identified, the proposed conditions of use 
are identical to the conditions of use EPA approved for the preceding 
year;
    (D) Any conditions or limitations on the eligibility for re-
certification identified in the preceding year's notice of approval of 
the emergency exemption have been satisfied;
    (E) The applicant is not aware of any alternative chemical or non-
chemical practice that may offer a meaningful level of pest control, or 
has provided documentation that each such known practice does not 
provide adequate control or is not economically or environmentally 
feasible.
    (c) Information required for a quarantine exemption. An application 
for a quarantine exemption shall provide all of the following 
information concerning the nature of the emergency:
    (1) The scientific and common name of pest;
    (2) The origin of pest and the means of its introduction or spread 
if known; and
    (3) The anticipated impact of not controlling the pest.
    (d) Information required for a public health exemption. An 
application for a public health exemption shall provide all the 
following information concerning the nature of the emergency:
    (1) The scientific and common name of the pest to be controlled and, 
if the pest is a vector, a description of the disease it is expected to 
transmit;
    (2) A discussion of the magnitude of the health problems which are 
expected to occur without the pesticide use; and
    (3) Discussion of the availability of medical treatment for the 
health problem.

[51 FR 1902, Jan. 15, 1986, as amended at 58 FR 34203, June 23, 1993; 71 
FR 4511, Jan. 27, 2006]



Sec. 166.22  Consultation with the Secretary of Agriculture and Governors of 

the States.

    The Agency, in determining whether or not such emergency conditions 
exist, shall consult with the Secretary of Agriculture and the Governor 
of any State concerned if they request such determination.



Sec. 166.24  Public notice of receipt of application and opportunity for 

public comment.

    (a) Publication requirement. The Administrator shall issue a notice 
of receipt in the Federal Register for a specific, quarantine, or public 
health exemption and request public comment when any one of the 
following criteria is met:
    (1) The application proposes use of a new chemical;
    (2) The application proposes the first food use of an active 
ingredient;
    (3) The application proposes any use of a pesticide if the pesticide 
has been subject to a suspension notice under section 6(c) of the Act;
    (4) The application proposes use of a pesticide which:
    (i) Was the subject of a notice under section 6(b) of the Act and 
was subsequently cancelled, and
    (ii) Is intended for a use that poses a risk similar to the risk 
posed by any use of the pesticide which was the subject of the notice 
under section 6(b);
    (5) The application proposes use of a pesticide which:
    (i) Contains an active ingredient which is or has been the subject 
of a Special Review, and

[[Page 321]]

    (ii) Is intended for a use that could pose a risk similar to the 
risk posed by any use of the pesticide which is or has been the subject 
of the Special Review;
    (6) The application proposes use of a pesticide which:
    (i) Was voluntarily canceled under section 6(f) of the Act, and
    (ii) Is intended for a use that poses a risk similar to the risk 
posed by any use of the pesticide which was voluntarily canceled under 
section 6(f);
    (7) The application proposes use of a pesticide for a specific or 
public health exemption, if:
    (i) An emergency exemption has been requested or approved for that 
use in any 3 previous years, or any 5 previous years if the use is 
supported by the IR-4 program, and
    (ii) A complete application for registration of that use and/or a 
petition for tolerance for residues in or on the commodity has not been 
submitted to the Agency; or
    (8) The Administrator determines that publication of notice is 
appropriate.
    (b) Contents. The notice of receipt of an application for an 
emergency exemption shall contain the following information:
    (1) The name of the applicant;
    (2) The name of the active ingredient requested for use, including, 
if available, the common name and the Chemical Abstracts Service (CAS) 
number;
    (3) The total amount of product or active ingredient proposed for 
use;
    (4) The geographical location where treatment is proposed;
    (5) The proposed number of acres or other appropriate units proposed 
to be treated;
    (6) A summary of the applicant's description of the emergency 
conditions including the pest and the site or crop to be treated;
    (7) A description of the major conditions of use of the pesticide as 
proposed by the applicant;
    (8) If the pesticide proposed for use meets the criteria of 
paragraph (a) (3), (4), or (5) of this section, an identification of the 
types of risks that were the basis for EPA's regulatory action; and
    (9) The name, telephone number, and address of a person in the 
Agency who can provide further information.
    (c) Length of comment period. Normally, a notice of receipt shall 
give the public 15 days in which to file comments on the application. 
The Administrator may shorten or eliminate the comment period if he 
determines that the time available for a decision on the application 
requires it and shall state reasons for such action in a notice in the 
Federal Register. The Administrator may extend the comment period if 
additional time for comment is requested and such an extension would not 
interfere with a timely decision on the application.

[51 FR 1902, Jan. 15, 1986, as amended at 71 FR 4511, Jan. 27, 2006]



Sec. 166.25  Agency review.

    (a) General. The Agency will review all requests as expeditiously as 
possible, making every attempt to respond to requests prior to the time 
when the proposed use is needed. The Agency will review the application 
and other available data necessary to make a determination with respect 
to all of the following:
    (1) Whether an emergency condition exists or will exist;
    (2) The Agency's ability and intention to establish a time-limited 
tolerance(s) or exemption(s) from the requirement of a tolerance for any 
pesticide residues resulting from the authorized use, identifying the 
level of permissible residues in or on food or feed resulting from the 
proposed use;
    (3) The anticipated benefits to be derived from the proposed use; 
and
    (4) The potential risks to human health, endangered or threatened 
species, beneficial organisms, and the environment from the proposed 
use.
    (b) Criteria for approval. The Administrator may authorize a 
specific, public health, or quarantine exemption, based on the 
information available to the Agency, after:
    (1) He determines that:
    (i) An emergency condition exists;
    (ii) The use of the pesticide under the exemption will not cause 
unreasonable adverse effects on the environment;
    (iii) Registration of the pesticide use for which the exemption is 
requested has not been suspended under section 6(c) of the Act or 
cancelled following a notice under section 6(b) of the Act,

[[Page 322]]

unless the use is authorized in accordance with the provisions of 
Sec. Sec. 164.130 through 164.133 of this chapter;
    (2) Giving due consideration to:
    (i) Whether the pesticide is reasonably likely to be used in 
compliance with the requirements imposed by the Agency under the 
exemption; and
    (ii) The progress which has been made toward registration of the 
proposed use, if a repeated specific or public health exemption is 
sought. It shall be presumed that if a complete application for 
registration of a use, which has been under a specific or public health 
exemption for any 3 previous years, or any 5 previous years if the use 
is supported for registration by the IR-4 program, has not been 
submitted, reasonable progress towards registration has not been made.

[51 FR 1902, Jan. 15, 1986, as amended at 71 FR 4511, Jan. 27, 2006]



Sec. 166.28  Duration of exemption.

    (a) Specific or public health exemptions. EPA shall allow use of a 
pesticide under a specific or public health exemption for as long a 
period as is reasonably expected to be necessary but in no case for 
longer than 1 year.
    (b) Quarantine exemption. EPA shall allow use of a pesticide under a 
quarantine exemption for as long a period as is deemed necessary but in 
no case for longer than 3 years. Quarantine exemptions may be renewed. 
Interim reports containing the information specified in Sec. 166.32(b) 
to the extent available shall be filed annually.



Sec. 166.30  Notice of Agency decision.

    (a) Notification of applicants. The Agency shall notify an applicant 
of its decision to approve or deny an application request for an 
emergency exemption in a timely manner.
    (1) Incomplete applications. The Agency may discontinue the 
processing of any application that does not address all of the 
requirements of Sec. 166.20 until such time the additional information 
is submitted by the applicant.
    (2) Complete applications--(i) Denials. The Agency shall provide the 
specific reasons and rationale for denying the exemption request. If the 
denial is based on a specific information gap, the decision shall be 
reconsidered in a timely manner when the information gap is filled.
    (ii) Approvals. The Agency shall provide the specific terms and 
conditions under which the exempted pesticide may be used.
    (b) Federal Register publication. (1) At least quarterly, the 
Administrator shall issue a notice in the Federal Register announcing 
all approvals of specific, quarantine, and public health exemptions. The 
notice shall contain all of the following:
    (i) The name of the applicant;
    (ii) The pesticide authorized for use;
    (iii) The crop or site to be treated; and
    (iv) The name, address, and telephone number of a person in the 
Agency who can provide further information.
    (2) In addition, if EPA has issued a Notice of Receipt of an 
application for an exemption, it will issue a notice of its final 
decision and the reasons for that decision.

[51 FR 1902, Jan. 15, 1986, as amended at 71 FR 4512, Jan. 27, 2006]



Sec. 166.32  Reporting and recordkeeping requirements for specific, 

quarantine, and public health exemptions.

    (a) Unexpected adverse effects information. Any unexpected adverse 
effects resulting from the use of a pesticide under a specific, 
quarantine, or public health exemption must be immediately reported to 
the Agency.
    (b) Interim and final reports. A final report summarizing the 
results of pesticide use under any specific, quarantine, or public 
health exemption must be submitted to the Agency within 6 months from 
the expiration of the exemption unless otherwise specified by the 
Agency. For quarantine exemptions granted for longer than 1 year, 
interim reports must be submitted annually. When an application for 
renewal of the exemption is submitted before the expiration of the 
exemption or before submission of the final report, an interim report 
must be submitted with the application. The information in interim and 
final reports shall include all of the following:
    (1) Total acreage, amount of commodity or other unit treated and the 
total quantity of the pesticide used;

[[Page 323]]

    (2) A discussion of the effectiveness of the pesticide in dealing 
with the emergency condition;
    (3) A description of any unexpected adverse effects which resulted 
from use of the pesticide under the exemption;
    (4) The results of any monitoring required and/or carried out under 
the exemption;
    (5) A discussion of any enforcement actions taken in connection with 
the exemption;
    (6) Method(s) of disposition of a food crop, if required to be 
destroyed under an exemption; and
    (7) Any other information requested by the Administrator.
    (c) Records. Records for all treatments involving the first food use 
of a pesticide will be maintained by the agency to which the emergency 
exemption was granted for a minimum of 2 years following the date of 
expiration of the exemption. On request by the Agency these records 
shall be made available to the Administrator. Records will include all 
of the following:
    (1) Locations where the pesticide was applied;
    (2) Dates of application (range); and
    (3) Total quantity of the pesticide used.

[51 FR 1902, Jan. 15, 1986, as amended at 58 FR 34203, June 23, 1993; 71 
FR 4512, Jan. 27, 2006]



Sec. 166.34  EPA review of information obtained in connection with emergency 

exemptions.

    EPA shall review information submitted in connection with emergency 
exemptions and, when applicable, use it in connection with other 
regulatory decisions under the Act.



Sec. 166.35  Revocation or modification of exemptions.

    (a) Grounds. The Administrator may revoke or modify the terms or 
conditions of a specific, quarantine, or public health exemption if he 
determines one of the following:
    (1) An emergency no longer exists;
    (2) Use of the pesticide under the exemption may cause unreasonable 
adverse effects on the environment;
    (3) The pesticide authorized under the exemption is not effective at 
controlling the pest or conditions causing the emergency; or
    (4) The terms and conditions established by the exemption and these 
regulations are not being complied with.
    (b) Implementation. The revocation or modification becomes effective 
as soon as the Administrator notifies the State or Federal agency which 
submitted the application. Upon notification, the applicant is required 
immediately to take all necessary steps to assure that further use 
complies with the terms and conditions of any modification or, if the 
exemption has been revoked, to stop further use.



                       Subpart C_Crisis Exemptions



Sec. 166.40  Authorization.

    The head of a Federal or State agency, the Governor of a State, or 
their official designee, may issue a crisis exemption in situations 
involving an unpredictable emergency situation when:
    (a) An unpredictable emergency condition exists;
    (b) The time element with respect to the application of the 
pesticide is critical, and there is not sufficient time either to 
request a specific, quarantine, or public health exemption or, if such a 
request has been submitted, for EPA to complete review of the request; 
and
    (c) EPA has provided verbal confirmation that, for food uses, a 
tolerance or exemption from the requirement of a tolerance can be 
established in a timely manner, responsive to the projected timeframe of 
use of the chemical and harvest of the commodity, and that, for any use, 
the Agency has no other objection.

[51 FR 1902, Jan. 15, 1986, as amended at 71 FR 4512, Jan. 27, 2006]



Sec. 166.41  Limitations.

    The crisis provisions may not be utilized to authorize a pesticide 
use if any of the following has occurred:
    (a) EPA has informed the head of the Federal or State agency, the 
Governor, or their official designee, not to issue such an exemption;
    (b) The pesticide use has been suspended under section 6(c) of the 
Act;

[[Page 324]]

    (c) The pesticide use has been cancelled following a notice issued 
under section 6(b) of the Act;
    (d) The pesticide contains a new chemical; or
    (e) The application proposes the first food use of a pesticide.



Sec. 166.43  Notice to EPA and registrants or basic manufacturers.

    (a) Timing of notice. (1) The State or Federal Agency issuing the 
crisis exemption must notify the Administrator in advance of utilization 
of the crisis provisions.
    (2) The State or Federal agency issuing the crisis exemption shall 
notify the registrant(s) or, if appropriate, the basic manufacturer(s) 
of the pesticide(s) being used under the crisis exemption at the same 
time notice is given to EPA or as soon thereafter as possible.
    (b) Contents of notice. Information required to be provided in 
notices shall include all of the following:
    (1) The name of the product and active ingredient authorized for 
use, along with the common name and CAS number if available, including a 
copy of the EPA registered label and use directions appropriate to the 
authorized use;
    (2) The site on which the pesticide is to be used or is being used;
    (3) The use pattern;
    (4) The date on which the pesticide use is to begin and the date 
when the use will end;
    (5) An estimate of the level of residues of the pesticide expected 
to result from use under the crisis exemption;
    (6) Earliest anticipated harvest date of the treated commodity;
    (7) Description of the emergency situation; and
    (8) Any other pertinent information available at the time.

[51 FR 1902, Jan. 15, 1986, as amended at 58 FR 34203, June 23, 1993; 71 
FR 4512, Jan. 27, 2006]



Sec. 166.45  Duration of crisis exemption.

    A crisis exemption may be authorized for:
    (a) Only as long as is necessary to control the pest or conditions 
causing the emergency; and
    (b) No longer than 15 days, unless an application requesting a 
specific, quarantine, or public health exemption for this use has been 
submitted to the Agency.



Sec. 166.49  Public notice of crisis exemptions.

    (a) Periodic notices. At least quarterly, the Administrator shall 
issue a notice in the Federal Register announcing issuance of crisis 
exemptions. The notice shall contain all of the following:
    (1) The name of the applicant;
    (2) The pesticide authorized for use;
    (3) The crop or site to be treated; and
    (4) The name, address, and telephone number of a person in the 
Agency who can provide further information.
    (b) Annual reports. Annually, the Agency shall issue a notice in the 
Federal Register that shall summarize:
    (1) The number of crisis exemptions declared; and
    (2) The number of crisis exemptions revoked.

[51 FR 1902, Jan. 15, 1986, as amended at 71 FR 4512, Jan. 27, 2006]



Sec. 166.50  Reporting and recordkeeping requirements for crisis exemption.

    (a) Adverse effects information. Any adverse effects resulting from 
the use of a pesticide under a crisis exemption must be immediately 
reported to the Agency.
    (b) Final reports. (1) A report summarizing the results of treatment 
under a crisis exemption will be required to be submitted to the Agency 
within 3 months following the last date of treatment. If a specific, 
quarantine, or public health exemption has been approved while the 
crisis exemption is in effect, however, the crisis exemption report may 
be incorporated into the specific, quarantine, or public health 
exemption final report required under Sec. 166.32(b) and submitted at 
the time it is due.
    (2) Information to be included in the crisis exemption report 
includes the same information as required in Sec. 166.32(b) and an 
explanation as to why there was a need to utilize the crisis provisions.

[[Page 325]]

    (c) Records. Records will be maintained for a minimum of 2 years 
following the date of expiration of the exemption. On request by the 
Agency, these records shall be made available to the Administrator. 
Records will include all of the following:
    (1) Location where the pesticide was applied;
    (2) Dates of application (range); and
    (3) Total quantity of the pesticide used.

[51 FR 1902, Jan. 15, 1986, as amended at 58 FR 34203, June 23, 1993]



Sec. 166.53  EPA review of crisis exemption and revocation of authority.

    (a) Review. When a crisis exemption is about to be or has already 
been declared by a State or Federal agency, EPA will undertake an 
expedited review of the pesticide to determine if use of the pesticide 
may result in such unreasonable health or environmental risks that the 
crisis authority should not be exercised or the crisis exemption should 
be revoked.
    (b) Revocation--(1) Individual crisis exemptions. A crisis exemption 
for the use of a specific pesticide may be revoked if the Administrator 
determines that:
    (i) There are insufficient data to determine the risks posed from 
the use;
    (ii) Such action is necessary to protect man or the environment; or
    (iii) The State or Federal agency is not complying with the 
requirements of this subpart C.
    (2) State or Federal agency authority. The Administrator may revoke 
the authority of a State or Federal agency to issue crisis exemptions 
for any pesticide if he determines that:
    (i) Such action is necessary to protect man or the environment; or
    (ii) The State or Federal agency is not complying with the 
requirements of this subpart C.
    (c) Reason for revocation. The Agency shall provide the specific 
reasons for revoking an agency's authority to issue a crisis exemption 
and for revoking an issued crisis exemption.



PART 167_REGISTRATION OF PESTICIDE AND ACTIVE INGREDIENT PRODUCING 

ESTABLISHMENTS, SUBMISSION OF PESTICIDE REPORTS--Table of Contents



                      Subpart A_General Provisions

Sec.
167.3 Definitions.

                   Subpart B_Registration Requirements

167.20 Establishments requiring registration.

Subparts C-D [Reserved]

           Subpart E_Recordkeeping and Reporting Requirements

167.85 Reporting requirements.
167.90 Where to obtain and submit forms.

    Authority: 7 U.S.C. 136 (e) and (w).

    Source: 53 FR 35058, Sept. 8, 1988; 54 FR 32638, Aug. 9, 1989, 
unless otherwise noted.



                      Subpart A_General Provisions



Sec. 167.3  Definitions.

    Terms used in this part shall have the meanings set forth for such 
terms in the Federal Insecticide, Fungicide, and Rodenticide Act. In 
addition, when used in this part, the following terms shall have the 
meanings stated below:
    Act means the Federal Insecticide, Fungicide, and Rodenticide Act, 
as amended, 7 U.S.C. 136 et seq.
    Amount of pesticidal product means quantity, expressed in weight or 
volume of the product, and is to be reported in pounds for solid or 
semi-solid pesticides and active ingredients or gallons for liquid 
pesticides and active ingredients, or number of individual retail units 
for devices.
    Current production [sales or distribution] means amount of planned 
production in the calendar year in which the pesticides report is 
submitted, including new pesticidal products not previously sold or 
distributed.
    Custom blender means any establishment which provides the service of 
mixing pesticides to a customer's specifications, usually a 
pesticide(s)-fertilizer(s), pesticide-pesticide, or a pesticide-animal 
feed mixture, when: (1) The blend is prepared to the order of

[[Page 326]]

the customer and is not held in inventory by the blender; (2) the blend 
is to be used on the customer's property (including leased or rented 
property); (3) the pesticide(s) used in the blend bears end-use labeling 
directions which do not prohibit use of the product in such a blend; (4) 
the blend is prepared from registered pesticides; (b) the blend is 
delivered to the end-user along with a copy of the end-use labeling of 
each pesticide used in the blend and a statement specifying the 
composition of mixture; and (6) no other pesticide production activity 
is performed at the establishment.
    Device means any device or class of devices as defined by the Act 
and determined by the Administrator pursuant to section 25(c) to be 
subject to the provisions of section 7 of the Act.
    Establishment means any site where a pesticidal product, active 
ingredient, or device is produced, regardless of whether such site is 
independently owned or operated, and regardless of whether such site is 
domestic and producing a pesticidal product for export only, or whether 
the site is foreign and producing any pesticidal product for import into 
the United States.
    Past year means the calendar year immediately prior to that in which 
the report is submitted.
    Pesticidal product means a pesticide, active ingredient, or device.
    Pesticidal product report means information showing the types and 
amounts of pesticidal products which were: (1) Produced in the past 
calendar year; (2) produced in the current calendar year; and, (3) sold 
or distributed in the past calendar year. For active ingredients, the 
pesticidal product report must include information on the types and 
amounts of an active ingredient for which there is actual or 
constructive knowledge of its use or intended use as a pesticide. This 
pesticidal product report also pertains to those products produced for 
export only which must also be reported. A positive or a negative annual 
report is required in order to maintain registration for the 
establishment.
    Produce means to manufacture, prepare, propagate, compound, or 
process any pesticide, including any pesticide produced pursuant to 
section 5 of the Act, any active ingredient or device, or to package, 
repackage, label, relabel, or otherwise change the container of any 
pesticide or device.
    Producer means any person, as defined by the Act, who produces any 
pesticide, active ingredient, or device (including packaging, 
repackaging, labeling and relabeling).
    Sold or distributed means the aggregate amount of a pesticidal 
product released for shipment by the establishment in which the 
pesticidal product was produced.
    Type of pesticidal product refers to each individual product as 
identified by: the product name; EPA Registration Number (or EPA File 
Symbol, if any, for planned products, or Experimental Permit Number, if 
the pesticide is produced under an Experimental Use Permit); active 
ingredients; production type (technical, formulation, repackaging, 
etc.); and, market for which the product was produced (domestic, 
foreign, etc.). In cases where a pesticide is not registered, 
registration is not applied for, or the pesticide is not produced under 
an Experimental Use Permit, the term shall also include the chemical 
formulation.



                   Subpart B_Registration Requirements



Sec. 167.20  Establishments requiring registration.

    (a) Who must register. (1) Any establishment where a pesticidal 
product is produced must be registered with the Agency. This requirement 
does not apply to custom blenders as defined in this part.
    (2) Any establishment where a substance is produced must be 
registered with the Agency if the producer intends the substance to be 
used as an active ingredient of a pesticide, or has actual or 
constructive knowledge that the substance will be used by any person as 
an active ingredient of a pesticide.
    (3) Any domestic establishment producing a pesticidal product for 
export, or any unregistered pesticide, or any foreign establishment 
producing a pesticidal product for import into the United States must be 
registered. Also, any establishment, either foreign or

[[Page 327]]

domestic, which produces a pesticidal product for use under an 
Experimental Use Permit, FIFRA section 18 Emergency Exemption or section 
24(c) Special Local Needs registration, must be registered.
    (b) Information required. An applicant for establishment 
registration must submit the following information:
    (1) Name and address of the company.
    (2) The type of ownership (individual, partnership, cooperative 
association, corporation, or any organized group of persons whether 
incorporated or not).
    (3) The name and address of each producing establishment for which 
registration is sought.
    (c) When to apply. An application for establishment registration 
must be submitted, and an establishment registration number must be 
assigned by the Agency, before any production may occur at an 
establishment. In the case of an establishment which has not previously 
been required to be registered and is not currently registered, the 
producer must apply for establishment registration by submitting an 
application within 180 days after the effective date of this regulation.
    (d) Assignment of establishment registration number. The Agency will 
return incomplete or inaccurately completed applications to the 
applicant. If the application is complete and accurate, the Agency will 
register the establishment and assign a registration number to the 
establishment. The establishment registration number will be entered on 
the application, and a copy of the application will be returned to the 
applicant.
    (e) Amendment. If at any time after the first report there is a 
change in the information required to be submitted under paragraph (b) 
of this section, that new information must be reported to EPA, in 
writing on letterhead stationery or on forms supplied by the Agency, 
within 30 days after such change occurs.
    (f) Duration of registration. Establishment registration will remain 
effective provided pesticide reports are submitted annually pursuant to 
the requirements of this part. Failure to submit a report may result in 
termination of establishment registration, civil and/or criminal penalty 
assessments.

[53 FR 35058, Sept. 8, 1988; 54 FR 32638, Aug. 9, 1989, as amended at 58 
FR 34203, June 23, 1993]

Subparts C-D [Reserved]



           Subpart E_Recordkeeping and Reporting Requirements



Sec. 167.85  Reporting requirements.

    (a) Who must report. Each producer operating an establishment must 
submit the reports required by this section concerning any pesticide, 
active ingredient, or device produced at each establishment. Custom 
blenders are not required to report production to the Agency.
    (b) Information required. The pesticide report shall include the 
following: (1) Name and address of the establishment; (2) amount of each 
pesticidal product: (i) Produced during the past year; (ii) sold or 
distributed during the past year; (iii) estimated to be produced during 
the current year. The report shall only include those pesticidal 
products actually produced at the reporting establishment. Reports 
submitted by foreign-producing establishments shall cover only those 
pesticidal products exported to the United States.
    (c) How to report. The reports required by this section must be made 
on forms supplied by the Agency. It is the ultimate responsibility of 
companies to obtain, complete, and submit the form each year.
    (d) When to report. A producer operating an establishment must 
submit an initial report no later than 30 days after the first 
registration of each establishment the producer operates. Thereafter, 
the producer must submit an annual report on or before March 1 of each 
year, even if the producer has produced no pesticidal product for that 
reporting year.

[53 FR 35058, Sept. 8, 1988; 54 FR 32638, Aug. 9, 1989, as amended at 58 
FR 34203, June 23, 1993]

[[Page 328]]



Sec. 167.90  Where to obtain and submit forms.

    (a) Where to obtain forms. Any person may obtain blank forms for the 
applications and reports required by this part from any EPA Regional 
Office, or from the address listed in paragraph (b) of this section.
    (b) Where to submit applications and reports. Each producer 
operating an establishment, with the exception of those establishments 
not found at the same location as their company headquarters, must 
submit applications and reports required by this part to the EPA 
Regional Office which serves the area where the establishment is 
located. The list of Regional Office addresses is found in 40 CFR 1.7. 
Applications and reports for those establishments not found at the same 
location as their company headquarters to be submitted by the company 
headquarters to the Regional Office having jurisdiction over the State 
in which the company headquarters is located. A foreign producer who 
exports any pesticide product, device, or active ingredient to the 
United States must submit all applications and reports to:

U.S. Environmental Protection Agency, Office of Enforcement and 
Compliance Assurance, Office of Compliance, Agriculture and Ecosystems 
Division (2225A), Ariel Rios Building, 1200 Pennsylvania Avenue, N.W., 
Washington, DC 20460, ATTN: FIFRA Foreign Establishment Registration 
Contact.

[53 FR 35058, Sept. 8, 1988; 54 FR 32638, Aug. 9, 1989, as amended at 62 
FR 49620, Sept. 23, 1997; 65 FR 4577, Jan. 31, 2000]



PART 168_STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS--Table of 

Contents



Subpart A--General Provisions [Reserved]

                          Subpart B_Advertising

Sec.
168.22 Advertising of unregistered pesticides, unregistered uses of 
          registered pesticides and FIFRA section 24(c) registrations.

Subpart C [Reserved]

     Subpart D_Export Policy and Procedures for Exporting Pesticides

168.65 [Reserved]
168.66 Labeling of pesticide products and devices intended solely for 
          export.
168.67 Definitions.
168.68 Applicability.
168.69 Registered export pesticide products.
168.70 Unregistered export pesticide products.
168.71 Export pesticide devices.
168.75 Procedures for exporting unregistered pesticides--purchaser 
          acknowledgement statements.
168.85 Other export requirements.

    Authority: 7 U.S.C. 136-136y.

    Source: 54 FR 1125, Jan. 11, 1989, unless otherwise noted.

Subpart A--General Provisions [Reserved]



                          Subpart B_Advertising



Sec. 168.22  Advertising of unregistered pesticides, unregistered uses of 

registered pesticides and FIFRA section 24(c) registrations.

    (a) FIFRA sections 12(a)(1) (A) and (B) make it unlawful for any 
person to ``offer for sale'' any pesticide if it is unregistered, or if 
claims made for it as part of its distribution or sale differ 
substantially from any claim made for it as part of the statement 
required in connection with its registration under FIFRA section 3. EPA 
interprets these provisions as extending to advertisements in any 
advertising medium to which pesticide users or the general public have 
access.
    (b) EPA regards it as unlawful for any person who distributes, 
sells, offers for sale, holds for sale, ships, delivers for shipment, or 
receives and (having so received) delivers or offers to deliver any 
pesticide, to place or sponsor advertisements which recommend or suggest 
the purchase or use of:
    (1) Any pesticide for a use authorized under a FIFRA section 5 
experimental use permit (EUP).
    (2) Any pesticide for a use authorized under a FIFRA section 18 
emergency exemption, except for advertisements that:
    (i) Are placed in media which address primarily persons in the 
geographical area to which the exemption applies.

[[Page 329]]

    (ii) State the name and address of one or more retail dealers who 
stock the pesticide.
    (iii) Contain a prominent notice of the limitations on use under the 
section 18 emergency exemption.
    (3) Any pesticide for any use authorized only by a FIFRA section 
24(c) special local need registration, unless the advertisement contains 
a prominent notice of the limitations on use under the section 24(c) 
registrations.
    (4) Any unregistered pesticide for any use unless the advertisement 
is one permitted by paragraph (b) (2) or (3) of this section.
    (5) A registered pesticide product for an unregistered use, unless 
the advertisement is one permitted by paragraph (b) (2) or (3) of this 
section. However, as a matter of policy, the Agency will not regard as 
unlawful the advertisement of uses permitted by FIFRA section 2(ee) 
provided the product is not an antimicrobial pesticide targeted against 
human pathogens (see 51 FR 19174; May 28, 1986).
    (c) For purposes of paragraph (b) of this section, a ``prominent 
notice of the limitations on use'' is one which sets forth the 
limitations on use in a manner reasonably likely to be understood by 
persons to whom the advertisement is addressed. For printed advertising, 
this criterion will be met by a legend in 6-point or larger type.

Subpart C [Reserved]



     Subpart D_Export Policy and Procedures for Exporting Pesticides

    Source: 58 FR 9085, Feb. 18, 1993, unless otherwise noted.



Sec. 168.65  [Reserved]



Sec. 168.66  Labeling of pesticide products and devices intended solely for 

export.

    (a) This subpart describes the labeling requirements applicable to 
pesticide products and devices that are intended solely for export from 
the United States under the provisions of FIFRA section 17(a). The 
requirements for pesticide production reporting, recordkeeping and 
inspection and purchaser acknowledgement provisions can be found in the 
following parts:
    (1) Pesticide production reporting requirements under FIFRA section 
7 are located in part 167 of this chapter (as referenced in Sec. 
168.85(b));
    (2) Recordkeeping and inspection requirements under FIFRA section 8 
are located in part 169 of this chapter (as referenced in Sec. 
168.85(a));
    (3) Purchaser acknowledgement statement provisions under FIFRA 
section 17(a) are located in Sec. 168.75.
    (b) The labeling of pesticide products and devices intended solely 
for export must comply with the requirements in Sec. 156.10(a)(4) of 
this chapter.
    (c) The labeling of pesticide products and devices intended solely 
for export must comply with this regulation no later than January 21, 
2014.

[78 FR 4077, Jan. 18, 2013]



Sec. 168.67  Definitions.

    Terms used in this subpart have the same meanings as in the Act and 
as in Sec. 152.3 of this chapter, unless otherwise defined in this 
section.
    Export pesticide device means a device, as defined in FIFRA section 
2(h), that is intended solely for export from the United States to 
another country.
    Export pesticide product means a pesticide product, as defined in 
Sec. 152.3 of this chapter, that is intended solely for export from the 
United States to another country.

[78 FR 4077, Jan. 18, 2013]



Sec. 168.68  Applicability.

    This subpart applies to all export pesticide products and export 
pesticide devices that are exported for any purpose, including any 
research purpose.

[78 FR 4077, Jan. 18, 2013]



Sec. 168.69  Registered export pesticide products.

    (a) Each export pesticide product that is registered under FIFRA 
section 3 or FIFRA section 24(c) must bear labeling approved by EPA for 
its registration and comply with the requirements of Sec. 168.66(b).
    (b) For the purposes of this subpart, a registered export pesticide 
product is considered to be any of the following:

[[Page 330]]

    (1) A pesticide product of composition, packaging and labeling as 
described in its registration under FIFRA section 3;
    (2) A pesticide product that has been modified in compliance with 
the notification or non-notification provisions of Sec. 152.46 of this 
chapter, and any associated procedures issued under Sec. 156.10(e) of 
this chapter, regardless of whether such modification has been made for 
the pesticide product's registration under FIFRA section 3;
    (3) A pesticide product initially registered by a State under FIFRA 
section 24(c), and whose Federal registration has not been disapproved 
by EPA under Sec. 162.164 of this chapter.
    (c) The text of the labeling of the export pesticide product must be 
provided in English and, if applicable, the following foreign languages:
    (1) The predominant or official language of the country of final 
destination, if known; and
    (2) The predominant or official language of the importing country.

[78 FR 4077, Jan. 18, 2013]



Sec. 168.70  Unregistered export pesticide products.

    (a) Any export pesticide product that does not meet the terms of 
Sec. 168.69 is an unregistered export pesticide product for purposes of 
this subpart.
    (b) Each unregistered export pesticide product must bear labeling 
that complies with all requirements of this section and Sec. 168.66(b).
    (1) The labeling must comply with all of the prominence and 
legibility requirements of Sec. 156.10(a)(2) of this chapter.
    (2) The labeling must comply with all the language requirements in 
Sec. Sec. 168.69(c) and 156.10(a)(3) of this chapter.
    (3) The labeling must bear the following information:
    (i) The name and address of the producer, in accordance with the 
requirements of Sec. 156.10(c) of this chapter;
    (ii) The net weight or measure of contents, in accordance with the 
requirements of Sec. 156.10(d) of this chapter;
    (iii) The pesticide producing establishment number, in accordance 
with the requirements of Sec. 156.10(f) of this chapter;
    (iv) An ingredients statement, in accordance with the requirements 
of Sec. 156.10(g) of this chapter, except that:
    (A) The ingredients statement need not appear in a second language 
besides English if English is the official or predominant language in 
the importing country and the country of final destination, if known; 
and
    (B) An export pesticide product intended solely for research and 
development purposes, (and which bears the statement ``For research and 
development purposes only. Not for distribution, sale, or use,'' or 
similar language) may bear coded ingredient information to protect 
confidentiality.
    (v) Human hazard and precautionary statements in accordance with the 
requirements of subpart D of part 156 of this chapter. The statements 
must be true and accurate translations of the English statements.
    (vi) The statement ``Not Registered for Use in the United States of 
America,'' which may be amplified by additional statements accurately 
describing the reason(s) why the export pesticide product is not 
registered in the United States, or is not registered for particular 
uses in the United States.
    (c) This section also applies to all unregistered pesticide products 
and devices that are intended solely for export and that are 
transferred, distributed, or sold between registered establishments 
operated by the same producer according to Sec. 152.30(a) of this 
chapter if:
    (1) The transfer, distribution or sale occurs between a point in the 
United States and a point outside the United States, or
    (2) The transfer occurs within the United States solely for the 
purpose of export from the United States.

[78 FR 4077, Jan. 18, 2013]



Sec. 168.71  Export pesticide devices.

    (a) Each export pesticide device sold or distributed anywhere in the 
United States must bear labeling that complies with all requirements of 
this section and Sec. 168.66(b).
    (b) The labeling of each export pesticide device must meet all of 
the prominence and legibility requirements of Sec. 156.10(a)(2) of this 
chapter.

[[Page 331]]

    (c) The labeling must also comply with all the language requirements 
in Sec. 168.69(c) and Sec. 156.10(a)(3) of this chapter.
    (d) The labeling must bear the following information:
    (1) The name and address of the producer, meeting the requirements 
of Sec. 156.10(c) of this chapter;
    (2) The producing establishment number, meeting the requirements of 
Sec. 156.10(f) of this chapter;
    (3) The statement ``Not Registered for Use in the United States of 
America,'' which may be amplified by additional statements describing 
the reason why the export pesticide device is not registered in the 
United States, such as ``because pesticide devices are not required to 
be registered in the United States.''
    (e) An export pesticide device is not required to bear an 
ingredients statement.

[78 FR 4077, Jan. 18, 2013]



Sec. 168.75  Procedures for exporting unregistered pesticides--purchaser 

acknowledgement statements.

    This section describes how EPA interprets and will enforce 
requirements of FIFRA section 17(a)(2). Section 17(a)(2) provides that 
any person exporting a pesticide other than a pesticide registered for 
use under FIFRA section 3 or sold under FIFRA section 6(a)(1), shall 
obtain a statement signed by the foreign purchaser prior to export, 
acknowledging that the purchaser understands that such pesticide is not 
registered for use in the United States and cannot be sold in the United 
States. Section 17(a)(2) requires that a copy of the statement be 
transmitted to an appropriate official of the government of the 
importing country.
    (a) Products subject to the requirement. EPA will not consider an 
exporter of an unregistered pesticide to be in violation of FIFRA 
section 17(a)(2) if, prior to export of the pesticide, the exporter 
submits to EPA a statement signed by the foreign purchaser which affirms 
that the purchaser is aware that the pesticide is not registered for use 
in the United States and cannot be sold for use in the United States. 
The exporter must also include with the submission of the purchaser 
acknowledgement statement to EPA, a certification signed by the exporter 
affirming that the export did not occur until the statement signed by 
the foreign purchaser was obtained by the exporter. Except as provided 
in paragraph (b) of this section, all pesticide products produced for 
export which cannot be sold for use in the United States in the form 
that they are produced for export, are considered to be unregistered 
pesticides. This includes pesticides which are of a different 
formulation, including composition (except for variation within 
certified limits), or type of formulation, and pesticides which are 
packaged for use patterns for which they are not registered, which may 
be evidenced by package type or label use statements. This also includes 
unregistered products which are under development as pesticidal products 
and which are being exported for research testing.
    (b) Exceptions. Under the specific circumstances discussed below, 
EPA will not treat a registered product which has been modified slightly 
for export purposes, as unregistered for the purposes of the purchaser 
acknowledgement statement requirement. Any changes to the registered 
product for export purposes must be documented in accordance with the 
record-keeping requirements at Sec. 169.2 of this chapter and this 
policy.
    (1) Labeling on immediate product. EPA will not treat as 
unregistered for the purposes of section 17(a)(2), a registered 
pesticide product which cannot be sold or distributed for use in the 
United States because its immediate product container does not bear a 
label approved under a FIFRA section 3 registration, but which could be 
sold or distributed in the United States with the approved label 
attached to the immediate product container, provided that the label and 
labeling approved under a current FIFRA section 3 registration for the 
product is either attached to the immediate product container or 
accompanies the product at all times as supplemental labeling as 
provided in paragraph (c) of this section.
    (2) Packaging. (i) Certain changes may be made to a product's 
labeling or

[[Page 332]]

packaging without affecting the registration status of the product, as 
specified in Sec. 152.46(b) of this chapter and this policy. These 
changes include any changes in package size and label net contents, 
provided no change in use directions or requirement for child-resistant 
packaging would be necessary for the product to be registered for use in 
the United States. For example, if child-resistant packaging is required 
for a particular pesticide product in the United States, and the product 
will be exported without child-resistant packaging, the product would be 
considered unregistered and therefore subject to all the requirements of 
FIFRA section 17(a), as described in Sec. 168.75 of this chapter 
including the requirement for a purchaser acknowledgement statement.
    (ii) If an exporter needed to repackage a product in a size to meet 
a foreign purchaser's specifications, that modification would not affect 
the registration status of the export product. Other modifications to 
the label used for export purposes which will not affect the export 
product's registration status are: the use of metric units for net 
contents, dosages, and other numeric expressions; the use of a different 
format for the label, provided that the information does not contradict 
the U.S. label; revision of non-mandatory U.S. label statements, 
consistent with 40 CFR part 156, including additions or changes required 
by other Federal statutes or regulations; a change of the name or 
address of the registrant, except for a change resulting from transfer 
of ownership, which requires that a registrant keep his name and address 
current with the Agency; and any correction of typographical or printing 
errors that appeared on the U.S. labeling. (See Sec. 152.46(b)).
    (3) Labeling statements. The following statements which appear on 
any of the product labels or labeling will not affect the status of the 
product, provided that they do not contradict the approved FIFRA section 
3 labeling:
    (i) It is permissible to add explanatory language which accurately 
explains the meaning of a use classification. For example, the statement 
``restricted use pesticide'' may be expanded to read: ``Restricted in 
the United States of America to use by certified applicators'' or 
``Restricted Use Pesticide. In The United States this product is 
restricted to use by applicators determined by each state to be 
competent in pesticide application and the human health and 
environmental consequences of misuse.'' If the explanatory language 
falsely represents or is misleading regarding the U.S. use 
classification, the product will be considered misbranded. In addition, 
a use classification can only be listed if one has been assigned 
pursuant to the U.S. registration.
    (ii) An exporter who is also the manufacturer of a U.S. registered 
pesticide may add new uses to the label of that product for export 
purposes, without triggering the requirements of section 17(a)(2), as 
long as the new uses are within the same general use patterns as those 
for the registered product. The general pesticide use patterns are: 
terrestrial food crop and terrestrial non-food crop; greenhouse food 
crop and greenhouse nonfood crop; aquatic food crop and aquatic nonfood 
crop' indoor use' and forestry use. Adding new uses to the label which 
change the use pattern, such as changes from nonfood to food use, 
outdoor to indoor use, or terrestrial to aquatic use, render the product 
unregistered and subject to the requirements of section 17 for 
unregistered products. If the new use added to the label is a food or 
feed use, a tolerance must already be established for the use of that 
pesticide in or on that commodity.
    (4) Composition. EPA will not treat a registered product as 
unregistered for the purposes of the purchaser acknowledgement statement 
requirement under the following specific circumstances:
    (i) The formula of the exported product is within certified limits 
of the formula of the U.S. registered product.
    (ii) An exporter, who is also the manufacturer of a U.S. registered 
pesticide, may decrease the percentage of the active ingredient(s) of 
that product by adding a List 4 inert ingredient, without causing the 
product to be treated as ``unregistered'' and triggering the

[[Page 333]]

requirement to obtain a purchaser acknowledgement statement as a 
condition for export. In EPA's Policy Statement on Inert Ingredients in 
Pesticide Products, EPA included inert ingredients on List 4-a list of 
inert ingredients posing minimal hazard or risk-if the inert ingredients 
were generally regarded as innocuous. The provisions of this paragraph 
do not apply to those pesticide products intended for public health uses 
which are required or conditionally required to submit efficacy data 
pursuant to Sec. 158.400 or Sec. 161.640 of this chapter, as 
applicable. Any differences in formula or composition caused by adding a 
List 4 inert must be reflected in records which show the complete 
formula of the export product in accordance with the requirements of 
Sec. 169.2 and this policy.
    (iii) A change in the color or fragrance of the export product will 
not affect the product's registration status as long as the following 
conditions are met. The change in color must result only from the 
addition of a dye included on the list of the chemicals exempted from 
the requirement of a tolerance at 40 CFR 180.910, 180.920, 180.930, and 
180.950, and the dye must not be a List 1 inert. (List 1 inerts are 
those inerts which the Agency has identified as presenting toxicological 
concerns. The classification of inerts is explained in EPA's Policy 
Statement on Inert Ingredients in Pesticide Products. The change in 
fragrance must result only from the addition of a chemical included on 
the list of the chemicals exempted from the requirement of a tolerance 
at 40 CFR 180.910, 180.920, 180.930, and 180.950, and the chemical must 
not be a List 1 inert. The change in fragrance must not result in a 
pesticide product containing a food or food-like fragrance. (See ``Food 
Fragrances in Pesticide Formulations,'' EPA's Office of Pesticide 
Programs Policy and Criteria Notice number 2155.1, November 20, 1975.) 
Any difference in color or fragrance of the export product in accordance 
with this section must be reflected in records which show the complete 
formula of the export product in accordance with the requirements of 
Sec. 169.2 and this policy.
    (5) Research and development products. An unregistered pesticide 
product exported only for research and development purposes is subject 
to the notification requirements of this section, unless its use fits 
within the criteria described in this paragraph.
    (i) An unregistered pesticide product exported solely for research 
and development purposes will not be considered to be in violation of 
the notification requirements if the export of the research and 
development product:
    (A) Would not involve land uses of more than 10 acres (4.05 
hectares), or be used on or affect food or feed crops which are intended 
for consumption.
    (B) Would not involve aquatic uses of more than 1 acre (0.405 
hectares), or any aquatic uses which involve water used for irrigation, 
drinking or recreation, or be used on or affect plants or animals taken 
for food or feed from such waters.
    (C) Would not involve tests on animals intended for food or feed.
    (ii) Shipments to different purchasers, to different countries of 
final destination, or which occur more than a calendar year apart will 
be evaluated separately. When determining whether total shipments exceed 
the criteria described in this paragraph, EPA will evaluate the total 
amount of shipments by a single exporter during a calendar year for use 
in a particular country.
    (iii) An exporter bears the burden of demonstrating that the product 
meets these criteria before the research product is shipped. This may be 
met by documenting before the product is shipped and maintaining records 
for the time period required by Sec. 169.2(h) of this chapter from the 
date of the last shipment relevant to such records. The records to be 
maintained consist of:
    (A) The identity of the purchaser and country of intended use of the 
research product.
    (B) The amount shipped.
    (C) The intended research use by the purchaser, including the type 
of application site, rate of application, and measures taken for 
protection of humans from direct or dietary exposure.
    (c) Procedures. An exporter of an unregistered pesticide product 
must submit a purchaser acknowledgement statement to EPA containing the 
information stated in paragraph (c)(1) of

[[Page 334]]

this section, and a statement signed by the exporter certifying that the 
exportation did not occur until the signed acknowledgement statement had 
been obtained from the purchaser. If the foreign purchaser signs a 
purchaser acknowledgement statement in their own language, it must be 
accompanied by an English translation when it is submitted to EPA by the 
exporter. These statements shall be submitted in accordance with one of 
the two options for submission described in paragraph (c)(2) of this 
section.
    (1) Contents of the purchaser acknowledgement statements. The 
purchaser acknowledgement statement must include the following 
information in a format that is clearly understandable:
    (i) Name, address, and EPA identification number, if applicable, of 
the exporter.
    (ii) Name and address of the foreign purchaser.
    (iii) Identity of the product and the active ingredient(s), 
including:
    (A) The Chemical Abstract Services (CAS) Registry number for each 
active ingredient.
    (B) The chemical nomenclature for each active ingredient as used by 
the International Union of Pure and Applied Chemists (IUPAC).
    (C) Other known chemical or common names; or if the export involves 
a research product, a code name or identification number that can be 
used by EPA to identify the product from the exporter's records. If a 
code name or identification number is used, additional information must 
be attached to the certification statement submitted with the purchaser 
acknowledgement statement which will enable EPA to identify the product. 
This attached information may be claimed as confidential, and EPA will 
not forward this information with the purchaser acknowledgement 
statement to foreign governments.
    (iv) If known or reasonably ascertainable, the country or countries 
of final destination of the export shipment, i.e., where the exported 
pesticide is intended to be used, if different from the country of the 
foreign purchaser's address.
    (v) A statement that indicates that the foreign purchaser 
understands that the product is not registered for use in the United 
States and cannot be sold in the United States.
    (vi) The signature of the foreign purchaser.
    (vii) The date of the foreign purchaser's signature.
    (2) Reporting options. At the discretion of the exporter, the 
requirements of paragraph (c)(1) of this section may be met on a per-
shipment or annual basis, as stated in paragraphs (c)(2)(i) and 
(c)(2)(ii) of this section. If the procedures in paragraph (c)(2)(ii) of 
this section are not followed, EPA will consider paragraph (c)(2)(i) of 
this section, requiring pershipment purchaser acknowledgement 
statements, to be applicable in full. Where paragraph (c)(2)(i) of this 
section is applicable, each shipment which does not meet the 
requirements of that paragraph will be considered to be a separate 
violation of FIFRA.
    (i) Per-shipment purchaser acknowledgment statement. Unless the 
exporter chooses to follow the procedures described in paragraph 
(c)(2)(ii) of this section for the annual reporting procedures, the 
exporter must obtain and submit to EPA, a signed purchaser 
acknowledgement statement prior to each shipment of an unregistered 
pesticide according to the following procedures:
    (A) Prior to each shipment in a calendar year of an unregistered 
pesticide product to a particular purchaser in a foreign country, the 
exporter must provide the foreign purchaser with instructions about the 
required information on a purchaser acknowledgement statement, and 
inform the foreign purchaser that the pesticide product cannot be 
exported from the United States until the exporter has received from the 
foreign purchaser a properly completed, signed, and dated acknowledgment 
statement.
    (B) The exporter must obtain, prior to each shipment in a calendar 
year of an unregistered pesticide product to a particular purchaser in a 
foreign country, a signed purchaser acknowledgment statement which 
contains the information set forth in paragraph (c)(1) of this section.
    (C) The exporter must sign a statement certifying that export did 
not

[[Page 335]]

take place until a signed purchaser acknowledgement statement was 
received. The exporter must also specify the chemical identity of any 
research product which is referred to by code in the purchaser 
acknowledgement statement. The information regarding the specific 
identity of research products, which may be included in the statement or 
consist of an attachment to the certification, may be claimed as 
confidential.
    (D) The exporter must submit the signed acknowledgement statement 
from the foreign purchaser, and the accompanying certification by the 
exporter including attachments, to EPA within 7 working days of the 
exporter's receipt of the purchaser acknowledgement statement, or by the 
date of export, whichever occurs first. This information must be 
transmitted to the Office of Pesticide Programs' Document Processing 
Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b), 
Attention: Purchaser Acknowledgement Statement.
    (ii) Annual reporting procedures. Unless the exporter chooses to 
follow the per-shipment reporting option described in paragraph 
(c)(2)(i) of this section, the exporter must follow the procedures for 
annual summary reporting which include the requirement of a purchaser 
acknowledgement statement for the first shipment each calendar year of 
an unregistered pesticide product to a particular purchaser, and an 
annual summary of shipments to that purchaser. The annual summary 
reporting procedures are as follows:
    (A) Prior to the first shipment each calendar year of an 
unregistered pesticide product to a particular purchaser in a foreign 
country, the exporter must provide the foreign purchaser with 
instructions about the required information on a purchaser 
acknowledgement statement, and inform the foreign purchaser that the 
pesticide product cannot be exported from the United States until the 
exporter has received from the foreign purchaser a properly completed, 
signed, and dated purchaser acknowledgement statement.
    (B) The exporter must obtain, prior to the first shipment each 
calendar year of an unregistered pesticide product to a particular 
purchaser in a foreign country, a signed purchaser acknowledgement 
statement which contains the information set forth in paragraph (c)(1) 
of this section.
    (C) The exporter must sign a statement certifying that export did 
not take place until a signed purchaser acknowledgement statement was 
received, indicating that this statement is for the first shipment to a 
particular purchaser in a specific country for that calendar year, and 
that the exporter will meet all the purchaser acknowledgement statement 
requirements as described in this paragraph (c)(2)(ii) of this section. 
The exporter must also specify the chemical identity of any research 
product which is referred to by code in the purchaser acknowledgement 
statement. The information regarding the specific identity of research 
products, which may be included in the statement or consist of an 
attachment to the certification, may be claimed as confidential.
    (D) The exporter must submit the signed acknowledgement statement 
from the foreign purchaser, and the accompanying certification by the 
exporter including attachments, to EPA within 7 working days of the 
exporter's receipt of the purchaser acknowledgement statement, or by the 
date of export, whichever occurs first. This information must be 
transmitted to the Office of Pesticide Programs' Document Processing 
Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b), 
Attention: Purchaser Acknowledgement Statement.
    (E) The exporter, who has chosen to comply with the requirements of 
this paragraph instead of providing per-shipment purchaser 
acknowledgement statements in accordance with paragraph (c)(2)(i) of 
this section, must submit an annual summary report to EPA. An annual 
summary report is required for each unregistered pesticide exported 
within the preceding calendar year. The report must be in writing, 
signed by the exporter, and include the following information:
    (1) Name, address, and EPA identification number if applicable, of 
the exporter.
    (2) Name and address of the foreign purchaser, and the date the 
purchaser

[[Page 336]]

acknowledgement statement, submitted to EPA during the previous calendar 
year, was signed by the purchaser.
    (3) The identity of the product and the active ingredients, 
including: the Chemical Abstract Services (CAS) registry number for each 
active ingredient, the chemical nomenclature for each active ingredient 
used by the International Union of Pure and Applied Chemists (IUPAC), 
and other known chemical or common names, or if the export involves a 
research product, the code name or identification number that can be 
used by EPA to identify the product from the exporter's records.
    (4) The dates of each shipment of the pesticide exported to the 
foreign purchaser during that calendar year.
    (5) If known, or reasonably ascertainable, the country or countries 
of final destination of the export shipments, i.e., where the exported 
pesticide was intended to be used, if different from the foreign 
purchaser's address.
    (F) The exporter shall submit the annual summary no later than March 
1st of the following calendar year. The annual summary shall be sent to 
the Office of Pesticide Programs' Document Processing Desk at the 
appropriate address as set forth in 40 CFR 150.17(a) or (b), Attention: 
Annual Summary of Exports.
    (iii) Confidentiality claims. Persons submitting the information 
specified in the purchaser acknowledgement statement may assert a claim 
of business confidentiality by marking the information claimed 
confidential as ``FIFRA Confidential Business Information.'' Information 
so claimed will not be disclosed, with the exception of disclosure to 
the foreign governments, except in accordance with the procedures set 
forth in 40 CFR part 2, 7 U.S.C. 136(h), and this policy statement. If 
such claim is not asserted, EPA may disclose the information to the 
public without providing further notice prior to disclosure or an 
opportunity to object. Notwithstanding any claim of confidentiality, the 
purchaser acknowledgement statement will continue to be forwarded to the 
appropriate foreign government officials in its entirety, as required by 
section 17(a)(2).
    (3) Recordkeeping. Except as specifically stated, the requirement to 
retain records under part 169 of this chapter applies to all pesticide 
producers, regardless of whether a particular product is intended for 
export. All records shall be maintained in accordance with the time 
period required by Sec. 169.2(h) of this chapter. Producers must also 
maintain certain records pertaining to pesticide products intended for 
export. In addition to the requirement that a copy of the purchaser 
acknowledgement statement be kept, as stated at Sec. 169.2(h)(3) of 
this chapter, the following records must be maintained:
    (i) Copies of the instructions provided to foreign purchasers in 
accordance with paragraphs (c)(2)(i)(A) and (c)(2)(ii)(A) of this 
section.
    (ii) Copies of signed purchaser acknowledgement statements obtained 
according to paragraphs (c)(2)(i)(B) and (c)(2)(ii)(B) of this section.
    (iii) Copies of the certification from the exporter; and copies of 
any accompanying information regarding the identity of coded R&D 
products.
    (d) Agency transmission of purchaser acknowledgement statements. EPA 
will transmit a copy of each purchaser acknowledgement statement to the 
appropriate government official in each of the intended destination 
countries. After receipt of the Annual Summary the following calendar 
year, EPA will also transmit a copy of that document to the appropriate 
government official in each of the intended destination countries. In 
the case that no Annual Summary has been received within 30 days of the 
date at which such summary is required to be submitted, EPA will send 
written notification to the appropriate government official indicating 
that no summary was submitted, and may also take enforcement action 
against the exporter.

[58 FR 9085, Feb. 18, 1993, as amended at 69 FR 23117, Apr. 28, 2004; 71 
FR 35546, June 21, 2006; 72 FR 61029, Oct. 26, 2007]



Sec. 168.85  Other export requirements.

    This section describes other requirements found in regulations that 
apply to exporters of pesticides, devices, and

[[Page 337]]

active ingredients used in producing a pesticide.
    (a) Recordkeeping and inspection. Exporters of pesticides, devices 
and active ingredients must keep records and permit inspections of those 
records in accordance with part 169 of this chapter. Exporters must keep 
records of the product labeling used, including the EPA registered 
labeling, any foreign labeling on or attached to the product when 
shipped, and, as applicable, any supplemental labeling used. Producers 
of pesticides for export shall maintain these records in a manner that 
shows exactly which labels and labeling accompanied each shipment of a 
pesticide product to a foreign country. As stated at Sec. 168.75(c), 
when research product identity information appears on the labeling in an 
encoded manner, information translating the code shall be maintained in 
records. These records shall be maintained for the time period required 
by Sec. 169.2(h) of this chapter following the last export of such 
pesticides. All records required by part 169 of this chapter shall be 
made available for inspection and copying by EPA or its duly authorized 
representatives.
    (b) Pesticide production establishment requirements. Exporters of 
pesticides, devices, and active ingredients must submit annual reports 
to EPA in accordance with part 167 of this chapter, concerning those 
products that are exported. All products required to be labeled ``Not 
Registered for Use in the United States of America'' must be reported as 
unregistered production regardless of whether a purchaser 
acknowledgement statement is required.



PART 169_BOOKS AND RECORDS OF PESTICIDE PRODUCTION AND DISTRIBUTION--Table of 

Contents



Sec.
169.1 Definitions.
169.2 Maintenance of records.
169.3 Inspection.

    Authority: 7 U.S.C. 136f and 136w.

    Source: 45 FR 54338, Aug. 15, 1980, unless otherwise noted.



Sec. 169.1  Definitions.

    Terms used in this part shall have the meanings set forth for such 
terms in the Federal Insecticide, Fungicide, and Rodenticide Act, as 
amended. In addition, as used in this part, the following terms shall 
have the meanings set forth below:
    (a) Amount of pesticide or active ingredient. The term ``amount of 
pesticide or active ingredient'' means the weight or volume of the 
pesticide or active ingredient used in producing a pesticide expressed 
as weight for solid or semi-solid products and as weight or volume of 
liquid products.
    (b) Batch. The term ``batch'' means a quantity of a pesticide 
product or active ingredient used in producing a pesticide made in one 
operation or lot or if made in a continuous or semi-continuous process 
or cycle, the quantity produced during an interval of time to be 
specified by the producer.
    (c) Device. The term ``device'' means any device or class of device 
as defined by the Act and determined by the Administrator to be subject 
to the provisions of the Act.
    (d) Inability. The term ``inability'' means the incapacity of any 
person to maintain, furnish or permit access to any records under this 
Act and regulations, where such incapacity arises out of causes beyond 
the control and without the fault or negligence of such person. Such 
causes may include, but are not restricted to acts of God or of the 
public enemy, fires, floods, epidemics, quarantine restrictions, 
strikes, and unusually severe weather, but in every case, the failure 
must be beyond the control and without the fault or negligence of said 
person.
    (e) Producer. The term ``producer'' means the person, as defined by 
the Act, who produces or imports any pesticide or device or active 
ingredient used in producing a pesticide.



Sec. 169.2  Maintenance of records.

    All producers of pesticides, devices, or active ingredients used in 
producing pesticides subject to this Act, including pesticides produced 
pursuant to an experimental use permit and pesticides, devices, and 
pesticide active ingredients produced for export, shall maintain the 
following records:

[[Page 338]]

    (a) Records showing the product name, EPA Registration Number, 
Experimental Permit Number if the pesticide is produced under an 
Experimental Use Permit, amounts per batch and batch identification 
(numbers, letters, etc.) of all pesticides produced. In cases where the 
product is an active ingredient used in producing a pesticide or where 
the product is a pesticide which is not registered, is not the subject 
of an application for registration, or is not produced under an 
Experimental Use Permit, the records shall also show the complete 
formula. The batch identification shall appear on all production control 
records. These records shall be retained for a period of two (2) years.
    (b) Records showing the brand names and quantities of devices 
produced. These records shall be retained for a period of two (2) years.
    (c) Records showing the following information regarding the receipt, 
by the producer, of all pesticides, devices, and active ingredients used 
in producing pesticides:
    (1) Brand name of the pesticide or device, or common or chemical 
name of the pesticide active ingredient;
    (2) Name and address of shipper;
    (3) Name of delivering carrier;
    (4) Date received; and
    (5) Quantities received.

These records are not intended to cover receipt of pesticides used for 
in-plant maintenance, extermination, or sanitation programs, etc. 
Shipping and receiving documents such as invoices, freight bills, 
receiving tickets, etc., which provide the required information will be 
considered satisfactory for the purposes of this section. These records 
shall be retained for a period of two (2) years.
    (d) Records showing the following information regarding the shipment 
of all pesticides, devices, and active ingredients used in producing 
pesticides:
    (1) Brand name of pesticide or device, or the common or chemical 
name of the pesticide active ingredient;
    (2) Name and address of consignee;
    (3) Where the pesticide is produced pursuant to an experimental use 
permit (FIFRA section 5), a special exemption (section 18), or a special 
local need (section 24), the information required under these sections 
and any regulations promulgated thereto regarding the distribution of 
such pesticides;
    (4) Name of originating carrier;
    (5) Date shipped or delivered for shipment; and
    (6) Quantities shipped or delivered for shipment.

Such records are required regardless of whether any shipment or receipt 
of shipment is between plants owned or otherwise controlled by the same 
person. Shipping and receiving documents such as invoices, freight 
bills, receiving tickets, etc., which provide the required information 
will be considered satisfactory for purposes of this section. These 
records shall be retained for a period of two (2) years.
    (e) Inventory records with respect to the types and amounts of 
pesticides or pesticide active ingredients, or quantities of devices in 
stock which he has produced. These records may be disposed of when a 
more current inventory record is prepared.
    (f) Copies of all domestic advertising of the restricted uses of any 
pesticide registered for restricted use which the producer caused to 
have prepared, including any radio or television scripts for all such 
pesticides. These records shall be retained for a period of two (2) 
years.
    (g) Copies of all guarantees given pursuant to section 12(a)(2)(C) 
of the Act. These records shall be retained for a period of one (1) year 
after expiration of the guarantee.
    (h) In the case of all pesticides, devices, and active ingredients 
used in producing pesticides intended solely for export to any foreign 
country:
    (1) Copies of the specification or directions of the foreign 
purchaser for the production of such pesticides, devices, or pesticide 
active ingredients;
    (2) Copies of labels or labeling required to comply with section 
17(a)(1) of the Act; and
    (3) For any pesticide other than a pesticide registered under 
section 3 or sold under section 6(a)(1) of the Act, copies of a 
statement signed by the foreign purchaser of the pesticide acknowledging 
that the purchaser understands that such pesticide is not registered for 
use in the United States and

[[Page 339]]

cannot be sold in the United States under this Act.

These records shall be retained for a period of 2 years after expiration 
of the contract.
    (i) Records on the method of disposal (burial, incineration, etc.) 
date or dates of disposal, location of the disposal sites, and the types 
and amounts of pesticides or pesticide active ingredients disposed of by 
the producer or his contractor. With regard to the disposal of 
containers accumulated during production, the Agency will consider 
satisfactory a statement, attested to by a responsible firm official, 
describing in general terms the method and location of disposal, e.g., 
all containers are taken periodically to a certain site. Records of 
deviations from normal practice must be maintained. In addition, any 
records on the disposal of pesticides or pesticide active ingredients 
and/or containers specified pursuant to section 19 of the Act and any 
regulations promulgated thereto shall also be maintained. The above 
requirements apply to those products bearing label instructions for 
disposal and to any other products specified under any regulations 
promulgated pursuant to section 19. These records shall be retained for 
twenty (20) years or may be forwarded after three (3) years to the 
Environmental Protection Agency Regional Administrator for maintenance. 
Notwithstanding these record keeping requirements, whenever any producer 
of pesticides or pesticide active ingredients is complying with a rule 
promulgated under the authority of the Resource Conservation and 
Recovery Act of 1976 (RCRA) (Pub. L. 94-580, 90 Stat. 2795, October 21, 
1976), for the handling or disposal of hazardous wastes, as defined by 
RCRA or any regulations promulgated thereunder, such producer will no 
longer be required to maintain records in accordance with this 
subsection.
    (j) Records of any tests conducted on human beings whether performed 
by the producer himself or authorized and/or paid for by the producer. 
Such records shall include: The names and addresses of subjects tested, 
dates of tests, types of tests, written consent of subjects to test, and 
all information and instructions given to the subjects regarding the 
nature and purpose of the tests and of any physical and mental health 
consequences which were reasonably foreseen therefrom, and any adverse 
effects of the test on the subjects, including any such effects coming 
to the attention of the producer after completion of the tests. These 
records shall be retained for twenty (20) years or may be forwarded 
after three (3) years to the Environmental Protection Agency Regional 
Administrator for maintenance.
    (k) Records containing research data relating to registered 
pesticides including all test reports submitted to the Agency in support 
of registration or in support of a tolerance petition, all underlying 
raw data, and interpretations and evaluations thereof, whether in the 
possession of the producer or in the possession of the independent 
testing facility or laboratory (if any) which performed such tests on 
behalf of the producer. These records shall be retained as long as the 
registration is valid and the producer is in business.

[45 FR 54338, Aug. 15, 1980, as amended at 58 FR 9090, Feb. 18, 1993]



Sec. 169.3  Inspection.

    (a) Producers. Any producer of any pesticide, device, or active 
ingredient used in producing a pesticide which is subject to this Act 
shall, upon request of any officer or employee of the Agency or of any 
State or political subdivision, duly designated by the Administrator, 
furnish or permit such person at all reasonable times to have access to 
and to copy all records required to be maintained by this part, 
including records in the possession of an independent testing facility 
or laboratory which performed tests on behalf of the producer. Such 
inspection will be conducted in accordance with procedures detailed in 
section 8(b) of the Act.
    (b) Distributors, carriers, dealers, etc. Any distributor, carrier, 
dealer, or any other person who sells or offers for sale, delivers or 
offers for delivery any pesticide, device, or active ingredient used in 
producing a pesticide which is subject to this Act, shall, upon request 
of any officer or employee of the Agency or of any State or political 
subdivision, duly designated by the Administrator, furnish or permit 
such person

[[Page 340]]

at all reasonable times to have access to and copy all records showing 
the delivery or holding of such pesticide, device, or active ingredient 
used in producing a pesticide, including the quantity, the date of 
shipment and receipt, and the name and address of the consignor and 
consignee, and any guarantee received pursuant to section 12(b)(1) of 
the Act.
    (c) Confidentiality. Any record which is subject to the regulations 
under this part, and which may be confidential, shall be treated in 
accordance with the provisions of section 10 of the Act. The 
availability to the public of information provided to, or otherwise 
obtained by, the Administrator under this part shall be governed by part 
2 of this chapter.
    (d) Inability. (1) In the event of the inability of any person to 
produce records containing the information required to be maintained, 
furnished for inspection, or given access to, all other records and 
information regarding the same shall be provided.
    (2) Where no such inability exists and any such person fails to give 
access to and permit copying of such records as required, such failure 
shall be deemed a refusal to keep records required or a refusal to allow 
the inspection of any such records or both.



PART 170_WORKER PROTECTION STANDARD--Table of Contents



                      Subpart A_General Provisions

Sec.
170.1 Scope and purpose.
170.3 Definitions.
170.7 General duties and prohibited actions.
170.9 Violations of this part.

                     Subpart B_Standard for Workers

170.102 Applicability of this subpart.
170.103 Exceptions.
170.104 Exemptions.
170.110 Restrictions associated with pesticide applications.
170.112 Entry restrictions.
170.120 Notice of applications.
170.122 Providing specific information about applications.
170.124 Notice of applications to handler employers.
170.130 Pesticide safety training for workers.
170.135 Posted pesticide safety information.
170.150 Decontamination.
170.160 Emergency assistance.

                Subpart C_Standard for Pesticide Handlers

170.202 Applicability of this subpart.
170.203 Exceptions.
170.204 Exemptions.
170.210 Restrictions during applications.
170.222 Providing specific information about applications.
170.224 Notice of applications to agricultural employers.
170.230 Pesticide safety training for handlers.
170.232 Knowledge of labeling and site-specific information.
170.234 Safe operation of equipment.
170.235 Posted pesticide safety information.
170.240 Personal protective equipment.
170.250 Decontamination.
170.260 Emergency assistance.

    Authority: 7 U.S.C. 136w.

    Source: 57 FR 38151, Aug. 21, 1992, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 170.1  Scope and purpose.

    This part contains a standard designed to reduce the risks of 
illness or injury resulting from workers' and handlers' occupational 
exposures to pesticides used in the production of agricultural plants on 
farms or in nurseries, greenhouses, and forests and also from the 
accidental exposure of workers and other persons to such pesticides. It 
requires workplace practices designed to reduce or eliminate exposure to 
pesticides and establishes procedures for responding to exposure-related 
emergencies.



Sec. 170.3  Definitions.

    Terms used in this part have the same meanings they have in the 
Federal Insecticide, Fungicide, and Rodenticide Act, as amended. In 
addition, the following terms, when used in this part, shall have the 
following meanings:
    Agricultural employer means any person who hires or contracts for 
the services of workers, for any type of compensation, to perform 
activities related to the production of agricultural plants, or any 
person who is an owner of or is responsible for the management

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or condition of an agricultural establishment that uses such workers.
    Agricultural establishment means any farm, forest, nursery, or 
greenhouse.
    Agricultural plant means any plant grown or maintained for 
commercial or research purposes and includes, but is not limited to, 
food, feed, and fiber plants; trees; turfgrass; flowers, shrubs; 
ornamentals; and seedlings.
    Chemigation means the application of pesticides through irrigation 
systems.
    Commercial pesticide handling establishment means any establishment, 
other than an agricultural establishment, that:
    (1) Employs any person, including a self-employed person, to apply 
on an agricultural establishment, pesticides used in the production of 
agricultural plants.
    (2) Employs any person, including a self-employed person, to perform 
on an agricultural establishment, tasks as a crop advisor.
    Crop advisor means any person who is assessing pest numbers or 
damage, pesticide distribution, or the status or requirements of 
agricultural plants. The term does not include any person who is 
performing hand labor tasks.
    Early entry means entry by a worker into a treated area on the 
agricultural establishment after a pesticide application is complete, 
but before any restricted-entry interval for the pesticide has expired.
    Farm means any operation, other than a nursery or forest, engaged in 
the outdoor production of agricultural plants.
    Forest means any operation engaged in the outdoor production of any 
agricultural plant to produce wood fiber or timber products.
    Fumigant means any pesticide product that is a vapor or gas, or 
forms a vapor or gas on application, and whose method of pesticidal 
action is through the gaseous state.
    Greenhouse means any operation engaged in the production of 
agricultural plants inside any structure or space that is enclosed with 
nonporous covering and that is of sufficient size to permit worker 
entry. This term includes, but is not limited to, polyhouses, mushroom 
houses, rhubarb houses, and similar structures. It does not include such 
structures as malls, atriums, conservatories, arboretums, or office 
buildings where agricultural plants are present primarily for aesthetic 
or climatic modification.
    Hand labor means any agricultural activity performed by hand or with 
hand tools that causes a worker to have substantial contact with 
surfaces (such as plants, plant parts, or soil) that may contain 
pesticide residues. These activities include, but are not limited to, 
harvesting, detasseling, thinning, weeding, topping, planting, sucker 
removal, pruning, disbudding, roguing, and packing produce into 
containers in the field. Hand labor does not include operating, moving, 
or repairing irrigation or watering equipment or performing the tasks of 
crop advisors.
    Handler means any person, including a self-employed person:
    (1) Who is employed for any type of compensation by an agricultural 
establishment or commercial pesticide handling establishment to which 
subpart C of this part applies and who is:
    (i) Mixing, loading, transferring, or applying pesticides.
    (ii) Disposing of pesticides or pesticide containers.
    (iii) Handling opened containers of pesticides.
    (iv) Acting as a flagger.
    (v) Cleaning, adjusting, handling, or repairing the parts of mixing, 
loading, or application equipment that may contain pesticide residues.
    (vi) Assisting with the application of pesticides.
    (vii) Entering a greenhouse or other enclosed area after the 
application and before the inhalation exposure level listed in the 
labeling has been reached or one of the ventilation criteria established 
by this part (Sec. 170.110(c)(3)) or in the labeling has been met:
    (A) To operate ventilation equipment.
    (B) To adjust or remove coverings used in fumigation.
    (C) To monitor air levels.
    (viii) Entering a treated area outdoors after application of any 
soil fumigant to adjust or remove soil coverings such as tarpaulins.
    (ix) Performing tasks as a crop advisor:

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    (A) During any pesticide application.
    (B) Before the inhalation exposure level listed in the labeling has 
been reached or one of the ventilation criteria established by this part 
(Sec. 170.110(c)(3)) or in the labeling has been met.
    (C) During any restricted-entry interval.
    (2) The term does not include any person who is only handling 
pesticide containers that have been emptied or cleaned according to 
pesticide product labeling instructions or, in the absence of such 
instructions, have been subjected to triple-rinsing or its equivalent.
    Handler employer means any person who is self-employed as a handler 
or who employs any handler, for any type of compensation.
    Immediate family includes only spouse, children, stepchildren, 
foster children, parents, stepparents, foster parents, brothers, and 
sisters.
    Nursery means any operation engaged in the outdoor production of any 
agricultural plant to produce cut flowers and ferns or plants that will 
be used in their entirety in another location. Such plants include, but 
are not limited to, flowering and foliage plants or trees; tree 
seedlings; live Christmas trees; vegetable, fruit, and ornamental 
transplants; and turfgrass produced for sod.
    Owner means any person who has a present possessory interest (fee, 
leasehold, rental, or other) in an agricultural establishment covered by 
this part. A person who has both leased such agricultural establishment 
to another person and granted that same person the right and full 
authority to manage and govern the use of such agricultural 
establishment is not an owner for purposes of this part.
    Restricted-entry interval means the time after the end of a 
pesticide application during which entry into the treated area is 
restricted.
    Treated area means any area to which a pesticide is being directed 
or has been directed.
    Worker means any person, including a self-employed person, who is 
employed for any type of compensation and who is performing activities 
relating to the production of agricultural plants on an agricultural 
establishment to which subpart B of this part applies. While persons 
employed by a commercial pesticide handling establishment are performing 
tasks as crop advisors, they are not workers covered by the requirements 
of subpart B of this part.



Sec. 170.7  General duties and prohibited actions.

    (a) General duties. The agricultural employer or the handler 
employer, as appropriate, shall:
    (1) Assure that each worker subject to subpart B of this part or 
each handler subject to subpart C of this part receives the protections 
required by this part.
    (2) Assure that any pesticide to which subpart C of this part 
applies is used in a manner consistent with the labeling of the 
pesticide, including the requirements of this part.
    (3) Provide, to each person who supervises any worker or handler, 
information and directions sufficient to assure that each worker or 
handler receives the protections required by this part. Such information 
and directions shall specify which persons are responsible for actions 
required to comply with this part.
    (4) Require each person who supervises any worker or handler to 
assure compliance by the worker or handler with the provisions of this 
part and to assure that the worker or handler receives the protections 
required by this part.
    (b) Prohibited actions. The agricultural employer or the handler 
employer shall not take any retaliatory action for attempts to comply 
with this part or any action having the effect of preventing or 
discouraging any worker or handler from complying or attempting to 
comply with any requirement of this part.



Sec. 170.9  Violations of this part.

    (a) Under the Federal Insecticide, Fungicide, and Rodenticide Act (7 
U.S.C. 136 et seq.) (FIFRA) section 12(a)(2)(G) it is unlawful for any 
person ``to use any registered pesticide in a manner inconsistent with 
its labeling.'' When this part is referenced on a label,

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users must comply with all of its requirements except those that are 
inconsistent with product-specific instructions on the labeling. For the 
purposes of this part, EPA interprets the term ``use'' to include:
    (1) Preapplication activities, including, but not limited to:
    (i) Arranging for the application of the pesticide;
    (ii) Mixing and loading the pesticide; and
    (iii) Making necessary preparations for the application of the 
pesticide, including responsibilities related to worker notification, 
training of handlers, decontamination, use and care of personal 
protective equipment, emergency information, and heat stress management.
    (2) Application of the pesticide.
    (3) Post-application activities necessary to reduce the risks of 
illness and injury resulting from handlers' and workers' occupational 
exposures to pesticide residues during the restricted-entry interval 
plus 30 days. These activities include, but are not limited to, 
responsibilities related to worker training, notification, and 
decontamination.
    (4) Other pesticide-related activities, including, but not limited 
to, providing emergency assistance, transporting or storing pesticides 
that have been opened, and disposing of excess pesticides, spray mix, 
equipment wash waters, pesticide containers, and other pesticide-
containing materials.
    (b) A person who has a duty under this part, as referenced on the 
pesticide product label, and who fails to perform that duty, violates 
FIFRA section 12(a)(2)(G) and is subject to a civil penalty under 
section 14. A person who knowingly violates section 12(a)(2)(G) is 
subject to section 14 criminal sanctions.
    (c) FIFRA section 14(b)(4) provides that a person is liable for a 
penalty under FIFRA if another person employed by or acting for that 
person violates any provision of FIFRA. The term ``acting for'' includes 
both employment and contractual relationships.
    (d) The requirements of this part, including the decontamination 
requirements, shall not, for the purposes of section 653(b)(1) of title 
29 of the U.S. Code, be deemed to be the exercise of statutory authority 
to prescribe or enforce standards or regulations affecting the general 
sanitary hazards addressed by the OSHA Field Sanitation Standard, 29 CFR 
1928.110, or other agricultural, nonpesticide hazards.



                     Subpart B_Standard for Workers



Sec. 170.102  Applicability of this subpart.

    Except as provided by Sec. Sec. 170.103 and 170.104, this subpart 
applies when any pesticide product is used on an agricultural 
establishment in the production of agricultural plants.

[60 FR 21952, May 3, 1995]



Sec. 170.103  Exceptions.

    Exceptions. This subpart does not apply when any pesticide is 
applied on an agricultural establishment in the following circumstances:
    (a) For mosquito abatement, Mediterranean fruit fly eradication, or 
similar wide-area public pest control programs sponsored by governmental 
entities;
    (b) On livestock or other animals, or in or about animal premises;
    (c) On plants grown for other than commercial or research purposes, 
which may include plants in habitations, home fruit and vegetable 
gardens, and home greenhouses;
    (d) On plants that are in ornamental gardens, parks, and public or 
private lawns and grounds that are intended only for aesthetic purposes 
or climatic modification;
    (e) By injection directly into agricultural plants. Direct injection 
does not include ``hack and squirt,'' ``frill and spray,'' chemigation, 
soil-incorporation, or soil-injection;
    (f) In a manner not directly related to the production of 
agricultural plants, including, but not limited to, structural pest 
control, control of vegetation along rights-of-way and in other noncrop 
areas, and pasture and rangeland use;
    (g) For control of vertebrate pests;
    (h) As attractants or repellents in traps;

[[Page 344]]

    (i) On the harvested portions of agricultural plants or on harvested 
timber; and
    (j) For research uses of unregistered pesticides.

[57 FR 38151, Aug. 21, 1992. Redesignated at 60 FR 21952, May 3, 1995]



Sec. 170.104  Exemptions.

    The workers listed in this section are exempt from the specified 
provisions of this subpart.
    (a) Owners of agricultural establishments. (1) The owner of an 
agricultural establishment is not required to provide to himself or 
members of his immediate family who are performing tasks related to the 
production of agricultural plants on their own agricultural 
establishment the protections of:
    (i) Section 170.112(c)(5) through (9).
    (ii) Section 170.112(c)(5) through (9) as referenced in Sec. Sec. 
170.112(d)(2)(iii) and 170.112(e).
    (iii) Section 170.120.
    (iv) Section 170.122.
    (v) Section 170.130.
    (vi) Section 170.135.
    (vii) Section 170.150.
    (viii) Section 170.160.
    (2) The owner of the agricultural establishment must provide the 
protections listed in paragraph (a)(1)(i) through (viii) of this section 
to other workers and other persons who are not members of his immediate 
family.
    (b) Crop advisors. (1) Provided that the conditions of paragraph 
(b)(2) of this section are met, a person who is certified or licensed as 
a crop advisor by a program acknowledged as appropriate in writing by 
EPA or a State or Tribal lead agency for pesticide enforcement, and 
persons performing crop advising tasks under such qualified crop 
advisor's direct supervision, are exempt from the provisions of:
    (i) Section 170.150.
    (ii) Section 170.160.

A person is under the direct supervision of a crop advisor when the crop 
advisor exerts the supervisory controls set out in paragraphs 
(b)(2)(iii) and (iv) of this section. Direct supervision does not 
require that the crop advisor be physically present at all times, but 
the crop advisor must be readily accessible to the employees at all 
times.
    (2) Conditions of exemption. (i) The certification or licensing 
program requires pesticide safety training that includes, at least, all 
the information in Sec. 170.230(c)(4).
    (ii) Applies only when performing crop advising tasks in the treated 
area.
    (iii) The crop advisor must make specific determinations regarding 
the appropriate personal protective equipment, appropriate 
decontamination supplies, and how to conduct the tasks safely. The crop 
advisor must convey this information to each person under his direct 
supervision in a language that the person understands.
    (iv) Before entering a treated area, the certified or licensed crop 
advisor must inform, through an established practice of communication, 
each person under his direct supervision of the pesticide product and 
active ingredient(s) applied, method of application, time of 
application, the restricted entry interval, which tasks to undertake, 
and how to contact the crop advisor.

[60 FR 21952, May 3, 1995, as amended at 73 FR 75598, Dec. 12, 2008]



Sec. 170.110  Restrictions associated with pesticide applications.

    (a) Farms and forests. During the application of any pesticide on a 
farm or in a forest, the agricultural employer shall not allow or direct 
any person, other than an appropriately trained and equipped handler, to 
enter or to remain in the treated area.
    (b) Nurseries. In a nursery, during any pesticide application 
described in column A of Table 1 of this paragraph, the agricultural 
employer shall not allow or direct any person, other than an 
appropriately trained and equipped handler, to enter or to remain in the 
area specified in column B of Table 1 of this paragraph. After the 
application is completed, until the end of any restricted-entry 
interval, the entry-restricted area is the treated area.

[[Page 345]]



      Table 1--Entry-Restricted Areas in Nurseries During Pesticide
                              Applications
------------------------------------------------------------------------
                                              B. Workers are Prohibited
   A. During Application of a Pesticide:                 in:
------------------------------------------------------------------------
(1)(a) Applied:                              Treated area plus 100 feet
                                              in all directions on the
                                              nursery
    (i) Aerially, or
    (ii) In an upward direction, or
    (iii) Using a spray pressure greater
     than 150 psi, or
  (b) Applied as a:
    (i) Fumigant, or
    (ii) Smoke, or
    (iii) Mist, or
    (iv) Fog, or
    (v) Aerosol.
(2)(a) Applied downward using:               Treated are plus 25 feet in
                                              all directions on the
                                              nursery
    (i) A height of greater than 12 inches
     from the planting medium, or
    (ii) A fine spray, or
    (iii) A spray pressure greater than 40
     psi and less than 150 psi.
  (b) Not as in 1 or 2(a) above but for
   which a respiratory protection device is
   required for application by the product
   labeling.
(3) Applied otherwise.                       Treated area
------------------------------------------------------------------------

    (c) Greenhouses. (1) When a pesticide application described in 
column A of Table 2 under paragraph (c)(4) of this section takes place 
in a greenhouse, the agricultural employer shall not allow or direct any 
person, other than an appropriately trained and equipped handler, to 
enter or to remain in the area specified in column B of Table 2 until 
the time specified in column C of Table 2 has expired.
    (2) After the time specified in column C of Table 2 under paragraph 
(c)(4) of this section has expired, until the expiration of any 
restricted-entry interval, the agricultural employer shall not allow or 
direct any worker to enter or to remain in the treated area as specified 
in column D of Table 2 under paragraph (c)(4) of this section, except as 
provided in Sec. 170.112.
    (3) When column C of Table 2 under paragraph (c)(4) of this section 
specifies that ventilation criteria must be met, ventilation shall 
continue until the air concentration is measured to be equal to or less 
than the inhalation exposure level the labeling requires to be achieved. 
If no inhalation exposure level is listed on the labeling, ventilation 
shall continue until after:
    (i) Ten air exchanges are completed; or
    (ii) Two hours of ventilation using fans or other mechanical 
ventilating systems; or
    (iii) Four hours of ventilation using vents, windows or other 
passive ventilation; or
    (iv) Eleven hours with no ventilation followed by 1 hour of 
mechanical ventilation; or
    (v) Eleven hours with no ventilation followed by 2 hours of passive 
ventilation; or
    (vi) Twenty-four hours with no ventilation.
    (4) The following Table 2 applies to paragraphs (c) (1), (2), and 
(3) of this section.

                  Table 2--Greenhouse Entry Restrictions Associated With Pesticide Applications
----------------------------------------------------------------------------------------------------------------
                                                                                         D. After the Expiration
                                                                                           of Time in Column C
                                            B. Workers are                                Until the Restricted-
   A. When a Pesticide is Applied:          Prohibited in:             C. Until:         Entry Interval Expires,
                                                                                           the Entry-Restricted
                                                                                                 Area is:
----------------------------------------------------------------------------------------------------------------
(1) As a fumigant                      Entire greenhouse plus   The ventilation          No entry restrictions
                                        any adjacent structure   criteria of paragraph    after criteria in
                                        that cannot be sealed    (c)(3) of this section   column C are met
                                        off from the treated     are met
                                        area
(2) As a                               Entire enclosed area     The ventilation          Entire enclosed area is
                                                                 criteria of paragraph    the treated area
                                                                 (c)(3) of this section
                                                                 are met
  (i) Smoke, or
  (ii) Mist, or
  (iii) Fog, or

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  (iv) Aerosol
(3) Not in 1 or 2 above, and for       Entire enclosed area     The ventilation          Treated area
 which a respiratory protection                                  criteria of paragraph
 device is required for application                              (c)(3) of this section
 by the product labeling                                         are met
(4) Not in 1, 2, or 3 above, and:      Treated area plus 25     Application is complete  Treated area
                                        feet in all directions
                                        in the enclosed area
  (i) From a height of greater than
   12 in. from the planting medium,
   or
  (ii) As a fine spray, or
  (iii) Using a spray pressure
   greater than 40 psi
(5) Otherwise                          Treated area             Application is complete  Treated area
----------------------------------------------------------------------------------------------------------------



Sec. 170.112  Entry restrictions.

    (a) General restrictions. (1) After the application of any pesticide 
on an agricultural establishment, the agricultural employer shall not 
allow or direct any worker to enter or to remain in the treated area 
before the restricted-entry interval specified on the pesticide labeling 
has expired, except as provided in this section.
    (2) Entry-restricted areas in greenhouses are specified in column D 
in table 2 under Sec. 170.110(c)(4).
    (3) When two or more pesticides are applied at the same time, the 
restricted-entry interval shall be the longest of the applicable 
intervals.
    (4) The agricultural employer shall assure that any worker who 
enters a treated area under a restricted-entry interval as permitted by 
paragraphs (c), (d), and (e) of this section uses the personal 
protective equipment specified in the product labeling for early-entry 
workers and follows any other requirements on the pesticide labeling 
regarding early entry.
    (b) Exception for activities with no contact. A worker may enter a 
treated area during a restricted-entry interval if the agricultural 
employer assures that both of the following are met:
    (1) The worker will have no contact with anything that has been 
treated with the pesticide to which the restricted-entry interval 
applies, including, but not limited to, soil, water, air, or surfaces of 
plants; and
    (2) No such entry is allowed until any inhalation exposure level 
listed in the labeling has been reached or any ventilation criteria 
established by Sec. 170.110(c)(3) or in the labeling have been met.
    (c) Exception for short-term activities. A worker may enter a 
treated area during a restricted-entry interval for short-term 
activities if the agricultural employer assures that the following 
requirements are met:
    (1) No hand labor activity is performed.
    (2) The time in treated areas under a restricted-entry interval for 
any worker does not exceed 1 hour in any 24-hour period.
    (3) No such entry is allowed for the first 4 hours following the end 
of the application, and no such entry is allowed thereafter until any 
inhalation exposure level listed in the labeling has been reached or any 
ventilation criteria established by Sec. 170.110(c)(3) or in the 
labeling have been met.
    (4) The personal protective equipment specified on the product 
labeling

[[Page 347]]

for early entry is provided to the worker. Such personal protective 
equipment shall conform to the following standards:
    (i) Personal protective equipment (PPE) means devices and apparel 
that are worn to protect the body from contact with pesticides or 
pesticide residues, including, but not limited to, coveralls, chemical-
resistant suits, chemical-resistant gloves, chemical-resistant footwear, 
respiratory protection devices, chemical-resistant aprons, chemical-
resistant headgear, and protective eyewear.
    (ii) Long-sleeved shirts, short-sleeved shirts, long pants, short 
pants, shoes, socks, and other items of work clothing are not considered 
personal protective equipment for the purposes of this section and are 
not subject to the requirements of this section, although pesticide 
labeling may require that such work clothing be worn during some 
activities.
    (iii) When ``chemical-resistant'' personal protective equipment is 
specified by the product labeling, it shall be made of material that 
allows no measurable movement of the pesticide being used through the 
material during use.
    (iv) When ``waterproof'' personal protective equipment is specified 
by the product labeling, it shall be made of material that allows no 
measurable movement of water or aqueous solutions through the material 
during use.
    (v) When a ``chemical-resistant suit'' is specified by the product 
labeling, it shall be a loose-fitting, one- or two-piece, chemical-
resistant garment that covers, at a minimum, the entire body except 
head, hands, and feet.
    (vi) When ``coveralls'' are specified by the product labeling, they 
shall be a loose-fitting, one- or two-piece garment, such as a cotton or 
cotton and polyester coverall, that covers, at a minimum, the entire 
body except head, hands, and feet. The pesticide product labeling may 
specify that the coveralls be worn over a layer of clothing. If a 
chemical-resistant suit is substituted for coveralls, it need not be 
worn over a layer of clothing.
    (vii)(A) Gloves shall be of the type specified on the pesticide 
product labeling. Gloves made of leather, cotton, or other absorbent 
materials must not be worn for early-entry activities, unless gloves 
made of these materials are listed as acceptable for such use on the 
product labeling. If chemical-resistant gloves with sufficient 
durability and suppleness are not obtainable, leather gloves may be worn 
on top of chemical-resistant gloves. However, once leather gloves have 
been worn for this use, they shall not be worn thereafter for any other 
purpose, and they shall only be worn over chemical-resistant gloves.
    (B) Separable glove liners may be worn beneath chemical-resistant 
gloves, unless the pesticide product labeling specifically prohibits 
their use. Separable glove liners are defined as separate glove-like 
hand coverings made of lightweight material, with or without fingers. 
Work gloves made from lightweight cotton or poly-type material are 
considered to be glove liners if worn beneath chemical-resistant gloves. 
Separable glove liners may not extend outside the chemical-resistant 
gloves under which they are worn. Chemical-resistant gloves with non-
separable absorbent lining materials are prohibited.
    (C) If used, separable glove liners must be discarded immediately 
after a total of no more than 10 hours of use or within 24 hours of when 
first put on, whichever comes first. The liners must be replaced 
immediately if directly contacted by pesticide. Used glove liners shall 
not be reused. Contaminated liners must be disposed of in accordance 
with any Federal, State, or local regulations.
    (viii) When ``chemical-resistant footwear'' is specified by the 
product labeling, it shall be one of the following types of footwear: 
chemical-resistant shoes, chemical-resistant boots, or chemical-
resistant shoe coverings worn over shoes or boots. If chemical-resistant 
footwear with sufficient durability and a tread appropriate for wear in 
rough terrain is not obtainable for workers, then leather boots may be 
worn in such terrain.
    (ix) When ``protective eyewear'' is specified by the product 
labeling, it shall be one of the following types of eyewear: goggles; 
face shield; safety glasses with front, brow, and temple protection; or 
a full-face respirator.

[[Page 348]]

    (x) When ``chemical-resistant headgear'' is specified by the product 
labeling, it shall be either a chemical-resistant hood or a chemical-
resistant hat with a wide brim.
    (5) The agricultural employer shall assure that the worker, before 
entering the treated area, either has read the product labeling or has 
been informed, in a manner that the worker can understand, of all 
labeling requirements related to human hazards or precautions, first 
aid, symptoms of poisoning, personal protective equipment specified for 
early entry, and any other labeling requirements related to safe use.
    (6) The agricultural employer shall assure that:
    (i) Workers wear the personal protective equipment correctly for its 
intended purpose and use personal protective equipment according to 
manufacturer's instructions.
    (ii) Before each day of use, all personal protective equipment is 
inspected for leaks, holes, tears, or worn places, and any damaged 
equipment is repaired or discarded.
    (iii) Personal protective equipment that cannot be cleaned properly 
is disposed of in accordance with any applicable Federal, State, and 
local regulations.
    (iv) All personal protective equipment is cleaned according to 
manufacturer's instructions or pesticide product labeling instructions 
before each day of reuse. In the absence of any such instructions, it 
shall be washed thoroughly in detergent and hot water.
    (v) Before being stored, all clean personal protective equipment is 
dried thoroughly or is put in a well-ventilated place to dry.
    (vi) Personal protective equipment contaminated with pesticides is 
kept separately and washed separately from any other clothing or 
laundry.
    (vii) Any person who cleans or launders personal protective 
equipment is informed that such equipment may be contaminated with 
pesticides, of the potentially harmful effects of exposure to 
pesticides, and of the correct way(s) to handle and clean personal 
protective equipment and to protect themselves when handling equipment 
contaminated with pesticides.
    (viii) All clean personal protective equipment is stored separately 
from personal clothing and apart from pesticide-contaminated areas.
    (ix) Each worker is instructed how to put on, use, and remove the 
personal protective equipment and is informed about the importance of 
washing thoroughly after removing personal protective equipment.
    (x) Each worker is instructed in the prevention, recognition, and 
first aid treatment of heat-related illness.
    (xi) Workers have a clean place(s) away from pesticide-storage and 
pesticide-use areas for storing personal clothing not in use; putting on 
personal protective equipment at the start of any exposure period; and 
removing personal protective equipment at the end of any exposure 
period.
    (7) When personal protective equipment is required by the labeling 
of any pesticide for early entry, the agricultural employer shall assure 
that no worker is allowed or directed to perform the early-entry 
activity without implementing, when appropriate, measures to prevent 
heat-related illness.
    (8) During any early-entry activity, the agricultural employer shall 
provide a decontamination site in accordance with Sec. 170.150.
    (9) The agricultural employer shall not allow or direct any worker 
to wear home or to take home personal protective equipment contaminated 
with pesticides.
    (d) Exception for an agricultural emergency. (1) An ``agricultural 
emergency'' means a sudden occurrence or set of circumstances which the 
agricultural employer could not have anticipated and over which the 
agricultural employer has no control, and which requires entry into a 
treated area during a restricted-entry interval, when no alternative 
practices would prevent or mitigate a substantial economic loss. A 
substantial economic loss means a loss in profitability greater than 
that which would be expected based on the experience and fluctuations of 
crop yields in previous years. Only losses caused by the agricultural 
emergency

[[Page 349]]

specific to the affected site and geographic area are considered. The 
contribution of mismanagement cannot be considered in determining the 
loss.
    (2) A worker may enter a treated area under a restricted-entry 
interval in an agricultural emergency to perform tasks, including hand 
labor tasks, necessary to mitigate the effects of the agricultural 
emergency, if the agricultural employer assures that all the following 
criteria are met:
    (i) A State, Tribal, or Federal Agency having jurisdiction declares 
the existence of circumstances that could cause an agricultural 
emergency on that agricultural establishment.
    (ii) The agricultural employer determines the agricultural 
establishment is subject to the circumstances declared under paragraph 
(d)(2)(i) of this section that result in an agricultural emergency 
meeting the criteria of paragraph (d)(1) of this section.
    (iii) The requirements of paragraphs (c) (3) through (9) of this 
section are met.
    (e) Exception requiring Agency approval. The Agency may, in 
accordance with paragraphs (e) (1) through (3) of this section, grant an 
exception from the requirements of this section. An exception may be 
withdrawn in accordance with paragraph (e)(6) of this section.
    (1) Exception requiring agency approval. A request for an exception 
must be submitted to the Office of Pesticide Programs' Document 
Processing Desk at the appropriate address as set forth in 40 CFR 
150.17(a) or (b) and must be accompanied by two copies of the following 
information:
    (i) The name, address, and telephone number of the submitter.
    (ii) The time period for which the exception is requested.
    (iii) A description of the crop(s) and specific crop production 
task(s) for which the exception is requested. Such a description must 
include an explanation as to the necessity of applying pesticides of a 
type and at a frequency such that the restricted-entry interval would 
interfere with necessary and time-sensitive hand labor tasks for the 
period for which the exception is sought.
    (iv) A description of the geographic area for which the exception is 
requested. If the exception request is for a limited geographic area, 
the explanation must include a description as to why the circumstances 
of exposure or economic impact resulting from the prohibition of routine 
hand labor tasks during the restricted-entry interval are unique to the 
geographic area named in the exception.
    (v) An explanation as to why, for each requested crop-task 
combination, alternative practices would not be technically or 
financially viable. Such alternative practices might include: 
rescheduling the pesticide application or hand labor activity; using a 
non-chemical pest control alternative; using an alternative to the hand 
labor tasks, such as machine cultivation; or substituting a pesticide 
with a shorter restricted-entry interval. This information should 
include estimates or data on per acre revenue and cost of production for 
the crop and area for which the exception is requested. These estimates 
or data should include: the situation prior to implementation of this 
final rule, the situation after implementation of this final rule if the 
exception is not granted, the situation after implementation of this 
final rule if the exception is granted, and specific information on 
individual factors which cause differences in revenues and costs among 
the three situations.
    (vi) A description or documentation of the safety and feasibility of 
such an exception, including, but not limited to, the feasibility of 
performing the necessary hand labor activity while wearing the personal 
protective equipment required for early entry for the pesticide(s) 
expected to be applied, the means of mitigating heat-related illness 
concerns, the period of time required daily per worker to perform the 
hand labor activity, any suggested methods of reducing the worker's 
exposure, and any other mitigating factors, such as the availability of 
running water for routine and emergency decontamination and mechanical 
devices that would reduce the workers' contact

[[Page 350]]

with the treated surfaces. The information should include the costs 
associated with early-entry, such as decontamination facilities, special 
information and training for the workers, heat stress avoidance 
procedures, and provision, inspection, cleaning, and maintenance of 
personal protective equipment. EPA will not grant exceptions where the 
costs of early entry equal or exceed the expected loss in value of crop 
yield or quality.
    (2) Notice of receipt. (i) When a request for an exception is 
submitted to the Agency along with all of the information required in 
paragraph (e)(1) of this section, the Agency shall issue a notice in the 
Federal Register stating that an exception is being considered, 
describing the nature of the exception, and allowing at least 30 days 
for interested parties to comment.
    (ii) If a request for an exception is submitted to the Agency 
without all of the information required in paragraph (e)(1) of this 
section, the Agency shall return the request to the submitter.
    (3) Exception decision. EPA will publish in the Federal Register its 
decision whether to grant the request for exception. EPA will base its 
decision on whether the benefits of the exception outweigh the costs, 
including the value of the health risks attributable to the exception. 
If the exception is granted, the notice will state the nature of and 
reasons for the exception.
    (4) Presumptive denial. (i) Except as provided in paragraph 
(e)(4)(ii) of this section, persons requesting an exception may assume 
that the exception has been denied if EPA has not issued its decision 
whether to grant the exception within 9 months from the comment-closure 
date specified in the Federal Register notice in which the Agency 
announced, in accordance with paragraph (e)(2) of this section, that it 
would consider the exception.
    (ii) Persons requesting an exception may not assume that the request 
has been denied as provided by paragraph (e)(4)(i) of this section if 
the Agency has taken action to extend its review period for a specified 
time interval due to the complexity of the exception request or to the 
number of exception requests concurrently under Agency review. EPA shall 
state the reason(s) for the delay in issuing a decision on the exception 
request. A notice of such an action may be published in the Federal 
Register or persons who requested the exception may be directly notified 
of the action.
    (5) Agricultural employer duties. When a worker enters a treated 
area during a restricted-entry interval under an exception granted under 
paragraph (e) of this section, the agricultural employer shall assure 
that the requirements of paragraphs (c) (3) through (9) of this section 
are met, unless the notice granting the exception specifically indicates 
otherwise.
    (6) Withdrawing an exception. An exception may be withdrawn by the 
Agency at any time if the Agency receives poisoning information or other 
data that indicate that the health risks imposed by this early-entry 
exception are unacceptable or if the Agency receives other information 
that indicates that the exception is no longer necessary or prudent. If 
the Agency determines that an exception should be withdrawn, it will 
publish a notice in the Federal Register, stating the basis for its 
determination. Affected parties would then have 30 days to request a 
hearing on the Agency's determination. The exception, however, would be 
discontinued as of the date specified by EPA in the notice, which may 
include any of the 30-day period and the time required for any 
subsequent hearing process. Thereafter the Agency will decide whether to 
withdraw the exception and will publish a notice in the Federal Register 
stating its decision.
    (7) List of exceptions granted by EPA. The following administrative 
exceptions from the requirements of this section have been granted by 
EPA. Each exception listed in paragraph (e)(7) of this section contains 
a reference to the Federal Register notice in which EPA has granted the 
exception and the effective dates of the exception. The terms and 
conditions of the exception appear in the referenced Federal Register 
notice.
    (i) Exception to perform irrigation tasks under specified conditions 
published in the Federal Register of May 3, 1995.

[[Page 351]]

    (ii) Exceptions to perform limited contact tasks under specified 
conditions published in the Federal Register of May 3, 1995.

[57 FR 38151, Aug. 21, 1992, as amended at 59 FR 30264, June 10, 1994; 
60 FR 21954, May 3, 1995; 62 FR 52003, Oct. 3, 1997; 69 FR 53346, Sept. 
1, 2004; 71 FR 35546, June 21, 2006; 73 FR 75598, Dec. 12, 2008]



Sec. 170.120  Notice of applications.

    (a) Notification to workers of pesticide applications in 
greenhouses. The agricultural employer shall notify workers of any 
pesticide application in the greenhouse in accordance with this 
paragraph.
    (1) All pesticide applications shall be posted in accordance with 
paragraph (c) of this section.
    (2) If the pesticide product labeling has a statement requiring both 
the posting of treated areas and oral notification to workers, the 
agricultural employer shall also provide oral notification of the 
application to the worker in accordance with paragraph (d) of this 
section.
    (3) Notice need not be given to a worker if the agricultural 
employer can assure that one of the following is met:
    (i) From the start of the application until the end of the 
application and during any restricted-entry interval, the worker will 
not enter, work in, remain in, or pass through the greenhouse; or
    (ii) The worker applied (or supervised the application of) the 
pesticide for which the notice is intended and is aware of all 
information required by paragraphs (d)(1) through (3) of this section.
    (b) Notification to workers on farms, in nurseries, or in forests of 
pesticide applications. The agricultural employer shall notify workers 
of any pesticide application on the farm or in the nursery or forest in 
accordance with this paragraph.
    (1) If the pesticide product labeling has a statement requiring both 
the posting of treated areas and oral notification to workers, the 
agricultural employer shall post signs in accordance with paragraph (c) 
of this section and shall provide oral notification of the application 
to the worker in accordance with paragraph (d) of this section.
    (2) For any pesticide other than those for which the labeling 
requires both posting and oral notification of applications, the 
agricultural employer shall give notice of the application to the worker 
either by the posting of warning signs in accordance with paragraph (c) 
of this section or orally in accordance with paragraph (d) of this 
section, and shall inform the workers as to which method of notification 
is in effect.
    (3) Notice need not be given to a worker if the agricultural 
employer can assure that one of the following is met:
    (i) From the start of the application until the end of the 
application and during any restricted-entry interval, the worker will 
not enter, work in, remain in, or pass through on foot the treated area 
or any area within \1/4\ mile of the treated area; or
    (ii) The worker applied (or supervised the application of) the 
pesticide for which the notice is intended and is aware of all 
information required by (d)(1) through (3) of this section.
    (c) Posted warning signs. The agricultural employer shall post 
warning signs in accordance with the following criteria:
    (1) The warning sign shall have a background color that contrasts 
with red. The words ``DANGER'' and ``PELIGRO,'' plus ``PESTICIDES'' and 
``PESTICIDAS,'' shall be at the top of the sign, and the words ``KEEP 
OUT'' and ``NO ENTRE'' shall be at the bottom of the sign. Letters for 
all words must be clearly legible. A circle containing an upraised hand 
on the left and a stern face on the right must be near the center of the 
sign. The inside of the circle must be red, except that the hand and a 
large portion of the face must be in a shade that contrasts with red. 
The length of the hand must be at least twice the height of the smallest 
letters. The length of the face must be only slightly smaller than the 
hand. Additional information such as the name of the pesticide and the 
date of application may appear on the warning sign if it does not 
detract from the appearance of the sign or change the meaning of the 
required information. A

[[Page 352]]

black-and-white example of a warning sign meeting these requirements, 
other than the size requirements, follows:
[GRAPHIC] [TIFF OMITTED] TC01MY92.111

    (2) The standard sign shall be at least 14 inches by 16 inches with 
letters at least 1 inch in height. Farms and forests shall use the 
standard size sign unless a smaller sign is necessary because the 
treated area is too small to accommodate a sign of this size. In 
nurseries

[[Page 353]]

and greenhouses, the agricultural employer may, at any time, use a sign 
smaller than the standard size sign. Whenever a small sign is used on 
any establishment, there are specific posting distances depending on the 
size of the lettering and symbol on the sign. If a sign is used with 
DANGER and PELIGRO in letters at least \7/8\ inch in height and the 
remaining letters at least \1/2\ inch in height and a red circle at 
least 3 inches in diameter containing an upraised hand and a stern face, 
the signs shall be no further than 50 feet apart. If a sign is used with 
DANGER and PELIGRO in letters at least \7/16\ inch in height and the 
remaining letters at least \1/4\ inch in height and a red circle at 
least 1\1/2\ inches in diameter containing an upraised hand and a stern 
face, the signs shall be no further than 25 feet apart. A sign with 
DANGER and PELIGRO in letters less than \7/16\ inch in height or with 
any words in letters less than \1/4\ inch in height or a red circle 
smaller than 1\1/2\ inches in diameter containing an upraised hand and a 
stern face will not satisfy the requirements of the rule. All signs must 
meet the requirements of paragraph (c)(1) of this section.
    (3) The employer may replace the Spanish portion of the warning sign 
with a non-English language read by the largest group of workers who do 
not read English. The replacement sign must be in the same format as the 
original sign and be visible and legible.
    (4) On farms and in forests and nurseries, the signs shall be 
visible from all usual points of worker entry to the treated area, 
including at least each access road, each border with any labor camp 
adjacent to the treated area, and each footpath and other walking route 
that enters the treated area. When there are no usual points of worker 
entry, signs shall be posted in the corners of the treated area or in 
any other location affording maximum visibility.
    (5) In greenhouses, the signs shall be posted so they are visible 
from all usual points of worker entry to the treated area including each 
aisle or other walking route that enters the treated area. When there 
are no usual points of worker entry to the treated area, signs shall be 
posted in the corners of the treated area or in any other location 
affording maximum visibility.
    (6) The signs shall:
    (i) Be posted no sooner than 24 hours before the scheduled 
application of the pesticide.
    (ii) Remain posted throughout the application and any restricted-
entry interval.
    (iii) Be removed within 3 days after the end of the application and 
any restricted-entry interval and before agricultural-worker entry is 
permitted, other than entry permitted by Sec. 170.112.
    (7) The signs shall remain visible and legible during the time they 
are posted.
    (8) When several contiguous areas are to be treated with pesticides 
on a rotating or sequential basis, the entire area may be posted. Worker 
entry, other than entry permitted by Sec. 170.112, is prohibited for 
the entire area while the signs are posted.
    (d) Oral warnings. The agricultural employer shall provide oral 
warnings to workers in a manner that the worker can understand. If a 
worker will be on the premises during the application, the warning shall 
be given before the application takes place. Otherwise, the warning 
shall be given at the beginning of the worker's first work period during 
which the application is taking place or the restricted-entry interval 
for the pesticide is in effect. The warning shall consist of:
    (1) The location and description of the treated area.
    (2) The time during which entry is restricted.
    (3) Instructions not to enter the treated area until the restricted-
entry interval has expired.

[57 FR 38151, Aug. 21, 1992, as amended at 61 FR 33207, June 26, 1996]



Sec. 170.122  Providing specific information about applications.

    When workers are on an agricultural establishment and, within the 
last 30 days, a pesticide covered by this subpart has been applied on 
the establishment or a restricted-entry interval has been in effect, the 
agricultural employer shall display, in accordance with this section, 
specific information about the pesticide.

[[Page 354]]

    (a) Location, accessibility, and legibility. The information shall 
be displayed in the location specified for the pesticide safety poster 
in Sec. 170.135(d) and shall be accessible and legible, as specified in 
Sec. 170.135 (e) and (f).
    (b) Timing. (1) If warning signs are posted for the treated area 
before an application, the specific application information for that 
application shall be posted at the same time or earlier.
    (2) The information shall be posted before the application takes 
place, if workers will be on the establishment during application. 
Otherwise, the information shall be posted at the beginning of any 
worker's first work period.
    (3) The information shall continue to be displayed for at least 30 
days after the end of the restricted-entry interval (or, if there is no 
restricted-entry interval, for at least 30 days after the end of the 
application) or at least until workers are no longer on the 
establishment, whichever is earlier.
    (c) Required information. The information shall include:
    (1) The location and description of the treated area.
    (2) The product name, EPA registration number, and active 
ingredient(s) of the pesticide.
    (3) The time and date the pesticide is to be applied.
    (4) The restricted-entry interval for the pesticide.



Sec. 170.124  Notice of applications to handler employers.

    Whenever handlers who are employed by a commercial pesticide 
handling establishment will be performing pesticide handling tasks on an 
agricultural establishment, the agricultural employer shall provide to 
the handler employer, or assure that the handler employer is aware of, 
the following information concerning any areas on the agricultural 
establishment that the handler may be in (or may walk within \1/4\ mile 
of) and that may be treated with a pesticide or that may be under a 
restricted-entry interval while the handler will be on the agricultural 
establishment:
    (a) Specific location and description of any such areas; and
    (b) Restrictions on entering those areas.



Sec. 170.130  Pesticide safety training for workers.

    (a) General requirement--(1) Agricultural employer assurance. The 
agricultural employer shall assure that each worker, required by this 
section to be trained, has been trained according to this section during 
the last 5 years, counting from the end of the month in which the 
training was completed.
    (2) Requirement for workers performing early-entry activities. 
Before a worker enters a treated area on the agricultural establishment 
during a restricted-entry interval to perform early-entry activities 
permitted by Sec. 170.112 and contacts anything that has been treated 
with the pesticide to which the restricted-entry interval applies, 
including but not limited to, soil, water, or surfaces of plants, the 
agricultural employer shall assure that the worker has been trained.
    (3) Requirements for other agricultural workers--(i) Information 
before entry. Except as provided in paragraph (a)(2) of this section, 
before a worker enters any areas on the agricultural establishment 
where, within the last 30 days a pesticide to which this subpart applies 
has been applied or the restricted-entry interval for such pesticide has 
been in effect, the agricultural employer shall assure that the worker 
has been provided the pesticide safety information specified in 
paragraph (c) of this section, in a manner that agricultural workers can 
understand, such as by providing written materials or oral communication 
or by other means. The agricultural employer must be able to verify 
compliance with this requirement.
    (ii) Training before the 6th day of entry. Except as provided in 
paragraph (a)(2) of this section, before the 6th day that a worker 
enters any areas on the agricultural establishment where, within the 
last 30 days a pesticide to which this subpart applies has been applied 
or a restricted-entry interval for such pesticide has been in effect, 
the agricultural employer shall assure that the worker has been trained.
    (b) Exceptions. The following persons need not be trained under this 
section:
    (1) A worker who is currently certified as an applicator of 
restricted-use

[[Page 355]]

pesticides under part 171 of this chapter.
    (2) A worker who satisfies the training requirements of part 171 of 
this chapter.
    (3) A worker who satisfies the handler training requirements of 
Sec. 170.230(c).
    (4) A worker who is certified or licensed as a crop advisor by a 
program acknowledged as appropriate in writing by EPA or a State or 
Tribal lead agency for pesticide enforcement, provided that a 
requirement for such certification or licensing is pesticide safety 
training that includes all the information set out in Sec. 
170.230(c)(4).
    (c) Pesticide safety information. The pesticide safety information 
required by paragraph (a)(3)(i) shall be presented to workers in a 
manner that the workers can understand. At a minimum, the following 
information shall be provided:
    (1) Pesticides may be on or in plants, soil, irrigation water, or 
drifting from nearby applications.
    (2) Prevent pesticides from entering your body by:
    (i) Following directions and/or signs about keeping out of treated 
or restricted areas.
    (ii) Washing before eating, drinking, using chewing gum or tobacco, 
or using the toilet.
    (iii) Wearing work clothing that protects the body from pesticide 
residues.
    (iv) Washing/showering with soap and water, shampoo hair, and put on 
clean clothes after work.
    (v) Washing work clothes separately from other clothes before 
wearing them again.
    (vi) Washing immediately in the nearest clean water if pesticides 
are spilled or sprayed on the body. As soon as possible, shower, 
shampoo, and change into clean clothes.
    (3) Further training will be provided within 5 days.
    (d) Training programs. (1) General pesticide safety information 
shall be presented to workers either orally from written materials or 
audiovisually. The information must be presented in a manner that the 
workers can understand (such as through a translator) using nontechnical 
terms. The presenter also shall respond to workers' questions.
    (2) The person who conducts the training shall meet at least one of 
the following criteria:
    (i) Be currently certified as an applicator of restricted-use 
pesticides under part 171 of this chapter; or
    (ii) Be currently designated as a trainer of certified applicators 
or pesticide handlers by a State, Federal, or Tribal agency having 
jurisdiction; or
    (iii) Have completed a pesticide safety train-the-trainer program 
approved by a State, Federal, or Tribal agency having jurisdiction; or
    (iv) Satisfy the training requirements in part 171 of this chapter 
or in Sec. 170.230(c).
    (3) Any person who issues an EPA-approved Worker Protection Standard 
worker training certificate must assure that the worker who receives the 
training certificate has been trained in accordance with paragraph 
(d)(4) of this section.
    (4) The training materials shall convey, at a minimum, the following 
information:
    (i) Where and in what form pesticides may be encountered during work 
activities.
    (ii) Hazards of pesticides resulting from toxicity and exposure, 
including acute and chronic effects, delayed effects, and sensitization.
    (iii) Routes through which pesticides can enter the body.
    (iv) Signs and symptoms of common types of pesticide poisoning.
    (v) Emergency first aid for pesticide injuries or poisonings.
    (vi) How to obtain emergency medical care.
    (vii) Routine and emergency decontamination procedures, including 
emergency eyeflushing techniques.
    (viii) Hazards from chemigation and drift.
    (ix) Hazards from pesticide residues on clothing.
    (x) Warnings about taking pesticides or pesticide containers home.
    (xi) Requirements of this subpart designed to reduce the risks of 
illness or injury resulting from workers' occupational exposure to 
pesticides, including application and entry restrictions, the design of 
the warning sign, posting of

[[Page 356]]

warning signs, oral warnings, the availability of specific information 
about applications, and the protection against retaliatory acts.
    (e) Verification of training. (1) Except as provided in paragraph 
(e)(2) of this section, if the agricultural employer assures that a 
worker possesses an EPA-approved Worker Protection Standard worker 
training certificate, then the requirements of paragraph (a) and (c) of 
this section will have been met.
    (2) If the agricultural employer is aware or has reason to know that 
an EPA-approved Worker Protection Standard worker training certificate 
has not been issued in accordance with this section, or has not been 
issued to the worker bearing the certificate, or the training was 
completed more than 5 years before the beginning of the current month, a 
worker's possession of that certificate does not meet the requirements 
of paragraph (a) of this section.

[57 FR 38151, Aug. 21, 1992, as amended at 60 FR 21947, 21952, May 3, 
1995; 73 FR 75598, Dec. 12, 2008]



Sec. 170.135  Posted pesticide safety information.

    (a) Requirement. When workers are on an agricultural establishment 
and, within the last 30 days, a pesticide covered by this subpart has 
been applied on the establishment or a restricted-entry interval has 
been in effect, the agricultural employer shall display, in accordance 
with this section, pesticide safety information.
    (b) Pesticide safety poster. A safety poster must be displayed that 
conveys, at a minimum, the following basic pesticide safety concepts:
    (1) Help keep pesticides from entering your body. At a minimum, the 
following points shall be conveyed:
    (i) Avoid getting on your skin or into your body any pesticides that 
may be on plants and soil, in irrigation water, or drifting from nearby 
applications.
    (ii) Wash before eating, drinking, using chewing gum or tobacco, or 
using the toilet.
    (iii) Wear work clothing that protects the body from pesticide 
residues (long-sleeved shirts, long pants, shoes and socks, and a hat or 
scarf).
    (iv) Wash/shower with soap and water, shampoo hair, and put on clean 
clothes after work.
    (v) Wash work clothes separately from other clothes before wearing 
them again.
    (vi) Wash immediately in the nearest clean water if pesticides are 
spilled or sprayed on the body. As soon as possible, shower, shampoo, 
and change into clean clothes.
    (vii) Follow directions about keeping out of treated or restricted 
areas.
    (2) There are Federal rules to protect workers and handlers, 
including a requirement for safety training.
    (c) Emergency medical care information. (1) The name, address, and 
telephone number of the nearest emergency medical care facility shall be 
on the safety poster or displayed close to the safety poster.
    (2) The agricultural employer shall inform workers promptly of any 
change to the information on emergency medical care facilities.
    (d) Location. (1) The information shall be displayed in a central 
location on the farm or in the nursery or greenhouse where it can be 
readily seen and read by workers.
    (2) The information shall be displayed in a location in or near the 
forest in a place where it can be readily seen and read by workers and 
where workers are likely to congregate or pass by, such as at a 
decontamination site or an equipment storage site.
    (e) Accessibility. Workers shall be informed of the location of the 
information and shall be allowed access to it.
    (f) Legibility. The information shall remain legible during the time 
it is posted.



Sec. 170.150  Decontamination.

    (a)(1) Requirement. The agricultural employer must provide 
decontamination supplies for workers in accordance with this section 
whenever:
    (i) Any worker on the agricultural establishment is performing an 
activity in the area where a pesticide was applied or a restricted-entry 
interval (REI) was in effect within the last 30 days, and;
    (ii) The worker contacts anything that has been treated with the 
pesticide, including, but not limited to

[[Page 357]]

soil, water, plants, plant surfaces, and plant parts.
    (2) Exception. The 30-day time period established in paragraph 
(a)(1)(i) of this section shall not apply if the only pesticides used in 
the treated area are products with an REI of 4 hours or less on the 
label (but not a product without an REI on the label). When workers are 
in such treated areas, the agricultural employer shall provide 
decontamination supplies for not less than 7 days following the 
expiration of any applicable REI.
    (b) General conditions. (1) The agricultural employer shall provide 
workers with enough water for routine washing and emergency eyeflushing. 
At all times when the water is available to workers, the employer shall 
assure that it is of a quality and temperature that will not cause 
illness or injury when it contacts the skin or eyes or if it is 
swallowed.
    (2) When water stored in a tank is to be used for mixing pesticides, 
it shall not be used for decontamination or eyeflushing, unless the tank 
is equipped with properly functioning valves or other mechanisms that 
prevent movement of pesticides into the tank.
    (3) The agricultural employer shall provide soap and single-use 
towels in quantities sufficient to meet worker's needs.
    (4) To provide for emergency eyeflushing, the agricultural employer 
shall assure that at least 1 pint of water is immediately available to 
each worker who is performing early-entry activities permitted by Sec. 
170.112 and for which the pesticide labeling requires protective 
eyewear. The eyeflush water shall be carried by the early-entry worker, 
or shall be on the vehicle the early-entry worker is using, or shall be 
otherwise immediately accessible.
    (c) Location. (1) The decontamination supplies shall be located 
together and be reasonably accessible to and not more than \1/4\ mile 
from where workers are working.
    (2) For worker activities performed more than \1/4\ mile from the 
nearest place of vehicular access:
    (i) The soap, single-use towels, and water may be at the nearest 
place of vehicular access.
    (ii) The agricultural employer may permit workers to use clean water 
from springs, streams, lakes, or other sources for decontamination at 
the remote work site, if such water is more accessible than the water 
located at the nearest place of vehicular access.
    (3) The decontamination supplies shall not be maintained in an area 
being treated with pesticides.
    (4) The decontamination supplies shall not be maintained in an area 
that is under a restricted-entry interval, unless the workers for whom 
the supplies are provided are performing early-entry activities 
permitted by Sec. 170.112 and involving contact with treated surfaces 
and the decontamination supplies would otherwise not be reasonably 
accessible to those workers.
    (d) Decontamination after early-entry activities. At the end of any 
exposure period for workers engaged in early-entry activities permitted 
by Sec. 170.112 and involving contact with anything that has been 
treated with the pesticide to which the restricted-entry interval 
applies, including, but not limited to, soil, water, air, or surfaces of 
plants, the agricultural employer shall provide, at the site where the 
workers remove personal protective equipment, soap, clean towels, and a 
sufficient amount of water so that the workers may wash thoroughly.

[57 FR 38151, Aug. 21, 1992, as amended at 61 FR 33212, June 26, 1996]



Sec. 170.160  Emergency assistance.

    If there is reason to believe that a person who is or has been 
employed on an agricultural establishment to perform tasks related to 
the production of agricultural plants has been poisoned or injured by 
exposure to pesticides used on the agricultural establishment, 
including, but not limited to, exposures from application, splash, 
spill, drift, or pesticide residues, the agricultural employer shall:
    (a) Make available to that person prompt transportation from the 
agricultural establishment, including any labor camp on the agricultural 
establishment, to an appropriate emergency medical facility.
    (b) Provide to that person or to treating medical personnel, 
promptly upon

[[Page 358]]

request, any obtainable information on:
    (1) Product name, EPA registration number, and active ingredients of 
any product to which that person might have been exposed.
    (2) Antidote, first aid, and other medical information from the 
product labeling.
    (3) The circumstances of application or use of the pesticide on the 
agricultural establishment.
    (4) The circumstances of exposure of that person to the pesticide.



                Subpart C_Standard for Pesticide Handlers



Sec. 170.202  Applicability of this subpart.

    Except as provided by Sec. Sec. 170.203 and 170.204, this subpart 
applies when any pesticide is handled for use on an agricultural 
establishment.

[60 FR 21952, May 3, 1995]



Sec. 170.203  Exceptions.

    Exceptions. This subpart does not apply when any pesticide is 
handled for use on an agricultural establishment in the following 
circumstances:
    (a) For mosquito abatement, Mediterranean fruit fly eradication, or 
similar wide-area public pest control programs sponsored by governmental 
entities.
    (b) On livestock or other animals, or in or about animal premises.
    (c) On plants grown for other than commercial or research purposes, 
which may include plants in habitations, home fruit and vegetable 
gardens, and home greenhouses.
    (d) On plants that are in ornamental gardens, parks, and public or 
private lawns and grounds and that are intended only for aesthetic 
purposes or climatic modification.
    (e) In a manner not directly related to the production of 
agricultural plants, including, but not limited to, structural pest 
control, control of vegetation along rights-of-way and in other noncrop 
areas, and pasture and rangeland use.
    (f) For control of vertebrate pests.
    (g) As attractants or repellents in traps.
    (h) On the harvested portions of agricultural plants or on harvested 
timber.
    (i) For research uses of unregistered pesticides.

[57 FR 38151, Aug. 21, 1992. Redesignated at 60 FR 21952, May 3, 1995]



Sec. 170.204  Exemptions.

    The handlers listed in this section are exempt from the specified 
provisions of this subpart.
    (a) Owners of agricultural establishments. (1) The owner of an 
agricultural establishment is not required to provide to himself or 
members of his immediate family who are performing handling tasks on 
their own agricultural establishment the protections of:
    (i) Section 170.210(b) and (c).
    (ii) Section 170.222.
    (iii) Section 170.230.
    (iv) Section 170.232.
    (v) Section 170.234.
    (vi) Section 170.235.
    (vii) Section 170.240(e) through (g).
    (viii) Section 170.250.
    (ix) Section 170.260.
    (2) The owner of the agricultural establishment must provide the 
protections listed in paragraphs (a)(1) (i) through (ix) of this section 
to other handlers and other persons who are not members of his immediate 
family.
    (b) Crop advisors. (1) Provided that the conditions of paragraph 
(b)(2) of this section are met, a person who is certified or licensed as 
a crop advisor by a program acknowledged as appropriate in writing by 
EPA or a State or Tribal lead agency for pesticide enforcement, and 
persons performing crop advising tasks under such qualified crop 
advisor's direct supervision, are exempt from the provisions of:
    (i) Section 170.232.
    (ii) Section 170.240.
    (iii) Section 170.250.
    (iv) Section 170.260.

A person is under the direct supervision of a crop advisor when the crop 
advisor exerts the supervisory controls set out in paragraphs (b)(2)(iv) 
and (v) of this section. Direct supervision does not require that the 
crop advisor be physically present at all times, but the crop advisor 
must be readily accessible to the employees at all times.

[[Page 359]]

    (2) Conditions of exemption. (i) The certification or licensing 
program requires pesticide safety training that includes, at least, all 
the information in Sec. 170.230(c)(4).
    (ii) No entry into the treated area occurs until after application 
ends.
    (iii) Applies only when performing crop advising tasks in the 
treated area.
    (iv) The crop advisor must make specific determinations regarding 
the appropriate PPE, appropriate decontamination supplies, and how to 
conduct the tasks safely. The crop advisor must convey this information 
to each person under his direct supervision in a language that the 
person understands.
    (v) Before entering a treated area, the certified or licensed crop 
advisor must inform, through an established practice of communication, 
each person under his direct supervision of the pesticide products and 
active ingredient(s) applied, method of application, time of 
application, the restricted entry interval, which tasks to undertake, 
and how to contact the crop advisor.

[60 FR 21953, May 3, 1995, as amended at 73 FR 75599, Dec. 12, 2008]



Sec. 170.210  Restrictions during applications.

    (a) Contact with workers and other persons. The handler employer and 
the handler shall assure that no pesticide is applied so as to contact, 
either directly or through drift, any worker or other person, other than 
an appropriately trained and equipped handler.
    (b) Handlers handling highly toxic pesticides. The handler employer 
shall assure that any handler who is performing any handling activity 
with a product that has the skull and crossbones symbol on the front 
panel of the label is monitored visually or by voice communication at 
least every 2 hours.
    (c) Fumigant applications in greenhouses. The handler employer shall 
assure:
    (1) That any handler who handles a fumigant in a greenhouse, 
including a handler who enters the greenhouse before the acceptable 
inhalation exposure level or ventilation criteria have been met to 
monitor air levels or to initiate ventilation, maintains continuous 
visual or voice contact with another handler.
    (2) That the other handler has immediate access to the personal 
protective equipment required by the fumigant labeling for handlers in 
the event entry into the fumigated greenhouse becomes necessary for 
rescue.



Sec. 170.222  Providing specific information about applications.

    When handlers (except those employed by a commercial pesticide 
handling establishment) are on an agricultural establishment and, within 
the last 30 days, a pesticide covered by this subpart has been applied 
on the establishment or a restricted-entry interval has been in effect, 
the handler employer shall display, in accordance with this section, 
specific information about the pesticide.
    (a) Location, accessibility, and legibility. The information shall 
be displayed in the same location specified for the pesticide safety 
poster in Sec. 170.235(d) of this part and shall be accessible and 
legible, as specified in Sec. 170.235(e) and (f) of this part.
    (b) Timing. (1) If warning signs are posted for the treated area 
before an application, the specific application information for that 
application shall be posted at the same time or earlier.
    (2) The information shall be posted before the application takes 
place, if handlers (except those employed by a commercial pesticide 
handling establishment) will be on the establishment during application. 
Otherwise, the information shall be posted at the beginning of any such 
handler's first work period.
    (3) The information shall continue to be displayed for at least 30 
days after the end of the restricted-entry interval (or, if there is no 
restricted-entry interval, for at least 30 days after the end of the 
application) or at least until the handlers are no longer on the 
establishment, whichever is earlier.
    (c) Required information. The information shall include:
    (1) The location and description of the treated area.
    (2) The product name, EPA registration number, and active 
ingredient(s) of the pesticide.

[[Page 360]]

    (3) The time and date the pesticide is to be applied.
    (4) The restricted-entry interval for the pesticide.



Sec. 170.224  Notice of applications to agricultural employers.

    Before the application of any pesticide on or in an agricultural 
establishment, the handler employer shall provide the following 
information to any agricultural employer for the establishment or shall 
assure that any agricultural employer is aware of:
    (a) Specific location and description of the treated area.
    (b) Time and date of application.
    (c) Product name, EPA registration number, and active ingredient(s).
    (d) Restricted-entry interval.
    (e) Whether posting and oral notification are required.
    (f) Any other product-specific requirements on the product labeling 
concerning protection of workers or other persons during or after 
application.



Sec. 170.230  Pesticide safety training for handlers.

    (a) Requirement. Before any handler performs any handling task, the 
handler employer shall assure that the handler has been trained in 
accordance with this section during the last 5 years, counting from the 
end of the month in which the training was completed.
    (b) Exceptions. The following persons need not be trained under this 
section:
    (1) A handler who is currently certified as an applicator of 
restricted-use pesticides under part 171 of this chapter.
    (2) A handler who satisfies the training requirements of part 171 of 
this chapter.
    (3) A handler who is certified or licensed as a crop advisor by a 
program acknowledged as appropriate in writing by EPA or a State or 
Tribal lead agency for pesticide enforcement, provided that a 
requirement for such certification or licensing is pesticide safety 
training that includes all the information set out in Sec. 
170.230(c)(4).
    (c) Training programs. (1) General pesticide safety information 
shall be presented to handlers either orally from written materials or 
audiovisually. The information must be presented in a manner that the 
handlers can understand (such as through a translator). The presenter 
also shall respond to handlers' questions.
    (2) The person who conducts the training shall meet at least one of 
the following criteria:
    (i) Be currently certified as an applicator of restricted-use 
pesticides under part 171 of this chapter; or
    (ii) Be currently designated as a trainer of certified applicators 
or pesticide handlers by a State, Federal, or Tribal agency having 
jurisdiction; or
    (iii) Have completed a pesticide safety train-the-trainer program 
approved by a State, Federal, or Tribal agency having jurisdiction.
    (3) Any person who issues an EPA-approved Worker Protection Standard 
handler training certificate must assure that the handler who receives 
the training certificate has been trained in accordance with paragraph 
(c)(4) of this section.
    (4) The pesticide safety training materials must convey, at a 
minimum, the following information:
    (i) Format and meaning of information contained on pesticide labels 
and in labeling, including safety information such as precautionary 
statements about human health hazards.
    (ii) Hazards of pesticides resulting from toxicity and exposure, 
including acute and chronic effects, delayed effects, and sensitization.
    (iii) Routes by which pesticides can enter the body.
    (iv) Signs and symptoms of common types of pesticide poisoning.
    (v) Emergency first aid for pesticide injuries or poisonings.
    (vi) How to obtain emergency medical care.
    (vii) Routine and emergency decontamination procedures.
    (viii) Need for and appropriate use of personal protective 
equipment.
    (ix) Prevention, recognition, and first aid treatment of heat-
related illness.
    (x) Safety requirements for handling, transporting, storing, and 
disposing of pesticides, including general procedures for spill cleanup.
    (xi) Environmental concerns such as drift, runoff, and wildlife 
hazards.

[[Page 361]]

    (xii) Warnings about taking pesticides or pesticide containers home.
    (xiii) Requirements of this subpart that must be followed by handler 
employers for the protection of handlers and other persons, including 
the prohibition against applying pesticides in a manner that will cause 
contact with workers or other persons, the requirement to use personal 
protective equipment, the provisions for training and decontamination, 
and the protection against retaliatory acts.
    (d) Verification of training. (1) Except as provided in paragraph 
(d)(2) of this section, if the handler employer assures that a handler 
possesses an EPA-approved Worker Protection Standard handler training 
certificate, then the requirements of paragraph (a) of this section will 
have been met.
    (2) If the handler employer is aware or has reason to know that an 
EPA-approved Worker Protection Standard handler training certificate has 
not been issued in accordance with this section, or has not been issued 
to the handler bearing the certificate, or the handler training was 
completed more than 5 years before the beginning of the current month, a 
handler's possession of that certificate does not meet the requirements 
of paragraph (a) of this section.

[57 FR 38151, Aug. 21, 1992, as amended at 60 FR 21953, May 3, 1995]



Sec. 170.232  Knowledge of labeling and site-specific information.

    (a) Knowledge of labeling information. (1) The handler employer 
shall assure that before the handler performs any handling activity, the 
handler either has read the product labeling or has been informed in a 
manner the handler can understand of all labeling requirements related 
to safe use of the pesticide, such as signal words, human hazard 
precautions, personal protective equipment requirements, first aid 
instructions, environmental precautions, and any additional precautions 
pertaining to the handling activity to be performed.
    (2) The handler employer shall assure that the handler has access to 
the product labeling information during handling activities.
    (b) Knowledge of site-specific information. Whenever a handler who 
is employed by a commercial pesticide handling establishment will be 
performing pesticide handling tasks on an agricultural establishment, 
the handler employer shall assure that the handler is aware of the 
following information concerning any areas on the agricultural 
establishment that the handler may be in (or may walk within \1/4\ mile 
of) and that may be treated with a pesticide or that may be under a 
restricted-entry interval while the handler will be on the agricultural 
establishment:
    (1) Specific location and description of any such areas; and
    (2) Restrictions on entering those areas.



Sec. 170.234  Safe operation of equipment.

    (a) The handler employer shall assure that before the handler uses 
any equipment for mixing, loading, transferring, or applying pesticides, 
the handler is instructed in the safe operation of such equipment, 
including, when relevant, chemigation safety requirements and drift 
avoidance.
    (b) The handler employer shall assure that, before each day of use, 
equipment used for mixing, loading, transferring, or applying pesticides 
is inspected for leaks, clogging, and worn or damaged parts, and any 
damaged equipment is repaired or is replaced.
    (c) Before allowing any person to repair, clean, or adjust equipment 
that has been used to mix, load, transfer, or apply pesticides, the 
handler employer shall assure that pesticide residues have been removed 
from the equipment, unless the person doing the cleaning, repairing, or 
adjusting is a handler employed by the agricultural or commercial 
pesticide handling establishment. If pesticide residue removal is not 
feasible, the handler employer shall assure that the person who repairs, 
cleans, or adjusts such equipment is informed:
    (1) That such equipment may be contaminated with pesticides.
    (2) Of the potentially harmful effects of exposure to pesticides.
    (3) Of the correct way to handle such equipment.

[[Page 362]]



Sec. 170.235  Posted pesticide safety information.

    (a) Requirement. When handlers (except those employed by a 
commercial pesticide handling establishment) are on an agricultural 
establishment and, within the last 30 days, a pesticide covered by this 
subpart has been applied on the establishment or a restricted-entry 
interval has been in effect, the handler employer shall display, in 
accordance with this section, pesticide safety information.
    (b) Pesticide safety poster. A safety poster must be displayed that 
conveys, at a minimum, the following basic pesticide safety concepts:
    (1) Help keep pesticides from entering your body. At a minimum, the 
following points shall be conveyed:
    (i) Avoid getting on your skin or into your body any pesticides that 
may be on plants and soil, in irrigation water, or drifting from nearby 
applications.
    (ii) Wash before eating, drinking, using chewing gum or tobacco, or 
using the toilet.
    (iii) Wear work clothing that protects the body from pesticide 
residues (long-sleeved shirts, long pants, shoes and socks, and a hat or 
scarf).
    (iv) Wash/shower with soap and water, shampoo hair, and put on clean 
clothes after work.
    (v) Wash work clothes separately from other clothes before wearing 
them again.
    (vi) Wash immediately in the nearest clean water if pesticides are 
spilled or sprayed on the body. As soon as possible, shower, shampoo, 
and change into clean clothes.
    (vii) Follow directions about keeping out of treated or restricted 
areas.
    (2) There are Federal rules to protect workers and handlers 
including a requirement for safety training.
    (c) Emergency medical care information. (1) The name, address, and 
telephone number of the nearest emergency medical care facility shall be 
on the safety poster or displayed close to the safety poster.
    (2) The handler employer shall inform handlers promptly of any 
change to the information on emergency medical care facilities.
    (d) Location. (1) The information shall be displayed in a central 
location on the farm or in the nursery or greenhouse where it can be 
readily seen and read by handlers.
    (2) The information shall be displayed in a location in or near the 
forest in a place where it can be readily seen and read by handlers and 
where handlers are likely to congregate or pass by, such as at a 
decontamination site or an equipment storage site.
    (e) Accessibility. Handlers shall be informed of the location of the 
information and shall be allowed access to it.
    (f) Legibility. The information shall remain legible during the time 
it is posted.



Sec. 170.240  Personal protective equipment.

    (a) Requirement. Any person who performs tasks as a pesticide 
handler shall use the clothing and personal protective equipment 
specified on the labeling for use of the product.
    (b) Definition. (1) Personal protective equipment (PPE) means 
devices and apparel that are worn to protect the body from contact with 
pesticides or pesticide residues, including, but not limited to, 
coveralls, chemical-resistant suits, chemical-resistant gloves, 
chemical-resistant footwear, respiratory protection devices, chemical-
resistant aprons, chemical-resistant headgear, and protective eyewear.
    (2) Long-sleeved shirts, short-sleeved shirts, long pants, short 
pants, shoes, socks, and other items of work clothing are not considered 
personal protective equipment for the purposes of this section and are 
not subject to the requirements of this section, although pesticide 
labeling may require that such work clothing be worn during some 
activities.
    (c) Provision. When personal protective equipment is specified by 
the labeling of any pesticide for any handling activity, the handler 
employer shall provide the appropriate personal protective equipment in 
clean and operating condition to the handler.
    (1) When ``chemical-resistant'' personal protective equipment is 
specified by the product labeling, it shall be made of material that 
allows no measurable movement of the pesticide being used through the 
material during use.

[[Page 363]]

    (2) When ``waterproof'' personal protective equipment is specified 
by the product labeling, it shall be made of material that allows no 
measurable movement of water or aqueous solutions through the material 
during use.
    (3) When a ``chemical-resistant suit'' is specified by the product 
labeling, it shall be a loose-fitting, one- or two-piece chemical-
resistant garment that covers, at a minimum, the entire body except 
head, hands, and feet.
    (4) When ``coveralls'' are specified by the product labeling, they 
shall be a loose-fitting, one- or two-piece garment, such as a cotton or 
cotton and polyester coverall, that covers, at a minimum, the entire 
body except head, hands, and feet. The pesticide product labeling may 
specify that the coveralls be worn over another layer of clothing.
    (5)(i) Gloves shall be of the type specified on the pesticide 
product labeling. Gloves made of leather, cotton, or other absorbent 
materials may not be worn while mixing, loading, applying, or otherwise 
handling pesticides, unless gloves made of these materials are listed as 
acceptable for such use on the product labeling.
    (ii) Separable glove liners may be worn beneath chemical-resistant 
gloves, unless the pesticide product labeling specifically prohibits 
their use. Separable glove liners are defined as separate glove-like 
hand coverings, made of lightweight material, with or without fingers. 
Work gloves made from lightweight cotton or poly-type material are 
considered to be glove liners if worn beneath chemical-resistant gloves. 
Separable glove liners may not extend outside the chemical-resistant 
gloves under which they are worn. Chemical-resistant gloves with non-
separable absorbent lining materials are prohibited.
    (iii) If used, separable glove liners must be discarded immediately 
after a total of no more than 10 hours of use or within 24 hours of when 
first put on, whichever comes first. The liners must be replaced 
immediately if directly contacted by pesticide. Used glove liners shall 
not be reused. Contaminated liners must be disposed of in accordance 
with any Federal, State, or local regulations.
    (6) When ``chemical-resistant footwear'' is specified by the product 
labeling, one of the following types of footwear must be worn:
    (i) Chemical-resistant shoes.
    (ii) Chemical-resistant boots.
    (iii) Chemical-resistant shoe coverings worn over shoes or boots.
    (7) When ``protective eyewear'' is specified by the product 
labeling, one of the following types of eyewear must be worn:
    (i) Goggles.
    (ii) Face shield.
    (iii) Safety glasses with front, brow, and temple protection.
    (iv) Full-face respirator.
    (8) When a ``chemical-resistant apron'' is specified by the product 
labeling, an apron that covers the front of the body from mid-chest to 
the knees shall be worn.
    (9) When a respirator is specified by the product labeling, it shall 
be appropriate for the pesticide product used and for the activity to be 
performed. The handler employer shall assure that the respirator fits 
correctly.
    (10) When ``chemical-resistant headgear'' is specified by the 
product labeling, it shall be either a chemical resistant hood or a 
chemical-resistant hat with a wide brim.
    (d) Exceptions to personal protective equipment specified on product 
labeling--(1) Body protection. (i) A chemical-resistant suit may be 
substituted for ``coveralls,'' and any requirement for an additional 
layer of clothing beneath is waived.
    (ii) A chemical-resistant suit may be substituted for ``coveralls'' 
and a chemical-resistant apron.
    (2) Boots. If chemical-resistant footwear with sufficient durability 
and a tread appropriate for wear in rough terrain is not obtainable, 
then leather boots may be worn in such terrain.
    (3) Gloves. If chemical-resistant gloves with sufficient durability 
and suppleness are not obtainable, then during handling activities with 
roses or other plants with sharp thorns, leather gloves may be worn over 
chemical-resistant glove liners. However, once leather gloves are worn 
for this use, thereafter they shall be worn only with chemical-resistant 
liners and they shall not be worn for any other use.

[[Page 364]]

    (4) Closed systems. If handling tasks are performed using properly 
functioning systems that enclose the pesticide to prevent it from 
contacting handlers or other persons, and if such systems are used and 
are maintained in accordance with that manufacturer's written operating 
instructions, exceptions to labeling-specified personal protective 
equipment for the handling activity are permitted as provided in 
paragraphs (d)(4)(i) and (ii) of this section.
    (i) Persons using a closed system to mix or load pesticides with a 
signal word of DANGER or WARNING may substitute a long-sleeved shirt, 
long pants, shoes, socks, chemical-resistant apron, and any protective 
gloves specified on the labeling for handlers for the labeling-specified 
personal protective equipment.
    (ii) Persons using a closed system to mix or load pesticides other 
than those in paragraph (d)(4)(i) of this section or to perform other 
handling tasks may substitute a long-sleeved shirt, long pants, shoes, 
and socks for the labeling-specified personal protective equipment.
    (iii) Persons using a closed system that operates under pressure 
shall wear protective eyewear.
    (iv) Persons using a closed system shall have all labeling-specified 
personal protective equipment immediately available for use in an 
emergency.
    (5) Enclosed cabs. If handling tasks are performed from inside a cab 
that has a nonporous barrier which totally surrounds the occupants of 
the cab and prevents contact with pesticides outside of the cab, 
exceptions to personal protective equipment specified on the product 
labeling for that handling activity are permitted as provided in 
paragraphs (d)(5) (i) through (iv) of this section.
    (i) Persons occupying an enclosed cab may substitute a long-sleeved 
shirt, long pants, shoes, and socks for the labeling-specified personal 
protective equipment. If a respiratory protection device is specified on 
the pesticide product labeling for the handling activity, it must be 
worn.
    (ii) Persons occupying an enclosed cab that has a properly 
functioning ventilation system which is used and maintained in 
accordance with the manufacturer's written operating instructions and 
which is declared in writing by the manufacturer or by a governmental 
agency to provide respiratory protection equivalent to or greater than a 
dust/mist filtering respirator may substitute a long-sleeved shirt, long 
pants, shoes, and socks for the labeling-specified personal protective 
equipment. If a respiratory protection device other than a dust/mist-
filtering respirator is specified on the pesticide product labeling, it 
must be worn.
    (iii) Persons occupying an enclosed cab that has a properly 
functioning ventilation system which is used and maintained in 
accordance with the manufacturer's written operating instructions and 
which is declared in writing by the manufacturer or by a governmental 
agency to provide respiratory protection equivalent to or greater than 
the vapor- or gas-removing respirator specified on pesticide product 
labeling may substitute a long-sleeved shirt, long pants, shoes, and 
socks for the labeling-specified personal protective equipment. If an 
air-supplying respirator or a self-contained breathing apparatus (SCBA) 
is specified on the pesticide product labeling, it must be worn.
    (iv) Persons occupying an enclosed cab shall have all labeling-
specified personal protective equipment immediately available and stored 
in a chemical-resistant container, such as a plastic bag. They shall 
wear such personal protective equipment if it is necessary to exit the 
cab and contact pesticide-treated surfaces in the treated area. Once 
personal protective equipment is worn in the treated area, it must be 
removed before reentering the cab.
    (6) Aerial application--(i) Use of gloves. The wearing of chemical-
resistant gloves when entering or leaving an aircraft used to apply 
pesticides is optional, unless such gloves are required on the pesticide 
product labeling. If gloves are brought into the cockpit of an aircraft 
that has been used to apply pesticides, the gloves shall be kept in an 
enclosed container to prevent contamination of the inside of the 
cockpit.

[[Page 365]]

    (ii) Open cockpit. Persons occupying an open cockpit shall use the 
personal protective equipment specified in the product labeling for use 
during application, except that chemical-resistant footwear need not be 
worn. A helmet may be substituted for chemical-resistant headgear. A 
visor may be substituted for protective eyewear.
    (iii) Enclosed cockpit. Persons occupying an enclosed cockpit may 
substitute a long-sleeved shirt, long pants, shoes, and socks for 
labeling-specified personal protective equipment.
    (7) Crop advisors. Crop advisors entering treated areas while a 
restricted-entry interval is in effect may wear the personal protective 
equipment specified on the pesticide labeling for early-entry activities 
instead of the personal protective equipment specified on the pesticide 
labeling for handling activities, provided:
    (i) Application has been completed for at least 4 hours.
    (ii) Any inhalation exposure level listed in the labeling has been 
reached or any ventilation criteria established by Sec. 170.110(c)(3) 
or in the labeling have been met.
    (e) Use of personal protective equipment. (1) The handler employer 
shall assure that personal protective equipment is used correctly for 
its intended purpose and is used according to the manufacturer's 
instructions.
    (2) The handler employer shall assure that, before each day of use, 
all personal protective equipment is inspected for leaks, holes, tears, 
or worn places, and any damaged equipment is repaired or discarded.
    (f) Cleaning and maintenance. (1) The handler employer shall assure 
that all personal protective equipment is cleaned according to the 
manufacturer's instructions or pesticide product labeling instructions 
before each day of reuse. In the absence of any such instructions, it 
shall be washed thoroughly in detergent and hot water.
    (2) If any personal protective equipment cannot be cleaned properly, 
the handler employer shall dispose of the personal protective equipment 
in accordance with any applicable Federal, State, and local regulations. 
Coveralls or other absorbent materials that have been drenched or 
heavily contaminated with an undiluted pesticide that has the signal 
word DANGER or WARNING on the label shall be not be reused.
    (3) The handler employer shall assure that contaminated personal 
protective equipment is kept separately and washed separately from any 
other clothing or laundry.
    (4) The handler employer shall assure that all clean personal 
protective equipment shall be either dried thoroughly before being 
stored or shall be put in a well ventilated place to dry.
    (5) The handler employer shall assure that all personal protective 
equipment is stored separately from personal clothing and apart from 
pesticide-contaminated areas.
    (6) The handler employer shall assure that when dust/mist filtering 
respirators are used, the filters shall be replaced:
    (i) When breathing resistance becomes excessive.
    (ii) When the filter element has physical damage or tears.
    (iii) According to manufacturer's recommendations or pesticide 
product labeling, whichever is more frequent.
    (iv) In the absence of any other instructions or indications of 
service life, at the end of each day's work period.
    (7) The handler employer shall assure that when gas- or vapor-
removing respirators are used, the gas- or vapor-removing canisters or 
cartridges shall be replaced:
    (i) At the first indication of odor, taste, or irritation.
    (ii) According to manufacturer's recommendations or pesticide 
product labeling, whichever is more frequent.
    (iii) In the absence of any other instructions or indications of 
service life, at the end of each day's work period.
    (8) The handler employer shall inform any person who cleans or 
launders personal protective equipment:
    (i) That such equipment may be contaminated with pesticides.
    (ii) Of the potentially harmful effects of exposure to pesticides.
    (iii) Of the correct way(s) to clean personal protective equipment 
and to protect themselves when handling such equipment.
    (9) The handler employer shall assure that handlers have a clean 
place(s)

[[Page 366]]

away from pesticide storage and pesticide use areas where they may:
    (i) Store personal clothing not in use.
    (ii) Put on personal protective equipment at the start of any 
exposure period.
    (iii) Remove personal protective equipment at the end of any 
exposure period.
    (10) The handler employer shall not allow or direct any handler to 
wear home or to take home personal protective equipment contaminated 
with pesticides.
    (g) Heat-related illness. When the use of personal protective 
equipment is specified by the labeling of any pesticide for the handling 
activity, the handler employer shall assure that no handler is allowed 
or directed to perform the handling activity unless appropriate measures 
are taken, if necessary, to prevent heat-related illness.

[57 FR 38151, Aug. 21, 1992, as amended at 69 FR 53346, Sept. 1, 2004]



Sec. 170.250  Decontamination.

    (a) Requirement. During any handling activity, the handler employer 
shall provide for handlers, in accordance with this section, 
decontamination supplies for washing off pesticides and pesticide 
residues.
    (b) General conditions. (1) The handler employer shall provide 
handlers with enough water for routine washing, for emergency 
eyeflushing, and for washing the entire body in case of an emergency. At 
all times when the water is available to handlers, the handler employer 
shall assure that it is of a quality and temperature that will not cause 
illness or injury when it contacts the skin or eyes or if it is 
swallowed.
    (2) When water stored in a tank is to be used for mixing pesticides, 
it shall not be used for decontamination or eye flushing, unless the 
tank is equipped with properly functioning valves or other mechanisms 
that prevent movement of pesticides into the tank.
    (3) The handler employer shall provide soap and single-use towels in 
quantities sufficient to meet handlers' needs.
    (4) The handler employer shall provide one clean change of clothing, 
such as coveralls, for use in an emergency.
    (c) Location. The decontamination supplies shall be located together 
and be reasonably accessible to and not more than \1/4\ mile from each 
handler during the handling activity.
    (1) Exception for mixing sites. For mixing activities, 
decontamination supplies shall be at the mixing site.
    (2) Exception for pilots. Decontamination supplies for a pilot who 
is applying pesticides aerially shall be in the airplaine or at the 
aircraft loading site.
    (3) Exception for handling pesticides in remote areas. When handling 
activities are performed more than \1/4\ mile from the nearest place of 
vehicular access:
    (i) The soap, single-use towels, clean change of clothing, and water 
may be at the nearest place of vehicular access.
    (ii) The handler employer may permit handlers to use clean water 
from springs, streams, lakes, or other sources for decontamination at 
the remote work site, if such water is more accessible than the water 
located at the nearest place of vehicular access.
    (4) Decontamination supplies in treated areas. The decontamination 
supplies shall not be in an area being treated with pesticides or in an 
area under a restricted-entry interval, unless:
    (i) The decontamination supplies are in the area where the handler 
is performing handling activities;
    (ii) The soap, single-use towels, and clean change of clothing are 
in enclosed containers; and
    (iii) The water is running tap water or is enclosed in a container.
    (d) Emergency eyeflushing. To provide for emergency eyeflushing, the 
handler employer shall assure that at least 1 pint of water is 
immediately available to each handler who is performing tasks for which 
the pesticide labeling requires protective eyewear. The eyeflush water 
shall be carried by the handler, or shall be on the vehicle or aircraft 
the handler is using, or shall be otherwise immediately accessible.
    (e) Decontamination after handling activities. At the end of any 
exposure period, the handler employer shall provide at the site where 
handlers remove personal protective equipment, soap, clean towels, and a 
sufficient amount

[[Page 367]]

of water so that the handlers may wash thoroughly.

[57 FR 38151, Aug. 21, 1992, as amended at 61 FR 33213, June 26, 1996]



Sec. 170.260  Emergency assistance.

    If there is reason to believe that a person who is or has been 
employed by an agricultural establishment or commercial pesticide 
handling establishment to perform pesticide handling tasks has been 
poisoned or injured by exposure to pesticides as a result of that 
employment, including, but not limited to, exposures from handling tasks 
or from application, splash, spill, drift, or pesticide residues, the 
handler employer shall:
    (a) Make available to that person prompt transportation from the 
place of employment or the handling site to an appropriate emergency 
medical facility.
    (b) Provide to that person or to treating medical personnel, 
promptly upon request, any obtainable information on:
    (1) Product name, EPA registration number, and active ingredients of 
any product to which that person might have been exposed.
    (2) Antidote, first aid, and other medical information from the 
product labeling.
    (3) The circumstances of handling of the pesticide.
    (4) The circumstances of exposure of that person to the pesticide.



PART 171_CERTIFICATION OF PESTICIDE APPLICATORS--Table of Contents



Sec.
171.1 General.
171.2 Definitions.
171.3 Categorization of commercial applicators of pesticides.
171.4 Standards for certification of commercial applicators.
171.5 Standards for certification of private applicators.
171.6 Standards for supervision of noncertified applicators by certified 
          private and commercial applicators.
171.7 Submission and approval of State plans for certification of 
          commercial and private applicators of restricted use 
          pesticides.
171.8 Maintenance of State plans.
171.9 Submission and approval of Government Agency Plan.
171.10 Certification of applicators on Indian Reservations.
171.11 Federal certification of pesticide applicators in States or on 
          Indian Reservations where there is no approved State or Tribal 
          certification plan in effect.

    Authority: 7 U.S.C. 136i and 136w.

    Source: 39 FR 36449, Oct. 9, 1974, unless otherwise noted.



Sec. 171.1  General.

    This section deals with the certification of applicators of 
restricted use pesticides.



Sec. 171.2  Definitions.

    (a) Terms used in this subpart have the same meaning as in the Act. 
In addition, the following definitions are applicable to all aspects of 
the certification of pesticide applicator program in this part:
    (1) The term accident means an unexpected, undesirable event, caused 
by the use or presence of a pesticide, that adversely affects man or the 
environment.
    (2) The term Act means the Federal Insecticide, Fungicide, and 
Rodenticide Act, as amended (86 Stat. 973), and other legislation 
supplementary thereto and amendatory thereof.
    (3) The term Administrator means the Administrator of the 
Environmental Protection Agency, or any office or employee of the Agency 
to whom authority has heretofore been delegated, or to whom authority 
may hereafter be delegated, to act in his stead.
    (4) The term Agency, unless otherwise specified, means the United 
States Environmental Protection Agency.
    (5) The term agricultural commodity means any plant, or part 
thereof, or animal, or animal product, produced by a person (including 
farmers, ranchers, vineyardists, plant propagators, Christmas tree 
growers, aquaculturists, floriculturists, orchardists, foresters, or 
other comparable persons) primarily for sale, consumption, propagation, 
or other use by man or animals.
    (6) The term calibration of equipment means measurement of dispersal 
or output of application equipment and adjustment of such equipment to 
control the rate of dispersal, and droplet or particle size of a 
pesticide dispersed by the equipment.

[[Page 368]]

    (7) The term certification means the recognition by a certifying 
agency that a person is competent and thus authorized to use or 
supervise the use of restricted use pesticides.
    (8) The term certified applicator means any individual who is 
certified to use or supervise the use of any restricted use pesticides 
covered by his certification.
    (9) The term commercial applicator means a certified applicator 
(whether or not he is a private applicator with respect to some uses) 
who uses or supervises the use of any pesticide which is classified for 
restricted use for any purpose or on any property other than as provided 
by the definition of ``private applicator.''
    (10) The term compatibility means that property of a pesticide which 
permits its use with other chemicals without undesirable results being 
caused by the combination.
    (11) The term competent means properly qualified to perform 
functions associated with pesticide application, the degree of 
capability required being directly related to the nature of the activity 
and the associated responsibility.
    (12) The term common exposure route means a likely way (oral, 
dermal, respiratory) by which a pesticide may reach and/or enter an 
organism.
    (13) The term environment means water, air, land, and all plants and 
man and other animals living therein, and the interrelationships which 
exist among them.
    (14) The term forest means a concentration of trees and related 
vegetation in non-urban areas sparsely inhabited by and infrequently 
used by humans; characterized by natural terrain and drainage patterns.
    (15) The term hazard means a probability that a given pesticide will 
have an adverse effect on man or the environment in a given situation, 
the relative likelihood of danger or ill effect being dependent on a 
number of interrelated factors present at any given time.
    (16) The term host means any plant or animal on or in which another 
lives for nourishment, development, or protection.
    (17) The term non-target organism means a plant or animal other than 
the one against which the pesticide is applied.
    (18) The term ornamental means trees, shrubs, and other plantings in 
and around habitations generally, but not necessarily located in urban 
and suburban areas, including residences, parks, streets, retail 
outlets, industrial and institutional buildings.
    (19) The term practical knowledge means the possession of pertinent 
facts and comprehension together with the ability to use them in dealing 
with specific problems and situations.
    (20) The term private applicator means a certified applicator who 
uses or supervises the use of any pesticide which is classified for 
restricted use for purposes of producing any agricultural commodity on 
property owned or rented by him or his employer or (if applied without 
compensation other than trading of personal services between producers 
of agricultural commodities) on the property of another person.
    (21) The term protective equipment means clothing or any other 
materials or devices that shield against unintended exposure to 
pesticides.
    (22) The term regulated pest means a specific organism considered by 
a State or Federal agency to be a pest requiring regulatory 
restrictions, regulations, or control procedures in order to protect the 
host, man and/or his environment.
    (23) The term restricted use pesticide means a pesticide that is 
classified for restricted use under the provisions of section 3(d)(1)(C) 
of the Act.
    (24) The term standard means the measure of knowledge and ability 
which must be demonstrated as a requirement for certification.
    (25) The term State means a State, the District of Columbia, the 
Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Trust 
Territory of the Pacific Islands, and American Samoa.
    (26) The term susceptibility means the degree to which an organism 
is affected by a pesticide at a particular level of exposure.
    (27) The term toxicity means the property of a pesticide to cause 
any adverse physiological effects.

[[Page 369]]

    (28) The term under the direct supervision of means the act or 
process whereby the application of a pesticide is made by a competent 
person acting under the instructions and control of a certified 
applicator who is responsible for the actions of that person and who is 
available if and when needed, even though such certified applicator is 
not physically present at the time and place the pesticide is applied.
    (b) Limited. The following definitions apply only to dealers, 
dealerships and transactions in States or on Indian Reservations where 
EPA conducts a Federal Pesticide Applicator Certification Program.
    (1) The term restricted use pesticide retail dealer means any person 
who makes available for use any restricted use pesticide, or who offers 
to make available for use any such pesticide.
    (2) The term make available for use means to distribute, sell, ship, 
deliver for shipment, or receive and (having so received) deliver, to 
any person. However, the term excludes transactions solely between 
persons who are pesticide producers, registrants, wholesalers, or retail 
sellers, acting only in those capacities.
    (3) The term dealership means any site owned or operated by a 
restricted use pesticide retail dealer where any restricted use 
pesticide is made available for use, or where the dealer offers to make 
available for use any such pesticide.
    (4) The term uncertified person means any person who is not holding 
a currently valid certification document indicating that he is certified 
under section 11 of FIFRA in the category of the restricted use 
pesticide made available for use.
    (5) The term principal place of business means the principal 
location, either residence or office, in the State in which an 
individual, partnership, or corporation applies pesticides.

[39 FR 36449, Oct. 9, 1974, as amended at 48 FR 53974, Nov. 1983; 73 FR 
75599, Dec. 12, 2008]



Sec. 171.3  Categorization of commercial applicators of pesticides.

    (a) Procedure. Categories of applicators (other than private) using 
or supervising the use of restricted use pesticides are identified 
below. State systems of applicator identification shall adopt these 
categories as needed, along with such appropriate subcategories as are 
necessary to meet the particular requirements of the State.
    (b) Categories--(1) Agricultural pest control--(i) Plant. This 
category includes commercial applicators using or supervising the use of 
restricted use pesticides in production of agricultural crops, including 
without limiting the foregoing, tobacco, peanuts, cotton, feed grains, 
soybeans and forage; vegetables; small fruits; tree fruits and nuts; as 
well as on grasslands and non-crop agricultural lands.
    (ii) Animal. This category includes commercial applicators using or 
supervising the use of restricted use pesticides on animals, including 
without limiting the foregoing, beef cattle, dairy cattle, swine, sheep, 
horses, goats, poultry, and livestock, and to places on or in which 
animals are confined.

Doctors of Veterinary Medicine engaged in the business of applying 
pesticides for hire, publicly holding themselves out as pesticide 
applicators, or engaged in large-scale use of pesticides are included in 
this category.
    (2) Forest pest control. This category includes commercial 
applicators using or supervising the use of restricted use pesticides in 
forests, forest nurseries, and forest seed producing areas.
    (3) Ornamental and turf pest control. This category includes 
commercial applicators using or supervising the use of restricted use 
pesticides to control pests in the maintenance and production of 
ornamental trees, shrubs, flowers, and turf.
    (4) Seed treatment. This category includes commercial applicators 
using or supervising the use of restricted use pesticides on seeds.
    (5) Aquatic pest control. This category includes commercial 
applicators using or supervising the use of any restricted use pesticide 
purposefully applied to standing or running water, excluding applicators 
engaged in public health related activities included in category 8 
below.
    (6) Right-of-way pest control. This category includes commercial 
applicators

[[Page 370]]

using or supervising the use of restricted use pesticides in the 
maintenance of public roads, electric powerlines, pipelines, railway 
rights-of-way or other similar areas.
    (7) Industrial, institutional, structural and health related pest 
control. This category includes commercial applicators using or 
supervising the use of restricted use pesticides in, on, or around food 
handling establishments, human dwellings, institutions, such as schools 
and hospitals, industrial establishments, including warehouses and grain 
elevators, and any other structures and adjacent areas, public or 
private; and for the protection of stored, processed, or manufactured 
products.
    (8) Public health pest control. This category includes State, 
Federal or other governmental employees using or supervising the use of 
restricted use pesticides in public health programs for the management 
and control of pests having medical and public health importance.
    (9) Regulatory pest control. This category includes State, Federal 
or other governmental employees who use or supervise the use of 
restricted use pesticides in the control of regulated pests.
    (10) Demonstration and research pest control. This category 
includes: (i) individuals who demonstrate to the public the proper use 
and techniques of application of restricted use pesticides or supervise 
such demonstration, and (ii) persons conducting field research with 
pesticides, and in doing so, use or supervise the use of restricted use 
pesticides. Included in the first group are such persons as extension 
specialists and county agents, commercial representatives demonstrating 
pesticide products, and those individuals demonstrating methods used in 
public programs. The second group includes: State, Federal, commercial 
and other persons conducting field research on or utilizing restricted 
use pesticides.
    (c) Other categories and subcategories. Any State submitting a plan 
pursuant to this section for the certification of applicators, as 
provided for below, may designate such subcategories within the above 10 
categories as it deems necessary. In addition, a State may delete a 
category not needed or may request the Administrator's approval of 
additional major categories.



Sec. 171.4  Standards for certification of commercial applicators.

    (a) Determination of competency. Competence in the use and handling 
of pesticides shall be determined on the basis of written examinations, 
and, as appropriate, performance testing, based upon standards set forth 
below and which are approved by the Administrator. Such examination and 
testing shall include the general standards applicable to all categories 
(Sec. 171.4(b)) and the additional standards specifically identified 
for each category or subcategory (if any) in which an applicator is to 
be classified (Sec. 171.4(c)). State standards must conform and be at 
least equal to those prescribed herein. In developing the details of 
standards at the State level and in structuring examinations, it is 
important to recognize and reflect the extent of competency appropriate 
and necessary to a particular category.
    (b) General standards for all categories of certified commercial 
applicators. (1) All commercial applicators shall demonstrate practical 
knowledge of the principles and practices of pest control and safe use 
of pesticides. Testing shall be based on examples of problems and 
situations appropriate to the particular category or subcategory of the 
applicator's certification and the following areas of competency:
    (i) Label & labeling comprehension. (a) The general format and 
terminology of pesticide labels and labeling;
    (b) The understanding of instructions, warnings, terms, symbols, and 
other information commonly appearing on pesticide labels;
    (c) Classification of the product, general or restricted; and
    (d) Necessity for use consistent with the label.
    (ii) Safety. Factors including:
    (a) Pesticide toxicity and hazard to man and common exposure routes;
    (b) Common types and causes of pesticide accidents;
    (c) Precautions necessary to guard against injury to applicators and 
other individuals in or near treated areas;
    (d) Need for and use of protective clothing and equipment;
    (e) Symptoms of pesticide poisoning;

[[Page 371]]

    (f) First aid and other procedures to be followed in case of a 
pesticide accident; and
    (g) Proper identification, storage, transport, handling, mixing 
procedures and disposal methods for pesticides and used pesticide 
containers, including precautions to be taken to prevent children from 
having access to pesticides and pesticide containers.
    (iii) Environment. The potential environmental consequences of the 
use and misuse of pesticides as may be influenced by such factors as:
    (a) Weather and other climatic conditions;
    (b) Types of terrain, soil or other substrate;
    (c) Presence of fish, wildlife and other non-target organisms; and
    (d) Drainage patterns.
    (iv) Pests. Factors such as: (a) Common features of pest organisms 
and characteristics of damage needed for pest recognition;
    (b) Recognition of relevant pests; and
    (c) Pest development and biology as it may be relevant to problem 
identification and control.
    (v) Pesticides. Factors such as:
    (a) Types of pesticides;
    (b) Types of formulations;
    (c) Compatibility, synergism, persistence and animal and plant 
toxicity of the formulations;
    (d) Hazards and residues associated with use;
    (e) Factors which influence effectiveness or lead to such problems 
as resistance to pesticides; and
    (f) Dilution procedures.
    (vi) Equipment. Factors including: (a) Types of equipment and 
advantages and limitations of each type; and
    (b) Uses, maintenance and calibration.
    (vii) Application techniques. Factors including:
    (a) Methods of procedure used to apply various formulations of 
pesticides, solutions, and gases, together with a knowledge of which 
technique of application to use in a given situation;
    (b) Relationship of discharge and placement of pesticides to proper 
use, unnecessary use, and misuse; and
    (c) Prevention of drift and pesticide loss into the environment.
    (viii) Laws and regulations. Applicable State and Federal laws and 
regulations.
    (c) Specific standards of competency for each category of commercial 
applicators. Some of the factors referenced in paragraph (b) of this 
section are of particular importance because of the different types of 
activities carried out by applicators in each category. Such factors 
must be especially stressed and specifically reflected in State 
certification standards, as appropriate. For example, practical 
knowledge of drift problems should be required of agricultural 
applicators but not of seed treatment applicators. The latter, however, 
should be particularly knowledgeable of the hazards of the misuse of 
treated seed and the necessary precautionary techniques. Many 
applicators in Sec. 171.3(b) (8), (9), and (10) will have had 
considerable formal education, training and experience in preparation 
for their positions. Their competency with respect to the use and 
handling of pesticides will have been determined by examining boards of 
their professional scientific societies utilizing standards which equal 
or exceed those prescribed herein. Such standards should be consulted by 
States in developing their State standards for certification of such 
applicators under these regulations. Commercial applicators in each 
category shall be particularly qualified with respect to the practical 
knowledge standards elaborated below:
    (1) Agricultural pest control--(i) Plant. Applicators must 
demonstrate practical knowledge of crops grown and the specific pests of 
those crops on which they may be using restricted use pesticides. The 
importance of such competency is amplified by the extensive areas 
involved, the quantities of pesticides needed, and the ultimate use of 
many commodities as food and feed. Practical knowledge is required 
concerning soil and water problems, pre-harvest intervals, re-entry 
intervals, phytotoxicity, and potential for environmental contamination, 
non-target injury and community problems resulting from the use of 
restricted use pesticides in agricultural areas.
    (ii) Animal. Applicators applying pesticides directly to animals 
must demonstrate practical knowledge of such

[[Page 372]]

animals and their associated pests. A practical knowledge is also 
required concerning specific pesticide toxicity and residue potential, 
since host animals will frequently be used for food. Further, the 
applicator must know the relative hazards associated with such factors 
as formulation, application techniques, age of animals, stress and 
extent of treatment.
    (2) Forest pest control. Applicators shall demonstrate practical 
knowledge of types of forests, forest nurseries, and seed production in 
their State and the pests involved. They should possess practical 
knowledge of the cyclic occurrence of certain pests and specific 
population dynamics as a basis for programming pesticide applications. A 
practical knowledge is required of the relative biotic agents and their 
vulnerability to the pesticides to be applied. Because forest stands may 
be large and frequently include natural aquatic habitats and harbor 
wildlife, the consequences of pesticide use may be difficult to assess. 
The applicator must therefore demonstrate practical knowledge of control 
methods which will minimize the possibility of secondary problems such 
is unintended effects on wildlife. Proper use of specialized equipment 
must be demonstrated, especially as it may relate to meteorological 
factors and adjacent land use.
    (3) Ornamental and turf pest control. Applicators shall demonstrate 
practical knowledge of pesticide problems associated with the production 
and maintenance of ornamental trees, shrubs, plantings, and turf, 
including cognizance of potential phytotoxicity due to a wide variety of 
plant material, drift, and persistence beyond the intended period of 
pest control. Because of the frequent proximity of human habitations to 
application activities, applicators in this category must demonstrate 
practical knowledge of application methods which will minimize or 
prevent hazards to humans, pets, and other domestic animals.
    (4) Seed-treatment. Applicators shall demonstrate practical 
knowledge of types of seeds that require chemical protection against 
pests and factors such as seed coloration, carriers, and surface active 
agents which influence pesticide binding and may affect germination. 
They must demonstrate practical knowledge of hazards associated with 
handling, sorting and mixing, and misuse of treated seed such as 
introduction of treated seed into food and feed channels, as well as 
proper disposal of unused treated seeds.
    (5) Aquatic pest control. Applicators shall demonstrate practical 
knowledge of the secondary effects which can be caused by improper 
application rates, incorrect formulations, and faulty application of 
restricted use pesticides used in this category. They shall demonstrate 
practical knowledge of various water use situations and the potential of 
downstream effects. Further, they must have practical knowledge 
concerning potential pesticide effects on plants, fish, birds, 
beneficial insects and other organisms which may be present in aquatic 
environments. These applicators shall demonstrate practical knowledge of 
the principles of limited area application.
    (6) Right-of-way pest control. Applicators shall demonstrate 
practical knowledge of a wide variety of environments, since rights-of-
way can traverse many different terrains, including waterways. They 
shall demonstrate practical knowledge of problems on runoff, drift, and 
excessive foliage destruction and ability to recognize target organisms. 
They shall also demonstrate practical knowledge of the nature of 
herbicides and the need for containment of these pesticides within the 
right-of-way area, and the impact of their application activities in the 
adjacent areas and communities.
    (7) Industrial, institutional, structural and health related pest 
control. Applicators must demonstrate a practical knowledge of a wide 
variety of pests, including their life cycles, types of formulations 
appropriate for their control, and methods of application that avoid 
contamination of food, damage and contamination of habitat, and exposure 
of people and pets. Since human exposure, including babies, children, 
pregnant women, and elderly people, is frequently a potential problem, 
applicators must demonstrate practical knowledge of the specific factors 
which

[[Page 373]]

may lead to a hazardous condition, including continuous exposure in the 
various situations encountered in this category. Because health related 
pest control may involve outdoor applications, applicators must also 
demonstrate practical knowledge of environmental conditions, 
particularly related to this activity.
    (8) Public health pest control. Applicators shall demonstrate 
practical knowledge of vector-disease transmission as it relates to and 
influences application programs. A wide variety of pests is involved, 
and it is essential that they be known and recognized, and appropriate 
life cycles and habitats be understood as a basis for control strategy. 
These applicators shall have practical knowledge of a great variety of 
environments ranging from streams to those conditions found in 
buildings. They should also have practical knowledge of the importance 
and employment of such non-chemical control methods as sanitation, waste 
disposal, and drainage.
    (9) Regulatory pest control. Applicators shall demonstrate practical 
knowledge of regulated pests, applicable laws relating to quarantine and 
other regulation of pests, and the potential impact on the environment 
of restricted use pesticides used in suppression and eradication 
programs. They shall demonstrate knowledge of factors influencing 
introduction, spread, and population dynamics of relevant pests. Their 
knowledge shall extend beyond that required by their immediate duties, 
since their services are frequently required in other areas of the 
country where emergency measures are invoked to control regulated pests 
and where individual judgments must be made in new situations.
    (10) Demonstration and research pest control. Persons demonstrating 
the safe and effective use of pesticides to other applicators and the 
public will be expected to meet comprehensive standards reflecting a 
broad spectrum of pesticide uses. Many different pest problems 
situations will be encountered in the course of activities associated 
with demonstration, and practical knowledge of problems, pests, and 
population levels occurring in each demonstration situation is required. 
Further, they should demonstrate an understanding of a pesticide-
organism interactions and the importance of integrating pesticide use 
with other control methods. In general, it would be expected that 
applicators doing demonstration pest control work possess a practical 
knowledge of all of the standards detailed in Sec. 171.4(b). In 
addition, they shall meet the specific standards required for paragraphs 
(c) (1) through (7) of this section as may be applicable to their 
particular activity.

Persons conducting field research or method improvement work with 
restricted use pesticides should be expected to know the general 
standards detailed in 171.4(b). In addition, they shall be expected to 
know the specific standards required for paragraphs (c) (1) through (9) 
of this section, applicable to their particular activity, or 
alternatively, to meet the more inclusive requirements listed under 
``Demonstration.''
    (d) Special standards. This space reserved for possible issuance of 
Special Standards.
    (e) The above standards do not apply to the following persons for 
purposes of these regulations. (1) Persons conducting laboratory type 
research involving restricted use pesticides; and
    (2) Doctors of Medicine and Doctors of Veterinary Medicine applying 
pesticides as drugs or medication during the course of their normal 
practice.



Sec. 171.5  Standards for certification of private applicators.

    (a) Competence in the use and handling of pesticides by a private 
applicator will be determined by procedures set forth below. State 
standards must conform and be at least equal to those prescribed herein. 
As a minimum requirement for certification, a private applicator must 
show that he possesses a practical knowledge of the pest problems and 
pest control practices associated with his agricultural operations; 
proper storage, use, handling and disposal of the pesticides and 
containers; and his related legal responsibility. This practical 
knowledge includes ability to:
    (1) Recognize common pests to be controlled and damage caused by 
them.

[[Page 374]]

    (2) Read and understand the label and labeling information--
including the common name of pesticides he applied; pest(s) to be 
controlled, timing and methods of application; safety precautions; any 
pre-harvest or re-entry restrictions; and any specific disposal 
procedures.
    (3) Apply pesticides in accordance with label instructions and 
warnings, including the ability to prepare the proper concentration of 
pesticide to be used under particular circumstances taking into account 
such factors as area to be covered, speed at which application equipment 
will be driven, and the quantity dispersed in a given period of 
operation.
    (4) Recognize local environmental situations that must be considered 
during application to avoid contamination.
    (5) Recognize poisoning symptoms and procedures to follow in case of 
a pesticide accident.
    (b) Such competence of each private applicator shall be verified by 
the responsible State agency through the administration of a private 
applicator certification system which ensures that the private 
applicator is competent, based upon the standards set forth above, to 
use the restricted use pesticides under limitations of applicable State 
and Federal laws and regulations. A certification system shall employ a 
written or oral testing procedure, or such other equivalent system as 
may be approved as part of a State plan.
    (1) In any case where a person, at the time of testing for 
certification, is unable to read a label, the responsible State agency 
may employ a testing procedure, previously approved by the 
Administrator, which can adequately assess the competence of such person 
with regard to all of the above standards. Certification must be related 
and limited to the use and handling of each individual pesticide for 
which he desires certification at any time. Therefore, the applicator 
will be authorized to use only the pesticide(s) for which he has 
demonstrated competence. A specific procedure is required for Sec. 
171.5(a)(2) relating to label comprehension, with testing designed to 
assure his knowledge of the following:
    (i) Understanding of the label and labeling information including 
those items indicated in that subsection.
    (ii) Sources of advice and guidance necessary for the safe and 
proper use of each pesticide related to his certification.
    (2) [Reserved]



Sec. 171.6  Standards for supervision of noncertified applicators by certified 

private and commercial applicators.

    (a) Certified applicators whose activities indicate a supervisory 
role must demonstrate a practical knowledge of Federal and State 
supervisory requirements, including labeling, regarding the application 
of restricted use pesticides by noncertified applicators.

The availability of the certified applicator must be directly related to 
the hazard of the situation. In many situations, where the certified 
applicator is not required to be physically present, ``direct 
supervision'' shall include verifiable instruction to the competent 
person, as follows: (1) Detailed guidance for applying the pesticide 
properly, and (2) provisions for contacting the certified applicator in 
the event he is needed. In other situations, and as required by the 
label, the actual physical presence of a certified applicator may be 
required when application is made by a noncertified applicator.
    (b) [Reserved]



Sec. 171.7  Submission and approval of State plans for certification of 

commercial and private applicators of restricted use pesticides.

    If any State, at any time, desires to certify applicators of 
restricted use pesticides, the Governor of that State shall submit a 
State plan for that purpose. The Administrator shall approve the plan 
submitted by any State, or any modification thereof, if the plan in his 
judgment--
    (a) Designates a State agency as the agency responsible for 
administering the plan throughout the State. Since several other 
agencies or organizations may also be involved in administering portions 
of the State plan, all of these shall be identified in the State plan, 
particularly any other agencies or organizations responsible for 
certifying

[[Page 375]]

applicators and suspending or revoking certification. In the extent that 
more than one governmental agency will be responsible for performing 
certain functions under the State plans, the plans shall identify which 
functions are to be performed by which agency and indicate how the 
program will be coordinated by the lead agency to ensure consistency of 
programs within the State. The lead agency will serve as the central 
contact point for the Environmental Protection Agency in carrying out 
the certification program. The numbers and job titles of the responsible 
officials of the lead agency and cooperating units shall be included.
    (b) Contains satisfactory assurances that such lead agency has or 
will have the legal authority and qualified personnel necessary to carry 
out the plan:
    (1) Satisfactory assurances that the lead agency or other 
cooperating agencies have the legal authority necessary to carry out the 
plans should be in the form of an opinion of the Attorney General or the 
legal counsel of the lead agency. In addition:
    (i) The lead agency should submit a copy of each appropriate State 
law and regulation.
    (ii) In those States where any requisite legal authorities are 
pending enactment and/or promulgation, the Governor (or Chief Executive) 
may request that a State plan be approved contingent upon the enactment 
and/or promulgation of such authorities. Plans approved on a contingency 
basis will be subject to such reasonable terms and conditions, 
concerning the duration of the contingency approval and other matters, 
as the Administrator may impose. During the period of the contingency 
approval, the State will have an approved certification program and may 
proceed to certify applicators, who will then be permitted to use or 
supervise the use of pesticides classified for restricted use under 
FIFRA, as amended.
    (iii) The State plan should indicate by citations to specific laws 
(whether enacted or pending enactment) and/or regulations (whether 
promulgated or pending promulgation) that the State has legal 
authorities as follows:
    (A) Provisions for and listing of the acts which constitute grounds 
for denying, suspending, and revoking certification of applicators, and 
for assessing criminal and/or civil penalties. Such grounds should 
include, at a minimum, misuse of a pesticide and falsification of any 
records required to be maintained by the certified applicator.
    (B) Provisions for reviewing an applicator's certification to 
determine whether suspension or revocation of the certification is 
appropriate in the event of criminal conviction under section 14(b) of 
the amended FIFRA, a final order imposing civil penalty under section 
14(a) of the amended FIFRA, or conclusion of a State enforcement action.
    (C) Provisions for right-of-entry by consent or warrant by 
appropriate State officials at reasonable times for sampling, 
inspection, and observation purposes.
    (D) Provisions making it unlawful for persons other than certified 
applicators or persons working under their direct supervision to use 
restricted use pesticides.
    (E) Provisions requiring certified commercial applicators to keep 
and maintain for the period of at least two years routine operational 
records containing information on kinds, amounts, uses, dates, and 
places of application of restricted use pesticides; and for ensuring 
that such records will be available to appropriate State officials.
    (2) Satisfactory assurances that the lead agency and any cooperating 
organizations have qualified personnel necessary to carry out the plan 
will be demonstrated by including the numbers, job titles and job 
functions of persons so employed.
    (c) Gives satisfactory assurances that the State will devote 
adequate funds to the administration of the plan.
    (d) Provides that the State agency will make reports to the 
Administrator in a manner and containing information that the 
Administrator may from time to time require, including:
    (1) An annual report to be submitted by the lead agency, at a time 
to be specified by the State, to include the following information:

[[Page 376]]

    (i) Total number of applicators, private and commercial, by 
category, currently certified; and number of applicators, private and 
commercial, by category, certified during the last reporting period.
    (ii) Any changes in commercial applicator subcategories.
    (iii) A summary of enforcement activities related to use of 
restricted use pesticides during the last reporting period.
    (iv) Any significant proposed changes in required standards of 
competency.
    (v) Proposed changes in plans and procedures for enforcement 
activities related to use of restricted use pesticides for the next 
reporting period.
    (vi) Any other proposed changes from the State plan that would 
significantly affect the State certification program.
    (2) Other reports as may be required by the Administrator shall be 
submitted from time to time to meet specific needs.
    (e) Contains satisfactory assurances that the State standards for 
the certification of applicators of pesticides conform to those 
standards prescribed by the Administrator under Sec. Sec. 171.1 through 
171.6. Such assurances should consist of:
    (1) A detailed description of the State's plan for certifying 
applicators and a discussion of any special situations, problems, and 
needs together with an explanation of how the State intends to handle 
them. The State plan should include the following elements as a minimum:
    (i) For commercial applicators:
    (A) A list and description of categories and subcategories to be 
used in the State, such categories to be consistent with those defined 
in Sec. 171.3.
    (B) An estimate of the number of commercial applicators by category 
expected to be certified by the State.
    (C) The standards of competency elaborated by the State. These shall 
conform and be at least equal to those prescribed in Sec. 171.4 for the 
various categories of applicators utilized by the State. The standards 
shall also cover each of the points listed in the general standards in 
Sec. 171.4(b) and the points covered in the appropriate specific 
standards set forth in Sec. 171.4(c).
    (D) For each category and subcategory listed under Sec. 
171.7(e)(1)(i)(A), either submission of examinations or a description of 
the types and contents of examinations (e.g., multiple choice, true-
false) and submission of sample examination questions; and a description 
of any performance testing used to determine competency of applicators.
    (ii) For private applicators:
    (A) An estimate of the number of private applicators expected to be 
certified by the State.
    (B) The standards of competency elaborated by the State. These shall 
conform and be at least equal to those prescribed in Sec. 171.5(a), 
including the five requirements listed in Sec. 171.5(a) (1) through 
(5).
    (C) Types and contents of examinations and/or submission of detailed 
description of methods other than examination used to determine 
competency of private applicators.
    (D) A description of any special procedure of testing that a State 
develops to determine the competency of a private applicator who is 
unable to read the label as prescribed in Sec. 171.5(b)(1).
    (2) A provision for issuance by the State of appropriate credentials 
or documents verifying certification of applicators.
    (3) If appropriate, a description of any existing State licensing, 
certification or authorization programs for private applicators or for 
one or more categories of commercial applicators may be included. If 
these programs are determined by EPA to meet standards of competency 
prescribed by Sec. Sec. 171.1 through 171.6, States may certify 
applicators so licensed, certified or authorized without any additional 
demonstration of competency provided:
    (i) The commercial applicators who were licensed, certified, or 
authorized have demonstrated their competency based on written 
examinations and, as appropriate, performance testing, conforming to the 
standards set forth in Sec. 171.4, and
    (ii) The private applicators who were licensed, certified, or 
authorized have demonstrated their competency by written or oral testing 
procedures or other acceptable equivalent system, conforming to the 
standards set forth in Sec. 171.5.

[[Page 377]]

    (4) A statement that the State accepts Federal employees qualified 
under the Government Agency Plan (GAP) as fully meeting the requirements 
for certification by that State; or a description of any additional 
requirements these employees must meet to apply restricted use 
pesticides in that State. Any such additional requirements shall be 
consistent with and shall not exceed standards established for other 
comparable applicators in that State.
    (i) Until such time as the GAP has been fully developed and approved 
by EPA, this statement (Sec. 171.7(e)(4)) is not required. However, 
within 60 days after final approval of the GAP, the State should forward 
such a statement for inclusion in its State plan.
    (5) A description of any cooperative agreements a State has made 
with any Indian Governing Body to certify or assist in the certification 
of applicators not subject to State jurisdiction. (Sec. 171.10).
    (6) A description of any arrangements that a State has made or plans 
to make relating to reciprocity with other States or jurisdictions for 
the acceptance of certified applicators from those States or 
jurisdictions. However, those arrangements should meet these conditions:
    (i) The State according reciprocity should provide for issuance of 
an appropriate document verifying certification based upon the 
certifying document issued by the other States or jurisdictions.
    (ii) The State according reciprocity should have enforcement 
procedures that cover out-of-State applicators determined to be 
competent and certified within the State or jurisdiction.
    (iii) The detailed State or jurisdiction standards of competency, 
for each category identified in the reciprocity arrangement should be 
sufficiently comparable to justify waiving an additional determination 
of competency by the State granting reciprocity.
    (f) In responding to the preceding requirements, a State may 
describe in its State plan other regulatory activities implemented under 
State laws or regulations which will contribute to the desired control 
of the use of restricted use pesticides by certified applicators. Such 
other regulatory activities, if described, will be considered by the 
Administrator in evaluating whether or not a State's certified 
applicator program satisfies the requirements of Sec. 171.7 (a) through 
(e).

[40 FR 11702, Mar. 12, 1975]



Sec. 171.8  Maintenance of State plans.

    (a) Any State certification program approved under Sec. 171.7 shall 
be maintained in accordance with the State plan approved under that 
section. Accordingly, the State plan should include:
    (1) Provisions to assure that certified applicators comply with 
standards for the use of restricted use pesticides and carry out their 
responsibility to provide adequate supervision of noncertified 
applicators.
    (2) Provisions to ensure that certified applicators continue to meet 
the requirements of changing technology and to assure a continuing level 
of competency and ability to use pesticides safely and properly.
    (b) An approved State plan and the certification program carried out 
under such plan may not be substantially modified without the prior 
approval of the Administrator. A proposed change may be submitted for 
approval at any time but all applicable requirements prescribed by these 
Regulations must be satisfied for the modification to be eligible for 
approval by the Administrator.
    (c) Whenever the Administrator determines that a State is not 
administering the certification program in accordance with the State 
plan approved under Sec. 171.7, he shall so notify the State and 
provide for a hearing at the request of the State and, if appropriate 
corrective action is not taken within a reasonable time, not to exceed 
ninety days, the Administrator shall withdraw approval of the plan.

[40 FR 11704, Mar. 12, 1975]



Sec. 171.9  Submission and approval of Government Agency Plan.

    This section is included to provide for certain Federal employees 
including those whose duties may require

[[Page 378]]

them to use or supervise the use of restricted use pesticides in a 
number of States.
    (a) Sections 171.1 through 171.8 will, with the necessary changes, 
apply to the Government Agency Plan (GAP) for determining and attesting 
to the competency of Federal employees to use or supervise the use of 
restricted use pesticides.
    (b) Federal employees qualified under the GAP shall:
    (1) Be prepared to present the Federal form issued to them attesting 
to their competency to appropriate State officials.
    (2) Fulfill any additional requirements States may have enumerated 
in their State plans as provided for under Sec. 171.7(e)(4).
    (c) The employing Federal agency shall ensure that certified 
employees using or supervising the use of restricted use pesticides 
within a Federal facility are subject to the same or equivalent 
provisions prescribed under Sec. 171.7(b)(1)(iii) (A)-(E).

[40 FR 11704, Mar. 12, 1975]



Sec. 171.10  Certification of applicators on Indian Reservations.

    This section applies to applicators on Indian Reservations.
    (a) On Indian Reservations \1\ not subject to State jurisdiction the 
appropriate Indian Governing Body \2\ may choose to utilize the State 
certification program, with the concurrence of the State, or develop its 
own plan for certifying private and commercial applicators to use or 
supervise the use of restricted use pesticides.
---------------------------------------------------------------------------

    \1\ The term Indian Reservation means any federally-recognized 
reservation established by Treaty, Agreement, Executive Order, or Act of 
Congress.
    \2\ The term Indian Governing Body means the governing body of any 
tribe, band, or group of Indians subject to the jurisdiction of the 
United States and recognized by the United States as possessing power of 
self-government.
---------------------------------------------------------------------------

    (1) If the Indian Governing Body decides to utilize the State 
certification program, it should enter into a cooperative agreement with 
the State. This agreement should include matters concerning funding and 
proper authority for enforcement purposes. Such agreement and any 
amendments thereto shall be incorporated in the State plan, and 
forwarded to the Administrator for approval or disapproval.
    (2) If the Indian Governing Body decides to develop its own 
certification plan, it shall be based on either Federal standards 
(Sec. Sec. 171.1 through 171.8) or State standards for certification 
which have been accepted by EPA. Such a plan shall be submitted through 
the United States Department of the Interior to the EPA Administrator 
for approval.
    (b) On Indian Reservations where the State has assumed jurisdiction 
under other Federal laws, anyone using or supervising the use of 
restricted use pesticides shall be certified under the appropriate State 
certification plan.
    (c) Non-Indians applying restricted use pesticides on Indian 
Reservations not subject to State jurisdiction shall be certified either 
under a State certification plan accepted by the Indian Governing Body 
or under the Indian Reservation certification plan.
    (d) Nothing in this section is intended either to confer or deny 
jurisdiction to the States over Indian Reservations not already 
conferred or denied under other laws or treaties.

[40 FR 11704, Mar. 12, 1975]



Sec. 171.11  Federal certification of pesticide applicators in States or on 

Indian Reservations where there is no approved State or Tribal certification 

plan in effect.

    (a) Applicability. This section applies to persons in any State and 
on any Indian Reservation where, because there is no approved State or 
Tribal certification plan in effect, the Administrator implements an EPA 
plan for the Federal certification of applicators of restricted use 
pesticides.
    (b) Certification requirement. In any State or on any Indian 
Reservation where this section is applicable, any person who uses or 
supervises the use of any pesticide classified for restricted use must 
be certified in accordance with this section. However, a competent 
person who is not certified may use a restricted use pesticide under the

[[Page 379]]

direct supervision of a certified applicator for uses authorized by the 
certified applicator's certification. Private applicator certification 
shall authorize only those uses, or the supervision of those uses, 
described in Sec. 171.2(t). Commercial applicator certification shall 
authorize only those uses, or the supervision of those uses, included 
within the specific category(ies) or subcategory(ies), described in 
Sec. 171.3(b) or an applicable Federal plan, in which the applicator is 
certified.
    (c) Certification of commercial applicators--(1) Categories for 
commercial applicators. Categories referred to in this section are the 
same as those listed in Sec. 171.3(b). Determination of competency in 
each category shall conform to the requirements of Sec. 171.4(a).
    (2) Subcategories. The Administrator may adopt subcategories as he 
or she deems necessary, consonant with the needs of the individual State 
or Reservation.
    (3) Standards for certification. The standards of competency for 
certification of commercial applicators under this section are the same 
as those listed in Sec. 171.4 (b) and (c) and Sec. 171.6.
    (4) Certification procedure. An individual who desires to be 
certified or recertified under this paragraph shall complete the EPA 
certification form and submit the form to the appropriate EPA Regional 
Office. In order to be initially certified as a commercial applicator 
under this paragraph, an individual must take and pass written 
examinations approved by the Administrator and administered by the 
Administrator or any other party approved by him or her. A general 
examination will be given, based on the general standards found in Sec. 
171.4(b) and the standards for supervision found in Sec. 171.6. In 
addition, specific category and subcategory examinations will be given, 
based on the appropriate category or subcategory standards found in 
Sec. 171.4(c) and the applicable Federal plan. The Administrator will 
notify the individual in writing of the results of the examinations 
within 45 days unless special circumstances justify a longer time 
period. The Administrator will issue to each person who has passed a 
general examination and one or more category or subcategory examinations 
a commercial applicator certificate covering each category and 
subcategory in which he or she has qualified. A commercial applicator 
certificate is valid for a period of three years from the date of 
issuance, unless earlier suspended or revoked by the Administrator (two 
years from the date of issuance, in the case of certificates issued 
prior to [effective date of amended rule]), and is valid within the 
State or Indian Reservation named on the certificate.
    (5) Re-examination. Individuals failing to pass the required 
certification examination(s) may be re-examined after notification of 
failure. An individual seeking re-examination need take only the 
examination(s) which he or she originally failed.
    (6) Renewal of commercial applicator certification. A certified 
commercial applicator may qualify for recertification by taking and 
passing written examinations as specified in paragraph (c)(4) of this 
section, or by successfully completing any available training program 
approved for this purpose by the Administrator. Recertification 
procedures must be completed by the certified commercial applicator 
during the twelve month period preceding the expiration date of his or 
her certificate.
    (7) Recordkeeping requirements. (i) Each self-employed certified 
commercial applicator, each firm employing a certified commercial 
applicator, and each person who contracts with a certified commercial 
applicator (or his or her employer) to have a restricted use pesticide 
applied on property owned or operated by another person shall keep and 
maintain at their principal place of business true and accurate records 
of the use of restricted use pesticides, providing the following 
information:
    (A) Name and address of the person for whom the pesticide was 
applied;
    (B) Location of the pesticide application;
    (C) Target pest(s);
    (D) Specific crop or commodity, as appropriate, and site, to which 
the pesticide was applied;
    (E) Year, month, day, and time of application;
    (F) Trade name and EPA registration number of the pesticide applied;

[[Page 380]]

    (G) Amount of the pesticide applied and percentage of active 
ingredient per unit of the pesticide used; and
    (H) Type and amount of the pesticide disposed of, method of 
disposal, date(s) of disposal, and location of the disposal site.
    (ii) Availability of required records. Each certified commercial 
applicator shall keep all records required under this paragraph current 
and shall make such records available for inspection and copying by 
representatives of EPA for a period of at least two years from the date 
of use of the pesticide.
    (d) Certification of private applicators--(1) Certification 
procedures. An individual who desires to be certified or recertified 
under this paragraph shall complete the EPA certification form and 
submit the form to the appropriate EPA Regional Office. In order to be 
certified or recertified as a private applicator to use restricted use 
pesticides, an individual must be determined competent with respect to 
the use and handling of pesticide. Standards for such determination are 
the same as those listed in Sec. Sec. 171.5 and 171.6. The 
Administrator will offer one or more of the following certification 
options, including at least one option which does not require the 
applicator to take an examination--
    (i) Approved training course. The individual may successfully 
complete an approved training course. Approved training courses may 
include courses sponsored by EPA, State cooperative extension services, 
State vocational agricultural courses, or private educational groups. 
Each training course for certification must be approved for that purpose 
by the Administrator and include, at a minimum, coverage of the private 
applicator standards listed in Sec. Sec. 171.5 and 171.6, and a 
demonstration that the individual has successfully completed the 
training course. Subject to the approval of the Administrator, this 
demonstration may be accomplished by completion of a no pass/no fail 
written questionnaire or a workbook, receipt of a passing grade in an 
approved course offered by an educational institution, or any other 
equivalent procedure.
    (ii) Written examination. The individual may pass a written 
examination approved by the Administrator and administered by the 
Administrator or any other party approved by him or her.
    (iii) Self-study program. The individual may successfully complete a 
self-study learning program approved by the Administrator and 
administered by the Administrator or any other party approved by him or 
her.
    (iv) Non-reader certification. Non-readers may be certified for 
specific use(s) of a single product by successfully completing an 
approved training course as specified in (d)(1) (i) of this section, or 
by passing an oral examination approved by the Administrator and 
administered by the Administrator or any other party approved by him or 
her. Such training or testing shall incorporate a specific procedure 
relating to label comprehension, as described in Sec. 171.5(b)(1).
    (2) Issuance of certificates. The Administrator will issue a private 
applicator certificate to each individual who successfully completes any 
available certification option. Individuals who, for any reason, fail to 
complete successfully a certification option may attempt to complete the 
same option or, if available, an alternative option. A private 
applicator certificate is valid for a period of four years from the date 
of issuance (three years from the date of issuance, in the case of 
certificates issued before [effective date of amended rule]), unless 
earlier suspended or revoked by the Administrator, and is valid within 
the State or Indian Reservation named on the certificate.
    (3) Renewal of private applicator certification. A certified private 
applicator may qualify for recertification by successfully completing 
any available certification option during the twelve month period 
preceding the expiration date of his or her certificate.
    (e) Recognition of other certificates. The Administrator may issue a 
certificate to an individual possessing any other valid Federal, State, 
or Tribal certificate without further demonstration of competency. The 
individual shall submit the EPA certification form and written evidence 
of valid certification to the appropriate EPA Regional Office. The 
Administrator may deny issuance of such certificate if the

[[Page 381]]

standards of competency for each category or subcategory identified in 
the other Federal, State, or Tribal certificate are not sufficiently 
comparable to justify waiving further demonstration of competency. The 
Administrator may revoke, suspend, or modify such certificate if the 
Federal, State, or Tribal certificate upon which it is based is revoked, 
suspended, or modified. Unless suspended or revoked, a certificate 
issued under this paragraph is valid until the expiration date of the 
Federal, State, or Tribal certificate.
    (f) Denial, suspension, modification or revocation of a certificate. 
(1) The Administrator may suspend all or part of a certificate issued 
pursuant to this section, or, after opportunity for a hearing, may deny 
issuance of, or revoke or modify, a certificate issued pursuant to this 
section, if he or she finds that the applicant or certificate holder has 
been convicted under section 14(b) of the amended FIFRA, has been 
subject to a final order imposing a civil penalty under section 14(a) of 
the amended FIFRA, or has committed any of the following acts:
    (i) Used any registered pesticide in a manner inconsistent with its 
labeling;
    (ii) Made available for use, or used, any registered pesticide 
classified for restricted use other than in accordance with section 3(d) 
of the amended FIFRA and any regulations promulgated thereunder;
    (iii) Refused to keep and maintain any records required pursuant to 
this section;
    (iv) Made false or fraudulent records, invoices or reports;
    (v) Failed to comply with any limitations or restrictions on or in a 
duly issued certificate; or,
    (vi) Violated any provision of the amended FIFRA and the regulations 
promulgated thereunder.
    (2) If the Administrator decides to deny, revoke, or modify a 
certificate, he or she will:
    (i) Notify the applicant or certificate holder of:
    (A) The ground(s) upon which the denial, revocation or modification 
is based;
    (B) The time period during which the denial, revocation or 
modification is effective, whether permanent or otherwise;
    (C) The conditions, if any, under which the individual may become 
certified or recertified; and,
    (D) Any additional conditions the Administrator may impose.
    (ii) Provide the applicant or certificate holder an opportunity to 
request a hearing prior to final Agency action to deny, revoke or modify 
the certificate.
    (3) If a hearing is requested by an applicant or certificate holder 
pursuant to paragraph (f)(2)(ii) of this section, the Administrator 
will:
    (i) Notify the affected applicant or certificate holder of those 
assertions of law and fact upon which the action to deny, revoke or 
modify the certificate is based;
    (ii) Provide the affected applicant or certificate holder an 
opportunity to offer written statements of facts, explanations, 
comments, and arguments relevant to the proposed action;
    (iii) Provide the affected applicant or certificate holder such 
other procedural opportunities as the Administrator may deem appropriate 
to ensure a fair and impartial hearing; and
    (iv) Appoint an attorney in the Agency as Presiding Officer to 
conduct the hearing. No person shall serve as Presiding Officer if he or 
she has had any prior connection with the specific case.
    (4) The Presiding Officer appointed pursuant to paragraph (f)(3)(iv) 
of this section shall:
    (i) Conduct a fair, orderly, and impartial hearing, without 
unnecessary delay;
    (ii) Consider all relevant evidence, explanation, comment, and 
argument submitted pursuant to paragraphs (f)(3)(ii) and (iii) of this 
section; and,
    (iii) Promptly notify the affected applicant or certificate holder 
of his or her decision and order. Such an order is a final Agency action 
subject to judicial review in accordance with Section 16 of the amended 
FIFRA.
    (5) If the Administrator decides to suspend all or part of a 
certificate, he or she will:
    (i) First determine that the public health, interest or welfare 
warrants immediate action to suspend the certificate;

[[Page 382]]

    (ii) Notify the certificate holder of the ground(s) upon which the 
suspension action is based;
    (iii) Notify the certificate holder of the time period during which 
the suspension is effective; and,
    (iv) Notify the certificate holder of his or her intent to revoke or 
modify the certificate, as appropriate, in accord with paragraph (f)(2) 
of this section. If such revocation or modification notice has not 
previously been issued, it will be issued at the same time the 
suspension notice is issued.
    (6) In cases where the act constituting grounds for suspension, 
revocation, or modification of a certificate is neither willful nor 
contrary to the public interest, health, or safety, the affected 
certificate holder may have additional procedural rights under 5 U.S.C. 
558(c).
    (7) Any notice, decision, or order issued by the Administrator under 
paragraph (f) of this section, and any documents filed by an applicant 
or certificate holder in a hearing under paragraph (f) of this section, 
shall be available to the public except as otherwise provided by section 
10 of the amended FIFRA or by part 2 of this title. Any such hearing at 
which oral testimony is presented shall be open to the public, except 
that the Presiding Officer may exclude the public to the extent 
necessary to allow presentation of information which may be entitled to 
confidentiality under section 10 of the amended FIFRA or under part 2 of 
this title.
    (g) Pesticide dealer reporting and recordkeeping requirements, 
availability of records, and failure to comply--(1) Reporting 
requirements. Each person who is a restricted use pesticide retail 
dealer in a State or on an Indian Reservation where the Administrator 
conducts the applicator certification and training program shall:
    (i) Report to the Environmental Protection Agency (EPA) the business 
name by which the restricted use pesticide retail dealer operates, and 
the name and business address of each of his dealerships. For dealers or 
dealerships in Nebraska this initial report must be submitted to EPA, 
Region VII, 324 E. 11th Street, Kansas City, MO 64106. For dealers or 
dealerships in Colorado this initial report must be submitted to EPA, 
Region VIII, 1860 Lincoln Street, Denver, Colorado 80295. This report 
shall be submitted to the appropriate EPA regional office no later than 
60 days after the date the person first becomes a restricted use 
pesticide retail dealer, or within 60 days after the publication of the 
effective date of this final rule, whichever date is later.
    (ii) Submit revisions to the initial report to the appropriate EPA 
regional office listed above reflecting any name changes, additions or 
deletions of dealerships. Revisions shall be submitted to EPA within 10 
days of the occurrence of such change, addition or deletion.
    (2) Recordkeeping requirement. Recordkeeping is required when making 
restricted use pesticides available to:
    (i) Certified applicators. Each restricted use pesticide retail 
dealer shall maintain at each individual dealership records of each 
transaction where a restricted use pesticide is made available for use 
by that dealership to a certified applicator. Record of each such 
transaction shall be maintained for a period of 24 months after the date 
of the transaction, and shall include the following information:
    (A) Name and address of the residence or principal place of business 
of each person to whom the pesticide was made available for use.
    (B) The certification number on the document evidencing that 
person's certification, the State (or other governmental unit) that 
issued the doucment, the expiration date of the certification, and the 
categories in which the applicator is certified, if appropriate.
    (C) The product name, EPA registration number, and the State special 
local need registration number, granted under section 24(c) of the FIFRA 
(if any) on the label of the pesticide.
    (D) The quantity of the pesticide made available for use in the 
transaction.
    (E) The date of the transaction.
    (ii) Uncertified persons. No dealer or dealership may make a 
restricted use pesticide available to an uncertified person unless he 
can document that the restricted use pesticide will be used

[[Page 383]]

by a certified applicator, and he maintains the records required in this 
subsection. Each restricted use pesticide retail dealer shall maintain 
records at each individual dealership of each transaction where a 
restricted use pesticide was made available to an uncertified person for 
use by a certified applicator. Records of each such transaction shall be 
maintained for a period of 24 months after the date of the transaction, 
and shall include the following information:
    (A) The name and address of the residence or principal place of 
business of the uncertified person to whom the restricted use pesticide 
is made available for use by a certified applicator.
    (B) The name and address of the residence or principal place of 
business of the certified applicator who will use the restricted use 
pesticide.
    (C) The certified applicator's certification number, the State (or 
other governmental unit) that issued his certification document, the 
expiration date of the certification, and the categories in which the 
applicator is certified, if appropriate.
    (D) The product name, EPA registration number, and the State special 
local need registration number, granted under section 24(c) of the FIFRA 
(if any) on the label of the pesticide.
    (E) The quantity of the pesticide made available for use in the 
transaction.
    (F) The date of the transaction.
    (G) At the time of each transaction, EPA recommends that the dealer 
obtain the information required in paragraph (g)(2)(ii) (A) through (C) 
of this section and assure himself that the restricted use pesticide is 
made available for use by a certified applicator by examining one of the 
following sets of documents:
    (1) The original of the certified applicator's certification 
document, and a driver's license or other State, county, or Tribal 
identification document issued to the uncertified person to whom the 
restricted use pesticide is made available.
    (2) A photocopy or facsimile of the certified applicator's 
certification document, together with a statement signed by the 
certified applicator authorizing the uncertified person to purchase the 
restricted use pesticide on his behalf, and a driver's license or other 
State, county, or Tribal identification document issued to the 
uncertified person to whom the restricted use pesticide is made 
available.
    (3) A photocopy or facsimile of the certified applicator's 
certification document, together with a copy of a signed contract or 
agreement, between the uncertified person to whom the restricted use 
pesticide is being made available for use and the identified certified 
applicator, which provides for the use of the restricted use pesticide 
by the identified certified applicator, and a driver's license or other 
State, county, or Tribal identification document issued to the 
uncertified person to whom the restricted use pesticide is made 
available.
    (3) Availability of required records. Each pesticide dealer shall, 
upon request of any officer or employee of EPA duly designated by the 
Administrator, furnish or permit such person at all reasonable times to 
have access to and copy all records required to be maintained under this 
section.
    (4) Failure to comply. Any person who fails to comply with the 
provisions of this rule may be subject to civil or criminal sanctions, 
under section 14 of the Act, or 18 U.S.C. 1001. Violations include 
failure to submit or falsification of any report required under this 
paragraph, failure to maintain or falsification of records as required 
under this section, and making available for use any pesticide 
classified for restricted use to a person who is not a certified 
commercial applicator other than in accordance with these regulations 
and section 3(d) of the amended FIFRA or rules promulgated thereunder.

[43 FR 24837, June 8, 1978, as amended at 48 FR 29855, June 29, 1983; 48 
FR 53974, Nov. 29, 1983; 49 FR 17759, Apr. 25, 1984; 58 FR 34203, June 
23, 1993; 77 FR 39642, July 5, 2012]



PART 172_EXPERIMENTAL USE PERMITS--Table of Contents



         Subpart A_Federal Issuance of Experimental Use Permits

Sec.
172.1 Definitions.

[[Page 384]]

172.2 General.
172.3 Scope of requirement.
172.4 Applications.
172.5 The permit.
172.6 Labeling.
172.7 Importation of technical material.
172.8 Program surveillance and reporting of data.
172.9 Renewals.
172.10 Refusals to issue and revocation.
172.11 Publication.

          Subpart B_State Issuance of Experimental Use Permits

172.20 Scope.
172.21 Definitions.
172.22 General.
172.23 State plans.
172.24 State issuance of permits.
172.25 Administration of State programs.
172.26 EPA review of permits.

   Subpart C_Notification for Certain Genetically Modified Microbial 
                               Pesticides

172.43 Definitions.
172.45 Requirement for a notification.
172.46 Submission of a notification.
172.48 Data requirements for a notification.
172.50 Response to a notification.
172.52 Notification exemption process.
172.57 Submission of information regarding potential unreasonable 
          adverse effects.
172.59 Enforcement.

    Authority: 7 U.S.C. 136c, 136w. Section 172.4 is also issued under 
31 U.S.C. 9701.

    Source: 40 FR 18782, Apr. 30, 1975, unless otherwise noted.



         Subpart A_Federal Issuance of Experimental Use Permits



Sec. 172.1  Definitions.

    Terms used in this part have the same meaning as in the Act. In 
addition, as used in this part, the following terms shall apply:
    Act means the Federal Insecticide, Fungicide and Rodenticide Act, as 
amended.
    Applicant means any person who applies for an experimental use 
permit pursuant to section 5 of the Act.
    Cooperator means any person who grants permission to a permittee or 
a permittee's designated participant for the use of an experimental use 
pesticide at an application site owned or controlled by the cooperator.
    Experimental animals means individual animals or groups of animals, 
regardless of species, intended for use and used solely for research 
purposes. The term does not include animals intended to be used for any 
food purposes
    Participant means any person acting as a representative of the 
permittee and responsible for making available for use, or supervising 
the use or evaluation of, an experimental use pesticide to be applied at 
a specific application site.
    Permittee means any applicant to whom an experimental use permit has 
been granted.
    Value for pesticide purposes means that characteristic of a 
substance or mixture of substances which produces an efficacious action 
on a pest.

[73 FR 75599, Dec. 12, 2008]



Sec. 172.2  General.

    (a) Pursuant to section 5 of the Federal Insecticide, Fungicide, and 
Rodenticide Act, as amended (86 Stat. 983), and except as herein 
provided by Sec. 172.3, any person wishing to accumulate information 
necessary to register under section 3 of the Act and the regulations 
thereunder (1) a pesticide not registered with this Agency or (2) a 
registered pesticide for a use not previously approved in the 
registration of the pesticide may apply to the Administrator at any time 
for an experimental use permit.
    (b) Pesticides under experimental use permits may not be sold or 
distributed other than through participants and, if sold or distributed 
through participants, may be used only at an application site of a 
cooperator and in accordance with the terms and conditions of the 
experimental use permit.



Sec. 172.3  Scope of requirement.

    (a) An experimental use permit (EUP) is generally required for 
testing of any unregistered pesticide or any registered pesticide being 
tested for an unregistered use. However, as described in paragraph (b) 
of this section, certain of such tests are presumed not to involve 
unreasonable adverse effects and, therefore, do not require an EUP.
    (b) Except as provided in subpart C of this part or as specifically 
determined by the Environmental Protection Agency (EPA), it may be 
presumed that EUPs are not required when:

[[Page 385]]

    (1) The experimental use of the pesticide is limited to:
    (i) Laboratory or greenhouse tests,
    (ii) Limited replicated field trials as described in paragraph (c) 
of this section to confirm such tests, or
    (iii) Other tests as described in paragraph (c) of this section 
whose purpose is only to assess the pesticide's potential efficacy, 
toxicity, or other properties.
    (2) The producer, applicator, or any other person conducting the 
test does not expect to receive any benefit in pest control from the 
pesticide's use.
    (c) For purposes of paragraphs (b)(1)(ii) and (b)(1)(iii) of this 
section, the following types of experimental tests are presumed not to 
need an EUP:
    (1) A small-scale test involving use of a particular pesticide that 
is conducted on a cumulative total of no more than 10 acres of land per 
pest, except that:
    (i) When testing for more than one target pest occurs at the same 
time and in the same locality, the 10 acre limitation shall encompass 
all of the target pests.
    (ii) Any food or feed crops involved in, or affected by, such tests 
(including, but not limited to, crops subsequently grown on such land 
which may reasonably be expected to contain residues of the tested 
pesticides) shall be destroyed or consumed only by experimental animals 
unless an appropriate tolerance or exemption from a tolerance has been 
established under the Federal Food, Drug, and Cosmetic Act (FFDCA) for 
residues of the pesticide.
    (2) A small-scale test involving the use of a particular pesticide 
that is conducted on a cumulative total of no more than 1 surface acre 
of water per pest, except that:
    (i) When the testing for more than one target pest occurs at the 
same time and in the same locality, the 1 acre limitation shall 
encompass all of the target pests.
    (ii) Waters which are involved in or affected by such tests are not 
used for irrigation purposes, drinking water supplies, or body contact 
recreational activities.
    (iii) Testing shall not be conducted in any waters which contain or 
affect fish, shellfish, plants, or animals taken for recreational or 
commercial purposes and used for food or feed, unless an appropriate 
tolerance or exemption from a tolerance has been established under the 
FFDCA for residues of the pesticide.
    (3) Animal treatment tests involving the use of a particular 
pesticide that are conducted only on experimental animals which will not 
be used for food or feed, unless an appropriate tolerance or an 
exemption from a tolerance has been established for animal products and 
byproducts under the FFDCA for residues of the pesticide.
    (d) The examples in paragraphs (c)(1), (c)(2), and (c)(3) of this 
section are not all-inclusive and do not preclude testing in larger 
areas or larger numbers of units if the intended use meets the criteria 
of paragraph (a) of this section. However, tests which do not come 
within the examples in paragraphs (c)(1), (c)(2), and (c)(3) of this 
section, absent a specific determination by EPA to the contrary, require 
an EUP. Persons intending to conduct tests who are uncertain whether the 
testing may be conducted without a permit may submit a request for 
determination to the Office of Pesticide Programs' Document Processing 
Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b). 
Such a request shall include the information listed in Sec. 
172.4(b)(1)(ii) and (b)(1)(iii) and in the case of an unregistered 
product, the information in Sec. 172.4(b)(3)(i).
    (e) Notwithstanding paragraphs (b) through (d) of this section, EPA 
may, on a case-by-case basis, require that certain testing of a 
particular pesticide or class of pesticides be carried out under an EUP, 
if it is determined that such EPA oversight is warranted. If EPA 
determines that an EUP is required, it will notify the developer of the 
pesticide of the need for an EUP and provide opportunity for comment or 
objections before imposing the requirement.
    (f) No EUP is required for a substance or mixture of substances 
being put through tests for the sole purpose of gathering data required 
for approval of such substance or mixture under the FFDCA (21 U.S.C. 301 
et seq.) as:
    (1) A ``new drug'' (21 U.S.C. sec. 321(p) and sec. 355).

[[Page 386]]

    (2) A ``new animal drug'' (21 U.S.C. sec. 321(w) and sec. 360(b)), 
or
    (3) An ``animal feed'' (21 U.S.C. sec. 321 (x)) containing a ``new 
animal drug'' (21 U.S.C. sec. 360(b)).
    (g) Paragraph (f) of this section shall not apply when a purpose of 
such test is to accumulate information necessary to register a pesticide 
under section 3 of the Act.

[59 FR 45611, Sept. 1, 1994, as amended at 71 FR 35546, June 21, 2006; 
73 FR 75599, Dec. 12, 2008]



Sec. 172.4  Applications.

    (a) Time for submission. An application or request for amendment to 
an existing permit shall be submitted as far as possible in advance of 
the intended date of shipment or use to the Office of Pesticide 
Programs' Document Processing Desk at the appropriate address as set 
forth in 40 CFR 150.17(a) or (b).
    (b) Contents of applications--(1) General requirements. (i) The name 
and address of the applicant;
    (ii) The registration number of the product, if registered;
    (iii) The purpose or objectives of the proposed testing; a 
description in detail of the proposed testing program including test 
parameters; a designation of the pest organism(s) involved; the amount 
of pesticide product proposed for use; the crops, fauna, flora, sites, 
modes, dosage rates, and situation of application on or in which the 
pesticide is to be used; the States in which the proposed program will 
be conducted; the number of acres, number of structural sites, or number 
of animals by State to be treated or included in the area of 
experimental use; the proposed dates or period(s) during which the 
testing program is to be conducted; and the manner in which supervision 
of the program will be accomplished;
    (iv) The name, street address, telephone number, and qualifications 
of all participants in the program (whether or not in the employ of the 
applicant). A permit must be amended to add or change participants;
    (v) The name and street address of all cooperators, if available at 
the time an application is submitted or as soon thereafter as available;
    (vi) A description and the specific results of any appropriate prior 
testing of the product conducted by the applicant to determine toxicity 
and effects in or on target organisms at the site of application; and to 
determine phytotoxicity and other forms of toxicity or effects on 
nontarget plants, animals, and insects at or near the site of 
application; and to determine adverse effects on the environment;
    (vii) The proposed method of storage and disposition of any unused 
experimental use pesticide and its containers; and
    (viii) Such other additional pertinent information as the 
Administrator may require.
    (2) Requirement for tolerance. If the experimental use pesticide is 
to be used in such a manner that any residue can reasonably be expected 
to result in or on food or feed, the applicant must:
    (i) Submit evidence that a tolerance or exemption from the 
requirement of a tolerance has been established for residues of the 
pesticide in or on such food or feed under section 408 of the Federal 
Food, Drug, and Cosmetic Act; or
    (ii) Submit a petition proposing establishment of a tolerance or an 
exemption from the requirement of a tolerance under section 408 of the 
Federal Food, Drug, and Cosmetic Act; or
    (iii) Certify that the food or feed derived from the experimental 
program will be destroyed or fed only to experimental animals for 
testing purposes, or otherwise disposed of in a manner which will not 
endanger man or the environment. The method of such destruction or 
disposition shall be provided in the application for the permit.
    (3) Additional requirements for unregistered pesticide products. (i) 
A complete confidential statement of composition for the formulation to 
be tested giving the name and percentage by weight of each ingredient, 
active and inert;
    (ii) Chemical and physical properties of each active ingredient of 
the formulation to be tested, including, but not limited to, the 
manufacturing or laboratory processes and analytical methods suitable 
for determining the active ingredients in the formulation;
    (iii) Appropriate date, if available, on the rate of decline of 
residues on the treated crop or environmental site or other information 
for determination

[[Page 387]]

regarding entry of persons into treated areas; and
    (iv) Results of toxicity tests and other data relevant to the 
product's potential for causing injury to the users or other persons who 
may be exposed, including any available epidemiological information as 
to man.
    (c) Fees. The payment of fees for experimental use permits shall 
apply as specified in subpart U of part 152 of the chapter.

[40 FR 18782, Apr. 30, 1975, as amended at 53 FR 19115, May 26, 1988; 71 
FR 35546, June 21, 2006; 73 FR 75599, Dec. 12, 2008]



Sec. 172.5  The permit.

    (a) Issuance. The Experimental Use Permit shall be issued when the 
Administrator determines that the conditions of section 5 of the Act, 
and the regulations thereunder, have been met subject to such terms and 
conditions as the Administrator determines are warranted.
    (b) Duration. Permits will be effective for a specified period of 
time, normally one year, depending upon the crop or site to be tested 
and the requirements of the testing program submitted. The applicant 
should propose a suitable duration of the permit commensurate with the 
program submitted. Permits and associated temporary tolerances may be 
renewed, extended, or amended upon request if circumstances warrant.
    (c) Limitations. The quantity of a pesticide allowed by a permit may 
be less than requested if it is determined that the available 
information on efficacy, toxicity or other hazards, the need for data, 
or the adequacy of program supervision does not justify the quantity of 
the pesticide requested. Other limitations may also be placed in the 
permit if necessary for the protection of the public health and the 
environment.
    (d) Additions. With respect to an experimental use pesticide 
containing any chemical or combination of chemicals not included in any 
previously registered pesticides, the Administrator may require that 
additional studies be conducted during the permit period to gather data 
to support the establishment of tolerances and/or registration. To the 
extent practicable, the applicant will be notified of any such 
requirements before or at the time an experimental use permit is issued.
    (e) Maintenance of records. All producers of pesticides produced 
pursuant to an experimental use permit shall maintain records in 
accordance with part 169.



Sec. 172.6  Labeling.

    (a) Contents. Except as provided by paragraph (b) of this section, 
all pesticides shipped or used under an experimental use permit shall be 
labeled with directions and conditions for use which shall include the 
following:
    (1) The prominent statement, ``For Experimental Use Only'';
    (2) The Experimental Use Permit number;
    (3) The statement, ``Not for sale to any person other than a 
participant or cooperator of the EPA-approved Experimental Use 
Program'';
    (4) The name, brand, or trademark;
    (5) The name and address of the permittee, producer, or registrant;
    (6) The net contents;
    (7) An ingredient statement;
    (8) Warning or caution statements;
    (9) Any appropriate limitations on entry of persons into treated 
areas;
    (10) The establishment registration number, except in those cases 
where application of the pesticide is made solely by the producer; and
    (11) The directions for use, except that the Administrator may 
approve the use of the experimental program as labeling provided that 
such program is to be distributed with the product.
    (b) Supplemental labeling. In the case of a registered pesticide, 
the Administrator may, at his discretion, permit a pesticide to be used 
under an experimental use permit with supplemental labeling as approved 
by him.



Sec. 172.7  Importation of technical material.

    Technical materials may be imported without registration in 
sufficient quantities to formulate a pesticide for which an Experimental 
Use Permit has been requested if the application for such permit states 
that such importation will occur.

[[Page 388]]



Sec. 172.8  Program surveillance and reporting of data.

    (a) The permittee shall supervise the test program and evaluate the 
results of testing at each site of application. It will further be the 
responsibility of the permittee to report immediately to the 
Administrator, or to any person designated by him, any adverse effects 
from use of, or exposure to, the pesticide.
    (b) The permittee shall submit the following reports to the 
Registration Division during the experimental program.
    (1) [Reserved]
    (2) A final report shall be submitted within 180 days after the 
expiration of the permit, unless a request for extension of time is 
approved, and shall include:
    (i) All data gathered during the testing program; field notes need 
not be submitted but must be maintained and submitted upon request;
    (ii) A description of the disposition of any pesticide containers 
and any unused pesticides including amounts disposed of and the method 
and site of disposition; and
    (iii) The method of disposition of affected food and/or feed.

The data under paragraph (b)(2)(i) of this section above may be 
submitted as part of an application for registration submitted within 
180 days after the expiration of the permit, provided that the final 
report shall include a statement that such application has been made, 
and the date of such application.
    (c) In addition to the reporting requirements provided for elsewhere 
in this part, in the case of any meat-producing animals or birds that 
receive a direct treatment or application of any experimental use 
pesticide, the name and location of the packing plant where the animals 
will be processed shall be sent to the U.S. Department of Agriculture, 
Animal and Plant Health Inspection Service, Washington, DC 20250, at 
least 10 days before the animals are to be shipped for slaughter. This 
requirement may be waived, on request, by the USDA. These provisions do 
not exempt treated food-producing animals and their products from 
compliance with other applicable inspection requirements.
    (d) Failure to submit required reports may constitute grounds for 
revocation of the permit.
    (e) For the purpose of supervising the use of experimental use 
pesticides, the Agency may require the permittee or any participant to 
give reasonable advance notification of the intended dates, times, and 
sites on which such experimental use pesticide will be applied.
    (f) The permittee or participants in the experimental use program 
will permit any authorized representative of the Agency, upon 
presentation of official identification, entry, at any reasonable time, 
to any premises involved in the testing program to inspect and to 
determine whether there has been compliance with the terms and 
conditions of the permit.

[40 FR 18782, Apr. 30, 1975, as amended at 60 FR 32097, June 19, 1995]



Sec. 172.9  Renewals.

    Applications for renewal of experimental use permits and temporary 
tolerances, to provide for additional testing, shall be submitted prior 
to expiration of the permit. Requirements for renewals are the same as 
for applications under Sec. 172.4, except that information previously 
submitted may be incorporated by reference.



Sec. 172.10  Refusals to issue and revocation.

    (a) Refusal. At any time that the Administrator determines that an 
experimental use permit is not justified, or that the issuance of such a 
permit would cause unreasonable adverse effects on the environment, or 
that for any other reason provided for under the law a permit shall not 
be issued, he shall notify the applicant in writing.
    (b) Revocation. The Administrator may revoke an experimental use 
permit if he finds that its terms or conditions are being violated or 
that its terms or conditions are inadequate to avoid unreasonable 
adverse effects on the environment, or if new evidence is obtained which 
demonstrates that the tolerance will be inadequate to protect the public 
health, or for failure to meet any other provision of this part 172. The 
Administrator will notify the permittee in writing of such revocation.

[[Page 389]]

The permittee shall notify all participants of such revocation as soon 
as possible after he receives notice of revocation. The revocation of a 
permit shall not preclude the Administrator from initiating civil or 
criminal sanctions for the violations of the permit conditions or 
otherwise as authorized by law.
    (c) Hearing. In the event that an applicant for an experimental use 
permit wishes to contest the refusal to issue an experimental use 
permit, or an experimental use permittee wishes to contest the 
revocation of any such permit, he shall, within twenty days after 
receipt of notice of such refusal or revocation, file with the 
Administrator a written request for an opportunity to confer with the 
Administrator or his designee. Within twenty days after such conference, 
the applicant or permittee will be notified of the Administrator's final 
decision.



Sec. 172.11  Publication.

    (a) Notice of receipt of an experimental use permit application. The 
Administrator shall publish notice in the Federal Register of receipt of 
an application for an experimental use permit upon finding that issuance 
of the experimental use permit may be of regional or national 
significance. This notice shall include:
    (1) The active ingredients,
    (2) Use pattern(s),
    (3) Quantity of pesticide,
    (4) Total acreage,
    (5) Location of area of application,
    (6) A statement soliciting comments from any interested persons 
regarding the application.
    (b) Public hearing. The Administrator may hold a public hearing, and 
publish notice in the Federal Register of the date and location of the 
hearing, when he determines that there is sufficient interest in the 
application to warrant a hearing, based upon the comments received in 
response to the Notice of Receipt of an Application, or that a hearing 
would otherwise be in the public interest.
    (c) Issuance of experimental use permit. The Administrator shall 
give prompt notice in the Federal Register of the issuance of an 
experimental use permit. The notice shall include:
    (1) The active ingredients,
    (2) Use pattern(s),
    (3) Quantity of pesticide,
    (4) Total acreage,
    (5) Location of area of application,
    (6) A statement indicating where the experimental use permit is 
available for public inspection.



          Subpart B_State Issuance of Experimental Use Permits

    Source: 44 FR 41787, July 18, 1979, unless otherwise noted.



Sec. 172.20  Scope.

    This subpart sets forth regulations governing State issuance of 
experimental use permits pursuant to section 5(f) of the Federal 
Insecticide, Fungicide, and Rodenticide Act, as amended (FIFRA). It also 
sets forth regulations governing authorization by the Administrator of 
State experimental use permit programs.



Sec. 172.21  Definitions.

    Terms used in this subpart shall have the meaning set forth in FIFRA 
and in Sec. 172.1.
    Designated State agency means the State agency designated by State 
law or other authority to be responsible for registering pesticides to 
meet special local needs.
    Public or private agricultural research agency or educational 
institution means any organization engaged in research pertaining to the 
agricultural use of pesticides, or any educational institution engaged 
in pesticide research. Any research agency or educational institution 
whose principal function is to promote, or whose principal source of 
income is directly derived from, the sale or distribution of pesticides 
(or their active ingredients) does not come within the meaning of this 
term.

[73 FR 75599, Dec. 12, 2008]



Sec. 172.22  General.

    (a) Experimental use permits are not required under this rule in 
those situations described in Sec. 172.3 of subpart A pertaining to 
Federal experimental use permits.
    (b) Subpart B is not applicable to experimental use permits issued 
by a

[[Page 390]]

State, as required by State law, to a permittee who already holds a 
valid Federal experimental use permit issued under subpart A for the 
same purpose, or who is not required to obtain a permit under this rule.
    (c) Pesticide products used under experimental use permits may not 
be sold or distributed other than through participants, and, if sold or 
distributed through participants, may be used only at an application 
site of a cooperator and in accordance with the terms and conditions of 
the experimental use permit.
    (d) Establishments in which pesticide products under State 
experimental use permits are produced shall be registered as required by 
40 CFR 167.2(a) and producers of such products shall maintain books and 
records as required by 40 CFR 169.2.
    (e) Pesticide products and their containers used under this rule 
must also be packaged, stored, transported, used, and disposed of in 
accordance with all applicable Federal laws and regulations, including 
the Resource Conservation and Recovery Act of 1976 as amended (Pub. L. 
94-580; 90 Stat. 2795; 42 U.S.C. 6901 et seq.) (RCRA), and rules 
thereunder.



Sec. 172.23  State plans.

    (a) Submission. (1) A State may, by submitting a State plan, request 
the Administrator to authorize the designated State agency to issue 
experimental use permits under section 5(f) of FIFRA.
    (2) A State shall request authorization to issue experimental use 
permits by having the Governor or Chief Executive Officer or his 
designated agent submit a State plan in writing to the Administrator.
    (b) Contents. A State plan shall include--
    (1) A designation of the State agency responsible for the 
administration of the State experimental use permit program.
    (2) An opinion of the State attorney general or the legal counsel of 
the designated State agency that the State has the requisite legal 
authorities as set forth in paragraph (c)(1)(i) of this section, 
accompanied by copies of the applicable State laws and regulations.
    (3) A description of procedures that the designated State agency 
will follow:
    (i) To review experimental use permit applications, to ensure that 
experimental use permits will be issued in accordance with the terms and 
conditions of the authorization, FIFRA, and this subpart; and
    (ii) To supervise use pursuant to the permits, and to ensure that 
permits are used in accordance with their terms and conditions, FIFRA, 
and this subpart.
    (c) Criteria for EPA acceptance of State plan. (1) The Administrator 
shall grant authorization to issue experimental use permits if the State 
plan establishes that the designated State agency--
    (i) Has adequate legal authority under State law to implement the 
plan, including authority:
    (A) To issue experimental use permits, subject to limitations 
necessary for the protection of public health and the environment;
    (B) To supervise the use of a pesticide pursuant to an experimental 
use permit, as provided in Sec. 172.25(c);
    (C) To deny an experimental use permit if it determines that a 
permit is not justified, or that the issuance of the permit would cause 
unreasonable adverse effects on the environment;
    (D) To amend or revoke an experimental use permit, if the designated 
State agency finds that:
    (1) The terms and conditions of the permit are being violated, or 
are inadequate to avoid unreasonable adverse effects on the environment;
    (2) Any required tolerance under the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.) has been revoked by EPA, or any 
exemption from the requirement for tolerance has been withdrawn by EPA; 
or
    (3) A failure by the permittee or any cooperator to meet any other 
provision of FIFRA or this subpart has occurred;
    (E) To enter, by consent or by warrant or by other legal means, in 
connection with an experimental use permit, a permittee's or 
cooperator's premises at reasonable times in order to sample or inspect 
any pesticides used or property treated, to inspect any equipment or 
records kept, or to

[[Page 391]]

observe any activities conducted, as necessary to enforce compliance 
with State law, the terms of the permit, and this subpart;
    (F) To comply in all other respects with the requirements of this 
subpart, including labeling requirements; and
    (ii) Utilizes procedures for the review of each permit which are 
adequate to ensure that the State program will be administered in 
accordance with the purposes of FIFRA and this subpart.
    (2) After receiving a State plan, EPA shall publish a Federal 
Register notice announcing the fact and inviting interested parties to 
comment thereon.
    (d) Approval, rejection, and revocation. (1) EPA shall approve or 
reject the State plan within 90 days after receipt of all information 
necessary for final review of the plan, including copies of effective 
statutes and regulations which satisfy the requirements of this subpart.
    (2) The Administrator may at any time revoke the authorization of a 
State to issue experimental use permits if he determines that the 
designated State agency has not complied with the requirements of this 
subpart or with the terms and conditions of such authorization. State 
experimental use permits issued prior to the revocation of authority 
shall remain valid until they expire or until three years from the date 
of revocation of the State's authority, whichever comes first, unless 
sooner revoked by EPA under Sec. 172.26(c) of this subpart.
    (3) Notices of approval, rejection, and revocation shall be 
published in the Federal Register, as well as the basis for such 
approval, rejection, or revocation.
    (4) Prior to rejecting or revoking authorization, the Administrator 
shall notify the State in writing of his intention to take such action, 
along with the basis for such action, and shall afford the State the 
opportunity for a hearing, and time to take corrective action.



Sec. 172.24  State issuance of permits.

    (a) General. Upon approval of a State plan by the Administrator 
under Sec. 172.23, the designated State agency is authorized to issue, 
amend, renew, deny or revoke experimental use permits subject to the 
terms of the authorization and these regulations.
    (b) Authority. A designated State agency may issue an experimental 
use permit--
    (1) To any person for the purpose of gathering the data necessary to 
support the State registration of a pesticide to meet special local 
needs under section 24(c), FIFRA.
    (2) To any agricultural research agency or educational institution 
conducting work within the State for the purpose of experimentation:
    (i) Which is done within the State; and
    (ii) Which is not directly intended to result in the registration of 
a specific pesticide product.
    (3) For use of a restricted use pesticide only if the pesticide is 
to be used by, or under the direct supervision of, an applicator 
certified in accordance with section 11 of FIFRA.
    (c) Limitations. (1) In the case of applicants who need to gather 
data required to register a pesticide product to meet a special local 
need under section 24(c) of FIFRA, a State may only issue experimental 
use permits for the types of pesticide products and uses which it has 
authority to register under section 24(c).
    (2) A State may not issue an experimental use permit under Sec. 
172.24(b)(1) or Sec. 172.24(b)(2) for any of the following:
    (i) A product containing an active or inert ingredient not contained 
in any EPA-registered product;
    (ii) A product containing an active or inert ingredient which is 
currently subject to an EPA cancellation or suspension of registration 
order, or which is currently subject to an EPA notice of intent to 
suspend or cancel registration because of human health, environmental or 
efficacy considerations; except that the State may issue a permit for 
such a product for a purpose or in a formulation--
    (A) Which was not specifically considered in, or which is not 
subject to, such suspension or cancellation proceedings, after 
consultation with appropriate EPA officials; or
    (B) Which was specifically considered during such proceedings but 
not suspended, cancelled, or subjected to a notice of intent to suspend 
or cancel;

[[Page 392]]

    (iii) A use of a product which has been the subject of a notice of 
denial of registration published in the Federal Register pursuant to 
section 3(c)(6) of FIFRA and part 154 of this chapter; or
    (iv) A use of a product which may involve use in or on food or feed 
other than as authorized under Sec. 172.24(d), Requirement of 
tolerance.
    (3) A State may not issue an experimental use permit for use of a 
pesticide product in an area or in an amount in excess of that necessary 
to accomplish the purposes for which the permit was issued under 
paragraph (b) of this section.
    (d) Requirement of tolerance. If the experimental use pesticide is 
to be used in or on food or feed, the applicant must--
    (1) Submit evidence that:
    (i) A tolerance or exemption from the requirement of a tolerance has 
been established for residues of the pesticide in or on such food or 
feed under section 408 of the Federal Food, Drug and Cosmetic Act; and
    (ii) The proposed program would not reasonably be expected to result 
in residues of the pesticide in or on such food or feed in excess of 
that authorized under section 408 of the Federal Food, Drug and Cosmetic 
Act; and
    (iii) All inert ingredients in the pesticide are exempted from the 
requirement of a tolerance under the appropriate section of 40 CFR part 
180, subpart D; or
    (2) Certify that the food or feed derived from the experimental 
program will be destroyed or fed only to experimental animals for 
testing purposes, or otherwise disposed of in a manner which will not 
endanger man or the environment. The method of destruction or disposal 
shall be described in the application for the permit.

[44 FR 41787, July 18, 1979, as amended at 50 FR 49020, Nov. 27, 1985; 
73 FR 75599, Dec. 12, 2008]



Sec. 172.25  Administration of State programs.

    (a) General. State experimental use permit programs shall be 
consistent with the Federal experimental use permit program, as set 
forth in subpart A of 40 CFR part 172.
    (b) Procedures leading to issuance. An application for an 
experimental use permit shall be made in writing, and shall contain 
sufficient information, including a confidential statement of formula 
for any new product, to enable the State to determine whether use 
pursuant to the permit would be in accordance with the purposes of FIFRA 
and this subpart.
    (c) Labeling. (1) New products shall bear labeling satisfying the 
requirements of Sec. 172.6(a), except that the prominent statement 
``For Distribution and Experimental Use Only Within (State)'' shall be 
used in place of ``For Experimental Use Only''. The designated State 
agency may approve, as directions for use on labeling, the experimental 
program, provided such program is to be distributed with the product.
    (2) The designated State agency may permit an EPA or State 
registered pesticide to be used under an experimental use permit with 
supplemental labeling as approved by the State agency. In exercising 
this discretion, the designated State agency shall ensure that the 
supplemental labeling and the registered label together satisfy the 
requirements of Sec. 172.6(a).
    (d) Duration. State experimental use permits shall be issued for a 
specified period of time, not to exceed three years, depending upon the 
nature of the pest problem and the requirements of the testing program 
submitted. The designated State agency may renew, extend or amend the 
stated duration of a permit, if circumstances warrant.
    (e) Limitations. The designated State agency shall impose such 
limitations in the permit as are necessary to protect health and the 
environment, including limitations on quantity, sites, area, disposal, 
and other aspects of pesticide use.
    (f) Program surveillance and reporting of data. (1) The permittee 
shall supervise the test program and evaluate the results of testing at 
each site of application. The designated State agency shall require the 
permittee to report to it immediately any adverse effects resulting from 
use of, or exposure to, the pesticide.

[[Page 393]]

    (2) During the course of the program, the designated State agency 
shall require the permittee to submit such reports (both special and 
periodic) as are necessary to supervise effectively the progress of the 
program to prevent unreasonable adverse effects on man or the 
environment. The designated State agency shall also require the 
permittee to submit a final report at the conclusion of the program. 
Where applicable, such reports shall also be made available to the U.S. 
Department of Agriculture, Food Service and Quality Service (FSQS), as 
required by Sec. 172.8(c).
    (g) Disposal. All pesticides and pesticide containers, whether 
disposed of during the course of a State permit or remaining at the 
termination of a permit, must either be:
    (1) Disposed of in accordance with a disposal plan approved as part 
of the experimental program; or
    (2) Returned to the permittee for storage or disposal in accordance 
with the requirements of RCRA and rules there under; or
    (3) If the product is currently registered, used in accordance with 
the registered label.

[44 FR 41787, July 18, 1979, as amended at 60 FR 32097, June 19, 1995]



Sec. 172.26  EPA review of permits.

    (a) Notification of State action. (1) Within 10 days after the 
issuance of an experimental use permit, the designated State agency 
shall notifiy EPA of the action by forwarding to the appropriate EPA 
Regional Office a copy of the permit, a description of the experimental 
program to be conducted under the terms of the permit, a copy of the 
approved labeling, and a copy of the confidential statement of formula 
for any new product.
    (2) Within 10 days after amendment or revocation of an experimental 
use permit by a State, the designated State agency shall notify the 
appropriate EPA Regional Office in writing of the amendment or 
revocation. The notice shall include a brief explanation of the reason 
for the amendment or revocation. If amendments to permits include 
changes in the approved labeling, the designated State agency shall also 
forward a copy of the amended labeling.
    (3) EPA shall give notice in the Federal Register of State issuance 
of experimental use permits.
    (b) Reports. The designated State agency shall submit the following 
reports to EPA:
    (1) An annual report covering the number of permits issued, the 
names and addresses of permittees, the names of the products covered by 
permits, and the State permit numbers issued;
    (2) Reports, as requested by EPA, containing any information that 
EPA may determine necessary to ensure that a State has acted in 
compliance with provisions of FIFRA and this subpart; and
    (3) Reports of any serious adverse effect(s), as soon thereafter as 
possible, from use of, or exposure to, a pesticide used pursuant to an 
experimental use permit.
    (c) Revocation by EPA. (1) The Administrator may revoke an 
experimental use permit issued under this subpart if he finds:
    (i) That its terms and conditions are being violated;
    (ii) That its terms and conditions are inadequate to avoid 
unreasonable adverse effects on the environment;
    (iii) That new evidence demonstrates that any tolerance upon which 
the permit is based will be inadequate to protect the public health, or 
that any exemption from the requirement for a tolerance is no longer 
appropriate; or
    (iv) That a failure by the permittee to meet any other provisions of 
FIFRA or this subpart has occurred.
    (2) The Administrator shall, prior to revoking a State experimental 
use permit, consult with the State agency which issued the permit, 
except in cases where continued use of the pesticide under the permit 
would create an imminent hazard to man or the environment.
    (3) The Administrator shall notify the designated State agency, in 
writing, of the revocation, and the State agency shall notify the 
permittee, also in writing, of the revocation.
    (4) The permittee shall notify all participants of the revocation 
within 10 days after he receives notice of revocation.
    (5) The revocation of a permit shall not preclude the Administrator 
from

[[Page 394]]

initiating civil or criminal sanctions for violations of the permit 
conditions or other violations, as authorized by law.
    (6) If a permittee wishes to contest the revocation of a State 
experimental use permit, he shall, within 30 days after receipt of 
notice of such revocation, file with the Administrator a written request 
for an opportunity to confer with the Administrator or his designee. The 
revocation of the permit shall remain effective pending the outcome of 
any conference requested under this paragraph.
    (7) If a permittee requests a conference under paragraph (c)(6) of 
this section, the Administrator shall provide the permittee:
    (i) With information as to the time, place and nature of the 
conference, and of the matters of fact and law asserted by the Agency as 
grounds for the revocation action;
    (ii) An opportunity to offer a written statement of facts, 
explanations, and arguments relevant to the revocation action;
    (iii) All other procedural opportunities to which the permittee may 
be entitled by law.
    (8) The Administrator shall notify the affected permittee and State 
Agency, in writing, of his final decision on the revocation matter as 
expeditiously as possible and shall attempt to do so within 30 days 
after the conclusion of a conference conducted under paragraph (c)(7). 
The Administrator shall also provide the permittee and the State agency 
with a written statement of the reasons for his decision, which shall 
take into account the evidence presented pursuant to paragraph 
(c)(7)(ii) of this section.
    (9) A decision to revoke a permit under paragraph (c)(8) of this 
section is a final Agency action subject to judicial review as provided 
by law.

[44 FR 41787, July 18, 1979, as amended at 73 FR 75599, Dec. 12, 2008]



   Subpart C_Notification for Certain Genetically Modified Microbial 

                               Pesticides

    Source: 59 FR 45612, Sept. 1, 1994, unless otherwise noted.



Sec. 172.43  Definitions.

    Terms used in this subpart shall, with the exception of those 
defined below, have the meaning set forth in the Act and in Sec. 172.1.
    Containment and inactivation controls means any combination of 
mechanical, procedural, or biological controls designed and operated to 
restrict environmental release of viable microorganisms from a facility.
    Deliberately modified means the directed addition, rearrangement, or 
removal of nucleotide sequences to or from genetic material.
    Introduction of genetic material means the movement of nucleotide 
sequences into a microorganism, regardless of the technique used.
    Inversions of genetic material means the replacement of an internal 
section of a chromosome in the reverse orientation.
    Microbial pesticide means a microbial agent intended for preventing, 
destroying, repelling, or mitigating any pest, or intended for use as a 
plant regulator, defoliant, or desiccant, that:
    (1) Is a eucaryotic microorganism including, but not limited to, 
protozoa, algae and fungi;
    (2) Is a procaryotic microorganism, including, but not limited to, 
Eubacteria and Archaebacteria; or
    (3) Is a parasitically replicating microscopic element, including, 
but not limited to, viruses.
    Microbial pesticides resulting from rearrangements means a microbial 
pesticide resulting from translocations or inversions of genetic 
material.
    Microorganism means a bacterium, fungus, alga, virus, or protozoan.
    Nonindigenous microbial pesticide means a microbial pesticide 
brought into one of the following geographic areas from outside that 
area:
    (1) The continental United States, including Alaska, and the 
immediately adjoining countries (i.e., Canada and Mexico).
    (2) The Hawaiian Islands.
    (3) The Caribbean Islands including Puerto Rico and the U.S. Virgin 
Islands.

[[Page 395]]

    Pesticidal property means a characteristic exhibited by a 
microorganism that contributes to the intentional use of the 
microorganism to prevent, destroy, repel, or mitigate a pest or to act 
as a plant regulator, defoliant, or desiccant.
    Single genome means the sum total of chromosomal and 
extrachromosomal genetic material of an isolate and any descendants 
derived under axenic culture conditions from that isolate.
    Small-scale test means the experimental use of a microbial pesticide 
in a facility such as a laboratory or greenhouse, or use in limited 
replicated field trials or other tests as described in Sec. 172.3(c).
    Test or testing means any use of a microbial pesticide consistent 
with section 5 of the Act, including limited replicated field trials and 
associated activities.
    Translocations of genetic material means a chromosomal configuration 
in which part of a chromosome becomes attached to a different 
chromosome, or inserts in a different location on the same chromosome.

[59 FR 45612, Sept. 1, 1994, as amended at 72 FR 61029, Oct. 26, 2007]



Sec. 172.45  Requirement for a notification.

    (a) Who must submit a Notification. Notwithstanding Sec. 172.3, any 
person who plans to conduct small-scale testing of a type of microbial 
pesticide identified in paragraph (c) of this section must submit a 
Notification to EPA and obtain prior approval for either of the 
following tests:
    (1) Small-scale tests that involve an intentional environmental 
introduction of that microbial pesticide.
    (2) Small-scale tests performed in a facility without adequate 
containment and inactivation controls as provided in paragraph (e) of 
this section.
    (b) Alternative to Notification. In lieu of a Notification, any 
person required to submit a Notification under paragraph (a) of this 
section may submit an application for an experimental use permit (EUP) 
to EPA for approval.
    (c) Small-scale testing that requires a Notification. As provided in 
paragraph (a) of this section, and notwithstanding any other approval by 
any governmental entity, EPA review and approval are required prior to 
the initiation of any small-scale test involving either of the following 
microbial pesticides:
    (1) Microbial pesticides whose pesticidal properties have been 
imparted or enhanced by the introduction of genetic material that has 
been deliberately modified.
    (2) Nonindigenous microbial pesticides that have not been acted upon 
by the U.S. Department of Agriculture (i.e., either by issuing or 
denying a permit or determining that a permit is unnecessary; or a 
permit is not pending with the USDA).
    (d) Small-scale testing that does not require a Notification. (1) 
Testing conducted with microbial pesticides identified in paragraph (c) 
of this section, but made exempt pursuant to Sec. 172.52, does not 
require a Notification. The following microbial pesticides (or classes 
of pesticides) are exempt from the notification requirement in paragraph 
(a) of this section:
    (i) Microbial pesticides resulting from deletions or rearrangements 
within a single genome that are brought about by the introduction of 
genetic material that has been deliberately modified.
    (ii) [Reserved]
    (2) Testing conducted in a facility with adequate containment and 
inactivation controls, as provided in paragraph (e) of this section, 
does not require a Notification.
    (e) Selection and use of containment and inactivation controls. (1) 
Selection and use of containment and inactivation controls for a 
particular microbial pesticide shall take into account the following:
    (i) Factors relevant to the microbial pesticide's ability to survive 
in the environment.
    (ii) Potential routes of release in air, solids, and liquids; in or 
on waste materials and equipment; in or on people (including maintenance 
and custodial personnel); and in or on other organisms such as insects 
and rodents.
    (iii) Procedures for transfer of materials between facilities.
    (iv) Plans for routine or emergency clean-up and test termination.

[[Page 396]]

    (2) For purposes of paragraph (e)(1) of this section, EPA will 
presume that compliance with the containment provisions of the National 
Institutes of Health (NIH) ``Guidelines for Research Involving 
Recombinant DNA Molecules'' (51 FR 16958, May 7, 1986) constitutes 
selection and use of adequate containment and inactivation controls.
    (3) The selection of containment and inactivation controls shall be 
approved by an authorized official of the organization that is 
conducting the test prior to commencement of the test.
    (4) Records shall be developed and maintained describing the 
selection and use of the containment and inactivation controls, 
including contingency plans for emergency clean-up and test termination, 
that will be used during the test. These records shall be available for 
inspection at the test facility. In addition, these records shall be 
submitted to EPA at EPA's request and within the time frame specified in 
EPA's request.
    (5) Subsequent to any EPA review of the containment/inactivation 
controls selected under paragraph (e)(1) of this section, changes to the 
controls necessary to prevent unreasonable adverse effects must be made 
upon EPA request. Failure to comply with EPA's request shall result in 
automatic revocation of the exemption from the requirement to submit a 
Notification.



Sec. 172.46  Submission of a notification.

    (a) When to submit a Notification. A Notification shall be submitted 
for approval at least 90 days prior to the initiation of the proposed 
test.
    (b) Where to submit a notification. A notification shall be 
submitted to the Office of Pesticide Programs' Document Processing Desk 
at the appropriate address as set forth in 40 CFR 150.17(a) or (b), 
Attention: Biotechnology Notification Review.
    (c) How to format a Notification. A Notification submitted under 
this section must comply with the following procedures, but is not 
required to comply with the format and other provisions governing 
submission of data in Sec. Sec. 158.32 and 158.33 or Sec. Sec. 161.32 
and 161.33 of this chapter. However, because data submitted with the 
Notification may subsequently be used to support other regulatory 
actions (e.g., used in EUP or registration applications), it is 
recommended that such data comply with EPA requirements in Sec. Sec. 
158.32 and 158.33 of this chapter.
    (1) Each Notification must be accompanied by a transmittal document 
that clearly identifies the EPA action supported as a Biotechnology 
Notification Review.
    (2) Five copies of each Notification must be submitted to EPA.
    (3) Any claims of confidentiality for information submitted in the 
Notification must be made as described in paragraph (d) of this section.
    (d) How to make confidential business information (CBI) claims in a 
Notification. Although it is strongly recommended that the submitter 
minimize the amount of data and other information claimed as CBI, a 
submitter may assert a claim of confidentiality for all or part of the 
information submitted to EPA in a Notification (See part 2, subpart B of 
this chapter). To assert such a claim, the submitter must comply with 
the following procedures:
    (1) Any claim of confidentiality must accompany the information at 
the time the information is submitted to EPA. Failure to assert a claim 
at that time will be considered a waiver of confidentiality for the 
information submitted, and the information may be made available to the 
public, subject to section 10(g) of the Act, with no further notice to 
the submitter.
    (2) Of the five copies of the Notification required by paragraph (c) 
of this section, four copies must be complete with the information that 
is claimed confidential clearly marked in the manner described in Sec. 
2.203(b) of this chapter. All information claimed as confidential must 
be deleted from the fifth copy, but it must be otherwise complete. The 
first page of the fifth copy must be marked ``Contains no information 
claimed as confidential.'' EPA may include the fifth copy in a public 
file without further notice. EPA will consider incomplete a Notification 
containing information claimed as CBI that is not submitted in 
accordance with this paragraph and will suspend the review period on the 
Notification until such procedures are followed.

[[Page 397]]

    (3) Any claim of confidentiality must be accompanied, at the time 
the claim is made, by comments substantiating the claim and explaining 
why the submitter believes that the information should not be disclosed. 
The submitter should refer to Sec. 2.204(e)(4) of this chapter for 
points to address in the substantiation. If such comments are themselves 
claimed confidential and are marked confidential when submitted to EPA, 
they will be treated as such in accordance with Sec. 2.205(c) of this 
chapter. EPA will consider incomplete all Notifications containing 
information claimed as CBI that are not accompanied by substantiation, 
and will suspend the review period on such Notifications until the 
required substantiation is provided.
    (4) EPA will disclose information that is subject to a claim of 
confidentiality asserted under this section only to the extent and by 
means of the procedures set forth in section 10 of the Act, in this 
subpart, and in part 2 of this chapter.

[59 FR 45612, Sept. 1, 1994, as amended at 71 FR 35546, June 21, 2006; 
72 FR 61029, Oct. 26, 2007; 73 FR 75600, Dec. 12, 2008]



Sec. 172.48  Data requirements for a notification.

    This section identifies the data and information to be included in 
each Notification. When specific information is not submitted, an 
explanation of why it is not practical or necessary to provide the 
information is to be provided.
    (a) The identity of the microorganism which constitutes the 
microbial pesticide including:
    (1) Summary of data supporting the taxonomic designation and its 
interpretation.
    (2) Means and limit of detection using sensitive and specific 
methods (e.g., note the use of any markers that are used to distinguish 
the introduced population from native microorganisms). Introduction into 
the microbial pesticide of a unique genetic marker is encouraged.
    (b) Description of the natural habitat of the parental strain of the 
microbial pesticide including information on:
    (1) Physical and chemical features important to growth and survival 
of the parental strain.
    (2) Biological features of the parental strain that would have an 
impact on the microbial pesticide (e.g., presence of phages that infect 
the microorganism).
    (3) Competitors.
    (c) Information on the host range of the microbial pesticide, if 
any, with an assessment of infectivity and pathogenicity to nontarget 
organisms.
    (d) Information on survival and the ability of the microbial 
pesticide to increase in numbers (biomass) in the environment (e.g., in 
the environment into which the microbial pesticide will be introduced, 
and in substantially different environments that may be in the immediate 
vicinity). These data may be derived from the scientific literature or 
from tests conducted in a laboratory or other containment facility.
    (e) The identity of possible transmission vectors (e.g., insects).
    (f) Data on relative environmental competitiveness compared to the 
parental strain of the microbial pesticide.
    (g) Description of the methods used to genetically modify the 
microbial pesticide.
    (h) The identity and location of the gene segments that have been 
rearranged or inserted/deleted (host source, nature, and, for example, 
base sequence data, or restriction enzyme map of the genes).
    (i) Information on the control region of the genes, and a 
description of the new traits or characteristics that are expressed.
    (j) Data on potential for genetic transfer and exchange with other 
organisms and on genetic stability of any inserted sequences in the 
microbial pesticide.
    (k) A description of the proposed testing program including:
    (1) The purpose or objectives of the proposed testing.
    (2) Designation of the pest organisms involved (common and 
scientific names).
    (3) The States in which the proposed program will be conducted.
    (4) The exact location of the test sites (including proximity to 
residences and human activities, surface water, etc.).

[[Page 398]]

    (5) The crops, fauna, flora, geographical description of sites, 
modes, dosage rates, frequency, and situation of application on or in 
which the pesticide is to be used.
    (6) The total amount of pesticide product proposed for use in the 
testing.
    (7) The method of application.
    (8) A comparison of the natural habitat of the microbial pesticide 
with the proposed test site.
    (9) The number of acres, structural sites, or animals/plants by 
State, to be treated or included in the area of experimental use.
    (10) Procedures to be used to protect the test area from intrusion 
by unauthorized individuals.
    (11) The proposed dates or periods during which the testing program 
is to be conducted, and the manner in which supervision of the program 
will be accomplished.
    (12) Description of procedures for monitoring the microbial 
pesticide within and adjacent to the test site during the test.
    (13) The method of sanitation or disposal of plants, animals, soils, 
farm tools, machinery etc., that will be exposed to the microbial 
pesticide during or after the test.
    (14) Means of evaluating potential adverse effects and methods of 
controlling the microbial pesticide if detected beyond the test area.
    (l) A statement of composition for the formulation to be tested, 
giving:
    (1) The name and percentage by weight (or other suitable units) of 
each ingredient, active and inert.
    (2) Production methods.
    (3) Extraneous microorganisms present as contaminants.
    (4) Amount and potency of any toxin present.
    (5) Where applicable, the number of viable microorganisms per unit 
weight or volume of the product or other appropriate system for 
designating the quantity of active ingredient.
    (m) Any additional factual information regarding the potential for 
unreasonable adverse effects on the environment.



Sec. 172.50  Response to a notification.

    (a) EPA will review and evaluate each Notification as expeditiously 
as possible and will make a determination no later than 90 days after 
receipt of the complete Notification; however, under no circumstances 
shall the proposed test proceed until the submitter has received notice 
from EPA of its approval of such test.
    (b) For each Notification, EPA may make the following 
determinations:
    (1) Require additional information from the submitter to assess the 
proposed test adequately.
    (2) Approve the proposed test.
    (3) Approve the proposed test provided that the submitter makes 
certain modifications to the test proposal.
    (4) Require an EUP for the test.
    (5) Disapprove the proposed test because of the potential for 
unreasonable adverse effects. Such disapproval by EPA shall be 
considered the equivalent of denial of an EUP and the remedies for such 
denial provided by Sec. 172.10 are available to the submitter.
    (c) If the proposed test is approved by EPA, then the submitter 
shall perform the test in the same manner described in the Notification, 
subject to any requirements imposed under paragraph (b)(3) of this 
section.



Sec. 172.52  Notification exemption process.

    (a) Initiation of the exemption process. Pesticides may be added to 
the list of exemptions in Sec. 172.45(d) by rule at EPA's initiative or 
in response to a petition submitted in accordance with paragraph (b) of 
this section.
    (b) Petitions for exemption from the requirement for a 
Notification--(1) Who may submit a petition. Any person may submit a 
petition requesting an exemption from the notification requirements of 
this subpart for a specific microbial pesticide or class of microbial 
pesticides.
    (2) Where to submit a petition. All petitions shall be submitted to 
the Office of Pesticide Programs' Document Processing Desk at the 
appropriate address as set forth in 40 CFR 150.17(a) or (b).
    (3) Content of petition. Each petition shall contain the following:
    (i) Name and address of petitioner and name, address, and telephone 
number of a person who may be contacted for further information.

[[Page 399]]

    (ii) Description of the exemption requested, including the specific 
microbial pesticide or class of microbial pesticides to be tested under 
the petition for exemption.
    (iii) Basis for the petitioner's contention that the specific 
microbial pesticide or class of microbial pesticides meet the criteria 
of Sec. 172.3 for small-scale tests of pesticides that do not require 
an EUP.
    (iv) Discussion of the extent to which the microbial pesticide or 
class of microbial pesticides covered by the petition differ from 
microbial pesticides that are already registered or subject to an EUP 
under the Act.
    (4) Administrative action on a petition. EPA will review and 
evaluate petitions as expeditiously as possible and may request further 
information from the petitioner to assess the proposed exemption 
adequately. No later than 180 days after the submission of a petition, 
or 90 days after the last submission of additional information by the 
petitioner, whichever is later, EPA will take one of the following 
actions with respect to the petition:
    (i) Grant the petition and publish a notice of proposed rulemaking 
in the Federal Register for a 45-day comment period proposing the 
exemption requested by the petitioner.
    (ii) Grant the petition and publish a notice of proposed rulemaking 
in the Federal Register for a 45-day comment period proposing an 
exemption under such terms and conditions as EPA deems appropriate.
    (iii) Deny the petition and provide the petitioner with a written 
explanation of EPA's decision.
    (5) Confidential business information (CBI) claims. To assert a 
claim of confidentiality, the petitioner must comply with the applicable 
procedures in Sec. 172.46(d).
    (6) Supplements, amendments, and withdrawals. The petitioner may 
supplement, amend, or withdraw his or her petition in writing without 
EPA approval at any time prior to the granting or denial of the petition 
under paragraph (b)(4) of this section. The withdrawal of a petition 
shall be without prejudice to the resubmission of the petition at a 
later date.

[59 FR 45612, Sept. 1, 1994, as amended at 71 FR 35546, June 21, 2006]



Sec. 172.57  Submission of information regarding potential unreasonable 

adverse effects.

    Any person using a microbial pesticide in small-scale testing 
covered by this subpart who obtains information regarding potential 
unreasonable adverse effects on health or the environment must within 30 
days of receipt of such information submit the information to EPA, 
unless the person has actual knowledge that EPA has been adequately 
informed of such information. The requirement to submit information 
applies both to those microbial pesticides subject to the notification 
requirements under Sec. 172.45(c) and those that are exempt under Sec. 
172.45(d).



Sec. 172.59  Enforcement.

    (a) Imminent threat of substantial harm to health or the 
environment. The use of a microbial pesticide in small-scale testing 
covered by this subpart (whether subject to the notification 
requirements of Sec. 172.45(c) or exempt under Sec. 172.45(d)) in a 
manner that creates an imminent threat of substantial harm to health or 
the environment is prohibited, and is considered a violation of section 
12(a)(2)(S) of the Act.
    (b) EPA response to violations. Under section 14 of the Act, EPA may 
seek civil or criminal penalties for violations of the Act. Failure to 
comply with the regulations in this part could result in civil or 
criminal penalties. Moreover, under sections 14 and 16(c) of the Act, 
EPA may at any time take appropriate action against violators to prevent 
or otherwise restrain use of a microbial pesticide in small-scale 
testing if it is determined that:
    (1) Such use would create an imminent threat of substantial harm to 
health or the environment that is prohibited under paragraph (a) of this 
section; or
    (2) The terms or conditions on which approval of the testing was 
granted under this subpart C are violated.

[[Page 400]]



PART 173_PROCEDURES GOVERNING THE RESCISSION OF STATE PRIMARY ENFORCEMENT 

RESPONSIBILITY FOR PESTICIDE USE VIOLATIONS--Table of Contents



Sec.
173.1 Applicability.
173.2 Definitions.
173.3 Initiation of rescission proceedings.
173.4 Informal conference and settlement.
173.5 Request for hearing.
173.6 Publication of the notice; scheduling the hearing.
173.7 Hearing and recommended decision.
173.8 Final order.
173.9 Judicial review.

    Authority: 7 U.S.C. 136w and 136w-2.

    Source: 46 FR 26059, May 11, 1981, unless otherwise noted.



Sec. 173.1  Applicability.

    These procedures govern any proceeding to rescind a State's primary 
enforcement responsibility for pesticide use violations conducted under 
section 27(b) of the Federal Insecticide, Fungicide, and Rodenticide 
Act, as amended (FIFRA), 7 U.S.C. 136 et seq.



Sec. 173.2  Definitions.

    For purposes of this part:
    (a) Administrator means the Administrator of the United States 
Environmental Protection Agency or his delegate.
    (b) Notice of intent to rescind means a notice to a State issued 
under Sec. 173.3 which initiates a proceeding to rescind the State's 
primary enforcement responsibility for pesticide use violations.
    (c) State means the agency or agencies primarily responsible for 
enforcing pesticide use laws or regulations within the State or 
jurisdiction undergoing rescission proceedings.
    (d) Party to the proceeding shall mean the State or the Agency's 
Office of Enforcement.
    (e) Presiding Officer means an attorney appointed by the 
Administrator to conduct the rescission proceeding. The Presiding 
Officer shall be an employee or representative of the Agency and shall 
not have had prior direct connection with the specific proceeding except 
in circumstances where subsequent hearings are in order.



Sec. 173.3  Initiation of rescission proceedings.

    (a) Whenever the Administrator determines that a State having 
primary enforcement responsibility for pesticide use violations is not 
carrying out such responsibility, or cannot carry out such 
responsibility due to the lack of adequate legal authority, the 
Administrator shall notify the State in writing of his intent to rescind 
its primary enforcement responsibility, in whole or in part, by serving 
upon the State a notice of intent to rescind.
    (b) The notice of intent to rescind shall:
    (1) Specify those aspects of the State's pesticide use enforcement 
program determined to be inadequate;
    (2) Specify the facts which underlie the findings contained in the 
rescission notice;
    (3) Have attached thereto copies of any relevant documents 
discoverable under the Federal Rules of Civil Procedure and the Freedom 
of Information Act which contain data relied upon by the Administrator 
in making his decision to issue the notice;
    (4) Have attached thereto a copy of this part; and
    (5) Be sent to the State by certified mail, return receipt 
requested.
    (c) The State may respond in writing to the findings specified in 
the notice of intent to rescind.



Sec. 173.4  Informal conference and settlement.

    (a) After receipt of a notice of intent to rescind, the State may 
request that an informal conference be held between appropriate State 
and EPA officials to discuss the findings made in the notice of intent 
to rescind. The informal conference shall then be held in the State. If 
the Administrator finds, on the basis of information submitted by the 
State at the conference, that the deficiencies specified in the notice 
did not exist or were corrected by the State, the Administrator shall 
issue an order withdrawing the notice of intent to rescind and 
terminating the rescission proceeding.
    (b) At any time after receipt of a notice of intent to rescind and 
before the issuance of a final order, the State and EPA may resolve the 
issues raised in

[[Page 401]]

the notice by agreement. Any settlement agreement shall be in writing 
and signed by the parties and shall:
    (1) Detail the deficiencies found in the State program;
    (2) Specify the steps the State has taken or will take to remedy the 
deficiencies; and
    (3) Set forth a precise schedule for each remedial action yet to be 
initiated.
    (c) If a written agreement is signed by the parties, the 
Administrator shall issue an order withdrawing the notice of intent to 
rescind and terminating the rescission proceeding. If the State does not 
comply with the terms of the settlement agreement, the Administrator may 
reissue the notice of intent to rescind.



Sec. 173.5  Request for hearing.

    A State may request a hearing before a Presiding Officer not later 
than sixty (60) days after receipt of a notice of intent to rescind.



Sec. 173.6  Publication of the notice; scheduling the hearing.

    (a) If the Administrator has not issued an order terminating the 
rescission proceeding within sixty (60) days after service of the notice 
of intent to rescind upon the State, the Administrator shall publish the 
notice of intent to rescind in the Federal Register. The Administrator 
may modify the original notice of intent to rescind before its 
publication by deleting those deficiencies listed in the original notice 
which have been corrected or which were shown not to have existed. The 
public may submit comments upon the matters specified in the published 
notice of intent to rescind within the time specified therein.
    (b) Concurrently with the publication of the notice of intent to 
rescind, the Administrator shall schedule a hearing in the State if one 
has been requested by the State. The date, time, and location of the 
hearing shall be published in the Federal Register along with the notice 
of intent to rescind.
    (c) If a hearing is requested and the Administrator has not issued 
an order terminating the rescission proceeding, the Administrator shall 
provide for a hearing as scheduled. Representatives of the State, EPA, 
and the public may present evidence at the hearing. The Administrator 
shall appoint a Presiding Officer who shall preside over the hearing and 
make a recommended decision regarding the adequacy of the State's 
pesticide use enforcement program. The Administrator, after consultation 
with the State, may prescribe additional procedures governing the 
conduct of the hearing.
    (d) If a termination order is issued or the hearing is rescheduled 
after the notice of intent to rescind is published in the Federal 
Register, such order or notice rescheduling the hearing shall also be 
published in the Federal Register.



Sec. 173.7  Hearing and recommended decision.

    (a) The Presiding Officer shall:
    (1) Conduct a fair and impartial hearing, without unnecessary delay;
    (2) Ensure that the facts are fully elicited; and
    (3) Consider all evidence, comment, and argument which is submitted 
by persons who will be affected by the outcome of the proceeding and 
which is not irrelevant, immaterial, unduly repetitious, or otherwise 
unreliable or of little probative value. The Presiding Officer may 
require any prospective witness to make available, in advance of the 
hearing, a brief summary of his or her testimony.
    (b) If, following the close of the hearing, the Presiding Officer 
finds that the State has corrected, or has agreed in writing to correct, 
the deficiencies specified in the notice of intent to rescind or has 
shown that such deficiencies do not exist, the Presiding Officer shall 
issue a decision recommending that the notice of intent to rescind be 
withdrawn and that the rescission proceeding be terminated.
    (c) If, following the close of the hearing, the Presiding Officer 
finds that the State has not corrected the deficiencies in its program, 
the Presiding Officer shall issue a decision recommending that the 
State's primary enforcement responsibility for pesticide use violations 
be rescinded in whole or in part.
    (d) The recommended decision of the Presiding Officer shall become 
final

[[Page 402]]

Agency action forty-five (45) days after its service upon the parties 
and without further proceedings unless (1) an appeal to the 
Administrator is taken from it by a party to the proceeding, or (2) the 
Administrator elects, sua sponte, to review the recommended decision.



Sec. 173.8  Final order.

    (a) If the State does not request a hearing within the sixty-day 
time period and the Administrator has not issued an order withdrawing 
the notice of intent to rescind, the Administrator shall issue a final 
order as soon as practicable after the time for public comment on the 
notice of intent to rescind has elapsed. The final order shall either 
withdraw the notice of intent to rescind and terminate the proceeding or 
rescind, in whole or in part, the State's primary enforcement 
responsibility for pesticide use violations.
    (b) If a hearing has been held and the Presiding Officer has made a 
recommended decision, then either the Office of Enforcement or the State 
may appeal the recommended decision to the Administrator or the 
Administrator may elect to review the recommended decision on his own 
initiative.
    (c) After an appeal or sua sponte review the Administrator shall 
issue a final order terminating the rescission proceeding or rescinding, 
in whole or in part, the State's primary enforcement responsibility for 
pesticide use violations.
    (d) In no event may the Administrator issue his final decision 
sooner than ninety (90) days after service of the notice of intent to 
rescind on a State.
    (e) Any final order, or a recommended decision which becomes a final 
order under Sec. 173.7(c), shall be published in the Federal Register.



Sec. 173.9  Judicial review.

    The State may appeal an order rescinding, in whole or in part, its 
primary enforcement responsibility for pesticide use violations to the 
appropriate federal court pursuant to section 16 of FIFRA.



PART 174_PROCEDURES AND REQUIREMENTS FOR PLANT-INCORPORATED PROTECTANTS--Table 

of Contents



                      Subpart A_General Provisions

Sec.
174.1 Scope and purpose.
174.3 Definitions.
174.9 Confidential business information claims for plant-incorporated 
          protectant submissions.

                          Subpart B_Exemptions

174.21 General qualifications for exemptions.
174.25 Plant-incorporated protectant from sexually compatible plant.

Subpart C--Registration Procedures and Requirements [Reserved]

                 Subpart D_Monitoring and Recordkeeping

174.71 Submission of information regarding adverse effects.

Subparts E-F [Reserved]

Subpart G--Labeling Requirements [Reserved]

Subpart H--Data Requirements [Reserved]

Subpart I [Reserved]

Subpart J--Good Laboratory Practices [Reserved]

Subpart K--Export Requirements [Reserved]

Subparts L-T [Reserved]

Subpart U--Experimental Use Permits [Reserved]

Subpart V [Reserved]

              Subpart W_Tolerances and Tolerance Exemptions

174.500 Scope and purpose.
174.501 Bacillus thuringiensis Vip3Aa protein in corn and cotton; 
          exemption from the requirement of a tolerance.
174.502 Bacillus thuringiensis Cry1A.105 protein; exemption from the 
          requirement of a tolerance.
174.504 Bacillus thuringiensis Cry1F protein in cotton; exemption from 
          the requirement of a tolerance.
174.505 Bacillus thuringiensis modified Cry3A protein (mCry3A) in corn; 
          exemption from the requirement of a tolerance.

[[Page 403]]

174.506 Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins in corn; 
          exemption from the requirement of a tolerance.
174.507 Nucleic acids that are part of a plant-incorporated protectant; 
          exemption from the requirement of a tolerance.
174.508 Pesticidal substance from sexually compatible plant; exemption 
          from the requirement of a tolerance.
174.509 Bacillus thuringiensis Cry3A protein; exemption from the 
          requirement of a tolerance.
174.510 Bacillus thuringiensis Cry1Ac protein in all plants; exemption 
          from the requirement of a tolerance.
174.511 Bacillus thuringiensis Cry1Ab protein in all plants; exemption 
          from the requirement of a tolerance.
174.512 Coat Protein of Potato Virus Y; exemption from the requirement 
          of a tolerance.
174.513 Potato Leaf Roll Virus Resistance Gene (also known as orf1/orf2 
          gene); exemption from the requirement of a tolerance.
174.514 Coat Protein of Watermelon Mosaic Virus-2 and Zucchini Yellow 
          Mosaic Virus; exemption from the requirement for a tolerance.
174.515 Coat Protein of Papaya Ringspot Virus; exemption from the 
          requirement of a tolerance.
174.516 Coat protein of cucumber mosaic virus; exemption from the 
          requirement of a tolerance.
174.517 Bacillus thuringiensis Cry9C protein in corn; exemption from the 
          requirement of a tolerance.
174.518 Bacillus thuringiensis Cry3Bb1 protein in corn; exemption from 
          the requirement of a tolerance.
174.519 Bacillus thuringiensis Cry2Ab2 protein in corn and cotton; 
          exemption from the requirement of a tolerance.
174.520 Bacillus thuringiensis Cry1F protein in corn; exemption from the 
          requirement of a tolerance.
174.521 Neomycin phosphotransferase II; exemption from the requirement 
          of a tolerance.
174.522 Phosphinothricin Acetyltransferase (PAT); exemption from the 
          requirement of a tolerance.
174.523 CP4 Enolpyruvylshikimate-3-phosphate (CP4 EPSPS) synthase in all 
          plants; exemption from the requirement of a tolerance.
174.524 Glyphosate Oxidoreductase GOX or GOXv247 in all plants; 
          exemption from the requirement of a tolerance.
174.525 E. coli B-D-glucuronidase enzyme as a plant-incorporated 
          protectant inert ingredient; exemption from the requirement of 
          a tolerance.
174.526 Hygromycin B phosphotransferase (APH4) marker protein in all 
          plants; exemption from the requirement of a tolerance.
174.527 Phosphomannose isomerase in all plants; exemption from the 
          requirement of a tolerance.
174.529 Bacillus thuringiensis modified Cry1Ab protein as identified 
          under OECD Unique Identifier SYN-IR67B-1 in cotton; exemption 
          from the requirement of a tolerance.
174.530 Bacillus thuringiensis Cry2Ae protein in cotton; exemption from 
          the requirement of a tolerance.
174.531 Coat protein of plum pox virus; exemption from the requirement 
          of a tolerance.
174.532 Bacillus thuringiensis eCry3.1Ab protein in corn; exemption from 
          the requirement of a tolerance.
174.533 Glycine max Herbicide-Resistant Acetolactate Synthase (GM-HRA) 
          inert ingredient; exemption from the requirement of a 
          tolerance.

              Subpart X_List of Approved Inert Ingredients

174.700 Scope and purpose.
174.705 Inert ingredients from sexually compatible plant.

Subparts Y-Z [Reserved]

    Authority: 7 U.S.C. 136-136y; 21 U.S.C. 346a and 371.

    Source: 66 FR 37814, July 19, 2001, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 174.1  Scope and purpose.

    The characteristics of plant-incorporated protectants such as their 
production and use in plants, their biological properties, and their 
ability to spread and increase in quantity in the environment 
distinguish them from traditional chemical pesticides. Therefore, plant-
incorporated protectants are subject to some different regulatory 
requirements and procedures than traditional chemical pesticides. This 
part sets forth regulatory requirements, criteria, and procedures 
applicable to plant-incorporated protectants under FIFRA and FFDCA. When 
applied to plant-incorporated protectants, the definitions and 
regulations in this part supersede the regulations found in parts 150 
through 180 of this chapter to the extent that the regulations conflict. 
Unless otherwise superseded by this part, the regulations

[[Page 404]]

in parts 150 through 180 of this chapter apply to plant-incorporated 
protectants.



Sec. 174.3  Definitions.

    Terms used in this part have the same meaning as in FIFRA. In 
addition, the following terms have the meaning set forth in this 
section.
    Active ingredient means a pesticidal substance that is intended to 
be produced and used in a living plant, or in the produce thereof, and 
the genetic material necessary for the production of such a pesticidal 
substance.
    Administrator means the Administrator of the United States 
Environmental Protection Agency or his/her delegate.
    Bridging crosses between plants means the utilization of an 
intermediate plant in a cross to produce a viable zygote between the 
intermediate plant and a first plant, in order to cross the plant 
resulting from that zygote with a third plant that would not otherwise 
be able to produce viable zygotes from the fusion of its gametes with 
those of the first plant. The result of the bridging cross is the mixing 
of genetic material of the first and third plant through the formation 
of an intermediate zygote.
    Cell fusion means the fusion in vitro of two or more cells or 
protoplasts.
    Conventional breeding of plants means the creation of progeny 
through either: The union of gametes, i.e., syngamy, brought together 
through processes such as pollination, including bridging crosses 
between plants and wide crosses, or vegetative reproduction. It does not 
include use of any of the following technologies: Recombinant DNA; other 
techniques wherein the genetic material is extracted from an organism 
and introduced into the genome of the recipient plant through, for 
example, micro-injection, macro-injection, micro-encapsulation; or cell 
fusion.
    EPA means the United States Environmental Protection Agency.
    Exudate means a substance gradually discharged or secreted across 
intact cellular membranes or cell walls and present in the intercellular 
spaces or on the exterior surfaces of the plant.
    FFDCA means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 
et seq.).
    FIFRA means the Federal Insecticide, Fungicide, and Rodenticide Act, 
as amended (7 U.S.C. 136 et seq.).
    Food includes articles used for food or drink by humans or other 
animals.
    Food plant means a plant which either in part or in toto, is used as 
food.
    Genetic material necessary for the production means both: Genetic 
material that encodes a substance or leads to the production of a 
substance; and regulatory regions. It does not include noncoding, 
nonexpressed nucleotide sequences.
    Genome means the sum of the heritable genetic material in the plant, 
including genetic material in the nucleus and organelles.
    In a living plant means inside the living plant, on the surface of 
the living plant, or as an exudate from the living plant.
    Inert ingredient, means any substance, such as a selectable marker, 
other than the active ingredient, where the substance is used to confirm 
or ensure the presence of the active ingredient, and includes the 
genetic material necessary for the production of the substance, provided 
that genetic material is intentionally introduced into a living plant in 
addition to the active ingredient.
    Living plant means a plant, plant organ, or plant part that is 
alive, viable, or dormant. Examples of plant parts include, but are not 
limited to, seeds, fruits, leaves, roots, stems, flowers, and pollen.
    Noncoding, nonexpressed nucleotide sequences means the nucleotide 
sequences are not transcribed and are not involved in gene expression. 
Examples of noncoding, nonexpressed nucleotide sequences include, but 
are not limited to, linkers, adapters, homopolymers, and sequences of 
restriction enzyme recognition sites.
    Nucleic acids means ribosides or deoxyribosides of adenine, thymine, 
guanine, cytosine, and uracil; polymers of the deoxyribose-5'-
monophosphates of thymine, cytosine, guanine, and adenine linked by 
successive 3'-5' phosphodiester bonds (also known as deoxyribonucleic 
acid); and polymers

[[Page 405]]

of the ribose-5'-monophosphates of uracil, cytosine, guanine, and 
adenine linked by successive 3'-5' phosphodiester bonds (also known as 
ribonucleic acid). The term does not apply to nucleic acid analogues 
(e.g., dideoxycytidine), or polymers containing nucleic acid analogues.
    Pesticidal substance, means a substance that is intended to be 
produced and used in a living plant, or in the produce thereof, for a 
pesticidal purpose, during any part of a plant's life cyle (e.g., in the 
embryo, seed, seedling, mature plant).
    Plant, for plant-incorporated protectants, means an organism 
classified using the 5-kingdom classification system of Whittaker in the 
kingdom Plantae. This includes, but is not limited to, bryophytes such 
as mosses, pteridophytes such as ferns, gymnosperms such as conifers, 
and angiosperms such as most major crop plants.
    Plant-incorporated protectant means a pesticidal substance that is 
intended to be produced and used in a living plant, or in the produce 
thereof, and the genetic material necessary for production of such a 
pesticidal substance. It also includes any inert ingredient contained in 
the plant, or produce thereof.
    Produce thereof, when used with respect to plants containing plant- 
incorporated protectants only, means a product of a living plant 
containing a plant-incorporated protectant, where the pesticidal 
substance is intended to serve a pesticidal purpose after the product 
has been separated from the living plant. Examples of such products 
include, but are not limited to, agricultural produce, grains, and 
lumber. Products such as raw agricultural commodities bearing pesticide 
chemical residues are not ``produce thereof'' when the residues are not 
intended to serve a pesticidal purpose in the produce.
    Recipient plant means the living plant in which the plant-
incorporated protectant is intended to be produced and used.
    Recombinant DNA means the genetic material has been manipulated in 
vitro through the use of restriction endonucleases and/or other enzymes 
that aid in modifying genetic material, and subsequently introduced into 
the genome of the plant.
    Regulatory region means genetic material that controls the 
expression of the genetic material that encodes a pesticidal substance 
or leads to the production of a pesticidal substance. Examples of 
regulatory regions include, but are not limited to, promoters, 
enhancers, and terminators.
    Sexually compatible, when referring to plants, means a viable zygote 
is formed only through the union of two gametes through conventional 
breeding.
    Source means the donor of the genetic material that encodes a 
pesticidal substance or leads to the production of a pesticidal 
substance.
    Vegetative reproduction means either:
    (1) In seed plants, reproduction by apomixis, or
    (2) In other plants, reproduction by fragmentation, or division of 
the somatic body.
    Wide crosses means to facilitate the formation of viable zygotes 
through the use of surgical alteration of the plant pistil, bud 
pollination, mentor pollen, immunosuppressants, in vitro fertilization, 
pre-pollination and post-pollination hormone treatments, manipulation of 
chromosome numbers, embryo culture, or ovary and ovule cultures.



Sec. 174.9  Confidential business information claims for plant-incorporated 

protectant submissions.

    Although it is strongly recommended that the submitter minimize the 
amount of data and other information claimed as Confidential Business 
Information (CBI), a submitter may assert a claim of confidentiality for 
all or part of the information submitted to EPA in a submission for a 
plant-incorporated protectant. (See part 2, subpart B of this chapter.) 
To assert such a claim, the submitter must comply with all of the 
following procedures:
    (a) Any claim of confidentiality must accompany the information at 
the time the information is submitted to EPA. Failure to assert a claim 
at that time constitutes a waiver of confidentiality for the information 
submitted, and the information may be made available to the public, 
subject to section 10(g) of

[[Page 406]]

FIFRA, with no further notice to the submitter.
    (b) Any claim of confidentiality must be accompanied, at the time 
the claim is made, by comments substantiating the claim and explaining 
why the submitter believes that the information should not be disclosed. 
The submitter must address each of the points listed in Sec. 
2.204(e)(4) of this chapter in the substantiation. EPA will consider 
incomplete all plant-incorporated protectant submissions containing 
information claimed as CBI that are not accompanied by substantiation, 
and will suspend any applicable review of such submissions until the 
required substantiation is provided.



                          Subpart B_Exemptions



Sec. 174.21  General qualifications for exemptions.

    A plant-incorporated protectant is exempt from the requirements of 
FIFRA, other than the requirements of Sec. 174.71, if it meets all of 
the following criteria:
    (a) The plant-incorporated protectant meets the criteria listed in 
at least one of the sections in Sec. Sec. 174.25 through 174.50.
    (b) When the plant-incorporated protectant is intended to be 
produced and used in a crop used as food, the residues of the plant-
incorporated protectant are either exempted from the requirement of a 
tolerance under FFDCA (as amended, 21 U.S.C. 321 et seq.) as codified at 
Sec. Sec. 174.507 through 174.508, or no tolerance would otherwise be 
required for the plant-incorporated protectant.
    (c) Any inert ingredient that is part of the plant-incorporated 
protectant is on the list codified at Sec. 174.705. Plant-incorporated 
protectants that are not exempt from the requirements of FIFRA under 
this subpart are subject to all the requirements of FIFRA.

[66 FR 37814, July 19, 2001, as amended at 72 FR 20434, Apr. 25, 2007]



Sec. 174.25  Plant-incorporated protectant from sexually compatible plant.

    A plant-incorporated protectant is exempt if all of the following 
conditions are met:
    (a) The genetic material that encodes the pesticidal substance or 
leads to the production of the pesticidal substance is from a plant that 
is sexually compatible with the recipient plant.
    (b) The genetic material has never been derived from a source that 
is not sexually compatible with the recipient plant.

Subpart C--Registration Procedures and Requirements [Reserved]



                 Subpart D_Monitoring and Recordkeeping



Sec. 174.71  Submission of information regarding adverse effects.

    (a) Any person who produces, for sale or distribution, a plant-
incorporated protectant exempt under subpart B of this part, who obtains 
any information regarding adverse effects on human health or the 
environment alleged to have been caused by the plant-incorporated 
protectant must submit such information to EPA. This requirement does 
not apply to any person who does not produce a plant-incorporated 
protectant exempt under subpart B of this part. This may include, for 
example, researchers performing field experiments, breeders making 
crosses among plant varieties with the goal of developing new plant 
varieties, or a person who only sells propagative materials (e.g., seed) 
to farmers without producing the propagative materials themselves. EPA 
must receive the report within 30 calendar days of the date the producer 
first possesses or knows of the information.
    (b) Adverse effects on human health or the environment for purposes 
of plant-incorporated protectant means at a minimum information about 
incidents affecting humans or other nontarget organisms where both:
    (1) The producer is aware, or has been informed, that a person or 
nontarget organism allegedly suffered a toxic or adverse effect due to 
exposure to (e.g., ingestion of) a plant-incorporated protectant.
    (2) The producer has or could reasonably obtain information 
concerning where the incident occurred.

[[Page 407]]

    (c) All of the following information, if available, must be included 
in a report.
    (1) Name of reporter, address, and telephone number.
    (2) Name, address, and telephone of contact person (if different 
than reporter).
    (3) Description of incident.
    (4) Date producer became aware of incident.
    (5) Date of incident.
    (6) Location of incident.
    (d) Reports and questions should be submitted to the Office of 
Pesticide Programs' Document Processing Desk at the appropriate address 
as set forth in 40 CFR 150.17(a) or (b).

[66 FR 37814, July 19, 2001, as amended at 71 FR 35546, June 21, 2006]

Subparts E-F [Reserved]

Subpart G--Labeling [Reserved]

Subpart H--Data Requirements [Reserved]

Subpart I [Reserved]

Subpart J--Good Laboratory Practices [Reserved]

Subpart K--Export Requirements [Reserved]

Subparts L-T [Reserved]

Subpart U--Experimental Use Permits [Reserved]

Subpart V [Reserved]



              Subpart W_Tolerances and Tolerance Exemptions



Sec. 174.500  Scope and purpose.

    This subpart lists the tolerances and exemptions from the 
requirement of a tolerance for residues of plant-incorporated 
protectants in or on food commodities.

[72 FR 20434, Apr. 25, 2007]



Sec. 174.501  Bacillus thuringiensis Vip3Aa protein in corn and cotton; 

exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Vip3Aa proteins in or on corn or 
cotton are exempt from the requirement of a tolerance when used as 
plant-incorporated protectants in or on the food and feed commodities of 
corn; corn, field; corn, sweet; corn, pop; and cotton; cotton, 
undelinted seed; cotton, refined oil; cotton, meal; cotton, hay; cotton, 
hulls; cotton, forage; and cotton, gin byproducts.

[73 FR 45624, Aug. 6, 2008]



Sec. 174.502  Bacillus thuringiensis Cry1A.105 protein; exemption from the 

requirement of a tolerance.

    (a) Residues of Bacillus thuringiensis Cry1A.105 protein in or on 
the food and feed commodities of corn; corn, field, flour; corn, field, 
forage; corn, field, grain; corn, field, grits; corn, field, meal; corn, 
field, refined oil; corn, field, stover; corn, sweet, forage; corn, 
sweet, kernel plus cob with husk removed; corn, sweet, stover; and corn, 
pop, grain and corn, pop, stover are exempt from the requirement of a 
tolerance when the Bacillus thuringiensis Cry1A.105 protein is used as a 
plant-incorporated protectant in these food and feed corn commodities.
    (b) A time-limited exemption from the requirement of a tolerance is 
established for residues of Bacillus thuringiensis Cry1A.105 protein in 
or on the food and feed commodities of cotton; cotton, forage; cotton, 
gin byproducts; cotton, hay; cotton, hulls; cotton, meal; cotton, 
refined oil; and cotton, undelinted seed when the Bacillus thuringiensis 
Cry1A.105 protein is used as a plant-incorporated protectant in these 
food and feed cotton commodities. The exemption from the requirement of 
a tolerance expires and is revoked on November 22, 2010.

[74 FR 39543, Aug. 7, 2009]



Sec. 174.504  Bacillus thuringiensis Cry1F protein in cotton; exemption from 

the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry1F protein in cotton are 
exempt from the requirement of a tolerance

[[Page 408]]

when used as a plant-incorporated protectant in food and feed 
commodities of cotton.

[72 FR 20434, Apr. 25, 2007]



Sec. 174.505  Bacillus thuringiensis modified Cry3A protein (mCry3A) in corn; 

exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis modified Cry3A protein (mCry3A) 
in corn are exempt from the requirement of a tolerance when used as 
plant-incorporated protectant in the food and feed commodities of corn; 
corn, field; corn, sweet; and corn, pop.

[72 FR 20434, Apr. 25, 2007]



Sec. 174.506  Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins in corn; 

exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 proteins in 
corn are exempted from the requirement of a tolerance when used as 
plant-incorporated protectants in the food and feed commodities of corn; 
corn, field; corn, sweet; and corn, pop.

[72 FR 20434, Apr. 25, 2007]



Sec. 174.507  Nucleic acids that are part of a plant-incorporated protectant; 

exemption from the requirement of a tolerance.

    Residues of nucleic acids that are part of a plant-incorporated 
protectant are exempt from the requirement of a tolerance.

[66 FR 37830, July 19, 2001. Redesignated at 72 FR 20434, April 25, 
2007]



Sec. 174.508  Pesticidal substance from sexually compatible plant; exemption 

from the requirement of a tolerance.

    Residues of a pesticidal substance that is part of a plant-
incorporated protectant from a sexually compatible plant are exempt from 
the requirement of a tolerance if all the following conditions are met:
    (a) The genetic material that encodes for the pesticidal substance 
or leads to the production of the pesticidal substance is from a plant 
that is sexually compatible with the recipient food plant.
    (b) The genetic material has never been derived from a source that 
is not sexually compatible with the recipient food plant.
    (c) The residues of the pesticidal substance are not present in food 
from the plant at levels that are injurious or deleterious to human 
health.

[66 FR 37854, July 19, 2001. Redesignated at 72 FR 20434, April 25, 
2007]



Sec. 174.509  Bacillus thuringiensis Cry3A protein; exemption from the 

requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry3A protein are exempted from 
the requirement of a tolerance when used as a plant-incorporated 
protectant in potatoes.

[72 FR 20435, Apr. 25, 2007]



Sec. 174.510  Bacillus thuringiensis Cry1Ac protein in all plants; exemption 

from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry1Ac protein in all plants are 
exempt from the requirement of a tolerance when used as plant-
incorporated protectants in all food commodities.

[72 FR 20435, Apr. 25, 2007]



Sec. 174.511  Bacillus thuringiensis Cry1Ab protein in all plants; exemption 

from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry1Ab protein in all plants are 
exempt from the requirement of a tolerance when used as plant-
incorporated protectants in all food commodities.

[72 FR 20435, Apr. 25, 2007]



Sec. 174.512  Coat Protein of Potato Virus Y; exemption from the requirement 

of a tolerance.

    Residues of Coat Protein of Potato Virus Y are exempt from the 
requirement of a tolerance when used as a plant-incorporated protectant 
in or on all food commodities.

[72 FR 20435, Apr. 25, 2007]

[[Page 409]]



Sec. 174.513  Potato Leaf Roll Virus Resistance Gene (also known as orf1/orf2 

gene); exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the plant-incorporated protectant Potato Leaf Roll Virus 
Resistance Gene (also known as orf1/orf2 gene) in or on all food 
commodities.

[72 FR 20435, Apr. 25, 2007]



Sec. 174.514  Coat Protein of Watermelon Mosaic Virus-2 and Zucchini Yellow 

Mosaic Virus; exemption from the requirement for a tolerance.

    Residues of Coat Protein of Watermelon Mosaic Virus-2 and Zucchini 
Yellow Mosaic Virus are exempt from the requirement of a tolerance when 
used as a plant-incorporated protectant in or on all food commodities.

[72 FR 20435, Apr. 25, 2007]



Sec. 174.515  Coat Protein of Papaya Ringspot Virus; exemption from the 

requirement of a tolerance.

    Residues of Coat Protein of Papaya Ringspot Virus are exempt from 
the requirement of a tolerance when used as a plant-incorporated 
protectant in or on all food commodities.

[72 FR 20435, Apr. 25, 2007]



Sec. 174.516  Coat protein of cucumber mosaic virus; exemption from the 

requirement of a tolerance.

    Residues of Coat Protein of Cucumber Mosaic Virus are exempt from 
the requirement of a tolerance when used as a plant-incorporated 
protectant in or on all food commodities.

[72 FR 20435, Apr. 25, 2007]



Sec. 174.517  Bacillus thuringiensis Cry9C protein in corn; exemption from the 

requirement of a tolerance.

    The plant-incorporated protectant Bacillus thuringiensis Cry9C 
protein in corn is exempted from the requirement of a tolerance for 
residues, only in corn used for feed; as well as in meat, poultry, milk, 
or eggs resulting from animals fed such feed.

[72 FR 20435, Apr. 25, 2007]



Sec. 174.518  Bacillus thuringiensis Cry3Bb1 protein in corn; exemption from 

the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry3Bb1 protein in corn are 
exempt from the requirement of a tolerance when used as plant-
incorporated protectants in the food and feed commodities of corn; corn, 
field; corn, sweet; and corn, pop.

[72 FR 20435, Apr. 25, 2007]



Sec. 174.519  Bacillus thuringiensis Cry2Ab2 protein in corn and cotton; 

exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry2Ab2 protein in or on corn or 
cotton are exempt from the requirement of a tolerance when used as a 
plant-incorporated protectant in the food and feed commodities of corn; 
corn, field; corn, sweet; corn, pop; and cotton seed, cotton oil, cotton 
meal, cotton hay, cotton hulls, cotton forage, and cotton gin 
byproducts.

[73 FR 37850, July 2, 2008]



Sec. 174.520  Bacillus thuringiensis Cry1F protein in corn; exemption from the 

requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry1F protein in corn are exempt 
from the requirement of a tolerance when used as plant-incorporated 
protectants in the food and feed commodities of corn; corn, field; corn, 
sweet; and corn, pop.

[72 FR 20435, Apr. 25, 2007]



Sec. 174.521  Neomycin phosphotransferase II; exemption from the requirement 

of a tolerance.

    Residues of the neomycin phosphotransferase II (NPTII) enzyme are 
exempted from the requirement of a tolerance in all food commodities 
when used as a plant-incorporated protectant inert ingredient.

[72 FR 20435, Apr. 25, 2007]

[[Page 410]]



Sec. 174.522  Phosphinothricin Acetyltransferase (PAT); exemption from the 

requirement of a tolerance.

    Residues of the Phosphinothricin Acetyltransferase (PAT) enzyme are 
exempt from the requirement of a tolerance when used as plant-
incorporated protectant inert ingredients in all food commodities.

[72 FR 20435, Apr. 25, 2007]



Sec. 174.523  CP4 Enolpyruvylshikimate-3-phosphate (CP4 EPSPS) synthase in all 

plants; exemption from the requirement of a tolerance.

    Residues of the CP4 Enolpyruvylshikimate-3-phosphate (CP4 EPSPS) 
synthase enzyme in all plants are exempt from the requirement of a 
tolerance when used as plant-incorporated protectant inert ingredients 
in all food commodities.

[72 FR 20435, Apr. 25, 2007]



Sec. 174.524  Glyphosate Oxidoreductase GOX or GOXv247 in all plants; 

exemption from the requirement of a tolerance.

    Residues of the Glyphosate Oxidoreductase GOX or GOXv247 enzyme in 
all plants are exempt from the requirement of a tolerance when used as 
plant-incorporated protectant inert ingredients in all food commodities.

[72 FR 20435, Apr. 25, 2007]



Sec. 174.525  E. coli B-D-glucuronidase enzyme as a plant-incorporated 

protectant inert ingredient; exemption from the requirement of a tolerance.

    Residues of E. coli B-D-glucuronidase enzyme are exempt from the 
requirement of a tolerance when used as a plant-incorporated protectant 
inert ingredient in all food commodities.

[72 FR 20435, Apr. 25, 2007]



Sec. 174.526  Hygromycin B phosphotransferase (APH4) marker protein in all 

plants; exemption from the requirement of a tolerance.

    Residues of the Hygromycin B phosphotransferase (APH4) enzyme in all 
plants are exempt from the requirement of a tolerance when used as a 
plant-incorporated protectant inert ingredient in cotton.

[72 FR 20435, Apr. 25, 2007]



Sec. 174.527  Phosphomannose isomerase in all plants; exemption from the 

requirement of a tolerance.

    Residues of the phosphomannose isomerase (PMI) enzyme in plants are 
exempt from the requirement of a tolerance when used as plant-
incorporated protectant inert ingredients in all food commodities.

[72 FR 20435, Apr. 25, 2007]



Sec. 174.529  Bacillus thuringiensis modified Cry1Ab protein as identified 

under OECD Unique Identifier SYN-IR67B-1 in cotton; exemption from the 

requirement of a tolerance.

    Residues of Bacillus thuringiensis modified Cry1Ab protein as 
identified under OECD Unique Identifier SYN-IR67B-1 are exempt from the 
requirement of a tolerance when used as a plant-incorporated protectant 
in cotton; cotton, undelinted seed; cotton, refined oil; cotton, meal; 
cotton, hay; cotton, hulls; cotton, forage; and cotton, gin byproducts.

[73 FR 40764, July 16, 2008]



Sec. 174.530  Bacillus thuringiensis Cry2Ae protein in cotton; exemption from 

the requirement of a tolerance.

    Residues of Bacillus thuringiensis Cry2Ae protein in or on the food 
and feed commodities of cotton; cotton, undelinted seed; cotton, gin 
byproducts; cotton, forage; cotton, hay; cotton, hulls; cotton, meal; 
and cotton, refined oil, are exempt from the requirement of a tolerance 
when Bacillus thuringiensis Cry2Ae protein is used as a plant-
incorporated protectant in cotton.

[77 FR 6475, Feb. 8, 2012]

[[Page 411]]



Sec. 174.531  Coat protein of plum pox virus; exemption from the requirement 

of a tolerance.

    Residues of the coat protein of plum pox virus in or on the food 
commodities of fruit, stone, Group 12; and almond, are exempt from the 
requirement of a tolerance in these food commodities when expressed by 
the plant-incorporated protectant, coat protein gene of plum pox virus, 
and used in accordance with good agricultural practices.

[75 FR 29435, May 26, 2010]



Sec. 174.532  Bacillus thuringiensis eCry3.1Ab protein in corn; exemption from 

the requirement of a tolerance.

    Residues of Bacillus thuringiensis eCry3.1Ab protein in corn, in or 
on the food and feed commodities of corn; corn, field; corn, sweet; and 
corn, pop are exempt from the requirement of a tolerance when Bacillus 
thuringiensis eCry3.1Ab protein in corn is used as a plant-incorporated 
protectant.

[77 FR 47291, Aug. 8, 2012]



Sec. 174.533  Glycine max Herbicide-Resistant Acetolactate Synthase (GM-HRA) 

inert ingredient; exemption from the requirement of a tolerance.

    Residues of Glycine max herbicide-resistant acetolactate synthase 
(GM-HRA) enzyme in or on the food and feed commodities of soybean are 
exempt from the requirement of a tolerance when used as a plant-
incorporated protectant inert ingredient.

[78 FR 9321, Feb. 8, 2013]



              Subpart X_List of Approved Inert Ingredients



Sec. 174.700  Scope and purpose.

    This subpart lists the inert ingredients that have been exempted 
from FIFRA and FFDCA section 408 requirements and may be used in a 
plant-incorporated protectant listed in subpart B of this part.

[66 FR 37814, July 19, 2001. Redesignated at 72 FR 20434, Apr. 25, 2007]



Sec. 174.705  Inert ingredients from sexually compatible plant.

    An inert ingredient, and residues of the inert ingredient, are 
exempt if all of the following conditions are met:
    (a) The genetic material that encodes the inert ingredient or leads 
to the production of the inert ingredient is derived from a plant 
sexually compatible with the recipient food plant.
    (b) The genetic material has never been derived from a source that 
is not sexually compatible with the recipient food plant.
    (c) The residues of the inert ingredient are not present in food 
from the plant at levels that are injurious or deleterious to human 
health.

[66 FR 37814, July 19, 2001. Redesignated at 72 FR 20434, Apr. 25, 2007]

Subparts Y-Z [Reserved]



PART 176_TIME-LIMITED TOLERANCES FOR EMERGENCY EXEMPTIONS--Table of Contents



Sec.
176.1 Scope and applicability.
176.3 Definitions.
176.5 Establishment of a time-limited tolerance or exemption.
176.7 Information needed to establish a tolerance.
176.9 Publication of a tolerance.
176.11 Duration of a tolerance.
176.13 Modification of a time-limited tolerance.
176.15 Effect of a tolerance.

    Authority: 21 U.S.C. 346a and 371.

    Source: 65 FR 64131, Oct. 25, 2000, unless otherwise noted.



Sec. 176.1  Scope and applicability.

    This part describes the procedures and criteria under which EPA will 
establish time-limited tolerances and exemptions from the requirement of 
a tolerance for pesticide chemical residues associated with use of 
pesticides under emergency or crisis exemptions under FIFRA section 18. 
This part applies only to tolerances issued on the initiative of EPA as 
the result of the issuance of an emergency exemption or the declaration 
of a crisis exemption. This part does not cover time-limited tolerances 
in any other circumstances.

[[Page 412]]



Sec. 176.3  Definitions.

    The terms have the same meaning as in the Federal Insecticide, 
Fungicide, and Rodenticide Act section 2, and in the Federal Food, Drug, 
and Cosmetic Act section 201 and Sec. 166.3 of this chapter. In 
addition, the following terms are defined for the purposes of this part.
    Agency means the U.S. Environmental Protection Agency.
    Applicant means any entity authorized under section 18 of FIFRA to 
request an emergency exemption that requests such an exemption under 
Sec. 166.20 of this chapter, or issues a crisis exemption under Sec. 
166.40 of this chapter.
    Crisis exemption means an exemption authorized under FIFRA section 
18, in accordance with Sec. Sec. 166.40 through 166.53 of this chapter.
    Emergency exemption means a specific, quarantine, or public health 
exemption authorized under FIFRA section 18 and the regulations at 
Sec. Sec. 166.20 through 166.35 of this chapter.
    EPA means the U.S. Environmental Protection Agency.
    FFDCA means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 
et seq.).
    FIFRA means the Federal Insecticide, Fungicide, and Rodenticide Act 
(7 U.S.C 136 et seq.).
    Tolerance means the maximum amount of a pesticide chemical residue 
that may lawfully be present in or on a raw agricultural commodity, or 
processed food, or animal feed, expressed as parts per million by weight 
of the pesticide chemical residue in the food or feed.
    Tolerance exemption means a formal determination by the Agency 
pursuant to FFDCA section 408(c), 21 U.S.C 346a(c), that no tolerance is 
needed for a given pesticide chemical residue in or on a particular food 
commodity. For purposes of this part, the term ``tolerance'' shall 
include an exemption from the requirement of a tolerance.



Sec. 176.5  Establishment of a time-limited tolerance or exemption.

    EPA will establish a time-limited tolerance for pesticide chemical 
residues in or on raw or processed food or feed resulting from the use 
of a pesticide chemical, if EPA authorizes an emergency exemption or a 
crisis exemption. EPA will consider establishing such a tolerance only 
if an applicant acting under authority of FIFRA section 18 either has 
requested an emergency exemption, has stated its intention to issue a 
crisis exemption, or has issued a crisis exemption for a use that may 
result, directly or indirectly, in pesticide chemical residues in food 
or feed.



Sec. 176.7  Information needed to establish a tolerance.

    (a) EPA will establish a time-limited tolerance only if EPA can 
determine that the tolerance is safe, that is, there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue. EPA will base its determination upon data 
submitted by the applicant and other readily available data. If, taking 
into account the limited duration and emergency nature of a section 18 
application, and based on the available data the Agency cannot conclude 
that there is a reasonable certainty that no harm will result from the 
use proposed by the applicant or granted pursuant to a crisis exemption, 
EPA will not establish a tolerance.
    (b) Data and other relevant information to support the establishment 
of a time-limited tolerance may be submitted by the applicant, or by any 
other person, in support of the time-limited tolerance. The applicant 
may also cite relevant data previously submitted to the Agency.



Sec. 176.9  Publication of a tolerance.

    (a) If EPA issues an emergency exemption or crisis exemption under 
FIFRA section 18, and EPA concludes that the tolerance for residues 
resulting from use of the pesticide under the exemption will be safe, 
then EPA will establish the tolerance by publishing an amendment to 40 
CFR part 180 in the Federal Register.
    (b) A tolerance under this part may be established without prior 
publication of a proposed tolerance or comment period.



Sec. 176.11  Duration of a tolerance.

    (a) Tolerances issued under this part will become effective upon 
publication

[[Page 413]]

in the Federal Register, unless otherwise specified by the 
Administrator.
    (b) Unless extended, tolerances will automatically expire and be 
revoked, without further action by EPA, at the time set out in the final 
rule published in Federal Register.
    (c) The Administrator may revoke a tolerance at any time if the 
Administrator determines that the tolerance is no longer safe.



Sec. 176.13  Modification of a time-limited tolerance.

    If additional emergency or crisis exemptions are authorized that 
would extend use beyond the date originally authorized, or if EPA 
determines that the duration of a time-limited tolerance is insufficient 
to allow treated commodities to clear the channels of trade, EPA may 
modify the time-limited tolerance by publication of a final rule in the 
Federal Register. EPA will use the same criteria and procedures for 
modification as for establishing tolerances under this part.



Sec. 176.15  Effect of a tolerance.

    The establishment of a tolerance under this part does not alter the 
requirement that any applicant comply with procedures established in 
part 166 of this chapter for emergency exemptions of FIFRA.



PART 178_OBJECTIONS AND REQUESTS FOR HEARINGS--Table of Contents



                      Subpart A_General Provisions

Sec.
178.3 Definitions.

   Subpart B_Procedures for Filing Objections and Requests for Hearing

178.20 Right to submit objections and requests for a hearing.
178.25 Form and manner of submission of objections.
178.27 Form and manner of submission of request for evidentiary hearing.
178.30 Response by Administrator to objections and to requests for 
          hearing.
178.32 Rulings on requests for hearing.
178.35 Modification or revocation of regulation or prior order.
178.37 Order responding to objections on which a hearing was not 
          requested or was denied.

Subpart C [Reserved]

                        Subpart D_Judicial Review

178.65 Judicial review.
178.70 Administrative record.

    Authority: 21 U.S.C. 346a, 371(a); Reorg. Plan No. 3 of 1970.

    Source: 55 FR 50291, Dec. 5, 1990, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 178.3  Definitions.

    For the purposes of this part:
    Administrator means the Administrator of the Agency, or any officer 
or employee of the Agency to whom the Administrator delegates the 
authority to perform functions under this part.
    Agency means the United States Environmental Protection Agency.
    Assistant Administrator means the Agency's Assistant Administrator 
for Chemical Safety and Pollution Prevention, or any officer or employee 
of the Agency's Office of Chemical Safety and Pollution Prevention to 
whom the Assistant Administrator delegates the authority to perform 
functions under this part.
    FFDCA means the Federal Food, Drug, and Cosmetic Act, as amended, 21 
U.S.C. 301-392.

[55 FR 50291, Dec. 5, 1990, as amended at 57 FR 28087, June 24, 1992; 77 
FR 46292, Aug. 3, 2012]



   Subpart B_Procedures for Filing Objections and Requests for Hearing



Sec. 178.20  Right to submit objections and requests for a hearing.

    (a) On or before the 60th day after the date of publication in the 
Federal Register of an order under part 180 of this chapter 
establishing, modifying, or revoking a regulation, or denying all or any 
portion of a petition, a person adversely affected by such order or 
petition denial may submit, in accordance with Sec. 178.25, one or more 
written objections to the order (or to the action that is the subject of 
the order).
    (b) A person may include with any such objection a written request 
for an evidentiary hearing on such objection in accordance with Sec. 
178.27

[[Page 414]]

    (c) A person who submits objections need not request a hearing. For 
instance, if the person's objections are of a purely legal or policy 
nature, a hearing request would be inappropriate; the purpose of an 
evidentiary hearing is to resolve factual disputes. The Administrator 
will rule on the objections, whether or not a hearing is requested.
    (d) As a matter of discretion, the Administrator may order a hearing 
on an objection even though no person has requested a hearing.

[55 FR 50291, Dec. 5, 1990, as amended at 70 FR 33359, June 8, 2005]



Sec. 178.25  Form and manner of submission of objections.

    (a) To be considered by the Administrator, an objection must:
    (1) Be in writing.
    (2) Specify with particularity the provision(s) of the order, 
regulation, or denial objected to, the basis for the objection(s), and 
the relief sought.
    (3) Be signed by the objector.
    (4) State the objector's name and mailing address.
    (5) Be accompanied by the fee prescribed by Sec. 180.33(i) of this 
chapter, if the objection is to an order or regulation issued under part 
180 of this chapter.
    (6) Be submitted to the hearing clerk.
    (7) Be received by the Hearing Clerk not later than the close of 
business of the 60th day following the date of the publication in the 
Federal Register of the order to which the objection is taken (or, if 
such 60th day is a Saturday, Sunday, or Federal holiday, not later than 
the close of business of the next government business day after such 
60th day).
    (b) Submissions to the hearing clerk shall be made as follows:
    (1) Mailed submissions should be addressed to: Office of the Hearing 
Clerk (1900L), Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW., Washington, DC 20460-0001.
    (2) For hand/courier delivery the Office of the Hearing Clerk is 
located at Suite 350, 1099 14\th\ St., NW., Washington, DC 20005.

[55 FR 50291, Dec. 5, 1990, as amended at 69 FR 39864, July 1, 2004; 70 
FR 33359, June 8, 2005; 71 FR 35546, June 21, 2006]



Sec. 178.27  Form and manner of submission of request for evidentiary hearing.

    To be considered by the Administrator, a request for an evidentiary 
hearing must meet the criteria in Sec. 178.32, and must:
    (a) Be submitted as a part of, and specifically request an 
evidentiary hearing on an objection that complies with the requirements 
of Sec. 178.25.
    (b) Include a statement of the factual issue(s) on which a hearing 
is requested and the requestor's contentions on each such issue.
    (c) Include a copy of any report, article, survey, or other written 
document (or the pertinent pages thereof) upon which the objector relies 
to justify an evidentiary hearing, unless the document is an EPA 
document that is routinely available to any member of the public.
    (d) Include a summary of any evidence not described in paragraph 
(a)(3) of this section upon which the objector relies to justify an 
evidentiary hearing.
    (e) Include a discussion of the relationship between the factual 
issues and the relief requested by the objection.



Sec. 178.30  Response by Administrator to objections and to requests for 

hearing.

    The Administrator will respond to objections, and to requests for a 
hearing on such objections, as set forth in this section.
    (a) Denial of objections that are improperly submitted or that seek 
an unavailable form of relief. The Administrator will by order issued 
under Sec. 178.37 deny each objection and each request for a hearing 
that is included with such an objection, if:
    (1) The objection is found not to conform to Sec. 178.25.
    (2) The action requested by the objection is inconsistent with any 
provision of FFDCA.
    (3) The action requested by the objection is inconsistent with any 
generic, e.g., non-chemical specific, interpretation of a provision of 
FFDCA in any regulation in this chapter (the proper procedure in such a 
case is for the person to petition for an amendment of the regulation 
involved).

[[Page 415]]

    (b) Denial of improperly submitted requests for hearing. The 
Administrator will then determine whether any objection that has not 
been denied under paragraph (a) of this section was accompanied by a 
request for an evidentiary hearing that conforms to Sec. 178.27. The 
Administrator will deny under Sec. 178.37 each request that does not 
conform to Sec. 178.27.
    (c) Grouping of certain related objections. If the Administrator 
then finds (1) That two or more undenied objections are substantially 
similar, or are related in such a way that any judicial review of the 
Administrator's action on those objections should occur at the same 
time, and (2) that one or more of those objections was accompanied by an 
undenied request for an evidentiary hearing on that objection, the 
Administrator will treat those objections as a group and will rule on 
them only after ruling under Sec. 178.32 on the associated request for 
hearing.
    (d) Rulings on objections for which a request for hearing has been 
granted. If the Administrator rules under Sec. 178.32 that an 
evidentiary hearing should be held on an objection, the Administrator 
will resolve the issues raised by any other objection grouped with it 
under paragraph (c) of this section in conjunction with the evidentiary 
hearing upon which the hearing request was granted, unless the 
Administrator for good cause determines otherwise.
    (e) Rulings on objections for which no request for hearing was 
received, or for which each request for hearing was denied. Except as 
provided in paragraphs (c) and (d) of this section, if no hearing was 
requested on an objection, or if each such request that was made is 
denied under the criteria of paragraphs (a) or (b) of this section or 
Sec. 178.32(b), the Administrator will rule on the objection under 
Sec. 178.37.



Sec. 178.32  Rulings on requests for hearing.

    (a) In the case of each request for an evidentiary hearing that was 
not denied under Sec. 178.30(a) or (b), the Administrator will 
determine whether such a hearing on one or more of the objections is 
justified, and will publish in the Federal Register the determination in 
an order issued under Sec. 178.37 or a Notice of Hearing issued under 
Sec. 179.20 of this chapter. If some requests for a hearing are denied 
and others pertaining to the same order or regulation are granted, the 
denial order and the hearing notice may be combined into a single 
document and shall be issued at the same time unless the Administrator 
for good cause determines otherwise.
    (b) A request for an evidentiary hearing will be granted if the 
Administrator determines that the material submitted shows the 
following:
    (1) There is a genuine and substantial issue of fact for resolution 
at a hearing. An evidentiary hearing will not be granted on issues of 
policy or law.
    (2) There is a reasonable possibility that available evidence 
identified by the requestor would, if established, resolve one or more 
of such issues in favor of the requestor, taking into account 
uncontested claims or facts to the contrary. An evidentiary hearing will 
not be granted on the basis of mere allegations, denials, or general 
descriptions of positions and contentions, nor if the Administrator 
concludes that the data and information submitted, even if accurate, 
would be insufficient to justify the factual determination urged.
    (3) Resolution of the factual issue(s) in the manner sought by the 
person requesting the hearing would be adequate to justify the action 
requested. An evidentiary hearing will not be granted on factual issues 
that are not determinative with respect to the action requested. For 
example, a hearing will not be granted if the Administrator concludes 
that the action would be the same even if the factual issue were 
resolved in the manner sought.
    (c) Where appropriate, the Administrator will make rulings on any 
issues raised by an objection which are necessary for resolution prior 
to determining whether a request for an evidentiary hearing should be 
granted.



Sec. 178.35  Modification or revocation of regulation or prior order.

    (a) If the Administrator determines upon review of an objection or 
request for hearing that the regulation or prior order in question 
should be modified or

[[Page 416]]

revoked, the Administrator will publish an order setting forth any 
revision to the regulation or prior order that the Administrator has 
found to be warranted.
    (b) The Administrator will provide an opportunity for objections and 
requests for hearing on such order to the extent required by law. Such 
objections to the modification or revocation of the regulation, and 
requests for a hearing on such objections, may be submitted under 
Sec. Sec. 178.20 through 178.27.
    (c) Objections and requests for hearing that are not affected by the 
modification or revocation will remain on file and be acted upon in 
accordance with this part.

[55 FR 50291, Dec. 5, 1990, as amended at 70 FR 33359, June 8, 2005]



Sec. 178.37  Order responding to objections on which a hearing was not 

requested or was denied.

    (a) The Administrator will publish in the Federal Register an order 
under FFDCA section 408(g)(2)(B) or section 408(g)(2)(C) setting forth 
the Administrator's determination on each denial of a request for a 
hearing, and on each objection submitted under Sec. 178.20 on which:
    (1) A hearing was not requested.
    (2) A hearing was requested, but denied.
    (b) Each order published under paragraph (a) of this section must 
state the reasons for the Administrator's determination. If the order 
denies a request for a hearing on the objection, the order also must 
state the reason for that denial (e.g., why the request for a hearing 
did not conform to Sec. 178.27, or why the request was denied under 
Sec. 178.32).
    (c) Each order published under paragraph (a) of this section must 
state its effective date.

[55 FR 50291, Dec. 5, 1990, as amended at 70 FR 33359, June 8, 2005]

Subpart C [Reserved]



                        Subpart D_Judicial Review



Sec. 178.65  Judicial review.

    An order issued under Sec. 178.37 is final agency action reviewable 
in the courts as provided by FFDCA section 408(h), as of the date of 
publication of the order in the Federal Register. The failure to file a 
petition for judicial review within the period ending on the 60th day 
after the date of the publication of the order constitutes a waiver 
under FFDCA section 408(h) of the right to judicial review of the order 
and of any regulation promulgated by the order.

[70 FR 33359, June 8, 2005]



Sec. 178.70  Administrative record.

    (a) For purposes of judicial review, the record of an administrative 
proceeding that culminates in an order under Sec. 178.37 consists of:
    (1) The objection ruled on (and any request for hearing that was 
included with the objection).
    (2) Any order issued under Sec. 180.7(g) of this chapter to which 
the objection related, and:
    (i) Any regulation or petition denial that was the subject of that 
order.
    (ii) The petition to which such order responded.
    (iii) Any amendment or supplement of the petition.
    (iv) The data and information submitted in support of the petition.
    (v) The notice of filing of the petition.
    (3) Any order issued under Sec. 180.29(f) of this chapter to which 
the objection related, the regulation that was the subject of that 
order, and each related Notice of Proposed Rulemaking.
    (4) Any comments submitted by members of the public in response to 
the Notice of Filing or Notice of Proposed Rulemaking, any data or 
information submitted as part of the comments, the Administrator's 
response to comments and the documents or information relied on by the 
Administrator in issuing the regulation or order.
    (5) All other documents or information submitted to the docket for 
the rulemaking in question.
    (6) The order issued under Sec. 178.37.
    (b) The record will be closed as of the date of the Administrator's 
decision unless another date for closing of the

[[Page 417]]

record is specified in the order issued under Sec. 178.37.

[55 FR 50291, Dec. 5, 1990, as amended at 70 FR 33359, June 8, 2005]



PART 179_FORMAL EVIDENTIARY PUBLIC HEARING--Table of Contents



                      Subpart A_General Provisions

Sec.
179.3 Definitions.
179.5 Other authority.

                     Subpart B_Initiation of Hearing

179.20 Notice of hearing.
179.24 Ex parte discussions; separation of functions.

             Subpart C_Participation and Appearance; Conduct

179.42 Notice of participation.
179.45 Appearance.
179.50 Conduct at oral hearings or conferences.

                       Subpart D_Presiding Officer

179.60 Designation and qualifications of presiding officer.
179.70 Authority of presiding officer.
179.75 Disqualification of deciding officials.
179.78 Unavailability of presiding officer.

                      Subpart E_Hearing Procedures

179.80 Filing and service.
179.81 Availability of documents.
179.83 Disclosure of data and information.
179.85 Purpose of preliminary conference.
179.86 Time and place of preliminary conference.
179.87 Procedures for preliminary conference.
179.89 Motions.
179.90 Summary decisions.
179.91 Burden of going forward; burden of persuasion.
179.93 Testimony.
179.94 Transcripts.
179.95 Admission or exclusion of evidence; objections; offers of proof.
179.97 Conferences during hearing.
179.98 Briefs and arguments.

                     Subpart F_Decisions and Appeals

179.101 Interlocutory appeal from ruling of presiding officer.
179.105 Initial decision.
179.107 Appeal from or review of initial decision.
179.110 Determination by Administrator to review initial decision.
179.112 Decision by Administrator on appeal or review of initial 
          decision.
179.115 Motion to reconsider a final order.
179.117 Designation and powers of judicial officer.

                        Subpart G_Judicial Review

179.125 Judicial review.
179.130 Administrative record.

    Authority: 21 U.S.C. 346a, 371(a); Reorg. Plan No. 3 of 1970.

    Source: 55 FR 50293, Dec. 5, 1990, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 179.3  Definitions.

    Administrator means the Administrator of the Agency, or any officer 
or employee of the Agency to whom the Administrator has delegated the 
authority to perform functions under this part.
    Agency means the United States Environmental Protection Agency.
    Assistant Administrator means the Agency's Assistant Administrator 
for Chemical Safety and Pollution Prevention, or any officer or employee 
of the Agency's Office of Chemical Safety and Pollution Prevention to 
whom the Assistant Administrator has delegated the authority to perform 
functions under this part.
    FFDCA means the Federal Food, Drug, and Cosmetic Act, as amended, 21 
U.S.C. 301-392.
    FIFRA means the Federal Insecticide, Fungicide, and Rodenticide Act, 
7 U.S.C. 136-136y.
    Judicial Officer means a person who has been designated by the 
Administrator under Sec. 179.117 to serve as a judicial officer.
    OCSPP means the Agency's Office of Chemical Safety and Pollution 
Prevention.
    Office of the Administrator means the Agency's Administrator and 
Deputy Administrator and their immediate staff, including the judicial 
officer.

[55 FR 50293, Dec. 5, 1990, as amended at 57 FR 28087, June 24, 1992; 77 
FR 46292, Aug. 3, 2012]



Sec. 179.5  Other authority.

    Questions regarding procedural matters arising under this part or 
part 178 of this chapter that are not addressed

[[Page 418]]

by this part or part 178 of this chapter shall be resolved by the 
Administrator or presiding officer, as appropriate.



                     Subpart B_Initiation of Hearing



Sec. 179.20  Notice of hearing.

    (a) If the Administrator determines under Sec. 178.32 of this 
chapter that a hearing is justified on any issue, the Administrator will 
file with the hearing clerk and publish in the Federal Register a Notice 
of Hearing. The Notice of Hearing will set forth:
    (1) The docket number for the hearing.
    (2) Each order, regulation, or petition denial that is the subject 
of the hearing, and a statement specifying any part of any such 
regulation or order that has been stayed in the Administrator's 
discretion.
    (3) The identity of each person whose request for a hearing has been 
granted, and of any other person whose petition under Sec. 180.7 of 
this chapter occasioned the order that the hearing concerns.
    (4) A statement of the issues of fact on which a hearing has been 
found to be justified.
    (5) A statement of the objections whose resolution depends on the 
resolution of those issues of fact.
    (6) A statement that the presiding officer will be designated by the 
Chief Administrative Law Judge.
    (7) The time within which notices of participation should be filed 
under Sec. 179.42.
    (8) The date, time, and place of the preliminary conference, or a 
statement that the date, time, and place will be announced in a later 
notice, and the place of the hearing.
    (9) The time within which parties must submit written information 
and views under Sec. 179.83.
    (10) Designations with respect to separation of functions published 
under Sec. 179.24(b)(2).
    (b) The statement of the issues of fact on which a hearing has been 
justified determines the scope of the hearing and the matters on which 
evidence may be introduced. The issues may be revised by the presiding 
officer. A party may obtain interlocutory review by the Administrator of 
a decision by the presiding officer to revise the issues to include an 
issue on which the Administrator has not granted a request for a hearing 
or to eliminate an issue on which a request for a hearing has been 
granted.
    (c) A hearing is deemed to begin on the date of publication of the 
Notice of Hearing.

[55 FR 50293, Dec. 5, 1990, as amended at 70 FR 33359, June 8, 2005]



Sec. 179.24  Ex parte discussions; separation of functions.

    (a) Any person may meet or correspond with any officer or employee 
of the Agency concerning a matter under parts 178 or 180 of this chapter 
prior to publication of a Notice of Hearing under Sec. 179.20.
    (b) Upon publication of a Notice of Hearing, the following 
separation of function rules apply:
    (1) OCSPP, as a party to the hearing, is responsible for 
presentation of its position at the hearing and in any pleading or oral 
argument before the Administrator. The Pesticides and Toxic Substances 
Division of the Office of General Counsel shall advise and represent 
OCSPP with respect to the hearing and in any pleading or oral argument 
before the Administrator. An employee or other representatives of OCSPP 
may not participate in or advise the Administrator or any of his 
representatives on any decision under this part, other than as witness 
or counsel in public proceedings, except as provided by paragraph (b)(2) 
of this section. There is to be no other communication between 
representatives of OCSPP and the presiding officer or any representative 
of the Office of the Administrator concerning the merits of the hearing 
until after issuance of the decision of the Administrator.
    (2) The Administrator may designate persons who otherwise would be 
regarded as representatives of OCSPP, to serve as representatives of the 
Office of the Administrator on matters pertaining to the hearing, and 
may also designate persons who otherwise would be regarded as 
representatives of the Office of the Administrator to serve as 
representatives of OCSPP. Such designations will be included in the 
Notice of Hearing published underSec. 179.20.

[[Page 419]]

    (3) The Office of the Administrator is responsible for the final 
decision of the matter, with the advice and participation of anyone in 
the Agency other than representatives of OCSPP.
    (c) Between the date of publication of the Notice of Hearing and the 
date of the Administrator's final decision on the matter, communication 
concerning the matter involved in the hearing will be restricted as 
follows:
    (1) No person outside the Agency may have an ex parte communication 
with the presiding officer or any representative of the Office of the 
Administrator concerning the merits of the hearing. Neither the 
presiding officer nor any representative of the Office of the 
Administrator may have any ex parte communication with a person outside 
the Agency concerning the merits of the hearing.
    (2) A written communication contrary to this section must be 
immediately served on all other participants and filed with the hearing 
clerk by the presiding officer at the hearing, or by the Administrator, 
depending on who received the communication. An oral communication 
contrary to this section must be immediately recorded in a written 
memorandum and similarly served on all other parties and filed with the 
hearing clerk. A person, including a representative of a party in the 
hearing, who is involved in an oral communication contrary to this 
section, must, to the extent necessary to determine the substance of the 
communication, be made available for cross-examination during the 
hearing with respect to the substance of that communication. Rebuttal 
testimony pertinent to a written or oral communication contrary to this 
section will be permitted.
    (d) The prohibitions specified in paragraph (c) of this section also 
apply to a person who, in advance of the publication of a Notice of 
Hearing, knows that the notice has been signed. The prohibitions become 
applicable to such a person as of the time the knowledge is acquired.
    (e) The making of a communication contrary to this section may, 
consistent with the interests of justice and the policies underlying the 
FFDCA, result in a decision adverse to the person knowingly making or 
causing the making of the communication.

[55 FR 50293, Dec. 5, 1990, as amended at 57 FR 28087, June 24, 1992; 70 
FR 33359, June 8, 2005; 77 FR 46292, Aug. 3, 2012]



             Subpart C_Participation and Appearance; Conduct



Sec. 179.42  Notice of participation.

    (a) OCSPP shall be a party to a hearing under this part. Any other 
person may participate as a party in such a hearing to the extent 
specified by this section.
    (b) A person desiring to participate in a hearing must file with the 
hearing clerk within 30 days after publication of the Notice of Hearing 
under Sec. 179.20, a Notice of Participation in the following form:

                         Notice of Participation

Docket No. --------------------
Under 40 CFR part l79, please enter the participation of: --------------
          ----------
(Name) ----------------------------------
(Street address) --------------------------
(City and State) --------------------------
(Telephone number) --------------------
Service on the above will be accepted by: ------------------------
(Name) ----------------------------------
(Street address) --------------------------
(City and State) --------------------------
(Telephone number) --------------------
Signed: --------------------------------
Date: ------------------------

    (c) An amendment to a Notice of Participation must be filed with the 
hearing clerk and served on all parties.
    (d) No person may participate in a hearing who has not filed a 
written Notice of Participation or whose participation has been stricken 
under paragraph (f) of this section.
    (e) The presiding officer may permit the late filing of a Notice of 
Participation upon a showing of good cause. Arrangements and agreements 
previously made in the proceeding shall apply to any party admitted 
late.
    (f) The presiding officer may strike the participation of a person 
for failure to comply with any requirement of this

[[Page 420]]

subpart. Any person whose participation is striken may obtain 
interlocutory review thereof by the Administrator.

[55 FR 50293, Dec. 5, 1990, as amended at 57 FR 28087, June 24, 1992; 77 
FR 46292, Aug. 3, 2012]



Sec. 179.45  Appearance.

    (a) A party to a hearing may appear in person or by counsel or other 
representative in the hearing.
    (b) The presiding officer may strike a person's right to appear in 
the hearing for violation of the rules of conduct in Sec. l79.50.



Sec. 179.50  Conduct at oral hearings or conferences.

    The parties and their representatives must conduct themselves with 
dignity and observe the same standards of practice and ethics that would 
be required of parties in a judicial proceeding. Disrespectful, 
disorderly, or contumacious language or conduct, refusal to comply with 
directions, use of dilatory tactics, or refusal to adhere to reasonable 
standards of orderly and ethical conduct during any hearing constitute 
grounds for immediate exclusion from the proceeding by the presiding 
officer.



                       Subpart D_Presiding Officer



Sec. 179.60  Designation and qualifications of presiding officer.

    The presiding officer in a hearing will be an administrative law 
judge qualified under 5 U.S.C. 3l05 and designated by the Agency's chief 
administrative law judge.



Sec. 179.70  Authority of presiding officer.

    The presiding officer shall conduct the hearing in a fair and 
impartial manner subject to the precepts of the Administrative Procedure 
Act. The presiding officer has all powers necessary to conduct a fair, 
expeditious, and orderly hearing, including the power to:
    (a) Specify and change the date, time, and place for conferences, 
and issue and modify a schedule for the hearing.
    (b) Establish an orderly manner for developing evidentiary facts at 
preliminary conferences under Sec. 179.87, for making rulings on oral 
testimony and cross-examination under Sec. 179.93, and for making other 
similar evidentiary rulings in accord with these regulations.
    (c) Prepare statements of the areas of factual disagreement among 
the participants.
    (d) Hold conferences to settle, simplify, or determine the issues in 
a hearing or to consider other matters that may expedite the hearing.
    (e) Administer oaths and affirmations.
    (f) Control the course of the hearing and the conduct of the 
participants.
    (g) Examine witnesses and strike their testimony if they fail to 
respond fully to proper questions.
    (h) Rule on, admit, exclude, or limit evidence.
    (i) Set the time for filing pleadings.
    (j) Rule on motions and other procedural matters.
    (k) Rule on motions for summary decision under Sec. l79.90.
    (l) Conduct the hearing in stages if the number of parties is large 
or the issues are numerous and complex.
    (m) Strike the participation of any person under Sec. l79.42(f), or 
exclude any person from the hearing under Sec. l79.50, or take other 
reasonable disciplinary action.
    (n) Take any other action for the fair, expeditious, and orderly 
conduct of the hearing that is not in conflict with law or these rules.



Sec. 179.75  Disqualification of deciding officials.

    (a) A deciding official in a hearing under this part (including, 
e.g., the Administrator, judicial officer, or presiding officer) shall 
not decide any matter in connection with which he or she has a financial 
interest in any of the parties, or a relationship that would make it 
otherwise inappropriate for him or her to act.
    (b) A party may request that a deciding official disqualify himself/
herself and withdraw from the proceeding. The party may obtain 
interlocutory review by the Administrator of a denial of such a request 
made to any deciding official other than the Administrator.

[[Page 421]]

    (c) A deciding official who is aware of grounds for disqualification 
shall withdraw from the proceeding.



Sec. 179.78  Unavailability of presiding officer.

    If the presiding officer is unable to act for any reason, his or her 
powers with respect to the hearing will be assigned by the Chief 
Administrative Law Judge to another presiding officer. The substitution 
will not affect the hearing, i.e., the testimony of the witnesses will 
not be taken anew except as the new presiding officer may order upon the 
request of a party where the credibility of a witness is of particular 
importance.



                      Subpart E_Hearing Procedures



Sec. 179.80  Filing and service.

    (a) All documents required or authorized to be filed by a party to a 
hearing under this part regarding any matter to be decided by the 
presiding officer, the judicial officer, or the Administrator shall be 
filed in triplicate with the hearing clerk, in the manner specified by 
Sec. 178.25(b) of this chapter. Each filing shall prominently note the 
docket number. To determine compliance with deadlines in a hearing, a 
document is considered filed on the date it is actually received by the 
hearing clerk. When this part allows a response by a party to a 
submission and prescribes a period of time for the filing of the 
response, an additional 3 days are allowed for the filing of the 
response if the submission is served by mail.
    (b) Each notice, order, decision, or other document issued under 
this part by the presiding officer, the judicial officer, or the 
Administrator shall be filed with the hearing clerk. The hearing clerk 
shall immediately serve all parties with a copy of such order, decision, 
or other document.
    (c) At the same time that a party files any document with the 
hearing clerk, the party shall serve a copy thereof on each other party, 
unless the presiding officer specifies otherwise. Each filing shall be 
accompanied by a certificate of service, or a statement that service is 
not required. Service on a party is accomplished by mailing a submission 
to the address shown in the Notice of Participation or by personal 
delivery.
    (d) The presiding officer may grant an extension of time for the 
filing of any pleading, document, or motion (1) Upon timely motion by a 
party, for good cause shown, and after consideration of prejudice to 
other parties, or (2) upon the presiding officer's own motion.
    (e) A motion by a party for an extension may only be made after 
serving a copy of the motion on all other parties, unless the movant can 
show good cause why doing so is impracticable. The motion shall be filed 
in advance of the date on which the pleading, document, or motion is due 
to be filed, unless the failure of the party to make a timely motion for 
an extension was the result of excusable neglect.



Sec. 179.81  Availability of documents.

    (a) All orders, decisions, pleadings, transcripts, exhibits, and 
other docket entries shall become part of the official docket and shall 
be retained by the hearing clerk. Except as otherwise provided by 
paragraph (b) of this section or part 2 of this chapter, all documents 
that are a part of the official docket shall be made available to the 
public for reasonable inspection during Agency business hours. Copies of 
such documents may be obtained by members of the public as provided in 
part 2 of this chapter.
    (b) Whenever any information or data are required to be produced or 
examined in a hearing and any party makes a business confidentiality 
claim regarding such information under part 2 of this chapter, the 
availability of such information to the other parties or to the public 
shall be determined by EPA in accordance with part 2 of this chapter, 
including specifically the procedures and principles set forth in Sec. 
2.30l(g)(3) and (g)(4) of this chapter. The presiding officer shall make 
the determinations with respect to the matters referred to in Sec. 
2.301(g)(3) and (g)(4) to the extent provided, and shall take such steps 
as are necessary for the protection of information entitled to 
confidential treatment or otherwise exempt from public disclosure, 
including issuance of protective orders to parties

[[Page 422]]

or taking testimony in a closed hearing.



Sec. 179.83  Disclosure of data and information.

    (a) Within 60 days of the publication of the Notice of Hearing under 
Sec. l79.20, or, if no party will be prejudiced, within another period 
set by the presiding officer, the Assistant Administrator shall file 
with the hearing clerk, in accordance with Sec. 179.80, the following 
documents numbered and organized in the manner prescribed by the 
presiding officer:
    (1) The portions of the administrative record of the proceeding 
developed under part 178 of this chapter, and under part 180 of this 
chapter, that are relevant to the issues in the hearing.
    (2) All documents in the files of OCSPP containing factual 
information or expert opinion, whether favorable or unfavorable to the 
position of OCSPP, which relate to the issues involved in the hearing. 
For purposes of this paragraph, ``files'' means the principal files in 
OCSPP in which documents relating to each of the issues in the hearing 
are ordinarily kept. Documents that are internal memoranda reflecting 
the deliberative process, or are attorney work product, or were prepared 
specifically for use in connection with the hearing, are not required to 
be submitted.
    (3) All other documentary data and information upon which OCSPP 
plans to rely upon in the hearing.
    (4) A narrative position statement on the factual issues in the 
Notice of Hearing and the nature of the supporting evidence that OCSPP 
intends to introduce.
    (5) A signed statement that, to the best knowledge and belief of the 
Assistant Administrator, the submission complies with this section.
    (b) Within 70 days of the publication of the Notice of Hearing or, 
if no party will be prejudiced, within another period of time set by the 
presiding officer, each party other than OCSPP shall submit to the 
hearing clerk in accordance with Sec. 179.80 the following documents, 
numbered and organized in the manner prescribed by the presiding 
officer:
    (1) Any objections that the administrative record filed under 
paragraph (a)(l) of this section is incomplete.
    (2) All documents (other than those filed under paragraph (a) of 
this section) in the party's files containing factual information or 
expert opinion, whether favorable or unfavorable to the party's 
position, that relates to the issues involved in the hearing. For 
purposes of this paragraph, ``files'' means the party's principal files 
in which documents relating to each of the issues in the hearing are 
ordinarily kept. Documents that are attorney work product, or were 
prepared specifically for use in connection with the hearing, are not 
required to be submitted.
    (3) All other documentary data and information the party plans to 
rely upon in the hearing.
    (4) A narrative position statement on the factual issues in the 
Notice of Hearing and the nature of the supporting evidence the party 
intends to introduce.
    (5) A signed statement that, to the best knowledge and belief of the 
party, the submission complies with this section.
    (c) Submissions required by paragraphs (a) and (b) of this section 
may be supplemented later in the proceeding, with the approval of the 
presiding officer, upon a showing that the material contained in the 
supplement was not reasonably known by or available to the party when 
the submission was made or that the relevance of the material contained 
in the supplement could not reasonably have been foreseen.
    (d) If a party fails to comply substantially and in good faith with 
this section, the presiding officer may infer that such failure was for 
the purpose of withholding information that is unfavorable to the 
party's position, and may make such further adverse inferences and 
findings with respect to such failure as are warranted.
    (e) Parties may reference each other's submissions. To reduce 
duplicative submissions, parties are encouraged to exchange and 
consolidate lists of documentary evidence. If a particular document is 
bulky or in limited supply and cannot reasonably be reproduced, and it 
constitutes relevant evidence, the

[[Page 423]]

presiding officer may authorize submission of a reduced number of 
copies.
    (f) The presiding officer will rule on questions relating to this 
section.

[55 FR 50293, Dec. 5, 1990, as amended at 57 FR 28087, June 24, 1992; 70 
FR 33359, June 8, 2005; 77 FR 46292, Aug. 3, 2012]



Sec. 179.85  Purpose of preliminary conference.

    The presiding officer will conduct one or more preliminary 
conferences for the following purposes:
    (a) To determine the areas of factual disagreement to be considered 
at the hearing.
    (b) To establish any necessary procedural rules to control the 
course of the hearing and the schedule for the hearing.
    (c) To group parties with substantially similar interests, for 
purposes of presenting evidence, making objections, cross-examination, 
and presenting oral argument.
    (d) To obtain stipulations and admissions of facts.
    (e) To take other action that may expedite the hearing.



Sec. 179.86  Time and place of preliminary conference.

    A preliminary conference will commence at the date, time, and place 
announced in the Notice of Hearing, or as otherwise specified by the 
Administrator or presiding officer in a subsequent notice. The 
preliminary conference may not commence until after expiration of the 
time for filing notices of participation under Sec. 179.42. The 
presiding officer may specify that two or more such conferences shall be 
held.



Sec. 179.87  Procedures for preliminary conference.

    Parties in a hearing must appear at the preliminary conference(s) 
prepared to present a position on the matters specified in Sec. 179.85. 
A preliminary conference may be held by telephone, or other electronic 
means, if appropriate.
    (a) To expedite the hearing, parties are encouraged to prepare in 
advance for the conference. Parties should cooperate with each other and 
should request information and begin preparation of testimony at the 
earliest possible time. Failure of a party to appear at the preliminary 
conference or to raise matters that could reasonably be anticipated and 
resolved at that time will not delay the progress of the hearing, and 
constitutes a waiver of the rights of the party regarding such matters 
as objections to the agreements reached, actions taken, or rulings 
issued. Such failure to appear may also be grounds for striking the 
party's participation under Sec. 179.42(f).
    (b) Each party shall bring to the preliminary conference the 
following specific information, which will be filed with the hearing 
clerk under Sec. 179.80:
    (1) Any additional information to supplement the submission which 
may have been filed under Sec. 179.83, and/or which may be filed if 
approved under Sec. 179.83(c).
    (2) A list setting forth each person who has been identified as a 
witness whose oral or written testimony will be offered by the party at 
the hearing, with a full curriculum vitae for each and a summary of the 
expected testimony (including a list of the principal exhibits on which 
the witness will rely) or a statement as to when such a summary will be 
furnished. A party may amend its witness and document list to add, 
delete, or substitute witnesses or documents.
    (c) The presiding officer may hold preliminary conferences off the 
record in an effort to reach agreement on disputed factual or procedural 
questions.
    (d) The presiding officer shall issue and file under Sec. 179.80 a 
written order reciting the actions taken at each preliminary conference 
and setting forth the schedule for the hearing. The order will control 
the subsequent course of the hearing unless modified by the presiding 
officer for good cause.



Sec. 179.89  Motions.

    A motion, unless made in the course of a preliminary conference or a 
transcribed oral hearing before the presiding officer, must be filed in 
the manner prescribed by Sec. 179.80 and include a draft order. A 
response may be filed within 10 days of service of a motion. The moving 
party has no right to reply, except as permitted by the presiding 
officer. The presiding officer shall rule upon the motion.

[[Page 424]]



Sec. 179.90  Summary decisions.

    (a) After the hearing commences, a party may file a written motion, 
with or without supporting affidavits or brief, for a summary decision 
on any issue in the hearing. Any other party may, within 10 days after 
service of the motion, which time may be extended for an additional 10 
days for good cause shown, serve opposing affidavits or brief or 
countermove for summary decision. The presiding officer may set the 
matter for argument and call for the submission of briefs if not 
submitted by the parties.
    (b) The presiding officer will grant the motion if the objections, 
requests for hearing, other pleadings, affidavits, and other material 
filed in connection with the hearing, or matters officially noticed, 
show that there is no genuine disagreement as to any material fact 
bearing on the issue and that a party is entitled to summary decision.
    (c) Affidavits should set forth facts that would be admissible in 
evidence and show affirmatively that the affiant is competent to testify 
to the matters stated. When a properly supported motion for summary 
decision is made, a party opposing the motion may not rest upon mere 
allegations or denials or general descriptions of positions and 
contentions; affidavits or other responses must demonstrate specifically 
that there is a genuine issue of material fact for the hearing.
    (d) Should it appear from the affidavits of a party opposing the 
motion that for sound reasons stated, facts essential to justify the 
opposition cannot be presented by affidavit, the presiding officer may 
deny the motion for summary decision, order a continuance to permit 
affidavits or additional evidence to be obtained, or issue other just 
order.
    (e) If a summary decision is not rendered upon all issues or for all 
the relief asked, and evidentiary facts need to be developed, the 
presiding officer will issue an order specifying the facts that appear 
without substantial controversy and directing further evidentiary 
proceedings. The facts so specified will be deemed established.
    (f) A party may obtain interlocutory review by the Administrator of 
a summary decision of the presiding officer.



Sec. 179.91  Burden of going forward; burden of persuasion.

    (a) The party whose request for an evidentiary hearing was granted 
has the burden of going forward in the hearing with evidence as to the 
issues relevant to that request for a hearing.
    (b) The party or parties who contend that a regulation satisfies the 
criteria of section 408 of the FFDCA has the burden of persuasion in the 
hearing on that issue, whether the proceeding concerns the 
establishment, modification, or revocation of a tolerance or exemption 
from the requirement for a tolerance.

[55 FR 50293, Dec. 5, 1990, as amended at 70 FR 33359, June 8, 2005]



Sec. 179.93  Testimony.

    (a) The presiding officer will conduct such proceedings as are 
necessary for the taking of oral direct testimony and for the conduct of 
oral examination of witnesses by the parties. The presiding officer 
shall limit oral examination to prevent irrelevant, immaterial or unduly 
repetitious examination.
    (b) Direct testimony shall be submitted in writing, except that the 
presiding officer may order direct testimony to be presented orally in 
those unusual cases where the memory or demeanor of the witness is of 
importance. Written direct testimony shall be in the form of a verified 
statement of fact or opinion prepared by the witness, in narrative form 
or in question-and-answer form. Written direct testimony may incorporate 
exhibits. Such a verified statement or exhibit may not be admitted into 
evidence sooner than 14 days (or such other reasonable period as the 
presiding officer may order) after the witness has delivered to the 
presiding officer and each party a copy of the statement or exhibit. The 
admissibility of the evidence contained in such a statement is subject 
to the same rules as if such testimony had been given orally.
    (c) Oral cross-examination of witnesses will be permitted. Each 
exhibit that a party intends to rely upon in cross-examining a witness 
shall be furnished to the other parties not later than 3 days (or such 
other reasonable period as the presiding officer may

[[Page 425]]

order) before such exhibit is used in the cross-examination.
    (d) Witnesses shall give testimony under oath or affirmation.



Sec. 179.94  Transcripts.

    (a) The hearing clerk shall make arrangements to have all oral 
testimony stenographically reported or recorded and transcribed, with 
evidence that is admitted in the form of written testimony or exhibits 
attached or incorporated as appropriate.
    (b) Unless the presiding officer orders otherwise, parties shall 
have 15 days from the date that the transcript of particular oral 
testimony first becomes available to propose corrections in the 
transcript of that testimony. Corrections are permitted only for 
transcription errors. The presiding officer shall promptly order 
justified corrections.
    (c) As soon as practicable after the taking of the last evidence, 
the presiding officer shall certify:
    (1) That the original transcript is a true transcript of the oral 
testimony offered or received at the hearing, except in such particulars 
as the presiding officer specifies.
    (2) That the written testimony and exhibits accompanying the 
transcript are all the written testimony and exhibits introduced at the 
hearing, with such exceptions as the presiding officer specifies.
    (3) The transcript with attached or incorporated material, as so 
certified by the presiding officer, shall be submitted to and filed by 
the hearing clerk under Sec. 179.80.
    (d) Copies of the transcript shall be available to the public in 
accordance with Sec. 179.81; parties may make special arrangements 
through the hearing clerk to obtain copies on an ongoing, expedited 
basis.



Sec. 179.95  Admission or exclusion of evidence; objections; offers of proof.

    (a) Written material identified as direct testimony or as an 
evidentiary exhibit and offered by a party in a hearing, and oral 
testimony, whether on direct or on cross-examination, is admissible as 
evidence unless the presiding officer excludes it (on objection of a 
party or on the presiding officer's own initiative) because it is 
irrelevant, immaterial, or unduly repetitive, or because its exclusion 
is necessary to enforce a specific requirement of this part relating to 
the admissibility of evidence.
    (b) If a party objects to the admission or rejection of any evidence 
or to the limitation of the scope of any examination or cross-
examination, the party shall state briefly the grounds for such 
objection. The transcript shall include any argument or debate thereon, 
unless the presiding officer, with the consent of all the parties, 
orders that such argument not be transcribed. The ruling and the reasons 
given therefor by the presiding officer on any objection shall be a part 
of the transcript. An automatic exception to that ruling will follow.
    (c) Whenever evidence is deemed inadmissible, the party offering 
such evidence may make an offer of proof, which shall be included in the 
transcript. The offer of proof for excluded oral testimony shall consist 
of a brief statement describing the nature of the evidence excluded. If 
the evidence consists of a document or exhibit, it shall be inserted in 
the record in total. If the Administrator in reviewing the record under 
Sec. 179.112 decides that the presiding officer's ruling in excluding 
the evidence was erroneous and prejudicial, the hearing may be reopened 
to permit the taking of such evidence, or, where appropriate, the 
Administrator may evaluate the evidence and proceed to a final decision.
    (d) Official notice may be taken of Agency proceedings, any matter 
that might be judicially noticed by the courts of the United States, or 
any other fact within the knowledge and experience of the Agency as an 
expert agency. Any party shall be given adequate opportunity to show 
that such facts are erroneously noticed by presenting evidence to the 
contrary.



Sec. 179.97  Conferences during hearing.

    The presiding officer may schedule and hold conferences as needed to 
monitor the progress of the hearing, narrow and simplify the issues, and 
consider and rule on motions, requests, or other matters concerning the 
development of the evidence.

[[Page 426]]



Sec. 179.98  Briefs and arguments.

    (a) Promptly after the taking of evidence is completed, the 
presiding officer will announce a schedule for the filing of briefs. 
Briefs must include a statement of position on each issue, with specific 
and complete citations to the evidence and points of law relied on. 
Briefs must contain proposed findings of fact and conclusions of law.
    (b) The presiding officer may, as a matter of discretion, permit 
oral argument after the briefs are filed.



                     Subpart F_Decisions and Appeals



Sec. 179.101  Interlocutory appeal from ruling of presiding officer.

    (a) Except as provided in paragraph (b) of this section and in 
Sec. Sec. 179.20(b), 179.42(f), 179.75(b), and 179.90(f), rulings of 
the presiding officer may not be appealed to the Administrator before 
the Administrator's consideration of the entire record of the hearing.
    (b) A ruling of the presiding officer is subject to interlocutory 
appeal to the Administrator if the presiding officer certifies on the 
record or by document submitted under Sec. 179.80 that immediate review 
is necessary to prevent exceptional delay, expense, or prejudice to any 
party or substantial harm to the public interest. When an order or 
ruling is not certified by the presiding officer, it shall be reviewed 
by the Administrator only upon appeal from the initial decision except 
when the Administrator determines upon the request of a party and in 
exceptional circumstances, that delaying review would be deleterious to 
vital public or private interests. Except in extraordinary 
circumstances, proceedings will not be stayed pending an interlocutory 
appeal. Where a stay is granted, a stay of more than 30 days must be 
approved by the Administrator.
    (c) Ordinarily, the interlocutory appeal will be decided on the 
basis of the submission made to the presiding officer, but the 
Administrator may allow further briefs and oral arguments. Any oral 
argument will be transcribed and the transcript will be prepared and 
certified in the same manner as provided in Sec. 179.94.



Sec. 179.105  Initial decision.

    (a) After the filing of briefs and any oral argument, the presiding 
officer shall prepare and file an initial decision on the issues of fact 
in the hearing and the objections relating to those issues.
    (b) The initial decision must be based on a fair evaluation of the 
entire record, and must contain:
    (1)(i) A conclusion that no change is warranted in the order or 
regulation to which objection was taken; or
    (ii) A conclusion that changes in the order or regulation are 
warranted, the language of the order or regulation as changed, and an 
effective date for the order or regulation as changed.
    (2) Findings of fact supported by reliable, probative and 
substantial evidence that has been found admissible by the presiding 
officer, and adequate citations to the record supporting those findings.
    (3) Conclusions on legal and policy issues, if such conclusions are 
necessary to resolve the objections.
    (4) A discussion of the reasons for the findings and conclusions, 
including a discussion of the significant contentions made by any party.
    (c) Except as otherwise provided by order of the Administrator filed 
in accordance with Sec. 179.80, after the initial decision is filed, 
the presiding officer has no further jurisdiction over the matter and 
any motions or requests filed with the hearing clerk will be decided by 
the Administrator.
    (d) The initial decision becomes the final decision of the 
Administrator by operation of law unless a party files exceptions with 
the hearing clerk under Sec. 179.107 or the Administrator files a 
notice of review under Sec. 179.110.

[55 FR 50293, Dec. 5, 1990, as amended at 70 FR 33360, June 8, 2005]



Sec. 179.107  Appeal from or review of initial decision.

    (a) A party may appeal an initial decision to the Administrator by 
filing exceptions with the hearing clerk, and serving them on the other 
parties, within the period specified in the initial decision. The period 
may not exceed 30 days, unless extended by the

[[Page 427]]

Administrator under paragraph (d) of this section.
    (b) Exceptions must specifically identify alleged errors in the 
findings of fact or conclusions of law or policy in the initial decision 
and, if errors in the findings of fact are alleged, must provide 
supporting citations to evidence of record. Oral argument before the 
Administrator may be requested in the exceptions.
    (c) Any reply to the exceptions is to be filed and served within the 
timeperiod specified in the initial decision. The timeperiod may not 
exceed 30 days after the end of the period (including any extensions) 
for filing exceptions, unless extended by the Administrator under 
paragraph (d) of this section.
    (d) The Administrator may extend the time for filing exceptions or 
replies to exceptions for good cause shown.
    (e) If the Administrator decides to hear oral argument, the parties 
will be informed of the date, time, and place; the amount of time 
allotted to each party, and the issues to be addressed.



Sec. 179.110  Determination by Administrator to review initial decision.

    Within 10 days following the expiration of the time for filing 
exceptions (including any extensions), the Administrator may file with 
the hearing clerk, and serve on the parties, a notice of the 
Administrator's determination to review the initial decision. The 
Administrator may invite the parties to file briefs or present oral 
argument on the matter. The time for filing briefs or presenting oral 
argument will be specified in that or a later notice.



Sec. 179.112  Decision by Administrator on appeal or review of initial 

decision.

    (a) On appeal from or review of the initial decision, the 
Administrator shall have the same powers as did the presiding officer in 
making the initial decision. On the Administrator's own initiative or on 
motion, the Administrator may remand the matter to the presiding officer 
for any further action necessary for a proper decision.
    (b) The scope of the issues on appeal to, or on review by the 
Administrator is the same as the scope of the issues before the 
presiding officer, unless the Administrator specifies otherwise.
    (c) After the filing of briefs and any oral argument, the 
Administrator will issue a final decision on the issues of fact in the 
hearing and the objections related to those issues. A final decision 
must contain the elements required for an initial decision by Sec. 
179.105(b).
    (d) The Administrator may adopt the initial decision as the final 
decision.
    (e) The Administrator's decision, or a summary of the decision and a 
notice of its availability, will be published in the Federal Register.



Sec. 179.115  Motion to reconsider a final order.

    A party may file a motion requesting the Administrator to reconsider 
a final decision under this part. Any such motion must be filed within 
10 days after service of the final decision, and must set forth the 
matters claimed to have been erroneously decided and the nature of the 
alleged errors. Such a motion shall not stay the effective date of the 
final decision unless specifically so ordered by the Administrator.



Sec. 179.117  Designation and powers of judicial officer.

    (a) One or more judicial officers may be designated by the 
Administrator. A judicial officer shall be an attorney who is a 
permanent or temporary employee of the Agency or of another Federal 
agency. A judicial officer may perform other duties. A judicial officer 
who performs any duty under this part may not be employed by OCSPP, by 
the Pesticides and Toxic Substances Division of the Office of General 
Counsel, or by any other person who is a representative of OCSPP in the 
hearing. A person may not be designated as a judicial officer in a 
hearing if he or she performed any prosecutorial or investigative 
functions in connection with that hearing or any other factually related 
hearing.
    (b) The Administrator may delegate to the judicial officer all or 
part of the Administrator's authority to act in a given proceeding under 
this part. Such a delegation does not prevent the judicial officer from 
referring any motion

[[Page 428]]

or case to the Administrator when appropriate.

[55 FR 50293, Dec. 5, 1990, as amended at 57 FR 28087, June 24, 1992; 77 
FR 46292, Aug. 3, 2012]



                        Subpart G_Judicial Review



Sec. 179.125  Judicial review.

    (a) The Administrator's final decision is final agency action 
reviewable in the courts as provided by FFDCA section 408(h), as of the 
date of publication of the order in the Federal Register. The failure of 
a person to file a petition for judicial review within the period ending 
on the 60th day after the date of the publication of the order 
constitutes a waiver under FFDCA section 408(h) of the right to judicial 
review of the order and of any regulation promulgated by the order.
    (b) The record for judicial review of a final decision under this 
part consists of the record described in Sec. 179.130.

[55 FR 50293, Dec. 5, 1990, as amended at 70 FR 33360, June 8, 2005]



Sec. 179.130  Administrative record.

    (a) For purposes of judicial review, the record of a hearing that 
culminates in a final decision of the Administrator under Sec. 
179.105(d) or Sec. 179.112(c) ruling on an objection shall consist of:
    (1) The objection ruled on (and any request for hearing that was 
included with the objection).
    (2) Any order issued under Sec. 180.7(g) of this chapter to which 
the objection related, and:
    (i) The regulation or petition denial that was the subject of that 
order.
    (ii) The petition to which such order responded.
    (iii) Any amendment or supplement of the petition.
    (iv) The data and information submitted in support of the petition.
    (v) The notice of filing of the petition.
    (3) Any order issued under Sec. 180.29(f) of this chapter to which 
the objection related, the regulation that was the subject of that 
order, and each related Notice of Proposed Rulemaking.
    (4) The comments submitted by members of the public in response to 
the Notice of Filing or Notice of Proposed Rulemaking, and the 
information submitted as part of the comments, the Administrator's 
response to comments and the documents or information relied on by the 
Administrator in issuing the regulation or order.
    (5) All other documents or information submitted to the docket for 
the rulemaking in question under parts 177 or part 180 of this chapter.
    (6) The Notice of Hearing published under Sec. 179.20.
    (7) All notices of participation filed under Sec. 179.42.
    (8) Any Federal Register notice issued under this part that pertains 
to the proceeding.
    (9) All submissions filed under Sec. 179.80.
    (10) Any document of which official notice was taken under Sec. 
179.95.
    (b) The record of the administrative proceeding is closed:
    (1) With respect to the taking of evidence, when specified by the 
presiding officer.
    (2) With respect to pleadings, at the time specified in Sec. 
179.98(a) for the filing of briefs.
    (c) The presiding officer may reopen the record to receive further 
evidence at any time before the filing of the initial decision.

[55 FR 50293, Dec. 5, 1990, as amended at 70 FR 33360, June 8, 2005]



PART 180_TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD--

Table of Contents



          Subpart A_Definitions and Interpretative Regulations

Sec.
180.1 Definitions and interpretations.
180.3 Tolerances for related pesticide chemicals.
180.4 Exceptions.
180.5 Zero tolerances.
180.6 Pesticide tolerances regarding milk, eggs, meat, and/or poultry; 
          statement of policy.

                    Subpart B_Procedural Regulations

180.7 Petitions proposing tolerances or exemptions for pesticide 
          residues in or on raw agricultural commodities or processed 
          foods.
180.8 Withdrawal of petitions without prejudice.

[[Page 429]]

180.9 Substantive amendments to petitions.
180.29 Establishment, modification, and revocation of tolerance on 
          initiative of Administrator.
180.30 Judicial review.
180.31 Temporary tolerances.
180.32 Procedure for modifying and revoking tolerances or exemptions 
          from tolerances.
180.33 Fees.
180.34 Tests on the amount of residue remaining.
180.35 Tests for potentiation.
180.40 Tolerances for crop groups.
180.41 Crop group tables.

                      Subpart C_Specific Tolerances

180.101 Specific tolerances; general provisions.
180.103 Captan; tolerances for residues.
180.106 Diuron; tolerances for residues.
180.108 Acephate; tolerances for residues.
180.110 Maneb; tolerances for residues.
180.111 Malathion; tolerances for residues.
180.114 Ferbam; tolerances for residues.
180.116 Ziram; tolerances for residues.
180.117 S-Ethyl dipropylthiocarbamate; tolerances for residues.
180.121 Methyl parathion; tolerances for residues.
180.123 Inorganic bromide residues resulting from fumigation with methyl 
          bromide; tolerances for residues.
180.123a Inorganic bromide residues in peanut hay and peanut hulls; 
          statement of policy.
180.124 Methyl bromide; tolerances for residues.
180.127 Piperonyl butoxide; tolerances for residues.
180.128 Pyrethrins; tolerances for residues.
180.129 o-Phenylphenol and its sodium salt; tolerances for residues.
180.130 Hydrogen Cyanide; tolerances for residues.
180.132 Thiram; tolerances for residues.
180.142 2,4-D; tolerances for residues.
180.145 Fluorine compounds; tolerances for residues.
180.151 Ethylene oxide; tolerances for residues.
180.153 Diazinon; tolerances for residues.
180.154 Azinphos-methyl; tolerances for residues.
180.155 1-Naphthaleneacetic acid; tolerances for residues.
180.163 Dicofol; tolerances for residues.
180.169 Carbaryl; tolerances for residues.
180.172 Dodine; tolerances for residues.
180.175 Maleic hydrazide; tolerances for residues.
180.176 Mancozeb; tolerances for residues.
180.178 Ethoxyquin; tolerances for residues.
180.181 Chlorpropham; tolerances for residues.
180.182 Endosulfan; tolerances for residues.
180.183 Disulfoton; tolerances for residues.
180.184 Linuron; tolerances for residues.
180.185 DCPA; tolerances for residues.
180.189 Coumaphos; tolerances for residues.
180.190 Diphenylamine; tolerances for residues.
180.191 Folpet; tolerances for residues.
180.198 Trichlorfon; tolerances for residues.
180.200 Dicloran; tolerances for residues.
180.202 p-Chlorophenoxyacetic acid; tolerances for residues.
180.204 Dimethoate; tolerances for residues.
180.205 Paraquat; tolerances for residues.
180.206 Phorate; tolerances for residues.
180.207 Trifluralin; tolerances for residues.
180.208 Benfluralin; tolerances for residues.
180.209 Terbacil; tolerances for residues.
180.210 Bromacil; tolerances for residues.
180.211 Propachlor; tolerances for residues.
180.212 S-Ethyl cyclohexylethylthiocarba mate; tolerances for residues.
180.213 Simazine; tolerances for residues.
180.215 Naled; tolerances for residues.
180.217 Metiram; tolerances for residues.
180.220 Atrazine; tolerances for residues.
180.222 Prometryn; tolerances for residues.
180.225 Phosphine; tolerances for residues.
180.226 Diquat; tolerances for residues.
180.227 Dicamba; tolerances for residues.
180.229 Fluometuron; tolerances for residues.
180.231 Dichlobenil; tolerances for residues.
180.232 Butylate; tolerances for residues.
180.235 Dichlorvos; tolerances for residues.
180.236 Triphenyltin hydroxide; tolerances for residues.
180.241 Bensulide; tolerances for residues.
180.242 Thiabendazole; tolerances for residues.
180.243 Propazine; tolerances for residues.
180.245 Streptomycin; tolerances for residues.
180.249 Alachlor; tolerances for residues.
180.252 Tetrachlorvinphos; tolerances for residues.
180.253 Methomyl; tolerances for residues.
180.254 Carbofuran; tolerances for residues.
180.257 Chloroneb; tolerances for residues.
180.258 Ametryn; tolerances for residues.
180.259 Propargite; tolerances for residues.
180.261 Phosmet; tolerances for residues.
180.262 Ethoprop; tolerances for residues.
180.263 Phosalone; tolerances for residues.
180.269 Aldicarb; tolerances for residues.
180.272 Tribuphos; tolerances for residues.
180.274 Propanil; tolerances for residues.
180.275 Chlorothalonil; tolerances for residues.
180.276 Formetanate hydrochloride; tolerances for residues.
180.278 Phenmedipham; tolerances for residues.
180.284 Zinc phosphide; tolerances for residues.
180.287 Amitraz; tolerances for residues.
180.288 2-(Thiocyanomethylthio) benzothiazole; tolerances for residues.

[[Page 430]]

180.289 Methanearsonic acid; tolerances for residues.
180.291 Pentachloronitrobenzene; tolerance for residues.
180.292 Picloram; tolerances for residues.
180.293 Endothall; tolerances for residues.
180.297 N-1-Naphthyl phthalamic acid; tolerances for residues.
180.298 Methidathion; tolerances for residues.
180.299 Dicrotophos; tolerances for residues.
180.300 Ethephon; tolerances for residues.
180.301 Carboxin; tolerances for residues.
180.303 Oxamyl; tolerances for residues.
180.304 Oryzalin; tolerances for residues.
180.311 Cacodylic acid; tolerances for residues.
180.314 Triallate; tolerances for residues.
180.315 Methamidophos; tolerances for residues.
180.316 Pyrazon; tolerances for residues.
180.317 Propyzamide; tolerances for residues.
180.318 4-(2-Methyl-4-chlorophenoxy) butyric acid; tolerance for 
          residues.
180.319 Interim tolerances.
180.324 Bromoxynil; tolerances for residues.
180.328 Napropamide; tolerances for residues.
180.330 S-(2-(Ethylsulfinyl)ethyl) O,O-dimethyl phosphorothioate; 
          tolerances for residues.
180.331 4-(2,4-Dichlorophenoxy) butyric acid; tolerances for residues.
180.332 Metribuzin; tolerances for residues.
180.337 Oxytetracycline; tolerances for residues.
180.339 MCPA; tolerances for residues.
180.341 2,4-Dinitro-6-octylphenyl crotonate and 2,6-dinitro-4-
          octylphenyl crotonate; tolerances for residues.
180.342 Chlorpyrifos; tolerances for residues.
180.345 Ethofumesate; tolerances for residues.
180.349 Fenamiphos; tolerances for residues.
180.350 Nitrapyrin; tolerances for residues.
180.352 Terbufos; tolerances for residues.
180.353 Desmedipham; tolerances for residues.
180.355 Bentazon; tolerances for residues.
180.356 Norflurazon; tolerances for residues.
180.360 Asulam; tolerance for residues.
180.361 Pendimethalin; tolerances for residues.
180.362 Fenbutatin-oxide; tolerances for residues.
180.364 Glyphosate; tolerances for residues.
180.367 n-Octyl bicycloheptenedicarbox imide; tolerances for residues.
180.368 Metolachlor; tolerances for residues.
180.370 5-Ethoxy-3-(trichloromethyl)-1, 2, 4-thiadiazole; tolerances for 
          residues.
180.371 Thiophanate-methyl; tolerances for residues.
180.372 2,6-Dimethyl-4-tridecylmorpholine; tolerances for residues.
180.373 [Reserved]
180.377 Diflubenzuron; tolerances for residues.
180.378 Permethrin; tolerances for residues.
180.380 Vinclozolin; tolerances for residues.
180.381 Oxyfluorfen; tolerances for residues.
180.383 Sodium salt of acifluorfen; tolerances for residues.
180.384 Mepiquat (N,N-dimethylpiperidin ium); tolerances for residues.
180.385 Diclofop-methyl; tolerances for residues.
180.388-180.389 [Reserved]
180.390 Tebuthiuron; tolerances for residues.
180.395 Hydramethylnon; tolerances for residues.
180.396 Hexazinone; tolerances for residues.
180.399 Iprodione; tolerances for residues.
180.401 Thiobencarb; tolerances for residues.
180.403 Thidiazuron; tolerances for residues.
180.404 Profenofos; tolerances for residues.
180.405 Chlorsulfuron; tolerances for residues.
180.407 Thiodicarb; tolerances for residues.
180.408 Metalaxyl; tolerances for residues.
180.409 Pirimiphos-methyl; tolerances for residues.
180.410 Triadimefon; tolerances for residues.
180.411 Fluazifop-P-butyl; tolerances for residues.
180.412 Sethoxydim; tolerances for residues.
180.413 Imazalil; tolerances for residues.
180.414 Cyromazine; tolerances for residues.
180.415 Aluminum tris (O-ethylphospho nate); tolerances for residues.
180.416 Ethalfluralin; tolerances for residues.
180.417 Triclopyr; tolerances for residues.
180.418 Cypermethrin and an isomer zeta-cypermethrin; tolerances for 
          residues.
180.419 Chlorpyrifos-methyl; tolerances for residues.
180.420 Fluridone; tolerances for residues.
180.421 Fenarimol; tolerances for residues.
180.422 Tralomethrin; tolerances for residues.
180.425 Clomazone; tolerances for residues.
180.426 2-[4,5-Dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-
          yl]-3-quinoline carboxylic acid; tolerance for residues.
180.427 Tau-Fluvalinate; tolerances for residues.
180.428 Metsulfuron methyl; tolerances for residues.
180.429 Chlorimuron ethyl; tolerances for residues.
180.430 Fenoxaprop-ethyl; tolerances for residues.
180.431 Clopyralid; tolerances for residues.
180.432 Lactofen; tolerances for residues.
180.433 Fomesafen; tolerances for residues.
180.434 Propiconazole; tolerances for residues.
180.435 Deltamethrin; tolerances for residues.
180.436 Cyfluthrin and the isomer beta-cyfluthrin; tolerances for 
          residues.

[[Page 431]]

180.437 Methyl 2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-p-
          toluate and methyl 6-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-
          2-yl)-m-toluate; tolerances for residues.
180.438 Lambda-cyhalothrin and an isomer gamma-cyhalothrin; tolerances 
          for residues.
180.439 Thifensulfuron methyl; tolerances for residues.
180.440 Tefluthrin; tolerances for residues.
180.441 Quizalofop ethyl; tolerances for residues.
180.442 Bifenthrin; tolerances for residues.
180.443 Myclobutanil; tolerances for residues.
180.444 Sulfur dioxide; tolerances for residues.
180.445 Bensulfuron methyl; tolerances for residues.
180.446 Clofentezine; tolerances for residues.
180.447 Imazethapyr; tolerances for residues.
180.448 Hexythiazox; tolerance for residues.
180.449 Avermectin B1 and its delta-8,9-isomer; tolerances 
          for residues.
180.450 Beta-(4-Chlorophenoxy)-alpha-(1,1-dimethylethyl)-1H-1,2,4-
          triazole-1-ethanol; tolerances for residues.
180.451 Tribenuron methyl; tolerances for residues.
180.452 Primisulfuron-methyl; tolerances for residues.
180.454 Nicosulfuron; tolerances for residues.
180.455 Procymidone; tolerances for residues.
180.457 Bitertanol; tolerances for residues.
180.458 Clethodim; tolerances for residues.
180.459 Triasulfuron; tolerances for residues.
180.460 Benoxacor; tolerances for residues.
180.461 Cadusafos; tolerances for residues.
180.462 Pyridate; tolerances for residues.
180.463 Quinclorac; tolerances for residues.
180.464 Dimethenamid; tolerances for residues.
180.465 4-(Dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane.
180.466 Fenpropathrin; tolerances for residues.
180.467 Carbon disulfide; tolerances for residues.
180.468 Flumetsulam; tolerances for residues.
180.469 Dichlormid; tolerances for residues.
180.470 Acetochlor; tolerances for residues.
180.471 Furilazole; tolerances for residues.
180.472 Imidacloprid; tolerances for residues.
180.473 Glufosinate ammonium; tolerances for residues.
180.474 Tebuconazole; tolerances for residues.
180.475 Difenoconazole; tolerances for residues.
180.476 Triflumizole; tolerances for residues.
180.477 Flumiclorac pentyl; tolerances for residues.
180.478 Rimsulfuron; tolerances for residues.
180.479 Halosulfuron-methyl; tolerances for residues.
180.480 Fenbuconazole; tolerances for residues.
180.481 Prosulfuron; tolerances for residues.
180.482 Tebufenozide; tolerances for residues.
180.484 Flutolanil; tolerances for residues.
180.485 Cyproconazole; tolerances for residues.
180.486 Chlorethoxyfos; tolerances for residues.
180.487 Pyrithiobac sodium; tolerances for residues.
180.490 Imazapic-ammonium; tolerances for residues.
180.491 Propylene oxide; tolerances for residues.
180.492 Triflusulfuron-methyl; tolerances for residues.
180.493 Dimethomorph; tolerances for residues.
180.494 Pyridaben; tolerance for residues.
180.495 Spinosad; tolerances for residues.
180.496 Thiazopyr; tolerances for residues.
180.497 Clofencet; tolerances for residues.
180.498 Sulfentrazone; tolerances for residues.
180.499 Propamocarb; tolerances for residues.
180.500 Imazapyr; tolerances for residues.
180.501 Hydroprene; tolerances for residues.
180.502 Aminoethoxyvinylglycine hydrochloride (aviglycine HCl); 
          tolerances for residues.
180.503 Cymoxanil, tolerance for residues.
180.504 [Reserved]
180.505 Emamectin; tolerances for residues.
180.506 Cyclanilide; tolerances for residues.
180.507 Azoxystrobin; tolerances for residues.
180.509 Mefenpyr-diethyl; tolerance for residues.
180.510 Pyriproxyfen; tolerances for residues.
180.511 Buprofezin; tolerances for residues.
180.512 [Reserved]
180.513 Chlorfenapyr; tolerances for residues.
180.514 Cloransulam-methyl; tolerances for residues.
180.515 Carfentrazone-ethyl; tolerances for residues.
180.516 Fludioxonil; tolerances for residues.
180.517 Fipronil; tolerances for residues.
180.518 Pyrimethanil; tolerances for residues.
180.519 Bromide ion and residual bromine; tolerances for residues.
180.521 Fumigants for grain-mill machinery; tolerances for residues.
180.522 Fumigants for processed grains used in production of fermented 
          malt beverage; tolerances for residues.
180.523 Metaldehyde; tolerances for residues.

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180.525 Resmethrin; tolerances for residues.
180.526 Synthetic isoparaffinic petroleum hydrocarbons; tolerances for 
          residues.
180.527 Flufenacet, N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-
          (trifluoromethyl)-1, 3, 4-thiadiazol-2-yl] oxy]acetamide and 
          its metabolites containing the 4-fluoro-N-methylethyl 
          benzenamine tolerances for residues.
180.530 2,2-Dimethyl-1,3-benzodioxol-4-ol methylcarbamate; tolerances 
          for residues.
180.532 Cyprodinil; tolerances for residues.
180.533 Esfenvalerate; tolerances for residues.
180.535 Fluroxypyr 1-methylheptyl ester; tolerances for residues.
180.537 Isoxaflutole; tolerances for residues.
180.539 d-Limonene; tolerances for residues.
180.540 Fenitrothion; tolerances for residues.
180.541 Propetamphos; tolerances for residues.
180.543 Diclosulam; tolerances for residues.
180.544 Methoxyfenozide; tolerances for residues.
180.545 Prallethrin (RS)-2-methyl-4-oxo-3-(2-propynyl)cyclopent-2-enyl 
          (1RS)-cis, trans -chrysanthemate; tolerances for residues.
180.546 Mefenoxam; tolerances for residues.
180.547 Prohexadione calcium; tolerances for residues.
180.548 Tralkoxydim; tolerances for residues.
180.549 Diflufenzopyr; tolerances for residues.
180.551 Fluthiacet-methyl; tolerances for residues.
180.552 Sulfosulfuron; tolerances for residues.
180.553 Fenhexamid; tolerances for residues.
180.554 Kresoxim-methyl; tolerances for residues.
180.555 Trifloxystrobin; tolerances for residues.
180.556 Pymetrozine; tolerances for residues.
180.557 Tetraconazole; tolerances for residues.
180.559 Clodinafop-propargyl; tolerances for residues.
180.560 Cloquintocet-mexyl; tolerances for residues.
180.561 Acibenzolar-S-methyl; tolerances for residues.
180.562 Flucarbazone-sodium; tolerances for residues.
180.563 Ethametsulfuron-methyl; tolerances for residues.
180.564 Indoxacarb; tolerances for residues.
180.565 Thiamethoxam; tolerances for residues.
180.566 Fenpyroximate; tolerances for residues.
180.567 Zoxamide; tolerances for residues.
180.568 Flumioxazin; tolerances for residues.
180.569 Forchlorfenuron; tolerances for residues.
180.570 Isoxadifen-ethyl; tolerances for residues.
180.571 Mesotrione; tolerances for residues.
180.572 Bifenazate; tolerance for residues.
180.573 Tepraloxydim; tolerances for residues.
180.574 Fluazinam; tolerances for residues.
180.575 Sulfuryl fluoride; tolerances for residues.
180.576 Cyhalofop-butyl; tolerances for residues.
180.577 Bispyribac-sodium; tolerances for residues.
180.578 Acetamiprid; tolerances for residues.
180.579 Fenamidone; tolerances for residues.
180.580 Iodosulfuron-Methyl-Sodium; tolerances for residues.
180.581 Iprovalicarb; tolerances for residues.
180.582 Pyraclostrobin; tolerances for residues.
180.583 Triticonazole; tolerances for residues.
180.584 Tolylfluanid; tolerances for residues.
180.585 Pyraflufen-ethyl; tolerances for residues.
180.586 Clothianidin; tolerances for residues.
180.587 Famoxadone; tolerance for residues.
180.588 Quinoxyfen; tolerances for residues.
180.589 Boscalid; tolerances for residues.
180.590 2, 6-Diisopropylnaphthalene (2, 6-DIPN); tolerances for 
          residues.
180.591 Trifloxysulfuron; tolerances for residues.
180.592 Butafenacil; tolerances for residues.
180.593 Etoxazole; tolerances for residues.
180.594 Thiacloprid; tolerances for residues.
180.595 Flufenpyr-ethyl; tolerances for residues.
180.596 Fosthiazate; tolerances for residues.
180.597 Mesosulfuron-methyl; tolerances for residues.
180.598 Novaluron; tolerances for residues.
180.599 Acequinocyl; tolerances for residues.
180.600 Propoxycarbazone; tolerances for residues
180.601 Cyazofamid; tolerances for residues.
180.602 Spiroxamine; tolerances for residues.
180.603 Dinotefuran; tolerances for residues.
180.604 Mepanipyrim; tolerances for residues.
180.605 Penoxsulam; tolerances for residues.
180.607 Spiromesifen; tolerances for residues.
180.608 Spirodiclofen; tolerances for residues.
180.609 Fluoxastrobin; tolerances for residues.
180.610 Aminopyralid; tolerances for residues.
180.611 Pinoxaden; tolerances for residues.
180.612 Topramezone; tolerances for residues.
180.613 Flonicamid; tolerances for residues.
180.614 Kasugamycin; tolerances for residues.

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180.615 Amicarbazone; tolerances for residues.
180.616 Fenpropimorph; tolerances for residues.
180.617 Metconazole; tolerances for residues.
180.618 Benthiavalicarb-isopropyl; tolerance for residues.
180.619 Epoxiconazole; tolerances for residues.
180.620 Etofenprox; tolerances for residues.
180.621 Dithianon; tolerances for residues.
180.622 Ethaboxam; tolerances for residues.
180.623 Flufenoxuron; tolerances for residues.
180.624 Metrafenone; tolerances for residues.
180.625 Orthosulfamuron; tolerances for residues.
180.626 Prothioconazole; tolerances for residues.
180.627 Fluopicolide; tolerances for residues.
180.628 Chlorantraniliprole; tolerances for residues.
180.629 Flutriafol; tolerances for residues.
180.630 Flusilazole; tolerances for residues.
180.631 Pyrasulfotole; tolerances for residues.
180.632 Fenazaquin; import tolerances for residues.
180.633 Florasulam; tolerances for residues.
180.634 Tembotrione; tolerances for residues.
180.635 Spinetoram; tolerances for residues.
180.636 1,3-dichloropropene; tolerances for residues.
180.637 Mandipropamid; tolerances for residues.
180.638 Pyroxsulam; tolerances for residues.
180.639 Flubendiamide; tolerances for residues.
180.640 Pyridalyl; tolerances for residues.
180.641 Spirotetramat; tolerances for residues.
180.642 Gentamicin; tolerances for residues.
180.643 Uniconazole; tolerances for residues.
180.644 Cyprosulfamide; tolerances for residues.
180.645 Thiencarbazone-methyl; tolerances for residues.
180.646 Ipconazole; tolerances for residues.
180.647 d-Phenothrin; tolerances for residues.
180.648 Meptyldinocap; tolerances for residues.
180.649 Saflufenacil; tolerances for residues.
180.650 Isoxaben; tolerances for residues.
180.651 Imazosulfuron; tolerances for residues.
180.652 Ethiprole; tolerances for residues.
180.653 Indaziflam; tolerances for residues.
180.654 Isopyrazam; tolerances for residues.
180.655 Flazasulfuron; tolerances for residues.
180.656 Amisulbrom; tolerances for residues.
180.657 Metaflumizone; tolerances for residues.
180.658 Penthiopyrad; tolerances for residues.
180.659 Pyroxasulfone; tolerances for residues.
180.660 Pyriofenone; tolerances for residues.
180.661 Fluopyram; tolerances for residues.
180.662 Trinexapac-ethyl; tolerances for residues.
180.663 Ametoctradin; tolerances for residues.
180.664 Penflufen; tolerances for residues.
180.665 Sedaxane; tolerances for residues.
180.666 Fluxapyroxad; tolerances for residues.
180.667 Cyflufenamid, tolerance for residues.
180.668 Sulfoxaflor; tolerances for residues.
180.669 Picoxystrobin; tolerances for residues.
180.671 Fenpyrazamine; tolerances for residues.
180.673 Triforine; tolerances for residues.

                  Subpart D_Exemptions From Tolerances

180.900 Exemptions from the requirement of a tolerance.
180.905 Pesticide chemicals; exemptions from the requirement of a 
          tolerance.
180.910 Inert ingredients used pre- and post-harvest; exemptions from 
          the requirement of a tolerance.
180.920 Inert ingredients used pre-harvest; exemptions from the 
          requirement of a tolerance.
180.930 Inert ingredients applied to animals; exemptions from the 
          requirement of a tolerance.
180.940 Tolerance exemptions for active and inert ingredients for use in 
          antimicrobial formulations (Food-contact surface sanitizing 
          solutions).
180.950 Tolerance exemptions for minimal risk active and inert 
          ingredients.
180.960 Polymers; exemptions from the requirement of a tolerance.
180.1011 Viable spores of the microorganism Bacillus thuringiensis 
          Berliner; exemption from the requirement of a tolerance.
180.1016 Ethylene; exemption from the requirement of a tolerance.
180.1017 Diatomaceous earth; exemption from the requirement of a 
          tolerance.
180.1019 Sulfuric acid; exemption from the requirement of a tolerance.
180.1020 Sodium chlorate; exemption from the requirement of a tolerance.
180.1021 Copper; exemption from the requirement of a tolerance.
180.1022 Iodine-detergent complex; exemption from the requirement of a 
          tolerance.
180.1023 Propanoic acid; exemptions from the requirement of a tolerance.
180.1025 Xylene; exemption from the requirement of a tolerance.
180.1027 Nuclear polyhedrosis virus of Heliothis zea; exemption from the 
          requirement of a tolerance.
180.1033 Methoprene; exemption from the requirement of a tolerance.

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180.1037 Polybutenes; exemption from the requirement of a tolerance.
180.1040 Ethylene glycol; exemption from the requirement of a tolerance.
180.1041 Nosema locustae; exemption from the requirement of a tolerance.
180.1043 Gossyplure; exemption from the requirement of a tolerance.
180.1049 Carbon dioxide; exemption from the requirement of a tolerance.
180.1050 Nitrogen; exemption from the requirements of a tolerance.
180.1052 2,2,5-trimethyl-3-dichloroacetyl-1,3-oxazolidine; exemption 
          from the requirement of a tolerance.
180.1054 Calcium hypochlorite; exemptions from the requirement of a 
          tolerance.
180.1056 Boiled linseed oil; exemption from requirement of tolerance.
180.1057 Phytophthora palmivora; exemption from requirement of 
          tolerance.
180.1058 Sodium diacetate; exemption from the requirement of a 
          tolerance.
180.1064 Tomato pinworm insect pheromone; exemption from the requirement 
          of a tolerance.
180.1065 2-Amino-4,5-dihydro-6-methyl-4-propyl-s-triazolo(1,5-
          alpha)pyrimidin-5-one; exemption from the requirement of a 
          tolerance.
180.1067 Methyl eugenol and malathion combination; exemption from the 
          requirement of a tolerance.
180.1068 C12-C18 fatty acid potassium salts; 
          exemption from the requirement of a tolerance.
180.1069 (Z)-11-Hexadecenal; exemption from the requirement of a 
          tolerance.
180.1070 Sodium chlorite; exemption from the requirement of a tolerance.
180.1071 Peanuts, Tree Nuts, Milk, Soybeans, Eggs, Fish, Crustacea, and 
          Wheat; exemption from the requirement of a tolerance.
180.1072 Poly-D-glucosamine (chitosan); exemption from the requirement 
          of a tolerance.
180.1073 Isomate-M; exemption from the requirement of a tolerance.
180.1074 F.D.&C. Blue No. 1; exemption from the requirement of a 
          tolerance.
180.1075 Colletotrichum gloeosporioides f. sp. aeschynomene; exemption 
          from the requirement of a tolerance.
180.1076 Viable spores of the microorganism Bacillus popilliae; 
          exemption from the requirement of a tolerance.
180.1080 Plant volatiles and pheromone; exemptions from the requirement 
          of a tolerance.
180.1083 Dimethyl sulfoxide; exemption from the requirement of a 
          tolerance.
180.1084 Monocarbamide dihydrogen sulfate; exemption from the 
          requirement of a tolerance.
180.1086 3,7,11-Trimethyl-1,6,10-dodeca triene-1-ol and 3,7,11-
          trimethyl-2,6,10-dodecatriene-3-ol; exemption from the 
          requirement of a tolerance.
180.1087 Sesame stalks; exemption from the requirement of a tolerance.
180.1089 Poly-N-acetyl-D-glucosamine; exemption from the requirement of 
          a tolerance.
180.1090 Lactic acid; exemption from the requirement of a tolerance.
180.1091 Aluminum isopropoxide and aluminum secondary butoxide; 
          exemption from the requirement of a tolerance.
180.1092 Menthol; exemption from the requirement of a tolerance.
180.1095 Chlorine gas; exemptions from the requirement of a tolerance.
180.1097 GBM-ROPE; exemption from the requirement of a tolerance.
180.1098 Gibberellins [Gibberellic Acids (GA3 and GA4 + GA7), and Sodium 
          or Potassium Gibberellate]; exemption from the requirement of 
          a tolerance.
180.1100 Gliocladium virens isolate GL-21; exemption from the 
          requirement of a tolerance.
180.1101 Parasitic (parasitoid) and predatory insects; exemption from 
          the requirement of a tolerance.
180.1102 Trichoderma harzianum KRL-AG2 (ATCC 20847) strain T-
          22; exemption from requirement of a tolerance.
180.1103 Isomate-C; exemption from the requirement of a tolerance.
180.1107 Delta endotoxin of Bacillus thuringiensis variety kurstaki 
          encapsulated into killed Pseudomonas fluorescens; exemption 
          from the requirement of a tolerance.
180.1108 Delta endotoxin of Bacillus thuringiensis variety San Diego 
          encapsulated into killed Pseudomonas fluorescens; exemption 
          from the requirement of a tolerance.
180.1110 3-Carbamyl-2,4,5-trichlorobenzoic acid; exemption from the 
          requirement of a tolerance.
180.1111 Bacillus subtilis GB03; exemption from the requirement of a 
          tolerance.
180.1113 Lagenidium giganteum; exemption from the requirement of a 
          tolerance.
180.1114 Pseudomonas fluorescens A506, Pseudomonas fluorescens 1629RS, 
          and Pseudomonas syringae 742RS; exemptions from the 
          requirement of a tolerance.
180.1118 Spodoptera exigua nuclear poly hedrosis virus; exemption from 
          the requirement of a tolerance.
180.1119 Azadirachtin; exemption from the requirement of a tolerance.
180.1120 Streptomyces sp. strain K61; exemption from the requirement of 
          a tolerance.
180.1121 Boric acid and its salts, borax (sodium borate decahydrate), 
          disodium octaborate tetrahydrate, boric oxide (boric 
          anhydride), sodium borate and sodium metaborate; exemptions 
          from the requirement of a tolerance.

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180.1122 Inert ingredients of semiochemical dispensers; exemptions from 
          the requirement of a tolerance.
180.1124 Arthropod pheromones; exemption from the requirement of a 
          tolerance.
180.1126 Codlure, (E,E)-8,10-Dodecadien-1-ol; exemption from the 
          requirement of a tolerance.
180.1127 Biochemical pesticide plant floral volatile attractant 
          compounds: cinna maldehyde, cinnamyl alcohol, 4-methoxy 
          cinnamaldehyde, 3-phenyl propanol, 4-methoxy phenethyl 
          alcohol, indole, and 1,2,4-trimethoxybenzene; exemptions from 
          the requirement of a tolerance.
180.1128 Bacillus subtilis MBI 600; exemption from the requirement of a 
          tolerance.
180.1130 N-(n-octyl)-2-pyrrolidone and N-(n-dodecyl)-2-pyrrolidone; 
          exemptions from the requirement of a tolerance.
180.1131 Ampelomyces quisqualis isolate M10; exemption from the 
          requirement of a tolerance.
180.1135 Pasteuria penetrans; exemption from the requirement of a 
          tolerance.
180.1139 Sodium 5-nitroguaiacolate; exemption from the requirement of a 
          tolerance.
180.1140 Sodium o-nitrophenolate; exemption from the requirement of a 
          tolerance.
180.1141 Sodium p-nitrophenolate; exemption from the requirement of a 
          tolerance.
180.1142 1,4-Dimethylnaphthalene; exemption from the requirement of a 
          tolerance.
180.1143 Methyl anthranilate; exemption from the requirement of a 
          tolerance.
180.1144 Candida oleophila isolate I-182; exemption from the requirement 
          of a tolerance.
180.1145 Pseudomonas syringae; exemption from the requirement of a 
          tolerance.
180.1146 Beauveria bassiana Strain GHA; exemption from the requirement 
          of a tolerance.
180.1148 Occlusion Bodies of the Granulosis Virus of Cydia pomenella; 
          tolerance exemption.
180.1149 Inclusion bodies of the multi-nuclear polyhedrosis virus of 
          Anagrapha falcifera; exemption from the requirement of a 
          tolerance.
180.1150 6-Benzyladenine; exemption from the requirement of a tolerance.
180.1153 Lepidopteran pheromones; exemption from the requirement of a 
          tolerance.
180.1154 CryIA(c) and CryIC derived delta-endotoxins of Bacillus 
          thuringiensis var. kurstaki encapsulated in killed Pseudomonas 
          fluorescens, and the expression plasmid and cloning vector 
          genetic constructs.
180.1156 Cinnamaldehyde; exemption from the requirement of a tolerance.
180.1157 Cytokinins; exemption from the requirement of a tolerance.
180.1158 Auxins; exemption from the requirement of a tolerance.
180.1159 Pelargonic acid; exemption from the requirement of tolerances.
180.1160 Jojoba oil; exemption from the requirement of a tolerance.
180.1161 Clarified hydrophobic extract of neem oil; exemption from the 
          requirement of a tolerance.
180.1162 Acrylate polymers and copolymers; exemption from the 
          requirement of a tolerance.
180.1163 Killed Myrothecium verrucaria; exemption from the requirement 
          of a tolerance.
180.1165 Capsaicin; exemption from the requirement of a tolerance.
180.1167 Allyl isothiocyanate as a component of food grade oil of 
          mustard; exemption from the requirement of a tolerance.
180.1176 Sodium bicarbonate; exemption from the requirement of a 
          tolerance.
180.1177 Potassium bicarbonate; exemption from the requirement of a 
          tolerance.
180.1178 Formic acid; exemption from the requirement of a tolerance.
180.1179 Plant extract derived from Opuntia lindheimeri, Quercus 
          falcata, Rhus aromatica, and Rhizophoria mangle; exemption 
          from the requirement of a tolerance.
180.1180 Kaolin; exemption from the requirement of a tolerance.
180.1181 Bacillus cereus strain BPO1; exemption from the requirement of 
          a tolerance.
180.1187 L-glutamic acid; exemption from the requirement of a tolerance.
180.1188 Gamma aminobutyric acid; exemption from the requirement of a 
          tolerance.
180.1189 Methyl salicylate; exemption from the requirement of a 
          tolerance.
180.1191 Ferric phosphate; exemption from the requirement of a 
          tolerance.
180.1193 Potassium dihydrogen phosphate; exemption from the requirement 
          of a tolerance.
180.1195 Titanium dioxide.
180.1196 Peroxyacetic acid; exemption from the requirement of a 
          tolerance.
180.1197 Hydrogen peroxide; exemption from the requirement of a 
          tolerance.
180.1198 Gliocladium catenulatum strain J1446; exemption from the 
          requirement of a tolerance.
180.1199 Lysophosphatidylethanolamine (LPE); exemption from the 
          requirement of a tolerance.
180.1200 Pseudomonas fluorescens strain PRA-25; temporary exemption from 
          the requirement of a tolerance.
180.1201 Trichoderma harzianum strain T-39; exemption from the 
          requirement of a tolerance.
180.1202 Bacillus sphaericus; exemption from the requirement of a 
          tolerance.
180.1204 Harpin protein; exemption from the requirement of a tolerance.

[[Page 436]]

180.1205 Beauveria bassiana ATCC 74040; exemption from the 
          requirements of a tolerance.
180.1206 Aspergillus flavus AF36; exemption from the requirement of a 
          tolerance.
180.1207 N-acyl sarcosines and sodium N-acyl sarcosinates; exemption 
          from the requirement of a tolerance.
180.1209 Bacillus subtilis strain QST 713 and strain QST 713 variant 
          soil; exemption from the requirement of a tolerance.
180.1210 Phosphorous acid; exemption from the requirement of a 
          tolerance.
180.1212 Pseudomonas chlororaphis Strain 63-28; exemption from the 
          requirement of a tolerance.
180.1213 Coniothyrium minitans strain CON/M/91-08; exemption from the 
          requirement of a tolerance.
180.1218 Indian Meal Moth Granulosis Virus; exemption from the 
          requirement of a tolerance.
180.1219 Foramsulfuron; exemption from the requirement of a tolerance.
180.1220 1-Methylcyclopropene; exemption from the requirement of a 
          tolerance.
180.1221 Pseudozyma flocculosa strain PF-A22 UL; exemption from the 
          requirement of a tolerance.
180.1222 Sucrose octanoate esters; exemption from the requirement of a 
          tolerance.
180.1223 Imazamox; exemption from the requirement of a tolerance.
180.1224 Bacillus pumilus GB34; exemption from the requirement of a 
          tolerance.
180.1225 Decanoic acid; exemption from the requirement of a tolerance.
180.1226 Bacillus pumilus strain QST2808; temporary exemption from the 
          requirement of a tolerance.
180.1228 Diallyl sulfides; exemption from the requirement of a 
          tolerance.
180.1230 Ferrous sulfate; exemption from the requirement of a tolerance.
180.1231 Lime; exemption from the requirement of a tolerance.
180.1232 Lime-sulfur; exemption from the requirement of a tolerance.
180.1233 Potassium sorbate; exemption from the requirement of a 
          tolerance.
180.1234 Sodium carbonate; exemption from the requirement of a 
          tolerance.
180.1235 Sodium hypochlorite; exemption from the requirement of a 
          tolerance.
180.1236 Sulfur; exemption from the requirement of a tolerance.
180.1237 Sodium metasilicate; exemption from the requirement of a 
          tolerance.
180.1240 Thymol; exemption from the requirement of a tolerance.
180.1241 Eucalyptus oil; exemption from the requirement of a tolerance.
180.1243 Bacillus subtilis var. amylolique faciens strain FZB24; 
          exemption from the requirement of a tolerance.
180.1244 Ammonium bicarbonate; exemption from the requirement of a 
          tolerance.
180.1245 Rhamnolipid biosurfactant; exemption from the requirement of a 
          tolerance.
180.1246 Yeast Extract Hydrolysate from Saccharomyces cerevisiae: 
          exemption from the requirement of a tolerance.
180.1248 Exemption of citronellol from the requirement of a tolerance.
180.1250 C8, C10, and C12 fatty acid mono esters of glycerol and 
          propylene glycol; exemption from the requirement of a 
          tolerance.
180.1251 Geraniol; exemption from the requirement of a tolerance.
180.1253 Streptomyces lydicus WYEC 108; exemption from the requirement 
          of a tolerance.
180.1254 Aspergillus flavus NRRL 21882; exemption from the requirement 
          of a tolerance.
180.1255 Bacillus pumilus strain QST 2808; exemption from the 
          requirement of a tolerance.
180.1256 Alternaria destruens strain 059; exemption from the requirement 
          of a tolerance.
180.1257 Paecilomyces lilacinus strain 251; exemption from the 
          requirement of a tolerance.
180.1258 Acetic acid; exemption from the requirement of a tolerance.
180.1259 Reynoutria sachalinensis extract; exemption from the 
          requirement of a tolerance.
180.1260 Muscodor albus QST 20799 and the volatiles produced on 
          rehydration; exemption from the requirement of a tolerance.
180.1261 Xanthomonas campestris pv. vesicatoria and Pseudomonas syringae 
          pv. tomato specific Bacteriophages.
180.1262 Sorbitol octanoate; exemption from the requirement of a 
          tolerance.
180.1263 Tetrahydrofurfuryl alcohol; exemption from the requirement of a 
          tolerance.
180.1267 Pantoea agglomerans strain C9-1; exemption from the requirement 
          of a tolerance.
180.1268 Potassium silicate; exemption from the requirement of a 
          tolerance.
180.1269 Bacillus mycoides isolate J; exemption from the requirement of 
          a tolerance.
180.1270 Isophorone; exemption from the requirement of a tolerance.
180.1271 Eucalyptus oil; exemption from the requirement of a tolerance.
180.1272 Pantoea agglomerans strain E325; exemption from the requirement 
          of a tolerance.
180.1273 Beauveria bassiana HF23; exemption from the requirement of a 
          tolerance.
180.1274 Tris (2-ethylhexyl) phosphate; exemption from the requirement 
          of a tolerance.
180.1275 Pythium; exception from the requirement of a tolerance.

[[Page 437]]

180.1276 Tobacco mild green mosaic tobamovirus (TMGMV); temporary 
          exemption from the requirement of a tolerance.
180.1277 Dibasic esters; exemption from the requirement of a tolerance.
180.1278 Quillaja saponaria extract (saponins); exemption from the 
          requirement of a tolerance.
180.1279 Zucchini yellow mosaic virus--weak strain; exemption from the 
          requirement of a tolerance.
180.1280 Poly(hexamethylenebiguanide) hydrochloride (PHMB); exemption 
          from the requirement of a tolerance.
180.1281 S-Abscisic Acid, (S)-5-(1-hydroxy-2,6,6-trimethyl-4-oxo-1-
          cyclohex-2-enyl)-3-methyl-penta-(2Z,4E)-dienoic Acid; 
          exemption from the requirement of a tolerance.
180.1282 Bacillus firmus I-1582; exemption from the requirement of a 
          tolerance.
180.1283 (Z)-7,8-epoxy-2-methyloctadecane (Disparlure); exemption from 
          the requirement of a tolerance.
180.1284 Ammonium salts of higher fatty acids (C8-
          C18 saturated; C8-C12 
          unsaturated); exemption from the requirement of a tolerance.
180.1285 Polyoxin D zinc salt; exemption from the requirement of a 
          tolerance.
180.1287 Extract of Chenopodium ambrosioides near ambrosioides; 
          exemption from the requirement of a tolerance.
180.1288 Tristyrylphenol ethoxylates; exemption from the requirement of 
          a tolerance.
180.1289 Candida oleophila Strain O; exemption from the requirement of a 
          tolerance.
180.1290 Pasteuria usgae; exemption from the requirement of a tolerance.
180.1291 Cold pressed neem oil; exemption from the requirement of a 
          tolerance.
180.1292 Ulocladium oudemansii (U3 Strain); exemption from the 
          requirement of a tolerance.
180.1293 Trichoderma gamsii strain ICC 080; exemption from the 
          requirement of a tolerance.
180.1294 Trichoderma asperellum strain ICC 012; exemption from the 
          requirement of a tolerance.
180.1295 Laminarin; exemption from the requirement of a tolerance.
180.1296 Terpene Constituents [alpha]-terpinene, d-limonene and p-
          cymene, of the Extract of Chenopodium ambrosioides near 
          ambrosioides as Synthetically Manufactured; exemption from the 
          requirement of a tolerance.
180.1297 Homobrassinolide; exemption from the requirement of a 
          tolerance.
180.1298 Trichoderma hamatum isolate 382; exemption from the requirement 
          of a tolerance.
180.1299 Prohydrojasmon; temporary exemption from the requirement of a 
          tolerance.
180.1300 Potassium hypochlorite; exemption from the requirement of a 
          tolerance.
180.1301 Escherichia coli O157:H7 specific bacteriophages; temporary 
          exemption from the requirement of a tolerance.
180.1302 Sodium Ferric Ethylenediaminetetraacetate (EDTA); exemption 
          from the requirement of a tolerance.
180.1303 Metarhizium anisopliae strain F52; exemption from the 
          requirement of a tolerance.
180.1304 Pseudomonas fluorescens strain CL145A; exemption from the 
          requirement of a tolerance.
180.1305 Chromobacterium subtsugae strain PRAA4-1\T\; exemption from the 
          requirement of a tolerance.
180.1306 Isaria fumosorosea (formerly Paecilomyces fumosoroseus) Apopka 
          strain 97; exemption from the requirement of a tolerance.
180.1307 Bacteriophage of Clavibacter michiganensis subspecies 
          michiganensis; exemption from the requirement of a tolerance.
180.1308 Bacillus amyloliquefaciens strain D747; exemption from the 
          requirement of a tolerance.
180.1309 Bacillus subtilis strain CX-9060; exemption from the 
          requirement of a tolerance.
180.1310 Trichoderma virens strain G-41; exemption from the requirement 
          of a tolerance.
180.1311 Pasteuria nishizawae--Pn1; exemption from the requirement of a 
          tolerance.
180.1312 Aureobasidium pullulans strains DSM 14940 and DSM 14941; 
          exemption from the requirement of a tolerance.
180.1313 Bacillus pumilus strain GHA 180; exemption from the requirement 
          of a tolerance.
180.1314 Killed, nonviable Streptomyces acidiscabies strain RL-110\T\; 
          exemption from the requirement of a tolerance.
180.1315 Natamycin; exemption from the requirement of a tolerance.
180.1316 Pasteuria spp. (Rotylenchulus reniformis nematode)--Pr3; 
          exemption from the requirement of a tolerance.
180.1317 Pesticide chemicals; exemption from the requirements of a 
          tolerance.
180.1318 3-decen-2-one; exemption from the requirement of a tolerance.
180.1319 Banda de Lupinus albus doce (BLAD); exemption from the 
          requirement of a tolerance.
180.1320 Methyl jasmonate; exemption from the requirement of a 
          tolerance.

[[Page 438]]

180.1322 Bacillus pumilus strain BU F-33; exemption from the requirement 
          of a tolerance.

Subpart E_Pesticide Chemicals Not Requiring a Tolerance or an Exemption 
                            from a Tolerance

180.2000 Scope.
180.2003 Definitions.
180.2010 Threshold of regulation determinations.
180.2020 Non-food determinations.

    Authority: 21 U.S.C. 321(q), 346a and 371.

    Source: 36 FR 22540, Nov. 25, 1971, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 180 appear at 62 FR 
66023, Dec. 17, 1997.

                                GLOSSARY

    Note: The items in this glossary were compiled as an aid to the 
users of the Code of Federal Regulations. Inclusion or exclusion from 
this glossary has no legal significance.
APPLI = APPLICATION
C-I MET = CHOLINESTERASE-INHIBITING METABOLITES
CARB = CARBAMATES
EPWRR = EDIBLE PORTION WITH RIND REMOVED
EXC = EXCEPT
I (IN PPM COLUMN) = INTERIM TOLERANCE
INC = INCLUDING
K=CWHR = KERNEL PLUS COB WITH HUSK REMOVED
MBYP = MEAT BYPRODUCTS
MIN = MINIMUM
N (IN PPM COLUMN) = NEGLIGIBLE RESIDUES
NMT = NOT MORE THAN
NON-PER BAG/PKGD RAC = NON-PERISHABLE PACKAGED OR BAGGED RAW 
AGRICULTURAL COMMODITY
PPM = PART(S) PER MILLION
POST-H = POSTHARVEST APPLICATION
PRE-H = PREHARVEST APPLICATION
PRE-S = PRESLAUGHTER APPLICATION
PRODS = PRODUCTS rollert
T (IN PPM COLUMN) = TEMPORARY TOLERANCE

[41 FR 4537, Jan. 30, 1976]



          Subpart A_Definitions and Interpretative Regulations



Sec. 180.1  Definitions and interpretations.

    (a) Administrator, without qualification, means the Administrator of 
the Environmental Protection Agency.
    (b) Agency, without qualification, means the Environmental 
Protection Agency.
    (c) FFDCA means the Federal Food, Drug, and Cosmetic Act, as 
amended, 21 U.S.C. 301-392.
    (d) Raw agricultural commodities include, among other things, fresh 
fruits, whether or not they have been washed and colored or otherwise 
treated in their unpeeled natural form; vegetables in their raw or 
natural state, whether or not they have been stripped of their outer 
leaves, waxed, prepared into fresh green salads, etc.; grains, nuts, 
eggs, raw milk, meats, and similar agricultural produce. It does not 
include foods that have been processed, fabricated, or manufactured by 
cooking, freezing, dehydrating, or milling.
    (e) Where a raw agricultural commodity bearing a pesticide chemical 
residue that has been exempted from the requirement of a tolerance, or 
which is within a tolerance permitted under FFDCA section 408, is used 
in preparing a processed food, the processed food will not be considered 
unsafe within the meaning of FFDCA sections 402 and 408(a), despite the 
lack of a tolerance or exemption for the pesticide chemical residue in 
the processed food, if:
    (1) The pesticide chemical has been used in or on the raw 
agricultural commodity in conformity with a tolerance under this 
section;
    (2) The pesticide chemical residue has been removed to the extent 
possible in good manufacturing practice; and
    (3) The concentration of the pesticide chemical residue in the 
processed food is not greater than the tolerance prescribed for the 
pesticide chemical residue on the raw agricultural commodity.
    (f) For the purpose of computing fees as required by Sec. 180.33, 
each group of related crops listed in Sec. 180.34(e) and each crop 
group or subgroup listed in Sec. 180.41 is counted as a single raw 
agricultural commodity in a petition or request for tolerances or 
exemption from the requirement of a tolerance.
    (g) Tolerances and exemptions established for pesticide chemicals in 
or on the general category of raw agricultural commodities listed in 
column A apply to the corresponding specific raw

[[Page 439]]

agricultural commodities listed in column B. However, a tolerance or 
exemption for a specific commodity in column B does not apply to the 
general category in column A.

------------------------------------------------------------------------
                  A                                    B
------------------------------------------------------------------------
Alfalfa                               Medicago sativa L. Subsp. sativa,
                                       (alfalfa, lucerne); Onobrychis
                                       viciifolia Scop. (sainfoin, holy
                                       clover, esparcet); and Lotus
                                       corniculatus L. (trefoil); and
                                       varieties and/or hybrids of
                                       these.
------------------------------------------------------------------------
Banana                                Banana, plantain.
------------------------------------------------------------------------
Bean                                  Cicer arietinum (chickpea,
                                       garbanzo bean); Lupinus spp.
                                       (including sweet lupine, white
                                       sweet lupine, white lupine, and
                                       grain lupine). Phaseolus spp.
                                       (including kidney bean, lima
                                       bean, mung bean, navy bean, pinto
                                       bean, snap bean, and waxbean;
                                       Vicia faba (broad bean, fava
                                       bean); Vigna spp. (including
                                       asparagus bean, blackeyed pea and
                                       cowpea).
------------------------------------------------------------------------
Bean, dry                             All beans above in dry form only.
------------------------------------------------------------------------
Bean, succulent                       All beans above in succulent form
                                       only.
------------------------------------------------------------------------
Blackberry                            Rubus eubatus (including
                                       bingleberry, black satin berry,
                                       boysenberry Cherokee blackberry,
                                       Chesterberry, Cheyenne
                                       blackberry, coryberry,
                                       darrowberry, dewberry, Dirksen
                                       thornless berry, Himalayaberry,
                                       hullberry, Lavacaberry, lowberry,
                                       Lucretiaberry, mammoth
                                       blackberry, marionberry,
                                       nectarberry, olallieberry, Oregon
                                       evergreen berry, phenomenalberry,
                                       rangerberry, ravenberry,
                                       rossberry, Shawnee blackberry,
                                       and varieties and/or hybrids of
                                       these).
------------------------------------------------------------------------
Broccoli                              Broccoli, chinese broccoli (gia
                                       lon, white flowering broccoli).
------------------------------------------------------------------------
Cabbage                               Cabbage, Chinese cabbage (tight-
                                       heading varieties only).
------------------------------------------------------------------------
Caneberry                             Rubus spp. (including blackberry);
                                      Rubus caesius (youngberry);
                                      Rubus loganbaccus (loganberry);
                                      Rubus idaeus (red and black
                                       raspberry); cultivars, varieties,
                                       and/or hybrids of these.
------------------------------------------------------------------------
Celery                                Celery, Florence fennel (sweet
                                       anise, sweet fennel, finochio)
                                       (fresh leaves and stalks only).
------------------------------------------------------------------------
Cherry                                Cherry, sweet, and cherry, tart.
------------------------------------------------------------------------
Endive                                Endive, escarole.
------------------------------------------------------------------------
Fruit, citrus                         Grapefruit, lemon, lime, orange,
                                       tangelo, tangerine, citrus
                                       citron, kumquat, and hybrids of
                                       these.
------------------------------------------------------------------------
Garlic                                Garlic, great headed; garlic, and
                                       serpent garlic.
------------------------------------------------------------------------
Lettuce                               Lettuce, head; and lettuce, leaf
------------------------------------------------------------------------
Lettuce, head                         Lettuce, head; crisphead varieties
                                       only
------------------------------------------------------------------------
Lettuce, leaf                         Lettuce, leaf; cos (romaine),
                                       butterhead varieties
------------------------------------------------------------------------
Marjoram                              Origanum spp. (includes sweet or
                                       annual marjoram, wild marjoram or
                                       oregano, and pot marjoram).
------------------------------------------------------------------------
Melon                                 Muskmelon, including hybrids and/
                                       or varieties of Cucumis melo
                                       (including true cantaloupe,
                                       cantaloupe, casaba, Santa Claus
                                       melon, crenshaw melon, honeydew
                                       melon, honey balls, Persian
                                       melon, golden pershaw melon,
                                       mango melon, pineapple melon,
                                       snake melon); and watermelon,
                                       including hybrids and/or
                                       varieties of (Citrullus spp.).
------------------------------------------------------------------------
Muskmelon                             Cucumis melo (includes true
                                       cantaloupe, cantaloupe, casaba,
                                       Santa Claus melon, crenshaw
                                       melon, honeydew melon, honey
                                       balls, Persian melon, golden
                                       pershaw melon, mango melon,
                                       pineapple melon, snake melon, and
                                       other varieties and/or hybrids of
                                       these.)
------------------------------------------------------------------------
Onion                                 Bulb onion; green onion; and
                                       garlic.
------------------------------------------------------------------------

[[Page 440]]

 
Onion, bulb                           Bulb onion; garlic; great headed
                                       garlic; serpent garlic; Chinese
                                       onion; pearl onion; potato onion;
                                       and shallot, bulb.
------------------------------------------------------------------------
Onion, green                          Green onion; lady's leek; leek;
                                       wild leek; Beltsville bunching
                                       onion; fresh onion; tree onion,
                                       tops; Welsh onion; and shallot,
                                       fresh leaves.
------------------------------------------------------------------------
Peach                                 Peach, nectarine
------------------------------------------------------------------------
Pea                                   Cajanus cajan (includes pigeon
                                       pea); Cicer spp. (includes
                                       chickpea and garbanzo bean); Lens
                                       culinaris (lentil); Pisum spp.
                                       (includes dwarf pea, garden pea,
                                       green pea, English pea, field
                                       pea, and edible pod pea). [Note:
                                       A variety of pesticide tolerances
                                       have been previously established
                                       for pea and/or bean. Chickpea/
                                       garbanzo bean is now classified
                                       in both the bean and the pea
                                       categories. For garbanzo bean/
                                       chickpea only, the highest
                                       established pea or bean tolerance
                                       will apply to pesticide residues
                                       found in this commodity.]
------------------------------------------------------------------------
Pea, dry                              All peas in dry form only.
------------------------------------------------------------------------
Pea, succulent                        All peas in succulent form only.
------------------------------------------------------------------------
Pepper                                All varieties of pepper including
                                       pimento and bell, hot, and sweet
                                       pepper.
------------------------------------------------------------------------
Radish, oriental, roots               Raphanus sativus var.
                                       longipinnatus (roots and tops),
                                       including Chinese or Japanese
                                       radish (both white and red),
                                       winter radish, daikon, lobok, lo
                                       pak, and other cultivars and/or
                                       hybrids of these.
------------------------------------------------------------------------
Radish, oriental, tops)               Raphanus sativus var.
                                       longipinnatus (roots and tops),
                                       including Chinese or Japanese
                                       radish (both white and red),
                                       winter radish, daikon, lobok, lo
                                       pak, and other cultivars and/or
                                       hybrids of these.
------------------------------------------------------------------------
Rapeseed                              Brassica napus, B. campestris, and
                                       Crambe abyssinica (oilseed-
                                       producing varieties only which
                                       include canola and crambe.)
------------------------------------------------------------------------
Raspberry                             Rubus spp. (including bababerry;
                                       black raspberry; blackcap;
                                       caneberry; framboise; frambueso;
                                       himbeere; keriberry; mayberry;
                                       red raspberry; thimbleberry;
                                       tulameen; yellow raspberry; and
                                       cultivars, varieties, and/or
                                       hybrids of these).
------------------------------------------------------------------------
Sorghum, grain, grain                 Sorghum spp. [sorghum, grain,
                                       sudangrass (seed crop), and
                                       hybrids of these grown for its
                                       seed].
------------------------------------------------------------------------
Sorghum, forage, stover               Sorghum spp. [sorghum, forage;
                                       sorghum, stover; sudangrass, and
                                       hybrids of these grown for forage
                                       and/or stover.
------------------------------------------------------------------------
Squash                                Pumpkin, summer squash, and winter
                                       squash.
------------------------------------------------------------------------
Sugar apple                           Annona squamosa L. (sugar apple,
                                       sweetsop, anon), and its hybrid
                                       A. squamosa L. x A. cherimoya M.
                                       (atemoya). Also A. reticulata L.
                                       (true custard apple).
------------------------------------------------------------------------
Squash, summer                        Fruits of the gourd
                                       (Cucurbitaceae) family that are
                                       consumed when immature, 100% of
                                       the fruit is edible either cooked
                                       or raw, once picked it cannot be
                                       stored, has a soft rind which is
                                       easily penetrated, and if seeds
                                       were harvested they would not
                                       germinate; e.g., Cucurbita pepo
                                       (i.e., crookneck squash,
                                       straightneck squash, scallop
                                       squash, and vegetable marrow);
                                       Lagenaria spp. (i.e., spaghetti
                                       squash, hyotan, cucuzza); Luffa
                                       spp. (i.e., hechima, Chinese
                                       okra); Momordica spp. (i.e.,
                                       bitter melon, balsam pear, balsam
                                       apple, Chinese cucumber); Sechium
                                       edule (chayote); and other
                                       cultivars and/or hybrids of
                                       these.
------------------------------------------------------------------------
Sweet potato                          Sweet potato, yam.
------------------------------------------------------------------------
Tangerine                             Tangerine (mandarin or mandarin
                                       orange); clementine;
                                       Mediterranean mandarin; satsuma
                                       mandarin; tangelo; tangor;
                                       cultivars, varieties, and/or
                                       hybrids of these.
------------------------------------------------------------------------
Tomato                                Tomato, tomatillo.
------------------------------------------------------------------------
Turnip tops or turnip greens          Broccoli raab (raab, raab salad),
                                       hanover salad, turnip tops
                                       (turnip greens).
------------------------------------------------------------------------

[[Page 441]]

 
Wheat                                 Wheat, triticale.
------------------------------------------------------------------------

    (h) Unless otherwise specified in this paragraph or in tolerance 
regulations prescribed in this part for specific pesticide chemicals, 
the raw agricultural commodity or processed food to be examined for 
pesticide residues, shall consist of the whole raw agricultural 
commodity or processed food.
    (1) The raw agricultural commodity bananas, when examined for 
pesticide residues, shall not include any crown tissue or stalk.
    (2) Shell shall be removed and discarded from nuts before 
examination for pesticide residues.
    (3) Caps (hulls) shall be removed and discarded from strawberries 
before examination for pesticide residues.
    (4) Stems shall be removed and discarded from melons before 
examination for pesticide residues.
    (5) Roots, stems, and outer sheaths (or husks) shall be removed and 
discarded from garlic bulbs and dry bulb onions, and only the garlic 
cloves and onion bulbs shall be examined for pesticide residues.
    (6) Where a tolerance is established on a root vegetable including 
tops and/or with tops, and the tops and the roots are marketed together, 
they shall be analyzed separately and neither the pesticide residue on 
the roots nor the pesticide residue on the tops shall exceed the 
tolerance level, except that in the case of carrots, parsnips, and 
rutabagas, the tops shall be removed and discarded before analyzing 
roots for pesticide residues.
    (7) The crowns (leaves at the top of the fruit) shall be removed and 
discarded from pineapples before examination for pesticide residues.
    (8) The term lima beans means the beans and the pod.
    (9) The term peanuts means the peanut meat after removal of the 
hulls.
    (10) For processed foods consisting primarily of one ingredient and 
sold in a form requiring further preparation prior to consumption (e.g., 
fruit juice concentrates, dehydrated vegetables, and powdered potatoes), 
the processed food to be examined for residues shall be the whole 
processed commodity after compensating for or reconstituting to the 
commodity's normal moisture content, unless a tolerance for the 
concentrated or dehydrated food form is included in this part. If there 
exists a tolerance for a specific pesticide on the processed food in its 
concentrated or dehydrated food form, for the purpose of determining 
whether the food is in compliance with that tolerance, the processed 
food to be examined for residues shall be the whole processed commodity 
on an ``as is'' basis.
    (i) The term pesticide chemical shall have the meaning specified in 
FFDCA section 201(q)(1), as amended, except as provided in Sec. 180.4.
    (j) The term negligible residue means any amount of a pesticide 
chemical remaining in or on a raw agricultural commodity or group of raw 
agricultural commodities that would result in a daily intake regarded as 
toxicologically insignificant on the basis of scientific judgment of 
adequate safety data. Ordinarily this will add to the diet an amount 
which will be less than 1/2,000th of the amount that has been 
demonstrated to have no effect from feeding studies on the most 
sensitive animal species tested. Such toxicity studies shall usually 
include at least 90-day feeding studies in two species of mammals.
    (k) The term nonperishable raw agricultural commodity means any raw 
agricultural commodity not subject to rapid decay or deterioration that 
would render it unfit for consumption. Examples are cocoa beans, coffee 
beans, field-dried beans, field-dried peas, grains, and nuts. Not 
included are eggs, milk, meat, poultry, fresh fruits, and vegetables 
such as onions, parsnips, potatoes, and carrots.
    (l) The term tolerance with regional registration means any 
tolerance which is established for pesticide residues resulting from the 
use of the pesticide pursuant to a regional registration. Such a 
tolerance is supported by residue data from specific growing regions

[[Page 442]]

for a raw agricultural commodity. Individual tolerances with regional 
registration are designated in separate subsections in 40 CFR 180.101 
through 180.999, as appropriate. Additional residue data which are 
representative of the proposed use area are required to expand the 
geographical area of usage of a pesticide on a raw agricultural 
commodity having an established ``tolerance with regional 
registration.'' Persons seeking geographically broader registration of a 
crop having a ``tolerance with regional registration'' should contact 
the appropriate EPA product manager concerning additional residue data 
required to expand the use area.
    (m) The term pesticide chemical residue shall have the meaning 
specified in FFDCA section 201(q)(2), as amended, except as provided in 
Sec. 180.4.
    (n) The term food commodity means:
    (1) Any raw agricultural commodity (food or feed) as defined in 
section 201(r) of the Federal Food, Drug, and Cosmetic Act (FFDCA); and
    (2) Any processed food or feed as defined in section 201(gg) of the 
FFDCA.

[36 FR 22540, Nov. 25, 1971]

    Editorial Note: For Federal Register citations affecting Sec. 
180.1, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.3  Tolerances for related pesticide chemicals.

    (a) Pesticide chemicals that cause related pharmacological effects 
will be regarded, in the absence of evidence to the contrary, as having 
an additive deleterious action. (For example, many pesticide chemicals 
within each of the following groups have related pharmacological 
effects: Chlorinated organic pesticides, arsenic-containing chemicals, 
metallic dithiocarbamates, cholinesterase-inhibiting pesticides.)
    (b) Tolerances established for such related pesticide chemicals may 
limit the amount of a common component (such as 
As2O3) that may be present, or may limit the 
amount of biological activity (such as cholinesterase inhibition) that 
may be present, or may limit the total amount of related pesticide 
chemicals (such as chlorinated organic pesticides) that may be present.
    (c)(1) Where tolerances for inorganic bromide in or on the same raw 
agricultural commodity are set in two or more sections in this part 
(example: Sec. Sec. 180.123 and 180.199), the overall quantity of 
inorganic bromide to be tolerated from use of the same pesticide in 
different modes of application or from two or more pesticide chemicals 
for which tolerances are established is the highest of the separate 
applicable tolerances. For example, where the bromide tolerance on 
asparagus from methyl bromide commodity fumigation is 100 parts per 
million (40 CFR 180.123) and on asparagus from methyl bromide soil 
treatment is 300 parts per million (40 CFR 180.199), the overall 
inorganic bromide tolerance for asparagus grown on methyl bromide-
treated soil and also fumigated with methyl bromide after harvest is 300 
parts per million.
    (2) Where tolerances are established in terms of inorganic bromide 
residues only from use of organic bromide fumigants on raw agricutural 
commodities, such tolerances are sufficient to protect the public 
health, and no additional concurrent tolerances for the organic 
pesticide chemicals from such use are necessary. This conclusion is 
based on evidence of the dissipation of the organic pesticide or its 
conversion to inorganic bromide residues in the food when ready to eat.
    (d)(1) Where tolerances are established for both calcium cyanide and 
hydrogen cyanide on the same raw agricultural commodity, the total 
amount of such pesticides shall not yield more residue than that 
permitted by the larger of the two tolerances, calculated as hydrogen 
cyanide.
    (2) Where tolerances are established for residues of both O,O-
diethyl S-[2-(ethylthio)ethyl] phosphorodithioate and demeton (a mixture 
of O,O-diethyl O-(and S-) [2-(ethylthio)ethyl] phosphorothioates) on the 
same raw agricultural commodity, the total amount of such pesticides 
shall not yield more residue than that permitted by the larger of the 
two tolerances, calculated as demeton.
    (3) Where tolerances are established for both terpene 
polychlorinates (chlorinated mixture of camphene, pinene, and related 
terpenes, containing 65-66 percent chlorine) and toxaphene

[[Page 443]]

(chlorinated camphene containing 67-69 percent chlorine) on the same raw 
agricultural commodities, the total amount of such pesticides shall not 
yield more residue than that permitted by the larger of the two 
tolerances, calculated as a chlorinated terpene of molecular weight 
396.6 containing 67 percent chlorine.
    (4) Where a tolerance is established for more than one pesticide 
containing arsenic found in, or on a raw agricultural commodity, the 
total amount of such pesticide shall not exceed the highest established 
tolerance calculated as As2O3.
    (5) Where tolerances are established for more than one member of the 
class of dithiocarbamates listed in paragraph (e)(3) of this section on 
the same raw agricultural commodity, the total residue of such 
pesticides shall not exceed that permitted by the highest tolerance 
established for any one member of the class, calculated as zinc 
ethylenebisdithiocarbamate.
    (6) Where tolerances are established for residues of both S,S,S-
tributyl phosphorotrithioate and tributyl phosphorotrithioite in or on 
the same raw agricultural commodity, the total amount of such pesticides 
shall not yield more residue than that permitted by the higher of the 
two tolerances, calculated as S,S,S-tributyl phosphorotrithioate.
    (7) Where tolerances are established for residues of O,S-dimethyl 
phosphoramidothioate, resulting from the use of acephate (O,S-dimethyl 
acetylphos-phoramidothioate) and/or O,S - dimethylphosphoramidothioate 
on the same agricultural commodity, the total amount of O,S-dimethyl-
phosphoramidothioate shall not yield more residue than that permitted by 
the higher of the two tolerances.
    (8) Where a tolerance is established for more than one pesticide 
having the metabolites 1-(3,4-dichlorophenyl)-3-methylurea (DCPMU) and 
3,4-dichlorophenylurea (DCPU) found in or on a raw agricultural 
commodity, the total amount of such residues shall not exceed the 
highest established tolerance for a pesticide having these metabolites.
    (9) Where a tolerance is established for more than one pesticide 
having as metabolites compounds containing the benzimidazole moiety 
found in or on a raw agricultural commodity, the total amount of such 
residues shall not exceed the highest established tolerance for a 
pesticide having these metabolites.
    (10) Where a tolerance is established for triclopyr, chloropyrifos, 
and chlorpyrifos-methyl having the common metabolite 3,5,6-trichloro-2-
pyridinol on the same raw agricultural commodity, the total amount of 
such residues shall not exceed the highest established tolerance for any 
of the pesticides having the metabolites.
    (11) Where tolerances are established for more than one pesticide 
having the metabolite 3,5,6-trichloro-2-pyridinol found in or on the raw 
agricultural commodity, the total amount of such residues shall not 
exceed the highest established tolerance for a pesticide having this 
metabolite.
    (12) Where tolerances are established for residues of methomyl, 
resulting from the use of thiodicarb and/or methomyl on the same raw 
agricultural commodity, the total amount of methomyl shall not yield 
more residue than that permitted by the higher of the two tolerances.
    (e) Except as noted in paragraphs (e)(1) and (2) of this section, 
where residues from two or more chemicals in the same class are present 
in or on a raw agricultural commodity the tolerance for the total of 
such residues shall be the same as that for the chemical having the 
lowest numerical tolerance in this class, unless a higher tolerance 
level is specifically provided for the combined residues by a regulation 
in this part.
    (1) Where residues from two or more chemicals in the same class are 
present in or on a raw agricultural commodity and there are available 
methods that permit quantitative determination of each residue, the 
quantity of combined residues that are within the tolerance may be 
determined as follows:
    (i) Determine the quantity of each residue present.
    (ii) Divide the quantity of each residue by the tolerance that would 
apply if it occurred alone, and multiply by 100 to determine the 
percentage of the permitted amount of residue present.

[[Page 444]]

    (iii) Add the percentages so obtained for all residues present.
    (iv) The sum of the percentages shall not exceed 100 percent.
    (2) Where residues from two or more chemicals in the same class are 
present in or on a raw agricultural commodity and there are available 
methods that permit quantitative determinations of one or more, but not 
all, of the residues, the amounts of such residues as may be 
determinable shall be deducted from the total amount of residues present 
and the remainder shall have the same tolerance as that for the chemical 
having the lowest numerical tolerance in that class. The quantity of 
combined residues that are within the tolerance may be determined as 
follows:
    (i) Determine the quantity of each determinable residue present.
    (ii) Deduct the amounts of such residues from the total amount of 
residues present and consider the remainder to have the same tolerance 
as that for the chemical having the lowest numerical tolerance in that 
class.
    (iii) Divide the quantity of each determinable residue by the 
tolerance that would apply if it occurred alone and the quantity of the 
remaining residue by the tolerance for the chemical having the lowest 
numerical tolerance in that class and multiply by 100 to determine the 
percentage of the permitted amount of residue present.
    (iv) Add the percentages so obtained for all residues present.
    (v) The sum of the percentages shall not exceed 100 percent.
    (3) The following pesticides are members of the class of 
dithiocarbamates:

A mixture of 5.2 parts by weight of ammoniates of [ethylenebis 
(dithiocarbamato)] zinc with 1 part by weight ethylenebis 
[dithiocarbamic acid] bimolecular and trimolecular cyclic 
anhydrosulfides and disulfides.
2-Chloroallyl diethyldithiocarbamate.
Coordination product of zinc ion and maneb containing 20 percent 
manganese, 2.5 percent zinc, and 77.5 percent 
ethylenebisdithiocarbamate.
Ferbam.
Maneb.
Manganous dimethyldithiocarbamate.
Sodium dimethyldithiocarbamate.
Thiram.
Zineb.
Ziram.

    (4) The following are members of the class of chlorinated organic 
pesticides:

Aldrin.
BHC (benzene hexachloride).
1,1-Bis(p-chlorophenyl)-2,2,2-trichloroethanol.
Chlorbenside (p-chlorobenzyl p-chlorophenyl sulfide).
Chlordane.
Chlorobenzilate (ethyl 4,4'-dichlorobenzilate).
p-Chlorophenoxyacetic acid.
p-Chlorophenyl-2,4,5-trichlorophenyl sulfide.
2,4-D (2,4-dichlorophenoxyacetic acid).
DDD (TDE).
DDT.
1,1-Dichloro-2,2-bis(p-ethylphenyl) ethane.
2,6-Dichloro-4-nitroaniline.
2,4-Dichlorophenyl p-nitrophenyl ether.
Dieldrin.
Dodecachlorooctahydro-1,3,4-metheno-2H-cyclobuta[cd]pentalene.
Endosulfan (6,7,8,9,10,10-hexachloro-1,5,5a, 6,9,9a-hexahydro-6,9-
methano-2,4,3-benzodioxathiepin-3-oxide).
Endosulfan sulfate (6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-hexahydro-
6,9-methano-2,4,3-benzodioxathiepin-3,3-dioxide).
Heptachlor (1,4,5,6,7,8,8-heptachlor-3a,4,7, 7a-tetrahydro-4,7-
methanoindene).
Heptachlor epoxide (1,4,5,6,7,8,8-heptachloro-2,3-epoxy-2,3,3a,4,7,7a-
hexahydro-4,7-methanoindene).
Hexachlorophene (2,2'-methylenebis(3,4,6-trichlorophenol) and its 
monosodium salt.
Isopropyl 4,4'-dichlorobenzilate.
Lindane.
Methoxychlor.
Ovex (p-chlorophenyl p-chlorobenzenesulfonate).
Sesone (sodium 2,4-dichlorophenoxyethyl sulfate, SES).
Sodium 2,4-dichlorophenoxyacetate.
Sodium trichloroacetate.
Sulphenone (p-chlorophenyl phenyl sulfone).
Terpene polychlorinates (chlorinated mixture of camphene, pinene, and 
related terpenes 65-66 percent chlorine).
2,3,5,6-Tetrachloronitrobenzene.
Tetradifon (2,4,5,4'-tetrachlorodiphenyl sulfone).
Toxaphene (chlorinated camphene).
Trichlorobenzoic acid.
Trichlorobenzyl chloride.

    (5) The following are members of the class of cholinesterase-
inhibiting pesticides:

Acephate (O,S-dimethyl acetyl-phosphoramidothioate) and its 
cholinesterase-inhibiting metabolite O,S-dimethyl phosphoramidothioate.
Aldicarb (2-methyl-2-(methylthio) propionaldehyde O-
(methylcarbamoyl)oxime) and its

[[Page 445]]

chlorinesterase-inhibiting metabolites 2-methyl-2-
(methylsulfinyl)propionaldehyde O-(methycarbamoyl) oxime and 2-methyl-2-
(methylsulfonyl)propionaldehyde O-(methylcarbamoyl)oxime.
4-tert-Butyl-2-chlorophenyl methyl methyl phosphoramidate.
S-[(tert-Butylthio)methyl] O,O-diethyl phosphorodithioate and its 
cholinesterase-inhibiting metabolites.
Carbaryl (1-naphthyl N-methylcarbamate).
Carbofuran (2,3,-dihydro-2,2-dimethyl-7-benzofuranyl-N-methylcarbamate).
Carbofuran metabolite (2,3-dihydro-2,2-dimethyl-3-hydroxy-7-benofuranyl 
N-methylcarbamate).
Carbophenothion (S-[(p-chlorophenyl) thiolmethyl] O,O-diethyl 
phosphorodithioate) and its cholinesterase-inhibiting metabolites.
Chlorpyrifos (O,O-diethyl O-(3,5,6-trichloro-2-
pyridyl)phosphorothioate).
Chlorpyrifos-methyl (O,O-dimethyl-O-(3,5,6-trichloro-2-pyridyl) 
phosphorothioate.
2-Chloro-1-(2,4,5-trichlorophenyl)vinyl dimethyl phosphate.
2-Chloro-1-(2,4-dichlorophenyl) vinyl diethyl phosphate.
Coumaphos (O,O-diethyl O-3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl 
phosran-7-yl phosphate).
Coumaphos oxygen analog (O,O-diethyl O-3-chloro-4-methyl-2-oxo-2H-1-
benzopyphorothioate).
Dialifor (S-(2-chloro-1-phthalimidoethyl) O,O-diethyl 
phosphorodithioate).
Dialifor oxygen analog (S-(2-chloro-1-phthalimidoethyl) O,O-diethyl 
phosphorothioate).
Demeton (a mixture of O,O-diethyl O-(and S) [2-ethylthio)ethyl] 
phosphorothioates).
Ethiolate (S-ethyl diethylthiocarbamate).
2,2-Dichlorovinyl dimethyl phosphate.
O,O-Diethyl S-[2-(ethylthio)ethyl] phosphorodithioate and its 
cholinesterase-inhibiting metabolites.
O,O-Diethyl O-(2-diethylamino-6-methyl-4-pyrimidinyl) phosphorothioate 
and its oxygen analog diethyl 2-diethylamino-6-methyl-4-pyrimidinyl 
phosphate.
O,O-Diethyl O-(2-isoprophyl-4-methyl-6-pyrimidinyl) phosphorothioate.
O,O-Diethyl O-[p-(methylsulfinyl)phenyl] phosphorothioate and its 
cholinesterase-inhibiting metabolites.
Diethyl 2-pyrazinyl phosphate.
O,O-Diethyl O-2-pyrazinyl phosphorothioate.
S-(O,O-Diisopropyl phosphorodithioate) of N-(2-mercaptoethyl) 
benzenesulfonamide
S-(O,O-Diisopropyl phosphorodithioate) of N-(2-mercaptoethyl) 
benzenesulfonamide
2-(Dimethylamino)-5.6-dimethyl-4-pyrimidinyl dimethylcarbamate and its 
metabolites 5,6-dimethyl-2-(formylmethylamino)-4-pyrimidinyl 
dimethylcarbamate and 5,6-dimethyl-2-(methylamino)-4-pyrimidinyl 
dimethylcarbamate (both calculated as parent).
Dimethoate (O,O-dimethyl S-(N-methyl-carbamoylmethyl) 
phosphorodithioate).
Dimethoate oxygen analog (O,O-dimethyl S-(N-methylcarbamoylmethyl) 
phosphorothioate).
O,O-Dimethyl O-p-(dimethylsulfamoyl) phenyl phosphate.
O,O-Dimethyl O-p-(dimethylsulfamoyl) phenyl phosphorothioate.
3,5-Dimethyl-4-(methylthio) phenyl methylcarbamate.
O,O-Dimethyl S-[4-oxo-1,2,3-benzotriazin-3-(4H)-ylmethyl] 
phosphorodithioate.
Dimethyl phosphate of 3-hydroxy-N,N-dimethyl-cis-crotonamide.
Dimethyl phosphate of 3-hydroxy-N-methyl-cis-crotonamide.
Dimethyl phosphate of [alpha]-methylbenzyl 3-hydroxy-cis-crotonate.
O,O-Dimethyl 2,2,2-trichloro-1-hydroxyethyl phosphonate.
O,O-Dimethyl phosphorodithioate, S-ester with 4-(mercaptomethyl)-2-
methozy-[Delta]2-1,3,4-thiadiazolin-5-one.
Dioxathion (2,3-p-dioxanedithiol S,S-bis (O,O-
diethylphosphorodithioate)) containing approximately 70 percent cis and 
trans isomers and approximately 30 percent related compounds.
EPN.
Ethephon ((2- - chloroethyl) phosphonic acid).
Ethion.
Ethion oxygen analog (S-[[(diethoxyphosphinothioyl)thio] methyl] O,O-
diethyl phosphorothioate).
O- Ethyl O-[4-(methylthio) phenyl] S-propyl phosphorodithioate and its 
cholinesterase-inhibiting metabolites.
O-Ethyl S,S-dipropylphosphorodithioate.
Ethyl 3-methyl-4-(methylthio)phenyl (1-methylethyl) phosphoramidate and 
its cholinesterase-inhibiting metabolites.
O-Ethyl S-phenyl ethylphosphonodithioate.
O-Ethyl S-phenyl ethylphosphonothiolate.
m-(1-Ethylpropyl)phenyl methylcarbamate.
S-[2-Ethylsulfinyl)ethyl] O,O-dimethyl phosphorothioate and its 
cholinesterase-inhibiting metabolites, (primarily S-[2-(ethyl-
sulfonyl)ethyl] O,O-dimethyl phosphorothioate).
Fenthion (O,O-dimethyl O-[3-methyl-4-(methylthio)phenyl]phosphorothioate 
and its cholinesterase-inhibiting metabolites.
Malathion.
N-(Mercaptomethyl)phthalimide S-(O,O-dimethyl phosphorodithioate).
N-(Mercaptomethyl)phthalimide S-(O,O-dimethyl phosphorothioate).
Methomyl (S-methyl N-[(methylcarbamoyl)oxy]thioacetimidate).
1-Methoxycarbonyl-1-propen-2-yl dimethyl phosphate and its beta isomer.
m-(1-Methylbutyl)phenyl methylcarbamate.
Methyl parathion.

[[Page 446]]

Naled (1,2-dibromo-2,2-dichloroethyl dimethyl phosphate).
Oxamyl (methyl N',N'-dimethyl-N-[(methylcarbamoyl)oxy]-1-
thiooxamimidate)
Parathion.
Phorate (O,O-diethyl S-(ethylthio)methyl phosphorodithioate) and its 
cholinesterase-inhibiting metabolites.
Phosalone (S-(6-chloro-3-mercaptomethyl)-2-benzoxazolinone) O,O-diethyl 
phosphorodithioate).
Phosphamidon (2-chloro-2-diethylcarbamoyl-1-methylvinyl dimethyl 
phosphate) including all of its related cholinesterase-inhibiting 
compounds.
Pirimiphos-methyl O-[2-diethylamino-6-methyl-pyrimidinyl) O,O-dimethyl 
phosphorothioate
Ronnel.
Schradan (octamethylpyrophosphoramide).
Tetraethyl pyrophosphate.
O,O,O',O'-Tetramethyl O,O'-sulfinyldi-p-phenylene phosphorothioate.
O,O,O',O'-Tetramethyl O,O'-thiodi-p-phenylene phosphorothioate.
Tributyl phosphorotritlioite.
S,S,S-Tributyl phosphorothrithioate.
3,4,5-Trimethylphenyl methylcarbamate and its isomer 2,3,5-
trimethylphenyl methylcarbamate.

    (6) The following pesticides are members of the class of 
dinitrophenols:

2,4-Dinitro-6-octylphenyl crotonate and 2,6-dinitro-4-octylphenyl 
crotonate, mixture of.
4,6-Dinitro-o-cresol and its sodium salt.
Dinoseb (2-sec-butyl-4,6-dinitrophenol) and its alkanolamine, ammonium, 
and sodium salts.

[41 FR 8969, Mar. 2, 1976]

    Editorial Note: For Federal Register citations affecting Sec. 
180.3, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.4  Exceptions.

    The substances listed in this section are excepted from the 
definitions of ``pesticide chemical'' and ``pesticide chemical residue'' 
under FFDCA section 201(q)(3) and are therefore exempt from regulation 
under FFDCA section 402(a)(2)(B) and 408. These substances are subject 
to regulation by the Food and Drug Administration as food additives 
under FFDCA section 409.
    (a) Inert ingredients in food packaging treated with a pesticide, 
when such inert ingredients are the components of the food packaging 
material (e.g. paper and paperboard, coatings, adhesives, and polymers).
    (b) [Reserved]

[63 FR 10720, Mar. 4, 1998, as amended at 73 FR 54976, Sept. 24, 2008]



Sec. 180.5  Zero tolerances.

    A zero tolerance means that no amount of the pesticide chemical may 
remain on the raw agricultural commodity when it is offered for 
shipment. A zero tolerance for a pesticide chemical in or on a raw 
agricultural commodity may be established because, among other reasons:
    (a) A safe level of the pesticide chemical in the diet of two 
different species of warm-blooded animals has not been reliably 
determined.
    (b) The chemical is carcinogenic to or has other alarming 
physiological effects upon one or more of the species of the test 
animals used, when fed in the diet of such animals.
    (c) The pesticide chemical is toxic, but is normally used at times 
when, or in such manner that, fruit, vegetables, or other raw 
agricultural commodities will not bear or contain it.
    (d) All residue of the pesticide chemical is normally removed 
through good agricultural practice such as washing or brushing or 
through weathering or other changes in the chemical itself, prior to 
introduction of the raw agricultural commodity into interstate commerce.



Sec. 180.6  Pesticide tolerances regarding milk, eggs, meat, and/or poultry; 

statement of policy.

    (a) When establishing tolerances for pesticide residues in or on raw 
agricultural commodities, consideration is always given to possible 
residues of those pesticide chemicals or their conversion products 
entering the diet of man through the ingestion of milk, eggs, meat, and/
or poultry produced by animals fed agricultural products bearing such 
pesticide residues. In each instance an evaluation of all available data 
will result in a conclusion either:
    (1) That finite residues will actually be incurred in these foods 
from feed use of the raw agricultural commodity including its 
byproducts; or
    (2) That it is not possible to establish with certainty whether 
finite residues

[[Page 447]]

will be incurred, but there is a reasonable expectation of finite 
residues; or
    (3) That it is not possible to establish with certainty whether 
finite residues will be incurred, but there is no reasonable expectation 
of finite residues.
    (b) When the data show that finite residues will actually be 
incurred in milk, eggs, meat, and/or poultry, a tolerance will be 
established on the raw agricultural commodity used as feed provided that 
tolerances can be established at the same time, on the basis of the 
toxicological and other data available, for the finite residues incurred 
in milk, eggs, meat, and/or poultry. When it is not possible to 
determine with certainty whether finite residues will be incurred in 
milk, eggs, meat, and/or poultry but there is a reasonable expectation 
of finite residues in light of data reflecting exaggerated pesticides 
levels in feeding studies, a tolerance will be established on the raw 
agricultural commodity provided that appropriate tolerances can be 
established at the same time, on the basis of the toxicological and 
other data available, for the finite residues likely to be incurred in 
these foods through the feed use of the raw agricultural commodity or 
its byproducts. When it is not possible to determine with certainty 
whether finite residues will be incurred in milk, eggs, meat, and/or 
poultry but there is no reasonable expectation of finite residues in 
light of data such as those reflecting exaggerated pesticide levels in 
feeding studies and those elucidating the biochemistry of the pesticide 
chemical in the animal, a tolerance may be established on the raw 
agricultural commodity without the necessity of a tolerance on food 
products derived from the animal.
    (c) The principles outlined in paragraphs (a) and (b) of this 
section will also be followed with respect to tolerances for residues 
which will actually be incurred or are reasonably to be expected in 
milk, eggs, meat, and/or poultry by the use of pesticides directly on 
the animal or administered purposely in the feed or drinking water.
    (d) Tolerances contemplated by paragraphs (a) and (b) of this 
section will in addition to toxicological considerations be conditioned 
on the availability of a practicable analytical method to determine the 
pesticide residue; that is, the method must be sensitive and reliable at 
the tolerance level or in special cases at a higher level where such 
level is deemed satisfactory and safe in light of the toxicity of the 
pesticide residue and of the unlikelihood of such residue exceeding the 
tolerance. The analytical methods to be used for enforcement purposes 
will be those set forth in the ``Pesticide Analytical Manual'' (see 
Sec. 180.101(c)). The sensitivities of these methods are expressed in 
that manual.



                    Subpart B_Procedural Regulations



Sec. 180.7  Petitions proposing tolerances or exemptions for pesticide 

residues in or on raw agricultural commodities or processed foods.

    (a) Petitions to be filed with the Agency under the provisions of 
FFDCA section 408(d) shall be submitted in duplicate. If any part of the 
material submitted is in a foreign language, it shall be accompanied by 
an accurate and complete English translation. The petition shall be 
accompanied by an advance deposit for fees described in Sec. 180.33. 
The petition shall state the petitioner's mail address to which notice 
of objection under FFDCA section 408(g)(2) may be sent. The petition 
must be signed by the petitioner or by his attorney or agent, or (if a 
corporation) by an authorized official.
    (b) Petitions shall include the following information:
    (1) An informative summary of the petition and of the data, 
information, and arguments submitted or cited in support of the 
petition. Both a paper and electronic copy of the summary should be 
submitted. The electronic copy should be formatted according to the 
Office of Pesticide Programs' current standard for electronic data 
submission as specified at http://www.epa.gov/pesticides/regulating/
registering/submissions/index.htm.
    (2) A statement that the petitioner agrees that such summary or any 
information it contains may be published as a part of the notice of 
filing of the petition to be published under FFDCA

[[Page 448]]

section 408(d)(3) and as a part of a proposed or final regulation issued 
under FFDCA section 408.
    (3) The name, chemical identity, and composition of the pesticide 
chemical residue and of the pesticide chemical that produces the 
residue.
    (4) Data showing the recommended amount, frequency, method, and time 
of application of the pesticide chemical.
    (5) Full reports of tests and investigations made with respect to 
the safety of the pesticide chemical, including full information as to 
the methods and controls used in conducting those tests and 
investigations.
    (6) Full reports of tests and investigations made with respect to 
the nature and amount of the pesticide chemical residue that is likely 
to remain in or on the food, including a description of the analytical 
methods used. (See Sec. 180.34 for further information about residue 
tests.)
    (7) Proposed tolerances for the pesticide chemical residue if 
tolerances are proposed.
    (8) Practicable methods for removing any amount of the residue that 
would exceed any proposed tolerance.
    (9) A practical method for detecting and measuring the levels of the 
pesticide chemical residue in or on the food, or for exemptions, a 
statement why such a method is not needed.
    (10) If the petition relates to a tolerance for a processed food, 
reports of investigations conducted using the processing method(s) used 
to produce that food.
    (11) Such information as the Administrator may require to make the 
determination under FFDCA section 408(b)(2)(C).
    (12) Such information as the Administrator may require on whether 
the pesticide chemical may have an effect in humans that is similar to 
an effect produced by a naturally occurring estrogen or other endocrine 
effects.
    (13) Information regarding exposure to the pesticide chemical 
residue due to any tolerance or exemption already granted for such 
residue.
    (14) Information concerning any maximum residue level established by 
the Codex Alimentarius Commission for the pesticide chemical residue 
addressed in the petition. If a Codex maximum residue level has been 
established for the pesticide chemical residue and the petitioner does 
not propose that this level be adopted, a statement explaining the 
reasons for this departure from the Codex level.
    (15) Such other data and information as the Administrator requires 
by regulation to support the petition.
    (16) Reasonable grounds in support of the petition.
    (c) The data specified under paragraphs (b)(1) through (b)(16) of 
this section should be on separate sheets or sets of sheets, suitably 
identified. If such data have already been submitted with an earlier 
application, the present petition may incorporate it by reference to the 
earlier one.
    (d) Except as noted in paragraph (e) of this section, a petition 
shall not be accepted for filing if any of the data prescribed by FFDCA 
section 408(d) are lacking or are not set forth so as to be readily 
understood. The availability to the public of information provided to, 
or otherwise obtained by, the Agency under this part shall be governed 
by part 2 of this chapter. The Administrator shall make the full text of 
the summary referenced in paragraph (b)(1) of this section available to 
the public in the public docket at http://www.regulations.gov no later 
than publication in the Federal Register of the notice of the petition 
filing.
    (e) The Administrator shall notify the petitioner within 15 days 
after its receipt of acceptance or nonacceptance of a petition, and if 
not accepted the reasons therefor. If petitioner desires, the petitioner 
may supplement a deficient petition after notification as to 
deficiencies. If the petitioner does not wish to supplement or explain 
the petition and requests in writing that it be filed as submitted, the 
petition shall be filed and the petitioner so notified.
    (f) A notice of the filing of a petition for a pesticide chemical 
residue tolerance that the Administrator determines has met the 
requirements of paragraph (b) of this section shall be published in the 
Federal Register by the Administrator within 30 days after such 
determination. The notice shall state the name of the pesticide chemical 
residue and the commodities for

[[Page 449]]

which a tolerance is sought and announce the availability of a 
description of the analytical methods available to the Administrator for 
the detection and measurement of the pesticide chemical residue with 
respect to which the petition is filed or shall set forth the 
petitioner's statement of why such a method is not needed. The notice 
shall explicitly reference the specific docket identification number in 
the public docket at http://www.regulations.gov where the full text of 
the summary required in paragraph (b) of this section is located, and 
refer interested parties to this document for further information on the 
petition. The full text of the summary may be omitted from the notice.
    (g) The Administrator may request a sample of the pesticide chemical 
at any time while a petition is under consideration. The Administrator 
shall specify in its request for a sample of the pesticide chemical, a 
quantity which it deems adequate to permit tests of analytical methods 
used to determine residues of the pesticide chemical and of methods 
proposed by the petitioner for removing any residues of the chemical 
that exceed the tolerance proposed.
    (h) The Administrator shall determine, in accordance with the Act, 
whether to issue an order that establishes, modifies, or revokes a 
tolerance regulation (whether or not in accord with the action proposed 
by the petitioner), whether to publish a proposed tolerance regulation 
and request public comment thereon under Sec. 180.29, or whether to 
deny the petition. The Administrator shall publish in the Federal 
Register such order or proposed regulation. After receiving comments on 
any proposed regulation, the Administrator may issue an order that 
establishes, modifies, or revokes a tolerance regulation. An order 
published under this section shall describe briefly how to submit 
objections and requests for a hearing under part 178 of this chapter. A 
regulation issued under this section shall be effective on the date of 
publication in the Federal Register unless otherwise provided in the 
regulation.

[70 FR 33360, June 8, 2005, as amended at 73 FR 75600, Dec. 12, 2008]



Sec. 180.8  Withdrawal of petitions without prejudice.

    In some cases the Administrator will notify the petitioner that the 
petition, while technically complete, is inadequate to justify the 
establishment of a tolerance or the tolerance requested by petitioner. 
This may be due to the fact that the data are not sufficiently clear or 
complete. In such cases, the petitioner may withdraw the petition 
pending its clarification or the obtaining of additional data. This 
withdrawal may be without prejudice to a future filing. A deposit for 
fees as specified in Sec. 180.33 shall accompany the resubmission of 
the petition.

[70 FR 33361, June 8, 2005]



Sec. 180.9  Substantive amendments to petitions.

    After a petition has been filed, the petitioner may submit 
additional information or data in support thereof, but in such cases the 
petition will be given a new filing date.

[70 FR 33361, June 8, 2005]



Sec. 180.29  Establishment, modification, and revocation of tolerance on initiative of Administrator.

    (a) Upon the Administrator's own initiative, the Administrator may 
propose, under FFDCA section 408(e), the issuance of a regulation 
establishing a tolerance for a pesticide chemical or exempting it from 
the necessity of a tolerance, or a regulation modifying or revoking an 
existing tolerance or exemption.
    (b) The Administrator shall provide a period of not less than 60 
days for persons to comment on the proposed regulation, except that a 
shorter period for comment may be provided if the Administrator for good 
cause finds that it would be in the public interest to do so and states 
the reasons for the finding in the notice of proposed rulemaking.
    (c) After reviewing any timely comments received, the Administrator 
may by order establish, modify, or revoke a tolerance regulation, which 
order and regulation shall be published in the Federal Register. An 
order published

[[Page 450]]

under this section shall state that persons may submit objections and 
requests for a hearing in the manner described in part 178 of this 
chapter.
    (d) Any final regulation issued under this section shall be 
effective on the date of publication in the Federal Register unless 
otherwise provided in the regulation.

[70 FR 33361, June 8, 2005]



Sec. 180.30  Judicial review.

    (a) Under FFDCA section 408(h), judicial review is available in the 
United States Courts of Appeal as to the following actions:
    (1) Regulations establishing general procedures and requirements 
under FFDCA section 408(e)(1)(C).
    (2) Orders issued under FFDCA section 408(f)(1)(C) requiring the 
submission of data.
    (3) Orders issued under FFDCA section 408(g)(2)(C) ruling on 
objections to establishment, modification, or revocation of a tolerance 
or exemption under FFDCA section 408(d)(4), or any regulation that is 
the subject of such an order. The underlying action here is Agency 
disposition of a petition seeking the establishment, modification, or 
revocation of a tolerance or exemption.
    (4) Orders issued under FFDCA section 408(g)(2)(C) ruling on 
objections to the denial of a petition under FFDCA section 408(d)(4).
    (5) Orders issued under FFDCA section 408(g)(2)(C) ruling on 
objections to the establishment, modification, suspension, or revocation 
of a tolerance or exemption under FFDCA section 408(e)(1)(A) or 
(e)(1)(B). The underlying action here is the establishment, 
modification, suspension, or revocation of a tolerance or exemption upon 
the initiative of EPA including EPA actions pursuant to FFDCA sections 
408(b)(2)(B)(v), 408(b)(2)(E)(ii), 408(d)(4)(C)(ii), 408(l)(4), and 
408(q)(1).
    (6) Orders issued under FFDCA section 408(g)(2)(C) ruling on 
objections to the revocation or modification of a tolerance or exemption 
under FFDCA section 408(f)(2) for noncompliance with requirements for 
the submission of data.
    (7) Orders issued under FFDCA section 408(g)(2)(C) ruling on 
objections to rules issued under FFDCA sections 408(n)(3) and 408(d) or 
(e) regarding determinations pertaining to State authority to establish 
regulatory limits on pesticide chemical residues.
    (8) Orders issued under FFDCA section 408(g)(2)(C) ruling on 
objections to orders issued under FFDCA section 408(n)(5)(C) authorizing 
States to establish regulatory limits not identical to certain 
tolerances or exemptions.
    (b) Any issue as to which review is or was obtainable under 
paragraph (a) of this section shall not be the subject of judicial 
review under any other provision of law. In part, this means that, for 
the Agency actions subject to the objection procedure in FFDCA section 
408(g)(2), judicial review is not available unless an adversely affected 
party exhausts these objection procedures, and any petition procedures 
preliminary thereto.

[70 FR 33362, June 8, 2005]



Sec. 180.31  Temporary tolerances.

    (a) A temporary tolerance (or exemption from a tolerance) 
established under the authority of FFDCA section 408(r) shall be deemed 
to be a tolerance (or exemption from the requirement of a tolerance) for 
the purposes of FFDCA section 408(a)(1) or (a)(2) and for the purposes 
of Sec. 180.30.
    (b) A request for a temporary tolerance or a temporary exemption 
from a tolerance by a person who has obtained or is seeking an 
experimental permit for a pesticide chemical under the Federal 
Insecticide, Fungicide, and Rodenticide Act shall be accompanied by such 
data as are available on subjects outlined in Sec. 180.7(b) and an 
advance deposit to cover fees as provided in Sec. 180.33.
    (c) To obtain a temporary tolerance, a requestor must comply with 
the petition procedures specified in FFDCA section 408(d) and Sec. 
180.7 except as provided in this section.
    (d) A temporary tolerance or exemption from a tolerance may be 
issued for a period designed to allow the orderly marketing of the raw 
agricultural commodities produced while testing a pesticide chemical 
under an experimental permit issued under authority of the Federal 
Insecticide, Fungicide, and Rodenticide Act if the Administrator 
concludes that the safety standard in

[[Page 451]]

FFDCA section 408(b)(2) or (c), as applicable, is met. Subject to the 
requirements of FFDCA section 408(e), a temporary tolerance or exemption 
from a tolerance may be revoked if the experimental permit is revoked, 
or may be revoked at any time if it develops that the application for a 
temporary tolerance contains a misstatement of a material fact or that 
new scientific data or experience with the pesticide chemical indicates 
that it does not meet the safety standard in FFDCA section 408(b)(2) or 
(c), as applicable.
    (e) Conditions under which a temporary tolerance is established 
shall include:
    (1) A limitation on the amount of the chemical to be used on the 
designated crops permitted under the experimental permit.
    (2) A limitation for the use of the chemical on the designated crops 
to bona fide experimental use by qualified persons as indicated in the 
experimental permit.
    (3) A requirement that the person or firm which obtains the 
experimental permit for which the temporary tolerance is established 
will immediately inform the Environmental Protection Agency of any 
reports on findings from the experimental use that have a bearing on 
safety.
    (4) A requirement that the person or firm which obtained the 
experimental permit for which the temporary tolerance is established 
will keep records of production, distribution, and performance for a 
period of 2 years and, on request, at any reasonable time, make these 
records available to any authorized officer or employee of the 
Environmental Protection Agency.

[70 FR 33362, June 8, 2005]



Sec. 180.32  Procedure for modifying and revoking tolerances or exemptions 

from tolerances.

    (a) The Administrator on his/her own initiative may propose the 
issuance of a regulation modifying or revoking a tolerance for a 
pesticide chemical residue on raw agricultural commodities or processed 
foods or modifying or revoking an exemption from tolerance for such 
residue.
    (b) Any person may file with the Administrator a petition proposing 
the issuance of a regulation modifying or revoking a tolerance or 
exemption from a tolerance for a pesticide chemical residue. The 
petition shall furnish reasonable grounds for the action sought. 
Reasonable grounds shall include an explanation showing wherein the 
person has a substantial interest in such tolerance or exemption from 
tolerance and an assertion of facts (supported by data if available) 
showing that new uses for the pesticide chemical have been developed or 
old uses abandoned, that new data are available as to toxicity of the 
chemical, or that experience with the application of the tolerance or 
exemption from tolerance may justify its modification or revocation. 
Evidence that a person has registered or has submitted an application 
for the registration of a pesticide under the Federal Insecticide, 
Fungicide, and Rodenticide Act will be regarded as evidence that the 
person has a substantial interest in a tolerance or exemption from the 
requirement of a tolerance for a pesticide chemical that consists in 
whole or in part of the pesticide. New data should be furnished in the 
form specified in Sec. 180.7(b) for submitting petitions, as 
applicable.
    (c) The procedures for completing action on an Administrator 
initiated proposal or a petition shall be those specified in Sec. Sec. 
180.29 and 180.7, as applicable.

[70 FR 33362, June 8, 2005]



Sec. 180.33  Fees.

    (a) Each petition for the establishment of a new tolerance or a 
tolerance higher than already established, shall be accompanied by a fee 
of $80,950, plus $2,025 for each raw agricultural commodity more than 
nine on which the establishment of a tolerance is requested, except as 
provided in paragraphs (b), (d), and (h) of this section.
    (b) Each petition for the establishment of a tolerance at a lower 
numerical level or levels than a tolerance already established for the 
same pesticide chemical, or for the establishment of a tolerance on 
additional raw agricultural commodities at the same numerical level as a 
tolerance already established for the same pesticide chemical, shall be 
accompanied by a fee of $18,500 plus $1,225 for each raw

[[Page 452]]

agricultural commodity on which a tolerance is requested.
    (c) Each petition for an exemption from the requirement of a 
tolerance or repeal of an exemption shall be accompanied by a fee of 
$14,925.
    (d) Each petition or request for a temporary tolerance or a 
temporary exemption from the requirement of a tolerance shall be 
accompanied by a fee of $32,325 except as provided in paragraph (e) of 
this section. A petition or request to renew or extend such temporary 
tolerance or temporary exemption shall be accompanied by a fee of 
$4,600.
    (e) A petition or request for a temporary tolerance for a pesticide 
chemical which has a tolerance for other uses at the same numerical 
level or a higher numerical level shall be accompanied by a fee of 
$16,075, plus $1,225 for each raw agricultural commodity on which the 
temporary tolerance is sought.
    (f) Each petition for revocation of a tolerance shall be accompanied 
by a fee of $10,125. Such fee is not required when, in connection with 
the change sought under this paragraph, a petition is filed for the 
establishment of new tolerances to take the place of those sought to be 
revoked and a fee is paid as required by paragraph (a) of this section.
    (g) If a petition or a request is not accepted for processing 
because it is technically incomplete, the fee, less $2,025 for handling 
and initial review, shall be returned. If a petition is withdrawn by the 
petitioner after initial processing, but before significant Agency 
scientific review has begun, the fee, less $2,025 for handling and 
initial review, shall be returned. If an unacceptable or withdrawn 
petition is resubmitted, it shall be accompanied by the fee that would 
be required if it were being submitted for the first time.
    (h) Each petition for a crop group tolerance, regardless of the 
number of raw agricultural commodities involved, shall be accompanied by 
a fee equal to the fee required by the analogous category for a single 
tolerance that is not a crop group tolerance, i.e., paragraphs (a) 
through (f) of this section, without a charge for each commodity where 
that would otherwise apply.
    (i) Objections under section 408(d)(5) of the Act shall be 
accompanied by a filing fee of $4,050.
    (j) The person who files a petition for judicial review of an order 
under section 408(h) of the Act shall pay the costs of preparing the 
record on which the order is based unless the person has no financial 
interest in the petition for judicial review.
    (k) No fee under this section will be imposed on the Interregional 
Research Project Number 4 (IR-4 Program).
    (l) The Administrator may waive or refund part or all of any fee 
imposed by this section if the Administrator determines in his or her 
sole discretion that such a waiver or refund will promote the public 
interest or that payment of the fee would work an unreasonable hardship 
on the person on whom the fee is imposed. A request for waiver or refund 
of a fee shall be submitted to the Office of Pesticide Programs' 
Document Processing Desk at the appropriate address as set forth in 40 
CFR 150.17(a) or (b). A fee of $2,025 shall accompany every request for 
a waiver or refund, as specified in paragraph (m) of this section, 
except that the fee under this paragraph shall not be imposed on any 
person who has no financial interest in any action requested by such 
person under paragraphs (a) through (j) of this section. The fee for 
requesting a waiver or refund shall be refunded if the request is 
granted.
    (m) All deposits and fees required by the regulations in this part 
shall be paid by money order, bank draft, or certified check drawn to 
the order of the Environmental Protection Agency. All deposits and fees 
shall be forwarded to the Environmental Protection Agency, Headquarters 
Accounting Operations Branch, Office of Pesticide Programs (Tolerance 
Fees), P.O. Box 360277M, Pittsburgh, PA 15251. The payments should be 
specifically labeled ``Tolerance Petition Fees'' and should be 
accompanied only by a copy of the letter or petition requesting the 
tolerance. The actual letter or petition, along with supporting data, 
shall be forwarded within 30 days of payment to the Office of Pesticide 
Programs' Document Processing Desk at the appropriate address as set 
forth in 40 CFR 150.17(a) or (b). A petition will not be

[[Page 453]]

accepted for processing until the required fees have been submitted. A 
petition for which a waiver of fees has been requested will not be 
accepted for processing until the fee has been waived or, if the waiver 
has been denied, the proper fee is submitted after notice of denial. A 
request for waiver or refund will not be accepted after scientific 
review has begun on a petition.
    (n) This fee schedule will be changed annually by the same 
percentage as the percent change in the Federal General Schedule (GS) 
pay scale. In addition, processing costs and fees will periodically be 
reviewed and changes will be made to the schedule as necessary. When 
automatic adjustments are made based on the GS pay scale, the new fee 
schedule will be published in the Federal Register as a final rule to 
become effective 30 days or more after publication, as specified in the 
rule. When changes are made based on periodic reviews, the changes will 
be subject to public comment.
    (o) No fee required by this section shall be levied during the 
period beginning on October 1, 2003, and ending September 30, 2008.

[68 FR 24371, May 7, 2003, as amended at 69 FR 12544, Mar. 17, 2004; 70 
FR 33363, June 8, 2005; 71 FR 35547, June 21, 2006]



Sec. 180.34  Tests on the amount of residue remaining.

    (a) Data in a petition on the amount of residue remaining in or on a 
raw agricultural commodity should establish the residue that may remain 
when the pesticide chemical is applied according to directions 
registered under the Federal Insecticide, Fungicide, and Rodenticide 
Act, or according to directions contained in an application for 
registration. These data should establish the residues that may remain 
under conditions most likely to result in high residues on the 
commodity.
    (b) The petition should establish the reliability of the residue 
data reported in it. Sufficient information should be submitted about 
the analytical method to permit competent analysts to apply it 
successfully.
    (c) If the pesticide chemical is absorbed into a living plant or 
animal when applied (is systemic), residue data may be needed on each 
plant or animal on which a tolerance or exemption is requested.
    (d) If the pesticide chemical is not absorbed into the living plant 
or animal when applied (is not systemic), it may be possible to make a 
reliable estimate of the residues to be expected on each commodity in a 
group of related commodities on the basis of less data than would be 
required for each commodity in the group, considered separately.
    (e) Each of the following groups of crops lists raw agricultural 
commodities that are considered to be related for the purpose of 
paragraph (d) of this section. Commodities not listed in this paragraph 
are not considered to be related for the purpose of paragraph (d) of 
this section.
    (1) Apples, crabapples, pears, quinces.
    (2) Avocados, papayas.
    (3) Blackberries, boysenberries, dewberries, loganberries, 
raspberries.
    (4) Blueberries, currants, gooseberries, huckleberries.
    (5) Cherries, plums, prunes.
    (6) Oranges, citrus citron, grapefruit, kumquats, lemons, limes, 
tangelos, tangerines.
    (7) Mangoes, persimmons.
    (8) Peaches, apricots, nectarines.
    (9) Beans, peas, soybeans (each in dry form).
    (10) Beans, peas, soybeans (each in succulent form).
    (11) Broccoli, brussels sprouts, cauliflower, kohlrabi.
    (12) Cantaloups, honeydew melons, muskmelons, pumpkins, watermelons, 
winter squash.
    (13) Carrots, garden beets, sugar beets, horseradish, parsnips, 
radishes, rutabagas, salsify roots, turnips.
    (14) Celery, fennel.
    (15) Cucumbers, summer squash.
    (16) Lettuce, endive (escarole), Chinese cabbage, salsify tops.
    (17) Onions, garlic, leeks, shallots (green, or in dry bulb form).
    (18) Potatoes, Jerusalem-artichokes, sweetpotatoes, yams.
    (19) Spinach, beet tops, collards, dandelion, kale, mustard greens, 
parsley, Swiss chard, turnip tops, watercress.
    (20) Tomatoes, eggplants, peppers, pimentos.

[[Page 454]]

    (21) Pecans, almonds, brazil nuts, bush nuts, butternuts, chestnuts, 
filberts, hazelnuts, hickory nuts, walnuts.
    (22) Field corn, popcorn, sweet corn (each in grain form).
    (23) Milo, sorghum (each in grain form).
    (24) Wheat, barley, oats, rice, rye (each in grain form).
    (25) Alfalfa, Bermuda grass, bluegrass, brome grass, clovers, cowpea 
hay, fescue, lespedeza, lupines, orchard grass, peanut hay, peavine hay, 
rye grass, soybean hay, sudan grass, timothy, and vetch.
    (26) Corn forage, sorghum forage.
    (27) Sugarcane, cane sorghum.

[36 FR 22540, Nov. 25, 1971, as amended at 39 FR 28286, Aug. 6, 1974; 39 
FR 28977, Aug. 13, 1974; 40 FR 6972, Feb. 18, 1975; 45 FR 82928, Dec. 
17, 1980; 48 FR 29860, June 29, 1983; 60 FR 26635, May 17, 1995; 73 FR 
75600, Dec. 12, 2008]



Sec. 180.35  Tests for potentiation.

    Experiments have shown that certain cholinesterase-inhibiting 
pesticides when fed together to test animals are more toxic than the sum 
of their individual toxicities when fed separately. One substance 
potentiates the toxicity of the other. Important toxicological 
interactions also have been observed between pesticides and other 
substances. Wherever there is reason to believe that a pesticide 
chemical for which a tolerance is proposed may interact with other 
pesticide chemicals or other substances to which man is exposed, it may 
be necessary to require special experimental data regarding potentiation 
capacities to evaluate the safety of the proposed tolerance. This 
necessarily will be determined on a case-by-case basis.



Sec. 180.40  Tolerances for crop groups.

    (a) Group or subgroup tolerances may be established as a result of:
    (1) A petition from a person who has submitted an application for 
the registration of a pesticide under the Federal Insecticide, 
Fungicide, and Rodenticide Act.
    (2) On the initiative of the Administrator.
    (3) A petition by an interested person.
    (b) The tables in Sec. 180.41 are to be used in conjunction with 
this section for the establishment of crop group tolerances. Each table 
in Sec. 180.41 lists a group of raw agricultural commodities that are 
considered to be related for the purposes of this section. Refer also to 
Sec. 180.1(g) for a listing of commodities for which established 
tolerances may be applied to certain other related and similar 
commodities.
    (c) When there is an established or proposed tolerance for all of 
the representative commodities for a specific group or subgroup of 
related commodities, a tolerance may be established for all commodities 
in the associated group or subgroup. Tolerances may be established for a 
crop group or, alternatively, tolerances may be established for one or 
more of the subgroups of a crop group.
    (d) The representative crops are given as an indication of the 
minimum residue chemistry data base acceptable to the Agency for the 
purposes of establishing a group tolerance. The Agency may, at its 
discretion, allow group tolerances when data on suitable substitutes for 
the representative crops are available (e.g., limes instead of lemons).
    (e) Since a group tolerance reflects maximum residues likely to 
occur on all individual crops within a group, the proposed or registered 
patterns of use for all crops in the group or subgroup must be similar 
before a group tolerance is established. The pattern of use consists of 
the amount of pesticide applied, the number of times applied, the timing 
of the first application, the interval between applications, and the 
interval between the last application and harvest. The pattern of use 
will also include the type of application; for example, soil or foliar 
application, or application by ground or aerial equipment.
    (f) When the crop grouping contains commodities or byproducts that 
are utilized for animal feed, any needed tolerance or exemption from a 
tolerance for the pesticide in meat, milk, poultry and/or eggs must be 
established before a tolerance will be granted for the group as a whole. 
The representative crops include all crops in the group that could be 
processed such

[[Page 455]]

that residues may concentrate in processed food and/or feed. Processing 
data will be required prior to establishment of a group tolerance. 
Tolerances will not be granted on a group basis as to processed foods 
prepared from crops covered by the group tolerance.
    (g) If maximum residues (tolerances) for the representative crops 
vary by more than a factor of 5 from the maximum value observed for any 
crop in the group, a group or subgroup tolerance will ordinarily not be 
established. In this case individual crop tolerances, rather than group 
tolerances, will normally be established.
    (h) Alternatively, a commodity with a residue level significantly 
higher or lower than the other commodities in a group may be excluded 
from the group tolerance (e.g., cereal grains, except corn). In this 
case an individual tolerance at the appropriate level for the unique 
commodity would be established, if necessary. The alternative approach 
of excluding a commodity with a significantly higher or lower residue 
level will not be used to establish a tolerance for a commodity 
subgroup. Most subgroups have only two representative commodities; to 
exclude one such commodity and its related residue data would likely 
provide insufficient residue information to support the remainder of the 
subgroup. Residue data from crops additional to those representative 
crops in a grouping may be required for systemic pesticides.
    (i) The commodities included in the groups will be updated 
periodically either at the initiative of the Agency or at the request of 
an interested party. Persons interested in updating this section should 
contact the Registration Division of the Office of Pesticide Programs.
    (j) When EPA amends a crop group in a manner that expands or 
contracts the commodities that are covered by the group, EPA will 
initially retain the pre-existing as well as the revised crop group in 
the CFR. The revised crop group will have the same number as the pre-
existing crop group; however, the revised crop group number will be 
followed by a hyphen and the final two digits of the year in which it 
was established (e.g., if Crop Group 1 is amended in 2007, the revised 
group will be designated as Crop Group 1-07). If the pre-existing crop 
group had crop subgroups, these subgroups will be numbered in a similar 
fashion in the revised crop group. The name of the revised crop group 
will not be changed from the pre-existing crop group unless the revision 
so changes the composition of the crop group that the pre-existing name 
is no longer accurate. Once a revised crop group is established, EPA 
will no longer establish tolerances under the pre-existing crop group. 
At appropriate times, EPA will amend tolerances for crop groups that 
have been superseded by revised crop groups to conform the pre-existing 
crop group to the revised crop group. Once all of the tolerances for the 
pre-existing crop group have been updated, the pre-existing crop group 
will be removed from the CFR.
    (k) Establishment of a tolerance does not substitute for the 
additional need to register the pesticide under a companion law, the 
Federal Insecticide, Fungicide, and Rodenticide Act. The Registration 
Division of the Office of Pesticide Programs should be contacted 
concerning procedures for registration of new uses of a pesticide.

[60 FR 26635, May 17, 1995, as amended at 70 FR 33363, June 8, 2005; 72 
FR 69155, Dec. 7, 2007; 75 FR 56014, Sept. 15, 2010]



Sec. 180.41  Crop group tables.

    (a) The tables in this section are to be used in conjunction with 
Sec. 180.40 to establish crop group tolerances.
    (b) Commodities not listed are not considered as included in the 
groups for the purposes of this paragraph, and individual tolerances 
must be established. Miscellaneous commodities intentionally not 
included in any group include asparagus, avocado, banana, fig, globe 
artichoke, hops, mango, papaya, pawpaw, peanut, persimmon, pineapple, 
water chestnut, and watercress.
    (c) Each group is identified by a group name and consists of a list 
of representative commodities followed by a list of all commodity 
members for

[[Page 456]]

the group. If the group includes subgroups, each subgroup lists the 
subgroup name, the representative commodity or commodities, and the 
member commodities for the subgroup. Subgroups, which are a subset of 
their associated crop group, are established for some but not all crops 
groups.
    (1) Crop Group 1: Root and Tuber Vegetables Group.
    (i) Representative commodities. Carrot, potato, radish, and sugar 
beet.
    (ii) Table. The following table 1 lists all the commodities included 
in Crop Group 1 and identifies the related crop subgroups.

            Table 1--Crop Group 1: Root and Tuber Vegetables
------------------------------------------------------------------------
                                                           Related crop
                      Commodities                           subgroups
------------------------------------------------------------------------
Arracacha (Arracacia xanthorrhiza).....................           1C, 1D
Arrowroot (Maranta arundinacea)........................           1C, 1D
Artichoke, Chinese (Stachys affinis)...................           1C, 1D
Artichoke, Jerusalem (Helianthus tuberosus)............           1C, 1D
Beet, garden (Beta vulgaris)...........................           1A, 1B
Beet, sugar (Beta vulgaris)............................               1A
Burdock, edible (Arctium lappa)........................           1A, 1B
Canna, edible (Queensland arrowroot) (Canna indica)....           1C, 1D
Carrot (Daucus carota).................................           1A, 1B
Cassava, bitter and sweet (Manihot esculenta)..........           1C, 1D
Celeriac (celery root) (Apium graveolens var. rapaceum)           1A, 1B
Chayote (root) (Sechium edule).........................           1C, 1D
Chervil, turnip-rooted (Chaerophyllum bulbosum)........           1A, 1B
Chicory (Cichorium intybus)............................           1A, 1B
Chufa (Cyperus esculentus).............................           1C, 1D
Dasheen (taro) (Colocasia esculenta)...................           1C, 1D
Ginger (Zingiber officinale)...........................           1C, 1D
Ginseng (Panax quinquefolius)..........................           1A, 1B
Horseradish (Armoracia rusticana)......................           1A, 1B
Leren (Calathea allouia)...............................           1C, 1D
Parsley, turnip-rooted (Petroselinum crispum var.                 1A, 1B
 tuberosum)............................................
Parsnip (Pastinaca sativa).............................           1A, 1B
Potato (Solanum tuberosum).............................               1C
Radish (Raphanus sativus)..............................           1A, 1B
Radish, oriental (daikon) (Raphanus sativus subvar.               1A, 1B
 longipinnatus)........................................
Rutabaga (Brassica campestris var. napobrassica).......           1A, 1B
Salsify (oyster plant) (Tragopogon porrifolius)........           1A, 1B
Salsify, black (Scorzonera hispanica)..................           1A, 1B
Salsify, Spanish (Scolymus hispanicus).................           1A, 1B
Skirret (Sium sisarum).................................           1A, 1B
Sweet potato (Ipomoea batatas).........................           1C, 1D
Tanier (cocoyam) (Xanthosoma sagittifolium)............           1C, 1D
Turmeric (Curcuma longa)...............................           1C, 1D
Turnip (Brassica rapa var. rapa).......................           1A, 1B
Yam bean (jicama, manoic pea) (Pachyrhizus spp.).......           1C, 1D
Yam, true (Dioscorea spp.).............................           1C, 1D
------------------------------------------------------------------------

    (iii) Table. The following table 2 identifies the crop subgroups for 
Crop Group 1, specifies the representative commodity(ies) for each 
subgroup, and lists all the commodities included in each subgroup.

                 Table 2--Crop Group 1 Subgroup Listing
------------------------------------------------------------------------
      Representative commodities                  Commodities
------------------------------------------------------------------------
  Crop Subgroup 1A. Root vegetables
              subgroup.
Carrot, radish, and sugar beet.......  Beet, garden; beet, sugar;
                                        burdock, edible; carrot;
                                        celeriac; chervil, turnip-
                                        rooted; chicory; ginseng;
                                        horseradish; parsley, turnip-
                                        rooted; parsnip; radish; radish,
                                        oriental; rutabaga; salsify;
                                        salsify, black; salsify,
                                        Spanish; skirret; turnip.
  Crop Subgroup 1B. Root vegetables
    (except sugar beet) subgroup.
Carrot and radish....................  Beet, garden; burdock, edible;
                                        carrot; celeriac; chervil,
                                        turnip-rooted; chicory; ginseng;
                                        horseradish; parsley, turnip-
                                        rooted; parsnip; radish; radish,
                                        oriental; rutabaga; salsify;
                                        salsify, black; salsify,
                                        Spanish; skirret; turnip.

[[Page 457]]

 
 Crop Subgroup 1C. Tuberous and corm
         vegetables subgroup.
Potato...............................  Arracacha; arrowroot; artichoke,
                                        Chinese; artichoke, Jerusalem;
                                        canna, edible; cassava, bitter
                                        and sweet; chayote (root);
                                        chufa; dasheen; ginger; leren;
                                        potato; sweet potato; tanier;
                                        turmeric; yam bean; yam, true.
 Crop Subgroup 1D. Tuberous and corm
 vegetables (except potato) subgroup.
Sweet potato.........................  Arracacha; arrowroot; artichoke,
                                        Chinese; artichoke, Jerusalem;
                                        canna, edible; cassava, bitter
                                        and sweet; chayote (root);
                                        chufa; dasheen; ginger; leren;
                                        sweet potato; tanier; turmeric;
                                        yam bean; yam, true.
------------------------------------------------------------------------

    (2) Crop Group 2. Leaves of Root and Tuber Vegetables (Human Food or 
Animal Feed) Group (Human Food or Animal Feed) Group.
    (i) Representative commodities. Turnip and garden beet or sugar 
beet.
    (ii) Commodities. The following is a list of all the commodities 
included in Crop Group 2:

Crop Group 2: Leaves of Root and Tuber Vegetables (Human Food or Animal 
                        Feed) Group--Commodities

Beet, garden (Beta vulgaris)
Beet, sugar (Beta vulgaris)
Burdock, edible (Arctium lappa)
Carrot (Daucus carota)
Cassava, bitter and sweet (Manihot esculenta)
Celeriac (celery root) (Apium graveolens var. rapaceum)
Chervil, turnip-rooted (Chaerophyllum bulbosum)
Chicory (Cichorium intybus)
Dasheen (taro) (Colocasia esculenta)
Parsnip (Pastinaca sativa)
Radish (Raphanus sativus)
Radish, oriental (daikon) (Raphanus sativus subvar. longipinnatus)
Rutabaga (Brassica campestris var. napobrassica)
Salsify, black (Scorzonera hispanica)
Sweet potato (Ipomoea batatas)
Tanier (cocoyam) (Xanthosoma sagittifolium)
Turnip (Brassica rapa var. rapa)
Yam, true (Dioscorea spp.)

    (3) Crop Group 3. Bulb Vegetables (Allium spp.) Group.
    (i) Representative commodities. Onion, green; and onion, dry bulb.
    (ii) Commodities. The following is a list of all the commodities in 
Crop Group 3.

      Crop Group 3: Bulb Vegetable (Allium spp.) Group--Commodities
Garlic, bulb (Allium sativum)
Garlic, great headed, (elephant) (Allium ampeloprasum var. ampeloprasum)
Leek (Allium ampeloprasum, A. porrum, A. tricoccum)
Onion, dry bulb and green (Allium cepa, A. fistulosum)
Onion, Welsh, (Allium fistulosum)
Shallot (Allium cepa var. cepa)
 

    (4) Crop Group 3-07. Bulb Vegetable Group.
    (i) Representative Commodities. Onion, bulb and onion, green.
    (ii) Table. The following Table 1 lists all the commodities listed 
in Crop Group 3-07 and identifies the related crop subgroups.

             Table 1--Crop Group 3-07: Bulb Vegetable Group
------------------------------------------------------------------------
                  Commodities                     Related crop subgroups
------------------------------------------------------------------------
Chive, fresh leaves (Allium schoenoprasum L.)..                    3-07B
Chive, Chinese, fresh leaves (Allium tuberosum                     3-07B
 Rottler ex Spreng)............................
Daylily, bulb (Hemerocallis fulva (L.) L. var.                     3-07A
 fulva)........................................
Elegans hosta (Hosta Sieboldiana (Hook.) Engl).                    3-07B
Fritillaria, bulb (Fritillaria L. fritillary)..                    3-07A
Fritillaria, leaves (Fritillaria L. fritillary)                    3-07B
Garlic, bulb (Allium sativum L. var. sativum)                      3-07A
 (A. sativum Common Garlic Group)..............
Garlic, great headed, bulb (Allium ampeloprasum                    3-07A
 L. var. ampeloprasum) (A. ampeloprasum Great
 Headed Garlic Group)..........................
Garlic, Serpent, bulb (Allium sativum var.                         3-07A
 ophioscorodon or A. sativum Ophioscorodon
 Group)........................................
Kurrat (Allium kurrat Schweinf. Ex. K. Krause                      3-07B
 or A. ampeloprasum Kurrat Group)..............
Lady's leek (Allium cernuum Roth)..............                    3-07B
Leek Allium porrum L. (syn: A. ampeloprasum L.                     3-07B
 var. porrum (L.) J. Gay) (A.ampeloprasum Leek
 Group)........................................
Leek, wild (Allium tricoccum Aiton)............                    3-07B
Lily, bulb (Lilium spp. (Lilium Leichtlinii                        3-07A
 var. maximowiczii, Lilium lancifolium)).......

[[Page 458]]

 
Onion, Beltsville bunching (Allium x proliferum                    3-07B
 (Moench) Schrad.) (syn: Allium fistulosum L. x
 A. cepa L.)...................................
Onion, bulb (Allium cepa L. var. cepa) (A. cepa                    3-07A
 Common Onion Group)...........................
Onion, Chinese, bulb (Allium chinense G. Don.)                     3-07A
 (syn: A. bakeri Regel)........................
Onion, fresh (Allium fistulosum L. var.                            3-07B
 caespitosum Makino)...........................
Onion, green (Allium cepa L. var. cepa) (A.                        3-07B
 cepa Common Onion Group)......................
Onion, macrostem (Allium macrostemom Bunge)....                    3-07B
Onion, pearl (Allium porrum var. sectivum or A.                    3-07A
 ampeloprasum Pearl Onion Group)...............
Onion, potato, bulb (Allium cepa L. var.                           3-07A
 aggregatum G. Don.) (A. cepa Aggregatum Group)
Onion, tree, tops (Allium x proliferum (Moench)                    3-07B
 Schrad. ex Willd.) (syn: A. cepa var.
 proliferum (Moench) Regel; A. cepa L. var.
 bulbiferum L.H. Bailey; A. cepa L. var.
 viviparum (Metz.) Alef.)......................
Onion, Welsh, tops (Allium fistulosum L.)......                    3-07B
Shallot, bulb (Allium cepa var. aggregatum G.                      3-07A
 Don.).........................................
Shallot, fresh leaves (Allium cepa var.                            3-07B
 aggregatum G. Don.)...........................
Cultivars, varieties, and/or hybrids of these..  .......................
------------------------------------------------------------------------

    (iii) Table. The following Table 2 identifies the crop subgroups for 
Crop Group 3-07, specifies the representative commodities for each 
subgroup and lists all the commodities included in each subgroup.

               Table 2--Crop Group 3-07: Subgroup Listing
------------------------------------------------------------------------
     Representative commodities                   Commodities
------------------------------------------------------------------------
Crop subgroup 3-07A. Onion, bulb,     Daylily, bulb; fritillaria, bulb;
 subgroup.                             garlic, bulb; garlic, great-
Onion, bulb.........................   headed, bulb; garlic, serpent,
                                       bulb; lily, bulb; onion, bulb;
                                       onion, Chinese, bulb; onion,
                                       pearl; onion, potato, bulb;
                                       shallot, bulb; cultivars,
                                       varieties, and/or hybrids of
                                       these.
Crop subgroup 3-07B. Onion, green,    Chive, fresh leaves; chive,
 subgroup.                             Chinese, fresh leaves; elegans
Onion, green........................   hosta; fritillaria, leaves;
                                       kurrat; lady's leek; leek; leek,
                                       wild; Onion, Beltsville bunching;
                                       onion, fresh; onion, green;
                                       onion, macrostem; onion, tree,
                                       tops; onion, Welsh, tops;
                                       shallot, fresh leaves; cultivars,
                                       varieties, and/or hybrids of
                                       these.
------------------------------------------------------------------------

    (5) Crop Group 4. Leafy Vegetables (Except Brassica Vegetables) 
Group.
    (i) Representative commodities. Celery, head lettuce, leaf lettuce, 
and spinach (Spinacia oleracea).
    (ii) Table. The following table 1 lists all the commodities included 
in Crop Group 4 and identifies the related crop subgroups.

  Table 1--Crop Group 4: Leafy Vegetables (Except BRASSICA Vegetables)
                                  Group
------------------------------------------------------------------------
                                                           Related crop
                      Commodities                           subgroups
------------------------------------------------------------------------
Amaranth (leafy amaranth, Chinese spinach, tampala)                   4A
 (Amaranthus spp.).....................................
Arugula (Roquette) (Eruca sativa)......................               4A
Cardoon (Cynara cardunculus)...........................               4B
Celery (Apium graveolens var. dulce)...................               4B
Celery, Chinese (Apium graveolens var. secalinum)......               4B
Celtuce (Lactuca sativa var. angustana)................               4B
Chervil (Anthriscus cerefolium)........................               4A
Chrysanthemum, edible-leaved (Chrysanthemum coronarium                4A
 var. coronarium)......................................
Chrysanthemum, garland (Chrysanthemum coronarium var.                 4A
 spatiosum)............................................
Corn salad (Valerianella locusta)......................               4A
Cress, garden (Lepidium sativum).......................               4A
Cress, upland (yellow rocket, winter cress) (Barbarea                 4A
 vulgaris).............................................
Dandelion (Taraxacum officinale).......................               4A
Dock (sorrel) (Rumex spp.).............................               4A
Endive (escarole) (Cichorium endivia)..................               4A
Fennel, Florence (finochio) (Foeniculum vulgare                       4B
 Azoricum Group).......................................
Lettuce, head and leaf (Lactuca sativa)................               4A
Orach (Atriplex hortensis).............................               4A
Parsley (Petroselinum crispum).........................               4A
Purslane, garden (Portulaca oleracea)..................               4A
Purslane, winter (Montia perfoliata)...................               4A
Radicchio (red chicory) (Cichorium intybus)............               4A
Rhubarb (Rheum rhabarbarum)............................               4B

[[Page 459]]

 
Spinach (Spinacia oleracea)............................               4A
Spinach, New Zealand (Tetragonia tetragonioides, T.                   4A
 expansa)..............................................
Spinach, vine (Malabar spinach, Indian spinach)                       4A
 (Basella alba)........................................
Swiss chard (Beta vulgaris var. cicla).................               4B
------------------------------------------------------------------------

    (iii) Table. The following table 2 identifies the crop subgroups for 
Crop Group 4, specifies the representative commodities for each 
subgroup, and lists all the commodities included in each subgroup.

                 Table 2--Crop Group 4 Subgroup Listing
------------------------------------------------------------------------
      Representative commodities                  Commodities
------------------------------------------------------------------------
    Crop Subgroup 4A. Leafy greens
              subgroup.
Head lettuce and leaf lettuce, and     Amaranth; arugula; chervil;
 spinach (Spinacia oleracea).           chrysanthemum, edible-leaved;
                                        chrysanthemum, garland; corn
                                        salad; cress, garden; cress,
                                        upland; dandelion; dock; endive;
                                        lettuce; orach; parsley;
                                        purslane, garden; purslane,
                                        winter; radicchio (red chicory);
                                        spinach; spinach, New Zealand;
                                        spinach, vine.
   Crop Subgroup 4B. Leaf petioles
              subgroup.
Celery...............................  Cardoon; celery; celery, Chinese;
                                        celtuce; fennel, Florence;
                                        rhubarb; Swiss chard.
------------------------------------------------------------------------

    (6) Crop Group 5. Brassica (Cole) Leafy Vegetables Group.
    (i) Representative commodities. Broccoli or cauliflower; cabbage; 
and mustard greens.
    (ii) Table. The following table 1 lists all the commodities included 
in Crop Group 5 and identifies the related crop subgroups.

         Table 1--Crop Group 5: Brassica (Cole) Leafy Vegetables
------------------------------------------------------------------------
                                                           Related crop
                      Commodities                           subgroups
------------------------------------------------------------------------
Broccoli (Brassica oleracea var. botrytis).............               5A
Broccoli, Chinese (gai lon) (Brassica alboglabra)......               5A
Broccoli raab (rapini) (Brassica campestris)...........               5B
Brussels sprouts (Brassica oleracea var. gemmifera)....               5A
Cabbage (Brassica oleracea)............................               5A
Cabbage, Chinese (bok choy) (Brassica chinensis).......               5B
Cabbage, Chinese (napa) (Brassica pekinensis)..........               5A
Cabbage, Chinese mustard (gai choy) (Brassica                         5A
 campestris)...........................................
Cauliflower (Brassica oleracea var. botrytis)..........               5A
Cavalo broccolo (Brassica oleracea var. botrytis)......               5A
Collards (Brassica oleracea var. acephala).............               5B
Kale (Brassica oleracea var. acephala).................               5B
Kohlrabi (Brassica oleracea var. gongylodes)...........               5A
Mizuna (Brassica rapa Japonica Group)..................               5B
Mustard greens (Brassica juncea).......................               5B
Mustard spinach (Brassica rapa Perviridis Group).......               5B
Rape greens (Brassica napus)...........................               5B
------------------------------------------------------------------------

    (iii) Table. The following table 2 identifies the crop subgroups for 
Crop Group 5, specifies the representative commodity(ies) for each 
subgroup, and lists all the commodities included in each subgroup.

[[Page 460]]



                 Table 2--Crop Group 5 Subgroup Listing
------------------------------------------------------------------------
      Representative commodities                  Commodities
------------------------------------------------------------------------
   Crop Subgroup 5A. Head and stem
          Brassica subgroup
Broccoli or cauliflower; and cabbage.  Broccoli; broccoli, Chinese;
                                        brussels sprouts; cabbage;
                                        cabbage, Chinese (napa);
                                        cabbage, Chinese mustard;
                                        cauliflower; cavalo broccolo;
                                        kohlrabi
 
   Crop Subgroup 5B. Leafy Brassica
           greens subgroup.
Mustard greens.......................  Broccoli raab; cabbage, Chinese
                                        (bok choy); collards; kale;
                                        mizuna; mustard greens; mustard
                                        spinach; rape greens
------------------------------------------------------------------------

    (7) Crop Group 6. Legume Vegetables (Succulent or Dried) Group.
    (i) Representative commodities. Bean (Phaseolus spp.; one succulent 
cultivar and one dried cultivar); pea (Pisum spp.; one succulent 
cultivar and one dried cultivar); and soybean.
    (ii) Table. The following table 1 lists all the commodities included 
in Crop Group 6 and identifies the related crop subgroups.

      Table 1--Crop Group 6: Legume Vegetables (Succulent or Dried)
------------------------------------------------------------------------
                                                           Related crop
                      Commodities                           subgroups
------------------------------------------------------------------------
Bean (Lupinus spp.) (includes grain lupin, sweet lupin,               6C
 white lupin, and white sweet lupin)...................
Bean (Phaseolus spp.) (includes field bean, kidney            6A, 6B, 6C
 bean, lima bean, navy bean, pinto bean, runner bean,
 snap bean, tepary bean, wax bean).....................
Bean (Vigna spp.) (includes adzuki bean, asparagus            6A, 6B, 6C
 bean, blackeyed pea, catjang, Chinese longbean,
 cowpea, Crowder pea, moth bean, mung bean, rice bean,
 southern pea, urd bean, yardlong bean)................
Broad bean (fava bean) (Vicia faba)....................           6B, 6C
Chickpea (garbanzo bean) (Cicer arietinum).............               6C
Guar (Cyamopsis tetragonoloba).........................               6C
Jackbean (Canavalia ensiformis)........................               6A
Lablab bean (hyacinth bean) (Lablab purpureus).........               6C
Lentil (Lens esculenta)................................               6C
Pea (Pisum spp.) (includes dwarf pea, edible-pod pea,         6A, 6B, 6C
 En glish pea, field pea, garden pea, green pea, snow
 pea, sugar snap pea)..................................
Pigeon pea (Cajanus cajan).............................       6A, 6B, 6C
Soybean (Glycine max)..................................              N/A
Soybean (immature seed) (Glycine max)..................               6A
Sword bean (Canavalia gladiata)........................               6A
------------------------------------------------------------------------

    (iii) Table. The following table 2 identifies the crop subgroups for 
Crop Group 6, specifies the representative commodities for each 
subgroup, and lists all the commodities included in each subgroup.

                 Table 2--Crop Group 6 Subgroup Listing
------------------------------------------------------------------------
      Representative commodities                  Commodities
------------------------------------------------------------------------
   Crop Subgroup 6A. Edible-podded
     legume vegetables subgroup.
Any one succulent cultivar of edible-  Bean (Phaseolus spp.) (includes
 podded bean (Phaseolus spp.) and any   runner bean, snap bean, wax
 one succulent cultivar of edible-      bean); bean (Vigna spp.)
 podded pea (Pisum spp.)..              (includes asparagus bean,
                                        Chinese longbean, moth bean,
                                        yardlong bean); jackbean; pea
                                        (Pisum spp.) (includes dwarf
                                        pea, edible-pod pea, snow pea,
                                        sugar snap pea); pigeon pea;
                                        soybean (immature seed); sword
                                        bean.
 
 Crop Subgroup 6B. Succulent shelled
        pea and bean subgroup.
Any succulent shelled cultivar of      Bean (Phaseolus spp.) (includes
 bean (Phaseolus spp.) and garden pea   lima bean (green)); broad bean
 (Pisum spp.)..                         (succulent); bean (Vigna spp.)
                                        (includes blackeyed pea, cowpea,
                                        southern pea); pea (Pisum spp.)
                                        (includes English pea, garden
                                        pea, green pea); pigeon pea.
 

[[Page 461]]

 
 Crop Subgroup 6C. Dried shelled pea
  and bean (except soybean) subgroup
Any one dried cultivar of bean         Dried cultivars of bean (Lupinus
 (Phaseolus spp.); and any one dried    spp.) (includes grain lupin,
 cultivar of pea (Pisum spp.).          sweet lupin, white lupin, and
                                        white sweet lupin); (Phaseolus
                                        spp.) (includes field bean,
                                        kidney bean, lima bean (dry),
                                        navy bean, pinto bean; tepary
                                        bean; bean (Vigna spp.)
                                        (includes adzuki bean, blackeyed
                                        pea, catjang, cowpea, Crowder
                                        pea, moth bean, mung bean, rice
                                        bean, southern pea, urd bean);
                                        broad bean (dry); chickpea;
                                        guar; lablab bean; lentil; pea
                                        (Pisum spp.) (includes field
                                        pea); pigeon pea.
------------------------------------------------------------------------

    (8) Crop Group 7. Foliage of Legume Vegetables Group.
    (i) Representative commodities. Any cultivar of bean (Phaseolus 
spp.), field pea (Pisum spp.), and soybean.
    (ii) Table. The following table 1 lists the commodities included in 
Crop Group 7.

        Table 1--Crop Group 7: Foliage of Legume Vegetables Group
------------------------------------------------------------------------
      Representative commodities                  Commodities
------------------------------------------------------------------------
Any cultivar of bean (Phaseolus spp.)  Plant parts of any legume
 and field pea (Pisum spp.), and        vegetable included in the legume
 soybean (Glycine max).                 vegetables that will be used as
                                        animal feed.
------------------------------------------------------------------------

    (iii) Table. The following table 2 identifies the crop subgroup for 
Crop Group 7 and specifies the representative commodities for the 
subgroup, and lists all the commodities included in the subgroup.

                 Table 2--Crop Group 7 Subgroup Listing
------------------------------------------------------------------------
      Representative commodities                  Commodities
------------------------------------------------------------------------
 Crop Subgroup 7A. Foliage of legume
vegetables (except soybeans) subgroup
Any cultivar of bean (Phaseolus        Plant parts of any legume
 spp.), and field pea (Pisum spp.).     vegetable (except soybeans)
                                        included in the legume
                                        vegetables group that will be
                                        used as animal feed.
------------------------------------------------------------------------

    (9) Crop Group 8. Fruiting Vegetables Group.
    (i) Representative commodities. Tomato, bell pepper, and one 
cultivar of non-bell pepper.
    (ii) Commodities. The following is a list of all the commodities 
included in Crop Group 8:

    Crop Group 8: Fruiting Vegetables (Except Cucurbits)--Commodities

Eggplant (Solanum melongena)
Groundcherry (Physalis spp.)
Pepino (Solanum muricatum)
Pepper (Capsicum spp.) (includes bell pepper, chili pepper, cooking 
pepper, pimento, sweet pepper)
Tomatillo (Physalis ixocarpa)
Tomato (Lycopersicon esculentum)

    (10) Crop Group 8-10. Fruiting Vegetable Group.
    (i) Representative commodities. Tomato, standard size, and one 
cultivar of small tomato; bell pepper and one cultivar of small nonbell 
pepper.
    (ii) Commodities. The following is a list of all commodities 
included in the Crop group 8-10.

           Table 1--Crop Group 8-10: Fruiting Vegetable Group
------------------------------------------------------------------------
               Commodities                    Related crop subgroups
------------------------------------------------------------------------
African eggplant, Solanum macrocarpon L.  8-10B, 8-10C
Bush tomato, Solanum centrale J.M. Black  8-10A

[[Page 462]]

 
Cocona, Solanum sessiliflorum Dunal.....  8-10A
Currant tomato, Lycopersicon              8-10A
 pimpinellifolium L.
Eggplant, Solanum melongena L...........  8-10B, 8-10C
Garden huckleberry, Solanum scabrum Mill  8-10A
Goji berry, Lycium barbarum L...........  8-10A
Groundcherry, Physalis alkekengi L., P.   8-10A
 grisea (Waterf.) M. Martinez, P.
 peruviana L., P. pubescens L.
Martynia, Proboscidea louisianica         8-10B, 8-10C
 (Mill.) Thell.
Naranjilla, Solanum quitoense Lam.......  8-10A
Okra, Abelmoschus esculentus (L.) Moench  8-10B, 8-10C
Pea eggplant, Solanum torvum Sw.........  8-10B, 8-10C
Pepino, Solanum muricatum Aiton.........  8-10B, 8-10C
Pepper, bell, Capsicum annuum L. var.     8-10B
 annuum, Capsicum spp.
Pepper, nonbell, Capsicum chinese Jacq.,  8-10B, 8-10C
 C. annuum L. var. annuum, C. frutescens
 L., C. baccatum L., C. pubescens Ruiz &
 Pav., Capsicum spp.
Roselle, Hibiscus sabdariffa L..........  8-10B, 8-10C
Scarlet eggplant, Solanum aethiopicum L.  8-10B, 8-10C
Sunberry, Solanum retroflexum Dunal.....  8-10A
Tomatillo, Physalis philadelphica Lam...  8-10A
Tomato, Solanum lycopersicum L., Solanum  8-10A
 lycopersicum L. var. lycopersicum.
Tree tomato, Solanum betaceum Cav.......  8-10A
Cultivars, varieties and/or hybrids of
 these.
------------------------------------------------------------------------

    (iii) Table. The following Table 2 identifies the crop subgroups for 
Crop Group 8-10, specifies the representative commodities for each 
subgroup and lists all the commodities included in each subgroup.

               Table 2--Crop Group 8-10. Subgroup Listing
------------------------------------------------------------------------
       Representative commodities                  Commodities
------------------------------------------------------------------------
  Crop subgroup 8-10A. Tomato subgroup
 
Tomato, standard size, and one cultivar  Bush tomato; cocona; currant
 of small tomato.                         tomato; garden huckleberry;
                                          goji berry; groundcherry;
                                          naranjilla; sunberry;
                                          tomatillo; tomato; tree
                                          tomato; cultivars, varieties,
                                          and/or hybrids of these.
  Crop subgroup 8-10B. Pepper/Eggplant
                subgroup
 
Bell pepper and one cultivar of small    African eggplant; bell pepper;
 nonbell pepper.                          eggplant; Martynia; nonbell
                                          pepper; okra; pea eggplant;
                                          pepino; roselle; scarlet
                                          eggplant; cultivars,
                                          varieties, and/or hybrids of
                                          these.
  Crop subgroup 8-10C. Nonbell pepper/
           Eggplant subgroup
 
One cultivar of small nonbell pepper or  African eggplant; eggplant;
 one cultivar of small eggplant.          martynia; nonbell pepper;
                                          okra; pea eggplant; pepino;
                                          roselle; scarlet eggplant;
                                          cultivars, varieties, and/or
                                          hybrids of these.
------------------------------------------------------------------------

    (11) Crop Group 9. Cucurbit Vegetables Group.
    (i) Representative commodities. Cucumber, muskmelon, and summer 
squash.
    (ii) Table. The following table 1 lists all the commodities included 
in Crop Group 9 and identifies the related subgroups.

               Table 1--Crop Group 9: Cucurbit Vegetables
------------------------------------------------------------------------
                                                           Related crop
                      Commodities                           subgroups
------------------------------------------------------------------------
Chayote (fruit) (Sechium edule)........................               9B
Chinese waxgourd (Chinese preserving melon) (Benincasa                9B
 hispida)..............................................
Citron melon (Citrullus lanatus var. citroides)........               9A
Cucumber (Cucumis sativus).............................               9B
Gherkin (Cucumis anguria)..............................               9B
Gourd, edible (Lagenaria spp.) (includes hyotan,                      9B
 cucuzza); (Luffa acutangula, L. cylindrica) (includes
 hechima, Chinese okra)................................
Momordica spp. (includes balsam apple, balsam pear,                   9B
 bitter melon, Chinese cucumber).......................
Muskmelon (hybrids and/or cultivars of Cucumis melo)                  9A
 (includes true cantaloupe, cantaloupe, casaba,
 crenshaw melon, golden pershaw melon, honeydew melon,
 honey balls, mango melon, Persian melon, pineapple
 melon, Santa Claus melon, and snake melon)............

[[Page 463]]

 
Pumpkin (Cucurbita spp.)...............................               9B
Squash, summer (Cucurbita pepo var. melopepo) (includes               9B
 crookneck squash, scallop squash, straightneck squash,
 vegetable marrow, zucchini)...........................
Squash, winter (Cucurbita maxima; C. moschata)                        9B
 (includes butternut squash, calabaza, hubbard squash);
 (C. mixta; C. pepo) (includes acorn squash, spaghetti
 squash)...............................................
Watermelon (includes hybrids and/or varieties of                      9A
 Citrullus lanatus)....................................
------------------------------------------------------------------------

    (iii) Table. The following table 2 identifies the crop subgroups for 
Crop Group 9, specifies the representative commodities for each 
subgroup, and lists all the commodities included in each subgroup.

                 Table 2--Crop Group 9 Subgroup Listing
------------------------------------------------------------------------
      Representative commodities                  Commodities
------------------------------------------------------------------------
   Crop Subgroup 9A. Melon subgroup
Cantaloupes..........................  Citron melon; muskmelon;
                                        watermelon
  Crop Subgroup 9B. Squash/cucumber
               subgroup
One cultivar of summer squash and      Chayote (fruit); Chinese
 cucumber..                             waxgourd; cucumber; gherkin;
                                        gourd, edible; Momordica spp.;
                                        pumpkin; squash, summer; squash,
                                        winter.
------------------------------------------------------------------------

    (12) Crop Group 10. Citrus Fruit Group.
    (i) Representative commodities. Sweet orange; lemon and grapefruit.
    (ii) Commodities. The following is a list of all the commodities in 
Crop Group 10:

   Crop Group 10: Citrus Fruits (Citrus spp., Fortunella spp.) Group--
                               Commodities

Calamondin (Citrus mitisxCitrofortunella mitis)
Citrus citron (Citrus medica)
Citrus hybrids (Citrus spp.) (includes chironja, tangelo, tangor)
Grapefruit (Citrus paradisi)
Kumquat (Fortunella spp.)
Lemon (Citrus jambhiri, Citrus limon)
Lime (Citrus aurantiifolia)
Mandarin (tangerine) (Citrus reticulata)
Orange, sour (Citrus aurantium)
Orange, sweet (Citrus sinensis)
Pummelo (Citrus grandis, Citrus maxima)
Satsuma mandarin (Citrus unshiu)

    (13) Crop Group 10-10. Citrus Fruit Group.
    (i) Representative commodities. Orange or Tangerine/Mandarin, Lemon 
or Lime, and Grapefruit.
    (ii) Commodities. The following is a list of all the commodities in 
Crop Group 10-10.

              Table 1--Crop Group 10-10: Citrus Fruit Group
------------------------------------------------------------------------
                 Commodities                     Related crop subgroups
------------------------------------------------------------------------
Australian desert lime, Eremocitrus glauca     10-10B
 (Lindl.) Swingle.
Australian finger lime, Microcitrus            10-10B
 australasica (F. Muell.) Swingle.
Australian round lime, Microcitrus australis   10-10B
 (A. Cunn. Ex Mudie) Swingle.
Brown River finger lime, Microcitrus papuana   10-10B
 Winters.
Calamondin, Citrofortunella microcarpa         10-10A
 (Bunge) Wijnands.
Citron, Citrus medica L......................  10-10A
Citrus hybrids, Citrus spp. Eremocitrus spp.,  10-10A
 Fortunella spp., Microcitrus spp., and
 Poncirus spp.
Grapefruit, Citrus paradisi Macfad...........  10-10C
Japanese summer grapefruit, Citrus             10-10C
 natsudaidai Hayata.
Kumquat, Fortunella spp......................  10-10B
Lemon, Citrus limon (L.) Burm. f.............  10-10B
Lime, Citrus aurantiifolia (Christm.) Swingle  10-10B
Mediterranean mandarin, Citrus deliciosa Ten.  10-10A
Mount White lime, Microcitrus garrowayae       10-10B
 (F.M. Bailey) Swingle.
New Guinea wild lime, Microcitrus warburgiana  10-10B
 (F.M. Bailey) Tanaka.
Orange, sour, Citrus aurantium L.............  10-10A
Orange, sweet, Citrus sinensis (L.) Osbeck...  10-10A
Pummelo, Citrus maxima (Burm.) Merr..........  10-10C
Russell River lime, Microcitrus inodora (F.M.  10-10B
 Bailey) Swingle.

[[Page 464]]

 
Satsuma mandarin, Citrus unshiu Marcow.......  10-10A
Sweet lime, Citrus limetta Risso.............  10-10B
Tachibana orange, Citrus tachibana (Makino)    10-10A
 Tanaka.
Tahiti lime, Citrus latifolia (Yu. Tanaka)     10-10B
 Tanaka.
Tangelo, Citrus xtangelo J.W. Ingram & H.E.    10-10A, 10-10C
 Moore.
Tangerine (Mandarin), Citrus reticulata        10-10A
 Blanco.
Tangor, Citrus nobilis Lour..................  10-10A
Trifoliate orange, Poncirus trifoliata (L.)    10-10A
 Raf.
Uniq fruit, Citrus aurantium Tangelo group...  10-10C
Cultivars, varieties and/or hybrids of these.
------------------------------------------------------------------------

    (iii) Table. The following Table 2 identifies the crop subgroups for 
Crop Group 10-10, specifies the representative commodities for each 
subgroup and lists all the commodities included in each subgroup.

               Table 2--Crop Group 10-10: Subgroup Listing
------------------------------------------------------------------------
       Representative commodities                  Commodities
------------------------------------------------------------------------
 Crop Subgroup 10-10A. Orange subgroup
 
Orange or tangerine/mandarin...........  Calamondin; citron; citrus
                                          hybrids; mediterranean
                                          mandarin; orange, sour;
                                          orange, sweet; satsuma
                                          mandarin; tachibana orange;
                                          tangerine (mandarin); tangelo;
                                          tangor; trifoliate orange;
                                          cultivars, varieties, and/or
                                          hybrids of these.
    Crop Subgroup 10-10B. Lemon/Lime
                subgroup
 
Lemon or lime..........................  Australian desert lime;
                                          Australian finger lime;
                                          Australian round lime; brown
                                          river finger lime; kumquat;
                                          lemon; lime; mount white lime;
                                          New Guinea wild lime; Russell
                                          River lime; sweet lime; Tahiti
                                          lime; cultivars , varieties,
                                          and/or hybrids of these.
    Crop Subgroup 10-10C. Grapefruit
                subgroup
 
Grapefruit.............................  Grapefruit; Japanese summer
                                          grapefruit; pummelo; tangelo;
                                          uniq fruit; cultivars,
                                          varieties, and/or hybrids of
                                          these.
------------------------------------------------------------------------

    (14) Crop Group 11: Pome Fruits Group.
    (i) Representative commodities. Apple and pear.
    (ii) Commodities. The following is a list of all the commodities 
included in Crop Group 11:

              Crop Group 11: Pome Fruits Group--Commodities

Apple (Malus domestica)
Crabapple (Malus spp.)
Loquat (Eriobotrya japonica)
Mayhaw (Crataegus aestivalis, C. opaca, and C. rufula)
Pear (Pyrus communis)
Pear, oriental (Pyrus pyrifolia)
Quince (Cydonia oblonga)

    (15) Crop group 11-10. Pome Fruit Group.
    (i) Representative commodities. Apple and Pear
    (ii) Commodities. The following is a list of all the commodities in 
Crop Group 11-10.

             Crop Group 11-10: Pome Fruit Group--Commodities

Apple, Malus domestica Borkh.
Azarole, Crataegus azarolus L.
Crabapple, Malus sylvestris (L.) Mill., M. prunifolia (Willd.) Borkh.
Loquat, Eriobotrya japonica (Thunb.) Lindl.
Mayhaw, Crataegus aestivalis (Walter) Torr. & A. Gray, C. opaca
Hook. & Arn., and C. rufula Sarg.
Medlar, Mespilus germanica L.
Pear, Pyrus communis L.
Pear, Asian, Pyrus pyrifolia (Burm. f.) Nakai var. culta (Makino) Nakai
Pseudocydonia sinensis (Thouin) C.K. Schneid.
Quince, Cydonia oblonga Mill.
Quince, Chinese, Chaenomeles speciosa (Sweet) Nakai,
Quince, Japanese, Chaenomeles japonica (Thunb.) Lindl. ex Spach
Tejocote, Crataegus mexicana DC.
Cultivars, varieties and/or hybrids of these.

    (16) Crop Group 12. Stone Fruits Group.
    (i) Representative commodities. Sweet cherry or tart cherry; peach; 
and plum

[[Page 465]]

or fresh prune (Prunus domestica, Prunus spp.)
    (ii) Commodities. The following is a list of all the commodities 
included in Crop Group 12:

             Crop Group 12: Stone Fruits Group--Commodities

Apricot (Prunus armeniaca)
Cherry, sweet (Prunus avium),
Cherry, tart (Prunus cerasus)
Nectarine (Prunus persica)
Peach (Prunus persica)
Plum (Prunus domestica, Prunus spp.)
Plum, Chickasaw (Prunus angustifolia)
Plum, Damson (Prunus domestica spp. insititia)
Plum, Japanese (Prunus salicina)
Plumcot (Prunus. armeniacaxP. domestica)
Prune (fresh) (Prunus domestica, Prunus spp.)

    (17) Crop Group 12-12: Stone Fruit Group.
    (i) Representative commodities. Sweet cherry or Tart cherry; Peach; 
and Plum or Prune plum.
    (ii) Commodities. The following Table 1 is a list of all commodities 
included in Crop Group 12-12.

              Table 1--Crop Group 12-12: Stone Fruit Group
------------------------------------------------------------------------
                                                           Related crop
                      Commodities                            subgroup
------------------------------------------------------------------------
Apricot (Prunus armeniaca L.)..........................           12-12C
Apricot, Japanese (Prunus mume Siebold & Zucc.)........           12-12C
Capulin (Prunus serotina Ehrh. var. salicifolia (Kunth)           12-12A
 Koehne)...............................................
Cherry, black (Prunus serotina Ehrh.)..................           12-12A
Cherry, Nanking (Prunus tomentosa Thunb.)..............           12-12A
Cherry, sweet (Prunus avium (L.) L.)...................           12-12A
Cherry, tart (Prunus cerasus L.).......................           12-12A
Jujube, Chinese (Ziziphus jujuba Mill.)................           12-12C
Nectarine (Prunuspersica (L.) Batsch var. nucipersica             12-12B
 (Suckow) C.K. Schneid)................................
Peach (Prunus persica (L.) Batsch var. persica)........           12-12B
Plum (Prunus domestica L. subsp. domestica)............           12-12C
Plum, American (Prunus americana Marshall).............           12-12C
Plum, beach (Prunus maritima Marshall).................           12-12C
Plum, Canada (Prunus nigra Aiton)......................           12-12C
Plum, cherry (Prunus cerasifera Ehrh.).................           12-12C
Plum, Chickasaw (Prunus angustifolia Marshall).........           12-12C
Plum, Damson (Prunus domestica L. subsp. insititia (L.)           12-12C
 C.K. Schneid.)........................................
Plum, Japanese (Prunus salicina Lindl.; P. salicina               12-12C
 Lindl. var. salicina).................................
Plum, Klamath (Prunus subcordata Benth.)...............           12-12C
Plum, prune (Prunus domestica L. subsp. domestica).....           12-12C
Plumcot (Prunus hybr.).................................           12-12C
Sloe (Prunus spinosa L.)...............................           12-12C
Cultivars, varieties, and/or hybrids of these..........
------------------------------------------------------------------------

    (iii) Crop subgroups. The following Table 2 identifies the crop 
subgroups for Crop Group 12-12, specifies the representative commodities 
for each subgroup, and lists all the commodities included in each 
subgroup.

               Table 2--Crop Group 12-12: Subgroup Listing
------------------------------------------------------------------------
    Representative commodities                   Commodities
------------------------------------------------------------------------
                  Crop subgroup 12-12A. Cherry subgroup
------------------------------------------------------------------------
Cherry, sweet or Cherry, tart.....  Capulin; Cherry, black; Cherry,
                                     Nanking; Cherry, sweet; Cherry,
                                     tart; cultivars, varieties, and/or
                                     hybrids of these.
------------------------------------------------------------------------
                  Crop subgroup 12-12B. Peach subgroup
------------------------------------------------------------------------
Peach.............................  Peach; Nectarine; cultivars,
                                     varieties, and/or hybrids of these.
------------------------------------------------------------------------
                   Crop subgroup 12-12C. Plum subgroup
------------------------------------------------------------------------
Plum or Prune plum................  Apricot; Apricot, Japanese; Jujube,
                                     Chinese; Plum; Plum, American;
                                     Plum, beach; Plum, Canada; Plum,
                                     cherry; Plum, Chickasaw; Plum,
                                     Damson; Plum, Japanese; Plum,
                                     Klamath; Plumcot; Plum, prune;
                                     Sloe; cultivars, varieties, and/or
                                     hybrids of these.
------------------------------------------------------------------------


[[Page 466]]

    (18) Crop Group 13. Berries Group.
    (i) Representative commodities. Any one blackberry or any one 
raspberry; and blueberry.
    (ii) Table. The following table 1 lists all the commodities included 
in Crop Group 13 and identifies the related subgroups.

                  Table 1--Crop Group 13: Berries Group
------------------------------------------------------------------------
                                                           Related crop
                      Commodities                           subgroups
------------------------------------------------------------------------
Blackberry (Rubus eubatus) (including bingleberry,                   13A
 black satin berry, boysenberry, Cherokee blackberry,
 Chesterberry, Cheyenne blackberry, coryberry,
 darrowberry, dewberry, Dirksen thornless berry,
 Himalayaberry, hullberry, Lavacaberry, lowberry,
 Lucretiaberry, mammoth blackberry, marionberry,
 nectarberry, olallieberry, Oregon evergreen berry,
 phenomenalberry, rangeberry, ravenberry, rossberry,
 Shawnee blackberry, youngberry, and varieties and/or
 hybrids of these).....................................
Blueberry (Vaccinium spp.).............................              13B
Currant (Ribes spp.)...................................              13B
Elderberry (Sambucus spp.).............................              13B
Gooseberry (Ribes spp.)................................              13B
Huckleberry (Gaylussacia spp.).........................              13B
Loganberry (Rubus loganobaccus)........................              13A
Raspberry, black and red (Rubus occidentalis, Rubus                  13A
 strigosus, Rubus idaeus)..............................
------------------------------------------------------------------------

    (iii) Table. The following table 2 identifies the crop subgroups for 
Crop Group 13, specifies the representative commodities for each 
subgroup, and lists all the commodities included in each subgroup.

                Table 2--Crop Group 13 Subgroups Listing
------------------------------------------------------------------------
      Representative commodities                  Commodities
------------------------------------------------------------------------
     Crop Subgroup 13A. Caneberry
 (blackberry and raspberry) subgroup.
Any one blackberry or any one          Blackberry; loganberry; red and
 raspberry..                            black raspberry; cultivars and/
                                        or hybrids of these.
Crop Subgroup 13B. Bushberry
 subgroup..
Blueberry, highbush..................  Blueberry, highbush and lowbush;
                                        currant; elderberry; gooseberry;
                                        huckleberry.
------------------------------------------------------------------------

    (19) Crop Group 13-07. Berry and Small Fruit Crop Group
    (i) Representative commodities. Any one blackberry or any one 
raspberry; highbush blueberry; elderberry or mulberry; grape; fuzzy 
kiwifruit, and strawberry.
    (ii) Table. The following Table 1 lists all the commodities listed 
in Crop Group 13-07 and identifies the related crop subgroups.

       Table 1--Crop Group 13-07: Berry and Small Fruit Crop Group
------------------------------------------------------------------------
                  Commodities                     Related crop subgroups
------------------------------------------------------------------------
Amur river grape (Vitis amurensis Rupr)........   13-07D, 13-07E, 13-07F
Aronia berry (Aronia spp.).....................                   13-07B
Bayberry (Myrica spp.).........................                   13-07C
Bearberry (Arctostaphylos uva-ursi)............           13-07G, 13-07H
Bilberry (Vaccinium myrtillus L.)..............           13-07G, 13-07H
Blackberry (Rubus spp.) (including Andean                         13-07A
 blackberry, arctic blackberry, bingleberry,
 black satin berry, boysenberry, brombeere,
 California blackberry, Chesterberry, Cherokee
 blackberry, Cheyenne blackberry, common
 blackberry, coryberry, darrowberry, dewberry,
 Dirksen thornless berry, evergreen blackberry,
 Himalayaberry, hullberry, lavacaberry,
 loganberry, lowberry, Lucretiaberry, mammoth
 blackberry, marionberry, mora, mures deronce,
 nectarberry, Northern dewberry, olallieberry,
 Oregon evergreen berry, phenomenalberry,
 rangeberry, ravenberry, rossberry, Shawnee
 blackberry, Southern dewberry, tayberry,
 youngberry, zarzamora, and cultivars,
 varieties and/or hybrids of these.)...........
Blueberry, highbush (Vaccinium spp.)...........                   13-07B
Blueberry, lowbush (Vaccinium angustifolium                       13-07B
 Aiton)........................................
Buffalo currant (Ribes aureum Pursh)...........                   13-07B
Buffaloberry (Shepherdia argentea (Pursh)                         13-07C
 Nutt.)........................................
Che (Cudrania tricuspidata Bur. Ex Lavallee)...                   13-07C
Chilean guava (Myrtus ugni Mol.)...............                   13-07B

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Chokecherry (Prunus virginiana L.).............                   13-07C
Cloudberry (Rubus chamaemorus L.)..............           13-07G, 13-07H
Cranberry (Vaccinium macrocarpon Aiton)........           13-07G, 13-07H
Currant, black (Ribes nigrum L.)...............                   13-07B
Currant, red (Ribes rubrum L.).................                   13-07B
Elderberry (Sambucus spp.).....................           13-07B, 13-07C
European barberry (Berberis vulgaris L.).......                   13-07B
Gooseberry (Ribes spp.)........................  13-07B, 13-07D, 13-07E,
                                                                  13-07F
Grape (Vitis spp.).............................           13-07D, 13-07F
Highbush cranberry (Viburnum opulus L. var.                       13-07B
 Americanum Aiton).............................
Honeysuckle, edible (Lonicera caerula L. var.                     13-07B
 emphyllocalyx Nakai, Lonicera caerula L var .
 edulis Turcz. ex herder)......................
Huckleberry (Gaylussacia spp.).................                   13-07B
Jostaberry (Ribes x nidigrolaria Rud. Bauer and                   13-07B
 A. Bauer).....................................
Juneberry (Saskatoon berry) (Amelanchier spp.).           13-07B, 13-07C
Kiwifruit, fuzzy (Actinidia deliciosa A. Chev.)           13-07D, 13-07E
 (C.F. Liang and A.R. Fergusons, Actinida
 chinensis Planch.)............................
Kiwifruit, hardy (Actinidia arguta (Siebold and   13-07D, 13-07E, 13-07F
 Zucc.) Planch. ex Miq)........................
Lingonberry (Vaccinium vitis-idaea L.).........    13-07B, 13-07G 13-07H
Maypop (Passiflora incarnata L.)...............           13-07E, 13-07F
Mountain pepper berries (Tasmannia                                13-07C
 lanceolata)(Poir.) A.C.Sm.....................
Mulberry (Morus spp.)..........................                   13-07C
Muntries (Kunzea pomifera F. Muell.)...........           13-07G, 13-07H
Native currant (Acrotriche depressa R. BR.)....                   13-07B
Partridgeberry (Mitchella repens L.)...........           13-07G, 13-07H
Phalsa (Grewia subinaequalis DC.)..............                   13-07C
Pincherry (Prunus pensylvanica L.f.)...........                   13-07C
Raspberry, black and red (Rubus spp.)..........                   13-07A
Riberry (Syzygium luehmannii)..................                   13-07C
Salal (Gaultheria shallon Pursh.)..............           13-07B, 13-07C
Schisandra berry (Schisandra chinensis (Turcz.)   13-07D, 13-07E, 13-07F
 Baill.).......................................
Sea buckthorn (Hippophae rhamnoides L.)........                   13-07B
Serviceberry (Sorbus spp.).....................                   13-07C
Strawberry (Fragaria x ananassa Duchesne)......                   13-07G
Wild raspberry (Rubus muelleri Lefevre ex P.J.                    13-07A
 Mull).........................................
Cultivars, varieties, and/or hybrids of these..  .......................
------------------------------------------------------------------------

    (iii) Table. The following Table 2 identifies the crop subgroups for 
Crop Group 13-07, specifies the representative commodities for each 
subgroup and lists all the commodities included in each subgroup.

               Table 2--Crop Group 13-07: Subgroup Listing
------------------------------------------------------------------------
      Representative commodities                  Commodities
------------------------------------------------------------------------
Crop Subgroup 13-07A. Caneberry
 subgroup
    Any one blackberry or any one      Blackberry; loganberry;
     raspberry..                        raspberry, red and black; wild
                                        raspberry; cultivars, varieties,
                                        and/or hybrids of these.
Crop Subgroup 13-07B. Bushberry
 subgroup.
    Blueberry, highbush..............  Aronia berry; blueberry,
                                        highbush; blueberry, lowbush;
                                        buffalo currant; Chilean guava;
                                        currant, black; currant, red;
                                        elderberry; European, barberry;
                                        gooseberry; cranberry, highbush;
                                        honeysuckle, edible;
                                        huckleberry; jostaberry;
                                        Juneberry; lingonberry; native
                                        currant; salal; sea buckthorn;
                                        cultivars, varieties, and/or
                                        hybrids of these.
Crop Subgroup 13-07C. Large shrub/
 tree berry subgroup.
    Elderberry or mulberry...........  Bayberry; buffaloberry; che;
                                        chokecherry; elderberry;
                                        Juneberry; mountain pepper
                                        berries; mulberry; phalsa;
                                        pincherry; riberry; salal;
                                        serviceberry; cultivars,
                                        varieties, and/or hybrids of
                                        these.
Crop Subgroup 13-07D. Small fruit
 vine climbing subgroup.
    Grape and fuzzy kiwifruit........  Amur river grape; gooseberry;
                                        grape; kiwifruit, fuzzy;
                                        kiwifruit, hardy; Maypop;
                                        schisandra berry; cultivars,
                                        varieties, and /or hybrids of
                                        these.
Crop Subgroup 13-07E. Small fruit
 vine climbing subgroup, except
 grape.
    Fuzzy kiwifruit..................  Amur river grape; gooseberry;
                                        kiwifruit, fuzzy; kiwifruit,
                                        hardy; Maypop; schisandra berry;
                                        cultivars, varieties, and/or
                                        hybrids of these.

[[Page 468]]

 
Crop Subgroup 13-07F. Small fruit
 vine climbing subgroup except fuzzy
 kiwifruit.
    Grape............................  Amur river grape; gooseberry;
                                        grape; kiwifruit, hardy; Maypop;
                                        schisandra berry; cultivars
                                        varieties, and/or hybrids of
                                        these.
Crop Subgroup 13-07G. Low growing
 berry subgroup.
    Strawberry.......................  Bearberry; bilberry; blueberry,
                                        lowbush; cloudberry; cranberry;
                                        lingonberry; muntries;
                                        partridgeberry; strawberry;
                                        cultivars, varieties, and/or
                                        hybrids of these.
Crop Subgroup 13-07H. Low growing
 berry subgroup, except strawberry.
    Cranberry........................  Bearberry; bilberry; blueberry,
                                        lowbush; cloudberry; cranberry;
                                        lingonberry; muntries;
                                        partridgeberry; cultivars,
                                        varieties, and/or cultivars of
                                        these.
------------------------------------------------------------------------

    (20) Crop Group 14. Tree Nuts Group.
    (i) Representative commodities. Almond and pecan.
    (ii) Commodities. The following is a list of all the commodities 
included in Crop Group 14:

                  Crop Group 14: Tree Nuts--Commodities

Almond (Prunus dulcis)
Beech nut (Fagus spp.)
Brazil nut (Bertholletia excelsa)
Butternut (Juglans cinerea)
Cashew (Anacardium occidentale)
Chestnut (Castanea spp.)
Chinquapin (Castanea pumila)
Filbert (hazelnut) (Corylus spp.)
Hickory nut (Carya spp.)
Macadamia nut (bush nut) (Macadamia spp.)
Pecan (Carya illinoensis)
Walnut, black and English (Persian) (Juglans spp.)

    (21) Crop Group 14-12. Tree Nut Group.
    (i) Representative commodities. Almond and Pecan.
    (ii) Commodities. The following is a list of all commodities 
included in Crop Group 14-12.

                    Crop Group 14-12: Tree Nut Group

African nut-tree (Ricinodendron heudelotii (Baill.) Heckel)
Almond (Prunus dulcis (Mill.) D.A. Webb)
Beechnut (Fagus grandifolia Ehrh.; F. sylvatica L.)
Brazil nut (Bertholletia excelsa Humb. & Bonpl.)
Brazilian pine (Araucaria angustifolia (Bertol.) Kuntze)
Bunya (Araucaria bidwillii Hook.)
Bur oak (Quercus macrocarpa Michx.)
Butternut (Juglans cinerea L.)
Cajou nut (Anacardium giganteum Hance ex Engl.)
Candlenut (Aleurites moluccanus (L.) Willd.)
Cashew (Anacardium occidentale L.)
Chestnut (Castanea crenata Siebold & Zucc.; C. dentata (Marshall) 
Borkh.; C. mollissima Blume; C. sativa Mill.)
Chinquapin (Castaneapumila (L.) Mill.)
Coconut (Cocos nucifera L.)
Coquito nut (Jubaea chilensis (Molina) Baill.)
Dika nut (Irvingia gabonensis (Aubry-Lecomte ex O'Rorke) Baill.)
Ginkgo (Ginkgo biloba L.)
Guiana chestnut (Pachira aquatica Aubl.)
Hazelnut (Filbert) (Corylus americana Marshall; C. avellana L.; C. 
californica (A. DC.) Rose; C. chinensis Franch.)
Heartnut (Juglans ailantifolia Carri[egrave]re var. cordiformis (Makino) 
Rehder)
Hickory nut (Carya cathayensis Sarg.; C. glabra (Mill.) Sweet; C. 
laciniosa (F. Michx.) W. P. C. Barton; C. myristiciformis (F. Michx.) 
Elliott; C. ovata (Mill.) K. Koch; C. tomentosa (Lam.) Nutt.)
Japanese horse-chestnut (Aesculus turbinate Blume)
Macadamia nut (Macadamia integrifolia Maiden & Betche; M. tetraphylla 
L.A.S. Johnson)
Mongongo nut (Schinziophyton rautanenii (Schinz) Radcl.-Sm.)
Monkey-pot (Lecythis pisonis Cambess.)
Monkey puzzle nut (Araucaria araucana (Molina) K. Koch)
Okari nut (Terminalia kaernbachii Warb.)
Pachira nut (Pachira insignis (Sw.) Savigny)
Peach palm nut (Bactris gasipaes Kunth var. gasipaes)
Pecan (Carya illinoinensis (Wangenh.) K. Koch)
Pequi (Caryocar brasiliense Cambess.; C. villosum (Aubl.) Pers; C. 
nuciferum L.)
Pili nut (Canarium ovatum Engl.; C. vulgare Leenh.)
Pine nut (Pinus edulis Engelm.; P. koraiensis Siebold & Zucc.; P. 
sibirica Du Tour; P. pumila (Pall.) Regel; P. gerardiana Wall. ex D. 
Don; P. monophylla Torr. & Fr[eacute]m.; P. quadrifolia Parl. ex Sudw.; 
P. pinea L.)
Pistachio (Pistacia vera L.)
Sapucaia nut (Lecythis zabucaja Aubl.)
Tropical almond (Terminalia catappa L.)

[[Page 469]]

Walnut, black (Juglans nigra L.; J. hindsii Jeps. ex R. E. Sm.; J. 
microcarpa Berland.)
Walnut, English (Juglans regia L.)
Yellowhorn (Xanthoceras sorbifolium Bunge)
Cultivars, varieties, and/or hybrids of these
    (22) Crop Group 15. Cereal Grains Group.
    (i) Representative commodities. Corn (fresh sweet corn and dried 
field corn), rice, sorghum, and wheat.
    (ii) Commodities. The following is a list of all the commodities 
included in Crop Group 15:

                Crop Group 15: Cereal Grains--Commodities

Barley (Hordeum spp.)
Buckwheat (Fagopyrum esculentum)
Corn (Zea mays)
Millet, pearl (Pennisetum glaucum)
Millet, proso (Panicum milliaceum)
Oats (Avena spp.)
Popcorn (Zea mays var. everta)
Rice (Oryza sativa)
Rye (Secale cereale)
Sorghum (milo) (Sorghum spp.)
Teosinte (Euchlaena mexicana)
Triticale (Triticum-Secale hybrids)
Wheat (Triticum spp.)
Wild rice (Zizania aquatica)

    (23) Crop Group 16. Forage, Fodder and Straw of Cereal Grains Group.
    (i) Representative commodities. Corn, wheat, and any other cereal 
grain crop.
    (ii) Commodities. The commodities included in Crop Group 16 are: 
Forage, fodder, and straw of all commodities included in the group 
cereal grains group.
    (24) Crop Group 17. Grass Forage, Fodder, and Hay Group.
    (i) Representative commodities. Bermuda grass; bluegrass; and 
bromegrass or fescue.
    (ii) Commodities. The commodities included in Crop Group 17 are: Any 
grass, Gramineae family (either green or cured) except sugarcane and 
those included in the cereal grains group, that will be fed to or grazed 
by livestock, all pasture and range grasses and grasses grown for hay or 
silage.
    (25) Crop Group 18. Nongrass Animal Feeds (Forage, Fodder, Straw, 
and Hay) Group.
    (i) Representative commodities. Alfalfa and clover (Trifolium spp.)
    (ii) Commodities. The following is a list of all the commodities 
included in Crop Group 18:

 Crop Group 18: Nongrass Animal Feeds (Forage, Fodder, Straw, and Hay) 
                           Group--Commodities

Alfalfa (Medicago sativa subsp. sativa)
Bean, velvet (Mucuna pruriens var. utilis)
Clover (Trifolium spp., Melilotus spp.)
Kudzu (Pueraria lobata)
Lespedeza (Lespedeza spp.)
Lupin (Lupinus spp.)
Sainfoin (Onobrychis viciifolia);
Trefoil (Lotus spp.)
Vetch (Vicia spp.)
Vetch, crown (Coronilla varia)
Vetch, milk (Astragalus spp).

    (26) Crop Group 19. Herbs and Spices Group.
    (i) Representative commodities. Basil (fresh and dried); black 
pepper; chive; and celery seed or dill seed.
    (ii) Table. The following table 1 lists all the commodities included 
in Crop Group 19 and identifies the related subgroups.

             Table 1--Crop Group 19: Herbs and Spices Group
------------------------------------------------------------------------
                                                                Related
                         Commodities                              crop
                                                               subgroups
------------------------------------------------------------------------
Allspice (Pimenta dioica)....................................        19B
Angelica (Angelica archangelica).............................        19A
Anise (anise seed) (Pimpinella anisum).......................        19B
Anise, star (Illicium verum).................................        19B
Annatto (seed)...............................................        19B
Balm (lemon balm) (Melissa officinalis)......................        19A
Basil (Ocimum basilicum).....................................        19A
Borage (Borago officinalis)..................................        19A
Burnet (Sanguisorba minor)...................................        19A
Camomile (Anthemis nobilis)..................................        19A
Caper buds (Capparis spinosa)................................        19B
Caraway (Carum carvi)........................................        19B
Caraway, black (Nigella sativa)..............................        19B
Cardamom (Elettaria cardamomum)..............................        19B
Cassia bark (Cinnamomum aromaticum)..........................        19B
Cassia buds (Cinnamomum aromaticum)..........................        19B
Catnip (Nepeta cataria)......................................        19A
Celery seed (Apicum graveolens)..............................        19B
Chervil (dried) (Anthriscus cerefolium)......................        19A
Chive (Allium schoenoprasum).................................        19A
Chive, Chinese (Allium tuberosum)............................        19A
Cinnamon (Cinnamomum verum)..................................        19B
Clary (Salvia sclarea).......................................        19A
Clove buds (Eugenia caryophyllata)...........................        19B
Coriander (cilantro or Chinese parsley) (leaf) (Coriandrum           19A
 sativum)....................................................
Coriander (cilantro) (seed) (Coriandrum sativum).............        19B
Costmary (Chrysanthemum balsamita)...........................        19A
Culantro (leaf) (Eryngium foetidum)..........................        19A
Culantro (seed) (Eryngium foetidum)..........................        19B
Cumin (Cuminum cyminum)......................................        19B
Curry (leaf) (Murraya koenigii)..............................        19A
Dill (dillweed) (Anethum graveolens).........................        19A
Dill (seed) (Anethum graveolens).............................        19B
Fennel (common) (Foeniculum vulgare).........................        19B
Fennel, Florence (seed) (Foeniculum vulgare Azoricum Group)..        19B
Fenugreek (Trigonella foenumgraecum).........................        19B
Grains of paradise (Aframomum melegueta).....................        19B

[[Page 470]]

 
Horehound (Marrubium vulgare)................................        19A
Hyssop (Hyssopus officinalis)................................        19A
Juniper berry (Juniperus communis)...........................        19B
Lavender (Lavandula officinalis).............................        19A
Lemongrass (Cymbopogon citratus).............................        19A
Lovage (leaf) (Levisticum officinale)........................        19A
Lovage (seed) (Levisticum officinale)........................        19B
Mace (Myristica fragrans)....................................        19B
Marigold (Calendula officinalis).............................        19A
Marjoram (Origanum spp.) (includes sweet or annual marjoram,         19A
 wild marjoram or oregano, and pot marjoram).................
Mustard (seed) (Brassica juncea, B. hirta, B. nigra).........        19B
Nasturtium (Tropaeolum majus)................................        19A
Nutmeg (Myristica fragrans)..................................        19B
Parsley (dried) (Petroselinum crispum).......................        19A
Pennyroyal (Mentha pulegium).................................        19A
Pepper, black (Piper nigrum).................................        19B
Pepper, white................................................        19B
Poppy (seed) (Papaver somniferum)............................        19B
Rosemary (Rosemarinus officinalis)...........................        19A
Rue (Ruta graveolens)........................................        19A
Saffron (Crocus sativus).....................................        19B
Sage (Salvia officinalis)....................................        19A
Savory, summer and winter (Satureja spp.)....................        19A
Sweet bay (bay leaf) (Laurus nobilis)........................        19A
Tansy (Tanacetum vulgare)....................................        19A
Tarragon (Artemisia dracunculus).............................        19A
Thyme (Thymus spp.)..........................................        19A
Vanilla (Vanilla planifolia).................................        19B
Wintergreen (Gaultheria procumbens)..........................        19A
Woodruff (Galium odorata)....................................        19A
Wormwood (Artemisia absinthium)..............................        19A
------------------------------------------------------------------------

    (iii) Table. The following table 2 identifies the crop subgroups for 
Crop Group 19, specifies the representative commodities for each 
subgroup, and lists all the commodities included in each subgroup.

                    Table 2--Crop Group 19 Subgroups
------------------------------------------------------------------------
      Representative commodities                  Commodities
------------------------------------------------------------------------
  Crop Subgroup 19A. Herb subgroup.
Basil (fresh and dried) and chive....  Angelica; balm; basil; borage;
                                        burnet; camomile; catnip;
                                        chervil (dried); chive; chive,
                                        Chinese, clary; coriander
                                        (leaf); costmary; culantro
                                        (leaf); curry (leaf); dillweed;
                                        horehound; hyssop; lavender;
                                        lemongrass; lovage (leaf);
                                        marigold; marjoram (Origanum
                                        spp.); nasturtium; parsley
                                        (dried); pennyroyal; rosemary;
                                        rue; sage; savory, summer and
                                        winter; sweet bay; tansy;
                                        tarragon; thyme; wintergreen;
                                        woodruff; and wormwood.
 
  Crop Subgroup 19B. Spice subgroup.
Black pepper; and celery seed or dill  Allspice; anise (seed); anise,
 seed..                                 star; annatto (seed); caper
                                        (buds); caraway; caraway, black;
                                        cardamom; cassia (buds); celery
                                        (seed); cinnamon; clove (buds);
                                        coriander (seed); culantro
                                        (seed); cumin; dill (seed);
                                        fennel, common; fennel, Florence
                                        (seed); fenugreek; grains of
                                        paradise; juniper (berry);
                                        lovage (seed); mace; mustard
                                        (seed); nutmeg; pepper, black;
                                        pepper, white; poppy (seed);
                                        saffron; and vanilla.
------------------------------------------------------------------------

    (27) Crop Group 20. Oilseed Group.
    (i) Representative commodities. Rapeseed (canola varieties only); 
sunflower, seed and cottonseed.
    (ii) Table. The following Table 1 lists all the commodities listed 
in Crop Group 20 and identifies the related crop subgroups and includes 
cultivars and/or varieties of these commodities.

                  Table 1--Crop Group 20: Oilseed Group
------------------------------------------------------------------------
                                                           Related crop
                      Commodities                           subgroups
------------------------------------------------------------------------
Borage, Borago officinalis L...........................             20A
Calendula, Calendula officinalis L.....................             20B
Castor oil plant, Ricinus communis L...................             20B
Chinese tallowtree, Triadica sebifera (L.) Small.......             20B
Cottonseed, Gossypium hirsutum L. Gossypium spp........              20C
Crambe, Crambe hispanica L.; C. abyssinica Hochst. ex               20A
 R.E. Fr...............................................
Cuphea, Cuphea hyssopifolia Kunth......................             20A
Echium, Echium plantagineum L..........................             20A
Euphorbia, Euphorbia esula L...........................             20B
Evening primrose, Oenothera biennis L..................             20B
Flax seed, Linum usitatissimum L.......................             20A
Gold of pleasure, Camelina sativa (L.) Crantz..........             20A

[[Page 471]]

 
Hare's ear mustard, Conringia orientalis (L.) Dumort...             20A
Jojoba, Simmondsia chinensis (Link) C.K. Schneid.......             20B
Lesquerella, Lesquerella recurvata (Engelm. ex A. Gray)             20A
 S. Watson.............................................
Lunaria, Lunaria annua L...............................             20A
Meadowfoam, Limnanthes alba Hartw. ex Benth............             20A
Milkweed, Asclepias spp................................             20A
Mustard seed, Brassica hirta Moench, Sinapis alba L.                20A
 subsp. Alba...........................................
Niger seed, Guizotia abyssinica (L.f.) Cass............             20B
Oil radish, Raphanus sativus L. var. oleiformis Pers...             20A
Poppy seed, Papaver somniferum L. subsp. Somniferum....             20A
Rapeseed, Brassica spp.; B. napus L....................             20A
Rose hip, Rosa rubiginosa L............................             20B
Safflower, Carthamus tinctorious L.....................             20B
Sesame, Sesamum indicum L., S. radiatum Schumach. &                 20A
 honn..................................................
Stokes aster, Stokesia laevis (Hill) Greene............             20B
Sunflower, Helianthus annuus L.........................             20B
Sweet rocket, Hesperis matronalis L....................             20A
Tallowwood, Ximenia americana L........................             20B
Tea oil plant, Camellia oleifera C. Abel...............             20B
Vernonia, Vernonia galamensis (Cass.) Less.............             20B
Cultivars, varieties, and/or hybrids of these..........
------------------------------------------------------------------------

    (iii) Table. The following Table 2 identifies the crop subgroups for 
Crop Group 20, specifies the representative commodities for each 
subgroup and lists all the commodities included in each subgroup.

                Table 2--Crop Group 20: Subgroup Listing
------------------------------------------------------------------------
       Representative commodities                  Commodities
------------------------------------------------------------------------
  Crop subgroup 20A. Rapeseed subgroup
 
Rapeseed, canola varieties only........  Borage; crambe; cuphea; echium;
                                          flax seed; gold of pleasure;
                                          hare's ear mustard;
                                          lesquerella; lunaria;
                                          meadowfoam; milkweed; mustard
                                          seed; oil radish; poppy seed;
                                          rapeseed; sesame; sweet rocket
                                          cultivars, varieties, and/or
                                          hybrids of these.
 Crop subgroup 20B. Sunflower subgroup
 
Sunflower, seed........................  Calendula; castor oil plant;
                                          chinese tallowtree; euphorbia;
                                          evening primrose; jojoba;
                                          niger seed; rose hip;
                                          safflower; stokes aster;
                                          sunflower; tallowwood; tea oil
                                          plant; vernonia; cultivars,
                                          varieties, and/or hybrids of
                                          these.
 Crop subgroup 20C. Cottonseed subgroup
 
Cottonseed.............................  Cottonseed; cultivars,
                                          varieties, and/or hybrids of
                                          these.
------------------------------------------------------------------------


[[Page 472]]

    (28) Crop Group 21. Edible fungi Group.
    (i) Representative commodities. White button mushroom and any one 
oyster mushroom or any Shiitake mushroom.
    (ii) Table. The following is a list of all the commodities in Crop 
Group 21. There are no related subgroups.

             Crop Group 21--Edible Fungi Group--Commodities
Blewitt (Lepista nuda)
Bunashimeji (Hypsizygus marrmoreus)
Chinese mushroom (Volvariella volvacea) (Bull.) Singer
Enoki (Flammulina velutipes) (Curt.) Singer
Hime-Matsutake (Agaricus blazei) Murill
Hirmeola (Auricularia auricular)
Maitake (Grifola frondosa)
Morel (Morchella spp.)
Nameko (Pholiota nameko)
Net Bearing (Dictyophora)
Oyster mushroom (Pleurotus spp.)
Pom Pom (Hericium erinaceus)
Reishi mushroom (Ganoderma lucidum (Leyss. Fr.) Karst.)
Rodman's agaricus (Agaricus bitorquis) (Quel.) Saccardo
Shiitake mushroom (Lentinula edodes (Berk.) Pegl.)
Shimeji (Tricholoma conglobatum)
Stropharia (Stropharia spp.)
Truffle (Tuber spp.)
White button mushroom (Agaricus bisporous (Lange) Imbach)
White Jelly Fungi (Tremella fuciformis)
 


[60 FR 26635, May 17, 1995, as amended at 72 FR 69156, 69157, Dec. 7, 
2007; 73 FR 52, Jan. 2, 2008; 75 FR 76289, Dec. 8, 2010; 77 FR 50620, 
Aug. 22, 2012]



                      Subpart C_Specific Tolerances

    Editorial Note: Nomenclature changes to subpart C appear at 67 FR 
41803-41808, June 19, 2002; 67 FR 42393-42397, June 21, 2002; 68 FR 
39430-39435, July 1, 2003; 71 FR 74804-74812, Dec. 13, 2006; 72 FR 
53137-53151, Sept. 18, 2007; 72 FR 61536, Oct. 31, 2007; 73 FR 60155-
60157, Oct. 10, 2008; 75 FR 56014, Sept. 15, 2010; and 76 FR 34885, June 
15, 2011.



Sec. 180.101  Specific tolerances; general provisions.

    (a) The tolerances established for pesticide chemicals in this 
subpart C apply to residues resulting from their application prior to 
harvest or slaughter, unless otherwise stated. Tolerances are expressed 
in terms of parts by weight of the pesticide chemical per one million 
parts by weight of the raw agricultural commodity.
    (b) The poisonous and deleterious substances for which tolerances 
are established by the regulations in this subpart C are named by their 
common names wherever practicable, otherwise by their chemical names.
    (c) The analytical methods to be used for determining whether 
pesticide residues, including negligible residues, in or on raw 
agricultural commodities are in compliance with the tolerances 
established in this part 180 are identified among the methods contained 
or referenced in the Food and Drug Administration's ``Pesticide 
Analytical Manual'' which is available from the Food and Drug 
Administration, Department of Health, Education, and Welfare, 200 C 
Street SW., Washington, DC 20204.



Sec. 180.103  Captan; tolerances for residues.

    (a)(1) General. Tolerances are established for residues of the 
fungicide, captan (N-trichloromethylthio-4-cyclohexene-1,2-
dicarboximide) in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond......................................................        0.25
Almond, hulls...............................................       75.0
Animal feed, nongrass, group 18.............................        0.05
Apple.......................................................       25.0
Apricot.....................................................       10.0
Blueberry...................................................       20.0
Caneberry, subgroup 13A.....................................       25.0
Cherry, sweet...............................................       50.0
Cherry, tart................................................       50.0
Cotton, undelinted seed.....................................        0.05
Dill, seed..................................................        0.05
Flax, seed..................................................        0.05
Grape.......................................................       25.0
Grain, cereal, forage, fodder and straw, group 16...........        0.05
Grain, cereal, group 15.....................................        0.05
Grass, forage...............................................        0.05
Grass, hay..................................................        0.05
Nectarine...................................................       25.0
Okra........................................................        0.05
Peach.......................................................       15.0
Peanut......................................................        0.05
Peanut, hay.................................................        0.05
Pear........................................................       25.0
Plum, prune, fresh..........................................       10.0
Rapeseed, forage............................................        0.05
Rapeseed, seed..............................................        0.05
Safflower, seed.............................................        0.05
Sesame, seed................................................        0.05
Strawberry..................................................       20.0
Sunflower, seed.............................................        0.05
Vegetable, brassica leafy, group 5..........................        0.05
Vegetable, bulb, group 3....................................        0.05
Vegetable, cucurbit, group 9................................        0.05
Vegetable, foliage of legume, group 7.......................        0.05
Vegetable, fruiting, group 8................................        0.05
Vegetable, leafy, except brassica, group 4..................        0.05
Vegetable, leaves of root and tuber, group 2................        0.05
Vegetable, legume, group 6..................................        0.05
Vegetable, root and tuber, group 1..........................        0.05
------------------------------------------------------------------------

    (2) Tolerances are established for the combined residues of the 
fungicide,

[[Page 473]]

captan (N-trichloromethylthio-4-cyclohexene-1,2-dicarboximide) and its 
metabolite 1,2,3,6-tetrahydrophthalimide (THPI), measured at THPI, in or 
on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.15
Cattle, meat................................................        0.20
Cattle, meat byproducts.....................................        0.30
Goat, fat...................................................        0.15
Goat, meat..................................................        0.20
Goat, meat byproducts.......................................        0.30
Hog, fat....................................................        0.15
Hog, meat...................................................        0.20
Hog, meat byproducts........................................        0.30
Horse, fat..................................................        0.15
Horse, meat.................................................        0.20
Horse, meat byproducts......................................        0.30
Milk........................................................        0.10
Sheep, fat..................................................        0.15
Sheep, meat.................................................        0.20
Sheep, meat byproducts......................................        0.30
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[72 FR 52016, Sept. 12, 2007]



Sec. 180.106  Diuron; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the herbicide diuron, 3-(3,4-dichlorophenyl)-1,1-dimethylurea and its 
metabolites convertible to 3,4-dichloroaniline in or on food 
commodities, as follows:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        3.0
Alfalfa, hay................................................        2.0
Apple.......................................................        0.1
Artichoke, globe............................................        1
Asparagus...................................................        7
Banana......................................................        0.1
Berry group 13..............................................        0.1
Cattle, fat.................................................        1
Cattle, meat................................................        1
Cattle, meat byproducts.....................................        1
Citrus, oil.................................................        3.0
Corn, field, grain..........................................        0.1
Corn, pop, grain............................................        0.1
Cotton, undelinted seed.....................................        0.2
Fish - freshwater finfish, farm raised......................        2.0
Fruit, citrus, group 10, except lemon.......................        0.05
Goat, fat...................................................        1
Goat, meat..................................................        1
Goat, meat byproducts.......................................        1
Grain, aspirated fractions..................................        5.0
Grape.......................................................        0.05
Grass, forage, except bermudagrass..........................        2
Grass, hay, except bermudagrass.............................        2
Hazelnut....................................................        0.1
Hog, fat....................................................        1
Hog, meat...................................................        1
Hog, meat byproducts........................................        1
Horse, fat..................................................        1
Horse, meat.................................................        1
Horse, meat byproducts......................................        1
Lemon.......................................................        0.5
Nut, macadamia..............................................        0.05
Olive.......................................................        1
Papaya......................................................        0.5
Peach.......................................................        0.1
Pear........................................................        1
Pea, field, seed............................................        0.1
Pea, field, vines...........................................        2
Pea, field, hay.............................................        2
Pecan.......................................................        0.05
Peppermint, tops............................................        1.5
Pineapple...................................................        0.1
Pineapple, process residue..................................        0.4
Sheep, fat..................................................        1
Sheep, meat.................................................        1
Sheep, meat byproducts......................................        1
Sorghum, grain, forage......................................        2
Sorghum, grain, grain.......................................        0.5
Sorghum, grain, stover......................................        2
Spearmint, tops.............................................        1.5
Sugarcane, cane.............................................        0.2
Sugarcane, molasses.........................................        0.7
Walnut......................................................        0.05
Wheat, bran.................................................        0.7
Wheat, forage...............................................        2
Wheat, grain................................................        0.5
Wheat, hay..................................................        2
Wheat, straw................................................        1.5
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with a 
regional registration as defined in Sec. 180.1(l) are established for 
the combined residues of the herbicide diuron (3-(3,4-dichlorophenyl)-
1,1-dimethylurea and its metabolites convertible to 3,4-dichloroaniline) 
in or on the raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, bran................................................        0.7
Barley, grain...............................................        0.2
Barley, hay.................................................        2
Barley, straw...............................................        1.5
Cactus......................................................        0.05
Clover, forage..............................................        0.1
Clover, hay.................................................        1.0
Oat, forage.................................................        2
Oat, grain..................................................        0.1
Oat, hay....................................................        2
Oat, straw..................................................        1.5
Trefoil, forage.............................................        0.1
Trefoil, hay................................................        1.5
Vetch, forage...............................................        0.1
Vetch, hay..................................................        1.5
------------------------------------------------------------------------


[[Page 474]]

    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 2164, Jan. 14, 1998, as amended at 63 FR 57072, Oct. 26, 1998; 64 
FR 41305, July 30, 1999; 66 FR 28671, May 24, 2001; 67 FR 46883, July 
17, 2002; 69 FR 71717, Dec. 10, 2004; 72 FR 32540, June 13, 2007; 72 FR 
35666, June 29, 2007; 73 FR 54958, Sept. 24, 2008; 76 FR 34885, June 15, 
2011]



Sec. 180.108  Acephate; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
acephate, O,S-dimethyl acetyl phosphoramidothioate, including its 
metabolites and degradates other than methamidophos, in or on the 
commodities in the following table. Compliance with the tolerance levels 
specified in this paragraph is to be determined by measuring only 
acephate, O,S-dimethyl acetyl phosphoramidothioate, in or on the 
commodity.

------------------------------------------------------------------------
                                                               Parts per
                        Commodity \1\                           million
------------------------------------------------------------------------
Bean, dry, seed.............................................        3.0
Bean, succulent.............................................        3.0
Brussels sprouts............................................        3.0
Cattle, fat.................................................        0.1
Cattle, meat................................................        0.1
Cattle, meat byproducts.....................................        0.1
Cauliflower.................................................        2.0
Celery......................................................       10
Cotton, hulls...............................................        1.0
Cotton, meal................................................        1.0
Cotton, undelinted seed.....................................        0.5
Cranberry...................................................        0.5
Egg.........................................................        0.1
Goat, fat...................................................        0.1
Goat, meat..................................................        0.1
Goat, meat byproducts.......................................        0.1
Hog, fat....................................................        0.1
Hog, meat...................................................        0.1
Hog, meat byproducts........................................        0.1
Horse, fat..................................................        0.1
Horse, meat.................................................        0.1
Horse, meat byproducts......................................        0.1
Lettuce, head...............................................       10
Milk........................................................        0.1
Peanut......................................................        0.2
Pepper......................................................        4.0
Peppermint, tops............................................       27
Poultry, fat................................................        0.1
Poultry, meat...............................................        0.1
Poultry, meat byproducts....................................        0.1
Sheep, fat..................................................        0.1
Sheep, meat.................................................        0.1
Sheep, meat byproducts......................................        0.1
Spearmint, tops.............................................       27
Soybean, seed...............................................        1.0
------------------------------------------------------------------------
\1\ Where there is a direct use of methamidophos on the commodity,
  residues of methamidophos resulting from methamidophos application are
  regulated under 40 CFR 180.315.

    (2) A tolerance of 0.02 ppm is established for residues of acephate, 
O,S-dimethyl acetyl phosphoramidothioate, including its metabolites and 
degradates other than methamidophos, in or on all food items (other than 
those already covered by a higher tolerance as a result of use on 
growing crops) in food handling establishments where food and food 
products are held, processed, prepared and served, including food 
service, manufacturing and processing establishments, such as 
restaurants, cafeterias, supermarkets, bakeries, breweries, dairies, 
meat slaughtering and packing plants, and canneries, where application 
of acephate shall be limited solely to spot and/or crack and crevice 
treatment (a coarse, low-pressure spray shall be used to avoid 
atomization or splashing of the spray for spot treatments; equipment 
capable of delivering a pin-stream of insecticide shall be used for 
crack and crevice treatments). Spray concentration shall be limited to a 
maximum of 1.0 percent active ingredient. Contamination of food or food-
contact surfaces shall be avoided. Compliance with the tolerance levels 
specified in this paragraph is to be determined by measuring only 
acephate, O,S-dimethyl acetyl phosphoramidothioate, in or on the 
commodity.
    (3) Tolerances are established for residues of methamidophos, O,S-
dimethyl phosphoramidothioate, including its metabolites and degradates, 
in or on the commodities in the following table as a result of the 
application of acephate. Compliance with the tolerance levels specified 
in this paragraph is to be determined by measuring only methamidophos, 
O,S-dimethyl phosphoramidothioate, in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Bean, dry, seed............................................        1
Bean, succulent............................................        1
Brussels sprouts...........................................        0.5
Cauliflower................................................        0.5
Celery.....................................................        1
Cranberry..................................................        0.1
Lettuce, head..............................................        1
Pepper.....................................................        1
Peppermint, tops...........................................        1
Spearmint, tops............................................        1
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]

[[Page 475]]

    (c) Tolerances with regional registrations. A tolerance with a 
regional registration is established for residues of acephate, O,S-
dimethyl acetyl phosphoramidothioate, including its metabolites and 
degradates other than methamidophos, in or on the commodity in the 
following table. Compliance with the tolerance level specified in this 
paragraph is to be determined by measuring only acephate, O,S-dimethyl 
acetyl phosphoramidothioate, in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                        Commodity\1\                           million
------------------------------------------------------------------------
Nut, macadamia.............................................        0.05
------------------------------------------------------------------------
\1\ Where there is a direct use of methamidophos on the commodity,
  residues of methamidophos resulting from methamidophos application are
  regulated under 40 CFR 180.315.

    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 13542, Mar. 20, 1998, as amended at 67 FR 49615, July 31, 2002; 
73 FR 5108, Jan. 29, 2008; 75 FR 60237, Sept. 29, 2010]



Sec. 180.110  Maneb; tolerances for residues.

    (a) General. Tolerances for residues of the fungicide maneb 
(manganous ethylenebisdithiocarbamate), calculated as zinc 
ethylenebisdithiocarbamate, are established in or on raw agricultural 
commodities in the following table:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Almond..........................................        0.1     12/31/12
Apple...........................................          2     12/31/12
Apricot.........................................         10     12/31/12
Banana (not more than 0.5 part per million shall          4     12/31/12
 be in the pulp after peel is removed and
 discarded (preharvest application only)).......
Bean, dry, seed.................................          7     12/31/12
Bean, succulent.................................         10     12/31/12
Beet, sugar, tops...............................         45     12/31/12
Broccoli........................................         10     12/31/12
Brussels sprouts................................         10     12/31/12
Cabbage.........................................         10     12/31/12
Cabbage, Chinese, bok choy......................         10     12/31/12
Cabbage, Chinese, napa..........................         10     12/31/12
Carrot, roots...................................          7     12/31/12
Cauliflower.....................................         10     12/31/12
Celery..........................................          5     12/31/12
Collards........................................         10     12/31/12
Corn, sweet, kernel plus cob with husks removed.          5     12/31/12
Cranberry.......................................          7     12/31/12
Cucumber........................................          4     12/31/12
Eggplant........................................          7     12/31/12
Endive..........................................         10     12/31/12
Fig.............................................          7     12/31/12
Grape...........................................          7     12/31/12
Kale............................................         10     12/31/12
Kohlrabi........................................         10     12/31/12
Lettuce.........................................         10     12/31/12
Melon...........................................          4     12/31/12
Mustard greens..................................         10     12/31/12
Nectarine.......................................         10     12/31/12
Onion...........................................          7     12/31/12
Papaya..........................................         10     12/31/12
Peach...........................................         10     12/31/12
Pepper..........................................          7     12/31/12
Potato..........................................        0.1     12/31/12
Pumpkin.........................................          7     12/31/12
Squash, summer..................................          4     12/31/12
Squash, winter..................................          4     12/31/12
Tomato..........................................          4     12/31/12
Turnip, greens..................................         10     12/31/12
Turnip, roots...................................          7     12/31/12
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[62 FR 49924, Sept. 24, 1997, as amended at 63 FR 57072, Oct. 26, 1998; 
64 FR 13103, Mar. 17, 1999; 64 FR 72284, Dec. 27, 1999; 66 FR 64773, 
Dec. 14, 2001; 68 FR 37764, June 25, 2003; 70 FR 37696, June 30, 2005; 
70 FR 75739, Dec. 21, 2005; 74 FR 636, Jan. 7, 2009; 74 FR 46371, Sept. 
9, 2009; 76 FR 34885, June 15, 2011; 76 FR 40814, July 12, 2011]



Sec. 180.111  Malathion; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide malathion (O,O-dimethyl dithiophosphate of diethyl 
mercaptosuccinate) in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................      135
Alfalfa, hay................................................      135
Almond, hulls...............................................       50
Almond, postharvest.........................................        8
Apple.......................................................        8
Apricot.....................................................        8
Asparagus...................................................        8
Avocado.....................................................        8
Barley, grain, postharvest..................................        8
Bean, dry, seed.............................................        8
Bean, succulent.............................................        8
Beet, garden, roots.........................................        8
Beet, garden, tops..........................................        8
Beet, sugar, roots..........................................        1
Beet, sugar, tops...........................................        8
Blackberry..................................................        8
Blueberry...................................................        8
Boysenberry.................................................        8
Carrot, roots...............................................        8
Chayote, fruit..............................................        8

[[Page 476]]

 
Chayote, roots..............................................        8
Cherry......................................................        8
Chestnut....................................................        1
Clover, forage..............................................      135
Clover, hay.................................................      135
Corn, field, forage.........................................        8
Corn, field, grain, postharvest.............................        8
Corn, pop, grain, postharvest...............................        8
Corn, sweet, forage.........................................        8
Corn, sweet, kernel plus cob with husks removed.............        2
Cowpea, forage..............................................      135
Cowpea, hay.................................................      135
Cranberry...................................................        8
Cucumber....................................................        8
Currant.....................................................        8
Date, dried fruit...........................................        8
Dewberry....................................................        8
Eggplant....................................................        8
Fig.........................................................        8
Flax, seed..................................................        0.1
Garlic, bulb................................................        8
Gooseberry..................................................        8
Grape.......................................................        8
Grapefruit..................................................        8
Guava.......................................................        8
Hazelnut....................................................        1
Hop, dried cones............................................        1
Horseradish.................................................        8
Kumquat.....................................................        8
Leek........................................................        8
Lemon.......................................................        8
Lentil, seed................................................        8
Lespedeza, hay..............................................      135
Lime........................................................        8
Loganberry..................................................        8
Lupin, seed.................................................        8
Mango.......................................................        8
Melon.......................................................        8
Mushroom....................................................        8
Nectarine...................................................        8
Nut, macadamia..............................................        1
Oat, grain, postharvest.....................................        8
Okra........................................................        8
Onion, bulb.................................................        8
Onion, green................................................        8
Orange......................................................        8
Papaya......................................................        1
Parsnip.....................................................        8
Passionfruit................................................        8
Pea.........................................................        8
Pea, field, hay.............................................        8
Pea, field, vines...........................................        8
Peach.......................................................        8
Peanut, hay.................................................      135
Peanut, postharvest.........................................        8
Pear........................................................        8
Pecan.......................................................        8
Pepper......................................................        8
Peppermint, tops............................................        8
Pineapple...................................................        8
Plum........................................................        8
Plum, prune.................................................        8
Potato......................................................        8
Pumpkin.....................................................        8
Quince......................................................        8
Radish......................................................        8
Raspberry...................................................        8
Rice, grain, postharvest....................................        8
Rice, wild..................................................        8
Rutabaga....................................................        8
Rye, grain, postharvest.....................................        8
Safflower, seed.............................................        0.2
Salsify, roots..............................................        8
Salsify, tops...............................................        8
Shallot, bulb...............................................        8
Sorghum, grain, forage......................................        8
Sorghum, grain, grain, postharvest..........................        8
Soybean, forage.............................................      135
Soybean, hay................................................      135
Soybean, seed...............................................        8
Soybean, vegetable, succulent...............................        8
Spearmint, tops.............................................        8
Squash, summer..............................................        8
Squash, winter..............................................        8
Strawberry..................................................        8
Sunflower, seed, postharvest................................        8
Sweet potato, roots.........................................        1
Tangerine...................................................        8
Tomato......................................................        8
Trefoil, forage.............................................      135
Trefoil, hay................................................      135
Turnip, greens..............................................        8
Turnip, roots...............................................        8
Vegetable, brassica, leafy, group 5.........................        8
Vegetable, leafy, except brassica, group 4..................        8
Vetch, hay..................................................      135
Walnut......................................................        8
Wheat, grain, postharvest...................................        8
------------------------------------------------------------------------

    (2) Tolerances are established for the combined residues of the 
insecticide malathion (O,O-dimethyl dithiophosphate of diethyl 
mercaptosuccinate) and its metabolite, malaoxon (O,O-dimethyl 
thiophosphate of diethyl mercaptosuccinate), in or on the following food 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, straw...............................................       50
Corn, field, stover.........................................       30.0
Cotton, undelinted seed.....................................       20.0
Grass, forage...............................................      200
Grass, hay..................................................      270
Oat, forage.................................................        4.0
Oat, straw..................................................       50
Rye, forage.................................................        4.0
Rye, straw..................................................       50
Watercress..................................................        0.2
Wheat, forage...............................................        4.0
Wheat, straw................................................       50
------------------------------------------------------------------------

    (3) Tolerances are established for residues of the insecticide 
malathion (O,O-dimethyl dithiophosphate of diethyl mercaptosuccinate), 
in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        4
Cattle, meat\1\.............................................        4
Cattle, meat byproducts\1\..................................        4
Egg.........................................................        0.1
Goat, fat...................................................        4
Goat, meat\1\...............................................        4
Goat, meat byproducts\1\....................................        4
Hog, fat....................................................        4
Hog, meat\1\................................................        4

[[Page 477]]

 
Hog, meat byproducts\1\.....................................        4
Horse, fat..................................................        4
Horse, meat\1\..............................................        4
Horse, meat byproducts\1\...................................        4
Milk, fat...................................................        0.5
Poultry, fat................................................        4
Poultry, meat\1\............................................        4
Poultry, meat byproducts\1\.................................        4
Sheep, fat..................................................        4
Sheep, meat\1\..............................................        4
Sheep, meat byproducts\1\...................................        4
------------------------------------------------------------------------
\1\ The tolerance level shall not be exceeded in any cut of meat or in
  any meat byproducts from cattle, goat, hog, horse, poultry, or sheep.

    (4) Malathion may be safely used in accordance with the following 
conditions:
    (i) It is incorporated into paper trays in amounts not exceeding 100 
milligrams per square foot.
    (ii) Treated paper trays are intended for use only in the drying of 
grape (raisins).
    (iii) Total residues of malathion resulting from drying of grape on 
treated trays and from application to grape before harvest shall not 
exceed 12 parts per million on processed ready-to-eat raisins.
    (5) Residues of malathion in safflower, refined oil from application 
to the growing safflower plant shall not exceed 0.6 parts per million.
    (6) Malathion may be safely used for the control of insects during 
the drying of grape (raisins) in compliance with paragraph (a)(4) of 
this section by incorporation into paper trays in amounts not exceeding 
100 milligrams per square foot.
    (7) Malathion (O,O-dimethyl dithiophosphate of diethyl 
mercaptosuccinate) may be safely used in feed in accordance with the 
following conditions.
    (i) A tolerance of 50 parts per million is established for residues 
of malathion in citrus, dried pulp for cattle feed, when present as the 
result of the application of the pesticide to bagged citrus pulp during 
storage. Whether or not tolerances for residues of malathion on the 
fresh fruit have been established under section 408 of the Act, the 
total residue of malathion in the citrus, dried pulp shall not exceed 50 
parts per million.
    (ii) A tolerance of 10 parts per million is established for 
malathion in nonmedicated cattle feed concentrate blocks resulting from 
its application as a pesticide to paper used in packaging the 
nonmedicated cattle feed concentrate blocks.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[43 FR 22974, May 30, 1978, as amended at 43 FR 45584, Oct. 3, 1978; 44 
FR 38844, July 3, 1979; 45 FR 76145, Nov. 18, 1980; 47 FR 42738, Sept. 
29, 1982; 47 FR 55226, Dec. 8, 1982; 52 FR 45183, Nov. 25, 1987; 62 FR 
66023, 66025, Dec. 17, 1997; 65 FR 33694, May 24, 2000; 72 FR 35665, 
June 29, 2007; 73 FR 54959, Sept. 24, 2008; 74 FR 47455, Sept. 16, 2009; 
75 FR 60238, Sept. 29, 2010]



Sec. 180.114  Ferbam; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide ferbam (ferric dimethyldithiocarbamate), calculated as carbon 
disulfide, in or on the following food commodities:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   Revocation
                                                   million       Date
------------------------------------------------------------------------
Apple...........................................    4.0 \1\         None
Bean............................................    7.0 \1\     10/27/07
Cabbage.........................................    7.0 \1\     10/27/07
Cherry..........................................    4.0 \1\         None
Cranberry.......................................    4.0 \1\         None
Fruit, citrus, group 10.........................    4.0 \1\         None
Grape...........................................    4.0 \1\         None
Lettuce.........................................    7.0 \1\     10/27/07
Nectarine.......................................    4.0 \1\         None
Peach...........................................    4.0 \1\         None
Pear............................................    4.0 \1\         None
Raspberry.......................................    7.0 \1\     10/27/07
------------------------------------------------------------------------
\1\Some of these tolerances were established on the basis of data
  acquired at the public hearings held in 1950 (formerly Sec.  180.101)
  and the remainder were established on the basis of pesticide petitions
  presented under the procedure specified in the amendment to the
  Federal Food, Drug, and Cosmetic Act by Pub. L. 518, 83d Congress (68
  Stat. 511)

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registrations, as defined in Sec. 180.1(l), are established for 
residues of the fungicide ferbam (ferric dimethyldithiocarbamate), 
calculated as carbon disulfide, in or on the following food commodities:

[[Page 478]]



------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------
Mango.................................................           4.0 \1\
------------------------------------------------------------------------
\1\ This tolerance was established on the basis of data acquired at the
  public hearings held in 1950 (formerly Sec.  180.101) and the
  remainder was established on the basis of pesticide petitions
  presented under the procedure specified in the amendment to the
  Federal Food, Drug, and Cosmetic Act by Pub. L. 518, 83d Congress (68
  Stat. 511)

    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 57072, Oct. 26, 1998, as amended at 72 FR 53453, Sept. 19, 2007]



Sec. 180.116  Ziram; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide ziram (zinc dimethyldithiocarbamate), calculated as zinc 
ethylenebisdithiocarbamate, in or on the following food commodities:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Almond..........................................    \1\ 0.1         None
Apple...........................................    \1\ 7.0         None
Apricot.........................................    \1\ 7.0         None
Blackberry......................................    \1\ 7.0      5/11/13
Blueberry.......................................    \1\ 7.0         None
Cherry, sweet...................................    \1\ 7.0         None
Cherry, tart....................................    \1\ 7.0         None
Grape...........................................        7.0         None
Huckleberry.....................................        7.0         None
Peach...........................................        7.0         None
Pear............................................    \1\ 7.0         None
Pecan...........................................        0.1         None
Quince..........................................    \1\ 7.0         None
Strawberry......................................        7.0         None
Tomato..........................................    \1\ 7.0         None
------------------------------------------------------------------------
\1\ Some of these tolerances were established on the basis of data
  acquired at the public hearings held in 1950 (formerly Sec.  180.101)
  and the remainder were established on the basis of pesticide petitions
  presented under the procedure specified in the amendment to the
  Federal Food, Drug, and Cosmetic Act by Public Law 518, 83d Congress
  (68 Stat. 511).

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[68 FR 39437, July 1, 2003, as amended at 71 FR 54432, Sept. 15, 2006; 
73 FR 54959, Sept. 24, 2008; 77 FR 59123, Sept. 26, 2012]



Sec. 180.117  S-Ethyl dipropylthiocarbamate; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide S-ethyl dipropylthiocarbamate, including its metabolites and 
degradates, in or on the commodities in the following table. Compliance 
with the tolerance levels specified in this paragraph is to be 
determined by measuring only the sum of S-ethyl dipropylthiocarbamate, 
S-ethyl (2-hydroxypropyl)propylcarbamothioate, S-(2-
hydroxyethyl)dipropylcarbamothioate, and S-ethyl (3-
hydroxypropyl)propylcarbamothioate, calculated as the stoichiometric 
equivalent of S-ethyl dipropylthiocarbamate, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        0.2
Alfalfa, hay................................................        0.6
Almond......................................................        0.08
Almond, hulls...............................................        0.08
Bean, dry, seed.............................................        0.08
Bean, succulent.............................................        0.08
Beet, garden, tops..........................................        0.5
Beet, sugar, molasses.......................................        0.4
Beet, sugar, tops...........................................        0.5
Clover, forage..............................................        0.1
Clover, hay.................................................        0.1
Corn, field, forage.........................................        0.08
Corn, field, grain..........................................        0.08
Corn, field, stover.........................................        0.08
Corn, pop, grain............................................        0.08
Corn, pop, stover...........................................        0.08
Corn, sweet, forage.........................................        0.08
Corn, sweet, kernel plus cob with husks removed.............        0.08
Corn, sweet, stover.........................................        0.08
Cotton, gin byproducts......................................        0.20
Cotton, undelinted seed.....................................        0.08
Fruit, citrus, group 10.....................................        0.1
Lespedeza, forage...........................................        0.1
Lespedeza, hay..............................................        0.1
Pea, succulent..............................................        0.08
Safflower, seed.............................................        0.08
Sunflower, seed.............................................        0.08
Tomato......................................................        0.08
Trefoil, forage.............................................        0.1
Trefoil, hay................................................        0.1
Vegetable, root.............................................        0.1
Walnut......................................................        0.08
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[75 FR 60239, Sept. 29, 2010]



Sec. 180.121  Methyl parathion; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide methyl parathion, including its metabolites and degradates, 
in or on the commodities in the table in this paragraph. Compliance with 
the tolerance

[[Page 479]]

levels specified in this paragraph is to be determined by measuring only 
methyl parathion, O,O-dimethyl O-(4-nitrophenyl) phosphorothioate, in or 
on the commodity.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   Revocation
                                                   million       date
------------------------------------------------------------------------
Alfalfa, forage.................................       1.25     12/31/13
Alfalfa, hay....................................        5.0     12/31/13
Almond..........................................        0.1     12/31/13
Almond, hulls...................................        3.0     12/31/13
Barley..........................................        1.0     12/31/13
Corn, field, forage.............................        1.0     12/31/13
Corn, field, grain..............................        1.0     12/31/13
Corn, pop, grain................................        1.0     12/31/13
Corn, sweet, forage.............................        1.0     12/31/13
Corn, sweet, kernel plus cob with husks removed.        1.0     12/31/13
Cotton, undelinted seed.........................       0.75     12/31/13
Grass, forage...................................        1.0     12/31/13
Oat.............................................        1.0     12/31/13
Onion...........................................        1.0     12/31/13
Pea, field, vines...............................        1.0     12/31/13
Potato..........................................        0.1     12/31/13
Rapeseed, seed..................................        0.2     12/31/13
Rice, grain.....................................        1.0     12/31/13
Soybean, hay....................................        1.0     12/31/13
Soybean, seed...................................        0.1     12/31/13
Sunflower, seed.................................        0.2     12/31/13
Sweet potato, roots.............................        0.1     12/31/13
Walnut..........................................        0.1     12/31/13
Wheat...........................................        1.0     12/31/13
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
    (e) Revoked tolerances subject to the channel of trade provisions. 
The following table lists commodities for which methyl parathion use was 
unlawful after December 31, 1999, and the revoked tolerances. 
Commodities with residues of methyl parathion resulting from lawful use 
are subject to the channels of trade provisions of section 408(1)(5) of 
the FFDCA.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Apple........................................................          1
Artichoke, globe.............................................          1
Beet, garden, roots..........................................          1
Beet, garden, tops...........................................          1
Broccoli.....................................................          1
Brussels sprouts.............................................          1
Carrot, roots................................................          1
Cauliflower..................................................          1
Celery.......................................................          1
Cherry.......................................................          1
Collards.....................................................          1
Grape........................................................          1
Kale.........................................................          1
Kohlrabi.....................................................          1
Lettuce......................................................          1
Mustard greens...............................................          1
Nectarine....................................................          1
Peach........................................................          1
Pear.........................................................          1
Plum, prune, fresh...........................................          1
Rutabaga, roots..............................................          1
Rutabaga tops................................................          1
Spinach......................................................          1
Tomato.......................................................          1
Trefoil, forage..............................................       1.25
Trefoil, hay.................................................          5
Turnip, greens...............................................          1
Turnip, roots................................................          1
Vegetable, brassica, leafy, group 5..........................          1
Vetch, forage................................................          1
Vetch, hay...................................................          1
------------------------------------------------------------------------


[66 FR 1245, Jan. 5, 2001, as amended at 66 FR 38955, July 26, 2001; 67 
FR 38603, June 5, 2002; 72 FR 35666, June 29, 2007; 73 FR 54959, Sept. 
24, 2008; 74 FR 46372, Sept. 9, 2009; 76 FR 56652, Sept. 14, 2011]



Sec. 180.123  Inorganic bromide residues resulting from fumigation with methyl 

bromide; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
inorganic bromides (calculated as Br) in or on the following food 
commodities which have been fumigated with the antimicrobial agent and 
insecticide methyl bromide after harvest (with the exception of 
strawberry):

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   Revocation
                                                   million       Date
------------------------------------------------------------------------
Alfalfa, hay, postharvest.......................       50.0     10/31/11
Almond, postharvest.............................      200.0         None
Apple, postharvest..............................        5.0         None
Apricot, postharvest............................       20.0         None
Artichoke, jerusalem, postharvest...............       30.0         None
Asparagus, postharvest..........................      100.0         None
Avocado, postharvest............................       75.0         None
Barley, grain, postharvest......................       50.0         None
Bean, lima, postharvest.........................       50.0         None
Bean, postharvest...............................       50.0         None
Bean, snap, succulent, postharvest..............       50.0         None
Bean, succulent, postharvest....................       50.0         None
Beet, garden, roots, postharvest................       30.0         None
Beet, sugar, roots, postharvest.................       30.0         None
Blueberry, postharvest..........................       20.0         None
Butternut, postharvest..........................      200.0         None
Cabbage, postharvest............................       50.0         None
Cacao bean, roasted bean, postharvest...........       50.0         None
Cantaloupe, postharvest.........................       20.0         None
Carrot, roots, postharvest......................       30.0         None
Cashew, postharvest.............................      200.0         None
Cherry, sweet, postharvest......................       20.0         None
Cherry, tart, postharvest.......................         20         None
Chestnut, postharvest...........................      200.0         None
Cippolini, bulb, postharvest....................       50.0         None
Citron, citrus, postharvest.....................       30.0         None
Coconut, copra, postharvest.....................      100.0         None
Coffee, bean, green, postharvest................       75.0         None

[[Page 480]]

 
Corn, field, grain, postharvest.................       50.0         None
Corn, pop, postharvest..........................      240.0         None
Corn, sweet, kernel plus cob with husks removed,       50.0         None
 postharvest....................................
Cotton, undelinted seed, postharvest............      200.0     10/31/11
Cucumber, postharvest...........................       30.0         None
Cumin, seed, postharvest........................      100.0         None
Eggplant, postharvest...........................       20.0         None
Garlic, postharvest.............................       50.0         None
Ginger, postharvest.............................      100.0         None
Grape, postharvest..............................       20.0         None
Grapefruit, postharvest.........................       30.0         None
Hazelnut, postharvest...........................      200.0         None
Horseradish, postharvest........................       30.0         None
Kumquat, postharvest............................       30.0         None
Lemon, postharvest..............................       30.0         None
Lime, postharvest...............................       30.0         None
Melon, honeydew, postharvest....................       20.0         None
Muskmelon, postharvest..........................       20.0         None
Nectarine, postharvest..........................       20.0         None
Nut, brazil, postharvest........................      200.0         None
Nut, hickory, postharvest.......................      200.0         None
Nut, macadamia, postharvest.....................      200.0         None
Oat, postharvest................................       50.0         None
Okra, postharvest...............................       30.0         None
Onion, bulb, postharvest........................       20.0         None
Onion, green, postharvest.......................       20.0         None
Orange, postharvest.............................       30.0         None
Parsnip, roots, postharvest.....................       30.0         None
Peach, postharvest..............................       20.0         None
Peanut, postharvest.............................      200.0         None
Pear, postharvest...............................        5.0         None
Pea, blackeyed, postharvest.....................       50.0         None
Pea, postharvest................................       50.0         None
Pecan, postharvest..............................      200.0         None
Pepper, postharvest.............................       30.0         None
Pimento, postharvest............................       30.0         None
Pineapple, postharvest..........................       20.0         None
Pistachio, postharvest..........................      200.0         None
Plum, postharvest...............................       20.0         None
Pomegranate, postharvest........................      100.0         None
Potato, postharvest.............................       75.0         None
Pumpkin, postharvest............................       20.0         None
Quince, postharvest.............................        5.0         None
Radish, postharvest.............................       30.0         None
Rice, grain, postharvest........................       50.0         None
Rutabaga, roots, postharvest....................       30.0         None
Rutabaga, tops, postharvest.....................       30.0         None
Rye, grain, postharvest.........................       50.0         None
Salsify, roots, postharvest.....................       30.0         None
Sorghum, grain, grain, postharvest..............       50.0         None
Soybean, postharvest............................      200.0         None
Squash, summer, postharvest.....................       30.0         None
Squash, winter, postharvest.....................       20.0         None
Squash, zucchini, postharvest...................       20.0         None
Strawberry, postharvest.........................       60.0         None
Sweet potato, postharvest.......................       75.0         None
Tangerine, postharvest..........................       30.0         None
Timothy, hay, postharvest.......................       50.0     10/19/10
Tomato, postharvest.............................       20.0         None
Turnip, roots, postharvest......................       30.0         None
Walnut, postharvest.............................      200.0         None
Watermelon, postharvest.........................       20.0         None
Wheat...........................................       50.0         None
------------------------------------------------------------------------

    (2) Inorganic bromide may be present as a residue in certain 
processed food in accordance with the following conditions:
    (i) When inorganic bromide residues are present as a result of 
fumigation of the processed food with methyl bromide or from such 
fumigation in addition to the authorized use of methyl bromide on the 
source raw agricultural commodity, as provided for in this part, the 
total residues of inorganic bromides (calculated as Br) shall not exceed 
the following levels:
    (A) 400 parts per million in or on egg, dried and herb, processed 
and spice.
    (B) 325 parts per million in or on cheese, parmesan and cheese, 
roquefort cheese.
    (C) 250 parts per million in or on tomato, concentrated products and 
fig, dried fruit.
    (D) 125 parts per million in or on processed food other than those 
listed above.
    (ii) When inorganic bromide residues are present in malt beverage, 
fermented in accordance with 21 CFR 172.730(a)(2), the amount shall not 
exceed 25 parts per million (calculated as Br).
    (iii) Where tolerances are established on both the raw agricultural 
commodities and processed food made therefrom, the total residues of 
inorganic bromides in or on the processed food shall not be greater than 
those designated in paragraph (a)(2) of this section, unless a higher 
level is established elsewhere in this part.
    (3) Tolerances are established for residues of inorganic bromides 
(calculated as Br) as follows:
    (i) 400 parts per million for residues in or on dog food, resulting 
from fumigation with methyl bromide.
    (ii) 125 parts per million for residues in or on processed 
commodities for animal feedstuffs from barley, corn, grain sorghum, oat, 
rice, rye and wheat, resulting directly from fumigation with methyl 
bromide or from carryover and concentration of residues of inorganic 
bromides from fumigation of the grains with methyl bromide.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. A tolerance with 
regional registration, as defined in Sec. 180.1(l), is established for 
residues of inorganic bromides (calculated as Br) in or on the

[[Page 481]]

following food commodity grown in soil fumigated with methyl bromide.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Ginger, postharvest.........................................      100
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[71 FR 74812, Dec. 13, 2006, as amended at 75 FR 60239, Sept. 29, 2010]



Sec. 180.123a  Inorganic bromide residues in peanut hay and peanut hulls; 

statement of policy.

    (a) Investigations by the Food and Drug Administration show that 
peanut hay and peanut shells have been used as feed for meat and dairy 
animals. While many growers now harvest peanuts with combines and leave 
the hay on the ground to be incorporated into the soil, some growers 
follow the practice of curing peanuts on the vines in a stack and save 
the hay for animal feed. Peanut shells or hulls have been used to a 
minor extent as roughage for cattle feed. It has been established that 
the feeding to cattle of peanut hay and peanut hulls containing residues 
of inorganic bromides will contribute considerable residues of inorganic 
bromides to the meat and milk.
    (b) There are no tolerances for inorganic bromides in meat and milk 
to cover residues from use of such peanut hulls as animal feed. Peanut 
hulls containing residues of inorganic bromides from the use of methyl 
bromide are unsuitable as an ingredient in the feed of meat and dairy 
animals and should not be represented, sold, or used for that purpose.

[58 FR 65555, Dec. 15, 1993]



Sec. 180.124  Methyl bromide; tolerances for residues.

    (a) General. A tolerance is established for residues of the fumigant 
methyl bromide, including metabolites and degradates, in or on the 
commodity in the table below. Compliance with the tolerance level 
specified below is to be determined by measuring only methyl bromide.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cotton, undelinted seed.....................................      150
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[77 FR 35298, June 13, 2012]



Sec. 180.127  Piperonyl butoxide; tolerances for residues.

    (a) General. (1) Tolerances for residues of the insecticide 
piperonyl butoxide [(butyl carbityl)(6-propyl piperonyl)ether] are 
established in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, postharvest.........................................        8
Apple, postharvest..........................................        8
Barley, postharvest.........................................       20
Bean, postharvest...........................................        8
Birdseed, mixtures, postharvest.............................       20
Blackberry, postharvest.....................................        8
Blueberry, postharvest......................................        8
Boysenberry, postharvest....................................        8
Buckwheat, grain, postharvest...............................       20
Cattle, fat.................................................        0.1
Cattle, meat................................................        0.1
Cattle, meat byproducts.....................................        0.1
Cherry, sweet, postharvest..................................        8
Cherry, tart, postharvest...................................        8
Cacoa bean, roasted bean, postharvest.......................        8
Coconut, copra, postharvest.................................        8
Corn, field, grain, postharvest.............................       20
Corn, pop, postharvest......................................       20
Cotton, undelinted seed, postharvest........................        8
Crabapple, postharvest......................................        8
Currant, postharvest........................................        8
Dewberry, postharvest.......................................        8
Egg.........................................................        1
Fig, postharvest............................................        8
Flax, seed, postharvest.....................................        8
Goat, fat...................................................        0.1
Goat, meat..................................................        0.1
Goat, meat byproducts.......................................        0.1
Gooseberry, postharvest.....................................        8
Grape, postharvest..........................................        8
Guava, postharvest..........................................        8
Hog, fat....................................................        0.1
Hog, meat...................................................        0.1
Hog, meat byproducts........................................        0.1
Horse, fat..................................................        0.1
Horse, meat.................................................        0.1
Horse, meat byproducts......................................        0.1
Loganberry, postharvest.....................................        8
Mango, postharvest..........................................        8
Milk, fat...................................................        0.25
Muskmelon, postharvest......................................        8
Oat, postharvest............................................        8
Orange, postharvest.........................................        8
Peach, postharvest..........................................        8
Peanut, postharvest.........................................        8
Pea, postharvest............................................        8
Pear, postharvest...........................................        8
Pineapple, postharvest......................................        8
Plum, prune, fresh, postharvest.............................        8
Potato, postharvest.........................................        0.25
Poultry, fat................................................        3
Poultry, meat...............................................        3
Poultry, meat byproducts....................................        3

[[Page 482]]

 
Raspberry, postharvest......................................        8
Rice, postharvest...........................................       20
Rye, postharvest............................................       20
Sheep, fat..................................................        0.1
Sheep, meat.................................................        0.1
Sheep, meat byproducts......................................        0.1
Sorghum, grain, postharvest.................................        8
Sweet potato, postharvest...................................        0.25
Tomato, postharvest.........................................        8
Walnut, postharvest.........................................        8
Wheat, postharvest..........................................       20
------------------------------------------------------------------------

    (2) Piperonyl butoxide may be safely used in accordance with the 
following prescribed conditions:
    (i) It is used or intended for use in combination with pyrethrins 
for control of insects:
    (A) In cereal grain mills and in storage areas for milled cereal 
grain products, whereby the amount of piperonyl butoxide is at least 
equal to but not more than 10 times the amount of pyrethrins in the 
formulation.
    (B) On the outer ply of multiwall paper bags of 50 pounds or more 
capacity in amounts not exceeding 60 milligrams per square foot, whereby 
the amount of piperonyl butoxide is equal to 10 times the amount of 
pyrethrins in the formulation. Such treated bags are to be used only for 
food, dried.
    (C) On cotton bags of 50 pounds or more capacity in amounts not 
exceeding 55 milligrams per square foot of cloth, whereby the amount of 
piperonyl butoxide is equal to 10 times the amount of pyrethrins in the 
formulation. Such treated bags are constructed with waxed paper liners 
and are to be used only for food, dried that contain 4 percent fat or 
less.
    (D) In two-ply bags consisting of cellophane/polyolefin sheets bound 
together by an adhesive layer when it is incorporated in the adhesive. 
The treated sheets shall contain not more than 50 milligrams of 
piperonyl butoxide per square foot (538 milligrams per square meter). 
Such treated bags are to be used only for packaging plum, prune, dried; 
grape, raisin; and other fruit, dried and are to have a maximum ratio of 
3.12 milligrams of piperonyl butoxide per ounce of fruit (0.10 milligram 
of piperonyl butoxide per gram of product).
    (E) In food processing and food storage areas: Provided, That the 
food is removed or covered prior to such use.
    (ii) It is used or intended for use in combination with pyrethrins 
and N-octylbicycloheptene dicarboximide for insect control in accordance 
with 21 CFR 178.3730.
    (iii) A tolerance of 10 parts per million is established for 
residues of piperonyl butoxide in or on:
    (A) Grain, cereal, milled fractions when present therein as a result 
of its use in cereal grain mills and in storage areas for milled cereal 
grain products.
    (B) Food, dried when present as a result of migration from its use 
on the outer ply of multiwall paper bags of 50 pounds or more capacity.
    (C) Food treated in accordance with 21 CFR 178.3730.
    (D) Food, dried that contain 4 percent fat, or less, when present as 
a result of migration from its use on the cloth of cotton bags of 50 
pounds or more capacity constructed with waxed paper liners.
    (E) Food treated in accordance with paragraph (a)(2)(i)(D) and (E) 
of this section.
    (iv) To assure safe use of the pesticide, its label and labeling 
shall conform to that registered with the U.S. Environmental Protection 
Agency, and it shall be used in accordance with such label and labeling.
    (v) Where tolerances are established on both raw agricultural 
commodities and processed food made therefrom, the total residues of 
piperonyl butoxide in or on the processed food shall not be greater than 
that permitted by the larger of the two tolerances.
    (3) Piperonyl butoxide may be safely used in accordance with the 
following prescribed conditions:
    (i) It is used or intended for use in combination with pyrethrins 
for control of insects:
    (A) On the outer ply of multiwall paper bags of 50 pounds or more 
capacity in amounts not exceeding 60 milligrams per square foot.
    (B) On cotton bags of 50 pounds or more capacity in amounts not 
exceeding 55 milligrams per square foot of cloth. Such treated bags are 
constructed with waxed paper liners and

[[Page 483]]

are to be used only for feed, dried that contain 4 percent fat or less.
    (ii) It is used in combination with pyrethrins, whereby the amount 
of piperonyl butoxide is equal to 10 times the amount of pyrethrins in 
the formulation. Such treated bags are to be used only for feed, dried.
    (iii) A tolerance of 10 parts per million is established for 
residues of piperonyl butoxide when present as the result of migration:
    (A) In or on feed, dried from its use on the outer ply of multiwall 
paper bags of 50 pounds or more capacity.
    (B) In or on feed, dried that contain 4 percent fat, or less, from 
its use on cotton bags of 50 pounds or more capacity constructed with 
waxed paper liners.
    (iv) To assure safe use of the pesticide, its label and labeling 
shall conform to that registered with the U.S. Environmental Protection 
Agency.
    (v) Where tolerances are established on both the raw agricultural 
commodities and food, processed made therefrom, the total residues of 
piperonyl butoxide in or on the processed food shall not be greater than 
that permitted by the larger of the two tolerances.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[71 FR 74813, Dec. 13, 2006]



Sec. 180.128  Pyrethrins; tolerances for residues.

    (a) General. (1) Tolerances for residues of the insecticide 
pyrethrins ((1S)-2-methyl-4-oxo-3-(2Z)-2,4-pentadienylcyclopenten-1-yl 
(1R,3R)-2,2-dimethyl-3-(2-methyl-1-propenyl)cyclopropanecarboxylate 
(pyrethrin 1), (1S)-2-methyl-4-oxo-3-(2Z)-2,4-pentadienyl-2-cyclopenten-
1-yl (1R,3R)-3-[(1E)-3-methoxy-2-methyl-3-oxo-1-propenyl]-2,2-
dimethylcyclopropane-carboxylate (pyrethrin 2), (1S)-3-(2Z)-2-butenyl-2-
methyl-4-oxo-2-cyclopenten-1-yl (1R,3R)-2,2-dimethyl-3-(2-methyl-1-
propenyl)cyclopropanecarboxylate (cinerin 1), (1S)-3-(2Z)-2-butenyl-2-
methyl-4-oxo-2-cyclopenten-1-yl (1R,3R)-3-[(1E)-3-methoxy-2-methyl-3-
oxo-1-propenyl]-2,2-dimethylcyclopropanecarboxylate (cinerin 2), (1S)-2-
methyl-4-oxo-3-(2Z)-2-pentenyl-2-cyclopenten-1-yl (1R, 3R)-2,2-dimethyl-
3-(2-methyl-1-propenyl)cyclopropanecarboxylate (jasmolin 1), and (1S)-2-
methyl-4-oxo-3-(2Z)-pentenyl-2-cyclopenten-1-yl (1R,3R)-3-[(1E)-3-
methoxy-2-methyl-3-oxo-1-propenyl]-2,2-dimethylcyclopropanecarboxylate 
(jasmolin 2)), the insecticidally active principles of Chrysanthemum 
cinerariaefolium, which are measured as cumulative residues of pyrethrin 
1, cinerin 1, and jasmolin 1 are not to exceed the following:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, postharvest.........................................        1.0
Apple, postharvest..........................................        1.0
Barley, grain, postharvest..................................        3.0
Bean, succulent, postharvest................................        1.0
Birdseed, mixtures, postharvest.............................        3.0
Blackberry, postharvest.....................................        1.0
Blueberry, postharvest......................................        1.0
Boysenberry, postharvest....................................        1.0
Buckwheat, grain, postharvest...............................        3.0
Cacao bean, roasted bean, postharvest.......................        1.0
Cattle, fat.................................................        1.0
Cattle, meat................................................        0.05
Cattle, meat byproducts.....................................        0.05
Cherry, sweet, postharvest..................................        1.0
Cherry, tart, postharvest...................................        1.0
Coconut, copra, postharvest.................................        1.0
Corn, field, grain, postharvest.............................        3.0
Corn, pop, grain, postharvest...............................        3.0
Cotton, undelinted seed, postharvest........................        1.0
Crabapple, postharvest......................................        1.0
Currant, postharvest........................................        1.0
Dewberry, postharvest.......................................        1.0
Fig, postharvest............................................        1.0
Flax, seed, postharvest.....................................        1.0
Goat, fat...................................................        1.0
Goat, meat..................................................        0.05
Goat, meat byproducts.......................................        0.05
Gooseberry, postharvest.....................................        1.0
Grape, postharvest..........................................        1.0
Guava, postharvest..........................................        1.0
Hog, fat....................................................        1.0
Hog, meat...................................................        0.05
Hog, meat byproducts........................................        0.05
Horse, fat..................................................        1.0
Horse, meat.................................................        0.05
Horse, meat byproducts......................................        0.05
Loganberry, postharvest.....................................        1.0
Mango, postharvest..........................................        1.0
Milk, fat (reflecting negligible residues in milk)..........        0.05
Muskmelon, postharvest......................................        1.0
Oat, grain, postharvest.....................................        1.0
Orange, postharvest.........................................        1.0
Pea, dry, seed, postharvest.................................        1.0
Peach, postharvest..........................................        1.0
Peanut, postharvest.........................................        1.0
Pear, postharvest...........................................        1.0
Pineapple, postharvest......................................        1.0
Plum, prune, fresh, postharvest.............................        1.0
Potato, postharvest.........................................        0.05
Raspberry, postharvest......................................        1.0
Rice, grain, postharvest....................................        3.0

[[Page 484]]

 
Rye, grain, postharvest.....................................        3.0
Sheep, fat..................................................        1.0
Sheep, meat.................................................        0.05
Sheep, meat byproducts......................................        0.05
Sorghum, grain, grain, postharvest..........................        1.0
Sweet potato, postharvest...................................        0.05
Tomato, postharvest.........................................        1.0
Walnut, postharvest.........................................        1.0
Wheat, grain, postharvest...................................        3.0
------------------------------------------------------------------------

    (2) A tolerance of 1.0 ppm is established for residues of the 
insecticide pyrethrins in or on milled fractions derived from grain, 
cereal when present as a result of its use in cereal grain mills and in 
storage areas for milled cereal grain products.
    (3) A tolerance of 1.0 ppm is established for residues of the 
insecticide pyrethrins in or on all food items in food handling 
establishments where food and food products are held, processed, 
prepared and/or served. Food must be removed or covered prior to use.
    (4) Where tolerances are established on both the raw agricultural 
commodities and processed foods made there-from, the total residues of 
pyrethrins in or on the processed food shall not be greater than that 
permitted by the larger of the two tolerances.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[71 FR 74814, Dec. 13, 2006, as amended at 73 FR 5108, Jan. 29, 2008]



Sec. 180.129  o-Phenylphenol and its sodium salt; tolerances for residues.

    (a) General. Tolerances are established for combined residues of the 
fungicide o-phenylphenol and sodium o-phenylphenate, each expressed as 
o-phenylphenol, from postharvest application of either in or on the 
following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Apple.......................................................       25
Cantaloupe (NMT 10 ppm in edible portion)...................      125
Carrot, roots...............................................       20
Cherry......................................................        5
Citrus fruits...............................................       10
Cucumber....................................................       10
Lemon.......................................................       10
Nectarine...................................................        5
Orange......................................................       10
Pepper, bell................................................       10
Peach.......................................................       20
Pear........................................................       25.0
Pineapple...................................................       10
Plum, prune, fresh..........................................       20
Sweet potato, roots.........................................       15
Tomato......................................................       10
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[73 FR 54960, Sept. 24, 2008]



Sec. 180.130  Hydrogen Cyanide; tolerances for residues.

    (a) General. A tolerance for residues of the insecticide hydrogen 
cyanide from postharvest fumigation as a result of application of sodium 
cyanide is established as follows: 50 parts per million in or on Fruit, 
citrus.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[64 FR 39077, July 21, 1999]



Sec. 180.132  Thiram; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide thiram (tetramethyl thiuram disulfide) in or on raw 
agricultural commodities as follows:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Apple...........................................        7.0         None
Banana\1\.......................................       0.80      3/31/14
Peach...........................................        7.0         None
Strawberry......................................        7.0         None
------------------------------------------------------------------------
\1\ No U.S. registrations as of September 23, 2009.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[67 FR 49615, July 31, 2002, as amended at 74 FR 48391, Sept. 23, 2009]

[[Page 485]]



Sec. 180.142  2,4-D; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide, plant regulator, and fungicide 2,4-D, including its 
metabolites and degradates, in or on the commodities in the table below. 
Compliance with the tolerance levels is to be determined by measuring 
residues of 2,4-D (2,4-dichlorophenoxyacetic acid), both free and 
conjugated, determined as the acid, in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond hulls................................................        0.1
Asparagus...................................................        5.0
Barley, bran................................................        4.0
Barley, grain...............................................        2.0
Barley, straw...............................................       50
Berry, group 13.............................................        0.2
Cattle, fat.................................................        0.3
Cattle, kidney..............................................        4.0
Cattle, meat................................................        0.3
Cattle, meat byproducts, except kidney......................        0.3
Corn, field, forage.........................................        6.0
Corn, field, grain..........................................        0.05
Corn, field, stover.........................................       50
Corn, pop, grain............................................        0.05
Corn, pop, stover...........................................       50
Corn, sweet, forage.........................................        6.0
Corn, sweet, kernel plus cob with husks removed.............        0.05
Corn, sweet, stover.........................................       50
Cranberry...................................................        0.5
Fish........................................................        0.1
Fruit, citrus, group 10.....................................        3.0
Fruit, pome, group 11.......................................        0.05
Fruit, stone, group 12......................................        0.05
Goat, fat...................................................        0.3
Goat, kidney................................................        4.0
Goat, meat..................................................        0.3
Goat, meat byproducts, except kidney........................        0.3
Grain, aspirated fractions..................................       40
Grape.......................................................        0.05
Grass, forage...............................................      360
Grass, hay..................................................      300
Hop, dried cones............................................        0.2
Horse, fat..................................................        0.3
Horse, kidney...............................................        4.0
Horse, meat.................................................        0.3
Horse, meat byproducts, except kidney.......................        0.3
Millet, forage..............................................       25
Millet, grain...............................................        2.0
Millet, straw...............................................       50
Milk........................................................        0.05
Nut, tree, group 14.........................................        0.2
Oat, forage.................................................       25
Oat, grain..................................................        2.0
Oat, straw..................................................       50
Pistachio...................................................        0.05
Potato......................................................        0.4
Rice, grain.................................................        0.5
Rice, hulls.................................................        2.0
Rice, straw.................................................       10
Rye, bran...................................................        4.0
Rye, forage.................................................       25
Rye, grain..................................................        2.0
Rye, straw..................................................       50
Sheep, fat..................................................        0.3
Sheep, kidney...............................................        4.0
Sheep, meat.................................................        0.3
Sheep, meat byproducts, except kidney.......................        0.3
Shellfish...................................................        1.0
Sorghum, grain, forage......................................        0.2
Sorghum, grain, grain.......................................        0.2
Sorghum, grain, stover......................................        0.2
Soybean, forage.............................................        0.02
Soybean, hay................................................        2.0
Soybean, seed...............................................        0.02
Strawberry..................................................        0.05
Sugarcane, cane.............................................        0.05
Sugarcane, molasses.........................................        0.2
Teff, bran..................................................        4.0
Teff, forage................................................       25.0
Teff, grain.................................................        2.0
Teff, straw.................................................       50.0
Vegetable, leaves of root and tuber, group 2................        0.1
Vegetable, root and tuber, except potato, group 1...........        0.1
Wheat, bran.................................................        4.0
Wheat, forage...............................................       25
Wheat, grain................................................        2.0
Wheat, straw................................................       50
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration, as defined in Sec. 180.1(l), are established for residues 
of the herbicide, plant regulator, and fungicide 2,4-D, including its 
metabolites and degradates, in or on the commodities in the table below. 
Compliance with the tolerance levels is to be determined by measuring 
residues of 2,4-D (2,4-dichlorophenoxyacetic acid), both free and 
conjugated, determined as the acid, in or on the follow commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Rice, wild, grain...........................................        0.05
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. Tolerances are established for 
indirect or inadvertent residues of the herbicide, plant regulator, and 
fungicide 2,4-D, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerances levels is 
to be determined by measuring residues of 2,4-D (2,4-
dichlorophenoxyacetic acid), both free and conjugated, determined as the 
acid, in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Animal feed, nongrass, group 18.............................        0.2
Avocado.....................................................        0.05

[[Page 486]]

 
Cotton, undelinted seed.....................................        0.05
Dill, seed..................................................        0.05
Okra........................................................        0.05
Vegetable, brassica leafy, group 5..........................        0.4
Vegetable, bulb, group 3....................................        0.05
Vegetable, cucurbit, group 9................................        0.05
Vegetable, foliage of legume, group 7.......................        0.2
Vegetable, fruiting, group 8................................        0.05
Vegetable, leafy, except brassica, group 4..................        0.4
Vegetable, legume, group 6..................................        0.05
------------------------------------------------------------------------


[72 FR 52017, Sept. 12, 2007, as amended at 73 FR 53737, Sept. 17, 2008; 
74 FR 48411, Sept. 23, 2009; 76 FR 55817, Sept. 9, 2011]



Sec. 180.145  Fluorine compounds; tolerances for residues.

    (a) General. (1) Tolerances are established for combined residues of 
the insecticidal fluorine compounds cryolite and synthetic cryolite 
(sodium aluminum fluoride) in or on the following agricultural 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Apricot.....................................................        7
Blackberry..................................................        7
Blueberry...................................................        7
Boysenberry.................................................        7
Broccoli....................................................        7
Brussels sprouts............................................        7
Cabbage.....................................................        7
Cauliflower.................................................        7
Collards....................................................        7
Cranberry...................................................        7
Cucumber....................................................        7
Dewberry....................................................        7
Eggplant....................................................        7
Fruit, citrus...............................................        7
Grape.......................................................        7
Kale........................................................        7
Kohlrabi....................................................        7
Lettuce, head...............................................        7
Lettuce, leaf...............................................        7
Loganberry..................................................        7
Melon.......................................................        7
Nectarine...................................................        7
Peach.......................................................        7
Pepper......................................................        7
Plum, prune, fresh..........................................        7
Pumpkin.....................................................        7
Raspberry...................................................        7
Squash, summer..............................................        7
Squash, winter..............................................        7
Strawberry..................................................        7
Tomato......................................................        7
Youngberry..................................................        7
------------------------------------------------------------------------

    (2) Tolerances are established for residues of fluoride in or on the 
following commodities from the postharvest fumigation with sulfuryl 
fluoride for the control of insects:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
All processed food commodities not otherwise listed.........       70
Barley, bran, postharvest...................................       45.0
Barley, flour, postharvest..................................       45.0
Barley, grain, postharvest..................................       15.0
Barley, pearled barley, postharvest.........................       45.0
Cattle, meat, dried.........................................       40
Cheese......................................................        5.0
Cacao bean, roasted bean, postharvest.......................       20
Coconut, postharvest........................................       40
Coffee, bean, green, postharvest............................       15
Corn, field, flour, postharvest.............................       35.0
Corn, field, grain, postharvest.............................       10.0
Corn, field, grits, postharvest.............................       10.0
Corn, field, meal, postharvest..............................       30.0
Corn, pop, grain, postharvest...............................       10.0
Cotton, undelinted seed, postharvest........................       70
Egg, dried..................................................      900
Fruit, dried, except grape, raisin, postharvest.............        3.0
Ginger, postharvest.........................................       70
Grain, aspirated fractions, postharvest.....................       55.0
Grape, raisin, postharvest..................................        7.0
Hog, meat...................................................       20
Herbs and spices group 19, postharvest......................       70
Milk, powdered..............................................        5.0
Millet, grain, postharvest..................................       40.0
Nut, pine, postharvest......................................       20
Nut, tree, Group 14, postharvest............................       10.0
Oat, flour, postharvest.....................................       75.0
Oat, grain, postharvest.....................................       25.0
Oat, groats/rolled oats.....................................       75.0
Peanut, postharvest.........................................       15
Pistachio, postharvest......................................       10.0
Rice, bran, postharvest.....................................       31.0
Rice, flour, postharvest....................................       45
Rice, grain, postharvest....................................       12.0
Rice, hulls, postharvest....................................       35.0
Rice, polished rice, postharvest............................       25.0
Rice, wild, grain, postharvest..............................       25.0
Sorghum, grain, postharvest.................................       40.0
Triticale, grain, postharvest...............................       40.0
Vegetable, legume, group 6, postharvest.....................       70
Wheat, bran, postharvest....................................       40.0
Wheat, flour, postharvest...................................      125.0
Wheat, germ, postharvest....................................      130.0
Wheat, grain, postharvest...................................       40.0
Wheat, milled byproducts, postharvest.......................      130.0
Wheat, shorts, postharvest..................................       40.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration, as defined by Sec. 180.1(l), are established for the 
combined residues of the insecticidal fluorine compounds, cryolite and 
synthetic cryolite (sodium aluminum fluoride), in or on the following 
raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Kiwifruit...................................................       15
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[71 FR 74815, Dec. 13, 2006, as amended at 76 FR 34885, June 15, 2011]

[[Page 487]]



Sec. 180.151  Ethylene oxide; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
antimicrobial agent and insecticide ethylene oxide, when used as a 
postharvest fumigant in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Herb and spice, group 19, dried, except basil...............        7
Licorice, roots.............................................        7
Peppermint, tops, dried.....................................        7
Sesame, seed................................................        7
Spearmint, tops, dried......................................        7
Vegetable, dried............................................        7
Walnut......................................................       50
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the ethylene oxide 
reaction product, 2-chloroethanol, commonly referred to as ethylene 
chlorohydrin, when ethylene oxide is used as a postharvest fumigant in 
or on food commodities as follows:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Herb and spice, group 19, dried, except basil...............      940
Licorice, roots.............................................      940
Peppermint, tops, dried.....................................      940
Sesame, seed................................................      940
Spearmint, tops, dried......................................      940
Vegetable, dried............................................      940
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33695, May 24, 2000, as amended at 74 FR 46696, Sept. 11, 2009]



Sec. 180.153  Diazinon; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide diazinon, O,O-diethyl O-[6-methyl-2-(1-methylethyl)-4-
pyrimidinyl]phosphorothioate (CAS No. 333-41-5), in or on the following 
food commodities:

------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------
Almond, hulls.........................................               3.0
Apple.................................................              0.50
Apricot...............................................              0.20
Bean, lima............................................              0.50
Bean, snap, succulent.................................              0.50
Beet, garden, roots...................................              0.75
Beet, garden, tops....................................              0.70
Blueberry.............................................              0.50
Caneberry subgroup 13-07A.............................              0.75
Carrot, roots.........................................              0.75
Cattle, fat...........................................              0.50
Cherry, sweet.........................................              0.20
Cherry, tart..........................................              0.20
Cranberry.............................................              0.50
Endive................................................              0.70
Fig...................................................              0.50
Ginseng...............................................              0.75
Grape.................................................          0.75 \2\
Hazelnut..............................................              0.50
Kiwifruit \1\.........................................              0.75
Lettuce...............................................              0.70
Melon.................................................              0.75
Mushroom..............................................          0.75 \2\
Nectarine.............................................              0.20
Onion, bulb...........................................              0.75
Onion, green..........................................              0.75
Pea, succulent........................................              0.50
Peach.................................................              0.20
Pear..................................................              0.50
Pineapple.............................................              0.50
Plum, prune, fresh....................................              0.20
Radish................................................              0.50
Rutabaga..............................................              0.75
Spinach...............................................              0.70
Strawberry............................................              0.50
Tomato................................................              0.75
Vegetable, brassica, leafy, group 5...................              0.70
Watercress............................................              0.05
------------------------------------------------------------------------
\1\There are no domestic registrations for kiwifruit as of March 6,
  2002.
\2\The expiration/revocation date for this tolerance is 9/10/2010.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration, as defined in Sec. 180.1(l), are established for residues 
of the insecticide diazinon, O, O-diethyl O-[6-methyl-2-(1-methylethyl)-
4-pyrimidinyl]-phosphorothioate (CAS No. 333-41-5), in or on the 
following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond......................................................        0.50
Banana......................................................        0.20
Celery......................................................        0.70
Cucumber....................................................        0.75
Parsley, leaves.............................................        0.75
Parsnip.....................................................        0.50
Pepper......................................................        0.5
Potato......................................................        0.10
Squash, summer..............................................        0.50
Squash, winter..............................................        0.75
Sweet potato, roots.........................................        0.10
Swiss chard.................................................        0.70
Turnip, roots...............................................        0.50
Turnip, tops................................................        0.75
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[47 FR 42738, Sept. 29, 1982]

    Editorial Note: For Federal Register citations affecting Sec. 
180.153, see the List of CFR

[[Page 488]]

Sections Affected, which appears in the Finding Aids section of the 
printed volume and at www.fdsys.gov.



Sec. 180.154  Azinphos-methyl; tolerances for residues.

    (a) General. Tolerances for residues of the insecticide O,O-dimethyl 
S-[(4-oxo-1,2,3-benzotriazin-3(4H)-yl)methyl]phosphorodithioate in or on 
the following raw agricultural commodities:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   Revocation
                                                   million       Date
------------------------------------------------------------------------
Almond\1\.......................................        0.2         None
Almond, hulls\1\................................        5.0         None
Apple\2\........................................        1.5         None
Blackberry\3\...................................        2.0         None
Blueberry\2\....................................        5.0         None
Boysenberry\3\..................................        2.0         None
Brussels sprouts\4\.............................        2.0         None
Cherry\2\.......................................        2.0         None
Crabapple\2\....................................        1.5         None
Cranberry\3\....................................        0.5     12/31/12
Loganberry\3\...................................        2.0         None
Parsley, leaves\2\..............................        5.0         None
Parsley, turnip rooted, roots\2\................        2.0         None
Peach\3\........................................        2.0         None
Pear\2\.........................................        1.5         None
Pistachio\1\....................................        0.3         None
Plum, prune\5\..................................        2.0         None
Quince\5\.......................................        1.5         None
Raspberry\3\....................................        2.0         None
Walnut\1\.......................................        0.3         None
------------------------------------------------------------------------

    \1\There are no U.S. registrations as of October 30, 2009.
    \2\There are no U.S. registrations as of September 30, 2012.
    \3\There are no U.S. registrations since September 30, 2006.
    \4\There are no U.S. registrations since September 30, 2008.
    \5\There are no U.S. registrations since December 28, 2005.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 38752, June 22, 2000, as amended at 74 FR 46697, Sept. 11, 2009]



Sec. 180.155  1-Naphthaleneacetic acid; tolerances for residues.

    (a) General. Tolerances are established for the residues of 1-
naphthaleneacetic acid, including its metabolites and degradates in or 
on the commodities in the following table. Compliance with the tolerance 
levels specified is to be determined by measuring only 1-
naphthaleneacetic acid and its conjugates, calculated as the 
Stoichiometric equivalent of 1-naphthaleneacetic acid, in or on the 
commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Avocado.....................................................        0.05
Cherry, sweet...............................................        0.1
Fruit, pome, group 11-10....................................        0.15
Mango.......................................................        0.05
Olive.......................................................        0.7
Orange......................................................        0.1
Pineapple\1\................................................        0.05
Potato......................................................        0.01
Rambutan....................................................        2.0
Sapote, mamey...............................................        0.05
Tangerine...................................................        0.1
------------------------------------------------------------------------
\1\ There are no U.S. registrations since 1988.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[78 FR 30218, May 22, 2013]



Sec. 180.163  Dicofol; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide dicofol, including its metabolites and degradates, in or on 
the commodities in the table in this paragraph. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only dicofol as the sum of its p,p-dicofol and o,p-dicofol 
isomers: 4-chloro-[alpha]-(4-chlorophenyl)-[alpha]-
(trichloromethyl)benzenemethanol and 2-chloro-[alpha]-(4-chlorophenyl)-
[alpha]-(trichloromethyl)benzenemethanol, in or on the commodity.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Apple, wet pomace...............................       38.0     10/31/16
Bean, dry, seed.................................        0.5     10/31/16
Bean, succulent.................................        3.0     10/31/16
Butternut.......................................        0.1     10/31/16
Caneberry subgroup 13A..........................        5.0     10/31/16
Chestnut........................................        0.1     10/31/16
Citrus, dried pulp..............................       12.0     10/31/16
Citrus oil......................................      200.0     10/31/16
Cotton, refined oil.............................        0.5     10/31/16
Cotton, undelinted seed.........................        0.1     10/31/16
Fruit, citrus, group 10.........................        6.0     10/31/16
Fruit, pome, group 11...........................       10.0     10/31/16
Fruit, stone, group 12..........................        5.0     10/31/16
Grape...........................................        5.0     10/31/16
Grape, raisin...................................       20.0     10/31/16
Hazelnut........................................        0.1     10/31/16

[[Page 489]]

 
Hop, dried cones................................       65.0     10/31/16
Nut, hickory....................................        0.1     10/31/16
Nut, macadamia..................................        0.1     10/31/16
Pecan...........................................        0.1     10/31/16
Peppermint, oil.................................       30.0     10/31/16
Peppermint, tops................................       25.0     10/31/16
Spearmint, oil..................................       30.0     10/31/16
Spearmint, tops.................................       25.0     10/31/16
Strawberry......................................       10.0     10/31/16
Tea, dried......................................       50.0         None
Tea, plucked leaves.............................       30.0         None
Vegetable, cucurbit, group 9....................        2.0     10/31/16
Vegetable, fruiting, group 8....................        2.0     10/31/16
Walnut..........................................        0.1     10/31/16
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the insecticide 
dicofol, including its metabolites and degradates, in or on the 
commodities in the table in this paragraph. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only the sum of p,p-dicofol, 4-chloro-[alpha]-(4-
chlorophenyl)-[alpha]-(trichloromethyl)benzenemethanol, its isomer o,p-
dicofol, 2-chloro-[alpha]-(4-chlorophenyl)-[alpha]-
(trichloromethyl)benzenemethanol, and its metabolites 4-chloro-[alpha]-
(4-chlorophenyl)-[alpha]-(dichloromethyl)benzenemethanol and 2-chloro-
[alpha]-(4-chlorophenyl)-[alpha]-(dichloromethyl)benzenemethanol, 
calculated as the stoichiometric equivalent of p,p-dicofol, 4-chloro-
[alpha]-(4-chlorophenyl)-[alpha]-(trichloromethyl)benzenemethanol, in or 
on the commodity.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   Revocation
                                                   million       Date
------------------------------------------------------------------------
Cattle, fat.....................................       50.0     10/31/16
Cattle, liver...................................        5.0     10/31/16
Cattle, meat....................................        3.0     10/31/16
Cattle, meat byproducts, except liver...........        3.0     10/31/16
Egg.............................................       0.05     10/31/16
Goat, fat.......................................       50.0     10/31/16
Goat, liver.....................................        5.0     10/31/16
Goat, meat......................................        3.0     10/31/16
Goat, meat byproducts, except liver.............        3.0     10/31/16
Hog, fat........................................       50.0     10/31/16
Hog, liver......................................        5.0     10/31/16
Hog, meat.......................................        3.0     10/31/16
Hog, meat byproducts, except liver..............        3.0     10/31/16
Horse, fat......................................       50.0     10/31/16
Horse, liver....................................        5.0     10/31/16
Horse, meat.....................................        3.0     10/31/16
Horse, meat byproducts, except liver............        3.0     10/31/16
Milk, fat (reflecting 0.75 ppm in whole milk)...       22.0     10/31/16
Poultry, fat....................................        0.1     10/31/16
Poultry, meat...................................        0.1     10/31/16
Poultry, meat byproducts........................        0.1     10/31/16
Sheep, fat......................................       50.0     10/31/16
Sheep, liver....................................        5.0     10/31/16
Sheep, meat.....................................        3.0     10/31/16
Sheep, meat byproducts, except liver............        3.0     10/31/16
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 34826, June 26, 1998, as amended at 72 FR 35665, June 29, 2007; 
72 FR 41928, Aug. 1, 2007; 77 FR 59124, Sept. 26, 2012]



Sec. 180.169  Carbaryl; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide carbaryl, 1-naphthyl N-methylcarbamate per se, in or on the 
following food commodities:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Alfalfa, forage.................................         50         None
Alfalfa, hay....................................         75         None
Almond, hulls...................................         50         None
Apple, wet pomace...............................         15         None
Asparagus.......................................         15         None
Banana..........................................        5.0         None
Beet, sugar, roots..............................        0.5         None
Beet, sugar, tops...............................         25         None
Bushberry subgroup 13-07B.......................        3.0         None
Cabbage.........................................         21         None
Cactus, fruit...................................        5.0         None
Cactus, pads....................................         12         None
Caneberry subgroup 13-07A.......................       12.0         None
Citrus, oil.....................................         20         None
Clover, forage..................................         50         None
Clover, hay.....................................         70         None
Corn, field, forage.............................         30         None
Corn, field, grain..............................       0.02         None
Corn, field, stover.............................         20         None
Corn, pop, grain................................       0.02         None
Corn, pop, stover...............................         20         None
Corn, sweet, forage.............................        185         None
Corn, sweet, kernel plus cob with husks removed.        0.1         None
Corn, sweet, stover.............................        215         None
Cotton, undelinted seed.........................        5.0     10/31/09
Cranberry.......................................        3.0         None
Dandelion, leaves...............................         22         None
Endive..........................................         10         None
Flax, seed......................................        0.5         None
Fruit, citrus, group 10.........................         10         None
Fruit, pome, group 11...........................         12         None
Fruit, stone, group 12..........................         10         None
Grain, aspirated fractions......................         70         None
Grape...........................................         10         None
Grape, raisin...................................         12         None
Grass, forage...................................        100         None
Grass, hay......................................         15         None

[[Page 490]]

 
Leaf petiole subgroup 4B........................        3.0         None
Lettuce.........................................         10         None
Millet, proso, grain............................        1.0         None
Millet, proso, straw............................         20         None
Nut, tree group 14, except walnut...............        0.1         None
Okra............................................        4.0         None
Olive...........................................         10         None
Oyster..........................................       0.25         None
Parsley, leaves.................................         22         None
Pea and bean, dried shelled, except soybean,            1.0         None
 subgroup 6C....................................
Peanut..........................................       0.05         None
Peanut, hay.....................................         20         None
Pineapple.......................................        2.0         None
Pistachio.......................................        0.1         None
Rice, grain.....................................         15         None
Rice, hulls.....................................         30         None
Rice, straw.....................................         60         None
Sorghum grain, forage...........................         30         None
Sorghum grain, grain............................         10         None
Sorghum grain, stover...........................         30         None
Soybean, forage.................................         15         None
Soybean, hay....................................         15         None
Soybean, seed...................................        0.5         None
Spinach.........................................         22         None
Strawberry......................................        4.0         None
Sunflower, seed.................................        0.5         None
Sweet potato, roots.............................        0.2         None
Trefoil, forage.................................         15         None
Trefoil, hay....................................         25         None
Vegetable, brassica, leafy, group 5, except              10         None
 cabbage........................................
Vegetable, cucurbit, group 9....................        3.0         None
Vegetable, foliage of legume, subgroup 7A,               60         None
 except soybean.................................
Vegetable, fruiting, group 8....................        5.0         None
Vegetable, leaves of root and tuber, group 2,            75         None
 except sugar beet tops.........................
Vegetable, legume, edible podded, subgroup 6A...         10         None
Vegetable, root and tuber, group 1, except sugar        2.0         None
 beet and sweet potato..........................
Walnut..........................................        1.0         None
Wheat, forage...................................         30         None
Wheat, grain....................................        1.0         None
Wheat, hay......................................         30         None
Wheat, straw....................................         20         None
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the insecticide 
carbaryl, 1-naphthyl N-methylcarbamate, including its metabolites: 1-
naphthol (naphthyl-sulfate); 5,6-dihydrodihydroxycarbaryl; and 5,6-
dihydrodihydroxy naphthol, calculated as 1-naphthyl N-methylcarbamate 
and the free and conjugated residues of carbaryl: 5,6-dihydro-5,6-
dihydroxy carbaryl and 5-methoxy-6-hydroxy carbaryl, in or on the 
following food commodities:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Cattle, fat.....................................        0.5         None
Cattle, meat....................................        1.0         None
Cattle, meat byproducts.........................        3.0         None
Egg.............................................        0.5     10/31/09
Goat, fat.......................................        0.5         None
Goat, meat......................................        1.0         None
Goat, meat byproducts...........................        3.0         None
Hog, fat........................................        0.5         None
Hog, meat.......................................        1.0         None
Hog, meat byproducts............................        3.0         None
Horse, fat......................................        0.5         None
Horse, meat.....................................        1.0         None
Horse, meat byproducts..........................        3.0         None
Milk............................................        1.0         None
Poultry, fat....................................        5.0     10/31/09
Poultry, meat...................................        5.0     10/31/09
Sheep, fat......................................        0.5         None
Sheep, meat.....................................        1.0         None
Sheep, meat byproducts..........................        3.0         None
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registrations, as defined in Sec. 180.1(l), are established for 
residues of the insecticide carbaryl, 1-naphthyl N-methylcarbamate per 
se, in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Dillweed, fresh leaves......................................        0.2
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33695, May 24, 2000, as amended at 66 FR 38955, July 26, 2001; 67 
FR 49615, July 31, 2002; 70 FR 44492, Aug. 3, 2005; 73 FR 52611, Sept. 
10, 2008; 74 FR 10490, Mar. 11, 2009]



Sec. 180.172  Dodine; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide dodine, including its metabolites and degradates, in or on the 
commodities listed in the table below. Compliance with the tolerance 
levels specified in the table is to be determined by measuring only 
dodine, N-dodecylguanidine acetate; in or on the following commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hull...............................................         30.0
Apple......................................................          5.0
Apple, wet pomace..........................................         15.0
Banana.....................................................         0.50
Fruit, stone, crop group 12................................          5.0
Nuts, tree, crop group 14..................................          0.3
Peanut.....................................................        0.013
Pear.......................................................          5.0

[[Page 491]]

 
Strawberry.................................................          5.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[72 FR 52017, Sept. 12, 2007, as amended at 73 FR 45634, Aug. 6, 2008; 
77 FR 72237, Dec. 5, 2012]



Sec. 180.175  Maleic hydrazide; tolerances for residues.

    (a) General. (1) Tolerances for residues of the herbicide and plant 
regulator maleic hydrazide (1,2-dihydro-3,6-pyridazinedione) are 
established in or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Onion, bulb.................................................       15.0
Potato......................................................       50.0
------------------------------------------------------------------------

    (2) A food additive known as maleic hydrazide (1,2-dihydro-3,6-
pyridazinedione) may be present in potato, chips when used in accordance 
with the following conditions:
    (i) The food additive is present as a result of the application of a 
pesticide formulation containing maleic hydrazide to the growing potato 
plant in accordance with directions registered by the U.S. Environmental 
Protection Agency.
    (ii) The label of the pesticide formulation containing the food 
additive conforms to labeling registered by the U.S. Environmental 
Protection Agency.
    (iii) The food additive is present in an amount not to exceed 160 
parts per million by weight of the finished food.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[62 FR 64293, Dec. 5, 1997, as amended at 64 FR 11792, Mar. 10, 1999; 67 
FR 35048, May 17, 2002]



Sec. 180.176  Mancozeb; tolerances for residues.

    (a) General. Tolerances are established for residues of mancozeb (a 
coordination product of zinc ion and maneb (manganese 
ethylenebisdithiocarbamate)), including its metabolites and degradates, 
in or on the commodities in the following table. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only those mancozeb residues convertible to and expressed in 
terms of the degradate carbon disulfide.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond......................................................        0.1
Almond, hulls...............................................        4
Apple.......................................................        7
Asparagus (negligible residue)..............................        0.1
Atemoya.....................................................        3.0
Banana......................................................        4.0
Banana, pulp................................................        0.5
Barley, bran................................................       20
Barley, flour...............................................       20
Barley, grain...............................................        5
Barley, pearled barley......................................       20
Barley, straw...............................................       25
Beet, sugar, roots..........................................        2
Beet, sugar, tops...........................................       65
Broccoli....................................................        7
Cabbage.....................................................        9
Canistel....................................................       15.0
Carrot, roots...............................................        2
Cattle, kidney..............................................        0.5
Cattle, liver...............................................        0.5
Celery......................................................        5
Cherimoya...................................................        3.0
Corn, field, forage.........................................        5
Corn, field, grain..........................................        0.1
Corn, field, stover.........................................        5
Corn, pop, grain............................................        0.5
Corn, pop, stover...........................................        5
Corn, sweet, forage.........................................        5
Corn, sweet, kernel plus cob with husks removed.............        0.5
Corn, sweet, stover.........................................        5
Cotton, undelinted seed.....................................        0.5
Crabapple...................................................       10
Cranberry...................................................        7
Custard apple...............................................        3.0
Fennel......................................................       10
Ginseng.....................................................        1.2
Goat, kidney................................................        0.5
Goat, liver.................................................        0.5
Grape.......................................................        7
Hog, kidney.................................................        0.5
Hog, liver..................................................        0.5
Horse, kidney...............................................        0.5
Horse, liver................................................        0.5
Lettuce, head...............................................        3.5
Lettuce, leaf...............................................       18
Mango.......................................................       15.0
Oat, bran...................................................       20
Oat, flour..................................................       20
Oat, grain..................................................        5
Oat, groats/rolled oats.....................................       20
Oat, straw..................................................       25
Onion, bulb.................................................        0.5

[[Page 492]]

 
Papaya (whole fruit with no residue present in the edible          10
 pulp after the peel is removed and discarded)..............
Peanut......................................................        0.5
Peanut, hay.................................................       65
Pear........................................................       10
Pepper......................................................       12
Poultry, kidney.............................................        0.5
Poultry, liver..............................................        0.5
Quince......................................................       10
Rye, bran...................................................       20
Rye, grain..................................................        5
Rye, straw..................................................       25
Sapodilla...................................................       15.0
Sapote, mamey...............................................       15.0
Sapote, white...............................................       15.0
Sheep, kidney...............................................        0.5
Sheep, liver................................................        0.5
Star apple..................................................       15.0
Sugar apple.................................................        3.0
Tomato......................................................        4
Vegetable, cucurbit, group 9................................        2.0
Wheat, bran.................................................       20
Wheat, flour................................................       20
Wheat, germ.................................................       20
Wheat, grain................................................        5
Wheat, middlings............................................       20
Wheat, shorts...............................................       20
Wheat, straw................................................       25
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time limited tolerances are 
established in connection with use of the pesticide under a section 18 
emergency exemption granted by EPA for residues of mancozeb (a 
coordination product of zinc ion and maneb (manganese 
ethylenebisdithiocarbamate)), including its metabolites and degradates, 
in or on the commodities in the following table. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only those mancozeb residues convertible to and expressed in 
terms of the degradate carbon disulfide. The tolerances will expire and 
are revoked on the dates specified in the following table.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   Revocation
                                                   million       Date
------------------------------------------------------------------------
Ginseng.........................................        2.0     12/31/10
Walnut..........................................      0.015     12/31/13
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33708, May 24, 2000, as amended at 65 FR 49924, Aug. 16, 2000; 66 
FR 64773, Dec. 14, 2001; 68 FR 2247, Jan. 16, 2003; 69 FR 29458, May 24, 
2004; 71 FR 76199, Dec. 20, 2006; 74 FR 46372, Sept. 9, 2009; 75 FR 770, 
Jan. 6, 2010; 75 FR 50913, Aug. 18, 2010; 76 FR 18915, Apr. 6, 2011]



Sec. 180.178  Ethoxyquin; tolerances for residues.

    (a) General. A tolerance is established for residues of the plant 
regulator ethoxyquin (1,2-dihydro-6-ethoxy-2,2,4-trimethylquinoline) 
from preharvest or postharvest use in or on the following commodity:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Pear.........................................................          3
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 57073, Oct. 26, 1998]



Sec. 180.181  Chlorpropham; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
plant regulator and herbicide chlorpropham (isopropyl m-
chlorocarbanilate (CIPC) in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Potato......................................................       30
Potato, wet peel............................................       40
------------------------------------------------------------------------

    (2) Tolerances are established for the combined residues of the 
plant regulator and herbicide chlorpropham (isopropyl m-
chlorocarbanilate (CIPC) and its metabolite 4-hydroxychlorpropham-O-
sulfonic acid (4-HSA) in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.20
Cattle, kidney..............................................        0.30
Cattle, meat................................................        0.06
Cattle, meat byproducts except kidney.......................        0.06
Goat, fat...................................................        0.20
Goat, kidney................................................        0.30
Goat, meat..................................................        0.06
Goat, meat byproducts except kidney.........................        0.06

[[Page 493]]

 
Hog, fat....................................................        0.20
Hog, kidney.................................................        0.30
Hog, meat...................................................        0.06
Hog, meat byproducts except kidney..........................        0.06
Horse, fat..................................................        0.20
Horse, kidney...............................................        0.30
Horse, meat.................................................        0.06
Horse, meat byproducts except kidney........................        0.06
Milk........................................................        0.30
Sheep, fat..................................................        0.20
Sheep, kidney...............................................        0.30
Sheep, meat.................................................        0.06
Sheep, meat byproducts except kidney........................        0.06
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[43 FR 52487, Nov. 13, 1978, as amended at 63 FR 57073, Oct. 26, 1998; 
72 FR 37653, July 11, 2007]



Sec. 180.182  Endosulfan; tolerances for residues.

    (a)(1) General. Tolerances are established for residues of the 
insecticide endosulfan, including its metabolites and degradates, in or 
on the commodities in the table in this paragraph. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only the sum of endosulfan, 6,7,8,9,10,10-hexachloro-
1,5,5a,6,9,9a-hexahydro-6,9-methano-2,4,3-benzodioxathiepin 3-oxide 
(alpha and beta isomers), and its metabolite endosulfan sulfate, 
6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-hexahydro-6,9-methano-2,4,3-
benzodioxathiepin-3,3-dioxide, calculated as the stoichiometric 
equivalent of endosulfan, in or on the commodity.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Almond..........................................        0.3      7/31/12
Almond, hulls...................................        1.0      7/31/12
Apricot.........................................        2.0      7/31/12
Bean............................................        2.0      7/31/12
Broccoli........................................        3.0      7/31/12
Brussels sprouts................................        2.0      7/31/12
Cabbage.........................................        4.0      7/31/12
Cantaloupe......................................        1.0      7/31/12
Carrot, roots...................................        0.2      7/31/12
Cattle, fat.....................................       13.0      7/31/16
Cattle, liver...................................        5.0      7/31/16
Cattle, meat....................................        2.0      7/31/16
Cattle, meat byproducts, except liver...........        1.0      7/31/16
Cauliflower.....................................        2.0      7/31/12
Celery..........................................        8.0      7/31/12
Cherry, sweet...................................        2.0      7/31/12
Cherry, tart....................................        2.0      7/31/12
Collards........................................        2.0      7/31/12
Cotton, gin byproducts..........................       30.0      7/31/12
Cotton, undelinted seed.........................        1.0      7/31/12
Cucumber........................................        1.0      7/31/12
Eggplant........................................        1.0      7/31/12
Goat, fat.......................................       13.0      7/31/16
Goat, liver.....................................        5.0      7/31/16
Goat, meat......................................        2.0      7/31/16
Goat, meat byproducts, except liver.............        1.0      7/31/16
Hazelnut........................................        0.2      7/31/12
Hog, fat........................................       13.0      7/31/16
Hog, liver......................................        5.0      7/31/16
Hog, meat.......................................        2.0      7/31/16
Hog, meat byproducts, except liver..............        1.0      7/31/16
Horse, fat......................................       13.0      7/31/16
Horse, liver....................................        5.0      7/31/16
Horse, meat.....................................        2.0      7/31/16
Horse, meat byproducts, except liver............        1.0      7/31/16
Kale............................................        2.0      7/31/12
Lettuce, head...................................       11.0      7/31/12
Lettuce, leaf...................................        6.0      7/31/12
Milk, fat.......................................        2.0      7/31/16
Muskmelon.......................................        1.0      7/31/12
Mustard greens..................................        2.0      7/31/12
Mustard, seed...................................        0.2      7/31/12
Nectarine.......................................        2.0      7/31/12
Nut, macadamia..................................        0.2      7/31/12
Peach...........................................        2.0      7/31/12
Pear............................................        2.0      7/31/13
Pineapple.......................................        1.0      7/31/16
Pineapple, process residue......................       20.0      7/31/16
Plum............................................        2.0      7/31/12
Plum, prune.....................................        2.0      7/31/12
Sheep, fat......................................       13.0      7/31/16
Sheep, liver....................................        5.0      7/31/16
Sheep, meat.....................................        2.0      7/31/16
Sheep, meat byproducts, except liver............        1.0      7/31/16
Squash, summer..................................        1.0      7/31/12
Strawberry......................................        2.0      7/31/16
Sweet potato, roots.............................       0.15      7/31/12
Walnut..........................................        0.2      7/31/12
Watermelon......................................        1.0      7/31/12
------------------------------------------------------------------------

    (2) A tolerance is established for the combined residues of the 
insecticide endosulfan, 6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-
hexahydro-6,9-methano-2, 4,3-benzodioxathiepin-3-oxide (alpha and beta 
isomers), and its metabolite endosulfan sulfate, 6,7,8,9,10,10-
hexachloro-1,5,5a,6,9,9a-hexahydro-6,9-methano-2, 4,3-benzodioxathiepin-
3,3-dioxide in or on the commodity in the following table:

[[Page 494]]



------------------------------------------------------------------------
                                                             Expiration/
         Commodity                  Parts per million         revocation
                                                                 date
------------------------------------------------------------------------
Tea, dried.................  24 (reflecting less than 0.1        7/31/16
                              ppm in beverage tea)
                              resulting from application of
                              the insecticide to growing
                              tea.
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. (1) Tolerances with 
regional registration, as defined in Sec. 180.1(l), are established for 
residues of the insecticide endosulfan, including its metabolites and 
degradates, in or on the commodities in the table in this paragraph, 
when endosulfan is used in the state of Florida. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only the sum of endosulfan, 6,7,8,9,10,10-hexachloro-
1,5,5a,6,9,9a-hexahydro-6,9-methano-2,4,3-benzodioxathiepin 3-oxide 
(alpha and beta isomers), and its metabolite endosulfan sulfate, 
6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-hexahydro-6,9-methano-2,4,3-
benzodioxathiepin-3,3-dioxide, calculated as the stoichiometric 
equivalent of endosulfan, in or on the commodity.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Apple...........................................        1.0     12/31/14
Apple, wet pomace...............................        5.0     12/31/14
Blueberry.......................................        0.3     12/31/14
Corn, sweet, forage.............................       12.0     12/31/14
Corn, sweet, kernel plus cob with husks removed.        0.2     12/31/14
Corn, sweet, stover.............................       14.0     12/31/14
Pepper..........................................        2.0     12/31/14
Potato..........................................        0.2     12/31/14
Pumpkin.........................................        1.0     12/31/14
Squash, winter..................................        1.0     12/31/14
Tomato..........................................        1.0     12/31/14
------------------------------------------------------------------------

    (2) Tolerances with regional registrations. Tolerances with regional 
registration, as defined in Sec. 180.1(l), are established for residues 
of the insecticide endosulfan, including its metabolites and degradates, 
in or on the commodities in the table in this paragraph, when endosulfan 
is used in the United States (except Florida). Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only the sum of endosulfan, 6,7,8,9,10,10-hexachloro-
1,5,5a,6,9,9a-hexahydro-6,9-methano-2,4,3-benzodioxathiepin 3-oxide 
(alpha and beta isomers), and its metabolite endosulfan sulfate, 
6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-hexahydro-6,9-methano-2,4,3-
benzodioxathiepin-3,3-dioxide, calculated as the stoichiometric 
equivalent of endosulfan, in or on the commodity.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Apple...........................................        1.0      7/31/15
Apple, wet pomace...............................        5.0      7/31/15
Blueberry.......................................        0.3      7/31/15
Corn, sweet, forage.............................       12.0      7/31/15
Corn, sweet, kernel plus cob with husks removed.        0.2      7/31/15
Corn, sweet, stover.............................       14.0      7/31/15
Pepper..........................................        2.0      7/31/15
Potato..........................................        0.2      7/31/15
Pumpkin.........................................        1.0      7/31/15
Squash, winter..................................        1.0      7/31/15
Tomato..........................................        1.0      7/31/15
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33696, May 24, 2000, as amended at 71 FR 54433, Sept. 15, 2006; 
76 FR 56653, Sept. 14, 2011; 78 FR 8409, Feb. 6, 2013]



Sec. 180.183  Disulfoton; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide disulfoton, O,O-diethyl S-(2-(ethylthio)ethyl) 
phosphorodithioate, including its metabolites and degradates, in or on 
the commodities in the following table. Compliance with the tolerance 
levels specified in this paragraph is to be determined by measuring only 
the sum of disulfoton, O,O-diethyl S-(2-(ethylthio)ethyl) 
phosphorodithioate, and its metabolites demeton-S, O,O-diethyl S-(2-
(ethylthio)ethyl) phosphorothioate; disulfoton sulfoxide, O,O-diethyl S-
(2-(ethylsulfinyl)ethyl) phosphorodithioate; disulfoton oxygen analog 
sulfoxide, O,O-diethyl S-(2-(ethylsulfinyl)ethyl) phosphorothioate, 
disulfoton sulfone, O,O-diethyl S-(2-(ethylsulfonyl)ethyl)

[[Page 495]]

phosphorodithioate; and disulfoton oxygen analog sulfone, O,O-diethyl S-
(2-(ethylsulfonyl)ethyl) phosphorothioate; calculated as the 
stoichiometric equivalent of disulfoton, in or on the commodity.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   Revocation
                                                   million       Date
------------------------------------------------------------------------
Bean, lima......................................       0.75     12/31/13
Bean, snap, succulent...........................       0.75     12/31/13
Broccoli........................................       0.75     12/31/13
Brussels sprouts................................       0.75     12/31/13
Cabbage.........................................       0.75     12/31/13
Cauliflower.....................................       0.75     12/31/13
Coffee, green bean..............................        0.2      6/30/14
Cotton, undelinted seed.........................       0.75     12/31/13
Lettuce, head...................................       0.75     12/31/14
Lettuce, leaf...................................          2     12/31/14
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. A tolerance with 
regional registration is established for residues of the insecticide 
disulfoton, O,O-diethyl S-(2-(ethylthio)ethyl) phosphorodithioate, 
including its metabolites and degradates, in or on the commodity in the 
following table. Compliance with the tolerance levels specified in this 
paragraph is to be determined by measuring only the sum of disulfoton, 
O,O-diethyl S-(2-(ethylthio)ethyl) phosphorodithioate, and its 
metabolites demeton-S, O,O-diethyl S-(2-(ethylthio)ethyl) 
phosphorothioate; disulfoton sulfoxide, O,O-diethyl S-(2-
(ethylsulfinyl)ethyl) phosphorodithioate; disulfoton oxygen analog 
sulfoxide, O,O-diethyl S-(2-(ethylsulfinyl)ethyl) phosphorothioate, 
disulfoton sulfone, O,O-diethyl S-(2-(ethylsulfonyl)ethyl) 
phosphorodithioate; and disulfoton oxygen analog sulfone, O,O-diethyl S-
(2-(ethylsulfonyl)ethyl) phosphorothioate; calculated as the 
stoichiometric equivalent of disulfoton, in or on the commodity.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   Revocation
                                                   million       Date
------------------------------------------------------------------------
Asparagus.......................................        0.1     12/31/13
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 2165, Jan. 14, 1998, as amended at 63 FR 57073, Oct. 26, 1998; 66 
FR 38955, July 26, 2001; 67 FR 41806, June 19, 2002; 67 FR 49615, July 
31, 2002; 70 FR 44492, Aug. 3, 2005; 73 FR 54960, Sept. 24, 2008; 74 FR 
46697, Sept. 11, 2009; 75 FR 60240, Sept. 29, 2010]



Sec. 180.184  Linuron; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the herbicide linuron (3-(3,4-dichlorophenyl)-1-methoxy-1-methylurea) 
and its metabolites convertible to 3,4-dichloroaniline, calculated as 
linuron, in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Asparagus...................................................        7.0
Carrot, roots...............................................        1.0
Cattle, fat.................................................        0.2
Cattle, kidney..............................................        2.0
Cattle, liver...............................................        2.0
Cattle, meat................................................        0.1
Cattle, meat byproducts except kidney and liver.............        0.1
Celeriac....................................................        1.0
Corn, field, forage.........................................        1.0
Corn, field, grain..........................................        0.1
Corn, field, stover.........................................        6.0
Corn, sweet, forage.........................................        1.0
Corn, sweet, kernel plus cob with husks removed.............        0.25
Corn, sweet, stover.........................................        6.0
Cotton, gin byproducts......................................        5.0
Cotton, undelinted seed.....................................        0.25
Goat, fat...................................................        0.2
Goat, kidney................................................        2.0
Goat, liver.................................................        2.0
Goat, meat..................................................        0.1
Goat, meat byproducts except kidney and liver...............        0.1
Hog, fat....................................................        0.05
Hog, meat...................................................        0.05
Hog, meat byproducts........................................        0.1
Horse, fat..................................................        0.2
Horse, kidney...............................................        2.0
Horse, liver................................................        2.0
Horse, meat.................................................        0.1
Horse, meat byproducts except kidney and liver..............        0.1
Milk........................................................        0.05
Parsnip, roots..............................................        0.05
Parsnip, tops...............................................        0.05
Rhubarb.....................................................        0.5
Sheep, fat..................................................        0.2
Sheep, kidney...............................................        2.0
Sheep, liver................................................        2.0
Sheep, meat.................................................        0.1
Sheep, meat byproducts except kidney and liver..............        0.1
Sorghum, grain, forage......................................        1.0
Sorghum, grain, grain.......................................        0.25
Sorghum, grain, stover......................................        1.0
Soybean, seed...............................................        1.0
Soybean, vegetable..........................................        1.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in

[[Page 496]]

the following table are established for combined residues of the 
herbicide linuron (3-(3,4-dichlorophenyl)-1-methoxy-1-methylurea) and 
its metabolites convertible to 3,4-dichloroaniline, calculated as 
linuron, in or on the specified agricultural commodities, resulting from 
use of the pesticide pursuant to FIFRA section 18 emergency exemptions. 
The tolerance expires and is revoked on the date specified in the table.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Lentil..........................................        0.1     12/31/14
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. Tolerances with regional 
registrations, as defined in Sec. 180.1(l), are established for the 
combined residues of the herbicide linuron (3-(3,4-dichlorophenyl)-1-
methoxy-1-methylurea) and its metabolites convertible to 3,4-
dichloroaniline, calculated as linuron, in or on the following food 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Celery......................................................        0.5
Parsley, leaves.............................................        0.25
Potato......................................................        0.2
Wheat, forage...............................................        0.5
Wheat, grain................................................        0.05
Wheat, hay..................................................        0.5
Wheat, straw................................................        2.0
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[64 FR 41822, Aug. 2, 1999, as amended at 72 FR 37653, July 11, 2007; 73 
FR 51727, Sept. 5, 2008; 76 FR 81396, Dec. 28, 2011]



Sec. 180.185  DCPA; tolerances for residues.

    (a) General. Tolerances for the combined residues of the herbicide 
dimethyl tetrachloroterephthalate (DCPA) and its metabolites 
monomethyltetrachloroterephthalate (MTP) and tetrachloroterephthalic 
acid (TCP) (calculated as dimethyl tetrachloroterephthalate) are 
established in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cantaloupe..................................................        1.0
Garlic......................................................        1.0
Ginseng.....................................................        2.0
Horseradish.................................................        2.0
Muskmelon...................................................        1.0
Onion, bulb.................................................        1.0
Onion, green................................................        1.0
Strawberry..................................................        2.0
Tomato......................................................        1.0
Vegetable, brassica, leafy, group 5.........................        5.0
Watermelon..................................................        1.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration, as defined in Sec. 180.1(l), are established for the 
combined inadvertent residues of the herbicide dimethyl 
tetrachloroterephthalate (DCPA) and its metabolites monomethyl 
tetrachloroterephthalate acid (MTP) and terachlorophthalic acid (TCP) 
(calculated as DCPA) in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Radish, roots...............................................        2.0
Radish, tops................................................       15.0
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. Tolerances are established for 
the combined indirect or inadvertent residues of the herbicide dimethyl 
tetrachloroterephthalate (DCPA) and its metabolites monomethyl 
tetrachloroterephthalate acid (MTP) and terachlorophthalic acid (TCP) 
(calculated as DCPA) in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Basil, dried leaves.........................................       20.0
Basil, fresh leaves.........................................        5.0
Bean, dry...................................................        2.0
Bean, mung, seed............................................        2.0
Bean, snap, succulent.......................................        2.0
Celeriac....................................................        2.0
Chicory, roots..............................................        2.0
Chicory, tops...............................................        5.0
Chive.......................................................        5.0
Coriander, leaves...........................................        5.0
Corn, field, forage.........................................        0.4
Corn, field, grain..........................................        0.05
Corn, field, stover.........................................        0.4
Corn, pop, forage...........................................        0.4
Corn, pop, grain............................................        0.05
Corn, pop, stover...........................................        0.4
Corn, sweet, forage.........................................        0.4
Corn, sweet, kernel plus cob with husks removed.............        0.05
Corn, sweet, stover.........................................        0.4
Cotton, undelinted seed.....................................        0.2
Cucumber....................................................        1.0
Dill........................................................        5.0

[[Page 497]]

 
Eggplant....................................................        1.0
Lettuce.....................................................        2.0
Marjoram....................................................        5.0
Parsley, dried leaves.......................................       20.0
Parsley, leaves.............................................        5.0
Pea, blackeyed, seed........................................        2.0
Pepper......................................................        2.0
Pimento.....................................................        2.0
Potato......................................................        2.0
Radicchio...................................................        5.0
Radish, oriental, roots.....................................        2.0
Radish, oriental, tops......................................        2.0
Rutabaga....................................................        2.0
Soybean.....................................................        2.0
Squash, summer..............................................        1.0
Squash, winter..............................................        1.0
Sweet potato................................................        2.0
Turnip, roots...............................................        2.0
Turnip, tops................................................        5.0
Yam, true, tuber............................................        2.0
------------------------------------------------------------------------


[72 FR 52018, Sept. 12, 2007, as amended at 73 FR 53737, Sept. 17, 2008; 
73 FR 80302, Dec. 31, 2008; 74 FR 14744, Apr. 1, 2009]



Sec. 180.189  Coumaphos; tolerances for residues.

    (a) General. Tolerances for residues of the insecticide coumaphos 
(O,O-diethyl O-3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl 
phosphorothioate and its oxygen analog (O,O-diethyl O-3-chloro-4-methyl-
2-oxo-2H-1-benzopyran-7-yl phosphate) in or on food commodities as 
follows:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        1.0
Cattle, meat................................................        1.0
Cattle, meat byproducts.....................................        1.0
Goat, fat...................................................        1.0
Goat, meat..................................................        1.0
Goat, meat byproducts.......................................        1.0
Hog, fat....................................................        1.0
Hog, meat...................................................        1.0
Hog, meat byproducts........................................        1.0
Honey.......................................................        0.15
Honeycomb...................................................       45.0
Horse, fat..................................................        1.0
Horse, meat.................................................        1.0
Horse, meat byproducts......................................        1.0
Milk, fat (=n in whole milk)................................        0.5
Sheep, fat..................................................        1.0
Sheep, meat.................................................        1.0
Sheep, meat byproducts......................................        1.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[64 FR 39077, July 21, 1999, as amended at 65 FR 49936, Aug. 16, 2000; 
67 FR 46883, July 17, 2002; 69 FR 29458, May 24, 2004; 72 FR 28876, May 
23, 2007]



Sec. 180.190  Diphenylamine; tolerances for residues.

    (a) General. Tolerances for residues of the plant regulator 
diphenylamine are established in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Apple, wet pomace...........................................       30.0
Apple from preharvest or postharvest use, including use of         10.0
 impregnated wraps..........................................
Cattle, fat.................................................        0.01
Cattle, liver...............................................        0.1
Cattle, meat byproducts, except liver.......................        0.01
Cattle, meat................................................        0.01
Goat, fat...................................................        0.01
Goat, liver.................................................        0.1
Goat, meat byproducts, except liver.........................        0.01
Goat, meat..................................................        0.01
Horse, fat..................................................        0.01
Horse, liver................................................        0.1
Horse, meat byproducts, except liver........................        0.01
Horse, meat.................................................        0.01
Milk........................................................        0.01
Pear (post harvest).........................................        5.0
Sheep, fat..................................................        0.01
Sheep, liver................................................        0.1
Sheep, meat byproducts, except liver........................        0.01
Sheep, meat.................................................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[64 FR 25848, May 13, 1999, as amended at 66 FR 63198, Dec. 5, 2001; 72 
FR 16283, Apr. 4, 2007; 76 FR 34885, June 15, 2011]



Sec. 180.191  Folpet; tolerances for residues.

    (a) General. Tolerances are established for the fungicide folpet (N-
(trichloromethylthio)phthalimide) in or on raw agricultural commodities 
as follows:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Apple \1\...................................................        5.0
Cranberry \1\...............................................       15.0
Cucumber \1\................................................        2.0
Grape \1\...................................................       50.0
Grape, raisin \1\...........................................       80.0
Hop, dried cones............................................      120.0
Lettuce \1\.................................................       50.0
Melon \1\...................................................        3.0

[[Page 498]]

 
Onion,bulb \1\..............................................        2.0
Strawberry \1\..............................................        5.0
Tomato \1\..................................................       25.0
------------------------------------------------------------------------
\1\ No U.S. registrations.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registrations as defined in Sec. 180.1(l) are established for the 
fungicide folpet (N-(trichloromethylthio)phthalimide) in or on the 
following raw agricultural commodity:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Avocado.....................................................       25.0
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[61 FR 37222, July 17, 1996, as amended at 68 FR 10388, Mar. 5, 2003; 69 
FR 52192, Aug. 25, 2004; 72 FR 41928, Aug. 1, 2007]



Sec. 180.198  Trichlorfon; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide trichlorfon (dimethyl (2,2,2-trichloro-1-hydroxyethyl) 
phosphonate) in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat \1\.............................................        0.5
Cattle, meat \1\............................................        0.2
Cattle, meat byproducts \1\.................................        0.1
------------------------------------------------------------------------
 \1\ There are no U.S. registrations for cattle commodities as of June
  24, 1999.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[72 FR 54578, Sept. 26, 2007]



Sec. 180.200  Dicloran; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide dicloran, including its metabolites and degradates, in or on 
the commodities in the table in this paragraph. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only dicloran, 2,6-dichloro-4-nitroaniline, in or on the 
commodity.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                    million      date
------------------------------------------------------------------------
Apricot.........................................         20         None
Bean, snap, succulent...........................         20         None
Carrot, roots...................................         10      11/2/11
Celery..........................................         15         None
Cherry, sweet...................................         20         None
Cucumber........................................          5         None
Endive..........................................         10         None
Garlic..........................................          5         None
Grape...........................................         10         None
Lettuce.........................................         10         None
Nectarine.......................................         20         None
Onion...........................................         10         None
Peach...........................................         20         None
Plum, prune, fresh..............................         15         None
Potato..........................................       0.25     12/31/14
Rhubarb.........................................         10         None
Sweet potato, roots.............................         10         None
Tomato..........................................          5         None
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[77 FR 40815, July 11, 2012]



Sec. 180.202  p-Chlorophenoxyacetic acid; tolerances for residues.

    (a) General. A tolerance is established for the combined residues of 
the plant regulator p-chlorophenoxyacetic acid and its metabolite p-
chlorophenol to inhibit embryonic root development in or on the 
following food commodity:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Bean, mung, sprouts.........................................        0.2
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[68 FR 39439, July 1, 2003, as amended at 71 FR 56398, Sept. 27, 2006]



Sec. 180.204  Dimethoate; tolerances for residues.

    (a) General. Tolerances are established for total residues of the 
insecticide dimethoate (O,O-dimethyl S-(N- methylcarbamoylmethyl) 
phosphorodithioate) including its oxygen analog (O,O-dimethyl S-(N-

[[Page 499]]

methylcarbamoylmethyl) phosphorothioate) in or on the following food 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................       2.0
Alfalfa, hay................................................       2.0
Bean, dry, seed.............................................       2.0
Bean, lima..................................................       2.0
Bean, snap, succulent.......................................       2.0
Blueberry \1\...............................................       1.0
Broccoli....................................................       2.0
Cattle, meat byproducts.....................................       0.02
Cauliflower.................................................       2.0
Celery......................................................       2.0
Citrus, dried pulp..........................................       5.0
Corn, field, forage.........................................       1.0
Corn, field, grain..........................................       0.1
Corn, field, stover.........................................       1.0
Corn, pop, grain............................................       0.1
Corn, pop, stover...........................................       1.0
Corn, sweet, forage.........................................       1.0
Cotton, undelinted seed.....................................       0.1
Egg.........................................................       0.02
Endive......................................................       2.0
Goat, meat byproducts.......................................       0.02
Grapefruit..................................................       2.0
Hog, meat byproducts........................................       0.02
Horse, meat byproducts......................................       0.02
Kale........................................................       2.0
Lemon.......................................................       2.0
Lettuce, leaf...............................................       2.0
Melon.......................................................       1.0
Milk........................................................       0.002
Mustard greens..............................................       2.0
Orange......................................................       2.0
Pea.........................................................       2.0
Pear........................................................       2.0
Pecan.......................................................       0.1
Pepper......................................................       2.0
Potato......................................................       0.2
Poultry, meat byproducts....................................       0.02
Safflower, seed.............................................       0.1
Sheep, meat byproducts......................................       0.02
Sorghum, grain, forage......................................       0.1
Sorghum, grain, grain.......................................       0.1
Sorghum, grain, stover......................................       0.1
Soybean, forage.............................................       2.0
Soybean, hay................................................       2.0
Soybean, seed...............................................       0.05
Swiss chard.................................................       2.0
Tangerine...................................................       2.0
Tomato......................................................       2.0
Turnip, roots...............................................       0.2
Turnip, tops................................................       2.0
Wheat, forage...............................................       2.0
Wheat, grain................................................       0.04
Wheat, hay..................................................       2.0
Wheat, straw................................................       2.0
------------------------------------------------------------------------
\1\ There are U.S. registrations as of August 16, 1996.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration, as defined in Sec. 180.1(l), are established for total 
residues of dimethoate including its oxygen analog in or on the 
following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Asparagus...................................................        0.15
Brussels sprouts............................................        5.0
Cherry, sweet...............................................        2.0
Cherry, tart................................................        2.0
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33697, May 24, 2000, as amended at 69 FR 6567, Feb. 11, 2004; 73 
FR 53737, Sept. 17, 2008]



Sec. 180.205  Paraquat; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
desiccant, defoliant, and herbicide paraquat (1,1'-dimethyl-4,4'-
bipyridinium-ion) derived from application of either the bis(methyl 
sulfate) or the dichloride salt (both calculated as the cation) in or on 
the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Acerola.....................................................        0.05
Almond, hulls...............................................        0.5
Animal feed, nongrass, group 18, forage.....................       75.0
Animal feed, nongrass, group 18, hay........................      210.0
Artichoke, globe............................................        0.05
Asparagus...................................................        0.5
Atemoya.....................................................        0.05
Avocado.....................................................        0.05
Banana......................................................        0.05
Barley, grain...............................................        0.05
Barley, hay.................................................        3.5
Barley, straw...............................................        1.0
Beet, sugar, roots..........................................        0.5
Beet, sugar, tops...........................................        0.05
Berry group 13..............................................        0.05
Biriba......................................................        0.05
Cacao bean, bean............................................        0.05
Canistel....................................................        0.05
Carrot, roots...............................................        0.05
Cattle, fat.................................................        0.05
Cattle, kidney..............................................        0.5
Cattle, meat................................................        0.05
Cattle, meat byproducts, except kidney......................        0.05
Cherimoya...................................................        0.05
Coffee, bean, green.........................................        0.05
Corn, field, forage.........................................        3.0
Corn, field, grain..........................................        0.1
Corn, field, stover.........................................       10.0
Corn, pop, grain............................................        0.1
Corn, pop, stover...........................................       10.0
Corn, sweet, kernel plus cob with husks removed.............        0.05
Cotton, gin byproducts......................................      110.0
Cotton, undelinted seed.....................................        3.5
Cowpea, forage..............................................        0.1
Cowpea, hay.................................................        0.4
Cranberry...................................................        0.05
Custard apple...............................................        0.05
Egg.........................................................        0.01
Endive......................................................        0.05
Feijoa......................................................        0.05
Fig.........................................................        0.05
Fruit, citrus, group 10.....................................        0.05

[[Page 500]]

 
Fruit, pome, group 11.......................................        0.05
Fruit, stone, group 12......................................        0.05
Ginger......................................................        0.1
Goat, fat...................................................        0.05
Goat, kidney................................................        0.5
Goat, meat..................................................        0.05
Goat, meat byproducts, except kidney........................        0.05
Grain, aspirated fractions..................................       65.0
Grape.......................................................        0.05
Grass, forage...............................................       90.0
Grass, hay..................................................       40.0
Guar, seed..................................................        0.5
Guava.......................................................        0.05
Hog, fat....................................................        0.05
Hog, kidney.................................................        0.5
Hog, meat...................................................        0.05
Hog, meat byproducts, except kidney.........................        0.05
Hop, dried cones............................................        0.5
Horse, fat..................................................        0.05
Horse, kidney...............................................        0.5
Horse, meat.................................................        0.05
Horse, meat byproducts, except kidney.......................        0.05
Ilama.......................................................        0.05
Jaboticaba..................................................        0.05
Kiwifruit...................................................        0.05
Lentil, seed................................................        0.3
Lettuce.....................................................        0.05
Longan......................................................        0.05
Lychee......................................................        0.05
Mango.......................................................        0.05
Milk........................................................        0.01
Nut, tree, group 14.........................................        0.05
Okra........................................................        0.05
Olive.......................................................        0.05
Onion, bulb.................................................        0.1
Onion, green................................................        0.05
Papaya......................................................        0.05
Passionfruit................................................        0.2
Pawpaw......................................................        0.05
Pea and bean, dried shelled, except soybean, subgroup 6C,           0.3
 except guar bean...........................................
Pea and bean, succulent shelled, subgroup 6B................        0.05
Pea, field, hay.............................................        0.8
Pea, field, vines...........................................        0.2
Peanut......................................................        0.05
Peanut, hay.................................................        0.5
Peppermint, tops............................................        0.5
Persimmon...................................................        0.05
Pineapple...................................................        0.05
Pineapple, process residue..................................        0.25
Pistachio...................................................        0.05
Pomegranate.................................................        0.05
Potato......................................................        0.5
Pulasan.....................................................        0.05
Rambutan....................................................        0.05
Rhubarb.....................................................        0.05
Rice, grain.................................................        0.05
Rice, straw.................................................        0.06
Safflower, seed.............................................        0.05
Sapodilla...................................................        0.05
Sapote, black...............................................        0.05
Sapote, mamey...............................................        0.05
Sapote, white...............................................        0.05
Sheep, fat..................................................        0.05
Sheep, kidney...............................................        0.5
Sheep, meat.................................................        0.05
Sheep, meat byproducts, except kidney.......................        0.05
Sorghum, forage, forage.....................................        0.1
Sorghum, grain, forage......................................        0.1
Sorghum, grain, grain.......................................        0.05
Soursop.....................................................        0.05
Soybean, forage.............................................        0.4
Soybean, hay................................................       10.0
Soybean, hulls..............................................        4.5
Soybean, seed...............................................        0.7
Spanish lime................................................        0.05
Spearmint, tops.............................................        0.5
Star apple..................................................        0.05
Starfruit...................................................        0.05
Strawberry..................................................        0.25
Sugar apple.................................................        0.05
Sugarcane, cane.............................................        0.5
Sugarcane, molasses.........................................        3.0
Sunflower, seed.............................................        2.0
Turnip, greens..............................................        0.05
Turnip, roots...............................................        0.05
Vegetable, brassica, leafy, group 5.........................        0.05
Vegetable, cucurbit, group 9................................        0.05
Vegetable, fruiting, group 8................................        0.05
Vegetable, legume, edible podded, subgroup 6A...............        0.05
Wax jambu...................................................        0.05
Wheat, forage...............................................        0.5
Wheat, grain................................................        1.1
Wheat, hay..................................................        3.5
Wheat, straw................................................       50.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration as defined in Sec. 180.1(l), are established for residues 
of the pesticide paraquat (1,1'-dimethyl-4,4' bipyridinium ion) derived 
from application of either the bis(methyl sulfate) or the dichloride 
salt (both calculated as the cation) in or on the following food 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cassava.....................................................        0.05
Pea, pigeon, seed...........................................        0.05
Tanier......................................................        0.05
Taro, corm..................................................        0.1
Tyfon.......................................................        0.05
Yam, true, tuber............................................        0.05
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[46 FR 51614, Oct. 21, 1981]

    Editorial Note: For Federal Register citations affecting Sec. 
180.205, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.206  Phorate; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the insecticide phorate (O,O-diethyl S (ethylthio) 
methyl]phosphorodithioate), phorate sulfoxide, phorate sulfone, phorate 
oxygen

[[Page 501]]

analog, phorate oxygen analog sulfoxide, and phorate oxygen analog 
sulfone in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Bean, dry, seed.............................................        0.05
Bean, succulent.............................................        0.05
Beet, sugar, roots..........................................        0.3
Beet, sugar, tops...........................................        3.0
Coffee, green bean \1\......................................        0.02
Corn, field, forage.........................................        0.5
Corn, field, grain..........................................        0.05
Corn, sweet, forage.........................................        0.5
Corn, sweet, kernel plus cob with husks removed.............        0.05
Cotton, undelinted seed.....................................        0.05
Hop, dried cones............................................        2.0
Peanut......................................................        0.1
Potato......................................................        0.2
Sorghum, grain, grain.......................................        0.05
Sorghum, grain, stover......................................        0.1
Soybean, seed...............................................        0.05
Sugarcane, cane.............................................        0.05
Wheat, forage...............................................        1.5
Wheat, grain................................................        0.05
Wheat, hay..................................................        1.5
Wheat, straw................................................        0.05
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of September 1, 1993 for the use
  of phorate on the growing crop, coffee.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[58 FR 62038, Nov. 24, 1993, as amended at 63 FR 2165, Jan. 14, 1998; 63 
FR 57074, Oct. 26, 1998; 66 FR 50833, Oct. 5, 2001; 67 FR 49616, July 
31, 2002; 71 FR 74816, Dec. 13, 2006; 73 FR 53738, Sept. 17, 2008]



Sec. 180.207  Trifluralin; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide and plant growth regulator trifluralin, alpha, alpha, alpha-
trifluoro-2,6-dinitro-N,N-dipropyl-p-toluidine, in or on the following 
raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        3.0
Alfalfa, hay................................................        2.0
Almond, hulls...............................................        0.05
Asparagus...................................................        0.05
Barley, grain...............................................        0.05
Barley, hay.................................................        0.05
Barley, straw...............................................        0.05
Bean, mung, sprouts.........................................        2.0
Carrot, roots...............................................        1.0
Celery......................................................        0.05
Corn, field, forage.........................................        0.05
Corn, field, grain..........................................        0.05
Corn, field, stover.........................................        0.05
Cotton, gin byproducts......................................        0.05
Cotton, undelinted seed.....................................        0.05
Endive......................................................        0.05
Flax, seed..................................................        0.05
Fruit, citrus, group 10.....................................        0.05
Fruit, stone, group 12......................................        0.05
Grape.......................................................        0.05
Hop, dried cones............................................        0.05
Mustard, seed...............................................        0.05
Nut, tree, group 14.........................................        0.05
Okra........................................................        0.05
Peanut......................................................        0.05
Peanut, hay.................................................        0.05
Peppermint, oil.............................................        2.0
Peppermint, tops............................................        0.05
Rapeseed, seed..............................................        0.05
Safflower, seed.............................................        0.05
Sorghum, grain, forage......................................        0.05
Sorghum, grain, grain.......................................        0.05
Sorghum, grain, stover......................................        0.05
Spearmint, oil..............................................        2.0
Spearmint, tops.............................................        0.05
Sugarcane, cane.............................................        0.05
Sunflower, seed.............................................        0.05
Vegetable, brassica, leafy group 5..........................        0.05
Vegetable, bulb, group 3....................................        0.05
Vegetable, cucurbit, group 9................................        0.05
Vegetable, foliage of legume, group 7.......................        0.05
Vegetable, fruiting, group 8................................        0.05
Vegetable, leaves of root and tuber, group 2................        0.05
Vegetable, legume, group 6..................................        0.05
Vegetable, root and tuber, group 1, except carrot...........        0.05
Wheat, grain................................................        0.05
Wheat, straw................................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[45 FR 42619, June 25, 1980, as amended at 45 FR 56346, Aug. 25, 1980; 
45 FR 86493, Dec. 31, 1980; 46 FR 37250, July 20, 1981; 47 FR 13524, 
Mar. 31, 1982; 47 FR 20309, May 12, 1982; 63 FR 57074, Oct. 26, 1998; 64 
FR 39082, July 21, 1999; 70 FR 21643, Apr. 27, 2005; 71 FR 54433, Sept. 
15, 2006]



Sec. 180.208  Benfluralin; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide benfluralin, N-butyl-N-ethyl-[alpha][alpha][alpha]-trifluoro-
2,6-dinitro-p-toluidine, in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        0.05
Alfalfa, hay................................................        0.05
Clover, forage..............................................        0.05
Clover, hay.................................................        0.05
Lettuce.....................................................        0.05
Trefoil, forage.............................................        0.05

[[Page 502]]

 
Trefoil, hay................................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[68 FR 39439, July 1, 2003, as amended at 73 FR 52613, Sept. 10, 2008]



Sec. 180.209  Terbacil; tolerances for residues.

    (a) General. Tolerances are established for combined residues of the 
herbicide terbacil, (3-tert-butyl-5-chloro-6-methyluracil) and its 
metabolites [3-tert-butyl-5-chloro-6-hydroxymethyluracil], [6-chloro-
2,3-dihydro-7-hydroxymethyl 3,3-dimethyl-5H-oxazolo(3,2-a) pyrimidin-5-
one], and [6-chloro-2,3-dihydro-3,3,7-trimethyl-5H-oxazolo(3,2-a) 
pyrimidin-5-one], calculated as terbacil, in or on the following raw 
agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        1.0
Alfalfa, hay................................................        2.0
Apple.......................................................        0.3
Asparagus...................................................        0.4
Blueberry...................................................        0.2
Caneberry subgroup 13A......................................        0.2
Peach.......................................................        0.2
Peppermint, tops............................................        2.0
Spearmint, tops.............................................        2.0
Strawberry..................................................        0.1
Sugarcane, cane.............................................        0.4
Watermelon..................................................        1.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[71 FR 30818, May 31, 2006]



Sec. 180.210  Bromacil; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide bromacil (5-bromo-3-sec-butyl-6-methyluracil) in or on the 
following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Fruit, citrus...............................................        0.1
Pineapple...................................................        0.1
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[68 FR 39439, July 1, 2003]



Sec. 180.211  Propachlor; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the herbicide propachlor (2-chloro-N-isopropylacetanilide) and its 
metabolites containing the N-isopropylaniline moiety, calculated as 2-
chloro-N-isopropylacetanilide, in or on the following raw agricultural 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.05
Cattle, kidney..............................................        0.2
Cattle, meat................................................        0.02
Cattle, meat byproducts, except kidney......................        0.05
Corn, field, forage.........................................        3.0
Corn, field, grain..........................................        0.2
Corn, field, stover.........................................        1.0
Corn, sweet, forage.........................................        3.0
Goat, fat...................................................        0.05
Goat, kidney................................................        0.2
Goat, meat..................................................        0.02
Goat, meat byproducts, except kidney........................        0.05
Hog, fat....................................................        0.02
Hog, meat...................................................        0.02
Hog, meat byproducts........................................        0.02
Horse, fat..................................................        0.05
Horse, kidney...............................................        0.2
Horse, meat.................................................        0.02
Horse, meat byproducts, except kidney.......................        0.05
Milk........................................................        0.02
Sheep, fat..................................................        0.05
Sheep, kidney...............................................        0.2
Sheep, meat.................................................        0.02
Sheep, meat byproducts, except kidney.......................        0.05
Sorghum, forage, forage.....................................        8.0
Sorghum, grain, forage......................................        8.0
Sorghum, grain, grain.......................................        0.25
Sorghum, grain, stover......................................       12.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[47 FR 25959, June 16, 1982, as amended at 47 FR 28381, June 30, 1982; 
47 FR 28626, July 1, 1982; 47 FR 46701, Oct. 20, 1982; 63 FR 57074, Oct. 
26, 1998; 72 FR 53454, Sept. 19, 2007]

[[Page 503]]



Sec. 180.212  S-Ethyl cyclohexylethylthio carbamate; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide S-ethyl cyclohexylethylthiocarbamate in or on the following 
food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Beet, garden, roots..........................................   0.05(N)
Beet, garden, tops...........................................   0.05(N)
Beet, sugar, roots...........................................   0.05(N)
Beet, sugar, tops............................................   0.05(N)
Spinach......................................................   0.05(N)
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[68 FR 39439, July 1, 2003]



Sec. 180.213  Simazine; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the herbicide simazine (2-chloro-4,6-bis(ethylamino)-s-triazine) and its 
two chlorinated degradates (2-amino-4-chloro-6-ethylamino-s-triazine and 
2,4-diamino-6-chloro-s-triazine), the total residue to be measured in or 
on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond......................................................        0.25
Almond, hulls...............................................        0.25
Apple.......................................................        0.20
Avocado.....................................................        0.20
Blackberry..................................................        0.20
Blueberry...................................................        0.20
Cattle, meat................................................        0.03
Cattle, meat byproducts.....................................        0.03
Cherry......................................................        0.25
Corn, field, forage.........................................        0.20
Corn, field, grain..........................................        0.20
Corn, field, stover.........................................        0.25
Corn, pop, grain............................................        0.20
Corn, pop, stover...........................................        0.25
Corn, sweet, forage.........................................        0.20
Corn, sweet, kernel plus cob with husks removed.............        0.25
Corn, sweet, stover.........................................        0.25
Cranberry...................................................        0.25
Currant.....................................................        0.25
Egg.........................................................        0.03
Goat, meat..................................................        0.03
Goat, meat byproducts.......................................        0.03
Grape.......................................................        0.20
Grapefruit..................................................        0.25
Hazelnut....................................................        0.20
Horse, meat.................................................        0.03
Horse, meat byproducts......................................        0.03
Lemon.......................................................        0.25
Loganberry..................................................        0.20
Milk........................................................        0.03
Nut, macadamia..............................................        0.25
Olive.......................................................        0.20
Orange......................................................        0.25
Peach.......................................................        0.20
Pear........................................................        0.25
Pecan.......................................................        0.20
Plum........................................................        0.20
Raspberry...................................................        0.20
Sheep, meat.................................................        0.03
Sheep, meat byproducts......................................        0.03
Strawberry..................................................        0.25
Walnut......................................................        0.2
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 2165, Jan. 14, 1998, as amended at 63 FR 57074, Oct. 26, 1998; 72 
FR 35665, June 29, 2007; 72 FR 53454, Sept. 19, 2007]



Sec. 180.215  Naled; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide naled (1,2-dibromo-2,2-dichloro-ethyl dimethyl phosphate) 
and its conversion product 2,2-dichlorovinyl dimethyl phosphate, 
expressed as naled, resulting from the application of the pesticide to 
growing crops or from direct application to livestock and poultry, in or 
on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        0.5
Almond......................................................        0.5
Bean, dry, seed.............................................        0.5
Bean, succulent.............................................        0.5
Beet, sugar, roots..........................................        0.5
Beet, sugar, tops...........................................        0.5
Broccoli....................................................        1
Brussels sprouts............................................        1
Cabbage.....................................................        1
Cauliflower.................................................        1
Celery......................................................        3
Collards....................................................        3
Cotton, undelinted seed.....................................        0.5
Cucumber....................................................        0.5
Eggplant....................................................        0.5
Grape.......................................................        0.5
Grapefruit..................................................        3
Grass, forage...............................................       10
Hop, dried cones............................................        0.5
Kale........................................................        3
Legume, forage..............................................       10
Lemon.......................................................        3
Melon.......................................................        0.5
Orange, sweet...............................................        3

[[Page 504]]

 
Peach.......................................................        0.5
Pea, succulent..............................................        0.5
Pepper......................................................        0.5
Pumpkin.....................................................        0.5
Safflower, seed.............................................        0.5
Spinach.....................................................        3
Squash, summer..............................................        0.5
Squash, winter..............................................        0.5
Strawberry..................................................        1
Swiss chard.................................................        3
Tangerine...................................................        3
Tomato......................................................        0.5
Turnip, greens..............................................        3
Walnut......................................................        0.5
------------------------------------------------------------------------

    (2) A tolerance of 0.5 part per million is established for the 
pesticide naled in or on all raw agricultural commodities, except those 
otherwise listed in this section, from use of the pesticide for area 
pest (mosquito and fly) control.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[42 FR 46304, Sept. 15, 1977, as amended at 54 FR 20125, May 10, 1989; 
63 FR 57074, Oct. 26, 1998; 66 FR 50833, Oct. 5, 2001; 77 FR 59124, 
Sept. 26, 2012]



Sec. 180.217  Metiram; tolerances for residues.

    (a) General. Tolerances are established for residues of a metiram (a 
mixture of 5.2 parts by weight of ammoniates of [ethylenebis 
(dithiocarbamato)] zinc with 1 part by weight ethylenebis 
[dithiocarbamic acid] bimolecular and trimolecular cyclic 
anhydrosulfides and disulfides), including its metabolites and 
degradates, in or on the commodities in the following table. Compliance 
with the tolerance levels specified in this paragraph is to be 
determined by measuring only those metiram residues convertible to and 
expressed in terms of the degradate carbon disulfide.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Apple.......................................................        0.5
Apple, pomace, wet..........................................        2
Banana \1\..................................................        3
Grape, wine \1\.............................................        5
Potato......................................................        0.2
------------------------------------------------------------------------
\1\ There are no U.S. registrations on bananas and grape, wine as of
  April 29, 2011.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 57074, Oct. 26, 1998, as amended at 76 FR 23891, Apr. 29, 2011]



Sec. 180.220  Atrazine; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the herbicide atrazine (2-chloro-4-ethylamino-6-isopropylamino-s-
triazine) and its chlorinated metabolites 2-amino-4-chloro-6-
isopropylamino-s-triazine, 2-amino-4-chloro-6-ethylamino-s-triazine, and 
2,4-diamino-6-chloro-s-triazine, in or on the following food 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.02
Cattle, meat................................................        0.02
Cattle, meat byproducts.....................................        0.02
Corn, field, forage.........................................        1.5
Corn, field, grain..........................................        0.20
Corn, field, stover.........................................        0.5
Corn, pop, forage...........................................        1.5
Corn, pop, grain............................................        0.20
Corn, pop, stover...........................................        0.5
Corn, sweet, forage.........................................       15
Corn, sweet, kernel plus cob with husks removed.............        0.20
Corn, sweet, stover.........................................        2.0
Goat, fat...................................................        0.02
Goat, meat..................................................        0.02
Goat, meat byproducts.......................................        0.02
Grass, forage...............................................        4.0
Grass, hay..................................................        4.0
Guava.......................................................        0.05
Horse, fat..................................................        0.02
Horse, meat.................................................        0.02
Horse, meat byproducts......................................        0.02
Milk........................................................        0.02
Nut, macadamia..............................................        0.20
Sheep, fat..................................................        0.02
Sheep, meat.................................................        0.02
Sheep, meat byproducts......................................        0.02
Sorghum, forage, forage.....................................        0.25
Sorghum, grain, forage......................................        0.25
Sorghum, grain, grain.......................................        0.20
Sorghum, grain, stover......................................        0.50
Sugarcane, cane.............................................        0.20
Wheat, forage...............................................        1.5
Wheat, grain................................................        0.10
Wheat, hay..................................................        5.0
Wheat, straw................................................        0.50
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established for 
indirect

[[Page 505]]

or inadvertant residues of atrazine, 2-chloro-4-ethylamino-6-
isopropylamino-s-triazine, in or on the following raw agricultural 
commodity when present therein as a result of application of atrazine to 
the growing crops in paragraph (a) of this section:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Vegetable, leafy, except brassica, group 4..................        0.25
------------------------------------------------------------------------


[43 FR 29121, July 6, 1978, as amended at 44 FR 67116, Nov. 23, 1979; 47 
FR 3771, Jan. 27, 1982; 47 FR 8012, Feb. 24, 1982; 63 FR 57075, Oct. 26, 
1998; 67 FR 46893, July 17, 2002; 69 FR 6567, Feb. 11, 2004; 72 FR 
35666, June 29, 2007; 72 FR 53454, Sept. 19, 2007; 73 FR 37852, July 2, 
2008; 76 FR 56654, Sept. 14, 2011]



Sec. 180.222  Prometryn; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide prometryn (2,4-bis(isopropylamino)-6-methylthio-s-triazine) in 
or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Carrot, roots...............................................        0.45
Celeriac, roots.............................................        0.05
Celeriac, tops..............................................        0.20
Cilantro, leaves............................................        3.5
Coriander, dried leaves.....................................        9.0
Cotton, gin byproducts......................................        1.0
Cotton, undelinted seed.....................................        0.25
Leaf petioles subgroup 4B...................................        0.50
Okra........................................................        0.05
Parsley, dried leaves.......................................        1.5
Parsley, leaves.............................................        0.60
Pea, pigeon, seed...........................................        0.25
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional exemptions. Tolerances with regional 
registration, as defined in Sec. 180.1(l), are established for residues 
of the herbicide prometryn (2,4-bis(isopropylamino-6-methylthio-s- 
triazine) in or on the following raw agricultural commodity:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Dill........................................................        0.3
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. Tolerances are established for 
indirect or inadvertent residues of the herbicide prometryn, 2,4-
bis(isopropylamino)-6-methylthio-s-triazine, in or on the following food 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, forage..............................................        0.3
Barley, hay.................................................        1.0
Barley, straw...............................................        0.3
Oat, forage.................................................        0.3
Oat, hay....................................................        1.0
Oat, straw..................................................        0.3
Rye, forage.................................................        0.3
Rye, hay....................................................        1.0
Rye, straw..................................................        0.3
Triticale, forage...........................................        0.3
Triticale, hay..............................................        1.0
Triticale, straw............................................        0.3
Wheat, forage...............................................        0.3
Wheat, hay..................................................        1.0
Wheat, straw................................................        0.3
------------------------------------------------------------------------


[43 FR 29121, July 6, 1978, as amended at 45 FR 51782, Aug. 5, 1980; 54 
FR 6918, Feb. 15, 1989; 60 FR 20434, Apr. 26, 1995; 63 FR 17692, Apr. 
10, 1998; 63 FR 57075, Oct. 26, 1998; 64 FR 39082, July 21, 1999; 74 FR 
47456, Sept. 16, 2009; 74 FR 67108, Dec. 18, 2009; 76 FR 34885, June 15, 
2011]



Sec. 180.225  Phosphine; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
phosphine in or on the following raw agricultural commodities (RACs) 
resulting from post-harvest fumigation for the control of insects with 
phosphine gas or phosphide compounds that produce phosphine gas.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond......................................................        0.1
Avocado.....................................................        0.01
Banana......................................................        0.01
Barley, grain...............................................        0.1
Cabbage, Chinese, bok choy..................................        0.01
Cabbage, Chinese, napa......................................        0.01
Cacao bean, dried bean......................................        0.1
Cashew......................................................        0.1
Citron, citrus..............................................        0.01
Coffee, bean, green.........................................        0.1
Corn, field, grain..........................................        0.1
Corn, pop, grain............................................        0.1
Cotton, undelinted seed.....................................        0.1
Date, dried fruit...........................................        0.1
Dill, seed..................................................        0.01
Eggplant....................................................        0.01
Endive......................................................        0.01
Grapefruit..................................................        0.01
Hazelnut....................................................        0.1
Kumquat.....................................................        0.01
Lemon.......................................................        0.01
Lettuce.....................................................        0.01
Lime........................................................        0.01
Mango.......................................................        0.01
Millet, grain...............................................        0.1
Mushroom....................................................        0.01
Nut, brazil.................................................        0.1
Oat, grain..................................................        0.1
Okra........................................................        0.01
Orange, sweet...............................................        0.01
Papaya......................................................        0.01

[[Page 506]]

 
Peanut......................................................        0.1
Pecan.......................................................        0.1
Pepper......................................................        0.01
Persimmon...................................................        0.01
Pistachio...................................................        0.1
Rice, grain.................................................        0.1
Rye, grain..................................................        0.1
Safflower, seed.............................................        0.1
Salsify, tops...............................................        0.01
Sesame, seed................................................        0.1
Sorghum, grain..............................................        0.1
Soybean, seed...............................................        0.1
Sunflower, seed.............................................        0.1
Sweet potato, roots.........................................        0.01
Tangelo.....................................................        0.01
Tangerine...................................................        0.01
Tomato......................................................        0.01
Vegetable, legume, group 6, except soybean..................        0.01
Walnut......................................................        0.1
Wheat, grain................................................        0.1
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the fumigant in or on 
all RACs resulting from preharvest treatment of pest burrows in 
agricultural and non-crop land areas.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
All raw agricultural commodities resulting from preharvest          0.01
 treatment of pest burrows..................................
------------------------------------------------------------------------

    (3) Residues resulting from fumigation of processed food:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Processed food..............................................        0.01
------------------------------------------------------------------------

    (4) Residues resulting from fumigation of animal feed:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Animal feed.................................................        0.1
------------------------------------------------------------------------

    (5) To assure safe use of this pesticide, it must be used in 
compliance with the labeling conforming to that registered by the U.S. 
Environmental Protection Agency (EPA) under FIFRA. Labeling shall bear a 
restriction to aerate the finished food/feed for 48 hours before it is 
offered to the consumer, unless EPA specifically determines that a 
different time period is appropriate. Where appropriate, a warning shall 
state that under no condition should any formulation containing aluminum 
or magnesium phosphide be used so that it will come in contact with any 
processed food, except processed brewer's rice, malt, and corn grits 
stored in breweries for use in the manufacture of beer.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertant residues. [Reserved]

[64 FR 72950, Dec. 29, 1999, as amended at 71 FR 74816, Dec. 13, 2006; 
72 FR 41929, Aug. 1, 2007; 74 FR 46372, Sept. 9, 2009]



Sec. 180.226  Diquat; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
plant growth regulator and herbicide diquat, (6,7-dihydrodipyrido (1,2-
a:2[min]1[min]-c)pyrazinediium) derived from application of the 
dibromide salt and calculated as the cation in or on the following food 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, seed...............................................        3.0
Cattle, fat.................................................        0.05
Cattle, meat................................................        0.05
Cattle, meat byproducts.....................................        0.05
Canola, meal................................................        6.0
Canola, seed................................................        2.0
Egg.........................................................        0.05
Goat, fat...................................................        0.05
Goat, meat..................................................        0.05
Goat, meat byproducts.......................................        0.05
Hog, fat....................................................        0.05
Hog, meat...................................................        0.05
Hog, meat byproducts........................................        0.05
Horse, fat..................................................        0.05
Horse, meat.................................................        0.05
Horse, meat byproducts......................................        0.05
Milk........................................................        0.02
Potato......................................................        0.1
Poultry, fat................................................        0.05
Poultry, meat...............................................        0.05
Poultry, meat byproducts....................................        0.05
Sheep, fat..................................................        0.05
Sheep, meat.................................................        0.05
Sheep, meat byproducts......................................        0.05
------------------------------------------------------------------------

    (2)(i) Tolerances are established for residues of the herbicide 
diquat (6,7 dihydrodipyrido(1,2-a:2'1'-c)pyrazinediium) (calculated as 
the cation) derived from the application of the dibromide salt to ponds, 
lakes, reservoirs, marshes, drainage ditches, canals, streams, and 
rivers which are slow-moving or quiescent in programs of the Corp of 
Engineers or other Federal or State public agencies and to ponds, lakes 
and drainage ditches only where there is little or no outflow of water 
and which are totally under the

[[Page 507]]

control of the user, in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Avocado.....................................................        0.2
Berry group 13..............................................        0.05
Cotton, undelinted seed.....................................        0.2
Cranberry...................................................        0.05
Fish........................................................        2.0
Fruit, citrus, group 10.....................................        0.05
Fruit, pome, group 11.......................................        0.02
Fruit, stone, group 12......................................        0.02
Grain, cereal, forage, fodder and straw, group 16...........        0.02
Grain, cereal, group 15.....................................        0.02
Grape.......................................................        0.05
Grass, forage, fodder and hay, group 17.....................        0.2
Hop, dried cones............................................        0.2
Nut, tree, group 14.........................................        0.02
Shellfish...................................................       20.0
Strawberry..................................................        0.05
Sugarcane, cane.............................................        0.2
Vegetable, brassica, leafy, group 5.........................        0.05
Vegetable, cucurbit, group 9................................        0.02
Vegetable, foliage of legume, group 7.......................        0.2
Vegetable, fruiting, group 8................................        0.05
Vegetable, leafy, except brassica, group 4..................        0.05
Vegetable, root and tuber, group 1..........................        0.02
Vegetable, seed and pod.....................................        0.05
------------------------------------------------------------------------

    (ii) Where tolerances are established at higher levels from other 
uses of diquat on the subject crops, the higher tolerances applies also 
to residues of the aquatic uses cited in this paragraph.
    (3) Tolerances are established for the plant growth regulator diquat 
(6,7 dihydrodipyrido(1,2-a:2'1'-c)pyrazinediium) derived from 
application of the dibromide salt and calculated as the cation in or on 
the following food commodites:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Banana\1\...................................................        0.05
Coffee, bean, green\1\......................................        0.05
Soybean, hulls..............................................        0.6
------------------------------------------------------------------------
\1\There are no U.S. registrations as of May 26, 2010.

    (4) A tolerance of 0.5 part per million is established for residues 
of diquat in potato, granules/flakes and potato, chips.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33709, May 24, 2000, as amended at 72 FR 41929, Aug. 1, 2007; 75 
FR 29441, May 26, 2010; 75 FR 60241, Sept. 29, 2010]



Sec. 180.227  Dicamba; tolerances for residues.

    (a) General. (1) Tolerances are established for the residues of the 
herbicide dicamba (3,6-dichloro-o-anisic acid), including its 
metabolites and degradates, in or on the commodities in the table below. 
Compliance with the tolerance levels is to be determined by measuring 
only the sum of the residues of dicamba (3,6-dichloro-o-anisic acid) and 
its metabolite, 3,6-dichloro-5-hydroxy-o-anisic acid, calculated as the 
stoichiometric equivalent of dicamba, in or on the following 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, grain...............................................        6.0
Barley, hay.................................................        2.0
Barley, straw...............................................       15.0
Corn, field, forage.........................................        3.0
Corn, field, grain..........................................        0.1
Corn, field, stover.........................................        3.0
Corn, pop, grain............................................        0.1
Corn, pop, stover...........................................        3.0
Corn, sweet, forage.........................................        0.50
Corn, sweet, kernel plus cob with husks removed.............        0.04
Corn, sweet, stover.........................................        0.50
Cotton, undelinted seed.....................................        0.2
Grass, forage, fodder and hay, group 17, forage.............      125.0
Grass, forage, fodder and hay, group 17, hay................      200.0
Millet, proso, forage.......................................       90.0
Millet, proso, grain........................................        2.0
Millet, proso, hay..........................................       40.0
Millet, proso, straw........................................       30.0
Oat, forage.................................................       90.0
Oat, grain..................................................        2.0
Oat, hay....................................................       40.0
Oat, straw..................................................       30.0
Rye, forage.................................................       90.0
Rye, grain..................................................        2.0
Rye, straw..................................................       30.0
Sorghum, grain, forage......................................        3.0
Sorghum, grain, grain.......................................        4.0
Sorghum, grain, stover......................................       10.0
Sugarcane, cane.............................................        0.3
Sugarcane, molasses.........................................        5.0
Teff, forage................................................       90.0
Teff, grain.................................................        6.0
Teff, hay...................................................       40.0
Teff, straw.................................................       30.0
Wheat, forage...............................................       90.0
Wheat, grain................................................        2.0
Wheat, hay..................................................       40.0
Wheat, straw................................................       30.0
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the herbicide 
dicamba, 3,6-dichloro-o-anisic acid, including its metabolites and 
degradates, in or on the commodities in the table below. Compliance with 
the tolerance levels is to be determined by measuring only the residues 
of dicamba (3,6-dichloro-o-anisic acid) and its metabolite, 3,6-

[[Page 508]]

dichloro-2-hydroxybenzoic acid, calculated as the stoichiometric 
equivalent of dicamba, in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Asparagus...................................................        4.0
Cattle, fat.................................................        0.3
Cattle, kidney..............................................       25.0
Cattle, meat................................................        0.25
Cattle, meat byproducts, except kidney......................        3.0
Goat, fat...................................................        0.3
Goat, kidney................................................       25.0
Goat, meat..................................................        0.25
Goat, meat byproducts, except kidney........................        3.0
Hog, fat....................................................        0.3
Hog, kidney.................................................       25.0
Hog, meat...................................................        0.25
Hog, meat byproducts, except kidney.........................        3.0
Horse, fat..................................................        0.3
Horse, kidney...............................................       25.0
Horse, meat.................................................        0.25
Horse, meat byproducts, except kidney.......................        3.0
Milk........................................................        0.2
Sheep, fat..................................................        0.3
Sheep, kidney...............................................       25.0
Sheep, meat.................................................        0.25
Sheep, meat byproducts, except kidney.......................        3.0
------------------------------------------------------------------------

    (3) Tolerances are established for residues of the herbicide 
dicamba, 3,6-dichloro-o-anisic acid, including its metabolites and 
degradates, in or on the commodities in the table below. Compliance with 
the tolerance levels is to be determined by measuring only the residues 
of dicamba, 3,6-dichloro-o-anisic acid, and its metabolites, 3,6-
dichloro-5-hydroxy-o-anisic acid, and 3,6-dichloro-2-hydroxybenzoic 
acid, calculated as the stoichiometric equivalent of dicamba, in or on 
the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grain, aspirated fractions..................................     1000
Soybean, hulls..............................................       30.0
Soybean, seed...............................................       10.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33709, May 24, 2000, as amended at 72 FR 35665, June 29, 2007; 73 
FR 17918, Apr. 2, 2008; 73 FR 54960, Sept. 24, 2008; 75 FR 60241, Sept. 
29, 2010; 76 FR 55806, Sept. 9, 2011]



Sec. 180.229  Fluometuron; tolerances for residues.

    (a) General. (1) Tolerances are established for the combined 
residues of the herbicide fluometuron, N, N-dimethyl-N'-[3-
(trifluoromethyl)phenyl]urea, and its metabolite, trifluoromethylaniline 
(TFMA) determined as TFMA, in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cotton, gin byproducts......................................        3.5
Cotton, undelinted seed.....................................        1.0
------------------------------------------------------------------------

    (2) Tolerances are established for the combined residues of the 
herbicide fluometuron, N,N-dimethyl-N'-[3-(trifluoromethyl)phenyl]urea, 
and its metabolites determined as TFMA and the hydroxylated metabolites: 
CGA-236431, 1-(4-hydroxy-3-trifluoromethylphenyl)urea; CGA-236432, 1-
methyl-3-(4-hydroxy-3-trifluoromethylphenyl)urea; and CGA-13211, 1,1-
dimethyl-3-(4-hydroxy-3-trifluoromethylphenyl)urea, in or on the 
following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, meat byproducts.....................................        0.1
Egg.........................................................        0.1
Goat, meat byproducts.......................................        0.1
Hog, meat byproducts........................................        0.1
Horse, meat byproducts......................................        0.1
Milk........................................................        0.02
Poultry, fat................................................        0.1
Poultry, meat...............................................        0.1
Poultry, meat byproducts....................................        0.1
Sheep, meat byproducts......................................        0.1
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established for 
the combined residues of the herbicide fluometuron, N, N-dimethyl-N'-[3-
(trifluoromethyl)phenyl]urea, and its metabolite, trifluoromethylaniline 
(TFMA) determined as TFMA, in or on the following food commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grain, cereal, forage, fodder, and straw group 16, forage...        3.0
Grain, cereal, forage, fodder, and straw, group 16, stover..        6.0
Grain, cereal, group 15.....................................        0.5
Peanut......................................................        0.1

[[Page 509]]

 
Peanut, hay.................................................        4.0
Peanut, meal................................................        0.2
Soybean, forage.............................................        3.0
Soybean, hay................................................        3.0
Soybean, seed...............................................        2.0
Rice, hulls.................................................        1.0
Wheat, milled byproducts....................................        1.0
------------------------------------------------------------------------


[73 FR 52613, Sept. 10, 2008]



Sec. 180.231  Dichlobenil; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the herbicide dichlobenil (2,6-dichlorobenzonitrile) and its metabolite 
2,6-dichlorobenzamide in or on the following raw agricultural 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Apple.......................................................        0.5
Bushberry subgroup 13-07B...................................        0.15
Caneberry subgroup 13-07A...................................        0.10
Cranberry...................................................        0.1
Fruit, stone, group 12......................................        0.15
Grape.......................................................        0.15
Hazelnut....................................................        0.1
Pear........................................................        0.5
Rhubarb.....................................................        0.06
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registration. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[36 FR 22540, Nov. 25, 1971, as amended at 63 FR 57075, Oct. 26, 1998; 
66 FR 63198, Dec. 5, 2001; 73 FR 50570, Aug. 27, 2008]



Sec. 180.232  Butylate; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide butylate, including its metabolites and degradates, in or on 
the commodities in the table in this paragraph. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only butylate, S-ethyl bis (2-methylpropyl) carbamothioate, in 
or on the commodity.

------------------------------------------------------------------------
                                                            Expiration/
                  Commodity                    Parts per    Revocation
                                                million        Date
------------------------------------------------------------------------
Corn, field, forage.........................        0.1          3/23/13
Corn, field, grain..........................        0.1          3/23/13
Corn, field, stover.........................        0.1          3/23/13
Corn, pop, grain............................        0.1          3/23/13
Corn, pop, stover...........................        0.1          3/23/13
Corn, sweet, forage.........................        0.1          3/23/13
Corn, sweet, kernel plus cob with husks             0.1          3/23/13
 removed....................................
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[68 FR 39439, July 1, 2003, as amended at 76 FR 23493, Apr. 27, 2011; 77 
FR 59125, Sept. 26, 2012]



Sec. 180.235  Dichlorvos; tolerances for residues.

    (a) General. (1) Tolerances for residues of the insecticide 2,2-
dichlorovinyl dimethyl phosphate are established as follows:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat..................................................   0.02(N)
Cattle, meat.................................................   0.02(N)
Cattle, meat byproducts......................................   0.02(N)
Egg..........................................................   0.05(N)
Goat, fat....................................................   0.02(N)
Goat, meat...................................................   0.02(N)
Goat, meat byproducts........................................   0.02(N)
Horse, fat...................................................   0.02(N)
Horse, meat..................................................   0.02(N)
Horse, meat byproducts.......................................   0.02(N)
Milk.........................................................   0.02(N)
Mushroom (residues expressed as naled).......................   0.5
Poultry, fat.................................................   0.05(N)
Poultry, meat................................................   0.05(N)
Poultry, meat byproducts.....................................   0.05(N)
Raw agricultural commodities, nonperishable, bulk stored        0.5
 regardless of fat content, postharvest......................
Raw agricultural commodities nonperishable, packaged or         0.5
 bagged, containing 6 percent fat or less, postharvest.......
Raw agricultural commodities, nonperishable, packaged or        2
 bagged, containing more than 6 percent fat, postharvest.....
Sheep, fat...................................................   0.02(N)
Sheep, meat..................................................   0.02(N)
Sheep, meat byproducts.......................................   0.02(N)
------------------------------------------------------------------------

    (2) The tolerance of 0.1 part per million prescribed by 21 CFR 
556.180 for negligible residues of 2,2-dichlorovinyl dimethyl phosphate 
in hog, fat; hog, meat; hog, meat byproducts; and hog, skin covers both 
its use as an anthelmintic in swine feed and as an insecticide applied 
directly to swine.

[[Page 510]]

    (3) Dichlorvos may be present as a residue from application as an 
insecticide on packaged or bagged nonperishable processed food (see: 21 
CFR 170.3(j)) in an amount in such food not in excess of 0.5 part per 
million (ppm). To assure safe use of the insecticide, its label and 
labeling shall conform to the label and labeling registered by the U.S. 
Environmental Protection Agency, and the usage employed shall conform 
with such label or labeling.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[47 FR 55223, Dec. 8, 1982, as amended at 55 FR 26440, June 28, 1990; 56 
FR 29183, June 26, 1991; 63 FR 57075, Oct. 26, 1998; 65 FR 33697, May 
24, 2000; 74 FR 46373, Sept. 9, 2009; 77 FR 59125, Sept. 26, 2012]



Sec. 180.236  Triphenyltin hydroxide; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the fungicide triphenyltin hydroxide (TPTH) and its monophenyltin (MPTH) 
and diphenyltin (DPTH) hydroxide and oxide metabolites, expressed in 
terms of parent TPTH, in or on the following raw agricultural 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Beet, sugar, roots..........................................        0.05
Beet, sugar, tops...........................................       10.0
Cattle, fat.................................................        0.2
Cattle, kidney..............................................        2.0
Cattle, liver...............................................        4.0
Cattle, meat................................................        0.5
Goat, fat...................................................        0.2
Goat, kidney................................................        2.0
Goat, liver.................................................        4.0
Goat, meat..................................................        0.5
Hog, fat....................................................        0.3
Hog, meat...................................................        0.06
Hog, meat byproducts........................................        0.3
Horse, fat..................................................        0.2
Horse, kidney...............................................        2.0
Horse, liver................................................        4.0
Horse, meat.................................................        0.5
Milk........................................................        0.06
Pecan.......................................................        0.05
Potato......................................................        0.05
Sheep, fat..................................................        0.2
Sheep, kidney...............................................        2.0
Sheep, liver................................................        4.0
Sheep, meat.................................................        0.5
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[72 FR 41929, Aug. 1, 2007]



Sec. 180.241  Bensulide; tolerances for residues.

    (a) General. Tolerances are established for the residues of S-(O,O-
diisopropyl phosphorodithioate) of N-(2-mercaptoethyl) 
benzenesulfonamide including its oxygen analog S-(O,O-diisopropyl 
phosphorothioate) of N-(2-mercaptoethyl) benzenesulfonamide in or on the 
following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Onion, bulb.................................................        0.10
Vegetable, brassica, leafy group 5..........................        0.15
Vegetable, cucurbits group 9................................        0.15
Vegetable, fruiting group 8.................................        0.10
Vegetable, leafy except brassica group 4....................        0.15
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration, as defined in Sec. 180.1(l), are established for the 
residues of S-(O,O-diisopropyl phosphorodithioate) of N-(2-
mercaptoethyl) benzenesulfonamide including its oxygen analog S-(O,O-
diisopropyl phosphorothioate) of N-(2-mercaptoethyl) benzenesulfonamide 
in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Carrot, roots...............................................        0.10
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[68 FR 39440, July 1, 2003, as amended at 73 FR 53738, Sept. 17, 2008]



Sec. 180.242  Thiabendazole; tolerances for residues.

    (a) General. (1) Tolerances are established for the combined 
residues of the fungicide thiabendazole (2-(4-thiazolyl)benzimidazole) 
and its metabolite benzimidazole (free and conjugated) in or on the 
following food commodities:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   Revocation
                                                   million       Date
------------------------------------------------------------------------
Apple, wet pomace...............................       12.0         None

[[Page 511]]

 
Avocado\1\......................................       10.0         None
Banana, postharvest.............................        3.0         None
Bean, dry, seed.................................        0.1         None
Beet, sugar, dried pulp.........................        3.5     12/25/10
Beet, sugar, roots..............................       0.25     12/25/10
Beet, sugar, tops...............................       10.0     12/25/10
Cantaloupe\1\...................................       15.0         None
Carrot, roots, postharvest......................       10.0         None
Citrus, oil.....................................       15.0         None
Corn, field, forage.............................       0.01         None
Corn, field, grain..............................       0.01         None
Corn, field, stover.............................       0.01         None
Corn, pop, forage...............................       0.01         None
Corn, pop, grain................................       0.01         None
Corn, pop, stover...............................       0.01         None
Corn, sweet, forage.............................       0.01         None
Corn, sweet, kernels plus cop with husks removed       0.01         None
Corn, sweet, stover.............................       0.01         None
Fruit, citrus, group 10, postharvest............       10.0         None
Fruit, pome, group 11, postharvest..............        5.0         None
Mango...........................................       10.0         None
Mushroom........................................       40.0         None
Papaya, postharvest.............................        5.0         None
Potato, postharvest.............................       10.0         None
Soybean.........................................        0.1         None
Strawberry\1\...................................        5.0         None
Sweet potato (postharvest to sweet potato              0.05         None
 intended only for use as seed).................
Wheat, grain....................................        1.0         None
Wheat, straw....................................        1.0         None
------------------------------------------------------------------------

    \1\There are no U.S. registrations on the indicated commodity.
    (2) Tolerances are established for the combined residues of 
thiabendazole (2-(4-thiazolyl)benzimidazole) and its metabolites 5-
hydroxythiabendazole (free and conjugated) and benzimidazole in or on 
the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, meat................................................        0.1
Cattle, meat byproducts.....................................        0.4
Goat, meat byproducts.......................................        0.4
Hog, meat byproducts........................................        0.3
Horse, meat byproducts......................................        0.4
Milk........................................................        0.1
Sheep, meat byproducts......................................        0.4
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional exemptions. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[42 FR 32783, June 28, 1977]

    Editorial Note: For Federal Register citations affecting Sec. 
180.242, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.243  Propazine; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide propazine, 2-chloro-4,6-bis(isopropylamino)-s-triazine, 
including its metabolites and degradates, in or on the commodities in 
the following table. Compliance with the tolerance levels specified in 
this paragraph is to be determined by measuring only the sum of 
propazine, 2-chloro-4,6-bis(isopropylamino)-s-triazine, and its two 
chlorinated degradates, 2-amino-4-chloro-6-isopropylamino-s-triazine and 
2,4-diamino-6-chloro-s-triazine, calculated as the stoichiometric 
equivalent of propazine, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Sorghum, grain, forage......................................        0.25
Sorghum, grain, grain.......................................        0.25
Sorghum, grain, stover......................................        0.25
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[75 FR 60242, Sept. 29, 2010]



Sec. 180.245  Streptomycin; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
fungicide streptomycin in or on food commodities as follows:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Bean, dry, seed.............................................        0.5
Bean, succulent.............................................        0.5
Fruit, pome, group 11.......................................        0.25
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the fungicide 
streptomycin from treatment of seedling plants before transplanting in 
or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Celery......................................................        0.25
Pepper......................................................        0.25
Tomato......................................................        0.25
------------------------------------------------------------------------

    (3) Tolerances are established for residues of the fungicide 
streptomycin

[[Page 512]]

from treatment of seed pieces in or on the following food commodity:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Potato......................................................        0.25
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of streptomycin, in or on the agricultural 
commodities, as specified in the following table, resulting from use of 
the pesticide pursuant to FIFRA section 18 emergency exemptions. 
Compliance with the tolerance levels listed in the following table is to 
be determined by measuring the levels of streptomycin only, in or on the 
commodities listed in the table. The tolerances expire on the dates 
specified in the table.

------------------------------------------------------------------------
                                                   Parts per  Expiration
                    Commodity                       million      date
------------------------------------------------------------------------
Grapefruit.......................................       0.15  12/31/2015
Grapefruit, dried pulp...........................       0.40  12/31/2015
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[68 FR 39440, July 1, 2003, as amended at 73 FR 54960, Sept. 24, 2008; 
78 FR 29055, May 17, 2013]



Sec. 180.249  Alachlor; tolerances for residues.

    (a) General. Tolerances are established for combined residues of 
alachlor (2-chloro-2',6'-diethyl-N-(methoxymethyl)acetanilide) and its 
metabolites which can be converted to 2,6-diethylaniline (DEA) or 2-
ethyl-6-(1-hydroxyethyl)aniline (1-HEEA) upon basic hydrolysis, 
calculated as alachlor in or on the following raw agricultural 
commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Beans, dry..................................................        0.1
Beans, succulent lima.......................................        0.1
Cattle, fat.................................................        0.02
Cattle, meat byproducts.....................................        0.02
Cattle, meat................................................        0.02
Corn, field, forage.........................................        2.0
Corn, field, grain..........................................        0.2
Corn, field, pop............................................        0.2
Corn, field, stover.........................................        2.0
Corn, pop, stover...........................................        2.0
Corn, sweet (K+CWHR)........................................        0.05
Corn, sweet, stover.........................................        2.0
Cotton, gin byproducts......................................        0.7
Cotton, undelinted seed.....................................        0.03
Cowpea, forage..............................................        5.0
Cowpea, hay.................................................        5.0
Egg.........................................................        0.02
Goat, fat...................................................        0.02
Goat, meat byproducts.......................................        0.02
Goat, meat..................................................        0.02
Hog, fat....................................................        0.02
Hog meat byproducts.........................................        0.02
Hog, meat...................................................        0.02
Horse, fat..................................................        0.02
Horse, meat byproducts......................................        0.02
Horse, meat.................................................        0.02
Milk........................................................        0.02
Peanut......................................................        0.5
Poultry, fat................................................        0.02
Poultry, meat byproducts....................................        0.02
Poultry, meat...............................................        0.02
Sheep, fat..................................................        0.02
Sheep, meat byproducts......................................        0.02
Sheep, meat.................................................        0.02
Sorghum grain, forage.......................................        2.0
Sorghum, grain, grain.......................................        0.1
Sorghum, grain, stover......................................        1.0
Soybeans, seed..............................................        1.0
Sunflower, meal.............................................        3.4
Sunflower, seed.............................................        2.5
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established for 
indirect or inadvertent residues of alachlor (2-chloro-2',6'-diethyl-N-
(methoxymethyl)acetanilide) and its metabolites which can be converted 
to 2,6-diethylaniline (DEA) or 2-ethyl-6-(1-hydroxyethyl)aniline (1-
HEEA) upon basic hydrolysis, calculated as alachlor, in or on the 
following raw agricultural commodities when present therein as a result 
of the application of alachlor to the growing crops in paragraph (a) of 
this section:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Animal feed, nongrass, group 18, forage.....................        1.4
Animal feed, nongrass, group 18, hay........................        1.2
Grain, cereal, forage, and straw, group 16 except corn,             0.8
 sorghum, rice, straw.......................................
Grain, cereal, forage, fodder and straw, group 16 except            0.6
 corn, sorghum, rice, forage................................
Grain, cereal, forage, fodder, and straw, group 16 except           0.8
 for corn, sorghum, rice, hay...............................
Grain, cereal, group 15 except corn, sorghum, rice..........        0.05
------------------------------------------------------------------------


[72 FR 54584, Sept. 26, 2007]

[[Page 513]]



Sec. 180.252  Tetrachlorvinphos; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the insecticide tetrachlorvinphos [(Z)-2-chloro-1-(2,4,5-
trichlorophenyl) vinyl dimethyl phosphate], including its metabolites, 
1-(2,4,5-trichlorophenyl)-ethanol (free and conjugated forms), 2,4,5-
trichloroacetophenone, and 1-(2,4,5-trichlorophenyl)-ethanediol, in or 
on the following commodities:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                    million      date
------------------------------------------------------------------------
Cattle, fat (of which no more than 0.1 ppm is           0.2      8/18/13
 tetrachlorvinphos per se)......................
Cattle, kidney (of which no more than 0.05 ppm          1.0      8/18/13
 is tetrachlorvinphos per se)...................
Cattle, liver (of which no more than 0.05 ppm is        0.5      8/18/13
 tetrachlorvinphos per se)......................
Cattle, meat (of which no more than 2.0 ppm is          2.0      8/18/13
 tetrachlorvinphos per se)......................
Cattle, meat byproducts, except kidney and liver        1.0      8/18/13
Egg (of which no more than 0.05 ppm is                  0.2      8/18/13
 tetrachlorvinphos per se)......................
Hog, fat (of which no more than 0.1 ppm is              0.2      8/18/13
 tetrachlorvinphos per se)......................
Hog, kidney (of which no more than 0.05 ppm is          1.0      8/18/13
 tetrachlorvinphos per se)......................
Hog, liver (of which no more than 0.05 ppm is           0.5      8/18/13
 tetrachlorvinphos per se)......................
Hog, meat (of which no more than 2.0 ppm is             2.0      8/18/13
 tetrachlorvinphos per se)......................
Hog, meat byproducts, except kidney and liver...        1.0      8/18/13
Milk, fat (reflecting negligible residues in           0.05      8/18/13
 whole milk and of which no more than 0.05 ppm
 is tetrachlorvinphos per se)...................
Poultry, fat (of which no more than 7.0 ppm is          7.0      8/18/13
 tetrachlorvinphos per se)......................
Poultry, liver (of which no more than 0.05 ppm          2.0      8/18/13
 is tetrachlorvinphos per se)...................
Poultry, meat (of which no more than 3.0 ppm is         3.0      8/18/13
 tetrachlorvinphos per se)......................
Poultry, meat byproducts, except liver..........        2.0      8/18/13
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[76 FR 57659, Sept. 16, 2011, as amended at 78 FR 15882, Mar. 13, 2013]



Sec. 180.253  Methomyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide methomyl, including its metabolites and degradates, in or on 
the commodities in the table in this paragraph. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only methomyl, methyl N-[ (methylamino)carbonyl] oxy]ethani 
midothioate, in or on the commodity.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Alfalfa, forage.................................         10         None
Alfalfa, hay....................................         10         None
Apple...........................................          1         None
Asparagus.......................................          2         None
Avocado.........................................          2         None
Barley, grain...................................          1         None
Barley, hay.....................................         10         None
Barley, straw...................................         10         None
Bean, dry, seed.................................        0.1         None
Bean, forage....................................         10         None
Bean, succulent.................................          2         None
Beet, garden, tops..............................          6         None
Bermudagrass, forage............................         10         None
Bermudagrass, hay...............................         40         None
Blueberry.......................................          6         None
Broccoli........................................          3         None
Brussels sprouts................................          2         None
Cabbage.........................................          5         None
Cabbage, Chinese, bok choy......................          5         None
Cabbage, Chinese, napa..........................          5         None
Cauliflower.....................................          2         None
Celery..........................................          3         None
Collards........................................          6         None
Corn, field, forage.............................         10         None
Corn, field, grain..............................        0.1         None
Corn, field, stover.............................         10         None
Corn, pop, grain................................        0.1         None
Corn, pop, stover...............................         10         None
Corn, sweet, forage.............................         10         None
Corn, sweet, kernel plus cob with husks removed.        0.1         None
Corn, sweet, stover.............................         10         None
Cotton, undelinted seed.........................        0.1         None
Dandelion, leaves...............................          6         None
Endive..........................................          5         None
Grape...........................................          5     12/31/16
Grapefruit......................................          2         None
Hop, dried cones \1\............................         12         None
Kale............................................          6         None
Lemon...........................................          2         None
Lentil, seed....................................        0.1         None
Lettuce.........................................          5         None
Mustard greens..................................          6         None
Nectarine.......................................          5         None
Oat, forage.....................................         10         None
Oat, grain......................................          1         None
Oat, hay........................................         10         None
Oat, straw......................................         10         None
Onion, green....................................          3         None
Orange..........................................          2         None
Parsley, leaves.................................          6         None
Pea.............................................          5         None
Pea, field, vines...............................         10         None
Peach...........................................          5         None
Peanut..........................................        0.1         None

[[Page 514]]

 
Pecan...........................................        0.1         None
Pepper, bell....................................          2         None
Pepper, nonbell.................................          2         None
Peppermint, tops................................          2         None
Pomegranate.....................................        0.2         None
Rye, forage.....................................         10         None
Rye, grain......................................          1         None
Rye, straw......................................         10         None
Sorghum, grain, forage..........................          1         None
Sorghum, grain, grain...........................        0.2         None
Soybean, forage.................................         10         None
Soybean, seed...................................        0.2         None
Spearmint, tops.................................          2         None
Spinach.........................................          6         None
Swiss chard.....................................          6         None
Tangerine.......................................          2         None
Tomato..........................................          1         None
Turnip, greens..................................          6         None
Vegetable, brassica, leafy, group 5.............        6.0         None
Vegetable, cucurbit, group 9....................        0.2         None
Vegetable, fruiting, group 8....................        0.2         None
Vegetables, leafy \2\...........................        0.2         None
Vegetable, root and tuber, group 1..............        0.2         None
Wheat, forage...................................         10         None
Wheat, grain....................................          1         None
Wheat, hay......................................         10         None
Wheat, straw....................................         10         None
------------------------------------------------------------------------
\1\ There are no U.S. registrations for use of methomyl on hop, dried
  cone, as of February 14, 1990.
\2\ Except for Beet (tops), broccoli, Brussels sprouts, cabbage,
  cabbage, Chinese, cauliflower, celery, collards, dandelions, endive
  (escarole), kale, lettuce, mustard greens, parsley, spinach, Swiss
  chard, turnip, greens (tops), and watercress.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. A tolerance with 
regional registration, as defined in Sec. 180.1(l), is established for 
residues of the insecticide methomyl, including its metabolites and 
degradates, in or on the commodity in the table in this paragraph. 
Compliance with the tolerance level specified in this paragraph is to be 
determined by measuring only methomyl, methyl N-[[(methylamino) 
carbonyl]oxy] ethani midothioate, in or on the commodity.
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33697, May 24, 2000, as amended at 72 FR 35666, June 29, 2007; 74 
FR 46373, Sept. 9, 2009; 75 FR 60242, Sept. 29, 2010; 76 FR 34885, June 
15, 2011; 77 FR 59125, Sept. 26, 2012]



Sec. 180.254  Carbofuran; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the insecticide carbofuran (2,3-dihydro-2,2-dimethyl-7-benzofuranyl-N-
methylcarbamate), its carbamate metabolite-2,3-dihydro-2,2-dimethyl-3-
hydroxy-7-benzofuranyl-N-methylcarbamate, and its phenolic metabolites 
2,3-dihydro-2,2-dimethyl-7-benzofuranol, 2,3-dihydro-2,2-dimethyl-3,-
oxo-7-benzofuranol and 2,3-dihydro-2,2-dimethyl-3,7-benzofurandiol in or 
on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                  Parts per  Expiration/
                    Commodity                      million    Revocation
                                                    (ppm)        date
------------------------------------------------------------------------
Alfalfa, forage (of which no more than 5 ppm are         10     12/31/09
 carbamates)....................................
Alfalfa, hay (of which no more than 20 ppm are           40     12/31/09
 carbamates)....................................
Banana..........................................        0.1     12/31/09
Barley, grain (of which not more than 0.1 ppm is        0.2     12/31/09
 carbamates)....................................
Barley, straw (of which no more than 1.0 ppm is         5.0     12/31/09
 carbamates)....................................
Beet, sugar, roots..............................        0.1     12/31/09
Beet, sugar, tops (of which no more than 1 ppm            2     12/31/09
 is carbamates).................................
Coffee, bean, green.............................        0.1     12/31/09
Corn, field, forage (of which no more than 5 ppm         25     12/31/09
 are carbamates)................................
Corn, field, grain (of which no more than 0.1           0.2     12/31/09
 ppm is carbamates).............................
Corn, field, stover (of which no more than 5 ppm         25     12/31/09
 are carbamates)................................
Corn, pop, grain (of which no more than 0.1 ppm         0.2     12/31/09
 is carbamates).................................
Corn, pop, stover (of which no more than 5 ppm           25     12/31/09
 are carbamates)................................
Corn, sweet, forage (of which no more than 5 ppm         25     12/31/09
 are carbamates)................................
Corn, sweet, kernel plus cob with husks removed         1.0     12/31/09
 (of which no more than 0.2 ppm is carbamates)..
Corn, sweet, stover (of which no more than 5 ppm         25     12/31/09
 is carbamates).................................
Cotton, undelinted seed (of which no more than          1.0     12/31/09
 0.2 ppm is carbamates).........................
Cranberry (of which no more than 0.3 ppm is             0.5     12/31/09
 carbamates)....................................
Cucumber (of which not more than 0.2 ppm is             0.4     12/31/09
 carbamates)....................................
Grape (of which no more than 0.2 ppm is                 0.4     12/31/09
 carbamates)....................................
Grape, raisin (of which no more than 1.0 ppm is         2.0     12/31/09
 carbamate......................................
Grape, raisin, waste (of which no more than 3.0         6.0     12/31/09
 ppm is carbamates..............................
Melon (of which not more than 0.2 ppm is                0.4     12/31/09
 carbamates)....................................
Milk (of which no more than 0.02 ppm is                 0.1     12/31/09
 carbamates)....................................
Oat, grain (of which not more than 0.1 ppm is           0.2     12/31/09
 carbamates)....................................
Oat, straw (of which not more than 1.0 ppm is           5.0     12/31/09
 carbamates)....................................
Pepper (of which no more than 0.2 ppm is                  1     12/31/09
 carbamates)....................................
Potato (of which no more than 1 ppm is                    2     12/31/09
 carbamates)....................................
Pumpkin (of which not more than 0.6 ppm is              0.8     12/31/09
 carbamates)....................................

[[Page 515]]

 
Rice, grain.....................................        0.2     12/31/09
Rice, straw (of which no more than 0.2 ppm is             1     12/31/09
 carbamates)....................................
Sorghum, forage (of which no more than 0.5 ppm            3     12/31/09
 is carbamates).................................
Sorghum, grain, grain...........................        0.1     12/31/09
Sorghum, grain, stover (of which no more than             3     12/31/09
 0.5 ppm is carbamates).........................
Strawberry (of which no more than 0.2 ppm is            0.5     12/31/09
 carbamates)....................................
Soybean (of which not more than 0.2 ppm is              1.0     12/31/09
 carbamates)....................................
Soybean, forage (of which not more than 20.0 ppm       35.0     12/31/09
 are carbamates)................................
Soybean, hay (of which not more than 20.0 ppm          35.0     12/31/09
 are carbamates)................................
Squash (of which not more than 0.6 ppm is               0.8     12/31/09
 carbamates)....................................
Sugarcane, cane.................................        0.1     12/31/09
Sunflower, seed (of which not more than 0.5 ppm         1.0     12/31/09
 is carbamates).................................
Wheat, grain (of which not more than 0.1 ppm is         0.2     12/31/09
 carbamates)....................................
Wheat, straw (of which not more than 1.0 ppm is         5.0     12/31/09
 carbamates)....................................
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registration. Tolerances with regional 
registration, as defined in Sec. 180.1(m), are established for the 
combined residues of the insecticide carbofuran (2,3-dihydro-2,2-
dimethyl-7-benzofuranyl-N-methylcarbamate), its carbamate metabolite 
2,3-dihydro-2,2-dimethyl-3-hydroxy-7-benzofuranyl-N-methylcarbamate, and 
its phenolic metabolites 2,3-dihydro-2,2-dimethyl-7-benzofuranol, 2,3-
dihydro-2,2-dimethyl-3-oxo-7-benzofuranol, and 2,3-dihydro-2,2-dimethyl-
3,7-benzofurandiol in or on the following raw agricultural commodity:

------------------------------------------------------------------------
                                                  Parts per  Expiration/
                    Commodity                      million    Revocation
                                                    (ppm)        date
------------------------------------------------------------------------
Artichoke, globe (of which not more than 0.2 ppm        0.4     12/31/09
 is carbamates).................................
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[39 FR 20597, June 12, 1974]

    Editorial Note: For Federal Register citations affecting Sec. 
180.254, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.257  Chloroneb; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide chloroneb, including its metabolites and degradates, in or on 
the commodities in the table in this paragraph. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only the sum of chloroneb, 1,4-dichloro-2,5-dimethoxybenzene, 
and its metabolite 2,5-dichloro-4-methoxyphenol (free and conjugated), 
calculated as the stoichiometric equivalent of chloroneb, in or on the 
commodity.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Bean, dry, seed.................................        0.2      4/16/12
Bean, succulent.................................        0.2      4/16/12
Beet, sugar, roots..............................        0.2      4/16/12
Beet, sugar, tops...............................        0.2      4/16/12
Cowpea, forage..................................        2.0      4/16/12
Cowpea, hay.....................................        2.0      4/16/12
Cattle, fat.....................................        0.2      4/16/12
Cattle, meat....................................        0.2      4/16/12
Cattle, meat byproducts.........................        0.2      4/16/12
Cotton, gin byproducts..........................        1.0      4/16/12
Cotton, undelinted seed.........................        0.2      4/16/12
Goat, fat.......................................        0.2      4/16/12
Goat, meat......................................        0.2      4/16/12
Goat, meat byproducts...........................        0.2      4/16/12
Hog, fat........................................        0.2      4/16/12
Hog, meat.......................................        0.2      4/16/12
Hog, meat byproducts............................        0.2      4/16/12
Horse, fat......................................        0.2      4/16/12
Horse, meat.....................................        0.2      4/16/12
Horse, meat byproducts..........................        0.2      4/16/12
Milk............................................       0.05      4/16/12
Sheep, fat......................................        0.2      4/16/12
Sheep, meat.....................................        0.2      4/16/12
Sheep, meat byproducts..........................        0.2      4/16/12
Soybean, forage.................................        2.0      4/16/12
Soybean, hay....................................        2.0      4/16/12
Soybean, seed...................................        0.2      4/16/12
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[68 FR 39440, July 1, 2003, as amended at 72 FR 53460, Sept. 19, 2007; 
76 FR 56654, Sept. 14, 2011]



Sec. 180.258  Ametryn; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
desiccant and herbicide (2-ethylamino)-4-

[[Page 516]]

(isopropylamino)-6-(methylthio)-s-triazine in or on the following raw 
agricultural commodities:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   Revocation
                                                   million       Date
------------------------------------------------------------------------
Banana..........................................       0.25      6/16/10
Corn, field, forage.............................        0.1         None
Corn, field, grain..............................       0.05         None
Corn, field, stover.............................       0.05         None
Corn, pop, grain................................       0.05         None
Corn, pop, stover...............................       0.05         None
Corn, sweet, forage.............................        0.5      6/16/10
Corn, sweet, kernel plus cob with husks removed.       0.25      6/16/10
Corn, sweet, stover.............................        0.5      6/16/10
Pineapple.......................................       0.05         None
Sugarcane, cane.................................       0.05         None
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[43 FR 29121, July 6, 1978, as amended at 48 FR 13175, Mar. 30, 1983; 48 
FR 21132, May 11, 1983; 52 FR 33237, Sept. 2, 1987; 63 FR 57075, Oct. 
26, 1998; 73 FR 54961, Sept. 24, 2008; 74 FR 47456, Sept. 16, 2009]



Sec. 180.259  Propargite; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
pesticide propargite (2-(p-tert-butylphenoxy) cyclohexyl 2-propynyl 
sulfite) in or on the following food commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond......................................................        0.1
Almond, hulls...............................................       55.0
Bean, dry, seed.............................................        0.2
Cattle, fat.................................................        0.1
Cattle, meat................................................        0.1
Cattle, meat byproducts.....................................        0.1
Citrus, oil.................................................       30.0
Corn, field, forage.........................................       10.0
Corn, field, grain..........................................        0.1
Corn, field, stover.........................................       10.0
Corn, pop, grain............................................        0.1
Corn, pop, stover...........................................       10.0
Corn, sweet, forage.........................................       10.0
Corn, sweet, stover.........................................       10.0
Cotton, undelinted seed.....................................        0.1
Egg.........................................................        0.1
Goat, fat...................................................        0.1
Goat, meat..................................................        0.1
Goat, meat byproducts.......................................        0.1
Grain, aspirated fractions..................................        0.4
Grape.......................................................       10.0
Grapefruit..................................................        5.0
Hog, fat....................................................        0.1
Hog, meat...................................................        0.1
Hog, meat byproducts........................................        0.1
Hop, dried cones............................................      100.0
Horse, fat..................................................        0.1
Horse, meat.................................................        0.1
Horse, meat byproducts......................................        0.1
Lemon.......................................................        5.0
Milk, fat (0.08 ppm in milk)................................        2.0
Nectarine...................................................        4.0
Orange......................................................       10.0
Peanut......................................................        0.1
Peppermint, tops............................................       50.0
Poultry, fat................................................        0.1
Potato......................................................        0.1
Sheep, fat..................................................        0.1
Sheep, meat.................................................        0.1
Sheep, meat byproducts......................................        0.1
Sorghum, grain, forage......................................       10.0
Sorghum, grain, grain.......................................        5.0
Sorghum, grain, stover......................................       10.0
Spearmint, tops.............................................       50.0
Tea, dried..................................................       10.0
Walnut......................................................        0.1
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration, as defined in Sec. 180.1(l), are established for residues 
of propargite in or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Corn, sweet, kernel plus cob with husks removed.............        0.1
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33710, May 24, 2000, as amended at 72 FR 41930, Aug. 1, 2007; 73 
FR 54961, Sept. 24, 2008; 76 FR 34885, June 15, 2011]



Sec. 180.261  Phosmet; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide phosmet, N-(mercaptomethyl) phthalimide S-(O,O-dimethyl 
phosphorodithioate), including its metabolites and degradates, in or on 
the commodities in the following table. Compliance with the tolerance 
levels specified in this paragraph is to be determined by measuring only 
the sum of phosmet, N-(mercaptomethyl) phthalimide S-(O,O-dimethyl 
phosphorodithioate), and its oxygen analog, N-(mercaptomethyl) 
phthalimide S-(O,O-dimethyl phosphorothioate, calculated as the 
stoichiometric equivalent of phosmet, in or on the commodity.

[[Page 517]]



------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................       20
Alfalfa, hay................................................       40
Almond, hulls...............................................       10
Apple.......................................................       10
Apricot.....................................................        5
Blueberry...................................................       10
Cattle, fat.................................................        0.2
Cattle, meat................................................        0.1
Cattle, meat byproducts.....................................        0.1
Cherry......................................................       10
Cranberry...................................................       10
Fruit, citrus, group 10.....................................        5
Goat, fat...................................................        0.1
Goat, meat..................................................        0.1
Goat, meat byproducts.......................................        0.1
Grape.......................................................       10
Hog, fat....................................................        0.2
Hog, meat...................................................        0.04
Hog, meat byproducts........................................        0.04
Horse, fat..................................................        0.1
Horse, meat.................................................        0.1
Horse, meat byproducts......................................        0.1
Kiwifruit...................................................       25
Milk........................................................        0.1
Nectarine...................................................        5
Nut, tree, group 14.........................................        0.1
Pea, dry, seed..............................................        0.5
Pea, field, hay.............................................       20
Pea, field, vines...........................................       10
Pea, succulent..............................................        1
Peach.......................................................       10
Pear........................................................       10
Plum, prune, fresh..........................................        5
Potato......................................................        0.1
Sheep, fat..................................................        0.1
Sheep, meat.................................................        0.1
Sheep, meat byproducts......................................        0.1
Sweet potato, roots.........................................       12
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration are established for residues of the insecticide phosmet, N-
(mercaptomethyl) phthalimide S-(O,O-dimethyl phosphorodithioate), 
including its metabolites and degradates, in or on the commodities in 
the following table. Compliance with the tolerance levels specified in 
this paragraph is to be determined by measuring only the sum of phosmet, 
N-(mercaptomethyl) phthalimide S-(O,O-dimethyl phosphorodithioate), and 
its oxygen analog, N-(mercaptomethyl) phthalimide S-(O,O-dimethyl 
phosphorothioate, calculated as the stoichiometric equivalent of 
phosmet, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Crabapple...................................................       20
Pistachio...................................................        0.1
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[43 FR 46538, Oct. 10, 1978, as amended at 45 FR 8981, Feb. 11, 1980; 48 
FR 37213, Aug. 17, 1983; 52 FR 48539, Dec. 23, 1987; 53 FR 657, Jan. 11, 
1988; 53 FR 39090, Oct. 5, 1988; 63 FR 57075, Oct. 26, 1998; 67 FR 
49616, July 31, 2002; 74 FR 46698, Sept. 11, 2009; 75 FR 60242, Sept. 
29, 2010]



Sec. 180.262  Ethoprop; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
nematocide and insecticide ethoprop, O-ethyl S,S-dipropyl 
phosphorodithioate, including its metabolites and degradates, in or on 
the commodities in the following table. Compliance with the tolerance 
levels specified in this paragraph is to be determined by measuring only 
ethoprop, O-ethyl S,S-dipropyl phosphorodithioate, in or on the 
commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Banana......................................................        0.02
Bean, lima..................................................        0.02
Bean, snap, succulent.......................................        0.02
Cabbage.....................................................        0.02
Corn, field, forage.........................................        0.02
Corn, field, grain..........................................        0.02
Corn, field, stover.........................................        0.02
Corn, sweet, forage.........................................        0.02
Corn, sweet, kernel plus cob with husks removed.............        0.02
Corn, sweet, stover.........................................        0.02
Cucumber....................................................        0.02
Hop, dried cones............................................        0.02
Peppermint, tops............................................        0.02
Pineapple\1\................................................        0.02
Potato......................................................        0.02
Spearmint, tops.............................................        0.02
Sugarcane, cane.............................................        0.02
Sweet potato, roots.........................................        0.02
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of July 23, 2009, except for
  existing stocks bearing old labeling whose sale, distribution, and use
  is allowed, provided it is consistent with the terms of the
  cancellation order of July 9, 2009; i.e., the EPA will allow the
  technical registrant to continue to sell and distribute existing
  stocks of the amended registered product bearing old labeling for use
  on pineapple for 18 months (until January 9, 2011) and persons other
  than the registrant may continue to sell and/or use existing stocks of
  product bearing the old labeling until such stocks are exhausted,
  provided that such use is consistent with the terms of the previously
  approved labeling on, or that accompanied, the modified product.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]

[[Page 518]]

    (d) Indirect or inadvertent residues. [Reserved]

[47 FR 53004, Nov. 24, 1982, as amended at 48 FR 51485, Nov. 9, 1983; 52 
FR 33237, Sept. 2, 1987; 53 FR 30053, Aug. 10, 1988; 63 FR 57075, Oct. 
26, 1998; 64 FR 39078, July 21, 1999; 66 FR 38955, July 26, 2001; 67 FR 
49616, July 31, 2002; 73 FR 53731, Sept. 17, 2008; 73 FR 54961, Sept. 
24, 2008; 74 FR 46373, Sept. 9, 2009; 75 FR 60242, Sept. 29, 2010]



Sec. 180.263  Phosalone; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide phosalone, S-(6-chloro-3-(mercaptomethyl)-2-benzoxazolinone) 
O,O-diethyl phosphorodithioate, in or on the following food commodities:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   Revocation
                                                   million       Date
------------------------------------------------------------------------
Apple\1\........................................       10.0      9/30/13
Cherry\1\.......................................       15.0      9/30/13
Grape\1\........................................       10.0      9/30/13
Peach\1\........................................       15.0      9/30/13
Pear\1\.........................................       10.0      9/30/13
Plum, prune, fresh\1\...........................       15.0      9/30/13
------------------------------------------------------------------------
\1\There are no U.S. registrations since 1992.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[74 FR 46698, Sept. 11, 2009]



Sec. 180.269  Aldicarb; tolerances for residues.

    (a) General. Tolerances are established for combined residues of the 
insecticide and nematocide aldicarb (2-methyl-2-
(methylthio)propionaldehyde O-(methylcarbamoyl) oxime and its 
cholinesterase-inhibiting metabolites 2-methyl 2-(methylsulfinyl) 
propionaldehyde O-(methylcarbamoyl) oxime and 2-methyl-2-
(methylsulfonyl) propionaldehyde O-(methylcarbamoyl) oxime in or on the 
following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Bean, dry, seed.............................................        0.1
Beet, sugar, roots..........................................        0.05
Beet, sugar, tops...........................................        1
Citrus, dried pulp..........................................        0.6
Coffee, bean, green.........................................        0.1
Cotton, undelinted seed.....................................        0.1
Cotton, hulls...............................................        0.3
Grapefruit..................................................        0.3
Lemon.......................................................        0.3
Lime........................................................        0.3
Orange, sweet...............................................        0.3
Peanut......................................................        0.05
Pecan.......................................................        0.5
Potato......................................................        1
Sorghum, grain, bran........................................        0.5
Sorghum, grain, grain.......................................        0.2
Sorghum, grain, stover......................................        0.5
Soybean.....................................................        0.02
Sugarcane, cane.............................................        0.02
Sweet potato, roots.........................................        0.1
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33710, May 24, 2000, as amended at 69 FR 6567, Feb. 11, 2004; 73 
FR 54961, Sept. 24, 2008]



Sec. 180.272  Tribuphos; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
defoliant tribuphos (S,S,S-tributyl phosphorotrithioate) in or on food 
commodities as follows:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.15
Cattle, meat................................................        0.02
Cattle, meat byproducts.....................................        0.02
Cotton, gin byproducts......................................       40.0
Cotton, undelinted seed.....................................        4.0
Goat, fat...................................................        0.15
Goat, meat..................................................        0.02
Goat, meat byproducts.......................................        0.02
Hog, fat....................................................        0.15
Hog, meat...................................................        0.02
Hog, meat byproducts........................................        0.02
Horse, fat..................................................        0.15
Horse, meat.................................................        0.02
Horse, meat byproducts......................................        0.02
Milk........................................................        0.01
Sheep, fat..................................................        0.15
Sheep, meat.................................................        0.02
Sheep, meat byproducts......................................        0.02
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33698, May 24, 2000, as amended at 67 FR 49616, July 31, 2002; 72 
FR 53460, Sept. 19, 2007]

[[Page 519]]



Sec. 180.274  Propanil; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the herbicide propanil (3[min], 4[min]-dichloropropionanilide) and its 
metabolites convertible to 3, 4-dichloroaniline (3, 4-DCA) in or on the 
following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.10
Cattle, meat................................................        0.05
Cattle, meat byproducts.....................................        1.0
Crayfish....................................................        0.05
Egg.........................................................        0.30
Goat, fat...................................................        0.10
Goat, meat..................................................        0.05
Goat, meat byproducts.......................................        1.0
Hog, fat....................................................        0.10
Hog, meat...................................................        0.05
Hog, meat byproducts........................................        1.0
Horse, fat..................................................        0.10
Horse, meat.................................................        0.05
Horse, meat byproducts......................................        1.0
Milk........................................................        0.05
Poultry, fat................................................        0.05
Poultry, meat...............................................        0.10
Poultry, meat byproducts....................................        0.50
Rice, bran..................................................       40
Rice, grain.................................................       10
Rice, hulls.................................................       30
Rice, straw.................................................       75
Sheep, fat..................................................        0.10
Sheep, meat.................................................        0.05
Sheep, meat byproducts......................................        1.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 34827, June 26, 1998, as amended at 72 FR 28888, May 23, 2007]



Sec. 180.275  Chlorothalonil; tolerances for residues.

    (a) General. (1) Tolerances are established for the fungicide 
chlorothalonil (tetrachloroisophthalonitrile) and its metabolite 4-
hydroxy-2,5,6-trichloroisophthalonitrile in or on the following food 
commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond......................................................        0.05
Almond, hulls...............................................        1.0
Apricot.....................................................        0.5
Asparagus...................................................        0.1
Banana (NMT 0.05 ppm in edible pulp)........................        0.5
Bean, dry, seed.............................................        0.1
Bean, snap, succulent.......................................        5
Blueberry...................................................        1.0
Brassica, head and stem, subgroup 5A........................        5.0
Carrot, roots...............................................        1
Celery......................................................       15
Cherry, sweet...............................................        0.5
Cherry, tart................................................        0.5
Cocoa bean, dried bean......................................        0.05
Coffee, bean, green.........................................        0.20
Corn, sweet, kernel plus cob with husks removed.............        1
Cranberry...................................................        5.0
Ginseng.....................................................        4.0
Horseradish.................................................        4.0
Lentil......................................................        0.10
Lychee......................................................       15
Mango.......................................................        1.0
Mushroom....................................................        1.0
Nectarine...................................................        0.5
Okra........................................................        6.0
Onion, bulb.................................................        0.5
Onion, green................................................        5
Papaya......................................................       15
Parsnip, roots..............................................        1
Passionfruit................................................        3
Pea, edible podded..........................................        5
Peach.......................................................        0.5
Peanut......................................................        0.3
Pistachio...................................................        0.2
Plum........................................................        0.2
Plum, prune.................................................        0.2
Potato......................................................        0.1
Rhubarb.....................................................        4.0
Soybean.....................................................        0.2
Starfruit...................................................        3.0
Tomato......................................................        5
Vegetable, cucurbit, group 9................................        5.0
Vegetable, fruiting, group 8, except tomato.................        6.0
Yam, true...................................................        0.10
------------------------------------------------------------------------

    (2) Tolerances are established for the metabolite 4-hydroxy-2,5,6-
trichloroisophthalonitrile in or on the following food commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.1
Cattle, kidney..............................................        0.5
Cattle, meat byproducts, except kidney......................        0.05
Cattle, meat................................................        0.03
Goat, fat...................................................        0.1
Goat, kidney................................................        0.5
Goat, meat byproducts, except kidney........................        0.05
Goat, meat..................................................        0.03
Hog, fat....................................................        0.1
Hog, kidney.................................................        0.5
Hog, meat byproducts, except kidney.........................        0.05
Hog, meat...................................................        0.03
Horse, fat..................................................        0.1
Horse, kidney...............................................        0.5
Horse, meat byproducts, except kidney.......................        0.05
Horse, meat.................................................        0.03
Milk........................................................        0.1
Sheep, fat..................................................        0.1
Sheep, kidney...............................................        0.5
Sheep, meat byproducts, except kidney.......................        0.05
Sheep, meat.................................................        0.03
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]

[[Page 520]]

    (c) Tolerances with regional registrations. Tolerances with regional 
registration, as defined in Sec. 180.1(l), are established for the 
combined residues of chlorothalonil and its metabolite in or on the 
following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Hazelnut....................................................        0.1
Peppermint, tops............................................        2
Persimmon...................................................        1.5
Spearmint, tops.............................................        2
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[42 FR 56114, Oct. 21, 1977]

    Editorial Note: For Federal Register citations affecting Sec. 
180.275, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.276  Formetanate hydrochloride; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide formetanate hydrochloride, including its metabolites and 
degradates, in or on the commodities in the table in this paragraph. 
Compliance with the tolerance levels specified in this paragraph is to 
be determined by measuring only formetanate hydrochloride, N,N-dimethyl-
N'-[3-[(methylamino) carbonyl] oxy]phenyl]methani midamide 
hydrochloride, in or on the commodity.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                    million      date
------------------------------------------------------------------------
Apple...........................................       0.50     12/31/13
Apple, wet pomace...............................        1.5     12/31/13
Grapefruit......................................        1.5         None
Lemon...........................................       0.60         None
Lime............................................       0.03         None
Nectarine.......................................       0.40         None
Orange..........................................        1.5         None
Peach...........................................       0.40     12/31/13
Pear............................................       0.50     12/31/13
Tangelo.........................................       0.03         None
Tangerine.......................................       0.03         None
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[77 FR 40815, July 11, 2012]



Sec. 180.278  Phenmedipham; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the herbicide phenmedipham (3-methoxycarbonylaminophenyl-3[min]-
methylcarbanilate) in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Beet, garden, roots.........................................        0.2
Beet, garden, tops..........................................        0.2
Beet, sugar, dried pulp.....................................        0.5
Beet, sugar, molasses.......................................        0.2
Beet, sugar, roots..........................................        0.1
Beet, sugar, tops...........................................        0.1
Spinach.....................................................        4.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[72 FR 28888, May 23, 2007]



Sec. 180.284  Zinc phosphide; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
phosphine resulting from the use of the rodenticide zinc phosphide in or 
on the raw agricultural commodities as follows:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        0.2
Alfalfa, hay................................................        0.2
Barley, grain...............................................        0.05
Barley, hay.................................................        0.2
Barley, straw...............................................        0.2
Bean, dry, seed.............................................        0.05
Beet, sugar, roots..........................................        0.05
Beet, sugar, tops...........................................        0.2
Grape.......................................................        0.01
Grass, rangeland, forage....................................        0.1
Grass, rangeland, hay.......................................        0.1
Potato......................................................        0.05
Sugarcane, cane.............................................        0.01
Timothy, hay................................................        0.5
Timothy, forage.............................................        0.5
Wheat, forage...............................................        0.05
Wheat, grain................................................        0.05
Wheat, hay..................................................        0.05
Wheat, straw................................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration, as defined in Sec. 180.1(l), are established for residues 
of phosphine resulting from the use of the rodenticide zinc phosphide in 
or on the following

[[Page 521]]

raw agricultural commodities as follows:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Artichoke, globe............................................        0.01
Beet, sugar, roots..........................................        0.04
Beet, sugar, tops...........................................        0.02
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 45182, Aug. 25, 1998, as amended at 63 FR 67799, Dec. 9, 1998; 64 
FR 40772, July 28, 1999; 64 FR 61791, Nov. 15, 1999; 65 FR 8874, Feb. 
23, 2000; 65 FR 49941, Aug. 16, 2000; 65 FR 62634, Oct. 19, 2000; 66 FR 
64773, Dec. 14, 2001; 68 FR 2247, Jan. 16, 2003; 68 FR 56195, Sept. 30, 
2003; 70 FR 7046, Feb. 10, 2005; 74 FR 46373, Sept. 9, 2009; 76 FR 
34885, June 15, 2011]



Sec. 180.287  Amitraz; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide amitraz (N'-[2,4-dimethylphenyl]-N-[[(2,4-
dimethylphenyl)imino]methyl]]-N-methylmethanimidamide), including its 
metabolites and degradates, in or on the commodities in the following 
table. Compliance with the tolerance levels specified is to be 
determined by measuring amitraz residues convertible to 2,4-
dimethylaniline, expressed as the stoichiometric equivalent of amitraz, 
in or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.1
Cattle, meat................................................        0.02
Cattle, meat byproducts.....................................        0.2
Cotton, undelinted seed \1\.................................        1.0
Hog, fat....................................................        0.1
Hog, kidney.................................................        0.1
Hog, liver..................................................        0.1
Hog, meat...................................................        0.05
Hog, meat byproducts........................................        0.3
Honey.......................................................        0.2
Honeycomb...................................................        9
Milk........................................................        0.03
Milk, fat...................................................        0.2
------------------------------------------------------------------------
\1\There are no U.S. registrations on cottonseed as of May 3, 2006.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[44 FR 70145, Dec. 6, 1979, as amended at 51 FR 16846, May 7, 1986; 52 
FR 5767, Feb. 26, 1987; 57 FR 53568, Nov. 12, 1992; 58 FR 14316, Mar. 
17, 1993; 60 FR 12704, Mar. 8, 1995; 67 FR 49616, July 31, 2002; 72 FR 
53454, Sept. 19, 2007; 74 FR 47456, Sept. 16, 2009; 78 FR 17133, Mar. 
20, 2013]



Sec. 180.288  2-(Thiocyanomethyl thio)benzothiazole; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide 2-(thiocyanomethylthio)benzothiazole in or on the following 
food commodities:

------------------------------------------------------------------------
                                                                  Parts
                           Commodity                               per
                                                                 million
------------------------------------------------------------------------
Barley, grain.................................................   0.1(N)
Barley, straw.................................................   0.1(N)
Beet, sugar, roots............................................   0.1(N)
Beet, sugar, tops.............................................   0.1(N)
Corn, field, forage...........................................   0.1(N)
Corn, field, grain............................................   0.1
Corn, field, stover...........................................   0.1
Corn, pop, grain..............................................   0.1
Corn, pop, stover.............................................   0.1
Cotton, forage................................................   0.1(N)
Cotton, undelinted seed.......................................   0.1(N)
Oat, forage...................................................   0.1(N)
Oat, grain....................................................   0.1(N)
Oat, hay......................................................   0.1(N)
Oat, straw....................................................   0.1(N)
Rice, grain...................................................   0.1(N)
Rice, straw...................................................   0.1(N)
Safflower, seed...............................................   0.1(N)
Sorghum, grain, forage........................................   0.1(N)
Sorghum, grain, grain.........................................   0.1(N)
Sorghum, grain, stover........................................   0.1(N)
Wheat, forage.................................................   0.1(N)
Wheat, grain..................................................   0.1(N)
Wheat, hay....................................................   0.1(N)
Wheat, straw..................................................   0.1(N)
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[68 FR 39440, July 1, 2003, as amended at 74 FR 46374, Sept. 9, 2009]



Sec. 180.289  Methanearsonic acid; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide methanearsonic acid, including its metabolites and degradates, 
in or on the commodities in the table in this paragraph. Compliance with 
the tolerance levels specified in this paragraph is to be determined by 
measuring only

[[Page 522]]

methanearsonic acid, from application of the disodium and monosodium 
salts of methanearsonic acid, calculated as the stoichiometric 
equivalent of As2O3, in or on the commodity.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   Revocation
                                                   million       Date
------------------------------------------------------------------------
Cotton, undelinted seed.........................        0.7         None
Cotton, hulls...................................        0.9         None
Fruit, citrus...................................       0.35     12/31/12
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 34828, June 26, 1998, as amended at 77 FR 59126, Sept. 26, 2012]



Sec. 180.291  Pentachloronitrobenzene; tolerance for residues.

    (a) General. Tolerances are established for the combined residues of 
the fungicide pentachloronitrobenzene (PCNB) and its metabolites 
pentachloroaniline (PCA), and pentachlorothioanisole (PCTA), in or on 
the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Bean........................................................        0.1
Brassica, head and stem, subgroup 5A........................        0.1
Cotton, undelinted seed.....................................        0.1
Garlic, bulb................................................        0.1
Peanut......................................................        1.0
Potato......................................................        0.1
Soybean, forage.............................................        0.02
Soybean, hay................................................        0.02
Soybean, seed...............................................        0.02
Vegetable, fruiting, group 8................................        0.1
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registrations, as defined in Sec. 180.1(l), are established for the 
combined residues of the fungicide pentachloronitrobenzene (PCNB) and 
its metabolites pentachloroaniline (PCA), and pentachlorothioanisole 
(PCTA), in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Collards....................................................        0.2
Kale........................................................        0.2
Mustard, greens.............................................        0.2
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[74 FR 47456, Sept. 16, 2009]



Sec. 180.292  Picloram; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide picloram, 4-amino-3,5,6-trichloropicolinic acid, including its 
metabolites and degradates, in or on the commodities in the following 
table from its application in the acid form or in the form of its salts. 
Compliance with the tolerance levels specified in this paragraph is to 
be determined by measuring only picloram, 4-amino-3,5,6-
trichloropicolinic acid, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, grain...............................................        0.5
Barley, pearled barley......................................        3.0
Barley, straw...............................................        1.0
Cattle, fat.................................................        0.4
Cattle, meat................................................        0.4
Cattle, meat byproducts.....................................       15
Egg.........................................................        0.05
Goat, fat...................................................        0.4
Goat, meat..................................................        0.4
Goat, meat byproducts.......................................       15
Grain, aspirated fractions..................................        4.0
Grass, forage...............................................      400
Grass, hay..................................................      225
Hog, fat....................................................        0.05
Hog, meat...................................................        0.05
Hog, meat byproducts........................................        0.05
Horse, fat..................................................        0.4
Horse, meat.................................................        0.4
Horse, meat byproducts......................................       15
Milk........................................................        0.25
Oat, forage.................................................        1.0
Oat, grain..................................................        0.5
Oat, groats/rolled oats.....................................        3.0
Oat, straw..................................................        1.0
Poultry, fat................................................        0.05
Poultry, meat...............................................        0.05
Poultry, meat byproducts....................................        0.05
Sheep, fat..................................................        0.4
Sheep, meat.................................................        0.4
Sheep, meat byproducts......................................       15
Wheat, bran.................................................        3.0
Wheat, forage...............................................        1.0
Wheat, germ.................................................        3.0
Wheat, grain................................................        0.5
Wheat, middlings............................................        3.0
Wheat, shorts...............................................        3.0
Wheat, straw................................................        1.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]

[[Page 523]]

    (d) Indirect or inadvertent residues. [Reserved]

[41 FR 19221, May 11, 1976, as amended at 47 FR 53005, Nov. 24, 1982; 64 
FR 425, Jan. 5, 1999; 64 FR 39082, July 21, 1999; 72 FR 41930, Aug. 1, 
2007; 75 FR 60243, Sept. 29, 2010]



Sec. 180.293  Endothall; tolerances for residues.

    (a) General. (1) Tolerances are established for the combined 
residues of endothall, 7-oxabicyclo [2, 2, 1] heptane-2, 3-dicarboxylic 
acid and its monomethyl ester in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cotton, undelinted seed.....................................        0.1
Fish........................................................        0.1
Hop, dried cones............................................        0.1
Potato......................................................        0.1
Rice, grain.................................................        0.05
Rice, straw.................................................        0.05
------------------------------------------------------------------------

    (2) An interim tolerance of 0.2 parts per million is established for 
residues of the herbicide endothall (7 - oxabicyclo[2.2.1] heptane-2,3-
dicarboxylic acid) in water, potable from use of its potassium, sodium, 
di-N, N-dimethylalkylamine, and mono-N-N,-dimethylalkylamine salts as 
algicides or herbicides to control aquatic plants in canals, lakes, 
ponds, and other potential sources of water, potable.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established for 
the indirect or inadvertent combined residues of the herbicide, 
endothall (7 - oxabicyclo[2.2.1] heptane-2,3-dicarboxylic acid) in 
potable water from use of its potassium, sodium, di-N, N -
dimethylalkylamine, and mono- N-N, -dimethylalkylamine salts as 
algicides or herbicides to control aquatic plants in canals, lakes, 
ponds, and other potable water sources that may lead to endothall 
residues in or on the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hulls..............................................       15.0
Animal feed, nongrass, group 18, forage....................        4.0
Animal feed, nongrass, group 18, hay.......................       10
Apple, wet pomace..........................................        0.15
Beet, sugar, molasses......................................        1.5
Brassica, head and stem subgroup 5A........................        0.1
Brassica, leafy, subgroup 5B...............................        2.0
Bushberry subgroup 13-07B..................................        0.6
Caneberry subgroup 13-07A..................................        0.6
Cattle, fat................................................        0.01
Cattle, kidney.............................................        0.20
Cattle, liver..............................................        0.10
Cattle, meat...............................................        0.03
Corn, field, grain.........................................        0.07
Corn, pop, grain...........................................        0.07
Corn, sweet, kernel plus cob with husks removed............        0.3
Citrus, dried pulp.........................................        0.1
Egg........................................................        0.05
Feed commodities not otherwise listed......................       10.0
Food commodities not otherwise listed......................        5.0
Fruit, citrus group 10.....................................        0.05
Fruit, pome, group 11......................................        0.05
Fruit, stone, group 12.....................................        0.3
Goat, fat..................................................        0.005
Goat, kidney...............................................        0.15
Goat, liver................................................        0.05
Goat, meat.................................................        0.015
Grain, aspirated fractions.................................       35.0
Grain cereal, forage, fodder and straw, group 16...........       10.0
Grain, cereal, group 15, except corn.......................        4.0
Grape......................................................        1.0
Grape, raisin..............................................        5.0
Grass, forage, fodder, and hay group 17, forage............        3.5
Grass, forage, fodder, and hay group 17, hay...............       18.0
Herb and spice, group 19...................................        5.0
Hog, fat...................................................        0.005
Hog, kidney................................................        0.10
Hog, liver.................................................        0.05
Hog, meat..................................................        0.01
Milk.......................................................        0.03
Nut, tree, group 14........................................        0.05
Okra.......................................................        0.05
Pea and bean, dried shelled, subgroup 6C...................        0.2
Pea and bean, succulent shelled, subgroup 6B...............        2.0
Peppermint, tops...........................................        5.0
Pistachio..................................................        0.05
Poultry, fat...............................................        0.015
Poultry, liver.............................................        0.05
Poultry, meat..............................................        0.015
Poultry, meat byproducts...................................        0.20
Rice, hulls................................................        8.0
Sheep, fat.................................................        0.005
Sheep, kidney..............................................        0.15
Sheep, liver...............................................        0.05
Sheep, meat................................................        0.015
Soybean, hulls.............................................        0.5
Soybean, seed..............................................        0.2
Spearmint, tops............................................        5.0
Tomato, paste..............................................        0.1
Tomato, puree..............................................        0.1
Vegetable, bulb, group 3-07................................        0.5
Vegetable, cucurbit, group 9...............................        1.5
Vegetable, foliage of legume, group 7......................        4.0
Vegetable, fruiting, group 8...............................        0.05
Vegetable, leafy, except brassica, group 4.................        2.0
Vegetable, leaves of root and tuber, group 2...............        3.0
Vegetable, legume, edible, podded, subgroup 6A.............        2.0
Vegetable, root and tuber, group 1.........................        1.0
Wheat, milled byproducts...................................        5.0
------------------------------------------------------------------------


[[Page 524]]


[41 FR 23717, June 11, 1976, as amended at 51 FR 4498, Feb. 5, 1986; 62 
FR 49931, Sept. 24, 1997; 63 FR 42249, Aug. 7, 1998; 67 FR 35048, May 
17, 2002; 71 FR 47106, Aug. 16, 2006; 71 FR 74816, Dec. 13, 2006; 72 FR 
52018, Sept. 12, 2007; 74 FR 67097, Dec. 18, 2009]



Sec. 180.297  N-1-Naphthyl phthalamic acid; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide N-1-naphthyl phthalamic acid from application of its sodium 
salt in or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cantaloupe...................................................   0.1(N)
Cucumber.....................................................   0.1(N)
Muskmelon....................................................   0.1(N)
Watermelon...................................................   0.1(N)
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[45 FR 32306, May 16, 1980, as amended at 63 FR 57075, Oct. 26, 1998]



Sec. 180.298  Methidathion; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide methidathion, including its metabolites and degradates, in 
or on the commodities in the table in this paragraph. Compliance with 
the tolerance levels specified in this paragraph is to be determined by 
measuring only methidathion, S-[(5-methoxy-2-oxo-1,3,4-thiadiazol-3(2H)-
yl)methyl] O,O-dimethyl phosphorodithioate, in or on the commodity.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Almond, hulls...................................        6.0     12/31/16
Artichoke, globe................................       0.05     12/31/16
Citrus, oil.....................................      420.0     12/31/16
Cotton, undelinted seed.........................        0.2     12/31/16
Fruit, citrus, group 10, except tangerine.......        4.0     12/31/16
Fruit, pome, group 11...........................       0.05     12/31/16
Fruit, stone, group 12..........................       0.05     12/31/16
Mango...........................................       0.05     12/31/16
Nut, tree, group 14.............................       0.05     12/31/16
Olive...........................................       0.05     12/31/16
Safflower, seed.................................        0.5     12/31/16
Sorghum, forage, forage.........................        2.0     12/31/16
Sorghum, grain, forage..........................        2.0     12/31/16
Sorghum, grain, grain...........................        0.2     12/31/16
Sorghum, grain, stover..........................        2.0     12/31/16
Sunflower, seed.................................        0.5     12/31/16
Tangerine.......................................        6.0     12/31/16
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration, as defined in Sec. 180.1(l), are established for residues 
of the insecticide methidathion, including its metabolites and 
degradates, in or on the commodities in the table in this paragraph. 
Compliance with the tolerance levels specified in this paragraph is to 
be determined by measuring only methidathion, S-[(5-methoxy-2-oxo-1,3,4-
thiadiazol-3(2H)-yl)methyl] O,O-dimethyl phosphorodithioate, in or on 
the commodity.

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per   revocation
                                                  million       date
------------------------------------------------------------------------
Kiwifruit.....................................         0.1      12/31/16
Longan........................................         0.1      12/31/16
Starfruit.....................................         0.1      12/31/16
Sugar apple...................................         0.2      12/31/16
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[43 FR 44845, Sept. 29, 1978]

    Editorial Note: For Federal Register citations affecting Sec. 
180.298, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.299  Dicrotophos; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide dicrotophos, dimethyl phosphate of 3-hydroxy-N,N-dimethyl-
cis-crotonamide, in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cotton, gin byproducts......................................        2.0
Cotton, undelinted seed.....................................        0.2
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]

[[Page 525]]

    (d) Indirect or inadvertent residues. [Reserved]

[73 FR 52613, Sept. 10, 2008]



Sec. 180.300  Ethephon; tolerances for residues.

    (a) General. Tolerances are established for residues of the plant 
regulator ethephon [(2-chloroethyl) phosphonic acid] in or on food 
commodities as follows:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Apple......................................................        5.0
Apple, juice...............................................       10.0
Barley, bran...............................................        5.0
Barley, grain..............................................        2.0
Barley, straw..............................................       10.0
Blackberry.................................................       30.0
Blueberry..................................................       20.0
Cantaloupe.................................................        2.0
Cattle, fat................................................        0.02
Cattle, kidney.............................................        1.0
Cattle, meat...............................................        0.02
Cattle, meat byproducts, except kidney.....................        0.2
Cherry.....................................................       10.0
Coffee, bean, green........................................        0.5
Cotton, gin byproducts.....................................      180.0
Cotton, undelinted seed....................................        6.0
Cucumber...................................................        0.1
Egg........................................................        0.002
Goat, fat..................................................        0.02
Goat, kidney...............................................        1.0
Goat, meat.................................................        0.02
Goat, meat byproducts, except kidney.......................        0.2
Grape......................................................        2.0
Grape, raisin..............................................       12.0
Hazelnut...................................................        0.80
Hog, fat...................................................        0.02
Hog, kidney................................................        1.0
Hog, meat..................................................        0.02
Hog, meat byproducts, except kidney........................        0.2
Horse, fat.................................................        0.02
Horse, kidney..............................................        1.0
Horse, meat................................................        0.02
Horse, meat byproducts, except kidney......................        0.2
Milk.......................................................        0.01
Nut, macadamia.............................................        0.5
Pepper.....................................................       30.0
Pineapple..................................................        2.0
Poultry, fat...............................................        0.02
Poultry, liver.............................................        0.05
Poultry, meat..............................................        0.01
Poultry, meat byproducts, except liver.....................        0.01
Sheep, fat.................................................        0.02
Sheep, kidney..............................................        1.0
Sheep, meat................................................        0.02
Sheep, meat byproducts, except kidney......................        0.2
Sugarcane, molasses........................................        1.5
Tomato.....................................................        2.0
Walnut.....................................................        0.5
Wheat, bran................................................        5.0
Wheat, germ................................................        5.0
Wheat, grain...............................................        2.0
Wheat, middlings...........................................        5.0
Wheat, shorts..............................................        5.0
Wheat, straw...............................................       10.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. A tolerance with 
regional registration, as defined in Sec. 180.1(m), of 0.1 part per 
million is established for residues of the plant regulator ethephon [(2-
chloroethyl)phosphonic acid] in or on the food commodity sugarcane.
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33710, May 24, 2000, as amended at 72 FR 53455, Sept. 19, 2007; 
75 FR 56015, Sept. 15, 2010]



Sec. 180.301  Carboxin; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the fungicide carboxin (5,6-dihydro-2-methyl-1,4-oxathiin-3-
carboxanilide) and its metabolites determined as aniline and expressed 
as parent compound, in or on food commodities as follows:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, grain...............................................        0.2
Barley, straw...............................................        0.2
Bean, dry, seed.............................................        0.2
Bean, succulent.............................................        0.2
Canola, seed................................................        0.03
Cattle, fat.................................................        0.05
Cattle, meat byproducts.....................................        0.1
Cattle, meat................................................        0.05
Corn, field, forage.........................................        0.2
Corn, field, grain..........................................        0.2
Corn, field, stover.........................................        0.2
Corn, pop, grain............................................        0.2
Corn, pop, stover...........................................        0.2
Corn, sweet, forage.........................................        0.2
Corn, sweet, kernel plus cob with husks removed.............        0.2
Corn, sweet, stover.........................................        0.2
Cotton, undelinted seed.....................................        0.2
Egg.........................................................        0.05
Goat, fat...................................................        0.05
Goat, meat byproducts.......................................        0.1
Goat, meat..................................................        0.05
Hog, fat....................................................        0.05
Hog, meat byproducts........................................        0.1
Hog, meat...................................................        0.05
Horse, fat..................................................        0.05
Horse, meat byproducts......................................        0.1
Horse, meat.................................................        0.05
Milk........................................................        0.05
Oat, forage.................................................        0.5
Oat, grain..................................................        0.2
Oat, straw..................................................        0.2
Onion, bulb.................................................        0.2
Peanut......................................................        0.2
Peanut, hay.................................................        0.2
Poultry, fat................................................        0.1
Poultry, meat byproducts....................................        0.1
Poultry, meat...............................................        0.1
Rice, grain.................................................        0.2
Rice, straw.................................................        0.2
Safflower, seed.............................................        0.2
Sheep, fat..................................................        0.05
Sheep, meat byproducts......................................        0.1
Sheep, meat.................................................        0.05

[[Page 526]]

 
Soybean, seed...............................................        0.2
Wheat, forage...............................................        0.5
Wheat, grain................................................        0.2
Wheat, straw................................................        0.2
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[47 FR 55222, Dec. 8, 1982, as amended at 50 FR 81, Jan. 2, 1985; 62 FR 
4915, Feb. 3, 1997; 63 FR 4586, Jan. 30, 1998; 64 FR 11801, Mar. 10, 
1999; 66 FR 9773, Feb. 12, 2001; 66 FR 64773, Dec. 14, 2001; 67 FR 
40218, June 12, 2002; 67 FR 72853, Dec. 9, 2002; 71 FR 56383, Sept. 27, 
2006]



Sec. 180.303  Oxamyl; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the insecticide oxamyl, methyl N,N-dimethyl-N-[(methylcarbamoyl)-oxy]-1-
thiooxamimidate, and its oxime metabolite methyl N,N-dimethyl-N-hydroxy-
1-thiooxamimidate calculated as oxamyl in or on the following food 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Apple.......................................................        2
Banana......................................................        0.3
Cantaloupe..................................................        2.0
Carrot......................................................        0.1
Celery......................................................       10.0
Cotton, undelinted seed.....................................        0.2
Cucumber....................................................        2.0
Eggplant....................................................        2.0
Fruit, citrus, group 10.....................................        3
Garlic, bulb................................................        0.2
Melon, honeydew.............................................        2.0
Onion, bulb.................................................        0.2
Peanut......................................................        0.05
Peanut, hay.................................................        2.0
Pear........................................................        2.0
Peppermint, tops............................................       10.0
Pepper, bell................................................        2.0
Pepper, nonbell.............................................        5.0
Pineapple...................................................        1
Pineapple, process residue..................................        2.0
Pumpkin.....................................................        2.0
Soybean, seed...............................................        0.1
Spearmint, tops.............................................       10.0
Squash, summer..............................................        2.0
Squash, winter..............................................        2.0
Tomato......................................................        2
Vegetable, tuberous and corm, subgroup 1C...................        0.1
Watermelon..................................................        2.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[73 FR 54961, Sept. 24, 2008]



Sec. 180.304  Oryzalin; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide oryzalin, 3,5-dinitro-N4,N4-
dipropylsulfanilamide, in or on the following raw agricultural 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        0.05
Avocado.....................................................        0.05
Berry group 13..............................................        0.05
Cranberry...................................................        0.05
Fig.........................................................        0.05
Fruit, citrus, group 10.....................................        0.05
Fruit, pome, group 11.......................................        0.05
Fruit, stone, group 12......................................        0.05
Grape.......................................................        0.05
Kiwifruit...................................................        0.05
Nut, tree, group 14.........................................        0.05
Olive.......................................................        0.05
Pistachio...................................................        0.05
Pomegranate.................................................        0.05
Strawberry..................................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration, as defined in Sec. 180.1(l), are established for residues 
of oryzalin, 3,5-dinitro-N4,N4-
dipropylsulfanilamide, in or on the following raw agricultural 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Guava.......................................................        0.05
Papaya......................................................        0.05
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[71 FR 54434, Sept. 15, 2006, as amended at 76 FR 34885, June 15, 2011]



Sec. 180.311  Cacodylic acid; tolerances for residues.

    (a) General. A tolerance is established for residues of the 
defoliant cacodylic acid, dimethylarsinic acid, including its 
metabolites and degradates, in or on the commodity in the following 
table. Compliance with the tolerance level specified in this paragraph 
is to be determined by measuring only those cacodylic acid residues 
convertible to As2O3, expressed as the stoichiometric

[[Page 527]]

equivalent of cacodylic acid, in or on the commodity.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   Revocation
                                                   million       Date
------------------------------------------------------------------------
Cotton, undelinted seed.........................        2.8       1/1/12
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[69 FR 6567, Feb. 11, 2004, as amended at 75 FR 60243, Sept. 29, 2010]



Sec. 180.314  Triallate; tolerances for residues.

    (a) General. Tolerances are established for residues of triallate, 
S-2,3,4-trichloroallyl diisopropylthiocarbamate and its metabolite 
2,3,3-trichloroprop-2-enesulfonic acid (TCPSA) in or on the following 
food commodity:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Bermudagrass, hay...........................................        0.3
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with a 
regional registration, as defined in 180.1(l),are established for 
residues of the herbicide (S-2, 3, 4-trichloroallyl 
diisopropylthiocarbamate) and its metabolite 2, 3, 3-trichloroprop-2-
enesulfonic acid (TCPSA) in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, grain...............................................        0.05
Barley, hay.................................................        1.0
Barley, straw...............................................        0.3
Beet, sugar, dried pulp.....................................        0.2
Beet, sugar, roots..........................................        0.1
Beet, sugar, tops...........................................        0.5
Pea, dry....................................................        0.2
Pea, field, hay.............................................        1.0
Pea, field, vines...........................................        0.5
Pea, succulent..............................................        0.2
Wheat, forage...............................................        0.5
Wheat, grain................................................        0.05
Wheat, hay..................................................        1.0
Wheat, straw................................................        1.0
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[72 FR 28888, May 23, 2007, as amended at 73 FR 5109, Jan. 29, 2008; 73 
FR 53738, Sept. 17, 2008; 74 FR 29963, June 24, 2009]



Sec. 180.315  Methamidophos; tolerances for residues.

    (a) General. Tolerances are established for residues of 
methamidophos, O,S-dimethyl phosphoramidothioate, including its 
metabolites and degradates, in or on the commodities in the following 
table as a result of the application of methamidophos. Compliance with 
the tolerance levels specified in this paragraph is to be determined by 
measuring only methamidophos, O,S-dimethyl phosphoramidothioate, in or 
on the commodity.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   Revocation
                                                   million       Date
------------------------------------------------------------------------
Broccoli\1\.....................................        1.0     12/31/12
Cabbage\2\......................................        1.0     12/31/12
Cotton, undelinted seed.........................        0.1     12/31/13
Potato..........................................        0.1     12/31/13
------------------------------------------------------------------------
\1\ There are no U.S. registrations since 1989.
\2\ There are no U.S. registrations since 2001.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. A tolerance with a 
regional registration is established for residues of methamidophos, O,S-
dimethyl phosphoramidothioate, including its metabolites and degradates, 
in or on the commodity in the following table as a result of the 
application of methamidophos. Compliance with the tolerance levels 
specified in this paragraph is to be determined by measuring only 
methamidophos, O,S-dimethyl phosphoramidothioate, in or on the 
commodity.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   Revocation
                                                   million       Date
------------------------------------------------------------------------
Tomato..........................................        2.0     12/31/13
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[75 FR 60243, Sept. 29, 2010]

[[Page 528]]



Sec. 180.316  Pyrazon; tolerances for residues.

    (a) General. Tolerances are established for combined residues of the 
herbicide pyrazon (5-amino-4-chloro-2-phenyl-3(2H)-pyridazinone) and its 
metabolites (calculated as pyrazon) in or on the following food 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Beet, garden, roots.........................................        0.9
Beet, garden, tops..........................................        7.0
Beet, sugar, molasses.......................................        1.5
Beet, sugar, roots..........................................        0.2
Beet, sugar, tops...........................................        3.0
Cattle, fat.................................................        0.10
Cattle, liver...............................................        0.15
Cattle, meat................................................        0.10
Cattle, meat byproducts, except liver.......................        0.10
Goat, fat...................................................        0.10
Goat, liver.................................................        0.15
Goat, meat..................................................        0.10
Goat, meat byproducts, except liver.........................        0.10
Horse, fat..................................................        0.10
Horse, liver................................................        0.15
Horse, meat.................................................        0.10
Horse, meat byproducts, except liver........................        0.10
Milk........................................................        0.02
Sheep, fat..................................................        0.10
Sheep, liver................................................        0.15
Sheep, meat.................................................        0.10
Sheep, meat byproducts, except liver........................        0.10
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established for 
combined residues of the herbicide pyrazon, 5-amino-4-chloro-2-phenyl-
3(2H)-pyridazinone, and its metabolites (calculated as pyrazon), in or 
on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Corn, field, forage.........................................        0.5
Corn, field, stover.........................................        0.5
Soybean, forage.............................................        0.5
Soybean, hay................................................        0.5
Wheat, forage...............................................        0.3
Wheat, hay..................................................        0.2
Wheat, straw................................................        0.1
------------------------------------------------------------------------


[68 FR 39441, July 1, 2003, as amended at 73 FR 52614, Sept. 10, 2008]



Sec. 180.317  Propyzamide; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide propyzamide, including its metabolites and degradates, in or 
on the commodities in the table in this paragraph. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only those propyzamide residues convertible to methyl 3,5-
dichlorobenzoate, expressed as the stoichiometric equivalent of 
propyzamide, 3,5-dichloro-N-(1,1-dimethyl-2-propynyl)benzamide, in or on 
the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, seed...............................................       10.0
Animal feed, nongrass, group 18.............................       10.0
Apple.......................................................        0.1
Artichoke, globe............................................        0.01
Blackberry..................................................        0.05
Blueberry...................................................        0.05
Boysenberry.................................................        0.05
Cattle, fat.................................................        0.2
Cattle, kidney..............................................        0.4
Cattle, liver...............................................        0.4
Cattle, meat................................................        0.02
Cattle, meat byproducts, except kidney and liver............        0.02
Egg.........................................................        0.02
Endive......................................................        1.0
Fruit, stone, group 12......................................        0.1
Goat, fat...................................................        0.2
Goat, kidney................................................        0.4
Goat, liver.................................................        0.4
Goat, meat..................................................        0.02
Goat, meat byproducts, except kidney and liver..............        0.02
Grape.......................................................        0.1
Hog, fat....................................................        0.2
Hog, kidney.................................................        0.4
Hog, liver..................................................        0.4
Hog, meat...................................................        0.02
Hog, meat byproducts, except kidney and liver...............        0.02
Horse, fat..................................................        0.2
Horse, kidney...............................................        0.4
Horse, liver................................................        0.4
Horse, meat.................................................        0.02
Horse, meat byproducts, except kidney and liver.............        0.02
Lettuce, head...............................................        1.0
Milk........................................................        0.02
Pear........................................................        0.1
Poultry, fat................................................        0.02
Poultry, liver..............................................        0.2
Poultry, meat...............................................        0.02
Poultry, meat byproducts, except liver......................        0.02
Radicchio...................................................        2.0
Raspberry...................................................        0.05
Sheep, fat..................................................        0.2
Sheep, kidney...............................................        0.4
Sheep, liver................................................        0.4
Sheep, meat.................................................        0.02
Sheep, meat byproducts, except kidney and liver.............        0.02
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration, as defined in Sec. 180.1(l), are established for residues 
of the herbicide propyzamide, including its metabolites and degradates, 
in or on the commodities in the table in this paragraph. Compliance with 
the tolerance levels

[[Page 529]]

specified in this paragraph is to be determined by measuring only those 
propyzamide residues convertible to methyl 3,5-dichlorobenzoate, 
expressed as the stoichiometric equivalent of propyzamide, 3,5-dichloro-
N-(1,1-dimethyl-2-propynyl)benzamide, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Pea, field, seed............................................        0.05
Rhubarb.....................................................        0.1
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. Tolerances are established for 
indirect or inadvertent residues of the herbicide propyzamide, including 
its metabolites and degradates, in or on the commodities in the table in 
this paragraph. Compliance with the tolerance levels specified in this 
paragraph is to be determined by measuring only those propyzamide 
residues convertible to methyl 3,5-dichlorobenzoate, expressed as the 
stoichiometric equivalent of propyzamide, 3,5-dichloro-N-(1,1-dimethyl-
2-propynyl)benzamide, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grain, cereal, forage, group 16.............................        0.6
Grain, cereal, hay, group 16................................        0.2
Grain, cereal, straw, group 16..............................        0.3
------------------------------------------------------------------------


[72 FR 52018, Sept. 12, 2007, as amended at 76 FR 23493, Apr. 27, 2011]



Sec. 180.318  4-(2-Methyl-4-chlorophenoxy) butyric acid; tolerance for 

residues.

    (a) General. (1) A tolerance is established for the herbicide 4-(2-
methyl-4-chlorophenoxy) butyric acid in or on the following food 
commodity:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Pea..........................................................   0.1(N)
------------------------------------------------------------------------

    (2) Tolerances are established for the combined residues, free and 
conjugated, of the herbicide MCPB, 4-(4-chloro-2-methylphenoxy)butanoic 
acid, and its metabolite MCPA, (4-chloro-2-methylphenoxy)acetic acid, in 
or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Peppermint, tops............................................        0.20
Spearmint, tops.............................................        0.20
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[68 FR 39441, July 1, 2003, as amended at 73 FR 66785, Nov. 12, 2008]



Sec. 180.319  Interim tolerances.

    (a) General. While petitions for tolerances for negligible residues 
are pending and until action is completed on these petitions, interim 
tolerances are established for residues of the listed pesticide 
chemicals in or on the following raw agricultural commodities:

----------------------------------------------------------------------------------------------------------------
                                                                                                    Expiration/
           Substances                     Uses           Tolerance in parts   Raw  agricultural     revocation
                                                            per million           commodity            date
----------------------------------------------------------------------------------------------------------------
Coordination product of zinc ion  Fungicide...........  1.0 (Calculated as   Potato.............            None
 and maneb.                                              zinc ethylene-
                                                         bisdithio-
                                                         carbamate).
Endothall (7-oxabicyclo-          Herbicide...........  0.2................  Beet, sugar........            None
 (2,2,1)heptane 2,3-dicarboxylic
 acid.
Methyl parathion................  Herbicide...........  0.5................  Rye................        12/31/13
----------------------------------------------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[77 FR 59126, Sept. 26, 2012]



Sec. 180.324  Bromoxynil; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
herbicide bromoxynil, including its metabolites and degradates, in or on 
the commodities in the table below. Compliance

[[Page 530]]

with the tolerance levels is to be determined by measuring only 
bromoxynil, 3,5-dibromo-4-hydroxybenzonitrile, resulting from 
application of its octanoic and/or heptanoic acid ester, in or on the 
commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        0.1
Alfalfa, hay................................................        0.5
Barley, grain...............................................        0.05
Barley, hay.................................................        9.0
Barley, straw...............................................        4.0
Corn, field, forage.........................................        0.3
Corn, field, grain..........................................        0.05
Corn, field, stover.........................................        0.2
Corn, pop, grain............................................        0.05
Corn, pop, stover...........................................        0.2
Flax, seed..................................................        0.1
Garlic......................................................        0.1
Grain, aspirated fractions..................................        1.2
Grass, forage...............................................       18
Grass, hay..................................................        5.0
Oat, forage.................................................        0.3
Oat, grain..................................................        0.05
Oat, hay....................................................        9.0
Oat, straw..................................................        4.0
Onion, bulb.................................................        0.1
Peppermint, hay.............................................        0.1
Rye, forage.................................................        1.0
Rye, grain..................................................        0.05
Rye, straw..................................................        2.0
Sorghum, grain, forage......................................        0.8
Sorghum, grain, grain.......................................        0.2
Sorghum, grain, stover......................................        0.2
Spearmint, hay..............................................        0.1
Wheat, forage...............................................        1.0
Wheat, grain................................................        0.05
Wheat, hay..................................................        4.0
Wheat, straw................................................        2.0
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the herbicide 
bromoxynil, 3,5-dibromo-4-hydroxybenzonitrile, including its metabolites 
and degradates, in or on the commodities in the table below. Compliance 
with the tolerance levels is to be determined by measuring only 
bromoxynil and its metabolite, 3,5-dibromo-4-hydroxybenzoic acid (DBHA), 
resulting from application of its octanoic and/or heptanoic acid ester, 
in or on the commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        1
Cattle, meat byproducts.....................................        3.5
Cattle, meat................................................        0.5
Cotton, gin byproducts......................................        7.0
Cotton, hulls...............................................        5.0
Cotton, undelinted seed.....................................        1.5
Egg.........................................................        0.05
Goat, fat...................................................        1
Goat, meat byproducts.......................................        3.5
Goat, meat..................................................        0.5
Hog, fat....................................................        1
Hog, meat byproducts........................................        3.5
Hog, meat...................................................        0.5
Horse, fat..................................................        1
Horse, meat byproducts......................................        3.5
Horse, meat.................................................        0.5
Milk........................................................        0.4
Poultry, fat................................................        0.05
Poultry, meat byproducts....................................        0.3
Poultry, meat...............................................        0.05
Sheep, fat..................................................        1
Sheep, meat byproducts......................................        3.5
Sheep, meat.................................................        0.5
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[62 FR 33023, June 18, 1997, as amended at 63 FR 26480, May 13, 1998; 66 
FR 47402, Sept. 12, 2001; 70 FR 7046, Feb. 10, 2005; 72 FR 35666, June 
29, 2007; 72 FR 41930, Aug. 1, 2007; 76 FR 31491, June 1, 2011]



Sec. 180.328  Napropamide; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide napropamide, N,N-diethyl-2-(1-napthalenyloxy) propionamide, in 
or on the following food commodities:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Almond, hulls...................................        0.1         None
Asparagus.......................................        0.1         None
Basil...........................................        0.1         None
Berry group 13..................................        0.1         None
Coffee, green bean..............................        0.1         None
Cranberry.......................................        0.1         None
Grape...........................................        0.1         None
Kiwifruit.......................................        0.1         None
Marjoram........................................        0.1         None
Nut, tree, group 14.............................        0.1         None
Peppermint, tops................................        0.1         None
Persimmon.......................................        0.1         None
Rhubarb.........................................        0.1         None
Rosemary........................................        0.1         None
Savory, summer..................................        0.1         None
Savory, winter..................................        0.1         None
Spearmint, tops.................................        0.1         None
Strawberry......................................        0.1         None
Sweet potato, roots.............................        0.1         None
Vegetable, brassica, leafy, group 5.............        0.1         None
Vegetable, fruiting, group 8....................        0.1         None
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[73 FR 52614, Sept. 10, 2008, as amended at 76 FR 34885, June 15, 2011]

[[Page 531]]



Sec. 180.330  S-(2-(Ethylsulfinyl)ethyl) O,O-dimethyl phosphorothioate; 

tolerances for residues.

    (a) General. (1) Tolerances are established for the combined 
residues of the insecticide oxydemeton-methyl (S-(2-
(ethylsulfinyl)ethyl) O,O-dimethyl phosphorothioate) and its metabolite 
oxydemeton-methyl sulfone in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        5.0
Alfalfa, hay................................................       11.0
Bean, lima..................................................        0.2
Beet, sugar, roots..........................................        0.3
Beet, sugar, tops...........................................        0.5
Broccoli....................................................        1.0
Brussels sprouts............................................        1.0
Cabbage.....................................................        2.0
Cauliflower.................................................        1.0
Clover, forage..............................................        5.0
Clover, hay.................................................       10.0
Corn, sweet, forage.........................................        1.0
Corn, sweet, kernel plus cob with husks removed.............        0.5
Corn, sweet, stover.........................................        3.0
Cotton, undelinted seed.....................................        0.02
Cucumber....................................................        1.0
Eggplant....................................................        1.0
Grapefruit..................................................        1.0
Hazelnut....................................................        0.05
Lemon.......................................................        1.0
Lettuce, head...............................................        2.0
Melon.......................................................        0.2
Onion, bulb.................................................        0.05
Orange......................................................        1.0
Pepper......................................................        0.75
Peppermint, tops............................................       12.5
Pumpkin.....................................................        0.2
Safflower, seed.............................................        1.0
Sorghum, forage, forage.....................................        2.0
Sorghum, grain, forage......................................        2.0
Sorghum, grain, grain.......................................        0.75
Spearmint, tops.............................................       12.5
Squash, summer..............................................        1.0
Squash, winter..............................................        0.3
Strawberry..................................................        2.0
Walnut......................................................        0.05
------------------------------------------------------------------------

    (2) Tolerances are established for the combined residues of the 
insecticide oxydemeton-methyl (S-(2-(ethylsulfinyl)ethyl) O,O-dimethyl 
phosphorothioate) and its cholinesterase-inhibiting metabolites in or on 
the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.01
Cattle, meat................................................        0.01
Cattle, meat byproducts.....................................        0.01
Egg.........................................................        0.01
Goat, fat...................................................        0.01
Goat, meat..................................................        0.01
Goat, meat byproducts.......................................        0.01
Hog, fat....................................................        0.01
Hog, meat...................................................        0.01
Hog, meat byproducts........................................        0.01
Horse, fat..................................................        0.01
Horse, meat.................................................        0.01
Horse, meat byproducts......................................        0.01
Milk........................................................        0.01
Poultry, fat................................................        0.01
Poultry, meat...............................................        0.01
Poultry, meat byproducts....................................        0.01
Sheep, fat..................................................        0.01
Sheep, meat.................................................        0.01
Sheep, meat byproducts......................................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registrations, as defined in Sec. 180.1(l), are established for the 
combined residues of the insecticide oxydemeton-methyl (S-(2-
(ethylsulfinyl)-ethyl) O,O-dimethyl phosphorothioate) and its metabolite 
oxydemeton-methyl sulfone in or on the following food commodities:

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Broccoli raab.............................        2.0
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[72 FR 54578, Sept. 26, 2007]



Sec. 180.331  4-(2,4-Dichlorophenoxy) butyric acid; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide 4-(2,4-dichlorophenoxy) butyric acid (2,4-DB), both free and 
conjugated, determined as the acid, in or on food commodities, as 
follows:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        0.7
Alfalfa, hay................................................        2.0
Cattle, meat byproducts.....................................        0.05
Clover, forage..............................................        0.2
Clover, hay.................................................        0.2
Goat, meat byproducts.......................................        0.05
Hog, meat byproducts........................................        0.05
Horse, meat byproducts......................................        0.05
Peanut......................................................        0.2
Peppermint, tops............................................        0.2
Sheep, meat byproducts......................................        0.05
Soybean, forage.............................................        0.7
Soybean, hay................................................        2.0
Soybean, seed...............................................        0.5
Spearmint, tops.............................................        0.2
Trefoil, forage.............................................        0.7
Trefoil, hay................................................        2.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]

[[Page 532]]

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[73 FR 54961, Sept. 24, 2008, as amended at 74 FR 46374, Sept. 9, 2009]



Sec. 180.332  Metribuzin; tolerances for residues.

    (a) General. Tolerances are established for combined residues of the 
herbicide metribuzin (4-amino-6-(1,1-dimethyl- ethyl)-3-(methylthio)-
;1,2,4-triazin-5(4H)-one) and its triazinone metabolites in or on food 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        2.0
Alfalfa, hay................................................        7.0
Asparagus...................................................        0.1
Barley, grain...............................................        0.75
Barley, hay.................................................        7.0
Barley, pearled barley......................................        3.0
Barley, straw...............................................        1.0
Carrot, roots...............................................        0.3
Cattle, fat.................................................        0.7
Cattle, meat................................................        0.7
Cattle, meat byproducts.....................................        0.7
Corn, field, forage.........................................        0.1
Corn, field, grain..........................................        0.05
Corn, field, stover.........................................        0.1
Corn, pop, grain............................................        0.05
Corn, sweet, forage.........................................        0.1
Corn, sweet, kernel plus cob with husks removed.............        0.05
Corn, sweet, stover.........................................        0.1
Egg.........................................................        0.01
Goat, fat...................................................        0.7
Goat, meat..................................................        0.7
Goat, meat byproducts.......................................        0.7
Grass, forage...............................................        2.0
Grass, hay..................................................        7.0
Hog, fat....................................................        0.7
Hog, meat...................................................        0.7
Hog, meat byproducts........................................        0.7
Horse, fat..................................................        0.7
Horse, meat.................................................        0.7
Horse, meat byproducts......................................        0.7
Lentil......................................................        0.05
Milk........................................................        0.05
Pea, dry, seed..............................................        0.05
Pea, field, hay.............................................        4.0
Pea, field, vines...........................................        0.5
Pea, succulent..............................................        0.1
Potato......................................................        0.6
Potato, chips...............................................        3.0
Potato, processed potato waste..............................        3.0
Poultry, fat................................................        0.7
Poultry, meat...............................................        0.7
Poultry, meat byproducts....................................        0.7
Sainfoin, forage............................................        2.0
Sainfoin, hay...............................................        7.0
Sheep, fat..................................................        0.7
Sheep, meat.................................................        0.7
Sheep, meat byproducts......................................        0.7
Soybean, seed...............................................        0.3
Soybean, forage.............................................        4.0
Soybean, hay................................................        4.0
Sugarcane, cane.............................................        0.1
Sugarcane, molasses.........................................        2.0
Tomato......................................................        0.1
Wheat, bran.................................................        3.0
Wheat, forage...............................................        2.0
Wheat, germ.................................................        3.0
Wheat, grain................................................        0.75
Wheat, hay..................................................        7.0
Wheat, middlings............................................        3.0
Wheat, shorts...............................................        3.0
Wheat, straw................................................        1.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[42 FR 62913, Dec. 14, 1977, as amended at 43 FR 41396, Sept. 18, 1978; 
44 FR 26744, May 7, 1979; 44 FR 45387, Aug. 2, 1979; 52 FR 23654, June 
24, 1987; 55 FR 26440, June 28, 1990; 62 FR 66024, 66025, Dec. 17, 1997; 
65 FR 33698, May 24, 2000; 66 FR 63198, Dec. 5, 2001; 67 FR 49617, July 
31, 2002]



Sec. 180.337  Oxytetracycline; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide/bactericide oxytetracycline, including its metabolites and 
degradates, in or on the commodities in the table in this paragraph. 
Compliance with the tolerance levels specified in this paragraph is to 
be determined by measuring only oxytetracycline, 
(4S,4aR,5S,5aR,6S,12aS)-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-
octahydro-3,5,6,10,12,12a-hexahydroxy-6-methyl-1,11-dioxo-2-
naphthacenecarboxamide, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Apple.......................................................        0.35
Peach.......................................................        0.35
Pear........................................................        0.35
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[76 FR 23493, Apr. 27, 2011]



Sec. 180.339  MCPA; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
herbicide

[[Page 533]]

MCPA ((4-chloro-2-methylphenoxy)acetic acid), both free and conjugated, 
resulting from the direct application of MCPA or its sodium or 
dimethylamine salts, or its 2-ethylhexyl ester in or on the following 
food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        0.5
Alfalfa, hay................................................        2.0
Barley, grain...............................................        1.0
Barley, hay.................................................       40
Barley, straw...............................................       25
Clover, forage..............................................        0.5
Clover, hay.................................................        2.0
Flax, seed..................................................        0.1
Grain, aspirated fractions..................................        3.0
Grass, forage...............................................      300
Grass, hay..................................................       20
Lespedeza, forage...........................................        0.5
Lespedeza, hay..............................................        2.0
Oat, forage.................................................       20
Oat, grain..................................................        1.0
Oat, hay....................................................      115
Oat, straw..................................................       25
Pea, dry....................................................        0.1
Pea, field, hay.............................................        0.1
Pea, succulent..............................................        0.1
Pea, field, vines...........................................        0.1
Rye, forage.................................................       20
Rye, grain..................................................        1.0
Rye, straw..................................................       25
Trefoil, forage.............................................        0.5
Trefoil, hay................................................        2.0
Vetch, forage...............................................        0.5
Vetch, hay..................................................        2.0
Wheat, forage...............................................       20
Wheat, grain................................................        1.0
Wheat, hay..................................................      115
Wheat, straw................................................       25
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the herbicide MCPA 
((4-chloro-2-methylphenoxy)acetic acid) resulting from the direct 
application of MCPA or its sodium or dimethylamine salts, or its 2-
ethylhexyl ester in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.1
Cattle, meat................................................        0.1
Cattle, meat byproducts.....................................        0.1
Goat, fat...................................................        0.1
Goat, meat..................................................        0.1
Goat, meat byproducts.......................................        0.1
Hog, fat....................................................        0.1
Hog, meat...................................................        0.1
Hog, meat byproducts........................................        0.1
Horse, fat..................................................        0.1
Horse, meat.................................................        0.1
Horse, meat byproducts......................................        0.1
Milk........................................................        0.1
Sheep, fat..................................................        0.1
Sheep meat..................................................        0.1
Sheep meat byproducts.......................................        0.1
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[72 FR 28888, May 23, 2007, as amended at 73 FR 5109, Jan. 29, 2008]



Sec. 180.341  2,4-Dinitro-6-octylphenyl crotonate and 2,6-dinitro-4-

octylphenyl crotonate; tolerances for residues.

    (a) General. Tolerances are established for combined negligible 
residues of a fungicide and insecticide that is a mixture of 2,4-
dinitro-6-octylphenyl crotonate and 2,6-dinitro-4-octylphenyl crotonate 
in or on raw agricultural commodities as follows:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Apple \1\...................................................        0.1
Grape \1\...................................................        0.1
------------------------------------------------------------------------
\1\ There are no U.S. registrations on apple and grape as of October 24,
  2002.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[40 FR 29715, July 15, 1975, as amended at 63 FR 57076, Oct. 26, 1998; 
69 FR 43924, July 23, 2004]



Sec. 180.342  Chlorpyrifos; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
pesticide chlorpyrifos per se (O,O-diethyl-O-(3,5,6-trichloro-2-pyridyl) 
phosphorothioate) in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        3.0
Alfalfa, hay................................................       13
Almond......................................................        0.2
Almond, hulls...............................................       12
Apple.......................................................        0.01
Apple, wet pomace...........................................        0.02
Banana......................................................        0.1
Beet, sugar, dried pulp.....................................        5.0
Beet, sugar, molasses.......................................       15
Beet, sugar, roots..........................................        1.0
Beet, sugar, tops...........................................        8.0
Cattle, fat.................................................        0.3
Cattle, meat................................................        0.05
Cattle, meat byproducts.....................................        0.05
Cherry, sweet...............................................        1.0
Cherry, tart................................................        1.0

[[Page 534]]

 
Citrus, dried pulp..........................................        5.0
Citrus, oil.................................................       20
Corn, field, forage.........................................        8.0
Corn, field, grain..........................................        0.05
Corn, field, refined oil....................................        0.25
Corn, field, stover.........................................        8.0
Corn, sweet, forage.........................................        8.0
Corn, sweet, kernel plus cob with husk removed..............        0.05
Corn, sweet, stover.........................................        8.0
Cotton, undelinted seed.....................................        0.2
Cranberry...................................................        1.0
Cucumber....................................................        0.05
Egg.........................................................        0.01
Fig.........................................................        0.01
Fruit, citrus, group 10.....................................        1.0
Goat, fat...................................................        0.2
Goat, meat..................................................        0.05
Goat, meat byproducts.......................................        0.05
Hazelnut....................................................        0.2
Hog, fat....................................................        0.2
Hog, meat...................................................        0.05
Hog, meat byproducts........................................        0.05
Horse, fat..................................................        0.25
Horse, meat.................................................        0.25
Horse, meat byproducts......................................        0.25
Kiwifruit...................................................        2.0
Milk, fat (Reflecting 0.01 ppm in whole milk)...............        0.25
Nectarine...................................................        0.05
Onion, bulb.................................................        0.5
Peach.......................................................        0.05
Peanut......................................................        0.2
Peanut, refined oil.........................................        0.2
Pear........................................................        0.05
Pecan.......................................................        0.2
Pepper......................................................        1.0
Peppermint, tops............................................        0.8
Peppermint, oil.............................................        8.0
Plum, prune, fresh..........................................        0.05
Poultry, fat................................................        0.1
Poultry, meat...............................................        0.1
Poultry, meat byproducts....................................        0.1
Pumpkin.....................................................        0.05
Radish......................................................        2.0
Rutabaga....................................................        0.5
Sheep, fat..................................................        0.2
Sheep, meat.................................................        0.05
Sheep, meat byproducts......................................        0.05
Spearmint, tops.............................................        0.8
Spearmint, oil..............................................        8.0
Sorghum, grain, forage......................................        0.5
Sorghum, grain, grain.......................................        0.5
Sorghum, grain, stover......................................        2.0
Soybean, seed...............................................        0.3
Strawberry..................................................        0.2
Sunflower, seed.............................................        0.1
Sweet potato, roots.........................................        0.05
Turnip, roots...............................................        1.0
Turnip, tops................................................        0.3
Vegetable, brassica, leafy, group 5.........................        1.0
Vegetable, legume, group 6. except soybean..................        0.05
Walnut......................................................        0.2
Wheat, forage...............................................        3.0
Wheat, grain................................................        0.5
Wheat, straw................................................        6.0
------------------------------------------------------------------------

    (2) Chlorpyrifos [O,O-diethyl O-(3,5,6-trichloro-2-pyridyl) 
phosphorothioate] may be safely used in accordance with the following 
prescribed conditions.
    (i) Application shall be limited solely to spot and/or crack and 
crevice treatment in food handling establishments where food and food 
products are held, processed, prepared or served. Contamination of food 
or food contact surfaces shall be avoided. Food must be removed or 
covered during treatment.
    (ii) Spray concentration for spot treatment shall be limited to a 
maximum of 0.5 percent of the active ingredient by weight. A course, 
low-pressure spray shall be used to avoid atomization or splashing of 
the spray.
    (iii) Paint-on application for spot treatment shall be limited to a 
maximum of 2 percent of the active ingredient by weight.
    (iv) Crack and crevice treatment shall be limited to a maximum of 2 
percent of the active ingredient by weight. Equipment capable of 
delivering a pin-stream of insecticide shall be used.
    (v) Application via adhesive strips shall contain a maximum of 10% 
by weight of the controlled-release product in food-handling 
establishments where food and food products are held, processed, 
prepared, or served. A maximum of 36 strips (or 5.15 grams of 
chlorpyrifos) is to be used per 100 square feet of floor space. The 
strips are not to be placed in exposed areas where direct contact with 
food, utensils, and food-contact surfaces would be likely to occur.
    (vi) To assure safe use of the insecticide, its label and labeling 
shall conform to that registered by the U.S. Environmental Protection 
Agency, and it shall be used in accordance with such label and labeling.
    (3) A tolerance of 0.1 part per million is established for residues 
of chlorpyrifos, per se, in or on food commodities (other than those 
already covered by a higher tolerance as a result of use on growing 
crops) in food service establishments where food and food products are 
prepared and served, as a result of the application of chlorpyrifos in 
microencapsulated form.
    (i) Application of a microencapsulated product shall be limited 
solely to spot and/or crack and crevice treatment in food handling 
establishments where food and food products are prepared and served. All 
treatments shall be applied in such a manner as to avoid contamination 
of food or food contact surfaces.

[[Page 535]]

    (ii) Spray concentrations shall be limited to a maximum of 0.5 
percent of the active ingredient by weight.
    (iii) For crack and crevice treatment, equipment capable of 
delivering a pin stream of spray directly into cracks and crevices or 
capable of applying small amounts of insecticide into cracks and 
crevices shall be used.
    (iv) For spot treatment, an individual spot shall not exceed 2 
square feet.
    (v) To assure safe use of the insecticide, its label and labeling 
shall conform to that registered by the U.S. Environmental Protection 
Agency, and it shall be used in accordance with such label and labeling.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration, as defined in 180.1(l), are established for residues of 
the pesticide chlorpyrifos per se (O,O-diethyl- O-(3,5,6-trichloro-2-
pyridyl) phosphorothioate) in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Asparagus...................................................        5.0
Grape.......................................................        0.01
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33711, May 24, 2000, as amended at 67 FR 49617, July 31, 2002; 71 
FR 74817, Dec. 13, 2006; 73 FR 53739, Sept. 17, 2008; 76 FR 56656, Sept. 
14, 2011]



Sec. 180.345  Ethofumesate; tolerances for residues.

    (a) General. Tolerances for the combined residues of the herbicide 
ethofumesate (2-ethoxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl 
methanesulfonate) and its metabolites 2-hydroxy-2,3-dihydro-3,3-
dimethyl-5-benzofuranyl methanesulfonate and 2,3-dihydro-3,3-dimethyl-2-
oxo-5-benzofuranyl methanesulfonate both calculated as parent compound 
in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Beet, garden, roots.........................................        0.5
Beet, garden, tops..........................................        5.0
Beet, sugar, molasses.......................................        0.5
Beet, sugar, refined sugar..................................        0.2
Beet, sugar, roots..........................................        0.3
Beet, sugar, tops...........................................        4.0
Cattle, fat.................................................        0.05
Cattle, meat................................................        0.05
Cattle, meat byproducts.....................................        0.05
Garlic......................................................        0.25
Goat, fat...................................................        0.05
Goat, meat..................................................        0.05
Goat, meat byproducts.......................................        0.05
Grass, straw................................................        1.0
Horse, fat..................................................        0.05
Horse, meat.................................................        0.05
Horse, meat byproducts......................................        0.05
Onion, bulb.................................................        0.25
Shallot, bulb...............................................        0.25
Shallot, fresh leaves.......................................        0.25
Sheep, fat..................................................        0.05
Sheep, meat.................................................        0.05
Sheep, meat byproducts......................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registration. Tolerances with regional 
registration as defined in 40 CFR 180.1(l) are established for the 
combined residues of ethofumesate,(2-ethoxy -2, 3-dihydro-3, 3-dimethyl-
5-benzofuranyl methanesulfonate) and its metabolites 2-hydroxy-2,3-
dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate and 2,3-dihydro-
3,3-dimethyl-2-oxo-5-benzofuranyl methanesulfonate (both calculated as 
the parent compound) in or on the raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Carrot, roots...............................................        7.0
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 34828, June 26, 1998, as amended at 71 FR 51516, Aug. 30, 2006; 
72 FR 52019, Sept. 12, 2007]



Sec. 180.349  Fenamiphos; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
nematicide/insecticide fenamiphos, ethyl 3-methyl-4-(methylthio)phenyl 
1-(methylethyl)phosphoramidate, including its metabolites and 
degradates, in or on the commodities in the following table. Compliance 
with the tolerance levels specified in this paragraph is to be 
determined by measuring only the sum of fenamiphos, ethyl 3-methyl-4-
(methylthio)phenyl 1-(methylethyl)phosphoramidate, and its

[[Page 536]]

cholinesterase inhibiting metabolites ethyl 3-methyl-4-
(methylsulfinyl)phenyl 1-(methylethyl)phosphoramidate and ethyl 3-
methyl-4-(methylsulfonyl)phenyl 1-(methylethyl)phosphoramidate, 
calculated as the stoichiometric equivalent of fenamiphos, in or on the 
commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Banana\1\...................................................        0.1
Grape\1\....................................................        0.1
Grape, raisin\1\............................................        0.3
Pineapple\1\................................................        0.3
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of May 31, 2007.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33712, May 24, 2000, as amended at 73 FR 53739, Sept. 17, 2008; 
75 FR 60243, Sept. 29, 2010]



Sec. 180.350  Nitrapyrin; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the soil microbiocide nitrapyrin [2-chloro-6-(trichloromethyl) pyridine] 
and its metabolite, 6-chloropicolinic acid in or on the following raw 
agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Corn, field, forage.........................................        1.0
Corn, field, grain..........................................        0.1
Corn, field, milled byproducts..............................        0.2
Corn, field, stover.........................................        1.0
Corn, pop, grain............................................        0.1
Corn, pop, stover...........................................        1.0
Corn, sweet, forage.........................................        1.0
Corn, sweet, kernel plus cob with husks removed.............        0.1
Corn, sweet, stover.........................................        1.0
Sorghum, forage, forage.....................................        0.5
Sorghum, grain, forage......................................        0.5
Sorghum, grain, grain.......................................        0.1
Sorghum, grain, stover......................................        0.5
Wheat, bran.................................................        3.0
Wheat, forage...............................................        2.0
Wheat, grain................................................        0.5
Wheat, milled byproducts, except flour......................        2.0
Wheat, straw................................................        6.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[46 FR 58315, Dec. 1, 1981, as amended at 47 FR 22957, May 26, 1982; 52 
FR 33238, Sept. 2, 1987; 58 FR 32304, June 9, 1993; 63 FR 57076, Oct. 
26, 1998; 72 FR 53461, Sept. 19, 2007]



Sec. 180.352  Terbufos; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the insecticide terbufos (phosphorodithioic acid, S-(t-butylthio)methyl 
O,O-diethyl ester) and its phosphorylated (cholinesterase-inhibiting) 
metabolites (phosphorothioic acid, S-(t-butylthio)methyl O,O-diethyl 
ester; phosphorothioic acid, S-(t-butylsulfinyl)methyl O,O-diethyl 
ester; phosphorothioic acid, S-(t-butylsulfonyl)methyl O,O-diethyl 
ester; phosphorodithioic acid, S-(t-butylsulfinyl)methyl O,O-diethyl 
ester; and phosphorodithioic acid, S-(t-butylsulfonyl)methyl O,O-diethyl 
ester) in or on food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Banana.......................................................   0.025
Beet, sugar, roots...........................................   0.05
Beet, sugar, tops............................................   0.1
Coffee, green bean \1\.......................................   0.05
Corn, field, forage..........................................   0.5
Corn, field, grain...........................................   0.5
Corn, field, stover..........................................   0.5
Corn, pop, grain.............................................   0.5
Corn, pop, stover............................................   0.5
Corn, sweet, kernel plus cob with husks removed..............   0.05
Corn, sweet, forage..........................................   0.5
Corn, sweet, stover..........................................   0.5
Sorghum, grain, forage.......................................   0.5
Sorghum, grain, grain........................................   0.05
Sorghum, grain, stover.......................................   0.5
------------------------------------------------------------------------
\1\ There are no U. S. registrations as of August 2, 1995, for the use
  of terbufos on the growing crop, coffee.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[73 FR 53740, Sept. 17, 2008]



Sec. 180.353  Desmedipham; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide desmedipham, (ethyl-m-hydroxycarbanilate carbanilate) in or

[[Page 537]]

on the following raw agricultural commodities in the table that follows:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Beet, garden, roots.........................................        0.05
Beet, garden, tops..........................................        1.0
Beet, sugar, roots..........................................        0.1
Beet, sugar, tops...........................................        5.0
Spinach.....................................................        6.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[40 FR 4658, Jan. 31, 1975, as amended at 62 FR 45747, Aug. 29, 1997; 63 
FR 49472, Sept. 16, 1998; 64 FR 46292, Aug. 25, 1999; 65 FR 82293, Dec. 
28, 2000; 66 FR 64773, Dec. 14, 2001; 68 FR 37764, June 25, 2003; 69 FR 
71717, Dec. 10, 2004; 72 FR 53449, Sept. 19, 2007; 73 FR 53740, Sept. 
17, 2008]



Sec. 180.355  Bentazon; tolerances for residues.

    (a) General. (1) Tolerances are established for the combined 
residues of the herbicide bentazon (3-isopropyl-1H-2,1,3-
benzothiadiazin-4(3H)-one-2,2-dioxide) and its 6- and 8-hydroxy 
metabolites in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Bean, dry, seed.............................................        0.05
Bean, succulent.............................................        0.5
Corn, field, forage.........................................        3.0
Corn, field, grain..........................................        0.05
Corn, field, stover.........................................        3.0
Corn, pop, grain............................................        0.05
Corn, sweet, kernel plus cob with husks removed.............        0.05
Cowpea, forage..............................................       10.0
Cowpea, hay.................................................        3.0
Flax, seed..................................................        1.0
Pea, dry, seed..............................................        1.0
Pea, field, hay.............................................        8.0
Pea, field, vines...........................................        3.0
Pea, succulent..............................................        3.0
Peanut......................................................        0.05
Peanut, hay.................................................        3.0
Pepper, nonbell.............................................        0.05
Peppermint, tops............................................        1.0
Rice, grain.................................................        0.05
Rice, hulls.................................................        0.25
Rice, straw.................................................        3.0
Sorghum, forage.............................................        0.20
Sorghum, grain, grain.......................................        0.05
Sorghum, grain, stover......................................        0.05
Soybean, forage.............................................        8.0
Soybean, hay................................................        8.0
Soybean, seed...............................................        0.05
Spearmint, tops.............................................        1.0
------------------------------------------------------------------------

    (2) Tolerances are established for the combined residues of the 
herbicide bentazon (3-isopropyl-1H-2,1,3-benzothiadiazin-4(3H)-one-2,2-
dioxide) and its metabolite 2-amino-N-isopropyl benzamide (AIBA) in or 
on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.05
Cattle, meat byproducts.....................................        0.05
Cattle, meat................................................        0.05
Egg.........................................................        0.05
Goat, fat...................................................        0.05
Goat, meat byproducts.......................................        0.05
Goat, meat..................................................        0.05
Hog, fat....................................................        0.05
Hog, meat byproducts........................................        0.05
Hog, meat...................................................        0.05
Milk........................................................        0.02
Poultry, fat................................................        0.05
Poultry, meat byproducts....................................        0.05
Poultry, meat...............................................        0.05
Sheep, fat..................................................        0.05
Sheep, meat byproducts......................................        0.05
Sheep, meat.................................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration as defined in Sec. 180.1(m), are established for combined 
residues of the herbicide, bentazon (3-isopropyl-1H-2, 1,3-
benzothiadiazin-4(3H)-one-2,2-dioxide) and its 6- and 8-hydroxy 
metabolites in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Clover, forage..............................................        1.0
Clover, hay.................................................        2.0
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[42 FR 26979, May 26, 1977]

    Editorial Note: For Federal Register citations affecting Sec. 
180.355, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.356  Norflurazon; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the herbicide norflurazon (4-chloro-5-(methylamino)-2-(alpha, alpha, 
alpha-trifluoro-m-tolyl)-3-(2H)-pyridazinone) and its desmethyl 
metabolite 4-chloro-5-(amino)-2-alpha, alpha, alpha-trifluoro-m-tolyl)-
3(2H)-pyridazinone in

[[Page 538]]

or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        3.0
Alfalfa, hay................................................        5.0
Alfalfa, seed...............................................        0.1
Almond, hulls...............................................        1.0
Almond......................................................        0.1
Apple.......................................................        0.1
Apricot.....................................................        0.1
Asparagus...................................................        0.05
Avocado.....................................................        0.20
Blackberry..................................................        0.1
Blueberry...................................................        0.2
Cattle, fat.................................................        0.1
Cattle, liver...............................................        0.50
Cattle, meat................................................        0.1
Cattle, meat byproducts, except liver.......................        0.1
Cherry......................................................        0.1
Citrus, dried pulp..........................................        0.4
Citrus, molasses............................................        1.0
Cotton, undelinted seed.....................................        0.1
Cranberry...................................................        0.1
Fruit, citrus...............................................        0.2
Goat, fat...................................................        0.1
Goat, liver.................................................        0.50
Goat, meat..................................................        0.1
Goat, meat byproducts, except liver.........................        0.1
Grape.......................................................        0.1
Hazelnut....................................................        0.1
Hog, fat....................................................        0.1
Hog, liver..................................................        0.50
Hog, meat...................................................        0.1
Hog, meat byproducts, except liver..........................        0.1
Hop, dried cones............................................        3.0
Hop, vines..................................................        1.0
Horse, fat..................................................        0.1
Horse, liver................................................        0.50
Horse, meat.................................................        0.1
Horse, meat byproducts, except liver........................        0.1
Milk........................................................        0.1
Nectarine...................................................        0.1
Peach.......................................................        0.1
Peanut......................................................        0.05
Peanut, hay.................................................        5.50
Peanut, hay.................................................        1.5
Pear........................................................        0.1
Pecan.......................................................        0.1
Plum, prune, fresh..........................................        0.1
Poultry, fat................................................        0.1
Poultry, meat...............................................        0.1
Poultry, meat byproducts....................................        0.1
Raspberry...................................................        0.2
Sheep, fat..................................................        0.1
Sheep, liver................................................        0.50
Sheep, meat.................................................        0.1
Sheep, meat byproducts, except liver........................        0.1
Soybean.....................................................        0.1
Soybean, forage.............................................        1.0
Soybean, hay................................................        1.0
Walnut......................................................        0.1
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registration. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[47 FR 14909, Apr. 7, 1982]

    Editorial Note: For Federal Register citations affecting Sec. 
180.356, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.360  Asulam; tolerance for residues.

    (a) General. Tolerances are established for the combined residues of 
asulam (methyl sulfanilylcarbamate) and its sulfanilamide containing 
metabolites in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.05
Cattle, meat................................................        0.05
Cattle, meat byproducts.....................................        0.2
Goat, fat...................................................        0.05
Goat, meat..................................................        0.05
Goat, meat byproducts.......................................        0.2
Hog, fat....................................................        0.05
Hog, meat...................................................        0.05
Hog, meat byproducts........................................        0.2
Horse, fat..................................................        0.05
Horse, meat.................................................        0.05
Horse, meat byproducts......................................        0.2
Milk........................................................        0.05
Sheep, fat..................................................        0.05
Sheep, meat.................................................        0.05
Sheep, meat byproducts......................................        0.2
Sugarcane, cane.............................................        1.0
Sugarcane, molasses.........................................       30
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[68 FR 39441, July 1, 2003, as amended at 72 FR 37654, July 11, 2007]



Sec. 180.361  Pendimethalin; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide pendimethalin, including its metabolites and degradates, in or 
on the commodities. Compliance with the tolerance levels specified in 
the following table below is to be determined by measuring only 
pendimethalin, [N- (1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], 
and its metabolite, 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl 
alcohol, calculated as the stoichiometric equivalent of pendimethalin, 
in or on the following commodities:

[[Page 539]]



------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        3.5
Alfalfa, hay................................................        4.0
Alfalfa, seed...............................................        0.10
Almond, hulls...............................................        0.4
Apple, wet pomace...........................................        0.20
Artichoke, globe............................................        0.1
Asparagus...................................................        0.15
Beans.......................................................        0.10
Beans, forage...............................................        0.10
Beans, hay..................................................        0.10
Brassica head and stem, subgroup 5-A........................        0.1
Brassica, leafy greens, subgroup 5B.........................        0.20
Carrot......................................................        0.5
Citrus, oil.................................................        0.5
Corn, field, forage.........................................        0.1
Corn, field, grain..........................................        0.1
Corn, field, stover.........................................        0.1
Corn, pop, grain............................................        0.1
Corn, sweet, forage.........................................        0.1
Corn, sweet, kernel plus cob with husks removed.............        0.1
Corn, sweet, stover.........................................        0.1
Cotton, gin byproducts......................................        3.0
Cotton, undelinted seed.....................................        0.1
Crayfish....................................................        0.05
Fruit, citrus, group 10.....................................        0.1
Fruit, pome, group 11.......................................        0.10
Fruit, small vine climbing, except grape, subgroup 13-07E...        0.10
Fruit, stone, group 12......................................        0.10
Garlic......................................................        0.1
Grape.......................................................        0.1
Grass forage, fodder, and hay crop group 17, forage.........       20
Grass forage, fodder, and hay crop group 17, hay............       13
Grass forage, fodder, and hay crop group 17, straw..........        4.0
Juneberry...................................................        0.10
Leek........................................................        0.20
Lettuce, leaf...............................................        4.0
Melon subgroup 9A...........................................        0.10
Nut, tree, group 14.........................................        0.1
Olive.......................................................        0.1
Onion, bulb.................................................        0.1
Onion, green................................................        0.20
Onion, welsh................................................        0.20
Peanut......................................................        0.1
Peanut, hay.................................................        0.1
Peas (except field peas)....................................        0.10
Peppermint, oil.............................................        1.0
Peppermint, tops............................................        0.2
Pistachio...................................................        0.1
Pomegranate.................................................        0.10
Potato......................................................        0.1
Rice, grain.................................................        0.1
Rice, straw.................................................        0.1
Shallot.....................................................        0.2
Sorghum, forage.............................................        0.1
Sorghum, grain, grain.......................................        0.1
Sorghum, grain, stover......................................        0.1
Soybean, forage.............................................        0.1
Soybean, hay................................................        0.1
Soybean, seed...............................................        0.1
Spearmint, oil..............................................        1.0
Spearmint, tops.............................................        0.2
Strawberry..................................................        0.10
Sugarcane, cane.............................................        0.1
Sunflower, seed.............................................        0.1
Turnip greens...............................................        0.20
Vegetable, fruiting, group 8................................        0.10
Vegetable, soybean, succulent...............................        0.10
Wheat, grain................................................        0.10
Wheat, forage...............................................        3.0
Wheat, hay..................................................        0.60
Wheat, straw................................................        0.30
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for combined residues 
of the herbicide pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzenamine], and its metabolite 4-[(1-ethylpropyl)amino]-2-
methyl-3,5-dinitrobenzyl alcohol, in or on the specified agricultural 
commodities, resulting from use of the pesticide pursuant to FIFRA 
section 18 emergency exemptions. The tolerances expire and are revoked 
on the date specified in the table.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Bermuda grass, forage...........................         25     12/31/10
Bermuda grass, hay..............................         60     12/31/10
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[49 FR 15293, Apr. 18, 1984]

    Editorial Note: For Federal Register citations affecting Sec. 
180.361, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.362  Fenbutatin-oxide; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
miticide/acaricide fenbutatin-oxide, including its metabolites and 
degradates, in or on the plant commodities in the table in this 
paragraph. Compliance with the tolerance levels specified in this 
paragraph is to be determined by measuring only fenbutatin-oxide, 
hexakis (2-methyl-2-phenylpropyl) distannoxane, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................       80.0
Apple.......................................................       15.0
Apple, wet pomace...........................................      100.0
Cherry, sweet...............................................        6.0
Cherry, tart................................................        6.0
Citrus, dried pulp..........................................      100.0
Citrus, oil.................................................      140.0

[[Page 540]]

 
Cucumber....................................................        4.0
Eggplant....................................................        6.0
Fruit, citrus, group 10.....................................       20.0
Grape.......................................................        5.0
Grape, raisin...............................................       20.0
Nut, tree, group 14.........................................        0.5
Papaya......................................................        2.0
Peach.......................................................       10.0
Pear........................................................       15.0
Pistachio...................................................        0.5
Plum, prune, fresh..........................................        4.0
Plum, prune, dried..........................................       20.0
Strawberry..................................................       10.0
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the miticide/
acaricide fenbutatin-oxide, including its metabolites and degradates, in 
or on the animal commodities in the table in this paragraph. Compliance 
with the tolerance levels specified in this paragraph is to be 
determined by measuring only the sum of fenbutatin-oxide, hexakis (2-
methyl-2-phenylpropyl) distannoxane, and its organotin metabolites, 
dihydroxybis(2-methyl-2-phenylpropyl) stannane and 2-methyl-2-
phenylpropylstannoic acid, calculated as the stoichiometric equivalent 
of fenbutatin-oxide, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.5
Cattle, meat................................................        0.5
Cattle, meat byproducts.....................................        0.5
Egg.........................................................        0.1
Goat, fat...................................................        0.5
Goat, meat..................................................        0.5
Goat, meat byproducts.......................................        0.5
Hog, fat....................................................        0.5
Hog, meat...................................................        0.5
Hog, meat byproducts........................................        0.5
Horse, fat..................................................        0.5
Horse, meat.................................................        0.5
Horse, meat byproducts......................................        0.5
Milk, fat...................................................        0.1
Poultry, fat................................................        0.1
Poultry, meat...............................................        0.1
Poultry, meat byproducts....................................        0.1
Sheep, fat..................................................        0.5
Sheep, meat.................................................        0.5
Sheep, meat byproducts......................................        0.5
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. A tolerance with 
regional registration, as defined in Sec. 180.1(l), is established for 
residues of the miticide/acaricide fenbutatin-oxide, including its 
metabolites and degradates, in or on the plant commodity in the table in 
this paragraph. Compliance with the tolerance level specified in this 
paragraph is to be determined by measuring only fenbutatin-oxide, 
hexakis (2-methyl-2-phenylpropyl) distannoxane, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Raspberry...................................................       10.0
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33713, May 24, 2000, as amended at 72 FR 41930, Aug. 1, 2007; 73 
FR 5109, Jan. 29, 2008; 76 FR 23494, Apr. 27, 2011]



Sec. 180.364  Glyphosate; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
glyphosate, including its metabolites and degradates, in or on the 
commodities listed below resulting from the application of glyphosate, 
the isopropylamine salt of glyphosate, the ethanolamine salt of 
glyphosate, the dimethylamine salt of glyphosate, the ammonium salt of 
glyphosate, and the potassium salt of glyphosate. Compliance with the 
following tolerance levels is to be determined by measuring only 
glyphosate (N-(phosphonomethyl)glycine).

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Acerola.....................................................        0.2
Alfalfa, seed...............................................        0.5
Almond, hulls...............................................       25
Aloe vera...................................................        0.5
Ambarella...................................................        0.2
Animal feed, nongrass, group 18.............................      400
Artichoke, globe............................................        0.2
Asparagus...................................................        0.5
Atemoya.....................................................        0.2
Avocado.....................................................        0.2
Bamboo, shoots..............................................        0.2
Banana......................................................        0.2
Barley, bran................................................       30
Beet, sugar, dried pulp.....................................       25
Beet, sugar, roots..........................................       10
Beet, sugar, tops...........................................       10
Berry and small fruit, group 13-07..........................        0.20
Betelnut....................................................        1.0
Biriba......................................................        0.2
Blimbe......................................................        0.2
Breadfruit..................................................        0.2
Cacao bean, bean............................................        0.2
Cactus, fruit...............................................        0.5
Cactus, pads................................................        0.5
Canistel....................................................        0.2
Canola, seed................................................       20
Carrot......................................................        5.0
Chaya.......................................................        1.0
Cherimoya...................................................        0.2
Citrus, dried pulp..........................................        1.5
Coconut.....................................................        0.1
Coffee, bean, green.........................................        1.0

[[Page 541]]

 
Corn, pop, grain............................................        0.1
Corn, sweet, kernel plus cob with husk removed..............        3.5
Cotton, gin byproducts......................................      210
Custard apple...............................................        0.2
Date, dried fruit...........................................        0.2
Dokudami....................................................        2.0
Durian......................................................        0.2
Epazote.....................................................        1.3
Feijoa......................................................        0.2
Fig.........................................................        0.2
Fish........................................................        0.25
Fruit, citrus, group 10-10..................................        0.50
Fruit, pome, group 11-10....................................        0.20
Fruit, stone, group 12......................................        0.2
Galangal, roots.............................................        0.2
Ginger, white, flower.......................................        0.2
Gourd, buffalo, seed........................................        0.1
Governor's plum.............................................        0.2
Gow kee, leaves.............................................        0.2
Grain, cereal, forage, fodder and straw, group 16, except         100
 field corn, forage and field corn, stover..................
Grain, cereal, group 15 except field corn, popcorn, rice,          30
 sweet corn, and wild rice..................................
Grass, forage, fodder and hay, group 17.....................      300
Guava.......................................................        0.2
Herbs subgroup 19A..........................................        0.2
Hop, dried cones............................................        7.0
Ilama.......................................................        0.2
Imbe........................................................        0.2
Imbu........................................................        0.2
Jaboticaba..................................................        0.2
Jackfruit...................................................        0.2
Kava, roots.................................................        0.2
Kenaf, forage...............................................      200
Leucaena, forage............................................      200
Longan......................................................        0.2
Lychee......................................................        0.2
Mamey apple.................................................        0.2
Mango.......................................................        0.2
Mangosteen..................................................        0.2
Marmaladebox................................................        0.2
Mioga, flower...............................................        0.2
Noni........................................................        0.20
Nut, pine...................................................        1.0
Nut, tree, group 14.........................................        1.0
Oilseeds, group 20, except canola...........................       40
Okra........................................................        0.5
Olive.......................................................        0.2
Oregano, Mexican, leaves....................................        2.0
Palm heart..................................................        0.2
Palm heart, leaves..........................................        0.2
Palm, oil...................................................        0.1
Papaya......................................................        0.2
Papaya, mountain............................................        0.2
Passionfruit................................................        0.2
Pawpaw......................................................        0.2
Pea, dry....................................................        8.0
Peanut......................................................        0.1
Peanut, hay.................................................        0.5
Pepper leaf, fresh leaves...................................        0.2
Peppermint, tops............................................      200
Perilla, tops...............................................        1.8
Persimmon...................................................        0.2
Pineapple...................................................        0.1
Pistachio...................................................        1.0
Pomegranate.................................................        0.2
Pulasan.....................................................        0.2
Quinoa, grain...............................................        5.0
Rambutan....................................................        0.2
Rice, grain.................................................        0.1
Rice, wild, grain...........................................        0.1
Rose apple..................................................        0.2
Sapodilla...................................................        0.2
Sapote, black...............................................        0.2
Sapote, mamey...............................................        0.2
Sapote, white...............................................        0.2
Shellfish...................................................        3.0
Soursop.....................................................        0.2
Spanish lime................................................        0.2
Spearmint, tops.............................................      200
Spice subgroup 19B..........................................        7.0
Star apple..................................................        0.2
Starfruit...................................................        0.2
Stevia, dried leaves........................................        1.0
Sugar apple.................................................        0.2
Sugarcane, cane.............................................        2.0
Sugarcane, molasses.........................................       30
Surinam cherry..............................................        0.2
Sweet potato................................................        3.0
Tamarind....................................................        0.2
Tea, dried..................................................        1.0
Tea, instant................................................        7.0
Teff, forage................................................      100
Teff, grain.................................................        5.0
Teff, hay...................................................      100
Ti, leaves..................................................        0.2
Ti, roots...................................................        0.2
Ugli fruit..................................................        0.5
Vegetable, bulb, group 3-07.................................        0.20
Vegetable, cucurbit, group 9................................        0.5
Vegetable, foliage of legume, subgroup 7A, except soybean...        0.2
Vegetable, fruiting, group 8-10 (except okra)...............        0.10
Vegetable, leafy, brassica, group 5.........................        0.2
Vegetable, leafy, except brassica, group 4..................        0.2
Vegetable, leaves of root and tuber, group 2, except sugar          0.2
 beet tops..................................................
Vegetable, legume, group 6 except soybean and dry pea.......        5.0
Vegetables, root and tuber, group 1, except carrot, sweet           0.20
 potato, and sugar beet.....................................
Wasabi, roots...............................................        0.2
Water spinach, tops.........................................        0.2
Watercress, upland..........................................        0.2
Wax jambu...................................................        0.2
Yacon, tuber................................................        0.2
------------------------------------------------------------------------

    (2) Tolerances are established for residues of glyphosate, including 
its metabolites and degradates, in or on the commodities listed below 
resulting from the application of glyphosate, the isopropylamine salt of 
glyphosate, the ethanolamine salt of glyphosate, the dimethylamine salt 
of glyphosate, the ammonium salt of glyphosate, and the potassium salt 
of glyphosate. Compliance with the following tolerance levels is to be 
determined by measuring only glyphosate (N-(phosphonomethyl)glycine) and 
its metabolite N-acetyl-glyphosate (N-acetyl-N-(phosphonomethyl)glycine; 
calculated as the stoichiometric equivalent of glyphosate).

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             Million
------------------------------------------------------------------------
Cattle, meat byproducts.....................................        5.0

[[Page 542]]

 
Corn, field, forage.........................................       13
Corn, field, grain..........................................        5.0
Corn, field, stover.........................................      100
Egg.........................................................        0.05
Goat, meat byproducts.......................................        5.0
Grain aspirated fractions...................................      310.0
Hog, meat byproducts........................................        5.0
Horse, meat byproducts......................................        5.0
Poultry, meat...............................................        0.10
Poultry, meat byproducts....................................        1.0
Sheep, meat byproducts......................................        5.0
Soybean, forage.............................................      100.0
Soybean, hay................................................      200.0
Soybean, hulls..............................................      120.0
Soybean, seed...............................................       20.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[45 FR 64911, Oct. 1, 1980]

    Editorial Note: For Federal Register citations affecting Sec. 
180.364, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.367  n-Octyl bicycloheptenedi carboximide; tolerances for residues.

    (a) General. A tolerance of 5 parts per million is established for 
residues of the insecticide synergist N-octyl bicycloheptene 
dicarboximide, including its metabolites and degradates, in or on all 
food items in food handling establishments where food and food products 
are held, processed, prepared and/or served, provided that the food is 
removed or covered prior to such use, except for bagged food in 
warehouse storage which need not be removed or covered prior to 
applications of formulations containing N-octyl bicycloheptene 
dicarboximide. Compliance with the tolerance level specified in this 
paragraph is to be determined by measuring only N-octyl bicycloheptene 
dicarboximide, in or on the commodity.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33713, May 24, 2000, as amended at 75 FR 60243, Sept. 29, 2010]



Sec. 180.368  Metolachlor; tolerances for residues.

    (a) General. (1) Tolerances are established for the combined 
residues (free and bound) of the herbicide metolachlor, 2-chloro-N-(2- 
ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide, and its 
metabolites, determined as the derivatives, 2- [(2-ethyl-6- 
methylphenyl)amino]-1-propanol and 4-(2-ethyl-6-methylphenyl)-2- 
hydroxy-5-methyl-3-morpholinone, each expressed as the parent compound 
in the following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        0.30
Animal feed, nongrass, group 18.............................        1.0
Cattle, fat.................................................        0.02
Cattle, kidney..............................................        0.20
Cattle, liver...............................................        0.05
Cattle, meat................................................        0.02
Cattle, meat byproducts, except kidney and liver............        0.04
Corn, field, forage.........................................        6.0
Corn, field, grain..........................................        0.10
Corn, field, stover.........................................        6.0
Corn, pop, grain............................................        0.10
Corn, pop, stover...........................................        6.0
Corn, sweet, forage.........................................        6.0
Corn, sweet, kernel plus cob with husks removed.............        0.10
Corn, sweet, stover.........................................        6.0
Cotton, gin byproducts......................................        4.0
Cotton, undelinted seed.....................................        0.10
Dillweed....................................................        0.50
Egg.........................................................        0.02
Goat, fat...................................................        0.02
Goat, kidney................................................        0.20
Goat, liver.................................................        0.05
Goat, meat..................................................        0.02
Goat, meat byproducts, except kidney and liver..............        0.04
Grass, forage...............................................       10
Grass, hay..................................................        0.20
Horse, fat..................................................        0.02
Horse, kidney...............................................        0.20
Horse, liver................................................        0.05
Horse, meat.................................................        0.02
Horse, meat byproducts, except kidney and liver.............        0.04
Milk........................................................        0.02
Nut, tree, group 14.........................................        0.10
Okra........................................................        0.50
Peanut......................................................        0.20
Peanut, hay.................................................       20
Peanut, meal................................................        0.40
Potato......................................................        0.20
Poultry, fat................................................        0.02
Poultry, meat...............................................        0.02
Poultry, meat byproducts....................................        0.05
Safflower, seed.............................................        0.10
Sheep, fat..................................................        0.02
Sheep, kidney...............................................        0.20
Sheep, liver................................................        0.05
Sheep, meat.................................................        0.02
Sheep, meat byproducts, except kidney and liver.............        0.04
Sorghum, grain, forage......................................        1.0
Sorghum, grain, grain.......................................        0.30
Sorghum, grain, stover......................................        4.0
Soybean, forage.............................................        5.0

[[Page 543]]

 
Soybean, hay................................................        8.0
Soybean, seed...............................................        0.20
Tomato......................................................        0.10
Vegetable, foliage of legume, subgroup 7A, except soybean...       15.0
Vegetable, legume, group 6..................................        0.30
------------------------------------------------------------------------

    (2) Tolerances are established for residues of S-metolachlor, 
including its metabolites and degradates, in or on the commodity(s), as 
defined. Compliance with the tolerance levels specified in the following 
table below is to be determined by measuring only the sum of free and 
bound S-metolachlor, S-2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-
1-methylethyl)acetamide, its R-enantiomer, and its metabolites, 
determined as the derivatives, 2-(2-ethyl-6-methylphenyl)amino-1-
propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-
morpholinone, calculated as the stoichiometric equivalent of S-
metolachlor, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Asparagus...................................................        0.10
Beet, garden, leaves........................................        1.8
Beet, sugar, molasses.......................................        2.0
Beet, sugar, roots..........................................        0.5
Beet, sugar, tops...........................................       15.0
Brassica, head and stem, subgroup 5A........................        0.60
Brassica, leafy greens, subgroup 5B.........................        1.8
Bushberry subgroup 13-07B...................................        0.15
Caneberry subgroup 13-07A...................................        0.10
Carrot, roots...............................................        0.40
Cattle, fat.................................................        0.02
Cattle, kidney..............................................        0.20
Cattle, liver...............................................        0.05
Cattle, meat................................................        0.02
Cattle, meat byproducts, except kidney and liver............        0.04
Cilantro, leaves............................................        8.0
Coriander, seed.............................................        0.13
Corn, field, grain..........................................        0.10
Corn, field, forage.........................................        6.0
Corn, field, stover.........................................        6.0
Corn, pop, grain............................................        0.10
Corn, pop, stover...........................................        6.0
Corn, sweet, forage.........................................        6.0
Corn, sweet, kernel plus cob with husks removed.............        0.10
Corn, sweet, stover.........................................        6.0
Cotton, gin byproducts......................................        4.0
Cotton, undelinted seed.....................................        0.10
Cucumber....................................................        0.13
Egg.........................................................        0.02
Grain, aspirated fractions..................................        0.70
Goat, fat...................................................        0.02
Goat, kidney................................................        0.20
Goat, liver.................................................        0.05
Goat, meat..................................................        0.02
Goat, meat byproducts, except kidney and liver..............        0.04
Grass, forage...............................................       10.0
Grass, hay..................................................        0.20
Horse, fat..................................................        0.02
Horse, kidney...............................................        0.20
Horse, liver................................................        0.05
Horse, meat.................................................        0.02
Horse, meat byproducts, except kidney and liver.............        0.04
Leaf petioles, subgroup 4B..................................        0.10
Melon, subgroup 9A..........................................        0.10
Milk........................................................        0.02
Okra........................................................        0.10
Onion, bulb, subgroup 3-07A.................................        0.10
Onion, green, subgroup 3-07B................................        2.0
Peanut......................................................        0.20
Peanut, hay.................................................       20.0
Peanut, meal................................................        0.40
Poultry, fat................................................        0.02
Poultry, meat...............................................        0.02
Poultry, meat byproducts....................................        0.05
Pumpkin.....................................................        0.10
Safflower, seed.............................................        0.10
Sesame, seed................................................        0.13
Sheep, fat..................................................        0.02
Sheep, kidney...............................................        0.20
Sheep, liver................................................        0.05
Sheep, meat.................................................        0.02
Sheep, meat byproducts, except kidney and liver.............        0.04
Sorghum, grain, forage......................................        1.0
Sorghum, grain, grain.......................................        0.3
Sorghum, grain, stover......................................        4.0
Sorghum, sweet, stalk.......................................        4.0
Soybean, forage.............................................        5.0
Soybean, hay................................................        8.0
Soybean, seed...............................................        0.20
Spinach.....................................................        0.50
Squash, winter..............................................        0.10
Sunflower, seed.............................................        0.50
Sunflower, meal.............................................        1.0
Tomato, paste...............................................        0.30
Turnip, greens..............................................        1.8
Vegetable, foliage of legume, except soybean, subgroup 7A...       15.0
Vegetable, fruiting, group 8, except tabasco pepper.........        0.10
Vegetable, legume, group 6..................................        0.30
Vegetable, root, except sugar beet, subgroup 1B, except             0.30
 carrot.....................................................
Vegetable, tuberous and corm, subgroup 1C...................        0.20
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. (1) Tolerances with 
regional registration as defined in 180.1(l) are established for the 
combined residues (free and bound) of the herbicide metolachlor [2-
chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide] 
and its metabolites, determined as the derivatives, 2-[2-ethyl-6-
methylphenyl)amino]-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-
5-methyl-3-morpholinone, each expressed as the parent compound, in or on 
the following raw agricultural commodities:

[[Page 544]]



------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Pepper, nonbell.............................................        0.50
------------------------------------------------------------------------

    (2) Tolerances with regional registration are established for 
residues of S-metolachlor, including its metabolites and degradates, in 
or on the commodities identified in the following table below. 
Compliance with the tolerance levels specified in the following table 
below is to be determined by measuring only the sum of free and bound S-
metolachlor, S-2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-
methylethyl)acetamide, its R-enantiomer, and its metabolites, determined 
as the derivatives, 2-(2-ethyl-6-methylphenyl)amino-1-propanol and 4-(2-
ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone, calculated as 
the stoichiometric equivalent of S-metolachlor, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Pepper, tabasco.............................................        0.50
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. (1) Tolerances are established 
for the indirect or inadvertent combined residues (free and bound) of 
the herbicide metolachlor, 2-chloro-N-(2-ethyl-6- methylphenyl)-N-(2-
methoxy-1-methylethyl)acetamide, and its metabolites, determined as the 
derivatives, 2-[(2-ethyl-6-methylphenyl)amino]-1-propanol and 4-(2-
ethyl-6-methylphenyl)-2- hydroxy-5-methyl-3-morpholinone, each expressed 
as the parent compound in the following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Animal feed, nongrass, group 18.............................        1.0
Barley, grain...............................................        0.10
Barley, hay.................................................        0.80
Barley, straw...............................................        0.80
Buckwheat, grain............................................        0.10
Millet, forage..............................................        0.50
Millet, grain...............................................        0.10
Millet, hay.................................................        0.80
Millet, straw...............................................        0.80
Oat, forage.................................................        0.50
Oat, grain..................................................        0.10
Oat, hay....................................................        0.80
Oat, straw..................................................        0.80
Rice, grain.................................................        0.10
Rye, forage.................................................        0.50
Rye, grain..................................................        0.10
Rye, straw..................................................        0.80
Wheat, forage...............................................        0.50
Wheat, grain................................................        0.10
Wheat, hay..................................................        0.80
Wheat, straw................................................        0.80
------------------------------------------------------------------------

    (2) Tolerances for are established for the indirect or inadvertent 
residues of S-metolachlor, including its metabolites and degradates, in 
or on the commodities identified in the following table below. 
Compliance with the tolerance levels specified in the following table 
below is to be determined by measuring only the sum of free and bound S-
metolachlor, S-2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-
methylethyl)acetamide, its R-enantiomer, and its metabolites, determined 
as the derivatives, 2-(2-ethyl-6-methylphenyl)amino-1-propanol and 4-(2-
ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone, calculated as 
the stoichiometric equivalent of S-metolachlor, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Animal feed, nongrass, group 18.............................        1.0
Barley, grain...............................................        0.10
Barley, hay.................................................        0.50
Barley, straw...............................................        0.50
Buckwheat, grain............................................        0.10
Millet, forage..............................................        0.50
Millet, grain...............................................        0.10
Millet, hay.................................................        0.50
Millet, straw...............................................        0.50
Oat, forage.................................................        0.50
Oat, grain..................................................        0.10
Oat, hay....................................................        0.50
Oat, straw..................................................        0.50
Rice, grain.................................................        0.10
Rye, forage.................................................        0.50
Rye, grain..................................................        0.10
Rye, straw..................................................        0.50
Wheat, forage...............................................        0.50
Wheat, grain................................................        0.10
Wheat, hay..................................................        0.50
Wheat, straw................................................        0.50
------------------------------------------------------------------------


[73 FR 53740, Sept. 17, 2008, as amended at 74 FR 48412, Sept. 23, 2009; 
75 FR 56903, Sept. 17, 2010; 77 FR 48906, Aug. 15, 2012; 77 FR 59127, 
Sept. 26, 2012]



Sec. 180.370  5-Ethoxy-3-(trichloromethyl)-1,2,4-thiadiazole; tolerances for 

residues.

    (a) General. Tolerances are established for residues of the 
fungicide 5-ethoxy-3-(trichloromethyl)-1,2,4-thiadiazole and its 
monoacid metabolite 3-carboxy-5-ethoxy-1,2,4-thiadiazole in or on the 
following raw agricultural commodities:

[[Page 545]]



------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, grain...............................................        0.1
Barley, hay.................................................        0.1
Corn, field, forage.........................................        0.1
Corn, field, grain..........................................        0.1
Corn, field, stover.........................................        0.1
Corn, sweet, forage.........................................        0.1
Corn, sweet, stover.........................................        0.1
Cotton, gin byproducts......................................        0.1
Cotton, undelinted seed.....................................        0.1
Peanut......................................................        0.1
Peanut, hay.................................................        0.1
Safflower, seed.............................................        0.1
Sorghum, grain, forage......................................        0.1
Sorghum, grain, grain.......................................        0.1
Tomato......................................................        0.15
Vegetable, foliage of legume, group 7.......................        0.1
Vegetable, legume, group 6..................................        0.1
Wheat, forage...............................................        0.1
Wheat, grain................................................        0.1
Wheat, straw................................................        0.1
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[47 FR 49845, Nov. 3, 1982, as amended at 48 FR 12088, Mar. 23, 1983; 63 
FR 57076, Oct. 26, 1998; 72 FR 41931, Aug. 1, 2007; 73 FR 54961, Sept. 
24, 2008]



Sec. 180.371  Thiophanate-methyl; tolerances for residues.

    (a) General. Tolerances are established for residues of thiophanate-
methyl, dimethyl ((1,2-phenylene) bis (iminocarbonothioyl)) 
bis(carbamate), including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance levels 
specified in this paragraph is to be determined by measuring only the 
sum of thiophanate-methyl, dimethyl ((1,2-phenylene) bis 
(iminocarbonothioyl)) bis(carbamate), and its metabolite, methyl 2-
benzimidazoyl carbamate (MBC), calculated as the stoichiometric 
equivalent of thiophanate-methyl, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond......................................................        0.1
Almond, hulls...............................................        0.5
Apple.......................................................        2.0
Apricot.....................................................       15.0
Banana......................................................        2.0
Bean, dry, seed.............................................        0.2
Bean, snap, succulent.......................................        2.0
Beet, sugar, roots..........................................        0.2
Cherry, sweet...............................................       20.0
Cherry, tart................................................       20.0
Grain, aspirated fractions..................................       12
Grape.......................................................        5.0
Onion, bulb.................................................        0.5
Onion, green................................................        3.0
Peach.......................................................        3.0
Peanut......................................................        0.1
Peanut, hay.................................................        5.0
Pear........................................................        3.0
Pecan.......................................................        0.1
Pistachio...................................................        0.1
Plum........................................................        0.5
Potato......................................................        0.1
Soybean, hulls..............................................        1.5
Soybean, seed...............................................        0.2
Strawberry..................................................        7.0
Vegetable, cucurbit, group 9................................        1.0
Wheat, forage...............................................        1.1
Wheat, grain................................................        0.1
Wheat, hay..................................................        0.1
Wheat, straw................................................        0.1
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. A tolerance with a 
regional registration is established for residues of thiophanate-methyl, 
dimethyl ((1,2-phenylene) bis(iminocarbonothioyl)) bis(carbamate), 
including its metabolites and degradates, in or on the commodity in the 
following table. Compliance with the tolerance level specified in this 
paragraph is to be determined by measuring only the sum of thiophanate-
methyl, dimethyl ((1,2-phenylene) bis (iminocarbonothioyl)) 
bis(carbamate), and its metabolite, methyl 2-benzimidazoyl carbamate 
(MBC), calculated as the stoichiometric equivalent of thiophanate-
methyl, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Canola, seed................................................        0.1
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[75 FR 60244, Sept. 29, 2010]



Sec. 180.372  2,6-Dimethyl-4-tridecylmorpholine; tolerances for residues.

    (a) General. A tolerance is established for residues of the 
fungicide 2,6-dimethyl-4-tridecylmorpholine in or on the following food 
commodity:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Banana \1\..................................................        1.0
------------------------------------------------------------------------
\1\ There are no U.S. registrations.


[[Page 546]]

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[73 FR 54961, Sept. 24, 2008]



Sec. 180.373  [Reserved]



Sec. 180.377  Diflubenzuron; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide diflubenzuron (N-[[(4-chlorophenyl)amino]carbonyl]-2,6-
difluorobenzamide) in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Artichoke, globe............................................        6.0
Cattle, fat.................................................        0.05
Cattle, meat................................................        0.05
Cotton, undelinted seed.....................................        0.2
Egg.........................................................        0.05
Goat, fat...................................................        0.05
Goat, meat..................................................        0.05
Grapefruit..................................................        0.5
Hog, fat....................................................        0.05
Hog, meat...................................................        0.05
Horse, fat..................................................        0.05
Horse, meat.................................................        0.05
Milk........................................................        0.05
Mushroom....................................................        0.2
Orange, sweet...............................................        0.5
Poultry, fat................................................        0.05
Poultry, meat byproducts....................................        0.05
Poultry, meat...............................................        0.05
Sheep, fat..................................................        0.05
Sheep, meat.................................................        0.05
Soybean.....................................................        0.05
Soybean, hulls..............................................        0.5
Tangerine...................................................        0.5
------------------------------------------------------------------------

    (2) Tolerances are established for combined residues of the 
insecticide diflubenzuron and its metabolites 4-chlorophenlyurea and 4-
chloroaniline in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        6.0
Barley, grain...............................................        0.06
Barley, hay.................................................        3.0
Barley, straw...............................................        1.8
Brassica, leafy greens, subgroup 5B.........................        9.0
Cattle, meat byproducts.....................................        0.15
Fruit, stone, group 12, except cherry.......................        0.07
Goat, meat byproducts.......................................        0.15
Grain, aspirated fractions..................................       11
Grass, forage, fodder, and hay, group 17....................        6.0
Hog, meat byproducts........................................        0.15
Horse, meat byproducts......................................        0.15
Nut, tree, group 14.........................................        0.06
Oat, forage.................................................        7.0
Oat, grain..................................................        0.06
Oat, hay....................................................        6.0
Oat, straw..................................................        3.5
Peanut......................................................        0.10
Peanut, hay.................................................       55
Peanut, refined oil.........................................        0.20
Pear........................................................        0.50
Pepper......................................................        1.0
Pistachio...................................................        0.06
Pummelo.....................................................        0.50
Rice, grain.................................................        0.02
Rice, straw.................................................        0.8
Sheep, meat byproducts......................................        0.15
Turnip greens...............................................        9.0
Wheat, forage...............................................        7.0
Wheat, grain................................................        0.06
Wheat, hay..................................................        6.0
Wheat, straw................................................        3.5
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for of the insecticide diflubenzuron, (N-[[(4-
chlorophenyl)amino]carbonyl]-2,6- difluorobenzamide and its metabolites 
4-chlorophenylurea and 4-chloroaniline, in connection with use of the 
pesticide under section 18 emergency exemptions granted by EPA. The 
tolerances are specified in the following table, and will expire and are 
revoked on the dates specified.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Alfalfa, forage.................................        6.0     12/31/14
Alfalfa, hay....................................        6.0     12/31/14
Lemon...........................................        0.8     12/31/10
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33699, May 24, 2000]

    Editorial Note: For Federal Register citations affecting Sec. 
180.377, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.378  Permethrin; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the insecticide cis- and trans-permethrin isomers [cis-(3-
phenoxyphenyl)methyl 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropane 
carboxylate] and [trans-(3-phenoxyphenyl)methyl 3-(2,2-dichloroethenyl)-
2,2-

[[Page 547]]

dimethylcyclopropane carboxylate] in/on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................       20
Alfalfa, hay................................................       45
Almond......................................................        0.05
Almond, hulls...............................................       20
Artichoke, globe............................................        5.0
Asparagus...................................................        2.0
Avocado.....................................................        1.0
Broccoli....................................................        2.0
Brussels sprouts............................................        1.0
Cabbage.....................................................        6.0
Cattle, fat.................................................        1.5
Cattle, meat................................................        0.10
Cattle, meat byproducts.....................................        0.10
Cauliflower.................................................        0.5
Cherry, sweet...............................................        4.0
Cherry, tart................................................        4.0
Corn, field, forage.........................................       50
Corn, field, grain..........................................        0.05
Corn, field, stover.........................................       30
Corn, pop, grain............................................        0.05
Corn, pop, stover...........................................       30
Corn, sweet, forage.........................................       50
Corn, sweet, kernel plus cob with husks removed.............        0.10
Corn, sweet, stover.........................................       30
Egg.........................................................        0.10
Eggplant....................................................        0.50
Fruit, pome, group 11.......................................        0.05
Garlic, bulb................................................        0.10
Grain, aspirated fractions..................................        0.50
Goat, fat...................................................        1.5
Goat, meat..................................................        0.10
Goat, meat byproducts.......................................        0.10
Hazelnut....................................................        0.05
Hog, fat....................................................        0.05
Hog, meat...................................................        0.05
Hog, meat byproducts........................................        0.05
Horse, fat..................................................        1.5
Horse, meat.................................................        0.10
Horse, meat byproducts......................................        0.10
Horseradish.................................................        0.50
Kiwifruit...................................................        2.0
Leaf petioles subgroup 4B...................................        5.0
Leafy greens subgroup 4A....................................       20
Lettuce, head...............................................       20
Milk, fat (reflecting 0.88 ppm in whole milk)...............        3.0
Mushroom....................................................        5.0
Onion, bulb.................................................        0.10
Peach.......................................................        1.0
Pepper, bell................................................        0.50
Pistachio...................................................        0.10
Potato......................................................        0.05
Poultry, fat................................................        0.15
Poultry, meat...............................................        0.05
Poultry, meat byproducts....................................        0.05
Sheep, fat..................................................        1.5
Sheep, meat.................................................        0.10
Sheep, meat byproducts......................................        0.10
Soybean, seed...............................................        0.05
Spinach.....................................................       20
Tomato......................................................        2.0
Vegetable, cucurbit, group 9................................        1.5
Walnut......................................................        0.05
Watercress..................................................        5.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration, as defined in Sec. 180.1(l) are established for the 
combined residues of the insecticide cis- and trans-permethrin isomers 
[cis-(3-phenoxyphenyl)methyl 3-(2,2-dichloroethenyl)-2,2-
dimethylcyclopropane carboxylate] and [trans-(3-phenoxyphenyl)methyl 3-
(2,2-dichloroethenyl)-2,2-dimethylcyclopropane carboxylate] in/on the 
following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Collards....................................................       15
Grass, forage...............................................       15
Grass, hay..................................................       15
Papaya......................................................        1.0
Turnip, tops................................................       10
Turnip, roots...............................................        0.20
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[72 FR 52019, Sept. 12, 2007]



Sec. 180.380  Vinclozolin; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the fungicide vinclozolin (3-(3,5-dichlorophenyl)-5-ethenyl-5-methyl-
2,4-oxazolidinedione) and its metabolites containing the 3,5-
dichloroaniline moiety in or on the food commodities in the table below. 
There are no U.S. registrations for grape (wine) as of July 30, 1997.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   Revocation
                                                   million       Date
------------------------------------------------------------------------
Bean, succulent.................................        2.0     11/30/05
Canola, seed....................................        1.0     11/30/08
Cattle, fat.....................................       0.05     11/30/08
Cattle, meat....................................       0.05     11/30/08
Cattle, meat byproducts.........................       0.05     11/30/08
Egg.............................................       0.05     11/30/08
Goat, fat.......................................       0.05     11/30/08
Goat, meat......................................       0.05     11/30/08
Goat, meat byproducts...........................       0.05     11/30/08
Grape, wine.....................................       6. 0         None
Hog, fat........................................       0.05     11/30/08
Hog, meat.......................................       0.05     11/30/08
Hog, meat byproducts............................       0.05     11/30/08
Horse, fat......................................       0.05     11/30/08
Horse, meat.....................................       0.05     11/30/08
Horse, meat byproducts..........................       0.05     11/30/08
Lettuce, head...................................       10.0     11/30/05
Lettuce, leaf...................................       10.0     11/30/05
Milk............................................       0.05     11/30/08
Poultry, fat....................................        0.1     11/30/08
Poultry, meat...................................        0.1     11/30/08
Poultry, meat byproducts........................        0.1     11/30/08
Sheep, fat......................................       0.05     11/30/08
Sheep, meat.....................................       0.05     11/30/08
Sheep, meat byproducts..........................       0.05     11/30/08
------------------------------------------------------------------------


[[Page 548]]

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
    (e) Revoked tolerances subject to the channel of trade provisions. 
The following table lists commodities with residues of vinclozolin 
resulting from lawful use are subject to the channels of trade 
provisions of section 408(l)(5) of the FFDCA:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cucumber....................................................        1.0
Fruit, stone, except plum, prune, fresh.....................       25.0
Pepper, bell................................................        3.0
Strawberry..................................................       10.0
------------------------------------------------------------------------


[62 FR 38474, July 18, 1997, as amended at 63 FR 7308, Feb. 13, 1998; 65 
FR 44468, July 18, 2000; 67 FR 40189, June 12, 2002; 68 FR 56189, Sept. 
30, 2003; 68 FR 69323, Dec. 12, 2003; 70 FR 55268, Sept. 21, 2005]



Sec. 180.381  Oxyfluorfen; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide oxyfluorfen [2-chloro-1-(3-ethoxy-4-nitrophenoxy)-4-
(trifluoromethyl)benzene] in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        0.1
Artichoke, globe............................................        0.05
Avocado.....................................................        0.05
Banana......................................................        0.05
Broccoli....................................................        0.05
Cabbage.....................................................        0.05
Cacao bean, dried bean......................................        0.05
Cattle, fat.................................................        0.01
Cattle, meat................................................        0.01
Cattle, meat byproducts.....................................        0.01
Cauliflower.................................................        0.05
Coffee, bean, green.........................................        0.05
Corn, field, grain..........................................        0.05
Cotton, undelinted seed.....................................        0.05
Date, dried fruit...........................................        0.05
Egg.........................................................        0.03
Feijoa......................................................        0.05
Fig.........................................................        0.05
Fruit, pome, group 11.......................................        0.05
Fruit, stone, group 12......................................        0.05
Goat, fat...................................................        0.01
Goat, meat..................................................        0.01
Goat, meat byproducts.......................................        0.01
Grape.......................................................        0.05
Hog, fat....................................................        0.01
Hog, meat...................................................        0.01
Hog, meat byproducts........................................        0.01
Horse, fat..................................................        0.01
Horse, meat.................................................        0.01
Horse, meat byproducts......................................        0.01
Horseradish.................................................        0.05
Kiwifruit...................................................        0.05
Milk........................................................        0.01
Nut, tree, group 14.........................................        0.05
Olive.......................................................        0.05
Onion, bulb.................................................        0.05
Peppermint, tops............................................        0.05
Persimmon...................................................        0.05
Pistachio...................................................        0.05
Pomegranate.................................................        0.05
Poultry, fat................................................        0.2
Poultry, meat...............................................        0.01
Poultry, meat byproducts....................................        0.01
Sheep, fat..................................................        0.01
Sheep, meat.................................................        0.01
Sheep, meat byproducts......................................        0.01
Soybean.....................................................        0.05
Spearmint, tops.............................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration are established for residues of the herbicide oxyfluorfen 
[2-chloro-1-(3-ethoxy-4-nitrophenoxy)-4-(trifluoromethyl)benzene] in or 
on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Blackberry..................................................        0.05
Chickpea, seed..............................................        0.05
Grass, forage...............................................        0.05
Grass, hay..................................................        0.05
Grass, seed screenings......................................        0.05
Guava.......................................................        0.05
Papaya......................................................        0.05
Raspberry...................................................        0.05
Taro, corm..................................................        0.05
Taro, leaves................................................        0.05
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[45 FR 85022, Dec. 24, 1980]

    Editorial Note: For Federal Register citations affecting Sec. 
180.381, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.383  Sodium salt of acifluorfen; tolerances for residues.

    (a) General. Tolerances are established for combined residues of the 
herbicide sodium salt of acifluorfen, sodium 5-[2-chloro-4-
(trifluoromethyl)phenoxy]-2-nitrobenzoate, and its metabolites (the 
corresponding acid, methyl ester, and amino analogues) in or on the 
following raw agricultural commodities:

[[Page 549]]



------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Peanut......................................................        0.1
Rice, grain.................................................        0.1
Rice, straw.................................................        0.2
Soybean, seed...............................................        0.1
Strawberry..................................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional restrictions. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[45 FR 24877, Apr. 11, 1980, as amended at 46 FR 61272, Dec. 16, 1981; 
47 FR 39490, Sept. 8, 1982; 61 FR 30165, June 14, 1996; 62 FR 39974, 
July 25, 1997; 67 FR 35048, May 17, 2002; 69 FR 6567, Feb. 11, 2004; 71 
FR 54434, Sept. 15, 2006]



Sec. 180.384  Mepiquat (N,N-dimethylpip eridinium); tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
plant growth regulator mepiquat (N,N-dimethylpiperidinium) in or on the 
following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, meat byproducts.....................................        0.1
Cotton, gin byproducts......................................        6.0
Cotton, undelinted seed.....................................        2.0
Goat, meat byproducts.......................................        0.1
Hog, meat byproducts........................................        0.1
Horse, meat byproducts......................................        0.1
Sheep, meat byproducts......................................        0.1
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the plant growth 
regulator mepiquat chloride (N,N-dimethylpiperidinium chloride) in or on 
the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.1
Cattle, meat................................................        0.1
Goat, fat...................................................        0.1
Goat, meat..................................................        0.1
Grape.......................................................        1.0
Grape, raisin...............................................        5.0
Hog, fat....................................................        0.1
Hog, meat...................................................        0.1
Horse, fat..................................................        0.1
Horse, meat.................................................        0.1
Sheep, fat..................................................        0.1
Sheep, meat.................................................        0.1
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[67 FR 3118, Jan. 23, 2002]



Sec. 180.385  Diclofop-methyl; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the herbicide diclofop-methyl (methyl 2-[4-(2,4-
dichlorophenoxy)phenoxy]propanoate) and its metabolites, 2-[4-(2,4-
dichlorophenoxy)phenoxy]propanoic acid and 2-[4-(2,4-dichloro-5-
hydroxyphenoxy)phenoxy]propanoic acid, in or on the following raw 
agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, grain...............................................        0.1
Barley, straw...............................................        0.1
Wheat, grain................................................        0.1
Wheat, straw................................................        0.1
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[45 FR 23425, Apr. 7, 1980, as amended at 50 FR 20211, May 15, 1985; 51 
FR 3599, Jan. 29, 1986; 51 FR 19176, May 28, 1986; 63 FR 57077, Oct. 26, 
1998; 72 FR 41931, Aug. 1, 2007]



Sec. Sec. 180.388-180.389  [Reserved]



Sec. 180.390  Tebuthiuron; tolerances for residues.

    (a) General. (1) Tolerances are established for the combined 
residues of the herbicide tebuthiuron (N-(5-(1,1-dimethylethyl)-1,3,4-
thiadiazol-2-yl)-N,N'-dimethylurea) and its metabolites N-(5-(2-hydroxy-
1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N,N'-dimethylurea, N-(5-(1,1-
dimethylethyl)-1,3,4-thiadiazol-2-yl)-N-methylurea, and N-(5-(1,1-
dimethylethyl)-1,3,4-thiadiazol-2-yl)-N'-hydroxymethyl-N-methylurea in 
or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grass, forage...............................................       10.0
Grass, hay..................................................       10.0
------------------------------------------------------------------------

    (2) Tolerances are established for the combined residues of the 
herbicide

[[Page 550]]

tebuthiuron (N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N,N'-
dimethylurea) and its metabolites N-(5-(1,1-dimethylethyl)-1,3,4-
thiadiazol-2-yl)-N-methylurea, N-(5-(1,1-dimethylethyl)-1,3,4-
thiadiazol-2-yl)urea, 2-dimethylethyl-5-amino-1,3,4-thiadiazole, and N-
(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-N'-hydroxymethyl-N-
methylurea in or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        1.0
Cattle, meat................................................        1.0
Cattle, meat byproducts.....................................        5.0
Goat, fat...................................................        1.0
Goat, meat..................................................        1.0
Goat, meat byproducts.......................................        5.0
Horse, fat..................................................        1.0
Horse, meat.................................................        1.0
Horse, meat byproducts......................................        5.0
Sheep, fat..................................................        1.0
Sheep, meat.................................................        1.0
Sheep, meat byproducts......................................        5.0
------------------------------------------------------------------------

    (3) A tolerance is established for the combined residues of the 
herbicide tebuthiuron (N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-
N,N'-dimethylurea) and its metabolites N-(5-(1,1-dimethylethyl)-1,3,4-
thiadiazol-2-yl)-N-methylurea, N-(5-(2-hydroxy-1,1-dimethylethyl)-1,3,4-
thiadiazol-2-yl)-N-methylurea, N-(5-(1,1-dimethylethyl)-1,3,4-
thiadiazol-2-yl)urea, N-(5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl)-
N'-hydroxymethyl-N-methylurea, and N-(5-(2-hydroxy-1,1-dimethylethyl)-
1,3,4-thiadiazol-2-yl)-N'-hydroxymethyl-N-methylurea in or on the 
following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Milk........................................................        0.8
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[72 FR 53461, Sept. 19, 2007]



Sec. 180.395  Hydramethylnon; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide tetrahydro-5,5-dimethyl-2(1H)-pyrimidinone(3-(4-
(trifluoromethyl)phenyl)-1-(2-(4-(trifluoromethyl)phenyl)ethenyl)-2-
propenylidene)hydrazone in or on the following raw agricultural 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grass, forage...............................................        2.0
Grass, hay..................................................        2.0
Pineapple...................................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[45 FR 55198, Aug. 19, 1980, as amended at 63 FR 10543, Mar. 4, 1998; 63 
FR 65073, Nov. 25, 1998; 66 FR 28672, May 24, 2001; 68 FR 37764, June 
25, 2003; 68 FR 48312, Aug. 13, 2003; 72 FR 41931, Aug. 1, 2007]



Sec. 180.396  Hexazinone; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
herbicide hexazinone, 3-cyclohexyl-6-(dimethylamino)-1-methyl-1,3,5-
triazine-2,4-(1H, 3H)-dione, including its metabolites and degradates, 
in or on the commodities in the following table. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only the sum of hexazinone, 3-cyclohexyl-6-(dimethylamino)-1-
methyl-1,3,5-triazine-2,4-(1H, 3H)-dione, and its plant metabolites: 
metabolite A, 3-(4-hydroxycyclohexyl)-6-(dimethylamino)-1-methyl-1,3,5-
triazine-2,4-(1H, 3H)-dione, metabolite B, 3-cyclohexyl-6-(methylamino)-
1-methyl-1,3,5-triazine-2,4-(1H, 3H)-dione, metabolite C, 3-(4-
hydroxycyclohexyl)-6-(methylamino)-1-methyl-1,3,5-triazine-2,4-(1H, 3H)-
dione, metabolite D, 3-cyclohexyl-1-methyl-1,3,5-triazine-2,4,6-(1H, 3H, 
5H)-trione, and metabolite E, 3-(4-hydroxycyclohexyl)-1-methyl-1,3,5-
triazine-2,4,6-(1H, 3H, 5H)-trione, calculated as the stoichiometric 
equivalent of hexazinone, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        2.0
Alfalfa, hay................................................        4.0

[[Page 551]]

 
Alfalfa, seed...............................................        2.0
Blueberry...................................................        0.6
Grass, forage...............................................      250
Grass, hay..................................................      230
Pineapple...................................................        0.6
Sugarcane, cane.............................................        0.6
Sugarcane, molasses.........................................        4.0
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the herbicide 
hexazinone, 3-cyclohexyl-6-(dimethylamino)-1-methyl-1,3,5-triazine-2,4-
(1H, 3H)-dione, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance levels 
specified in this paragraph is to be determined by measuring only the 
sum of hexazinone, 3-cyclohexyl-6-(dimethylamino)-1-methyl-1,3,5-
triazine-2,4-(1H, 3H)-dione, and its animal tissue metabolites: 
metabolite B, 3-cyclohexyl-6-(methylamino)-1-methyl-1,3,5-triazine-2,4-
(1H, 3H)-dione, and metabolite F, 3-cyclohexyl-6-amino-1-methyl-1,3,5-
triazine-2,4-(1H, 3H)-dione, calculated as the stoichiometric equivalent 
of hexazinone, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.1
Cattle, meat................................................        0.5
Cattle, meat byproducts.....................................        4.0
Goat, fat...................................................        0.1
Goat, meat..................................................        0.5
Goat, meat byproducts.......................................        4.0
Hog, fat....................................................        0.1
Hog, meat...................................................        0.5
Hog, meat byproducts........................................        4.0
Horse, fat..................................................        0.1
Horse, meat.................................................        0.5
Horse, meat byproducts......................................        4.0
Sheep, fat..................................................        0.1
Sheep, meat.................................................        0.5
Sheep, meat byproducts......................................        4.0
------------------------------------------------------------------------

    (3) A tolerance is established for residues of the herbicide 
hexazinone, 3-cyclohexyl-6-(dimethylamino)-1-methyl-1,3,5-triazine-2,4-
(1H, 3H)-dione, including its metabolites and degradates, in or on the 
commodity in the following table. Compliance with the tolerance level 
specified in this paragraph is to be determined by measuring only the 
sum of hexazinone, 3-cyclohexyl-6-(dimethylamino)-1-methyl-1,3,5-
triazine-2,4-(1H, 3H)-dione, and its metabolites: metabolite B, 3-
cyclohexyl-6-(methylamino)-1-methyl-1,3,5-triazine-2,4-(1H, 3H)-dione, 
metabolite C, 3-(4-hydroxycyclohexyl)-6-(methylamino)-1-methyl-1,3,5-
triazine-2,4-(1H, 3H)-dione, metabolite C-2, 3-(3-hydroxycyclohexyl)-6-
(methylamino)-1-methyl-1,3,5-triazine-2,4-(1H, 3H)-dione, and metabolite 
F, 3-cyclohexyl-6-amino-1-methyl-1,3,5-triazine-2,4-(1H, 3H)-dione, 
calculated as the stoichiometric equivalent of hexazinone, in or on the 
commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Milk........................................................       11
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33713, May 24, 2000, as amended at 71 FR 56399, Sept. 27, 2006; 
75 FR 60244, Sept. 29, 2010]



Sec. 180.399  Iprodione; tolerances for residues.

    (a) General. (1) Tolerances are established for the combined 
residues of the fungicide iprodione [3-(3,5-dichlorophenyl)-N-(1-
methylethyl)-2,4-dioxo-1-imidazolidinecarboxamide], its isomer 3-(1-
methylethyl)-N-(3,5-dichlorophenyl)-2,4-dioxo-1-
imidazolidinecarboxamide, and its metabolite 3-(3,5-dichlorophenyl)-2,4-
dioxo-1-imidazolidine-carboxamide in or on the following food 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        2.0
Almond......................................................        0.3
Apricot.....................................................       20.0
Bean, dry, seed.............................................        2.0
Bean, forage................................................       90.0
Bean, succulent.............................................        2.0
Blueberry...................................................       15.0
Boysenberry.................................................       15.0
Broccoli....................................................       25.0
Caneberry subgroup 13A......................................       25.0
Carrot, roots...............................................        5.0
Cherry, sweet, postharvest..................................       20.0
Cherry, tart................................................       20.0
Cotton, undelinted seed.....................................        0.10
Cowpea, hay.................................................       90.0
Currant.....................................................       15.0
Garlic......................................................        0.1
Ginseng.....................................................        2.0
Ginseng, dried root.........................................        4.0
Grape.......................................................       60.0
Grape, raisin...............................................      300
Kiwifruit...................................................       10.0
Lettuce.....................................................       25.0
Nectarine, postharvest......................................       20.0

[[Page 552]]

 
Onion, bulb.................................................        0.5
Peach, postharvest..........................................       20.0
Peanut......................................................        0.5
Peanut, hay.................................................      150.0
Plum, postharvest...........................................       20.0
Plum, prune.................................................       20.0
Potato......................................................        0.5
Raspberry...................................................       15.0
Rice, bran..................................................       30.0
Rice, grain.................................................       10.0
Rice, hulls.................................................       50.0
Rice, straw.................................................       20.0
Strawberry..................................................       15.0
------------------------------------------------------------------------

    (2) Tolerances are established for the combined residues of 
iprodione [3-(3,5-dichlorophenyl)-N-(1-methylethyl)-2,4-dioxo-1-
imidazolidinecarboxamide], its isomer [3-(1-methylethyl)-N-(3,5-
dichlorophenyl)-2,4-dioxo-1-imidazolidinecarboxamide, and its 
metabolites [3-(3,5-dichlorophenyl)-2,4-dioxo-1-imidazolidine-
carboxamide] and [N-(3,5-dichloro-4-hydroxyphenyl)-ureido-carboxamide], 
all expressed as iprodione equivalents in or on the following food 
commodities of animal origin:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.5
Cattle, kidney..............................................        3.0
Cattle, liver...............................................        3.0
Cattle, meat................................................        0.5
Cattle, meat byproducts, except kidney and liver............        0.5
Egg.........................................................        1.5
Goat, fat...................................................        0.5
Goat, kidney................................................        3.0
Goat, liver.................................................        3.0
Goat, meat..................................................        0.5
Goat, meat byproducts, except kidney and liver..............        0.5
Hog, fat....................................................        0.5
Hog, kidney.................................................        3.0
Hog, liver..................................................        3.0
Hog, meat...................................................        0.5
Hog, meat byproducts, except kidney and liver...............        0.5
Horse, fat..................................................        0.5
Horse, kidney...............................................        3.0
Horse, liver................................................        3.0
Horse, meat.................................................        0.5
Horse, meat byproducts, except kidney and liver.............        0.5
Milk........................................................        0.5
Poultry, fat................................................        3.5
Poultry, liver..............................................        5.0
Poultry, meat...............................................        1.0
Poultry, meat byproducts, except liver......................        1.0
Sheep, fat..................................................        0.5
Sheep, kidney...............................................        3.0
Sheep, liver................................................        3.0
Sheep, meat.................................................        0.5
Sheep, meat byproducts, except kidney and liver.............        0.5
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration, as defined in Sec. 180.1(l), are established for the 
combined residues of the fungicide iprodione [3-(3,5-dichlorophenyl)-N-
(1-methylethyl)-2,4-dioxo-1-imidazolidinecarboxamide], its isomer [3-(1-
methylethyl)-N-(3,5-dichlorophenyl)-2,4-dioxo-1-
imidazolidinecarboxamide], and its metabolite [3-(3,5-dichlorophenyl)-
2,4-dioxo-1-imidazolidinecarboxamide] in or on the following food 
commodity:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Mustard greens..............................................       15.0
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[48 FR 40385, Sept. 7, 1983]

    Editorial Note: For Federal Register citations affecting Sec. 
180.399, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.401  Thiobencarb; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the herbicide thiobencarb (S-[(4-chlorophenyl)methyl]diethyl-
carbamothioate) and its chlorobenzyl and chlorophenyl moiety-containing 
metabolites in or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Part per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.2
Cattle, meat byproducts.....................................        0.2
Cattle, meat................................................        0.2
Egg.........................................................        0.2
Goat, fat...................................................        0.2
Goat, meat byproducts.......................................        0.2
Goat, meat..................................................        0.2
Hog, fat....................................................        0.2
Hog, meat byproducts........................................        0.2
Hog, meat...................................................        0.2
Horse, fat..................................................        0.2
Horse, meat byproducts......................................        0.2
Horse, meat.................................................        0.2
Milk........................................................        0.05
Poultry, fat................................................        0.2
Poultry, meat byproducts....................................        0.2
Poultry, meat...............................................        0.2
Rice, grain.................................................        0.2
Rice, straw.................................................        1.0
Sheep, fat..................................................        0.2
Sheep, meat byproducts......................................        0.2
Sheep, meat.................................................        0.2
------------------------------------------------------------------------


[[Page 553]]

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration, as defined in Sec. 180.1(l), are established for residues 
of the herbicide thiobencarb (S-[(4-chloro-
phenyl)methyl]diethylcarbamothioate) and its chlorobenzyl and 
chlorophenyl moiety-containing metabolites in or on the following raw 
agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Celery......................................................        0.2
Endive......................................................        0.2
Lettuce.....................................................        0.2
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[47 FR 6833, Feb. 17, 1982, as amended at 56 FR 2440, Jan. 23, 1991; 76 
FR 34885, June 15, 2011]



Sec. 180.403  Thidiazuron; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the defoliant thidiazuron (N-phenyl-N-1,2,3-thiadiazol-5-ylurea) and its 
aniline containing metabolites in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.4
Cattle, meat................................................        0.4
Cattle, meat byproducts.....................................        0.4
Cotton, gin byproducts......................................       24.0
Cotton, undelinted seed.....................................        0.3
Goat, fat...................................................        0.4
Goat, meat..................................................        0.4
Goat, meat byproducts.......................................        0.4
Hog, fat....................................................        0.4
Hog, meat...................................................        0.4
Hog, meat byproducts........................................        0.4
Horse, fat..................................................        0.4
Horse, meat.................................................        0.4
Horse, meat byproducts......................................        0.4
Milk........................................................        0.05
Sheep, fat..................................................        0.4
Sheep, meat.................................................        0.4
Sheep, meat byproducts......................................        0.4
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33700, May 24, 2000, as amended at 72 FR 53462, Sept. 19, 2007]



Sec. 180.404  Profenofos; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide profenofos (O-(4-bromo-2-chlorophenyl)-O-ethyl-S-propyl 
phosphorothioate) in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.05
Cattle, meat................................................        0.05
Cattle, meat byproducts.....................................        0.05
Cotton, gin byproducts......................................       55.0
Cotton, undelinted seed.....................................        2.0
Goat, fat...................................................        0.05
Goat, meat..................................................        0.05
Goat, meat byproducts.......................................        0.05
Horse, fat..................................................        0.05
Horse, meat.................................................        0.05
Horse, meat byproducts......................................        0.05
Milk........................................................        0.01
Sheep, fat..................................................        0.05
Sheep, meat.................................................        0.05
Sheep, meat byproducts......................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33700, May 24, 2000, as amended at 66 FR 50833, Oct. 5, 2001; 67 
FR 49617, July 31, 2002; 72 FR 54579, Sept. 26, 2007]



Sec. 180.405  Chlorsulfuron; tolerances for residues.

    (a) General. (1) Tolerances are established for the combined 
residues of chlorsulfuron (2-chloro-N-[(4-methoxy-6-methyl-1,3,5-
triazin-2-yl)aminocarbonyl]benzenesulfonamide) and its metabolite, 2-
chloro-5-hydroxy-N-[(4-methoxy-6-methyl-1,3,5-triazin-2-
yl)aminocarbonyl] benzenesulfonamide in or on the following raw 
agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, grain...............................................        0.1
Barley, straw...............................................        0.5
Oat, forage.................................................       20.0
Oat, grain..................................................        0.1
Oat, straw..................................................        0.5
Wheat, forage...............................................       20.0
Wheat, grain................................................        0.1
Wheat, straw................................................        0.5
------------------------------------------------------------------------

    (2) Tolerances are established for residues of chlorsulfuron (2-
chloro-N-[(4-methoxy-6-methyl-1,3,5-triazin-2-

[[Page 554]]

yl)aminocarbonyl] benzenesulfonamide) in or on the following raw 
agricultural commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.3
Cattle, meat................................................        0.3
Cattle, meat byproducts.....................................        0.3
Goat, fat...................................................        0.3
Goat, meat..................................................        0.3
Goat, meat byproducts.......................................        0.3
Grass, forage...............................................       11.0
Grass, hay..................................................       19.0
Hog, fat....................................................        0.3
Hog, meat...................................................        0.3
Hog, meat byproducts........................................        0.3
Horse, fat..................................................        0.3
Horse, meat.................................................        0.3
Horse, meat byproducts......................................        0.3
Milk........................................................        0.1
Sheep, fat..................................................        0.3
Sheep, meat.................................................        0.3
Sheep, meat byproducts......................................        0.3
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[67 FR 52873, Aug. 14, 2002]



Sec. 180.407  Thiodicarb; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the insecticide thiodicarb (dimethyl N,N'-
[thiobis[[(methylimino)carbonyloxy]] bis[ethanimidothioate]) and its 
metabolite methomyl (S-methyl N-[(methylcarbamoyl) oxy]thioacetimidate) 
in or on the following food commodities or groups. The time-limited 
tolerances expire and are revoked on the dates listed in the following 
table:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Broccoli........................................     7.0         None
Cabbage.........................................     7.0         None
Cauliflower.....................................     7.0         None
Corn, sweet, kernel plus cob with husks removed.     2.0         None
Cotton, undelinted seed.........................     0.4         None
Soybean, hulls..................................     0.8         None
Soybean.........................................     0.2         None
Vegetable, leafy, except brassica, group 4......      35         None
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[62 FR 44595, Aug. 22, 1997, as amended at 75 FR 60245, Sept. 29, 2010]



Sec. 180.408  Metalaxyl; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the fungicide metalaxyl [N-(2,6-dmethylphyenyl)-N-(methoxyacetyl) 
alanine methylester] and its metabolites containing the 2,6-
dimethylaniline moiety, and N-(2-hydroxy methyl-6-methylphenyl)-N-
(methoxyacetyl)-alanine methyl ester, each expressed as metalaxyl 
equivalents, in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        6.0
Alfalfa, hay................................................       20.0
Almond......................................................        0.5
Almond, hulls...............................................       10.0
Apple.......................................................        0.2
Apple, wet pomace...........................................        0.4
Apricot, dried..............................................        4.0
Asparagus...................................................        7.0
Avocado.....................................................        4.0
Beet, garden, roots.........................................        0.1
Beet, garden, tops..........................................        0.1
Beet, sugar.................................................        0.1
Beet, sugar, molasses.......................................        1.0
Beet, sugar, roots..........................................        0.5
Beet, sugar, tops...........................................       10.0
Blueberry...................................................        2.0
Broccoli....................................................        2.0
Brussels sprouts............................................        2.0
Cabbage.....................................................        1.0
Cattle, fat.................................................        0.4
Cattle, kidney..............................................        0.4
Cattle, liver...............................................        0.4
Cattle, meat................................................        0.05
Cattle, meat byproducts, except kidney and liver............        0.05
Cauliflower.................................................        1.0
Citrus, oil.................................................        7.0
Citrus, dried pulp..........................................        7.0
Clover, forage..............................................        1.0
Clover, hay.................................................        2.5
Cotton, undelinted seed.....................................        0.1
Cranberry...................................................        4.0
Egg.........................................................        0.05
Fruit, citrus...............................................        1.0
Fruit, stone, group 12......................................        1.0
Ginseng.....................................................        3.0
Goat, fat...................................................        0.4
Goat, kidney................................................        0.4
Goat, liver.................................................        0.4
Goat, meat..................................................        0.05
Goat, meat byproducts, except kidney and liver..............        0.05
Grain, cereal, group 15, except barley, oat and wheat.......        0.1
Grain, crop.................................................        0.1
Grape.......................................................        2.0
Grape, raisin...............................................        6.0
Grass, forage...............................................       10.0
Grass, hay..................................................       25.0
Hog, fat....................................................        0.4

[[Page 555]]

 
Hog, kidney.................................................        0.4
Hog, liver..................................................        0.4
Hog, meat...................................................        0.05
Hog, meat byproducts, except kidney and liver...............        0.05
Hop, dried cones............................................       20
Hop, vines..................................................        2.0
Horse, fat..................................................        0.4
Horse, kidney...............................................        0.4
Horse, liver................................................        0.4
Horse, meat.................................................        0.05
Horse, meat byproducts, except kidney and liver.............        0.05
Lettuce, head...............................................        5.0
Milk........................................................        0.02
Mustard greens..............................................        5.0
Onion, bulb.................................................        3.0
Onion, green................................................       10.0
Peanut......................................................        0.2
Peanut, hay.................................................       20.0
Peanut, meal................................................        1.0
Peanut, hulls...............................................        2.0
Pineapple...................................................        0.1
Pineapple, fodder...........................................        0.1
Pineapple, forage...........................................        0.1
Plum, prune, dried..........................................        4.0
Potato, chips...............................................        4.0
Potato, granules, flakes....................................        4.0
Potato, processed potato waste..............................        4.0
Potato, wet peel............................................        4.0
Poultry, fat................................................        0.4
Poultry, kidney.............................................        0.4
Poultry, liver..............................................        0.4
Poultry, meat...............................................        0.05
Poultry, meat byproducts, except kidney and liver...........        0.05
Potato......................................................        0.5
Raspberry...................................................        0.5
Sheep, fat..................................................        0.4
Sheep, kidney...............................................        0.4
Sheep, liver................................................        0.4
Sheep, meat.................................................        0.05
Sheep, meat byproducts, except kidney and liver.............        0.05
Soybean, hulls..............................................        2.0
Soybean, meal...............................................        2.0
Soybean, seed...............................................        1.0
Spinach.....................................................       10.0
Strawberry..................................................       10.0
Sunflower, seed.............................................        0.1
Sunflower, forage...........................................        0.1
Tomato, paste...............................................        3.0
Tomato, puree...............................................        3.0
Vegetable, brassica, leafy, group 5, except broccoli,               0.1
 cabbage, cauliflower, brussels sprouts, and mustard greens.
Vegetable, cucurbit, group 9................................        1.0
Vegetable, foilage of legume, group 7.......................        8.0
Vegetable, fruiting, group 8................................        1.0
Vegetable, leafy, except brassica, group 4, except spinach..        5.0
Vegetable, leaves of root and tuber, group 2................       15.0
Vegetable, legume, cannery waste............................        5.0
Vegetable, legume, group 6..................................        0.2
Vegetable, root and tuber, group 1..........................        0.5
Walnut......................................................        0.5
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration (refer to Sec. 180.1(m)) are established for the combined 
residues of the fungicide metalaxyl [N-(2,6-dimethylphenyl)-N-
(methoxyacetyl) alanine methyl ester] and its metabolites containing the 
2,6-dimethylaniline moiety, and N-(2-hydroxy methyl-6-methyl)-N-
(methoxyacetyl)-alanine methylester, each expressed as metalaxyl, in or 
on the following raw agricultural commodity:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Papaya......................................................        0.1
------------------------------------------------------------------------

    (d) Indirect or inadvertent tolerances. Tolerances are established 
for indirect or inadvertent residues of metalaxyl in or on the food 
commodities when present therein as a result of the application of 
metalaxyl to growing crops listed in paragraph (a) of this section and 
other non-food crops to read as follows:

------------------------------------------------------------------------
                                                               Part per
                          Commodity                             million
------------------------------------------------------------------------
Barley, bran................................................        1.0
Barley, flour...............................................        1.0
Barley, grain...............................................        0.2
Barley, pearled barley......................................        1.0
Barley, straw...............................................        2.0
Grain, cereal, forage, fodder and straw, group 16, except           1.0
 barley, oat, and wheat; forage.............................
Grain, cereal, forage, fodder and straw, group 16, except           1.0
 barley, oat, and wheat; stover.............................
Grain, cereal, forage, fodder and straw, group 16, except           1.0
 barley, oat, and wheat; straw..............................
Oat, flour..................................................        1.0
Oat, forage.................................................        2.0
Oat, grain..................................................        0.2
Oat, groats, rolled oats....................................        1.0
Oat, straw..................................................        2.0
Wheat, bran.................................................        1.0
Wheat, flour................................................        1.0
Wheat, forage...............................................        2.0
Wheat, germ.................................................        1.0
Wheat, grain................................................        0.2
Wheat, middlings............................................        1.0
Wheat, shorts...............................................        1.0
Wheat, straw................................................        2.0
------------------------------------------------------------------------


[65 FR 33700, May 24, 2000, as amended at 72 FR 35666, June 29, 2007; 74 
FR 46374, Sept. 9, 2009; 75 FR 56015, Sept. 15, 2010]



Sec. 180.409  Pirimiphos-methyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide pirimiphos-methyl (O-(2-diethylamino-6-methyl-4-pyrimidinyl) 
O,O-dimethyl phosphorothioate) in or on the following raw agricultural 
commodities:

[[Page 556]]



------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.02
Cattle, meat byproducts.....................................        0.02
Corn, field, grain..........................................        8.0
Corn, pop, grain............................................        8.0
Goat, fat...................................................        0.02
Goat, meat byproducts.......................................        0.02
Grain, aspirated fractions..................................       20.0
Hog, fat....................................................        0.02
Hog, meat byproducts........................................        0.02
Horse, fat..................................................        0.02
Horse, meat byproducts......................................        0.02
Poultry, fat................................................        0.02
Sheep, fat..................................................        0.02
Sheep, meat byproducts......................................        0.02
Sorghum, grain, grain.......................................        8.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33714, May 24, 2000, as amended at 67 FR 41807, June 19, 2002; 67 
FR 49617, July 31, 2002; 70 FR 44492, Aug. 3, 2005; 72 FR 53462, Sept. 
19, 2007]



Sec. 180.410  Triadimefon; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the fungicide triadimefon, 1-(4-chlorophenoxy)-3,3-dimethyl-1-(1H-1,2,4-
triazol-1-yl)-2-butanone, and triadimenol, [beta]-(4-chlorophenoxy)-
[alpha]-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol, expressed as 
triadimefon, in or on the following food commodities:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   Revocation
                                                   million       Date
------------------------------------------------------------------------
Pineapple.......................................        2.0         None
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[73 FR 54962, Sept. 24, 2008, as amended at 76 FR 34885, June 15, 2011]



Sec. 180.411  Fluazifop-P-butyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide fluazifop-P-butyl, including its metabolites and degradates, 
in or on the following commodities in the table. Compliance with the 
tolerance levels specified in the table below is to be determined by 
measuring only the sum of fluazifop-P-butyl, butyl(R)-2-[4-[[5-
(trifluoromethyl)-2-pyridinyl]oxy]phenoxy]propanoate, and the free and 
conjugated forms of the resolved isomer of fluazifop, (R)-2-[4-[[5-
(trifluoromethyl)-2-pyridinyl]oxy]phenoxy]propanoic acid, calculated as 
the stoichiometric equivalent of fluazifop, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Banana......................................................        0.01
Beans, dry, seed............................................       50
Beet, sugar, dried pulp.....................................        1.0
Beet, sugar, molasses.......................................        3.5
Beet, sugar, roots..........................................        0.25
Carrot, roots...............................................        2.0
Cattle, fat.................................................        0.05
Cattle, meat................................................        0.05
Cattle, meat byproducts.....................................        0.05
Citrus, dried pulp..........................................        0.40
Citrus, juice...............................................        0.06
Citrus, oil.................................................       30.0
Cotton, gin byproducts......................................        1.5
Cotton, refined oil.........................................        1.3
Cotton, undelinted seed.....................................        1.0
Egg.........................................................        0.05
Endive......................................................        6.0
Fruit, citrus, group 10.....................................        0.03
Fruit, stone................................................        0.05
Goat, fat...................................................        0.05
Goat, meat..................................................        0.05
Goat, meat byproducts.......................................        0.05
Grape.......................................................        0.01
Hog, fat....................................................        0.05
Hog, meat...................................................        0.05
Hog, meat byproducts........................................        0.05
Horse, fat..................................................        0.05
Horse, meat.................................................        0.05
Horse, meat byproducts......................................        0.05
Milk........................................................        0.05
Nut, macadamia..............................................        0.1
Onion, bulb.................................................        0.5
Peanut......................................................        1.5
Peanut, meal................................................        2.2
Pecans......................................................        0.05
Poultry, fat................................................        0.05
Poultry, meat...............................................        0.05
Poultry, meat byproducts....................................        0.05
Potato\1\...................................................        1.0
Potato, chips\1\............................................        2.0
Potato, granules/flakes\1\..................................        4.0
Sheep, fat..................................................        0.05
Sheep, meat.................................................        0.05
Sheep, meat byproducts......................................        0.05
Soybean, seed...............................................        2.5
Sweet potato, roots.........................................        0.05
------------------------------------------------------------------------
\1\ No U.S. registrations.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registrations are established for residues of the herbicide fluazifop-P-
butyl, including its metabolites and degradates,

[[Page 557]]

in or on the following commodities in the table. Compliance with the 
tolerance levels specified in the table below is to be determined by 
measuring only the sum of fluazifop-P-butyl, butyl(R)-2-[4-[[5-
(trifluoromethyl)-2-pyridinyl]oxy]phenoxy]propanoate, and the free and 
conjugated forms of the resolved isomer of fluazifop, (R)-2-[4-[[5-
(trifluoromethyl)-2-pyridinyl]oxy]phenoxy]propanoic acid, calculated as 
the stoichiometric equivalent of fluazifop, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Asparagus...................................................        3.0
Coffee, bean................................................        0.1
Pepper, tabasco.............................................        1.0
Rhubarb.....................................................        0.5
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33714, May 24, 2000, as amended at 74 FR 9372, Mar. 4, 2009; 74 
FR 46374, Sept. 9, 2009; 74 FR 47457, Sept. 16, 2009; 76 FR 5703, Feb. 
2, 2011; 76 FR 59908, Sept. 28, 2011]



Sec. 180.412  Sethoxydim; tolerances for residues.

    (a) General. Tolerances are established for combined residues of the 
herbicide 2-[1-(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-
cyclohexen-1-one (CAS Reg. No. 74051-80-2) and its metabolites 
containing the 2-cyclohexen-1-one moiety (calculated as the herbicide) 
in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................       40
Alfalfa, hay................................................       40
Almond, hulls...............................................        2.0
Apricot.....................................................        0.2
Apple, wet pomace...........................................        0.8
Asparagus...................................................        4.0
Bean, succulent.............................................       15
Beet, sugar, molasses.......................................       10
Beet, sugar, tops...........................................        3.0
Blueberry...................................................        4.0
Borage, meal................................................       10
Borage, seed................................................        6.0
Buckwheat, flour............................................       25
Buckwheat, grain............................................       19
Caneberry subgroup 13 A.....................................        5.0
Canola, meal................................................       40
Canola, seed................................................       35
Cattle, fat.................................................        0.2
Cattle, meat................................................        0.2
Cattle, meat byproducts.....................................        1.0
Cherry, sweet...............................................        0.2
Cherry, tart................................................        0.2
Citrus, dried pulp..........................................        1.5
Clover, forage..............................................       35
Clover, hay.................................................       55
Coriander, leaves...........................................        4.0
Corn, field, forage.........................................        2.0
Corn, field, grain..........................................        0.5
Corn, field, stover.........................................        2.5
Corn, sweet, forage.........................................        3.0
Corn, sweet, kernel plus cob with husk removed..............        0.4
Corn, sweet, stover.........................................        3.5
Cotton, undelinted seed.....................................        5.0
Cowpea, forage..............................................       15
Cowpea, hay.................................................       50
Crambe, meal................................................       40.0
Crambe, seed................................................       35.0
Cranberry...................................................        2.5
Cuphea, seed................................................       35.0
Dillweed, fresh leaves......................................       10
Echium, seed................................................       35.0
Egg.........................................................        2.0
Flax, seed..................................................        5.0
Fruit, citrus, group 10.....................................        0.5
Fruit, pome, group 11.......................................        0.2
Goat, fat...................................................        0.2
Goat, meat..................................................        0.2
Goat, meat byproducts.......................................        1.0
Gold of pleasure, meal......................................       40.0
Gold of pleasure, seed......................................       35.0
Grape.......................................................        1.0
Grape, raisin...............................................        2.0
Hare's ear mustard, seed....................................       35.0
Hog, fat....................................................        0.2
Hog, meat...................................................        0.2
Hog, meat byproducts........................................        1.0
Horse, fat..................................................        0.2
Horse, meat.................................................        0.2
Horse, meat byproducts......................................        1.0
Juneberry...................................................        5.0
Lesquerella, seed...........................................       35.0
Lingonberry.................................................        5.0
Lunaria, seed...............................................       35.0
Meadowfoam, seed............................................       35.0
Milk........................................................        0.5
Milkweed, seed..............................................       35.0
Mustard, seed...............................................       35.0
Nectarine...................................................        0.2
Nut, tree, group 14.........................................        0.2
Oil radish, seed............................................       35.0
Okra........................................................        2.5
Pea and bean, dried shelled, except soybean, subgroup 6C....       25
Pea, field, hay.............................................       40
Pea, field, vines...........................................       20
Pea, succulent..............................................       10
Peach.......................................................        0.2
Peanut......................................................       25
Peppermint, tops............................................       30
Pistachio...................................................        0.2
Poppy, seed.................................................       35.0
Potato granules/flakes......................................        8.0
Potato waste, processed.....................................        8.0
Poultry, fat................................................        0.2
Poultry, meat...............................................        0.2
Poultry, meat byproducts....................................        2.0
Radish, tops................................................        4.5
Rapeseed, meal..............................................       40
Rapeseed, seed..............................................       35
Safflower, seed.............................................       15
Salal.......................................................        5.0
Sesame, seed................................................       35.0
Sheep, fat..................................................        0.2
Sheep, meat.................................................        0.2
Sheep, meat byproducts......................................        1.0

[[Page 558]]

 
Soybean, hay................................................       10
Soybean, seed...............................................       16
Spearmint, tops.............................................       30
Strawberry..................................................       10
Sunflower, meal.............................................       20
Sunflower, seed.............................................        7.0
Sweet rocket, seed..........................................       35.0
Turnip, tops................................................        5.0
Vegetable, brassica, leafy, group 5.........................        5.0
Vegetable, bulb, group 3....................................        1.0
Vegetable, cucurbit, group 9................................        4.0
Vegetable, fruiting, group 8................................        4.0
Vegetable, leafy, except brassica, group 4..................        4.0
Vegetable, root and tuber, group 1..........................        4.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registration. Tolerances with regional 
registration, as defined in Sec. 180.1(l), are established for the 
combined residues of the herbicide 2-[1-(ethoxyimino)butyl]-5-[2-
(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one) and its metabolites 
containing the 2-cyclohexen-1-one moiety (calculated as the herbicide) 
in or on the following commodities:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   Revocation
                                                   million       Date
------------------------------------------------------------------------
Artichoke, globe................................        5.0         None
Rhubarb.........................................        0.3         None
------------------------------------------------------------------------

    (d) Indirect and inadvertent residues. [Reserved]

[62 FR 17740, Apr. 11, 1997]

    Editorial Note: For Federal Register citations affecting Sec. 
180.412, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.413  Imazalil; tolerances for residues.

    (a) General. (1) Tolerances are established for the combined 
residues of the fungicide imazalil, 1-[2-(2,4-dichlorophenyl)-2-(2-
propenyloxy)ethyl]-1H-imidazole, and its metabolite, 1-(2,4-
dichlorophenyl)-2-(1H-imidazole-1-yl)-1-ethanol, in or on the following 
food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Banana......................................................        3.0
Barley, grain...............................................        0.1
Barley, hay.................................................        0.5
Barley, straw...............................................        0.5
Citrus, dried pulp..........................................       25.0
Citrus, oil.................................................      200.0
Fruit, citrus, postharvest..................................       10.0
Wheat, forage...............................................        0.5
Wheat, grain................................................        0.1
Wheat, hay..................................................        0.5
Wheat, straw................................................        0.5
------------------------------------------------------------------------

    (2) Tolerances are established for the combined residues of the 
fungicide imazalil, 1-[2-(2,4-dichlorophenyl)-2-(2-propenyloxy)ethyl]-
1H-imidazole, and its metabolites, 3-[2-(2,4-dichlorophenyl)-2-(2,3-
dihydroxypropoxy)ethyl]-2,4-imidazolidinedione (FK772) and 3-[2-(2,4-
dichlorophenyl)-2-(hydroxy)]-2,4-imidazolidinedione (FK284), in or on 
the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.01
Cattle, meat................................................        0.01
Cattle, meat byproducts.....................................        0.2
Goat, fat...................................................        0.01
Goat, meat..................................................        0.01
Goat, meat byproducts.......................................        0.2
Horse, fat..................................................        0.01
Horse, meat.................................................        0.01
Horse, meat byproducts......................................        0.2
Milk........................................................        0.02
Sheep, fat..................................................        0.01
Sheep, meat.................................................        0.01
Sheep, meat byproducts......................................        0.2
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33715, May 24, 2000, as amended at 67 FR 46893, July 17, 2002; 71 
FR 54434, Sept. 15, 2006]



Sec. 180.414  Cyromazine; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide cyromazine, including its metabolites and degradates, in or 
on the commodities in the table in this paragraph. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only cyromazine, N-cyclopropyl-1,3,5-triazine-2,4,6-triamine, 
in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Bean, dry, except cowpea....................................        3.0

[[Page 559]]

 
Bean, lima..................................................        1.0
Bean, succulent.............................................        2.0
Broccoli....................................................        1.0
Cabbage, abyssinian.........................................       10.0
Cabbage, seakale............................................       10.0
Cattle, fat.................................................        0.05
Cattle, kidney..............................................        0.2
Cattle, meat................................................        0.05
Cattle, meat byproducts, except kidney......................        0.05
Egg.........................................................        0.25
Garlic......................................................        0.2
Garlic, great-headed, bulb..................................        0.2
Goat, fat...................................................        0.05
Goat, kidney................................................        0.2
Goat, meat..................................................        0.05
Goat, meat byproducts, except kidney........................        0.05
Hanover salad, leaves.......................................       10.0
Hog, fat....................................................        0.05
Hog, kidney.................................................        0.2
Hog, meat...................................................        0.05
Hog, meat byproducts, except kidney.........................        0.05
Horse, fat..................................................        0.05
Horse, kidney...............................................        0.2
Horse, meat.................................................        0.05
Horse, meat byproducts, except kidney.......................        0.05
Leek........................................................        3.0
Mango \1\...................................................        0.3
Milk........................................................        0.05
Mushroom....................................................        1.0
Onion, bulb.................................................        0.2
Onion, green................................................        3.0
Onion, potato...............................................        3.0
Onion, tree.................................................        3.0
Onion, welsh................................................        3.0
Pepper......................................................        1.0
Potato......................................................        0.8
Poultry, fat (from chicken layer hens and chicken breeder           0.05
 hens only).................................................
Poultry, meat (from chicken layer hens and chicken breeder          0.05
 hens only).................................................
Poultry, meat byproducts (from chicken layer hens and               0.05
 chicken breeder hens only).................................
Rakkyo, bulb................................................        0.2
Shallot, bulb...............................................        0.2
Shallot, fresh leaves.......................................        3.0
Sheep, fat..................................................        0.05
Sheep, kidney...............................................        0.2
Sheep, meat.................................................        0.05
Sheep, meat byproducts, except kidney.......................        0.05
Tomato......................................................        0.5
Turnip, greens..............................................       10.0
Vegetable, brassica, leafy, group 5, except broccoli........       10.0
Vegetable, leafy, except brassica, group 4..................        7.0
Vegetable, cucurbit, group 9................................        1.0
------------------------------------------------------------------------
\1\There are no U.S. registrations on mango as of May 4, 2000.

    (2) A tolerance of 5.0 parts per million is established for residues 
of the insecticide cyromazine, including its metabolites and degradates, 
in or on poultry feed when used as a feed additive only in feed for 
chicken layer hens and chicken breeder hens at the rate of not more than 
0.01 pound of cyromazine per ton of poultry feed for control of flies in 
manure of treated chicken layer hens and chicken breeder hens, provided 
the feeding of cyromazine-treated feed must stop at least 3 days (72 
hours) before slaughter. If the feed is formulated by any person other 
than the end user, the formulator must inform the end user, in writing, 
of the 3-day (72 hours) pre-slaughter interval. Compliance with the 
tolerance level specified in this paragraph is to be determined by 
measuring only cyromazine, N-cyclopropyl-1,3,5-triazine-2,4,6-triamine, 
in or on the commodity.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established for 
indirect or inadvertent residues of the insecticide cyromazine, 
including its metabolites and degradates, in or on the commodities in 
the table in this paragraph when present therein as a result of the 
application of cyromazine to growing crops listed in paragraph (a)(1) of 
this section. Compliance with the tolerance levels specified in this 
paragraph is to be determined by measuring only cyromazine, N-
cyclopropyl-1,3,5-triazine-2,4,6-triamine, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cotton, undelinted seed.....................................        0.1
Corn, sweet, kernel plus cob with husks removed.............        0.5
Corn, sweet, forage.........................................        0.5
Corn, sweet, stover.........................................        0.5
Radish, roots...............................................        0.5
Radish, tops................................................        0.5
------------------------------------------------------------------------


[65 FR 25860, May 4, 2000, as amended at 67 FR 72593, Dec. 6, 2002; 68 
FR 55269, Sept. 24, 2003; 75 FR 22256, Apr. 28, 2010; 76 FR 23494, Apr. 
27, 2011]



Sec. 180.415  Aluminum tris (O-ethylphosphonate); tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide aluminum tris (O-ethylphosphonate), including its metabolites 
and degradates, in or on the commodities in the table in this paragraph. 
Compliance with the tolerance levels specified in this paragraph is to 
be determined by measuring only aluminum tris (O-ethylphosphonate), in 
or on the commodity.

[[Page 560]]



------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Avocado.....................................................       25
Banana......................................................        3.0
Bushberry subgroup 13B......................................       40
Caneberry subgroup 13A......................................        0.1
Cranberry...................................................        0.5
Fruit, citrus, group 10.....................................        5.0
Fruit, pome, group 11.......................................       10
Ginseng.....................................................        0.1
Hop, dried cones............................................       45
Juneberry...................................................       40
Lingonberry.................................................       40
Nut, macadamia..............................................        0.20
Onion, bulb.................................................        0.5
Onion, green................................................       10.0
Pea, succulent..............................................        0.3
Pineapple...................................................        0.1
Salal.......................................................       40
Strawberry..................................................       75
Tomato......................................................        3
Turnip, greens..............................................       40
Turnip, roots...............................................       15
Vegetable, brassica, leafy, group 5.........................       60
Vegetable, cucurbit, group 9................................       15
Vegetable, leafy, except brassica, group 4..................      100
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration, as defined in Sec. 180.1(l), are established for residues 
of the fungicide aluminum tris (O-ethylphosphonate), including its 
metabolites and degradates, in or on the commodities in the table in 
this paragraph. Compliance with the tolerance levels specified in this 
paragraph is to be determined by measuring only aluminum tris (O-
ethylphosphonate), in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Asparagus...................................................        0.1
Grape.......................................................       10
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[64 FR 36801, July 8, 1999, as amended at 64 FR 37875, July 14, 1999; 65 
FR 50438, Aug. 18, 2000; 67 FR 55346, Aug. 29, 2002; 68 FR 11335, Mar. 
10, 2003; 70 FR 7047, Feb. 10, 2005; 76 FR 23494, Apr. 27, 2011]



Sec. 180.416  Ethalfluralin; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide ethalfluralin [N-ethyl-N-(2-methyl-2-propenyl)-2,6-dinitro-4-
(trifluoromethyl)benzenamine] in or on the following raw agricultural 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Bean, dry, seed.............................................        0.05
Dill, dried leaves..........................................        0.05
Dill, fresh leaves..........................................        0.05
Mustard, seed...............................................        0.05
Peanut......................................................        0.05
Pea, dry, seed..............................................        0.05
Potato......................................................        0.05
Rapeseed, seed..............................................        0.05
Safflower, seed.............................................        0.05
Soybean.....................................................        0.05
Sunflower, seed.............................................        0.05
Vegetable, cucurbit, group 9................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[49 FR 391, Jan. 4, 1984, as amended at 50 FR 4976, Feb. 5, 1985; 52 FR 
11262, Apr. 8, 1987; 62 FR 66014, Dec. 17, 1997; 64 FR 5191, Feb. 3, 
1999; 64 FR 54782, Oct. 8, 1999; 66 FR 37598, July 19, 2001; 66 FR 
41454, Aug. 8, 2001; 67 FR 2342, Jan. 17, 2002; 67 FR 49617, July 31, 
2002; 72 FR 68534, Dec. 5, 2007]



Sec. 180.417  Triclopyr; tolerances for residues.

    (a) General. (1) Tolerances for residues of the herbicide triclopyr 
per se, as a result of the application/use of butoxyethyl ester of 
triclopyr and triethyylamine salt of triclopyr, are established in or on 
the following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Egg.........................................................        0.05
Fish........................................................        3.0
Grass, forage...............................................      700.0
Grass, hay..................................................      200.0
Milk........................................................        0.01
Poultry, fat................................................        0.1
Poultry, meat...............................................        0.1
Poultry, meat byproducts, except kidney.....................        0.1
Rice, grain.................................................        0.3
Rice, straw.................................................       10.0
Shellfish...................................................        3.5
------------------------------------------------------------------------

    (2) Tolerances for the combined residues of the herbicide triclopyr 
((3,5,6-trichloro-2-pyridinyl)oxy) acetic acid and its metabolite 3,5,6-
trichloro-2-pyridinol (TCP), as a result of the application/use of 
butoxyethyl ester of triclopyr or the triethylamine salt of triclopyr, 
are established in or on the following raw agricultural commodities:

[[Page 561]]



------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.05
Cattle, kidney..............................................        0.5
Cattle, liver...............................................        0.5
Cattle, meat................................................        0.05
Cattle, meat byproducts, except kidney and liver............        0.05
Goat, fat...................................................        0.05
Goat, kidney................................................        0.5
Goat, liver.................................................        0.5
Goat, meat..................................................        0.05
Goat, meat byproducts, except kidney and liver..............        0.05
Hog, fat....................................................        0.05
Hog, kidney.................................................        0.5
Hog, liver..................................................        0.5
Hog, meat...................................................        0.05
Hog, meat byproducts, except kidney and liver...............        0.05
Horse, fat..................................................        0.05
Horse, kidney...............................................        0.5
Horse, liver................................................        0.5
Horse, meat.................................................        0.05
Horse, meat byproducts, except kidney and liver.............        0.05
Sheep, fat..................................................        0.05
Sheep, kidney...............................................        0.5
Sheep, liver................................................        0.5
Sheep, meat.................................................        0.05
Sheep, meat byproducts, except kidney and liver.............        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[50 FR 18486, May 1, 1985, as amended at 55 FR 26440, June 28, 1990; 60 
FR 4095, Jan. 20, 1995; 62 FR 46894, Sept. 5, 1997; 63 FR 45406, Aug. 
26, 1998; 67 FR 35048, May 17, 2002; 67 FR 58725, Sept. 18, 2002; 72 FR 
41931, Aug. 1, 2007]



Sec. 180.418  Cypermethrin and an isomer zeta-cypermethrin; tolerances for 

residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide cypermethrin ()alpha cyano-(3-
phenoxyphenyl)methyl()cis,trans-3(2,2-
dichloroethenyl-2,2-dimethylcyclopropanecarboxylate in or on the 
following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A........................        2.0
Brassica, leafy greens, subgroup 5B.........................       14.0
Cattle, fat.................................................        1.0
Cattle, meat................................................        0.2
Cattle, meat byproducts.....................................        0.05
Cotton, gin byproducts......................................       11.0
Cotton, undelinted seed.....................................        0.5
Egg.........................................................        0.05
Goat, fat...................................................        1.0
Goat, meat..................................................        0.2
Goat, meat byproducts.......................................        0.05
Hog, fat....................................................        0.1
Hog, meat...................................................        0.05
Horse, fat..................................................        1.0
Horse, meat.................................................        0.2
Horse, meat byproducts......................................        0.05
Lettuce, head...............................................        4.0
Milk, fat (reflecting 0.10 in whole milk)...................        2.5
Onion, bulb.................................................        0.1
Onion, green................................................        6.0
Pecan.......................................................        0.05
Poultry, fat................................................        0.05
Poultry, meat...............................................        0.05
Sheep, fat..................................................        1.0
Sheep, meat.................................................        0.2
Sheep, meat byproducts......................................        0.05
------------------------------------------------------------------------

    (2) Tolerances are established for residues of zeta-cypermethrin, 
(S-cyano(3-phenoxyphenyl) methyl ())(cis-trans 3-
(2,2-dichloroethenyl)-2,2 dimethylcyclopropanecarboxylate), including 
its metabolites and degradates, in or on the commodities in the 
following table. Compliance with the tolerance levels specified in the 
following table is to be determined by measuring only total 
cypermethrin, cyano(3-phenoxyphenyl)methyl 3-(2,2-dichloroethenyl)-2,2-
dimethylcyclopropane carboxylate, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, hay................................................       15.00
Alfalfa, forage.............................................        5.00
Alfalfa, seed...............................................        0.50
Almond, hulls...............................................        6
Animal feed, nongrass, group 18, forage.....................        8
Animal feed, nongrass, group 18, hay........................       40
Artichoke, globe............................................        0.60
Avocado.....................................................        0.50
Barley, grain...............................................        3.0
Barley, hay.................................................        6.0
Barley, straw...............................................       20.0
Beet, sugar, roots..........................................        0.05
Beet, sugar, tops...........................................        0.20
Berry group 13..............................................        0.8
Borage, seed................................................        0.2
Brassica, head and stem, subgroup 5A........................        2.00
Brassica, leafy greens, subgroup 5B.........................       14.00
Buckwheat, grain............................................        3.0
Buckwheat, hay..............................................        6.0
Buckwheat, straw............................................       20.0
Cabbage.....................................................        2.00
Canistel....................................................        0.50
Castor oil plant, refined oil...............................        0.4
Castor oil plant, seed......................................        0.2
Cattle, fat.................................................        1.00
Cattle, meat................................................        0.2
Cattle, meat byproducts.....................................        0.05
Chinese tallowtree, refined oil.............................        0.4
Chinese tallowtree, seed....................................        0.2
Cilantro, leaves............................................       10
Citrus, dried pulp..........................................        1.8
Citrus, oil.................................................        4.0
Corn, field, forage.........................................        0.20
Corn, field, grain..........................................        0.05
Corn, field, stover.........................................        3.00
Corn, pop, grain............................................        0.05
Corn, pop, stover...........................................        3.00

[[Page 562]]

 
Corn, sweet, forage.........................................       15.00
Corn, sweet, kernel plus cob with husks removed.............        0.05
Corn, sweet, stover.........................................       15.00
Cotton, undelinted seed.....................................        0.5
Crambe, seed................................................        0.2
Cuphea, seed................................................        0.2
Echium, seed................................................        0.2
Egg.........................................................        0.05
Euphorbia, refined oil......................................        0.4
Euphorbia, seed.............................................        0.2
Evening primrose, refined oil...............................        0.4
Evening primrose, seed......................................        0.2
Flax, seed..................................................        0.2
Food commodities/feed commodities (other than those covered         0.05
 by a higher tolerance as a result of use on growing crops)
 in food/feed handling establishments.......................
Fruit, citrus, group 10.....................................        0.35
Fruit, pome, group 11.......................................        2
Fruit, stone, group 12......................................        1
Goat, fat...................................................        1.00
Goat, meat..................................................        0.2
Goat, meat byproducts.......................................        0.05
Gold of pleasure, seed......................................        0.2
Grain, aspirated fractions..................................       10.0
Grape.......................................................        2
Grass, forage, fodder, and hay, group 17, forage............       10
Grass, forage, fodder and hay, group 17, hay................       35
Hare's-ear mustard, seed....................................        0.2
Hog, fat....................................................        0.1
Hog, meat...................................................        0.05
Horse, fat..................................................        1.00
Horse, meat.................................................        0.2
Horse, meat byproducts......................................        0.05
Jojoba, refined oil.........................................        0.4
Jojoba, seed................................................        0.2
Lesquerella, seed...........................................        0.2
Lunaria, seed...............................................        0.2
Mango.......................................................        0.70
Meadowfoam, seed............................................        0.2
Milk, fat (reflecting 0.10 in whole milk)...................        2.50
Milkweed, seed..............................................        0.2
Mustard, seed...............................................        0.2
Niger seed, refined oil.....................................        0.4
Niger seed, seed............................................        0.2
Nut, tree, group 14.........................................        0.05
Oat, grain..................................................        3.0
Oat, hay....................................................        6.0
Oat, straw..................................................       20.0
Oil radish, seed............................................        0.2
Okra........................................................        0.2
Onion, bulb.................................................        0.10
Onion, green................................................        3.00
Papaya......................................................        0.50
Pea and bean, dried shelled, except soybean, subgroup 6C....        0.05
Pea and bean, succulent shelled, subgroup 6B................        0.1
Peanut......................................................        0.05
Pecan.......................................................        0.05
Pistachio...................................................        0.05
Poppy, seed.................................................        0.2
Poultry, fat................................................        0.05
Poultry, meat...............................................        0.05
Rapeseed....................................................        0.2
Rice, grain.................................................        1.50
Rice, hulls.................................................        6.00
Rice, straw.................................................        2.00
Rice, wild, grain...........................................        1.5
Rose hip, refined oil.......................................        0.4
Rose hip, seed..............................................        0.2
Rye, grain..................................................        3.0
Rye, hay....................................................        6.0
Rye, straw..................................................       20.0
Safflower, seed.............................................        0.2
Sapodilla...................................................        0.50
Sapote, black...............................................        0.50
Sapote, mamey...............................................        0.50
Sesame, seed................................................        0.2
Sheep, fat..................................................        1.00
Sheep, meat.................................................        0.2
Sheep, meat byproducts......................................        0.05
Sorghum, grain, forage......................................        0.1
Sorghum, grain, grain.......................................        0.5
Sorghum, grain, stover......................................        5.0
Soybean, seed...............................................        0.05
Star apple..................................................        0.50
Stokes aster, refined oil...................................        0.4
Stokes aster, seed..........................................        0.2
Sugarcane, cane.............................................        0.60
Sunflower, refined oil......................................        0.5
Sunflower, seed.............................................        0.2
Sweet rocket, seed..........................................        0.2
Tallowwood, refined oil.....................................        0.4
Tallowwood, seed............................................        0.2
Tea oil plant, refined oil..................................        0.4
Tea oil plant, seed.........................................        0.2
Turnip, greens..............................................       14
Vegetable, cucurbit, group 9................................        0.2
Vegetable, fruiting, group 8................................        0.2
Vegetable, leafy, except brassica, group 4..................       10.00
Vegetable, legume, edible podded, subgroup 6A...............        0.5
Vegetable, root and tuber, group 1, except sugar beet.......        0.1
Vernonia, refined oil.......................................        0.4
Vernonia, seed..............................................        0.2
Wheat, forage...............................................        3.0
Wheat, grain................................................        0.2
Wheat, hay..................................................        6.0
Wheat, straw................................................        7.0
------------------------------------------------------------------------

    (3) Tolerances are established for residues of the insecticide, 
alpha-cypermethrin, (R)-cyano(3-phenoxyphenyl)methyl (1S,3S)-rel-3-(2,2-
dichloroethenyl)-2,2-dimethylcyclopropane carboxylate, including its 
metabolites and degradates, in or on the commodities in the table below. 
Compliance with the tolerance levels specified below is to be determined 
by measuring only total cypermethrin, cyano(3-phenoxyphenyl)methyl 3-
(2,2-dichloroethenyl)-2,2-dimethylcyclopropane carboxylate, in or on the 
commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, hay................................................       15
Beet, sugar, roots..........................................        0.05
Beet, sugar, tops...........................................        0.20
Brassica, head and stem, subgroup 5A........................        2.0
Cattle, fat.................................................        1.0
Cattle, meat................................................        0.20
Cattle, meat byproducts.....................................        0.05
Citrus, dried pulp..........................................        1.8
Citrus, oil.................................................        4.0
Corn, field, grain..........................................        0.05

[[Page 563]]

 
Corn, pop, grain............................................        0.05
Corn, sweet, kernel plus cob with husks removed.............        0.05
Cotton, undelinted seed.....................................        0.50
Egg.........................................................        0.05
Fruit, citrus, group 10-10..................................       10
Goat, fat...................................................        1.0
Goat, meat..................................................        0.20
Goat, meat byproducts.......................................        0.05
Hog, fat....................................................        1.0
Hog, meat...................................................        0.05
Horse, fat..................................................        1.0
Horse, meat.................................................        0.20
Horse, meat byproducts......................................        0.05
Milk, fat, reflecting 0.10 ppm in whole milk................        2.5
Nut, tree, group 14-12......................................        0.05
Pea and bean, dried shelled, except soybean, subgroup 6C....        0.05
Pea and bean, succulent shelled, subgroup 6B................        0.10
Poultry, fat................................................        0.05
Poultry, meat...............................................        0.05
Rice, grain.................................................        1.5
Sheep, fat..................................................        1.0
Sheep, meat.................................................        0.20
Sheep, meat byproducts......................................        0.05
Sorghum, grain, grain.......................................        0.50
Soybean, seed...............................................        0.05
Vegetable, cucurbit, group 9................................        0.20
Vegetable, fruiting, group 8-10.............................        0.20
Vegetable, leafy, group 4...................................       10
Vegetable, legume, edible podded, subgroup 6A...............        0.50
Vegetable, root and tuber, group 1, except sugar beet.......        0.10
Wheat, grain................................................        0.20
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[62 FR 63235, 63243, Nov. 26, 1997, as amended at 63 FR 48586, Sept. 11, 
1998; 66 FR 47993, Sept. 17, 2001; 67 FR 6430, Feb. 12, 2002; 67 FR 
56495, Sept. 4, 2002; 69 FR 71717, Dec. 10, 2004; 71 FR 78382, Dec. 29, 
2006; 72 FR 53462, Sept. 19, 2007; 72 FR 71801, Dec. 19, 2007; 73 FR 
1525, Jan. 9, 2008; 77 FR 72984, Dec. 7, 2012; 78 FR 7275, Feb. 1, 2013]



Sec. 180.419  Chlorpyrifos-methyl; tolerances for residues.

    (a) General. (1) Tolerances are established for the combined 
residues of the insecticide chlorpyrifos-methyl [O,-O,-dimethyl O-
(3,5,6-trichloro-2-pyridyl)] phosphorothioate and its metabolite (3,5,6-
trichloro-2-pyridinol) in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, grain...............................................        6.0
Cattle, fat.................................................        0.5
Cattle, meat................................................        0.5
Cattle, meat byproducts.....................................        0.5
Egg.........................................................        0.1
Goat, fat...................................................        0.5
Goat, meat..................................................        0.5
Goat, meat byproducts.......................................        0.5
Hog, fat....................................................        0.5
Hog, meat...................................................        0.5
Hog, meat byproducts........................................        0.5
Horse, fat..................................................        0.5
Horse, meat.................................................        0.5
Horse, meat byproducts......................................        0.5
Milk, fat (0.05 ppm (N) in whole milk.......................        1.25
Oat, grain..................................................        6.0
Poultry, fat................................................        0.5
Poultry, meat...............................................         .5
Poultry, meat byproducts....................................         .5
Rice, grain.................................................        6.0
Sheep, fat..................................................        0.5
Sheep, meat.................................................        0.5
Sheep, meat byproducts......................................        0.5
Sorghum, grain..............................................        6.0
Wheat, grain................................................        6.0
------------------------------------------------------------------------

    (2) Tolerances are established for the combined residues of the 
insecticide chlorpyrifos-methyl (O,-O- dimethyl-O-(3,5,6-trichloro-2-
pyridyl) phosphorothioate and its metabolite (3,5,6-trichloro-2-
pyridinol) in or on the following food commodities when present therein 
as a result of application to stored grains:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, bran................................................       90
Barley, pearled barley......................................       90
Rice, bran..................................................       30
Rice, hulls.................................................       30
Rice, polished rice.........................................       30
Sorghum, grain, bran........................................       90
Wheat, bran.................................................       30
Wheat, germ.................................................       30
Wheat, middlings............................................       30
Wheat, shorts...............................................       30
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33715, May 24, 2000, as amended at 74 FR 46374, Sept. 9, 2009]



Sec. 180.420  Fluridone; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
herbicide fluridone, including its metabolites and degradates, in or on 
the commodities in the table in this paragraph. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only the sum of

[[Page 564]]

fluridone, 1-methyl-3-phenyl-5-(3-(trifluoromethyl)phenyl)-4(1H)-
pyridinone, and its bound residues, calculated as the stoichiometric 
equivalent of fluridone, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Crayfish....................................................        0.5
Fish........................................................        0.5
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the herbicide 
fluridone, including its metabolites and degradates, in or on the 
commodities in the table in this paragraph. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only fluridone, 1-methyl-3-phenyl-5-(3-
(trifluoromethyl)phenyl)-4(1H)-pyridinone, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.05
Cattle, kidney..............................................        0.1
Cattle, liver...............................................        0.1
Cattle, meat................................................        0.05
Cattle, meat byproducts.....................................        0.05
Egg.........................................................        0.05
Goat, fat...................................................        0.05
Goat, kidney................................................        0.1
Goat, liver.................................................        0.1
Goat, meat..................................................        0.05
Goat, meat byproducts.......................................        0.05
Hog, fat....................................................        0.05
Hog, kidney.................................................        0.1
Hog, liver..................................................        0.1
Hog, meat...................................................        0.05
Hog, meat byproducts........................................        0.05
Horse, fat..................................................        0.05
Horse, kidney...............................................        0.1
Horse, liver................................................        0.1
Horse, meat.................................................        0.05
Horse, meat byproducts......................................        0.05
Milk........................................................        0.05
Poultry, fat................................................        0.05
Poultry, kidney.............................................        0.01
Poultry, liver..............................................        0.01
Poultry, meat...............................................        0.05
Poultry, meat byproducts....................................        0.05
Sheep, fat..................................................        0.05
Sheep, kidney...............................................        0.1
Sheep, liver................................................        0.1
Sheep, meat.................................................        0.05
Sheep, meat byproducts......................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of the 
herbicide fluridone, 1-methyl-3-phenyl-5-(3-(trifluoromethyl)phenyl)-
4(1H)-pyridinone, including its metabolites and degradates in or on the 
specified agricultural commodities, resulting from use of the pesticide 
pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) section 18 emergency exemptions. Compliance with the tolerance 
levels specified below is to be determined by measuring only fluridone. 
The tolerances expire on the date specified in the table.

------------------------------------------------------------------------
                                                   Parts per  Expiration
                    Commodity                       million      date
------------------------------------------------------------------------
Cotton, undelinted seed..........................        0.1    12/31/14
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established for 
indirect or inadvertent residues of the herbicide fluridone, including 
its metabolites and degradates, in or on the irrigated crop commodities 
and crop groupings in the table in this paragraph, resulting from use of 
irrigation water containing residues of 0.15 parts per million following 
applications of fluridone on or around aquatic sites. Where tolerances 
are established at higher levels from other uses of fluridone on the 
crops in the table in this paragraph, the higher tolerance also applies 
to residues in or on the irrigated commodity. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only fluridone, 1-methyl-3-phenyl-5-(3-
(trifluoromethyl)phenyl)-4(1H)-pyridinone, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Animal feed, nongrass, group 18.............................        0.15
Avocado.....................................................        0.1
Berry, group 13.............................................        0.1
Cotton, undelinted seed.....................................        0.1
Cranberry...................................................        0.1
Fruit, citrus, group 10.....................................        0.1
Fruit, pome, group 11.......................................        0.1
Fruit, stone, group 12......................................        0.1
Grain, cereal, forage, fodder and straw, group 16...........        0.1
Grain, cereal, group 15.....................................        0.1
Grape.......................................................        0.1
Grass, forage...............................................        0.15
Hop, dried cones............................................        0.1
Nut, tree, group 14.........................................        0.1
Okra........................................................        0.1
Strawberry..................................................        0.1
Vegetable, brassica, leafy, group 5.........................        0.1
Vegetable, cucurbit, group 9................................        0.1
Vegetable, fruiting, group 8................................        0.1
Vegetable, leafy, except brassica, group 4..................        0.1
Vegetable, leaves of root and tuber, group 2................        0.1
Vegetable, legume, group 6..................................        0.1
Vegetable, root and tuber, group 1..........................        0.1
------------------------------------------------------------------------


[[Page 565]]


[76 FR 23495, Apr. 27, 2011, as amended at 77 FR 66720, Nov. 7, 2012]



Sec. 180.421  Fenarimol; tolerances for residues.

    (a) General. Tolerances are established for residues of fenarimol, 
including its metabolites and degradates, in or on the commodities in 
the following table. Compliance with the tolerance levels specified in 
the following table is to be determined by measuring only fenarimol 
alpha-(2 chlorophenyl)-alpha-(4-chlorophenyl)-5-pyrimidinemethanol.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Apple.......................................................        0.3
Apple, wet pomace...........................................        0.3
Banana......................................................        0.25
Cattle, fat.................................................        0.01
Cattle, kidney..............................................        0.01
Cattle, meat................................................        0.01
Cattle, meat byproducts, except kidney......................        0.05
Cherry, sweet...............................................        1.0
Cherry, tart................................................        1.0
Goat, fat...................................................        0.01
Goat, kidney................................................        0.01
Goat, meat..................................................        0.01
Goat, meat byproducts, except kidney........................        0.05
Grape.......................................................        0.1.
Hazelnut....................................................        0.02
Hop, dried cones............................................        5.0
Horse, fat..................................................        0.01
Horse, kidney...............................................        0.01
Horse, meat.................................................        0.01
Horse, meat byproducts, except kidney.......................        0.05
Pear........................................................        0.1
Pecan.......................................................        0.02
Sheep, fat..................................................        0.01
Sheep, kidney...............................................        0.01
Sheep, meat.................................................        0.01
Sheep, meat byproducts, except kidney.......................        0.05
Vegetable, cucurbit, group 9*...............................        0.20
------------------------------------------------------------------------
*There are no U.S. registrations as of August 27, 2010.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[51 FR 39662, Oct. 30, 1986, as amended at 53 FR 27349, July 20, 1988; 
53 FR 44403, Nov. 3, 1988; 54 FR 45734, Oct. 31, 1989; 60 FR 33354, June 
28, 1995; 62 FR 49937, Sept. 24, 1997; 62 FR 61447, Nov. 18, 1997; 67 FR 
35048, May 17, 2002; 67 FR 41807, June 19, 2002; 69 FR 6567, Feb. 11, 
2004; 71 FR 32846, June 7, 2006; 71 FR 54434, Sept. 15, 2006; 74 FR 
68173, Dec. 23, 2009; 75 FR 56897, Sept. 17, 2010]



Sec. 180.422  Tralomethrin; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide tralomethrin, including its metabolites and degradates, in 
or on the commodities in the table in this paragraph. Compliance with 
the tolerance levels specified in this paragraph is to be determined by 
measuring only the sum of tralomethrin, (S)-cyano(3-phenoxyphenyl)methyl 
(1R,3S)-2,2-dimethyl-3-(1,2,2,2-tetrabromoethyl)cyclopropanecarboxylate, 
and its metabolites (S)-cyano(3-phenoxyphenyl)methyl (1R,3R)-3-(2,2-
dibromoethenyl)-2,2-dimethylcyclopropanecarboxylate and (S)-cyano(3-
phenoxyphenyl)methyl (1S,3R)-3-(2,2-dibromoethenyl)-2,2-
dimethylcyclopropanecarboxylate, calculated as the stoichiometric 
equivalent of tralomethrin, in or on the commodity.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Broccoli........................................        0.5       7/9/13
Cotton, undelinted seed.........................       0.02       7/9/13
Cotton, oil.....................................       0.20       7/9/13
Lettuce, head...................................       1.00       7/9/13
Lettuce, leaf...................................       3.00       7/9/13
Soybean, seed...................................       0.05       7/9/13
Sunflower, seed.................................       0.05       7/9/13
------------------------------------------------------------------------

    (2) A tolerance of 0.02 part per million with an expiration/
revocation date of July 9, 2013 is established for residues of the 
insecticide tralomethrin, including its metabolites and degradates, in 
or on food commodities (other than those covered by a higher tolerance 
as a result of use on growing crops) in food-handling establishments. 
Compliance with the tolerance level specified in this paragraph is to be 
determined by measuring only the sum of tralomethrin, (S)-cyano(3-
phenoxyphenyl)methyl (1R,3S)-2,2-dimethyl-3-(1,2,2,2-
tetrabromoethyl)cyclopropanecarboxylate, and its metabolites (S)-
cyano(3-phenoxyphenyl)methyl (1R,3R)-3-(2,2-dibromoethenyl)-2,2-
dimethylcyclopropanecarboxylate and (S)-cyano(3-phenoxyphenyl)methyl 
(1S,3R)-3-(2,2-dibromoethenyl)-2,2-dimethylcyclopropanecarboxylate, 
calculated as the stoichiometric equivalent of tralomethrin, in or on 
the commodity.

[[Page 566]]

    (i) The insecticide may be present as a residue from application of 
tralomethrin in food-handling establishments, including food service, 
manufacturing, and processing establishments, such as restaurants, 
cafeterias, supermarkets, bakeries, breweries, dairies, meat 
slaughtering and packing plants, and canneries.
    (ii) The application shall be made in accordance with the following 
prescribed conditions: Application shall be limited to a general surface 
and spot and/or crack and crevice treatment in food-handling 
establishments where food and food products are held, processed, 
prepared, and served. General surface application may be used only when 
the facility is not in operation provided exposed food has been covered 
or removed from the area being treated. All food-contact surfaces and 
equipment must be thoroughly cleaned after general surface applications. 
Spot and/or crack and crevice application may be used while the facility 
is in operation provided exposed food is covered or removed from the 
area being treated prior to application. Spray concentration shall be 
limited to a maximum of 0.06 percent active ingredient. Contamination of 
food and food-contact surfaces shall be avoided.
    (3) A tolerance of 0.02 part per million with an expiration/
revocation date of July 9, 2013 is established for residues of the 
insecticide tralomethrin, including its metabolites and degradates, in 
or on feed commodities (other than those covered by a higher tolerance 
as a result of use on growing crops) in feed-handling establishments. 
Compliance with the tolerance level specified in this paragraph is to be 
determined by measuring only the sum of tralomethrin, (S)-cyano(3-
phenoxyphenyl)methyl (1R,3S)-2,2-dimethyl-3-(1,2,2,2-
tetrabromoethyl)cyclopropanecarboxylate, and its metabolites (S)-
cyano(3-phenoxyphenyl)methyl (1R,3R)-3-(2,2-dibromoethenyl)-2,2-
dimethylcyclopropanecarboxylate and (S)-cyano(3-phenoxyphenyl)methyl 
(1S,3R)-3-(2,2-dibromoethenyl)-2,2-dimethylcyclopropanecarboxylate, 
calculated as the stoichiometric equivalent of tralomethrin, in or on 
the commodity.
    (i) The insecticide may be present as a residue from application of 
tralomethrin in feed-handling establishments, including feed 
manufacturing and processing establishments.
    (ii) The application shall be made in accordance with the following 
prescribed conditions: Application shall be limited to a general surface 
and spot and/or crack and crevice treatment in feed-handling 
establishments where feed and feed products are held or processed. 
General surface application may be used only when the facility is not in 
operation provided exposed feed has been covered or removed from the 
area being treated. All feed-contact surfaces and equipment must be 
thoroughly cleaned after general surface applications. Spot and/or crack 
and crevice application may be used while the facility is in operation 
provided exposed feed is covered or removed from the area being treated 
prior to application. Spray concentration shall be limited to a maximum 
of 0.06 percent active ingredient. Contamination of feed and feed-
contact surfaces shall be avoided.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[62 FR 63001, Nov. 26, 1997, as amended at 62 FR 66025, Dec. 17, 1997; 
65 FR 33701, May 24, 2000; 71 FR 74817, Dec. 13, 2006; 77 FR 59127, 
Sept. 26, 2012]



Sec. 180.425  Clomazone; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide clomazone, including its metabolites and degradates, in or on 
the commodities in the table in this paragraph. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only clomazone, 2-[(2-chlorophenyl)methyl]-4,4-dimethyl-3-
isoxazolidinone, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Bean, snap, succulent.......................................        0.05
Cabbage.....................................................        0.1
Cotton, undelinted seed.....................................        0.05

[[Page 567]]

 
Cucumber....................................................        0.1
Pea, succulent..............................................        0.05
Pepper......................................................        0.05
Peppermint, tops............................................        0.05
Pumpkin.....................................................        0.1
Rice, grain.................................................        0.02
Rice, straw.................................................        0.02
Soybean.....................................................        0.05
Spearmint, tops.............................................        0.05
Squash, summer..............................................        0.1
Squash, winter..............................................        0.1
Sugarcane, cane.............................................        0.05
Sweet potato, roots.........................................        0.05
Vegetable, cucurbit, group 9................................        0.05
Vegetable, tuberous and corm, except potato, subgroup 1D....        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[51 FR 9446, Mar. 19, 1986]

    Editorial Note: For Federal Register citations affecting Sec. 
180.425, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.426  2-[4,5-Dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-

yl]-3-quinoline carboxylic acid; tolerance for residues.

    A tolerance is established for residues of the herbicide 2-[4,5-
dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-3-quinoline 
carboxylic acid, in or on the raw agricultural commodity soybean at 0.05 
part per million.

[51 FR 13309, Apr. 2, 1986]



Sec. 180.427  Tau-Fluvalinate; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide tau-fluvalinate, cyano-(3-phenoxyphenyl)methyl N-[2-chloro-
4-(trifluoromethyl)phenyl]-D-valinate, in or on the following food 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Honey.......................................................        0.02
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect and inadvertent residues. [Reserved]

[65 FR 33701, May 24, 2000, as amended at 67 FR 49617, July 31, 2002; 73 
FR 52616, Sept. 10, 2008]



Sec. 180.428  Metsulfuron methyl; tolerances for residues.

    (a) General. (1) Tolerances are established for the combined 
residues of the herbicide metsulfuron methyl (methyl 2-[[[[(4-methoxy-6-
methyl-1,3,5- triazin- 2-yl)amino]carbonyl]amino] sulfonyl] benzoate) 
and its metabolite methyl 2-[[[[(4-methoxy-6-methyl-1-,3,5- triazin-2-
yl)amino]carbonyl]amino] sulfonyl]-4-hydroxybenzoate in or on the 
following raw material agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, grain...............................................        0.1
Barley, hay.................................................       20.0
Barley, straw...............................................        0.3
Grass, forage...............................................       15.0
Grass, hay..................................................       15.0
Grass, straw................................................       15.0
Sorghum, grain, forage......................................        0.2
Sorghum, grain, grain.......................................        0.1
Sorghum, grain, stover......................................        0.2
Sugarcane, cane.............................................        0.05
Wheat, forage...............................................        5.0
Wheat, grain................................................        0.1
Wheat, hay..................................................       20.0
Wheat, straw................................................        0.3
------------------------------------------------------------------------

    (2) Tolerances are established for residues of metsulfuron methyl 
(methyl-2[[[[(4-methoxy- 6-methyl-1,3,5-triazin-2- 
yl)amino]carbonyl]amino] sulfonyl] benzoate) in or on the following raw 
agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.1
Cattle, kidney..............................................        0.5
Cattle, meat................................................        0.1
Cattle, meat byproducts.....................................        0.1
Goat, fat...................................................        0.1
Goat, kidney................................................        0.5
Goat, meat..................................................        0.1
Goat, meat byproducts.......................................        0.1
Hog, fat....................................................        0.1
Hog, kidney.................................................        0.5
Hog, meat...................................................        0.1
Hog, meat byproducts........................................        0.1
Horse, fat..................................................        0.1
Horse, kidney...............................................        0.5
Horse, meat.................................................        0.1
Horse, meat byproducts......................................        0.1
Milk........................................................        0.05
Sheep, fat..................................................        0.1
Sheep, kidney...............................................        0.5
Sheep, meat.................................................        0.1
Sheep, meat byproducts......................................        0.1
------------------------------------------------------------------------


[[Page 568]]

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[64 FR 70191, Dec. 16, 1999, as amended at 66 FR 64773, Dec. 14, 2001; 
67 FR 51097, Aug. 7, 2002]



Sec. 180.429  Chlorimuron ethyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide chlorimuron ethyl, including its metabolites and degradates, 
in or on the commodities in the table below. Compliance with the 
tolerance levels specified in the following table is to be determined by 
measuring only chlorimuron ethyl, ethyl 2-[[[[(4-chloro-6-
methoxypyrimidin-2yl)amino]carbonyl]sulfonyl]benzoate] in or on the 
following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Berry, low growing, except strawberry, subgroup 13-07H......        0.02
Corn, field, forage.........................................        0.5
Corn, field, grain..........................................        0.01
Corn, field, stover.........................................        2.0
Grain, aspirated fractions..................................        3.0
Peanut......................................................        0.02
Soybean, forage.............................................        0.45
Soybean, hay................................................        1.8
Soybean, seed...............................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[74 FR 10494, Mar. 11, 2009, as amended at 74 FR 67087, Dec. 18, 2009]



Sec. 180.430  Fenoxaprop-ethyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide fenoxaprop-ethyl, including its metabolites and degradates, in 
or on the commodities in the table in this paragraph. Compliance with 
the tolerance levels specified in this paragraph is to be determined by 
measuring only the sum of fenoxaprop-ethyl, ()-
ethyl 2-[4-[(6-chloro-2-benzoxazolyl)oxy]phenoxy]propanoate, and its 
metabolites, 2-[4-[(6-chloro-2-benzoxazolyl)oxy]phenoxy]propanoic acid 
and 6-chloro-2,3-dihydrobenzoxazol-2-one, calculated as the 
stoichiometric equivalent of fenoxaprop-ethyl, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, grain...............................................        0.05
Barley, straw...............................................        0.1
Cattle, fat.................................................        0.05
Cattle, meat byproducts.....................................        0.05
Cattle, meat................................................        0.05
Cotton, undelinted seed.....................................        0.05
Goat, fat...................................................        0.05
Goat, meat byproducts.......................................        0.05
Goat, meat..................................................        0.05
Hog, fat....................................................        0.05
Hog, meat byproducts........................................        0.05
Hog, meat...................................................        0.05
Horse, fat..................................................        0.05
Horse, meat byproducts......................................        0.05
Horse, meat.................................................        0.05
Milk........................................................        0.02
Peanut......................................................        0.05
Peanut, hulls...............................................        0.05
Rice, grain.................................................        0.05
Sheep, fat..................................................        0.05
Sheep, meat byproducts......................................        0.05
Sheep, meat.................................................        0.05
Soybean.....................................................        0.05
Wheat, grain................................................        0.05
Wheat, straw................................................        0.50
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the herbicide fenoxaprop-ethyl, including 
its metabolites and degradates, in or on the commodities in the table in 
this paragraph in connection with use of fenoxaprop-ethyl under section 
18 emergency exemptions granted by EPA. Compliance with the tolerance 
levels specified in this paragraph is to be determined by measuring only 
the sum of fenoxaprop-ethyl, ()-ethyl 2-[4-[(6-
chloro-2-benzoxazolyl)oxy]phenoxy]propanoate, and its metabolites, 2-[4-
[(6-chloro-2-benzoxazolyl)oxy]phenoxy]propanoic acid and 6-chloro-2,3-
dihydrobenzoxazol-2-one, calculated as the stoichiometric equivalent of 
fenoxaprop-ethyl, in or on the commodity. The tolerances expire and are 
revoked on the dates specified in the table in this paragraph.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Grass, forage...................................       0.05     12/31/13
Grass, hay......................................       0.05     12/31/13
------------------------------------------------------------------------


[[Page 569]]

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 1377, Jan. 9, 1998, as amended at 63 FR 19837, Apr. 22, 1998; 73 
FR 33718, June 13, 2008; 75 FR 80346, Dec. 22, 2010; 76 FR 23495, Apr. 
27, 2011]



Sec. 180.431  Clopyralid; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide clopyralid, including its metabolites and degradates, in or on 
the commodities in the table below from its application in the acid form 
or in the form of its salts. Compliance with the tolerance levels 
specified below is to be determined by measuring only clopyralid, (3,6-
dichloro-2-pyridinecarboxylic acid), in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Apple.......................................................        0.05
Asparagus...................................................        1.0
Barley, bran................................................       12
Barley, grain...............................................        3.0
Barley, hay.................................................        9.0
Barley, pearled barley......................................       12
Barley, straw...............................................        9.0
Beet, garden, tops..........................................        3.0
Beet, garden, roots.........................................        4.0
Beet, sugar, molasses.......................................       10
Beet, sugar, roots..........................................        2.0
Beet, sugar, tops...........................................        3.0
Brassica, head and stem, subgroup 5A........................        2.0
Brassica, leafy greens, subgroup 5B.........................        5.0
Bushberry subgroup 13-07B...................................        0.50
Canola, meal................................................        6.0
Canola, seed................................................        3.0
Cattle, fat.................................................        1.0
Cattle, liver...............................................        3.0
Cattle, meat................................................        1.0
Cattle, meat byproducts, except liver.......................       36.0
Corn, field, forage.........................................        3.0
Corn, field, grain..........................................        1.0
Corn, field, milled byproducts..............................        1.5
Corn, field, stover.........................................       10.0
Corn, pop, grain............................................        1.0
Corn, pop, stover...........................................       10.0
Corn, sweet, forage.........................................        7.0
Corn, sweet, kernel plus cob with husks removed.............        1.0
Corn, sweet, stover.........................................       10.0
Cranberry...................................................        4.0
Egg.........................................................        0.1
Flax, meal..................................................        6.0
Fruit, stone, group 12......................................        0.5
Goat, fat...................................................        1.0
Goat, liver.................................................        3.0
Goat, meat..................................................        1.0
Goat, meat byproducts, except liver.........................       36.0
Grass, forage...............................................      500.0
Grass, hay..................................................      500.0
Hog, fat....................................................        0.2
Hog, meat...................................................        0.2
Hog, meat byproducts........................................        0.2
Hop, dried cones............................................        5.0
Horse, fat..................................................        1.0
Horse, liver................................................        3.0
Horse, meat.................................................        1.0
Horse, meat byproducts, except liver........................       36.0
Milk........................................................        0.2
Oat, forage.................................................        9.0
Oat, grain..................................................        3.0
Oat, groats/rolled oats.....................................       12
Oat, straw..................................................        9.0
Peppermint, tops............................................        3.0
Plum, prune, dried..........................................        1.5
Poultry, fat................................................        0.2
Poultry, meat...............................................        0.2
Poultry, meat byproducts....................................        0.2
Rapeseed, forage............................................        3.0
Rapeseed, meal..............................................        6.0
Rapeseed, subgroup 20A, except gold of pleasure.............        3.0
Sheep, fat..................................................        1.0
Sheep, liver................................................        3.0
Sheep, meat.................................................        1.0
Sheep, meat byproducts, except liver........................       36.0
Spearmint, tops.............................................        3.0
Spinach.....................................................        5.0
Strawberry..................................................        4.0
Swiss chard.................................................        3.0
Teff, forage................................................        9.0
Teff, grain.................................................        3.0
Teff, hay...................................................        9.0
Teff, straw.................................................        9.0
Turnip, greens..............................................        4.0
Turnip, roots...............................................        1.0
Wheat, bran.................................................       12
Wheat, forage...............................................        9.0
Wheat, germ.................................................       12
Wheat, grain................................................        3.0
Wheat, middling.............................................       12
Wheat, shorts...............................................       12
Wheat, straw................................................        9.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[52 FR 10566, Apr. 2, 1987]

    Editorial Note: For Federal Register citations affecting Sec. 
180.431, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.432  Lactofen; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide lactofen, including its metabolites and degradates, in or on 
the commodities in the table in this paragraph. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only lactofen, 2-ethoxy-1-methyl-2-oxoethyl 5-[2-chloro-4-

[[Page 570]]

(trifluoromethyl)phenoxy]-2-nitrobenzoate, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Beans, snap, succulent, except lima bean....................        0.01
Cotton, gin byproducts......................................        0.02
Cotton, undelinted seed.....................................        0.01
Peanut......................................................        0.01
Soybean, seed...............................................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration, as defined in Sec. 180.1(l), are established for residues 
of the herbicide lactofen, including its metabolites and degradates, in 
or on the commodities in the table in this paragraph. Compliance with 
the tolerance levels specified in this paragraph is to be determined by 
measuring only lactofen, 2-ethoxy-1-methyl-2-oxoethyl 5-[2-chloro-4-
(trifluoromethyl)phenoxy]-2-nitrobenzoate, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Okra........................................................        0.02
Vegetables, fruiting, group 08..............................        0.02
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[69 FR 57216, Sept. 24, 2004, as amended at 72 FR 33906, June 20, 2007; 
76 FR 23496, Apr. 27, 2011]



Sec. 180.433  Fomesafen; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide fomesafen, including its metabolites and degradates, in or on 
the following commodities. Compliance with the tolerance levels 
specified in the following table below is to be determined by measuring 
only fomesafen, 5-[2-chloro-4-(trifluoromethyl)phenoxy]-N-
(methylsulfonyl)-2-nitrobenzamide, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Bean, dry....................................................       0.05
Bean, snap, succulent........................................       0.05
Cotton, gin byproducts.......................................      0.025
Cotton, undelinted seed......................................      0.025
Pepper, bell.................................................      0.025
Pepper, non-bell.............................................      0.025
Potato.......................................................      0.025
Soybean......................................................       0.05
Tomato.......................................................      0.025
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[71 FR 25951, May 3, 2006, as amended at 72 FR 52020, Sept. 12, 2007; 76 
FR 12882, Mar. 9, 2011]



Sec. 180.434  Propiconazole; tolerances for residues.

    (a) General. Tolerances are established for residues of 
propiconazole, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only those 
propiconazole residues convertible to 2,4-dichlorobenzoic acid (2,4-
DCBA), expressed as the stoichiometric equivalent of propiconazole, in 
or on the commodity in the table below:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        7.0
Banana......................................................        0.2
Barley, bran................................................        6.0
Barley, grain...............................................        3.0
Barley, hay.................................................       30
Barley, straw...............................................       20
Bean, dry seed..............................................        0.40
Bean, snap..................................................        0.70
Bean, succulent shelled.....................................        0.10
Beet, garden, roots.........................................        0.30
Beet, garden, tops..........................................        5.5
Beet, sugar, dried pulp.....................................        1.0
Beet, sugar, molasses.......................................        1.5
Beet, sugar, roots..........................................        0.3
Beet, sugar, tops...........................................       10
Bushberry, subgroup 13-07B..................................        1.0
Caneberry, subgroup 13-07A..................................        1.0
Carrot, roots...............................................        0.25
Cattle, fat.................................................        0.05
Cattle, kidney..............................................        2.0
Cattle, liver...............................................        2.0
Cattle, meat................................................        0.05
Cattle, meat byproducts, except liver and kidney............        0.05
Cilantro, leaves............................................       13
Citrus, oil.................................................     1000
Corn, field, forage.........................................       12
Corn, field, grain..........................................        0.2
Corn, field, stover.........................................       30
Corn, pop, grain............................................        0.2
Corn, pop, stover...........................................       30
Corn, sweet, forage.........................................        6.0
Corn, sweet, kernel plus cob with husks removed.............        0.1
Corn, sweet, stover.........................................       30
Fruit, citrus, group 10-10..................................        8.0
Fruit, stone, group 12, except plum.........................        4.0

[[Page 571]]

 
Goat, fat...................................................        0.05
Goat, kidney................................................        2.0
Goat, liver.................................................        2.0
Goat, meat..................................................        0.05
Goat, meat byproducts, except liver and kidney..............        0.05
Grain, aspirated fractions..................................      110
Grass, forage...............................................        0.5
Grass, hay..................................................        0.5
Grass, straw................................................       40
Hog, kidney.................................................        0.2
Hog, liver..................................................        0.2
Horse, fat..................................................        0.05
Horse, kidney...............................................        2.0
Horse, liver................................................        2.0
Horse, meat.................................................        0.05
Horse, meat byproducts, except liver and kidney.............        0.05
Leaf petioles subgroup 4B...................................        5.0
Low growing berry subgroup 13-07G, except cranberry.........        1.3
Milk........................................................        0.05
Mushroom....................................................        0.1
Nut, tree, group 14.........................................        0.1
Oat, forage.................................................        4.0
Oat, grain..................................................        3.0
Oat, hay....................................................       15
Oat, straw..................................................       10
Onion, bulb subgroup 3-07A..................................        0.2
Onion, green, subgroup 3-07B................................        9.0
Parsley, fresh leaves.......................................       13
Parsley, dried leaves.......................................       35
Peanut......................................................        0.2
Peanut, hay.................................................       20
Peppermint, tops............................................       10.0
Pineapple...................................................        4.5
Pineapple, process residue..................................        7.0
Pistachio...................................................        0.1
Plum........................................................        0.60
Rice, bran..................................................       15
Rice, grain.................................................        7.0
Rice, hulls.................................................       20
Rice, straw.................................................       18
Rye, bran...................................................        0.6
Rye, forage.................................................        9.0
Rye, grain..................................................        0.3
Rye, straw..................................................       10
Sheep, fat..................................................        0.05
Sheep, kidney...............................................        2.0
Sheep, liver................................................        2.0
Sheep, meat.................................................        0.05
Sheep, meat byproducts, except liver and kidney.............        0.05
Sorghum, grain, forage......................................       12
Sorghum, grain, grain.......................................        3.5
Sorghum, grain, stover......................................       15
Soybean, forage.............................................       11
Soybean, hay................................................       30
Soybean, seed...............................................        2.0
Spearmint, tops.............................................       10.0
Sugarcane, cane.............................................        0.4
Tomato......................................................        3.0
Vegetable, foliage of legume, group 7.......................       30
Wheat, bran.................................................        0.6
Wheat, forage...............................................       15
Wheat, grain................................................        0.3
Wheat, hay..................................................       30
Wheat, straw................................................       20
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of propiconazole (1-[[2-(2,4-dichlorophenyl)-4-
propyl-1,3-dioxolan-2-yl] methyl]-1H-1,2,4-triazole) and its metabolites 
determined as 2,4-dichlorobenzoic acid and expressed as parent compound, 
in connection with use of the pesticide under section 18 emergency 
exemptions granted by EPA. The tolerances will expire and are revoked on 
the dates specified in the following table:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Avocado.........................................         10     12/31/13
Nectarine.......................................        2.0     12/31/13
Peach...........................................        2.0     12/31/13
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. A tolerance with 
regional registration, as defined in Sec. 180.1(l), is established for 
residues of 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-
yl]methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4-
dichlorobenzoic acid and expressed as parent compound, in or on the 
following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cranberry...................................................        1.0
Rice, wild, grain...........................................        0.5
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. Tolerances are established for 
the combined residues of the fungicide 1-[[2-(2,4-dichlorophenyl)-4-
propyl-1,3-dioxolan-2-yl] methyl]-1H-1,2,4-triazole and its metabolites 
determined as 2,4-dichlorobenzoic acid and expressed as parent compound 
in or on the following commodities when present therein as a result of 
application of propiconazole to growing crops in paragraphs (a) and (c) 
of this section:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        0.1
Alfalfa, hay................................................        0.1
------------------------------------------------------------------------


[71 FR 55306, Sept. 22, 2006, as amended at 72 FR 20439, Apr. 25, 2007; 
74 FR 12613, Mar. 25, 2009; 75 FR 80346, Dec. 22, 2010; 76 FR 27268, May 
11, 2011; 77 FR 38204, June 27, 2012; 77 FR 75044, Dec. 19, 2012; 78 FR 
23503, Apr. 19, 2013]



Sec. 180.435  Deltamethrin; tolerances for residues.

    (a) General. (1) Tolerances are established for the combined 
residues of the pesticide chemical deltamethrin [(1R,3R)-3-(2,2-
dibromovinyl)-2,2-

[[Page 572]]

dimethylcyclopropanecarboxylic acid (S)-alpha-cyano-3-phenoxybenzyl 
ester and its major metabolites, trans deltamethrin [(S)-alpha-cyano-m-
phenoxybenzyl(1R,3S)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate] and alpha-R-deltamethrin [(R)-alpha-
cyano-m-phenoxybenzyl-(1R,3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate] in or on the following agricultural 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        2.5
Apple, wet pomace...........................................        1.0
Artichoke, globe............................................        0.5
Barley, bran................................................        5.0
Cattle, fat.................................................        0.05
Cattle, meat................................................        0.02
Cattle, meat byproducts.....................................        0.05
Corn, field, forage.........................................        0.7
Corn, field, refined oil....................................        2.5
Corn, field, stover.........................................        5.0
Corn, pop, stover...........................................        5.0
Corn, sweet, forage.........................................       10
Corn, sweet, kernel plus cob with husks removed.............        0.03
Corn, sweet, stover.........................................       15
Cotton, refined oil.........................................        0.2
Cotton, undelinted seed.....................................        0.04
Egg.........................................................        0.02
Fruit, pome, Group 11.......................................        0.2
Goat, fat...................................................        0.05
Goat, meat..................................................        0.02
Goat, meat byproducts.......................................        0.05
Grain, aspirated fractions..................................       65
Grain, cereal, Group 15, except sweet corn..................        1.0
Hog, fat....................................................        0.05
Horse, fat..................................................        0.05
Horse, meat.................................................        0.02
Horse, meat byproducts......................................        0.05
Lychee*.....................................................        0.2
Milk, fat (reflecting 0.02 ppm in whole milk)...............        0.1
Nut, tree, Group 14.........................................        0.1
Onion, bulb.................................................        0.1
Onion, green................................................        1.5
Poultry, fat................................................        0.05
Poultry, meat...............................................        0.02
Poultry, meat byproducts....................................        0.02
Radish, tops................................................        4.0
Rapeseed....................................................        0.2
Rice, hulls.................................................        2.5
Rye, bran...................................................        5.0
Sheep, fat..................................................        0.05
Sheep, meat.................................................        0.02
Sheep, meat byproducts......................................        0.05
Sorghum, grain, forage......................................        0.5
Sorghum, grain, stover......................................        1.0
Soybean, seed...............................................        0.1
Soybean, hulls..............................................        0.2
Starfruit*..................................................        0.2
Sunflower, seed.............................................        0.1
Tomato......................................................        0.2
Tomato, paste...............................................        1.0
Tomato, puree...............................................        1.0
Vegetable, cucurbit, Group 9................................        0.2
Vegetable, fruiting, Group 8................................        0.3
Vegetable, root, except sugar beet, Subgroup IB.............        0.2
Vegetable, tuberous and corm, Subgroup IC...................        0.04
Wheat, bran.................................................        5.0
------------------------------------------------------------------------
*There are no U.S. registrations for use of deltamethrin on starfruit
  and lychee.

    (2) A tolerance of 0.05 ppm is established for residues of the 
insecticide deltamethrin (1R,3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylic acid (S)-alpha-cyano-3-phenoxybenzyl 
ester and its major metabolites, trans deltamethrin (S)-alpha-cyano-m-
phenoxybenzyl-(1R,3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate and alpha-R-deltamethrin[(R)-alpha-
cyano-m-phenoxybenzyl-(1R,3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate] as follows:
    (i) In or on all food/feed items (other than those covered by a 
higher tolerance as a result of use on growing crops) in food/feed 
handling establishments.
    (ii) The insecticide may be present as a residue from application of 
deltamethrin in food handling establishments, including food service, 
manufacturing and processing establishments, such as restaurants, 
cafeterias, supermarkets, bakeries, breweries, dairies, meat 
slaughtering and packing plants, and canneries, feed handling 
establishments including feed manufacturing and processing 
establishments, in accordance with the following prescribed conditions:
    (A) Application shall be limited to general surface and spot and/or 
crack and crevice treatment in food/feed handling establishments where 
food/feed and food/feed products are held, processed, prepared and 
served. General surface application may be used only when the facility 
is not in operation provided exposed food/feed has been covered or 
removed from the area being treated. Spot and/or crack and crevice 
application may be used while the facility is in operation provided 
exposed food/feed is covered or removed from the area being treated 
prior to application. Spray concentration shall be limited to a maximum 
of 0.06 percent active ingredient. Contamination of food/feed or food/
feed contact surfaces shall be avoided.

[[Page 573]]

    (B) To assure safe use of the insecticide, its label and labeling 
shall conform to that registered with the U.S. Environmental Protection 
Agency and shall be used in accordance with such label and labeling.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[62 FR 63001, Nov. 26, 1997, as amended at 63 FR 45414, Aug. 26, 1998; 
69 FR 62614, Oct. 27, 2004; 74 FR 46375, Sept. 9, 2009; 76 FR 34885, 
June 15, 2011]



Sec. 180.436  Cyfluthrin and the isomer beta-cyfluthrin; tolerances for 

residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide cyfluthrin (cyano(4-fluoro-3-phenoxyphenyl)methyl-3-(2,2-
dichloroethenyl)-2,2dimethyl-cyclopropane-carboxylate; CAS No. 68359-37-
5) in or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa.....................................................        5.0
Alfalfa, forage.............................................        5.0
Alfalfa, hay................................................       13
Almond, hulls...............................................        0.5
Barley, bran................................................        0.5
Barley, grain...............................................        0.15
Beet, sugar, dried pulp.....................................        1.0
Beet, sugar, roots..........................................        0.10
Brassica, head and stem, subgroup 5A........................        2.5
Brassica, leafy greens, subgroup 5B.........................        7.0
Buckwheat, grain............................................        0.15
Carrot, roots...............................................        0.20
Cattle, fat.................................................        2.0
Cattle, meat................................................        0.10
Cattle, meat byproducts.....................................        0.10
Citrus, dried pulp..........................................        0.3
Citrus, oil.................................................        0.3
Corn, field, grain..........................................        0.05
Corn, pop, grain............................................        0.05
Corn, sweet, kernel plus cob with husks removed.............        0.05
Cotton, hulls...............................................        2.0
Cotton, refined oil.........................................        2.0
Cotton, undelinted seed.....................................        1.0
Egg.........................................................        0.01
Fruit, citrus, group 10.....................................        0.2
Fruit, pome, group 11.......................................        0.5
Fruit, stone, group 12......................................        0.3
Goat, fat...................................................        2.0
Goat, meat..................................................        0.05
Goat, meat byproducts.......................................        0.05
Grain, aspirated fractions..................................      150
Grain, cereal, forage, fodder and hay, group 16, forage,           25
 except rice................................................
Grain, cereal, forage, fodder and hay, group 16, hay, except        6.0
 rice.......................................................
Grain, cereal, forage, fodder and hay, group 16, stover,           30
 except rice................................................
Grain, cereal, forage, fodder and hay, group 16, straw,             7.0
 except rice................................................
Grape.......................................................        1.0
Grape, raisin...............................................        3.5
Grass, forage, fodder and hay, group 17, forage.............       12
Grass, forage, fodder and hay, group 17, hay................       50
Hog, fat....................................................        0.5
Hog, meat...................................................        0.01
Hog, meat byproducts........................................        0.01
Hop, dried cones............................................       20.0
Hop, vines..................................................        4.0
Horse, fat..................................................        2.0
Horse, meat.................................................        0.05
Horse, meat byproducts......................................        0.05
Lettuce, head...............................................        2.0
Lettuce, leaf...............................................        3.0
Milk........................................................        0.2
Milk, fat...................................................        5.0
Millet, grain...............................................        0.15
Mustard greens..............................................        7.0
Nut, tree, group 14.........................................        0.01
Oat, bran...................................................        0.5
Oat, grain..................................................        0.15
Pea and bean, dried shelled, except soybean, subgroup 6C....        0.15
Pea, dry, seed..............................................        0.15
Pea, southern, succulent....................................        0.25
Peanut......................................................        0.01
Peanut, hay.................................................        6.0
Pepper......................................................        0.50
Pistachio...................................................        0.01
Poultry, fat................................................        0.01
Poultry, meat...............................................        0.01
Poultry, meat byproducts....................................        0.01
Radish, roots...............................................        1.0
Rye, bran...................................................        0.5
Rye, grain..................................................        0.15
Sheep, fat..................................................        2.0
Sheep, meat.................................................        0.05
Sheep, meat byproducts......................................        0.05
Sorghum, grain, grain.......................................        3.5
Soybean, forage.............................................        8.0
Soybean, hay................................................        4.0
Soybean, seed...............................................        0.03
Sugarcane, cane.............................................        0.05
Sugarcane, molasses.........................................        0.20
Sunflower, forage...........................................        5.0
Sunflower, seed.............................................        0.02
Teosinte, grain.............................................        0.05
Tomato......................................................        0.20
Tomato, dry pomace..........................................        5.0
Tomato, paste...............................................        0.5
Tomato, wet pomace..........................................        5.0
Triticale, grain............................................        0.15
Turnip, greens..............................................        7.0
Vegetable, cucurbit, group 9................................        0.1
Vegetable, fruiting, group 8................................        0.5
Vegetable, leafy, except brassica, group 4..................        6.0
Vegetable, tuberous and corm, subgroup 1C...................        0.01
Wheat, bran.................................................        0.5
Wheat, grain................................................        0.15
Wheat, shorts...............................................        0.5
------------------------------------------------------------------------

    (2) A tolerance of 0.05 ppm is established for residues of the 
insecticide cyfluthrin (cyano(4-fluoro-3-phenoxyphenyl)methyl-3-(2,2-
dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate;

[[Page 574]]

CAS Reg. No. 69359-37-5) in food commodities exposed to the insecticide 
during treatment of food-handling establishments where food and food 
products are held, processed, prepared, or served. Treatments may be 
made by general surface, spot, and/or crack and crevice applications.
    (i) General surface treatments shall be limited to a maximum of 3.8 
grams of active ingredient per 1,000 square feet, applying to walls, 
floors, and ceilings with a low-pressure system. Cover or remove all 
food processing and/or handling equipment during application. Do not 
apply directly to food products. Reapplications may be made at 10-day 
intervals.
    (ii) Crack and crevice or spot treatments shall be limited to a 
maximum of 0.1 percent of the active ingredient weight, applied with a 
low-pressure system with a pinpoint or variable-pattern nozzle. Dust 
formulation shall be limited to a maximum of 0.1 percent of the active 
ingredient by weight, applied using a hand duster, power duster, or 
other equipment capable of applying dust insecticide directly into voids 
and cracks and crevices. Dust applications should be made in a manner to 
avoid deposits on exposed surfaces or introducing the material into the 
air. Cover exposed food or remove food from premises. Do not apply 
directly to food. Reapplications may be made at 10-day intervals.
    (iii) To ensure safe use of the insecticide, its label and labeling 
shall conform to that registered by the Environmental Protection Agency, 
and it shall be used in accordance with such label and labeling.
    (3) A tolerance of 0.05 part per million is established for residues 
of the insecticide cyfluthrin (cyano(4-fluoro-3-phenoxyphenyl)methyl-3-
(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate; CAS Reg. No. 
68359-37-5) in feed commodities exposed to the insecticide during 
treatment of feed-handling establishments where feed and feed products 
are held, processed, prepared, or served. Treatments may be made by 
general surface, spot, and/or crack and crevice applications.
    (i) General surface tratments shall be limited to a maximum of 3.8 
grams of active ingredient per 1,000 square feet, applying to walls, 
floors, and ceilings with a low-pressure system. Cover or remove all 
feed processing and/or handling equipment during application. Do not 
apply directly to feed products. Reapplications may be made at 10-day 
intervals.
    (ii) Crack and crevice or spot treatments shall be limited to a 
maximum of 0.1 percent of the active ingredient by weight, applied with 
a low-pressure system with a pinpoint or variable-pattern nozzle. Dust 
formulation shall be limited to a maximum of 0.1 percent of the active 
ingredient by weight, applied using a hand duster, power duster, or 
other equipment capable of applying dust insecticide directly into voids 
and cracks and crevices. Dust applications should be made in a manner to 
avoid deposits on exposed surfaces or introducing the material into the 
air. Cover exposed feed or remove feed from premises. Do not apply 
directly to feed. Reapplications may be made at 10-day intervals.
    (iii) To ensure safe use of the insecticide, its label and labeling 
shall conform to that registered by EPA, and it shall be used in 
accordance with such label and labeling.
    (4) Tolerances are established for residues of the isomer, beta-
cyfluthrin, cyano(4-fluoro-3-phenoxyphenyl)methyl-3-(2,2-
dichloroethenyl)-2,2-dimethyl-cyclopropanecarboxylate [mixture 
comprising the enantiomeric pair (R)-[alpha]-cyano-4-fluoro-3-
phenoxybenzyl (1S,3S)-3-(2,2-dichlorovinyl)-2,2-
dimethylcyclopropanecarboxylate and (S)-[alpha]-cyano-4-fluoro-3-
phenoxybenzyl (1R,3R)-3-(2,2-dichlorovinyl)-2,2-
dimethylcyclopropanecarboxylate with the enantiomeric pair (R)-[alpha]-
cyano-4-fluoro-3-phenoxybenzyl (1S,3R)-3-(2,2-dichlorovinyl)-2,2-
dimethylcyclopropanecarboxylate and (S)-[alpha]-cyano-4-fluoro-3-
phenoxybenzyl (1R,3S)-3-(2,2-dichlorovinyl)-2,2-
dimethylcyclopropanecarboxylate], in or on the following raw 
agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa.....................................................        5.0
Alfalfa, forage.............................................        5.0
Alfalfa, hay................................................       13

[[Page 575]]

 
Almond, hulls...............................................        0.5
Barley, bran................................................        0.5
Barley, grain...............................................        0.15
Beet, sugar, dried pulp.....................................        1.0
Beet, sugar, roots..........................................        0.10
Brassica, head and stem, subgroup 5A........................        2.5
Brassica, leafy greens, subgroup 5B.........................        7.0
Buckwheat, grain............................................        0.15
Carrot, roots...............................................        0.20
Cattle, fat.................................................        2.0
Cattle, meat................................................        0.10
Cattle, meat byproducts.....................................        0.10
Citrus, dried pulp..........................................        0.3
Citrus, oil.................................................        0.3
Corn, field, grain..........................................        0.05
Corn, pop, grain............................................        0.05
Corn, sweet, kernel plus cob with husks removed.............        0.05
Cotton, hulls...............................................        2.0
Cotton, refined oil.........................................        2.0
Cotton, undelinted seed.....................................        1.0
Egg.........................................................        0.01
Fruit, citrus, group 10.....................................        0.2
Fruit, pome, group 11.......................................        0.5
Fruit, stone, group 12......................................        0.3
Goat, fat...................................................        2.0
Goat, meat..................................................        0.05
Goat, meat byproducts.......................................        0.05
Grain, aspirated fractions..................................      150
Grain, cereal, forage, fodder and hay, group 16, forage,           25
 except rice................................................
Grain, cereal, forage, fodder and hay, group 16, hay, except        6.0
 rice.......................................................
Grain, cereal, forage, fodder and hay, group 16, stover,           30
 except rice................................................
Grain, cereal, forage, fodder and hay, group 16, straw,             7.0
 except rice................................................
Grape.......................................................        1.0
Grape, raisin...............................................        3.5
Grass, forage, fodder and hay, group 17, forage.............       12
Grass, forage, fodder and hay, group 17, hay................       50
Hog, fat....................................................        0.5
Hog, meat...................................................        0.01
Hog, meat byproducts........................................        0.01
Hop, dried cones............................................       20.0
Hop, vines..................................................        4.0
Horse, fat..................................................        2.0
Horse, meat.................................................        0.05
Horse, meat byproducts......................................        0.05
Lettuce, head...............................................        2.0
Lettuce, leaf...............................................        3.0
Milk........................................................        0.2
Milk, fat...................................................        5.0
Millet, grain...............................................        0.15
Mustard greens..............................................        7.0
Nut, tree, group 14.........................................        0.01
Oat, bran...................................................        0.5
Oat, grain..................................................        0.15
Pea and bean, dried shelled, except soybean, subgroup 6C....        0.15
Pea, dry, seed..............................................        0.15
Pea, southern, succulent....................................        0.25
Peanut......................................................        0.01
Peanut, hay.................................................        6.0
Pepper......................................................        0.50
Pistachio...................................................        0.01
Poultry, fat................................................        0.01
Poultry, meat...............................................        0.01
Poultry, meat byproducts....................................        0.01
Radish, roots...............................................        1.0
Rye, bran...................................................        0.5
Rye, grain..................................................        0.15
Sheep, fat..................................................        2.0
Sheep, meat.................................................        0.05
Sheep, meat byproducts......................................        0.05
Sorghum, grain, grain.......................................        3.5
Soybean, forage.............................................        8.0
Soybean, hay................................................        4.0
Soybean, seed...............................................        0.03
Sugarcane, cane.............................................        0.05
Sugarcane, molasses.........................................        0.20
Sunflower, forage...........................................        5.0
Sunflower, seed.............................................        0.02
Teosinte, grain.............................................        0.05
Tomato......................................................        0.20
Tomato, paste...............................................        0.5
Tomato, pomace..............................................        5.0
Triticale, grain............................................        0.15
Turnip, greens..............................................        7.0
Vegetable, cucurbit, group 9................................        0.1
Vegetable, fruiting, group 8................................        0.5
Vegetable, leafy greens, except Brassica, group 4...........        6.0
Vegetable, tuberous and corm, subgroup 1C...................        0.01
Wheat, bran.................................................        0.5
Wheat, grain................................................        0.15
Wheat, shorts...............................................        0.5
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[53 FR 1924, Jan. 25, 1988]

    Editorial Note: For Federal Register citations affecting Sec. 
180.436, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.437  Methyl 2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-p-

toluate and methyl 6-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-m-toluate; 

tolerances for residues.

    Tolerances are established for the combined residues of the 
herbicide methyl 2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-p-
toluate and methyl 6-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-m-
toluate in or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, grain...............................................        0.10
Barley, straw...............................................        2.00
Sunflower, seed.............................................        0.10
Wheat, grain................................................        0.10
Wheat, straw................................................        2.00
------------------------------------------------------------------------


[53 FR 24069, June 27, 1988]

[[Page 576]]



Sec. 180.438  Lambda-cyhalothrin and an isomer gamma-cyhalothrin; tolerances 

for residues.

    (a) General. (1) Tolerances are established for the combined 
residues of the pyrethroid lambda-cyhalothrin, 1:1 mixture of (S)-
[alpha]-cyano-3-phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro-3,3,3-
trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate and (R)-
[alpha]-cyano-3-phenoxybenzyl-(Z)-(1S,3S)-3-(2-chloro-3,3,3-
trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate and its epimer 
expressed as epimer of lambda-cyhalothrin, a 1:1 mixture of (S)-[alpha]-
cyano-3-phenoxybenzyl-(Z)-(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop-1-
enyl)-2,2-dimethylcyclopropanecarboxylate and (R)-[alpha]-cyano-3-
phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate, on plants and livestocks, as indicated 
in the following table.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        5.0
Alfalfa, hay................................................        6.0
Almond, hulls...............................................        1.5
Apple, wet pomace...........................................        2.50
Avocado, imported...........................................        0.20
Barley, bran................................................        0.2
Barley, grain...............................................        0.05
Barley, hay.................................................        2.0
Barley, straw...............................................        2.0
Brassica, head and stem, subgroup 5A........................        0.4
Buckwheat, grain............................................        0.05
Canola, refined oil.........................................        2.0
Canola, seed................................................        1.0
Cattle, fat.................................................        3.0
Cattle, meat................................................        0.2
Cattle, meat byproducts.....................................        0.2
Corn, field, flour..........................................        0.15
Corn, field, forage.........................................        6.0
Corn, field, grain..........................................        0.05
Corn, field, stover.........................................        1.0
Corn, pop, grain............................................        0.05
Corn, pop, grain, flour.....................................        0.05
Corn, pop, stover...........................................        1.0
Corn, sweet, forage.........................................        6.0
Corn, sweet, stover.........................................        1.0
Corn, sweet, kernel plus cob with husks removed.............        0.05
Cotton, undelinted seed.....................................        0.05
Egg.........................................................        0.01
Fruit, pome, group 11.......................................        0.30
Fruit, stone, group 12......................................        0.50
Garlic......................................................        0.1
Goat, fat...................................................        3.0
Goat, meat..................................................        0.2
Goat, meat byproducts.......................................        0.2
Grain, aspirated fractions..................................        2.0
Grass, forage, fodder and hay, group 17.....................        7.0
Hog, fat....................................................        0.2
Hog, meat...................................................        0.01
Hog, meat byproducts........................................        0.02
Hop, dried cones............................................       10.0
Horse, fat..................................................        3.0
Horse, meat.................................................        0.2
Horse, meat byproducts......................................        0.2
Lettuce, head...............................................        2.0
Lettuce, leaf...............................................        2.0
Milk, fat (reflecting 0.4 ppm in whole milk)................       10.0
Nut, tree, group 14.........................................        0.05
Oat, grain..................................................        0.05
Oat, forage.................................................        2.0
Oat, hay....................................................        2.0
Oat, straw..................................................        2.0
Onion, bulb.................................................        0.1
Pea and bean, dried shelled, except soybean, subgroup 6C....        0.10
Pea and bean, succulent shelled, subgroup 6B................        0.01
Peanut......................................................        0.05
Peanut, hay.................................................        3.0
Pistachio...................................................        0.05
Poultry, fat................................................        0.03
Poultry, meat...............................................        0.01
Poultry, meat byproducts....................................        0.01
Rice, grain.................................................        1.0
Rice, hulls.................................................        5.0
Rice, straw.................................................        1.8
Rice, wild, grain...........................................        1.0
Rye, bran...................................................        0.2
Rye, grain..................................................        0.05
Rye, forage.................................................        2.0
Rye, straw..................................................        2.0
Sheep, fat..................................................        3.0
Sheep, meat.................................................        0.2
Sheep, meat byproducts......................................        0.2
Soybean.....................................................        0.01
Sorghum, grain, grain.......................................        0.2
Sorghum, grain, forage......................................        0.30
Sorghum, grain, stover......................................        0.50
Sugarcane, cane.............................................        0.05
Sunflower, forage...........................................        0.2
Sunflower, seed, hulls......................................        0.50
Sunflower, refined oil......................................        0.30
Sunflower, seed.............................................        0.2
Tomato......................................................        0.1
Tomato, dry pomace..........................................        6.0
Tomato, wet pomace..........................................        6.0
Vegetable, cucurbit, group 9................................        0.05
Vegetable, fruiting, group 8................................        0.20
Vegetable, legume, edible podded, subgroup 6A...............        0.20
Vegetable, tuberous and corm, subgroup 1C...................        0.02
Wheat, grain................................................        0.05
Wheat, forage...............................................        2.0
Wheat, hay..................................................        2.0
Wheat, straw................................................        2.0
Wheat, bran.................................................        0.2
------------------------------------------------------------------------

    (2) Tolerances \1\ are established for the combined residues of the 
pyrethroid [gamma-cyhalothrin (the isolated active isomer of lambda-
cyhalothrin) (S)-[min]-cyano-3-phenoxybenzyl (Z)-(1R,3R)-3-(2-chloro-
3,3,3-trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate)) and 
its epimer (R)-[min]-cyano-3-phenoxybenzyl (Z)-(1R,3R)-3-(2-chloro-
3,3,3-trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate in/on 
the following commodities:

[[Page 577]]



------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        5
Alfalfa, hay................................................        6
Almond, hulls...............................................        1.5
Apple, pomace, wet..........................................        2.50
Avocado, imported...........................................        0.20
Brassica, head and stem, subgroup 5A........................        0.4
Canola, seed................................................        0.15
Cattle, fat.................................................        3
Cattle, meat................................................        0.2
Cattle, meat byproducts.....................................        0.2
Corn, field, flour..........................................        0.15
Corn, field, forage.........................................        6.0
Corn, field, grain..........................................        0.05
Corn, field, stover.........................................        1.0
Corn, pop, grain............................................        0.05
Corn, pop, stover...........................................        1.0
Corn, sweet, forage.........................................        6.0
Corn, sweet, kernel plus cob with husks removed.............        0.05
Corn, sweet, stover.........................................        1.0
Cotton, undelinted seed.....................................        0.05
Egg.........................................................        0.01
Fruit, pome, group 11.......................................        0.30
Fruit, stone, group 12......................................        0.50
Garlic......................................................        0.10
Goat, fat...................................................        3.0
Goat, meat..................................................        0.2
Goat, meat byproducts.......................................        0.2
Grain, aspirated fractions..................................        2.0
Hog, fat....................................................        3.0
Hog, meat...................................................        0.2
Hog, meat byproducts........................................        0.2
Horse, fat..................................................        3.0
Horse, meat.................................................        0.2
Horse, meat byproducts......................................        0.2
Lettuce, head...............................................        2.0
Lettuce, leaf...............................................        2.0
Milk, fat (reflecting 0.20 ppm in whole milk)...............        5.0
Nut, tree, group 14.........................................        0.05
Okra........................................................        0.20
Onion, bulb.................................................        0.1
Pea and bean, dried shelled, except soybean, subgroup 6C....        0.10
Pea and bean, succulent shelled, subgroup 6B................        0.01
Peanut......................................................        0.05
Peanut, hay.................................................        3.0
Pistachio...................................................        0.05
Poultry, fat................................................        0.03
Poultry, meat...............................................        0.01
Poultry, meat byproducts....................................        0.01
Rice, grain.................................................        1.0
Rice, hulls.................................................        5.0
Rice, straw.................................................        1.8
Sheep, fat..................................................        3.0
Sheep, meat.................................................        0.2
Sheep, meat byproducts......................................        0.2
Sorghum, grain, forage......................................        0.30
Sorghum, grain, grain.......................................        0.20
Sorghum, grain, stover......................................        0.50
Soybean.....................................................        0.01
Sugarcane...................................................        0.05
Sunflower, forage...........................................        0.20
Sunflower, refined oil......................................        0.30
Sunflower, seed.............................................        0.20
Sunflower, seed, hulls......................................        0.50
Tomato......................................................        0.10
Tomato, dry pomace..........................................        6.0
Tomato, wet pomace..........................................        6.0
Vegetables, fruiting, group 8...............................        0.20
Vegetable, legume, edible podded, subgroup 6A...............        0.20
Wheat, bran.................................................        2.0
Wheat, forage...............................................        2.0
Wheat, grain................................................        0.05
Wheat, hay..................................................        2.0
Wheat, straw................................................        2.0
------------------------------------------------------------------------
\1\ The analytical enforcement methods for lambda-cyhalothrin are
  applicable for determination of gamma-cyhalothrin residues in plant
  and animal commodities.

    (3) A tolerance of 0.01 part per million is established for residues 
of the insecticide lamba-cyhalothrin and an isomer gamma-cyhalothrin in 
or on all food commodities (other than those already covered by a higher 
tolerance as a result of use on growing crops) in food-handling 
establishments where food products are held, processed, or prepared.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[71 FR 74817, Dec. 13, 2006, as amended at 72 FR 45663, Aug. 15, 2007; 
73 FR 39264, July 9, 2008; 76 FR 34885, June 15, 2011]



Sec. 180.439  Thifensulfuron methyl; tolerances for residues.

    (a) General. Tolerances are established for residues of 
thifensulfuron methyl, including its metabolites and degradates, in or 
on the commodities listed in the following table [below]. Compliance 
with the tolerance levels specified in the following table [below] is to 
be determined by measuring only thifensulfuron methyl (methyl 3-[[[[(4-
methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]amino] sulfonyl]-2-
thiophenecarboxylate).

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, grain...............................................        0.05
Barley, hay.................................................        0.8
Barley, straw...............................................        0.10
Canola, seed................................................        0.02
Chicory, roots..............................................        0.01
Chicory, tops...............................................        0.01
Corn, field, forage.........................................        0.10
Corn, field, grain..........................................        0.05
Corn, field, stover.........................................        0.10
Cotton, gin byproducts......................................        0.02
Cotton, undelinted seed.....................................        0.02
Flax, seed..................................................        0.02
Oat, forage.................................................        0.2
Oat, grain..................................................        0.05
Oat, hay....................................................        0.05
Oat, straw..................................................        0.10
Rice, grain.................................................        0.05
Rice, straw.................................................        0.05
Sorghum, grain, forage......................................        0.05
Sorghum, grain, grain.......................................        0.05

[[Page 578]]

 
Sorghum, grain, stover......................................        0.05
Soybean.....................................................        0.10
Wheat, forage...............................................        2.5
Wheat, grain................................................        0.05
Wheat, hay..................................................        0.7
Wheat, straw................................................        0.10
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances are 
established for residues of thifensulfuron methyl, including its 
metabolites and degradates, in or on the commodities listed in the 
following table [below]. Compliance with the tolerance levels specified 
in the following table [below] is to be determined by measuring only 
thifensulfuron methyl (methyl 3-[[[[(4-methoxy-6-methyl-1,3,5-triazin-2-
yl)amino]carbonyl]amino] sulfonyl]-2-thiophenecarboxylate).

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Safflower, seed.............................................        0.05
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[69 FR 55982, Sept. 17, 2004, as amended at 69 FR 63957, Nov. 3, 2004; 
72 FR 13184, Mar. 21, 2007; 73 FR 47075, Aug. 13, 2008; 75 FR 19277, 
Apr. 14, 2010; 77 FR 52240, Aug. 29, 2012]



Sec. 180.440  Tefluthrin; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the insecticide tefluthrin (2,3,5,6 tetrafluroro-4-methylphenyl)methyl-
(1 alpha, 3 alpha)-(Z)-()-3(2-chloro-3,3,3-
trifluoro-1-propenyl)-2,2-diemthylcyclopropanecarboxylate) and its 
metabolite (Z)-3-(2-chloro-3,3,3-trifluroro-1-propenyl)-2,2-
dimethylcyclopropanecarboxylic acid in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Corn, field, forage.........................................        0.06
Corn, field, grain..........................................        0.06
Corn, field, stover.........................................        0.06
Corn, pop, grain............................................        0.06
Corn, pop, stover...........................................        0.06
Corn, sweet, forage.........................................        0.06
Corn, sweet, kernel plus cob with husks removed.............        0.06
Corn, sweet, stover.........................................        0.06
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[62 FR 62961, Nov. 26, 1997, as amended at 74 FR 46375, Sept. 9, 2009]



Sec. 180.441  Quizalofop ethyl; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
herbicide quizalofop ethyl, including its metabolites and degradates, in 
or on the commodities in the following table. Compliance with the 
tolerance levels specified in the following table is to be determined by 
measuring only those quizalofop ethyl residues convertible to 2-methoxy-
6-chloroquinoxaline, expressed as the stoichiometric equivalent of 
quizalofop ethyl, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, grain...............................................        0.05
Barley, hay.................................................        0.05
Barley, straw...............................................        0.05
Bean, dry, seed.............................................        0.4
Bean, succulent.............................................        0.25
Beet, sugar, molasses.......................................        0.2
Beet, sugar, roots..........................................        0.1
Beet, sugar, tops...........................................        0.5
Cotton, undelinted seed.....................................        0.1
Cowpea, forage..............................................        3.0
Cowpea, hay.................................................        3.0
Crambe, meal................................................        2.0
Flax, seed..................................................        0.05
Gold of pleasure, meal......................................        2.0
Lentil, seed................................................        0.05
Pea, dry....................................................        0.25
Pea, field, hay.............................................        3.0
Pea, field, vines...........................................        3.0
Pea, succulent..............................................        0.3
Peppermint, tops............................................        2.0
Rapeseed, meal..............................................        2.0
Rapeseed subgroup 20A, except flax, seed....................        1.5
Sorghum, grain, aspirated grain fractions...................        1.0
Sorghum, grain, forage......................................        0.20
Sorghum, grain, grain.......................................        0.20
Sorghum, grain, stover......................................        0.30
Soybean, flour..............................................        0.5
Soybean, hulls..............................................        0.02
Soybean, meal...............................................        0.5
Soybean, seed...............................................        0.05
Soybean, soapstock..........................................        1.0
Spearmint, tops.............................................        2.0
Sunflower, seed.............................................        1.9
Wheat, forage...............................................        0.05
Wheat, grain................................................        0.05
Wheat, hay..................................................        0.05
Wheat, straw................................................        0.05
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the herbicide 
quizalofop ethyl,

[[Page 579]]

including its metabolites and degradates, in or on the commodities in 
the following table. Compliance with the tolerance levels specified in 
the following table is to be determined by measuring only those 
quizalofop ethyl residues convertible to quizalofop (2-[4-(6-
chloroquinoxalin-2-yl-oxy)phenoxy]propanoic acid), expressed as 
quizalofop, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.05
Cattle, meat................................................        0.02
Cattle, meat byproducts.....................................        0.05
Egg.........................................................        0.02
Goat, fat...................................................        0.05
Goat, meat..................................................        0.02
Goat, meat byproducts.......................................        0.05
Hog, fat....................................................        0.05
Hog, meat...................................................        0.02
Hog, meat byproducts........................................        0.05
Horse, fat..................................................        0.05
Horse, meat.................................................        0.02
Horse, meat byproducts......................................        0.05
Milk........................................................        0.01
Milk, fat...................................................        0.25
Poultry, fat................................................        0.05
Poultry, meat...............................................        0.02
Poultry, meat byproducts....................................        0.05
Sheep, fat..................................................        0.05
Sheep, meat.................................................        0.02
Sheep, meat byproducts......................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration are established for residues of the herbicide quizalofop 
ethyl, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance levels 
specified in the following table is to be determined by measuring only 
those quizalofop ethyl residues convertible to 2-methoxy-6-
chloroquinoxaline, expressed as the stoichiometric equivalent of 
quizalofop ethyl, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Pineapple...................................................        0.1
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 32759, June 16, 1998, as amended at 70 FR 7870, Feb. 16, 2005; 71 
FR 56378, Sept. 27, 2006; 76 FR 56045, Sept. 15, 2010; 77 FR 23630, Apr. 
20, 2012]



Sec. 180.442  Bifenthrin; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide bifenthrin, including its metabolites and degradates, in or 
on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only bifenthrin, 
(2-methyl [1,1[min]-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3,-trifluoro-
1-propenyl)-2,2-dimethylcyclopropanecarboxylate.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        2.0
Artichoke, globe............................................        1.0
Banana \1\..................................................        0.1
Beet, garden, roots.........................................        0.45
Beet, garden, tops..........................................       15
Brassica, head and stem, subgroup 5A, except cabbage........        0.6
Brassica, leafy greens, subgroup 5B.........................        3.5
Bushberry subgroup 13-07B...................................        1.8
Cabbage.....................................................        4.0
Caneberry subgroup 13A......................................        1.0
Cattle, fat.................................................        1.0
Cattle, meat byproducts.....................................        0.10
Cattle, meat................................................        0.5
Coriander, dried leaves.....................................       25
Coriander, leaves...........................................        6.0
Coriander, seed.............................................        5.0
Corn, field, forage.........................................        3.0
Corn, field, grain..........................................        0.05
Corn, field, stover.........................................        5.0
Corn, pop, grain............................................        0.05
Corn, pop, stover...........................................        5.0
Corn, sweet, forage.........................................        3.0
Corn, sweet, kernel plus cob with husk removed..............        0.05
Corn, sweet, stover.........................................        5.0
Cotton, undelinted seed.....................................        0.5
Eggplant....................................................        0.05
Egg.........................................................        0.05
Fruit, citrus, group 10.....................................        0.05
Goat, fat...................................................        1.0
Goat, meat byproducts.......................................        0.10
Goat, meat..................................................        0.5
Grain, aspirated fractions..................................       70
Grape.......................................................        0.2
Groundcherry................................................        0.5
Herb subgroup 19A...........................................        0.05
Hog, fat....................................................        1.0
Hog, meat byproducts........................................        0.10
Hog, meat...................................................        0.5
Hop, dried cones............................................       10.0
Horse, fat..................................................        1.0
Horse, meat byproducts......................................        0.10
Horse, meat.................................................        0.5
Leafy petioles subgroup 4B..................................        3.0
Lettuce, head...............................................        3.0
Mayhaw......................................................        1.4
Milk, fat (reflecting 0.1 ppm in whole milk)................        1.0
Nut, tree, group 14.........................................        0.05
Okra........................................................        0.50
Pea and bean, dried shelled, expect soybean, subgroup 6C....        0.15
Pea and bean, succulent shelled, subgroup 6B................        0.05
Peanut......................................................        0.05
Pear........................................................        0.5
Pepino......................................................        0.5

[[Page 580]]

 
Pepper, bell................................................        0.5
Pepper, nonbell.............................................        0.5
Pistachio...................................................        0.05
Poultry, fat................................................        0.05
Poultry, meat byproducts....................................        0.05
Poultry, meat...............................................        0.05
Radish, tops................................................        4.5
Rapeseed, seed..............................................        0.05
Sheep, fat..................................................        1.0
Sheep, meat byproducts......................................        0.1
Sheep, meat.................................................        0.5
Soybean, hulls..............................................        0.50
Soybean, refined oil........................................        0.30
Soybean, seed...............................................        0.2
Spinach.....................................................        0.2
Strawberry..................................................        3.0
Tea, dried \1\..............................................       30
Tomato......................................................        0.15
Turnip, greens..............................................        3.5
Vegetable, cucurbit, group 9................................        0.4
Vegetable, legume, edible podded, subgroup 6A...............        0.6
Vegetable, root, subgroup 1B except sugar beet and garden           0.10
 beet.......................................................
Vegetable, tuberous and corm, subgroup 1C...................        0.05
------------------------------------------------------------------------
\1\ There are no U.S. registrations.

    (2) A tolerance of 0.05 ppm is established for residues of the 
insecticide bifenthrin, (2-methyl[1,1'-biphenyl]-3-yl)methyl-3-(2-
chloro-3,3,3-trifluoro-1-propenyl)-2,2-dimethylcyclopropane-carboxylate, 
as follows:
    (i) In or on all food/feed items (other than those covered by a 
higher tolerance as a result of use on growing crops) in food/feed 
handling establishments.
    (ii) The insecticide may be present as a residue from application of 
bifenthrin in food handling establishments, including food service, 
manufacturing and processing establishments, such as restaurants, 
cafeterias, supermarkets, bakeries, breweries, dairies, meat 
slaughtering and packing plants, and canneries, feed handling 
establishments including feed manufacturing and processing 
establishments, in accordance with the following prescribed conditions:
    (A) Application shall be limited to general surface and spot and/or 
crack and crevice treatment in food/feed handling establishments where 
food/feed and food/feed products are held, processed, prepared and 
served. General surface application may be used only when the facility 
is not in operation provided exposed food/feed has been covered or 
removed from the area being treated. Spot and/or crack and crevice 
application may be used while the facility is in operation provided 
exposed food/feed is covered or removed from the area being treated 
prior to application. Spray concentration shall be limited to a maximum 
of 0.06 percent active ingredient. Contamination of food/feed or food/
feed contact surfaces shall be avoided.
    (B) To assure safe use of the insecticide, its label and labeling 
shall conform to that registered with the U.S. Environmental Protection 
Agency and shall be used in accordance with such label and labeling.
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the insecticide bifenthrin, including its 
metabolites and degradates, in connection with use of the pesticide 
under a Section 18 emergency exemption granted by EPA. Compliance with 
the tolerance levels specified below is to be determined by measuring 
only bifenthrin, (2-methyl [1,1[min]-biphenyl]-3-yl) methyl-3-(2-chloro-
3,3,3,-trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylate. These 
tolerances will expire and are revoked on the dates specified in the 
following table:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Apple...........................................        0.5     12/31/15
Nectarine.......................................        0.5     12/31/15
Peach...........................................        0.5     12/31/15
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. Tolerances with regional 
registrations are established for residues of the insecticide 
bifenthrin, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only bifenthrin, (2-
methyl [1,1[min]-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3,-trifluoro-1-
propenyl)-2,2-dimethylcyclopropanecarboxylate.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grass, forage...............................................        4.0
Grass, hay..................................................       15
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[62 FR 31002, June 6, 1997]

    Editorial Note: For Federal Register citations affecting Sec. 
180.442, see the List of CFR

[[Page 581]]

Sections Affected, which appears in the Finding Aids section of the 
printed volume and at www.fdsys.gov.



Sec. 180.443  Myclobutanil; tolerances for residues.

    (a) General. Tolerances are established for combined residues of the 
fungicide myclobutanil alpha-butyl-alpha-(4-chlorophenyl)-1H-1,2,4-
triazole-1-propanenitrile and its alcohol metabolite (alpha-(3-
hydroxybutyl)-alpha-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile 
(free and bound), in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond......................................................        0.1
Almond, hulls...............................................        2.0
Apple.......................................................        0.5
Apple, dry pomace...........................................        5.0
Apple, wet pomace...........................................        5.0
Artichoke, globe............................................        0.90
Asparagus...................................................        0.02
Banana, postharvest.........................................        4.0
Bean, snap, succulent.......................................        1.0
Caneberry subgroup 13A......................................        2.0
Canistel....................................................        3.0
Cattle, fat.................................................        0.05
Cattle, liver...............................................        1.0
Cattle, meat................................................        0.1
Cattle, meat byproducts, except liver.......................        0.2
Cherry, sweet...............................................        5.0
Cherry, tart................................................        5.0
Cilantro, leaves............................................        9.0
Cotton, undelinted seed.....................................        0.02
Currant.....................................................        3.0
Egg.........................................................        0.02
Fruit, stone, except cherry.................................        2.0
Goat, fat...................................................        0.05
Goat, liver.................................................        1.0
Goat, meat..................................................        0.1
Goat, meat byproducts, except liver.........................        0.2
Gooseberry..................................................        2.0
Grain, aspirated fractions..................................       35
Grape.......................................................        1.0
Grape, dried pomace.........................................       10.0
Grape, raisin...............................................       10.0
Grape, raisin, waste........................................       25.0
Grape, wet pomace...........................................       10.0
Hog, fat....................................................        0.05
Hog, liver..................................................        1.0
Hog, meat...................................................        0.1
Hog, meat byproducts, except liver..........................        0.2
Hop, dried cones............................................       10
Horse, fat..................................................        0.05
Horse, liver................................................        1.0
Horse, meat.................................................        0.1
Horse, meat byproducts, except liver........................        0.2
Leafy greens, subgroup 4A, except spinach...................        9.0
Mango.......................................................        3.0
Mayhaw......................................................        0.70
Milk........................................................        0.2
Okra........................................................        4.0
Papaya......................................................        3.0
Peppermint, tops............................................        3.0
Plum, prune, dried..........................................        8.0
Poultry, fat................................................        0.02
Poultry, meat...............................................        0.02
Poultry, meat byproducts....................................        0.02
Sapodilla...................................................        3.0
Sapote, black...............................................        3.0
Sapote, mamey...............................................        3.0
Sheep, fat..................................................        0.05
Sheep, liver................................................        1.0
Sheep, meat.................................................        0.1
Sheep, meat byproducts, except liver........................        0.2
Soybean, forage.............................................        3.5
Soybean, hay................................................       15
Soybean, refined oil........................................        0.40
Soybean, seed...............................................        0.25
Spearmint, tops.............................................        3.0
Star apple..................................................        3.0
Strawberry..................................................        0.50
Tomato......................................................        0.30
Tomato, puree...............................................        0.50
Tomato, paste...............................................        1.0
Vegetable, cucurbit, group 9................................        0.20
Vegetable, fruiting, group 8, except tomato.................        4.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established for 
residues of the fungicide myclobutanil alpha-butyl-alpha-(4-
chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile in or on the following 
food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Animal feed, nongrass, group 18.............................        0.03
Grain, cereal, forage, fodder and straw, group 16...........        0.03
Grain, cereal, group 15.....................................        0.03
Vegetable, brassica, leafy, group 5.........................        0.03
Vegetable, foliage of legume, group 7.......................        0.03
Vegetable, fruiting, group 8................................        0.03
Vegetable, leafy, except brassica, group 4..................        0.03
Vegetable, leaves of root and tuber, group 2................        0.03
Vegetable, legume, group 6..................................        0.03
Vegetable, root and tuber, group 1..........................        0.03
------------------------------------------------------------------------


[54 FR 6131, Feb. 8, 1989]

    Editorial Note: For Federal Register citations affecting Sec. 
180.443, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.444  Sulfur dioxide; tolerances for residues.

    (a) General. A tolerance is established as follows for sulfite 
residues of the fungicide sulfur dioxide (determined as 
(SO2)) in or on the following raw agricultural 
commodity(ies):

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grape, postharvest..........................................       10.0
------------------------------------------------------------------------


[[Page 582]]

    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of sulfur 
dioxide, including its metabolites and degradates in or on the specified 
agricultural commodities, resulting from use of the pesticide pursuant 
to FFIFRA section 18 emergency exemptions. Compliance with the tolerance 
levels specified below is to be determined by measuring only sulfur 
dioxide (SO2). The tolerances expire on the date specified in 
the table.

------------------------------------------------------------------------
                                                             Expiration/
                  Commodity                     Parts per    revocation
                                                 million        date
------------------------------------------------------------------------
Fig.........................................            10      12/31/14
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[54 FR 20126, May 10, 1989, as amended at 76 FR 56648, Sept. 14, 2011]



Sec. 180.445  Bensulfuron methyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide bensulfuron methyl (methyl-2[[[[[(4,6-dimethoxy-pyrimidin-2-
yl) amino] carbonyl] amino] sulfonyl] methyl] benzoate) in or on the 
following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Crayfish....................................................        0.05
Rice, grain.................................................        0.02
Rice, straw.................................................        0.3
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 9435, Feb. 25, 1998]



Sec. 180.446  Clofentezine; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide clofentezine, including its metabolites and degradates, in 
or on the commodities in the table in this paragraph. Compliance with 
the tolerance levels specified in this paragraph is to be determined by 
measuring only clofentezine, 3,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine, 
in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        5.0
Almond......................................................        0.5
Apple.......................................................        0.5
Apple, dry pomace...........................................        3.0
Apple, wet pomace...........................................        3.0
Apricot.....................................................        1.0
Cherry......................................................        1.0
Grape.......................................................        1.0
Nectarine...................................................        1.0
Peach.......................................................        1.0
Pear........................................................        0.5
Persimmon...................................................        0.05
Walnut......................................................        0.02
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the insecticide 
clofentezine, including its metabolites and degradates, in or on the 
commodities in the table in this paragraph. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only the sum of clofentezine, 3,6-bis(2-chlorophenyl)-1,2,4,5-
tetrazine, and its metabolite, 3-(2-chloro-4-hydroxyphenyl)-6-(2-
chlorophenyl)-1,2,4,5-tetrazine, calculated as the stoichiometric 
equivalent of clofentezine, in or on commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.05
Cattle, liver...............................................        0.4
Cattle, meat................................................        0.05
Cattle, meat byproducts, except liver.......................        0.05
Goat, fat...................................................        0.05
Goat, liver.................................................        0.4
Goat, meat..................................................        0.05
Goat, meat byproducts, except liver.........................        0.05
Hog, fat....................................................        0.05
Hog, liver..................................................        0.4
Hog, meat...................................................        0.05
Hog, meat byproducts, except liver..........................        0.05
Horse, fat..................................................        0.05
Horse, liver................................................        0.4
Horse, meat.................................................        0.05
Horse, meat byproducts, except liver........................        0.05
Milk........................................................        0.01
Sheep, fat..................................................        0.05
Sheep, liver................................................        0.4
Sheep, meat.................................................        0.05
Sheep, meat byproducts, except liver........................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]

[[Page 583]]

    (d) Indirect or inadvertent residues. [Reserved]

[56 FR 15503, Apr. 17, 1991, as amended at 56 FR 22335, May 15, 1991; 59 
FR 26947, May 25, 1994; 60 FR 12709, Mar. 8, 1995; 64 FR 19050, Apr. 19, 
1999; 70 FR 11572, Mar. 9, 2005; 74 FR 46375, Sept. 9, 2009; 76 FR 
23496, Apr. 27, 2011]



Sec. 180.447  Imazethapyr; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
herbicide imazethapyr, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo- 
1H-imidazol-2-yl]-5-ethyl-3-pyridine carboxylic acid, applied as its 
acid or ammonium salt, in or on the following raw agricultural 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Canola, seed \1\............................................        0.10
Soybean.....................................................        0.1
Vegetable, legume, group 6..................................        0.1
------------------------------------------------------------------------
1 There are no U.S. registrations for canola as of March 21, 2003.

    (2) Tolerances are established for the sum of the residues of the 
herbicide imazethapyr, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo- 
1H-imidazol-2-yl]-5-ethyl-3-pyridine carboxylic acid; its metabolite CL 
288511, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-
yl]-5-(1-hydroxyethyl)-3-pyridine carboxylic acid; and its metabolite CL 
182704, 5-[1-(beta-D-glucopyranosyloxy)ethyl]-2-[4,5-dihydro-4-methyl-4-
(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-3-pyridinecarboxylic acid, 
applied as its acid or ammonium salt, in or on the following 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, seed...............................................        0.15
Alfalfa, seed screenings....................................        0.15
Animal feed, nongrass, group 18, forage.....................        3.0
Animal feed, nongrass, group 18, hay........................        5.5
Peanut......................................................        0.1
Rice, bran..................................................        1.2
Rice, grain.................................................        0.3
Rice, straw.................................................        0.4
------------------------------------------------------------------------

    (3) A tolerance is established for the sum of residues of the 
herbicide imazethapyr, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo- 
1H-imidazol-2-yl]-5-ethyl-3-pyridine carboxylic acid, and its metabolite 
CL 288511, 2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5- oxo-1H-imidazol-
2-yl]-5-(1-hydroxyethyl)-3-pyridine carboxylic acid, applied as its acid 
or ammonium salt, in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, meat byproducts.....................................        0.10
Corn, field, forage.........................................        0.1
Corn, field, grain..........................................        0.1
Corn, field, stover.........................................        0.1
Crayfish....................................................        0.15
Goat, meat byproducts.......................................        0.10
Hog, meat byproducts........................................        0.10
Horse, meat byproducts......................................        0.10
Sheep, meat byproducts......................................        0.10
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration, as defined in Sec. 180.1(l) of this chapter, are 
established for the sum of residues of the herbicide imazethapyr, 2- 
[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-ethyl- 
3-pyridine carboxylic acid, as its ammonium salt, and its metabolite, 2- 
[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-(1- 
hydroxyethyl)-3-pyridine carboxylic acid, both free and conjugated, 
applied as its acid or ammonium salt, in or on the following raw 
agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Endive......................................................        0.1
Lettuce, head...............................................        0.1
Lettuce, leaf...............................................        0.1
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[67 FR 55331, Aug. 29, 2002, as amended at 68 FR 13849, Mar. 21, 2003; 
71 FR 6359, Feb. 8, 2006; 76 FR 34885, June 15, 2011]



Sec. 180.448  Hexythiazox; tolerance for residues.

    (a) General. Tolerances are established for residues of hexythiazox, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below is 
to be determined by measuring only hexythiazox and its metabolites 
containing the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety, 
calculated as the stoichiometric equivalent of hexythiazox.

[[Page 584]]



------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................       10
Apple, wet pomace...........................................        0.40
Caneberry subgroup 13A......................................        1.0
Cattle, fat.................................................        0.05
Cattle, meat byproducts.....................................        0.20
Citrus, dried pulp..........................................        0.60
Citrus, oil.................................................       24
Corn, field, forage.........................................        3.0
Corn, field, grain..........................................        0.02
Corn, field, stover.........................................        7.0
Date, dried fruit...........................................        1.0
Egg.........................................................        0.01
Fruit, pome, group 11.......................................        0.25
Fruit, stone, group 12......................................        1.0
Goat, fat...................................................        0.05
Goat, meat byproducts.......................................        0.20
Grain, aspirated fractions..................................        0.50
Grape.......................................................        1.0
Hog, fat....................................................        0.02
Hog, meat byproducts........................................        0.05
Hop, dried cones............................................        2.0
Horse, fat..................................................        0.05
Horse, meat byproducts......................................        0.20
Milk........................................................        0.05
Nut, tree, group 14.........................................        0.30
Peppermint, tops............................................        2.0
Pistachio...................................................        0.30
Plum, prune, dried..........................................        1.3
Poultry, fat................................................        0.05
Poultry, meat byproducts....................................        0.05
Sheep, fat..................................................        0.05
Sheep, meat byproducts......................................        0.20
Spearmint, tops.............................................        2.0
Strawberry..................................................        3.0
Tomato......................................................        0.50
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of hexythiazox, including its metabolites and 
degradates, in connection with use of the pesticide under section 18 
emergency exemptions granted by EPA. Compliance with the tolerance 
levels specified below is to be determined by measuring only hexythiazox 
and its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-
thiazolidine moiety, calculated as the stoichiometric equivalent of 
hexythiazox. These tolerances will expire and are revoked on the dates 
specified in the following table:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Corn, sweet, plus cobs with husks removed              0.02     12/31/12
 (K+CWHR).......................................
Corn, sweet, forage.............................        6.0     12/31/12
Corn, sweet, stover.............................        2.5     12/31/12
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. Tolerances with regional 
registrations as defined by Sec. 180.1(l), are established for residues 
of hexythiazox, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only hexythiazox and 
its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-
thiazolidine moiety, calculated as the stoichiometric equivalent of 
hexythiazox.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage (EPA Regions 9-11 only).....................       15
Alfalfa, hay (EPA Regions 9-11 only)........................       30
Bean, dried, seed (EPA Regions 7-12 only)...................        0.4
Bean, succulent (EPA Regions 7-12 only).....................        0.3
Corn, field, forage.........................................        6.0
Corn, field, grain..........................................        0.02
Corn, field, stover.........................................        2.5
Corn, sweet, forage (EPA Regions 7-12 only).................        4.0
Corn, sweet, kernel plus cob with husks removed (EPA Regions        0.1
 7-12 only).................................................
Cotton, gin byproducts, CA only.............................        3.0
Cotton, undelinted seed, CA only............................        0.20
Fruit, citrus group 10 (CA, AZ, TX only)....................        0.35
Potato......................................................        0.02
Timothy, forage (EPA Regions 9-11 only).....................       40
Timothy, hay (EPA Regions 9-11 only)........................       40
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[54 FR 17948, Apr. 26, 1989]

    Editorial Note: For Federal Register citations affecting Sec. 
180.448, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.449  Avermectin B1 and its delta-8,9-isomer; tolerances for residues.

    (a) General. Tolerances are established for residues of abamectin, 
including its metabolites and degradates, in or on the commodities in 
the following table. Compliance with the tolerance levels specified in 
the following table is to be determined by measuring only avermectin B1 
a mixture of avermectins containing greater than or equal to 80% 
avermectin B1 a (5-O-demethyl avermectin A1) and less than or equal to 
20% avermectin B1b (5-O-demethyl-25-de(1-methylpropyl)-25-(1-
methylethyl) avermectin A1) and its delta-8,9-isomer in or on the 
following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hulls..............................................        0.10
Apple......................................................        0.020
Apple, wet pomace..........................................        0.10
Avocado....................................................        0.020
Bean, dry, seed............................................        0.01

[[Page 585]]

 
Cattle, fat................................................        0.03
Cattle, meat...............................................        0.02
Cattle, meat byproducts....................................        0.06
Celeriac, roots............................................        0.05
Celeriac, tops.............................................        0.05
Chive, dried leaves........................................        0.02
Chive, fresh leaves........................................        0.01
Citrus, dried pulp.........................................        0.10
Citrus, oil................................................        0.10
Citrus.....................................................        0.02
Cotton, gin byproducts.....................................        1.0
Cotton, undelinted seed....................................        0.02
Food products in food handling establishments (other than          0.01
 those already covered by higher tolerances as a result of
 use on growing crops, and other than those already covered
 by tolerances on milk, meat, and meat byproducts).........
Fruit, stone, group 12.....................................        0.09
Goat, fat..................................................        0.01
Goat, meat.................................................        0.02
Goat, meat byproducts......................................        0.02
Grape......................................................        0.02
Herb subgroup 19A, except chive............................        0.030
Hog, fat...................................................        0.01
Hog, meat..................................................        0.02
Hog, meat byproducts.......................................        0.02
Hop, dried cones...........................................        0.20
Horse, fat.................................................        0.01
Horse, meat................................................        0.02
Horse, meat byproducts.....................................        0.02
Milk.......................................................        0.005
Nut, tree, group 14........................................        0.01
Onion, bulb, subgroup 3-07A................................        0.01
Pear.......................................................        0.02
Peppermint, tops...........................................        0.010
Pistachio..................................................        0.01
Plum, prune, dried.........................................        0.025
Poultry, meat..............................................        0.02
Poultry, meat byproducts...................................        0.02
Sheep, fat.................................................        0.01
Sheep, meat................................................        0.02
Sheep, meat byproducts.....................................        0.02
Spearmint, tops............................................        0.010
Strawberry.................................................        0.05
Vegetable, cucurbit, group 9...............................        0.005
Vegetable, fruiting, group 8...............................        0.020
Vegetable, leafy, except brassica, group 4.................        0.10
Vegetable, tuberous and corm, subgroup 01C.................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[62 FR 44095, Aug. 19, 1997]

    Editorial Note: For Federal Register citations affecting Sec. 
180.449, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.450  Beta-(4-Chlorophenoxy)-alpha-(1,1-dimethylethyl)-1H-1,2,4-

triazole-1-ethanol; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the fungicide [beta]-(4-chlorophenoxy)-[alpha]-(1,1-dimethylethyl)-1H-
1,2,4-triazole-1-ethanol (triadimenol) and its butanediol metabolite, 4-
(4-chlorophenoxy)-2,2-dimethyl-4-(1H-1,2,4-triazol-l-yl)-1,3-butanediol, 
calculated as triadimenol, in or on the following commodities:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   Revocation
                                                   million       Date
------------------------------------------------------------------------
Banana \1\......................................        0.2         None
Barley, grain...................................       0.05         None
Barley, straw...................................        0.2         None
Corn, field, forage.............................       0.05         None
Corn, field, grain..............................       0.05         None
Corn, field, stover.............................       0.05         None
Corn, pop, grain................................       0.05         None
Corn, pop, stover...............................       0.05         None
Corn, sweet, forage.............................       0.05         None
Corn, sweet, kernel plus cob with husks removed.       0.05         None
Corn, sweet, stover.............................       0.05         None
Cotton, undelinted seed.........................       0.02         None
Oat, forage.....................................        2.5         None
Oat, grain......................................       0.05         None
Oat, straw......................................        0.2         None
Rye, forage.....................................        2.5         None
Rye, grain......................................       0.05         None
Rye, straw......................................        0.1         None
Wheat, forage...................................        2.5         None
Wheat, grain....................................       0.05         None
Wheat, straw....................................        0.2         None
------------------------------------------------------------------------
\1\ There are no U.S. registrations for banana (whole) as of September
  22, 1993.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[73 FR 54962, Sept. 24, 2008, as amended at 74 FR 47457, Sept. 16, 2009; 
76 FR 34885, June 15, 2011]



Sec. 180.451  Tribenuron methyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide tribenuron methyl and its metabolites and degradates in or on 
the commodities in the following table. Compliance with the tolerance 
levels specified below is to be determined by measuring only tribenuron 
methyl, methyl-2-[[[[N-(4-methoxy-6-methyl-1,3,5-triazin-2-yl) 
methylamino] carbonyl] amino]

[[Page 586]]

sulfonyl] benzoate, in or on the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Barley, grain..............................................        0.05
Barley, hay................................................        0.4
Barley, straw..............................................        0.10
Canola, seed...............................................        0.02
Corn, field, forage........................................        0.15
Corn, field, grain.........................................        0.01
Corn, field, stover........................................        1.1
Cotton, gin byproducts.....................................        0.02
Cotton, undelinted seed....................................        0.02
Flax, seed.................................................        0.02
Grain, aspirated fractions.................................        1.5
Oat, forage................................................        0.05
Oat, grain.................................................        0.05
Oat, hay...................................................        0.05
Oat, straw.................................................        0.10
Rice, grain................................................        0.05
Rice, straw................................................        0.05
Sorghum, grain, forage.....................................        0.05
Sorghum, grain, grain......................................        0.05
Sorghum, grain, stover.....................................        0.05
Soybean, forage............................................        0.07
Soybean, hay...............................................        0.35
Soybean, hulls.............................................        0.04
Soybean, seed..............................................        0.01
Sunflower, seed............................................        0.05
Wheat, forage..............................................        0.3
Wheat, grain...............................................        0.05
Wheat, hay.................................................        0.5
Wheat, straw...............................................        0.10
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration, as defined in Sec. 180.1(l) are established for residues 
of the herbicide tribenuron methyl (methyl-2-[[[[N-(4-methoxy-6-methyl-
1,3,5-triazin-2-yl) methylamino] carbonyl]amino]sulfonyl] benzoate) in 
or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Grass, forage, fodder and hay, group 17, except                    0.10
 bermudagrass; forage......................................
Grass, forage, fodder and hay, group 17, except                    0.10
 bermudagrass; hay.........................................
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[69 FR 56718, Sept. 22, 2004, as amended at 72 FR 11789, Mar. 14, 2007; 
73 FR 47065, Aug. 13, 2008; 74 FR 67128, Dec. 18, 2009; 76 FR 34885, 
June 15, 2011]



Sec. 180.452  Primisulfuron-methyl; tolerances for residues.

    (a) General. Tolerances are established for residues of 
primisulfuron-methyl (3-[4,6-bis-(difluoromethoxy)-pyrimidin-2-yl]-1-(2-
methoxycarbonylphenylsulfonyl) urea) in or on the following raw 
agricultural commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................        0.10
Cattle, meat...............................................        0.10
Cattle, meat byproducts....................................        0.10
Corn, field, forage........................................        0.10
Corn, field, grain.........................................        0.02
Corn, field, stover........................................        0.10
Corn, pop, grain...........................................        0.02
Corn, pop, stover..........................................        0.10
Egg........................................................        0.10
Goat, fat..................................................        0.10
Goat, meat.................................................        0.10
Goat, meat byproducts......................................        0.10
Hog, fat...................................................        0.10
Hog, meat..................................................        0.10
Hog, meat byproducts.......................................        0.10
Horse, fat.................................................        0.10
Horse, meat................................................        0.10
Horse, meat byproducts.....................................        0.10
Milk.......................................................        0.02
Poultry, fat...............................................        0.10
Poultry, meat..............................................        0.10
Poultry, meat byproducts...................................        0.10
Sheep, fat.................................................        0.10
Sheep, meat................................................        0.10
Sheep, meat byproducts.....................................        0.10
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[55 FR 21548, May 25, 1990, as amended at 62 FR 66020, Dec. 17, 1997; 63 
FR 66458, Dec. 2, 1998; 67 FR 35049, May 17, 2002; 74 FR 46375, Sept. 9, 
2009; 74 FR 46699, Sept. 11, 2009; 77 FR 59128, Sept. 26, 2012]



Sec. 180.454  Nicosulfuron; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide nicosulfuron, including its metabolites and degradates, in or 
on the commodities in the following table [below]. Compliance with the 
tolerance levels specified in the following table [below] is to be 
determined by measuring only nicosulfuron, 3-Pyridinecarboxamide, 2-
[[[[(4,6-dimethoxy-2-pyrimidinyl)amino] carbonyl]amino]sulfonyl]-N,N-
dimethyl-.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.01
Cattle, meat................................................        0.01
Cattle, meat byproducts.....................................        0.05
Corn, field, forage.........................................        0.1

[[Page 587]]

 
Corn, field, grain..........................................        0.1
Corn, field, stover.........................................        0.1
Corn, pop, grain............................................        0.1
Corn, pop, stover...........................................        0.1
Corn, sweet, forage.........................................        0.1
Corn, sweet, kernel plus cob with husks removed.............        0.1
Corn, sweet, stover.........................................        0.1
Goat, fat...................................................        0.01
Goat, meat..................................................        0.01
Goat, meat byproducts.......................................        0.05
Grass, forage...............................................        9.0
Grass, hay..................................................       25.0
Horse, fat..................................................        0.01
Horse, meat.................................................        0.01
Horse, meat byproducts......................................        0.05
Milk........................................................        0.01
Sheep, fat..................................................        0.01
Sheep, meat.................................................        0.01
Sheep, meat byproducts......................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table [below] are established for residues of 
the herbicide nicosulfuron, 3-Pyridinecarboxamide, 2-[[[[(4,6-dimethoxy-
2-pyrimidinyl)amino] carbonyl]amino]sulfonyl]-N,N-dimethyl-, in or on 
the specified agricultural commodities, resulting from use of the 
pesticide pursuant to FFIFRA section 18 emergency exemptions. The 
tolerances expire and are revoked on the date specified in the table.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   Revokation
                                                   million       Date
------------------------------------------------------------------------
Bermuda grass, forage...........................         10     12/31/11
Bermuda grass, hay..............................         25     12/31/11
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[75 FR 17578, Apr. 7, 2010]



Sec. 180.455  Procymidone; tolerances for residues.

    A tolerance is established for the residues of the fungicide 
procymidone, N-(3,5-dichlorophenyl)-1,2-dimethylcyclopropane-1,2 
dicarboximide, in or on the following raw agricultural commodity:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Grape, wine................................................        5.0
------------------------------------------------------------------------


[59 FR 42514, Aug. 18, 1994]



Sec. 180.457  Bitertanol; tolerances for residues.

    (a) General. A tolerance is established for the residues of the 
fungicide bitertanol, [beta]-([1,1[min]-biphenyl]-4-yloxy)-[alpha]-(1,1-
dimethylethyl)-1H-1,2,4-triazole-1-ethanol, in or on the following raw 
agricultural commodity:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Banana \1\..................................................        0.5
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of April 1, 1992.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[74 FR 47457, Sept. 16, 2009]



Sec. 180.458  Clethodim; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide clethodim, including its metabolites and degradates, in or on 
the commodities in the table in this paragraph. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only the sum of clethodim, 2-[(1E)-1-[[[(2E)-3-chloro-2-
propenyl]oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-
cyclohexen-1-one, and its metabolites containing the 5-(2-
ethylthiopropyl)cyclohexene-3-one and 5-(2-ethylthiopropyl)-5-
hydroxycyclohexene-3-one moieties and their sulphoxides and sulphones, 
calculated as the stoichiometric equivalent of clethodim, in or on the 
commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        6.0
Alfalfa, hay................................................       10
Artichoke, globe............................................        1.2
Asparagus...................................................        1.7
Bean, dry, seed.............................................        2.5
Beet, sugar, molasses.......................................        1.0
Beet, sugar, roots..........................................        0.20
Beet, sugar, tops...........................................        1.0
Brassica, head and stem, subgroup 5A........................        3.0
Brassica, leafy greens, subgroup 5B.........................        3.0
Bushberry subgroup 13-07B...................................        0.20
Caneberry subgroup 13-07A...................................        0.30
Canola, meal................................................        1.0
Canola, seed................................................        0.50
Cattle, fat.................................................        0.2
Cattle, meat................................................        0.2

[[Page 588]]

 
Cattle, meat byproducts.....................................        0.2
Clover, forage..............................................       10.0
Clover, hay.................................................       20.0
Corn, field, forage.........................................        0.2
Corn, field, grain..........................................        0.2
Corn, field, stover.........................................        0.2
Cotton, meal................................................        2.0
Cotton, undelinted seed.....................................        1.0
Cranberry...................................................        0.50
Egg.........................................................        0.2
Flax, meal..................................................        1.0
Flax, seed..................................................        0.6
Goat, fat...................................................        0.2
Goat, meat..................................................        0.2
Goat, meat byproducts.......................................        0.2
Herb subgroup 19A...........................................       12.0
Hog, fat....................................................        0.2
Hog, meat...................................................        0.2
Hog, meat byproducts........................................        0.2
Hop, dried cones............................................        0.5
Horse, fat..................................................        0.2
Horse, meat.................................................        0.2
Horse, meat byproducts......................................        0.2
Leaf petioles subgroup 4B...................................        0.60
Leafy greens subgroup 4A....................................        2.0
Melon subgroup 9A...........................................        2.0
Milk........................................................        0.05
Mustard, seed...............................................        0.50
Onion, bulb.................................................        0.20
Onion, green................................................        2.0
Peach.......................................................        0.20
Peanut......................................................        3.0
Peanut, hay.................................................        3.0
Peanut, meal................................................        5.0
Peppermint, tops............................................        5.0
Potato......................................................        0.5
Potato, granules/flakes.....................................        2.0
Poultry, fat................................................        0.2
Poultry, meat...............................................        0.2
Poultry, meat byproducts....................................        0.2
Radish, tops................................................        0.70
Safflower, meal.............................................       10.0
Safflower, seed.............................................        5.0
Sesame, seed................................................        0.35
Sheep, fat..................................................        0.2
Sheep, meat.................................................        0.2
Sheep, meat byproducts......................................        0.2
Soybean.....................................................       10.0
Spearmint, tops.............................................        5.0
Squash/cucumber subgroup 9B.................................        0.50
Strawberry..................................................        3.0
Sunflower, meal.............................................       10.0
Sunflower, seed.............................................        5.0
Turnip, greens..............................................        3.0
Vegetable, fruiting group 8.................................        1.0
Vegetable, legume, group 6, except soybean..................        3.5
Vegetable, root, except sugar beet, subgroup 1B.............        1.0
Vegetable, tuberous and corm, subgroup 1C...................        1.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[76 FR 23496, Apr. 27, 2011, as amended at 77 FR 59128, Sept. 26, 2012]



Sec. 180.459  Triasulfuron; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide triasulfuron [3-(6-methoxy-4-methyl-1,3,5-triazin-2-yl)-1-(2-
(2-chloroethoxy)phenylsulfonyl)urea] in or on the following raw 
agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Barley, grain..............................................        0.02
Barley, straw..............................................        2.0
Cattle, fat................................................        0.1
Cattle, kidney.............................................        0.5
Cattle, meat byproducts, except kidney.....................        0.1
Cattle, meat...............................................        0.1
Goat, fat..................................................        0.1
Goat, kidney...............................................        0.5
Goat, meat byproducts, except kidney.......................        0.1
Goat, meat.................................................        0.1
Grass, forage..............................................        7.0
Grass, hay.................................................        2.0
Hog, fat...................................................        0.1
Hog, kidney................................................        0.5
Hog, meat byproducts.......................................        0.1
Hog, meat..................................................        0.1
Horse, fat.................................................        0.1
Horse, kidney..............................................        0.5
Horse, meat byproducts, except kidney......................        0.1
Horse, meat................................................        0.1
Milk.......................................................        0.02
Sheep, fat.................................................        0.1
Sheep, kidney..............................................        0.5
Sheep, meat byproducts, except kidney......................        0.1
Sheep, meat................................................        0.1
Wheat, forage..............................................        5.0
Wheat, grain...............................................        0.02
Wheat, straw...............................................        2.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[60 FR 36731, July 18, 1995, as amended at 63 FR 44152, Aug. 18, 1998; 
63 FR 66449, Dec. 2, 1998]



Sec. 180.460  Benoxacor; tolerances for residues.

    (a) General. Tolerances are established for residues of the inert 
ingredient (safener) benoxacor (4-(dichloroacetyl)-3,4-dihydro-3-methyl-
2H-1, 4-benzoxazine) at 0.01 parts per million (ppm) when used in 
pesticide formulations containing metolachlor or S-metolachlor in or on 
raw agricultural commodities for which tolerances have been established 
for metolachlor or S-metolachlor.

[[Page 589]]

    (b) Section 18 energency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 7305, Feb. 13, 1998, as amended at 70 FR 21631, Apr. 27, 2005]



Sec. 180.461  Cadusafos; tolerances for residues.

    A tolerance is established for the residues of the nematicide/
insecticide cadusafos, O-ethyl S,S-di-sec-butyl phosphorodithioate, in 
or on the following raw agricultural commodity:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Banana.....................................................        0.01
------------------------------------------------------------------------


There are no U.S. registrations as of May 10, 1994, for the nematicide/
insecticid cadusafos.

[59 FR 39467, Aug. 3, 1994]



Sec. 180.462  Pyridate; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide pyridate, including its metabolites and degradates, in or on 
the commodities in the table in this paragraph. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only the sum of pyridate, O-(6-chloro-3-phenyl-4-pyridazinyl)-
S-octyl-carbonothioate, and its metabolites, 6-chloro-3-phenyl-
pyridazine-4-ol and conjugates of 6-chloro-3-phenyl-pyridazine-4-ol, 
calculated as the stoichiometric equivalent of pyridate, in or on the 
commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A.......................        0.03
Cabbage....................................................        0.03
Chickpea, seed.............................................        0.1
Collards...................................................        0.03
Corn, field, forage........................................        0.03
Corn, field, grain.........................................        0.03
Corn, field, stover........................................        0.03
Corn, pop, grain...........................................        0.03
Corn, pop, stover..........................................        0.03
Peanut.....................................................        0.03
Peppermint, tops...........................................        0.20
Spearmint, tops............................................        0.20
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[57 FR 54303, Nov. 18, 1992, as amended at 62 FR 44558, Aug. 22, 1997; 
63 FR 53844, Oct. 7, 1998; 64 FR 46298, Aug. 25, 1999; 65 FR 25652, May 
3, 2000; 67 FR 35049, May 17, 2002; 72 FR 35665, June 29, 2007; 74 FR 
46376, Sept. 9, 2009; 76 FR 23496, Apr. 27, 2011]



Sec. 180.463  Quinclorac; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide quinclorac, including its metabolites and degradates, in or on 
the commodities in the table in this paragraph. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only quinclorac, 3,7-dichloro-8-quinolinecarboxylic acid, in 
or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Barley, grain..............................................        2.0
Berry, low growing, except strawberry, subgroup 13-07H.....        1.5
Cattle, fat................................................        0.7
Cattle, meat byproducts....................................        1.5
Cattle, meat...............................................        0.05
Egg........................................................        0.05
Goat, fat..................................................        0.7
Goat, meat byproducts......................................        1.5
Goat, meat.................................................        0.05
Grain, aspirated fractions.................................     1200
Grass, forage..............................................      150
Grass, hay.................................................      130
Hog, fat...................................................        0.7
Hog, meat byproducts.......................................        1.5
Hog, meat..................................................        0.05
Horse, fat.................................................        0.7
Horse, meat byproducts.....................................        1.5
Horse, meat................................................        0.05
Milk.......................................................        0.05
Poultry, fat...............................................        0.05
Poultry, meat byproducts...................................        0.1
Poultry, meat..............................................        0.05
Rhubarb....................................................        0.5
Rice, bran.................................................       15.0
Rice, grain................................................        5.0
Rice, straw................................................       12.0
Sheep, fat.................................................        0.7
Sheep, meat byproducts.....................................        1.5
Sheep, meat................................................        0.05
Sorghum, grain, forage.....................................        3.0
Sorghum, grain, grain......................................        6.0
Sorghum, grain, stover.....................................        1.0
Wheat, forage..............................................        1.0
Wheat, germ................................................        0.75
Wheat, grain...............................................        0.5
Wheat, hay.................................................        0.5
Wheat, straw...............................................        0.1
------------------------------------------------------------------------


[[Page 590]]

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the herbicide quinclorac, including its 
metabolites and degradates, in or on the commodity in the table in this 
paragraph. Compliance with the tolerance level specified in this 
paragraph is to be determined by measuring only quinclorac, 3,7-
dichloro-8-quinolinecarboxylic acid, in or on the commodity. The 
tolerance expires and is revoked on the date specified in the table in 
this paragraph.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Cranberry.......................................       15.0     12/31/12
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[57 FR 47996, Oct. 21, 1992, as amended at 64 FR 6548, 6549, Feb. 10, 
1999; 64 FR 14632, Mar. 26, 1999; 65 FR 33701, May 24, 2000; 67 FR 
35049, May 17, 2002; 72 FR 55073, Sept. 28, 2007; 74 FR 51490, Oct. 7, 
2009; 74 FR 67090, Dec. 18, 2009; 76 FR 23497, Apr. 27, 2011; 77 FR 
75566, Dec. 21, 2012]



Sec. 180.464  Dimethenamid; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide dimethenamid, 1(R,S)-2-chloro-N-[(1-methyl-2-methoxy)ethyl]-N-
(2,4-dimethylthien-3-yl)-acetamide, applied as either the 90:10 or 50:50 
S:R isomers, in or on the following food commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Bean, dry, seed............................................        0.01
Beet, garden, roots........................................        0.01
Beet, garden, tops.........................................        0.01
Beet, sugar, dried pulp....................................        0.01
Beet, sugar, molasses......................................        0.01
Beet, sugar, roots.........................................        0.01
Beet, sugar, tops..........................................        0.01
Corn, field, forage........................................        0.01
Corn, field, grain.........................................        0.01
Corn, field, stover........................................        0.01
Corn, pop, forage..........................................        0.01
Corn, pop, grain...........................................        0.01
Corn, pop, stover..........................................        0.01
Corn, sweet, forage........................................        0.01
Corn, sweet, kernel plus cob with husks removed............        0.01
Corn, sweet, stover........................................        0.01
Garlic.....................................................        0.01
Grass, forage..............................................        0.15
Grass, hay.................................................        2.5
Grass, seed screenings.....................................        0.01
Grass, straw...............................................        0.01
Hop, dried cones...........................................        0.05
Horseradish................................................        0.01
Leek.......................................................        0.01
Onion, bulb................................................        0.01
Onion, green...............................................        0.01
Onion, Welsh...............................................        0.01
Peanut.....................................................        0.01
Peanut, hay................................................        0.01
Radish, roots..............................................        0.01
Radish, tops...............................................        0.01
Rutabaga, roots............................................        0.01
Rutabaga, tops.............................................        0.1
Shallot, bulb..............................................        0.01
Shallot, fresh leaves......................................        0.01
Sorghum, grain, forage.....................................        0.01
Sorghum, grain, grain......................................        0.01
Sorghum, grain, stover.....................................        0.01
Soybean, seed..............................................        0.01
Turnip, greens.............................................        0.1
Turnip, roots..............................................        0.01
Turnip, tops...............................................        0.1
Vegetable, tuberous and corm, subgroup 1C..................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration are established for residues of dimethenamid, 1 (R,S)-2-
chloro-N-[(1-methyl-2-methoxy) ethyl]-N-(2,4-dimethylthien-3-yl)-
acetamide) in or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Pumpkin....................................................        0.01
Squash, winter.............................................        0.01
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 51551, Aug. 24, 2000, as amended at 67 FR 46884, July 17, 2002; 
69 FR 29459, May 24, 2004; 69 FR 57207, Sept. 24, 2004; 70 FR 24712, May 
11, 2005; 71 FR 25942, May 3, 2006; 71 FR 49354, Aug. 23, 2006; 72 FR 
44388, Aug. 8, 2007; 72 FR 73630, Dec. 28, 2007]



Sec. 180.465  4-(Dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane.

    (a) General. Tolerances are established for the residues of 4-
(dichloroacetyl)-1-oxa-4-azaspiro[4.5]decane, (CAS No. 71526-07-3) when 
used as an inert ingredient (safener) in or on the following raw 
agricultural commodities:

------------------------------------------------------------------------
               Commodity \1\                      Parts per million
------------------------------------------------------------------------
Corn, field, forage.......................  0.005

[[Page 591]]

 
Corn, field, grain........................  0.005
Corn, field, stover.......................  0.005
Corn, pop, grain..........................  0.005
Corn, pop, stover.........................  0.005
------------------------------------------------------------------------
\1\There are no U.S. registered products containing 4-(dichloroacetyl)-1-
  oxa-4-azaspiro[4.5]decane as of June 17, 2002.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[68 FR 4392, Jan. 29, 2003]



Sec. 180.466  Fenpropathrin; tolerances for residues.

    (a) General. Tolerances are established for residues of 
fenpropathrin, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance levels 
specified below is to be determined by measuring only fenpropathrin 
(alpha-cyano-3-phenoxy-benzyl 2,2,3,3 
tetramethylcyclopropanecarboxylate).

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Acerola....................................................        3.0
Almond, hulls..............................................        4.5
Atemoya....................................................        1.5
Avocado....................................................        1.0
Biriba.....................................................        1.5
Brassica, head and stem, subgroup 5A.......................        3.0
Bushberry subgroup 13B.....................................        3.0
Caneberry subgroup 13-07A..................................       12
Canistel...................................................        1.0
Cattle, fat................................................        1.0
Cattle, meat byproducts....................................        0.1
Cattle, meat...............................................        0.1
Cherimoya..................................................        1.5
Cherry, sweet..............................................        5.0
Cherry, tart...............................................        5.0
Citrus, dried pulp.........................................        4.0
Citrus, oil................................................       75
Cotton, refined oil........................................        3.0
Cotton, undelinted seed....................................        1.0
Custard apple..............................................        1.5
Egg........................................................        0.05
Feijoa.....................................................        3.0
Fruit, citrus, group 10....................................        2.0
Fruit, pome, group 11......................................        5.0
Fruit, stone, crop group 12, except cherry.................        1.4
Goat, fat..................................................        1.0
Goat, meat byproducts......................................        0.1
Goat, meat.................................................        0.1
Grape......................................................        5.0
Grape, raisin..............................................       10.0
Guava......................................................        3.0
Hog, fat...................................................        1.0
Hog, meat byproducts.......................................        0.1
Hog, meat..................................................        0.1
Horse, fat.................................................        1.0
Horse, meat byproducts.....................................        0.1
Horse, meat................................................        0.1
Ilama......................................................        1.5
Jaboticaba.................................................        3.0
Juneberry..................................................        3.0
Lingonberry................................................        3.0
Longan.....................................................        7.0
Lychee.....................................................        7.0
Mango......................................................        1.0
Melon subgroup 9A..........................................        0.5
Milk, fat (reflecting 0.08 ppm in whole milk)..............        2.0
Nut, tree, crop group 14...................................        0.10
Olive......................................................        5.0
Papaya.....................................................        1.0
Passionfruit...............................................        3.0
Pea, succulent.............................................        0.02
Peanut, hay................................................       20.0
Peanut.....................................................        0.01
Pistachio..................................................        0.10
Poultry, fat...............................................        0.05
Poultry, meat byproducts...................................        0.05
Poultry, meat..............................................        0.05
Pulasan....................................................        7.0
Rambutan...................................................        7.0
Salal......................................................        3.0
Sapodilla..................................................        1.0
Sapote, black..............................................        1.0
Sapote, mamey..............................................        1.0
Sheep, fat.................................................        1.0
Sheep, meat byproducts.....................................        0.1
Sheep, meat................................................        0.1
Soursop....................................................        1.5
Spanish lime...............................................        7.0
Squash/Cucumber subgroup 9B................................        0.5
Star apple.................................................        1.0
Starfruit..................................................        3.0
Strawberry.................................................        2.0
Sugar apple................................................        1.5
Tea, dried \1\.............................................        2.0
Vegetable, fruiting, group 8...............................        1.0
Wax jambu..................................................        3.0
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of November 28, 2012, for the use
  of fenpropathrin on tea, dried.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[62 FR 63034, Nov. 26, 1997, as amended at 63 FR 48116, Sept. 9, 1998; 
64 FR 3009, Jan. 20, 1999; 65 FR 11242, Mar. 2, 2000; 65 FR 24397, Apr. 
26, 2000; 65 FR 48620, Aug. 9, 2000; 66 FR 64774, Dec. 14, 2001; 67 FR 
35049, May 17, 2002; 70 FR 38789, July 6, 2005; 70 FR 55747, Sept. 23, 
2005; 74 FR 12606, Mar. 25, 2009; 77 FR 70908, Nov. 28, 2012]



Sec. 180.467  Carbon disulfide; tolerances for residues.

    Tolerances are established for the nematicide, insecticide, and 
fungicide carbon disulfide, from the application of sodium 
tetrathiocarbonate, in or on the following raw agricultural commodities:

[[Page 592]]



------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond.....................................................        0.1
Almond, hulls..............................................        0.1
Grape......................................................        0.1
Grapefruit.................................................        0.1
Lemon......................................................        0.1
Orange, sweet..............................................        0.1
Peach......................................................        0.1
Plum, prune, fresh.........................................        0.1
------------------------------------------------------------------------


[58 FR 33771, June 21, 1993, as amended at 62 FR 26949, May 16, 1997]



Sec. 180.468  Flumetsulam; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide flumetsulam, including its metabolites and degradates, in or 
on the commodities in the table in this paragraph. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only flumetsulam, N-(2,6-difluorophenyl)-5-methyl-(1,2,4)-
triazolo-(1,5a)-pyrimidine-2-sulfonamide, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Bean, dry, seed.............................................        0.05
Corn, field, forage.........................................        0.05
Corn, field, grain..........................................        0.05
Corn, field, stover.........................................        0.05
Soybean, seed...............................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[76 FR 23497, Apr. 27, 2011]



Sec. 180.469  Dichlormid; tolerances for residues.

    (a) General. Tolerances are established for residues of dichlormid, 
including its metabolites and degradates, when used as an inert 
ingredient (herbicide safener) in pesticide formulations, in or on the 
commodities in the following table. Compliance with the tolerances is to 
be determined by measuring only dichlormid (2,2-dichloro-N,N-di-2-
propenylacetamide).

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Corn, field, forage........................................        0.05
Corn, field, grain.........................................        0.05
Corn, field, stover........................................        0.05
Corn, pop, grain...........................................        0.05
Corn, pop, stover..........................................        0.05
Corn, sweet, forage........................................        0.05
Corn, sweet, kernel plus cob with husks removed............        0.05
Corn, sweet, stover........................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 16149, Mar. 27, 2000, as amended at 67 FR 51105, Aug. 7, 2002; 69 
FR 58290, Sept. 30, 2004; 70 FR 76699, Dec. 28, 2005; 74 FR 37623, July 
29, 2009; 76 FR 16310, Mar. 23, 2011]



Sec. 180.470  Acetochlor; tolerances for residues.

    (a) General. Tolerances are established for residues of acetochlor, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below is 
to be determined by measuring only acetochlor, 2-chloro-2'-methyl-6-
ethyl-N-ethoxymethylacetanilide, and its metabolites containing the 
ethyl methyl aniline (EMA) moiety and the hydroxyethyl methyl aniline 
(HEMA) moiety. Both parent and the named metabolites shall be determined 
as ethyl methyl aniline (EMA) and hydroxyethyl methyl aniline (HEMA), 
and calculated as the stoichiometric equivalents of acetochlor, in or on 
the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Corn, field, forage........................................        4.5
Corn, field, grain.........................................        0.05
Corn, field, stover........................................        2.5
Corn, pop, grain...........................................        0.05
Corn, pop, stover..........................................        2.5
Corn, sweet, forage........................................        1.5
Corn, sweet, kernels plus cob with husks removed...........        0.05
Corn, sweet, stover........................................        1.0
Cotton, gin byproducts.....................................        4.0
Cotton, undelinted seed....................................        0.6
Sorghum, grain, forage.....................................        1.6
Sorghum, grain, grain......................................        0.05
Sorghum, grain, stover.....................................        1.7
Soybean, meal..............................................        1.2
Soybean, seed..............................................        1.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]

[[Page 593]]

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established for 
indirect or inadvertent residues of acetochlor, including its 
metabolites and degradates, in or on the raw agricultural commodities in 
the table to this paragraph when present therein as a result of 
application of acetochlor to the growing crops in the table to paragraph 
(a) of this section. Compliance with the tolerance levels specified 
below is to be determined by measuring only acetochlor, 2-chloro-2'-
methyl-6-ethyl-N-ethoxymethylacetanilide, and its metabolites containing 
the ethyl methyl aniline (EMA) moiety and the hydroxyethyl methyl 
aniline (HEMA) moiety. Both parent and the named metabolites shall be 
determined as ethyl methyl aniline (EMA) and hydroxyethyl methyl aniline 
(HEMA), and calculated as the stoichiometric equivalents of acetochlor, 
in or on the following commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Animal feed, nongrass, group 18, forage....................        1.3
Animal feed, nongrass, group 18, hay.......................        3.5
Beet, sugar, root..........................................        0.05
Beet, sugar, tops..........................................        0.05
Grain, cereal, forage, fodder and straw, group 16, except          0.5
 corn, grain sorghum, rice and wheat, forage...............
Grain, cereal, forage, fodder and straw, group 16, except          2.0
 corn, grain sorghum, rice and wheat, hay..................
Grain, cereal, forage, fodder and straw, group 16, except          0.1
 corn, grain sorghum, rice and wheat, stover...............
Grain, cereal, forage, fodder and straw, group 16, except          0.3
 corn, grain sorghum, and wheat, straw.....................
Grain, cereal, group 15, except corn, grain sorghum, and           0.05
 wheat, grain..............................................
Pea and bean, dried shelled, except soybean, subgroup 6C...        0.05
Potato.....................................................        0.05
Soybean, forage............................................        0.7
Soybean, hay...............................................        1.0
Sunflower, seed............................................        0.05
Wheat, forage..............................................        0.5
Wheat, grain...............................................        0.02
Wheat, hay.................................................        2.0
Wheat, straw...............................................        0.1
------------------------------------------------------------------------


[72 FR 27468, May 16, 2007, as amended at 74 FR 29969, June 24, 2009; 74 
FR 47450, Sept. 16, 2009; 78 FR 13268, Feb. 27, 2013]



Sec. 180.471  Furilazole; tolerances for residues.

    (a) General. Tolerances are established for residues of furilazole; 
3-dichloroacetyl-5-(2-furanyl)-2, 2-dimethyloxazolidine (CAS Reg. No. 
121776-33-8) when used as an inert ingredient (safener) in pesticide 
formulations in or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Corn, field, forage........................................        0.01
Corn, field, grain.........................................        0.01
Corn, field, stover........................................        0.01
Corn, pop, grain...........................................        0.01
Corn, pop, stover..........................................        0.01
Sorghum, forage............................................        0.01
Sorghum, grain.............................................        0.01
Sorghum, stover............................................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 8867, Feb. 23, 2000, as amended at 67 FR 15735, Apr. 3, 2002; 72 
FR 57492, Oct. 10, 2007]



Sec. 180.472  Imidacloprid; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide imidacloprid, including its metabolites and degradates, in 
or on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only the sum of 
imidacloprid (1-[6-chloro-3-pyridinyl) methyl]-N-nitro-2-
imidazolidinimine) and its metabolites containing the 6-chloropyridinyl 
moiety, calculated as the stoichiometric equivalent of imidacloprid, in 
or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Acerola.....................................................        1.0
Almond, hulls...............................................        4.0
Apple.......................................................        0.5
Apple, wet pomace...........................................        3.0
Artichoke, globe............................................        2.5
Aspirated grain fractions...................................      240
Atemoya.....................................................        0.30
Avocado.....................................................        1.0
Banana......................................................        0.50
Beet, sugar, molasses.......................................        0.30
Beet, sugar, roots..........................................        0.05
Beet, sugar, tops...........................................        0.50
Biriba......................................................        0.30
Blueberry...................................................        3.5
Borage, seed................................................        0.05
Caneberry, subgroup 13-A....................................        2.5
Canistel....................................................        1.0
Canola, seed................................................        0.05

[[Page 594]]

 
Cattle, fat.................................................        0.30
Cattle, meat................................................        0.30
Cattle, meat byproducts.....................................        0.30
Cherimoya...................................................        0.30
Citrus, dried pulp..........................................        5.0
Coffee, bean, green.........................................        0.80
Cotton, gin byproducts......................................        4.0
Cotton, meal................................................        8.0
Cotton, undelinted seed.....................................        6.0
Crambe, seed................................................        0.05
Cranberry...................................................        0.05
Currant.....................................................        3.5
Custard apple...............................................        0.30
Egg.........................................................        0.02
Elderberry..................................................        3.5
Feijoa......................................................        1.0
Fish........................................................        0.05
Fish-shellfish, mollusc.....................................        0.05
Flax, seed..................................................        0.05
Fruit, citrus, group 10.....................................        0.70
Fruit, pome, group 11.......................................        0.6
Fruit, stone, group 12......................................        3.0
Goat, fat...................................................        0.30
Goat, meat..................................................        0.30
Goat, meat byproducts.......................................        0.30
Gooseberry..................................................        3.5
Grain, cereal, forage, fodder and straw, group 16, forage,          7.0
 except rice................................................
Grain, cereal, forage, fodder and straw, group 16, hay,             6.0
 except rice................................................
Grain, cereal, forage, fodder and straw, group 16, stover,          0.30
 except rice................................................
Grain, cereal, forage, fodder and straw, group 16, straw,           3.0
 except rice................................................
Grain, cereal, group 15, except rice........................        0.05
Grape.......................................................        1.0
Grape, juice................................................        1.5
Grape, raisin...............................................        1.5
Guava.......................................................        1.0
Herbs subgroup 19A, dried herbs.............................       48
Herbs subgroup 19-A, fresh herbs............................        8.0
Hog, fat....................................................        0.30
Hog, meat...................................................        0.30
Hog, meat byproducts........................................        0.30
Hop, dried cones............................................        6.0
Horse, fat..................................................        0.30
Horse, meat.................................................        0.30
Horse, meat byproducts......................................        0.30
Huckleberry.................................................        3.5
Ilama.......................................................        0.30
Jaboticaba..................................................        1.0
Juneberry...................................................        3.5
Kava, leaves................................................        4.0
Kava, roots.................................................        0.40
Leaf petioles subgroup 4B...................................        6.0
Leafy greens subgroup 4A....................................        3.5
Lettuce, head...............................................        3.5
Lettuce, leaf...............................................        3.5
Lingonberry.................................................        3.5
Longan......................................................        3.0
Lychee......................................................        3.0
Mango.......................................................        1.0
Milk........................................................        0.10
Mustard, black, seed........................................        0.05
Mustard, field, seed........................................        0.05
Mustard, Indian, seed.......................................        0.05
Mustard, rapeseed, seed.....................................        0.05
Mustard, seed...............................................        0.05
Nut, tree, group 14.........................................        0.05
Okra........................................................        1.0
Onion, dry bulbs, subgroup 3-07A............................        0.15
Onion, green, subgroup 3-07B................................        2.5
Papaya......................................................        1.0
Passionfruit................................................        1.0
Peanut......................................................        0.45
Peanut, hay.................................................       35
Peanut, meal................................................        0.75
Pecan.......................................................        0.05
Persimmon...................................................        3.0
Pistachio...................................................        0.05
Pomegranate.................................................        0.90
Potato, chip................................................        0.40
Potato, processed potato waste..............................        0.90
Poultry, fat................................................        0.05
Poultry, meat...............................................        0.05
Poultry, meat byproducts....................................        0.05
Pulasan.....................................................        3.0
Rambutan....................................................        3.0
Rapeseed, seed..............................................        0.05
Raspberry, wild.............................................        2.5
Safflower, seed.............................................        0.05
Salal.......................................................        3.5
Sapodilla...................................................        1.0
Sapote, black...............................................        1.0
Sapote, mamey...............................................        1.0
Sheep, fat..................................................        0.30
Sheep, meat.................................................        0.30
Sheep, meat byproducts......................................        0.30
Soursop.....................................................        0.30
Soybean, forage.............................................        8.0
Soybean, hay................................................       35
Soybean, meal...............................................        4.0
Soybean, seed...............................................        3.5
Spanish lime................................................        3.0
Star apple..................................................        1.0
Starfruit...................................................        1.0
Strawberry..................................................        0.50
Sugar apple.................................................        0.30
Sunflower, seed.............................................        0.05
Tomato, paste...............................................        6.0
Tomato, puree...............................................        3.0
Vegetable, brassica leafy, group 5..........................        3.5
Vegetable, cucurbit, group 9................................        0.5
Vegetable, fruiting, group 8................................        1.0
Vegetable, leaves of root and tuber, group 2................        4.0
Vegetable, legume, group 6, except soybean..................        4.0
Vegetable, root and tuber, group 1, except sugar beet.......        0.40
Watercress..................................................        3.5
Watercress, upland..........................................        3.5
Wax jambu...................................................        1.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the insecticide imidacloprid, including its 
metabolites and degradates in connection with use of the pesticide under 
a Section 18 emergency exemption granted by EPA. Compliance with the 
tolerance levels specified below is to be determined by measuring only 
the sum of imidacloprid (1-[6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine) and its metabolites containing the 6-chloropyridinyl 
moiety, calculated as the stoichiometric equivalent of imidacloprid. 
These tolerances will expire and are revoked on the dates specified in 
the following table:

[[Page 595]]



------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Sugarcane, cane.................................        6.0     12/31/15
Sugarcane, molasses.............................         50     12/31/15
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established for 
indirect or inadvertent residues of the insecticide imidacloprid, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below is 
to be determined by measuring only the sum of imidacloprid (1-[6-chloro-
3-pyridinyl) methyl]-N-nitro-2-imidazolidinimine) and its metabolites 
containing the 6-chloropyridinyl moiety, calculated as the 
stoichiometric equivalent of imidacloprid, in or on the following 
commodities, when present therein as a result of the application of the 
pesticide to growing crops listed in this section and other non-food 
crops as follows:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Rice, grain.................................................        0.05
Vegetable, foliage of legume, group 7.......................        2.5
Vegetable, legume, group 6..................................        0.3
------------------------------------------------------------------------


[75 FR 22251, Apr. 28, 2010, as amended at 78 FR 33743, June 5, 2013]



Sec. 180.473  Glufosinate ammonium; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide glufosinate ammonium, including its metabolites and 
degradates, in or on the commodities in the table below. Compliance with 
the tolerance levels specified below is to be determined by measuring 
the sum of glufosinate ammonium, butanoic acid, 2-amino-4-
(hydroxymethylphosphinyl) monoammonium salt, and its metabolites, 2-
(acetylamino)-4-(hydroxymethyl phosphinyl)butanoic acid, and 3-
(hydroxymethylphosphinyl)propanoic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hulls..............................................        0.50
Apple......................................................        0.05
Banana.....................................................        0.30
Banana, pulp...............................................        0.20
Beet, sugar, molasses......................................        5.0
Beet, sugar, roots.........................................        0.9
Beet, sugar, tops (leaves).................................        1.5
Bushberry subgroup 13B.....................................        0.15
Canola, meal...............................................        1.1
Canola, seed...............................................        0.40
Cattle, fat................................................        0.40
Cattle, meat...............................................        0.15
Cattle, meat byproducts....................................        6.0
Corn, field forage.........................................        4.0
Corn, field, grain.........................................        0.20
Corn, field, stover........................................        6.0
Corn, sweet, forage........................................        1.5
Corn, sweet, kernels plus cob with husks removed...........        0.30
Corn, sweet, stover........................................        6.0
Cotton, gin byproducts.....................................       15
Cotton, undelinted seed....................................        4.0
Egg........................................................        0.15
Fruit, citrus, group 10-10.................................        0.15
Fruit, pome, group 11-10...................................        0.25
Fruit, stone, group 12-12..................................        0.25
Goat, fat..................................................        0.40
Goat, meat.................................................        0.15
Goat, meat byproducts......................................        6.0
Grain aspirated fractions..................................       25
Grape......................................................        0.05
Hog, fat...................................................        0.40
Hog, meat..................................................        0.15
Hog, meat byproducts.......................................        6.0
Horse, fat.................................................        0.40
Horse, meat................................................        0.15
Horse, meat byproducts.....................................        6.0
Juneberry..................................................        0.10
Lingonberry................................................        0.10
Milk.......................................................        0.15
Nut, tree, group 14........................................        0.10
Olive......................................................        0.15
Pistachio..................................................        0.10
Potato.....................................................        0.80
Potato, chips..............................................        1.6
Potato granules/flakes.....................................        2.0
Poultry, fat...............................................        0.15
Poultry, meat..............................................        0.15
Poultry, meat byproducts...................................        0.60
Rice, grain................................................        1.0
Rice, hull.................................................        2.0
Rice, straw................................................        2.0
Salal......................................................        0.10
Sheep, fat.................................................        0.40
Sheep, meat................................................        0.15
Sheep, meat byproducts.....................................        6.0
Soybean....................................................        2.0
Soybean, hulls.............................................        5.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional restrictions. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established for 
indirect or inadvertent residues of glufosinate ammonium, including its 
metabolites and degradates, in or on the commodities in the table below, 
as a result of

[[Page 596]]

the application of glufosinate ammonium to crops listed in paragraph (a) 
of this section. Compliance with the tolerance levels specified below is 
to be determined by measuring the sum of glufosinate ammonium, butanoic 
acid, 2-amino-4-(hydroxymethylphosphinyl) monoammonium salt, and its 
metabolite, 3-(hydroxymethylphosphinyl) propanoic acid, expressed as 2-
amino-4-(hydroxymethylphosphinyl)butanoic acid equivalents.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Barley, hay................................................        0.40
Barley, straw..............................................        0.40
Buckwheat, fodder..........................................        0.40
Buckwheat, forage..........................................        0.40
Oat, forage................................................        0.40
Oat, hay...................................................        0.40
Oat, straw.................................................        0.40
Rye, forage................................................        0.40
Rye, straw.................................................        0.40
Teosinte...................................................        0.40
Triticale..................................................        0.40
Wheat, forage..............................................        0.40
Wheat, hay.................................................        0.40
Wheat, straw...............................................        0.40
------------------------------------------------------------------------


[68 FR 55849, Sept. 29, 2003, as amended at 71 FR 25945, May 3, 2006; 72 
FR 72625, Dec. 21, 2007; 76 FR 23497, Apr. 27, 2011; 77 FR 59113, Sept. 
26, 2012]



Sec. 180.474  Tebuconazole; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
tebuconazole, alpha-[2-(4-chlorophenyl)ethyl]-alpha-(1,1-dimethylethyl)-
1H-1,2,4-triazole-1-ethanol, including its metabolites and degradates, 
in or on the commodities in the table below. Compliance with the 
tolerance levels specified below is to be determined by measuring only 
tebuconazole [[alpha]-[2-(4-chlorophenyl) ethyl]-[alpha]-(1,1-
dimethylethyl)-1H-1,2,4-triazole-1-ethanol], in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        6.0
Apple, wet pomace...........................................        0.1
Asparagus...................................................        0.05
Banana......................................................        0.05
Barley, grain...............................................        0.15
Barley, hay.................................................        7.0
Barley, straw...............................................        3.5
Bean, dry seed..............................................        0.1
Bean, succulent.............................................        0.1
Beet, garden, roots.........................................        0.70
Beet, garden, tops..........................................        7.0
Brassica, leafy greens, subgroup 5B.........................        2.5
Cherry, sweet, pre- and post-harvest........................        5.0
Cherry, tart, pre- and post-harvest.........................        5.0
Coffee, green bean \1\......................................        0.15
Coffee, roasted bean \1\....................................        0.3
Corn, field, forage.........................................        4.0
Corn, field, grain..........................................        0.05
Corn, field, stover.........................................        3.5
Corn, pop, grain............................................        0.05
Corn, pop, stover...........................................        3.5
Corn, sweet, forage.........................................        7.0
Corn, sweet, kernel plus cob with husks removed.............        0.5
Corn, sweet, stover.........................................        6.0
Cotton, gin byproducts......................................       25.0
Cotton, undelinted seed.....................................        2.0
Fruit, pome, group 11.......................................        0.05
Fruit, stone, group 12, except cherry.......................        1.0
Grain, aspirated fractions..................................       16.0
Grape.......................................................        5.0
Grass, forage...............................................        8.0
Grass, hay..................................................       25.0
Grass, seed screenings......................................       55.0
Grass, straw................................................       30.0
Hop, dried cones............................................       35.0
Lychee......................................................        1.6
Mango, postharvest..........................................        0.15
Nut, tree, group 14.........................................        0.05
Oat, forage.................................................        0.10
Oat, grain..................................................        0.15
Oat, hay....................................................        0.10
Oat, straw..................................................        0.10
Okra........................................................        1.2
Onion, bulb, subgroup 3-07A.................................        0.2
Onion, green, subgroup 3-07B................................        1.3
Peach.......................................................        1.0
Peanut......................................................        0.1
Pistachio...................................................        0.05
Plum, pre- and post-harvest.................................        1.0
Soybean, forage.............................................       25
Soybean, hay................................................       50
Soybean, seed...............................................        0.08
Sunflower, seed.............................................        0.05
Sunflower, meal.............................................        0.2
Sunflower, refined oil......................................        0.2
Vegetable, cucurbit, group 9................................        0.09
Vegetable, fruiting, group 8................................        1.3
Wheat, forage...............................................        3.0
Wheat, germ.................................................        0.20
Wheat, grain................................................        0.15
Wheat, hay..................................................        7.0
Wheat, shorts...............................................        0.20
Wheat, straw................................................        1.5
------------------------------------------------------------------------
\1\There are no U.S. registrations as of 7/31/2008.

    (2) Tolerances are established for residues of the fungicide 
tebuconazole, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance levels 
specified in the following table is to be determined by measuring only 
the sum of tebuconazole (alpha-[2-(4-chlorophenyl)ethyl]-alpha-(1,1-
dimethylethyl)-1H-1,2,4-triazole-1-ethanol) and its diol metabolite (1-
(4-chlorophenyl)-4,4-dimethyl-3-(1H -1,2,4-triazole-1-yl-methyl)-
pentane-3,5-diol),

[[Page 597]]

calculated as the stoichiometric equivalent of tebuconzole, in or on the 
commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, meat byproducts....................................        0.2
Goat, meat byproducts......................................        0.2
Horse, meat byproducts.....................................        0.2
Milk.......................................................        0.1
Sheep, meat byproducts.....................................        0.2
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances are 
established for residues of the fungicide tebuconazole, including its 
metabolites and degradates, in or on the commodities in the following 
table. Compliance with the tolerance levels specified below is to be 
determined by measuring only tebuconazole, alpha-[2-(4-
chlorophenyl)ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-
ethanol, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Turnip, roots...............................................        0.5
Turnip, tops................................................        7.0
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[59 FR 39464, Aug. 3, 1994]

    Editorial Note: For Federal Register citations affecting Sec. 
180.474, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.475  Difenoconazole; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
difenoconazole, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance levels 
specified below is to be determined by measuring only difenoconazole, 1-
[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-
ylmethyl]-1H-1,2,4-triazole, in or on the following raw agricultural 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        7.0
Apple, wet pomace...........................................        4.5
Aspirated grain fractions...................................       95
Banana\1\...................................................        0.2
Barley, grain...............................................        0.1
Barley, hay.................................................        0.05
Barley, straw...............................................        0.05
Beet, sugar.................................................        0.3
Beet, sugar, dried pulp.....................................        1.9
Berry, low growing, subgroup 13-07G, except cranberry.......        2.5
Brassica, head and stem, subgroup 5A........................        1.9
Brassica, leafy green, subgroup 5B..........................       35
Canola, seed................................................        0.01
Carrot......................................................        0.50
Chickpea....................................................        0.08
Citrus, dried pulp..........................................        2.0
Citrus, oil.................................................       25
Corn, sweet, forage.........................................        0.01
Corn, sweet, kernel plus cob with husks removed.............        0.01
Corn, sweet, stover.........................................        0.01
Cotton, gin byproducts......................................        0.05
Cotton, undelinted seed.....................................        0.05
Fruit, citrus, group 10-10..................................        0.60
Fruit, pome, group 11-10....................................        1.0
Fruits, stone, group 12.....................................        2.5
Grape.......................................................        4.0
Grape, raisin...............................................        6.0
Mango \1\...................................................        0.07
Nut, tree, group 14.........................................        0.03
Oat, forage.................................................        0.15
Oat, grain..................................................        0.01
Oat, hay....................................................        0.05
Oat, straw..................................................        0.05
Onion, bulb, subgroup 3-07A.................................        0.20
Onion, green, subgroup 3-07B................................        6.0
Papaya\1\...................................................        0.30
Pistachio...................................................        0.03
Potato, wet peel............................................        7.3
Rye, forage.................................................        0.15
Rye, grain..................................................        0.01
Rye, straw..................................................        0.05
Soybean, hulls..............................................        0.20
Soybean, seed...............................................        0.15
Turnip, greens..............................................       35
Vegetable, cucurbit, group 9................................        0.70
Vegetable, fruiting, group 8-10.............................        0.60
Vegetable, tuberous and corm, subgroup 1C...................        4.0
Wax jambu \1\...............................................        1.5
Wheat, forage...............................................        0.1
Wheat, grain................................................        0.1
Wheat, hay..................................................        0.05
Wheat, straw................................................        0.1
------------------------------------------------------------------------
\1\There are no U.S. registrations.

    (2) Tolerances are established for residues of difenoconazole, 
including its metabolites and degradates, in the commodities in the 
table below. Compliance with the tolerance levels specified below is to 
be determined by measuring the sum of difenoconazole, 1-[2-[2-chloro-4-
(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-
triazole, and its metabolite, CGA-205375, 1-[2-chloro-4-(4-chloro-
phenoxy)phenyl]-2-[1,2,4]triazol-1-yl-ethanol, calculated as the 
stoichiometric equivalent of difenoconazole, in the following 
commodities:

[[Page 598]]



------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................        0.10
Cattle, liver..............................................        0.40
Cattle, meat...............................................        0.05
Cattle, meat byproduct (except liver)......................        0.10
Egg........................................................        0.02
Goat, fat..................................................        0.10
Goat, liver................................................        0.40
Goat, meat.................................................        0.05
Goat, meat byproduct (except liver)........................        0.10
Hog, fat...................................................        0.10
Hog, liver.................................................        0.40
Hog, meat..................................................        0.05
Hog, meat byproduct (except liver).........................        0.10
Horse, fat.................................................        0.10
Horse, liver...............................................        0.40
Horse, meat................................................        0.05
Horse, meat byproduct (except liver).......................        0.10
Milk.......................................................        0.01
Sheep, fat.................................................        0.10
Sheep, liver...............................................        0.40
Sheep, meat................................................        0.05
Sheep, meat byproduct (except liver).......................        0.10
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[64 FR 36254, July 6, 1999]

    Editorial Note: For Federal Register citations affecting Sec. 
180.475, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.476  Triflumizole; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
fungicide triflumizole, including its metabolites and degradates, in or 
on the commodities listed in the table below. Compliance with the 
tolerance levels specified below is to be determined by measuring only 
the parent compound triflumizole, 1-(1-((4-chloro-2-
(trifluoromethyl)phenyl)imino)-2-propoxyethyl)-1 H -imidazole, and its 
metabolites containing the 4-chloro-2-trifluoromethylaniline moiety, 
calculated as stoichiometric equivalent of the parent compound.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Apple......................................................        0.5
Apple, dry pomace..........................................        2.0
Apple, wet pomace..........................................        2.0
Brassica, head and stem, subgroup 5A.......................        8.0
Brassica, leafy greens, subgroup 5B........................       40
Canistel...................................................        2.5
Cherry, sweet..............................................        1.5
Cherry, tart...............................................        1.5
Cilantro, leaves...........................................       35
Grape......................................................        2.5
Grape, dried pomace........................................       15.0
Grape, raisin, waste.......................................       10.0
Grape, wet pomace..........................................       15.0
Hazelnut...................................................        0.05
Hop, dried cones...........................................       50
Leafy greens subgroup 4A, except spinach...................       35
Mango......................................................        2.5
Papaya.....................................................        2.5
Pear.......................................................        0.5
Pineapple..................................................        4.0
Sapodilla..................................................        2.5
Sapote, black..............................................        2.5
Sapote, mamey..............................................        2.5
Star apple.................................................        2.5
Strawberry.................................................        2.0
Swiss chard................................................       18
Turnip, greens.............................................       40
Vegetable, cucurbit, Group 9...............................        0.5
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the fungicide 
triflumizole, including its metabolites and degradates, in or on the 
commodities of animal origin listed in the table below. Compliance with 
the tolerance levels specified below is to be determined by measuring 
only the parent compound triflumizole, 1-(1-((4-chloro-2-
(trifluoromethyl)phenyl)imino)-2-propoxyethyl)-1 H -imidazole, the 
metabolite 4-chloro-2-hydroxy-6-trifluoromethylaniline sulfate, and 
other metabolites containing the 4-chloro-2-trifluoromethylaniline 
moiety, calculated as the parent compound.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................        0.5
Cattle, meat...............................................        0.05
Cattle, meat byproducts....................................        0.5
Egg........................................................        0.05
Goat, fat..................................................        0.5
Goat, meat.................................................        0.05
Goat, meat byproducts......................................        0.5
Hog, fat...................................................        0.5
Hog, meat..................................................        0.05
Hog, meat byproducts.......................................        0.5
Horse, fat.................................................        0.5
Horse, meat................................................        0.05
Horse, meat byproducts.....................................        0.5
Milk.......................................................        0.05
Poultry, fat...............................................        0.05
Poultry, meat..............................................        0.05
Poultry, meat byproducts...................................        0.1
Sheep, fat.................................................        0.5
Sheep, meat................................................        0.05
Sheep, meat byproducts.....................................        0.5
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]

[[Page 599]]

    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33702, May 24, 2000, as amended at 67 FR 40228, June 12, 2002; 67 
FR 54587, Aug. 23, 2002; 70 FR 7047, Feb. 10, 2005; 70 FR 17915, Apr. 8, 
2005; 71 FR 13279, Mar. 15, 2006; 71 FR 49358, Aug. 23, 2006; 74 FR 
26543, June 3, 2009; 74 FR 46376, Sept. 9, 2009; 76 FR 34885, June 15, 
2011]



Sec. 180.477  Flumiclorac pentyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide flumiclorac pentyl, including its metabolites and degradates, 
in or on the commodities in the table in this paragraph. Compliance with 
the tolerance levels specified in this paragraph is to be determined by 
measuring only flumiclorac pentyl, pentyl(2-chloro-4-fluoro-5-
(1,3,4,5,6,7-hexahydro-1,3-dioxo-2H-isoindol-2-yl)phenoxy)acetate, in or 
on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Corn, field, forage........................................        0.01
Corn, field, grain.........................................        0.01
Corn, field, stover........................................        0.01
Cotton, gin byproducts.....................................        3.0
Cotton, undelinted seed....................................        0.2
Soybean, hulls.............................................        0.02
Soybean, seed..............................................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33702, May 24, 2000, as amended at 71 FR 11533, Mar. 8, 2006; 76 
FR 23497, Apr. 27, 2011]



Sec. 180.478  Rimsulfuron; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide rimsulfuron, including its metabolites and degradates, in or 
on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only 
rimsulfuron, N-((4,6-dimethoxypyrimidin-2-yl)aminocarbonyl)-3-
(ethylsulfonyl)-2-pyridinesulfonamide), in or on the commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hulls..............................................        0.09
Bushberry, subgroup 13-07B.................................        0.01
Caneberry, subgroup 13-07A.................................        0.01
Chicory, roots.............................................        0.01
Chicory, tops..............................................        0.01
Corn, field, forage........................................        0.4
Corn, field, grain.........................................        0.1
Corn, field, stover........................................        2.5
Fruit, citrus, group 10....................................        0.01
Fruit, pome, group 11......................................        0.01
Fruit, stone, group 12.....................................        0.01
Grain, aspirated fractions.................................        4.5
Grape......................................................        0.01
Nut, tree, group 14........................................        0.01
Pistachio..................................................        0.01
Potato.....................................................        0.1
Soybean, forage............................................        0.25
Soybean, hay...............................................        1.2
Soybean, hulls.............................................        0.04
Soybean, seed..............................................        0.01
Tomato.....................................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 16696, Apr. 6, 1998, as amended at 72 FR 41913, Aug. 1, 2007; 74 
FR 67137, Dec. 18, 2009; 77 FR 3625, Jan. 25, 2012; 77 FR 46306, Aug. 3, 
2012]



Sec. 180.479  Halosulfuron-methyl; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
herbicide halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-
pyrimidiny)amino] carbonylaminosulfonyl]-3-chloro-1-methyl-1H-pyrazole-
4-carboxylate, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance levels 
specified in the following table is to be determined by measuring only 
those halosulfuron-methyl residues containing the 3-chlorosulfonamide 
(3-CSA) moiety, expressed as the stoichiometric equivalent of 
halosulfuron-methyl, in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................        0.05
Cattle, meat...............................................        0.05
Cattle, meat byproducts....................................        1.0
Goat, fat..................................................        0.05
Goat, meat.................................................        0.05
Goat, meat byproducts......................................        1.0
Hog, meat byproducts.......................................        0.1
Horse, fat.................................................        0.05
Horse, meat................................................        0.05

[[Page 600]]

 
Horse, meat byproducts.....................................        1.0
Milk.......................................................        0.05
Sheep, fat.................................................        0.05
Sheep, meat................................................        0.05
Sheep, meat byproducts.....................................        1.0
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the herbicide 
halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidiny) 
amino]carbonylamino sulfonyl] -3-chloro -1-methyl-1H-pyrazole-4- 
carboxylate, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance levels 
specified in the following table is to be determined by measuring only 
halosulfuron-methyl.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage............................................        1.0
Alfalfa, hay...............................................        2.0
Almond, hulls..............................................        0.2
Apple......................................................        0.05
Asparagus..................................................        0.8
Bean, dry, seed............................................        0.05
Bushberry, subgroup 13-07B.................................        0.05
Corn, field, forage........................................        0.2
Corn, field, grain.........................................        0.05
Corn, field, stover........................................        0.8
Corn, pop, grain...........................................        0.05
Corn, pop, stover..........................................        0.8
Corn, sweet, forage........................................        0.2
Corn, sweet, kernel plus cob with husks removed............        0.05
Corn, sweet, stover........................................        0.8
Cotton, gin byproducts.....................................        0.05
Cotton, undelinted seed....................................        0.05
Grass, forage, fodder, and hay, group 17, forage...........       20
Grass, forage, fodder, and hay, group 17, hay..............        0.5
Melon subgroup 9A..........................................        0.1
Millet, proso, forage......................................       10
Millet, proso, grain.......................................        0.01
Millet, proso, hay.........................................        0.01
Millet, proso, straw.......................................        0.01
Nut, tree, group 14........................................        0.05
Okra.......................................................        0.05
Pea and bean, succulent shelled, subgroup 6................        0.05
Pea and bean, succulent shelled, subgroup 6B...............        0.05
Pistachio..................................................        0.05
Rhubarb....................................................        0.05
Rice, grain................................................        0.05
Rice, straw................................................        0.2
Sorghum, grain, forage.....................................        0.05
Sorghum, grain, grain......................................        0.05
Sorghum, grain, stover.....................................        0.1
Soybean, seed..............................................        0.05
Squash/Cucumber subgroup 9B................................        0.5
Sugarcane, cane............................................        0.05
Vegetable, fruiting, group 8...............................        0.05
Vegetable, tuberous and corm, subgroup 1C..................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[64 FR 25448, May 12, 1999, as amended at 65 FR 58433, Sept. 29, 2000; 
66 FR 66340, Dec. 26, 2001; 66 FR 66786, Dec. 27, 2001; 67 FR 45649, 
July 10, 2002; 67 FR 59192, Sept. 20, 2002; 70 FR 51622, Aug. 31, 2005; 
72 FR 8927, Feb. 28, 2007; 74 FR 48401, Sept. 23, 2009; 75 FR 46853, 
Aug. 4, 2010; 76 FR 34886, June 15, 2011; 77 FR 71561, Dec. 3, 2012]



Sec. 180.480  Fenbuconazole; tolerances for residues.

    (a) General. Tolerances are established for combined residues of the 
fungicide fenbuconazole, alpha-[2-(4-chlorophenyl)- ethyl]-alpha-phenyl-
3-(1H-1,2,4-triazole)- 1-propanenitrile, and its metabolites RH-9129, 
cis-5-(4-chlorophenyl)- dihydro-3-phenyl-3-(1H-1,2,4- triazole-1-
ylmethyl)-2-3 H-furanone, and RH-9130, trans-5-(4- chlorophenyl)dihydro-
3-phenyl-3- (1H-1,2,4-triazole-1-ylmethyl)-2-3 H- furanone, expressed as 
fenbuconazole in or on the following agricultural commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond.....................................................        0.05
Almond, hulls..............................................        1.0
Apple......................................................        0.4
Apple, wet pomace..........................................        1.0
Banana.....................................................        0.3
Beet, sugar, dried pulp....................................        1.0
Beet, sugar, molasses......................................        0.4
Beet, sugar, roots.........................................        0.3
Beet, sugar, tops..........................................        9.0
Bushberry subgroup 13B.....................................        0.3
Cattle, meat byproducts....................................        0.05
Citrus, dried pulp.........................................        5.0
Citrus, oil................................................       40.0
Cranberry..................................................        0.5
Fruit, citrus, group 10....................................        1.0
Fruit, stone, group 12.....................................        1.0
Goat, meat byproducts......................................        0.05
Grain, aspirated fractions.................................        6.0
Grape \1\..................................................        1.0
Horse, meat byproducts.....................................        0.05
Peanut.....................................................        0.1
Pecan......................................................        0.05
Pepper.....................................................        0.40
Sheep, meat byproducts.....................................        0.05
Wheat, forage..............................................        4.0
Wheat, grain...............................................        0.1
Wheat, hay.................................................        8.0
Wheat, straw...............................................        8.0
------------------------------------------------------------------------
\1\There are no United States registrations for grape as of August 2006.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]

[[Page 601]]

    (d) Indirect or inadvertent residues. [Reserved]

[60 FR 11032, Mar. 1, 1995]

    Editorial Note: For Federal Register citations affecting Sec. 
180.480, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.481  Prosulfuron; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide prosulfuron and its metabolites and degradates in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified in the table below is to be determined by measuring only 
prosulfuron, 1-(4-methoxy-6-methyl-triazin-2-yl)-3-[2-(3,3,3-
trifluoropropyl)-phenylsulfonyl]-urea, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grain, cereal, forage, fodder, and straw, group 16, except          0.01
 rice, fodder...............................................
Grain, cereal, forage, fodder, and straw, group 16, except          0.10
 rice, forage...............................................
Grain, cereal, forage, fodder, and straw, group 16, except          0.20
 rice, hay..................................................
Grain, cereal, forage, fodder, and straw, group 16, except          0.02
 rice, straw................................................
Grain, cereal, group 15, except rice........................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registration. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[74 FR 67118, Dec. 18, 2009]



Sec. 180.482  Tebufenozide; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide tebufenozide, including its metabolites and degradates, in 
or on the commodities in the table in this paragraph. Compliance with 
the tolerance levels specified in this paragraph is to be determined by 
measuring only tebufenozide, 3,5-dimethylbenzoic acid 1-(1,1-
dimethylethyl)-2-(4-ethylbenzoyl)hydrazide, in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hulls..............................................       25
Apple......................................................        1.0
Apple, dry pomace..........................................        3.0
Apple, wet pomace..........................................        3.0
Berry group 13.............................................        3.0
Brassica, head and stem, subgroup 5A.......................        5.0
Brassica, leafy greens, subgroup 5B........................       10.0
Canola, refined oil........................................        4.0
Canola, seed...............................................        2.0
Citrus, oil................................................       15.0
Cotton.....................................................        1.5
Cotton, gin byproducts.....................................       30
Cranberry..................................................        1.0
Fruit, citrus, group 10....................................        0.80
Fruit, pome................................................        1.5
Grape......................................................        3.0
Kiwifruit \1\..............................................        0.5
Leaf petioles subgroup 4B..................................        2.0
Leafy greens subgroup 4A...................................       10.0
Nut, tree, group 14........................................        0.1
Peppermint, tops...........................................       10.0
Pistachio..................................................        0.1
Spearmint, tops............................................       10.0
Turnip, greens.............................................        9.0
Turnip, roots..............................................        0.3
Vegetable, fruiting, group 8...............................        1.0
Vegetable, tuberous and corm, except potato, subgroup 1D...        0.015
Walnut.....................................................        0.1
------------------------------------------------------------------------
\1\There are no U.S. registrations on kiwifruit as of June 15, 1999.

    (2) Tolerances are established for residues of the insecticide 
tebufenozide, including its metabolites and degradates, in or on the 
commodities in the table in this paragraph. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only the sum of tebufenozide, 3,5-dimethylbenzoic acid 1-(1,1-
dimethylethyl)-2-(4-ethylbenzoyl)hydrazide, and its metabolites, 3,5-
dimethylbenzoic acid 1-(1,1-dimethylethyl)-2-((4-
carboxymethyl)benzoyl)hydrazide, 3-hydroxymethyl-5-methylbenzoic acid 1-
(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide, stearic acid conjugate 
of 3-hydroxymethyl-5-methylbenzoic acid 1-(1,1-dimethylethyl)-2-(4-
ethylbenzoyl)hydrazide, and 3-hydroxymethyl-5-methylbenzoic acid 1-(1,1-
dimethylethyl)-2-(4-(1-hydroxyethyl)benzoyl)hydrazide, calculated as the 
stoichiometric equivalent of tebufenozide, in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................        0.1
Cattle, meat...............................................        0.08
Cattle, meat byproducts....................................        0.08
Goat, fat..................................................        0.1
Goat, meat.................................................        0.08

[[Page 602]]

 
Goat, meat byproducts......................................        0.08
Hog, fat...................................................        0.1
Hog, meat..................................................        0.08
Hog, meat byproducts.......................................        0.08
Horse, fat.................................................        0.1
Horse, meat................................................        0.08
Horse, meat byproducts.....................................        0.08
Milk.......................................................        0.04
Sheep, fat.................................................        0.1
Sheep, meat................................................        0.08
Sheep, meat byproducts.....................................        0.08
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established for 
indirect or inadvertent residues of the insecticide tebufenozide, 
including its metabolites and degradates, in or on the commodities in 
the table in this paragraph when present therein as a result of the 
application of tebufenozide to growing crops listed in the table to 
paragraph (a)(1) of this section. Compliance with the tolerance levels 
specified in this paragraph is to be determined by measuring only the 
sum of tebufenozide, 3,5-dimethylbenzoic acid 1-(1,1-dimethylethyl)-2-
(4-ethylbenzoyl)hydrazide, and its metabolite, 3,5-dimethylbenzoic acid 
1-(1,1-dimethylethyl)-2-(4-(1-hydroxyethyl)benzoyl)hydrazide, calculated 
as the stoichiometric equivalent of tebufenozide, in or on the 
commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Animal feed, nongrass, group 18............................        1.0
Grain, cereal, forage, fodder and straw, group 16..........        1.0
Grass, forage, fodder and hay, group 17....................        1.0
Vegetable, foliage of legume, group 7......................        0.20
------------------------------------------------------------------------


[60 FR 29347, May 31, 1995]

    Editorial Note: For Federal Register citations affecting Sec. 
180.482, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.484  Flutolanil; tolerances for residues.

    (a) General. Tolerances are established for residues of flutolanil, 
N-(3-(1-methylethoxy) phenyl)-2-(trifluoromethyl)benzamide, including 
its metabolites and degradates, in or on the commodities in the table 
below. Compliance with the tolerance levels specified below is to be 
determined by measuring only flutolanil and its metabolites converted to 
2-(trifluoromethyl) benzoic acid and calculated as flutolanil, in or on 
the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................        0.10
Cattle, kidney.............................................        1.00
Cattle, liver..............................................        2.00
Cattle, meat byproducts....................................        0.05
Cattle, meat...............................................        0.05
Cotton, gin byproducts.....................................        0.20
Cotton, undelinted seed....................................        0.20
Egg........................................................        0.05
Goat, fat..................................................        0.10
Goat, kidney...............................................        1.00
Goat, liver................................................        2.00
Goat, meat byproducts......................................        0.05
Goat, meat.................................................        0.05
Hog, fat...................................................        0.10
Hog, kidney................................................        1.00
Hog, liver.................................................        2.00
Hog, meat byproducts.......................................        0.05
Hog, meat..................................................        0.05
Horse, fat.................................................        0.10
Horse, kidney..............................................        1.00
Horse, liver...............................................        2.00
Horse, meat byproducts.....................................        0.05
Horse, meat................................................        0.05
Milk.......................................................        0.05
Peanut.....................................................        0.5
Peanut, hay................................................       15.0
Peanut, meal...............................................        1.0
Potato.....................................................        0.20
Potato, wet peel...........................................        0.30
Poultry, fat...............................................        0.05
Poultry, meat..............................................        0.05
Poultry, meat byproducts...................................        0.05
Rice, bran.................................................       10.0
Rice, grain................................................        7.0
Rice, hulls................................................       25.0
Rice, straw................................................       10.0
Sheep, fat.................................................        0.10
Sheep, kidney..............................................        1.00
Sheep, liver...............................................        2.00
Sheep, meat................................................        0.05
Sheep, meat byproducts.....................................        0.05
Soybean, forage............................................        8.0
Soybean, hay...............................................        2.5
Soybean, seed..............................................        0.20
Turnip, greens.............................................        0.1
Vegetable, brassica, leafy, group 5........................        0.1
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established for 
the indirect or inadvertent residues of flutolanil, N-(3-(1-
methylethoxy)phenyl)-2-(trifluoromethyl)benzamide, including its 
metabolites and degradates, in or on the commodities in the table below.

[[Page 603]]

Compliance with the tolerance levels specified below is to be determined 
by measuring only flutolanil and its metabolites converted to 2-
(trifluoromethyl) benzoic acid and calculated as flutolanil, in or on 
the following commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Wheat, bran.................................................        0.20
Wheat, forage...............................................        2.5
Wheat, grain................................................        0.05
Wheat, hay..................................................        1.2
Wheat, straw................................................        0.20
------------------------------------------------------------------------


[60 FR 42458, Aug. 16, 1995, as amended at 61 FR 33044, June 26, 1996; 
63 FR 42256, 42257, Aug. 7, 1998; 66 FR 10825, Feb. 20, 2001; 71 FR 
74818, Dec. 13, 2006; 72 FR 35665, June 29, 2007; 73 FR 33017, June 11, 
2008; 75 FR 17570, Apr. 7, 2010; 75 FR 80350, Dec. 22, 2010]



Sec. 180.485  Cyproconazole; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the free 
and conjugated forms of the fungicide cyproconazole, including its 
metabolites and degradates, in or on the commodities in the table below. 
Compliance with the proposed tolerance levels specified below is to be 
determined by measuring only cyproconazole ([alpha]-(4-chlorophenyl)-
[alpha]-(1-cyclopropylethyl)-1H-1,2,4-triazole-1-ethanol) in or on the 
following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Aspirated grain fractions..................................        2.5
Cattle, fat................................................        0.01
Cattle, meat byproducts (except liver).....................        0.01
Coffee bean, green (Imported) \1\..........................        0.1
Corn, field, forage........................................        0.60
Corn, field, grain.........................................        0.01
Corn, field, stover........................................        1.2
Goat, fat..................................................        0.01
Goat, meat byproducts (except liver).......................        0.01
Horse, fat.................................................        0.01
Horse, meat byproducts (except liver)......................        0.01
Peanut.....................................................        0.01
Peanut, hay................................................        6.0
Sheep, fat.................................................        0.01
Sheep, meat byproducts (except liver)......................        0.01
Soybean, forage............................................        1.0
Soybean, hay...............................................        3.0
Soybean, oil...............................................        0.10
Soybean, seed..............................................        0.05
Wheat, forage..............................................        0.80
Wheat, grain...............................................        0.05
Wheat, grain, milled byproducts............................        0.10
Wheat, hay.................................................        1.3
Wheat, straw...............................................        0.90
------------------------------------------------------------------------
\1\There are no U.S. registrations as of February 15, 2008 for use on
  coffee bean.

    (2) A tolerance is established for the combined residues of the free 
and conjugated forms of the fungicide cyproconazole, including its 
metabolites and degradates, in or on the commodity in the table below. 
Compliance with the tolerance level specified below is to be determined 
by measuring only the sum of cyproconazole ([alpha]-(4-chlorophenyl)-
[alpha]-(1-cyclopropylethyl)-1H-1,2,4-triazole-1-ethanol) and its 
metabolite [delta]-(4-chlorophenyl)-[beta],[delta]-dihydroxy-[gamma]-
methyl-1H-1,2,4-triazole-1-hexenoic acid, calculated as the 
stoichiometric equivalent of cyproconazole, in or on the following 
commodity:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Milk.......................................................        0.02
------------------------------------------------------------------------

    (3) Tolerances are established for the combined residues of the free 
and conjugated forms of the fungicide cyproconazole, including its 
metabolites and degradates, in or on the commodities in the table below. 
Compliance with the tolerance level specified below is to be determined 
by measuring only the sum of cyproconazole ([alpha]-(4-chlorophenyl)-
[alpha]-(1-cyclopropylethyl)-1H-1,2,4-triazole-1-ethanol) and its 
metabolite 2-(4-chlorophenyl)-3-cyclopropyl-1-[1,2,4]triazol-1-yl-
butane-2,3-diol, calculated as the stoichiometric equivalent of 
cyproconazole, in or on the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, liver..............................................        0.50
Goat, liver................................................        0.50
Hog, liver.................................................        0.01
Horse, liver...............................................        0.50
Sheep, liver...............................................        0.50
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 53835, Oct. 7, 1998, as amended at 71 FR 71058, Dec. 8, 2006; 73 
FR 27760, May 14, 2008; 78 FR 37473, June 21, 2013]



Sec. 180.486  Chlorethoxyfos; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide

[[Page 604]]

chlorethoxyfos, including its metabolites and degradates, in or on the 
commodities in the table in this paragraph. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only chlorethoxyfos, O,O-diethyl O-(1,2,2,2-tetrachloroethyl) 
phosphorothioate, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Corn, field, forage.........................................        0.01
Corn, field, grain..........................................        0.01
Corn, field, stover.........................................        0.01
Corn, pop, grain............................................        0.01
Corn, pop, stover...........................................        0.01
Corn, sweet, forage.........................................        0.01
Corn, sweet, kernel plus cob with husks removed.............        0.01
Corn, sweet, stover.........................................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[76 FR 23498, Apr. 27, 2011]



Sec. 180.487  Pyrithiobac sodium; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide, pyrithiobac sodium, (sodium 2-chloro-6-[(4,6-
dimethoxypyrimidin-2-yl)thio]benzoate), resulting from the application 
of the pesticide chemical in or on the following foods/feeds:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cotton, gin byproducts.....................................        0.15
Cotton, undelinted seed....................................        0.02
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[62 FR 54783, Oct. 22, 1997, as amended at 64 FR 56469, Oct. 20, 1999; 
67 FR 72110, Dec. 4, 2002]



Sec. 180.490  Imazapic-ammonium; tolerances for residues.

    (a) General. (1) Tolerances are established for combined residues of 
the herbicide imazapic, ()-2-[4,5-dihydro-4-
methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-methyl-3-
pyridinecarboxylic acid and its metabolite ()-2-
[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-
hydroxymethyl-3-pyridinecarboxylic acid, both free and conjugated, in or 
on the following food commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Grass, forage..............................................       15
Grass, hay.................................................       30
Peanut.....................................................        0.1
------------------------------------------------------------------------

    (2) Tolerances are also established for the combined residues of the 
herbicide imazapic, ()-2-[4,5-dihydro-4-methyl-4-
(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-methyl-3-pyridinecarboxylic 
acid and its free metabolite ()-2-[4,5-dihydro-4-
methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-hydroxymethyl-3-
pyridinecarboxylic acid, in or on the following food commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................        0.10
Cattle, kidney.............................................        1.0
Cattle, meat byproducts, except kidney.....................        0.1
Cattle, meat...............................................        0.1
Goat, fat..................................................        0.1
Goat, kidney...............................................        1.0
Goat, meat byproducts, except kidney.......................        0.1
Goat, meat.................................................        0.1
Horse, fat.................................................        0.1
Horse, kidney..............................................        1.0
Horse, meat byproducts, except kidney......................        0.1
Horse, meat................................................        0.1
Milk.......................................................        0.1
Sheep, fat.................................................        0.1
Sheep, kidney..............................................        1.0
Sheep, meat byproducts, except kidney......................        0.1
Sheep, meat................................................        0.1
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with reginal registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[64 FR 54224, Oct. 6, 1999, as amended at 66 FR 64774, Dec. 14, 2001; 66 
FR 66332, Dec. 26, 2001]



Sec. 180.491  Propylene oxide; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
fumigant propylene oxide, including its metabolites and degradates, in 
or on the commodities in the table in this paragraph. Compliance with 
the tolerance levels

[[Page 605]]

specified in this paragraph is to be determined by measuring only 
propylene oxide, when used as a postharvest fumigant, in or on the 
commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cacao bean, cocoa powder....................................      200
Cacao bean, dried bean......................................      200
Fig.........................................................        3.0
Garlic, dried...............................................      300
Grape, raisin...............................................        1.0
Herbs and spices, group 19, dried...........................      300
Nut, pine...................................................      300
Nut, tree, group 14.........................................      300
Nutmeat, processed, except peanuts..........................      300
Onion, dried................................................      300
Pistachio...................................................      300
Plum, prune, dried..........................................        2.0
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the reaction product, 
propylene chlorohydrin, including its metabolites and degradates, in or 
on the commodities in the table in this paragraph. Compliance with the 
tolerance levels specified in this paragraph is to be determined by 
measuring only the sum of propylene chlorohydrin (1-chloro-2-propanol), 
and its isomer 2-chloro-1-propanol, calculated as the stoichiometric 
equivalent of propylene chlorohydrin (1-chloro-2-propanol), that results 
from the use of propylene oxide as a postharvest fumigant, in or on the 
commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Basil, dried leaves.........................................     6000
Cacao bean, cocoa powder....................................       20.0
Cacao bean, dried bean......................................       20.0
Fig.........................................................        3.0
Garlic, dried...............................................     6000
Grape, raisin...............................................        4.0
Herbs and spices, group 19, dried, except basil.............     1500
Nut, pine...................................................       10.0
Nut, tree, group 14.........................................       10.0
Nutmeat, processed, except peanuts..........................       10.0
Onion, dried................................................     6000
Pistachio...................................................       10.0
Plum, prune, dried..........................................        2.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33702, May 24, 2000, as amended at 68 FR 39430, July 1, 2003; 72 
FR 49651, Aug. 29, 2007; 73 FR 54963, Sept. 24, 2008; 76 FR 38037, June 
29, 2011; 77 FR 28495, May 15, 2012]



Sec. 180.492  Triflusulfuron-methyl; tolerances for residues.

    (a) General. Tolerances are established for residues of 
triflusulfuron-methyl, including its metabolites and degradates, in or 
on the commodities listed in the table below. Compliance with the 
tolerance levels specified below is to be determined by measuring only 
triflusulfuron-methyl (methyl 2-[[[[[4-(dimethylamino)-6-(2,2,2-
trifluoroethoxy)-1,3,5-triazin-2-yl]amino]carbonyl]amino]sulfonyl]-3-
methylbenzoate) in or on the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Beet, garden, roots........................................        0.01
Beet, garden, tops.........................................        0.02
Beet, sugar, roots.........................................        0.05
Beet, sugar, tops..........................................        0.05
Chicory, roots.............................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[67 FR 40196, June 12, 2002, as amended at 76 FR 22625, Apr. 22, 2011]



Sec. 180.493  Dimethomorph; tolerances for residues.

    (a) General. Tolerances are established for the residues of the 
fungicide dimethomorph, (E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-
dimethoxyphenyl)-1-oxo-2-propenyl]morpholine, in or on the following 
commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A.......................        6.0
Brassica, leafy greens, subgroup 5B........................       30.0
Ginseng....................................................        0.90
Grape......................................................        3.0
Grape, raisin..............................................        7.0
Hop, dried cones...........................................       60
Lettuce, head..............................................       10
Lettuce, leaf..............................................       10
Onion, bulb, subgroup 3-07A................................        0.6
Onion, green, subgroup 3-07B...............................       15.0
Potato.....................................................        0.05
Potato, wet peel...........................................        0.20
Taro, corm.................................................        0.5
Taro, leaves...............................................        6.0
Turnip, greens.............................................       20.0
Vegetable, cucurbit, group 9...............................        0.5
Vegetable, fruiting, group 8...............................        1.5
Vegetable, leafy (except Brassica) group 4.................       30.0
------------------------------------------------------------------------


[[Page 606]]

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registrations are established for residues of the fungicide 
dimethomorph, (E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-
2-propenyl]morpholine, in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Bean, lima, succulent.......................................        0.60
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. Tolerances are established for 
the indirect or inadvertent residues of the fungicide dimethomorph, in 
or on the commodities in the following table. Compliance with the 
following tolerance levels specified in the following table is to be 
determined by measuring only dimethomorph (E,Z)-4-[3-(4-chlorophenyl)-3-
(3,4-dimethoxyphenyl)acryloyl]morpholine calculated in or on the 
following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Wheat, forage...............................................        0.15
Wheat, hay..................................................        0.15
Wheat, straw................................................        0.4
------------------------------------------------------------------------


[62 FR 26416, May 14, 1997]

    Editorial Note: For Federal Register citations affecting Sec. 
180.493, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.494  Pyridaben; tolerance for residues.

    (a) General. Tolerances are established for residues of the 
insecticide pyridaben [2-tert-butyl-5-(4-tert-butylbenzylthio)-4-
chloropyridazin-3(2H)-one] on the following plants, and of the 
insecticide pyridaben and its metabolites (2-tert-butyl-5-(4-(1-carboxy-
1-methylethyl)benzylthio)-4-chloropyridazin-3(2H)-one] and (2-tert-
butyl-5-[4(-1,1-dimethyl-2-hypdroxyethyl)benzylthio-4-chloropyridazinn-
3(2H)-one) on animals, as indicated in the following table.

------------------------------------------------------------------------
                                                             Revocation/
                    Commodity                     Parts per   expiration
                                                   million       date
------------------------------------------------------------------------
Almond, hulls...................................        4.0         None
Apple...........................................        0.5         None
Apple, wet pomace...............................       0.75         None
Canistel........................................       0.10         None
Cattle, fat.....................................       0.05         None
Cattle, meat....................................       0.05         None
Cattle, meat byproducts.........................       0.05         None
Citrus..........................................        0.5         None
Citrus, dried pulp..............................        1.5         None
Citrus, oil.....................................       10.0         None
Fruit, stone, group 12..........................        2.5         None
Goat, fat.......................................        0.0         None
Goat, meat......................................       0.05         None
Goat, meat byproducts...........................       0.05         None
Grape...........................................        1.5         None
Hog, fat........................................       0.05         None
Hog, meat.......................................       0.05         None
Hog, meat byproducts............................       0.05         None
Hop, dried cones................................       10.0         None
Horse, fat......................................       0.05         None
Horse, meat.....................................       0.05         None
Horse, meat byproducts..........................       0.05         None
Mango...........................................       0.10         None
Milk............................................       0.01         None
Nut, tree, group 14.............................       0.05         None
Papaya..........................................       0.10         None
Pear............................................       0.75         None
Pistachio.......................................       0.05         None
Sapodilla.......................................       0.10         None
Sapote, black...................................       0.10         None
Sapote, mamey...................................       0.10         None
Sheep, fat......................................       0.05         None
Sheep, meat.....................................       0.05         None
Sheep, meat byproduct...........................       0.05         None
Star apple......................................       0.10         None
Strawberry......................................        2.5         None
Tomato..........................................       0.15         None
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration, as defined in Sec. 180.1(m) are established for residues 
of the insecticide pyridaben [2-tert-butyl-5(4-tert-butylbenzylthio)-4-
chloropyridazin-3(2H)-one] in or on the following raw agricultural 
commodity:

------------------------------------------------------------------------
                                                   Parts per  Expiration
                    Commodity                       million      Date
------------------------------------------------------------------------
Cranberry........................................        0.5        None
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 43712, July 14, 2000, as amended at 66 FR 33199, June 21, 2001; 
70 FR 55769, Sept. 23, 2005; 76 FR 56015, Sept. 15, 2010]



Sec. 180.495  Spinosad; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide spinosad in or on the food commodities in the table to this 
paragraph.

[[Page 607]]

Spinosad is a fermentation product of Saccharopolyspora spinosa. The 
product consists of two related active ingredients: Spinosyn A (Factor 
A: CAS  131929-60-7) or 2-[(6-deoxy-2,3,4-tri-O -methyl-
[alpha]-L-manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-
methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-
Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D; CAS 
 131929-63-0) or 2-[(6-deoxy-2,3,4-tri-O-methyl-[alpha]-L-
manno-pyranosyl)oxy]-13-[[5-(dimethyl-amino)-tetrahydro-6-methyl-2H-
pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-
tetradecahydro-4,14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-
dione.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Acerola...................................................      1.5
Alfalfa, seed.............................................      0.15
Alfalfa, seed screenings..................................      2.0
Almond, hulls.............................................     19
Amaranth, grain, grain....................................      1.0
Amaranth, grain, stover...................................     10
Animal feed, nongrass, group, 18..........................      0.02
Animal feed, nongrass, group, 18, forage..................     35.0
Animal feed, nongrass, group, 18, hay.....................     30.0
Apple, dry pomace.........................................      0.5
Apple, wet pomace.........................................      0.5
Artichoke, globe..........................................      0.3
Asparagus.................................................      0.2
Atemoya...................................................      0.3
Avocado...................................................      0.3
Banana....................................................      0.25
Beet, sugar, molasses.....................................      0.75
Biriba....................................................      0.3
Brassica, head and stem, subgroup 5A......................      2.0
Brassica, leafy greens, subgroup 5B.......................     10.0
Bushberry subgroup 13B....................................      0.250
Caneberry subgroup 13A....................................      0.7
Canistel..................................................      0.3
Cattle, fat...............................................     50
Cattle, liver.............................................     10
Cattle, meat..............................................      2.0
Cattle, meat byproducts, except liver.....................      5.0
Cherimoya.................................................      0.3
Citrus, oil...............................................      3.0
Citrus, dried pulp........................................      0.5
Coriander, leaves.........................................      8.0
Corn, sweet, kernel plus cob with husks removed...........      0.02
Cotton, gin byproducts....................................      1.5
Cotton, undelinted seed...................................      0.02
Cranberry.................................................      0.01
Custard apple.............................................      0.3
Date......................................................      0.10
Egg.......................................................      0.30
Feijoa....................................................       .05
Fig.......................................................      0.10
Fish......................................................      4.0
Fish-shellfish, crustacean................................      4.0
Fish-shellfish, mollusc...................................      4.0
Food commodities..........................................      0.02
Fruit, citrus, group 10...................................      0.3
Fruit, pome, group 11.....................................      0.20
Fruit, stone, group 12....................................      0.20
Goat, fat.................................................     50
Goat, liver...............................................     10
Goat, meat................................................      2.0
Goat, meat byproducts, except liver.......................      5.0
Grain, aspirated fractions................................    200
Grain, cereal, group 15...................................      1.5
Grain, cereal, group 16, forage, except rice..............      2.5
Grain, cereal, group 16, hay, except rice.................     10.0
Grain, cereal, group, 16, stover, except rice.............     10.0
Grain, cereal, group, 16, straw, except rice..............      1.0
Grape.....................................................      0.50
Grape, raisin.............................................      0.70
Grass, forage, fodder and hay, group 17, forage...........     10.0
Grass, forage, fodder and hay, group 17, hay..............      5.0
Guava.....................................................      0.3
Herb subgroup 19A, dried..................................     22
Herb subgroup 19A, fresh..................................      3.0
Hog, fat..................................................      5.0
Hog, meat.................................................      0.50
Hog, meat byproducts......................................      2.0
Hop, dried cones..........................................     22
Horse, fat................................................     50
Horse, liver..............................................     10
Horse, meat...............................................      2.0
Horse, meat byproducts, except liver......................      5.0
Ilama.....................................................      0.3
Jaboticaba................................................      0.3
Juneberry.................................................      0.25
Lingonberry...............................................      0.250
Longan....................................................      0.3
Lychee....................................................      0.3
Mango.....................................................      0.3
Milk......................................................      7.0
Milk, fat.................................................     85
Nut, tree, group 14.......................................      0.10
Okra......................................................      0.40
Onion, green..............................................      2.0
Papaya....................................................      0.3
Passionfruit..............................................      0.3
Pea and bean, dried shelled, except soybean, subgroup 6C..      0.02
Pea and bean, succulent shelled, subgroup 6B..............      0.02
Peanut....................................................      0.02
Peanut, hay...............................................     11.0
Peppermint, tops..........................................      3.5
Pineapple.................................................      0.02
Pineapple, process residue................................      0.08
Pistachio.................................................      0.10
Pomegranate...............................................      0.30
Poultry, fat..............................................      1.3
Poultry, meat.............................................      0.10
Poultry, meat byproducts..................................      0.20
Pulasan...................................................      0.3
Rambutan..................................................      0.3
Rice, hulls...............................................      4.0
Salal.....................................................      0.250
Sapodilla.................................................      0.3
Sapote, black.............................................      0.3
Sapote, mamey.............................................      0.3
Sapote, white.............................................      0.3
Sheep, fat................................................     50
Sheep, liver..............................................     10
Sheep, meat...............................................      2.0
Sheep, meat byproducts, except liver......................      5.0
Soursop...................................................      0.3
Soybean...................................................      0.02
Spanish lime..............................................      0.3
Spearmint, tops...........................................      3.5
Spice, subgroup 19B, except black pepper..................      1.7
Star apple................................................      0.3

[[Page 608]]

 
Starfruit.................................................      0.3
Strawberry................................................      1.0
Sugar apple...............................................      0.3
Ti, leaves................................................     10.0
Vegetable, bulb, group 3, except green onion..............      0.10
Vegetable, cucurbit, group 9..............................      0.3
Vegetable, foliage of legume, group 7.....................      8.0
Vegetable, fruiting, group 8..............................      0.4
Vegetable, leafy, except brassica, group 4................      8.0
Vegetable, leaves of root and tuber, group 2..............     10.0
Vegetable, legume, edible podded, subgroup 6A.............      0.30
Vegetable, root and tuber, group 1........................      0.10
Watercress................................................      8.0
Wax jambu.................................................      0.3
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertant residues. [Reserved]

[72 FR 68540, Dec. 5, 2007, as amended at 74 FR 46376, Sept. 9, 2009; 74 
FR 48408, Sept. 23, 2009; 75 FR 60327, Sept. 30, 2010]



Sec. 180.496  Thiazopyr; tolerances for residues.

    Tolerances are established for combined residues of the herbicide 
thiazopyr (3-pyridinecaroxylic acid, 2-(difluoromethyl)-5-(4,5-dihydro-
2-thiazolyl)-4-(2-methylpropyl)-6-(trifluoromethyl)-, methyl ester) and 
its metabolites determined as 2-(difluoromethyl)-6-(trifluoromethyl)-
3,4,5-pyridinetricarboxylic acid, all expressed as the parent 
equivalents in or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per
                        Commodities                            million
------------------------------------------------------------------------
Grapefruit.................................................        0.05
Orange, sweet..............................................        0.05
------------------------------------------------------------------------


[62 FR 9978, Mar. 5, 1997]



Sec. 180.497  Clofencet; tolerances for residues.

    (a) General. Tolerances are established for residues of the plant 
growth regulator (hybridizing agent) clofencet, including its 
metabolites and degradates, in or on the commodities in the table in 
this paragraph. Compliance with the tolerance levels specified in this 
paragraph is to be determined by measuring only clofencet, potassium 2-
(4-chlorophenyl)-3-ethyl-2,5-dihydro-5-oxo-4-pyridazinecarboxylate, 
expressed as the free acid, in or on the commodity.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Cattle, fat.....................................       0.04      7/14/12
Cattle, kidney..................................       10.0      7/14/12
Cattle, meat....................................       0.15      7/14/12
Cattle, meat byproducts, except kidney..........        0.5      7/14/12
Egg.............................................        1.0      7/14/12
Goat, fat.......................................       0.04      7/14/12
Goat, kidney....................................       10.0      7/14/12
Goat, meat......................................       0.15      7/14/12
Goat, meat byproducts, except kidney............        0.5      7/14/12
Hog, fat........................................       0.04      7/14/12
Hog, kidney.....................................       10.0      7/14/12
Hog, meat.......................................       0.15      7/14/12
Hog, meat byproducts, except kidney.............        0.5      7/14/12
Horse, fat......................................       0.04      7/14/12
Horse, kidney...................................       10.0      7/14/12
Horse, meat.....................................       0.15      7/14/12
Horse, meat byproducts, except kidney...........        0.5      7/14/12
Milk............................................       0.02      7/14/12
Poultry, fat....................................       0.04      7/14/12
Poultry, meat...................................       0.15      7/14/12
Poultry, meat byproducts........................       0.20      7/14/12
Sheep, fat......................................       0.04      7/14/12
Sheep, kidney...................................       10.0      7/14/12
Sheep, meat.....................................       0.15      7/14/12
Sheep, meat byproducts, except kidney...........        0.5      7/14/12
Wheat, forage...................................       10.0      7/14/12
Wheat, grain....................................      250.0      7/14/12
Wheat, hay......................................       40.0      7/14/12
Wheat, straw....................................       50.0      7/14/12
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established for 
indirect or inadvertent residues of the plant growth regulator 
(hybridizing agent) clofencet, including its metabolites and degradates, 
in or on the commodities in the table in this paragraph. Compliance with 
the tolerance levels specified in this paragraph is to be determined by 
measuring only clofencet, potassium 2-(4-chlorophenyl)-3-ethyl-2,5-
dihydro-5-oxo-4-pyridazinecarboxylate, expressed as the free acid, in or 
on the commodity when present therein as a result of the application of 
clofencet to the growing crops in paragraph (a) of this section.

[[Page 609]]



------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Grain, cereal, forage, fodder and straw, group          4.0      7/14/12
 16, except rice, sweet corn, wheat, and wild
 rice; forage...................................
Grain, cereal, forage, fodder and straw, group         15.0      7/14/12
 16, except rice, sweet corn, wheat, and wild
 rice; hay......................................
Grain, cereal, forage, fodder and straw, group          1.0      7/14/12
 16, except rice, sweet corn, wheat, and wild
 rice; stover...................................
Grain, cereal, forage, fodder and straw, group          4.0      7/14/12
 16, except rice, sweet corn, wheat, and wild
 rice; straw....................................
Grain, cereal group 15, except rice, sweet corn,       20.0      7/14/12
 wheat, and wild rice...........................
Soybean.........................................       30.0      7/14/12
Soybean, forage.................................       10.0      7/14/12
Soybean, hay....................................       10.0      7/14/12
------------------------------------------------------------------------


[76 FR 56656, Sept. 14, 2011]



Sec. 180.498  Sulfentrazone; tolerances for residues.

    (a)(1) General. Tolerances are established for the combined residues 
of the free and conjugated forms of sulfentrazone, including its 
metabolites and degradates, in or on the commodities in the table below. 
Compliance with the tolerance levels specified below is to be determined 
by measuring only the sum of sulfentrazone (N-[2,4-dichloro-5-[4-
(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide) and its metabolite HMS (N-(2,4-dichloro-5-
(4-(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-
1-yl)phenyl)methanesulfonamide, calculated as the stoichiometric 
equivalent of sulfentrazone in or on the following commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Soybean, seed..............................................        0.05
------------------------------------------------------------------------

    (2) Tolerances are established for the combined residues of the free 
and conjugated forms of sulfentrazone, including its metabolites and 
degradates, in or on the commodities in the table below. Compliance with 
the tolerance levels specified below is to be determined by measuring 
only the sum of sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-
4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide) and its metabolites HMS (N-(2,4-dichloro-
5-(4-(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-
triazol-1-yl)phenyl)methanesulfonamide) and DMS (N-(2,4-dichloro-5-(4-
(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-
yl)phenyl)methanesulfonamide, calculated as the stoichiometric 
equivalent of sulfentrazone in or on the following commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Asparagus..................................................        0.15
Berry and small fruit, group 13-07.........................        0.15
Brassica, head and stem, subgroup 5A.......................        0.20
Brassica, leafy greens, subgroup 5B........................        0.40
Corn, field, forage........................................        0.20
Corn, field, grain.........................................        0.15
Corn, field, stover........................................        0.30
Flax.......................................................        0.15
Fruit, citrus, group 10-10.................................        0.15
Horseradish................................................        0.20
Melon, subgroup 9A.........................................        0.15
Nut, tree, group 14........................................        0.15
Pea and bean, dried shelled, except soybean, subgroup 6C...        0.15
Pea, succulent.............................................        0.15
Peanut.....................................................        0.20
Peanut, meal...............................................        0.40
Peppermint, tops...........................................        0.30
Pistachio..................................................        0.15
Rhubarb....................................................        0.15
Spearmint, tops............................................        0.30
Sugarcane, cane............................................        0.15
Sugarcane, molasses........................................        0.20
Sunflower subgroup 20B.....................................        0.20
Turnip, roots..............................................        0.15
Turnip, tops...............................................        0.60
Vegetable, fruiting, group 8-10............................        0.15
Vegetable, soybean, succulent..............................        0.15
Vegetable, tuberous and corm, subgroup 1C..................        0.15
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration are established for the combined residues of the free and 
conjugated forms of sulfentrazone, including its metabolites and 
degradates, in or on the commodities in the table below. Compliance with 
the tolerance levels specified below is to be determined by measuring 
only the sum of sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-
4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide) and its metabolites HMS (N-(2,4-dichloro-
5-(4-(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-
triazol-1-yl)phenyl)methanesulfonamide) and DMS (N-(2,4-dichloro-5-(4-

[[Page 610]]

(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-
yl)phenyl)methanesulfonamide, calculated as the stoichiometric 
equivalent of sulfentrazone in or on the following commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Bean, lima, succulent.......................................        0.15
Cowpea, succulent...........................................        0.15
Wheat, forage...............................................        0.50
Wheat, grain................................................        0.15
Wheat, hay..................................................        0.30
Wheat, straw................................................        1.5
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. Tolerances are established for 
inadvertent and indirect combined residues of the free and conjugated 
forms of sulfentrazone, including its metabolites and degradates, in or 
on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only the sum of 
sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-
methyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]methanesulfonamide) and its 
metabolites HMS (N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-3-
hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-yl)phenyl)methanesulfonamide) and 
DMS (N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-
triazol-1-yl)phenyl)methanesulfonamide, calculated as the stoichiometric 
equivalent of sulfentrazone in or on the following commodities when 
present therein as a result of the application of sulfentrazone to 
growing crops.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Grain, cereal (excluding sweet corn), Hulls................        0.30
Grain, cereal, forage, fodder and straw, group 16, except          0.2
 sweet corn; forage........................................
Grain, cereal, forage, fodder and straw, group 16, except          0.2
 sweet corn; hay...........................................
Grain, cereal, forage, fodder and straw, group 16, except          0.1
 sweet corn; stover........................................
Grain, cereal, forage, fodder and straw, group 16, except          0.6
 sweet corn; straw.........................................
Grain, cereal, group 15, except sweet corn.................        0.1
Grain, cereal, group 15, except sweet corn; bran...........        0.15
------------------------------------------------------------------------


[62 FR 10708, Mar. 10, 1997]

    Editorial Note: For Federal Register citations affecting Sec. 
180.498, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.499  Propamocarb; tolerances for residues.

    (a) General. Tolerances are established for the residues of 
propamocarb, including its metabolites and degradates, in or on the 
commodities specified in the following table resulting from the 
application of the hydrochloride salt of propamocarb. Compliance with 
the following tolerance levels is to be determined by measuring only 
propamocarb (propyl N-[3-(dimethylamino)propyl]carbamate):

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Lettuce, head..............................................       50
Lettuce, leaf..............................................       90
Potato.....................................................        0.06
Tomato, paste..............................................        5.0
Vegetable, cucurbit, group 9...............................        1.5
Vegetable, fruiting, group 8...............................        2.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerance with regional registrations. Tolerances with regional 
registrations are established for the residues of propamocarb, including 
its metabolites and degradates, in or on the commodities specified in 
the following table resulting from the application of the hydrochloride 
salt of propamocarb. Compliance with the following tolerance levels is 
to be determined by measuring only propamocarb (propyl N-[3-
(dimethylamino)propyl]carbamate):

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Bean, lima, succulent.......................................        2.0
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[62 FR 15620, Apr. 2, 1997, as amended at 62 FR 26966, May 16, 1997; 63 
FR 32136, June 12, 1998; 64 FR 16843, Apr. 7, 1999; 65 FR 58399, Sept. 
29, 2000; 66 FR 37598, July 19, 2001; 66 FR 48585, Sept. 21, 2001; 67 FR 
35049, May 17, 2002; 69 FR 47022, Aug. 4, 2004; 70 FR 7047, Feb. 10, 
2005; 78 FR 33736, June 5, 2013]



Sec. 180.500  Imazapyr; tolerances for residues.

    (a) General. Tolerances are being established for residues of the 
herbicide imazapyr, [2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-
imidazol-2-yl]-3-

[[Page 611]]

pyridinecarboxylic acid], applied as the acid or ammonium salt, in or on 
the following raw agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................        0.05
Cattle, kidney.............................................        0.20
Cattle, meat...............................................        0.05
Cattle, meat byproducts, except kidney.....................        0.05
Corn, field, forage........................................        0.05
Corn, field, grain.........................................        0.05
Corn, field, stover........................................        0.05
Fish.......................................................        1.0
Goat, fat..................................................        0.05
Goat, kidney...............................................        0.20
Goat, meat.................................................        0.05
Goats, meat byproducts, except kidney......................        0.05
Grass, forage..............................................      100
Grass, hay.................................................       30
Horse, fat.................................................        0.05
Horse, kidney..............................................        0.20
Horse, meat................................................        0.05
Horse, meat byproducts, except kidney......................        0.05
Milk.......................................................        0.01
Sheep, fat.................................................        0.05
Sheep, kidney..............................................        0.20
Sheep, meat................................................        0.05
Sheep, meat byproducts, except kidney......................        0.05
Shellfish..................................................        0.10
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[68 FR 55484, Sept. 26, 2003]



Sec. 180.501  Hydroprene; tolerances for residues.

    (a) General. A tolerance of 0.2 part per million is established for 
residues of hydroprene [(S)-(Ethyl (2E,4E,7S)-3,7,11-trimrthyl-2,4-
dodecadienoate)], (CAS Reg. No. 65733-18-8) on food commodities in food-
handling establishments in accordance with the following prescribed 
conditions:
    (1) Application shall be limited to spot, crack and crevice, 
perimeter and ultra low volume (ULV) fogging treatment in food storage 
or food-handling establishments, including warehouses, food service, 
manufacturing, and processing establishments such as restaurants, 
cafeterias, supermarkets, bakeries, breweries, dairies, meat 
slaughtering and packing plants, and canneries where food and food 
products are held, processed, and served: Provided that the food is 
removed or covered prior to such use, and food-processing surfaces are 
covered during treatment or thoroughly cleaned before using, or in the 
case of point-source device treatments, devices must not come into 
direct contact with food preparation surfaces and must be in a minimum 
distance of 3 feet from exposed foods.
    (2) To assure safe use of the insect growth regulator, the label and 
labeling shall conform to that registered by the U.S. Environmental 
Protection Agency, and it shall be used in accordance with such label 
and labeling.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[62 FR 61647, Nov. 19, 1997, as amended at 71 FR 74818, Dec. 13, 2006]



Sec. 180.502  Aminoethoxyvinylglycine hydrochloride (aviglycine HCl); 

tolerances for residues.

    (a) General. Tolerances are established for residues of 
aminoethoxyvinylglycine hydrochloride (aviglycine HCl) in or on the 
following food commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Apple......................................................        0.08
Fruit, stone, group 12, except cherry......................        0.170
Pear.......................................................        0.08
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[62 FR 24838, May 7, 1997, as amended at 64 FR 31129, June 10, 1999; 66 
FR 36481, 36484, July 12, 2001; 69 FR 7606, Feb. 18, 2004]



Sec. 180.503  Cymoxanil, tolerance for residues.

    (a) General. Tolerances are established for residues of the 
fungicide, cymoxanil, 2-cyano -N- [(ethylamino)carbonyl]-2-
(methoxyimino) acetamide, in or on the following food commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Caneberry, subgroup 13A-07.................................        4.0

[[Page 612]]

 
Cilantro, leaves...........................................       19
Hop, dried cones...........................................        7.0
Leafy greens, subgroup 4A..................................       19
Leaf petioles, subgroup 4B.................................        6.0
Lychee \1\.................................................        1.0
Onion, bulb, subgroup 3-07A................................        0.05
Onion, green, subgroup 3-07B...............................        1.1
Potato.....................................................        0.05
Vegetable, cucurbit, group 9...............................        0.05
Vegetable, fruiting, group 8...............................        0.2
------------------------------------------------------------------------
\1\ There is no U.S. registration for lychee.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with a regional registration. Tolerances with a 
regional registration as defined in Sec. 180.1(l) are established for 
the residues of the fungicide cymoxanil, 2-cyano -N- 
[(ethylamino)carbonyl]-2-(methoxyimino) acetamide) in or on the raw 
agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Grape......................................................        0.10
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[62 FR 26411, May 14, 1997, as amended at 62 FR 39956, July 25, 1997; 63 
FR 24949, May 6, 1998; 63 FR 66464, Dec. 2, 1998; 64 FR 6539, Feb. 10, 
1999; 64 FR 47689, Sept. 1, 1999; 66 FR 37598, July 19, 2001; 67 FR 
35049, May 17, 2002; 68 FR 41936, July 16, 2003; 70 FR 7047, Feb. 10, 
2005; 72 FR 37646, July 11, 2007; 73 FR 58885, Oct. 8, 2008; 76 FR 
34885, June 15, 2011]



Sec. 180.504  [Reserved]



Sec. 180.505  Emamectin; tolerances for residues.

    (a) General. (1) Tolerances are established for emamectin, including 
its metabolites and degradates, in or on the commodities in the table 
below. Compliance with the tolerance levels specified below is to be 
determined by measuring only the sum of emamectin (a mixture of a 
minimum of 90% 4[min]-epi-methylamino-4[min]-deoxyavermectin 
B1a and maximum of 10% 4[min]-epi-methylamino-4[min]-
deoxyavermectin B1b) and its metabolites 8,9-isomer of the 
B1a and B1b component of the parent (8,9-ZMA), or 
4[min]-deoxy-4[min]-epi-amino-avermectin B1a and 4'-deoxy-4'-
epi-amino-avermectin B1b; 4[min]-deoxy-4[min]-epi-amino 
avermectin B1a (AB1a); 4[min]-deoxy-4[min]-epi-(N-
formyl-N-methyl)amino-avermectin (MFB1a); and 4[min]-deoxy-
4[min]-epi-(N-formyl)amino-avermectin B1a (FAB1a), 
calculated as the stoichiometric equivalent of emamectin.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hulls..............................................        0.20
Apple, wet pomace..........................................        0.075
Cotton, gin byproducts.....................................        0.050
Cotton, undelinted seed....................................        0.025
Fruit, pome, group 11......................................        0.025
Nut, tree, group 14........................................        0.02
Pistachio..................................................        0.02
Tomato, paste..............................................        0.150
Turnip, greens.............................................        0.050
Vegetable, Brassica, leafy, group 5........................        0.050
Vegetable, cucurbit, group 9...............................        0.02
Vegetable, fruiting, group 8...............................        0.020
Vegetable, leafy, except Brassica, group 4.................        0.100
------------------------------------------------------------------------

    (2) Tolerances are established for emamectin, including its 
metabolites and degradates, in or on the commodities in the table below. 
Compliance with the tolerance levels specified below is to be determined 
by measuring only the sum of emamectin (MAB1a + 
MAB1b isomers) and the associated 8,9-Z isomers (8,9-
1a and 8,9-ZB1b).

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................        0.010
Cattle, liver..............................................        0.050
Cattle, meat...............................................        0.003
Cattle, meat byproducts, except liver......................        0.020
Goat, fat..................................................        0.010
Goat, liver................................................        0.050
Goat, meat.................................................        0.003
Goat, meat byproducts, except liver........................        0.020
Hog, fat...................................................        0.003
Hog, liver.................................................        0.020
Hog, meat..................................................        0.002
Hog, meat byproducts (except liver)........................        0.005
Horse, fat.................................................        0.010
Horse, liver...............................................        0.050
Horse, meat................................................        0.003
Horse, meat byproducts, except liver.......................        0.020
Milk.......................................................        0.003
Sheep, fat.................................................        0.010
Sheep, liver...............................................        0.050
Sheep, meat................................................        0.003
Sheep, meat byproducts, except liver.......................        0.020
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect and inadvertant residues. [Reserved]

[71 FR 18649, Apr. 12, 2006, as amended at 74 FR 2873, Jan. 16, 2009; 78 
FR 18511, Mar. 27, 2013]

[[Page 613]]



Sec. 180.506  Cyclanilide; tolerances for residues.

    (a) General. Tolerances are established for residues of the plant 
growth regulator, cyclanilide, [1-(2,4-dichlorophenylaminocarbonyl)-
cyclopropane carboxylic acid] determined as 2,4-dichloroaniline 
(calculated as cyclanilide) in or on the following food commodities and 
processed feed:

------------------------------------------------------------------------
                                                              Parts Per
                         Commodity                             Million
------------------------------------------------------------------------
Cattle, fat................................................        0.10
Cattle, meat...............................................        0.02
Cattle, meat byproducts, except kidney.....................        0.2
Cattle, kidney.............................................        2.0
Cotton, undelinted seed....................................        0.60
Cotton, gin byproducts.....................................       25.0
Goat, fat..................................................        0.10
Goat, meat.................................................        0.02
Goat, meat byproducts, except kidney.......................        0.20
Goat, kidney...............................................        2.0
Horse, fat.................................................        0.10
Horse, meat................................................        0.02
Horse, meat byproducts, except kidney......................        0.20
Horse, kidney..............................................        2.0
Hog, fat...................................................        0.10
Hog, meat..................................................        0.02
Hog, meat byproducts, except kidney........................        0.20
Hog, kidney................................................        2.0
Milk.......................................................        0.04
Sheep, fat.................................................        0.10
Sheep, meat................................................        0.20
Sheep, meat byproducts, except kidney......................        0.20
Sheep, kidney..............................................        2.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[62 FR 28355, May 23, 1997; 62 FR 34182, June 25, 1997]



Sec. 180.507  Azoxystrobin; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
fungicide, azoxystrobin, including its metabolites and degradates, in or 
on the commodities in the following table. Compliance with the tolerance 
levels specified in the table is to be determined by measuring only the 
sum of azoxystrobin, [methyl(E)-2-(2-(6-(2-cyanophenoxy) pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate], and the Z-isomer of azoxystrobin 
[methyl(Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3 
methoxyacrylate] in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Acerola....................................................        2.0
Almond, hulls..............................................        4.0
Animal feed, nongrass, group 18, forage....................       45
Animal feed, nongrass, group 18, hay.......................      120
Artichoke, globe...........................................        4.0
Asparagus..................................................        0.04
Atemoya....................................................        2.0
Avocado....................................................        2.0
Banana.....................................................        *
Barley, bran...............................................        6.0
Barley, forage.............................................       25
Barley, grain..............................................        3.0
Barley, hay................................................       10.0
Barley, straw..............................................       15.0
Berry, low growing, subgroup 13-07G, except cranberry......       10.0
Biriba.....................................................        2.0
Brassica, head and stem, subgroup 5A.......................        3.0
Brassica, leafy greens, subgroup 5B........................       25
Bushberry subgroup 13-07B..................................        5.0
Caneberry subgroup 13-07A..................................        5.0
Canistel...................................................        2.0
Cherimoya..................................................        2.0
Cilantro, leaves...........................................       30.0
Citrus, dried pulp.........................................       20.0
Citrus, oil................................................       40.0
Corn, field, forage........................................       12.0
Corn, field, grain.........................................        0.05
Corn, field, refined oil...................................        0.3
Corn, field, stover........................................       25.0
Corn, pop, grain...........................................        0.05
Corn, pop, stover..........................................       25.0
Corn, sweet, forage........................................       12.0
Corn, sweet, kernel plus cob with husks removed............        0.05
Corn, sweet, stover........................................       25.0
Cotton, gin byproducts.....................................       45
Cottonseed subgroup 20C....................................        0.7
Cranberry..................................................        0.50
Custard apple..............................................        2.0
Dragon fruit...............................................        2.0
Feijoa.....................................................        2.0
Fruit, citrus, group 10-10.................................       15.0
Fruit, small vine climbing, except fuzzy kiwifruit,                2.0
 subgroup 13-07F...........................................
Fruit, stone, group 12.....................................        1.5
Ginseng \1\................................................        0.5
Grain, aspirated fractions.................................      420
Grass, forage..............................................       15
Grass, hay.................................................       20
Guava......................................................        2.0
Herb Subgroup 19A, dried leaves............................      260
Herb Subgroup 19A, fresh leaves............................       50
Hop, dried cones...........................................       20.0
Ilama......................................................        2.0
Jaboticaba.................................................        2.0
Jackfruit..................................................        2.0
Longan.....................................................        2.0
Loquat.....................................................        2.0
Lychee.....................................................        2.0
Mango......................................................        2.0
Nut, tree, group 14........................................        0.02
Oats, forage...............................................        5.0
Oats, grain................................................        1.5
Oats, hay..................................................       10.0
Oats, straw................................................        3.0
Onion, bulb, subgroup 3-07A................................        1.0
Onion, green, subgroup 3-07B...............................        7.5
Papaya.....................................................        2.0
Passionfruit...............................................        2.0
Pawpaw.....................................................        2.0
Pea and bean, dried shelled, except soybean, subgroup 6C...        0.5

[[Page 614]]

 
Pea and bean, succulent shelled, subgroup 6B...............        0.5
Peanut.....................................................        0.2
Peanut, hay................................................       15.0
Peanut, refined oil........................................        0.6
Pepper/eggplant subgroup 8-10B.............................        3.0
Peppermint, tops...........................................       30
Persimmon..................................................        2.0
Pistachio..................................................        0.50
Pulasan....................................................        2.0
Rambutan...................................................        2.0
Rapeseed subgroup 20A......................................        1.0
Rice, grain................................................        5.0
Rice, hulls................................................       20
Rice, straw................................................       12
Rice, wild, grain..........................................        5.0
Rye, forage................................................        7.0
Rye, grain.................................................        0.2
Rye, straw.................................................        1.5
Sapodilla..................................................        2.0
Sapote, black..............................................        2.0
Sapote, mamey..............................................        2.0
Sapote, white..............................................        2.0
Sorghum, grain, forage.....................................       25
Sorghum, grain, grain......................................       11
Sorghum, grain, stover.....................................       40
Soursop....................................................        2.0
Soybean, hay...............................................       55.0
Soybean, hulls.............................................        1.0
Soybean, seed..............................................        0.5
Spanish lime...............................................        2.0
Spearmint, tops............................................       30
Spice Subgroup 19B, except black pepper....................       38
Star apple.................................................        2.0
Starfruit..................................................        2.0
Sugar apple................................................        2.0
Sugarcane, cane............................................        0.2
Sunflower subgroup 20B.....................................        0.5
Tamarind...................................................        2.0
Tomato, paste..............................................        0.6
Tomato subgroup 8-10A......................................        0.2
Turnip, greens.............................................       25
Vegetable, cucurbit, group 9...............................        0.3
Vegetable, foliage of legume, group 7......................       30.0
Vegetable, leafy, except brassica, group 4.................       30.0
Vegetable, leaves of root and tuber, group 2...............       50.0
Vegetable, legume, edible podded, subgroup 6A, except              3.0
 soybean...................................................
Vegetable, root, subgroup 1A...............................        0.5
Vegetable, tuberous and corm, subgroup 1C..................        8.0
Wasabi, dry................................................      260
Wasabi, fresh..............................................       50
Watercress.................................................        3.0
Wax jambu..................................................        2.0
Wheat, forage..............................................       15.0
Wheat, grain...............................................        0.2
Wheat, hay.................................................       30.0
Wheat, straw...............................................       10.0
------------------------------------------------------------------------
* 2.0 (of which not more than 0.1 is contained in the pulp)
\1\ There are no United States registrations for use of azoxystrobin on
  ginseng.

    (2) Tolerances are established for residues of the fungicide, 
azoxystrobin, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance levels 
specified in the table is to be determined by measuring only 
azoxystrobin, [methyl(E)-2-(2-(6-(2-cyanophenoxy) pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate] in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................       0.03
Cattle, meat................................................       0.01
Cattle, meat byproducts.....................................       0.07
Goat, fat...................................................       0.03
Goat, meat..................................................       0.01
Goat, meat byproducts.......................................       0.07
Hog, fat....................................................       0.010
Hog, meat...................................................       0.01
Hog, meat byproducts........................................       0.010
Horse, fat..................................................       0.03
Horse, meat.................................................       0.01
Horse, meat byproducts......................................       0.07
Milk........................................................       0.006
Sheep, fat..................................................       0.03
Sheep, meat.................................................       0.01
Sheep, meat byproducts......................................       0.07
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registration. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[62 FR 32235, June 13, 1997]

    Editorial Note: For Federal Register citations affecting Sec. 
180.507, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.509  Mefenpyr-diethyl; tolerance for residues.

    (a) General. Tolerances are established for residues of the safener, 
mefenpyr-diethyl, including its metabolites and degradates, when applied 
at a rate no greater than 0.053 pound safener per acre per growing 
season in or on the commodities in the table below. Compliance with the 
tolerance levels specified below is to be determined by measuring only 
the sum of mefenpyr-diethyl (1-(2,4-dichlorophenyl)-4,5-dihydro-5-
methyl-1H-pyrazole-3,5-dicarboxylic acid, diethyl ester) and its 2,4-
dichlorophenyl-pyrazoline metabolites, calculated as the stoichiometric 
equivalent of mefenpyr-diethyl, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, grain...............................................        0.05
Barley, hay.................................................        0.2
Barley, straw...............................................        0.5
Cattle, meat byproducts.....................................        0.1
Goat, meat byproducts.......................................        0.1
Grass, forage...............................................        1.6

[[Page 615]]

 
Grass, hay..................................................        0.2
Hog, meat byproducts........................................        0.1
Horse, meat byproducts......................................        0.1
Sheep, meat byproducts......................................        0.1
Sorghum, grain, forage......................................        0.4
Sorghum, grain, grain.......................................        0.04
Sorghum, grain, stover......................................        0.2
Wheat, forage...............................................        0.2
Wheat, grain................................................        0.05
Wheat, hay..................................................        0.2
Wheat, straw................................................        0.5
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established for 
the indirect or inadvertent residues of mefenpyr-diethyl, including its 
metabolites and degradates, when applied at a rate no greater than 0.053 
pound safener per acre per growing season in or on the commodities 
identified in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only the sum of 
mefenpyr-diethyl (1-(2,4-dichlorophenyl)-4,5-dihydro-5-methyl-1H-
pyrazole-3,5-dicarboxylic acid, diethyl ester) and its 2,4-
dichlorophenyl-pyrazoline metabolites, calculated as the stoichiometric 
equivalent of mefenpyr-diethyl, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Canola, seed................................................        0.02
Soybean, forage.............................................        0.1
Soybean, hay................................................        0.1
Soybean, seed...............................................        0.02
------------------------------------------------------------------------


[73 FR 74977, Dec. 10, 2008, as amended at 76 FR 23903, Apr. 29, 2011]



Sec. 180.510  Pyriproxyfen; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
pyriproxyfen, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance levels 
specified is determined by measuring only pyriproxyfen, 2-[1-methyl-2-
(4-phenoxyphenoxy) ethoxy]pyridine, in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Acerola....................................................        0.10
Almond, hulls..............................................        2.0
Animal feed, nongrass, group 18, forage....................        0.70
Animal feed, nongrass, group 18, hay.......................        1.1
Animal feed, nongrass, group 18, seed......................        2.0
Apple, wet pomace..........................................        0.8
Artichoke, globe...........................................        2.0
Asparagus..................................................        2.0
Atemoya....................................................        0.20
Avocado....................................................        1.0
Banana.....................................................        0.20
Beet, sugar, dried pulp....................................        3.0
Berry, low growing, except strawberry, subgroup 13-07H.....        1.0
Biriba.....................................................        0.20
Brassica, head and stem, subgroup 5A.......................        0.70
Brassica, leafy greens, subgroup 5B........................        2.0
Bushberry subgroup 13-07B..................................        1.0
Cacao bean, dried..........................................        0.02
Caneberry subgroup 13-07A..................................        1.0
Canistel...................................................        1.0
Canola, seed...............................................        0.20
Cherimoya..................................................        0.20
Citrus, oil................................................       20
Citrus, dried pulp.........................................        2.0
Coffee, instant............................................        0.10
Coffee, green bean.........................................        0.02
Cotton, gin byproducts.....................................        2.0
Cotton, undelinted seed....................................        0.05
Custard apple..............................................        0.20
Date.......................................................        0.30
Feijoa.....................................................        0.10
Fig........................................................        0.30
Fig, dried fruit...........................................        1.0
Fruit, citrus, group 10-10.................................        0.50
Fruit, pome, group 11-10...................................        0.20
Fruit, small, vine climbing, except grape, subgroup 13-07E.        0.35
Fruit, stone, group 12.....................................        1.0
Grain, cereal, group 15....................................        1.1
Grain, cereal, forage, fodder and straw, group 16..........        1.1
Grape......................................................        2.5
Grass, forage, fodder, and hay, group 17, forage...........        0.70
Grass, forage, fodder, and hay, group 17, hay..............        1.1
Guava......................................................        0.10
Herb subgroup 19A..........................................      100
Ilama......................................................        0.20
Jaboticaba.................................................        0.10
Lychee.....................................................        0.30
Mango......................................................        1.0
Nut, tree, group 14........................................        0.02
Olive......................................................        1.0
Olive, oil.................................................        2.0
Papaya.....................................................        1.0
Passionfruit...............................................        0.10
Pawpaw.....................................................        1.0
Peanut.....................................................        0.20
Pineapple..................................................        0.30
Pineapple, process residue.................................        1.1
Pistachio..................................................        0.02
Pomegranate................................................        0.20
Potato, chips..............................................        0.75
Potato, granules/flakes....................................        0.75
Potato, wet peel...........................................        0.75
Pulasan....................................................        0.30
Rambutan...................................................        0.30
Rice, hulls................................................        5.5
Safflower, seed............................................        0.20
Sapodilla..................................................        1.0
Sapote, black..............................................        1.0
Sapote, mamey..............................................        1.0

[[Page 616]]

 
Sapote, white..............................................        0.30
Sesame, seed...............................................        0.02
Soursop....................................................        0.20
Spanish lime...............................................        0.30
Star apple.................................................        1.0
Starfruit..................................................        0.10
Strawberry.................................................        0.30
Sugar apple................................................        0.20
Sugarcane..................................................        1.1
Tea........................................................        0.02
Vegetable, bulb, group 3-07................................        0.70
Vegetable, cucurbit, group 9...............................        0.10
Vegetable, foliage of legume, group 7......................        2.0
Vegetable, fruiting, group 8-10............................        0.80
Vegetable, leafy, except Brassica, group 4.................        3.0
Vegetable, leaves of root and tuber, group 2...............        2.0
Vegetable, legume, group 6.................................        0.20
Vegetable, root and tuber, group 1.........................        0.15
Walnut.....................................................        0.02
Watercress.................................................        2.0
Wax jambu..................................................        0.10
------------------------------------------------------------------------

    (2) A tolerance of 0.10 parts per million is established for all 
food commodities as a result of the proposed use of NYLAR in food 
handling establishments where food and food products are held, prepared, 
processed or served. Application is limited to space, general surface, 
spot, and/or crack and crevice treatment in food handling establishments 
where food and food products are held, processed, prepared and served. 
Space and general surface application may be used only when the facility 
is not in operation provided exposed food is covered or removed from the 
area being treated prior to application. Spot, and/or crack and crevice 
treatment may be used while the facility is in operation provided 
exposed food is covered or removed from the area being treated prior to 
application. Food contact surfaces should be thoroughly washed with an 
effective cleaning compound and rinced with potable water after use of 
the product. To assure safe use of this additive, its label and labeling 
shall conform to that registered with the U.S. Environmental Protection 
Agency, and shall be used in accordance with such label and labeling.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[64 FR 10233, Mar. 3, 1999]

    Editorial Note: For Federal Register citations affecting Sec. 
180.510, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.511  Buprofezin; tolerances for residues.

    (a) General. Tolerances are established for residues of buprofezin, 
including its metabolites and degradates in or on the commodities in the 
table below. Compliance with the tolerance levels specified below is to 
be determined by measuring only the buprofezin, 2-[(1,1-
dimethylethyl)imino]tetrahydro-3(1-methylethyl)-5-phenyl-4H-1,3,5-
thiadiazin-4-one, in the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Acerola....................................................        0.30
Almond, hulls..............................................        2.0
Apricot....................................................        9.0
Atemoya....................................................        0.30
Avocado....................................................        0.30
Banana.....................................................        0.20
Bean, snap, succulent......................................        0.02
Bean, succulent............................................        0.02
Berry, low growing, subgroup 13-07G........................        2.5
Birida.....................................................        0.30
Brassica, head and stem, subgroup 5A.......................       12.0
Brassica, leafy greens, subgroup 5B........................       60
Canistel...................................................        0.90
Cattle, fat................................................        0.05
Cattle, kidney.............................................        0.05
Cattle, liver..............................................        0.05
Cattle, meat...............................................        0.05
Cattle, meat byproducts....................................        0.05
Cherimoya..................................................        0.30
Citrus, dried pulp.........................................        7.5
Citrus, oil................................................       80
Coffee, green bean.........................................        0.35
Cotton, gin byproducts.....................................       20.0
Cotton, undelinted seed....................................        0.35
Custard apple..............................................        0.30
Feijoa.....................................................        0.30
Fruit, citrus, group 10....................................        2.5
Fruit, pome, group 11-10, except pear and pear, Asian......        3.0
Fruit, stone, group 12, except apricot and peach...........        1.9
Goat, fat..................................................        0.05
Goat, kidney...............................................        0.05
Goat, liver................................................        0.05
Goat, meat.................................................        0.05
Goat, meat byproducts......................................        0.05
Grape......................................................        2.5
Guava......................................................        0.3
Hog, fat...................................................        0.05
Hog, kidney................................................        0.05
Hog, liver.................................................        0.05
Hog, meat..................................................        0.05
Hog, meat byproducts.......................................        0.05
Horse, fat.................................................        0.05
Horse, kidney..............................................        0.05
Horse, liver...............................................        0.05
Horse, meat................................................        0.05
Horse, meat byproducts.....................................        0.05
Ilama......................................................        0.30

[[Page 617]]

 
Jaboticaba.................................................        0.30
Lettuce, head..............................................        6.0
Longan.....................................................        0.30
Lychee.....................................................        0.30
Mango......................................................        0.90
Milk.......................................................        0.01
Nut, tree group 14.........................................        0.05
Olive......................................................        3.5
Olive, oil.................................................        4.8
Papaya.....................................................        0.90
Passionfruit...............................................        0.30
Peach......................................................        9.0
Pear.......................................................        6.0
Pear, Asian................................................        6.0
Persimmon..................................................        1.9
Pistachio..................................................        0.05
Pomegranate................................................        1.9
Pulasan....................................................        0.30
Radicchio..................................................        6.0
Rambutan...................................................        0.30
Sapodilla..................................................        0.90
Sapote, black..............................................        0.90
Sapote, mamey..............................................        0.90
Sheep, fat.................................................        0.05
Sheep, kidney..............................................        0.05
Sheep, liver...............................................        0.05
Sheep, meat................................................        0.05
Sheep, meat byproducts.....................................        0.05
Soursop....................................................        0.30
Spanish lime...............................................        0.30
Star apple.................................................        0.90
Starfruit..................................................        0.30
Sugar apple................................................        0.30
Tea\1\.....................................................       20
Turnip, greens.............................................       60
Vegetable, cucurbit, group 9...............................        0.50
Vegetable, fruiting, group 8-10............................        2.0
Vegetable, leafy, except Brassica, group 4, except head           35
 lettuce and radicchio.....................................
Wax jambu..................................................        0.30
------------------------------------------------------------------------
\1\ There are no U.S. registrations at this time.

    (b) Section 18 emergency exemption. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[62 FR 40741, July 30, 1997, as amended at 63 FR 33585, June 19, 1998; 
63 FR 41727, Aug. 5, 1998; 64 FR 45887, Aug. 23, 1999; 64 FR 59655, Nov. 
3, 1999; 65 FR 52947, Aug. 31, 2000; 66 FR 46389, Sept. 5, 2001; 68 FR 
37771, June 25, 2003; 70 FR 17907, Apr. 8, 2005; 71 FR 55313, Sept. 22, 
2006; 72 FR 35187, June 27, 2007; 73 FR 19161, Apr. 9, 2008; 74 FR 
33158, July 10, 2009; 74 FR 48412, Sept. 23, 2009; 77 FR 63751, Oct. 17, 
2012; 77 FR 72985, Dec. 7, 2012]



Sec. 180.512  [Reserved]



Sec. 180.513  Chlorfenapyr; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide chlorfenapyr [4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-
(trifluoromethyl)-1H-pyrrole-3-carbonitrile] in or on the following raw 
agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Vegetable, fruiting, group 8...............................        1.0
------------------------------------------------------------------------

    (2) A tolerance of 0.01 parts per million is established for 
residues of chlorfenapyr in or on all food commodities (other than those 
covered by a higher tolerance as a result of use on growing crops) in 
food/feed handling areas where food/feed products are prepared, held, 
processed, or served and in accordance with the following prescribed 
conditions:
    (i) Application shall be no greater than a 0.5% active ingredient 
solution for spot crack and crevice use in food/feed handling 
establishments, where food and food products are held, processed, 
prepared and/or served.
    (ii) Application may only be undertaken when the facility is not in 
operation, and provided exposed food has been covered, or removed from 
the area being treated prior to application.
    (iii) Food contact surfaces and equipment should be throughly washed 
with an effective cleaning compound, and rinsed with potable water after 
each use of the product.
    (iv) Contamination of food or food contact surfaces shall be 
avoided. Application excludes any direct application to any food, food 
packaging, or any food contact surfaces.
    (v) To assure safe use, the label and labeling shall conform to that 
registered by the U.S. Environmental Protection Agency, and it shall be 
used in accordance with such label and labeling.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[68 FR 55527, Sept. 26, 2003, as amended at 70 FR 3654, Jan. 26, 2005]



Sec. 180.514  Cloransulam-methyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide, cloransulam-methyl, N-(2-

[[Page 618]]

carboxymethyl-6-chlorophenyl)-5-ethoxy-7-fluoro-(1,2,4)-triazolo[1,5c]-
pyrimidine-2-sulfonamide, plus its acid, cloransulam, calculated as 
parent ester in or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Soybean, forage............................................        0.1
Soybean, hay...............................................        0.2
Soybean, seed..............................................        0.02
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[62 FR 49163, Sept. 19, 1997]



Sec. 180.515  Carfentrazone-ethyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide carfentrazone-ethyl, including its metabolites and degradates, 
in or on the commodities listed in the following table. Compliance with 
the following tolerance levels is to be determined by measuring only the 
sum of carfentrazone-ethyl (ethyl-alpha-2-dichloro-5-[-4-
(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H -1,2,4-triazol-1-yl]-4-
fluorobenzenepropanoate) and its metabolite carfentrazone-
chloropropionic acid (alpha, 2-dichloro-5-[-4-difluoromethyl)-4,5-
dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4-fluorobenzenepropanoic 
acid), calculated as the stoichiometric equivalent of carfentrazone-
ethyl, in or on the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Acerola....................................................        0.10
Almond, hulls..............................................        0.20
Animal feed, nongrass, crop group 18, forage...............        2.0
Animal feed, nongrass, crop group 18, hay..................        5.0
Animal feed, nongrass, crop group 18, seed.................       15.0
Atemoya....................................................        0.10
Avocado....................................................        0.10
Banana.....................................................        0.20
Barley, bran...............................................        0.80
Barley, flour..............................................        0.80
Berry group 13.............................................        0.10
Birida.....................................................        0.10
Borage.....................................................        0.10
Cacao bean, bean...........................................        0.10
Cactus.....................................................        0.10
Caneberry subgroup 13A.....................................        0.1
Canistel...................................................        0.10
Canola.....................................................        0.10
Cattle, fat................................................        0.10
Cattle, meat...............................................        0.10
Cattle, meat byproducts....................................        0.10
Cherimoya..................................................        0.10
Coconut....................................................        0.10
Coffee, bean, green........................................        0.10
Corn, field, forage........................................        0.20
Corn, sweet, forage........................................        0.20
Corn, sweet, kernel plus cob with husk removed.............        0.10
Cotton, gin byproducts.....................................       10
Cotton, undelinted seed....................................        0.20
Cotton, hulls..............................................        0.60
Cotton, meal...............................................        0.35
Cotton, refined oil........................................        1.0
Crambe, seed...............................................        0.10
Custard apple..............................................        0.10
Date, dried fruit..........................................        0.10
Feijoa.....................................................        0.10
Fig........................................................        0.10
Fish.......................................................        0.30
Flax, seed.................................................        0.10
Fruit, citrus, group 10....................................        0.10
Fruit, pome, group 11......................................        0.10
Fruit, stone, group 12.....................................        0.10
Goat, fat..................................................        0.10
Goat, meat.................................................        0.10
Goat, meat byproducts......................................        0.10
Grain, aspirated grain fractions...........................        1.8
Grain, cereal, forage, fodder and straw group 16, except           1.0
 corn and sorghum; forage..................................
Grain, cereal, forage, fodder and straw, group 16, hay.....        0.30
Grain, cereal, forage, fodder and straw, group 16, stover..        0.30
Grain, cereal, forage, fodder and straw, group 16, except          0.10
 rice; straw...............................................
Grain, cereal, group 15....................................        0.10
Grain, cereal, group 15 (except rice grain and sorghum             0.10
 grain)....................................................
Grain, cereal, stover......................................        0.80
Grain, cereal, straw.......................................        3.0
Grape......................................................        0.10
Grass, forage..............................................        5.0
Grass, hay.................................................        8.0
Guava......................................................        0.10
Herbs and spices group 19..................................        2.0
Hog, fat...................................................        0.10
Hog, meat..................................................        0.10
Hog, meat byproducts.......................................        0.10
Hop, dried cones...........................................        0.10
Horse, fat.................................................        0.10
Horse, meat................................................        0.10
Horse, meat byproducts.....................................        0.10
Horseradish................................................        0.10
Ilama......................................................        0.10
Jaboticaba.................................................        0.10
Juneberry..................................................        0.10
Kava, roots................................................        0.10
Kiwifruit..................................................        0.10
Lingonberry................................................        0.10
Longan.....................................................        0.10
Lychee.....................................................        0.10
Mango......................................................        0.10
Milk.......................................................        0.05
Millet, flour..............................................        0.80
Mustard, seed..............................................        0.10
Noni.......................................................        0.10
Nut, tree, group 14........................................        0.10
Oat, flour.................................................        0.80
Okra.......................................................        0.10

[[Page 619]]

 
Olive......................................................        0.10
Palm heart.................................................        0.10
Palm heart, leaves.........................................        0.10
Papaya.....................................................        0.10
Passionfruit...............................................        0.10
Pawpaw.....................................................        0.10
Peanut.....................................................        0.10
Peanut, hay................................................        0.10
Persimmon..................................................        0.10
Pistachio..................................................        0.10
Pomegranate................................................        0.10
Poultry, meat byproducts...................................        0.10
Pulasan....................................................        0.10
Pummelo....................................................        0.10
Rambutan...................................................        0.10
Rapeseed, forage...........................................        0.10
Rapeseed, seed.............................................        0.10
Rice, grain................................................        1.3
Rice, hulls................................................        3.5
Rice, straw................................................        1.0
Rye, bran..................................................        0.80
Rye, flour.................................................        0.80
Safflower, seed............................................        0.10
Salal......................................................        0.10
Sapodilla..................................................        0.10
Sapote, black..............................................        0.10
Sapote, mamey..............................................        0.10
Sheep, fat.................................................        0.10
Sheep, meat................................................        0.10
Sheep, meat byproducts.....................................        0.10
Shellfish..................................................        0.30
Sorghum, forage............................................        0.20
Sorghum, grain.............................................        0.25
Sorghum, sweet.............................................        0.10
Soursop....................................................        0.10
Soybean, seed..............................................        0.10
Spanish lime...............................................        0.10
Star apple.................................................        0.10
Starfruit..................................................        0.10
Stevia.....................................................        0.10
Strawberry.................................................        0.10
Strawberrypear.............................................        0.10
Sugar apple................................................        0.10
Sugarcane..................................................        0.15
Sunflower, seed............................................        0.10
Tea, dried.................................................        0.10
Ti, leaves.................................................        0.10
Ti, roots..................................................        0.10
Vanilla....................................................        0.10
Vegetable, brassica, leafy, group 5........................        0.10
Vegetable, bulb, group 3...................................        0.10
Vegetable, cucurbit, group 9...............................        0.10
Vegetable, foliage of legume, except soybean, subgroup 7A..        0.10
Vegetable, fruiting, group 8...............................        0.10
Vegetable, leafy, except brassica, group 4.................        0.10
Vegetable, leaves of root and tuber, group 2...............        0.10
Vegetable, legume, group 6.................................        0.10
Vegetable, root and tuber, group 1.........................        0.10
Wasaba, roots..............................................        0.10
Wax jambu..................................................        0.10
Wheat, bran................................................        0.80
Wheat, flour...............................................        0.80
Wheat, germ................................................        0.80
Wheat, middlings...........................................        0.80
Wheat, shorts..............................................        0.80
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 52180, Sept. 30, 1998, as amended at 63 FR 65078, Nov. 25, 1998; 
64 FR 45890, Aug. 23, 1999; 65 FR 48626, Aug. 9, 2000; 66 FR 39647, 
39682, Aug. 1, 2001; 67 FR 35050, May 17, 2002; 67 FR 40211, June 12, 
2002; 68 FR 37765, June 25, 2003; 69 FR 29459, May 24, 2004; 69 FR 
58078, Sept. 29, 2004; 73 FR 9221, Feb. 20, 2008; 74 FR 46376, Sept. 9, 
2009; 76 FR 34886, June 15, 2011; 77 FR 26461, May 4, 2012]



Sec. 180.516  Fludioxonil; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
fungicide fludioxonil, including its metabolites and degradates, in or 
on the commodities in the following table. Compliance with the tolerance 
levels specified in the following table is to be determined by measuring 
only fludioxonil, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1-H-pyrrole-3-
carbonitrile).

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Acerola.....................................................        5.0
Animal feed, nongrass, group 18.............................        0.01
Atemoya.....................................................       20
Avocado.....................................................        5.0
Bean, dry...................................................        0.4
Bean, succulent.............................................        0.4
Beet, sugar, roots..........................................        0.02
Berry, low growing, subgroup 13-07G, except cranberry.......        3.0
Biriba......................................................       20
Brassica, head and stem, subgroup 5A........................        2.0
Brassica, leafy greens, subgroup 5B.........................       10
Bushberry subgroup 13-07B...................................        2.0
Caneberry subgroup 13-07A...................................        5.0
Canistel....................................................        5.0
Cherimoya...................................................       20
Citrus, oil.................................................      500
Cotton, gin byproducts......................................        0.05
Cotton, undelinted seed.....................................        0.05
Custard apple...............................................       20
Dragon fruit................................................        1.0
Feijoa......................................................        5.0
Flax, seed..................................................        0.05
Fruit, citrus, group 10-10..................................       10
Fruit, pome, group 11-10....................................        5.0
Fruit, small vine climbing, except fuzzy kiwifruit, subgroup        2.0
 13-07F.....................................................
Fruit, stone, group 12......................................        5.0
Ginseng.....................................................        4.0
Grain, cereal, group 15.....................................        0.02
Grain, cereal, forage, fodder, and straw, group 16..........        0.01
Grass, forage, fodder and hay, group 17.....................        0.01
Guava.......................................................        5.0
Herb subgroup 19A, dried leaves.............................       65
Herb subgroup 19A, fresh leaves.............................       10
Ilama.......................................................       20
Jaboticaba..................................................        5.0
Kiwifruit, fuzzy............................................       20
Leaf petioles subgroup 4B...................................       15
Leafy greens subgroup 4A....................................       30
Longan......................................................       20

[[Page 620]]

 
Lychee......................................................       20
Mango.......................................................        5.0
Melon subgroup 9A...........................................        0.03
Onion, bulb, subgroup 3-07A.................................        0.50
Onion, green, subgroup 3-07B................................        7.0
Papaya......................................................        5.0
Passionfruit................................................        5.0
Peanut......................................................        0.01
Peanut, hay.................................................        0.01
Pineapple...................................................       20
Pistachio...................................................        0.10
Pomegranate.................................................        5.0
Pulasan.....................................................       20
Rambutan....................................................       20
Rapeseed, forage............................................        0.01
Rapeseed, seed..............................................        0.01
Safflower, seed.............................................        0.01
Sapodilla...................................................        5.0
Sapote, black...............................................        5.0
Sapote, mamey...............................................        5.0
Soursop.....................................................       20
Spanish lime................................................       20
Spice subgroup 19B..........................................        0.02
Star apple..................................................        5.0
Starfruit...................................................        5.0
Sugar apple.................................................       20
Sunflower, seed.............................................        0.01
Tomato......................................................        5.0
Turnip, greens..............................................       10
Vegetable, cucurbit, group 9................................        0.45
Vegetable, foliage of legume, group 7.......................        0.01
Vegetable, fruiting, group 8-10, except tomato..............        0.50
Vegetable, leaves of root and tuber, group 2................       30
Vegetable, legume, group 6..................................        0.01
Vegetable, root, except sugar beet, subgroup 1B.............        0.75
Vegetable, tuberous and corm, subgroup 1C...................        6.0
Watercress..................................................        7.0
Wax jambu...................................................        5.0
Yam, true, tuber............................................        8.0
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the fungicide 
fludioxonil, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance levels 
specified in the following table is to be determined by measuring only 
the sum of fludioxonil, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1-H-
pyrrole-3-carbonitrile), and its metabolites converted to 2,2-difluoro-
l,3-benzodioxole-4-carboxylic acid, calculated as the stoichiometric 
equivalent of fludioxonil.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.05
Cattle, meat................................................        0.01
Cattle, meat byproducts.....................................        0.05
Goat, fat...................................................        0.05
Goat, meat..................................................        0.01
Goat, meat byproducts.......................................        0.05
Horse, fat..................................................        0.05
Horse, meat.................................................        0.01
Horse, meat byproducts......................................        0.05
Milk........................................................        0.01
Sheep, fat..................................................        0.05
Sheep, meat.................................................        0.01
Sheep, meat byproducts......................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[62 FR 56082, Oct. 29, 1997]

    Editorial Note: For Federal Register citations affecting Sec. 
180.516, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.517  Fipronil; tolerances for residues.

    (a) General. Therefore, tolerances are established for combined 
residues of the insecticide fipronil (5-amino-1-[2,6-dichloro-4-
(trifluoromethyl)phenyl]-4-[(1R,S)-(trifluoromethyl)sulfinyl]-1H-
pyrazole-3-carbonitrile) and its metabolites 5-amino-1-[2,6-dichloro-4-
(trifluoromethyl)phenyl]-4-[(trifluoromethyl) sulfonyl]-1H-pyrazole-3-
carbonitrile and 5-amino-1-[2,6-dichloro-4-(trifluoromethyl) phenyl]-4-
[(trifluoromethyl)thio]-1H-pyrazole-3-carbonitrile and its 
photodegradate 5-amino-1-(2,6-dichloro-4-(trifluoromethyl)phenyl]-4-
[(1R,S)-(trifluoromethyl)]-1H-pyrazole-3-carbonitrile in or on the 
following items at the levels specified:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................        0.40
Cattle, liver..............................................        0.10
Cattle, meat...............................................        0.04
Cattle, meat byproducts, except liver......................        0.04
Corn, field, grain.........................................        0.02
Corn, field, stover........................................        0.30
Corn, field, forage........................................        0.15
Egg........................................................        0.03
Goat, fat..................................................        0.40
Goat, liver................................................        0.10
Goat, meat.................................................        0.04
Goat, meat byproducts, except liver........................        0.04
Hog, fat...................................................        0.04
Hog, liver.................................................        0.02
Hog, meat..................................................        0.01
Hog, meat byproducts, except liver.........................        0.01
Horse, fat.................................................        0.40
Horse, liver...............................................        0.10
Horse, meat................................................        0.04
Horse, meat byproducts, except liver.......................        0.04
Milk, fat (reflecting 0.05 ppm in whole milk)..............        1.50
Potato.....................................................        0.03

[[Page 621]]

 
Potato, wet peel...........................................        0.10
Poultry, fat...............................................        0.05
Poultry, meat..............................................        0.02
Poultry, meat byproducts...................................        0.02
Rice, grain................................................        0.04
Rice, straw................................................        0.10
Sheep, fat.................................................        0.40
Sheep, liver...............................................        0.10
Sheep, meat................................................        0.04
Sheep, meat byproducts, except liver.......................        0.04
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions.. Time-limited tolerances are 
established for combined residues of the insecticide, fipronil, 5-amino-
1-(2,6-dichloro-4-(trifluoromethyl) phenyl)-4-((1,R,S)-
trifluoromethyl)sulfinyl)-1-H-pyrazole-3-carbonitrile and its 2 
metabolites MB45950 (5-amino-1-(2,6-dichloro-4-(trifluoromethyl)phenyl)-
4-[(trifluoromethyl)thio]-1H-pyrazole-3-carbonitrile) and MB46136 (5-
amino-1-(2,6-dichloro-4-(trifluoromethyl)phenyl)-4-
[(trifluoromethyl)sulfonyl]-1H-pyrazole-3-carbonitrile) and its 
photodegradate MB46513 (5-amino-1-(2,6-dichloro-4-
(trifluoromethyl)phenyl]-4-[(1R,S)-(trifluoromethyl)]-1H-pyrazole-3-
carbonitrile), in connection with use of the pesticide under Section 18 
emergency exemptions granted by EPA. The tolerances expire and are 
revoked on the dates specified in the table for this paragraph.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Rutabaga........................................        1.0     12/31/13
Turnip..........................................        1.0     12/31/13
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established for 
combined indirect or inadvertent residues of the insecticide fipronil 
and its metabolites and photodegradate in or on food commodities when 
present therein as a result of the application of fipronil to growing 
crops listed in paragraphs (a) and (b) of this section and other nonfood 
crops to read as follows:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Wheat, forage..............................................        0.02
Wheat, grain...............................................        0.005
Wheat, hay.................................................        0.03
Wheat, straw...............................................        0.03
------------------------------------------------------------------------


[62 FR 62979, Nov. 26, 1997, as amended at 63 FR 38495, July 17, 1998; 
72 FR 46913, Aug. 22, 2007; 74 FR 46377, Sept. 9, 2009; 75 FR 80346, 
Dec. 22, 2010]



Sec. 180.518  Pyrimethanil; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
fungicide pyrimethanil, including its metabolites and degradates, in or 
on the commodities in the following table Compliance with the tolerance 
levels specified in the following table is to be determined by measuring 
only pyrimethanil (4,6-dimethyl-N-phenyl-2-pyrimidinamine).

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond.....................................................        0.20
Almond, hulls..............................................       12
Apple, wet pomace..........................................       40
Banana.....................................................        0.10
Berry, low growing, subgroup 13-07G........................        3.0
Citrus, oil................................................      150
Fruit, citrus, group 10, except lemon, postharvest.........       10
Fruit, pome, group 11 (pre-harvest and post-harvest).......       14
Fruit, small, vine climbing, subgroup 13-07F, except fuzzy         5.0
 kiwifruit.................................................
Fruit, stone, group 12.....................................       10
Ginseng....................................................        1.5
Grape, raisin..............................................        8.0
Lemon, preharvest and postharvest..........................       11
Onion, bulb, subgroup 3-07A................................        2.0
Onion, green, subgroup 3-07B...............................        3.0
Pistachio..................................................        0.20
Tomato.....................................................        0.50
Vegetable, tuberous and corm, subgroup 1C..................        0.05
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the fungicide 
pyrimethanil, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance levels 
specified in the following table is to be determined by measuring only 
the sum of pyrimethanil and its metabolite 4-[4,6-dimethyl-2-
pyrimidinyl)amino]phenol, calculated as the stoichiometric equivalent of 
pyrimethanil.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................        0.01
Cattle, kidney.............................................        2.5
Cattle, meat...............................................        0.01
Cattle, meat byproducts, except kidney.....................        0.01
Goat, fat..................................................        0.01

[[Page 622]]

 
Goat, kidney...............................................        2.5
Goat, meat.................................................        0.01
Goat, meat byproducts, except kidney.......................        0.01
Horse, fat.................................................        0.01
Horse, kidney..............................................        2.5
Horse, meat................................................        0.01
Horse, meat byproducts, except kidney......................        0.01
Sheep, fat.................................................        0.01
Sheep, kidney..............................................        2.5
Sheep, meat................................................        0.01
Sheep, meat byproducts, except kidney......................        0.01
------------------------------------------------------------------------

    (3) Tolerances are established for residues of the fungicide 
pyrimethanil, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance levels 
specified in the following table is to be determined by measuring only 
the sum of pyrimethanil and its metabolite 4,6-dimethyl-2-(phenylamino)-
5-pyrimidinol, calculated as the stoichiometric equivalent of 
pyrimethanil.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Milk.......................................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[62 FR 63669, Dec. 2, 1997, as amended at 69 FR 52443, Aug. 26, 2004; 73 
FR 64251, Oct. 29, 2008; 74 FR 32448, July 8, 2009; 77 FR 45503, Aug. 1, 
2012]



Sec. 180.519  Bromide ion and residual bromine; tolerances for residues.

    (a) General. The food additives, bromide ion and residual bromine, 
may be present in water, potable in accordance with the following 
conditions:
    (1) The food additives are present as a result of treating water 
aboard ships with a polybrominated ion-exchange resin (as a source of 
bromine) under the supervision of trained personnel.
    (2) Residual bromine levels are controlled to not exceed 1.0 part 
per million (ppm) in the final treated water. Control is effected using 
calibrated recirculating or proportioning bromine feeder equipment and 
periodic checks of residual bromine using a bromine test kit. To assure 
safe use of the additives, the label and labeling of the disinfectant 
formulation containing the food additives shall conform to the label and 
labeling registered by the U.S. Environmental Protection Agency.
    (3) No tolerance is established for bromide ion levels.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[41 FR 17893, Apr. 29, 1976. Redesignated at 41 FR 26568, June 28, 1976, 
and at 53 FR 24667, June 29, 1988. Redesignated and amended at 63 FR 
34319, June 24, 1998; 71 FR 74818, Dec. 13, 2006]



Sec. 180.521  Fumigants for grain-mill machinery; tolerances for residues.

    (a) General. Fumigants may be safely used in or on grain-mill 
machinery in accordance with the following prescribed conditions:
    (1) The fumigants consist of methyl bromide.
    (2) To assure safe use of the fumigant, its label and labeling shall 
conform to the label and labeling registered by the U.S. Environmental 
Protection Agency.
    (3) Residues of inorganic bromides (calculated as Br) in milled 
fractions derived from cereal grain from all fumigation sources, 
including fumigation of grain-mill machinery, shall not exceed 125 parts 
per million.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[40 FR 14156, Mar. 28, 1975. Redesignated at 41 FR 26568, June 28, 1976, 
as amended at 49 FR 44459, Nov. 7, 1984. Further redesignated at 53 FR 
24667, June 29, 1988, as amended at 54 FR 6130, Feb. 8, 1989. Further 
redesignated and amended at 63 FR 34319, June 24, 1998]



Sec. 180.522  Fumigants for processed grains used in production of fermented 

malt beverage; tolerances for residues.

    (a) General. Fumigants for processed grain may be safely used, in 
accordance with the following conditions.
    (1) Methyl bromide. Total residues of inorganic bromides (calculated 
as Br)

[[Page 623]]

from the use of this fumigant shall not exceed 125 parts per milion.
    (2) Methyl bromide is used to fumigate corn grits and cracked rice 
in the production of fermented malt beverage.
    (3) To assure safe use of the fumigant, its label and labeling shall 
conform to the label and labeling registered by the U.S. Environmental 
Protection Agency, and the usage employed should conform with such label 
or labeling.
    (4) The total residue of inorganic bromides in fermented malt 
beverage, resulting from the use of corn grits and cracked rice 
fumigated with the fumigant described in paragraph (a)(2) of this 
section plus additional residues of inorganic bromides that may be 
present from uses in accordance with other regulations in this chapter 
promulgated under section 408 and/or 409 of the Act, does not exceed 25 
parts per million bromide (calculated as Br).
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[71 FR 74818, Dec. 13, 2006]



Sec. 180.523  Metaldehyde; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
molluscicide metaldehyde in or on food commodities, as follows:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Artichoke, globe............................................        0.07
Berry group 13..............................................        0.15
Cactus......................................................        0.07
Fruit, citrus, group 10.....................................        0.26
Lettuce.....................................................        1.73
Strawberry..................................................        6.25
Tomato......................................................        0.24
Vegetable, brassica, leafy, group 5.........................        2.5
Watercress..................................................        3.2
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[73 FR 54963, Sept. 24, 2008]



Sec. 180.525  Resmethrin; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide resmethrin [5-(phenylmethyl)-3-furanyl] methyl 2,2-dimethyl-
3-(2-methyl-1-propenyl) cyclopropanecarboxylate in or on food 
commodities at 3.0 ppm resulting from use of the insecticide in food 
handling and storage areas as a space concentration for spot/or crack 
and crevice treatment and shall be limited to a maximum of 3.00 percent 
of the active ingredient by weight, and as a space treatment shall be 
limited to a maximum of 0.5 fluid ounce of 3.0 percent active ingredient 
by weight per 1000 cubic feet of space provided that the food is removed 
or covered prior to such use. To assure safe use of the additive, its 
label and labeling shall conform to that registered with the U.S. 
Environmental Protection Agency, and shall be used in accordance with 
such label and labeling.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[71 FR 74819, Dec. 13, 2006]



Sec. 180.526  Synthetic isoparaffinic petroleum hydrocarbons; tolerances for 

residues.

    (a) General. Synthetic isoparaffinic petroleum hydrocarbons 
complying with 21 CFR 172.882 (a) and (b) may be safely used as a 
component of insecticide formulations for use on animal feed in an 
amount no greater than reasonably required to accomplish its intended 
effect as an adjuvant in the insecticide formulation and shall not be 
intended to accomplish any effect in animal feed. It is used or intended 
for use as a component of insecticide formulations used in compliance 
with regulations issued in 40 CFR part 180 and in this part.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]

[[Page 624]]

    (d) Indirect or inadvertent residues. [Reserved]

[40 FR 14161, Mar. 28, 1975, as amended at 50 FR 2959, Jan. 23, 1985, 
and amended at 53 FR 24668, 24669, June 29, 1988. Redesignated and 
amended at 63 FR 34319, June 24, 1998]



Sec. 180.527  Flufenacet, N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-

(trifluoromethyl)-1, 3, 4-thiadiazol-2-yl] oxy]acetamide and its metabolites 

containing the 4-fluoro-N-methylethyl benzenamine tolerances for 

residues.

    (a) General. Tolerances are established for the combined residues of 
the herbicide flufenacet, N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-
(trifluoromethyl)-1, 3, 4-thiadiazol-2-yl] oxy]acetamide and its 
metabolites containing the 4-fluoro-N-methylethyl benzenamine moiety in 
or on the following commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, kidney.............................................        0.05
Corn, field, forage........................................        0.4
Corn, field, grain.........................................        0.05
Corn, field, stover........................................        0.4
Corn, sweet, forage........................................        0.45
Corn, sweet, kernel plus cob with husks removed............        0.05
Corn, sweet, stover........................................        0.30
Goat, kidney...............................................        0.05
Hog, kidney................................................        0.05
Horse, kidney..............................................        0.05
Sheep, kidney..............................................        0.05
Soybean, seed..............................................        0.1
Wheat, bran................................................        0.80
Wheat, forage..............................................        6.0
Wheat, grain...............................................        0.60
Wheat, hay.................................................        1.2
Wheat, straw...............................................        0.35
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances are 
established for combined residues of flufenacet, N-(4-fluorophenyl)-N-
(1-methylethyl)-2-[[5-(trifluoromethyl)-1, 3, 4-thiadiazol-2-yl] 
oxy]acetamide, and its metabolites containing the 4-fluoro-N-methylethyl 
benzenamine moiety, with regional registration.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Grass, forage..............................................        7.0
Grass, hay.................................................        0.4
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. Tolerances are established for 
indirect or inadvertent residues of the herbicide flufenacet, N-(4-
fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-
thiadiazol-2-yl]oxy]acetamide and its metabolites containing the 4-
fluoro-N-methylethyl benzenamine moiety in or on the following raw 
agricultural commodities when present therein as a result of application 
of flufenacet to the growing crops in paragraph (a) of this section.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage............................................        0.1
Alfalfa, hay...............................................        0.1
Alfalfa, seed..............................................        0.1
Clover, forage.............................................        0.1
Clover, hay................................................        0.1
Grain, cereal, group 15, except rice.......................        0.1
Grain, cereal, forage, fodder, and straw, group 16, except         0.1
 rice......................................................
Grass, forage, fodder, and hay, group 17...................        0.1
------------------------------------------------------------------------


[63 FR 26473, May 13, 1998, as amended at 63 FR 50791, Sept. 23, 1998; 
64 FR 42846, Aug. 6, 1999; 65 FR 64366, Oct. 27, 2000; 68 FR 2247, Jan. 
16, 2003; 68 FR 37759, June 25, 2003; 70 FR 37696, June 30, 2005; 71 FR 
76200, Dec. 20, 2006; 72 FR 26310, May 9, 2007]



Sec. 180.530  2,2-Dimethyl-1,3-benzodioxol-4-ol methylcarbamate; tolerances 

for residues.

    (a) General. (1) The insecticide 2,2-dimethyl-1,3-benzodioxol-4-yl 
methylcarbamate may be safely used in spot and/or crack and crevice 
treatments in animal feed handling establishments, including feed 
manufacturing and processing establishments, such as stores, 
supermarkets, dairies, meat slaughtering and packing plants, and 
canneries until the tolerance expiration/revocation date of April 26, 
2005.
    (2) The insecticide 2,2-dimethyl-1,3-benzodioxol-4-yl 
methylcarbamate may be safely used in spot and/or crack and crevice 
treatments in food handling establishments, including food service, 
manufacturing and processing establishments, such as restaurants, 
cafeterias, supermarkets, bakeries, breweries, dairies, meat 
slaughtering and packing plants, and canneries until the tolerance 
expiration/revocation date of April 26, 2005.
    (3) To ensure safe use of the additive, its label and labeling shall 
conform to that registered with the U.S. Environmental Protection Agency 
and it shall be used in accordance with such label and labeling.

[[Page 625]]

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 34828, June 26, 1998, as amended at 69 FR 58083, Sept. 29, 2004]



Sec. 180.532  Cyprodinil; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
fungicide cyprodinil, including its metabolites and degradates, in or on 
the commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only cyprodinil 4-
cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond......................................................        0.02
Almond, hulls...............................................        8.0
Apple, wet pomace...........................................        4.6
Avocado.....................................................        1.2
Bean, dry...................................................        0.6
Bean, succulent.............................................        0.6
Berry, low growing, subgroup 13-07G, except cranberry.......        5.0
Brassica, head and stem, subgroup 5A........................        1.0
Brassica, leafy greens, subgroup 5B.........................       10.0
Bushberry subgroup 13-07B...................................        3.0
Caneberry subgroup 13-07A...................................       10
Canistel....................................................        1.2
Canola, seed \1\............................................        0.03
Citrus, dried pulp..........................................        8.0
Citrus, oil.................................................       60
Dragon fruit................................................        2.0
Fruit, pome, group 11-10....................................        1.7
Fruit, small vine climbing, except fuzzy kiwifruit, subgroup        3.0
 13-07F.....................................................
Fruit, stone, group 12......................................        2.0
Grape, raisin...............................................        5.0
Herb subgroup 19A, dried, except parsley....................       15.0
Herb subgroup 19A, fresh, except parsley....................        3.0
Kiwifruit...................................................        1.8
Leaf petioles subgroup 4B...................................       30
Leafy greens subgroup 4A....................................       50
Lemon.......................................................        0.60
Lime........................................................        0.60
Longan......................................................        2.0
Lychee......................................................        2.0
Mango.......................................................        1.2
Onion, bulb, subgroup 3-07A.................................        0.6
Onion, green, subgroup 3-07B................................        4.0
Papaya......................................................        1.2
Parsley, dried leaves.......................................      170
Parsley, leaves.............................................       35
Pistachio...................................................        0.10
Pulasan.....................................................        2.0
Rambutan....................................................        2.0
Sapodilla...................................................        1.2
Sapote, black...............................................        1.2
Sapote, mamey...............................................        1.2
Spanish lime................................................        2.0
Star apple..................................................        1.2
Turnip, greens..............................................       10.0
Vegetable, cucurbit, group 9................................        0.70
Vegetable, fruiting, group 8-10.............................        1.5
Vegetable, leaves of root and tuber, group 2................       10
Vegetable, root, except sugarbeet, subgroup 1B..............        0.75
Watercress..................................................       20
------------------------------------------------------------------------
\1\ Import only.

    (2) Tolerances are established for residues of the fungicide 
cyprodinil, including its metabolites and degradates, in the commodities 
in the table below. Compliance with the tolerance levels specified below 
is to be determined by measuring only the sum of cyprodinil 4-
cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine and free and conjugated 
CGA-304075 4-(4-cyclopropyl-6-methyl-pyrimidin-2-ylamino)-phenol, 
calculated as the stoichiometric equivalent of cyprodinil.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, meat byproducts.....................................        0.02
Goat, meat byproducts.......................................        0.02
Horse, meat byproducts......................................        0.02
Sheep, meat byproducts......................................        0.02
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 17706, Apr. 10, 1998]

    Editorial Note: For Federal Register citations affecting Sec. 
180.532, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.533  Esfenvalerate; tolerances for residues.

    (a) General. (1) Tolerances are established for the combined 
residues of the insecticide esfenvalerate, (S)-cyano(3-
phenoxyphenyl)methyl-(S)-4-chloro-[alpha]-(1-methylethyl)benzeneacetate, 
its non-racemic isomer, (R)-cyano(3-phenoxyphenyl)methyl-(R)-4-chloro-
[alpha]-(1-methylethyl)benzeneacetate and its diastereomers (S)-cyano(3-
phenoxyphenyl)methyl-(R)-4-chloro-[alpha]-(1-methylethyl)benzeneacetate 
and (R)-cyano(3-phenoxyphenyl)methyl-(S)-4-chloro-[alpha]-(1-
methylethyl)benzeneacetate, in or on food commodities as follows:

[[Page 626]]



------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond......................................................        0.2
Almond, hulls...............................................        5.0
Apple.......................................................        1.0
Artichoke, globe............................................        1.0
Bean, dry, seed.............................................        0.25
Bean, snap, succulent.......................................        1.0
Beet, sugar, roots..........................................        0.05
Beet, sugar, tops...........................................        5.0
Blueberry...................................................        1.0
Broccoli....................................................        1.0
Cabbage, except Chinese cabbage.............................        3.0
Caneberry subgroup 13A......................................        1.0
Cantaloupe..................................................        0.5
Carrot, roots...............................................        0.5
Cattle, fat.................................................        1.5
Cattle, meat................................................        1.5
Cattle, meat byproducts.....................................        1.5
Cauliflower.................................................        0.5
Collards....................................................        3.0
Corn, field, forage.........................................       15.0
Corn, field, grain..........................................        0.02
Corn, field, stover.........................................       15.0
Corn, pop, grain............................................        0.02
Corn, pop, stover...........................................       15.0
Corn, sweet, forage.........................................       15.0
Corn, sweet, kernel plus cob with husks removed.............        0.1
Corn, sweet, stover.........................................       15.0
Cotton, undelinted seed.....................................        0.2
Cucumber....................................................        0.5
Egg.........................................................        0.03
Eggplant....................................................        0.5
Elderberry..................................................        1.0
Fruit, stone, group 12......................................        3.0
Goat, fat...................................................        1.5
Goat, meat..................................................        1.5
Goat, meat byproducts.......................................        1.5
Gooseberry..................................................        1.0
Hazelnut....................................................        0.2
Hog, fat....................................................        1.5
Hog, meat...................................................        1.5
Hog, meat byproducts........................................        1.5
Horse, fat..................................................        1.5
Horse, meat.................................................        1.5
Horse, meat byproducts......................................        1.5
Kiwifruit...................................................        0.5
Lentil, seed................................................        0.25
Melon, honeydew.............................................        0.5
Milk........................................................        0.3
Milk, fat...................................................        7.0
Muskmelon...................................................        0.5
Mustard greens..............................................        5.0
Okra........................................................        0.5
Pea, dry, seed..............................................        0.25
Pea, succulent..............................................        0.5
Peanut......................................................        0.02
Pear........................................................        1.0
Pecan.......................................................        0.2
Pepper......................................................        0.5
Potato......................................................        0.02
Poultry, fat................................................        0.3
Poultry, liver..............................................        0.03
Poultry, meat...............................................        0.03
Poultry, meat byproducts, except liver......................        0.3
Pumpkin.....................................................        0.5
Radish, roots...............................................        0.3
Radish, tops................................................        3.0
Sheep, fat..................................................        1.5
Sheep, meat.................................................        1.5
Sheep, meat byproducts......................................        1.5
Sorghum, grain, forage......................................       10.0
Sorghum, grain, grain.......................................        5.0
Sorghum, grain, stover......................................       10.0
Soybean, hulls..............................................        0.5
Soybean, seed...............................................        0.05
Squash, summer..............................................        0.5
Squash, winter..............................................        0.5
Sugarcane, cane.............................................        1.0
Sunflower, seed.............................................        0.5
Sweet potato, roots.........................................        0.05
Tomato......................................................        0.5
Turnip, greens..............................................        7.0
Turnip, roots...............................................        0.5
Walnut......................................................        0.2
Watermelon..................................................        0.5
------------------------------------------------------------------------

    (2) A tolerance of 0.05 ppm on raw agricultural food commodities 
(other than those food commodities already covered by a higher tolerance 
as a result of use on growing crops) is established for the combined 
residues of the insecticide esfenvalerate, (S)-cyano(3-
phenoxyphenyl)methyl-(S)-4-chloro-[alpha]-(1-methylethyl)benzeneacetate, 
its non-racemic isomer, (R)-cyano(3-phenoxyphenyl)methyl-(R)-4-chloro-
[alpha]-(1-methylethyl)benzeneacetate and its diastereomers (S)-cyano(3-
phenoxyphenyl)methyl-(R)-4-chloro-[alpha]-(1-methylethyl)benzeneacetate 
and (R)-cyano(3-phenoxyphenyl)methyl-(S)-4-chloro-[alpha]-(1-
methylethyl)benzeneacetate as a result of the use of esfenvalerate in 
food-handling establishments.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registration are established for the combined residues of the 
insecticide esfenvalerate, (S)-cyano(3-phenoxyphenyl)methyl-(S)-4-
chloro-[alpha]-(1-methylethyl)benzeneacetate, its non-racemic isomer, 
(R)-cyano(3-phenoxyphenyl)methyl-(R)-4-chloro-[alpha]-(1-
methylethyl)benzeneacetate and its diastereomers (S)-cyano(3-
phenoxyphenyl)methyl-(R)-4-chloro-[alpha]-(1-methylethyl)benzeneacetate 
and (R)-cyano(3-phenoxyphenyl)methyl-(S)-4-chloro-[alpha]-(1-
methylethyl)benzeneacetate, in or on food commodities as follows:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cabbage, chinese, bok choy..................................        1.0
Kohlrabi....................................................        2.0
Lettuce, head...............................................        5.0
------------------------------------------------------------------------


[[Page 627]]

    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 23401, Apr. 29, 1998, as amended at 63 FR 48615, Sept. 11, 1998; 
74 FR 46699, Sept. 11, 2009]



Sec. 180.535  Fluroxypyr 1-methylheptyl ester; tolerances for residues.

    (a) General. Tolerances are established for combined residues of 
fluroxypyr 1-methylheptyl ester [1-methylheptyl ((4-amino-3,5-dichloro-
6-fluoro-2-pyridinyl)oxy)acetate] and its metabolite fluroxypyr [((4-
amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetic acid] in or on the 
following raw agricultural commodities. Compliance with the established 
tolerance levels is determined by measuring only the sum of fluroxypyr 
1-methylheptyl ester [1-methylheptyl ((4-amino-3, 5-dichloro-6-fluoro-2-
pyridinyl)oxy)acetate] and its metabolite fluroxypyr [((4-amino-3,5-
dichloro-6-fluoro-2-pyridinyl)oxy)acetic acid] calculated as the 
stoichiometric equivalent of fluroxypyr.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Barley, grain..............................................        0.5
Barley, hay................................................       12.0
Barley, hay................................................       20.0
Barley, straw..............................................       12.0
Cattle, fat................................................        0.1
Cattle, kidney.............................................        1.5
Cattle, meat...............................................        0.1
Cattle, meat byproducts....................................        0.1
Corn, field, forage........................................        1.0
Corn, field, grain.........................................        0.02
Corn, field, stover........................................        0.5
Corn, sweet, forage........................................        1.0
Corn, sweet, kernel plus cob with husks removed............        0.02
Corn, sweet, stover........................................        2.0
Fruit, pome, group 11......................................        0.02
Garlic, bulb...............................................        0.03
Goat, fat..................................................        0.1
Goat, kidney...............................................        1.5
Goat, meat.................................................        0.1
Goat, meat byproducts......................................        0.1
Grain, aspirated fractions.................................        0.6
Grass, forage..............................................      120
Grass, hay.................................................      160
Hog, fat...................................................        0.1
Hog, kidney................................................        1.5
Hog, meat..................................................        0.1
Hog, meat byproducts.......................................        0.1
Horse, fat.................................................        0.1
Horse, kidney..............................................        1.5
Horse, meat................................................        0.1
Horse, meat byproducts.....................................        0.1
Milk.......................................................        0.3
Millet, forage.............................................       12.0
Millet, grain..............................................        0.5
Millet, hay................................................       20.0
Millet, proso, straw.......................................       12.0
Oat, forage................................................       12.0
Oat, grain.................................................        0.5
Oat, hay...................................................       20.0
Oat, straw.................................................       12.0
Onion, bulb................................................        0.03
Rice, bran.................................................        3.0
Rice, grain................................................        1.5
Shallot, bulb..............................................        0.03
Sheep, fat.................................................        0.1
Sheep, kidney..............................................        1.5
Sheep, meat................................................        0.1
Sheep, meat byproducts.....................................        0.1
Sorghum, grain, forage.....................................        2.0
Sorghum, grain, grain......................................        0.02
Sorghum, grain, stover.....................................        4.0
Wheat, forage..............................................       12.0
Wheat, grain...............................................        0.5
Wheat, hay.................................................       20.0
Wheat, straw...............................................       12.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 52169, Sept. 30, 1998, as amended at 64 FR 22799, Apr. 28, 1999; 
66 FR 37598, July 19, 2001; 66 FR 47971, Sept. 17, 2001; 67 FR 46884, 
July 17, 2002; 67 FR 60146, Sept. 25, 2002; 68 FR 75438, Dec. 31, 2003; 
69 FR 2074, Jan. 14, 2004; 70 FR 3649, Jan. 26, 2005; 70 FR 7047, Feb. 
10, 2005; 71 FR 76204, Dec. 20, 2006; 72 FR 73635, Dec. 28, 2007; 78 FR 
3333, Jan. 16, 2013]



Sec. 180.537  Isoxaflutole; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide, isoxaflutole, including its metabolites and degradates, in or 
on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only the sum of 
isoxaflutole ((5-cyclopropyl-4-isoxazolyl) [2-(methylsulfonyl)-4-
(trifluoromethyl)phenyl] methanone) and its metabolite 1-(2-
methylsulfonyl-4-trifluoromethylphenyl)-2-cyano-3-cyclopropyl propan-
1,3-dione (RPA 202248), calculated as the stoichiometric equivalent of 
isoxaflutole, in or on the commodity:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Corn, field, forage.........................................        0.04
Corn, field, grain..........................................        0.02
Corn, field, stover.........................................        0.02
Grain, aspirated fractions..................................        0.30
Soybean, seed...............................................        0.05
------------------------------------------------------------------------


[[Page 628]]

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 50784, Sept. 23, 1998, as amended at 73 FR 75608, Dec. 12, 2008; 
76 FR 76314, Dec. 7, 2011]



Sec. 180.539  d-Limonene; tolerances for residues.

    (a) General. (1) The insecticide d-limonene may be safely used in 
insect-repellent tablecloths and in insect-repellent strips used in 
food- or feed-handling establishments.
    (2) To assure safe use of the insect repellent, its label and 
labeling shall conform to that registered by the U.S. Environmental 
Protection Agency, and it shall be used in accordance with such label 
and labeling.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33715, May 24, 2000, as amended at 70 FR 55268, Sept. 21, 2005]



Sec. 180.540  Fenitrothion; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide fenitrothion, O,O-dimethyl O-(4-nitro-m-tolyl) 
phosphorothioate, from the postharvest application of the insecticide to 
stored wheat in Australia, in or on the following food commodity:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Wheat, gluten \1\...........................................        3.0
------------------------------------------------------------------------
\1\ There are no U.S. registrations on food commodities since 1987.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[73 FR 54963, Sept. 24, 2008]



Sec. 180.541  Propetamphos; tolerances for residues.

    (a) General. A tolerance of 0.1 part per million is established for 
residues of the insecticide propetamphos, including its metabolites and 
degradates, in or on food or feed commodities when present therein as a 
result of the treatment of food- or feed-handling establishments with 
propetamphos. Direct application shall be limited solely to spot and/or 
crack and crevice treatment in food- or feed-handling establishments 
where food or feed and food or feed products are held, processed, 
prepared, served, or sold. Spray and dust concentrations shall be 
limited to a maximum of 1 percent active ingredient. For crack and 
crevice treatment, equipment capable of delivering a dust or a pin-
stream of spray directly into cracks and crevices shall be used. For 
spot treatment, a coarse, low-pressure spray shall be used to avoid 
contamination of food, feed, or food-contact/feed-contact surfaces. 
Compliance with the tolerance level specified in this paragraph is to be 
determined by measuring only propetamphos, 1-methylethyl-(2E)-3-
((ethylamino)methoxyphosphinothioyl)oxy)-2-butenoate, in or on the 
commodity.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 33716, May 24, 2000, as amended at 76 FR 23498, Apr. 27, 2011]



Sec. 180.543  Diclosulam; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide diclosulam [N-(2,6-dichlorophenyl)-5-ethoxy-7-fluoro[1,2,4] 
triazolo[1,5-c]pyrimidine-2-sulfonamide] in or on the following raw 
agricultural commodities as follows:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Peanut......................................................       0.020
Soybean, seed...............................................       0.020
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]

[[Page 629]]

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 12134, Mar. 8, 2000]



Sec. 180.544  Methoxyfenozide; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide methoxyfenozide, including its metabolites and degradates, 
in or on the commodities listed in the following table. Compliance with 
the tolerance levels specified in the following table is to be 
determined by measuring only methoxyfenozide (3-methoxy-2-methylbenzoic 
acid 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide) in or on 
the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Acerola....................................................        0.4
Almond, hulls..............................................       25
Animal feed, nongrass, group 18, forage....................       50.0
Animal feed, nongrass, group 18, hay.......................      150.0
Apple, wet pomace..........................................        7.0
Artichoke, globe...........................................        3.0
Avocado....................................................        0.6
Bean, dry, seed............................................        0.24
Beet, sugar, roots.........................................        0.50
Brassica, head and stem, subgroup 5A.......................        7.0
Brassica, leafy greens, subgroup 5B........................       30
Bushberry subgroup 13-07B..................................        3.0
Canistel...................................................        0.6
Cattle, fat................................................        0.50
Cattle, meat...............................................        0.02
Citrus, oil................................................      100
Coriander, leaves..........................................       30
Corn, field, forage........................................       15
Corn, field, grain.........................................        0.05
Corn, field, refined oil...................................        0.20
Corn, field, stover........................................      125
Corn, pop, grain...........................................        0.05
Corn, pop, stover..........................................      125
Corn, sweet, forage........................................       30
Corn, sweet, kernel plus cob with husks removed............        0.05
Corn, sweet, stover........................................       60
Cotton, gin byproducts.....................................       35
Cotton, undelinted seed....................................        2.0
Cranberry..................................................        0.5
Feijoa.....................................................        0.4
Fruit, citrus, group 10-10.................................        3.0
Fruit, pome, group 11......................................        1.5
Fruit, stone, group 12, except plum, prune, fresh..........        3.0
Goat, fat..................................................        0.50
Goat, meat.................................................        0.02
Grain, aspirated fractions.................................        2.0
Grape......................................................        1.0
Grape, raisin..............................................        1.5
Grass, forage, fodder and hay, group 17, forage............       18.0
Grass, forage, fodder and hay, group 17, hay...............       30.0
Guava......................................................        0.4
Hog, fat...................................................        0.1
Hog, meat..................................................        0.02
Horse, fat.................................................        0.50
Horse, meat................................................        0.02
Jaboticaba.................................................        0.4
Leaf petioles subgroup 4B..................................       25
Leafy greens subgroup 4A...................................       30
Longan.....................................................        2.0
Lychee.....................................................        2.0
Mango......................................................        0.6
Milk.......................................................        0.10
Nut, tree, group 14........................................        0.10
Okra.......................................................        2.0
Onion, green, subgroup 3-07B...............................        5.0
Papaya.....................................................        0.6
Passionfruit...............................................        0.4
Pea and bean, succulent shelled, subgroup 6B...............        0.2
Pea, blackeyed, seed.......................................        4.0
Pea, dry seed..............................................        2.5
Pea, southern, seed........................................        4.0
Peanut.....................................................        0.02
Peanut, hay................................................       55.0
Peanut, oil................................................        0.04
Peppermint, tops...........................................        7.0
Pistachio..................................................        0.10
Plum, prune, fresh.........................................        0.30
Pomegranate................................................        0.6
Poultry, fat...............................................        0.02
Poultry, meat..............................................        0.02
Pulasan....................................................        2.0
Rambutan...................................................        2.0
Sapodilla..................................................        0.6
Sapote, black..............................................        0.6
Sapote, mamey..............................................        0.6
Sheep, fat.................................................        0.50
Sheep, meat................................................        0.02
Soybean, aspirated grain fractions.........................      160
Soybean, forage............................................       30
Soybean, hay...............................................       80
Soybean, hulls.............................................        2.0
Soybean, seed..............................................        1.0
Spanish lime...............................................        2.0
Spearmint, tops............................................        7.0
Star apple.................................................        0.6
Starfruit..................................................        0.4
Strawberry.................................................        1.5
Turnip, greens.............................................       30
Vegetable, cucurbit, group 9...............................        0.3
Vegetable, foliage of legume, except soybean, subgroup 7A..       35
Vegetable, fruiting, group 8...............................        2.0
Vegetable, leaves of root and tuber, group 2...............       30
Vegetable, legume, edible podded, subgroup 6A..............        1.5
Vegetable, root, except sugar beet, Subgroup 1B............        0.90
Vegetable, tuberous and corm, except potato, subgroup 1D...        0.02
Wax jambu..................................................        0.4
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the insecticide 
methoxyfenozide, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance levels 
specified in the following table is to be determined by measuring only 
the sum of methoxyfenozide [3-methoxy-2-methylbenzoic acid 2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl)

[[Page 630]]

hydrazide] and its glucuronide metabolite ([beta]-D-Glucopyranuronic 
acid, 3-[[2-(1,1-dimethylethyl)-2-(3,5-dimethylbenzoyl)-
hydrazino]carbonyl]-2-methylphenyl-), calculated as the stoichiometric 
equivalent of methoxyfenozide.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, liver..............................................        0.40
Cattle, meat byproducts, except liver......................        0.10
Egg........................................................        0.02
Goat, liver................................................        0.40
Goat, meat byproducts, except liver........................        0.10
Hog, liver.................................................        0.1
Hog, meat byproducts, except liver.........................        0.02
Horse, liver...............................................        0.40
Horse, meat byproducts, except liver.......................        0.10
Poultry, liver.............................................        0.10
Poultry, meat byproducts, except liver.....................        0.02
Sheep, liver...............................................        0.40
Sheep, meat byproducts, except liver.......................        0.10
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of the 
insecticide methoxyfenozide, including its metabolites and degradates, 
in or on the specified agricultural commodities, resulting from use of 
the pesticide pursuant to FFIFRA section 18 emergency exemptions. 
Compliance with the tolerance levels specified in the following table is 
to be determined by measuring only methoxyfenozide [benzoic acid, 3-
methoxy-2-methyl-, 2-(3,5-dimethylbenzoyl)-2-(1,1-
dimethylethyl)hydrazide]. The expired tolerances will be revoked on the 
date specified in the table.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Sorghum, forage.................................       30.0     12/31/12
Sorghum, grain..................................       0.05     12/31/12
Sorghum, stover.................................       60.0     12/31/12
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent tolerances. (1) Tolerances are 
established for the indirect or inadvertent residues of the insecticide 
methoxyfenozide, including its metabolites and degradates, in or on the 
raw agricultural commodities in the following table, when present 
therein as a result of the application of methoxyfenozide to growing 
crops as listed in paragraph (a) of this section. Compliance with the 
tolerance levels specified in the following table is to be determined by 
measuring only methoxyfenozide [3-methoxy-2-methylbenzoic acid 2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide].

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Onion, bulb, subgroup 3-07A.................................        0.10
Potato......................................................        0.02
------------------------------------------------------------------------

    (2) Tolerances are established for the indirect or inadvertent 
residues of the insecticide methoxyfenozide, including its metabolites 
and degradates, in or on the raw agricultural commodities in the 
following table, when present therein as a result of the application of 
methoxyfenozide to growing crops as listed in paragraph (a) of this 
section. Compliance with the tolerance levels specified in the following 
table is to be determined by measuring only the sum of methoxyfenozide 
[3-methoxy-2-methylbenzoic acid, 2-(3,5-dimethylbenzoyl)-2-(1,1-
dimethylethyl) hydrazide] and the following metabolites (all calculated 
as the stoichiometric equivalent of methoxyfenozide): free phenol of 
methoxyfenozide [3,5-dimethylbenzoic acid N-tert-butyl-N[min]-(3-
hydroxy-2-methylbenzoyl) hydrazide], the glucose conjugate of the phenol 
[3,5-dimethyl benzoic acid N-tert-butyl-N[min]-[3 ([beta]-D-
glucopyranosyloxy)-2-methylbenzoyl]-hydrazide] and the malonylglycosyl 
conjugate of the phenol [3,5-dimethyl benzoic acid N-tert-butyl-N[min]-
[3 ([beta]-D-6-malonyl-glucopyranosyl-1-oxy)-2-methylbenzoyl]-
hydrazide].

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Animal feed, nongrass, group 18, straw......................        8.0
Grain, cereal, forage, fodder and straw group 16, except            6.0
 corn.......................................................
Herb and spice, group 19, except coriander, leaves..........        4.5
------------------------------------------------------------------------


[67 FR 59203, Sept. 20, 2002, as amended at 68 FR 32389, May 30, 2003; 
68 FR 37765, June 25, 2003; 69 FR 58097, Sept. 29, 2004; 70 FR 7047, 
Feb. 10, 2005; 70 FR 51604, Aug. 31, 2005; 70 FR 75739, Dec. 21, 2005; 
71 FR 32853, June 7, 2006; 73 FR 11826, Mar. 5, 2008; 74 FR 22468, May 
13, 2009; 74 FR 45335, Sept. 2, 2009; 76 FR 34886, June 15, 2011; 77 FR 
40812, July 11, 2012]

[[Page 631]]



Sec. 180.545  Prallethrin (RS)-2-methyl-4-oxo-3-(2-propynyl)cyclopent-2-enyl 

(1RS)-cis, trans-chrysanthemate; tolerances for residues.

    (a) General. (1) A tolerance of 1.0 ppm is established for residues 
of the insecticide prallethrin (RS)-2-methyl-4-oxo-3-(2-
propynyl)cyclopent-2-enyl (1RS)-cis, trans-chrysanthemate as follows:
    (2) In or on food commodities in food handling establishments where 
food and food products are held, processed, prepared and/or served.
    (3) Application shall be limited to space, general surface, and spot 
and/or crack and crevice treatment in food handling establishments where 
food and food products are held, processed, prepared and/or served. 
General surface or space spray applications may be used only when the 
facility is not in operation provided exposed food has been covered or 
removed from the area being treated prior to application. Spot and/or 
crack and crevice application may be used while the facility is in 
operation provided exposed food is covered or removed from the area 
being treated prior to application. Spray concentrate shall be limited 
to a maximum of 2.0% active ingredient. Contamination of food or food 
contact surfaces shall be avoided. Food contact surfaces and equipment 
should be throughly washed with an effective cleaning compound and 
rinsed with potable water after use of the product.
    (4) To assure safe use of the additive, its label and labeling shall 
conform to that registered with the U.S. Environmental Protection 
Agency, and it shall be used in accordance with such label and labeling.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 39313, June 26, 2000, as amended at 71 FR 74819, Dec. 13, 2006]



Sec. 180.546  Mefenoxam; tolerances for residues.

    (a) General. Tolerances are established for residues of mefenoxam, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below is 
to be determined by measuring only metalaxyl (methyl N-(2,6-
dimethylphenyl)-N-(methoxyacetyl)-DL-alaninate).

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Artichoke, globe...........................................        0.05
Atemoya....................................................        0.20
Bean, snap, succulent......................................        0.20
Bushberry subgroup 13-07B..................................        2.0
Caneberry subgroup 13-07A..................................        0.70
Canistel...................................................        0.40
Custard apple..............................................        0.20
Herbs, dried...............................................       55
Herbs, fresh...............................................        8.0
Kiwifruit..................................................        0.10
Mango......................................................        0.40
Onion, bulb, subgroup 3-07A................................        3.0
Onion, green, subgroup 3-07B...............................       10
Papaya.....................................................        0.40
Sapodilla..................................................        0.40
Sapote, black..............................................        0.40
Sapote, mamey..............................................        0.40
Spinach....................................................       10
Star apple.................................................        0.40
Starfruit..................................................        0.20
Sugar apple................................................        0.20
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertant residues. [Reserved]

[65 FR 57556, Sept. 25, 2000, as amended at 66 FR 48003, Sept. 17, 2001; 
67 FR 35050, May 17, 2002; 76 FR 4548, Jan. 26, 2011]



Sec. 180.547  Prohexadione calcium; tolerances for residues.

    (a) General. Tolerances are established for residues of the growth 
regulator, prohexadione calcium, including its metabolites and 
degradates, in or on the commodities in the table below. Compliance with 
the tolerance levels specified below is to be determined by measuring 
only prohexadione calcium (calcium 3-oxido-5-oxo-4-propionylcyclohex-3-
enecarboxylate)'' in or on the following commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, kidney.............................................        0.10
Cattle, meat byproducts, except kidney.....................        0.05
Cherry, sweet..............................................        0.40
Fruit, pome, group 11......................................        3.0
Goat, kidney...............................................        0.10
Goat, meat byproducts, except kidney.......................        0.05
Grass, forage \1\..........................................        0.10
Grass, hay \1\.............................................        0.10
Grass, seed screenings \1\.................................        3.5
Grass, straw \1\...........................................        1.2
Hog, kidney................................................        0.10
Hog, meat byproducts, except kidney........................        0.05

[[Page 632]]

 
Horse, kidney..............................................        0.10
Horse, meat byproducts, except kidney......................        0.05
Peanut.....................................................        1.0
Peanut, hay................................................        0.60
Sheep, kidney..............................................        0.10
Sheep, meat byproducts, except kidney......................        0.05
------------------------------------------------------------------------
\1\Registration is limited to grass grown for seed.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 25660, May 3, 2000, as amended at 66 FR 29712, June 1, 2001; 76 
FR 71464, Nov. 18, 2011]



Sec. 180.548  Tralkoxydim; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide, tralkoxydim, 2-Cyclohexen-1-one, 2-[1-(ethoxyimino)propyl]-3-
hydroxy-5-(2,4,6-trimethylphenyl)-(9Cl) in or on the raw agricultural 
commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Barley, grain..............................................        0.02
Barley, hay................................................        0.02
Barley, straw..............................................        0.05
Wheat, forage..............................................        0.05
Wheat, grain...............................................        0.02
Wheat, hay.................................................        0.02
Wheat, straw...............................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[63 FR 69199, Dec. 16, 1998, as amended at 68 FR 48302, Aug. 13, 2003; 
70 FR 70739, Nov. 23, 2005]



Sec. 180.549  Diflufenzopyr; tolerances for residues.

    (a) General. Tolerances are established for combined residues of 
diflufenzopyr, 2-(1-[([3,5-difluorophenylamino] 
carbonyl)hydrazono]ethyl)-3- pyridinecarboxylic acid, and its 
metabolites convertible to 8- methylpyrido[2,3-d]pyridazin-5(6H)-one, 
expressed as diflufenzopyr, in or on the following raw agricultural 
commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Corn, field, forage........................................        0.05
Corn, field, grain.........................................        0.05
Corn, field, stover........................................        0.05
Corn, pop, grain...........................................        0.05
Corn, pop, stover..........................................        0.05
Corn, sweet, forage........................................        0.05
Corn, sweet, kernel plus cob with husks removed............        0.05
Corn, sweet, stover........................................        0.05
Grass, forage..............................................       22.0
Grass, hay.................................................        7.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[64 FR 4308, Jan. 28, 1999, as amended at 67 FR 55338, Aug. 29, 2002; 76 
FR 34886, June 15, 2011]



Sec. 180.551  Fluthiacet-methyl; tolerances for residues.

    (a) General. (1) A tolerance is established for residues of the 
herbicide, fluthiacet-methyl, acetic acid [[2-chloro-4-fluoro-5-
[(tetrahydro-3-oxo-1H,3H-[1,3,4]thiadiazolo[3,4-[alpha]]pyridazin-1-
ylidene)amino]phenyl]thio]-methyl ester, in or on the food commodity:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Corn, field, forage.........................................       0.050
Corn, field, grain..........................................       0.010
Corn, field, stover.........................................       0.050
Corn, pop, grain............................................       0.010
Corn, pop, stover...........................................       0.050
Corn, sweet, forage.........................................       0.050
Corn, sweet, kernel plus cob with husks removed.............       0.010
Corn, sweet, stover.........................................       0.050
Soybean, seed...............................................       0.01
------------------------------------------------------------------------

    (2) A tolerance is established for the combined residues of the 
herbicide fluthiacet-methyland its acid metabolite: acetic acid, [[2-
chloro-4-fluoro-5-[tetrahydro-3-oxo-1H,3H-[1,3,4]thiadiazolo[3,4-
[alpha]]pyridazin-1-ylidene)amino]phenyl]thio]-methyl ester, and its 
acid metabolite, acetic acid, [[2-chloro-4-fluoro-5-[(tetrahydro-3-oxo-
1H,3H-[1,3,4]thiadiazolo[3,4-[alpha]]pyridazin-1-
ylidene)amino]phenyl]thio]- , in or on the following food commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cotton, gin byproducts.....................................        0.20

[[Page 633]]

 
Cotton, undelinted seed....................................        0.020
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[64 FR 18357, Apr. 14, 1999, as amended at 66 FR 65850, Dec. 21, 2001; 
71 FR 77625, Dec. 27, 2006]



Sec. 180.552  Sulfosulfuron; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide sulfosulfuron, 1-(4,6-dimethoxypyrimidin-2-yl)-3-[(2-
ethanesulfonyl-imidazo[1,2-a]pyridine-3-yl) sulfonyl]urea and its 
metabolites converted to 2-(ethylsulfonyl)-imidazo[1,2-a]pyridine and 
calculated as sulfosulfuron in or on the raw agricultural commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................        0.02
Cattle, meat...............................................        0.01
Cattle, meat byproducts....................................        0.3
Goat, fat..................................................        0.02
Goat, meat.................................................        0.01
Goat, meat byproducts......................................        0.3
Grass, forage, fodder and hay, group 17, forage............       14
Grass, forage, fodder and hay, group 17, hay...............       25
Hog, fat...................................................        0.005
Hog, meat..................................................        0.005
Hog, meat byproducts.......................................        0.05
Horse, fat.................................................        0.02
Horse, meat................................................        0.01
Horse, meat byproducts.....................................        0.3
Milk.......................................................        0.02
Sheep, fat.................................................        0.02
Sheep, meat................................................        0.01
Sheep, meat byproducts.....................................        0.3
Wheat, forage..............................................        4.0
Wheat, grain...............................................        0.02
Wheat, hay.................................................        0.3
Wheat, straw...............................................        0.1
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[64 FR 27192, May 19, 1999, as amended at 70 FR 69464, Nov. 16, 2005; 72 
FR 54574, Sept. 26, 2007]



Sec. 180.553  Fenhexamid; tolerances for residues.

    (a) General. Tolerances are established for the residues of the 
fungicide fenhexamid (N-2,3-dichloro-4-hydroxyphenyl)-1-methyl 
cyclohexanecarboxamide) in or on the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hulls..............................................        2.0
Almond.....................................................        0.02
Asparagus..................................................        0.02
Bushberry subgroup 13B.....................................        5.0
Caneberry subgroup 13A.....................................       20.0
Cilantro, leaves...........................................       30.0
Cucumber...................................................        2.0
Fruit, stone, group 12, except plum, prune, fresh,                10.0
 postharvest...............................................
Ginseng....................................................        0.3
Grape......................................................        4.0
Grape, raisin..............................................        6.0
Juneberry..................................................        5.0
Kiwifruit, postharvest.....................................       15.0
Leafy greens subgroup 4A, except spinach...................       30.0
Lingonberry................................................        5.0
Pear.......................................................       10
Pepper, nonbell............................................        0.02
Pistachio..................................................        0.02
Plum, prune, dried.........................................        2.5
Plum, prune, fresh.........................................        1.5
Pomegranate................................................        2.0
Salal......................................................        5.0
Strawberry.................................................        3.0
Vegetable, fruiting, group 8, except nonbell pepper........        2.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[64 FR 28924, May 28, 1999, as amended at 65 FR 19849, Apr. 13, 2000; 65 
FR 69883, Nov. 21, 2000; 67 FR 19120, Apr. 18, 2002; 68 FR 2247, Jan. 
16, 2003; 68 FR 55519, Sept. 26, 2003; 71 FR 15617, Mar. 29, 2006; 71 FR 
43664, Aug. 2, 2006; 73 FR 19154, Apr. 9, 2008]



Sec. 180.554  Kresoxim-methyl; tolerances for residues.

    (a) General. (1) Tolerances are established for the combined 
residues of the fungicide kresoxim-methyl (methyl (E)-2-[2-(2-
methylphenoxy)-methyl]phenyl-2-(methoxyimido)acetate) and its 
metabolites as follows: (E)-2-[2-(2-methylphenoxy)methyl]-phenyl-2-
(methoxyimido)acetic acid; (E)-2-[2-(2-hydroxymethylphenoxy)methyl]-
phenyl-2-(methoxyimido)acetic acid (free and glucose conjugated); and 
(E)-2-[2-(4-hydroxy-2-methylphenoxy)-

[[Page 634]]

methyl]phenyl-2-(methoxyimido)acetic acid (free and glucose conjugated) 
in or on the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Apple, dry pomace..........................................        1.0
Apple, wet pomace..........................................        1.0
Fruit, pome................................................        0.5
Grape......................................................        1.0
Grape, raisin..............................................        1.5
Pecan......................................................        0.15
Vegetable, cucurbit, group 9...............................        0.40
------------------------------------------------------------------------

    (2) Tolerances are established in or on the following commodities 
for the residues of the metabolite (E)-2-[2-(2-methylphenoxy)methyl]-
phenyl-2-(methoxyimido)acetic acid resulting from the use of the 
fungicide kresoxim-methyl:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, meat byproducts....................................        0.01
Goat, meat byproducts......................................        0.01
Sheep, meat byproducts.....................................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[64 FR 31136, June 10, 1999, as amended at 71 FR 50359, Aug. 25, 2006; 
74 FR 46377, Sept. 9, 2009]



Sec. 180.555  Trifloxystrobin; tolerances for residues.

    (a) General. Tolerances are established for residues of 
trifloxystrobin, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only the sum of 
trifloxystrobin, benzeneacetic acid, (E,E)-[alpha]-(methoxyimino)-2-
[[[[1-[3-(trifluoromethyl) phenyl]ethylidene] amino]oxy]methyl]-, methyl 
ester, and the free form of its acid metabolite CGA-321113, (E,E)-
methoxyimino-[2-[1-(3-trifluoromethyl-phenyl)-ethylideneaminooxymethyl]-
phenyl]acetic acid, calculated as the stoichiometric equivalent of 
trifloxystrobin, in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage............................................        0.01
Alfalfa, hay...............................................        0.01
Almond, hulls..............................................        9.0
Apple, wet pomace..........................................        5.0
Artichoke, globe...........................................        1.0
Asparagus..................................................        0.07
Banana \1\.................................................        0.10
Barley, grain..............................................        0.05
Barley, hay................................................        0.3
Barley, straw..............................................        5.0
Beet, sugar, dried pulp....................................        0.4
Beet, sugar, molasses......................................        0.2
Beet, sugar, roots.........................................        0.1
Beet, sugar, tops..........................................        4.0
Canistel...................................................        0.7
Cattle, fat................................................        0.1
Cattle, meat...............................................        0.1
Cattle, meat byproducts....................................        0.1
Citrus, dried pulp.........................................        1.0
Citrus, oil................................................       38
Coffee, green bean \2\.....................................        0.02
Corn, field, forage........................................        6.0
Corn, field, grain.........................................        0.05
Corn, field, stover........................................        7
Corn, field, refined oil...................................        0.1
Corn, pop, grain...........................................        0.05
Corn, pop, stover..........................................        7
Corn, sweet, cannery waste.................................        0.6
Corn, sweet, forage........................................        7.0
Corn, sweet, kernel plus cob with husks removed............        0.04
Corn, sweet, stover........................................        4.0
Egg........................................................        0.04
Fruit, citrus, group 10....................................        0.6
Fruit, pome................................................        0.5
Fruit, stone, group 12.....................................        2
Goat, fat..................................................        0.1
Goat, meat.................................................        0.1
Goat, meat byproducts......................................        0.1
Grain, aspirated fractions.................................        5.0
Grape......................................................        2.0
Grape, raisin..............................................        5.0
Grass, forage..............................................       12
Grass, hay.................................................       17
Hog, fat...................................................        0.05
Hog, meat..................................................        0.05
Hog, meat byproducts.......................................        0.05
Hop, dried cones...........................................       11.0
Horse, fat.................................................        0.1
Horse, meat................................................        0.1
Horse, meat byproducts.....................................        0.1
Leaf petioles subgroup 4B..................................        3.5
Mango......................................................        0.7
Milk.......................................................        0.02
Nut, tree, group 14........................................        0.04
Oat, forage................................................        0.3
Oat, grain.................................................        0.05
Oat, hay...................................................        0.3
Oat, straw.................................................        5.0
Papaya.....................................................        0.7
Peanut, hay................................................        4.0
Peanut.....................................................        0.05
Pistachio..................................................        0.04
Potato.....................................................        0.04
Poultry, fat...............................................        0.04
Poultry, meat..............................................        0.04
Poultry, meat byproducts...................................        0.04
Radish, tops...............................................       10
Rice, grain................................................        3.5
Rice, hulls................................................        8
Rice, straw................................................        7.5
Sapodilla..................................................        0.7
Sapote, black..............................................        0.7

[[Page 635]]

 
Sapote, mamey..............................................        0.7
Sheep, fat.................................................        0.1
Sheep, meat................................................        0.1
Sheep, meat byproducts.....................................        0.1
Soybean, forage............................................       10.0
Soybean, hay...............................................       25.0
Soybean, seed..............................................        0.08
Star apple.................................................        0.7
Strawberry.................................................        1.1
Vegetable, cucurbit, group 9...............................        0.50
Vegetable, fruiting........................................        0.5
Vegetable, root, except sugar beet, subgroup 1B............        0.1
Wheat, bran................................................        0.15
Wheat, forage..............................................        0.3
Wheat, grain...............................................        0.05
Wheat, hay.................................................        0.2
Wheat, straw...............................................        5.0
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of September 27, 1999 for use on
  banana.
\2\ There are no U.S. registrations as of January 18, 2012 for use on
  coffee, green bean.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[64 FR 51907, Sept. 27, 1999, as amended at 65 FR 44453, July 18, 2000; 
67 FR 35924, May 22, 2002; 68 FR 53304, Sept. 10, 2003; 70 FR 36532, 
June 24, 2005; 71 FR 15604, Mar. 29, 2006; 71 FR 55319, Sept. 22, 2006; 
72 FR 53445, Sept. 19, 2007; 73 FR 57, Jan. 2, 2008; 75 FR 33195, June 
11, 2010; 76 FR 69652, Nov. 9, 2011; 77 FR 12731, Mar. 2, 2012; 77 FR 
42658, July 20, 2012; 77 FR 65831, Oct. 31, 2012]



Sec. 180.556  Pymetrozine; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide pymetrozine 1,2,4-triazin-3(2H)-one,4,5-dihydro-6-methyl-4-
[(3-pyridinylmethylene) amino] in or on the following raw agricultural 
commodities. The tolerance level for each commodity is expressed in 
terms of the parent insecticide only, which serves as an indicator of 
the use of pymetrozine on these raw agricultural commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Asparagus..................................................        0.04
Brassica, head and stem, subgroup 5A.......................        0.5
Brassica, leafy greens, subgroup 5B........................        0.25
Cotton, gin byproducts.....................................        2.0
Cotton, undelinted seed....................................        0.3
Hop, dried cones...........................................        6.0
Pecan......................................................        0.02
Turnip, greens.............................................        0.25
Vegetable, fruiting, group 8...............................        0.2
Vegetable, cucurbit, group 9...............................        0.1
Vegetable, leafy, execpt brassica, group 4.................        0.6
Vegetable, tuberous and corm, subgroup 1C..................        0.02
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 48634, Aug. 9, 2000, as amended at 66 FR 14846, Mar. 14, 2001; 66 
FR 66794, Dec. 27, 2001; 70 FR 7047, Feb. 10, 2005; 70 FR 43298, July 
27, 2005]



Sec. 180.557  Tetraconazole; tolerances for residues.

    (a) General. Tolerances are established for residues of 
tetraconazole, including its metabolites and degradates, in or on the 
commodities listed below. Compliance with the following tolerance levels 
is to be determined by measuring only tetraconazole (1-[2-(2,4-
dichlorophenyl)-3-(1,1,2,2-tetrafluoroethoxy)propyl]-1H-1,2,4-triazole), 
in or on the following commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Aspirated grain fractions..................................        1.0
Beet sugar, dried pulp.....................................        0.15
Beet sugar, molasses.......................................        0.15
Beet sugar, root...........................................        0.05
Cattle, fat................................................        0.15
Cattle, liver..............................................        1.50
Cattle, meat...............................................        0.01
Cattle, meat byproducts (except liver).....................        0.15
Corn, field, forage........................................        1.1
Corn, field, grain.........................................        0.01
Corn, field, stover........................................        1.7
Corn, pop, grain...........................................        0.01
Corn, pop, stover..........................................        1.7
Eggs.......................................................        0.02
Goat, fat..................................................        0.15
Goat, liver................................................        1.50
Goat, meat.................................................        0.01
Goat, meat byproducts (except liver).......................        0.15
Hog, fat...................................................        0.01
Hog, liver.................................................        0.05
Hog, meat..................................................        0.01
Hog, meat byproducts (except liver)........................        0.01
Horse, fat.................................................        0.15
Horse, liver...............................................        1.50
Horse, meat................................................        0.01
Horse, meat byproducts (except liver)......................        0.15
Low growing berry subgroup 13-07G, except cranberry........        0.25
Milk.......................................................        0.03
Milk, fat..................................................        0.75
Peanut.....................................................        0.03
Peanut, oil................................................        0.10
Pecan......................................................        0.04
Poultry, fat...............................................        0.05
Poultry, meat..............................................        0.01

[[Page 636]]

 
Poultry meat byproducts....................................        0.05
Sheep, fat.................................................        0.15
Sheep, liver...............................................        1.50
Sheep, meat................................................        0.01
Sheep, meat byproducts (except liver)......................        0.15
Small fruit vine climbing, except fuzzy kiwifruit, subgroup        0.20
 13-07F....................................................
Soybean, refined oil.......................................        0.80
Soybean, seed..............................................        0.15
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[70 FR 20830, Apr. 22, 2005, as amended at 70 FR 31359, June 1, 2005; 72 
FR 18134, Apr. 11, 2007; 73 FR 67406, Nov. 14, 2008; 76 FR 53648, Aug. 
29, 2011]



Sec. 180.559  Clodinafop-propargyl; tolerances for residues.

    (a) General. Tolerances are established for clodinafop-propargyl, 
including its metabolites and degradates, in or on the commodities in 
the following table. Compliance with the tolerance levels specified in 
the following table is to be determined by measuring only clodinafop-
propargyl [(2R)-2-[4-[(5-chloro-3-fluoro-2-
pyridinyl)oxy]phenoxy]propanoic acid, 2-propynyl ester] and its 
metabolite clodinafop [(2R)-2-[4-[(5-chloro-3-fluoro-2- 
pyridinyl)oxy]phenoxy]propanoic acid].

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Wheat, forage...............................................        0.1
Wheat, grain................................................        0.02
Wheat, hay..................................................        0.1
Wheat, straw................................................        0.5
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 38774, June 22, 2000, as amended at 77 FR 72226, Dec. 5, 2012]



Sec. 180.560  Cloquintocet-mexyl; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
cloquintocet-mexyl, (acetic acid [(5-chloro-8-quinolinyl)oxy]-,1-
methylhexyl ester; CAS Reg. No. 99607-70-2) and its acid metabolite (5-
chloro-8-quinolinoxyacetic acid), when used as an inert ingredient 
(safener) in pesticide formulations containing the active ingredients 
clodinafop-propargyl (wheat only), dicamba (wheat only), flucarbazone-
sodium (wheat only), pinoxaden (wheat or barley), or pyroxsulum (wheat 
only) in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, grain...............................................        0.1
Barley, hay.................................................        0.1
Barley, straw...............................................        0.1
Wheat, forage...............................................        0.2
Wheat, grain................................................        0.1
Wheat, hay..................................................        0.5
Wheat, straw................................................        0.1
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 38764, June 22, 2000, as amended at 70 FR 74688, Dec. 16, 2005; 
73 FR 11820, Mar. 5, 2008; 75 FR 16020, Mar. 31, 2010; 76 FR 38035, June 
29, 2011]



Sec. 180.561  Acibenzolar-S-methyl; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
acibenzolar-S-methyl, benzo(1,2,3)thiadiazole-7-carbothioic acid-S-
methyl ester, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only those acibenzolar-
S-methyl residues convertible to benzo(1,2,3)thiadiazole-7-carboxylic 
acid (CGA-210007), expressed as the stoichiometric equivalent of 
acibenzolar-S-methyl, in or on the following raw agricultural 
commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Banana \1\..................................................        0.1
Berry, low growing, subgroup 13-07G.........................        0.15
Onion, bulb, subgroup 3-07A.................................        0.1
Spinach.....................................................        1.0
Tomato, paste...............................................        3.0
Vegetable, brassica, leafy, group 5.........................        1.0
Vegetable, cucurbit, group 9................................        2.0
Vegetable, fruiting, group 8................................        1.0
Vegetable, leafy, group 4...................................        0.25
------------------------------------------------------------------------
\1\ There are no United States registrations for banana.


[[Page 637]]

    (2) Tolerances are established for residues of acibenzolar- S -
methyl, benzo(1,2,3)thiadiazole-7-carbothioic acid- S -methyl ester, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below is 
to be determined by measuring only those acibenzolar- S -methyl residues 
convertible to benzo(1,2,3)thiadiazole-7-carboxylic acid (CGA-210007), 
expressed as the Stoichiometric equivalent of acibenzolar- S -methyl, in 
or on the following raw agricultural commodities.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Apple...........................................       0.05     12/31/15
Grapefruit......................................       0.05     12/31/15
Pear............................................       0.05     12/31/15
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 50446, Aug. 18, 2000, as amended at 70 FR 7861, Feb. 16, 2005; 71 
FR 76200, Dec. 20, 2006; 74 FR 24710, May 26, 2009; 76 FR 34886, June 
15, 2011; 77 FR 21676, Apr. 11, 2012; 77 FR 30406, May 23, 2012]



Sec. 180.562  Flucarbazone-sodium; tolerances for residues.

    (a) General. Tolerances are established for combined residues of the 
herbicide flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-methyl-5-oxo-N-
[[2(trifluoromethoxy)phenyl] sulfonyl]-1H-1,2,4-triazole 1-carboxamide, 
sodium salt) and its N-desmethyl metabolite; and its metabolites 
converted to 2-(trifluoromethoxy)benzene sulfonamide and calculated as 
flucarbazone-sodium in or on the following food commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, liver..............................................        1.50
Cattle, meat...............................................        0.01
Cattle, meat byproducts, except liver......................        0.01
Goat, liver................................................        1.50
Goat, meat.................................................        0.01
Goat, meat byproducts, except liver........................        0.01
Hog, liver.................................................        1.50
Hog, meat..................................................        0.01
Hog, meat byproducts, except liver.........................        0.01
Horse, liver...............................................        1.50
Horse, meat................................................        0.01
Horse, meat byproducts, except liver.......................        0.01
Milk.......................................................        0.005
Sheep, liver...............................................        1.50
Sheep, meat................................................        0.01
Sheep, meat byproducts, except liver.......................        0.01
Wheat, forage..............................................        0.30
Wheat, grain...............................................        0.01
Wheat, hay.................................................        0.10
Wheat, straw...............................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertant residues. [Reserved]

[70 FR 67915, Nov. 9, 2005, as amended at 71 FR 76931, Dec. 22, 2006]



Sec. 180.563  Ethametsulfuron-methyl; tolerances for residues.

    (a) General. A tolerance is established for residues of 
ethametsulfuron methyl (methyl 2- ((((4-ethoxy-6- (methylamino)-1,3,5- 
triazin-2-yl) amino) carbonyl) amino) sulfonyl) benzoate) in or on the 
following raw agricultural commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Canola, seed................................................        0.02
Crambe, seed................................................        0.02
Rapeseed, seed..............................................        0.02
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect of inadvertent residues. [Reserved]

[65 FR 57972, Sept. 27, 2000, as amended at 66 FR 18207, Apr. 6, 2001; 
67 FR 35050, May 17, 2002]



Sec. 180.564  Indoxacarb; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
indoxacarb, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only indoxacarb, (S)-
methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl] amino]carbonyl] indeno[1,2-e] [1,3,4] 
[oxadiazine-4a (3H) -carboxylate, and its

[[Page 638]]

R-enantiomer, (R)-methyl 7-chloro-2,5-dihydro-2- [[(methoxycarbonyl)[4- 
(trifluoromethoxy)phenyl] amino]carbonyl] indeno[1,2-
e][1,3,4][oxadiazine-4a(3H)-carboxylate.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Apple, wet pomace...........................................        3.0
Alfalfa, forage.............................................       10
Alfalfa, hay................................................       50
Beet, garden, roots.........................................        0.30
Beet, garden, tops..........................................        6.0
Bushberry subgroup 13-07B...................................        1.5
Cattle, fat.................................................        1.5
Cattle, meat................................................        0.05
Cattle, meat byproducts.....................................        0.03
Corn, sweet, forage.........................................       10
Corn, sweet, kernel plus cob with husk removed..............        0.02
Corn, sweet, stover.........................................       15
Cotton, gin byproducts......................................       15
Cotton, undelinted seed.....................................        2.0
Cranberry...................................................        0.90
Fruit, pome, except pear, group 11..........................        1.0
Fruit, stone, group 12......................................        0.90
Goat, fat...................................................        1.5
Goat, meat..................................................        0.05
Goat, meat byproducts.......................................        0.03
Grain, aspirated fractions..................................       45
Grape.......................................................        2.0
Grape, raisin...............................................        5.0
Hog, fat....................................................        1.5
Hog, meat...................................................        0.05
Hog, meat byproducts........................................        0.03
Horse, fat..................................................        1.5
Horse, meat.................................................        0.05
Horse, meat byproducts......................................        0.03
Milk........................................................        0.15
Milk, fat...................................................        4.0
Okra........................................................        0.50
Pea, southern, seed.........................................        0.10
Peanut......................................................        0.01
Peanut, hay.................................................       40
Pear........................................................        0.20
Pear, oriental..............................................        0.20
Peppermint, tops............................................       11
Sheep, fat..................................................        1.5
Sheep, meat.................................................        0.05
Sheep, meat byproducts......................................        0.03
Soybean, hulls..............................................        4.0
Soybean, seed...............................................        0.80
Spearmint, tops.............................................       11
Turnip, greens..............................................       12
Vegetable, Brassica, leafy, group 5.........................       12
Vegetable, cucurbit, group 9................................        0.60
Vegetable, fruiting, group 8................................        0.50
Vegetable, leafy, except Brassica, group 4..................       14
Vegetable, tuberous and corm, subgroup 1-C..................        0.01
------------------------------------------------------------------------

    (2) Tolerances are established for residues of indoxacarb, including 
its metabolites and degradates, in or on the commodities in the table 
below. Compliance with the tolerance levels specified below is to be 
determined by measuring only the sum of indoxacarb, (S)-methyl-7-chloro-
2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy)-
phenyl]amino]carbonyl]indeno[1,2e] [1,3,4]oxadiazine-4a(3H)-carboxylate, 
its R-enantiomer, (R)-methyl 7-chloro-2,5-dihydro-2-
[[(methoxycarbonyl)[4-(trifluoromethoxy) phenyl]amino]carbonyl]indeno 
[1,2-e] [1,3,4] oxadiazine-4a(3H)-carboxylate, and the metabolites: IN-
JT333, methyl 7-chloro-2,5-dihydro-2-[[[4-(trifluoromethoxy)phenyl]-
amino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylate; IN-
KT319, (E)-methyl 5-chloro-2,3,-dihydro-2-hydroxy-1-
[[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]amino]-
carbonyl]hydrazono]-1H-indene-2-carboxylate; IN-JU873, methyl 5-chloro-
2,3-dihydro-2-hydroxy-1-[[[[4-(triflurormethoxy)-
phenyl]amino]carbonyl]hydrazono]-1H-indene-2-carboxylate; IN-KG433, 
methyl 5-chloro-2,3,-dihydro-2-hydroxy-1-[[[ (methoxycarbonyl)[4- 
(trifluoromethoxy)phenyl] amino]carbonyl]- hydrazono]-1H-indene-2-
carboxylate; and IN-KB687, methyl [4- (trifluoromethoxy) phenyl] 
carbamate, calculated as the stoichiometric equivalent of indoxacarb in 
the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Egg.........................................................        0.20
Poultry, fat................................................        0.20
Poultry, meat...............................................        0.06
Poultry, meat byproducts....................................        0.06
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 58424, Sept. 29, 2000, as amended at 67 FR 41807, June 19, 2002; 
67 FR 47309, July 18, 2002; 67 FR 58730, Sept. 18, 2002; 68 FR 25830, 
May 14, 2003; 68 FR 27746, May 21, 2003; 69 FR 28842, May 19, 2004; 69 
FR 29459, May 24, 2004; 69 FR 32282, June 9, 2004; 72 FR 37641, July 11, 
2007; 74 FR 33165, July 10, 2009; 77 FR 8749, Feb. 15, 2012]



Sec. 180.565  Thiamethoxam; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide thiamethoxam, including its metabolites and degradates, in 
or on the following commodities. Compliance with the tolerance levels 
specified below is to be determined by measuring only thiamethoxam 3-
[(2-chloro-5-thiazolyl) methyl]tetrahydro-5- methyl-N-nitro-

[[Page 639]]

4H-1,3,5-oxadiazin-4- imine and its metabolite CGA-322704 N-[(2-chloro-
thiazol-5-yl) methyl]-N[min]-methyl-N[sec]-nitro-guanidine, calculated 
as the stoichiometric equivalent of thiamethoxam, in or on the following 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        0.05
Alfalfa, hay................................................        0.12
Almond, hulls...............................................        1.2
Artichoke, globe............................................        0.45
Avocado.....................................................        0.40
Barley, grain...............................................        0.4
Barley, hay.................................................        0.40
Barley, straw...............................................        0.40
Bean, succulent.............................................        0.02
Berry, low growing, subgroup 13-07G, except cranberry.......        0.30
Borage, seed................................................        0.02
Brassica, head and stem, subgroup 5-A.......................        4.5
Brassica, leafy greens, subgroup 5-B........................        3.0
Buckwheat, forage...........................................        0.50
Buckwheat, hay..............................................        0.02
Buckwheat, straw............................................        0.02
Bushberry subgroup 13-07B, except lingonberry and blueberry,        0.20
 lowbush....................................................
Caneberry subgroup 13-07A...................................        0.35
Canistel....................................................        0.40
Canola, seed................................................        0.02
Cattle, meat................................................        0.02
Cattle, meat byproducts.....................................        0.04
Citrus, dried pulp..........................................        0.60
Coffee, green, bean \1\.....................................        0.20
Corn, field, forage.........................................        0.10
Corn, field, stover.........................................        0.05
Corn, pop, forage...........................................        0.10
Corn, pop, stover...........................................        0.05
Corn, sweet, forage.........................................        0.10
Corn, sweet, kernel plus cob with husks removed.............        0.02
Corn, sweet, stover.........................................        0.05
Cotton, gin byproducts......................................        1.5
Cotton, undelinted seed.....................................        0.10
Crambe, seed................................................        0.02
Cranberry...................................................        0.02
Flax, seed..................................................        0.02
Food commodities and feed commodities (other than those             0.02
 covered by a higher tolerance as a result of use on growing
 crops) in food/feed handling establishments................
Fruit, citrus, group 10.....................................        0.40
Fruit, pome, group 11.......................................        0.2
Fruit, small, vine climbing, subgroup 13-07F, except fuzzy          0.20
 kiwifruit..................................................
Fruit, stone, group 12......................................        0.5
Goat, meat..................................................        0.02
Goat, meat byproducts.......................................        0.04
Grain, aspirated fractions..................................        2.0
Grain, cereal, group 15, except barley......................        0.02
Grape, raisin...............................................        0.30
Hog, meat...................................................        0.02
Hog, meat byproducts........................................        0.02
Hop, dried cones............................................        0.10
Horse, meat.................................................        0.02
Horse, meat byproducts......................................        0.04
Mango.......................................................        0.40
Milk........................................................        0.02
Millet, pearl, forage.......................................        0.02
Millet, pearl, stover.......................................        0.02
Millet, proso, forage.......................................        0.02
Millet, proso, stover.......................................        0.02
Millet, proso, straw........................................        0.02
Mustard, seed...............................................        0.02
Nut, tree, group 14.........................................        0.02
Oat, forage.................................................        0.50
Oat, hay....................................................        0.02
Oat, straw..................................................        0.02
Onion, dry bulb.............................................        0.03
Papaya......................................................        0.40
Peanut......................................................        0.05
Peanut, hay.................................................        0.25
Peanut, meal................................................        0.15
Peppermint, tops............................................        1.5
Pistachio...................................................        0.02
Potato......................................................        0.25
Radish, tops................................................        0.80
Rapeseed, seed..............................................        0.02
Rye, forage.................................................        0.50
Rye, straw..................................................        0.02
Safflower, seed.............................................        0.02
Sapodilla...................................................        0.40
Sapote, black...............................................        0.40
Sapote, mamey...............................................        0.40
Sheep, meat.................................................        0.02
Sheep, meat byproducts......................................        0.04
Sorghum, forage.............................................        0.02
Sorghum, grain, stover......................................        0.02
Soybean, hulls..............................................        0.08
Spearmint, tops.............................................        1.5
Star apple..................................................        0.40
Sunflower...................................................        0.02
Tea, dried \1\..............................................       20
Tomato, paste...............................................        0.80
Vegetable, cucurbit, group 9................................        0.2
Vegetable, fruiting, group 8................................        0.25
Vegetable, leafy, except brassica, group 4..................        4.0
Vegetable, legume, group 6..................................        0.02
Vegetable, root, subgroup 1A................................        0.05
Vegetable, tuberous and corm, except potato, subgroup 1D....        0.02
Wheat, forage...............................................        0.50
Wheat, hay..................................................        0.02
Wheat, straw................................................        0.02
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of March 27, 2013.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[65 FR 79762, Dec. 20, 2000]

    Editorial Note: For Federal Register citations affecting Sec. 
180.565, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.566  Fenpyroximate; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide fenpyroximate, including its metabolites and degradates, in 
or on the commodities in the table below. Compliance with the tolerance 
levels specified in the table is to be determined by

[[Page 640]]

measuring only the sum of fenpyroximate, (E)-1,1-dimethylethyl 4-
[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl)methylene amino]oxy]methyl] 
benzoate and its Z-isomer, (Z)-1,1-dimethylethyl 4- [[[[(1,3-dimethyl-5-
phenoxy-1H-pyrazol-4-yl)methylene] amino]oxy] methyl]benzoate, 
calculated as the stoichiometric equivalent of fenpyroximate.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hulls..............................................         3.0
Avocado....................................................         0.15
Bean, snap, succulent......................................         0.40
Berry, low growing, subgroup 13-07G........................         1.0
Canistel...................................................         0.15
Citrus, dried pulp.........................................         2.5
Citrus, oil................................................        10
Corn, field, forage........................................         2.0
Corn, field, grain.........................................         0.02
Corn, field, refined oil...................................         0.05
Corn, field, stover........................................         7.0
Corn, pop, forage..........................................         2.0
Corn, pop, grain...........................................         0.02
Corn, pop, stover..........................................         7.0
Cotton, gin byproducts.....................................        10
Cotton, undelinted seed....................................         0.10
Cucumber...................................................         0.40
Fruit, citrus, group 10-10.................................         0.50
Fruit, pome, group 11-10...................................         0.30
Fruit, small, vine climbing, except fuzzy kiwifruit,                1.0
 subgroup 13-07F...........................................
Fruit, stone, group 12-12..................................         2.0
Grain, aspirated fractions.................................         0.40
Hop, dried cones...........................................        10
Mango......................................................         0.15
Melon subgroup 9A..........................................         0.10
Nut, tree, group 14........................................         0.10
Papaya.....................................................         0.15
Peppermint, tops...........................................         7.0
Pistachio..................................................         0.10
Sapodilla..................................................         0.15
Sapote, black..............................................         0.15
Sapote, mamey..............................................         0.15
Spearmint, tops............................................         7.0
Star, apple................................................         0.15
Tea, dried \1\.............................................        20
Vegetable, fruiting, group 8-10............................         0.20
Vegetable, tuberous and corm, subgroup 1C..................         0.10
------------------------------------------------------------------------
\1\ There are no U.S. Registrations.

    (2) Tolerances are established for residues of the insecticide 
fenpyroximate, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified in the table is to be determined by measuring only the sum of 
fenpyroximate, (E)-1,1-dimethylethyl 4- [[[[(1,3-dimethyl-5-phenoxy-1H-
pyrazol-4-yl) methylene] amino]oxy]methyl]benzoate and its metabolites 
(E)-4-[(1,3-dimethyl-5- phenoxypyrazol-4-yl)-methyleneamino oxymethyl] 
benzoic acid and (E)-1,1-dimethylethyl-2-hydroxyethyl 4- [[[[(1,3-
dimethyl-5-phenoxy-1H-pyrazol-4-yl) methylene] amino]oxy] 
methyl]benzoate, calculated as the stoichiometric equivalent of 
fenpyroximate.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................        0.03
Cattle, meat...............................................        0.03
Cattle, meat byproducts, except kidney and liver...........        0.03
Goat, fat..................................................        0.03
Goat, meat.................................................        0.03
Goat, meat byproducts, except kidney and liver.............        0.03
Horse, fat.................................................        0.03
Horse, meat................................................        0.03
Horse, meat byproducts, except kidney and liver............        0.03
Milk.......................................................        0.015
Sheep, fat.................................................        0.03
Sheep, meat................................................        0.03
Sheep, meat byproducts, except kidney and liver............        0.03
------------------------------------------------------------------------

    (3) Tolerances are established for residues of the insecticide 
fenpyroximate, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified in the table is to be determined by measuring only the sum of 
fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[ (1,3-dimethyl -5-phenoxy-1H-
pyrazol-4-yl)methylene]amino]oxy]methyl] benzoate and its metabolite 
(E)-4-[(1,3-dimethyl-5- phenoxypyrazol-4-yl) -methyleneamino 
oxymethyl]benzoic acid, calculated as the stoichiometric equivalent of 
fenpyroximate.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, kidney..............................................        0.25
Cattle, liver...............................................        0.25
Goat, kidney................................................        0.25
Goat, liver.................................................        0.25
Horse, kidney...............................................        0.25
Horse, liver................................................        0.25
Sheep, kidney...............................................        0.25
Sheep, liver................................................        0.25
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the insecticide fenpyroximate, including its 
metabolites and degradates in or on the commodities in the table below. 
Compliance with the tolerance levels specified in the table is to be 
determined by measuring only the sum of fenpyroximate, (E)-1,1-
dimethylethyl 4-[[[[(1,3-dimethyl -5-phenoxy-1H-pyrazol-4-yl) methylene] 
amino]oxy]methyl]benzoate and its Z-

[[Page 641]]

isomer, (Z)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-
4-yl)methylene] amino]oxy]methyl] benzoate, calculated as the 
stoichiometric equivalent of fenpyroximate.

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
Honey.............................               0.10           12/31/13
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[66 FR 18568, Apr. 10, 2001, as amended at 69 FR 32464, June 10, 2004; 
71 FR 49368, Aug. 23, 2006; 72 FR 26321, May 9, 2007; 74 FR 37617, July 
29, 2009; 74 FR 63079, Dec. 2, 2009; 75 FR 80346, Dec. 22, 2010; 77 FR 
73951, Dec. 12, 2012; 78 FR 36097, June 17, 2013]



Sec. 180.567  Zoxamide; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of zoxamide 
(3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-
methylbenzamide) in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grape.......................................................        3.0
Grape, raisin...............................................       15.0
Tomato......................................................        2.0
Vegetable, cucurbit, group 9................................        1.0
------------------------------------------------------------------------

    (2) Tolerances are established for the combined residues of zoxamide 
and its metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid (RH-1455 
and RH-141455) and 3,5-dichloro-4-hydroxymethylbenzoic acid (RH-1452 and 
RH-141452) in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Potato......................................................       0.060
Potato, granules/flakes.....................................       0.30
Potato, wet peel............................................       0.10
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. A time-limited tolerance is 
established for residues of the fungicide zoxamide (3,5-dichloro-N-(3-
chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide) in connection 
with use of the pesticide under a section 18 emergency exemption granted 
by EPA. The tolerance will expire and is revoked on the date specified 
in the following table.

------------------------------------------------------------------------
                                                   Parts per  Revocation
                    Commodity                       million      date
------------------------------------------------------------------------
Ginseng..........................................       0.06    12/31/10
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[66 FR 18733, Apr. 11, 2001, as amended at 66 FR 49118, Sept. 26, 2001; 
69 FR 16805, Mar. 31, 2004; 71 FR 31104, June 1, 2006; 71 FR 76200, Dec. 
20, 2006; 75 FR 770, Jan. 6, 2010]



Sec. 180.568  Flumioxazin; tolerances for residues.

    (a) General. Tolerances are established for residues of flumioxazin, 
2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-
4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione, including its metabolites 
and degradates, in or on the commodities in the table below. Compliance 
with the tolerance levels specified below is to be determined by 
measuring only flumioxazin.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        3.0
Alfalfa, hay................................................        8.0
Almond, hulls...............................................        0.70
Artichoke, globe............................................        0.02
Asparagus...................................................        0.02
Bushberry subgroup 13-07B...................................        0.02
Cabbage.....................................................        0.02
Cabbage, Chinese, napa......................................        0.02
Corn, field, forage.........................................        0.02
Corn, field, grain..........................................        0.02
Corn, field, stover.........................................        0.02
Cotton, gin byproducts......................................        0.60
Cotton, undelinted seed.....................................        0.02
Fish, freshwater............................................        1.5
Fruit, pome, group 11.......................................        0.02
Fruit, stone, group 12......................................        0.02
Garlic......................................................        0.02
Grain, aspirated fractions..................................      100
Grape.......................................................        0.02
Hop, dried cones............................................        0.05
Leaf petioles subgroup 4B...................................        0.02
Nut, tree, group 14.........................................        0.02
Okra........................................................        0.02
Olive.......................................................        0.02
Onion, bulb.................................................        0.02
Pea and bean, dried shelled, except soybean, subgroup 6C....        0.07
Peanut......................................................        0.02
Peppermint, tops............................................        0.04
Pistachio...................................................        0.02
Pomegranate.................................................        0.02
Prickly pear, fruit.........................................        0.07
Prickly pear, pads..........................................        0.06
Rapeseed subgroup 20A.......................................        0.40
Shallot, bulb...............................................        0.02
Soybean, seed...............................................        0.02

[[Page 642]]

 
Spearmint, tops.............................................        0.04
Strawberry..................................................        0.07
Sugarcane, cane.............................................        0.20
Sunflower subgroup 20B......................................        0.50
Vegetable, cucurbit, group 9................................        0.03
Vegetable, fruiting, group 8................................        0.02
Vegetable, tuberous and corm, subgroup 1C...................        0.02
Wheat, forage...............................................        0.02
Wheat, grain................................................        0.40
Wheat, hay..................................................        0.02
Wheat, straw................................................        6.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[66 FR 19878, Apr. 18, 2001, as amended at 68 FR 51471, Aug. 27, 2003; 
69 FR 16831, Mar. 31, 2004; 69 FR 52198, Aug. 25, 2004; 71 FR 25956, May 
3, 2006; 71 FR 61413, Oct. 18, 2006; 73 FR 11831, Mar. 5, 2008; 73 FR 
39251, July 9, 2008; 75 FR 8265, Feb. 24, 2010; 75 FR 69009, Nov. 10, 
2010; 77 FR 58499, Sept. 21, 2012; 78 FR 20466, Apr. 5, 2013]



Sec. 180.569  Forchlorfenuron; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
plant growth regulator forchlorfenuron; N-(2-chloro-4-pyridinyl)-
N[min]phenyl urea in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Bushberry subgroup 13-07B...................................        0.01
Grape.......................................................        0.03
Grape, raisin...............................................        0.06
Kiwifruit...................................................        0.04
------------------------------------------------------------------------

    (2) Time-limited tolerances are established for residues of the 
plant growth regulator forchlorfenuron; N-(2-chloro-4-pyridinyl)-N '-
phenylurea in or on the food commodities:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Almond..........................................       0.01     12/31/11
Almond, hulls...................................       0.15     12/31/11
Cherry, sweet...................................       0.01     12/31/11
Fig.............................................       0.01     12/31/11
Pear............................................       0.01     12/31/11
Pistachio.......................................       0.01     12/31/11
Plum, prune, fresh..............................       0.01     12/31/11
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional restrictions. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[66 FR 22936, May 7, 2001, as amended at 69 FR 48805, Aug. 11, 2004; 69 
FR 58322, Sept. 30, 2004; 73 FR 47846, Aug. 15, 2008]



Sec. 180.570  Isoxadifen-ethyl; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
isoxadifen-ethyl (ethyl 5,5-diphenyl-2-isoxazoline-3-carboxylate, (CAS 
No. 163520-33-0), and its metabolite: 4,5-dihydro-5,5-diphenyl-3-
isoxazolecarboxylic acid, when used as an inert ingredient (safener) in 
or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Corn, field, forage.........................................        0.20
Corn, field, grain..........................................        0.08
Corn, field, stover.........................................        0.40
Corn, oil...................................................        0.50
Corn, pop, grain............................................        0.04
Corn, pop, stover...........................................        0.25
Corn, sweet, forage.........................................        0.30
Corn, sweet, kernel plus cob with husk removed..............        0.04
Corn, sweet, stover.........................................        0.45
------------------------------------------------------------------------

    (2) Tolerances are established for the residues of isoxadifen-ethyl 
(3-isoxazolecarboxylic acid, 4,5-dihydro-5,5-diphenyl-, ethyl ester (CAS 
No. 164520-33-0)), and its metabolites 4,5-dihydro-5,5-diphenyl-3-
isoxazolecarboxylic acid and [beta]-hydroxy-[beta]-benzenepropanenitrile 
when used as an inert ingredient (safener) in or on the following raw 
agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Rice, grain.................................................        0.10
Rice, hulls.................................................        0.50
Rice, straw.................................................        0.25
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[66 FR 33187, June 21, 2001, as amended at 66 FR 40141, Aug. 2, 2001; 67 
FR 12878, Mar. 20, 2002; 69 FR 29890, May 26, 2004; 72 FR 63997, Nov. 
14, 2007]

[[Page 643]]



Sec. 180.571  Mesotrione; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide mesotrione, including its metabolites and degradates, in or on 
the commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only mesotrione, 2-[4-
(methylsulfonyl)-2-nitrobenzoyl]-1,3-cyclohexanedione, in or on the 
following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Asparagus...................................................        0.01
Berry, group 13.............................................        0.01
Corn, field, forage.........................................        0.01
Corn, field, grain..........................................        0.01
Corn, field, stover.........................................        0.01
Corn, pop, grain............................................        0.01
Corn, pop, stover...........................................        0.01
Corn, sweet, forage.........................................        0.5
Corn, sweet, kernel plus cob with husks removed.............        0.01
Corn, sweet, stover.........................................        1.5
Cranberry...................................................        0.02
Flax, seed..................................................        0.01
Grass, forage...............................................        0.01
Grass, hay..................................................        0.01
Grass, seed screenings......................................        0.10
Grass, straw................................................        0.10
Lingonberry.................................................        0.01
Millet, forage..............................................        0.01
Millet, grain...............................................        0.01
Millet, hay.................................................        0.02
Millet, straw...............................................        0.02
Oat, forage.................................................        0.01
Oat, grain..................................................        0.01
Oat, hay....................................................        0.01
Oat, straw..................................................        0.01
Okra........................................................        0.01
Rhubarb.....................................................        0.01
Sorghum, grain, forage......................................        0.01
Sorghum, grain, grain.......................................        0.01
Sorghum, grain, stover......................................        0.01
Sorghum, sweet..............................................        0.01
Soybean, seed...............................................        0.01
Sugarcane, cane.............................................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[66 FR 33195, June 21, 2001, as amended at 67 FR 45656, July 10, 2002; 
68 FR 273, Jan. 3, 2003; 69 FR 58310, Sept. 30, 2004; 70 FR 14551, Mar. 
23, 2005; 72 FR 71802, Dec. 19, 2007; 73 FR 1512, Jan. 9, 2008; 73 FR 
9226, Feb. 20, 2008; 74 FR 67123, Dec. 18, 2009; 76 FR 34886, June 15, 
2011]



Sec. 180.572  Bifenazate; tolerance for residues.

    (a) General. (1) Tolerances are established for residues of 
bifenazate (1-methylethyl 2-(4-methoxy[1,1[min]-biphenyl]-3-
yl)hydrazinecarboxylate) including its metabolites and degradates, in or 
on the commodities listed in the following table. Compliance with the 
tolerance levels specified are to be determined by measuring only the 
sum of bifenazate and its metabolite diazinecarboxylic acid, 2-(4-
methoxy-[1,1[min]-biphenyl]-3-yl), 1-methylethyl ester (expressed as 
bifenazate) in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Acerola.....................................................        0.90
Almond, hulls...............................................       15
Apple, wet pomace...........................................        1.2
Atemoya.....................................................        1.6
Avocado.....................................................        7.0
Bean, dry seed..............................................        0.60
Berry, low-growing subgroup 13-07G..........................        1.5
Biriba......................................................        1.6
Black sapote................................................        7.0
Caneberry subgroup 13-07A...................................        5.0
Canistel....................................................        7.0
Cattle, fat.................................................        0.10
Cherimoya...................................................        1.6
Cotton, gin byproducts......................................       35
Cotton, undelinted seed.....................................        0.75
Custard apple...............................................        1.6
Feijoa......................................................        0.90
Fruit, pome, group 11.......................................        0.75
Fruit, small, vine climbing subgroup 13-07F, except fuzzy           1.0
 kiwifruit..................................................
Fruit, stone, group 12, except plum.........................        2.5
Goat, fat...................................................        0.10
Grape.......................................................        0.75
Grape, raisin...............................................        1.2
Guava.......................................................        0.9
Hog, fat....................................................        0.10
Hop, dried cones............................................       15
Horse, fat..................................................        0.10
Jaboticaba..................................................        0.90
Ilama.......................................................        1.6
Longan......................................................        5.0
Lychee......................................................        5.0
Mango.......................................................        7.0
Nut, tree, group 14.........................................        0.20
Okra........................................................        2.0
Papaya......................................................        7.0
Passionfruit................................................        0.90
Pea and bean, succulent shelled, subgroup 6B................        0.70
Peppermint, tops............................................       25
Pistachio...................................................        0.20
Plum........................................................        0.20
Pulasan.....................................................        5.0
Rambutan....................................................        5.0
Sapodilla...................................................        7.0
Sapote, mamey...............................................        7.0
Sheep, fat..................................................        0.10
Soursop.....................................................        1.6
Soybean, succulent shelled..................................        0.70
Spanish lime................................................        5.0
Spearmint, tops.............................................       25

[[Page 644]]

 
Star apple..................................................        7.0
Starfruit...................................................        0.90
Strawberry..................................................        1.5
Sugar apple.................................................        1.6
Vegetable, cucurbit, group 9................................        0.75
Vegetable, fruiting, group 8................................        2.0
Vegetable, legume, edible-podded, subgroup 6A...............        6.0
Vegetable, tuberous and corm, subgroup 1C...................        0.10
Wax jambu...................................................        0.90
------------------------------------------------------------------------

    (2) Tolerances are established for residues of bifenazate (1-
methylethyl 2-(4-methoxy[1,1'-biphenyl]-3-yl) hydrazinecarboxylate) 
including its metabolites and degradates, in or on the commodities 
listed in the following table. Compliance with the tolerance levels 
specified are to be determined by measuring only the sum of bifenazate 
and its metabolites diazinecarboxylic acid, 2-(4-methoxy-[1,1'-
biphenyl]-3-yl), 1-methylethyl ester (expressed as bifenazate); 1,1'-
biphenyl, 4-ol; and 1,1'-biphenyl, 4-oxysulfonic acid (expressed as 
1,1'-biphenyl, 4-ol) in or on the following food commodities:

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Cattle, meat..............................  0.02
Cattle, meat byproducts...................  0.02
Goat, meat................................  0.02
Goat, meat byproducts.....................  0.02
Hog, meat.................................  0.02
Hog, meat byproducts......................  0.02
Horse, meat...............................  0.02
Horse, meat byproducts....................  0.02
Milk......................................  0.02
Sheep, meat...............................  0.02
Sheep, meat byproducts....................  0.02
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of bifenazate (1-methylethyl 2-(4-methoxy[1,1'-
biphenyl]-3-yl)hydrazinecarboxylate) including its metabolites and 
degradates in connection with use of the pesticide under section 18 
emergency exemptions granted by EPA. Compliance with the tolerance 
levels specified in the following table are to be determined by 
measuring only the sum of bifenazate and its metabolite 
diazinecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl), 1-
methylethyl ester (expressed as bifenazate). The tolerances will expire 
and are revoked on the dates specified in the following table.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   Revocation
                                                   million       Date
------------------------------------------------------------------------
Timothy, forage.................................         50     12/31/13
Timothy, hay....................................        150     12/31/13
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[66 FR 34569, June 29, 2001]

    Editorial Note: For Federal Register citations affecting Sec. 
180.572, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.573  Tepraloxydim; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
tepraloxydim, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only the combined 
residues of tepraloxydim, (2-[1-[[[(2E)-3-chloro-2-propen-1-
yl]oxy]imino]propyl]-3-hydroxy-5-(tetrahydro-2H-pyran-4-yl)-2-
cyclohexen-1-one) and its metabolites convertible to GP (3-
(tetrahydropyran-4-yl)pentane-1,5-dioic acid) and OH-GP (3-hydroxy-3-
(tetrahydropyran-4-yl)pentane-1,5-dioic acid), calculated as 
tepraloxydim, in or on the commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cotton, undelinted seed.....................................        0.2
Cotton, gin byproducts......................................        3.0
Flax, seed..................................................        0.10
Grain, aspirated fraction...................................     1200.0
Pea and bean, dried shelled, except soybean, subgroup 6C \1\        0.10
Soybean, seed...............................................        6.0
Soybean, hulls..............................................        8.0
Sunflower subgroup 20B \1\..................................        0.20
------------------------------------------------------------------------
\1\ There are no U.S. registrations for commodities in this subgroup.

    (2) Tolerances are established for residues of tepraloxydim, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below is 
to be determined by measuring only the combined residues of tepraloxydim 
(2-[1-[[[(2E)-3-chloro-2-propen-1-yl]oxy]imino]propyl]-3-hydroxy-5-
(tetrahydro-2H-pyran-4-yl)-2-cyclohexen-1-one) and its metabolites

[[Page 645]]

convertible to GP (3-(tetrahydropyran-4-yl)pentane-1,5-dioic acid), OH-
GP (3-hydroxy-3-(tetrahydropyran-4-yl)pentane-1,5-dioic acid), and GL 
(3-(2-oxotetrahydropyran-4-yl)-1,5-dioic acid), calculated as 
tepraloxydim, in or on the commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.15
Cattle, kidney..............................................        0.50
Cattle, meat................................................        0.20
Cattle, meat byproducts, except kidney......................        0.20
Egg.........................................................        0.20
Goat, fat...................................................        0.15
Goat, kidney................................................        0.50
Goat, meat..................................................        0.20
Goat, meat byproducts, except kidney........................        0.20
Hog, fat....................................................        0.15
Hog, kidney.................................................        0.50
Hog, meat...................................................        0.20
Hog, meat byproducts, except kidney.........................        0.20
Horse, fat..................................................        0.15
Horse, kidney...............................................        0.50
Horse, meat.................................................        0.20
Horse, meat byproducts, except kidney.......................        0.20
Milk........................................................        0.10
Poultry, fat................................................        0.30
Poultry, liver..............................................        1.00
Poultry, meat...............................................        0.20
Poultry, meat byproducts, except liver......................        0.20
Sheep, fat..................................................        0.15
Sheep, kidney...............................................        0.50
Sheep, meat.................................................        0.20
Sheep, meat byproducts, except kidney.......................        0.20
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. A tolerance with 
regional registration, as defined in Sec. 180.1(l), is established for 
residues of tepraloxydim, including its metabolites and degradates, in 
or on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only the 
combined residues of tepraloxydim (2-[1-[[[(2E)-3-chloro-2-propen-1-
yl]oxy]imino]propyl]-3-hydroxy-5-(tetrahydro-2H-pyran-4-yl)-2-
cyclohexen-1-one) and its metabolites convertible to GP (3-
(tetrahydropyran-4-yl)pentane-1,5-dioic acid) and OH-GP (3-hydroxy-3-
(tetrahydropyran-4-yl)pentane-1,5-dioic acid), calculated as 
tepraloxydim, in or on the commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Canola, seed................................................        0.50
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

[66 FR 40150, Aug. 2, 2001 as amended at 72 FR 54588, Sept. 26, 2007; 76 
FR 34885, June 15, 2011; 76 FR 82152, Dec. 30, 2011]



Sec. 180.574  Fluazinam; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
fluazinam (3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-
5-(trifluoromethyl)-2-pyridinamine), including its metabolites and 
degradates, in or on the commodities in the table below. Compliance with 
the tolerance levels specified below is to be determined by measuring 
only fluazinam.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Apple.......................................................        2.0
Apple, wet pomace...........................................        5.0
Bushberry subgroup 13-07B...................................        7.0
Carrot, roots...............................................        0.70
Ginseng.....................................................        4.5
Lettuce, head...............................................        0.02
Lettuce, leaf...............................................        2.0
Melon subgroup 9A...........................................        0.07
Onion, bulb, subgroup 3-07A.................................        0.20
Pea and bean, dried shelled, except soybean, subgroup 6C,           0.02
 except pea.................................................
Pea and bean, succulent shelled, subgroup 6B, except pea....        0.04
Peanut......................................................        0.02
Pepper/eggplant subgroup 8-10B..............................        0.09
Potato......................................................        0.02
Soybean, seed...............................................        0.01
Soybean, hulls..............................................        0.05
Turnip, greens..............................................        0.01
Vegetable, Brassica leafy, group 5..........................        0.01
Vegetable, legume, edible-podded, subgroup 6A, except pea...        0.10
------------------------------------------------------------------------

    (2) Tolerances are established for residues of fluazinam, including 
its metabolites and degradates, in or on the commodities in the table 
below. Compliance with the tolerance levels specified below is to be 
determined by measuring only fluazinam and its metabolite AMGT (3-[[4-
amino-3-[[3-chloro-5-(trifluoromethyl)-2-pyridinyl]amino]-2-nitro-6-
(trifluoromethyl) phenyl]thio]-2-(beta-D-glucopyranosyloxy) propionic 
acid).

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grape, wine \1\.............................................        3.0
------------------------------------------------------------------------
\1\ No US registration as of March 15, 2002.

    (3) Tolerances are established for residues of fluazinam (3-chloro-
N-[3-chloro-2,6-dinitro-4-

[[Page 646]]

(trifluoromethyl)phenyl]-5-(trifluoromethyl)-2-pyridinamine), including 
its metabolites and degradates, in or on the commodities in the table 
below. Compliance with the tolerance levels specified below is to be 
determined by measuring only fluazinam, AMPA (2-(6-amino-3-chloro-
[alpha],[alpha],[alpha]-trifluoro-2-nitro-p-toluidino)-3-chloro-5-
(trifluoromethyl) pyridine), DAPA (3-chloro-2-(2,6-diamino-3-chloro-
[alpha],[alpha],[alpha].-trifluoro-p-toluidino)-5-
(trifluoromethyl)pyridine), and their sulfamate conjugates.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.05
Cattle, meat byproducts.....................................        0.05
Goat, fat...................................................        0.05
Goat, meat byproducts.......................................        0.05
Horse, fat..................................................        0.05
Horse, meat byproducts......................................        0.05
Sheep, fat..................................................        0.05
Sheep, meat byproducts......................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[66 FR 46738, Sept. 7, 2001, as amended at 67 FR 19130, Apr. 18, 2002; 
72 FR 60260, Oct. 24, 2007; 75 FR 26667, May 12, 2010; 76 FR 3029, Jan. 
19, 2011; 77 FR 66729, Nov. 7, 2012]



Sec. 180.575  Sulfuryl fluoride; tolerances for residues.

    (a)(1) General. Tolerances are established for residues of sulfuryl 
fluoride in or on the following commodities from the postharvest 
fumigation with sulfuryl fluoride for the control of insects:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
All processed food commodities not otherwise listed.........        2.0
Barley, bran, postharvest...................................        0.05
Barley, flour, postharvest..................................        0.05
Barley, grain, postharvest..................................        0.1
Barley, pearled barley, postharvest.........................        0.05
Cacao bean, roasted bean, postharvest.......................        0.2
Cattle, meat, dried.........................................        0.01
Cheese......................................................        2.0
Coconut, postharvest........................................        1.0
Coffee, bean, roasted bean, postharvest.....................        1.0
Corn, field, flour, postharvest.............................        0.01
Corn, field, grain, postharvest.............................        0.05
Corn, field, grits, postharvest.............................       15.0
Corn, field, meal, postharvest..............................        0.01
Corn, pop, grain, postharvest...............................        0.05
Cotton, undelinted seed, postharvest........................        0.5
Egg, dried..................................................        1.0
Fruit, dried, postharvest...................................        0.05
Ginger, postharvest.........................................        0.5
Grain, aspirated fractions, postharvest.....................        0.05
Herbs and spices group 19, postharvest......................        0.5
Hog, meat...................................................        0.02
Milk, powdered..............................................        2.0
Millet, grain, postharvest..................................        0.1
Nut, pine, postharvest......................................        0.2
Nut, tree, Group 14, postharvest............................        3.0
Oat, flour, postharvest.....................................        0.05
Oat, grain, postharvest.....................................        0.1
Oat, groats/rolled oats, postharvest........................        0.1
Peanut, postharvest.........................................        0.5
Pistachio, postharvest......................................        3.0
Rice, bran, postharvest.....................................        0.01
Rice, flour, postharvest....................................        0.05
Rice, grain, postharvest....................................        0.04
Rice, hulls, postharvest....................................        0.1
Rice, polished rice, postharvest............................        0.01
Rice, wild, grain, postharvest..............................        0.05
Sorghum, grain, grain, postharvest..........................        0.1
Triticale, grain, postharvest...............................        0.1
Vegetable, legume, group 6, postharvest.....................        0.5
Wheat, bran, postharvest....................................        0.05
Wheat, flour, postharvest...................................        0.05
Wheat, germ, postharvest....................................        0.02
Wheat, grain, postharvest...................................        0.1
Wheat, milled byproducts, postharvest.......................        0.05
Wheat, shorts, postharvest..................................        0.05
------------------------------------------------------------------------

    (2) To assure safe use of this pesticide commodities treated with 
sulfuryl fluoride must be aerated for at least 24 hours prior to 
entering commerce.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registration. [Reserved]
    (d) Indirect or inadvertant residues. [Reserved]

[67 FR 5740, Feb. 7, 2002, as amended at 69 FR 3257, Jan. 23, 2004; 70 
FR 40908, July 15, 2005]



Sec. 180.576  Cyhalofop-butyl; tolerances for residues.

    (a) General. Tolerances are established for residues of cyhalofop-
butyl, including its metabolites and degradates, in or on the 
commodities listed in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring cyhalofop butyl 
[R-(+)-n-butyl-2-(4(4-cyano-2-fluorophenoxy)-phenoxy)propionate], 
cyhalofop acid [R-(+)-2-(4(4-cyano-2-fluorophenoxy)-phenoxy)propionic 
acid], and the di-acid metabolite [(2R)-4-(4-(1-carboxyethoxy)phenoxy)-
3-fluorobenzoic acid].

[[Page 647]]



------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Rice, grain.................................................        0.40
Wild rice, grain............................................        0.40
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[67 FR 43256, June 27, 2002, as amended at 74 FR 15880, Apr. 8, 2009; 76 
FR 82157, Dec. 30, 2011]



Sec. 180.577  Bispyribac-sodium; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide bispyribac-sodium, including its metabolites and degradates, 
in or on the commodity listed below. Compliance with the tolerance level 
specified below is to be determined by measuring only bispyribac-sodium, 
(2,6-bis[(4,6-dimethoxy-2-pyrimidinyl)oxy]benzoic acid, sodium salt), in 
or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Fish, freshwater............................................        0.01
Rice, grain.................................................        0.02
Rice, straw.................................................        0.02
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[66 FR 48097, Sept. 18, 2001, as amended at 76 FR 5716, Feb. 2, 2011]



Sec. 180.578  Acetamiprid; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide acetamiprid (1E)-N-[(6-chloro-3-pyridinyl)methyl]-N'-cyano-
N-methylethanimidamide, including its metabolites and degradates, in or 
on the commodities in the table below as a result of the application of 
acetamiprid. Compliance with the tolerance levels specified below is to 
be determined by measuring only acetamiprid in or on the following 
commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hulls..............................................        5.0
Asparagus..................................................        0.80
Berry, low growing subgroups 13-07G........................        0.60
Brassica, head and stem, subgroup 5A.......................        1.20
Brassica, leafy greens, subgroup 5B........................       15
Bushberry subgroup 13-07B..................................        1.6
Caneberry subgroup 13-07A..................................        1.6
Canola, seed...............................................        0.010
Citrus, dried pulp.........................................        1.20
Corn, sweet, forage........................................       15
Corn, sweet, kernel plus cob with husks removed............        0.01
Corn, sweet, stover........................................       30
Cotton, gin byproducts.....................................       20.0
Cotton, undelinted seed....................................        0.60
Fruit, citrus, group 10-10.................................        1.0
Fruit, pome, group 11-10...................................        1.0
Fruit, small, vine climbing, except fuzzy kiwifruit,               0.35
 subgroup 13-07F...........................................
Fruit, stone, group 12, except plum, prune.................        1.20
Grain, aspirated fractions.................................        5.0
Mustard, seed..............................................        0.010
Nut, tree, group 14........................................        0.10
Onion, bulb, subgroup 3-07A................................        0.02
Onion, green, subgroup 3-07B...............................        4.5
Pea and bean, succulent shelled, subgroup 6B...............        0.40
Pistachio..................................................        0.10
Plum, prune, dried.........................................        0.40
Plum, prune, fresh.........................................        0.20
Soybean, hulls.............................................        0.04
Soybean, seed..............................................        0.03
Tea, dried\1\..............................................       50.0
Tomato, paste..............................................        0.40
Turnip greens..............................................       15
Vegetable, cucurbit, group 9...............................        0.50
Vegetable, fruiting, group 8-10............................        0.20
Vegetable, leafy, except brassica, group 4.................        3.00
Vegetable, legume, edible podded, subgroup 6A..............        0.60
Vegetable, tuberous and corm, group 1......................        0.01
------------------------------------------------------------------------
\1\There are no U.S. registrations as of February 10, 2010, for the use
  of acetamiprid on dried tea.

    (2) Tolerances are established for residues of the insecticide 
acetamiprid (1E)-N-[(6-chloro-3-pyridinyl)methyl]-N[min]-cyano-N-
methylethanimidamide, including its metabolites and degradates, in or on 
the commodities in the table below as a result of the application of 
acetamiprid. Compliance with the tolerance levels specified below is to 
be determined by measuring acetamiprid and (1E)-N-[(6-chloro-3-
pyridinyl)methyl]-N[min]-cyano-N-ethanimidamide in or on the following 
commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................        0.20
Cattle, meat...............................................        0.30
Cattle, meat byproducts....................................        0.70
Egg........................................................        0.010
Goat, fat..................................................        0.20
Goat, meat.................................................        0.30
Goat, meat byproducts......................................        0.70
Hog, fat...................................................        0.10

[[Page 648]]

 
Hog, meat..................................................        0.10
Hog, meat byproducts.......................................        0.20
Horse, fat.................................................        0.20
Horse, meat................................................        0.30
Horse, meat byproducts.....................................        0.70
Milk.......................................................        0.30
Poultry, fat...............................................        0.010
Poultry, liver.............................................        0.050
Poultry, meat..............................................        0.010
Sheep, fat.................................................        0.20
Sheep, meat................................................        0.30
Sheep, meat byproducts.....................................        0.70
------------------------------------------------------------------------

    (3) A tolerances of 0.01 ppm is established for residues of the 
insecticide acetamiprid, including its metabolites and degradates, in or 
on all food/feed items (other than those covered by a higher tolerance 
in paragraph (a)(1) or (a)(2) of this section as a result of the use on 
growing crops) as a result of the application of acetamiprid in food/
feed handling establishments. Compliance with the 0.01 ppm tolerance 
level is to be determined by measuring only acetamiprid (1E)-N-[(6-
chloro-3-pyridinyl)methyl]-N[min]-cyano-N-methylethanimidamide in or on 
the commodities.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registrations are established for residues of the insecticide 
acetamiprid (1E)-N-[(6-chloro-3-pyridinyl)methyl]-N[min]-cyano-N-
methylethanimidamide, including its metabolites and degradates, in or on 
the commodities in the table below as a result of the application of 
acetamiprid. Compliance with the tolerance levels specified below is to 
be determined by measuring only acetamiprid in or on the following 
commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Clover, forage..............................................        0.10
Clover, hay.................................................        0.01
------------------------------------------------------------------------

---------------------------------------------------------------------------
    (d) Indirect or inadvertent residues. [Reserved]

[67 FR 14659, Mar. 27, 2002, as amended at 68 FR 52352, Sept. 3, 2003; 
70 FR 19293, Apr. 13, 2005; 72 FR 67262, Nov. 28, 2007; 73 FR 2811, Jan. 
16, 2008; 75 FR 6582, Feb. 10, 2010; 77 FR 18716, Mar. 28, 2012; 77 FR 
43529, July 25, 2012; 78 FR 36676, June 19, 2013]



Sec. 180.579  Fenamidone; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
fungicide, fenamidone, including its metabolites and degradates, in or 
on the following commodities. Compliance with the tolerance levels is to 
be determined by measuring only fenamidone (4H-Imidazol-4-one, 3,5-
dihydro-5-methyl-2-(methylthio)-5-phenyl-3 (phenylamino)-,(S)-), in or 
on the commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A........................        5.0
Brassica, leafy greens, subgroup 5B.........................       55
Cilantro, leaves............................................       60
Cotton, gin byproducts......................................        0.02
Cotton, undelinted seed.....................................        0.02
Garlic......................................................        0.20
Garlic, great headed........................................        0.20
Leek........................................................        1.5
Okra........................................................        3.5
Onion, bulb.................................................        0.20
Onion, green................................................        1.5
Onion, welsh................................................        1.5
Pepper, nonbell.............................................        3.5
Shallot, bulb...............................................        0.20
Shallot, fresh leaves.......................................        1.5
Sunflower...................................................        0.02
Tomato, paste...............................................        2.2
Tomato, puree...............................................        2.0
Turnip, greens..............................................       55
Vegetable, cucurbit, group 9................................        0.15
Vegetable, fruiting, group 8, except nonbell pepper.........        1.0
Vegetable, leafy, except Brassica, group 4..................       60
Vegetable, root, except sugar beet, subgroup 1B, except             0.15
 radish.....................................................
Vegetable, tuberous and corm, subgroup 1C...................        0.02
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the fungicide 
fenamidone, including its metabolites and degradates, in or on the 
following commodities. Compliance with the tolerance levels is to be 
determined by measuring fenamidone (4H-Imidazol-4-one, 3,5-dihydro-5-
methyl-2-(methylthio)-5-phenyl-3 (phenylamino)-,(S)-), and its 
metabolite RPA 717879 (2,4-imidazolidinedione, 5-methyl-5-phenyl), in or 
on the commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.10
Cattle, meat................................................        0.10
Cattle, meat byproducts.....................................        0.10
Goat, fat...................................................        0.10
Goat, meat..................................................        0.10
Goat, meat byproducts.......................................        0.10
Milk........................................................        0.02
Sheep, fat..................................................        0.10
Sheep, meat.................................................        0.10
Sheep, meat byproducts......................................        0.10
------------------------------------------------------------------------


[[Page 649]]

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. A tolerance with 
regional registration as defined in Sec. 180.1(l) is established for 
residues of the fungicide fenamidone, including its metabolites and 
degradates, in or on the following commodities. Compliance with the 
tolerance levels is to be determined by measuring only fenamidone (4H-
Imidazol-4-one, 3,5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3 
(phenylam-ino)-,(S)-), in or on the commodity:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grape\1\....................................................        1.0
------------------------------------------------------------------------
\1\ Applicable to grapes grown East of the Rocky Mountains.

    (d) Indirect or inadvertent residues. Tolerances are established for 
residues of the fungicide fenamidone, including its metabolites and 
degradates, in or on the following commodities. Compliance with the 
tolerance levels is to be determined by measuring fenamidone (4H-
Imidazol-4-one, 3,5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3 
(phenylamino)-,(S)-), and its metabolite RPA 717879 (2,4-
imidazolidinedione, 5-methyl-5-phenyl), in or on the following 
commodities when present therein as a result of application of 
fenamidone to the crops in paragraph (a)(1).

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grain, cereal, group 15, except rice........................        0.1
Grain, cereal, forage, fodder and straw, group 16, except           0.5
 rice.......................................................
Soybean, forage.............................................        0.15
Soybean, hay................................................        0.25
Soybean, seed...............................................        0.02
Strawberry..................................................        0.02
------------------------------------------------------------------------


[67 FR 60976, Sept. 27, 2002, as amended at 69 FR 58066, Sept. 29, 2004; 
71 FR 55293, Sept. 22, 2006; 72 FR 60272, Oct. 24, 2007; 74 FR 34257, 
July 15, 2009; 76 FR 34885, June 15, 2011; 76 FR 70895, Nov. 16, 2011; 
77 FR 32401, June 1, 2012]



Sec. 180.580  Iodosulfuron-Methyl-Sodium; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide Iodosulfuron-Methyl-Sodium (methyl 4-iodo-2-[3-(4-methoxy-6-
methyl-1,3,5 triazin-2-yl)ureidosulfonyl]benzoate, sodium salt) in or on 
the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Corn, field, forage.........................................        0.05
Corn, field, grain..........................................        0.03
Corn, field, stover.........................................        0.05
Wheat, forage...............................................        0.10
Wheat, grain................................................        0.02
Wheat, hay..................................................        0.05
Wheat, straw................................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[67 FR 57532, Sept. 11, 2002, as amended at 74 FR 23644, May 20, 2009]



Sec. 180.581  Iprovalicarb; tolerances for residues.

    (a) General. Tolerances are established for residues of 
iprovalicarb, [2-methyl-1[[[(1S)-(4-methylphenyl) ethyl] amino]carbonyl] 
propyl]carbamic acid methylethylester, in or on the following 
commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grape \1\...................................................        2.0
Tomato \1\..................................................        1.0
------------------------------------------------------------------------
\1\There is no U.S. registration as of September 1, 2005.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[67 FR 54359, Aug. 22, 2002, as amended at 70 FR 55281, Sept. 21, 2005]



Sec. 180.582  Pyraclostrobin; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
fungicide pyradostrobin, including its metabolites and degradates, in or 
on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only the sum of 
pyraclostrobin (carbamic acid, [2-[[[ 1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy] methyl]phenyl]methoxy-, methyl ester) and its desmethoxy 
metabolite (methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-

[[Page 650]]

yl]oxy]methyl] phenylcarbamate), calculated as the stoichiometric 
equivalent of pyraclostrobin, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................       10
Alfalfa, hay................................................       30
Almond, hulls...............................................        7.0
Apple, wet pomace...........................................        8.0
Avocado.....................................................        0.6
Banana......................................................        0.04
Barley, grain...............................................        1.4
Barley, hay.................................................       25
Barley, straw...............................................        6.0
Bean, succulent shelled.....................................        0.5
Beet, sugar, dried pulp.....................................        1.0
Beet, sugar, roots..........................................        0.2
Beet, sugar, tops...........................................        8.0
Berry, group 13.............................................        4.0
Borage, seed................................................        0.45
Brassica, head and stem, subgroup 5A........................        5.0
Brassica, leafy greens, subgroup 5B.........................       16.0
Canistel....................................................        0.6
Castor oil plant, seed......................................        0.45
Chinese tallowtree, seed....................................        0.45
Citrus, dried pulp..........................................       12.5
Citrus, oil.................................................        9.0
Coffee, bean, green.........................................        0.3\1\
Corn, field, forage.........................................        5.0
Corn, field, grain..........................................        0.1
Corn, field, refined oil....................................        0.2
Corn, field, stover.........................................       17.0
Corn, pop, grain............................................        0.1
Corn, pop, stover...........................................       17.0
Corn, sweet, forage.........................................        5.0
Corn, sweet, kernel plus cob with husks removed.............        0.04
Corn, sweet, stover.........................................       23.0
Cotton, gin byproducts......................................       30
Cotton, undelinted seed.....................................        0.3
Crambe, seed................................................        0.45
Cuphea, seed................................................        0.45
Echium, seed................................................        0.45
Euphorbia, seed.............................................        0.45
Evening primrose, seed......................................        0.45
Flax, seed..................................................        0.45
Fruit, citrus, group 10.....................................        2.0
Fruit, pome, group 11.......................................        1.5
Fruit, stone, group 12......................................        2.5
Gold of pleasure, seed......................................        0.45
Grain, aspirated fractions..................................        2.5
Grape.......................................................        2.0
Grape, raisin...............................................        7.0
Grass, forage...............................................       10
Grass, hay..................................................        4.5
Grass, seed screenings......................................       27
Grass, straw grown for seed.................................       14
Hare's ear mustard, seed....................................        0.45
Hop, dried cones............................................       23.0
Jojoba, seed................................................        0.45
Lesquerella, seed...........................................        0.45
Lunaria, seed...............................................        0.45
Mango.......................................................        0.6
Meadowfoam, seed............................................        0.45
Milkweed, seed..............................................        0.45
Mustard, seed...............................................        0.45
Niger seed, seed............................................        0.45
Nut, tree, group 14.........................................        0.04
Oat, grain..................................................        1.2
Oat, hay....................................................       18
Oat, straw..................................................       15
Oil radish, seed............................................        0.45
Papaya......................................................        0.6
Pea, succulent..............................................        0.2
Pea and bean, dried shelled, except soybean, subgroup 6C....        0.5
Peanut......................................................        0.05
Peanut, refined oil.........................................        0.1
Peppermint, tops............................................        8.0
Pistachio...................................................        0.7
Poppy, seed.................................................        0.45
Radish, tops................................................       16
Rapeseed, seed..............................................        0.45
Rose hip, seed..............................................        0.45
Rye, grain..................................................        0.04
Rye, straw..................................................        0.5
Safflower, seed.............................................        0.45
Sapodilla...................................................        0.6
Sapote, black...............................................        0.6
Sapote, mamey...............................................        0.6
Sesame, seed................................................        0.45
Sorghum, grain, forage......................................        5.0
Sorghum, grain, grain.......................................        0.60
Sorghum, grain, stover......................................        0.80
Soybean, forage.............................................       11
Soybean, hay................................................       14
Soybean, hulls..............................................        0.06
Soybean, seed...............................................        0.04
Spearmint, tops.............................................        8.0
Star apple..................................................        0.6
Stokes aster, seed..........................................        0.45
Strawberry..................................................        1.2
Sunflower, seed.............................................        0.45
Sweet rocket, seed..........................................        0.45
Tallowwood, seed............................................        0.45
Tea oil plant, seed.........................................        0.45
Vegetable, bulb, group 3....................................        0.9
Vegetable, cucurbit, group 9................................        0.5
Vegetable, foliage of legume, except soybean, subgroup 7A...       25.0
Vegetable, fruiting, group 8................................        1.4
Vegetable, leafy, except brassica, group 4..................       29.0
Vegetable, leaves of root and tuber, group 2, except sugar         16.0
 beet.......................................................
Vegetable, legume, edible podded, subgroup 6A...............        0.5
Vegetable, root, except sugar beet, subgroup 1B.............        0.4
Vegetable, tuberous and corm, subgroup 1C...................        0.04
Vegetables, foliage of legume, group 7......................       25
Vernonia, seed..............................................        0.45
Wheat, grain................................................        0.02
Wheat, hay..................................................        6.0
Wheat, straw................................................        8.5
------------------------------------------------------------------------
\1\ There is no U.S. registration on coffee, bean, green as of September
  30, 2009.

    (2) Tolerances are established for combined residues of the 
fungicide pyraclostrobin carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-
pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester and its 
metabolites convertible to 1-(4-chlorophenyl)-1H-pyrazol-3-ol and 1-(4-
chloro-2-hydroxyphenyl)-1H-pyrazol-3-ol, expressed as parent compound, 
in or on the following raw agricultural commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.1

[[Page 651]]

 
Cattle, liver...............................................        1.5
Cattle, meat................................................        0.1
Cattle, meat byproducts, except liver.......................        0.2
Goat, fat...................................................        0.1
Goat, liver.................................................        1.5
Goat, meat..................................................        0.1
Goat, meat byproducts, except liver.........................        0.2
Hog, fat....................................................        0.1
Hog, liver..................................................        1.5
Hog, meat...................................................        0.1
Hog, meat byproducts, except liver..........................        0.2
Horse, fat..................................................        0.1
Horse, liver................................................        0.1
Horse, meat.................................................        0.1
Horse, meat byproducts, except liver........................        0.2
Milk........................................................        0.1
Poultry, eggs...............................................        0.10
Poultry, fat................................................        0.10
Poultry, meat...............................................        0.10
Poultry, meat byproducts....................................        0.10
Sheep, fat..................................................        0.1
Sheep, liver................................................        1.5
Sheep, meat.................................................        0.1
Sheep, meat byproducts, except liver........................        0.2
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. A time-limited tolerance is 
established for combined residues of the fungicide pyraclostrobin, 
(carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl] 
phenyl]methoxy-, methyl ester) and its desmethoxy metabolite (methyl-N-
[[[1-(4-chlorophenyl) pyrazol-3-yl]oxy]o-tolyl]carbamate) in connection 
with use of the pesticide under section 18 emergency exemptions granted 
by EPA. The time-limited tolerance will expire and is revoked on the 
date specified in the following table.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   Revocation
                                                   million       Date
------------------------------------------------------------------------
Endive, Belgian.................................       11.0     12/31/13
Sugarcane, cane.................................       0.02     12/31/14
Sugarcane, molasses.............................        0.4     12/31/14
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[67 FR 60901, Sept. 27, 2002, as amended at 69 FR 63100, Oct. 29, 2004; 
71 FR 17021, Apr. 5, 2006; 72 FR 54569, Sept. 26, 2007; 73 FR 15431, 
Mar. 24, 2008; 73 FR 21842, Apr. 23, 2008; 73 FR 44167, July 30, 2008; 
74 FR 11499, Mar. 18, 2009; 74 FR 51496, Oct. 7, 2009; 75 FR 770, Jan. 
6, 2010; 75 FR 42329, July 21, 2010; 75 FR 80346, Dec. 22, 2010; 76 FR 
81396, Dec. 28, 2011]



Sec. 180.583  Triticonazole; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide triticonazole, (1RS)-(E)-5-[(4-chlorophenyl)methylene]-2,2-
dimethyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol, from the 
treatment of seed prior to planting in or on raw agricultural 
commodities as follows:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grain, cereal, forage, fodder and straw, group 16, except           0.10
 rice.......................................................
Grain, cereal, group 15, except rice........................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[67 FR 60959, Sept. 27, 2002, as amended at 75 FR 4288, Jan. 27, 2010]



Sec. 180.584  Tolylfluanid; tolerances for residues.

    (a) General. Tolerances are established for residues of 
tolylfluanid, 1,1-dichloro-N-[(dimethylamino)-sulfonyl]-1-fluoro-N-(4-
methylphenyl)methanesulfenamide in or on the following commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Apple \1\...................................................        5.0
Grape \1\...................................................       11
Hop, dried cones \1\........................................       30
Tomato \1\..................................................        2.0
------------------------------------------------------------------------
\1\ No U.S. registration as of August 31, 2002.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[67 FR 60141, Sept. 25, 2002]



Sec. 180.585  Pyraflufen-ethyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide, pyraflufen-ethyl, including its metabolites and degradates, 
in the commodities in the table below. Compliance with the plant 
commodity tolerance

[[Page 652]]

levels specified in the table is to be determined by measuring only the 
sum of the parent pyraflufen-ethyl, ethyl 2-[2-chloro-5-(4-chloro-5-
difluoromethoxy)-1-methyl-1H-pyrazol-3-yl]-4-fluorophenoxy] acetate, and 
its acid metabolite, E-1, 2-chloro-5-(4-chloro-5-difluoromethoxy-1-
methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetic acid, calculated as the 
stoichiometric equivalent of pyraflufen-ethyl in or on the commodity. 
Compliance with the livestock commodity tolerance levels specified in 
the table is to be determined by measuring only the sum of the parent 
pyraflufen-ethyl, ethyl 2-[2-chloro-5-(4-chloro-5-difluoromethoxy)-1-
methyl-1H-pyrazol-3-yl]-4-fluorophenoxy] acetate and its acid 
metabolites: E-1, 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-
pyrazol-3-yl)-4-fluorophenoxyacetic acid, and E-9, 2-chloro-5-(4-chloro-
5-difluoromethoxy-1H-pyrazol-3-yl)-4-fluorophenoxyacetic acid, both 
calculated as the stoichiometric equivalent of pyraflufen-ethyl in or on 
the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        0.02
Cattle, fat.................................................        0.03
Cattle, meat................................................        0.03
Cattle, meat byproducts.....................................        0.03
Corn, field, forage.........................................        0.01
Corn, field, grain..........................................        0.01
Corn, field, stover.........................................        0.01
Cotton, gin byproducts......................................        1.5
Cotton, undelinted seed.....................................        0.04
Fruit, pome, group 11-10....................................        0.01
Fruit, stone, group 12......................................        0.01
Goat, fat...................................................        0.03
Goat, meat..................................................        0.03
Goat, meat byproducts.......................................        0.03
Grape.......................................................        0.01
Grass, forage, group 17.....................................        1.0
Grass, hay, group 17........................................        1.4
Horse, fat..................................................        0.03
Horse, meat.................................................        0.03
Horse, meat byproducts......................................        0.03
Milk........................................................        0.03
Nut, tree, group 14.........................................        0.01
Olive.......................................................        0.01
Peanut......................................................        0.01
Peanut, hay.................................................        0.07
Pistachio...................................................        0.01
Pomegranate.................................................        0.01
Potato......................................................        0.02
Sheep, fat..................................................        0.03
Sheep, meat.................................................        0.03
Sheep, meat byproducts......................................        0.03
Soybean, forage.............................................        0.05
Soybean, hay................................................        0.10
Soybean, seed...............................................        0.01
Wheat, forage...............................................        0.02
Wheat, grain................................................        0.01
Wheat, hay..................................................        0.01
Wheat, straw................................................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[68 FR 23055, Apr. 30, 2003, as amended at 68 FR 27739, May 21, 2003; 69 
FR 26312, May 12, 2004; 73 FR 51743, Sept. 5, 2008; 76 FR 31484, June 
11, 2011; 77 FR 75861, Dec. 26, 2012; 78 FR 13263, Feb. 27, 2013]



Sec. 180.586  Clothianidin; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide clothianidin, including its metabolites and degradates. 
Compliance with the tolerance levels specified below is to be determined 
by measuring only clothianidin, (E)-N-[(2-Chloro-5-thiazolyl)methyl]-
N[min] -methyl-N[sec] -nitroguanidine, in or on the following raw 
agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        1.5
Beet, sugar, dried pulp.....................................        0.03
Beet, sugar, molasses.......................................        0.05
Beet, sugar, roots..........................................        0.02
Berry, low-growing, subgroup 13-07H, except strawberry......        0.01
Canola, seed................................................        0.01
Cotton, gin byproducts......................................        4.5
Cotton, undelinted seed.....................................        0.20
Fig.........................................................        0.05
Fruit, pome.................................................        1.0
Grain, cereal, forage, fodder and straw, group 16, except           0.35
 rice, forage...............................................
Grain, cereal, forage, fodder and straw, group 16, except           0.07
 rice, hay..................................................
Grain, cereal, forage, fodder and straw, group 16, except           0.1
 rice, stover...............................................
Grain, cereal, forage, fodder and straw, group 16, except           0.05
 rice, straw................................................
Grain, cereal, group 15, except rice........................        0.01
Grape.......................................................        0.60
Milk........................................................        0.01
Mustard, seed...............................................        0.01
Nut, tree, group 14.........................................        0.01
Peach.......................................................        0.80
Pepper......................................................        0.80
Pomegranate.................................................        0.20
Potato, chips...............................................        0.6
Potato, granules/flakes.....................................        1.5
Rice, grain.................................................        0.01
Soybean, seed...............................................        0.02
Tea, dried \1\..............................................       70
Vegetable, brassica, leafy, group 5.........................        1.9
Vegetable, bulb, group 3-07.................................        0.45
Vegetable, cucurbit, group 9................................        0.06
Vegetable, fruiting, group 8, except pepper.................        0.20
Vegetable, leafy, except brassica, group 4..................        3.0
Vegetable, root, except sugar beet, subgroup 1B.............        0.8
Vegetable, tuberous and corm, subgroup 1C...................        0.3
------------------------------------------------------------------------
\1\ No U.S. registrations.


[[Page 653]]

    (2) Time-limited tolerances are established for residues of the 
insecticide clothianidin, including its metabolites and degradates. 
Compliance with the tolerance levels specified below is to be determined 
by measuring only clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-
3-methyl-2-nitroguanidine, in or on the following raw agricultural 
commodity:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Rice, seed......................................       0.01      6/23/12
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect and inadvertant residues. Tolerances are established 
for the indirect or inadvertent residues of the insecticide 
clothianidin, including its metabolites and degradates. Compliance with 
the tolerance levels specified below is to be determined by measuring 
only clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-
nitroguanidine, in or on the following raw agricultural commodities when 
present therein as a result of the application of clothianidin to crops 
listed in paragraph (a) of this section:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Animal feed, nongrass, group 18.............................        0.02
Grass, forage, fodder and hay, group 17.....................        0.02
Soybean, forage.............................................        0.02
Soybean, hay................................................        0.02
------------------------------------------------------------------------


[74 FR 65028, Dec. 9, 2009, as amended at 76 FR 7718, Feb. 11, 2011; 76 
FR 25246, May 4, 2011; 76 FR 34886, June 15, 2011; 77 FR 52252, Aug. 29, 
2012; 78 FR 19136, Mar. 29, 2013]



Sec. 180.587  Famoxadone; tolerance for residues.

    (a) General. Tolerances are established for residues of the 
fungicide famoxadone (3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-
oxazolidine-2,4-dione) in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Caneberry subgroup 13-07A...................................       10
Cattle, fat.................................................        0.02
Cattle, liver...............................................        0.05
Cilantro, leaves............................................       25
Goat, fat...................................................        0.02
Goat, liver.................................................        0.05
Grape, raisin \1\...........................................        4.0
Hop, dried cone.............................................       80
Horse, fat..................................................        0.02
Horse, liver................................................        0.05
Milk, fat (reflecting negligible residues in whole milk)....        0.06
Onion, bulb, subgroup 3-07A.................................        0.45
Onion, green, subgroup 3-07B................................       40
Potato......................................................        0.02
Sheep, fat..................................................        0.02
Sheep, liver................................................        0.05
Spinach.....................................................       50
Tomato......................................................        1.0
Vegetable, cucurbit, group 9................................        0.30
Vegetable, fruiting, group 8, except tomato.................        4.0
Vegetable, leafy, except Brassica, group 4, except spinach..       25
------------------------------------------------------------------------
 \1\ There are no U.S. registrations as of May 15, 2003.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with a regional registrations. Tolerances with a 
regional registration as defined in Sec. 180.1(l) are established for 
the residues of the fungicide famoxadone, 3-anilino-5-methyl-5-(4-
phenoxyphenyl)-1,3-oxazolidine-2,4-dione) in or on the raw agricultural 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grape.......................................................        2.5
------------------------------------------------------------------------

    (d) Indirect or inadvertant residues. [Reserved]

[68 FR 39471, July 2, 2003, as amended at 72 FR 28881, May 23, 2007; 74 
FR 9364, Mar. 4, 2009; 76 FR 34885, June 15, 2011]



Sec. 180.588  Quinoxyfen; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide quinoxyfen, 5,7-dichloro-4-(4-fluorophenoxy)quinoline in or on 
the following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Artichoke, globe............................................        1.4
Fruit, stone, group 12......................................        0.70
Hop, dried cones............................................        3.0
Gourd, edible...............................................        0.20
Grape.......................................................        0.60
Lettuce, head...............................................        7.0
Lettuce, leaf...............................................       19
Melon, subgroup 9A..........................................        0.08
Pepper, bell................................................        0.35
Pepper, nonbell.............................................        1.7
Pumpkin.....................................................        0.20

[[Page 654]]

 
Squash, winter..............................................        0.20
Strawberry..................................................        0.90
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[68 FR 55858, Sept. 29, 2003, as amended at 70 FR 4032, Jan. 28, 2005; 
71 FR 50354, Aug. 25, 2006; 74 FR 14743, Apr. 1, 2009]



Sec. 180.589  Boscalid; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
fungicide boscalid, including its metabolites and degradates, in or on 
the commodities listed below. Compliance with the tolerance levels 
specified below is to be determined by measuring only boscalid, 3-
pyridinecarboxamide, 2-chloro-N-(4[min]-chloro[1,1'-biphenyl]-2-yl), in 
or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................       30.0
Alfalfa, hay................................................       65.0
Almond, hulls...............................................       17
Apple, wet pomace...........................................       10
Avocado.....................................................        1.5
Banana, import \1\..........................................        0.40
Brassica, head and stem, subgroup 5A........................        3.0
Brassica, leafy greens, subgroup 5B.........................       18.0
Bushberry, subgroup 13B.....................................       13.0
Caneberry, subgroup13A......................................        6.0
Canistel....................................................        1.5
Canola, refined oil.........................................        5.0
Canola, seed................................................        3.5
Citrus, dried pulp..........................................        4.5
Citrus, oil.................................................       85.0
Coffee, green bean, import \1\..............................        0.05
Cotton, gin byproducts......................................       55.0
Cotton, undelinted seed.....................................        1.0
Cucumber....................................................        0.5
Fruit, citrus, group 10.....................................        1.6
Fruit, pome, group 11.......................................        3.0
Fruit, stone, group 12......................................        3.5
Grain, aspirated fractions..................................        3.0
Grape.......................................................        3.5
Grape, raisin...............................................        8.5
Hop, dried cones............................................       35
Leaf petioles subgroup 4B...................................       45
Leafy greens subgroup 4A, except head lettuce and leaf             60
 lettuce....................................................
Lettuce, head...............................................        6.5
Lettuce, leaf...............................................       11.0
Mango.......................................................        1.5
Nut, tree, group 14.........................................        0.70
Papya.......................................................        1.5
Pea and bean, dried shelled, except soybean, subgroup 6C,           2.5
 except cowpea, field pea and grain lupin...................
Pea and bean, succulent shelled, subgroup 6B, except cowpea.        0.6
Peanut......................................................        0.05
Peanut, meal................................................        0.15
Peanut, refined oil.........................................        0.15
Peppermint, tops............................................       30.0
Pistachio...................................................        0.70
Sapodilla...................................................        1.5
Sapote, black...............................................        1.5
Sapote, mamey...............................................        1.5
Soybean, hulls..............................................        0.2
Soybean, seed...............................................        0.1
Soybean, vegetable..........................................        2.0
Spearmint, tops.............................................       30.0
Star apple..................................................        1.5
Strawberry..................................................        4.5
Sunflower, seed.............................................        0.60
Vegetable, bulb, group 3....................................        3.0
Vegetable, cucurbit, group 9, except cucumber...............        1.6
Vegetable, fruiting, group 8................................        1.2
Vegetable, legume, edible podded, subgroup 6A...............        1.6
Vegetable, root, subgroup 1A, except sugar beet, garden             1.0
 beet, radish, and turnip...................................
Vegetable, tuberous and corm, subgroup 1C...................        0.05
------------------------------------------------------------------------
\1\No US registrations as of September 16, 2009.

    (2) Tolerances are established for residues of the fungicide 
boscalid, including its metabolites and degradates, in or on the 
commodities listed below. Compliance with the tolerance levels specified 
below is to be determined by measuring only the sum of boscalid, 3-
pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl), and 
metabolites 2-chloro-N-(4'-chloro-5-hydroxy-biphenyl-2-yl) nicotinamide 
and glucuronic acid conjugate of 2-chloro-N-(4[min]-chloro-5-hydroxy-
biphenyl-2-yl) nicotinamide, calculated as the stoichiometric equivalent 
of boscalid in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.30
Cattle, meat................................................        0.10
Cattle, meat byproducts.....................................        0.35
Egg.........................................................        0.02
Goat, fat...................................................        0.30
Goat, meat..................................................        0.10
Goat, meat byproducts.......................................        0.35
Hog, fat....................................................        0.20
Hog, meat...................................................        0.05
Hog, meat byproducts........................................        0.10
Horse, fat..................................................        0.30
Horse, meat.................................................        0.10
Horse, meat byproducts......................................        0.35
Milk........................................................        0.10
Poultry, fat................................................        0.20
Poultry, meat...............................................        0.05
Poultry, meat byproducts....................................        0.20
Sheep, fat..................................................        0.30
Sheep, meat.................................................        0.10
Sheep, meat byproducts......................................        0.35
------------------------------------------------------------------------


[[Page 655]]

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the fungicide boscalid, including its 
metabolites and degradates, in connection with use of the pesticide 
under section 18 emergency exemptions granted by EPA. Compliance with 
the tolerance level specified below is to be determined by measuring 
only boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4[min]-chloro[1,1'-
biphenyl]-2-yl). This tolerance will expire and is revoked on the date 
specified in the following table:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Endive, Belgian.................................         16     12/31/13
------------------------------------------------------------------------

    (c) Tolerances with regional registration. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established for 
the indirect or inadvertent residues of the fungicide boscalid, 
including its metabolites and degradates, in or on the commodities 
listed below. Compliance with the tolerance levels specified below is to 
be determined by measuring only boscalid, 3-pyridinecarboxamide, 2-
chloro-N-(4[min]-chloro[1,1'-biphenyl]-2-yl), in or on the following 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Animal feed, nongrass, group 18, forage, except alfalfa.....        1.0
Animal feed, nongrass, group 18, hay, except alfalfa........        2.0
Animal feed, nongrass, group 18, seed.......................        0.05
Beet, garden, roots.........................................        0.1
Beet, sugar, roots..........................................        0.1
Cotton, gin byproducts......................................        0.30
Cotton, undelinted seed.....................................        0.05
Cowpea, seed................................................        0.1
Flax, seed..................................................        3.5
Grain, cereal, forage, fodder and straw, group 16, forage...        2.0
Grain, cereal, forage, fodder and straw, group 16, stover...        1.5
Grain, cereal, forage, fodder and straw, group 16, straw....        3.0
Grain, cereal, group 15.....................................        0.20
Grass, forage, fodder, and hay, group 17, forage............        2.0
Grass, forage, fodder, and hay, group 17, hay...............        8.0
Grass, forage, fodder, and hay, group 17, seed screenings...        0.20
Grass, forage, fodder, and hay, group 17, straw.............        0.30
Lupin, grain, grain.........................................        0.1
Pea, field, seed............................................        0.1
Radish, roots...............................................        0.1
Rice, hulls.................................................        0.50
Turnip, roots...............................................        0.1
Vegetable, foliage of legume, group 7, forage...............        1.5
Vegetable, foliage of legume, group 7, hay..................        2.0
Vegetable, foliage of legume, group 7, vines................        0.05
Vegetable, leafy, except brassica, group 4, except celery,          1.0
 lettuce and spinach........................................
Vegetable, leaves of root and tuber, group 2................        0.1
------------------------------------------------------------------------


[68 FR 44651, July 30, 2003, as amended at 69 FR 19774, Apr. 14, 2004; 
70 FR 55293, Sept. 21, 2005; 71 FR 6364, Feb. 8, 2006; 71 FR 25961, May 
3, 2006; 71 FR 76190, Dec. 20, 2006; 73 FR 16558, Mar. 28, 2008; 74 FR 
47445, Sept. 16, 2009; 75 FR 770, Jan. 6, 2010; 75 FR 29907, May 28, 
2010; 75 FR 80346, Dec. 22, 2010]



Sec. 180.590  2, 6-Diisopropylnaphthalene (2, 6-DIPN); tolerances for 

residues.

    (a) General. Tolerances are established for residues of the growth 
inhibitor 2,6-DIPN, including its metabolites and degradates, in or on 
the commodities in the following table. Compliance with the tolerance 
levels specified in the following table is to be determined by measuring 
only 2,6-Diisopropylnaphthalene.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.2
Cattle, meat................................................        0.02
Cattle, meat byproducts, except fat.........................        0.02
Goat, fat...................................................        0.2
Goat, meat..................................................        0.02
Goat, meat byproducts, except fat...........................        0.02
Horse, fat..................................................        0.2
Horse, meat.................................................        0.02
Horse, meat byproducts, except fat..........................        0.02
Milk, fat...................................................        0.02
Potato, granules/flakes.....................................        5.5
Potato, wet peel............................................        6.0
Potato, whole...............................................        2.0
Sheep, fat..................................................        0.2
Sheep, meat.................................................        0.02
Sheep, meat byproducts, except fat..........................        0.02
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[71 FR 52011, Sept. 1, 2006, as amended at 74 FR 66579, Dec. 16, 2009; 
77 FR 32406, June 1, 2012]



Sec. 180.591  Trifloxysulfuron; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide trifloxysulfuron, N-[[(4,6-dimethoxy-2-
pyrimidinyl)amino]carbonyl]-3-(2,2,2-trifluoroethoxy)-2-
pyridinesulfonamide

[[Page 656]]

in or on the following raw agricultural commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond......................................................        0.02
Almond, hulls...............................................        0.01
Fruit, citrus, Group 10.....................................        0.03
Cotton, undelinted seed.....................................        0.05
Cotton, gin byproducts......................................        1.0
Sugarcane...................................................        0.01
Tomato......................................................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[68 FR 54386, Sept. 17, 2003]



Sec. 180.592  Butafenacil; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
herbicide butafenacil, (1,1-dimethyl-2-oxo-2-(2-propenyloxy)ethyl 2-
chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-
pyrimidinyl] benzoate) in or on the following raw agricultural 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cotton, gin byproducts......................................       10
Cotton, undelinted seed.....................................        0.50
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the herbicide 
butafenacil, (1,1-dimethyl-2-oxo-2-(2-propenyloxy)ethyl 2-chloro-5-[3,6-
dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-pyrimidinyl] 
benzoate) and its metabolite CGA-293731 (1-carboxy-1-methylethyl 2-
chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-
pyrimidinyl] benzoate), in or on the following livestock commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, kidney..............................................        0.05
Cattle, liver...............................................        0.50
Goat, kidney................................................        0.05
Goat, liver.................................................        0.50
Hog, kidney.................................................        0.05
Hog, liver..................................................        0.50
Horse, kidney...............................................        0.05
Horse, liver................................................        0.50
Sheep, kidney...............................................        0.05
Sheep, liver................................................        0.50
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect and inadvertant residues. [Reserved]

[68 FR 54827, Sept. 19, 2003]



Sec. 180.593  Etoxazole; tolerances for residues.

    (a) General. Tolerances are established for residues of etoxazole, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below is 
to be determined by measuring only etoxazole (2-(2,6-difluorophenyl)-4-
[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-dihydrooxazole) in or on the 
commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        2.0
Apple, wet pomace...........................................        0.50
Avocado.....................................................        0.20
Berry, low growing, subgroup 13-07G.........................        0.50
Caneberry subgroup 13-07A...................................        1.5
Canistel....................................................        0.20
Cattle, fat.................................................        0.02
Cattle, liver...............................................        0.01
Corn, field, forage.........................................        0.80
Corn, field, grain..........................................        0.01
Corn, field, refined oil....................................        0.03
Corn, field, stover.........................................        4.0
Corn, pop, grain............................................        0.01
Corn, pop, stover...........................................        4.0
Cotton, gin byproducts......................................        1.0
Cotton, undelinted seed.....................................        0.05
Fruit, pome, group 11.......................................        0.20
Fruit, small vine climbing, except fuzzy kiwifruit, subgroup        0.50
 13-07F.....................................................
Fruit, stone, group 12, except plum.........................        1.0
Goat, fat...................................................        0.02
Goat, liver.................................................        0.01
Grape, raisin...............................................        1.5
Hop, dried cones............................................        7.0
Horse, fat..................................................        0.02
Horse, liver................................................        0.01
Mango.......................................................        0.20
Melon subgroup 9A...........................................        0.20
Milk, fat...................................................        0.01
Nut, tree, group 14.........................................        0.01
Papaya......................................................        0.20
Pepper/eggplant subgroup 8-10B..............................        0.20
Peppermint, oil.............................................       20
Peppermint, tops............................................       10
Pistachio...................................................        0.01
Plum........................................................        0.15
Plum, prune, dried..........................................        0.30
Sapodilla...................................................        0.20
Sapote, black...............................................        0.20
Sapote, mamey...............................................        0.20
Sheep, fat..................................................        0.02
Sheep, liver................................................        0.01
Spearmint, oil..............................................       20
Spearmint, tops.............................................       10
Squash/cucumber subgroup 9B.................................        0.02
Star apple..................................................        0.20
Tangerine \1\...............................................        0.10
Tea, dried *................................................       15

[[Page 657]]

 
Tomato......................................................        0.20
------------------------------------------------------------------------
\1\There are no U.S. registrations for use of etoxazole on tangerines as
  of September 26, 2003.
* There are currently no U.S. registrations for tea as of April 13,
  2011.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect and inadvertant residues. [Reserved]

[68 FR 55493, Sept. 26, 2003, as amended at 70 FR 41625, July 20, 2005; 
72 FR 72963, Dec. 26, 2007; 74 FR 25160, May 27, 2009; 76 FR 20542, Apr. 
13, 2011; 77 FR 3621, Jan. 25, 2012]



Sec. 180.594  Thiacloprid; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide thiacloprid, including its metabolites and degradates in or 
on the commodities in the following table. Compliance with the tolerance 
levels specified in the following table is to be determined by measuring 
only thiacloprid ([3-[(6-chloro-3-pyridinyl)methyl]-2-
thiazolidinylidene] cyanamide) in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Apple, wet pomace..........................................        0.60
Cattle, fat................................................        0.020
Cattle, kidney.............................................        0.050
Cattle, liver..............................................        0.15
Cattle, meat...............................................        0.030
Cattle, meat byproducts....................................        0.050
Cherry subgroup 12-12A.....................................        0.5
Cotton, gin byproducts.....................................       11.0
Cotton, undelinted seed....................................        0.020
Fruit, pome, group 11......................................        0.30
Goat, fat..................................................        0.020
Goat, kidney...............................................        0.050
Goat, liver................................................        0.15
Goat, meat.................................................        0.030
Goat, meat byproducts......................................        0.050
Horse, fat.................................................        0.020
Horse, kidney..............................................        0.050
Horse, liver...............................................        0.15
Horse, meat................................................        0.030
Horse, meat byproducts.....................................        0.050
Milk.......................................................        0.030
Peach subgroup 12-12B......................................        0.5
Pepper.....................................................        1.0
Plum subgroup 12-12C.......................................        0.05
Sheep, fat.................................................        0.020
Sheep, kidney..............................................        0.050
Sheep, liver...............................................        0.15
Sheep, meat................................................        0.030
Sheep, meat byproducts.....................................        0.050
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[68 FR 55512, Sept. 26, 2003, as amended at 78 FR 8416, Feb. 6, 2013]



Sec. 180.595  Flufenpyr-ethyl; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
herbicide, flufenpyr-ethyl; acetic acid, [2-chloro-4-fluoro-5-[5-methyl-
6-oxo-4-(trifluoromethyl)-1-(6H)-pyridazinyl]-phenoxy]-ethyl ester], in 
or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Corn, field, grain..........................................        0.01
Soybean, seed...............................................        0.01
Sugarcane, cane.............................................        0.01
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the herbicide 
flufenpyr-ethyl; acetic acid, [2-chloro-4-fluoro-5-[5-methyl-6-oxo-4-
(trifluoromethyl)-1-(6H)-pyridazinyl]-phenoxy]-ethyl ester], and its 
metabolite, S-3153 acid-4-OH; [2-chloro-4-hydroxy-5-[5-methyl-6- oxo-4-
(trifluoromethyl)-1-(6H)-pyridazinyl]-phenoxy]-acetic acid, free and 
conjugated, in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Corn, field, forage.........................................        0.05
Corn, field, stover.........................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[68 FR 54842, Sept. 19, 2003]



Sec. 180.596  Fosthiazate; tolerances for residues.

    (a) General. A tolerance is established for residues of the 
insecticide fosthiazate, including its metabolites and degradates, in or 
on the commodity in the table in this paragraph. Compliance with the 
tolerance level specified in this paragraph is to be determined by 
measuring only the sum of fosthiazate, O-ethyl S-(1-methylpropyl)(2-oxo-
3-

[[Page 658]]

thiazolidinyl)phosphonothioate, and its metabolite, O-ethyl S-(1-
methylpropyl)(2-(methylsulfonyl)ethyl)phosphoramidothioate, calculated 
as the stoichiometric equivalent of fosthiazate, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Tomato......................................................        0.02
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[69 FR 18275, Apr. 7, 2004, as amended at 76 FR 23498, Apr. 27, 2011]



Sec. 180.597  Mesosulfuron-methyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide mesosulfuron-methyl, (methyl 2-[[[[(4,6-dimethoxy-2-
pyrimidinyl) amino]carbonyl]amino]sulfonyl] -4-[[(methylsulfonyl)amino] 
methyl]benzoate]) in or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, meat byproducts.....................................        0.01
Goat, meat byproducts.......................................        0.01
Grain, aspirated fractions..................................        0.60
Horse, meat byproducts......................................        0.01
Sheep, meat byproducts......................................        0.01
Wheat, forage...............................................        0.60
Wheat, germ.................................................        0.10
Wheat, grain................................................        0.03
Wheat, hay..................................................        0.06
Wheat, straw................................................        0.30
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[69 FR 18263, Apr. 7, 2004]



Sec. 180.598  Novaluron; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide novaluron, including its metabolites and degradates, in or 
on the following commodities. Compliance with the tolerance levels 
specified in the following table is to be determined by measuring only 
novaluron, (N-[[[3-chloro-4-[1,1,2-trifluoro-2- (trifluor 
omethoxy)ethoxy] phenyl]amino] carbonyl]-2,6-difluorobenzamide), in or 
on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Apple, wet pomace...........................................        8.0
Bean, dry, seed.............................................        0.30
Bean, snap, succulent.......................................        0.60
Berry, low growing, subgroup 13-07G, except lowbush                 0.45
 blueberry..................................................
Brassica, head and stem, subgroup 5A........................        0.50
Brassica, leafy greens, subgroup 5B.........................       25
Bushberry subgroup 13-07B...................................        7.0
Cattle, fat.................................................       11
Cattle, kidney..............................................        1.0
Cattle, liver...............................................        1.0
Cattle, meat................................................        0.60
Cattle, meat byproducts, except kidney and liver............       11
Cherry......................................................        8.0
Cocona......................................................        1.0
Corn, sweet, forage.........................................       16
Corn, sweet, kernel plus cob with husks removed.............        0.05
Corn, sweet, stover.........................................       50
Cotton, gin byproducts......................................       30
Cotton, undelinted seed.....................................        0.60
Egg.........................................................        1.5
Eggplant, African...........................................        1.0
Eggplant, pea...............................................        1.0
Eggplant, scarlet...........................................        1.0
Food commodities and feed commodities (other than those             0.01
 covered by a higher tolerance as a result of use on growing
 crops) in food and feed handling establishments............
Fruit, pome, group 11.......................................        2.0
Fruit, stone, group 12, except cherry.......................        1.9
Goat, fat...................................................       11
Goat, kidney................................................        1.0
Goat, liver.................................................        1.0
Goat, meat..................................................        0.60
Goat, meat byproducts, except kidney and liver..............       11
Goji berry..................................................        1.0
Grain, aspirated fractions..................................       25
Hog, fat....................................................        1.5
Hog, kidney.................................................        0.10
Hog, liver..................................................        0.10
Hog, meat...................................................        0.07
Hog, meat byproducts, except kidney and liver...............        1.5
Horse, fat..................................................       11
Horse, kidney...............................................        1.0
Horse, liver................................................        1.0
Horse, meat.................................................        0.60
Horse, meat byproducts, except kidney and liver.............       11
Huckleberry, garden.........................................        1.0
Martynia....................................................        1.0
Milk........................................................        1.0
Milk, fat...................................................       20
Naranjilla..................................................        1.0
Okra........................................................        1.0
Plum, prune, dried..........................................        2.6
Poultry, fat................................................        7.0
Poultry, kidney.............................................        0.80
Poultry, liver..............................................        0.80
Poultry, meat...............................................        0.40
Poultry, meat byproducts, except kidney and liver...........        7.0
Roselle.....................................................        1.0
Sheep, fat..................................................       11
Sheep, kidney...............................................        1.0
Sheep, liver................................................        1.0

[[Page 659]]

 
Sheep, meat.................................................        0.60
Sheep, meat byproducts, except kidney and liver.............       11
Sorghum, grain, forage......................................        6.0
Sorghum, grain, grain.......................................        3.0
Sorghum, grain, stover......................................       40
Sugarcane, cane.............................................        0.50
Sunberry....................................................        1.0
Swiss chard.................................................       12
Tomato, bush................................................        1.0
Tomato, currant.............................................        1.0
Tomato, tree................................................        1.0
Turnip, greens..............................................       25
Vegetable, cucurbit, group 9................................        0.15
Vegetable, fruiting, group 8................................        1.0
Vegetable, tuberous and corm, subgroup 1C...................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the insecticide novaluron, including its 
metabolites and degradates, in connection with use of the pesticide 
under section 18 emergency exemptions granted by EPA. Compliance with 
the tolerance levels specified in the following table is to be 
determined by measuring only novaluron, (N-[[[3-chloro-4-[1,1,2-
trifluoro-2-(trifluoromethoxy)ethoxy] phenyl]amino]carbonyl]-2,6-difluor 
obenzamide). These tolerances will expire and are revoked on the dates 
specified in the following table:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Strawberry......................................       0.50     12/31/11
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertant residues. [Reserved]

[69 FR 31021, June 2, 2004, as amended at 71 FR 17014, Apr. 5, 2006; 71 
FR 61911, Oct. 20, 2006; 73 FR 74982, Dec. 10, 2008; 74 FR 637, Jan. 7, 
2009; 74 FR 20891, May 6, 2009; 74 FR 65033, Dec. 9, 2009; 75 FR 4278, 
Jan. 27, 2010; 75 FR 29447, May 26, 2010; 76 FR 55814, Sept. 9, 2011]



Sec. 180.599  Acequinocyl; tolerances for residues.

    (a)General. Tolerances are established for residues of acequinocyl, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below is 
to be determined by measuring only the sum of acequinocyl [2-
(acetyloxy)-3-dodecyl-1,4-naphthalenedione] and its metabolite, 2-
dodecyl-3-hydroxy-1,4-naphthoquinone, calculated as the stoichiometric 
equivalent of acequinocyl, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        2.0
Apple, wet pomace...........................................        1.0
Bean, edible podded.........................................        0.25
Bean, succulent shelled.....................................        0.30
Berry, low growing, subgroup 13-07G.........................        0.50
Caneberry subgroup 13-07A...................................        4.0
Cattle, fat.................................................        0.02
Cattle, meat byproducts.....................................        0.02
Cherry, sweet...............................................        0.50
Cherry, tart................................................        1.0
Citrus, oil.................................................       30
Cowpea, forage..............................................        6.0
Cowpea, hay.................................................       18
Cucumber....................................................        0.15
Fruit, citrus, group 10.....................................        0.20
Fruit, pome, group 11.......................................        0.40
Fruit, small vine climbing, except fuzzy kiwifruit, subgroup        1.6
 13-07F.....................................................
Goat, fat...................................................        0.02
Goat, meat byproducts.......................................        0.02
Hop, dried cones............................................        4.0
Horse, fat..................................................        0.02
Horse, meat byproducts......................................        0.02
Melon subgroup 9A...........................................        0.15
Nut, tree, group 14.........................................        0.02
Okra........................................................        0.70
Pistachio...................................................        0.02
Sheep, fat..................................................        0.02
Sheep, meat byproducts......................................        0.02
Soybean, vegetable, succulent...............................        0.25
Vegetable, fruiting, group 8................................        0.70
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[69 FR 43533, July 21, 2004, as amended at 73 FR 17910, Apr. 2, 2008; 75 
FR 70148, Nov. 17, 2010; 77 FR 25909, May 2, 2012]



Sec. 180.600  Propoxycarbazone; tolerances for residues.

    (a) General. (1) Tolerances are established for combined residues of 
the herbicide propoxycarbazone methyl 2-[[[(4,5-dihydro-4-methyl-5-oxo-
3-propoxy-1H-1,2,4-triazol-1-yl)carbonyl]amino]sulfonyl]benzoate and its 
metabolite methyl 2-[[[(4,5-dihydro-3-(2-hydroxypropoxy)-4-methyl-5-oxo-
1H-1,2,4-triazol-1-yl)carbonyl]amino]sulfonyl]benzoate in/on the 
following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grass, forage...............................................       20

[[Page 660]]

 
Grass, hay..................................................       25
Wheat, forage...............................................       17
Wheat, grain................................................        0.02
Wheat, hay..................................................        0.15
Wheat, straw................................................        0.05
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the herbicide 
propoxycarbazone methyl 2-[[[ (4,5-dihydro-4-methyl-5-oxo-3- propoxy-1H-
1,2,4-triazol-1-yl) carbonyl] amino]sulfonyl] benzoate in/on the 
following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, meat................................................        0.05
Cattle, meat byproducts.....................................        0.3
Goat, meat..................................................        0.05
Goat, meat byproducts.......................................        0.3
Horse, meat.................................................        0.05
Horse, meat byproducts......................................        0.3
Milk........................................................        0.03
Sheep, meat.................................................        0.05
Sheep, meat byproducts......................................        0.3
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[69 FR 40781, July 7, 2004, as amended at 71 FR 52487, Sept. 6, 2006; 74 
FR 9377, Mar. 4, 2009]



Sec. 180.601  Cyazofamid; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide cyazofamid, including its metabolites and degradates, in or on 
the commodities in the following table. Compliance with the tolerance 
levels specified in the following table is to be determined by measuring 
only the sum of 4-chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-
imidazole-1-sulfonamide and its metabolite, 4-chloro-5-(4-methylphenyl)-
1H-imidazole-2-carbonitrile, calculated as the stoichiometric equivalent 
of cyazofamid, in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Basil, dried leaves.........................................       90
Basil, fresh leaves.........................................       30
Bean, succulent.............................................        0.5
Bean, succulent shelled.....................................        0.08
Brassica, head and stem, subgroup 5A........................        1.2
Brassica, leafy greens, subgroup 5B.........................       12.0
Carrot, roots...............................................        0.09
Hop dried cones.............................................       10.0
Leafy greens subgroup 4A....................................       10
Turnip, greens..............................................       12.0
Vegetable, cucurbit, group 9................................        0.10
Vegetable, fruiting, group 8-10.............................        0.9
Vegetable, tuberous and corm, subgroup 1C...................        0.02
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the fungicide cyazofamid, including its 
metabolites and degradates, in or on the commodities in the following 
table. Compliance with the tolerance levels specified in the following 
table is to be determined by measuring only the sum of cyazofamid, 4-
chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-imidazole-1-
sulfonamide and its metabolite CCIM, 4-chloro-5-(4-methylphenyl)-1H-
imidazole-2-carbonitrile, calculated as the stoichiometric equivalent of 
cyazofamid, resulting from use of the pesticide under FIFRA section 18 
emergency exemptions. The tolerances expire and are revoked on the date 
specified in the table.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Basil, dried....................................        144     12/31/14
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. Tolerances with regional 
registrations are established for residues of the fungicide cyazofamid, 
including its metabolites and degradates, in or on the commodities in 
the following table. Compliance with the tolerance levels specified in 
the following table is to be determined by measuring only the sum of 4-
chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-imidazole-1-
sulfonamide and its metabolite, 4-chloro-5-(4-methylphenyl)-1H-
imidazole-2-carbonitrile, calculated as the stoichiometric equivalent of 
cyazofamid, in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grape.......................................................        1.5
------------------------------------------------------------------------


[[Page 661]]

    (d) Indirect or inadvertent residues. [Reserved]

[69 FR 58299, Sept. 30, 2004, as amended at 73 FR 21839, Apr. 23, 2008; 
74 FR 32453, July 8, 2009; 75 FR 40751, July 14, 2010; 77 FR 4252, Jan. 
27, 2012; 77 FR 59119, Sept. 26, 2012]



Sec. 180.602  Spiroxamine; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide spiroxamine, including its metabolites and degradates, in or 
on the commodities in the table below. Compliance with the tolerance 
levels specified in the following table is to be determined by measuring 
only spiroxamine, [(8-(1,1-dimethylethyl)-N-ethyl-N-propyl-1,4-
dioxaspiro[4,5]decane-2-methanamine) in or on the commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Artichoke, globe, import \1\................................        0.7
Asparagus \1\...............................................        0.05
Banana (import).............................................        3.0
Grape (import)..............................................        1.0
Hop, dried cones............................................       50
Vegetable, fruiting , crop group 8 \1\......................        1.2
------------------------------------------------------------------------
\1\ No U.S. registration as of December 1, 2010.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[69 FR 42570, July 16, 2004, as amended at 75 FR 74640, Dec. 1, 2010]



Sec. 180.603  Dinotefuran; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
dinotefuran, (RS)-1-methyl-2-nitro-3-((tetrahydro-3-
furanyl)methyl)guanidine, including its metabolites and degradates, in 
or on the commodities listed in the following table. Compliance with the 
tolerance levels specified below is to be determined by measuring only 
the sum of dinotefuran and its metabolites DN, 1-methyl-3-(tetrahydro-3-
furylmethyl)guanidine, and UF, 1-methyl-3-(tetrahydro-3-
furylmethyl)urea, calculated as the stoichiometric equivalent of 
dinotefuran, in or on the commodities listed in the table below:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Berry, low growing, except strawberry, subgroup 13-07H......        0.2
Brassica, head and stem, subgroup 5A........................        1.4
Brassica, leafy greens, subgroup 5B.........................       15.0
Cotton, undelinted seed.....................................        0.4
Cotton, gin byproducts......................................        8.0
Fruit, small vine climbing, except fuzzy kiwifruit, subgroup        0.9
 13-07F.....................................................
Grape, raisin...............................................        2.5
Onion, bulb, subgroup 3-07A.................................        0.15
Onion, green, subgroup 3-07B................................        5.0
Peach.......................................................        1.0
Potato, chips...............................................        0.1
Potato, granules/flakes.....................................        0.15
Rice, grain.................................................        9.0
Tea, dried\1\...............................................       50
Tomato, paste...............................................        1.0
Turnip, greens..............................................       15.0
Vegetable, fruiting, group 8................................        0.7
Vegetable, cucurbit, group 9................................        0.5
Vegetable, leafy, except Brassica, group 4..................        5.0
Vegetable, tuberous and corm, subgroup 1C...................        0.05
Watercress..................................................        8.0
------------------------------------------------------------------------
\1\ There are no U.S. registrations for tea.

    (2) Tolerances are established for residues of dinotefuran, (RS)-1-
methyl-2-nitro-3-((tetrahydro-3-furanyl)methyl)guanidine, including its 
metabolites and degradates, in or on the commodities listed in the 
following table. Compliance with the tolerance levels specified below is 
to be determined by measuring only the sum of dinotefuran, (RS)-1-
methyl-2-nitro-3-((tetrahydro-3-furanyl)methyl)guanidine in or on the 
commodities listed in the table below:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.05
Cattle, meat................................................        0.05
Cattle, meat byproducts.....................................        0.05
Egg.........................................................        0.01
Goat, fat...................................................        0.05
Goat, meat..................................................        0.05
Goat, meat byproducts.......................................        0.05
Hog, fat....................................................        0.05
Hog, meat...................................................        0.05
Hog, meat byproducts........................................        0.05
Horse, fat..................................................        0.05
Horse, meat.................................................        0.05
Horse, meat byproducts......................................        0.05
Milk........................................................        0.05
Poultry, meat byproducts....................................        0.01
Sheep, fat..................................................        0.05
Sheep, meat.................................................        0.05
Sheep, meat byproducts......................................        0.05
------------------------------------------------------------------------

    (3) A tolerance of 0.01 parts per million is established for 
residues of the insecticide dinotefuran, (RS)-1-methyl-2-nitro-3-
((tetrahydro-3-furanyl)methyl)guanidine, including its metabolites and 
degradates, in or on all food and/or feed commodities

[[Page 662]]

(other than those covered by a higher tolerance as a result of use on 
growing crops or inadvertent residues) when residues result from 
application of dinotefuran in food and/or feed handling establishments 
where food and/or feed products are held, stored, processed, prepared, 
or served. Compliance with the tolerance level is to be determined by 
measuring only dinotefuran.
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of dinotefuran, (RS)-1-methyl-2-nitro-3-
((tetrahydro-3-furanyl)methyl)guanidine, including its metabolites and 
degradates, in or on the commodities in the table below resulting from 
use of the pesticide pursuant to FIFRA section 18 emergency exemptions. 
Compliance with the tolerance levels specified below is to be determined 
by measuring only the sum of dinotefuran and its metabolites DN, 1-
methyl-3-(tetrahydro-3-furylmethyl)guanidine, and UF, 1-methyl-3-
(tetrahydro-3-furylmethyl)urea, calculated as the stoichiometric 
equivalent of dinotefuran, in or on the commodities listed in the table 
below. The tolerances expire and are revoked on the dates specified in 
the table.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                    million      date
------------------------------------------------------------------------
Fruit, pome, group 11...........................        1.0     12/31/15
Fruit, stone, group 12..........................        1.0     12/31/15
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[70 FR 14546, Mar. 23, 2005, as amended at 74 FR 12601, Mar. 25, 2009; 
74 FR 67104, Dec. 18, 2009; 75 FR 770, Jan. 6, 2010; 77 FR 56138, Sept. 
12, 2012; 77 FR 67285, Nov. 9, 2012; 77 FR 70913, Nov. 28, 2012; 78 FR 
21272, Apr. 10, 2013; 78 FR 24683, Apr. 26, 2013]



Sec. 180.604  Mepanipyrim; tolerances for residues.

    (a) General. [Reserved]
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect of inadvertent residues. [Reserved]
    (e) Revoked tolerances subject to the channel of trade provisions. 
[Reserved]
    (f) Import tolerances. Tolerances are established for the combined 
residues of mepanipyrim, 4-methyl-N-phenyl-6-(1-propynyl)-2-
pyrimidinamine, and its metabolite, 4-methyl-N-phenyl-6-(2-
hydroxypropylk)-2-pyrimidinamine, both free and conjugated in or on the 
following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grape.......................................................        1.5
Grape, raisin...............................................        3.0
Strawberry..................................................        1.5
Tomato......................................................        0.5
------------------------------------------------------------------------


[68 FR 60827, Oct. 13, 2004]



Sec. 180.605  Penoxsulam; tolerances for residues.

    (a) General. Tolerances are established for the herbicide, 
penoxsulam (2-(2,2-difluoroethoxy)-N-(5,8-dimethoxy[1,2,4] triazolo[1,5-
c]pyrimidin-2-yl)-6-(trifluoromethyl)benzenesulfonamide) in/on the 
following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        0.01
Fish........................................................        0.01
Fish, shellfish, crustacean.................................        0.01
Fish, shellfish, mollusc....................................        0.02
Grape.......................................................        0.01
Nut, tree, group 14.........................................        0.01
Pistachio...................................................        0.01
Rice, grain.................................................        0.02
Rice, straw.................................................        0.50
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[69 FR 57197, Sept. 24, 2004, as amended at 72 FR 40763, July 25, 2007; 
74 FR 18648, Apr. 24, 2009]



Sec. 180.607  Spiromesifen; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide/miticide spiromesifen, including its metabolites and 
degradates, in or on the commodities listed below. Compliance with the 
tolerance levels specified below is to be determined by measuring

[[Page 663]]

only the sum of spiromesifen [2-oxo-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate] and 4-hydroxy-3-
(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one, calculated as the 
stoichiometric equivalent of spiromesifen, in or on the following 
primary crop commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Bean, dry...................................................        0.02
Bean, edible podded.........................................        0.80
Bean, succulent.............................................        0.10
Berry and small fruit, low growing berry, subgroup 13-07G...        2.0
Brassica, head and stem, subgroup 5A........................        2.0
Brassica, leafy greens, subgroup 5B.........................       12
Corn, field, forage.........................................        5.0
Corn, field, grain..........................................        0.02
Corn, field, stover.........................................        8.0
Corn, pop, grain............................................        0.02
Corn, pop, stover...........................................        4.0
Corn, sweet, forage.........................................       17
Corn, sweet, kernel plus cob with husks removed.............        0.02
Corn, sweet, stover.........................................       12
Cotton, gin byproducts......................................       15
Cotton, undelinted seed.....................................        0.50
Cowpea, forage..............................................       30
Cowpea, hay.................................................       86
Leaf petiole subgroup 4B....................................        6.0
Leafy greens subgroup 4A....................................       12
Pea, dry, seed..............................................        0.20
Peppermint, tops............................................       45
Spearmint, tops.............................................       45
Tea, dry....................................................       40
Tomato, paste...............................................        0.80
Vegetable, cucurbit, group 9................................        0.10
Vegetable, fruiting, group 8................................        0.45
Vegetable, tuberous and corm, subgroup 1C...................        0.02
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the insecticide/
miticide spiromesifen, including its metabolites and degradates, in or 
on the commodities listed below. Compliance with the tolerance levels 
specified below is to be determined by measuring only the sum of 
spiromesifen [2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-
yl 3,3-dimethylbutanoate] and its metabolites containing the 4-hydroxy-
3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one and 4-hydroxy-3-
[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-en-2-one 
moieties, calculated as the stoichiometric equivalent of spiromesifen, 
in the following livestock commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.10
Cattle, meat................................................        0.02
Cattle, meat byproducts.....................................        0.20
Goat, fat...................................................        0.10
Goat, meat..................................................        0.02
Goat, meat byproducts.......................................        0.20
Horse, fat..................................................        0.10
Horse, meat.................................................        0.02
Horse, meat byproducts......................................        0.20
Milk........................................................        0.01
Milk, fat...................................................        0.25
Sheep, fat..................................................        0.10
Sheep, meat.................................................        0.02
Sheep, meat byproducts......................................        0.20
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of the 
insecticide/miticide spiromesifen, including its metabolites and 
degradates, in or on the commodities listed below. Compliance with the 
tolerance levels specified below is to be determined by measuring only 
the sum of spiromesifen [2-oxo-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate] and 4-hydroxy-3-
(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one, calculated as the 
stoichiometric equivalent of spiromesifen, in or on the specified 
agricultural commodities, resulting from use of the pesticide pursuant 
to FIFRA section 18 emergency exemptions. The tolerances expire and are 
revoked on the date specified in the table.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Soybean, forage.................................         30     12/31/14
Soybean, hay....................................         86     12/31/14
Soybean, seed...................................       0.02     12/31/14
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established for 
the inadvertent or indirect residues of the insecticide/miticide 
spiromesifen, including its metabolites and degradates, in or on the 
commodities listed below. Compliance with the tolerance levels specified 
below is to be determined by measuring only the sum of spiromesifen [2-
oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-
dimethylbutanoate], 4-hydroxy-3-(2,4,6-trimethylphenyl)-1-
oxaspiro[4.4]non-3-en-2-one, and its metabolites containing the 4-
hydroxy-3-[4-(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-
en-2-one moiety,

[[Page 664]]

calculated as the stoichiometric equivalent of spiromesifen, in the 
following rotational crop commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        1.5
Alfalfa, hay................................................        3.0
Barley, grain...............................................        0.03
Barley, hay.................................................        0.25
Barley, straw...............................................        0.15
Beet, sugar, roots..........................................        0.03
Beet, sugar, tops...........................................        0.20
Oat, forage.................................................        0.20
Oat, grain..................................................        0.03
Oat, hay....................................................        0.25
Oat, straw..................................................        0.25
Vegetable, bulb, group 3-07.................................        0.09
Wheat, forage...............................................        0.20
Wheat, grain................................................        0.03
Wheat, hay..................................................        0.15
Wheat, straw................................................        0.25
------------------------------------------------------------------------


[70 FR 43283, July 27, 2005, as amended at 72 FR 3079, Jan. 24, 2007; 73 
FR 13140, Mar. 12, 2008; 73 FR 52606, Sept. 10, 2008; 74 FR 8492, Feb. 
25, 2009; 74 FR 15886, Apr. 8, 2009; 75 FR 5526, Feb. 3, 2010; 75 FR 
53586, Sept. 1, 2010; 76 FR 81396, Dec. 28, 2011; 78 FR 3337, Jan. 16, 
2013]



Sec. 180.608  Spirodiclofen; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
spirodiclofen, including its metabolites and degradates, in or on the 
commodities listed below. Compliance with the following tolerance levels 
is to be determined by measuring only spirodiclofen, 3-(2,4-
dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-
dimethylbutanoate.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................       20.0
Apple, wet pomace...........................................        2.4
Avocado.....................................................        1.0
Black sapote................................................        1.0
Canistel....................................................        1.0
Citrus, juice...............................................        0.60
Citrus, oil.................................................       20.0
Fruit, citrus, group 10.....................................        0.50
Fruit, pome, group 11.......................................        0.80
Fruit, stone, group 12......................................        1.0
Grape.......................................................        2.0
Grape, raisin...............................................        6.0
Hop, dried cones............................................       30
Mamey sapote................................................        1.0
Mango.......................................................        1.0
Nut, tree, group 14.........................................        0.10
Papaya......................................................        1.0
Pistachio...................................................        0.10
Sapodilla...................................................        1.0
Star apple..................................................        1.0
------------------------------------------------------------------------

    (2) Tolerances are established for residues of spirodiclofen (3-
(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-
dimethylbutanoate) and its free enol metabolite BAJ 2510 (3-(2,4-
dichlorophenyl)-4-hydroxy-1-oxaspiro[4,5]dec-3-en-2-one) in or on the 
following livestock commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.02
Cattle, meat byproducts.....................................        0.10
Cattle, meat................................................        0.02
Goat, fat...................................................        0.02
Goat, meat byproducts.......................................        0.1
Goat, meat..................................................        0.02
Horse, fat..................................................        0.02
Horse, meat byproducts......................................        0.1
Horse, meat.................................................        0.02
Milk........................................................        0.01
Milk, fat...................................................        0.03
Sheep, fat..................................................        0.02
Sheep. meat byproducts......................................        0.1
Sheep. meat.................................................        0.02
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[70 FR 40211, July 13, 2005, as amended at 73 FR 25539, May 7, 2008; 75 
FR 24434, May 5, 2010; 77 FR 73939, Dec. 12, 2012]



Sec. 180.609  Fluoxastrobin; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
fluoxastrobin, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only fluoxastrobin, 
(1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-
dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime and its Z isomer, 
(1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-
dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime, calculated as the 
stoichiometric equivalent of fluoxastrobin.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Berry, low growing, subgroup 13-07G........................        1.9
Corn, field, forage........................................        3.0
Corn, field, grain.........................................        0.02
Corn, field, stover........................................        4.5

[[Page 665]]

 
Corn, sweet, forage........................................       13
Corn, sweet, kernel plus cob with husks removed............        0.01
Corn, sweet, stover........................................       10
Grain, aspirated grain fractions...........................       60
Leaf petioles subgroup 4B..................................        4.0
Peanut.....................................................        0.02
Peanut, hay................................................       20.0
Peanut, refined oil........................................        0.06
Rice, grain................................................        4.0
Soybean, forage............................................        9.0
Soybean, hay...............................................        1.2
Soybean, hulls.............................................        0.20
Soybean, seed..............................................        0.05
Squash/cucumber subgroup 9B................................        0.50
Tomato, paste..............................................        1.5
Vegetable, fruiting, group 8...............................        1.0
Vegetable, tuberous and corm, subgroup 1C..................        0.010
Wheat, bran................................................        0.15
Wheat, forage..............................................        7.0
Wheat, hay.................................................       17
Wheat, straw...............................................       11
------------------------------------------------------------------------

    (2) Tolerances are established for residues of fluoxastrobin, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below is 
to be determined by measuring only fluoxastrobin, (1E)-[2-[[6-(2-
chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-
dioxazin-3-yl)methanone O-methyloxime, its Z isomer, (1Z)-[2-[[6-(2-
chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-
dioxazin-3-yl)methanone O-methyloxime, and its phenoxy-
hydroxypyrimidine, 6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinol, 
calculated as the stoichiometric equivalent of fluoxastrobin.


------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.10
Cattle, meat................................................        0.05
Cattle, meat byproducts.....................................        0.20
Goat, fat...................................................        0.10
Goat, meat..................................................        0.05
Goat, meat byproducts.......................................        0.20
Hog, fat....................................................        0.03
Hog, meat byproducts........................................        0.06
Horse, fat..................................................        0.10
Horse, meat.................................................        0.05
Horse, meat byproducts......................................        0.20
Milk........................................................        0.02
Milk, fat...................................................        0.50
Poultry, liver..............................................        0.06
Sheep, fat..................................................        0.10
Sheep, meat.................................................        0.05
Sheep, meat byproducts......................................        0.20
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established for 
the indirect or inadvertent residues of fluoxastrobin, including its 
metabolites and degradates, in or on the commodities in the table below, 
when present therein as a result of the application of fluoxastrobin to 
the growing crops listed in paragraph (a)(1) of this section. Compliance 
with the tolerance levels specified below is to be determined by 
measuring only fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime and its Z isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime, calculated as the stoichiometric equivalent of 
fluoxastrobin.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage............................................        0.050
Alfalfa, hay...............................................        0.10
Cotton, gin byproducts.....................................        0.020
Grain, cereal, forage, fodder, and straw, group 16, except         0.10
 corn......................................................
Grass, forage..............................................        0.10
Grass, hay.................................................        0.50
Vegetable, foliage of legume, group 7......................        0.050
------------------------------------------------------------------------


[74 FR 67113, Dec. 18, 2009, as amended at 75 FR 60333, Sept. 30, 2010; 
76 FR 50898, Aug. 17, 2011; 77 FR 26471, May 4, 2012; 77 FR 64915, Oct. 
24, 2012]



Sec. 180.610  Aminopyralid; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
herbicide aminopyralid, 4-amino-3,6-dichloro-2-pyridinecarboxylic acid, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below is 
to be determined by measuring only free and conjugated aminopyralid.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Corn, field, forage.........................................        0.30
Corn, field, grain..........................................        0.20
Corn, field, stover.........................................        0.20
Grain, aspirated fractions..................................        0.2
Grass, forage...............................................       25
Grass, hay..................................................       50
Wheat, bran.................................................        0.1

[[Page 666]]

 
Wheat, forage...............................................        2.0
Wheat, grain................................................        0.04
Wheat, hay..................................................        4.0
Wheat, straw................................................        0.25
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the herbicide 
aminopyralid, 4-amino-3,6-dichloro-2-pyridinecarboxylic acid, including 
its metabolites and degradates, in or on the commodities in the table 
below. Compliance with the tolerance levels specified below is to be 
determined by measuring only aminopyralid.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.02
Cattle, kidney..............................................        0.3
Cattle, meat................................................        0.02
Cattle, meat byproducts, except kidney......................        0.02
Goat, fat...................................................        0.02
Goat, kidney................................................        0.3
Goat, meat..................................................        0.02
Goat, meat byproducts, except kidney........................        0.02
Horse, fat..................................................        0.02
Horse, kidney...............................................        0.3
Horse, meat.................................................        0.02
Horse, meat byproducts, except kidney.......................        0.02
Milk........................................................        0.03
Sheep, fat..................................................        0.02
Sheep, kidney...............................................        0.3
Sheep, meat.................................................        0.02
Sheep, meat byproducts, except kidney.......................        0.02
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[70 FR 46428, Aug. 10, 2005, as amended at 75 FR 17584, Apr. 7, 2010]



Sec. 180.611  Pinoxaden; tolerances for residues.

    (a) General. (1) Tolerances are established for the combined 
residues of pinoxaden (8-(2,6-diethyl-4-methylphenyl)-1,2,4,5-
tetrahydro-7-oxo-7H-pyrazolo[1,2-d][1,4,5] oxadiazepin-9-yl 2,2-
dimethylpropanoate), and its metabolites 8-(2,6-diethyl-4-methyl-
phenyl)-tetrahydro-pyrazolo[1,2-d][1,4,5]oxadiazepine-7,9-dione (M2), 
and free and conjugated forms of 8-(2,6-diethyl-4-hydroxymethyl-phenyl)-
tetrahydro-pyrazolo[1,2-d][1,4,5] oxadiazepine-7,9-dione (M4), and 4-
(7,9-dioxo-hexahydro-pyrazolo[1,2-d] [1,4,5]oxadiazepin-8-yl)-3,5-
diethyl-benzoic acid (M6), calculated as pinoxaden, in/on the following 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, bran................................................        1.6
Barley, grain...............................................        0.9
Barley, hay.................................................        1.5
Barley, straw...............................................        1.0
Egg.........................................................        0.06
Poultry, fat................................................        0.06
Poultry, meat...............................................        0.06
Poultry, meat byproducts....................................        0.06
Wheat, bran.................................................        3.0
Wheat, forage...............................................        3.5
Wheat, grain................................................        1.3
Wheat, hay..................................................        2.0
Wheat, straw................................................        1.5
------------------------------------------------------------------------

    (2) For the combined residues of pinoxaden, 8-(2,6-diethyl-4-
methylphenyl)-1,2,4,5-tetrahydro-7-oxo-7H-pyrazolo[1,2-d][1,4,5] 
oxadiazepin-9-yl 2,2-dimethylpropanoate), and its metabolites M2, 8-
(2,6-diethyl-4-methyl-phenyl)-tetrahydro-pyrazolo[1,2-
d][1,4,5]oxadiazepine-7,9-dione, and free and conjugated forms of M4, 8-
(2,6-diethyl-4-hydroxymethyl-phenyl)-tetrahydro-pyrazolo[1,2-d][1,4,5] 
oxadiazepine-7,9-dione, calculated as pinoxaden, in/on the following 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.04
Cattle, meat................................................        0.04
Cattle, meat byproducts.....................................        0.04
Milk........................................................        0.02
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[70 FR 43322, July 27, 2005]



Sec. 180.612  Topramezone; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
herbicide topramezone, [3-(4,5-dihydro-3-isoxazolyl)-2-methyl-4-
(methylsulfonyl)phenyl](5-hydroxy-1-methyl-1H-pyrazol-4-yl)methanone, in 
or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, kidney..............................................        0.05

[[Page 667]]

 
Cattle, liver...............................................        0.15
Corn, field, forage.........................................        0.05
Corn, field, grain..........................................        0.01
Corn, field, stover.........................................        0.05
Corn, pop, grain............................................        0.01
Corn, pop, stover...........................................        0.05
Corn, sweet, forage.........................................        0.05
Corn, sweet, kernel plus cob with husks removed.............        0.01
Corn, sweet, stover.........................................        0.05
Goat, kidney................................................        0.05
Goat, liver.................................................        0.15
Horse, kidney...............................................        0.05
Horse, liver................................................        0.15
Sheep, kidney...............................................        0.05
Sheep, liver................................................        0.15
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[70 FR 46419, Aug. 10, 2005]



Sec. 180.613  Flonicamid; tolerances for residues.

    (a) General. (1) Tolerances are established for the residues of the 
insecticide flonicamid, including its metabolites and degradates, in or 
on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only the sum of 
flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide, 
and its metabolites, TFNA (4-trifluoromethylnicotinic acid), TFNA-AM (4-
trifluoromethylnicotinamide), and TFNG, N-(4-
trifluoromethylnicotinoyl)glycine, calculated as the stoichiometric 
equivalent of flonicamid, in or on the following commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Berry, low growing, subgroup 13-07G.........................        1.5
Brassica, head and stem, subgroup 5A........................        1.5
Brassica, leafy greens, subgroup 5B.........................       16
Cotton, gin byproducts......................................        6.0
Cotton, hulls...............................................        2.0
Cotton, meal................................................        1.0
Cotton, undelinted seed.....................................        0.50
Cucumber....................................................        1.5
Fruit, pome, group 11.......................................        0.20
Fruit, stone, group 12......................................        0.60
Hop, dried cones............................................        7.0
Okra........................................................        0.40
Potato, granules/flakes.....................................        0.40
Radish, tops................................................       16
Rapeseed subgroup 20A.......................................        1.5
Spinach.....................................................        9.0
Tomato, paste...............................................        2.0
Tomato, puree...............................................        0.50
Turnip, greens..............................................       16
Vegetable, cucurbit, group 9, except cucumber...............        0.4
Vegetable, fruiting, group 8................................        0.40
Vegetable, leafy, except brassica, group 4, except spinach..        4.0
Vegetable, root, except sugar beet, subgroup 1B.............        0.60
Vegetable, tuberous and corm, subgroup 1C...................        0.20
------------------------------------------------------------------------

    (2) Tolerances are established for the residues of the insecticide 
flonicamid, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only the sum of 
flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide, 
and its metabolites, TFNA (4-trifluoromethylnicotinic acid), and TFNA-AM 
(4-trifluoromethylnicotinamide), calculated as the Stoichiometric 
equivalent of flonicamid, in or on the following commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.03
Cattle, meat................................................        0.08
Cattle, meat byproducts.....................................        0.08
Egg.........................................................        0.04
Goat, fat...................................................        0.03
Goat, meat..................................................        0.08
Goat, meat byproducts.......................................        0.08
Horse, fat..................................................        0.03
Horse, meat.................................................        0.08
Horse, meat byproducts......................................        0.08
Milk........................................................        0.03
Poultry, fat................................................        0.03
Poultry, meat...............................................        0.03
Poultry, meat byproducts....................................        0.03
Sheep, fat..................................................        0.03
Sheep, meat.................................................        0.08
Sheep, meat byproducts......................................        0.08
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[70 FR 51614, Aug. 31, 2005, as amended at 71 FR 15608, Mar. 29, 2006; 
73 FR 17923, Apr. 2, 2008; 77 FR 67776, Nov. 14, 2012]



Sec. 180.614  Kasugamycin; tolerances for residues.

    (a) General. Tolerances are established for residues of kasugamycin, 
3-

[[Page 668]]

O-[2-amino-4-[(carboxyiminomethyl)amino]-2,3,4,6-tetradeoxy-[alpha]-D-
arabino-hexopyranosyl]-D-chiro-inositol in or on the following raw 
agricultural commodity:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Vegetable, fruiting, group 8 \1\............................        0.04
------------------------------------------------------------------------
\1\There is no U.S. registration as of September 1, 2005.

    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of 
kasugamycin, 3-O-[2-amino-4-[(carboxyiminomethyl)amino]-2,3,4,6-
tetradeoxy-[alpha]-D-arabino-hexopyranosyl]-D-chiro-inositol in or on 
the specified agricultural commodities, resulting from use of the 
pesticide pursuant to FFIFRA section 18 emergency exemptions. The 
tolerances expire and are revoked on the date specified in the table.

------------------------------------------------------------------------
                                    Parts per     Expiration/revocation
            Commodity                million              date
------------------------------------------------------------------------
Apple...........................         0.05                  12/31/15
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[70 FR 55752, Sept. 23, 2005, as amended at 75 FR 19272, Apr. 14, 2010; 
77 FR 74119, Dec. 13, 2012]



Sec. 180.615  Amicarbazone; tolerances for residues.

    (a) General. Tolerances are established for combined residues of the 
herbicide, amicarbazone [4-amino-4, 5-dihydro- N-(1,1-dimethylethyl)-3-
(1-methylethyl)-5-oxo-1H-1,2,4-triazole-1-carboxamide] and its 
metabolites DA amicarbazone [N-(1,1-dimethylethyl)-4,5-dihydro-3-(1-
methylethyl)-5-oxo-1H-1,2,4-triazole-1-carboxamide] and iPr-2-OH DA 
amicarbazone [N-(1,1-dimethylethyl)-4,5-dihydro-3-(1-hydroxy-1-
methylethyl)-5-oxo-1H-1,2,4-triazole-1-carboxamide], calculated as 
parent equivalents, in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.01
Cattle, liver...............................................        1.0
Cattle, meat................................................        0.01
Cattle, meat byproducts, except liver.......................        0.10
Corn, field, forage.........................................        0.80
Corn, field, grain..........................................        0.05
Corn, field, stover.........................................        1.0
Goat, fat...................................................        0.01
Goat, liver.................................................        1.0
Goat, meat..................................................        0.01
Goat, meat byproducts, except liver.........................        0.10
Hog, fat....................................................        0.01
Hog, liver..................................................        0.10
Hog, meat...................................................        0.01
Hog, meat byproducts, except liver..........................        0.01
Horse, fat..................................................        0.01
Horse, liver................................................        1.0
Horse, meat.................................................        0.01
Horse, meat byproducts, except liver........................        0.10
Milk........................................................        0.01
Sheep, fat..................................................        0.01
Sheep, liver................................................        1.0
Sheep, meat.................................................        0.01
Sheep, meat byproducts, except liver........................        0.10
Poultry, liver..............................................        0.10
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established for 
the indirect or inadvertent residues of amicarbazone [4-amino-4, 5-
dihydro-N-(1,1-dimethylethyl)-3-(1-methylethyl)-5-oxo-1H-1,2,4-triazole-
1-carboxamide] and its metabolites DA amicarbazone [N-(1,1-
dimethylethyl)-4,5-dihydro-3-(1-methylethyl)-5-oxo-1H-1,2,4-triazole-1-
carboxamide] and iPr-2-OH DA amicarbazone [N-(1,1-dimethylethyl)-4,5-
dihydro-3-(1-hydroxy-1-methylethyl)-5-oxo-1H-1,2,4-triazole-1-
carboxamide], calculated as parent equivalents, in or on the following 
commodities when present therein as a result of application of 
amicarbazone to the growing crops in paragraph (a) of this section:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        0.05
Alfalfa, hay................................................        0.10
Cotton, gin byproducts......................................        0.30
Cotton, undelinted seed.....................................        0.07

[[Page 669]]

 
Soybean, forage.............................................        1.50
Soybean, hay................................................        5.0
Soybean, seed...............................................        0.80
Wheat, bran.................................................        0.15
Wheat, flour................................................        0.15
Wheat, forage...............................................        0.50
Wheat, germ.................................................        0.15
Wheat, grain................................................        0.10
Wheat, hay..................................................        1.0
Wheat, middlings,...........................................        0.15
Wheat, shorts...............................................        0.15
Wheat, straw................................................        0.50
------------------------------------------------------------------------


[70 FR 55760, Sept. 23, 2005, as amended at 74 FR 46377, Sept. 9, 2009]



Sec. 180.616  Fenpropimorph; tolerances for residues.

    Tolerances are established for the residues of the fungicide 
fenpropimorph (rel-(2R,6S)-4-[3-[4-(1,1-dimethylethyl)phenyl]-2-
methylpropyl]-2,6-dimethylmorpholine) in or on the following commodity:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Banana*.....................................................        2.0
------------------------------------------------------------------------
*No U.S. registration as of February 10, 2006.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[71 FR 15612, Mar. 29, 2006]



Sec. 180.617  Metconazole; tolerances for residues.

    (a) General. Tolerances are established for residues of metconazole, 
including its metabolites and degradates, in or on the commodities in 
the following table. Compliance with the tolerance levels specified 
below is to be determined by measuring only metconazole [5-[(4-
chlorophenyl)methyl]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-
ylmethyl)cyclopentanol] as the sum of its cis- and trans-isomers in or 
on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        4.0
Banana \1\..................................................        0.1
Barley, grain...............................................        2.5
Barley, hay.................................................        7.0
Barley, straw...............................................        7.0
Beet, sugar, dried pulp.....................................        0.70
Beet, sugar, molasses.......................................        0.08
Beet, sugar, roots..........................................        0.07
Bushberry subgroup 13-07B...................................        0.40
Canola seed.................................................        0.04
Cattle, meat byproducts.....................................        0.04
Corn, field, forage.........................................        3.0
Corn, field, grain..........................................        0.02
Corn, field, stover.........................................        4.5
Corn, pop, grain............................................        0.02
Corn, pop, stover...........................................        4.5
Corn, sweet, forage.........................................        3.0
Corn, sweet, kernel plus cob with husks removed.............        0.01
Corn, sweet, stover.........................................       30.0
Cotton, gin byproducts......................................        8.0
Cotton, undelinted seed.....................................        0.25
Egg.........................................................        0.04
Fruit, stone, group 12......................................        0.20
Goat, meat byproducts.......................................        0.04
Grain, aspirated grain fractions............................        7.0
Horse, meat byproducts......................................        0.04
Nut, tree, group 14.........................................        0.04
Oat, grain..................................................        1.0
Oat, hay....................................................       17
Oat, straw..................................................        6.0
Peanut......................................................        0.04
Peanut, refined oil.........................................        0.05
Pistachio...................................................        0.04
Rye, grain..................................................        0.25
Rye, straw..................................................       14
Sheep, meat byproducts......................................        0.04
Soybean, forage.............................................        3.0
Soybean, hay................................................        6.0
Soybean, hulls..............................................        0.08
Soybean, seed...............................................        0.05
Sugarcane, cane.............................................        0.06
Vegetable, tuberous and corn, subgroup 1C...................        0.04
Wheat, grain................................................        0.15
Wheat, hay..................................................       16
Wheat, milled byproducts....................................        0.20
Wheat, straw................................................       18
------------------------------------------------------------------------
\1\ No U.S. registration as of August 30, 2006.

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for the residues of the fungicide metconazole, including its 
metabolites and degradates, in or on the commodities listed in the 
following table in connection with the use of the pesticide under 
section 18 emergency exemptions granted by EPA. The tolerances expire 
and are revoked on the dates specified in the following table. 
Compliance with the tolerance levels specified below is to be determined 
by measuring only metconazole (5-[(4-chlorophenyl)-methyl]-2,2-dimethyl-
1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol) as the sum of its cis- and 
trans-isomers in or on the following commodities:

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Sugarcane, cane.................................        1.6     12/31/14

[[Page 670]]

 
Sugarcane, molasses.............................        3.2     12/31/14
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[71 FR 56388, Sept. 27, 2006, as amended at 71 FR 76196, Dec. 20, 2006; 
73 FR 22828, Apr. 28, 2008; 74 FR 21266, May 7, 2009; 76 FR 50904, Aug. 
17, 2011; 76 FR 81396, Dec. 28, 2011; 77 FR 26456, May 4, 2012; 77 FR 
66723, Nov. 7, 2012]



Sec. 180.618  Benthiavalicarb-isopropyl; tolerance for residues.

    (a) General. Tolerances are established for the combined residues of 
benthiavalicarb-isopropyl, isopropyl[(S)-1-[[[(1R)-1-(6-fluoro-2-
benzothiazolyl)ethyl]amino] carbonyl]-2-methylpropyl]carbamate and 
isopropyl[(S)-1-[[[(1S)-1-(6-fluoro-2-benzothiazolyl)ethyl]amino] 
carbonyl]-2-methylpropyl]carbamate, in or on the following raw 
agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grape, imported.............................................        0.25
Grape, raisin...............................................        1.0
Tomato......................................................        0.45
------------------------------------------------------------------------
Note: There are no U.S. registrations as of July 30, 2006.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect of inadvertent residues. [Reserved]

[71 FR 52003, Sept. 1, 2006]



Sec. 180.619  Epoxiconazole; tolerances for residues.

    (a) General. Tolerances are established for the residues of the 
fungicide epoxiconazole [(rel-1-[[(2R,3S)-3-(2-chlorophenyl)-2-(4-
fluorophenyl)oxiranyl]methyl]-1H-1,2,4-triazole]) in or on the following 
commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Banana*....................................................        0.5
Coffee*....................................................        0.05
------------------------------------------------------------------------
*No U.S. Registration as of August 4, 2006

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional Registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[71 FR 53989, Sept. 13, 2006]



Sec. 180.620  Etofenprox; tolerances for residues.

    (a) General. A tolerance is established for residues of the 
insecticide etofenprox, including its metabolites and degradates, in or 
on the commodity in the table in this paragraph. Compliance with the 
tolerance level specified in this paragraph is to be determined by 
measuring only etofenprox, 2-(4-ethoxyphenyl)-2-methylpropyl 3-
phenoxybenzyl ether, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Rice, grain.................................................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[76 FR 23498, Apr. 27, 2011]



Sec. 180.621  Dithianon; tolerances for residues.

    (a) General. Tolerances are established for residues of dithianon, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below is 
to be determined by measuring only dithianon, 5, 10-dihydro-5,10-
dioxonaphtho(2,3-b)-1,4-dithiin-2,3-dicarbonitrile.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Fruit, pome, group 11\1\....................................        5
Grape \2\...................................................        3
Hop, dried cones\1\.........................................      100
 
------------------------------------------------------------------------
\1\No U.S. registration as of September 5, 2006.
\2\No U.S. registration as of January 29, 2010.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]

[[Page 671]]

    (d) Indirect or inadvertent residues. [Reserved]

[75 FR 5522, Feb. 3, 2010]



Sec. 180.622  Ethaboxam; tolerances for residues.

    (a) General. Tolerances are established for residues of ethaboxam, 
N-(cyano-2-thienylmethyl)-4-ethyl-2-(ethlyamino)-5-thiazolecarboxamide 
in or on the following commodity:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grape \1\...................................................        6.0
------------------------------------------------------------------------
\1\ There is no U.S. registration as of September 27, 2006

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[71 FR 56392, Sept. 27, 2006]



Sec. 180.623  Flufenoxuron; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide, flufenoxuron, 1-[4-(2-chloro-[alpha],[alpha],[alpha]-
trifluoro-p-tolyloxy)-2-fluorophenyl]-3-(2,6-difluorobenzoyl)urea, in or 
on the following food commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Apple \1\...................................................        0.50
Cattle, fat \1\.............................................        4.5
Cattle, meat \1\............................................        0.10
Cattle, meat byproducts \1\.................................        0.50
Goat, fat \1\...............................................        4.5
Goat, meat \1\..............................................        0.10
Goat, meat byproducts \1\...................................        0.50
Grape \1\...................................................        0.70
Grape, raisin \1\...........................................        2.0
Horse, fat \1\..............................................        4.5
Horse, meat \1\.............................................        0.10
Horse, meat byproducts \1\..................................        0.50
Milk........................................................        0.20
Milk, fat \1\...............................................        4.0
Orange \1\..................................................        0.30
Orange, oil \1\.............................................       60
Pear \1\....................................................        0.50
Sheep, fat \1\..............................................        4.5
Sheep, meat \1\.............................................        0.10
Sheep, meat byproducts \1\..................................        0.50
------------------------------------------------------------------------
\1\There are no U.S. registrations as of September 30, 2006.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional restrictions. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[71 FR 57436, Sept. 29, 2006]



Sec. 180.624  Metrafenone; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide metrafenone, including its metabolites and degradates, in or 
on the commodities in the table below. Compliance with the tolerance 
levels specified in the following table is to be determined by measuring 
only metrafenone (3-bromo-6-methoxy-2-methylphenyl)(2,3,4-trimethoxy-6-
methylphenyl)methanone in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grape.......................................................        4.5
Grape, raisin...............................................       17
------------------------------------------------------------------------

    (b) Section 18 emergency exemption. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[71 FR 54917, Sept. 20, 2006, as amended at 75 FR 75393, Dec. 3, 2010]



Sec. 180.625  Orthosulfamuron; tolerances for residues.

    (a) General. Tolerances are established for residues of 
orthosulfamuron 1-(4,6-dimethoxypyrimidin-2-yl)-3-[2-
(dimethylcarbamoyl)- phenylsulfamoyl] urea) per se in or on the 
following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Rice, grain.................................................        0.05
Rice, straw.................................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect and inadvertant residues. [Reserved]

[72 FR 8931, Feb. 28, 2007]



Sec. 180.626  Prothioconazole; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
prothioconazole,

[[Page 672]]

2-[2-(1-chlorocylcopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-1,2-
dihydro-3H-1,2,4-triazole-3-thion, including its metabolites and 
degradates, in or on the commodities in the table below. Compliance with 
the tolerance levels specified below is to be determined by measuring 
only prothioconazole and its metabolite prothioconazole-desthio, or 
[alpha]-(1-chlorocyclopropyl)-[alpha]-[(2-chlorophenyl)methyl]-1H-1,2,4-
triazole-1-ethanol, calculated as parent in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        0.02
Alfalfa, hay................................................        0.02
Beet, sugar, roots..........................................        0.25
Corn, sweet kernel plus cob with husks removed..............        0.04
Grain, aspirated grain fractions............................       11
Grain, cereal, forage, fodder and straw, group 16, except           8.0
 sorghum, and rice; forage..................................
Grain, cereal, forage, fodder and straw, group 16, except           7.0
 sorghum, and rice; hay.....................................
Grain, cereal, forage, fodder and straw, group 16, except          10
 sorghum, and rice; stover..................................
Grain, cereal, forage, fodder and straw, group 16, except           5.0
 sorghum, straw.............................................
Grain, cereal, group 15, except sweet corn and sorghum......        0.35
Pea and bean, dried shelled, except soybean, subgroup 6C....        0.9
Peanut......................................................        0.02
Potato......................................................        0.02
Rapeseed, seed..............................................        0.15
Rice, hulls.................................................        0.90
Soybean, forage.............................................        4.5
Soybean, hay................................................       17
Soybean, seed...............................................        0.15
------------------------------------------------------------------------

    (2) Tolerances are established for residues of prothioconazole, 2-
[2-(1-chlorocylcopropyl)-3-(2-chlorophenyl)-2-hydroxypropyl]-1,2-
dihydro-3H-1,2,4-triazole-3-thion, including its metabolites and 
degradates, in or on the commodities in the table below. Compliance with 
the tolerance levels specified below is to be determined by measuring 
only prothioconazole and its metabolites prothioconazole-desthio, or 
[alpha]-(1-chlorocyclopropyl)-[alpha]-[(2-chlorophenyl)methyl]-1H-1,2,4-
triazole-1-ethanol, and conjugates that can be converted to these two 
compounds by acid hydrolysis, calculated as parent in or on the 
commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.1
Cattle, meat................................................        0.02
Cattle, meat byproducts.....................................        0.2
Goat, fat...................................................        0.1
Goat, meat..................................................        0.02
Goat, meat byproducts.......................................        0.2
Hog, meat byproducts........................................        0.05
Horse, fat..................................................        0.1
Horse, meat.................................................        0.02
Horse, meat byproducts......................................        0.2
Milk........................................................        0.02
Poultry liver...............................................        0.02
Sheep, fat..................................................        0.1
Sheep, meat.................................................        0.02
Sheep, meat byproducts......................................        0.2
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[72 FR 11783, Mar. 14, 2007, as amended at 73 FR 14719, Mar. 19, 2008; 
74 FR 14749, Apr. 1, 2009; 74 FR 46699, Sept. 11, 2009; 75 FR 29914, May 
28, 2010; 76 FR 61592, Oct. 5, 2011]



Sec. 180.627  Fluopicolide; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide fluopicolide [2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]methyl]benzamide], including its metabolites and degradates, 
in or on the commodities in the table in this paragraph. Compliance with 
the tolerance levels specified below is to be determined by measuring 
only fluopicolide [2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]methyl]benzamide] in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A........................        5.0
Grape.......................................................        2.0
Grape, raisin...............................................        6.0
Potato, processed waste.....................................        0.05
Vegetable, brassica (cole) leafy subgroup 5B................       18
Vegetable, bulb, crop group 3-07............................        7.0
Vegetable, cucurbit, group 9................................        0.50
Vegetable, fruiting, group 8................................        1.60
Vegetable, leafy, except brassica, group 4..................       25
Vegetable, leaves of root and tuber, group 2................       15.0
Vegetable root, subgroup 1A.................................        0.15
Vegetable, tuberous and corm subgroup 1C....................        0.02
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established for 
residues

[[Page 673]]

of the fungicide fluopicolide [2,6-dichloro-N-[[3-chloro-5-
(trifluoromethyl)-2-pyridinyl]methyl]benzamide], including its 
metabolites and degradates, in or on the commodities in the table in 
this paragraph. Compliance with the tolerance levels specified below is 
to be determined by measuring only fluopicolide [2,6-dichloro-N-[[3-
chloro-5-(trifluoromethyl)-2-pyridinyl]methyl]benzamide] in or on the 
commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Wheat, aspirated grain fractions............................        0.07
Wheat, forage...............................................        0.20
Wheat, grain................................................        0.02
Wheat, hay..................................................        0.50
Wheat, milled byproducts....................................        0.07
Wheat, straw................................................        0.50
------------------------------------------------------------------------


[72 FR 14447, Mar. 28, 2007, as amended at 73 FR 5455, Jan. 30, 2008; 73 
FR 30498, May 28, 2008; 76 FR 22054, Apr. 20, 2011]



Sec. 180.628  Chlorantraniliprole; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide chlorantraniliprole, including its metabolites and 
degradates, in or on the commodities in the table below. Compliance with 
the tolerance levels specified below is to be determined by measuring 
only chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-
[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Acerola.....................................................        2.0
Alfalfa, seed...............................................        7.0
Almond, hulls...............................................        5.0
Animal feed, nongrass, group 18, forage.....................       25
Animal feed, nongrass, group 18, hay........................       90
Apple, wet pomace...........................................        2.5
Artichoke, globe............................................        4.0
Asparagus...................................................       13
Atemoya.....................................................        4.0
Avocado.....................................................        4.0
Banana......................................................        4.0
Beet, sugar, molasses.......................................        9.0
Berry, large shrub/tree, subgroup 13-07C....................        2.5
Berry, low growing, subgroup 13-07G.........................        1.0
Biriba......................................................        4.0
Brassica, head and stem, subgroup 5A........................        4.0
Brassica, leafy greens, subgroup 5B.........................       11
Bushberry, subgroup 13-07B..................................        2.5
Cacao bean..................................................        0.08
Cacao bean, chocolate.......................................        1.5
Cacao bean, cocoa powder....................................        1.5
Cacao bean, roasted bean....................................        0.8
Cactus......................................................       13
Canistel....................................................        4.0
Cattle, fat.................................................        0.5
Cattle, liver...............................................        0.3
Cattle, meat................................................        0.1
Cattle, meat byproducts, except liver.......................        0.2
Cherimoya...................................................        4.0
Cherry, sweet...............................................        2.0
Cherry, tart................................................        2.0
Citrus, dried pulp..........................................       14
Coffee, green bean..........................................        0.4
Coffee, instant.............................................        2.0
Corn, field, forage.........................................       14
Corn, field, grain..........................................        0.04
Corn, field, milled byproducts..............................        0.1
Corn, field, stover.........................................       14
Corn, pop, forage...........................................       14
Corn, pop, grain............................................        0.04
Corn, pop, stover...........................................       14
Corn, sweet, forage.........................................       14
Corn, sweet, kernel plus cobs with husk removed.............        0.02
Corn, sweet, stover.........................................       14
Cotton, gin byproduct.......................................       30
Cotton, hulls...............................................        0.40
Cottonseed subgroup 20C.....................................        0.3
Crayfish....................................................        8.0
Custard apple...............................................        4.0
Egg.........................................................        0.2
Feijoa......................................................        4.0
Fig.........................................................        4.0
Fruit, caneberry, subgroup 13-07A...........................        1.8
Fruit, citrus, group 10.....................................        1.4
Fruit, pome, group 11, except mayhaw........................        1.2
Fruit, small vine climbing, subgroup 13-07F.................        2.5
Fruit, stone, group 12, except cherry, chickasaw plum, and          4.0
 damson plum................................................
Goat, fat...................................................        0.5
Goat, liver.................................................        0.3
Goat, meat..................................................        0.1
Goat, meat byproducts, except liver.........................        0.2
Grain, aspirated grain fractions............................      640
Grape, raisin...............................................        5.0
Grass forage, fodder and hay, group 17......................       90
Guava.......................................................        4.0
Herb subgroup 19A, dried leaves.............................       90
Herb subgroup 19A, fresh leaves.............................       25
Hog, fat....................................................        0.02
Hog, meat byproducts........................................        0.02
Hop, dried cones............................................       90
Horse, fat..................................................        0.5
Horse, liver................................................        0.3
Horse, meat.................................................        0.1
Horse, meat byproducts, except liver........................        0.2
Ilama.......................................................        4.0
Jaboticaba..................................................        2.0
Longan......................................................        4.0
Lychee......................................................        2.0
Mango.......................................................        4.0
Mayhaw......................................................        0.6
Milk........................................................        0.05
Nut, tree, group 14.........................................        0.04
Olive.......................................................        4.0
Olive, oil..................................................       40
Onion, bulb, subgroup 3-07A.................................        0.30
Papaya......................................................        2.0
Passionfruit................................................        2.0
Peppermint, tops............................................        9.0
Persimmon...................................................        4.0
Pineapple...................................................        1.5
Pineapple, process residue..................................        3.0
Pistachio...................................................        0.04
Plum, chickasaw.............................................        2.0

[[Page 674]]

 
Plum, damson................................................        2.0
Pomegranate.................................................        4.0
Poultry, fat................................................        0.01
Poultry, meat byproducts....................................        0.02
Pulasan.....................................................        4.0
Rambutan....................................................        4.0
Rapeseed subgroup 20A.......................................        2.0
Rice, grain.................................................        0.15
Rice, hulls.................................................        0.4
Sapodilla...................................................        4.0
Sapote, black...............................................        4.0
Sapote, mamey...............................................        4.0
Sapote, white...............................................        4.0
Sheep, fat..................................................        0.5
Sheep, liver................................................        0.3
Sheep, meat.................................................        0.1
Sheep, meat byproducts, except liver........................        0.2
Soursop.....................................................        4.0
Spanish lime................................................        4.0
Spearmint, tops.............................................        9.0
Spice, subgroup 19B.........................................       14
Star apple..................................................        4.0
Starfruit...................................................        4.0
Sugar apple.................................................        4.0
Sugarcane, cane.............................................       14
Sugarcane, molasses.........................................      420
Sunflower subgroup 20B......................................        2.0
Tea, dried..................................................       50.0
Ti, leaves..................................................       13.0
Ti, root....................................................        0.3
Vegetable, cucurbit, group 9................................        0.5
Vegetable, foliage of legume, group 7.......................       90
Vegetable, fruiting, group 8-10.............................        1.4
Vegetable, leafy, except brassica, group 4..................       13
Vegetable, leaves of root and tuber, group 2................       40.0
Vegetable, legume, group 6..................................        2.0
Vegetable, root and tuber, group 1..........................        0.30
Wax jambu...................................................        4.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Time-limited tolerances are 
established for the indirect or inadvertent residues of the insecticide 
chlorantraniliprole, including its metabolites and degradates, in or on 
the commodities in the table below when present therein as a result of 
the application of chlorantraniliprole to the growing crops listed in 
paragraph (a) of this section. Compliance with the tolerance levels 
specified below is to be determined by measuring only 
chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-
[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Grain, cereal, forage, fodder and straw, group         0.20     04/10/14
 16.............................................
Leek............................................       0.20     04/10/14
Onion, green....................................       0.20     04/10/14
Onion, welsh....................................       0.20     04/10/14
Peanut, hay.....................................       0.20     04/10/14
Shallots, fresh leaves..........................       0.20     04/10/14
------------------------------------------------------------------------


[75 FR 5532, Feb. 3, 2010, as amended at 75 FR 17566, Apr. 7, 2010; 76 
FR 44821, July 27, 2011; 76 FR 59909, Sept. 28, 2011; 77 FR 60315, Oct. 
3, 2012; 77 FR 75561, Dec. 21, 2012]



Sec. 180.629  Flutriafol; tolerances for residues.

    (a) General. Tolerances are established for the residues of 
flutriafol, [()-[alpha]-(2-fluorophenyl)-[alpha]-
(4-fluorophenyl)-1H-1,2,4-triazole-1-ethanol], including its metabolites 
and degradates in or on the following commodities. Compliance with the 
following tolerances is to be determined by measuring flutriafol only.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Banana\1\...................................................        0.30
Beet, sugar.................................................        0.08
Cattle, meat byproducts.....................................        0.07
Corn, field, forage.........................................        0.75
Corn, field, grain..........................................        0.01
Corn, field, refined oil....................................        0.02
Corn, field, stover.........................................        1.5
Corn, pop...................................................        0.01
Corn, pop, stover...........................................        1.5
Fruit, pome, group 11-09....................................        0.40
Fruit, stone, group 12-10...................................        1.5
Goat, meat byproducts.......................................        0.07
Grain, aspirated fractions..................................        2.2
Grape.......................................................        1.5
Grape, raisin...............................................        2.4
Hog, meat byproducts........................................        0.02
Horse, meat byproducts......................................        0.07
Peanut......................................................        0.09
Sheep, meat byproducts......................................        0.07
Soybean, seed...............................................        0.35
------------------------------------------------------------------------
\1\There are no U.S. registrations as of October 26, 2011.

    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of 
flutriafol, [()-[alpha]-(2-fluorophenyl)-[alpha]-
(4-fluorophenyl)-1 H -1,2,4-triazole-1-ethanol], including its 
metabolites and degradates in or on the specified agricultural 
commodities, resulting from use of the pesticide pursuant to FIFRA 
section 18 emergency exemptions. The tolerances expire on the date 
specified in the table.

------------------------------------------------------------------------
                                                   Parts per  Expiration
                    Commodity                       million      date
------------------------------------------------------------------------
Cotton, gin byproducts...........................        0.5    12/31/14

[[Page 675]]

 
Cotton, meal.....................................        0.5    12/31/14
Cotton, refined oil..............................        0.5    12/31/14
Cotton, undelinted seed..........................       0.35    12/31/14
------------------------------------------------------------------------

    (c) Tolerances with regional registrations [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established for 
the indirect or inadvertent residues of the fungicide flutriafol, 
including its metabolites and degradates, in or on the commodities in 
the table below when present therein as a result of the application of 
flutriafol to the growing crops listed in the table to paragraph (a) of 
this section. Compliance with the following tolerance levels specified 
below is to be determined by measuring only flutriafol (()-[alpha]-(2-fluorophenyl)-[alpha]-(4-fluorophenyl)-1H-
1,2,4-triazole-1-ethanol) in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Corn, sweet, forage.........................................        0.09
Corn, sweet, kernel plus cob with husk removed..............        0.01
Corn, sweet, stover.........................................        0.07
Cotton, gin byproducts......................................        0.02
Cotton, undelinted seed.....................................        0.01
------------------------------------------------------------------------


[75 FR 26673, May 12, 2010, as amended at 76 FR 69647, Nov. 9, 2011; 77 
FR 47301, Aug. 8, 2012; 77 FR 48901, Aug. 15, 2012]



Sec. 180.630  Flusilazole; tolerances for residues.

    (a) General. [Reserved]
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the fungicide, flusilazole, (1-[[bis(4-
fluorophenyl)methylsilyl]methyl]-1H-1,2,4-triazole) in connection with 
use of the pesticide under Section 18 emergency exemptions granted by 
EPA. The tolerances expire and are revoked on the dates specified in the 
following table.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Soybean, aspirated grain fractions..............        2.6     12/31/10
Soybean, seed...................................       0.04     12/31/10
Soybean, oil....................................       0.10     12/31/10
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertant residues. [Reserved]

[72 FR 49660, Aug. 29, 2007]



Sec. 180.631  Pyrasulfotole; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide pyrasulfotole, including its metabolites and degradates, in or 
on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only the sum of 
pyrasulfotole ((5-hydroxy-1,3-dimethyl-1H-pyrazol-4-yl)[2-
(methylsulfonyl)-4-(trifluoromethyl)phenyl]methanone) and its desmethyl 
metabolite (5-hydroxy-3-methyl-1H-pyrazol-4-yl)[2-(methylsulfonyl)-4-
(trifluoromethyl)phenyl]methanone), calculated as the stoichiometric 
equivalent of pyrasulfotole, in or on the commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Aspirated grain fractions...................................        0.40
Barley, grain...............................................        0.02
Barley, hay.................................................        0.30
Barley, straw...............................................        0.20
Cattle, fat.................................................        0.03
Cattle, liver...............................................        3.0
Cattle, meat................................................        0.02
Cattle, meat byproducts, except liver.......................        0.70
Eggs........................................................        0.02
Goat, fat...................................................        0.03
Goat, liver.................................................        3.0
Goat, meat..................................................        0.02
Goat, meat byproducts, except liver.........................        0.70
Grass, forage...............................................       25
Grass, hay..................................................        3.5
Hog, fat....................................................        0.02
Hog, liver..................................................        0.30
Hog, meat...................................................        0.02
Hog, meat byproducts, except liver..........................        0.05
Horse, fat..................................................        0.03
Horse, liver................................................        3.0
Horse, meat.................................................        0.02
Horse, meat byproducts, except liver........................        0.70
Milk........................................................        0.03
Oat, forage.................................................        0.10
Oat, grain..................................................        0.08
Oat, hay....................................................        0.50
Oat, straw..................................................        0.20
Poultry, fat................................................        0.02
Poultry, meat...............................................        0.02
Poultry, meat byproducts....................................        0.20
Rye, forage.................................................        0.20
Rye, grain..................................................        0.02
Rye, straw..................................................        0.20
Sheep, fat..................................................        0.03
Sheep, liver................................................        3.0
Sheep, meat.................................................        0.02
Sheep, meat byproducts, except liver........................        0.70
Sorghum, grain, forage......................................        1.5
Sorghum, grain, grain.......................................        0.70
Sorghum, grain, stover......................................        0.80

[[Page 676]]

 
Wheat, forage...............................................        0.20
Wheat, grain................................................        0.02
Wheat, hay..................................................        0.80
Wheat, straw................................................        0.20
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[72 FR 45649, Aug. 15, 2007, as amended at 76 FR 23898, Apr. 29, 2011]



Sec. 180.632  Fenazaquin; import tolerances for residues.

    (a) General. Import tolerances are established for residues of the 
insecticide and miticide, fenazaquin, 4-tert-butylphenethyl quinazolin-
4-yl ether, in or on raw agricultural commodities as follows:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Apple.......................................................        0.2
Citrus Oil..................................................       10
Fruit, Citrus, Group 10, except Grapefruit..................        0.5
Pear........................................................        0.2
------------------------------------------------------------------------

    (b) Section is emergency exempotions. [Reserved]
    (c) Tolerances with regional registration. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[72 FR 44393, Aug. 8, 2007]



Sec. 180.633  Florasulam; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide florasulam N-(2,6-difluorophenyl)-8-fluoro-5-
methoxy(1,2,4)triazolo(1,5-c)pyrimidine-2-sulfonamide in or on the 
following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, grain...............................................        0.01
Barley, hay.................................................        0.05
Barley, straw...............................................        0.05
Oat, forage.................................................        0.05
Oat, grain..................................................        0.01
Oat, hay....................................................        0.05
Oat, straw..................................................        0.05
Rye, forage.................................................        0.05
Rye, grain..................................................        0.01
Rye, straw..................................................        0.05
Wheat, forage...............................................        0.05
Wheat, grain................................................        0.01
Wheat, hay..................................................        0.05
Wheat, straw................................................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[72 FR 55077, Sept. 28, 2007]



Sec. 180.634  Tembotrione; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
herbicide tembotrione, including its metabolites and degradates, in or 
on the commodities listed in the table to this paragraph. Compliance 
with the tolerance levels specified below is to be determined by 
measuring only the sum of tembotrione, 2-[2-chloro-4-(methylsulfonyl)-3-
[(2,2,2-trifluoroethoxy)methyl]benzoyl]-1,3-cyclohexanedione and its 
metabolite, 2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-trifluoroethoxy) 
methyl]benzoyl]-4,6-dihydroxy-1,3-cyclohexanedione, calculated as the 
stoichiometric equivalent of tembotrione, in or on the following 
commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, liver...............................................        0.40
Cattle, meat byproducts, except liver.......................        0.07
Corn, field, forage.........................................        0.60
Corn, field, grain..........................................        0.02
Corn, field, stover.........................................        0.45
Corn, pop, grain............................................        0.02
Corn, pop, stover...........................................        0.35
Corn, sweet, forage.........................................        0.35
Corn, sweet, stover.........................................        0.60
Goat, liver.................................................        0.40
Goat, meat byproducts, except liver.........................        0.07
Horse, liver................................................        0.40
Horse, meat byproducts, except liver........................        0.07
Poultry, liver..............................................        0.07
Sheep, liver................................................        0.40
Sheep, meat byproducts, except liver........................        0.07
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the herbicide 
tembotrione, including its metabolites and degradates, in or on the 
commodities listed in the table to this paragraph. Compliance with the 
tolerance levels specified below is to be determined by measuring only 
tembotrione, 2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-
trifluoroethoxy)methyl]benzoyl]-1,3-

[[Page 677]]

cyclohexanedione in or on the following commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Corn, sweet, kernel plus cob with husks removed.............        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[72 FR 55085, Sept. 28, 2007, as amended at 74 FR 47894, Sept. 18, 2009]



Sec. 180.635  Spinetoram; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the insecticide spinetoram, expressed as a combination of XDE-175-J: 1-
H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-
2,4-di-O-methyl-a-L-mannopyranosyl) oxy]-13-[[(2R,5S,6R)-5- 
(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl] oxy]-9-ethyl-
2,3,3a,4,5,5a,5b,6,9, 10,11,12,13,14,16a,16b- hexadecahydro 14-methyl-, 
(2R,3aR,5aR,5bS,9S, 13S,14R,16aS,16bR); XDE-175-L: 1H-as-indaceno[3,2-
d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O- ethyl-2,4-di-O-methyl-a-
L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-
methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9, 
10,11,12,13,14,16a,16b- tetradecahydro-4,14-dimethyl-, 
(2S,3aR,5aS,5bS,9S, 13S,14R,16aS,16bS); ND-J: (2R,3aR,5aR,5bS,9S, 
13S,14R,16aS,16bR)-9-ethyl-14-methyl-13-[[(2S,5S,6R)-6- methyl-5-
(methylamino)tetrahydro- 2H-pyran-2-yl]oxy]-7,15-dioxo-
2,3,3a,4,5,5a,5b,6,7,9, 10,11,12,13,14,15,16a,16b- octadecahydro-1H-as- 
indaceno[3,2-d]oxacyclododecin-2-yl 6-deoxy-3-O-ethyl-2,4-di-O-methyl- 
alpha-L-mannopyranoside; and NF-J: (2R,3S,6S)-6-([(2R,3aR,5aR,5bS,9S, 
13S,14R,16aS,16bR)- 2-[(6-deoxy-3-O-ethyl-2,4-di-O- methyl-alpha-L-
mannopyranosyl) oxy]-9-ethyl-14-methyl-7,15-dioxo-2, 
3,3a,4,5,5a,5b,6,7,9, 10,11,12,13,14,15,16a,16b- octadecahydro-1H-as- 
indaceno[3,2-d]oxacyclododecin-13-yl] oxy)-2-methyltetrahydro- 2H-pyran-
3-yl(methyl)formamide, in or on the following raw agricultural 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Acerola.....................................................        0.30
Almond, hulls...............................................       19
Amaranth grain, grain.......................................        1.0
Apple, wet pomace...........................................        0.50
Artichoke, globe............................................        0.30
Asparagus...................................................        0.04
Atemoya.....................................................        0.30
Avocado.....................................................        0.30
Banana......................................................        0.25
Beet, sugar, molasses.......................................        0.75
Biriba......................................................        0.30
Brassica, head and stem, subgroup 5A........................        2.0
Brassica, leafy greens, subgroup 5B.........................       10
Bushberry, subgroup 13B.....................................        0.25
Caneberry, subgroup 13A.....................................        0.70
Canistel....................................................        0.30
Cattle, fat.................................................        5.5
Cattle, liver...............................................        0.85
Cattle, meat................................................        0.20
Cattle, meat byproducts (except liver)......................        0.60
Cherimoya...................................................        0.30
Citrus, dried pulp..........................................        0.50
Citrus, oil.................................................        3.0
Corn, sweet, kernel plus cob with husks removed.............        0.04
Cotton, gin byproducts......................................        1.5
Cotton, undelinted seed.....................................        0.04
Cranberry...................................................        0.04
Custard apple...............................................        0.30
Date........................................................        0.10
Egg.........................................................        0.04
Feijoa......................................................        0.30
Fig.........................................................        0.10
Fruit, citrus, group 10.....................................        0.30
Fruit, pome, group 11.......................................        0.20
Fruit, stone, group 12......................................        0.20
Goat, fat...................................................        5.5
Goat, liver.................................................        0.85
Goat, meat..................................................        0.20
Goat, meat byproducts (except liver)........................        0.60
Grain, aspirated fractions..................................       20
Grain, cereal, group 15, except rice, sorghum, pearl millet         0.04
 and proso millet...........................................
Grain, cereal, group 16, forage.............................        3.5
Grain, cereal, group 16, hay................................       10
Grain, cereal, group 16, stover.............................       10
Grain, cereal, straw, group 16, except rice.................        1.0
Grape.......................................................        0.50
Grape, raisin...............................................        0.70
Guava.......................................................        0.30
Herb, dried, subgroup 19A...................................       22
Herb, fresh, subgroup 19A...................................        3.0
Hog, fat....................................................        0.40
Hog, meat...................................................        0.04
Hog, meat byproducts........................................        0.04
Hop, dried cones............................................       22
Horse, fat..................................................        5.5
Horse, liver................................................        0.85
Horse, meat.................................................        0.20
Horse, meat byproducts (except liver).......................        0.60
Ilama.......................................................        0.30
Jaboticaba..................................................        0.30
Juneberry...................................................        0.25
Lingonberry.................................................        0.25
Longan......................................................        0.30
Lychee......................................................        0.30
Mango.......................................................        0.30
Milk........................................................        0.30
Milk, fat...................................................        7.5
Millet, pearl, grain........................................        1.0

[[Page 678]]

 
Millet, proso, grain........................................        1.0
Nut, tree, group 14.........................................        0.10
Okra........................................................        0.40
Onion, green................................................        2.0
Papaya......................................................        0.30
Passionfruit................................................        0.30
Pea and bean, dried shelled, except soybean, subgroup 6C....        0.04
Pea and bean, succulent shelled, subgroup 6B................        0.04
Peanut......................................................        0.04
Peanut, hay.................................................       11
Peppermint, tops............................................        3.5
Pineapple...................................................        0.04
Pineapple, processed residue................................        0.15
Pistachio...................................................        0.10
Pomegranate.................................................        0.30
Poultry, fat................................................        0.10
Poultry, meat...............................................        0.04
Poultry, meat byproducts....................................        0.04
Pulasan.....................................................        0.30
Rambutan....................................................        0.30
Salal.......................................................        0.25
Sapodilla...................................................        0.30
Sapote, black...............................................        0.30
Sapote, mamey...............................................        0.30
Sapote, white...............................................        0.30
Sheep, fat..................................................        5.5
Sheep, liver................................................        0.85
Sheep, meat.................................................        0.20
Sheep, meat products (except liver).........................        0.60
Sorghum, grain, grain.......................................        1.0
Soursop.....................................................        0.30
Soybean, seed...............................................        0.04
Spanish lime................................................        0.30
Spearmint, tops.............................................        3.5
Spice, subgroup 19B, except black pepper....................        1.7
Star apple..................................................        0.30
Star fruit..................................................        0.30
Strawberry..................................................        1.0
Sugar apple.................................................        0.30
Ti, leaves..................................................       10
Vegetable, bulb, group 3, except green onion................        0.10
Vegetable, cucurbit, group 9................................        0.30
Vegetable, foliage of legume, group 7.......................        8.0
Vegetable, fruiting, group 8................................        0.40
Vegetable, leafy, except Brassica, group 4..................        8.0
Vegetable, leaves of root and tuber, group 2................       10
Vegetable, legume, edible podded, subgroup 6A...............        0.30
Vegetable, root and tuber, group 1..........................        0.10
Watercress..................................................        8.0
Wax jambu...................................................        0.30
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registration. [Reserved]
    (d) Indirect and invertent residues. [Reserved]

[72 FR 57499, Oct. 10, 2007, as amended at 73 FR 14714, Mar. 19, 2008; 
74 FR 40759, Aug. 13, 2009]



Sec. 180.636  1,3-dichloropropene; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the fungicide cis- and trans-1,3-dichloropropene and its metabolites 
cis- and trans-3-chloroacrylic acid, and cis- and trans-3-chloroallyl 
alcohol in or on the following commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grape........................................................      0.018
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[73 FR 8218, Feb. 13, 2008]



Sec. 180.637  Mandipropamid; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide mandipropamid, 4-chloro-N-[2-(3-methoxy-4-(2-
propynyloxy)phenyl]ethyl]-alpha-(2-propynyloxy)-benzeneacetamide in or 
on the following commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A........................        3
Brassica, leafy greens, subgroup 5B.........................       25
Grape.......................................................        1.4
Grape, raisin...............................................        3.0
Hop, dried cones............................................       50
Okra........................................................        1.0
Onion, dry bulb.............................................        0.05
Onion, green................................................        4
Potato, wet peel............................................        0.03
Vegetable, cucurbit, group 9................................        0.6
Vegetable, fruiting, group 8................................        1.0
Vegetable, leafy except Brassica, group 4...................       20
Vegetable, tuberous and corm, subgroup 1C...................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of the 
mandipropamid, 4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-
[alpha]-(2-propynyloxy)-benzeneacetamide in or on the specified 
agricultural commodities, resulting from use of the pesticide pursuant 
to FFIFRA section 18 emergency exemptions. The tolerances expire on the 
date specified in the table.

[[Page 679]]



------------------------------------------------------------------------
                                    Parts per     Expiration/revocation
            Commodity                million              date
------------------------------------------------------------------------
Basil, dried....................          240                  12/31/15
Basil, fresh....................           20                  12/31/15
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent tolerances. [Reserved]

[73 FR 2816, Jan. 16, 2008, as amended at 74 FR 33169, July 10, 2009; 76 
FR 55804, Sept. 9, 2011; 77 FR 74119, Dec. 13, 2012]



Sec. 180.638  Pyroxsulam; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide pyroxsulam, N-(5,7-dimethoxy[1,2,4]triazolo[1,5-a]pyrimidin-2-
yl)-2-methoxy-4-(trifluoromethyl)-3-pyridinesulfonamide in or on the raw 
agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Wheat, forage...............................................        0.06
Wheat, grain................................................        0.01
Wheat, hay..................................................        0.01
Wheat, straw................................................        0.03
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[73 FR 10402, Feb. 27, 2008]



Sec. 180.639  Flubendiamide; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
flubendiamide, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified in the table is to be determined by measuring only 
flubendiamide N\2\-[1, 1-dimethyl-2-(methylsulfonyl)ethyl]-3-iodo-N\1\-
[2-methyl-4- [1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-
benzenedicarboxamide, in or on the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hulls..............................................        9.0
Apple, wet pomace..........................................        5.0
Corn, field, forage........................................        8.0
Corn, field, grain.........................................        0.03
Corn, field, stover........................................       15
Corn, pop, grain...........................................        0.02
Corn, pop, stover..........................................       15
Corn, sweet, forage........................................        9.0
Corn, sweet, kernel plus cob with husks removed............        0.01
Corn, sweet, stover........................................       25
Cotton gin byproducts......................................       60
Cotton, undelinted seed....................................        0.90
Fruit, pome, group 11......................................        1.5
Fruit, stone, group 12.....................................        1.6
Grape......................................................        1.4
Nut, tree, group 14........................................        0.06
Okra.......................................................        0.30
Vegetable, cucurbit, group 9...............................        0.20
Vegetable, fruiting, group 8...............................        0.60
Vegetable, leafy, except Brassica, group 4.................       11
------------------------------------------------------------------------

    (2) Tolerances are established for residues of flubendiamide, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified in the 
table is to be determined by measuring only flubendiamide N\2\-[1,1-
dimethyl-2-(methylsulfonyl)ethyl]-3-iodo-N\1\-[2-methyl-4-[1,2,2,2-
tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-benzenedicarboxamide, 
in or on the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage............................................       25
Alfalfa, hay...............................................       65
Artichoke, globe...........................................        1.6
Berry, low growing, subgroup 13-07G, except cranberry......        1.5
Brassica, head and stem, subgroup 5A.......................        3.0
Brassica, leafy greens, subgroup 5B........................       25
Cattle, fat................................................        0.70
Cattle, meat...............................................        0.08
Cattle, meat byproducts....................................        0.60
Egg........................................................        0.40
Fruit, small fruit vine climbing except fuzzy kiwifruit,           1.4
 subgroup 13-07F...........................................
Goat, fat..................................................        0.70
Goat, meat.................................................        0.08
Goat, meat byproducts......................................        0.60
Grain, aspirated grain fractions...........................      153
Hog, fat...................................................        0.15
Hog, meat..................................................        0.03
Hog, meat byproducts.......................................        0.15
Horse, fat.................................................        0.70
Horse, meat................................................        0.08
Horse, meat byproducts.....................................        0.60
Milk.......................................................        0.15

[[Page 680]]

 
Milk, fat..................................................        1.0
Pea and bean, dried shelled, except soybean, subgroup 6C...        0.60
Pea and bean, succulent shelled, subgroup 6B...............        0.05
Peanut, hay................................................       60
Peanut, meal...............................................        0.03
Peanut, nutmeat............................................        0.02
Peanut, refined oil........................................        0.03
Pistachio..................................................        0.06
Poultry, fat...............................................        3.0
Poultry, liver.............................................        0.60
Poultry, meat..............................................        0.10
Rice, grain \1\............................................        0.50
Safflower, seed............................................        5.0
Sheep, fat.................................................        0.70
Sheep, meat................................................        0.08
Sheep, meat byproducts.....................................        0.60
Sorghum, grain, forage.....................................       12
Sorghum, grain, grain......................................        5.0
Sorghum, grain, stover.....................................       14
Soybean, forage............................................       18
Soybean, hay...............................................       60
Soybean, hulls.............................................        0.80
Soybean, seed..............................................        0.25
Sugarcane, cane............................................        0.30
Sunflower, seed............................................        5.0
Turnip, greens.............................................       25
Vegetable, foliage of legume, except soybean, subgroup 7A..       35
Vegetable, legume, edible podded, subgroup 6A..............        0.50
------------------------------------------------------------------------
\1\ There are no U.S. registrations for rice, grain.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established for 
residues of flubendiamide, including its metabolites and degradates, in 
or on the commodities in the table below. Compliance with the tolerance 
levels specified in the table is to be determined by measuring only 
flubendiamide N2-[1, 1-dimethyl-2-(methylsulfonyl)ethyl]-3-iodo-N1-[2-
methyl-4- [1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1, 2-
benzenedicarboxamide, in or on the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Barley, hay................................................        0.04
Barley, straw..............................................        0.07
Buckwheat..................................................        0.07
Clover, forage.............................................        0.15
Clover, hay................................................        0.04
Grass, forage..............................................        0.15
Grass, hay.................................................        0.04
Millet, pearl, forage......................................        0.15
Millet, pearl, hay.........................................        0.04
Millet, proso, forage......................................        0.15
Millet, proso, hay.........................................        0.04
Millet, proso, straw.......................................        0.07
Oats, forage...............................................        0.15
Oats, hay..................................................        0.04
Oats, straw................................................        0.07
Rye, forage................................................        0.15
Rye, straw.................................................        0.07
Teosinte, forage...........................................        0.15
Teosinte, hay..............................................        0.04
Teosinte, straw............................................        0.07
Triticale, forage..........................................        0.15
Triticale, hay.............................................        0.04
Triticale, straw...........................................        0.07
Wheat, forage..............................................        0.15
Wheat, hay.................................................        0.03
Wheat, straw...............................................        0.03
------------------------------------------------------------------------


[76 FR 16307, Mar. 23, 2011, as amended at 76 FR 55273, Sept. 7, 2011; 
77 FR 73945, Dec. 12, 2012]



Sec. 180.640  Pyridalyl; tolerances for residues.

    (a) General. Tolerances are established for residues of pyridalyl, 
pyridine,2-[3-[2,6-dichloro-4-[(3,3-dichloro-2-
propenyl)oxy]phenoxy]propoxy]-5-(trifluoromethyl, in or on the following 
raw agricultural commodities:)

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A........................        3.5
Mustard greens..............................................       30
Turnip greens...............................................       30
Vegetable, fruiting, group 8................................        1.0
Vegetables, leafy, except Brassica, group 4.................       20
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[73 FR 25533, May 7, 2008]



Sec. 180.641  Spirotetramat; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide spirotetramat, including its metabolites and degradates, in 
or on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only the sum of 
spirotetramat (cis-3-(2,5-dimethlyphenyl)-8-methoxy-2-oxo-1-
azaspiro[4.5]dec-3-en-4-yl-ethyl carbonate) and its metabolites cis-3-
(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]dec-3-en-2-one, 
cis-3-(2,5-dimethylphenyl)-3-hydroxy-8-methoxy-1-azaspiro[4.5]decane-
2,4-dione, cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-

[[Page 681]]

1-azaspiro[4.5]dec-3-en-4-yl beta-D-glucopyranoside, and cis-3-(2,5-
dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]decan-2-one, 
calculated as the stoichiometric equivalent of spirotetramat, in or on 
the following commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Acerola.....................................................        2.5
Almond, hulls...............................................        9.0
Artichoke, globe............................................        1.5
Aspirated grain fractions...................................       10.0
Avocado.....................................................        0.60
Berry, low growing, except strawberry, subgroup 13-07H......        0.30
Black sapote................................................        0.60
Brassica, head and stem, subgroup 5A........................        2.5
Brassica, leafy, subgroup 5B................................        8.0
Bushberry subgroup 13-07B...................................        3.0
Canistel....................................................        0.60
Citrus, oil.................................................        6.0
Coffee, green bean..........................................        0.20
Coffee, instant.............................................        0.50
Cotton gin byproducts\1\....................................       10.0
Cotton, undelinted seed\1\..................................        0.30
Feijoa......................................................        0.30
Fruit, citrus, group 10-10..................................        0.60
Fruit, pome, group 11-10....................................        0.70
Fruit, stone, group 12......................................        4.5
Grape, raisin...............................................        3.0
Guava.......................................................        2.5
Hop, dried cones............................................       10.0
Jaboticaba..................................................        2.5
Longan......................................................       13.0
Lychee......................................................       13.0
Mamey sapote................................................        0.60
Mango.......................................................        0.60
Nut, tree, group 14.........................................        0.25
Papaya......................................................        2.5
Passionfruit................................................        2.5
Pineapple...................................................        0.30
Pistachio...................................................        0.25
Pomegranate.................................................        0.50
Potato, flakes..............................................        1.6
Pulasan.....................................................       13.0
Rambutan....................................................       13.0
Sapodilla...................................................        0.60
Small fruit vine climbing subgroup, except fuzzy kiwifruit,         1.3
 subgroup 13-07F............................................
Soybean forage..............................................        8.0
Soybean hay.................................................       16.0
Soybean seed................................................        5.0
Spanish lime................................................        0.60
Star apple..................................................        0.60
Starfruit...................................................        2.5
Strawberry\1\...............................................        0.40
Taro, leaves................................................        9.0
Vegetable, bulb, group 3-07.................................        0.80
Vegetable, cucurbit, group 9................................        0.30
Vegetable, foliage of legume, except soybean, subgroup 07A..        7.0
Vegetable, fruiting, group 8-10.............................        2.5
Vegetable, leafy, except brassica, group 4..................        9.0
Vegetable, legume, group 06, except soybean.................        2.5
Vegetable, tuberous and corm, subgroup 1C...................        0.60
Watercress..................................................        2.0
Wax jambu...................................................        2.5
White sapote................................................        0.60
------------------------------------------------------------------------
\1\ Import tolerance only. There are no U.S. registrations for cotton or
  strawberry.

    (2) Tolerances are also established for residues of the insecticide 
spirotetramat, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only the sum of 
spirotetramat (cis-3-(2,5-dimethlyphenyl)-8-methoxy-2-oxo-1-
azaspiro[4.5]dec-3-en-4-yl-ethyl carbonate]) and its metabolite cis-3-
(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]dec-3-en-2-one, 
calculated as the stoichiometric equivalent of spirotetramat, in or on 
the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.02
Cattle, meat................................................        0.02
Cattle, meat byproducts.....................................        0.20
Eggs........................................................        0.02
Goat, fat...................................................        0.02
Goat, meat..................................................        0.02
Goat, meat byproducts.......................................        0.20
Hog, meat byproducts........................................        0.02
Horse, fat..................................................        0.02
Horse, meat.................................................        0.02
Horse, meat byproducts......................................        0.20
Milk........................................................        0.01
Poultry, meat byproducts....................................        0.02
Sheep, fat..................................................        0.02
Sheep, meat.................................................        0.02
Sheep, meat byproducts......................................        0.20
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with regional 
registrations are established for residues of the insecticide 
spirotetramat, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only the sum of 
spirotetramat (cis-3-(2,5-dimethlyphenyl)-8-methoxy-2-oxo-1-
azaspiro[4.5]dec-3-en-4-yl-ethyl carbonate) and its metabolites cis-3-
(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]dec-3-en-2-one, 
cis-3-(2,5-dimethylphenyl)-3-hydroxy-8-methoxy-1-azaspiro[4.5]decane-
2,4-dione, cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-1-
azaspiro[4.5]dec-3-en-4-yl beta-D-glucopyranoside, and cis-3-(2,5-
dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]decan-2-one, 
calculated as the stoichiometric equivalent of spirotetramat, in or on 
the following commodities.

[[Page 682]]



------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Banana......................................................        4.0
------------------------------------------------------------------------

    (d) Indirect or inadvertant residues. [Reserved]

[73 FR 39256, July 9, 2008, as amended at 76 FR 28681, May 18, 2011; 77 
FR 8746, Feb. 15, 2012; 77 FR 75859, Dec. 26, 2012; 78 FR 28512, May 15, 
2013]



Sec. 180.642  Gentamicin; tolerances for residues.

    (a) General. [Reserved]
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of 
gentamicin in or on the specified agricultural commodities, resulting 
from use of the pesticide pursuant to FIFRA section 18 emergency 
exemptions. The tolerances expire and are revoked on the date specified 
in the following table.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Apple...........................................       0.10     12/31/10
------------------------------------------------------------------------

    (c) Tolerance with regional restrictions. [Reserved]
    (d) Indirect or inadvertant residues. [Reserved]

[73 FR 44162, July 30, 2008]



Sec. 180.643  Uniconazole; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide/plant growth regulator uniconazole-P, (E)-(S)-1-(4-
chlorophenyl)-4,4-dimethyl-2-(1H-1,2,4-triazol-1-yl)pent-1-en-3-ol, its 
R-enantiomer and its Z-isomer in or on the following raw agricultural 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Vegetable, fruiting, group 8................................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertant residues. [Reserved]

[73 FR 51736, Sept. 5, 2008]



Sec. 180.644  Cyprosulfamide; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
herbicide safener cyprosulfamide, N-[[4-[(cyclopropylamino)carbonyl] 
phenyl]sulfonyl]-2-methoxybenzamide, in or on the following raw 
agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Corn, field, forage.........................................        0.20
Corn, field, grain..........................................        0.01
Corn, field, stover.........................................        0.20
Corn, pop, grain............................................        0.01
Corn, pop, stover...........................................        0.20
Corn, sweet, forage.........................................        0.40
Corn, sweet, kernel plus cob with husks removed.............        0.01
Corn, sweet, stover.........................................        0.35
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the herbicide safener 
cyprosulfamide, N-[[4-[(cyclopropylamino)carbonyl] phenyl]sulfonyl]-2-
methoxybenzamide, and its metabolite 4-(aminosulfonyl)-N-
cyclopropylbenzamide, calculated as cyprosulfamide, in or on the 
following raw agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, meat byproducts.....................................        0.02
Goat, meat byproducts.......................................        0.02
Horse, meat byproducts......................................        0.02
Sheep, meat byproducts......................................        0.02
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertant residues. [Reserved]

[73 FR 60974, Oct. 15, 2008]



Sec. 180.645  Thiencarbazone-methyl; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
thiencarbazone-methyl [methyl 4-[[[(4,5-dihydro-3-methoxy-4-methyl-5-
oxo-1H-1,2,4-triazol-1-yl)-carbonyl]amino]sulfonyl]-5-methyl-3-
thiophenecarboxylate], per se, in or on the following food and feed 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Corn, field, forage.........................................        0.04
Corn, field, grain..........................................        0.01

[[Page 683]]

 
Corn, field, stover.........................................        0.02
Corn, pop, grain............................................        0.01
Corn, pop, stover...........................................        0.01
Corn, sweet, forage.........................................        0.05
Corn, sweet, kernel plus cob with husks removed.............        0.01
Corn, sweet, stover.........................................        0.05
Wheat, forage...............................................        0.10
Wheat, grain................................................        0.01
Wheat, hay..................................................        0.01
Wheat, straw................................................        0.01
------------------------------------------------------------------------

    (2) Tolerances are established for combined residues of 
thiencarbazone-methyl and its metabolite BYH 18636-MMT [5-methoxy-4-
methyl-2,4-dihydro-3H-1,2,4-triazol-3-one], calculated as the parent 
compound, in or on the following food commodities of animal origin:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, meat................................................        0.02
Cattle, meat byproducts.....................................        0.02
Goat, meat..................................................        0.02
Goat, meat byproducts.......................................        0.02
Horse, meat.................................................        0.02
Horse, meat byproducts......................................        0.02
Milk........................................................        0.02
Sheep, meat.................................................        0.02
Sheep, meat byproducts......................................        0.02
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established for 
indirect or inadvertent combined residues of thiencarbazone-methyl and 
its metabolite BYH 18636-MMT-glucoside [2-hexopyranosyl-5-methoxy-4-
methyl-2,4-dihydro-3H-1,2,4-triazol-3-one], calculated as the parent 
compound, in or on the following food commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Soybean, forage.............................................        0.04
Soybean, hay................................................        0.15
------------------------------------------------------------------------


[73 FR 60968, Oct. 15, 2008]



Sec. 180.646  Ipconazole; tolerances for residues.

    (a) General. Tolerances are established for residues of ipconazole, 
(2-[(4-chlorophenyl)methyl]-5-(1-methylethyl)-1-(1H-1,2,4-triazole-1-
ylmethyl) cyclopentanol) from seed treatment in or on the following 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cotton, gin byproducts......................................        0.01
Cotton, undelinted seed.....................................        0.01
Grain, cereal, forage, fodder and straw, group 16, except           0.01
 rice.......................................................
Grain, cereal group 15, except rice.........................        0.01
Pea and bean, dried shelled, except soybean, subgroup 6C....        0.01
Peanut......................................................        0.01
Soybean, forage.............................................        0.01
Soybean, seed...............................................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[73 FR 69559, Nov. 19, 2008]



Sec. 180.647  d-Phenothrin; tolerances for residues.

    (a) General. A tolerance of 0.01 parts per million is established 
for residues of the insecticide d-phenothrin in or on all food/feed 
crops following wide-area mosquito adulticide applications.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[74 FR 32443, July 8, 2009]



Sec. 180.648  Meptyldinocap; tolerances for residues.

    (a) General. Tolerances are established for the combined residues of 
the fungicide meptyldinocap, 2-(1-methylheptyl)-4,6-dinitrophenyl (2E)-
2-butenoate and 2,4-DNOP, 2,4-dinitro-6-(1-methylheptyl)phenol expressed 
as meptyldinocap in or on the following commodities:

------------------------------------------------------------------------
                 Commodity                        Parts Per Million
------------------------------------------------------------------------
Grape.....................................  0.20
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[74 FR 48396, Sept. 23, 2009]

[[Page 684]]



Sec. 180.649  Saflufenacil; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
saflufenacil, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only the sum of 
saflufenacil, 2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-
(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluoro-N-[[methyl(1-
methylethyl)amino] sulfonyl]benzamide, and its metabolites N-[2-chloro-
5-(2,6-dioxo-4-(trifluoromethyl) -3,6-dihydro-1(2H)-pyrimidinyl)-4-
fluorobenzoyl]-N[min]-isopropyl sulfamide and N-[4-chloro-2-fluoro-5-
({[(isopropylamino) sulfonyl]amino{time} carbonyl) phenyl]urea, 
calculated as the stoichiometric equivalent of saflufenacil, in or on 
the commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        0.10
Banana \1\..................................................        0.03
Coffee, green bean \1\......................................        0.03
Cotton, gin byproducts......................................        0.45
Cottonseed subgroup 20C.....................................        0.20
Fruit, citrus, group 10.....................................        0.03
Fruit, pome, group 11.......................................        0.03
Fruit, stone, group 12......................................        0.03
Grain, aspirated fractions..................................       10
Grain, cereal, forage, fodder and straw group 16............        0.10
Grain, cereal, group 15.....................................        0.03
Grape.......................................................        0.03
Mango \1\...................................................        0.03
Nut, tree, group 14.........................................        0.03
Pea and bean, dried shelled, except soybean, subgroup 6C....        0.30
Pea and bean, succulent shelled, subgroup 6B................        0.03
Pea, hay....................................................       17
Pistachio...................................................        0.03
Rapeseed subgroup 20A.......................................        0.45
Soybean, hulls..............................................        0.50
Soybean, seed...............................................        0.10
Sunflower subgroup 20B......................................        1.0
Vegetable, foliage of legume, group 7 (except pea, hay).....        0.10
Vegetable, legume, edible podded, subgroup 6A...............        0.03
------------------------------------------------------------------------
\1\ No U.S. registration as of December 7, 2011.

    (2) Tolerances are established for residues of saflufenacil, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below is 
to be determined by measuring only saflufenacil, 2-chloro-5-[3,6-
dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-pyrimidinyl]-4-
fluoro-N-[[methyl(1-methylethyl)amino]sulfonyl] benzamide, in or on the 
commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.01
Cattle, liver...............................................        2.5
Cattle, meat................................................        0.01
Cattle, meat byproducts, except liver.......................        0.05
Goat, fat...................................................        0.01
Goat, liver.................................................        2.5
Goat, meat..................................................        0.01
Goat, meat byproducts, except liver.........................        0.05
Hog, fat....................................................        0.01
Hog, liver..................................................        0.80
Hog, meat...................................................        0.01
Hog, meat byproducts, except liver..........................        0.02
Horse, fat..................................................        0.01
Horse, liver................................................        2.5
Horse, meat.................................................        0.01
Horse, meat byproducts, except liver........................        0.05
Milk........................................................        0.01
Sheep, fat..................................................        0.01
Sheep, liver................................................        2.5
Sheep, meat.................................................        0.01
Sheep, meat byproducts, except liver........................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[74 FR 46689, Sept. 11, 2009, as amended at 76 FR 27261, May 11, 2011; 
76 FR 76309, Dec. 7, 2011]



Sec. 180.650  Isoxaben; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide isoxaben, including its metabolites and degradates, in or on 
the commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only isoxaben, N-[3-(1-
ethyl-1-methylpropyl)-5-isoxazolyl]-2, 6-dimethoxybenzamide, in or on 
the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        0.40
Grape.......................................................        0.01
Nut, tree, Group 14.........................................        0.02
Pistachio...................................................        0.02
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[75 FR 69360, Nov. 12, 2010]

[[Page 685]]



Sec. 180.651  Imazosulfuron; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide imazosulfuron, including its metabolites and degradates, in or 
on the following commodities. Compliance with the tolerance levels 
specified in the following table below is to be determined by measuring 
only imazosulfuron, 2-chloro-N-[[ (4,6-dimethoxy-2-pyrimidinyl)amino] 
carbonyl] imidazo-[1,2-[alpha]]pyridine-3-sulfonamide, in or on the 
commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Pepper, bell................................................        0.02
Pepper, non-bell............................................        0.02
Rice, grain.................................................        0.02
Tomato......................................................        0.02
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[75 FR 81884, Dec. 29, 2010]



Sec. 180.652  Ethiprole; tolerances for residues.

    (a) General. Tolerances (without U.S. registrations) are established 
for residues of the insecticide ethiprole, including its metabolites and 
degradate, in or on the following commodities listed in the table. 
Compliance with the tolerance levels specified in the table is to be 
determined by measuring only ethiprole [5-amino-1-[2,6-dichloro-4-
(trifluoromethyl)phenyl]-4-[(ethyl)-sulfinyl]-1H-pyrazole-3-
carbonitrile], in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Rice, grain \1\.............................................        1.7
Tea, dried \1\..............................................       30
------------------------------------------------------------------------
\1\ There are no U.S. registrations for rice and tea.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[76 FR 18921, Apr. 6, 2011]



Sec. 180.653  Indaziflam; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide indaziflam, N-[(1R,2S)-2,3-dihydro-2,6-dimethyl-1H-inden-1-
yl]-6-(1-fluoroethyl)-1,3,5-triazine-2,4-diamine, including its 
metabolites and degradates, in or on the commodities in the following 
table. Compliance with the tolerance levels specified in the table below 
is to be determined by measuring only indaziflam, in or on the 
commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        0.15
Fruit, citrus, group 10-10..................................        0.01
Fruit, pome, group 11-10....................................        0.01
Fruit, stone, group 12......................................        0.01
Grape.......................................................        0.01
Nut, tree, group 14.........................................        0.01
Olive.......................................................        0.01
Pistachio...................................................        0.01
Sugarcane, refined sugar \1\................................        0.01
------------------------------------------------------------------------
\1\ Tolerance without a corresponding U.S. registration.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[76 FR 18905, Apr. 6, 2011]



Sec. 180.654  Isopyrazam; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide isopyrazam, including its metabolites and degradates, in or on 
the commodity listed below. Compliance with the tolerance levels 
specified below is to be determined by measuring only isopyrazam, 3-
difluoromethyl-1-methyl-1H-pyrazole-4-carboxylic acid (9-isopropyl-
1,2,3,4-tetrahydro-1,4-methano-naphthalen-5-yl)-amide, in or on the 
following commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Banana\1\...................................................        0.05
------------------------------------------------------------------------
\1\ There is no U.S. registration for use of isopyrazam on banana.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]

[[Page 686]]

    (d) Indirect or inadvertent residues. [Reserved]

[76 FR 61596, Oct. 5, 2011]



Sec. 180.655  Flazasulfuron; tolerances for residues.

    (a) General. Tolerances are established for residues of 
flazasulfuron, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only flazasulfuron (N-
[[(4,6-dimethoxy-2-pyrimidinyl)amino] carbonyl]-3-(trifluoromethyl) -2-
pyridine sulfonamide).

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Fruit, citrus, group 10-10..................................        0.01
Grape.......................................................        0.01
Sugarcane...................................................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[77 FR 10968, Feb. 24, 2012]



Sec. 180.656  Amisulbrom; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide amisulbrom, including its metabolites and degradates, in or on 
the commodities listed below. Compliance with the tolerance levels is to 
be determined by measuring only amisulbrom, 3-[(3-bromo-6-fluoro-2-
methyl-1H-indole-1-yl) sulfonyl]-N, N-dimethyl-1H-1, 2, 4-triazole-1-
sulfonamide].

------------------------------------------------------------------------
                                                               Parts per
                        Commodity \1\                           million
------------------------------------------------------------------------
Grape.......................................................        0.40
Grape, raisin...............................................        1.0
Tomato......................................................        0.50
Tomato, paste...............................................        1.2
------------------------------------------------------------------------
\1\ There is no U.S. registration for use of amisulbrom on grape or
  tomato.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[76 FR 59914, Sept. 28, 2011]



Sec. 180.657  Metaflumizone; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide metaflumizone, including its metabolites and degradates, in 
or on the commodities listed in the following table. Compliance with the 
tolerance levels specified in the following table is to be determined by 
measuring only the sum of metaflumizone (E and Z isomers; 2-[2-(4-
cyanophenyl)-1-[3- (trifluoromethyl) phenyl]ethylidene]-N-[4-
(trifluoromethoxy) phenyl] hydrazine carboxamide) and its metabolite 4-
{2-oxo-2-[3-(trifluoro methyl) phenyl]ethyl{time} -benzonitrile, 
calculated as the stoichiometric equivalent of metaflumizone, in or on 
the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hulls...............................................        0.04
Fruit, citrus, group 10.....................................        0.04
Grape.......................................................        0.04
Nut, tree, group 14.........................................        0.04
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[77 FR 10386, Feb. 22, 2012]



Sec. 180.658  Penthiopyrad; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
penthiopyrad, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only penthiopyrad (N-
[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3- (trifluoromethyl) -1H-
pyrazole-4- carboxamide).

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        7.0
Alfalfa, hay................................................       20
Almond, hulls...............................................        6.0
Apple, wet pomace...........................................        1.5
Barley, grain...............................................        0.15
Barley, hay.................................................       80

[[Page 687]]

 
Barley, milled byproducts...................................        0.90
Barley, straw...............................................        1.0
Beet, sugar, dried pulp.....................................        1.5
Beet, sugar, roots..........................................        0.5
Berry, low growing, subgroup 13-07G.........................        3.0
Brassica, head and stem, subgroup 5A........................        5.0
Brassica, leafy greens, subgroup 5B.........................       50
Buckwheat, grain............................................        0.15
Canola......................................................        1.5
Corn, field, forage.........................................       40
Corn, field, grain..........................................        0.01
Corn, field, refined oil....................................        0.05
Corn, field, stover.........................................       15
Corn, pop, grain............................................        0.01
Corn, sweet, kernel plus cob with husks removed.............        0.01
Cotton, seed................................................        1.5
Cotton, gin byproducts......................................       15
Fruit, pome, group 11-10....................................        0.50
Fruit, stone, group 12......................................        4.0
Grain, aspirated fractions..................................       30
Millet, spp.................................................        0.80
Nut, tree, group 14.........................................        0.06
Oat, forage.................................................       40
Oat, grain..................................................        0.15
Oat, hay....................................................       80
Oat, straw..................................................        1.0
Pea and bean, dried shelled, except soybean, subgroup 6C....        0.40
Peanut......................................................        0.04
Peanut, hay.................................................       30
Peanut, refined oil.........................................        0.06
Pistachio...................................................        0.06
Potato, processed potato waste..............................        0.20
Rye, forage.................................................       40
Rye, grain..................................................        0.15
Rye, straw..................................................        1.0
Sorghum, forage.............................................       40
Sorghum, grain, grain.......................................        0.80
Sorghum, stover.............................................       15
Soybean, seed...............................................        0.40
Sunflower, seed.............................................        1.5
Teosinte, grain.............................................        0.15
Tomato, paste...............................................        3.5
Triticale, forage...........................................       40
Triticale, grain............................................        0.15
Triticale, hay..............................................       80
Triticale, straw............................................        1.0
Vegetable, bulb, group 3-07.................................        3.0
Vegetable, cucurbit, group 9................................        0.60
Vegetable, foliage of legume, group 7, hay..................      200
Vegetable, foliage of legume, group 7, vines/forage.........       50
Vegetable, fruiting, group 8-10.............................        3.0
Vegetable, leafy, except brassica, group 4..................       30
Vegetable, leaves of root and tuber, group 2................       50
Vegetable, legume, edible podded, subgroup 6A...............        4.0
Vegetable, legume, succulent shelled, subgroup 6B...........        0.40
Vegetable, root, subgroup 1B, except sugar beet.............        3.0
Vegetable, tuber and corm, subgroup 1C......................        0.06
Wheat, forage...............................................       40
Wheat, grain................................................        0.15
Wheat, hay..................................................       80
Wheat, milled byproducts....................................        0.30
Wheat, straw................................................        1.0
------------------------------------------------------------------------

    (2) Tolerances are established for residues of penthiopyrad, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below is 
to be determined by measuring only the sum of penthiopyrad (N-[2-(1,3-
dimethylbutyl)-3-thienyl] -1-methyl-3- (trifluoromethyl) -1H-pyrazole-4-
carboxamide) and its metabolite (1-methyl-3-trifluoromethyl- 1H-
pyrazole-4-carboxamide), calculated as the stoichiometric equivalent of 
penthiopyrad, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.03
Cattle, meat................................................        0.03
Cattle, meat byproducts.....................................        0.09
Goat, fat...................................................        0.03
Goat, meat..................................................        0.03
Goat, meat byproducts.......................................        0.09
Horse, fat..................................................        0.03
Horse, meat.................................................        0.03
Horse, meat byproducts......................................        0.09
Milk........................................................        0.02
Sheep, fat..................................................        0.03
Sheep, meat.................................................        0.03
Sheep, meat byproducts......................................        0.09
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[77 FR 14297, Mar. 9, 2012]



Sec. 180.659  Pyroxasulfone; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
herbicide pyroxasulfone, including its metabolites and degradates, in or 
on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only the sum of 
pyroxasulfone, 3-[[[5-(difluoromethoxy) -1-methyl-3-(trifluoromethyl)-
1H-pyrazol-4-yl]methyl]sulfonyl]-4,5-dihydro-5,5-dimethy lisoxazole, and 
its metabolite, 5-(difluoromethoxy)-1-methyl-3- (trifluoromethyl)-1H-
pyrazol-4-carboxylic acid (M-3), calculated as the stoichiometric 
equivalent of pyroxasulfone, in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Corn, field, grain.........................................        0.015
Corn, pop, grain...........................................        0.015
Corn, sweet, kernel plus cob with husks removed............        0.015
------------------------------------------------------------------------


[[Page 688]]

    (2) Tolerances are established for residues of the herbicide 
pyroxasulfone, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only the sum of 
pyroxasulfone, 3-[[[5-(difluoromethoxy) -1-methyl-3-(trifluoromethyl)-
1H-pyrazol-4-yl]methyl]sulfonyl]-4,5-dihydro-5,5-dimethylisoxazole, and 
its metabolites, 5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)-1H-
pyrazol-4-yl]methanesulfonic acid (M-1); 5-(difluoromethoxy)-1-methyl-3-
(trifluoromethyl)-1H-pyrazol-4-carboxylic acid (M-3); and [5-
(difluoromethoxy)-3- (trifluoromethyl)-1H-pyrazol-4-yl]methanesulfonic 
acid (M-25), calculated as the stoichiometric equivalent of 
pyroxasulfone, in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Corn, field, forage........................................        0.06
Corn, field, stover........................................        0.15
Corn, pop, stover..........................................        0.15
Corn, sweet, forage........................................        0.10
Corn, sweet, stover........................................        0.15
Soybean, forage............................................        1.0
Soybean, hay...............................................        2.0
------------------------------------------------------------------------

    (3) Tolerances are established for residues of the herbicide 
pyroxasulfone, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only the sum of 
pyroxasulfone, 3-[[[5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)-1H-
pyrazol-4-yl]methyl]sulfonyl]-4,5-dihydro-5,5-dimethylisoxazole, and its 
metabolites, 5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)-1H-
pyrazol-4-carboxylic acid (M-3); [5-(difluoromethoxy)-3-
(trifluoromethyl)-1H-pyrazol-4-yl]methanesulfonic acid (M-25); and 3-[1-
carboxy-2-(5,5-dimethyl-4,5-dihydroisoxazol-3-ylthio)ethylamino]-3-
oxopropanoic acid (M-28), calculated as the stoichiometric equivalent of 
pyroxasulfone, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Soybean, seed...............................................        0.06
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[77 FR 12213, Feb. 29, 2012, as amended at 78 FR 13257, Feb. 27, 2013]



Sec. 180.660  Pyriofenone; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide pyriofenone, including its metabolites and degradates, in or 
on the following commodities listed in the table. Compliance with the 
tolerance levels specified in the table is to be determined by measuring 
only pyriofenone, (5-chloro-2-methoxy-4-methyl-3-pyridinyl)(2,3,4-
trimethoxy-6-methylphenyl) methanone, in or on the following 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grape \1\...................................................        0.30
Grape, raisin \1\...........................................        0.50
------------------------------------------------------------------------
\1\ There are no U.S. registrations for grape and grape, raisin.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[77 FR 13506, Mar. 7, 2012]



Sec. 180.661  Fluopyram; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
fungicide Fluopyram, N-[2-[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]ethyl]-2-(trifluoromethyl)benzamide, including its metabolites 
and degradates in or on the commodities in the table below. Compliance 
with the tolerance levels specified in the table is to be determined by 
measuring only fluopyram in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond, hull................................................        8.0
Apple.......................................................        0.30
Apple, wet pomace...........................................        0.60
Banana \1\..................................................        1.0
Bean, dry...................................................        0.09
Beet, sugar, root...........................................        0.04

[[Page 689]]

 
Cherry......................................................        0.60
Grape, wine.................................................        2.0
Nut, tree, group 14.........................................        0.05
Peanut......................................................        0.02
Pistachio...................................................        0.05
Potato......................................................        0.02
Potato, processed potato waste..............................        0.08
Strawberry..................................................        1.5
Watermelon..................................................        1.0
------------------------------------------------------------------------
\1\ There are no U.S. registrations.

    (2) Tolerances are established for residues of the fungicide 
fluopyram, N-[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-
(trifluoromethyl)benzamide, including its metabolites and degradates. 
Compliance with the tolerance levels specified in the table below is to 
be determined by measuring only the sum of fluopyram and its metabolite, 
2-(trifluoromethyl)benzamide, calculated as the stoichiometric 
equivalent of fluopyram, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat.................................................        0.11
Cattle, meat................................................        0.15
Cattle, meat byproducts.....................................        1.1
Egg.........................................................        0.25
Goat, fat...................................................        0.11
Goat, meat..................................................        0.15
Goat, meat byproducts.......................................        1.1
Hog, fat....................................................        0.05
Hog, meat...................................................        0.05
Hog, meat byproducts........................................        0.70
Horse, fat..................................................        0.11
Horse, meat.................................................        0.15
Horse, meat byproducts......................................        1.1
Milk........................................................        0.07
Poultry, fat................................................        0.20
Poultry, meat...............................................        0.15
Poultry, meat byproducts....................................        0.60
Sheep, fat..................................................        0.11
Sheep, meat.................................................        0.15
Sheep, meat byproducts......................................        1.1
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. It is recommended that 
tolerances be established for indirect or inadvertent residues of 
fungicide fluopyram, N-[2-[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]ethyl]-2-(trifluoromethyl)benzamide, including its metabolites 
and degradates, in or on the commodities in the table below. Compliance 
with the tolerance levels specified in the table is to be determined by 
measuring only fluopyram in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.............................................        0.45
Alfalfa, hay................................................        1.1
Canola, seed................................................        1.8
Cotton, gin byproducts......................................        0.05
Cotton, undelinted seed.....................................        0.01
Grain, cereal, forage, fodder and straw, group 16, except           4.0
 rice; forage...............................................
Grain, cereal, forage, fodder and straw, group 16, except           7.0
 rice; hay, straw and stover................................
Grain, cereal, group 15, except rice........................        1.5
Soybean, forage.............................................        4.0
Soybean, hay................................................       15
Soybean, seed...............................................        0.10
------------------------------------------------------------------------


[77 FR 10975, Feb. 24, 2012]



Sec. 180.662  Trinexapac-ethyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the plant 
growth inhibitor, trinexapac-ethyl, including its metabolites and 
degradates, in or on the commodities in the table below. Compliance with 
the tolerance levels specified below is to be determined by measuring 
both trinexapac-ethyl, ethyl 4-(cyclopropylhydroxymethylene)-3,5-
dioxocyclohexanecarboxylate and the associated metabolite, trinexpac, 4-
(cyclopropylhydroxymethylene)-3,5-dioxocyclohexanecarboxylic acid, 
calculated as the stoichiometric equivalent of trinexapac-ethyl, in or 
on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, bran................................................        2.5
Barley, grain...............................................        2.0
Barley, hay.................................................        0.8
Barley, straw...............................................        0.4
Cattle, fat.................................................        0.02
Cattle, meat................................................        0.02
Cattle, meat byproducts.....................................        0.04
Goat, fat...................................................        0.02
Goat, meat..................................................        0.02
Goat, meat byproducts.......................................        0.04
Grass, forage...............................................        1.5
Grass, hay..................................................        4.0
Grass, seed screenings......................................       40.0
Grass, straw................................................       10.0
Hog, fat....................................................        0.02
Hog, meat...................................................        0.02
Hog, meat by-products.......................................        0.03
Horse, fat..................................................        0.02
Horse, meat.................................................        0.02
Horse, meat byproducts......................................        0.04
Oat, forage.................................................        1.0
Oat, grain..................................................        4.0
Oat, hay....................................................        1.5
Oat, straw..................................................        0.9
Sheep, fat..................................................        0.02
Sheep, meat.................................................        0.02

[[Page 690]]

 
Sheep, meat byproducts......................................        0.04
Sugarcane, cane.............................................        0.8
Sugarcane, molasses.........................................        2.5
Wheat, bran.................................................        6.0
Wheat, forage...............................................        1.0
Wheat, grain................................................        4.0
Wheat, hay..................................................        1.5
Wheat, middlings............................................       10.5
Wheat, straw................................................        0.9
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[77 FR 12745, Mar. 2, 2012, as amended at 77 FR 60919, Oct. 3, 2012]



Sec. 180.663  Ametoctradin; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide ametoctradin, including its metabolites and degradates, in or 
on the commodities in the following table. Compliance with the tolerance 
levels specified in the following table is to be determined by measuring 
only ametoctradin (5-ethyl-6-octyl[1,2,4]triazolo[1,5-a]pyrimidin-7-
amine).

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A........................        9.0
Brassica, leafy greens, subgroup 5B.........................       50
Grape.......................................................        4.0
Grape, raisin...............................................        8.0
Hop, dried cones............................................       10.0
Onion, bulb, subgroup 3-07A.................................        1.5
Onion, green, subgroup 3-07B................................       20.0
Spinach.....................................................       50.0
Vegetable, cucurbit, group 9................................        3.0
Vegetable, fruiting, group 8-10.............................        1.5
Vegetable, leafy, except Brassica, group 4, except spinach..       40.0
Vegetable, tuberous and corm, subgroup 1C...................        0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[77 FR 21734, May 9, 2012]



Sec. 180.664  Penflufen; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide penflufen, including its metabolites and degradates, in or on 
the following commodities listed in the table. Compliance with the 
tolerance levels specified in the table is to be determined by measuring 
only penflufen N-[2-(1,3-dimethylbutyl)phenyl]-5-fluoro-1,3-dimethyl-1H-
pyrazole-4-carboxamide, in or on the following commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage............................................        0.01
Alfalfa, hay...............................................        0.01
Cotton, gin by-products....................................        0.01
Grain cereal, forage, fodder and straw, group 16...........        0.01
Grain, cereal, group 15....................................        0.01
Oilseed, group 20..........................................        0.01
Vegetable, foliage of legume, group 7......................        0.01
Vegetable, legume, group 6.................................        0.01
Vegetable, tuberous and corm subgroup 1C...................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[77 FR 28281, May 14, 2012]



Sec. 180.665  Sedaxane; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide sedaxane, including its metabolites and degradates, in or on 
the commodities in the following table. Compliance with the tolerance 
levels specified in the following table is to be determined by measuring 
only sedaxane, N-[2-[1,1[min]-bicyclopropyl]-2-ylphenyl]-3-
(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide, as the sum of its 
cis- and trans-isomers in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Barley, grain..............................................        0.01
Barley, hay................................................        0.04
Barley, straw..............................................        0.01
Canola, seed...............................................        0.01
Corn, field, forage........................................        0.01
Corn, field, grain.........................................        0.01
Corn, field, stover........................................        0.01
Corn, pop, grain...........................................        0.01
Corn, pop, stover..........................................        0.01
Corn, sweet, forage........................................        0.01
Corn, sweet, kernel plus cob with husks removed............        0.01
Corn, sweet, stover........................................        0.01
Oat, forage................................................        0.015
Oat, grain.................................................        0.01
Oat, hay...................................................        0.06

[[Page 691]]

 
Oat, straw.................................................        0.01
Pea and bean, dried shelled, except soybean, subgroup 6C...        0.01
Rapeseed, subgroup 20A.....................................        0.01
Rye, forage................................................        0.015
Rye, grain.................................................        0.01
Rye, straw.................................................        0.01
Sorghum, grain, forage.....................................        0.01
Sorghum, grain, grain......................................        0.01
Sorghum, grain, stover.....................................        0.01
Soybean, forage............................................        0.05
Soybean, hay...............................................        0.04
Soybean, seed..............................................        0.01
Vegetable, foliage of legume, except soybean, subgroup 7A..        0.01
Wheat, forage..............................................        0.015
Wheat, grain...............................................        0.01
Wheat, hay.................................................        0.06
Wheat, straw...............................................        0.01
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect inadvertent residues. [Reserved]

[77 FR 36924, June 20, 2012, as amended at 78 FR 33748, June 5, 2013]



Sec. 180.666  Fluxapyroxad; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide fluxapyroxad, including its metabolites and degradates, in or 
on the commodities listed in the table below. Compliance with the 
tolerance levels specified below is to be determined by measuring only 
fluxapyroxad, 3-(difluoromethyl)-1-methyl-N-(3[min],4[min],5[min]-
trifluoro[1,1[min]-biphenyl]-2-yl)-1H-pyrazole-4-carboxamide in or on 
the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Apple, wet pomace..........................................        2.0
Beet, sugar................................................        0.1
Beet, sugar, dried pulp....................................        0.1
Beet, sugar, tops..........................................        7.0
Cattle, fat................................................        0.05
Cattle, meat...............................................        0.01
Cattle, meat byproducts....................................        0.03
Corn, field, grain.........................................        0.01
Corn, oil..................................................        0.03
Corn, pop, grain...........................................        0.01
Corn, sweet, kernels plus cobs with husks removed..........        0.15
Cotton, gin byproducts.....................................        0.01
Cotton, undelinted seed....................................        0.01
Egg........................................................        0.002
Fruit, pome, group 11......................................        0.8
Fruit, stone, group 12.....................................        2.0
Goat, fat..................................................        0.05
Goat, meat.................................................        0.01
Goat, meat byproducts......................................        0.03
Grain, aspirated fractions.................................       20.0
Grain, cereal, group 15, (except corn, field, grain; except        3.0
 corn, pop, grain; except corn, kernels plus cobs with
 husks removed; except wheat)..............................
Grain, cereal, forage, fodder and straw, group 16..........       20
Horse, fat.................................................        0.05
Horse, meat................................................        0.01
Horse, meat byproducts.....................................        0.03
Milk.......................................................        0.005
Oilseeds, group 20 (except cottonseed).....................        0.9
Pea and bean, dried shelled except soybean, subgroup 6C....        0.4
Pea and bean, succulent shelled, subgroup 6B...............        0.5
Peanut.....................................................        0.01
Peanut, refined oil........................................        0.02
Plum, prune, dried.........................................        3.0
Potato, wet peel...........................................        0.1
Rice, bran.................................................        4.5
Rice, hulls................................................        8.0
Sheep, fat.................................................        0.05
Sheep, meat................................................        0.01
Sheep, meat byproducts.....................................        0.03
Soybean, hulls.............................................        0.3
Soybean, seed..............................................        0.15
Vegetable, foliage of legume, group 7......................       30
Vegetables, fruiting, group 8..............................        0.7
Vegetable, legume, edible podded, subgroup 6A..............        2.0
Vegetable, tuberous and corm, subgroup 1C..................        0.02
Wheat, bran................................................        0.6
Wheat, grain...............................................        0.3
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[77 FR 28275, May 14, 2012, as amended at 77 FR 46307, Aug. 3, 2012]



Sec. 180.667  Cyflufenamid, tolerance for residues.

    (a) General. Tolerances are established for residues of the 
fungicide cyflufenamid, including its metabolites and degradates, in or 
on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only 
cyflufenamid, [N(Z)]-N-[[(cyclopropylmethoxy) amino][2,3-difluoro-6-
(trifluoromethyl)phenyl] methylene]benzene acetamide.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Apple, wet pomace...........................................        0.10
Berry, low growing, subgroup 13-07G, except cranberry.......        0.20
Fruit, pome, group 11.......................................        0.06
Fruit, small vine climbing, except fuzzy kiwifruit, subgroup        0.15
 13-07F.....................................................
Grape, raisin...............................................        0.30

[[Page 692]]

 
Vegetable, cucurbit, group 9................................        0.07
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[77 FR 38210, June 27, 2012]



Sec. 180.668  Sulfoxaflor; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide sulfoxaflor, including its metabolites and degradates, in or 
on the commodities in the table. Compliance with the tolerance levels 
specified is to be determined by measuring only sulfoxaflor (N-
[methyloxido[1-[6- (trifluoromethyl)-3-pyridinyl]ethyl]-[gamma]\4\-
sulfanylidene] cyanamide).

------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------
Almond, hulls.........................................               6.0
Barley, grain.........................................              0.40
Barley, hay...........................................               1.0
Barley, straw.........................................               2.0
Bean, dry seed........................................              0.20
Bean, succulent.......................................               4.0
Beet, sugar, dried pulp...............................              0.07
Beet, sugar, molasses.................................              0.25
Berry, low growing, subgroup 13-7G....................              0.70
Cattle, fat...........................................              0.10
Cattle, meat..........................................              0.15
Cattle, meat byproducts...............................              0.40
Cauliflower...........................................              0.08
Citrus, dried pulp....................................               3.6
Cotton, gin byproducts................................               6.0
Cotton, hulls.........................................              0.35
Cottonseed subgroup 20C...............................              0.20
Fruit, citrus, group 10-10............................              0.70
Fruit, pome, group 11-10..............................              0.50
Fruit, small, vine climbing, subgroup 13-07F, except                 2.0
 fuzzy kiwi fruit.....................................
Fruit, stone, group 12................................               3.0
Goat, fat.............................................              0.10
Goat, meat............................................              0.15
Goat, meat byproducts.................................              0.40
Grain, aspirated fractions............................              20.0
Grape, raisin.........................................               6.0
Hog, fat..............................................              0.01
Hog, meat.............................................              0.01
Hog, meat byproducts..................................              0.01
Horse, fat............................................              0.10
Horse, meat...........................................              0.15
Horse, meat byproducts................................              0.40
Leafy greens, subgroup 4A.............................               6.0
Leafy petiole, subgroup 4B............................               2.0
Milk..................................................              0.15
Nuts, tree, group 14..................................             0.015
Onion, bulb, subgroup 3-07A...........................              0.01
Onion, green, subgroup 3-07B..........................              0.70
Pistachio.............................................             0.015
Poultry, eggs.........................................              0.01
Poultry, fat..........................................              0.01
Poultry, meat.........................................              0.01
Poultry, meat byproducts..............................              0.01
Rapeseed, meal........................................              0.50
Rapeseed subgroup 20A.................................              0.40
Sheep, fat............................................              0.10
Sheep, meat...........................................              0.15
Sheep, meat byproducts................................              0.40
Soybean, seed.........................................              0.20
Tomato, paste.........................................              2.60
Tomato, puree.........................................              1.20
Vegetable, brassica, leafy, group 5, except                          2.0
 cauliflower..........................................
Vegetable, cucurbit, group 9..........................              0.40
Vegetable, fruiting, group 8-10.......................              0.70
Vegetable, leaves of root and tuber, group 2..........               3.0
Vegetable, legume, foliage, group 7...................               3.0
Vegetable, root and tuber, group 1....................              0.05
Watercress............................................               6.0
Wheat, forage.........................................               1.0
Wheat, grain..........................................              0.08
Wheat, hay............................................               1.5
Wheat, straw..........................................               2.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[77 FR 59565, Sept. 28, 2012, as amended at 78 FR 38227, June 26, 2013]



Sec. 180.669  Picoxystrobin; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide picoxystrobin, including its metabolites and degradates, in or 
on the commodities listed below. Compliance with the tolerance levels 
specified below is to be determined by measuring only picoxystrobin, 
methyl ([alpha]E)-[alpha]-(methoxymethylene)-2-[[[6- (trifluoromethyl) -
2-pyridinyl]oxy]methyl] benzeneacetate.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Barley, bran...............................................        0.5
Barley, grain..............................................        0.3
Cattle, fat................................................        0.01
Cattle, meat...............................................        0.01
Cattle, meat byproducts....................................        0.01
Corn, field, refined oil...................................        0.07
Eggs.......................................................        0.01
Goat, fat..................................................        0.01
Goat, meat.................................................        0.01
Goat, meat byproducts......................................        0.01
Grain, aspirated grain fractions...........................       10
Grain, cereal, forage, fodder, and straw, group 16, forage.       15
Grain, cereal, forage, fodder, and straw, group 16, hay....        5
Grain, cereal, forage, fodder, and straw, group 16, stover.       10

[[Page 693]]

 
Grain, cereal, forage, fodder, and straw, group 16, straw..        2
Grain, cereal, group 15, except rice and barley............        0.04
Hog, fat...................................................        0.01
Hog, meat..................................................        0.01
Hog, meat byproducts.......................................        0.01
Horse, fat.................................................        0.01
Horse, meat................................................        0.01
Horse, meat byproducts.....................................        0.01
Milk.......................................................        0.01
Pea and bean, dried shelled, except soybean, subgroup 6C...        0.06
Poultry, fat...............................................        0.01
Poultry, meat..............................................        0.01
Poultry, meat byproducts...................................        0.01
Rapeseed subgroup 20A......................................        0.08
Sheep, fat.................................................        0.01
Sheep, meat................................................        0.01
Sheep, meat byproducts.....................................        0.01
Soybean, forage............................................        1
Soybean, hay...............................................        3
Soybean, hulls.............................................        0.2
Soybean, seed..............................................        0.05
Vegetable, foliage of legume, except soybean, subgroup 7A..       40
Wheat, bran................................................        0.06
Wheat, germ................................................        0.09
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[77 FR 72231, Dec. 5, 2012]



Sec. 180.671  Fenpyrazamine; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide fenpyrazamine, in or on the following commodities. Compliance 
with the tolerance levels specified in the following table is to be 
determined by measuring only fenpyrazamine S-allyl 5-amino-2-isopropyl-
4-(2-methylphenyl)-3-oxo-2,3-dihydropyrazole-1-carbothioate, in or on 
the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond......................................................        0.02
Almond, hulls...............................................        1.5
Berry, low growing, subgroup 13-07G.........................        3
Bushberry subgroup 13-07B...................................        5
Caneberry subgroup 13-07A...................................        5
Fruit, small vine climbing, except fuzzy kiwifruit, subgroup        3
 13-07F.....................................................
Ginseng.....................................................        0.7
Grape, juice................................................        4
Lettuce, head...............................................        1.5
Lettuce, leaf...............................................        2
Pistachio...................................................        0.02
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[78 FR 14465, Mar. 6, 2013]



Sec. 180.673  Triforine; tolerances for residues.

    (a) General. Tolerances are established for residues of triforine, 
including its metabolites and degradates. Compliance with the tolerance 
levels specified in the following table is to be determined by measuring 
only triforine (N,N[min]-[1,2-piperazinediylbis(2,2,2-
trichloroehylidene)]bis[formamide]), in or on the following commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Blueberry \1\...............................................        1.0
Tomato \1\..................................................        0.5
------------------------------------------------------------------------
\1\ There are no U.S. registrations for blueberry and tomato.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[78 FR 32151, May 29, 2013. Redesignated at 78 FR 36677, June 19, 2013]



                  Subpart D_Exemptions From Tolerances



Sec. 180.900  Exemptions from the requirement of a tolerance.

    An exemption from a tolerance shall be granted when it appears that 
the total quantity of the pesticide chemical in or on all raw 
agricultural commodities for which it is useful under conditions of use 
currently prevailing or proposed will involve no hazard to the public 
health.

[69 FR 23117, Apr. 28, 2004]



Sec. 180.905  Pesticide chemicals; exemptions from the requirement of a 

tolerance.

    (a) When applied to growing crops, in accordance with good 
agricultural practice, the following pesticide chemicals are exempt from 
the requirement of a tolerance:
    (1) Petroleum oils.
    (2) Piperonyl butoxide.
    (3) Pyrethrins.

[[Page 694]]

    (4) Sabadilla.
    (b) When applied to growing crops, in accordance with good 
agricultural practice, the pesticides rotenone or derris or cube roots 
are exempt from the requirement of a tolerance. There are no U.S. 
registrations for use of rotenone, derris, or cube roots on food 
commodities as of March 23, 2011.
    (c) These pesticides are not exempted from the requirement of a 
tolerance when applied to a crop at the time of or after harvest.

[77 FR 59128, Sept. 26, 2012]



Sec. 180.910  Inert ingredients used pre- and post-harvest; exemptions from 

the requirement of a tolerance.

    Residues of the following materials are exempted from the 
requirement of a tolerance when used in accordance with good 
agricultural practice as inert (or occasionally active) ingredients in 
pesticide formulations applied to growing crops or to raw agricultural 
commodities after harvest:

------------------------------------------------------------------------
      Inert ingredients             Limits                 Uses
------------------------------------------------------------------------
Acetic acid..................  ................  Catalyst
Acetic anhydride.............  ................  Solvent, cosolvent
Acetone......................  ................   Do.
Alkanoic and alkenoic acids,   ................  Emulsifiers
 mono- and diesters of
 [alpha]-hydro-[omega]-
 hydroxypoly (oxyethylene)
 with molecular weight (in
 amu) range of 200 to 6,000.
Alkyl (C8-C24)                 ................  Surfactants, related
 benzenesulfonic acid and its                     adjuvants of
 ammonium, calcium,                               surfactants
 magnesium, potassium,
 sodium, and zinc salts.
C10-C18-Alkyl dimethyl amine   15% by weight in  Surfactant
 oxides (CAS Reg. Nos. 1643-    pesticide
 20-5, 2571-88-2, 2605-79-0,    formulation.
 3332-27-2, 61788-90-7, 68955-
 55-5, 70592-80-2, 7128-91-8,
 85408-48-6, and 85408-49-7).
[alpha]-Alkyl(C6-C15)-[omega]- Not to exceed     Surfactants, related
 hydroxypoly(oxyethylene)sulf   30% of            adjuvants of
 ate, and its ammonium,         pesticide         surfactants
 calcium, magnesium,            formulation.
 potassium, sodium, and zinc
 salts, poly(oxyethylene)
 content averages 2-4 moles
 (CAS Reg. Nos. 3088-31-1,
 9004-82-4, 9004-84-6, 13150-
 00-0, 25446-78-0, 26183-44-
 8, 32612-48-9, 50602-06-7,
 62755-21-9, 68424-50-0,
 68511-39-7, 68585-34-2,
 68611-55-2, 68891-38-3,
 73665-22-2).
[alpha]-alkyl (C12-C15)-       Not more than     Surfactant
 [omega]-hydroxypoly            20% of
 (oxypropylene) poly            pesticide
 (oxyethylene) copolymers       formulations.
 (where the poly
 (oxypropylene) content is 3-
 60 moles and the poly
 (oxyethylene) content is 5-
 80 moles).

[[Page 695]]

 
[alpha]-alkyl-[omega]-         ................  Surfactants, related
 hydroxypoly (oxypropylene)                       adjuvants of
 and/or poly (oxyethylene)                        surfactants
 polymers where the alkyl
 chain contains a minimum of
 six carbons (CAS Reg. Nos.
 9002-92-0, 9004-95-9, 9005-
 00-9, 26183-52-8, 34398-01-
 1, 52292-17-8, 66455-14-9,
 66455-15-0, 68002-97-1,
 68131-39-5, 68131-40-8,
 68154-96-1, 68213-23-0,
 68439-45-2, 68439-46-3,
 68526-94-3, 68439-50-9,
 68439-49-6, 68551-12-2,
 68951-67-7, 71243-46-4,
 97043-91-9, 9043-30-5, 60828-
 78-6, 61827-42-7, 24938-91-
 8, 68439-54-3, 69011-36-5,
 78330-20-8, 78330-21-9,
 106232-83-1, 127036-24-2,
 160875-66-1, 9004-98-2,
 68920-66-1, 61804-34-0,
 61791-28-4, 71060-57-6,
 26468-86-0, 31726-34-8,
 52609-19-5, 61791-20-6,
 68155-01-1, 69013-19-0,
 69364-63-2, 70879-83-3,
 78330-19-5, 97953-22-5,
 157627-86-6, 34398-05-5,
 72905-87-4, 84133-50-6,
 61702-78-1, 27306-79-2,
 169107-21-5, 61791-13-7,
 39587-22-9, 85422-93-1;
 68154-98-3, 61725-89-1,
 68002-96-0, 68154-97-2,
 68439-51-0, 68551-13-3,
 68603-25-8, 68937-66-6,
 68987-81-5, 69227-21-0,
 70750-27-5, 103818-93-5,
 166736-08-9, 120313-48-6,
 68213-24-1, 68458-88-8,
 68551-14-4, 69013-18-9,
 69227-22-1, 72854-13-8,
 73049-34-0, 78330-23-1,
 37311-02-7, 64366-70-7,
 37251-67-5, 9087-53-0,
 196823-11-7, 57679-21-7,
 111905-54-5, 61827-84-7,
 172588-43-1).
[alpha]-alkyl (minimum C6      Not to exceed     Surfactants, related
 linear or branched,            30% of            adjuvants of
 saturated and or               pesticide         surfactants
 unsaturated)-[omega]-          formulation.
 hydroxypolyoxyethylene
 polymer with or without
 polyoxypropylene, mixture of
 di- and monohydrogen
 phosphate esters and the
 corresponding ammonium,
 calcium, magnesium,
 monoethanolamine, potassium,
 sodium and zinc salts of the
 phosphate esters; minimum
 oxyethylene content averages
 2 moles; minimum
 oxypropylene content is 0
 moles (CAS Reg. Nos. 9046-01-
 9, 39464-66-9, 50643-20-4,
 52019-36-0, 68071-35-2,
 68458-48-0, 68585-36-4,
 68815-11-2, 68908-64-5,
 68511-37-5, 68130-47-2,
 42612-52-2, 58318-92-6,
 60267-55-2, 68070-99-5,
 68186-36-7, 68186-37-8,
 68610-65-1, 68071-17-0,
 936100-29-7, 936100-30-0,
 73038-25-2, 78330-24-2,
 154518-39-5, 317833-96-8,
 108818-88-8, 873662-29-4,
 61837-79-4, 68311-02-4,
 68425-73-0, 37280-82-3,
 68649-29-6, 67711-84-6,
 68891-13-4.
N-alkyl (C8-C18) primary       Concentration in  Surfactants, related
 amines and their acetate       formulated end-   adjuvants of
 salts where the alkyl group    use products      surfactants
 is linear and may be           not to exceed
 saturated and/or unsaturated   10% by weight
 (CAS Reg. Nos. 61790-57-6,     in herbicide
 61790-58-7, 61790-59-8,        products, 4% by
 61790-60-1, 61788-46-3,        weight in
 61790-33-8, 68155-38-4).       insecticide
                                products, and
                                4% by weight in
                                fungicide
                                products.
Alkyl (C8-C18) sulfate and     ................  Surfactants.
 its ammonium, calcium,
 isopropylamine, magnesium,
 potassium, sodium, and zinc
 salts.
Aluminum hydroxide...........  ................  Diluent, carrier
Aluminum oxide...............  ................  Diluent
Aluminum stearate............  ................  Surfactant
Amides, C5-C9, N-[3-           ................  Surfactant
 (dimethylamino) propyl] (CAS
 Reg. No. 1044764-00-2).
Amides, C6-C12, N-[3-          ................  Surfactant
 (dimethylamino) propyl] (CAS
 Reg. No. 1044764-06-8).

[[Page 696]]

 
Ammonium bicarbonate.........  ................  Surfactant, suspending
                                                  agent, dispersing
                                                  agent
Ammonium carbamate...........  ................  Synergist in aluminum
                                                  phosphide formulations
Ammonium chloride............  ................  Intensifier when used
                                                  with ammonium nitrate
                                                  as a dessicant or
                                                  defoliant. Fire
                                                  suppressant in
                                                  aluminum phosphide and
                                                  magnesium phosphide
                                                  formulations
Ammonium hydroxide...........  ................  Solvent, cosolvent,
                                                  neutralizer,
                                                  solubilizing agent
Ammonium salts of fatty acids  ................  Surfactant
 (C8-C18 saturated) (CAS Reg.
 No. 5972-76-9, 63718-65-0,
 16530-70-4, 32582-95-9, 2437-
 23-2, 191799-95-8, 16530-71-
 5, 93917-76-1, 5297-93-8,
 94266-36-1, 1002-89-7).
Ammonium stearate............  ................  Surfactant
Ammonium sulfate.............  ................  Solid diluent, carrier
Ammonium thiosulfate.........  ................  Intensifier when used
                                                  with ammonium nitrate
                                                  as desiccant or
                                                  defoliant
Amyl acetate.................  ................  Solvent, cosolvent,
                                                  attractant
Ascorbyl palmitate...........  ................  Preservative
Attapulgite-type clay........  ................  Solid diluent, carrier,
                                                  thickener
Bacillus thuringiensis         ................  Diluent, carrier
 fermentation solids and/or
 solubles.
Bentonite....................  ................  Solid diluent, carrier
Benzoic acid.................  ................  Preservative for
                                                  formulation
Bicyclo[3.1.1]hept-2-ene,      ................  Surfactants, related
 2,6,6-trimethyl-,                                adjuvants of
 homopolymer (Alpha-pinene,                       surfactants
 homopolymer)(CAS Reg. No.
 25766-18-1).
Bicyclo[3.1.1]heptane, 6,6-    ................  Surfactants, related
 dimethyl-2-methylene-,                           adjuvants of
 homopolymer (Beta-pinene,                        surfactants
 homopolymer) (CAS Reg. No.
 25719-60-2).
Bicyclo[3.1.1]hept-2-ene,      ................  Surfactants, related
 2,6,6-trimethyl-, polymer                        adjuvants of
 with 6,6- dimethyl-2-                            surfactants
 methylenebicyclo [3.1.1]
 heptane (Copolymer of alpha-
 and beta-pinene) (CAS Reg.
 No. 31393-98-3).
2-Bromo-2-nitro-1,3-           0.04% or less by  In-can preservative
 propanediol (CAS Reg. No. 52-  weight of the
 51-7).                         total pesticide
                                formulation.
Butane.......................  ................  Propellant
n-Butanol (CAS Reg. No. 71-36- ................  Solvent, cosolvent
 3).
Butylated hydroxyanisole.....  ................  Antioxidant
Butylated hydroxytoluene.....  ................   Do.
Calcareous shale.............  ................  Solid diluent carrier
Calcite......................  ................   Do.
Calcium carbonate............  ................   Do.
Calcium chloride.............  ................  Stabilizer
Calcium phosphate............  ................  Solid diluent, carrier
Calcium hydroxide............  ................   Do.
Calcium hypochlorite.........  ................  Sanitizing and
                                                  bleaching agent
Calcium lactate pentahydrate   ................  Nutrient, stabilizer
 (CAS Reg. No. 5743-47-5).
Calcium oxide................  ................  Solid diluent, carrier
Calcium salt of partially      ................  Coating agent
 dimerized rosin, conforming
 to 21 CFR 172.210.
Calcium silicate.............  ................  Solid diluent, carrier
Calcium stearate.............  ................   Do.
Carbon Dioxide (CAS Reg. No.   None............  Propellant
 124-38-9).
Carrageenan, conforming to 21  Minimum           Thickener
 CFR 172.620.                   molecular
                                weight (in
                                amu): 100,000.
Cetyl alcohol (CAS Reg. No.    Not more than     Evaporation retardant
 36653-82-4).                   5.0% of
                                pesticide
                                formulation.
Charcoal, activated..........  Meets             Carrier
                                specifications
                                in the Food
                                Chemical Codex.
Coconut shells...............  ................  Solid diluent and
                                                  carrier
Cod liver oil................  ................  Solvent, cosolvent
Croscarmellose sodium (CAS     ................  Disintegrant, solid
 Reg. No. 74811-65-7).                            diluent, carrier, and
                                                  thickener
n-Decyl alcohol (CAS Reg. No.  ................  Solvent or co-solvent
 112-30-1).
Dialkyl (C8-C18) dimethyl      Not more than     Flocculating agent in
 ammonium chloride.             0.2% in silica,   the manufacture of
                                hydrated silica.  silica, hydrated
                                                  silica for use as a
                                                  solid diluent, carrier
Diatomite (diatomaceous        ................  Solid diluent carrier
 earth).

[[Page 697]]

 
Diethylaminoethanol,           ................  Surfactant
 ethoxylated, propoxylated,
 reaction products with fatty
 acid dimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173188-75-4).
Diethylaminoethanol,           ................  Surfactant
 ethoxylated, propoxylated,
 reaction products with fatty
 acid trimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173188-83-4).
Diethylaminoethanol,           ................  Surfactant
 ethoxylated, reaction
 product with fatty acid
 dimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173188-72-1).
Diethylaminoethanol,           ................  Surfactant
 ethoxylated, reaction
 products with fatty acid
 trimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173188-81-2).
Diethylene glycol abietate...  ................  Surfactants, related
                                                  adjuvants of
                                                  surfactants
1,1-Difluoroethane (CAS Reg.   For aerosol       Aerosol propellant
 No. 75-37-6).                  pesticide
                                formulations
                                used for insect
                                control in food-
                                 and feed-
                                handling
                                establishments
                                and animals.
1,2-Dihydro-6-ethoxy-2,2,4-    Not more than     Antioxidant
 trimethylquinolene.            0.02% of
                                pesticide
                                formulation.
Diisopropyl adipate (CAS Reg.  40% in mosquito   Solvent, co-solvent.
 No. 6938-94-9).                control
                                formulations.
Dimethyl ether (methane,       ................  Propellant
 oxybis-) (CAS Reg. No. 115-
 10-6).
Dimethylaminoethanol,          ................  Surfactant
 ethoxylated, propoxylated,
 reaction products with fatty
 acid dimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173188-42-5).
Dimethylaminoethanol,          ................  Surfactant
 ethoxylated, propoxylated,
 reaction products with fatty
 acid trimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173188-67-4).
Dimethylaminoethanol,          ................  Surfactant
 ethoxylated, reaction
 products with fatty acid
 dimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173188-38-9).
Dimethylaminoethanol,          ................  Surfactant
 ethoxylated, reaction
 products with fatty acid
 trimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173188-49-2).
3,6-Dimethyl-4-octyn-3,6-diol  Not more than     Surfactants, related
                                2.5% of           adjuvants of
                                pesticide         surfactants
                                formulation.
Dipropylene glycol...........  ................  Solvent, cosolvent
Disodium phosphate...........  ................  Anticaking agent,
                                                  conditioning agent
Disodium zinc                  ................  Sequestrant
 ethylenediaminetetraacetate
 dihydride.
Dolomite.....................  ................  Solid diluent, carrier
Epoxidized linseed oil.......  ................  Surfactants, related
                                                  adjuvants of
                                                  surfactants
Epoxidized soybean oil.......  ................   Do.
Ethyl acetate................  ................  Solvent, cosolvent
Ethyl alcohol................  ................   Do.
Ethyl esters of fatty acids    ................  Solvent, cosolvent
 derived from edible fats and
 oils.
Ethyl maltol (CAS Reg.         Not more than     Odor masking agent
 No.4940-11-8).                 0.2 % of the
                                pesticide
                                formulation.
Ethylene glycol (CAS Reg. No.  Without           Encapsulating agent for
 107-21-1).                     limitation.       pesticides being
                                                  applied post-harvest
                                                  as residual, and crack
                                                  and crevice sprays in
                                                  and around food and
                                                  nonfood areas of
                                                  residential and
                                                  nonresidential
                                                  structures, including
                                                  food handling
                                                  establishments
Ethylene oxide adducts of      ................  Surfactants, related
 2,4,7,9-tetramethyl-5-                           adjuvants of
 decynediol, the ethylene                         surfactants
 oxide content averages 3.5,
 10 or 30 moles (CAS Reg. No.
 9014-85-1).
(S,S)-Ethylenediamine          ................  Sequestrant or
 disuccinic acid trisodium                        chelating agent
 salt (CAS Reg. No. 178949-82-
 1).
Ethylenediaminetetraacetic     3% of pesticide   Sequestrant
 acid.                          formulation.

[[Page 698]]

 
Ethylenediaminetetraacetic ac  5% of pesticide   Sequestrant
 id, tetrasodium salt.          formulation.
2-Ethyl-1-hexanol (CAS Reg.    Not more than     Solvent, adjuvant of
 No. 104-76-7).                 10% of            surfactants
                                pesticide.
Fatty acids, conforming to 21  ................  Binder, defoaming
 CFR 172.860.                                     agent, lubricant
FD&C Blue No. 1..............  Not more than     Dye
                                0.2% of
                                pesticide
                                formulation.
FD&C Red No. 40 (CAS Reg. No.  Not to exceed     Dye, coloring agent
 25956-17-6) conforming to 21   0.002% by
 CFR 74.340.                    weight of
                                pesticide
                                formulation.
Ferric Citrate (CAS Reg. No.   ................  Stabilizer
 2338-05-8).
Ferric sulfate...............  ................  Solid diluent, carrier
Furcelleran..................  ................  Thickener
D-glucopyranose, oligomeric,   ................  Surfactant
 C10	16-alkyl glycosides (CAS
 Reg. No. 110615-47-9).
Glycerides, edible fats and    ................  Emulsifier, dispersing
 oils derived from plants and                     agent
 animals, reaction products
 with sucrose (CAS Reg. Nos.
 100403-38-1, 100403-41-6,
 100403-39-2, 100403-40-5).
Glycerol mono-, di-, and       ................  Solvent, cosolvent
 triacetate.
Glyceryl monostearate........  ................  Emulsifier
Granite......................  ................   Do.
Graphite.....................  ................  Solid diluent, carrier
Gum arabic (acacia)..........  ................  Surfactant, suspending
                                                  agent, dispersing
                                                  agent
Gypsum.......................  ................  Solid diluent, carrier
Hexamethylenetetramine.......  For use in        Preservative
                                citrus washing
                                solutions only
                                at not more
                                than 1%.
3-hexen-1-ol, (3Z)- (CAS Reg.  Not more than     Odorant, alerting agent
 No. 928-96-1).                 0.4% of the
                                pesticide
                                formulation.
n-Hexyl alcohol (CAS Reg. No.  ................  Solvent, cosolvent
 111-27-3).
C9 rich aromatic hydrocarbons  ................  Solvent
 (CAS Reg. No. 64742-95-6).
C10	11 rich aromatic           ................  Solvent
 hydrocarbons (CAS Reg. No.
 64742-94-5).
C11	12 rich aromatic           ................  Solvent
 hydrocarbons (CAS Reg. No.
 64742-94-5).
Hydrochloric acid............  ................  Solvent, neutralizer
Hydroxyethylmorpholine, ethox  ................  Surfactant
 ylated, propoxylat-.
  ed, reaction products with
 fatty acid dimers, minimum
 number average molecular
 weight (in amu), 1,200 (CAS
 Reg. No. 1173189-06-4).
Hydroxyethylmorpholine, ethox  ................  Surfactant
 ylated, propoxylat-.
  ed, reaction products with
 fatty acid trimers, minimum
 number average molecular
 weight (in amu), 1,200 (CAS
 Reg. No. 1173189-17-7).
Hydroxyethylmorpholine,        ................  Surfactant
 ethoxylated, reaction
 products with fatty acid
 dimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173189-00-8).
Hydroxyethylmorpholine,        ................  Surfactant
 ethoxylated, reaction
 products with fatty acid
 trimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173189-09-7).
Hydroxyethylpiperidine, ethox  ................  Surfactant
 ylated, propoxylat-.
  ed, reaction products with
 fatty acid dimers, minimum
 number average molecular
 weight (in amu), 1,200 (CAS
 Reg. No. 1173189-22-4.
Hydroxyethylpiperidine, ethox  ................  Surfactant
 ylated, propoxylat-.
  ed, reaction products with
 fatty acid trimers, minimum
 number average molecular
 weight (in amu), 1,200 (CAS
 Reg. No. 1173189-28-0).
Hydroxyethylpiperidine,        ................  Surfactant
 ethoxylated, reaction
 products with fatty acid
 dimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173189-20-2).
Hydroxyethylpiperidine,        ................  Surfactant
 ethoxylated, reaction
 products with fatty acid
 trimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173189-25-7).

[[Page 699]]

 
Hydroxyethylidine              For use in        Stabilizer, chelator
 diphosphonic acid (HEDP)       antimicrobial
 (CAS Reg. No. 2809-21-4).      pesticide
                                formulations at
                                not more than 1
                                percent.
Iron oxide...................  ................  Solid diluent, carrier
Isobutane (CAS Reg. No. 75-28- None............  Propellant
 5).
Isopropyl myristate (CAS Reg.  ................  Solvent
 No. 110-27-0).
Kaolinite-type clay..........  ................  Solid diluent, carrier
Lactic acid..................  ................  Solvent
Lactic acid, 2-ethylhexyl      ................  Solvent
 ester (CAS Reg. No. 6283-86-
 9).
Lactic acid, 2-ethylhexyl      ................  Solvent
 ester, (2S)- (CAS Reg. No.
 186817-80-1).
Lactic acid, n-propyl ester,   ................  Solvent
 (S); (CAS Reg. No. 53651-69-
 7).
Lauryl alcohol...............  ................  Surfactant
Lignin (CAS Reg. No. 9005-53-  ................  Surfactant, related
 2).                                              adjuvants of
                                                  surfactants
Lignin, alkali (CAS Reg. No.   ................   Do.
 8068-05-1).
Lignin, alkali, oxidized,      ................   Do.
 sodium salt (CAS Reg. No.
 68201-23-0).
Lignin alkali reaction         ................   Do.
 products with disodium
 sulfite and formaldehyde
 (CAS Reg. No. 105859-97-0).
Lignin alkali reaction produc  ................   Do.
 ts with formaldehyde .
 and sodium bisulfite (CAS Re
 g. No. 68512-35-6).
Lignosulfonic acid (CAS Reg.   ................   Do.
 No. 8062-15-5).
Lignosulfonic acid, ammonium   ................   Do.
 calcium salt (CAS Reg. No.
 12710-04-2).
Lignosulfonic acid, ammonium   ................   Do.
 magnesium salt (CAS Reg. No.
 123175-37-1).
Lignosulfonic acid, ammonium   ................   Do.
 salt (CAS Reg. No. 8061-53-
 8).
Lignosulfonic acid, ammonium   ................   Do.
 sodium salt (CAS Reg. No.
 166798-73-8).
Lignosulfonic acid, calcium    ................   Do.
 magnesium salt (CAS Reg. No.
 55598-86-2).
Lignosulfonic acid, calcium    ................   Do.
 salt (CAS Reg. No. 8061-52-
 7).
Lignosulfonic acid, calcium    ................   Do.
 sodium salt (CAS Reg. No.
 37325-33-0).
Lignosulfonic acid,            ................   Do.
 ethoxylated, sodium salt
 (CAS Reg. No. 68611-14-3).
Lignosulfonic acid, magnesium  ................   Do.
 salt (CAS Reg. No. 8061-54-
 9).
Lignosulfonic acid, potassium  ................   Do.
 salt (CAS Reg. No. 37314-65-
 1).
Lignosulfonic acid, sodium     ................   Do.
 salt (CAS Reg. No. 8061-51-
 6).
Lignosulfonic acid, sodium     ................   Do.
 salt, oxidized (CAS Reg. No.
 68855-41-4).
Lignosulfonic acid, sodium     ................   Do.
 salt, polymer with
 formaldehyde and phenol (CAS
 Reg. No. 37207-89-9).
Lignosulfonic acid, sodium     ................   Do.
 salt, sulfomethylated (CAS
 Reg. No. 68512-34-5).
Lignosulfonic acid, zinc salt  ................   Do.
 (CAS Reg. No. 57866-49-6).
d-Limonene (CAS Reg. No. 5989- ................  Solvent, fragrance
 27-5).
Magnesium carbonate..........  ................  Anticaking agent,
                                                  conditioning agent
Magnesium chloride...........  ................  Safener
Magnesium lime...............  ................  Solid diluent, carrier
Magnesium oxide..............  ................   Do.
Magnesium silicate...........  ................   Do.
Magnesium stearate...........  ................  Surfactant
Magnesium sulfate............  ................  Solid diluent, carrier,
                                                  safener
Methyl alcohol...............  ................  Solvent
Methyl n-amyl ketone (CAS      ................  Solvent, cosolvent
 Reg. No. 110-43-0).
Methyl 5-(dimethylamino)-2-    ................  Solvent
 methyl-5-oxopentanoate
 (1174627-68-9).
Methyl esters of fatty acids   ................  Solvent, cosolvent
 derived from edible fats and
 oils.
Methyl esters of higher fatty  ................  Antidusting agent,
 acids conforming to 21 CFR                       surfactant
 573.640.
Methyl isobutyl ketone.......  ................  Solvent

[[Page 700]]

 
2-methyl-2,4-pentanediol (CAS  Without           Growing crops and food
 Reg. No. 107-41-5).            limitation.       animals
2-methyl-1,3-propanediol (CAS  ................  Solvent, surfactant
 Reg. No. 2163-42-0).
Methylated silicones.........  ................  Antifoaming agent
Mono-, di-, and                ................  Surfactants, related
 trimethylnapthalenesulfonic                      adjuvants of
 acids and napthalenesulfonic                     surfactants
 acids formaldehyde
 condensates, ammonium and
 sodium salts (CAS Reg. Nos
 9008-63-3, 9069-80-1, 9084-
 06-4, 36290-04-7, 91078-68-
 1, 141959-43-5, 68425-94-5).
Mica.........................  ................  Solid diluent, carrier
Mineral oil, U.S.P., or        ................  Diluent, carrier, and
 conforming to 21 CFR 172.878                     solvent
 or 178.3620(a) (CAS Reg. No.
 8012-95-1).
Monoammonium phosphate.......  No more than      Postharvest fumigation
                                3.75% by weight   in formulation with
                                in formulation.   aluminum phosphide
Mono- and diglycerides of C8-  ................  Surfactants, related
 C18  fatty acids.                                adjuvants of
                                                  surfactants
Montmorillonite-type clay....  ................  Solid diluent, carrier
Nonyl, decyl, and undecyl      ................  Surfactant.
 glycoside mixture with a
 mixture of nonyl, decyl, and
 undecyl oligosaccharides and
 related reaction products
 (primarily decanol and
 undecanol) produced as an
 aqueous-based liquid (50 to
 65% solids) from the
 reaction of primary alcohols
 (containing 15 to 20%
 secondary alcohol isomers)
 in a ratio of 20% C9, 40%
 C10, and 40% C11 with
 carbohydrates (average
 glucose to alkyl chain ratio
 1.3 to 1.8).
[alpha]-(p-Nonylphenol)-       Not to exceed 7%  Surfactants, related
 [omega]-                       of pesticide      adjuvants of
 hydroxypoly(oxyethylene)       formulation.      surfactants
 mixture of dihydrogen
 phosphate and monohydrogen
 phosphate esters and the
 corresponding ammonium,
 calcium, magnesium,
 potassium, sodium, and zinc
 salts of the phosphate
 esters; the nonyl group is a
 propylene trimer isomer and
 the poly(oxyethylene)
 content averages 4-14 or 30
 moles (CAS Reg. Nos. 51811-
 79-1, 59139-23-0, 67922-57-
 0, 68412-53-3, 68553-97-9,
 68954-84-7, 99821-14-4,
 152143-22-1, 51609-41-7,
 37340-60-6, 106151-63-7,
 68584-47-4, 52503-15-8,
 68458-49-1).
[alpha]-(p-Nonylphenyl)-       ................  Surfactants, related
 [omega]-                                         adjuvants of
 hydroxypoly(oxyethylene)                         surfactants
 produced by the condensation
 of 1 mole of nonylphenol
 (nonyl group is a propylene
 trimer isomer) with an
 average of 4-14 or 30-90
 moles of ethylene oxide; if
 a blend of products is used,
 the average number of moles
 of ethylene oxide reacted to
 produce any product that is
 a component of the blend
 shall be in the range of 4-
 14 or 30-90.
[alpha]-(p-Nonylphenol)-       Not to exceed 7%  Surfactants, related
 [omega]-                       of pesticide      adjuvants of
 hydroxypoly(oxyethylene)       formulation.      surfactants
 sulfate, ammonium, calcium,
 magnesium, potassium,
 sodium, and zinc salts the
 nonyl group is propylene
 trimer isomer and the
 poly(oxyethylene) content
 averages 4 moles (CAS Reg.
 Nos. 9014-90-8, 9051-57-4,
 9081-17-8, 68649-55-8, 68891-
 33-8.
1-Octanal (CAS Reg. No. 124-   Not more than     Odor masking agent
 13-0).                         0.2% of the
                                pesticide
                                formulation.
n-Octyl alcohol (CAS Reg. No.  ................  Solvent or co-solvent
 111-87-5).
Octyl and decyl glucosides     ................  Surfactants, related
 mixture with a mixture of                        adjuvants of
 octyl and                                        surfactants
 decyloligosaccharides and
 related reaction products
 (primarily n- decanol)
 produced as an aqueous-based
 liquid (68-72% solids) from
 the reaction of straight
 chain alcohols (C8(45%), C10
 (55%)) with anhydrous
 glucose.
Oleic acid...................  ................  Diluent
Oleic acid diester of [alpha]- ................  Surfactants, related
 hydro-[omega]-hydroxypoly                        adjuvants of
 (oxyethylene); the                               surfactants
 poly(oxyethylene) having
 average molecular weight (in
 amu) 400.

[[Page 701]]

 
[alpha]-Oleoyl-[omega]-        ................  Emulsifier
 hydroxypoly(oxyethylene),
 average molecular weight (in
 amu) of 600.
Oleyl alcohol (CAS Reg. No.    15%.............  Cosolvent
 143-28-2.
Oxalic acid..................  No more oxalic    Calcium chelating hard
                                acid should be    water inhibitor
                                used than is
                                necessary to
                                chelate calcium
                                and in no case
                                should more
                                than 2 lb
                                oxalic acid per
                                acre be used.
Palmitic acid................  ................  Diluent
Pentaerythritol ester of       ................  Plasticizer
 maleic anhydride modified
 wood rosin.
Petrolatum, conforming to 21   ................  Coating agent
 CFR 172.880.
Petroleum hydrocarbons, light  ................  Solvent, diluent.
 odorless conforming to 21
 CFR 172.884.
Petroleum hydrocarbons,        ................   Do.
 synthetic isoparaffinic,
 conforming to 21 CFR 172.882.
Petroleum naphtha, conforming  ................  Component of coating
 to 21 CFR 172.250(d).                            agent
Petroleum wax, conforming to   ................  Coating agent
 21 CFR 172.886(d).
Phosphoric acid..............  ................  Buffer
Polyethylene, conforming to    ................  Binder, carrier, and
 21 CFR 177.1520(c).                              coating agent
Polyethylene glycol[[alpha]-   ................  Surfactants, related
 hydro-[omega]-                                   adjuvants of
 hydroxypoly(oxyethylene)];                       surfactants
 mean molecular weight (in
 amu) 194 to 9,500 conforms
 to 21 CFR 178.3750.
Polyglycerol esters of fatty   ................  Surfactants, related
 acids conforming to 21 CFR                       adjuvants of
 172.854.                                         surfactants
Polyglyceryl phthalate ester   None............  Surfactants, related
 of coconut oil fatty acids,                      adjuvants of
 including fatty acid coco                        surfactants
 polymers with glyceryl and
 phthalic anhydride (CAS No.
 67746-02-5) and coconut oil
 polymer with glyceryl and
 phthalic anhydride (CAS No.
 66070-87-9).
Poly(oxy-1,2-ethanediyl),      ................  Surfactant
 [alpha]-(carboxymethyl)-
 [omega]-(nonylphenoxy)
 produced by the condensation
 of 1 mole of nonylphenol
 (nonyl group is a propylene
 trimer isomer) with an
 average of 4-14 or 30-90
 moles of ethylene oxide. The
 molecular weight (in amu)
 ranges are 454-894 and 1598-
 4238.
Poly(oxy-1,2-ethanediyl),      For use in post-  Surfactants
 [alpha]-[tris(1-               harvest
 phenylethyl)phenyl]-[omega]-   applications;
 hydroxy-, (CAS Reg. No.        not to exceed
 99734-09-5).                   15% by weight
                                in pesticide
                                formulations.
Polyoxyethylene (20) sorbitan  ................  Surfactants, related
 monostearate.                                    adjuvants of
                                                  surfactants
[Poly[oxy(methyl-1,2-          Not to exceed     Surfactant
 ethanediyl)], [alpha]-[2-      15% in the
 bis(2-                         formulated
 hydroxyethyl)amino]propyl]-    product; only
 [omega]-hydroxy,-ether with    for use with
 [alpha]-hydro-[omega]-         glyphosate.
 hydroxypoly(oxy-1,2-
 ethanediyl) (1:2), mono-
 C12	16 alkyl ethers, (CAS
 Reg. No. 176022-82-5).
Polysorbate 65, conforming to  ................  Emulsifier
 21 CFR 172.838.
Potassium aluminum silicate..  ................  Solid diluent, carrier
Potassium benzoate (Cas No.    None............  Preservative
 582-25-2).
Potassium hydroxide..........  ................  Neutralizer
Potassium phosphate..........  ................  Buffer
Potassium sulfate............  ................  Solid diluent
Propane......................  ................  Propellant
1,3-Propanediol (CAS Reg. No.  ................  Solvent, co-solvent,
 504-63-2).                                       diluent, or freeze-
                                                  point depressant
2-Propanol,                    Without           Neutralizer
 1,1[min],1[min][min]-          limitation.
 nitrilotris- (CAS No. 122-20-
 3).
n-Propanol...................  ................  Solvent, cosolvent
2-Propenoic acid, 2-methyl-,   ................  Encapsulating agent,
 polymer with ethyl 2-                            dispensers, resins,
 propenoate and methyl 2-                         fibers and beads
 methyl-2-propenoate,
 ammonium salt (CAS
 Registration No. 55989-05-
 4), minimum number average
 molecular weight (in amu),
 18,900..
Propylene glycol.............  ................  Solvent, cosolvent.
Propylene glycol alginate (as  ................  Defoaming agent
 defined in 21 CFR 172.858).
Propyl gallate...............  ................  Antioxidant

[[Page 702]]

 
Propyl p-hydroxybenzoate.....  ................  Preservative for
                                                  formulations
Pyrophyllite.................  ................  Solid diluent, carrier
Rhizobium inoculants (e.g.     ................  All leguminous food
 Sinorhizobium,                                   commodities
 Bradyrhizobium & Rhizobium).
Rosin, partially dimerized     ................  Surfactants, related
 (as defined in 21 CFR                            adjuvants of
 172.615).                                        surfactants
Rosin, partially hydrogenated  ................   Do.
 (as defined in 21 CFR
 172.615).
Rosin, wood..................  ................   Do.
Salts of fatty acids,          ................  Binder, emulsifier,
 conforming to 21 CFR 172.863.                    anticaking agent
Sand.........................  ................  Solid diluent, carrier
Shellac, bleached; refined,    ................  Coating agent
 food grade, arsenic and
 rosin-free.
Silver nitrate (Cas Reg. No.   For use on        Stabilizer
 7761-88-8).                    potatoes as
                                post-harvest
                                treatment to
                                control
                                sprouting at no
                                more than 0.06%
                                by weight in
                                pesticide
                                formulations.
Soapstone....................  ................  Solid diluent
Sodium acid pyrophosphate....  ................  Surfactant, suspending
                                                  agent, dispersing
                                                  agent, buffer
Sodium alkyl                   Limited to no     Surfactants, related
 naphthalenesulfonates (CAS     more than 30%     adjuvants of
 Reg. Nos. 68909-83-1, 68909-   by weight in      surfactants
 84-2, 68909-82-0, 27213-90-    pesticide end-
 7, 26264-58-4, 27178-87-6,     use products.
 111163-74-7, 908356-16-1,
 25417-20-3, 25638-17-9,
 145578-88-7, 1322-93-6, 1323-
 19-9, 7403-47-6, 68442-09-1,
 127646-44-0, 908356-18-3).
Sodium aluminum silicate.....  ................  Solid diluent, carrier
Sodium dioctylsulfosuccinate.  ................  Surfactants, related
                                                  adjuvants of
                                                  surfactants
Sodium 1,4-dihexyl             ................  Surfactants, related
 sulfosuccinate (CAS Reg. No.                     adjuvants of
 3006-15-3).                                      surfactants
Sodium 1,4-diisobutyl          ................  Surfactants, related
 sulfosuccinate (CAS Reg. No.                     adjuvants of
 127-39-9).                                       surfactants
Sodium 1,4-dipentyl            ................  Surfactants, related
 sulfosuccinate (CAS Reg. No.                     adjuvants of
 922-80-5).                                       surfactants
Sodium hexametaphosphate.....  ................  Surfactant, emulsifier,
                                                  wetting agent,
                                                  suspending agent,
                                                  dispersing agent,
                                                  buffer
Sodium hydroxide.............  ................  Neutralizer
Sodium metasilicate..........  ................  Surfactants,
                                                  emulsifiers, wetting
                                                  agents, dispersing
                                                  agents, buffer
Sodium monoalkyl and dialkyl   Not to exceed     Surfactants, related
 (C6-C16) phenoxy               20% in            adjuvants of
 benzenedisulfonates and        pesticide         surfactants
 related acids (CAS Reg. Nos.   formulations.
 147732-59-0, 147732-60-3,
 169662-22-0, 70191-75-2,
 36445-71-3, 39354-74-0,
 70146-13-3, 119345-03-8,
 149119-20-0, 149119-19-7,
 119345-04-9, 28519-02-0,
 25167-32-2, 30260-73-2,
 65143-89-7, 70191-76-3).
Sodium [alpha]-                ................  Surfactants, related
 olefinsulfonate (sodium C14-                     adjuvants of
 C16) (Olefin sulfonate).                         surfactants
Sodium N-oleoyl- N-methyl      ................  Surfactants, related
 taurine (CAS Reg. No. 137-20-                    adjuvants of
 2).                                              surfactants
Sodium and potassium salts of  Concentration in  Surfactants, related
 N-alkyl (C8-C18)-beta-         formulated end-   adjuvants of
 iminodipropionic acid where    use products      surfactants
 the C8-C18 is linear and may   not to exceed
 be saturated and/or            30% by weight
 unsaturated (CAS Reg. Nos.     in pesticide
 110676-19-2, 3655-00-3,        formulations.
 61791-56-8, 14960-06-6,
 26256-79-1, 90170-43-7,
 91696-17-2, 97862-48-1).
Sodium salt of sulfated oleic  ................  Surfactants, related
 acid.                                            adjuvants of
                                                  surfactants
Sodium silicate..............  ................  Surfactant, emulsifier,
                                                  wetting agent,
                                                  stabilizer, inhibitor
Sodium starch glycolate (CAS   Granular and      Disintegrant
 Reg. No. 9063-38-1).           tableted
                                products only;
                                not to exceed
                                8% of the
                                formulated
                                product.
Sodium sulfate...............  ................  Solid diluent, carrier
Sodium tripolyphosphate......  ................  Buffer, surfactant,
                                                  suspending agent,
                                                  dispersing agent,
                                                  anticaking agent,
                                                  conditioning agent
Sorbic acid (CAS Reg. No. 110- ................  Preservative for
 44-1).                                           formulations

[[Page 703]]

 
Sorbitan fatty acid esters     ................  Surfactants, related
 (fatty acids limited to C12,                     adjuvants or
 C14, C16, and C18 containing                     surfactants.
 minor amounts of associated
 fatty acids) and their
 derivatives; the
 poly(oxyethylene) content
 averages 5-20 moles.
Soybean flour................  Expires May 24,   Surfactant
                                2005..
Soybean oil-derived fatty      ................  Solvent, cosolvent
 acids.
Stearic acid.................  ................  Diluent
[alpha]-Stearoyl-[omega]-      ................  Emulsifier
 hydroxypoly(oxyethylene),
 average molecular weight (in
 amu) of 600.
[alpha]-Stearoyl-[omega]-      ................  Surfactants, related
 hydroxypoly(oxyethylene);                        adjuvants of
 the poly(oxyethylene)                            surfactants
 content averages either 8,
 9, or 40 moles; if a blend
 of products is used, the
 average number of moles
 ethylene oxide reacted to
 produce any product that is
 a component of the blend
 shall be either 8, 9, or 40.
Sucrose octaacetate..........  ................  Adhesive
Sulfite liquors and cooking    ................  Surfactant, related
 liquors, spent, oxidized                         adjuvants of
 (CAS Reg. No. 68514-09-0).                       surfactants
Sulfuric acid (CAS Reg.        Not to exceed     pH Control agent
 No.7664-93-9).                 10% of the
                                pesticide
                                formulation;
                                non-aerosol
                                formulations
                                only.
Synthetic paraffin and its     ................  Carrier, binder, and
 succinic derivatives                             carrying agent
 conforming to 21 CFR 172.275.
Synthetic petroleum wax,       ................  Binder, carrier, and
 conforming to 21 CFR 172.888.                    coating agent
Talc.........................  ................  Solid diluent, carriers
Tall oil; fatty acids not      ................  Surfactants, related
 less than 58%, rosin acids                       adjuvants of
 not more than 44%,                               surfactants
 unsaponifiables not more
 than 8%.
Tartrazine...................  ................  Dye
Terpenes and terpenoids,       ................  Surfactants, related
 turpentine oil, alpha-pinene                     adjuvants of
 fraction, polymd. (CAS Reg.                      surfactants
 No. 70750-57-1).
1,1,1,2-Tetrafluoroethane,     ................  Aerosol propellant
 (CAS Reg. No. 811-97-2).
Tetrahydrofurfuryl alcohol     Expires February  Solvent/cosolvent
 (THFA) (CAS Reg. No 97-99-4).  9, 2008.
N,N,N[min],N[sec],-tetrakis-   Concentration in  Stabilizer for
 (2-hydroxypropyl)              formulated end-   formulation.
 ethylenediamine (CAS Reg.      use products
 No. 102-60-3).                 not to exceed
                                20% by weight
                                in pesticide
                                formulations.
[alpha]-[p-(1,1,3,3-           Not to exceed 7%  Surfactants related
 tetramethylbutyl)phenyl]-      of pesticide      adjuvants of
 [omega]-                       formulation.      surfactants
 hydroxypoly(oxyethylene)
 produced by the condensation
 of 1 mole of p-(1,1,3,3-
 tetramethylbutyl)phenol with
 a range of 1-14 or 30-70
 moles of ethylene oxide: If
 a blend of products is used,
 the average range number of
 moles of ethylene oxide
 reacted to produce any
 product that is a component
 of the blend shall be in the
 range of 1-14 or 30-70 (CAS
 Reg. Nos. 9036-19-5, 9002-93-
 1).
2,4,7,9-Tetramethyl-5-decyn-   Not more than     Surfactants, related
 4, 7-diol.                     2.5% of           adjuvants of
                                pesticide         surfactants
                                formulation.
Tetrasodium pyrophosphate....  ................  Anticaking agent,
                                                  conditioning agent
Thiosulfuric acid, disodium    ................  Dechlorinator, reducing
 salt, anhydrous. (CAS Reg.                       agent
 No 7772-98-7).
Thiosulfuric acid, disodium    ................   Do.
 salt, pentahydrate. (CAS
 Reg. No. 10102-17-7).
d-Alpha tocopherol (CAS Reg.   None............  Safener
 No. 9-02-9.
d-Alpha tocopheryl acetate     None............   Do.
 (CAS Reg. No. 58-95-7).
dl-Alpha tocopherol (CAS Reg.  None............   Do.
 No.10191-41-0).
dl-Alpha tocopheryl acetate    None............   Do.
 (CAS Reg. No. 7695-91-2).
Tricalcium phosphate.........  ................  Surfactant, suspending
                                                  agent, dispersing
                                                  agent, anticaking
                                                  agent, conditioning
                                                  agent
Trisodium phosphate..........  ................  Surfactant, emulsifier,
                                                  wetting agent
Vermiculite..................  ................  Solid diluent, carrier.
Vitamin E (CAS Reg. No. 1406-  None............  Safener
 18-4).
Walnut shells................  ................  Leaching inhibitor,
                                                  binder for water-
                                                  dispersible
                                                  aggregates, sticker
                                                  and suspension
                                                  stabilizer
Wintergreen oil..............  ................  Attractant

[[Page 704]]

 
Wood flour...................  Derived from      Solid diluent and
                                wood free of      carrier
                                chemical
                                preservatives.
Xanthan gum-modified,          Not more than     Surfactant
 produced by the reaction of    0.5% of
 xanthan gum and glyoxal        pesticide
 (maximum 0.3% by weight).      formulation.
Xylene meeting the             In pesticide      Solvent, cosolvent
 specifications listed in 21    formulations
 CFR 172.884(b)(4).             for grain
                                storage only.
Zeolite (hydrated alkali       ................  Solid diluent, carrier
 aluminum silicate).
Zinc oxide...................  ................  Coating agent
Zinc sulfate (basic and        ................   Do.
 monohydrate).
Zinc sulfate (basic and        ................  Solid diluent, carrier
 monohydrate).
------------------------------------------------------------------------


[69 FR 23117, Apr. 28, 2004]

    Editorial Note: For Federal Register citations affecting Sec. 
180.910, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.920  Inert ingredients used pre-harvest; exemptions from the 

requirement of a tolerance.

    The following materials are exempted from the requirement of a 
tolerance when used in accordance with good agricultural practice as 
inert (or occasionally active) ingredients in pesticide formulations 
applied to growing crops only:

------------------------------------------------------------------------
      Inert ingredients             Limits                 Uses
------------------------------------------------------------------------
Acetophenone.................  ................  Attractant
Adenosine (CAS Reg. No. 58-61- Maximum of 0.5%   Synergist
 7).                            of formulation.
Alder bark...................  ................  Seed germination
                                                  stimulator
Alkyl (C12-C16) dimethyl       20% by weight in  Surfactant
 ammonio acetate (CAS Reg.      pesticide
 Nos. 683-10-3, 2601-33-4 and   formulation.
 693-33-4.
[alpha]-Alkyl (minimum C6      Not to exceed     Surfactants, related
 linear, branched, saturated    30% of            adjuvants of
 and/or unsaturated)-[omega]-   pesticide         surfactants
 hydroxypolyoxyethylene         formulation.
 polymer with or without
 polyoxypropylene, mixture of
 di- and monohydrogen
 phosphate esters and the
 corresponding ammonium,
 calcium, magnesium,
 monoethanolamine, potassium,
 sodium, and zinc salts of
 the phosphate esters;
 minimum oxyethylene content
 is 2 moles; minimum
 oxypropylene content is 0
 moles (CAS Reg. Nos. 9046-01-
 9, 37280-82-3, 39464-66-9,
 42612-52-2, 50643-20-4,
 52019-36-0, 58318-92-6,
 60267-55-2, 61837-79-4,
 67711-84-6, 68070-99-5,
 68071-35-2, 68071-17-0,
 68130-47-2, 68186-37-8,
 68186-36-7, 68311-02-4,
 68425-73-0, 68458-48-0,
 68511-37-5, 68610-65-1,
 68585-36-4, 68649-29-6,
 68815-11-2, 68908-64-5,
 68891-13-4, 73038-25-2,
 78330-24-2, 108818-88-8,
 154518-39-5, 317833-96-8,
 873662-29-4, 936100-29-7,
 936100-30-0).
N-alkyl(C8-C18)                Not to exceed     Surfactants, related
 dimethylamidopropylamines      20% by weight     adjuvants of
 where the alkyl group is       in herbicide      surfactants
 linear and may be saturated    formulations.
 and/or unsaturated (CAS Reg.
 Nos. 109-28-4, 3179-80-4,
 7651-02-7, 22890-10-4, 22890-
 11-5, 39669-97-1, 45267-19-
 4, 68140-01-2, 1147459-12-8,
 146987-98-6).
N-alkyl (C8-C18) primary       Concentration in  Surfactants, related
 amines and their acetate       formulated end-   adjuvants of
 salts where the alkyl group    use products      surfactants
 is linear and may be           not to exceed
 saturated and/or unsaturated   10% by weight
 (CAS Reg. Nos. 61790-57-6,     in herbicide
 61790-58-7, 61790-59-8,        products, 4% by
 61790-60-1, 61788-46-3,        weight in
 61790-33-8, 68155-38-4).       insecticide
                                products, and
                                4% by weight in
                                fungicide
                                products.

[[Page 705]]

 
N,N-Bis-[alpha]-ethyl-[omega]- Not to exceed     Surfactants, related
 hydroxypoly(oxy-1,2-           25% in            adjuvants of
 ethanediyl) C8-C18 saturated   herbicide         surfactants
 and unsaturated alkylamines;   formulations
 the poly(oxy-1,2-ethanediyl)   and 10% in
 content is 2-60 moles (CAS     insecticide and
 Reg. Nos. 10213-78-2, 25307-   fungicide
 17-9, 26635-92-7, 26635-93-    formulations.
 8, 288259-52-9, 58253-49-9,
 61790-82-7, 61791-14-8,
 61791-24-0, 61791-26-2,
 61791-31-9, 61791-44-4,
 68155-33-9, 68155-39-5,
 68155-40-8,70955-14-5, 73246-
 96-5, 1266162-49-5).
N,N-Bis-[alpha]-ethyl-[omega]- Not to exceed     Surfactants, related
 hydroxypoly(oxy-1,2-           25% in            adjuvants of
 ethanediyl/oxy(methyl-1,2-     herbicide         surfactants
 ethanediyl) C8-C18 saturated   formulations
 and unsaturated alkylamines;   and 10% in
 the poly(oxy-1,2-ethanediyl/   insecticide and
 oxy(methyl-1,2-ethanediyl)     fungicide
 content is 2-60 moles (CAS     formulations.
 Reg. Nos. 68213-26-3, 68153-
 97-9, 75601-76-2).
Aluminum sulfate.............  ................  Safener adjuvant
Ammonium chloride (CAS Reg.    ................  Carrier/nutrient
 No. 12125-02-9).
Ammonium formate (CAS Reg.     ................  Complexing or fixing
 No. 540-69-2).                                   agent
Ammonium nitrate (CAS Reg.     ................  Adjuvant/ intensifier
 No. 6484-52-2).                                  for herbicides
Ammonium polyphosphate (CAS    ................  Sequestrant, buffer, or
 Reg. No. 68333-79-9).                            surfactant
Barium sulfate...............  ................  Carrier
1,4-Benzenedicarboxylic acid,  For use in        Component of controlled
 dimethyl ester, polymer with   honeybee hive     release agent
 1,4-butanediol, adipic acid,   miticide
 and hexamethylene              formulations.
 diisocyanate, minimum number
 average molecular weight (in
 amu) 30,000 (CAS Reg. No.
 55231-08-8).
1,2-Benzisothiazolin-3-one...  Not more than     Preservative/stabilizer
                                0.1% of
                                formulation.
                                Not more than
                                0.02 lb to be
                                applied per
                                acre.
Boric acid...................  ................  Sequestrant
Buffalo gourd root powder      No more than 2.5  Gustatory stimulant
 (Cucurbita foetidissima root   lbs/acre/season
 powder); or, Zucchini juice    (3.4 gm/acre/
 (Cucurbita pepo juice) or      season of
 Hawkesbury melon Citrullus     Cucurbitacin).
 lanatus..
Butyl stearate...............  ................  Defoamer
[gamma]-Butyrolactone........  ................  Solvent
C.I. Pigment Blue 15  For seed          Dye, coloring agent
 (CAS Reg. No. 147-14-8;        treament use
 containing no more than 50     only.
 ppm polychlorinated
 biphenyls (PCBs)).
C.I. Pigment Green 7  For seed          Dye, coloring agent
 (CAS Reg. No. 1328-53-6;       treatment use
 containing no more than 50     only.
 ppm polychlorinated
 biphenyls (PCBs)).
C.I. Pigment Violet 23 (CAS Reg. No. 6358-30-    treatment use
 1; containing no more than     only.
 20 ppb of polychlorinated
 dibenzo-p-dioxins and/or
 polychlorinated
 dibenzofurans).
Calcium gluconate (CAS Reg.    ................  Sequestrant
 No. 299-28-5).
Camphor (CAS Reg. No. 76-22-   Not more than 5%  Deodorant, melting
 2).                            weight to         point adjustment
                                weight (w/w) of
                                pesticide
                                formulations.
Carbon Black (CAS Reg. No.     For seed          Colorant
 1333-86-4).                    treatment use
                                only.
Carbonic acid, dipotassium     ................  Buffering agent
 salt (CAS Reg. No. 584-08-7).
Carbonic acid, dipotassium     ................  Buffering agent
 salt, trihydrate (CAS Reg.
 No. 18662-52-7).
Carboxymethyl guar gum sodium  Without           Thicker/drift reduction
 salt (CAS Reg. No. 39346-76-   limitation.       agent
 4).
Carboxymethyl-hydroxypropyl    Without           Thicker/drift reduction
 guar (CAS Reg. No. 68130-15-   limitation.       agent
 4).
Carous chloride..............  10 ppm in         Tagging agent
                                formulation.
Carrageenan, conforming to 21  Not more than     Thickener and
 CFR 172.260.                   0.15% of          stabilizer for
                                pesticide         pesticide formulations
                                formulation.      applied to seeds
                                                  before planting
Chlorobenzene................  Contains not      Solvent, cosolvent
                                more than 1%
                                impurities. Not
                                for use after
                                edible parts of
                                plant begin to
                                form. Do not
                                graze livestock
                                in treated
                                areas within 48
                                hours after
                                application.

[[Page 706]]

 
5-Chloro-2-methyl-4-           Not more than     Preservative
 isothiazolin-3-one (in         0.0022% (22.5
 combination with 2-methyl-4-   ppm) in the
 isothiazolin-3-one).           formulation;
                                0.00022% (or
                                2.25 ppm) in
                                the final
                                solution
                                applied to
                                growing crops.
Choline chloride (CAS Reg.     ................  As a solvent
 No. 67-48-1).
Choline hydroxide (CAS Reg     Without           Neutralizer
 No. 123-41-1).                 limitation.
Cis-isomer of 1-(3-            Maximum of 0.14%  Preservative
 chloroallyl)-3,5,7-triaza-1-   by weight of
 azoniaadamantane chloride      formulation.
 (CAS Reg. No. 51229-78-8).
Copper naphthenate...........  Not more than     Mercaptan scavenger in
                                2.5% of           technical pesticide
                                formulation;
                                application
                                limited to
                                before edible
                                portions of
                                plants begin to
                                form.
Cyclohexane..................  ................  Solvent, cosolvent
Cyclohexanone................  ................   Do.
Cysteine (CAS Reg. No. 52-90-  Maximum of 0.5%   Synergist
 4).                            of formulation.
D&C Green No. 6..............  ................  Dye
D&C Red No. 17, technical      ................  Dye
 grade.
D&C Red No. 33 (CAS Reg. No.   ................  Dye
 3567-66-6); meeting the
 specifications listed in 21
 CFR 74.1333.
D&C Violet No. 2, technical    Not more than     Dye
 grade.                         0.005% of
                                pesticide
                                formulation.
Decanamide, N,N-dimethyl (CAS  ................  Emulsifier, solvent,
 Reg. No. 14433-76-2).                            cosolvent
Diammonium phosphate (CAS      ................  Buffer, surfactant
 Reg. No. 7783-28-0).
dibenzylidene sorbitol (32647- ................  Thinning agent
 67-9).
Diethanolamine...............  ................  Stabilizer, inhibitor
                                                  for formulations used
                                                  before crop emerges
                                                  from soil
Diethanolamine salts of alkyl  Not to exceed 7%  Surfactants, related
 (C8-C24) benzenesulfonic       of pesticide      adjuvants of
 acid (CAS Reg. Nos. 26545-53-  formulation.      surfactants
 9 and 68953-97-9).
Diethylene glycol............  ................  Deactivator, adjuvant
                                                  for formulations used
                                                  before crop emerges
                                                  from soil
Diethylene Glycol (CAS No.     Without           Solvent, stabilizer and/
 111-46-6).                     limitation.       or antifreeze
Diethylene glycol and          ................  Deactivator for
 diethylene glycol monobutyl,                     formulations used
 monoethyl, and monomethyl                        before crop emerges
 ethers.                                          from soil, stabilizer
Diethylene glycol mono butyl   Without           Pesticide inert
 ether (CAS Reg. No. 112-34-    limitation.       ingredient as a
 5).                                              solvent, stabilizer
                                                  and/or antifreeze
Diethylene Glycol MonoEthyl    Without           Solvent, stabilizer and/
 Ether (CAS Reg. No. 111-90-    limitation.       or antifreeze
 0).
Dimethylaminopropylamine,      ................  Surfactants, related
 isopropylamine,                                  adjuvants of
 ethanolamine, and                                surfactants
 triethanolamine salts of
 alkyl (C8-C24)
 benzenesulfonic acid (CAS
 Reg. Nos. 26264-05-1, 27323-
 41-7, 55470-69-4, 68411-31-
 4, 68584-24-7, 68584-25-8,
 68648-81-7, 68648-96-4,
 68649-00-3, 68910-32-7,
 68953-93-5, 90194-42-6,
 90194-53-9, 90218-35-2,
 157966-96-6, 319926-68-6,
 877677-48-0, 1093628-27-3).
3,6-Dimethyl-4-octyn-3,6-diol  In pesticide      Surfactants, related
                                formulations,     adjuvants of
                                for soil prior    surfactants
                                to planting or
                                to plants
                                before edible
                                parts form.
Dimethyl sulfoxide...........  ................  Solvent or cosolvent
                                                  for formulations used
                                                  before crop emerges
                                                  from soil or prior to
                                                  formation of edible
                                                  parts of food plants
Dipotassium hydrogen           ................  Buffering agent
 phosphate.
Dipropylene glycol monomethyl  ................  Stabilizer
 ether.
Douglas-fir bark, ground.....  ................  Solid diluent, carrier
Dysprosium chloride..........  10 ppm in         Tagging agent
                                formulation.
1,2-ethanediamine,N,N,N        For use in        Adjuvant or water
 [min], N [min]-tetramethyl-,   pesticide         conditioner
 polymer with 1,1[min]-         formulations
 oxybis[2-chloroethane] (CAS    applied to
 Reg. No. 31075-24-8).          cotton or wheat
                                only.
(S,S)-Ethylenediaminedisuccin  ................  Sequestrant or
 ic acid (CAS Reg. No. 20846-                     chelating agent
 91-7).
Ethylene glycol..............  ................  Antifreeze, deactivator
                                                  for all pesticides
                                                  used before crop
                                                  emerges from soil and
                                                  in herbicides before
                                                  or after crop emerges

[[Page 707]]

 
Ethylene glycol (CAS Reg. No.  Without           Pesticide inert
 107-21-1).                     limitation.       ingredient as a
                                                  solvent, stabilizer
                                                  and/or antifreeze.
Ethylene glycol monobutyl      ................  .......................
 ether.
2-Ethylhexanol...............  ................  Cosolvent, defoamer,
                                                  solvent for all
                                                  pesticides used before
                                                  crop emerges from soil
                                                  and in herbicides
                                                  before or after crop
                                                  emerges
Europic chloride.............  10 ppm in         Tagging agent
                                formulation.
FD&C Blue No. 1, methyl-       For seed          Dye, coloring agent
 polyethylene glycol            treatment use
 derivative (CAS Reg. No.       only; Number
 9079-34-9).                    average
                                molecular
                                weight (in amu)
                                is greater than
                                1,000; Not to
                                exceed 5% of
                                the formulated
                                pesticide
                                product.
FD&C Blue No. 1, polyethylene  For seed          Dye, coloring agent
 glycol derivative (CAS Reg.    treatment use
 No. 9079-33-8).                only; Number
                                average
                                molecular
                                weight (in amu)
                                is greater than
                                1,000; Not to
                                exceed 5% of
                                the formulated
                                pesticide
                                product.
FD&C Red No. 40 (CAS Reg. No.  For seed          Dye, coloring agent
 25956-17-6).                   treatment use
                                only. Not to
                                exceed 2% by
                                weight of the
                                pesticide
                                formulation.
Ferric chloride..............  ................  Not greater than 2% of
                                                  suspending, dispersing
                                                  agent, pesticide
                                                  formulation
Fluoroapatite................  ................  Solid diluent, carrier
Folic acid (CAS Reg. No. 59-   Maximum of 0.5%   Synergist
 30-3).                         of formulation.
Gluconic acid (and sodium      ................  Sequestrant
 salt).
l-Glutamic acid (C5 H9 NO4;    Seet treatment    Plant nutrient
 CAS Reg. No. 56-86-0).         use only.
[alpha]-D-glucopyranoside, 2-  ................  Surfactant
 ethylhexyl 6-O-[alpha]-D
 glucopyranosyl- (CAS Reg.
 No. 330980-61-5).
[alpha]-D-glucopyranoside, 2-  ................  Surfactant
 ethylhexyl (CAS Reg. No.
 125590-73-0).
Glutamine (CAS Reg. No. 56-85- Maximum of 0.5%   Synergist
 9).                            of formulation.
Glycerol--propylene oxide      ................  Component in water-
 polymer (CAS Reg. No. 25791-                     soluble film
 96-2).
Glyceryl triacetate..........  ................  Stabilizer
Glyceryl tris-12-              ................  Flow control agent
 hydroxystearate.
Graphite.....................  ................  Treatment aid for seeds
Guar                           ................  Thickener/drift
 hydroxypropyltrimethylammoni                     reduction agent
 um chloride (CAS Reg. No.
 71329-50-5).
Hexamethylenetetramine.......  ................  Stabilizer for carriers
                                                  in solid pesticide
                                                  formulations
2-(2'-hydroxy-3',5'-di-tert-   Maximum           Ultraviolet (UV)
 amylphenyl) benzotriazole      concentration     stabilizer
 (CAS Reg. No. 25973-55-1).     of 0.6% in
                                insecticide
                                formulations
                                applied to
                                adzuki beans,
                                canola,
                                chickpeas,
                                cotton, faba
                                beans, field
                                peas, lentils,
                                linola,
                                linseed,
                                lucerne,
                                lupins, mung
                                beans, navy
                                beans, pigeon
                                peas,
                                safflower,
                                sunflower, and
                                vetch.
2-Hydroxy-4-n-                 Not more than     Light stabilizer
 octoxybenzophenone (CAS Reg.   0.2 pt of
 No. 1843-05-6).                pesticide
                                formulation.
Hydroxypropyl guar gum.......  ................  Thickener
Isobornyl acetate............  ................  Solvent
Isobutyl alcohol.............  ................   Do.
Isobutylene-butene copolymers  For soil          Binder
                                application
                                only.
Isooctadecanol...............  Not more than 2%  Defoaming agent
                                of pesticide
                                formulation.
Lanthanum chloride...........  10 ppm in         Tagging agent.
                                formulation.
Magnesium nitrate (in          None............  Preservation
 combination with 2-methyl-4-
 isothiazolin-3-one and 5-
 chloro-2-methyl-4-
 isothiazolin-3-one).
Maleic acid and maleic         For pesticide     Stabilizer
 anhydride.                     formulations
                                applied to
                                apples with a
                                minimum
                                preharvest
                                interval of 21
                                days.
Manganese carbonate..........  ................  Plant nutrient

[[Page 708]]

 
Mesityl oxide................  Not for use       Solvent, cosolvent
                                after edible
                                parts of plant
                                begin to form.
                                Do not graze
                                livestock in
                                treated areas
                                within 48 hours
                                after
                                application.
Methionine (CAS Reg. No. 59-   Maximum of 0.5%   Synergist
 51-8).                         of formulation.
Methyl alcohol...............  ................   Do.
Methyl ethyl ketone..........  ................  Surfactant
Methyl p- hydroxybenzoate....  ................  Preservative for
                                                  formulations
Methyl isobutyl ketone.......  ................  Solvent, cosolvent
2-Methyl-4-isothiazolin-3-one  Not more than     Preservative
 (in combination with 5-        0.0022% (22.5
 chloro-2-methyl-4-             ppm) in the
 isothiazolin-3-one).           formulation;
                                0.00022% (or
                                2.25 ppm) in
                                the final
                                solution
                                applied to
                                growing crops.
Mono-, di-, and                ................  Surfactants, related
 trimethylnapthalenesulfonic                      adjuvants of
 acids and napthalenesulfonic                     surfactants
 acids formaldehyde
 condensates, ammonium and
 sodium salts (CAS Reg. Nos.
 9008-63-3, 9069-80-1, 9084-
 06-4, 36290-04-7, 91078-68-
 1, 141959-43-5, 68425-94-5).
Methyl oleate................  ................  Surfactant
2-Methyl-2,4-pentanediol.....  ................  Solvent for
                                                  formulations used
                                                  before crop emerges
                                                  from soil
Methyl poly(oxyethylene)C8-    Concentration in  Surfactants, related
 C18 alkylammonium chlorides    formulated end    adjuvants of
 where the poly(oxyethylene)    use products      surfactants
 content is n=2-15 and where    not to exceed
 C8-C18 alkyl is linear and     10% by weight
 may be saturated or            in herbicide
 unsaturated (CAS Reg. Nos.     products and 5%
 3010-24-0, 18448-65-2, 70750-  by weight in
 47-9, 22340-01-8, 67784-77-    all other
 4, 64755-05-1, 61791-10-4,     pesticide
 28724-32-5, 28880-55-9,        products.
 68187-69-9, 68607-27-2,
 60687-90-3.
N-Methylpyrrolidone (CAS Reg.  ................  Solvent, cosolvent
 No. 872-504).
Mixed phytosterols             ................  Surfactant
 (consisting of campesterol,
 sitosterol and stigmasterol,
 with minor amounts of
 associated plant sterols)
 derived from edible
 vegetable oils.
Mono- and bis-(1H, 1H, 2H, 2H- Not more than     Surfactant, related
 perfluoroalkyl) phosphates     0.5% of           adjvants of
 where the alkyl group is       pesticide         surfactants
 even numbered and in the C6-   formulation.
 C12 range.                     Expires
                                February 9,
                                2008.
Mono- and dialkyl (C8-C18)     ................  Surfactants, related
 methylated ammonium chloride                     adjuvants of
 compounds, where the alkyl                       surfactants
 group(s) (C8-C18) are
 derived from coconut,
 cottonseed, soya, tallow, or
 hogfat fatty acids.
Morpholine 4-C6-12 Acyl        ................  As a solvent
 Derivatives (CAS Reg. No.
 887947-29-7).
Nicotinamide (CAS Reg. No. 98- Maximum of 0.5%   Synergist
 92-0).                         of formulation.
[alpha]-(p-Nonylphenyl)-       ................  Surfactant
 [omega]-
 hydroxypoly(oxyethylene);
 produced by the condensation
 of 1 mole of nonylphenol
 (nonyl group is a propylene
 trimer isomer) with an
 average of 4-14 or 30-100
 moles of ethylene oxide; if
 a blend of products is used,
 the average number of moles
 of ethylene oxide reacted to
 produce any product that is
 a component of the blend
 shall be in the range 4-14
 or 30-100.
Octanamide, N,N-dimethyl (CAS  ................  Emulsifier, solvent,
 Reg. No. 1118-92-9).                             cosolvent
[alpha]-Oleoyl-[omega]-        ................  Component of defoamers
 (oleoyloxy)
 poly(oxyethylene) derived
 from [alpha]-hydro-[omega]-
 hydroxypoly(oxyethylene)
 (molecular weight 600 amu).
Oxo-decyl acetate (CAS reg.    ................  Solvent
 No. 108419-33-6).
Oxo-heptyl acetate (CAS Reg.   ................  Solvent
 No. 90438-79-2).
Oxo-hexyl acetate (CAS Reg.    ................  Solvent
 No. 88230-35-7).
Oxo-nonyl acetate (CAS Reg.    ................  Solvent
 No. 108419-34-7).
Oxo-octyl acetate (CAS Reg.    ................  Solvent
 No. 108419-32-5).
Oxo-tridecyl acetate (CAS      ................  Solvent
 Reg. No. 108419-35-8).
Phenol.......................  ................  Solvent, cosolvent

[[Page 709]]

 
Phenol, 2-(2H-benzotriazole-2- Maximum           Ultraviolet (UV)
 yl)-6-dodecyl-4-methyl; (CAS   concentration     stabilizer
 Reg. No. 23328-53-2).          of 0.6% in
                                insecticide
                                formulations
                                applied to
                                adzuki beans,
                                canola,
                                chickpeas,
                                cotton, faba
                                beans, field
                                peas, lentils,
                                linola,
                                linseed,
                                lucerne,
                                lupins, mung
                                beans, navy
                                beans, pigeon
                                peas,
                                safflower,
                                sunflower, and
                                vetch.
Phenolsulfonic acid--          Applied to        Dispersant surfactant
 formaldehyde--urea             growing plants
 condensate and its sodium      only.
 salt.
(Phthalocyaninato (2))         When used as a    Coloring agent, pigment
 copper; (C.I. pigment blue     colorant in low-
 No. 15).                       density plastic
                                films.
Pigment red 48...............  For seed          Dye
                                treatment use
                                only.
[alpha]-Pinene...............  Not more than 2%  Stabilizer
                                of formulation
                                by weight.
Poly(oxy-1,2-ethanediyl),      At a maximum of   Surfactant
 [alpha]-isotridecyl-[omega]-   10% in
 methoxy (CAS Reg. No. 345642-  formulation.
 79-7).
Poly(oxyethylene) adducts of   ................  Surfactant, related
 mixed phytosterols (such                         adjuvants
 sterols to consist of
 campesterol, stigmasterol
 and sitosterol with minor
 amounts of associated plant
 sterols) derived from edible
 vegetable oils;
 polyoxyethylene content
 averaging 5-26 moles.
Polyoxyethylene                Limited to        Surfactants, related
 polyoxypropylene mono(di-sec-  herbicide         adjuvants of
 butylphenyl) ether (CAS Reg.   formulations      surfactants
 No. 69029-39-6).               only, and to no
                                more than 30%
                                by weight in
                                herbicide
                                formulations
                                intended for
                                application to
                                turf.
Poly(oxyethylene) (5)          ................  Surfactants, related
 sorbitan monooleate.                             adjuvants of
                                                  surfactants
Polysorbate 60, conforming to  ................  Surfactant
 21 CFR 172.836.
Potassium dihydrogen           ................  Buffering agent
 phosphate.
2-Propanamine, compound with   Not more than     Surfactant
 [alpha]-phosphono-[omega]-     15% in the
 butoxypoly (oxy-1,2-           formulated
 ethanediyl) (2:1) (CAS Reg.    product.
 No. 431040-31-2).
2-Propanamine, compounds with  Not more than     Surfactant
 polyethylene glycol            15% in the
 dihydrogen phosphate C8	 10-   formulated
 alkyl ether (2:1) (CAS Reg.    product.
 No. 431062-72-5).
Propylene glycol monomethyl    ................  Solvent
 ether.
Pyridoxine (CAS Reg. No. 65-   Maximum of 0.5%   Synergist
 23-6).                         of formulation.
Rosin, dark wood (as defined   ................  Surfactants, related
 in 21 CFR 178.3870(a)(1)(v)).                    adjuvants of
                                                  surfactants
Rosin, gum...................  ................   Do.
Rosin, tall oil..............  ................   Do.
Scandium chloride............  10 ppm in         Tagging agent
                                formulation.
Sodium bisulfate (CAS Reg.     ................  Acidifying/buffering
 No. 7681-38-1).                                  agent
Sodium 1,4-dicyclohexyl        ................  Surfactants, related
 sulfosuccinate.                                  adjuvants of
                                                  surfactants
Sodium 1,4-dihexyl             ................  Surfactants, related
 sulfosuccinate (CAS Reg. No.                     adjuvants of
 3006-15-3).                                      surfactants
Sodium dihydrogen phosphate    ................  Buffering agent
 (CAS Reg. No. 7558-80-7)
 conforming to 21 CFR
 182.6778.
Sodium 1,4-diisobutyl          ................  Surfactants, related
 sulfosuccinate (CAS Reg. No.                     adjuvants of
 127-39-9).                                       surfactants
Sodium 1,4-dipentyl            ................  Surfactants, related
 sulfosuccinate (CAS Reg. No.                     adjuvants of
 922-80-5).                                       surfactants
Sodium metaborate............  ................  Sequestrant
Sodium molybdate.............  ................  Plant nutrient
Sodium nitrate...............  ................  Solid diluent
Sodium nitrite...............  Not more than 3%  Stabilizer, inhibitor.
                                of pesticide
                                formulation.
Sodium o-phenylphenate.......  Not more than     Preservative for
                                0.1% of           formulation
                                pesticide
                                formulation.
Sodium salt of the insoluble   ................  Surfactants, related
 fraction of rosin.                               adjuvants of
                                                  surfactants
Sodium salts of N-alkyl (C8-   Concentration in  Surfactants, related
 C18)-beta-iminodipropionic     formulated end-   adjuvants of
 acid where the C8-C18 is       use products      surfactants
 linear and may be saturated    not to exceed
 and/or unsaturated (CAS Reg.   30% by weight
 Nos. 3655-00-3, 61791-56-8,    in pesticide
 14960-06-6, 26256-79-1,        formulations.
 90170-43-7, 91696-17-2,
 97862-48-1).

[[Page 710]]

 
Sodium tetraborate...........  Not more than 2%  Buffering agent;
                                of pesticide      corrosion inhibitor
                                formulation.
Tallowamine, ethoxylated,      Not to exceed     Surfactants, related
 mixture of dihydrogen          20% of            adjuvants of
 phosphate and monohydrogen     pesticide         surfactants
 phosphate esters and the       formulation.
 corresponding ammonium,
 calcium, potassium, and
 sodium salts of the
 phosphate esters, where the
 poly(oxyethylene) content
 averages 2-20 moles (CAS
 Reg. No. 68308-48-5).
Tannin.......................  ................  Dispersing agent
Tertiary butylhydroquinone...  ................  Antioxidant
1-Tetradecanamine, N,N-        ................  Component in water-
 dimethyl-, N-oxide (CAS Reg.                     soluble film
 No. 3332-27-2).
N,N,N',N''-Tetrakis-(2-        Concentration in  Stabilizer for
 hydroxypropyl)                 formulated end-   formulations
 ethylenediamine (CAS Reg.      use products
 No. 102-60-3).                 not to exceed
                                20% by weight
                                in pesticide
                                formulations.
2,4,7,9-Tetramethyl-5-decyne   In pesticide      Surfactants, related
 4,7-diol.                      formulations,     adjuvants of
                                for application   surfactants
                                to soil prior
                                to planting or
                                to plants
                                before edible
                                parts form.
Tetrapotassium pyrophosphate   Not to exceed     Sequestrant, anticaking
 (CAS Reg. No. 7320-345).       10% of            agent, conditioning
                                formulation.      agent
Titanium dioxide (CAS Reg.     ................  Pigment/coloring agent
 No. 13463-67-7).                                 in plastic bags used
                                                  to wrap growing banana
                                                  (preharvest), colorant
                                                  on seeds for planting
Toluenesulfonic acid and its   ................  Solvent, cosolvent
 ammonium, calcium,
 magnesium, potassium,
 sodium, and zinc salts.
Triethanolamine..............  ................  Stabilizer, inhibitor
                                                  for formulations used
                                                  before crop emerges
                                                  from soil
Triethanolamine (CAS Reg. No.  ................  Stabilizer, inhibitor
 102-71-6).
Triethylene glycol...........  ................  Deactivator
Triethyl phosphate...........  ................  Stabilizer for
                                                  formulations used
                                                  before crop emerges
                                                  from soil
Trimethylolpropane (CAS Reg.   Not to exceed     Component in water-
 No. 77-99-6).                  15% by weight     soluble film
                                of the film.
[alpha]-[2,4,6-Tris[1-         Not more than     Surfactant.
 (phenyl)ethyl]phenyl]-         15% of the
 [omega]-hydroxy                formulation.
 poly(oxyethylene), the
 poly(oxyethylene) content
 averages 4-150 moles).
[alpha]-[2,4,6-Tris[1-         Not more than      Do.
 (phenyl)ethyl]phenyl]-         15% of the
 [omega]-hydroxy                formulation.
 poly(oxyethylene); mixture
 of monohydrogen and
 dihydrogen phosphate esters
 and the corresponding
 ammonium, calcium,
 magnesium, potassium,
 sodium, and zinc salts, the
 poly(oxyethylene) content
 averages 4-150 moles).
[alpha]-[2,4,6-Tris[1-         Not more than      Do.
 (phenyl)ethyl]phenyl]-         15% of the
 [omega]-hydroxy                pesticide
 poly(oxyethylene) sulfate,     formulation.
 and the corresponding
 ammonium, calcium,
 magnesium, potassium,
 sodium, and zinc salts, the
 poly(oxyethylene) content
 averages 4-150 moles.
Tryptophan (CAS Reg. No. 73-   Maximum of 0.5%   Synergist
 22-3).                         of formulation.
Valeric acid, normal.........  Not more than 2%  Stenching agent or
                                in pesticide      odorant
                                formulations.
Xylene.......................  ................  Solvent, cosolvent
Xylenesulfonic acid its        ................  Surfactants, related
 ammonium calcium, magnesium,                     adjuvants of
 potassium, sodium, and zinc                      surfactants
 salts.
Yucca extract from Yucca       ................  Wetting agent
 schidigera.
Ytterbium chloride...........  10 ppm in         Tagging agent
                                formulation.
Yttrium chloride.............  10 ppm in         Tagging agent
                                formulation.
Zinc orthophosphate..........  ................  Plant nutrient and
                                                  safener
Zinc stearate, conforming to   ................  Flow control agent
 21 CFR 182.5994 and 582.5994.
------------------------------------------------------------------------


[69 FR 23124, Apr. 28, 2004]

    Editorial Note: For Federal Register citations affecting Sec. 
180.920, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.

[[Page 711]]



Sec. 180.930  Inert ingredients applied to animals; exemptions from the 

requirement of a tolerance.

    The following materials are exempted from the requirement of a 
tolerance when used in accordance with good agricultural practice as 
inert (or occasionally active) ingredients in pesticide formulations 
applied to animals:

------------------------------------------------------------------------
      Inert ingredients             Limits                 Uses
------------------------------------------------------------------------
Acetic acid (CAS Reg. No. 64-  Not more than     Catalyst
 19-7).                         0.5% of
                                pesticide
                                formulation.
Acetic anhydride.............  ................  Solvent, cosolvent,
                                                  stabilizer
Acetone (Cas Reg. No. 67-64-   ................  Solvent or cosolvent
 1).
Alkanoic and alkenoic acids,   ................  Emulsifiers
 mono- and diesters of
 [alpha]-hydro-[omega]-
 hydroxypoly(oxyethylene)
 with molecular weight (in
 amu) range of 200 to 6,000.
Alkyl (C8-C24)                 ................  Surfactants,
 benzenesulfonic acid and its                     emulsifier, related
 ammonium, calcium,                               adjuvants of
 magnesium, potassium,                            surfactants
 sodium, and zinc salts.
Alkyl (C12-C16) dimethyl       20% by weight in  Surfactant
 ammonio acetate (CAS Reg.      pesticide
 Nos. 683-10-3, 2601-33-4 and   formulation.
 693-33-4.
[alpha]-Alkyl(C6-C15)-[omega]- Not to exceed     Surfactants, related
 hydroxypoly(oxyethylene)sulf   30% of            adjuvants of
 ate, and its ammonium,         pesticide         surfactants
 calcium, magnesium,            formulation.
 potassium, sodium, and zinc
 salts, poly(oxyethylene)
 content averages 2-4 moles
 (CAS Reg. Nos. 3088-31-1,
 9004-82-4, 9004-84-6, 13150-
 00-0, 25446-78-0, 26183-44-
 8, 32612-48-9, 50602-06-7,
 62755-21-9, 68424-50-0,
 68511-39-7, 68585-34-2,
 68611-55-2, 68891-38-3,
 73665-22-2).
[alpha]-alkyl (C12-C15)-       Not to exceed     Surfactant
 [omega]-hydroxypoly            20% of
 (oxypropylene)poly             pesticide
 (oxyethylene)copolymers        formulations.
 (where the
 poly(oxypropylene) content
 is 3-60 moles and the
 poly(oxyethylene) content is
 5-80 moles), the resulting
 ethoxylated propoxylated
 (C12-C15) alcohols having a
 minimum molecular weight (in
 amu) of 1,500, CAS Reg. No.
 68551-13-3.
[alpha]-alkyl-[omega]-         ................  Surfactants, related
 hydroxypoly (oxypropylene)                       adjuvants of
 and/or poly (oxyethylene)                        surfactants
 polymers where the alkyl
 chain contains a minimum of
 six carbons (CAS Reg. Nos.
 9002-92-0, 9004-95-9, 9005-
 00-9, 26183-52-8, 34398-01-
 1, 52292-17-8, 66455-14-9,
 66455-15-0, 68002-97-1,
 68131-39-5, 68131-40-8,
 68154-96-1, 68213-23-0,
 68439-45-2, 68439-46-3,
 68526-94-3, 68439-50-9,
 68439-49-6, 68551-12-2,
 68951-67-7, 71243-46-4,
 97043-91-9, 9043-30-5, 60828-
 78-6, 61827-42-7, 24938-91-
 8, 68439-54-3, 69011-36-5,
 78330-20-8, 78330-21-9,
 106232-83-1, 127036-24-2,
 160875-66-1, 9004-98-2,
 68920-66-1, 61804-34-0,
 61791-28-4, 71060-57-6,
 26468-86-0, 31726-34-8,
 52609-19-5, 61791-20-6,
 68155-01-1, 69013-19-0,
 69364-63-2, 70879-83-3,
 78330-19-5, 97953-22-5,
 157627-86-6, 34398-05-5,
 72905-87-4, 84133-50-6,
 61702-78-1, 27306-79-2,
 169107-21-5, 61791-13-7,
 39587-22-9, 85422-93-1;
 68154-98-3, 61725-89-1,
 68002-96-0, 68154-97-2,
 68439-51-0, 68551-13-3,
 68603-25-8, 68937-66-6,
 68987-81-5, 69227-21-0,
 70750-27-5, 103818-93-5,
 166736-08-9, 120313-48-6,
 68213-24-1, 68458-88-8,
 68551-14-4, 69013-18-9,
 69227-22-1, 72854-13-8,
 73049-34-0, 78330-23-1,
 37311-02-7, 64366-70-7,
 37251-67-5, 9087-53-0,
 196823-11-7, 57679-21-7,
 111905-54-5, 61827-84-7,
 172588-43-1).

[[Page 712]]

 
[alpha]-alkyl (minimum C6      Not to exceed     Surfactants, related
 linear or branched,            30% of            adjuvants of
 saturated and or               pesticide         surfactants
 unsaturated)-[omega]-          formulation.
 hydroxypolyoxyethylene
 polymer with or without
 polyoxypropylene, mixture of
 di- and monohydrogen
 phosphate esters and the
 corresponding ammonium,
 calcium, magnesium,
 monoethanolamine, potassium,
 sodium and zinc salts of the
 phosphate esters; minimum
 oxyethylene content averages
 2 moles; minimum
 oxypropylene content is 0
 moles (CAS Reg. Nos. 9046-01-
 9, 39464-66-9, 50643-20-4,
 52019-36-0, 68071-35-2,
 68458-48-0, 68585-36-4,
 68815-11-2, 68908-64-5,
 68511-37-5, 68130-47-2,
 42612-52-2, 58318-92-6,
 60267-55-2, 68070-99-5,
 68186-36-7, 68186-37-8,
 68610-65-1, 68071-17-0,
 936100-29-7, 936100-30-0,
 73038-25-2, 78330-24-2,
 154518-39-5, 317833-96-8,
 108818-88-8, 873662-29-4,
 61837-79-4, 68311-02-4,
 68425-73-0, 37280-82-3,
 68649-29-6, 67711-84-6,
 68891-13-4.
N-alkyl (C8-C18) primary       Concentration in  Surfactants, related
 amines and their acetate       formulated end-   adjuvants of
 salts where the alkyl group    use products      surfactants
 is linear and may be           not to exceed
 saturated and/or unsaturated   10% by weight
 (CAS Reg. Nos. 61790-57-6,     in herbicide
 61790-58-7, 61790-59-8,        products, 4% by
 61790-60-1, 61788-46-3,        weight in
 61790-33-8, 68155-38-4).       insecticide
                                products, and
                                4% by weight in
                                fungicide
                                products.
Alkyl (C8-C18) sulfate and     ................  Surfactant
 its ammonium, calcium,
 magnesium, potassium,
 sodium, and zinc salts.
N,N-Bis-[alpha]-ethyl-[omega]- Not to exceed     Surfactants, related
 hydroxypoly(oxy-1,2-           25% in            adjuvants of
 ethanediyl) C8-C18 saturated   herbicide         surfactants
 and unsaturated alkylamines;   formulations
 the poly(oxy-1,2-ethanediyl)   and 10% in
 content is 2-60 moles (CAS     insecticide and
 Reg. Nos. 10213-78-2, 25307-   fungicide
 17-9, 26635-92-7, 26635-93-    formulations.
 8, 288259-52-9, 58253-49-9,
 61790-82-7, 61791-14-8,
 61791-24-0, 61791-26-2,
 61791-31-9, 61791-44-4,
 68155-33-9, 68155-39-5,
 68155-40-8,70955-14-5, 73246-
 96-5, 1266162-49-5).
N,N-Bis-[alpha]-ethyl-[omega]- Not to exceed     Surfactants, related
 hydroxypoly(oxy-1,2-           25% in            adjuvants of
 ethanediyl/oxy(methyl-1,2-     herbicide         surfactants
 ethanediyl) C8-C18 saturated   formulations
 and unsaturated alkylamines;   and 10% in
 the poly(oxy-1,2-ethanediyl/   insecticide and
 oxy(methyl-1,2-ethanediyl)     fungicide
 content is 2-60 moles (CAS     formulations.
 Reg. Nos. 68213-26-3, 68153-
 97-9, 75601-76-2).
Ascorbyl palmitate...........  ................  Preservative
Attapulgite-type clay........  ................  Solid diluent, carrier
Barium sulfate (CAS Reg. No.   ................  Carrier, density
 7727-43-7).                                      control agent
Benzoic acid.................  ................  Preservative for
                                                  formulations
2-Bromo-2-nitro-1,3-           0.04% or less by  In-can preservative
 propanediol (CAS Reg. No. 52-  weight of the
 51-7).                         total pesticide
                                formulation.
Butane.......................  ................  Propellant
n-Butanol (CAS Reg. No. 71-36- ................  Solvent for blended
 3).                                              emulsifiers
Butylated hydroxyanisole.....  ................  Antioxidant
Butylated hydroxytoluene.....  ................   Do.
Calcium carbonate............  ................  Solid diluent, carrier
Calcium chloride.............  ................  Stabilizer
Calcium silicate, hydrated     ................  Anticaking agent, solid
 calcium silicate.                                diluent, carrier
Calcium stearate (CAS Reg.     ................  Stabilizer, component
 No. 1592-23-0).                                  of plastic animal tag
Calcium sulfate..............  ................  Solid diluent, carrier
Carbon black (CAS Reg. No.     ................  Colorant/pigment in
 1333-86-4).                                      animal tag
Carbon Dioxide (CAS Reg. No.   None............  Propellant
 124-38-9).
Carrageenan, conforming to 21  Minimum           Thickener
 CFR 172.620.                   molecular
                                weight (in
                                amu): 100,000.
Cyclohexanone................  ................  Solvent, cosolvent
D&C Green No. 6..............  ................  Dye, coloring agent
D&C Red No. 17...............  ................   Do.
D&C Violet No. 2.............  ................   Do.

[[Page 713]]

 
Dialkyl (C8-C18)               Not more than     Flocculating agent in
 dimethylammonium chloride.     0.2% in silica    the manufacture of
                                hydrated silica.  silica hydrated silica
                                                  for use as a solid
                                                  diluent, carrier
Diatomite (diatomaceous        ................  Solid diluent, carrier
 earth).
Diethanolamine salts of alkyl  Not to exceed 7%  Surfactants, related
 (C8-C24) benzenesulfonic       of pesticide      adjuvants of
 acid (CAS Reg. Nos. 26545-53-  formulation.      surfactants
 9 and 68953-97-9).
Diethylaminoethanol,           ................  Surfactant
 ethoxylated, propoxylated,
 reaction products with fatty
 acid dimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173188-75-4).
Diethylaminoethanol,           ................  Surfactant
 ethoxylated, propoxylated,
 reaction products with fatty
 acid trimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173188-83-4).
Diethylaminoethanol,           ................  Surfactant
 ethoxylated, reaction
 products with acid trimers,
 minimum number average
 molecular weight (in amu),
 1,200 (CAS Reg. No. 1173188-
 81-2).
Diethylaminoethanol,           ................  Surfactant
 ethoxylated, reaction
 product with fatty acid
 dimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173188-72-1).
Diethylphthalate.............  ................  Solvent, cosolvent
1,1-Difluoroethane (CAS Reg.   For aerosol       Aerosol propellant
 No. 75-37-6).                  pesticide
                                formulations
                                used for insect
                                control in food-
                                 and feed-
                                handling
                                establishments
                                and animals.
Dimethyl ether (CAS Reg. No.   ................  Propellant
 115-10-6).
Dimethylaminoethanol,          ................  Surfactant
 ethoxylated, propoxylated,
 reaction products with fatty
 acid dimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173188-42-5).
Dimethylaminoethanol,          ................  Surfactant
 ethoxylated, propoxylated
 reaction products with fatty
 acid trimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173188-67-4).
Dimethylaminoethanol,          ................  Surfactant
 ethoxylated, reaction
 products with fatty acid
 trimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173188-38-9).
Dimethylaminoethanol,          ................  Surfactant
 ethoxylated, reaction
 products with fatty acid
 trimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173188-49-2).
Dimethylaminopropylamine,      ................  Surfactants, related
 isopropylamine,                                  adjuvants of
 ethanolamine, and                                surfactants
 triethanolamine salts of
 alkyl (C8-C24)
 benzenesulfonic acid (CAS
 Reg. Nos. 26264-05-1, 27323-
 41-7, 55470-69-4, 68411-31-
 4, 68584-24-7, 68584-25-8,
 68648-81-7, 68648-96-4,
 68649-00-3, 68910-32-7,
 68953-93-5, 90194-42-6,
 90194-53-9, 90218-35-2,
 157966-96-6, 319926-68-6,
 877677-48-0, 1093628-27-3).
3,6-Dimethyl-4-octyne-3,6-     Not more than     Surfactants, related
 diol.                          2.5% of           adjuvants of
                                pesticide         surfactants
                                formulation.
Dimethylpolysiloxane (CAS      ................  Defoaming agent
 Reg. No. 9016-00-6).
Dipropylene glycol monomethyl  ................  Surfactants, related
 ether.                                           adjuvants of
                                                  surfactants
Epoxidized soybean oil (CAS    ................  Stabilizer,
 Reg. No. 8013-07-8).                             plasticizer, component
                                                  animal tag
Ethyl alcohol................  ................  Solvent, cosolvent
Ethyl maltol (CAS Reg.         Not more than     Odor masking agent
 No.4940-11-8).                 0.2 % of the
                                pesticide
                                formulation.
Ethylene oxide adducts of      ................  Surfactants, related
 2,4,7,9-tetramethyl-5-                           adjuvants of
 decynediol, the ethylene                         surfactants
 oxide content averages 3.5,
 10 or 30 moles (CAS Reg. No.
 9014-85-1).
2-Ethyl-1-hexanol (CAS Reg.    Not more than     Solvent, adjuvant of
 No. 104-76-7).                 10% of            surfactants
                                pesticide.
FD&C Blue No. 1..............  ................  Dye, coloring agent

[[Page 714]]

 
FD&C Yellow No. 6 Aluminum     Not more than 2%  Pigment in animal tag
 Lake (CAS Reg. No. 15790-07-   by weight of      and similar slow-
 5).                            pesticide         release devices
                                formulation.
D-glucopyranose, oligomeric,   ................  Surfactant
 C10	16-alkyl glycosides (CAS
 Reg. No. 110615-47-9).
Glycerol monooleate..........  ................  Surfactants, related
                                                  adjuvants of
                                                  surfactants
Glyceryl monostearate........  ................  Emulsifier
Glyceryl tris-12-              ................  Flow control agent
 hydroxystearate.
Graphite.....................  ................  Solid diluent, carrier
n-Hexyl alcohol (CAS Reg. No.  ................  Solvent, cosolvent
 111-27-3).
Hydroxyethylmorpholine,        ................  Surfactant
 ethoxylated, propoxylated,
 reaction products with fatty
 acid dimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173189-06-4).
Hydroxyethylmorpholine,        ................  Surfactant
 ethoxylated, propoxylated,
 reaction products with fatty
 acid trimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173188-67-4).
Hydroxyethylmorpholine,        ................  Surfactant
 ethoxylated, reaction
 products with fatty acid
 dimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173189-00-8).
Hydroxyethylmorpholine,        ................  Surfactant
 ethoxylated, reaction
 products with fatty acid
 trimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173189-09-7).
Hydroxyethylpiperidine,        ................  Surfactant
 ethoxylated, propoxylated,
 reaction products with fatty
 acid dimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173189-22-4).
Hydroxyethylpiperidine,        ................  Surfactant
 ethoxylated, propoxylated,
 reaction products with fatty
 acid trimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173189-28-0).
Hydroxyethylpiperidine,        ................  Surfactant
 ethoxylated, reaction
 products with fatty acid
 dimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173189-20-2).
Hydroxyethylpiperidine,        ................  Surfactant
 ethoxylated, reaction
 products with fatty acid
 trimers, minimum number
 average molecular weight (in
 amu), 1,200 (CAS Reg. No.
 1173189-25-7).
2-(2[min]-Hydroxy-5[min]-      Not more than     Ultraviolet light
 methylphenyl)benzotriazole     0.5% by weight    absorber/stabilizer in
 (CAS Reg. No. 2440-22-4).      of pesticide      animal tag and similar
                                formulation.      slow-release devices
Iron oxide (CAS Reg. No. 1309- ................  Colorant in pesticide
 37-1).                                           formulations for
                                                  animal tags
Isobutane (CAS Reg. No. 75-28- None............  Propellant
 5).
Isopropyl myristate, CAS Reg.  ................  Solvent
 No. 110-27-0.
Kaolinite-type clay..........  ................  Solid diluent, carrier
Kerosene, U.S.P. reagent.....  ................  Solvent, cosolvent
Lactic acid..................  ................  Solvent
Lactic acid, 2-ethylhexyl      ................  Solvent
 ester (CAS Reg. No. 6283-86-
 9).
Lactic acid, 2-ethylhexyl      ................  Solvent
 ester, (2S)- (CAS Reg. No.
 186817-80-1).
Lactic acid, n-propyl ester,   ................  Solvent
 (S); (CAS Reg. No. 53651-69-
 7).
Lignin (CAS Reg. No. 9005-53-  ................  Surfactant, related
 2).                                              adjuvants of
                                                  surfactants
Lignin, alkali (CAS Reg. No.   ................   Do.
 8068-05-1).
Lignin, alkali, oxidized,      ................   Do.
 sodium salt (CAS Reg. No.
 68201-23-0).
Lignin alkali reaction         ................   Do.
 products with disodium
 sulfite and formaldehyde
 (CAS Reg. No. 105859-97-0).
Lignin alkali reaction         ................   Do.
 products with formaldehyde
 and sodium bisulfite (CAS
 Reg. No. 68512-35-6).
Lignosulfonic acid (CAS Reg.   ................   Do.
 No. 8062-15-5).

[[Page 715]]

 
Lignosulfonic acid, ammonium   ................   Do.
 calcium salt (CAS Reg. No.
 12710-04-2).
Lignosulfonic acid, ammonium   ................   Do.
 magnesium salt (CAS Reg. No.
 123175-37-1).
Lignosulfonic acid, ammonium   ................   Do.
 salt (CAS Reg. No. 8061-53-
 8).
Lignosulfonic acid, ammonium   ................   Do.
 sodium salt (CAS Reg. No.
 166798-73-8).
Lignosulfonic acid, calcium    ................   Do.
 magnesium salt (CAS Reg. No.
 55598-86-2).
Lignosulfonic acid, calcium    ................   Do.
 salt (CAS Reg. No. 8061-52-
 7).
Lignosulfonic acid, calcium    ................   Do.
 sodium salt (CAS Reg. No.
 37325-33-0).
Lignosulfonic acid,            ................   Do.
 ethoxylated, sodium salt
 (CAS Reg. No. 68611-14-3).
Lignosulfonic acid, magnesium  ................   Do.
 salt (CAS Reg. No. 8061-54-
 9).
Lignosulfonic acid, potassium  ................   Do.
 salt (CAS Reg. No. 37314-65-
 1).
Lignosulfonic acid, sodium     ................   Do.
 salt (CAS Reg. No. 8061-51-
 6).
Lignosulfonic acid, sodium     ................   Do.
 salt, oxidized (CAS Reg. No.
 68855-41-4).
Lignosulfonic acid, sodium     ................   Do.
 salt, polymer with
 formaldehyde and phenol (CAS
 Reg. No. 37207-89-9).
Lignosulfonic acid, sodium     ................   Do.
 salt, sulfomethylated (CAS
 Reg. No. 68512-34-5).
Lignosulfonic acid, zinc salt  ................   Do.
 (CAS Reg. No. 57866-49-6).
d-Limonene (CAS Reg. No. 5989- ................  Solvent, fragrance
 27-5).
Magnesium carbonate..........  ................  Solid diluent, carrier
Magnesium silicate, hydrated   ................   Do.
 magnesium silicate.
Methyl alcohol...............  ................  Solvent, cosolvent
Methyl n-amyl ketone (CAS      ................  Solvent, cosolvent
 Reg. No. 110-43-0).
Methyl esters of higher fatty  ................  Antidusting agent
 acids conforming to 21 CFR
 573.640.
Methyl-p-hydroxybenzoate       Meets             Preservative
 (Methyl paraben).              specifications
                                of Food
                                Chemicals
                                Codex; not to
                                exceed 0.1% in
                                formulations.
Methyl isobutyl ketone.......  ................  Solvent, cosolvent
2-methyl-2,4-pentanediol (CAS  Without           Growing crops and food
 Reg. No.-107-41-5).            limitation.       animals
2-methyl-1,3-propanediol (CAS  ................  Solvent, surfactant
 Reg. No. 2163-42-0).
Mineral oil, U.S.P., or        ................  Solvent, diluent
 conforming to 21 CFR 172.878
 or 178.3620(a), (b).
Montmorillonite-type clay....  ................  Solid diluent, carrier
Nonyl, decyl, and undecyl      ................  Surfactant
 glycoside mixture with a
 mixture of nonyl, decyl, and
 undecyl oligosaccharides and
 related reaction products
 (primarily decanol and
 undecanol) produced as an
 aqueous-based liquid (50 to
 65% solids) from the
 reaction of primary alcohols
 (containing 15 to 20%
 secondary alcohol isomers)
 in a ratio of 20% C9, 40%
 C10, and 40% C11 with
 carbohydrates (average
 glucose to alkyl chain ratio
 1.3 to 1.8).

[[Page 716]]

 
[alpha]-(p-Nonylphenol)-       Not to exceed 7%  Surfactants, related
 [omega]-                       of pesticide      adjuvants of
 hydroxypoly(oxyethylene)       formulation.      surfactants
 mixture of dihydrogen
 phosphate and monohydrogen
 phosphate esters and the
 corresponding ammonium,
 calcium, magnesium,
 potassium, sodium, and zinc
 salts of the phosphate
 esters; the nonyl group is a
 propylene trimer isomer and
 the poly(oxyethylene)
 content averages 4-14 or 30
 moles (CAS Reg. Nos. 51811-
 79-1, 59139-23-0, 67922-57-
 0, 68412-53-3, 68553-97-9,
 68954-84-7, 99821-14-4,
 152143-22-1, 51609-41-7,
 37340-60-6, 106151-63-7,
 68584-47-4, 52503-15-8,
 68458-49-1).
[alpha]-(p-Nonylphenol)-       Not to exceed 7%  Surfactants, related
 [omega]-                       of pesticide      adjuvants of
 hydroxypoly(oxyethylene)       formulation.      surfactants
 sulfate, ammonium, calcium,
 magnesium, potassium,
 sodium, and zinc salts the
 nonyl group is propylene
 trimer isomer and the
 poly(oxyethylene) content
 averages 4 moles (CAS Reg.
 Nos. 9014-90-8, 9051-57-4,
 9081-17-8, 68649-55-8, 68891-
 33-8.
[alpha]-(p-Nonylphenyl)-       ................  Surfactants,
 [omega]-                                         emulsifier, related
 hydroxypoly(oxyethylene)                         adjuvants of
 produced by the condensation                     surfactants.
 of 1 mole of nonylphenol
 (nonyl group is a propylene
 trimer isomer) with an
 average of 4-15 or 30-90
 moles of ethylene oxide; if
 a blend of products is used,
 the average number of moles
 of ethylene oxide reacted to
 produce any product that is
 a component of the blend
 shall be in the range of 4-
 15 or 30-90 moles.
Octadecyl 3,5-di-tert-butyl-4- Not more than     Thermal stabilizer/
 hydroxyhydro cinnamate (CAS    0.5% by weight    antioxidant in animal
 Reg. No. 2082-79-3).           of pesticide      tag and similar slow-
                                formulation.      release devices
1-Octanal (CAS Reg. No. 124-   Not more than     Odor masking agent
 13-0).                         0.2% of the
                                pesticide
                                formulation.
Octyl and decyl glucosides     ................  Thermal stabilizer/
 mixture with a mixture of                        antioxidant in animal
 octyl and decyl                                  tag and similar slow-
 oligosaccharides and related                     release devices
 reaction products (primarily
 n-decanol) produced as an
 aqueous-based liquid (68-72%
 solids) from the reaction of
 straight chain alcohols
 (C8(45%), C10) with
 anhydrous glucose.
Octyl epoxytallate (CAS Reg.   ................  Plasticizer, component
 No. 61788-72-5).                                 animal tag
Oleic acid, conforming to 21   ................  Defoaming agent
 CFR 172.862 (CAS Reg. No.
 112-80-1).
[alpha]-Oleoyl-[omega]-        ................  Emulsifier
 hydroxypoly(oxyethylene),
 average molecular weight (in
 amu) of 600.
[alpha]-Oleoyl-[omega]-        ................  Emulsifier, defoaming
 (oleyloxy)poly(oxyethylene)                      agent
 derived from [alpha]-hydro-
 [omega]-
 hydroxypoly(oxyethylene),
 molecular weight (in amu)
 600.
Petroleum hydrocarbons,        ................  Solvent, diluent
 light, odorless, conforming
 to 21 CFR 172.884 or
 178.3650.
Petroleum hydrocarbons,        ................   Do.
 synthetic isoparaffinic,
 conforming to 21 CFR 172.882
 or 178.3530.
Phenol.......................  ................  Solvent, cosolvent
[alpha]-Pinene...............  Not more than 2%  Stabilizer
                                of formulation
                                by weight.
Polyethylene (CAS Reg. No.     ................  Component of plastic
 9002-88-4) conforming to 21                      slow release tag
 CFR 172.615.
Polyethylene glycol [[alpha]-  ................  Surfactants, related
 hydro-[omega]-                                   adjuvants of
 hydroxypoly(oxyethylene)];                       surfactants
 mean molecular weight (in
 amu) 194 to 9,500 conforms
 to 21 CFR 178.3750.
Potassium benzoate (Cas No.    None............  Preservative
 582-25-2).
Potassium hydroxide..........  Meeting Food      Neutralizer
                                Chemicals,
                                Codex
                                specifications.
Propane......................  ................  Propellant
1,2,3-Propanetriol,            ................  Emulsifier
 homopolymer
 diisooctadecanoate (CAS Reg.
 No. 63705-03-3).
n-Propanol...................  ................  Solvent, for blended
                                                  emulsifiers

[[Page 717]]

 
2-Propenoic acid, 2-methyl-,   ................  Encapsulating
 polymer with ethyl 2-                            agent,dispensers,
 propenoate and methyl 2-                         resins, fibers and
 methyl-2-propenoate,                             beads
 ammonium salt (CAS
 Registration No. 55989-05-
 4), minimum number average
 molecular weight (in amu),
 18,900..
Propylene glycol.............  ................  Solvent, cosolvent
Propylene glycol monomethyl    ................  Deactivator, emmolient
 ether.
Propyl gallate...............  ................  Antioxidant
Propyl p-hydroxybenzoate       Meets             Preservative
 (Propyl paraben).              specifications
                                of Food
                                Chemicals
                                Codex; not to
                                exceed 0.1% in
                                formulations.
Pyrophylite..................  ................  Solid diluent, carrier
Silica, hydrated silica......  ................  Anticaking agent, solid
                                                  diluent, carrier
Silica aerogel (finely         ................  Component of
 powdered microcellular                           antifoaming agent
 silica foam having a minimum
 silica content of 89.5%).
Soapstone....................  ................  Solid diluent
Sodium alkyl                   Limited to no     Surfactants, related
 naphthalenesulfonates (CAS     more than 30%     adjuvants of
 Reg. Nos. 68909-83-1, 68909-   by weight in      surfactants
 84-2, 68909-82-0, 27213-90-    pesticide end-
 7, 26264-58-4, 27178-87-6,     use products.
 111163-74-7, 908356-16-1,
 25417-20-3, 25638-17-9,
 145578-88-7, 1322-93-6, 1323-
 19-9, 7403-47-6, 68442-09-1,
 127646-44-0, 908356-18-3).
Sodium 1,4-dihexyl             ................  Surfactants, related
 sulfosuccinate (CAS Reg. No.                     adjuvants of
 3006-15-3).                                      surfactants
Sodium 1,4-diisobutyl          ................  Surfactants, related
 sulfosuccinate (CAS Reg. No.                     adjuvants of
 127-39-9).                                       surfactants
Sodium dioctylsulfosuccinate.  ................  Surfactants, related
                                                  adjuvants of
                                                  surfactants
Sodium 1,4-dipentyl            ................  Surfactants, related
 sulfosuccinate (CAS Reg. No.                     adjuvants of
 922-80-5).                                       surfactants
Sodium hydroxide.............  ................  Neutralizer
Sodium monoalkyl and dialkyl   Not to exceed     Surfactants, related
 (C6-C16) phenoxy               20% in            adjuvants of
 benzenedisulfonates and        pesticide         surfactants
 related acids (CAS Reg. Nos.   formulations.
 147732-59-0, 147732-60-3,
 169662-22-0, 70191-75-2,
 36445-71-3, 39354-74-0,
 70146-13-3, 119345-03-8,
 149119-20-0, 149119-19-7,
 119345-04-9, 28519-02-0,
 25167-32-2, 30260-73-2,
 65143-89-7, 70191-76-3).
Sodium N-oleoyl-N-methyl       ................  Surfactants, related
 taurine (CAS Reg. No. 137-20-                    adjuvants of
 2).                                              surfactants
Sodium and potassium salts of  Concentration in  Surfactants, related
 N-alkyl (C8-C18)-beta-         formulated end-   adjuvants of
 iminodipropionic acid where    use products      surfactants
 the C8-C18 is linear and may   not to exceed
 be saturated and/or            30% by weight
 unsaturated (CAS Reg. Nos.     in pesticide
 110676-19-2, 3655-00-3,        formulations.
 61791-56-8, 14960-06-6,
 26256-79-1, 90170-43-7,
 91696-17-2, 97862-48-1).
Sodium starch glycolate (CAS   Granular and      Disintegrant
 Reg. No. 9063-38-1).           tableted
                                products only;
                                not to exceed
                                8% of the
                                formulated
                                product.
Sodium sulfate...............  ................  Solid diluent, carrier
Sorbitan fatty acid esters     ................  Buffering agent;
 (fatty acids limited to C12,                     corrosion inhibition
 C14, C16, and C18 containing
 minor amounts of associated
 fatty acids) and
 poly(oxyethylene)
 derivatives of sorbitan
 fatty acid esters; the
 poly(oxyethylene) content
 averages 16-20 moles.
Sorbitol.....................  ................  Antidusting agent.
Stearic acid (CAS Reg. No. 57- ................  Lubricant, component
 11-4).                                           animal tag
[alpha]-Stearoyl-[omega]-      ................  Emulsifier
 hydroxypoly(oxyethylene),
 average molecular weight (in
 amu) of 600.
[alpha]-Stearoyl-[omega]-      ................  Surfactants; related
 hydroxypoly(oxyethylene);                        adjuvants of
 the poly(oxyethylene)                            surfactants
 content averages 8, 9, or 40
 moles; if a blend of
 products is used, the
 average number of moles of
 ethylene oxide reacted to
 produce any product that is
 a component of the blend
 shall be 8, 9, or 40.
Sulfite liquors and cooking    ................  Surfactant, related
 liquors, spent, oxidized                         adjuvants of
 (CAS Reg. No. 68514-09-0).                       surfactants
Sulfur (CAS Reg. No. 7704-34-  ................  Stabilizer
 9).
Talc.........................  ................   Do.

[[Page 718]]

 
Tall oil; fatty acids not      ................  Surfactants, related
 less than 58%, rosin acids                       adjuvants of
 not more than 44%,                               surfactants
 unsaponifiables not more
 than 8%.
Tartrazine...................  ................  Dye, coloring agent
N,N,N[min],N[sec],-tetrakis-   Concentration in  Stabilizer for
 (2-hydroxypropyl)              formulated end-   formulation.
 ethylenediamine (CAS Reg.      use products
 No. 102-60-3).                 not to exceed
                                20% by weight
                                in pesticide
                                formulations.
2,4,7,9-Tetramethyl-5-decyne-  Not more than     Surfactants, related
 4.7-diol.                      2.5% of           adjuvants of
                                pesticide         surfactants
                                formulation.
Titanium dioxide (CAS Reg.     ................  Pigment/colorant in
 No. 13463-67-7).                                 pesticide formulations
                                                  for animal tag
Toluenesulfonic acid and its   ................   Do.
 ammonium, calcium,
 magnesium, potassium,
 sodium, and zinc salts.
Triacetin (glyceryl            ................  Solvent, cosolvent
 triacetate).
Trisodium phosphate..........  ................  Precipitant, buffer,
                                                  filler
Xylene.......................  ................  Solvent, cosolvent
Xylenesulfonic acid and its    ................  Surfactants, related
 ammonium, calcium,                               adjuvants of
 magnesium, potassium,                            surfactants
 sodium, and zinc salts.
Zinc oxide...................  ................  Solid diluent, carrier
Zinc stearate, conforming to   ................  Water repellant,
 21 CFR 182.5994 and 582.5994.                    dessicant, and coating
                                                  agent.
Zinc stearate (CAS Reg. No.    ................  Water repellant,
 557-05-1).                                       desiccant, and coating
                                                  agent; stabilizer,
                                                  component of plastic
                                                  animal tag
Zinc sulfate (basic and        ................  Water repellant,
 monohydrate).                                    dessicant, and coating
                                                  agent
------------------------------------------------------------------------


[69 FR 23130, Apr. 28, 2004]

    Editorial Note: For Federal Register citations affecting Sec. 
180.930, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.940  Tolerance exemptions for active and inert ingredients for use in 

antimicrobial formulations (Food-contact surface sanitizing solutions).

    Residues of the following chemical substances are exempted from the 
requirement of a tolerance when used in accordance with good 
manufacturing practice as ingredients in an antimicrobial pesticide 
formulation, provided that the substance is applied on a semi-permanent 
or permanent food-contact surface (other than being applied on food 
packaging) with adequate draining before contact with food.
    (a) The following chemical substances when used as ingredients in an 
antimicrobial pesticide formulation may be applied to: Food-contact 
surfaces in public eating places, dairy-processing equipment, and food-
processing equipment and utensils.

------------------------------------------------------------------------
      Pesticide Chemical         CAS Reg. No.             Limits
------------------------------------------------------------------------
Acetic acid                    64-19-7           When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 290
                                                  ppm

[[Page 719]]

 
[alpha]-alkyl-[omega]-         9002-92-0, 9004-  None
 hydroxypoly (oxypropylene)     95-9, 9005-00-
 and/or poly (oxyethylene)      9, 26183-52-8,
 polymers where the alkyl       34398-01-1,
 chain contains a minimum of    52292-17-8,
 six carbons                    66455-14-9,
                                66455-15-0,
                                68002-97-1,
                                68131-39-5,
                                68131-40-8,
                                68154-96-1,
                                68213-23-0,
                                68439-45-2,
                                68439-46-3,
                                68526-94-3,
                                68439-50-9,
                                68439-49-6,
                                68551-12-2,
                                68951-67-7,
                                71243-46-4,
                                97043-91-9,
                                9043-30-5,
                                60828-78-6,
                                61827-42-7,
                                24938-91-8,
                                68439-54-3,
                                69011-36-5,
                                78330-20-8,
                                78330-21-9,
                                106232-83-1,
                                127036-24-2,
                                160875-66-1,
                                9004-98-2,
                                68920-66-1,
                                61804-34-0,
                                61791-28-4,
                                71060-57-6,
                                26468-86-0,
                                31726-34-8,
                                52609-19-5,
                                61791-20-6,
                                68155-01-1,
                                69013-19-0,
                                69364-63-2,
                                70879-83-3,
                                78330-19-5,
                                97953-22-5,
                                157627-86-6,
                                34398-05-5,
                                72905-87-4,
                                84133-50-6,
                                61702-78-1,
                                27306-79-2,
                                169107-21-5,
                                61791-13-7,
                                39587-22-9,
                                85422-93-1;
                                68154-98-3,
                                61725-89-1,
                                68002-96-0,
                                68154-97-2,
                                68439-51-0,
                                68551-13-3,
                                68603-25-8,
                                68937-66-6,
                                68987-81-5,
                                69227-21-0,
                                70750-27-5,
                                103818-93-5,
                                166736-08-9,
                                120313-48-6,
                                68213-24-1,
                                68458-88-8,
                                68551-14-4,
                                69013-18-9,
                                69227-22-1,
                                72854-13-8,
                                73049-34-0,
                                78330-23-1,
                                37311-02-7,
                                64366-70-7,
                                37251-67-5,
                                9087-53-0,
                                196823-11-7,
                                57679-21-7,
                                111905-54-5,
                                61827-84-7,
                                172588-43-1)
Ammonium chloride              12125-02-9        When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 48
                                                  ppm
Amylopectin, acid-hydrolyzed,  113894-85-2       None
 1-oxtenylbutanedioate
Amylopectin, hydrogen 1-       125109-81-1       None
 octadecenylbutanedioate
Ethanol                        64-17-5           None
Ethylenediaminetetraacetic     64-02-8           None
 acid (EDTA), tetrasodium
 salt
Hydrogen peroxide              7722-84-1         When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 91
                                                  ppm
Hypochlorous acid, sodium      7681-52-9         When ready for use, the
 salt                                             end-use concentration
                                                  of all hypochlorous
                                                  acid chemicals in the
                                                  solution is not to
                                                  exceed 200 ppm
                                                  determined as total
                                                  available chlorine
Iodine                         7553-56-2         When ready for use, the
                                                  total end-use
                                                  concentration of all
                                                  iodide-producing
                                                  chemicals in the
                                                  solution is not to
                                                  exceed 25 ppm of
                                                  titratable iodine

[[Page 720]]

 
Lipase, triacylglycerol        9001-62-1         When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 500
                                                  ppm
Magnesium oxide                1309-48-4         None
Methylene blue                 61-73-4           When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 0.4
                                                  ppm
2-Methyl-1,3-propanediol       2163-42-0         None
Nitric acid                    7697-37-2         When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 1,000
                                                  ppm
[alpha]-(p-Nonylphenyl)-       None              None
 [omega]-hydroxypoly
 (oxyethylene) average
 poly(oxyethylene) content 11
 moles)
Octadecanoic acid, calcium     1592-23-0         None
 salt
1-Octanesulfonic acid, sodium  5324-84-5         When ready for use, the
 salt                                             end-use concentration
                                                  is not to exceed 46
                                                  ppm
Octanoic acid                  124-07-2          When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 52
                                                  ppm
Oxirane, methyl-, polymer      9003-11-6         None
 with oxirane, minimum
 molecular weight (in amu),
 1900
Peroxyacetic acid              79-21-0           When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 58
                                                  ppm
Peroxyoctanoic acid            33734-57-5        When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 52
                                                  ppm
Phosphonic acid, (1-           2809-21-4         When ready for use, the
 hydroxyethylidene)bis-                           end-use concentration
                                                  is not to exceed 14
                                                  ppm
Phosphoric acid, trisodium     7601-54-9         When ready for use, the
 salt                                             end-use concentration
                                                  is not to exceed 5916
                                                  ppm
Potassium bromide              7758-02-3         When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 46
                                                  ppm total available
                                                  halogen
Potassium iodide               7681-11-0         When ready for use, the
                                                  total end-use
                                                  concentration of all
                                                  iodide-producing
                                                  chemicals in the
                                                  solution is not to
                                                  exceed 25 ppm of
                                                  titratable iodine
1,3-Propanediol                504-63-2          None
Quaternary ammonium            8001-54-5         When ready for use, the
 compounds, alkyl (C12-C18)                       end-use concentration
 benzyldimethyl, chlorides                        of all quaternary
                                                  chemicals in the
                                                  solution is not to
                                                  exceed 200 ppm of
                                                  active quaternary
                                                  compound
Quaternary ammonium            68424-85-1        When ready for use, the
 compounds: n-alkyl (C12-18)                      end-use concentration
 dimethyl benzyl ammonium                         of all quaternary
 chloride                                         chemicals in solution
                                                  is not to exceed 400
                                                  ppm of active
                                                  quaternary compound
Quaternary Ammonium            85409-23-0        When ready for use, the
 Compounds: n-alkyl (C 12-14)                     end-use concentration
 dimethyl ethylbenzyl                             of all quaternary
 ammonium chloride, average                       chemicals in solution
 molecular weight (in amu),                       is not to exceed 400
 377 to 384                                       ppm of active
                                                  quaternary compound.
Quaternary ammonium compounds  None              When ready for use, the
 n-alkyl (C12-C18) dimethyl                       end-use concentration
 ethylbenzyl ammonium                             of all quaternary
 chloride average molecular                       chemicals in the
 weight (in amu) 384                              solution is not to
                                                  exceed 200 ppm of
                                                  active quaternary
                                                  compound
Quaternary ammonium            None              When ready for use, the
 compounds, Di-n-Alkyl (C8-                       end-use concentration
 10) dimethyl ammonium                            of these specific in
 chloride, average molecular                      quaternary ammonium
 weight (in amu) 332 to 361                       compounds is not to
                                                  exceed 240 ppm of
                                                  active quaternary
                                                  ammonium compound; the
                                                  end-use concentration
                                                  of all quaternary
                                                  chemicals in the
                                                  solution is not to
                                                  exceed 400 ppm of
                                                  active quaternary
                                                  compound
Quaternary ammonium            148788-55-0/      When ready for use, the
 compounds, didecyl dimethyl    148812-654-1.     end-use concentration
 ammonium carbonate/didecyl                       of these specific
 dimethyl ammonium                                ammonium compounds is
 bicarbonate                                      not to exceed 400 ppm
                                                  of active quaternary
                                                  ammonium compound
Silver ions resulting from     14701-21-4        When ready for use, the
 the use of electrolytically-                     end-use concentration
 generated silver ions                            of silver ions is not
 stabilized in citric acid as                     to exceed 50 ppm of
 silver dihydrogen citrate                        active silver
 (does not include metallic
 silver)
Sulfuric acid monododecyl      151-21-3          When ready for use, the
 ester, sodium salt (sodium                       end-use concentration
 lauryl sulfate)                                  is not to exceed 350
                                                  ppm
1,3,5-Triazine-                2893-78-9         When ready for use, the
 2,4,6(1H,3H,5H)-trione, 1,3-                     end-use concentration
 dichloro-, sodium salt                           of all di- or
                                                  trichloroisocyanuric
                                                  acid chemicals in the
                                                  solution is not to
                                                  exceed 100 ppm
                                                  determined as total
                                                  available chlorine
Xylenesulfonic acid, sodium    1300-72-7         When ready for use, the
 salt                                             end-use concentration
                                                  is not to exceed 500
                                                  ppm
------------------------------------------------------------------------


[[Page 721]]

    (b) The following chemical substances when used as ingredients in an 
antimicrobial pesticide formulation may be applied to: Dairy processing 
equipment, and food-processing equipment and utensils.

------------------------------------------------------------------------
      Pesticide Chemical         CAS Reg. No.             Limits
------------------------------------------------------------------------
Acetic acid                    64-19-7           When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 686
                                                  ppm
Acetic acid, chloro-, sodium   68608-66-2        When ready for use, the
 salt, reaction products with                     end-use concentration
 4,5-dihydro-2-undecyl-1H-                        is not to exceed 42
 imidazole-1-ethanol and                          ppm chloroacetic acid
 sodium hydroxide
Benzenesulfonic acid, dodecyl- 27176-87-0        When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 5.5
                                                  ppm
Butanedioic acid, octenyl-     28805-58-5        When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 156
                                                  ppm
Butoxy monoether of mixed      None              None
 (ethylene-propylene)
 polyalkylene glycol, minimum
 average molecular weight (in
 amu), 2400
Calcium chloride               10043-52-4        When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 17
                                                  ppm
n-Carboxylic acids (C6-C12),   None              When ready for use, the
 consisting of a mixture of                       end-use concentration
 not less than 56% octanoic                       is not to exceed 39
 acid and not less than 40%                       ppm
 decanoic acid
Decanoic acid                  334-48-5          When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 90
                                                  ppm
Ethanesulfonic acid, 2-        132-43-4          When ready for use, the
 [cyclohexyl (1-oxohexadecyl)                     end-use concentration
 amino]-, sodium salt                             is not to exceed 237
                                                  ppm
Ethylenediaminetetraacetic     139-33-3          When ready for use, the
 acid (EDTA), disodium salt                       end-use concentration
                                                  is not to exceed 1400
                                                  ppm
FD&C Yellow No. 5              1934-21-0         None
 (Tartrazine) (conforming to
 21 CFR 74.705)
D-Gluconic acid, monosodium    527-07-1          When ready for use, the
 salt                                             end-use concentration
                                                  is not to exceed 760
                                                  ppm
Hydriodic acid                 10034-85-2        When ready for use, the
                                                  total end-use
                                                  concentration of all
                                                  iodide-producing
                                                  chemicals is not to
                                                  exceed 25 ppm of
                                                  titratable iodine
Hydrogen peroxide              7722-84-1         When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 465
                                                  ppm
Hypochlorous acid              7790-92-3         When ready for use, the
                                                  end-use concentration
                                                  of all hypochlorous
                                                  acid chemicals in the
                                                  solution is not to
                                                  exceed 200 ppm
                                                  determined as total
                                                  available chlorine
Iodine                         7553-56-2         When ready for use, the
                                                  total end-use
                                                  concentration of all
                                                  iodide-producing
                                                  chemicals in the
                                                  solution is not to
                                                  exceed 25 ppm of
                                                  titratable iodine
Lactic acid                    50-21-5           When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 138
                                                  ppm
Nonanoic acid                  112-05-0          When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 90
                                                  ppm
1-Octanamine, N,N-dimethyl-    7378-99-6         When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 113
                                                  ppm
1,2-Octanedisulfonic acid      113669-58-2       When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 102
                                                  ppm
1-Octanesulfonic acid          3944-72-7         When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 172
                                                  ppm
1-Octanesulfonic acid, sodium  5324-84-5         When ready for use, the
 salt                                             end-use concentration
                                                  is not to exceed 297
                                                  ppm
1-Octanesulfonic acid, 2-      113652-56-5       When ready for use, the
 sulfino-                                         end-use concentration
                                                  is not to exceed 102
                                                  ppm
Octanoic acid                  124-07-2          When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 176
                                                  ppm
Oxychloro species (including   None              When ready for use, the
 chlorine dioxide) generated                      end-use concentration
 by acidification of an                           is not to exceed 200
 aqueous solution of sodium                       ppm of chlorine
 chlorite                                         dioxide as determined
                                                  by the method titled,
                                                  Iodometric Method for
                                                  the Determination of
                                                  Available Chlorine
                                                  Dioxide (50-250 ppm
                                                  available chlorine
                                                  dioxide)
Peroxyacetic acid              79-21-0           When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 315
                                                  ppm
Peroxyoctanoic acid            33734-57-5        When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 122
                                                  ppm
Phosphonic acid, (1-           2809-21-4         When ready for use, the
 hydroxyethylidene)bis-                           end-use concentration
                                                  is not to exceed 34
                                                  ppm
Phosphoric acid                7664-38-2         None

[[Page 722]]

 
Phosphoric acid, monosodium    7558-80-7         When ready for use, the
 salt                                             end-use concentration
                                                  is not to exceed 350
                                                  ppm
Potassium iodide               7681-11-0         When ready for use, the
                                                  total end-use
                                                  concentration of all
                                                  iodide-producing
                                                  chemicals in the
                                                  solution is not to
                                                  exceed 25 ppm of
                                                  titratable iodine
Propanoic acid                 79-09-4           When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 297
                                                  ppm
2,6-Pyridinedicarboxylic acid  499-83-2          When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 1.2
                                                  ppm
Sulfuric acid                  7664-93-9         When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 288
                                                  ppm
Sulfuric acid monododecyl      151-21-3          When ready for use, the
 ester, sodium salt (sodium                       end-use concentration
 lauryl sulfate)                                  is not to exceed 350
                                                  ppm
------------------------------------------------------------------------

    (c) The following chemical substances when used as ingredients in an 
antimicrobial pesticide formulation may be applied to: Food-processing 
equipment and utensils.

------------------------------------------------------------------------
      Pesticide Chemical         CAS Reg. No.             Limits
------------------------------------------------------------------------
Acetic acid                    64-19-7           When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 686
                                                  ppm
Acetic acid, chloro-, sodium   68608-66-2        When ready for use, the
 salt, reaction products with                     end-use concentration
 4,5-dihydro-2-undecyl-1H-                        is not to exceed 42
 imidazole-1-ethanol and                          ppm chloroacetic acid
 sodium hydroxide
Ammonium chloride              12125-02-9        When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 48
                                                  ppm
Benzenesulfonic acid, dodecyl- 27176-87-0        When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 400
                                                  ppm
Benzenesulfonic acid, dodecyl- 25155-30-0        When ready for use, the
 , sodium salt                                    end-use concentration
                                                  is not to exceed 430
                                                  ppm
[1,1'-Biphenyl]-2-ol           90-43-7           When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 400
                                                  ppm
Boric acid, sodium salt        7775-19-1         None
Butanedioic acid, octenyl-     28805-58-5        When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 156
                                                  ppm
Butanedioic acid, sulfo-, 1,4- 1639-66-3         None
 dioctyl ester, sodium salt
Butoxy monoether of mixed      None              None
 (ethylene-propylene)
 polyalkylene glycol,
 cloudpoint of 90 - 100\o\C
 in 0.5 aqueous solution,
 average molecular weight (in
 amu), 3300
Butoxy monoether of mixed      None              None
 (ethylene-propylene)
 polyalkylene glycol, minimum
 average molecular weight (in
 amu), 2400
Calcium chloride               10043-52-4        When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 17
                                                  ppm
n-Carboxylic acids (C6-C12),   None              When ready for use, the
 consisting of a mixture of                       end-use concentration
 not less than 56% octanoic                       is not to exceed 39
 acid and not less than 40%                       ppm
 decanoic acid
3-Cyclohexene-1-               98-55-5           None
 methanol,[alpha],[alpha],4-
 trimethyl-
1-Decanaminium, N-decyl-N, N-  7173-51-5         When ready for use, the
 dimethyl-, chloride                              end-use concentration
                                                  is not to exceed 200
                                                  ppm of active
                                                  quaternary compound
Decanoic acid                  3347-48-5         When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 234
                                                  ppm
Ethanesulfonic acid, 2-        132-43-4          When ready for use, the
 [cyclohexyl (1-oxohexadecyl)                     end-use concentration
 amino]-, sodium salt                             is not to exceed 237
                                                  ppm
Ethanol                        64-17-5           None
Ethanol, 2 butoxy-             111-76-2          None
Ethanol, 2-(2-ethoxyethoxy)-   111-90-0          None
Ethylenediaminetetraacetic     139-33-3          When ready for use, the
 acid (EDTA), disodium salt                       end-use concentration
                                                  is not to exceed 1400
                                                  ppm
Ethylenediaminetetraacetic     64-02-8           None
 acid (EDTA), tetrasodium
 salt
Fatty acids, coco, potassium   61789-30-8        None
 salts
Fatty acids, tall-oil,         68309-27-3        When ready for use, the
 sulfonated, sodium salts                         end-use concentration
                                                  is not to exceed 66
                                                  ppm
FD&C Yellow No. 5              1934-21-0         None
 (Tartrazine) (conforming to
 21 CFR 74.705)

[[Page 723]]

 
D-Gluconic acid, monosodium    527-07-1          When ready for use, the
 salt                                             end-use concentration
                                                  is not to exceed 760
                                                  ppm
Hydriodic acid                 10034-85-2        When ready for use, the
                                                  total end-use
                                                  concentration of all
                                                  iodide-producing
                                                  chemicals in the
                                                  solution is not to
                                                  exceed 25 ppm of
                                                  titratable iodine
Hydrogen peroxide              7722-84-1         When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 1100
                                                  ppm
Hypochlorous acid              7790-92-3         When ready for use, the
                                                  end-use concentration
                                                  of all hypochlorous
                                                  acid chemicals in the
                                                  solution is not to
                                                  exceed 200 ppm
                                                  determined as total
                                                  available chlorine
Hypochlorous acid, calcium     7778-54-3         When ready for use, the
 salt                                             end-use concentration
                                                  of all hypochlorous
                                                  acid chemicals in the
                                                  solution is not to
                                                  exceed 200 ppm
                                                  determined as total
                                                  available chlorine
Hypochlorous acid, lithium     13840-33-0        When ready for use, the
 salt                                             end-use concentration
                                                  of all hypochlorous
                                                  acid chemicals in the
                                                  solution is not to
                                                  exceed 200 ppm
                                                  determined as total
                                                  available chlorine and
                                                  30 ppm lithium
Hypochlorous acid, potassium   7778-66-7         When ready for use, the
 salt                                             end-use concentration
                                                  of all hypochlorous
                                                  acid chemicals in the
                                                  solution is not to
                                                  exceed 200 ppm
                                                  determined as total
                                                  available chlorine
Hypochlorous acid, sodium      7681-52-9         When ready for use, the
 salt                                             end-use concentration
                                                  of all hypochlorous
                                                  acid chemicals in the
                                                  solution is not to
                                                  exceed 200 ppm
                                                  determined as total
                                                  available chlorine
Iodine                         7553-56-2         When ready for use, the
                                                  total end-use
                                                  concentration of all
                                                  iodide-producing
                                                  chemicals in the
                                                  solution is not to
                                                  exceed 25 ppm of
                                                  titratable iodine
Lactic acid                    50-21-5           None
Magnesium oxide                1309-48-4         None
Methylene blue                 61-73-4           When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 0.4
                                                  ppm
Neodecanoic acid               26896-20-8        When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 174
                                                  ppm
Nonanoic acid                  112-05-0          When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 90
                                                  ppm
[alpha]-(p-Nonylphenyl)-       None              None
 [omega]-hydroxypoly
 (oxyethylene) maximum
 average molecular weight (in
 amu), 748
[alpha]-(p-Nonylphenol)-       None              None
 [omega]-hydroxypoly
 (oxyethylene) average
 poly(oxyethylene) content 11
 moles
[alpha]-(p-Nonylphenyl)-       None              None
 [omega]-hydroxypoly
 (oxyethylene) produced by
 the condensation of 1 mole p-
 nonylphenol with 9 to 12
 moles ethylene oxide
[alpha]-(p-Nonylphenyl)-       None              None
 [omega]-hydroxypoly
 (oxyethylene), 9 to 13 moles
 ethylene oxide
Octadecanoic acid, calcium     1592-23-0         None
 salt
9-Octadecenoic acid (9Z)-,     68988-76-1        When ready for use, the
 sulfonated                                       end-use concentration
                                                  is not to exceed 312
                                                  ppm
9-Octadecenoic acid (9Z)-      68443-05-0        When ready for use, the
 sulfonated, sodium salts                         end-use concentration
                                                  is not to exceed 200
                                                  ppm
1-Octanamine, N,N-dimethyl-    7378-99-6         When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 113
                                                  ppm
1,2-Octanedisulfonic acid      113669-58-2       When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 102
                                                  ppm
1-Octanesulfonic acid          3944-72-7         When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 172
                                                  ppm
1-Octanesulfonic acid, sodium  5324-84-5         When ready for use, the
 salt                                             end-use concentration
                                                  is not to exceed 312
                                                  ppm
1-Octanesulfonic acid, 2-      113652-56-5       When ready for use, the
 sulfino-                                         end-use concentration
                                                  is not to exceed 102
                                                  ppm
Octanoic acid                  124-07-2          When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 234
                                                  ppm
Oxirane, methyl-, polymer      9003-11-6         None
 with oxirane, minimum
 molecular weight (in amu),
 1900
Oxirane, methyl-, polymer      106392-12-5       None
 with oxirane, block, average
 molecular weight (in amu),
 1900
Oxirane, methyl-, polymer      None              None
 with oxirane, block, minimum
 average molecular weight (in
 amu), 2000

[[Page 724]]

 
Oxirane, methyl-, polymer      None              None
 with oxirane, block, 27 to
 31 moles of
 polyoxypropylene, average
 molecular weight (in amu)
 2000
Oxychloro species              None              When ready for use, the
 (predominantly chlorite,                         end-use concentration
 chlorate and chlorine                            is not to exceed 200
 dioxide in an equilibrium                        ppm of chlorine
 mixture) generated either                        dioxide as determined
 (i) by directly metering a                       by the method titled,
 concentrated chlorine                            ``Iodometric Method
 dioxide solution prepared                        for the Determination
 just prior to use, into                          of Available Chlorine
 potable water, or (ii) by                        Dioxide (50-250 ppm
 acidification of an aqueous                      available chlorine
 alkaline solution of                             dioxide)''
 oxychloro species
 (predominately chlorite and
 chlorate) followed by
 dilution with potable water
Oxychloro species (including   None              When ready for use, the
 chlorine dioxide) generated                      end-use concentration
 by acidification of an                           is not to exceed 200
 aqueous solution of sodium                       ppm of chlorine
 chlorite                                         dioxide as determined
                                                  by the method titled,
                                                  ``Iodometric Method
                                                  for the Determination
                                                  of Available Chlorine
                                                  Dioxide (50-250 ppm
                                                  available chlorine
                                                  dioxide)''
2,4-Pentanediol, 2-methyl-     107-41-5          None
Peroxyacetic acid              79-21-0           When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 315
                                                  ppm
Peroxyoctanoic acid            33734-57-5        When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 122
                                                  ppm
Phenol, 4-chloro-2-            120-32-1          When ready for use, the
 (phenylmethyl)-                                  end-use concentration
                                                  is not to exceed 320
                                                  ppm
Phenol, 4-(1,1-                80-46-6           When ready for use, the
 dimethylpropyl)-                                 end-use concentration
                                                  is not to exceed 80
                                                  ppm
Phosphonic acid, (1-           2809-21-4         When ready for use, the
 hydroxyethylidene)bis-                           end-use concentration
                                                  is not to exceed 34
                                                  ppm
Phosphoric acid                7664-38-2         None
Phosphoric acid, monosodium    7558-80-7         When ready for use, the
 salt                                             end-use concentration
                                                  is not to exceed 350
                                                  ppm
Phosphoric acid, trisodium     7601-54-9         When ready for use, the
 salt                                             end-use concentration
                                                  is not to exceed 5916
                                                  ppm
Poly(oxy-1,2-ethanediyl),      None              None
 [alpha]-[(1,1,3,3-
 tetramethylbutyl) phenyl]-
 [omega]-hydroxy-, produced
 with one mole of the phenol
 and 4 to 14 moles ethylene
 oxide
Potassium bromide              7758-02-3         When ready for use, the
                                                  end-use concentration
                                                  of all bromide-
                                                  producing chemicals in
                                                  the solution is not to
                                                  exceed 200 ppm total
                                                  available halogen
Potassium iodide               7681-11-0         When ready for use, the
                                                  total end-use
                                                  concentration of all
                                                  iodide-producing
                                                  chemicals in the
                                                  solution is not to
                                                  exceed 25 ppm of
                                                  titratable iodine
Propanoic acid                 79-09-4           When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 297
                                                  ppm
2,6-Pyridinedicarboxylic acid  499-83-2          When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 1.2
                                                  ppm
Quaternary ammonium            8001-54-5         When ready for use, the
 compounds, alkyl (C12-C18)                       end-use concentration
 benzyldimethyl, chlorides                        of this specific
                                                  quaternary compound is
                                                  not to exceed 200 ppm
                                                  within the end-use
                                                  total concentration
                                                  that is not to exceed
                                                  400 ppm active
                                                  quaternary compound
Quaternary ammonium            None              When ready for use, the
 compounds, n-alkyl (C12-C14)                     end-use concentration
 dimethyl ethylbenzyl                             of this specific
 ammonium chloride, average                       quaternary compound is
 molecular weight (in amu),                       not to exceed 200 ppm
 377 to 384                                       within the end-use
                                                  total concentration
                                                  that is not to exceed
                                                  400 ppm active
                                                  quaternary compound
Quaternary ammonium            None              When ready for use, the
 compounds, n-alkyl (C12-C18)                     end-use concentration
 dimethyl ethylbenzyl                             of this specific
 ammonium chloride average                        quaternary compound is
 molecular weight (in amu)                        not to exceed 200 ppm
 384                                              within the end-use
                                                  total concentration
                                                  that is not to exceed
                                                  400 ppm active
                                                  quaternary compound
Quaternary ammonium            None              When ready for use, the
 compounds, di-n-Alkyl (C8-                       end-use concentration
 C10) dimethyl ammonium                           of this specific
 chloride, average molecular                      quaternary compound is
 weight (in amu), 332 to 361                      not to exceed 240 ppm
                                                  within the end-use
                                                  total concentration
                                                  that is not to exceed
                                                  400 ppm active
                                                  quaternary compound
Sodium-[alpha]-alkyl(C12-C15)- None              None
 [omega]-hydroxypoly
 (oxyethylene) sulfate with
 the poly(oxyethylene)
 content averaging one mole

[[Page 725]]

 
Sodium bromide                 7647-15-6         When ready for use, the
                                                  end-use concentration
                                                  of all bromide-
                                                  producing chemicals in
                                                  the solution is not to
                                                  exceed 200 ppm total
                                                  available halogen
Sodium iodide                  7681-82-5         When ready for use, the
                                                  total end-use
                                                  concentration of all
                                                  iodide-producing
                                                  chemicals in the
                                                  solution is not to
                                                  exceed 25 ppm of
                                                  titratable iodine
Sulfuric acid                  7664-93-9         When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 228
                                                  ppm
Sulfuric acid monododecyl      151-21-3          None
 ester, sodium salt (sodium
 lauryl sulfate)
1,3,5-Triazine-                2782-57-2         When ready for use, the
 2,4,6(1H,3H,5H)-trione, 1,3-                     end-use concentration
 dichloro-                                        of all di- or
                                                  trichloroisocyanuric
                                                  acid chemicals in the
                                                  solution is not to
                                                  exceed 100 ppm
                                                  determined as total
                                                  available chlorine
1,3,5-Triazine-                2244-21-5         When ready for use, the
 2,4,6(1H,3H,5H)-trione, 1,3-                     end-use concentration
 dichloro-, potassium salt                        of all di- or
                                                  trichloroisocyanuric
                                                  acid chemicals in the
                                                  solution is not to
                                                  exceed 100 ppm
                                                  determined as total
                                                  available chlorine
1,3,5-Triazine-                2893-78-9         When ready for use, the
 2,4,6(1H,3H,5H)-trione, 1,3-                     end-use concentration
 dichloro-, sodium salt                           of all di- or
                                                  trichloroisocyanuric
                                                  acid chemicals in the
                                                  solution is not to
                                                  exceed 100 ppm
                                                  determined as total
                                                  available chlorine
1,3,5-Triazine-                87-90-1           When ready for use, the
 2,4,6(1H,3H,5H)-trione,                          end-use concentration
 1,3,5-trichloro-                                 of all di- or
                                                  trichloroisocyanuric
                                                  acid chemicals in the
                                                  solution is not to
                                                  exceed 100 ppm
                                                  determined as total
                                                  available chlorine
1,3,5-Triazine, N,N',N''-      7673-09-8         When ready for use, the
 trichloro-2,4,6-triamino-                        end-use concentration
                                                  of all di- or
                                                  trichloroisocyanuric
                                                  acid chemicals in the
                                                  solution is not to
                                                  exceed 200 ppm
                                                  determined as total
                                                  available chlorine
------------------------------------------------------------------------


[69 FR 23136, Apr. 28, 2004, as amended at 71 FR 30811, May 31, 2006; 71 
FR 45423, Aug. 9, 2006; 71 FR 46125, Aug. 11, 2006; 72 FR 51186, Sept. 
6, 2007; 73 FR 37858, July 2, 2008; 73 FR 49107, Aug. 20, 2008; 73 FR 
53725, Sept. 17, 2008; 74 FR 27454, June 10, 2009; 74 FR 38944, Aug. 5, 
2009; 74 FR 40509, Aug. 12, 2009; 75 FR 40735, July 14, 2010; 76 FR 
55267, Sept. 7, 2011; 77 FR 45498, Aug. 1, 2012; 77 FR 50617, Aug. 22, 
2012; 77 FR 53150, Aug. 31, 2012; 77 FR 68692, Nov. 16, 2012; 78 FR 
35147, June 12, 2013]



Sec. 180.950  Tolerance exemptions for minimal risk active and inert 

ingredients.

    Unless specifically excluded, residues resulting from the use of the 
following substances as either an inert or an active ingredient in a 
pesticide chemical formulation, including antimicrobial pesticide 
chemicals, are exempted from the requirement of a tolerance under FFDCA 
section 408, if such use is in accordance with good agricultural or 
manufacturing practices.
    (a) Commonly consumed food commodities. Commonly consumed food 
commodities means foods that are commonly consumed for their nutrient 
properties. The term commonly consumed food commodities shall only apply 
to food commodities (whether a raw agricultural commodity or a processed 
commodity) in the form the commodity is sold or distributed to the 
public for consumption.
    (1) Included within the term commonly consumed food commodities are:
    (i) Sugars such as sucrose, lactose, dextrose and fructose, and 
invert sugar and syrup.
    (ii) Spices such as cinnamon, cloves, and red pepper.
    (iii) Herbs such as basil, anise, or fenugreek.
    (2) Excluded from the term commonly consumed food commodities are:
    (i) Any food commodity that is adulterated under 21 U.S.C. 342.
    (ii) Both the raw and processed forms of peanuts, tree nuts, milk, 
soybeans, eggs, fish, crustacea, and wheat.
    (iii) Alcoholic beverages.
    (iv) Dietary supplements.
    (b) Animal feed items. Animal feed items means meat meal and all 
items derived from field crops that are fed to livestock excluding both 
the raw and

[[Page 726]]

processed forms of peanuts, tree nuts, milk, soybeans, eggs, fish, 
crustacea, and wheat. Meat meal is an animal feed composed of dried 
animal fat and protein that has been sterilized. Other than meat meal, 
the term animal feed item does not extend to any item designed to be fed 
to animals that contains, to any extent, components of animals. Included 
within the term animal feed items are:
    (1) The hulls and shells of the commodities specified in paragraph 
(a)(2)(ii) of this section, and cocoa bean.
    (2) Bird feed such as canary seed.
    (3) Any feed component of a medicated feed meeting the definition of 
an animal feed item.
    (c) Edible fats and oils. Edible fats and oils means all edible 
(food or feed) fats and oils, derived from either plants or animals, 
whether or not commonly consumed, including products derived from 
hydrogenating (food or feed) oils, or liquefying (food or feed) fats.
    (1) Included within the term edible fats and oils are oils (such as 
soybean oil) that are derived from the commodities specified in 
paragraph (a)(2)(ii) of this section when such oils are highly refined 
via a solvent extraction procedure.
    (2) Excluded from the term edible fats and oils are plant oils used 
in the pesticide chemical formulation specifically to impart their 
characteristic fragrance and/or flavoring.
    (d) [Reserved]
    (e) Specific chemical substances. Residues resulting from the use of 
the following substances as either an inert or an active ingredient in a 
pesticide chemical formulation, including antimicrobial pesticide 
chemicals, are exempted from the requirement of a tolerance under FFDCA 
section 408, if such use is in accordance with good agricultural or 
manufacturing practices.

------------------------------------------------------------------------
                          Chemical                             CAS No.
------------------------------------------------------------------------
Acetic acid, sodium salt...................................     127-09-3
Alpha-cyclodextrin.........................................   10016-20-3
Amylopectin, acid-hydrolyzed, 1-octenylbutanedioate........  113894-85-2
Amylopectin, hydrogen 1-octadecenylbutanedioate............  125109-81-1
Animal glue................................................         None
Ascorbic acid (vitamin C)..................................      50-81-7
Beeswax....................................................    8012-89-3
Benzoic acid, sodium salt..................................     532-32-1
Beta-cyclodextrin..........................................    7585-39-9
Carbonic acid, monopotassium salt..........................     298-14-6
Carbonic acid, monosodium salt (sodium bicarbonate)........     144-55-8
Carnauba wax...............................................    8015-86-9
Carob gum (locust bean gum)................................    9000-40-2
Castor oil.................................................    8001-79-4
Castor oil, hydrogenated...................................    8001-78-3
Cellulose..................................................    9004-34-6
Cellulose acetate..........................................    9004-35-7
Cellulose, carboxy methyl ether, sodium salt...............    9004-32-4
Cellulose, 2-hydroxyethyl ether............................    9004-62-0
Cellulose, 2-hydroxypropyl ether...........................    9004-64-2
Cellulose, 2-hydroxypropyl methyl ether....................    9004-65-3
Cellulose, methyl ether....................................    9004-67-5
Cellulose, mixture with cellulose carboxymethyl ether,        51395-75-6
 sodium salt...............................................
Cellulose, pulp............................................   65996-61-4
Cellulose, regenerated.....................................   68442-85-3
Citric acid................................................      77-92-9
Citric acid, 2-(acetyloxy)-, tributyl ester................      77-90-7
Citric acid, calcium salt..................................    7693-13-2
Citric acid, calcium salt (2:3)............................     813-94-5
Citric acid, dipotassium salt..............................    3609-96-9
Citric acid, disodium salt.................................     144-33-2
Citric acid, monohydrate...................................    5949-29-1
Citric acid, monopotassium salt............................     866-83-1
Citric acid, monosodium salt...............................   18996-35-5
Citric acid, potassium salt................................    7778-49-6
Citric acid, triethyl ester................................      77-93-0
Citric acid, tripotassium salt.............................     866-84-2
Citric acid, tripotassium salt, monohydrate................    6100-05-6
Citric acid, sodium salt...................................     994-36-5
Citric acid, trisodium salt................................      68-04-2
Citric acid, trisodium salt, dihydrate.....................    6132-04-3
Citric acid, trisodium salt, pentahydrate..................    6858-44-2
Coffee grounds.............................................   68916-18-7
Dextrins...................................................    9004-53-9
1,3-Dioxolan-2-one, 4-methyl-(propylene carbonate).........     108-32-7
Fumaric acid...............................................     110-17-8
Gamma-cyclodextrin.........................................   17465-86-0
Gellan gum.................................................   71010-52-1
D-Glucitol (sorbitol)......................................      50-70-4
Glycerol (glycerin) (1,2,3-propanetriol)...................      56-81-5
Guar gum...................................................    9000-30-0
Humic acid.................................................    1413-93-6
Humic acid, potassium salt.................................   68514-28-3
Humic acid, sodium salt....................................   68131-04-4
Lactic acid, n-butyl ester.................................     138-22-7
Lactic acid, n-butyl ester, (S)............................   34451-19-9
Lactic acid, ethyl ester...................................      97-64-3
Lactic acid, ethyl ester,(S)...............................     687-47-8
Lanolin....................................................    8006-54-0
Lecithins..................................................    8002-43-5
Lecithins, soya............................................    8030-76-0
Licorice Extract...........................................   68916-91-6
Maltodextrin...............................................    9050-36-6
Paper......................................................         None
Potassium chloride.........................................    7447-40-7
2-Propanol (isopropyl alcohol).............................      67-63-0
Red cabbage color, expressed from edible red cabbage heads          None
 via a pressing process using only acidified water.........
Silica, amorphous, fumed (crystalline free)................  112945-52-5
Silica, amorphous, precipitated and gel....................    7699-41-4
Silica gel.................................................   63231-67-4
Silica gel, precipitated, crystalline-free.................  112926-00-8
Silica, hydrate............................................   10279-57-9
Silica, vitreous...........................................   60676-86-0

[[Page 727]]

 
Soap (The water soluble sodium or potassium salts of fatty          None
 acids produced by either the saponification of fats and
 oils, or the neutralization of fatty acid)................
Sorbic acid, potassium salt................................   24634-61-5
Soapbark (Quillaja saponin)................................    1393-03-9
Sodium alginate............................................    9005-38-3
Sodium chloride............................................    7647-14-5
Syrups, hydrolyzed starch, hydrogenated....................   68425-17-2
Ultramarine blue (C.I. Pigment Blue 29)....................   57455-37-5
Urea.......................................................      57-13-6
Vanillin...................................................     121-33-5
Xanthan gum................................................   11138-66-2
------------------------------------------------------------------------


[67 FR 36537, May 24, 2002]

    Editorial Note: For Federal Register citations affecting Sec. 
180.950, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.960  Polymers; exemptions from the requirement of a tolerance.

    Residues resulting from the use of the following substances, that 
meet the definition of a polymer and the criteria specified for defining 
a low-risk polymer in 40 CFR 723.250, as an inert ingredient in a 
pesticide chemical formulation, including antimicrobial pesticide 
chemical formulations, are exempted from the requirement of a tolerance 
under FFDCA section 408, if such use is in accordance with good 
agricultural or manufacturing practices.

------------------------------------------------------------------------
                  Polymer                              CAS No.
------------------------------------------------------------------------
Acetic acid ethenyl ester, polymer with     137091-12-4
 ethenol and ([alpha])-2-propenyl-
 ([omega])-hydroxypoly (oxy-1,2-
 ethanediyl) minimum number average
 molecular weight (in amu), 15,000
------------------------------------------------------------------------
Acetic acid ethenyl ester, polymer with 1-  25086-89-9
 ethenyl-2-pyrrolidinone
------------------------------------------------------------------------
Acetic acid ethenyl ester, polymer with     25820-49-9
 oxirane, minimum number average molecular
 weight (in amu), 17,000
------------------------------------------------------------------------
Acetic acid ethenyl ester, polymer with     924892-37-5
 sodium 2-methyl-2-[(1-oxo-2-propen-1-
 yl)amino]-1-propanesulfonate (1:1),
 hydrolyzed, minimum number average
 molecular weight (in amu), 61,000
------------------------------------------------------------------------
Acrylic acid-benzyl methacrylate-1-         1152297-42-1
 propanesulfonic acid, 2-methyl-2-[(1-oxo-
 2-propenyl)amino]-, monosodium salt,
 minimum number average molecular weight
 (in amu), 1500
------------------------------------------------------------------------
Acrylic acid, polymerized, and its ethyl    None
 and methyl esters
------------------------------------------------------------------------
Acrylic acid-sodium acrylate-sodium-2-      97953-25-8
 methylpropanesulfonate copolymer, minimum
 average molecular weight (in amu), 4,500
------------------------------------------------------------------------
Acrylic acid-stearyl methacrylate           27756-15-6
 copolymer, minimum number average
 molecular weight (in amu), 2,500
------------------------------------------------------------------------
Acrylic acid, styrene, [alpha]-methyl       89678-90-0
 styrene copolymer, ammonium salt, minimum
 number average molecular weight (in amu),
 1,250
------------------------------------------------------------------------
Acrylic acid terpolymer, partial sodium     151006-66-5
 salt, minimum number average molecular
 weight (in amu), 2,400
------------------------------------------------------------------------
Acrylic polymers composed of one or more    None
 of the following monomers: Acrylic acid,
 methyl acrylate, ethyl acrylate, butyl
 acrylate, hydroxyethyl acrylate,
 hydroxypropyl acrylate, hydroxybutyl
 acrylate, carboxyethyl acrylate,
 methacrylic acid, methyl methacrylate,
 ethyl methacrylate, butyl methacrylate,
 isobutyl methacrylate, hydroxyethyl
 methacrylate, hydroxypropyl methacrylate,
 hydroxybutyl methacrylate, lauryl
 methacrylate, and stearyl methacrylate;
 with none and/or one or more of the
 following monomers: Acrylamide, N-methyl
 acrylamide, N,N-dimethyl acrylamide, N-
 octylacrylamide, maleic anhydride, maleic
 acid, monoethyl maleate, diethyl maleate,
 monooctyl maleate, dioctyl maleate; and
 their corresponding sodium, potassium,
 ammonium, isopropylamine, triethylamine,
 monoethanolamine, and/or triethanolamine
 salts; the resulting polymer having a
 minimum number average molecular weight
 (in amu), 1,200
------------------------------------------------------------------------
Acrylonitrile-butadiene copolymer           9003-18-3
 conforming to 21 CFR 180.22, minimum
 average molecular weight (in amu), 1,000
------------------------------------------------------------------------
Acrylonitrile-styrene-hydroxypropyl         None
 methacrylate copolymer, minimum number
 average molecular weight (in amu),
 447,000
------------------------------------------------------------------------

[[Page 728]]

 
[alpha]-alkyl (C12-C15) - [omega]-          68551-13-3
 hydroxypoly(oxypropylene)poly(oxyethylene
 )copolymers (where the poly(oxypropylene)
 content is 3-60 moles and the
 poly(oxyethylene) content is 5-80 moles),
 the resulting ethoxylated propoxylated
 (C12-C15) alcohols having a minimum
 molecular weight (in amu), 1,500
------------------------------------------------------------------------
[alpha]-alkyl-[omega]-hydroxypoly           9002-92-0, 9004-95-9, 9005-
 (oxypropylene) and/or poly (oxyethylene)    00-9, 26183-52-8, 34398-01-
 polymers where the alkyl chain contains a   1, 52292-17-8, 66455-14-9,
 minimum of six carbons, minimum number      66455-15-0, 68002-97-1,
 average molecular weight (in amu) 1,100     68131-39-5, 68131-40-8,
                                             68154-96-1, 68213-23-0,
                                             68439-45-2, 68439-46-3,
                                             68526-94-3, 68439-50-9,
                                             68439-49-6, 68551-12-2,
                                             68951-67-7, 71243-46-4,
                                             97043-91-9, 9043-30-5,
                                             60828-78-6, 61827-42-7,
                                             24938-91-8, 68439-54-3,
                                             69011-36-5, 78330-20-8,
                                             78330-21-9, 106232-83-1,
                                             127036-24-2, 160875-66-1,
                                             9004-98-2, 68920-66-1,
                                             61804-34-0, 61791-28-4,
                                             71060-57-6, 26468-86-0,
                                             31726-34-8, 52609-19-5,
                                             61791-20-6, 68155-01-1,
                                             69013-19-0, 69364-63-2,
                                             70879-83-3, 78330-19-5,
                                             97953-22-5, 157627-86-6,
                                             34398-05-5, 72905-87-4,
                                             84133-50-6, 61702-78-1,
                                             27306-79-2, 169107-21-5,
                                             61791-13-7, 39587-22-9,
                                             85422-93-1; 68154-98-3,
                                             61725-89-1, 68002-96-0,
                                             68154-97-2, 68439-51-0,
                                             68551-13-3, 68603-25-8,
                                             68937-66-6, 68987-81-5,
                                             69227-21-0, 70750-27-5,
                                             103818-93-5, 166736-08-9,
                                             120313-48-6, 68213-24-1,
                                             68458-88-8, 68551-14-4,
                                             69013-18-9, 69227-22-1,
                                             72854-13-8, 73049-34-0,
                                             78330-23-1, 37311-02-7,
                                             64366-70-7, 37251-67-5,
                                             9087-53-0, 196823-11-7,
                                             57679-21-7, 111905-54-5,
                                             61827-84-7, 172588-43-1
------------------------------------------------------------------------
Alkyl (C12-C20) methacrylate-methacrylic    None
 acid copolymer, minimum molecular weight
 (in amu), 11,900
------------------------------------------------------------------------
2H-Azepin-2-one, 1-ethenylhexahydro-,       25189-83-7
 homopolymer
------------------------------------------------------------------------
1,3 Benzene dicarboxylic acid, 5-sulfo-,    212842-88-1
 1,3-dimethyl ester, sodium salt, polymer
 with 1,3-benzene dicarboxylic acid, 1,4-
 benzene dicarboxylic acid, dimethyl 1,4-
 benzene dicarboxylate and 1,2-ethanediol,
 minimum number average molecular weight
 (in amu), 2,580
------------------------------------------------------------------------
3,5-Bis(6-isocyanatohexyl)-2H-1,3,5-        87823-33-4
 oxadiazine-2,4,6-(3H,5H)-trione, polymer
 with diethylenetriamine, minimum number
 average molecular weight (in amu),
 1,000,000
------------------------------------------------------------------------
Polymer of one or more diglycidyl ethers    None
 of bisphenol A, resorcinol, glycerol,
 cyclohexanedimethanol, neopentyl glycol,
 and polyethylene glycol with one or more
 of the following: Polyoxypropylene
 diamine, polyoxypropylene triamine, N-
 aminoethyl-piperazine, trimethyl-1,6-
 hexanediamine isophorone diamine, N,N-
 dimethyl-1,3-diaminopropane, nadic methyl
 anhydride, 1,2-cyclohexane-dicarboxylic
 anhydride and 1,2,3,6-tetrahydrophthalic
 anhydride, minimum number average
 molecular weight (in amu), 400,000.
------------------------------------------------------------------------
Butadiene-styrene copolymer                 None
------------------------------------------------------------------------
1,4-Butanediol-methylenebis(4-              9018- 04-6
 phenylisocyanate)-poly(tetramethylene
 glycol) copolymer, minimum molecular
 weight (in amu) 158,000
------------------------------------------------------------------------
Butene, homopolymer                         9003-29-6
------------------------------------------------------------------------
2-butenedioic acid (2Z)-, monobutyl ester,  205193-99-3
 polymer with methoxyethene, sodium salt,
 minimum number average molecular weight
 (in amu), 18,200
------------------------------------------------------------------------
2-Butenedioic acid (Z)-, polymer with       139871-83-3
 ethenol and ethenyl acetate, sodium salt,
 minimum number average molecular weight
 (in amu), 75,000
------------------------------------------------------------------------
Butyl acrylate-vinyl acetate-acrylic acid   65405-40-5
 copolymer, minimum number average
 molecular weight (in amu), 18,000
------------------------------------------------------------------------

[[Page 729]]

 
Carbonic acid, diethyl ester, polymer with  1147260-65-8
 [alpha]-hydro-[omega]-
 hydroxypoly[oxy(methyl-1,2-ethanediyl)]
 ether with 2-ethyl-2-(hydroxymethyl)-1,3-
 propanediol (3:1), ester with [alpha]-
 [[[[5-(carboxyamino)-1,3,3-
 trimethylcyclohexyl]methyl]amino]carbonyl
 ]-[omega]-methoxypoly(oxy-1,2-
 ethanediyl), minimum number average
 molecular weight (in amu), 1,900
------------------------------------------------------------------------
Castor oil, ethoxylated, dioleate, minimum  110531-96-9
 number average molecular weight (in amu),
 1260..
------------------------------------------------------------------------
Castor oil, ethoxylated, oleate, minimum    220037-02-5
 number average molecular weight (in amu),
 1,600
------------------------------------------------------------------------
Castor oil, polymer with adipic acid,       1357486-09-9
 linoleic acid, oleic acid and ricinoleic
 acid, minimum number average molecular
 weight (in amu), 3,500
------------------------------------------------------------------------
Castor oil, polyoxyethylated; the           None
 poly(oxyethylene) content averages 5-54
 moles
------------------------------------------------------------------------
Chlorinated polyethylene                    64754-90-1
------------------------------------------------------------------------
Cross-linked nylon-type polymer formed by   None
 the reaction of a mixture of sebacoyl
 chloride and polymethylene
 polyphenylisocycanate with a mixture of
 ethylenediamine and diethylenetriamine
------------------------------------------------------------------------
Cross-linked polyurea-type encapsulating    None
 polymer
------------------------------------------------------------------------
Dimethylpolysiloxane minimum number         63148-62-9
 average molecular weight (in amu), 6,800
------------------------------------------------------------------------
Dimethyl silicone polymer with silica,      67762-90-7
 minimum number average molecular weight
 (in amu), 1,100,000
------------------------------------------------------------------------
[alpha]-(o,p-Dinonylphenyl)-[omega]-        9014-93-1
 hydroxypoly(oxyethylene) produced by
 condensation of 1 mole of dinonylphenol
 (nonyl group is a propylene trimer
 isomer) with an average of 140-160 moles
 of ethylene oxide
------------------------------------------------------------------------
Docosyl methacrylate-acrylic acid           None
 copolymer, or docosyl methacrylate-
 octadecyl methacrylate-acrylic acid
 copolymer, minimum number average
 molecular weight (in amu), 3,000
------------------------------------------------------------------------
1,12-Dodecanediol dimethacrylate polymer,   None
 minimum molecular weight (in amu),
 100,000
------------------------------------------------------------------------
[alpha]-(p-Dodecylphenyl)-[omega]-          9014-92-0
 hydroxypoly(oxyethylene) produced by the   26401-47-8
 condensation of 1 mole of dodecylphenol
 (dodecyl group is a propylene tetramer
 isomer) with an average of 30-70 moles of
 ethylene oxide
------------------------------------------------------------------------
1,2-Ethanediamine, N1-(2-aminoethyl)-,      35297-61-1
 polymer with 2,4-diisocyanato-1-
 methylbenzene, minimum number average
 molecular weight (in amu), one million
------------------------------------------------------------------------
1, 2-Ethanediamine, polymer with methyl     26316-40-5
 oxirane and oxirane, minimum number
 average molecular weight (in amu), 1,100
------------------------------------------------------------------------
Ethylene glycol dimethyacrylate-lauryl      None
 methacrylate copolymer, minimum molecular
 weight (in amu), 100,000
------------------------------------------------------------------------
Ethylene glycol dimethacrylate polymer,     None
 minimum molecular weight (in amu),
 100,000
------------------------------------------------------------------------
Fatty acids, tall-oil, ethoxylated          67784-86-5
 propoxylated, minimum number average
 molecular weight (in amu), 2,009
------------------------------------------------------------------------
Formaldehyde, polymer with [alpha]-[bis(1-  157291-93-5
 phenylethyl)phenyl]-[omega]-
 hydroxypoly(oxy-1,2-ethanediyl), number
 average molecular weight (in amu), 1,803
------------------------------------------------------------------------
Formaldehyde, polymer with 2-methyloxirane  37523-33-4
 and 4-nonylphenol, minimum number average
 molecular weight (in amu), 4,000
------------------------------------------------------------------------
Fumaric acid-isophthalic acid-styrene-      None
 ethylene/propylene glycol copolymer,
 minimum average molecular weight (in
 amu), 1x10\18\
------------------------------------------------------------------------

[[Page 730]]

 
Hexadecyl acrylate-acrylic acid copolymer,  None
 hexadecyl acrylate-butyl acrylate-acrylic
 acid copolymer, or hexadecyl acrylate-
 dodecyl acrylate-acrylic acid copolymer,
 minimum number average molecular weight
 (in amu), 3,000
------------------------------------------------------------------------
Hexamethyl disilizane, reaction product     68909-20-6
 with silica, minimum number average
 molecular weight (in amu), 645,000
------------------------------------------------------------------------
1,6-Hexanediol dimethyacrylate polymer,     None
 minimum molecular weight (in amu),
 100,000
------------------------------------------------------------------------
[alpha]-Hydro-[omega]-hydroxy-              330977-00-9
 poly(oxyethylene) C8 alkyl ether
 citrates, poly(oxyethylene) content is 4-
 12 moles, minimum number average
 molecular weight (in amu) 1,300
------------------------------------------------------------------------
[alpha]-Hydro-[omega]-hydroxy-              330985-58-5
 poly(oxyethylene) C10-C16-alkyl ether
 citrates, poly(oxyethylene) content is 4-
 12 moles, minimum number average
 molecular weight (in amu) 1,100
------------------------------------------------------------------------
[alpha]-Hydro-[omega]-hydroxy-              330985-61-0
 poly(oxyethylene) C16-C18-alkyl ether
 citrates, poly(oxyethylene) content is 4-
 12 moles, minimum number average
 molecular weight (in amu) 1,300
------------------------------------------------------------------------
[alpha]-Hydro-[omega]-                      25322-68-3
 hydroxypoly(oxyethylene), minimum number
 average molecular weight (in amu), 17,000
------------------------------------------------------------------------
[alpha]-Hydro-[omega]-                      None
 hydroxypoly(oxyethylene)poly
 (oxypropylene) poly(oxyethylene) block
 copolymer; the minimum poly(oxypropylene)
 content is 27 moles and the minimum
 molecular weight (in amu) is 1,900
------------------------------------------------------------------------
[alpha]-Hydro-[omega]-                      None
 hydroxypoly(oxypropylene); minimum
 molecular weight (in amu) 2,000
------------------------------------------------------------------------
12-Hydroxystearic acid-polyethylene glycol  70142-34-6
 copolymer, minimum number average
 molecular weight (in amu), 3,690
------------------------------------------------------------------------
Isodecyl alcohol ethoxylated (2-8 moles)    None
 polymer with chloromethyl oxirane,
 minimum number average molecular weight
 (in amu) 2,500
------------------------------------------------------------------------
Lauryl methacrylate-1,6-hexanediol          None
 dimethacrylate copolymer, minimum
 molecular weight (in amu), 100,000
------------------------------------------------------------------------
Maleic acid-butadiene copolymer             None
------------------------------------------------------------------------
Maleic acid monobutyl ester-vinyl methyl    25119-68-0
 ether copolymer, minimum average
 molecular weight (in amu), 52,000
------------------------------------------------------------------------
Maleic acid monoethyl ester-vinyl methyl    25087-06-3
 ether copolymer, minimum average
 molecular weight (in amu), 46,000
------------------------------------------------------------------------
Maleic acid monoisopropyl ester-vinyl       31307-95-6
 methyl ether copolymer, minimum average
 molecular weight (in amu), 49,000
------------------------------------------------------------------------
Maleic anhydride-diisobutylene copolymer,   37199-81-8
 sodium salt, minimum number average
 molecular weight (in amu) 5,0007-18,000
------------------------------------------------------------------------
Maleic anhydride-methylstyrene copolymer    60092-15-1
 sodium salt, minimum number average
 molecular weight (in amu), 15,000
------------------------------------------------------------------------
Maleic anhydride-methyl vinyl ether,        None
 copolymer, average molecular weight (in
 amu), 250,000
------------------------------------------------------------------------
Methacrylic acid-methyl methacrylate-       100934-04-1
 polyethylene glycol methyl ether
 methacrylate copolymer, minimum number
 averge molecular weight (in amu), 3,700
------------------------------------------------------------------------
Methacrylic acid-methyl methacrylate-       111740-36-4
 polyethylene glycol monomethyl ether
 methacrylate graft copolymer, minimum
 number average molecular weight (in amu),
 1,800
------------------------------------------------------------------------
Methacrylic copolymer, minimum number       63150-03-8
 average molecular weight (in amu), 15,000
------------------------------------------------------------------------

[[Page 731]]

 
Methyl methacrylate-methacrylic acid-       119724-54-8
 monomethoxypolyethylene glycol
 methacrylate copolymer,) minimum number
 average molecular weight (in amu), 2,730
------------------------------------------------------------------------
Methyl methacrylate-2-sulfoethyl            None
 methacrylate-
 dimethylaminoethylmethacrylate-glycidyl
 methacrylate-styrene-2-ethylhexyl
 acrylate graft copolymer, minimum average
 molecular weight (in amu), 9,600
------------------------------------------------------------------------
Methyl vinyl ether-maleic acid copolymer),  25153-40-6
 minimum number average molecular weight
 (in amu), 75,000
------------------------------------------------------------------------
Methyl vinyl ether-maleic acid copolymer,   62386-95-2
 calcium sodium salt, minimum number
 average molecular weight (in amu),
 900,000
------------------------------------------------------------------------
Monophosphate ester of the block copolymer  None
 [alpha]-hydro-[omega]-
 hydroxypoly(oxyethylene)
 poly(oxypropylene) poly(oxyethylene); the
 poly(oxypropylene) content averages 37-41
 moles, average molecular weight (in amu),
 8,000
------------------------------------------------------------------------
[alpha]-(p-Nonylphenyl)-[omega]-            None
 hydroxypoly(oxyethylene) mixture of
 dihydrogen phosphate and monohydrogen
 phosphate esters and the corresponding
 ammonium, calcium, magnesium,
 monoethanolamine, potassium, sodium, and
 zinc salts of the phosphate esters; the
 nonyl group is a propylene trimer isomer
 and the poly(oxyethylene) content
 averages 30 moles
------------------------------------------------------------------------
[alpha]-(p-Nonylphenyl)-[omega]-            None
 hydroxypoly(oxyethylene) sulfate, and its
 ammonium, calcium, magnesium,
 monoethanolamine, potassium, sodium, and
 zinc salts; the nonyl group is a
 propylene trimer isomer and the
 poly(oxyethylene) content averages 30-90
 moles of ethylene oxide
------------------------------------------------------------------------
[alpha]-(p-Nonylphenyl-[omega]-             None
 hydroxypoly(oxypropylene) block polymer
 with poly(oxyethylene); polyoxypropylene
 content of 10-60 moles; polyoxyethylene
 content of 10-80 moles; molecular weight
 (in amu), 1,200-7,100.
------------------------------------------------------------------------
[alpha]-([rho]-                             37251-69-7
 Nonylphenyl)poly(oxypropylene) block
 polymer with poly(oxyethylene); poly
 oxyethylene content 30 to 90 moles;
 minimum number average molecular weight
 (in amu), 1,889
------------------------------------------------------------------------
Octadecanoic acid, 12-hydroxy-,             58128-22-6),
 homopolymer, octadecanoate minimum number
 average molecular weight (in amu), 1,370
------------------------------------------------------------------------
[alpha]-cis-9-Octadecenyl-[omega]-          None
 hydroxypoly(oxyethylene); the octadecenyl
 group is derived from oleyl alcohol and
 the poly(oxyethylene) content averages 20
 moles
------------------------------------------------------------------------
Octadecyl acrylate-acrylic acid copolymer,  None
 octadecyl acrylate-dodecyl acrylate-
 acrylic acid copolymer, octadecyl
 methacrylate-butyl acrylate-acrylic acid
 copolymer, octadecyl methacrylate-hexyl
 acrylate-acrylic acid copolymer,
 octadecyl methacrylate-dodecyl acrylate-
 acrylic acid copolymer, or octadecyl
 methacrylate-dodecyl methacrylate-acrylic
 acid copolymer, minimum number average
 molecular weight (in amu) 3,000
------------------------------------------------------------------------
Oleic acid diester of [alpha]-hydro-        None
 [omega]-hydroxypoly(oxyethylene); the
 poly(oxyethylene), average molecular
 weight (in amu), 2,300
------------------------------------------------------------------------
2-oxepanone, homopolymer, minimum number    24980-41-4
 average molecular weight (in amu) 52,000
------------------------------------------------------------------------
Oxirane, decyl-, reaction products with     903890-89-1
 polyethylene-polypropylene glycol ether
 with trimethylolpropane (3:1)
------------------------------------------------------------------------
Oxirane, hexadecyl-, reaction products      893427-80-0
 with polyethylene-polypropylene glycol
 ether with trimethylolpropane (3:1)
------------------------------------------------------------------------
Oxirane, 2-methyl-, polymer with oxirane,   61419-46-3
 dimethyl ether, minimum number average
 molecular weight (in amu), 2,800
------------------------------------------------------------------------
Oxirane, methyl-, polymer with oxirane,     903890-90-4
 ether with 2-ethyl-2-(hydroxymethyl) -
 1,3 - propanediol (3:1), reaction
 products with tetradecyloxirane
------------------------------------------------------------------------

[[Page 732]]

 
Oxirane, methyl-, polymer with oxirane,     85637-75-8
 mono[2-(2-butoxyethoxy) ethyl] ether,
 minimum number average molecular weight
 (in amu), 2,500
------------------------------------------------------------------------
Oxirane, methyl-, polymer with Oxirane,     9038-95-3
 Monobutyl Ether
------------------------------------------------------------------------
Oxirane, 2-methyl-, polymer with oxirane,   9003-11-6
 minimum number average molecular weight
 (in amu), 1,100
------------------------------------------------------------------------
Oxirane, 2-methyl-, polymer with oxirane,   926031-36-9
 mono [2-[2-(2-
 butoxymethylethoxy)methylethoxy]methyleth
 yl] ether, minimum number average
 molecular weight (in amu), 3,000
------------------------------------------------------------------------
Polyamide polymer derived from sebacic      None
 acid, vegetable oil acids with or without
 dimerization, terephthalic acid and/or
 ethylenediamine
------------------------------------------------------------------------
Polyethylene glycol-polyisobutenyl          68650-28-2
 anhydride-tall oil fatty acid copolymer,
 minimum number average molecular weight
 (in amu), 2,960
------------------------------------------------------------------------
Polyethylene, oxidized, minimum number      None
 average molecular weight (in amu), 1,200
------------------------------------------------------------------------
Polymethylene polyphenylisocyanate,         None
 polymer with ethylene diamine, diethylene
 triamine and sebacoyl chloride, cross-
 linked; minimum number average molecular
 weight (in amu), 100,000
------------------------------------------------------------------------
Polyoxyalkylated glycerol fatty acid        61791-23-9, 68201-46-7,
 esters; the mono-, di-, or triglyceride     68440-49-3, 68458-88-8,
 mixtures of C8 through C22, primarily C8    68606-12-2, 68648-38-4,
 through C18 saturated and unsaturated,      70377-91-2, 70914-02-2,
 fatty acids containing up to 15% water by   72245-12-6, 72698-41-3,
 weight reacted with a minimum of three      180254-52-8, 248273-72-5,
 moles of either ethylene oxide or           308063-50-5, 952722-33-7
 propylene oxide; the resulting
 polyoxyalkylated glycerol ester polymer
 minimum number average molecular weight
 (in amu), 1,500
------------------------------------------------------------------------
Poly(oxy-1,2-ethanediyl), [alpha]-hydro-    39444-87-6
 [omega]-hydroxy-, polymer with 1, 1[min]-
 methylene-bis-[4-isocyanatocyclohexane],
 minimum number average molecular weight
 (in amu), 1800
------------------------------------------------------------------------
Polyoxyethylated primary amine (C14-C18);   None
 the fatty amine is derived from an animal
 source and contains 3% water; the
 poly(oxyethylene) content averages 20
 moles
------------------------------------------------------------------------
Polyoxyethylated sorbitol fatty acid        None
 esters; the polyoxyethylated sorbitol
 solution containing 15% water is reacted
 with fatty acids limited to C12, C14,
 C16, and C18, containing minor amounts of
 associated fatty acids; the
 poly(oxyethylene) content averages 30
 moles.
------------------------------------------------------------------------
Polyoxyethylated sorbitol fatty acid        None
 esters; the sorbitol solution containing
 up to 15% water is reacted with 20-50
 moles of ethylene oxide and aliphatic
 alkanoic and/or alkenoic fatty acids C8
 through C22 with minor amounts of
 associated fatty acids; the resulting
 polyoxyethylene sorbitol ester having a
 minimum molecular weight (in amu), 1,300
------------------------------------------------------------------------
Poly(oxyethylene/oxypropylene) monoalkyl    102900-02-7
 (C6-C10) ether sodium fumarate adduct,
 minimum number average molecular weight
 (in amu), 1,900
------------------------------------------------------------------------
Polyoxymethylene copolymer, minimum number  None
 average molecular weight (in amu), 15,000
------------------------------------------------------------------------
Poly(oxypropylene) block polymer with       None
 poly(oxyethylene), molecular weight (in
 amu), 1,800-16,000
------------------------------------------------------------------------
Poly(phenylhexylurea), cross-linked,        None
 minimum average molecular weight (in
 amu), 36,000
------------------------------------------------------------------------
Polypropylene                               9003-07-0
------------------------------------------------------------------------
Polystyrene, minimum number average         9003-53-6
 molecular weight (in amu), 50,000
------------------------------------------------------------------------
Polytetrafluoroethylene                     9002-84-0
------------------------------------------------------------------------
Polyvinyl acetate, copolymer with maleic    None
 anhydride, partially hydrolyzed, sodium
 salt, minimum number average molecular
 weight (in amu), 53,000
------------------------------------------------------------------------

[[Page 733]]

 
Polyvinylpyrrolidone butylated polymer,     26160-96-3
 minimum number average molecular weight
 (in amu), 9,500
------------------------------------------------------------------------
Polyvinyl acetate, minimum molecular        None
 weight (in amu), 2,000
------------------------------------------------------------------------
Polyvinyl acetate--polyvinyl alcohol        25213-24-5
 copolymer, minimum number average
 molecular weight (in amu), 50,000
------------------------------------------------------------------------
Polyvinyl alcohol                           9002-89-5
------------------------------------------------------------------------
Polyvinyl chloride                          None
------------------------------------------------------------------------
Polyvinyl chloride, minimum number average  9002-86-2
 molecular weight (in amu), 29,000
------------------------------------------------------------------------
Poly(vinylpyrrolidone), minimum number      9003-39-8
 average molecular weight (in amu), 4,000
------------------------------------------------------------------------
Poly(vinylpyrrolidone-1-eicosene), minimum  28211-18-9
 average molecular weight (in amu), 3,000
------------------------------------------------------------------------
Poly(vinylpyrrolidone-1-hexadecene),        63231-81-2
 minimum average molecular weight (in
 amu), 4,700
------------------------------------------------------------------------
1-propanesulfonic acid, 2-methyl-2-[(1-oxo- 107568-12-7
 2-propenyl)amino]-, monosodium salt,
 polymer with ethenol and ethenyl acetate,
 minimum number average molecular weight
 (in amu) 50,000
------------------------------------------------------------------------
2-Propene-1-sulfonic acid sodium salt,      None
 polymer with ethenol and ethenyl acetate,
 number average molecular weight (in amu)
 6,000-12,000
------------------------------------------------------------------------
2-propenoic acid, butyl ester, polymer      27306-39-4
 with ethenylbenzene, methyl 2-methyl-2-
 propenoate and 2-propenoic acid (in amu),
 1900.
------------------------------------------------------------------------
2-Propenoic acid, butyl ester, polymer      33438-19-6
 with ethyl 2-propenoate and N-
 (hydroxymethyl)-2-propenamide, minimum
 number average molecular weight (in amu),
 30,000
------------------------------------------------------------------------
2-Propenoic acid, 2-ethylhexyl ester,       25153-46-2
 polymer with ethenylbenzene 14,000
 daltons
------------------------------------------------------------------------
2-Propenoic acid, 2-ethylhexyl ester,       68240-06-2
 polymer with ethenylbenzene and 2-
 methylpropyl 2-methyl-2-propenoate,
 minimum number average molecular weight
 (in amu), 18,000
------------------------------------------------------------------------
2-Propenoic acid, 2-hydroxyethyl ester,     1007234-89-0
 polymer with [alpha]-[4-
 (ethenyloxy)butyl]-[omega]-hydroxypoly
 (oxy-1,2-ethanediyl), minimum number
 average molecular weight (in amu), 17,000
------------------------------------------------------------------------
[2-propenoic acid, 2-methyl-, C12-16-alkyl  950207-35-9
 esters, telomers with 1-dodecanethiol,
 polyethylene-polypropylene glycol ether
 with propylene glycol monomethacrylate
 (1:1), and styrene 2,2'-(1,2-
 diazenediyl)bis[2-methylbutanenitrile]-
 initiated, minimum number average
 molecular weight (in amu), 4,000.
------------------------------------------------------------------------
2-Propenoic acid, methyl ester, polymer     886993-11-9
 with ethenyl acetate, hydrolyzed, sodium
 salts
------------------------------------------------------------------------
2-Propenoic acid, 2-methyl-, 2-ethylhexyl   1283712-50-4
 ester, telomer with 1-dodecanethiol,
 ethenylbenzene and 2-methyloxirane
 polymer with oxirane monoether with 1,2-
 propanediol mono(2-methyl-2-propenoate),
 hydrogen 2-sulfobutanedioate, sodium
 salt, 2, 2[min]-(1,2-diazenediyl)bis[2-
 methylpropanenitrile]-initiated, minimum
 number average molecular weight (in amu),
 1,200.
------------------------------------------------------------------------
2-Propenoic acid, 2-methyl-, phenylmethyl   CASRN 1246766-57-3
 ester, polymer with 2-propenoic acid and
 sodium 2-methyl-2-[(1-oxo-2-propen-1-
 yl)amino]-1-propanesulfonate (1:1),
 peroxydisulfuric acid ([HO)S(O)2]202)
 sodium salt (1:2)-initiated minimum
 number average molecular weight  1,000 Daltons; maximum number average
 molecular weight 10,000 Daltons
------------------------------------------------------------------------
2-Propenoic acid, 2-methyl-, polymer with   25036-16-2
 butyl 2-propenoate and ethenylbenzene,
 minimum number average molecular weight
 (in amu), 17,000
------------------------------------------------------------------------

[[Page 734]]

 
2-Propenoic acid, 2-Methyl-, Polymer with   153163-36-1
 Butyl 2-Propenoate, Methyl 2-Methyl-2-
 Propenoate, Methyl 2-Propenoate and 2-
 Propenoic Acid, graft, Compound with 2-
 Amino-2-Methyl-1-Propanol
------------------------------------------------------------------------
2-Propenoic Acid, 2-Methyl-, Polymer with   146753-99-3
 Ethenylbenzene, 2-Ethylhexyl 2-
 Propenoate, 2-Hydroxyethyl 2-Propenoate,
 N-(Hydroxymethyl) -2-Methyl-2-Propenamide
 and Methyl 2-Methyl-2-Propenoate,
 Ammonium Salt
------------------------------------------------------------------------
2-Propenoic acid, 2-methyl-, polymers with  890051-63-5
 Bu acrylate, Et acrylate, Me methacrylate
 and polyethylene glycol methacrylate C16-
 18-alkyl ethers, minimum number average
 molecular weight (in amu), 13,000
------------------------------------------------------------------------
2-Propenoic acid, 2-methyl-, telomer with   1260001-65-7
 2-ethylhexyl 2-propenoate, 2-propanol and
 sodium 2-methyl-2-[(1-oxo-2-propen-1-yl)
 amino]-1-propanesulfonate (1:1), sodium
 salt, minimum number average molecular
 weight (in amu): 2,900
------------------------------------------------------------------------
2-Propenoic acid, monoester with 1,2-       955015-23-3
 propanediol, polymer with [alpha]-[4-
 (ethenyloxy) butyl]-[omega]-hydroxypoly
 (oxy-1,2-ethanediyl) and 2,5-furandione,
 minimum number average molecular weight
 (in amu), 25,000
------------------------------------------------------------------------
2-propenoic acid polymer, with 1,3-         25085-39-6
 butadiene and ethenylbenzene, minimum
 number average molecular weight (in amu),
 9400
------------------------------------------------------------------------
2-Propenoic acid, polymer with              129811-24-1
 ethenylbenzene and (1-methylethenyl)
 benzene, sodium salt, minimum number
 average molecular weight (in amu), 2,800
------------------------------------------------------------------------
2-Propenoic acid, polymer with [alpha]-[4-  251479-97-7
 (ethenyloxy) butyl]-[omega]-hydroxypoly
 (oxy-1,2-ethanediyl) and 2,5-furandione,
 sodium salt, minimum number average
 molecular weight (in amu), 25,000
------------------------------------------------------------------------
2-Propenoic acid, polymer with [alpha]-[4-  518026-64-7
 (ethenyloxy) butyl]-[omega]-hydroxypoly
 (oxy-1,2-ethanediyl) and 1,2-propanediol
 mono-2-propenoate, potassium sodium salt,
 minimum number average molecular weight
 (in amu), 16,000
------------------------------------------------------------------------
2-Propenoic acid, polymer with [alpha]-[4-  250591-84-5
 (ethenyloxy) butyl]-[omega]-hydroxypoly
 (oxy-1, 2-ethanediyl), sodium salt,
 minimum number average molecular weight
 (in amu), 24,000
------------------------------------------------------------------------
2-Propenoic acid, polymer with 2-           25085-02-3
 propenamide, sodium salt, minimum number
 average molecular weight (in amu), 18,000
------------------------------------------------------------------------
2-Propenoic acid, sodium salt, polymer      25987-30-8
 with 2-propenamide, minimum number
 average molecular weight (in amu), 18,000
------------------------------------------------------------------------
2-Propenoic, 2-methyl-, polymers with       888969-14-0
 ethyl acrylate and polyethylene glycol
 methylacrylate C18-22 alkyl ethers
------------------------------------------------------------------------
2-Pyrrolidone, 1-ethenyl-, polymer with     26008-54-8
 ethenol, minimum number average molecular
 weight (in amu), 23,000
------------------------------------------------------------------------
Silane, dichloromethyl- reaction product    68611-44-9
 with silica minimum number average
 molecular weight (in amu), 3,340,000
------------------------------------------------------------------------
Silane, trimethoxy[3-                       68584-82-7
 (oxiranylmethoxy)propyl]-, hydrolysis
 products with silica, minimum number
 average molecular weight (in amu),
 640,000
------------------------------------------------------------------------
Silicic acid, sodium salt, reaction         None
 products with chlorotrimethylsilane and
 iso-propyl alcohol, reaction with
 poly(oxypropylene)-poly(oxyethylene)
 glycol, minimum number average molecular
 weight (in amu), 75,000
------------------------------------------------------------------------
Sodium polyflavinoidsulfonate, consisting   None
 chiefly of the copolymer of catechin and
 leucocyanidin
------------------------------------------------------------------------
Soybean oil, ethoxylated; the               61791-23-9
 poly(oxyethylene) content averages 10
 moles or greater
------------------------------------------------------------------------
Starch, oxidized, polymers with Bu          204142-80-3
 acrylate, tert-Bu acrylate and styrene,
 minimum number average molecular weight
 (in amu), 10,000
------------------------------------------------------------------------

[[Page 735]]

 
Stearyl methacrylate-1,6-hexanediol         None
 dimethacrylate copolymer, minimum
 molecular weight (in amu), 100,000
------------------------------------------------------------------------
Styrene, copolymers with acrylic acid and/  None
 or methacrylic acid, with none and/or one
 or more of the following monomers:
 Acrylamidopropyl methyl sulfonic acid,
 methallyl sulfonic acid, 3-sulfopropyl
 acrylate, 3-sulfopropyl methacrylate,
 hydroxypropyl methacrylate, hydroxypropyl
 acrylate, hydroxyethyl methacrylate, and/
 or hydroxyethyl acrylate; and its sodium,
 potassium, ammonium, monoethanolamine,
 and triethanolamine salts; the resulting
 polymer having a minimum number average
 molecular weight (in amu), 1,200
------------------------------------------------------------------------
Styrene-ethylene-propylene block            108388-87-0
 copolymer, minimum number average
 molecular weight (in amu), 125,000
------------------------------------------------------------------------
Styrene, 2-ethylhexyl acrylate, butyl       30795-23-4
 acrylate copolymer, minimum number
 average molecular weight (in amu), 4,200
------------------------------------------------------------------------
Styrene-2-ethylhexyl acrylate-glycidyl      None
 methacrylate-2-acrylamido-2-
 methylpropanesulfonic acid graft
 copolymer, minimum number average
 molecular weight (in amu), 12,500
------------------------------------------------------------------------
Styrene-maleic anhydride copolymer          None
------------------------------------------------------------------------
Styrene-maleic anhydride copolymer, ester   None
 derivative
------------------------------------------------------------------------
Tetradecyl acrylate-acrylic acid            None
 copolymer, minimum number average
 molecular weight (in amu), 3,000
------------------------------------------------------------------------
Tetraethoxysilane, polymer with             104133-09-7
 hexamethyldisiloxane, minimum number
 average molecular weight (in amu), 2,500
------------------------------------------------------------------------
Tetraethoxysilane, polymer with             104133-09-7
 hexamethyldisiloxane, minimum number
 average molecular weight (in amu), 6,500
------------------------------------------------------------------------
[alpha]-[p-(1,1,3,3-                        9036-19-5
 Tetramethylbutyl)phenyl]-[omega]-          9002-93-1
 hydroxypoly(oxyethylene) produced by the
 condensation of 1 mole of p-(1,1,3,3-
 tetramethylbutyl)phenol with a range of
 30-70 moles of ethylene oxide
------------------------------------------------------------------------
[alpha]-[p-(1,1,3,3-                        None
 Tetramethylbutyl)phenyl]
 poly(oxypropylene) block polymer with
 poly(oxyethylene); the poly(oxypropylene)
 content averages 25 moles, the
 poly(oxyethylene) content averages 40
 moles, the molecular weight (in amu)
 averages 3,400
------------------------------------------------------------------------
[alpha]-[2,4,6-Tris[1-                      None
 (phenyl)ethyl]phenyl]-[omega]-hydroxy
 poly(oxyethylene) poly(oxypropylene)
 copolymer, the poly(oxypropylene) content
 averages 2-8 moles, the poly(oxyethylene)
 content averages 16-30moles, average
 molecular weight (in amu), 1,500
------------------------------------------------------------------------
Urea-formaldehyde copolymer, minimum        9011-05-6
 average molecular weight (in amu), 30,000
------------------------------------------------------------------------
Vinyl acetate-allyl acetate-monomethyl      None
 maleate copolymer, minimum average
 molecular weight (in amu), 20,000
------------------------------------------------------------------------
Vinyl acetate-ethylene copolymer, minimum   24937-78-8
 number average molecular weight (in amu),
 69,000
------------------------------------------------------------------------
Vinyl acetate polymer with none and/or one  None
 or more of the following monomers:
 Ethylene, propylene, N-methyl acrylamide,
 acrylamide, monoethyl maleate, diethyl
 maleate, monooctyl maleate, dioctyl
 maleate, maleic anhydride, maleic acid,
 octyl acrylate, butyl acrylate, ethyl
 acrylate, methyl acrylate, acrylic acid,
 octyl methacrylate, butyl methacrylate,
 ethyl methacrylate, methyl methacrylate,
 methacrylic acid, carboxyethyl acrylate,
 and diallyl phthalate; and their
 corresponding sodium, potassium,
 ammonium, isopropylamine, triethylamine,
 monoethanolamine and/or triethanolamine
 salts; the resulting polymer having a
 minimum number average molecular weight
 (in amu), 1,200
------------------------------------------------------------------------
Vinyl acetate-vinyl alcohol-alkyl lactone   None
 copolymer, minimum number average
 molecular weight (in amu), 40,000;
 minimum viscosity of 18 centipoise
------------------------------------------------------------------------

[[Page 736]]

 
Vinyl alcohol-disodium itaconate            None
 copolymer, minimum average molecular
 weight (in amu), 50,290
------------------------------------------------------------------------
Vinyl alcohol-vinyl acetate copolymer,      None
 benzaldehyde-o-sodium sulfonate
 condensate, minimum number average
 molecular weight (in amu), 20,000
------------------------------------------------------------------------
Vinyl alcohol-vinyl acetate-monomethyl      None
 maleate, sodium salt-maleic acid,
 disodium salt-[gamma]-butyrolactone
 acetic acid, sodium salt copolymer,
 minimum number average molecular weight
 (in amu), 20,000
------------------------------------------------------------------------
Vinyl chloride-vinyl acetate copolymers     None
------------------------------------------------------------------------
Vinyl pyrrolidone-acrylic acid copolymer,   28062-44-4
 minimum number average molecular weight
 (in amu), 6,000
------------------------------------------------------------------------
Vinyl pyrrolidone-                          30581-59-0
 dimethylaminoethylmethacrylate copolymer,
 minimum number average molecular weight
 (in amu), 20,000
------------------------------------------------------------------------
Vinyl pyrrolidone-styrene copolymer         25086-29-7
------------------------------------------------------------------------
------------------------------------------------------------------------


[67 FR 36528, May 24, 2002]

    Editorial Note: For Federal Register citations affecting Sec. 
180.960, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



Sec. 180.1011  Viable spores of the microorganism Bacillus thuringiensis 

Berliner; exemption from the requirement of a tolerance.

    (a) For the purposes of this section the microbial insecticide for 
which exemption from the requirement of a tolerance is being established 
shall have the following specifications:
    (1) The microorganism shall be an authentic strain of Bacillus 
thuringiensis Berliner conforming to the morphological and biochemical 
characteristics of Bacillus thuringiensis as described in Bergey's 
Manual of Determinative Bacteriology, Eighth Edition.
    (2) Spore preparations of Bacillus thuringiensis Berliner shall be 
produced by pure culture fermentation procedures with adequate control 
measures during production to detect any changes from the 
characteristics of the parent strain or contamination by other 
microorganisms.
    (3) Each lot of spore preparation, prior to the addition of other 
materials, shall be tested by subcutaneous injection of at least 1 
million spores into each of five laboratory test mice weighing 17 grams 
to 23 grams. Such test shall show no evidence of infection or injury in 
the test animals when observed for 7 days following injection.
    (4) Spore preparations shall be free of the Bacillus thuringiensis 
[beta]-exotoxin when tested with the fly larvae toxicity test 
(``Microbial Control of Insects and Mites,'' R.P.M. Bond et al., p. 280 
ff., 1971). This specification can be satisfied either by determining 
that each master seed lot brought into production is a Bacillus 
thuringiensis strain which does not produce [beta]-exotoxin under 
standard manufacturing conditions or by periodically determining that 
[beta]-exotoxin synthesized during spore production is eliminated by the 
subsequent spore-harvesting procedure.
    (b) Exemption from the requirement of a tolerance is established for 
residues of the microbial insecticide Bacillus thuringiensis Berliner, 
as specified in paragraph (a) of this section, in or on honey and 
honeycomb and all other raw agricultural commodities when it is applied 
either to growing crops, or when it is applied after harvest in 
accordance with good agricultural practices.

[36 FR 22540, Nov. 25, 1971, as amended at 38 FR 19045, July 17, 1973; 
42 FR 28540, June 3, 1977; 45 FR 43721, June 30, 1980; 45 FR 56347, Aug. 
25, 1980; 74 FR 26533, June 3, 2009]



Sec. 180.1016  Ethylene; exemption from the requirement of a tolerance.

    Ethylene is exempted from the requirement of a tolerance for 
residues when:

[[Page 737]]

    (a) For all food commodities, it is used as a plant regulator on 
plants, seeds, or cuttings and on all food commodities after harvest and 
when applied in accordance with good agricultural practices.
    (b) Injected into the soil to cause premature germination of 
witchweed in bean (lima and string), cabbage, cantaloupe, collard, corn, 
cotton, cucumber, eggplant, okra, onion, pasture grass, pea (field and 
sweet), peanut, pepper, potato, sweet potato, sorghum, soybean, squash, 
tomato, turnip, and watermelon fields as part of the U.S. Department of 
Agriculture witchweed control program.

[39 FR 33315, Sept. 17, 1974, as amended at 40 FR 19477, May 5, 1975; 64 
FR 31505, June 11, 1999]



Sec. 180.1017  Diatomaceous earth; exemption from the requirement of a 

tolerance.

    (a) Diatomaceous earth is exempted from the requirement of a 
tolerance for residues when used in accordance with good agricultural 
practice in pesticide formulations applied to growing crops, to food 
commodities after harvest, and to animals.
    (b) Diatomaceous earth may be safely used in accordance with the 
following conditions. Application shall be limited solely to spot and/or 
crack and crevice treatments in food or feed processing and food or feed 
storage areas in accordane with the precribed conditions:
    (1) It is used or intended for use for control of insects in food or 
feed processing and food or feed storage areas: Provided, That the food 
or feed is removed or covered prior to such use.
    (2) To assure safe use of the insecticide, its label and labeling 
shall conform to that registered by the U.S. Environmental Protection 
Agency, and it shall be used in accordance with such label and labeling.

[65 FR 33716, May 24, 2000]



Sec. 180.1019  Sulfuric acid; exemption from the requirement of a tolerance.

    (a) Residues of sulfuric acid are exempted from the requirement of a 
tolerance when used in accordance with good agricultural practice when 
used as a herbicide in the production of garlic and onions, and as a 
potato vine dessicant in the production of potatoes.
    (b) Residues of sulfuric acid are exempted from the requirement of a 
tolerance in cattle, meat; goat, meat; hog, meat; horse, meat; sheep, 
meat; poultry, fat; poultry, meat; poultry, meat, byproducts; egg; milk; 
fish, shellfish, and irrigated crops when it results from the use of 
sulfuric acid as an inert ingredient in a pesticide product used in 
irrigation conveyance systems and lakes, ponds, reservoirs, or bodies of 
water in which fish or shellfish are cultivated. The sulfuric acid is 
not to exceed 10% of the pesticide formulation (non-aerosol formulations 
only).

[69 FR 40787, July 7, 2004, as amended at 74 FR 26533, June 3, 2009]



Sec. 180.1020  Sodium chlorate; exemption from the requirement of a tolerance.

    Sodium chlorate is exempted from the requirement of a tolerance for 
residues when used as a defoliant or desiccant in accordance with good 
agricultural practice on the following crops:

Bean, dry, seed
Corn, field, forage
Corn, field, grain
Corn, field, stover
Corn, pop, grain
Corn, pop, stover
Corn, sweet, forage
Corn, sweet, stover
Cotton, undelinted seed
Flax, seed
Grain, aspirated fractions
Guar, seed
Pea, southern
Pepper, nonbell
Potato
Rice, grain
Rice, straw
Safflower, seed
Sorghum, forage, forage
Sorghum, grain, forage
Sorghum, grain, grain
Sorghum, grain, stover
Soybean, forage
Soybean, hay
Soybean, seed
Sunflower, seed
Wheat, grain

[74 FR 47457, Sept. 16, 2009]

[[Page 738]]



Sec. 180.1021  Copper; exemption from the requirement of a tolerance.

    (a) Copper is exempted from the requirement of a tolerance in 
cattle, meat; goat, meat; hog, meat; horse, meat; sheep, meat; milk, 
poultry, fat; poultry, meat; poultry, meat byproducts; egg, fish, 
shellfish, and irrigated crops when it results from the use of:
    (1) Copper sulfate as an algicide or herbicide in irrigation 
conveyance systems and lakes, ponds, reservoirs, or bodies of water in 
which fish or shellfish are cultivated.
    (2) Basic copper carbonate (malachite) as an algicide or herbicide 
in impounded and stagnant bodies of water
    (3) Copper triethanolamine and copper monoethanolamine as an 
algicide or herbicide in fish hatcheries, lakes, ponds, and reservoirs
    (4) Cuprous oxide bearing antifouling coatings for control of algae 
or other coatings for control of algae or other organisms on submerged 
concrete or other (irrigation) structures.
    (b) The following copper compounds are exempt from the requirement 
of a tolerance when applied (primarily) as a fungicide to growing crops 
using good agricultural practices:

------------------------------------------------------------------------
                Copper compounds                       CAS Reg. No.
------------------------------------------------------------------------
Basic copper carbonate (malachite).............                1184-64-1
Copper ammonia complex.........................               16828-95-8
Copper ethylenediamine complex.................               13426-91-0
Copper hydroxide...............................               20427-59-2
Copper octanoate...............................               20543-04-8
Copper oxychloride.............................                1332-65-6
Copper oxychloride sulfate.....................                8012-69-9
Copper salts of fatty and rosin acids..........                9007-39-0
Copper sulfate basic...........................                1344-73-6
Copper sulfate pentahydrate....................                7758-99-8
Cuprous oxide..................................                1317-19-1
------------------------------------------------------------------------

    (c) Copper sulfate pentahydrate (CAS Reg. No. 7758-99-8) is exempt 
from the requirement of a tolerance when applied as a fungicide to 
growing crops or to raw agricultural commodities after harvest, and as a 
bactericide/fungicide in or on meat, fat and meat by-products of cattle, 
sheep, hogs, goats, horses and poultry, milk and eggs when applied as a 
bactericide/fungicide to animal premises and bedding.
    (d) Copper (II) hydroxide (CAS Reg. No. 20427-59-2) is exempt from 
the requirement of a tolerance when applied to growing crops or to raw 
agricultural commodities as an inert ingredient (for pH control) in 
pesticide products.

[65 FR 68912, Nov. 15, 2000, as amended at 69 FR 4069, Jan. 28, 2004; 71 
FR 46110, Aug. 11, 2006; 74 FR 26534, June 3, 2009; 74 FR 47457, Sept. 
16, 2009]



Sec. 180.1022  Iodine-detergent complex; exemption from the requirement of a 

tolerance.

    The aqueous solution of hydriodic acid and elemental iodine, 
including one or both of the surfactants (a) polyoxypropylene-
polyoxyethylene glycol nomionic block polymers (minimum average 
molecular weight 1,900) and (b) [alpha]-(p- nonylphenyl)-omega- 
hydroxypoly (oxyethylene) having a maximum average molecular weight of 
748 and in which the nonyl group is a propylene trimer isomer, is 
exempted from the requirement of a tolerance for residues in egg, and 
poultry, fat; poultry, meat; poultry, meat byproducts when used as a 
sanitizer in poultry drinking water.

[74 FR 26534, June 3, 2009]



Sec. 180.1023  Propanoic acid; exemptions from the requirement of a tolerance.

    (a) Postharvest application of propanoic acid or a mixture of 
methylene bispropionate and oxy(bismethylene) bisproprionate when used 
as a fungicide is exempted from the requirement of a tolerance for 
residues in or on the following raw agricultural commodities: Alfalfa, 
forage; alfalfa, hay; alfalfa, seed; barley, grain; Bermudagrass, 
forage; Bermudagrass, hay; bluegrass, forage; bluegrass, hay; 
bromegrass, forage; bromegrass, hay; clover, forage; clover, hay; corn, 
field, grain; corn, pop, grain; cowpea, hay; fescue, forage; fescue, 
hay; lespedeza, forage; lespedeza, hay; lupin; oat, grain; orchardgrass, 
forage; orchardgrass, hay; peanut, hay; pea, field, hay; ryegrass, 
Italian, hay; sorghum, grain, grain; soybean, hay; sudangrass, forage; 
sudangrass, hay; timothy, forage; timothy, hay; vetch, forage; vetch, 
hay; and wheat, grain.
    (b) Propanoic acid is exempt from the requirement of a tolerance for 
residues

[[Page 739]]

in or on cattle, meat; cattle, meat byproducts; goat, meat; goat, meat 
byproducts; hog, meat; hog meat byproducts; horse, meat; horse, meat 
byproducts; sheep, meat; sheep meat byproducts; and, poultry, fat; 
poultry meat; poultry meat byproducts; milk, and egg when applied as a 
bactericide/fungicide to livestock drinking water, poultry litter, and 
storage areas for silage and grain.
    (c) Preharvest and postharvest application of propanoic acid (CAS 
Reg. No. 79-09-4), propanioc acid, calcium salt (CAS Reg. No. 4075-81-
4), and propanioc sodium salt (CAS Reg. No. 137-40-6) are exempted from 
the requirement of a tolerance on all crops when used as either an 
active or inert ingredient in accordance with good agricultural practice 
in pesticide formulations applied to growing crops, to raw agricultural 
commodities before and after harvest and to animals.

[69 FR 47025, Aug. 4, 2004, as amended at 74 FR 26534, June 3, 2009]



Sec. 180.1025  Xylene; exemption from the requirement of a tolerance.

    Xylene is exempted from the requirement of a tolerance when used as 
an aquatic herbicide applied to irrigation conveyance systems in 
accordance with the following conditions:
    (a) It is to be used only in programs of the Bureau of Reclamation, 
U.S. Department of Interior, and cooperating water user organizations.
    (b) It is to be applied as an emulsion at an initial concentration 
not to exceed 750 parts per million.
    (c) It is not to be applied when there is any likelihood that the 
irrigation water will be used as a source of raw water for a potable 
water system or where return flows of such treated irrigation water into 
receiving rivers and streams would contain residues of xylene in excess 
of 10 parts per million.
    (d) Xylene to be used as an aquatic herbicide shall meet the 
requirement limiting the presence of a polynuclear aromatic hydrocarbons 
as listed in 21 CFR 172.250.

[38 FR 16352, June 22, 1973, as amended at 50 FR 2980, Jan. 3, 1985]



Sec. 180.1027  Nuclear polyhedrosis virus of Heliothis zea; exemption from the 

requirement of a tolerance.

    (a) For the purposes of this section, the viral insecticide must be 
produced with an unaltered and unadulterated inoculum of the single-
embedded Heliothis zea nuclear polyhedrosis virus (HzSNPV). The identity 
of the seed virus must be assured by periodic checks.
    (b) Each lot of active ingredient of the viral insecticide shall 
have the following specifications:
    (1) The level of extraneous bacterial contamination of the final 
unformulated viral insecticide should not exceed 10\7\ colonies per gram 
as determined by an aerobic plate on trypticase soy agar.
    (2) Human pathogens, e.g., Salmonella, Shigella, or Vibrio, must be 
absent.
    (3) Safety to mice as determined by an intraperitoneal injection 
study must be demonstrated.
    (4) Identity of the viral product, as determined by the most 
sensitive and standardized analytical technique, e.g., restriction 
endonuclease and/or SDS-PAGE analysis, must be demonstrated.
    (c) Exemptions from the requirement of a tolerance are established 
for the residues of the microbial insecticide Heliothis zea NPV, as 
specified in paragraphs (a) and (b) of this section, in or on all 
agricultural commodities.

[60 FR 42460, Aug. 16, 1995, as amended at 74 FR 26534, June 3, 2009]



Sec. 180.1033  Methoprene; exemption from the requirement of a tolerance.

    Methoprene is exempt from the requirement of a tolerance in or on 
all food commodities when used to control insect larvae.

[68 FR 34829, June 11, 2003]



Sec. 180.1037  Polybutenes; exemption from the requirement of a tolerance.

    (a) Polybutenes are exempt from the requirement of a tolerance for 
residues in or on the raw agricultural commodity cotton, undelinted seed 
when used as a sticker agent for formulations of the attractant 
gossyplure (1:1

[[Page 740]]

mixture of (Z,Z)- and (Z,E)-7,11-hexadecadien-1-ol acetate) to disrupt 
the mating of the pink bollworm.
    (b) Polybutenes are exempt from the requirement of a tolerance for 
residues in or on the raw agricultural commodity artichoke when used as 
a sticker agent in multi-layered laminted controlled-release dispensers 
of (Z)-11-hexaadecenal to disrupt the mating of the artichoke plume 
moth.

[74 FR 26534, June 3, 2009]



Sec. 180.1040  Ethylene glycol; exemption from the requirement of a tolerance.

    Ethylene glycol as a component of pesticide formulations is exempt 
from the requirement of a tolerance when used in foliar applications to 
peanut plants.

[43 FR 41393, Sept. 18, 1978]



Sec. 180.1041  Nosema locustae; exemption from the requirement of a tolerance.

    The insecticide Nosema locustae is exempted from the requirement of 
a tolerance for residues in or on all raw agricultural commodities.

[47 FR 21537, May 19, 1982]



Sec. 180.1043  Gossyplure; exemption from the requirement of a tolerance.

    The pheromone gossyplure, a 1:1 mixture of (Z,Z)- and (Z,E)-7,11-
hexadecadien-1-ol acetate) is exempt from the requirement of a tolerance 
in or on the raw agricultural commodity cotton, undelinted seed when 
applied to cotton from capillary fibers.

[74 FR 26534, June 3, 2009]



Sec. 180.1049  Carbon dioxide; exemption from the requirement of a tolerance.

    The insecticide carbon dioxide is exempted from the requirement of a 
tolerance when used after harvest in modified atmospheres for stored 
insect control on food commodities.

[65 FR 33716, May 24, 2000]



Sec. 180.1050  Nitrogen; exemption from the requirements of a tolerance.

    The insecticide nitrogen is exempted from the requirements of a 
tolerance when used after harvest in modified atmospheres for stored 
product insect control on all food commodities.

[65 FR 33716, May 24, 2000]



Sec. 180.1052  2,2,5-trimethyl-3-dichloro acetyl-1,3-oxazolidine; exemption 

from the requirement of a tolerance.

    2,2,5-trimethyl-3-dichloroacetyl-1,3-oxazolidine is exempted from 
the requirement of a tolerance when used as an inert ingredient in 
formulations of the herbicides S-ethyl dipropylthiocarbamate, S-propyl 
dipropylthiocarbamate, and S-ethyl diisobutylthiocarbamate applied to 
corn fields before the corn plants emerge from the soil with a maximum 
of 0.5 pound of the inert ingredient per acre.

[45 FR 51201, Aug. 1, 1980]



Sec. 180.1054  Calcium hypochlorite; exemptions from the requirement of a 

tolerance.

    (a) Calcium hypochlorite is exempted from the requirement of a 
tolerance when used preharvest or postharvest in solution on all raw 
agricultural commodities.
    (b) Calcium hypochlorite is exempted from the requirement of a 
tolerance in or on grape when used as a fumigant postharvest by means of 
a chlorine generator pad.

[59 FR 59165, Nov. 16, 1994, as amended at 74 FR 26534, June 3, 2009]



Sec. 180.1056  Boiled linseed oil; exemption from requirement of tolerance.

    Boiled linseed oil (containing no more than 0.33 percent manganese 
naphthenate and no more than 0.33 percent cobalt naphthenate) is exempt 
from the requirement of a tolerance when used as a coating agent for S-
ethyl hexahydro-1H-azepine-1-carbothioate. No more than 15 percent of 
the pesticide formulation may consist of ``boiled linseed oil.'' This 
exemption is limited to use on rice before edible parts form.

[46 FR 33270, June 29, 1981]

[[Page 741]]



Sec. 180.1057  Phytophthora palmivora; exemption from requirement of 

tolerance.

    Phytophthora palmivora is exempted from the requirement of a 
tolerance in or on the raw agricultural commodity fruit, citrus.

[74 FR 26534, June 3, 2009]



Sec. 180.1058  Sodium diacetate; exemption from the requirement of a 

tolerance.

    Sodium diacetate, when used postharvest as a fungicide, is exempt 
from the requirement of a tolerance for residues in or on alfalfa, hay; 
Bermudagrass, hay; bluegrass, hay; bromegrass, hay; clover,hay; corm, 
field, grain; corn, pop, grain; oat, grain; orchardgrass, hay; sorghum, 
grain, grain; sudangrass, hay; ryegrass, Italian, hay; timothy, hay.

[74 FR 26534, June 3, 2009]



Sec. 180.1064  Tomato pinworm insect pheromone; exemption from the requirement 

of a tolerance.

    An exemption from the requirement of a tolerance is established for 
combined residues of both components of the tomato pinworm insect 
pheromone (E)-4-tridecen-1-yl acetate and (Z)-4-tridecen-1-yl acetate in 
or on all raw agricultural commodities (preharvest) in accordance with 
the following prescribed conditions:
    (a) Application shall be limited solely to point source dispensers 
or point source chopped fibers containing the tomato pinworm insect 
pheromone.
    (b) Cumulative yearly application cannot exceed 200 grams of tomato 
pinworm pheromone per acre.

[58 FR 34376, June 25, 1993]



Sec. 180.1065  2-Amino-4,5-dihydro-6-methyl-4-propyl-s-triazolo(1,5-

alpha)pyrimidin-5-one; exemption from the requirement of a tolerance.

    The inert ingredient, 2-amino-4,5-dihydro-6-methyl-4-propyl-s-
triazolo(1,5-alpha)pyrimidin-5-one is exempted from the requirement of a 
tolerance when used as an emetic at not more than 0.3 percent in 
formulations of paraquat dichloride. Further restrictions on this 
exemption are that this ingredient may not be advertised as an emetic 
and the paraquat product may not be promoted in any way because of the 
inclusion of this inert ingredient.

[70 FR 46431, Aug. 10, 2005]



Sec. 180.1067  Methyl eugenol and malathion combination; exemption from the 

requirement of a tolerance.

    The insect attractant methyl eugenol and the insecticide malathion 
are exempt from the requirement of tolerances on all raw agricultural 
commodities when used in combination in Oriental fruit fly eradication 
programs under the authority of the U.S. Department of Agriculture, in 
accordance with the following directions and specifications:
    (a) The combination shall be at the ratio of three parts methyl 
eugenol to one part technical malathion (3:1).
    (b) This combination is to be impregnated on a carrier (cigarette 
filter tips (cellulose acetate); cotton strings; fiberboard squares) or 
mixed with a jel cleared under 40 CFR 180.920 or 180.950.
    (c) The maximum actual dosage per application per acre shall be 
28.35 grams (one ounce avoirdupois) methyl eugenol and 9.45 grams (one-
third (0.33) ounce avoirdupois) technical malathion.

[47 FR 9002, Mar. 3, 1982, as amended at 69 FR 23142, Apr. 28, 2004]



Sec. 180.1068  C12-C18 fatty acid potassium salts; exemption from the 

requirement of a tolerance.

    C12-C18 fatty acids (saturated and 
unsaturated) potassium salts are exempted from the requirement of a 
tolerance for residues in or on all raw agricultural commodities when 
used in accordance with good agricultural practice.

[60 FR 34871, July 5, 1995]



Sec. 180.1069  (Z)-11-Hexadecenal; exemption from the requirement of a 

tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the biological insecticide (pheromone) (Z)-11-hexadecenal 
when used as a sex attractant on artichoke

[[Page 742]]

plants to control the artichoke plume moth.

[47 FR 14906, Apr. 7, 1982]



Sec. 180.1070  Sodium chlorite; exemption from the requirement of a tolerance.

    Sodium chlorite is exempted from the requirement of a tolerance for 
residues when used in accordance with good agricultural practice as a 
seed-soak treatment in the growing of the raw agricultural commodities 
vegetable, brassica, leafy, group 5 and radish, roots and radish, tops.

[74 FR 26534, June 3, 2009]



Sec. 180.1071  Peanuts, Tree Nuts, Milk, Soybeans, Eggs, Fish, Crustacea, and 

Wheat; exemption from the requirement of a tolerance.

    (a) General. Residues resulting from the following uses of the food 
commodity forms of peanuts, tree nuts, milk, soybeans, eggs (including 
putrescent eggs), fish, crustacea, and wheat are exempted from the 
requirement of a tolerance in or on all food commodities under FFDCA 
section 408 (when used as either an inert or an active ingredient in a 
pesticide formulation), if such use is in accordance with good 
agricultural practices:
    (1) Use in pesticide products intended to treat seeds.
    (2) Use in nursery and greenhouse operations, as defined in 40 CFR 
170.3, which includes seeding, potting and transplanting activities.
    (3) Pre-plant and at-transplant applications.
    (4) Incorporation into seedling and planting beds.
    (5) Applications to cuttings and bare roots.
    (6) Applications to the field that occur after the harvested crop 
has been removed.
    (7) Soil-directed applications around and adjacent to all plants.
    (8) Applications to rangelands, which is land, mostly grasslands, 
whose plants can provide food (i.e., forage) for grazing or browsing 
animals.
    (9) Use in chemigation and irrigation systems (via flood, drip, or 
furrow application with no overhead spray applications).
    (10) Application as part of a dry fertilizer on which an active 
ingredient is impregnated.
    (11) Aerial and ground applications that occur when no above-ground 
harvestable food commodities are present (usually pre-bloom).
    (12) Application as part of an animal feed-through product.
    (13) Applications as gel and solid (non-liquid/non-spray) crack and 
crevice treatments that place the gel or bait directly into or on top of 
the cracks and crevices via a mechanism such as a syringe.
    (14) Applications to the same crop from which the food commodity is 
derived, whether the plant fraction(s) intended for harvest are present 
or not, e.g., applications of peanut meal when applied to peanut plants.
    (b) Specific chemical substances. Residues resulting from the use of 
the following substances as either an inert or an active ingredient in a 
pesticide formulation are exempted from the requirement of a tolerance 
under FFDCA section 408, if such use is in accordance with good 
agricultural practices and such use is included in paragraph (a):

------------------------------------------------------------------------
                  Chemical Substance                        CAS No.
------------------------------------------------------------------------
Caseins..............................................          9000-71-9
Caseins, ammonium complexes..........................          9005-42-9
Caseins, hydrolyzates................................         65072-00-6
Caseins, potassium complexes.........................         68131-54-4
Caseins, sodium complexes............................          9005-46-3
------------------------------------------------------------------------


[70 FR 1360, Jan. 7, 2005]



Sec. 180.1072  Poly-D-glucosamine (chitosan); exemption from the requirement 

of a tolerance.

    (a) An exemption from the requirement of a tolerance is established 
for residues of the biological plant growth regulator poly-D-glucosamine 
when used as a seed treatment in or on barley, beans, oats, peas, rice, 
and wheat.
    (b) An exemption from the requirement of a tolerance is established 
for residues of the biological plant growth regulator poly-D-glucosamine 
when used as a pesticide in the production any raw agricultural 
commodity.

[60 FR 19524, Apr. 19, 1995]

[[Page 743]]



Sec. 180.1073  Isomate-M; exemption from the requirement of a tolerance.

    The oriental fruit moth pheromone (Isomate-M) (Z-8-dodecen-l-yl 
acetate, E-8-dodecen-l-yl acetate, Z-8-dodecen-l-ol) is exempt from the 
requirement of a tolerance in or on all the raw agricultural commodities 
(food and feed) including, peach; quince; nectarine; and nut, macadamia 
when used in orchards with encapsulated polyethylene tubing to control 
oriental fruit moth.

[74 FR 26534, June 3, 2009]



Sec. 180.1074  F.D.&C. Blue No. 1; exemption from the requirement of a 

tolerance.

    F.D.&C. Blue No. 1 is exempted from the requirement of a tolerance 
when used as an aquatic plant control agent.

[47 FR 25963, June 16, 1982]



Sec. 180.1075  Colletotrichum gloeosporioides f. sp. aeschynomene; exemption 

from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the mycoherbicide Colletotrichum gloeosporioides f. sp. 
aeschynomene in or on the following raw agricultural commodities:

                                Commodity

Aspirated grain fractions
Rice, grain
Soybean, forage
Soybean, hay
Soybean, seed

[47 FR 25742, June 15, 1982, as amended at 74 FR 26534, June 3, 2009]



Sec. 180.1076  Viable spores of the microorganism Bacillus popilliae; 

exemption from the requirement of a tolerance.

    (a) For the purposes of this section the microbial insecticide for 
which exemption from the requirement of a tolerance is being established 
shall have the following specifications:
    (1) The microorganism shall be an authentic strain of Bacillus 
popilliae conforming to the morphological and biochemical 
characteristics of Bacillus popilliae as described in Bergey's Manual of 
Determinative Bacteriology, Eighth Edition.
    (2) Spore preparations of Bacillus popilliae shall be produced by an 
extraction process from diseased Japanese beetles, and may contain a 
small percentage of the naturally occurring milky disease bacterium 
Bacillus lentimorbus.
    (3) Each lot of spore preparation, prior to the addition of other 
materials, shall be tested by subcutaneous injection of at least 1 
million spores into each of five laboratory test mice weighing 17 grams 
to 23 grams. Such test shall show no evidence of infection of injury in 
the test animals when observed for 7 days following injection.
    (b) Exemption from the requirement of a tolerance is established for 
residues of the microbial insecticide Bacillus popilliae, as specified 
in paragraph (a) of this section in or on grass, pasture, forage and 
grass, rangeland, forage when it is applied to growing crops in 
accordance with good agricultural practices.

[47 FR 38535, Sept. 1, 1982, as amended at 74 FR 26535, June 3, 2009]



Sec. 180.1080  Plant volatiles and pheromone; exemptions from the requirement 

of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the plant volatiles cyclic decadiene, cyclic decene, cyclic 
pentadecatriene, and decatriene and the pheromone Z-2-isopropenyl-1-
methylcyclobutaneethanol; Z-3,3-dimethyl-[Delta]1,[beta]-
cyclohexaneethanol; Z-3,3-dimethyl-[Delta]1,[alpha]-cyclohexaneethanal; 
E-3,3-dimethyl-[Delta]1,[alpha]-cyclohexaneethanal combination when 
applied to cotton in hollow synthetic fibers.

[48 FR 28442, June 22, 1983]



Sec. 180.1083  Dimethyl sulfoxide; exemption from the requirement of a 

tolerance.

    Dimethyl sulfoxide (DMSO) [CAS Registry Number 67-68-5] is exempted 
from the requirement of a tolerance when used as an inert solvent or 
cosolvent in formulations with the following pesticides when used in 
accordance with good agricultural practices in or on the following raw 
agricultural commodities:
    (a) Carbaryl (1-naphthyl methyl-carbamate)


[[Page 744]]


Pea, dry, seed
Pea, succulent

    (b) O-O-Diethyl O-(2-isopropyl-6-methyl-4-pyrimidinyl) 
phosphorothioate

Pea, dry, seed
Pea, succulent

[48 FR 54819, Dec. 7, 1983, as amended at 74 FR 26535, June 3, 2009]



Sec. 180.1084  Monocarbamide dihydrogen sulfate; exemption from the 

requirement of a tolerance.

    Monocarbamide dihydrogen sulfate is exempted from the requirement of 
a tolerance when used as a herbicide or desiccant in or on all raw 
agricultural commodities.

[53 FR 12152, Apr. 13, 1988]



Sec. 180.1086  3,7,11-Trimethyl-1,6,10-dodecatriene-1-ol and 3,7,11-trimethyl-

2,6,10-dodecatriene-3-ol; exemption from the requirement of a tolerance.

    The insect pheromone containing the active ingredients 3,7,11-
trimethyl-1,6,10-dodecatriene-1-ol and 3,7,11-trimethyl-2,6,10-
dodecatriene-3-ol is exempted from the requirement of a tolerance in or 
on all raw agricultural commodities.

[52 FR 12165, Apr. 15, 1987; 52 FR 29014, Aug. 5, 1987]



Sec. 180.1087  Sesame stalks; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the biorational nematicide sesame stalk in or on the 
following raw agricultural commodities: Almond; almond, hulls; cotton, 
undelinted seed; cotton, gin byproducts; soybean, seed; soybean, forage; 
soybean, hay; aspirated grain fractions; potato; beet, sugar, roots; 
beet, sugar, tops; tomato; pepper, bell; squash; strawberry; eggplant; 
cucumber; carrot, roots; radish, roots; radish, top; turnip, roots; 
turnip, tops; onion; pea, dry; pea, succulent; melon; grape; walnut; 
orange; grapefruit; mulberry; peach; apple; apricot; blackberry; 
loganberry; pecan; cherry; plum, and cranberry.

[74 FR 26535, June 3, 2009]



Sec. 180.1089  Poly-N-acetyl-D-glucosamine; exemption from the requirement of 

tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the biochemical nematicide poly-N-acetyl-D-glucosamine on a 
variety of agricultural crops.

[53 FR 10249, Mar. 30, 1988]



Sec. 180.1090  Lactic acid; exemption from the requirement of a tolerance.

    Lactic acid (2-hydroxypropanoic acid) is exempted from the 
requirement of a tolerance when used as a plant growth regulator in or 
on all raw agricultural commodities.

[53 FR 15286, May 4, 1988]



Sec. 180.1091  Aluminum isopropoxide and aluminum secondary butoxide; exemption from the requirement of a tolerance.

    Aluminum isopropoxide (CAS Reg. No. 555-31-7) and aluminum secondary 
butoxide (CAS Reg. No. 2269-22-9) are exempted from the requirement of a 
tolerance when used in accordance with good agricultural practices as 
stabilizers in formulations of the insecticide amitraz [N'-(2,4-
dimethylphenyl)-N-[[(2,4-dimethylphenyl)imino]-N-methylmethanimidamide] 
applied to growing crops or animals.

[53 FR 34509, Sept. 7, 1988; 53 FR 36696, Sept. 21, 1988]



Sec. 180.1092  Menthol; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the pesticidal chemical menthol in or on honey and honeycomb 
when used in accordance with good agricultural practice in over-
wintering bee hives.

[74 FR 26535, June 3, 2009]



Sec. 180.1095  Chlorine gas; exemptions from the requirement of a tolerance.

    Chlorine gas is exempted from the requirement of a tolerance when 
used preharvest or postharvest in solution on all raw agricultural 
commodities.

[56 FR 21309, May 8, 1991]

[[Page 745]]



Sec. 180.1097  GBM-ROPE; exemption from the requirement of a tolerance.

    The grape berry moth pheromone (GBM-ROPE) containing the active 
ingredients (Z)-9-dedecenyl acetate and (Z)-11-tetradecenyl acetate is 
exempt from the requirement of a tolerance in or on the raw agricultural 
commodity grape when used in orchards with encapsulated polyethylene 
tubing to control grape berry moth.

[74 FR 26535, June 3, 2009]



Sec. 180.1098  Gibberellins [Gibberellic Acids (GA3 and GA4 + GA7), and Sodium 

or Potassium Gibberellate]; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of gibberellins [gibberellic acids (GA3 and GA4 + GA7), and 
sodium or potassium gibberellate] in or on all food commodities when 
used as plant regulators on plants, seeds, or cuttings and on all food 
commodities after harvest in accordance with good agricultural 
practices.

[64 FR 31505, June 11, 1999]



Sec. 180.1100  Gliocladium virens isolate GL-21; exemption from the 

requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the biofungicide Gliocladium virens GL-21 in or on all raw 
agricultural commodities when used either as a fungicide for inoculation 
of plant growth media in greenhouses or on terrestrial food crops grown 
outdoors in accordance with good agricultural practices.

[60 FR 48659, Sept. 20, 1995; 60 FR 52248, Oct. 5, 1995]



Sec. 180.1101  Parasitic (parasitoid) and predatory insects; exemption from 

the requirement of a tolerance.

    Parasitic (parasitoid) and predatory insects are exempted from the 
requirement of a tolerance for residues when they are used in accordance 
with good agricultural and pest control practices to control insect 
pests of stored raw whole grains such as corn, small grains, rice, 
soybeans, peanuts, and other legumes either bulk or warehoused in bags. 
For the purposes of this rule, the parasites (parasitoids) and predators 
are considered to be species of Hymenoptera in the genera Trichogramma, 
Trichogrammatidae; Bracon, Braconidae; Venturia, Mesostenus, 
Ichneumonidae; Anisopteromalus, Choetospila, Lariophagus, Dibrachys, 
Habrocytus, Pteromalus, Pteromalidae; Cephalonomia, Holepyris, Laelius, 
Bethylidae; and of Hemiptera in the genera Xylocoris, Lyctocoris, and 
Dufouriellus, Anthocoridae. Whole insects, fragments, parts, and other 
residues of these parasites and predators remain subject to 21 U.S.C. 
342(a)(3).

[57 FR 14646, Apr. 22, 1992]



Sec. 180.1102  Trichoderma harzianum KRL-AG2 (ATCC #20847) strain T-22; 

exemption from requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the biofungicide Trichoderma harzianum KRL-AG2 (ATCC 
20847); also known as strain T-22 when applied in/or on all 
food commodities.

[64 FR 16860, Apr. 7, 1999]



Sec. 180.1103  Isomate-C; exemption from the requirement of a tolerance.

    The codling moth pheromone (Isomate-C) E,E-8,10-dodecenyl alcohol, 
dodecanol, tetradecanol is exempt from the requirements of a tolerance 
in or on all raw agricultural commodities when formulated in 
polyethylene pheromone dispensers for use in orchards with encapsulated 
polyethylene tubing to control codling moth.

[74 FR 26535, June 3, 2009]



Sec. 180.1107  Delta endotoxin of Bacillus thuringiensis variety kurstaki 

encapsulated into killed Pseudomonas fluorescens; exemption from the 

requirement of a tolerance.

    The delta endotoxin of Bacillus thuringiensis variety kurstaki 
encapsulated into killed Pseudomonas fluorescens is exempt from the 
requirements of a tolerance in or on all raw agricultural commodities.

[56 FR 28328, June 20, 1991]

[[Page 746]]



Sec. 180.1108  Delta endotoxin of Bacillus thuringiensis variety San Diego 

encapsulated into killed Pseudomonas fluorescens; exemption from the 

requirement of a tolerance.

    The delta endotoxin of Bacillus thuringiensis variety San Diego 
encapsulated into killed Pseudomonas fluorescens is exempt from the 
requirements of a tolerance in or on all raw agricultural commodities.

[56 FR 28326, June 20, 1991]



Sec. 180.1110  3-Carbamyl-2,4,5-trichloro benzoic acid; exemption from the 

requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
the residues of 3-carbamyl-2,4,5-trichlorobenzoic acid in or on all raw 
agricultural commodities which occur from the direct application of 
chlorothalonil to crops in Sec. 180.275 (a) and (b) and/or as an 
inadvertent residue resulting from the soil metabolism of chlorothalonil 
when applied to crops in Sec. 180.275 (a) and (b), and subsequent 
uptake by rotated crops when used according to approved agricultural 
practices.

[57 FR 24552, June 10, 1992]



Sec. 180.1111  Bacillus subtilis GB03; exemption from the requirement of a 

tolerance.

    The biofungicide Bacillus subtilis GB03 is exempted from the 
requirement of a tolerance in or on all raw agricultural commodities 
when used in accordance with good agricultural practices.

[73 FR 50556, Aug. 27, 2008]



Sec. 180.1113  Lagenidium giganteum; exemption from the requirement of a 

tolerance.

    Lagenidium giganteum (a fungal organism) is exempt from the 
requirement of a tolerance in or on the raw agricultural commodities 
aspirated grain fractions; grass, forage; grass, hay; rice, grain; rice, 
straw; soybean, seed; soybean, forage; soybean, hay; rice, wild, grain.

[74 FR 26535, June 3, 2009]



Sec. 180.1114  Pseudomonas fluorescens A506, Pseudomonas fluorescens 1629RS, 

and Pseudomonas syringae 742RS; exemptions from the requirement of a 

tolerance.

    The biological pesticides Pseudomonas fluorescens A506, Pseudomonas 
fluorescens 1629RS, and Pseudomonas syringae 742RS are exempted from the 
requirement of a tolerance in or on all raw agricultural commodities 
when applied as a frost protection agent or biological control agent to 
growing agricultural crops in accordance with good agricultural 
practices.

[57 FR 42700, Sept. 16, 1992]



Sec. 180.1118  Spodoptera exigua nuclear polyhedrosis virus; exemption from 

the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
the microbial pest control agent Spodoptera exigua nuclear polyhedrosis 
virus when used as a pesticide control agent on all raw agricultural 
commodities.

[58 FR 25784, Apr. 28, 1993]



Sec. 180.1119  Azadirachtin; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
the biochemical azadirachtin, which is isolated from the berries of the 
Neem tree (Azadirachta indica), when used as a pesticide at 20 grams or 
less per acre on all raw agricultural commodities.

[58 FR 8696, Feb. 17, 1993]



Sec. 180.1120  Streptomyces sp. strain K61; exemption from the requirement of 

a tolerance.

    The biological pesticide Streptomyces sp. strain K61 is exempted 
from the requirement of a tolerance in or on all raw agricultural 
commodities when used as a fungicide for the treatment of seeds, 
cuttings, transplants, and plants of agricultural crops in accordance 
with good agricultural practices.

[58 FR 21403, Apr. 21, 1993]

[[Page 747]]



Sec. 180.1121  Boric acid and its salts, borax (sodium borate decahydrate), 

disodium octaborate tetrahydrate, boric oxide (boric anhydride), sodium borate 

and sodium metaborate; exemptions from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the pesticidal chemical boric acid and its salts, borax 
(sodium borate decahydrate), disodium octaborate tetrahydrate, boric 
oxide (boric anhydride), sodium borate and sodium metaborate, in or on 
raw agricultural commodities when used as an active ingredient in 
insecticides, herbicides, or fungicides preharvest or postharvest in 
accordance with good agricultural practices.

[58 FR 44283, Aug. 20, 1993]



Sec. 180.1122  Inert ingredients of semiochemical dispensers; exemptions from 

the requirement of a tolerance.

    (a) All inert ingredients of semiochemical dispenser products 
formulated with, and/or contained in, dispensers made of polymeric 
matrix materials (including the monomers, plasticizers, dispersing 
agents, antioxidants, UV protectants, stabilizers, and other inert 
ingredients) are exempted from the requirement of a tolerance when used 
as carriers in pesticide formulations for application to growing crops 
only. These dispensers shall conform to the following specifications:
    (1) Exposure must be limited to inadvertent physical contact only. 
The design of the dispenser must be such as to preclude any 
contamination by its components of the raw agricultural commodity (RAC) 
or processed foods/feeds derived from the commodity by virtue of its 
proximity to the RAC or as a result of its physical size.
    (2) The dispensers must be applied discretely. This exemption does 
not apply to components of semiochemical formulations applied in a 
broadcast manner either to a crop field plot or to individual plants.
    (b) A semiochemical dispenser is a single enclosed or semi-enclosed 
unit that releases semiochemical(s) into the surrounding atmosphere via 
volatilization and is applied in a manner to provide discrete 
application of the semiochemical(s) into the environment.
    (c) Semiochemicals are chemicals that are emitted by plants or 
animals and modify the behavior of receiving organisms. These chemicals 
must be naturally occurring or substantially identical to naturally 
occurring semiochemicals.

[58 FR 64494, Dec. 8, 1993]



Sec. 180.1124  Arthropod pheromones; exemption from the requirement of a 

tolerance.

    Arthropod pheromones, as described in Sec. 152.25(b) of this 
chapter, when used in retrievably sized polymeric matrix dispensers are 
exempt from the requirement of a tolerance in or on all raw agricultural 
commodities when applied to growing crops only at a rate not to exceed 
150 grams active ingredient/acre/year in accordance with good 
agricultural practices.

[59 FR 14759, Mar. 30, 1994]



Sec. 180.1126  Codlure, (E,E)-8,10-Dodecadien-1-ol; exemption from the 

requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
the insect pheromone codlure, (E,E)-8,10-dodecadien-1-ol, on all raw 
agricultural commodities in accordance with the following prescribed 
conditions:
    (a) Application shall be limited solely to codlure dispensers that 
conform to the following specifications:
    (1) Commodity exposure must be limited to inadvertent physical 
contact. The design of the dispenser must be such as to preclude any 
exposure of its components to the raw agricultural commodity (RAC) or 
processed foods/feeds derived from the commodity due to its proximity to 
the RAC or as a result of its physical size. Dispensers must be of such 
size and construction that they are readily recognized post-application.
    (2) The dispensers must be applied discretely, i.e., placed in the 
field in easily perceived distinct locations in a manner that does not 
prevent later retrieval. This exemption does not apply

[[Page 748]]

to codlure applied in a broadcast manner either to a crop field plot or 
to individual plants.
    (b) A codlure dispenser is a single enclosed or semi-enclosed unit 
that releases codlure into the surrounding atmosphere via volatilization 
and is applied in a manner to provide discrete application (i.e., in 
easily perceived distinct locations in a manner that does not prevent 
later retrieval) of the codlure into the environment.

[59 FR 9931, Mar. 2, 1994]



Sec. 180.1127  Biochemical pesticide plant floral volatile attractant 

compounds: cinnamaldehyde, cinnamyl alcohol, 4-methoxy cinnamaldehyde, 3-

phenyl propanol, 4-methoxy phenethyl alcohol, indole, and 1,2,4-

trimethoxybenzene; exemptions from the requirement of a tolerance.

    Residues of the biochemical pesticide plant floral volatile 
attractant compounds: cinnamaldehyde, cinnamyl alcohol, 4-methoxy 
cinnamaldehyde, 3-phenyl propanol, 4-methoxy phenethyl alcohol, indole, 
and 1,2,4-trimethoxybenzene are exempt from the requirement of a 
tolerance in or on the following raw agricultural commodities: the 
following field crops--alfalfa, clover, cotton, dandelion, peanuts 
(including hay), rice, sorghum (milo), soybeans, sunflower, sweet 
potatoes, and wheat; the following vegetable crops--asparagus, beans 
(including forage hay), beets, carrots, celery, cole crops (cabbage, 
broccoli, brussels sprouts, cauliflower), collards (kale, mustard 
greens, turnip greens, kohlrabi), corn, fresh (field, sweet, pop, seed), 
corn fodder and forage, chinese cabbage, cowpeas, cucurbitis (cucumbers, 
squash, pumpkin), egg plant, endive (escarole), horseradish (radish, 
rutabagas, turnip roots), leafy greens (spinach, swiss chard), lettuce 
(head leaf), okra, parsley, parsnip, peas, peas with pods, peppers, 
potatoes, sugar beets, tomatoes; the following tree fruit, berry and nut 
crops--almonds, apples, apricots, berries (blackberry, boysenberry, 
dewberry, loganberry, raspberry), blueberry, cherry, citrus (grapefruit, 
kumquat, lemon, lime, orange, tangelo, and tangerine) cranberry, grapes, 
melons, (watermelon, honeydew, crenshaw, cantaloupe, casaba, persian), 
nectarines, pears, pecans, peaches, and strawberry as dispersed from the 
end-use product Corn Rootworm Bait [supreg], a pesticidal bait, in 
accordance with the prescribed conditions in paragraph (a) of this 
section.
    (a) Cumulative yearly application cannot exceed 20 grams of each 
floral attractant/acre/application.
    (b) [Reserved]

[59 FR 15857, Apr. 5, 1994]



Sec. 180.1128  Bacillus subtilis MBI 600; exemption from the requirement of a 

tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the biofungicide Bacillus subtilis MBI 600 in or on all food 
commodities, including residues resulting from post-harvest uses, when 
applied or used in accordance with good agricultural practices.

[74 FR 15869, Apr. 8, 2009]



Sec. 180.1130  N-(n-octyl)-2-pyrrolidone and N-(n-dodecyl)-2-pyrrolidone; 

exemptions from the requirement of a tolerance.

    N-(n-octyl)-2-pyrrolidone and N-(n-dodecyl)-2-pyrrolidone are exempt 
from the requirement of a tolerance when used as solvents in cotton 
defoliant formulations containing thidiazuron and diuron as active 
ingredients.

[59 FR 32084, June 22, 1994]



Sec. 180.1131  Ampelomyces quisqualis isolate M10; exemption from the 

requirement of a tolerance.

    The biological fungicide Ampelomyces quisqualis isolate M10 is 
exempted from the requirement of a tolerance in or on all raw 
agricultural commodities when used as a fungicide on agricultural crops 
in accordance with good agricultural practices.

[59 FR 33437, June 29, 1994]



Sec. 180.1135  Pasteuria penetrans; exemption from the requirement of a 

tolerance.

    The biological nematicide Pasteuria penetrans is exempted from the 
requirement of a tolerance in or on all raw agricultural commodities, 
except roots and tubers, when used as a nematicide

[[Page 749]]

in the production of fruits and vegetables in greenhouses.

[59 FR 66741, Dec. 28, 1994]



Sec. 180.1139  Sodium 5-nitroguaiacolate; exemption from the requirement of a 

tolerance.

    The biochemical sodium 5-nitroguiacolate is exempted from the 
requirement of a tolerance when used as a plant growth regulator in end-
use products at a concentration of 0.1% by weight and applied at an 
application rate of 20 g of a.i. per acre or less per application, in or 
on all food commodities.

[65 FR 66181, Nov. 3, 2000]



Sec. 180.1140  Sodium o-nitrophenolate; exemption from the requirement of a 

tolerance.

    The biochemical sodium o-nitrophenolate is exempted from the 
requirement of a tolerance when used as a plant growth regulator in end-
use products at a concentration of 0.2% by weight and applied at an 
application rate of 20 g of a.i. per acre or less per application, in or 
on all food commodities.

[65 FR 66181, Nov. 3, 2000]



Sec. 180.1141  Sodium p-nitrophenolate; exemption from the requirement of a 

tolerance.

    The biochemical sodium p-nitrophenolate is exempted from the 
requirement of a tolerance when used as a plant growth regulator in end-
use product at a concentration of 0.3% by weight and applied at an 
application rate of 20 g of a.i. per acre or less per application, in or 
on all food commodities.

[65 FR 66181, Nov. 3, 2000]



Sec. 180.1142  1,4-Dimethylnaphthalene; exemption from the requirement of a 

tolerance.

    An exemption from the requirement of a tolerance is established for 
the residues of the plant growth regulator, 1,4-dimethylnaphthalene 
(1,4-DMN), when applied postharvest to all sprouting root, tuber, and 
bulb crops in accordance with good agricultural practices.

[77 FR 68697, Nov. 16, 2012]



Sec. 180.1143  Methyl anthranilate; exemption from the requirement of a 

tolerance.

    Residues of methyl anthranilate, a biochemical pesticide, are exempt 
from the requirement of a tolerance in or on all food commodities, when 
used in accordance with good agricultural practices.

[67 FR 51088, Aug. 7, 2002]



Sec. 180.1144  Candida oleophila isolate I-182; exemption from the requirement 

of a tolerance.

    Candida oleophila isolate I-182, when used as a post-harvest 
biological fungicide, is exempted from the requirement of a tolerance in 
or on all raw agricultural commodities.

[60 FR 11033, Mar. 1, 1995]



Sec. 180.1145  Pseudomonas syringae; exemption from the requirement of a 

tolerance.

    Pseudomonas syringae is exempted from the requirement of a tolerance 
on all raw agricultural commodities when applied postharvest according 
to good agricultural practices.

[60 FR 12703, Mar. 8, 1995]



Sec. 180.1146  Beauveria bassiana Strain GHA; exemption from the requirement 

of a tolerance.

    Beauveria bassiana Strain GHA is exempted from the requirement of a 
tolerance in or on all raw agricultural commodities when applied to 
growing crops according to good agricultural practices.

[60 FR 18547, Apr. 12, 1995]



Sec. 180.1148  Occlusion Bodies of the Granulosis Virus of Cydia pomenella; 

tolerance exemption.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pest control agent Occlusion Bodies of the 
Granulosis Virus of Cydia pomonella (codling moth) in or on all raw 
agricultural commodities.

[60 FR 42450, Aug. 16, 1995]

[[Page 750]]



Sec. 180.1149  Inclusion bodies of the multi-nuclear polyhedrosis virus of 

Anagrapha falcifera; exemption from the requirement of a tolerance.

    The microbial pest control agent inclusion bodies of the multi-
nuclear polyhedrosis virus of Anagrapha falcifera is exempted from the 
requirement of a tolerance in or on all raw agricultural commodities 
when used to control certain lepidopteran pest species.

[60 FR 37020, July 19, 1995]



Sec. 180.1150  6-Benzyladenine; exemption from the requirement of a tolerance.

    The biochemical plant regulator 6-benzyladenine (6-BA) is exempt 
from the requirement of a tolerance in or on apple and pear when applied 
at a rate of <=182 grams of active ingredient per acre per season, and 
in or on pistachio when applied at a rate of <=60 grams of active 
ingredient per acre per season.

[72 FR 13179, Mar. 21, 2007]



Sec. 180.1153  Lepidopteran pheromones; exemption from the requirement of a 

tolerance.

    Lepidopteran pheromones that are naturally occurring compounds, or 
identical or substantially similar synthetic compounds, designated by an 
unbranched aliphatic chain (between 9 and 18 carbons) ending in an 
alcohol, aldehyde or acetate functional group and containing up to 3 
double bonds in the aliphatic backbone, are exempt from the requirement 
of a tolerance in or on all raw agricultural commodities. This exemption 
only pertains to those situations when the pheromone is: Applied to 
growing crops at a rate not to exceed 150 grams active ingredient/acre/
year in accordance with good agricultural practices; and applied as a 
post-harvest treatment to stored food commodities at a rate not to 
exceed 3.5 grams active ingredient/1,000 ft\2\/year (equivalent to 150 
grams active ingredient/acre/year) in accordance with good agricultural 
practices.

[71 FR 45399, Aug. 9, 2006]



Sec. 180.1154  CryIA(c) and CryIC derived delta-endotoxins of Bacillus 

thuringiensis var. kurstaki encapsulated in killed Pseudomonas fluorescens, 

and the expression plasmid and cloning vector genetic constructs.

    CryIA(c) and CryIC derived delta-endotoxins of Bacillus 
thuringiensis var. kurstaki encapsulated in killed Pseudomonas 
fluorescens and the expression plasmid and cloning vector genetic 
constructs are exempt from the requirement of a tolerance when used in 
or on all raw agricultural commodities.

[60 FR 47489, Sept. 13, 1995]



Sec. 180.1156  Cinnamaldehyde; exemption from the requirement of a tolerance.

    Cinnamaldehyde (3-phenyl-2-propenal) is exempted from the 
requirement of a tolerance in or on all food commodities, when used as a 
fungicide, insecticide, and algaecide in accordance with good 
agricultual practices.

[64 FR 7804, Feb. 17, 1999; 64 FR 14099, Mar. 24, 1999]



Sec. 180.1157  Cytokinins; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of cytokinins (specifically: aqueous extract of seaweed meal 
and kinetin) in or on all food commodities when used as plant regulators 
on plants, seeds, or cuttings and on all food commodities after harvest 
in accordance with good agricultural practices.

[64 FR 31505, June 11, 1999]



Sec. 180.1158  Auxins; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of auxins (specifically: indole-3-acetic acid and indole-3-
butyric acid) in or on all food commodities when used as plant 
regulators on plants, seeds, or cuttings and on all food commodities 
after harvest in accordance with good agricultural practices.

[64 FR 31505, June 11, 1999]

[[Page 751]]



Sec. 180.1159  Pelargonic acid; exemption from the requirement of tolerances.

    (a) An exemption from the requirement of a tolerance is established 
for residues of pelargonic acid in or on all food commodities when used 
as a plant regulator on plants, seeds, or cuttings and on all food 
commodities after harvest in accordance with good agricultural 
practices.
    (b) Pelargonic acid when used as an herbicide is exempt from the 
requirement of a tolerance on all plant food commodities provided that:
    (1) Applications are not made directly to the food commodity except 
when used as a harvest aid or desiccant to: any root and tuber 
vegetable, bulb vegetable or cotton.
    (2) When pelargonic acid is used as a harvest aid or desiccant, 
applications must be made no later than 24 hours prior to harvest.
    (c) An exemption from the requirement of a tolerance is established 
for residues of pelargonic acid in or on all raw agricultural 
commodities and in processed commodities, when such residues result from 
the use of pelargonic acid as an antimicrobial treatment in solutions 
containing a diluted end-use concentration of pelargonic acid up to 170 
ppm per application on food contact surfaces such as equipment, 
pipelines, tanks, vats, fillers, evaporators, pasteurizers and aseptic 
equipment in restaurants, food service operations, dairies, breweries, 
wineries, beverage and food processing plants.

[62 FR 28364, May 23, 1997, as amended at 64 FR 31505, June 11, 1999; 68 
FR 7935, Feb. 19, 2003]



Sec. 180.1160  Jojoba oil; exemption from the requirement of a tolerance.

    The insecticide and spray tank adjuvant jojoba oil is exempted from 
the requirement of a tolerance in or on all raw agricultural commodities 
when applied at the rate of 1.0% or less of the final spray in 
accordance with good agricultural practices, provided the jojoba oil 
does not contain simmondsin, simmondsin-2-ferulate, and related 
conjugated organonitriles including demethyl simmondsin and 
didemethylsimmondsin.

[61 FR 2121, Jan. 25, 1996]



Sec. 180.1161  Clarified hydrophobic extract of neem oil; exemption from the 

requirement of a tolerance.

    Clarified hydrophobic extract of neem oil is exempt from the 
requirement of a tolerance on all food commodities when used as a 
botanical fungicide/insecticide/miticide.

[67 FR 43552, June 28, 2002]



Sec. 180.1162  Acrylate polymers and copolymers; exemption from the 

requirement of a tolerance.

    (a) Acrylate polymers and copolymers are exempt from the requirement 
of a tolerance when used as inert ingredients in pesticidal formulations 
applied to growing, raw agricultural commodities. This tolerance 
exemption covers the acrylate polymers/copolymers that are intrinsically 
safe and already listed in TSCA inventory or will meet the polymer 
tolerance exemption from requirements of premanufacturing notification 
under 40 CFR 723.250. Polymers exempted can be used as dispensers, 
resins, fibers, and beads, as long as the fibers, beads and resins 
particle sizes are greater than 10 microns and insoluble in water. This 
exemption pertains to the acrylate polymers/copolymers used as inert 
ingredients for sprayable and dispenser pesticide formulations that are 
applied on food crops. Any acrylate polymers/copolymers used for 
encapsulating material must be cleared as an inert ingredient when used 
in pesticide formulation applied on food crops.
    (b) For the purposes of this exemption, acrylate polymers/copolymers 
used as inert ingredients in an end-use formulation must meet the 
definition for a polymer as given in 40 CFR 723.250(b), are not 
automatically excluded by 40 723.250(d), and meet the tolerance 
exemption criteria in 40 CFR 723.250(e)(1), 40 CFR 723.250 (e)(2) or 40 
CFR 723.250(e)(3). Therefore, acrylate polymers and copolymers that are 
already listed in the TSCA inventory or will meet the polymer tolerance 
exemption under 40 CFR 723.250 as amended on March 29, 1995 are covered 
by this exemption.

[61 FR 6551, Feb. 21, 1996]

[[Page 752]]



Sec. 180.1163  Killed Myrothecium verrucaria; exemption from the requirement 

of a tolerance.

    Killed Myrothecium verrucaria is exempted from the requirement of a 
tolerance in or on all raw agricultural commodities when applied as a 
pre-seed or pre- or post-planting soil treatment alone or mixed with 
water and the mixed suspension be applied through drip or border 
irrigation systems and the indicator mycotoxin levels do not exceed 15 
ppm.

[61 FR 11315, Mar. 20, 1996, as amended at 61 FR 58332, Nov. 14, 1996]



Sec. 180.1165  Capsaicin; exemption from the requirement of a tolerance.

    Capsaicin is exempt from the requirement of a tolerance in or on all 
food commodities when used in accordance with approved label rates and 
good agricultural practice.

[63 FR 39521, July 23, 1998]



Sec. 180.1167  Allyl isothiocyanate as a component of food grade oil of 

mustard; exemption from the requirement of a tolerance.

    The insecticide and repellent Allyl isothiocyanate is exempt from 
the requirement of a tolerance for residues when used as a component of 
food grade oil of mustard, in or on all raw agricultural commodities, 
when applied according to approved labeling.

[61 FR 24894, May 17, 1996]



Sec. 180.1176  Sodium bicarbonate; exemption from the requirement of a 

tolerance.

    The biochemical pesticide sodium bicarbonate is exempted from the 
requirement of a tolerance in or on all raw agricultural commodities 
when applied as a fungicide or post-harvest fungicide in accordance with 
good agricultural practices.

[61 FR 67473, Dec. 23, 1996]



Sec. 180.1177  Potassium bicarbonate; exemption from the requirement of a 

tolerance.

    The biochemical pesticide potassium bicarbonate is exempted from the 
requirement of a tolerance in or on all raw agricultural commodities 
when applied as a fungicide or post-harvest fungicide in accordance with 
good agricultural practices.

[61 FR 67473, Dec. 23, 1996]



Sec. 180.1178  Formic acid; exemption from the requirement of a tolerance.

    The pesticide formic acid is exempted from the requirement of a 
tolerance in or on honey and honeycomb when used to control tracheal 
mites and suppress varroa mites in bee colonies, and applied in 
accordance with label use directions.

[74 FR 26535, June 3, 2009]



Sec. 180.1179  Plant extract derived from Opuntia lindheimeri, Quercus 

falcata, Rhus aromatica, and Rhizophoria mangle; exemption from the 

requirement of a tolerance.

    The biochemical pesticide plant extract derived from Opuntia 
lindheimeri, Quercus falcata, Rhus aromatica, and Rhizophoria mangle is 
exempted from the requirement of a tolerance in or on all raw 
agricultural commodities when applied as a nematicide/plant regulator in 
accordance with good agricultural practices.

[62 FR 24842, May 7, 1997]



Sec. 180.1180  Kaolin; exemption from the requirement of a tolerance.

    (a) The biochemical pesticide kaolin is temporarily exempted from 
the requirement of a tolerance for residues of the insecticide Kaolin, 
when used on crops (apples, apricots, bananas, beans, cane berries, 
citrus fruits, corn, cotton, cranberries, cucurbits, grapes, melons, 
nuts, ornamentals, peaches, peanuts, pears, peppers, plums, potatoes, 
seed crops, small grains, soybeans, strawberries, sugar beets, and 
tomatoes) to control certain insect, fungus, and bacterial damage to 
plants. This temporary exemption from the requirement of a tolerance 
will permit the marketing of the food commodities in this paragraph when 
treated in accordance with the provisions of experimental use permit 
70060-EUP-1, which is being issued under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136).

[[Page 753]]

This temporary exemption from the requirement of a tolerance expires and 
is revoked December 31, 1999. This temporary exemption from the 
requirement of a tolerance may be revoked at any time if the 
experimental use permit is revoked or if any experience with or 
scientific data on this pesticide indicate that the tolerance is not 
safe.
    (b) Kaolin is exempted from the requirement of a tolerance for 
residues when used on or in food commodities to aid in the control of 
insects, fungi, and bacteria (food/feed use).

[62 FR 19685, Apr. 23, 1997, as amended at 63 FR 9430, Feb. 25, 1998]



Sec. 180.1181  Bacillus cereus strain BPO1; exemption from the requirement of 

a tolerance.

    An exemption from the requirement of a tolerance for residues of the 
Bacillus cereus strain BPO1 in or on all raw agricultural commodities 
when applied/used in accordance with label directions.

[67 FR 70017, Nov. 20, 2002]



Sec. 180.1187  L-glutamic acid; exemption from the requirement of a tolerance.

    L-glutamic acid is exempt from the requirement of a tolerance on all 
food commodities when used in accordance with good agricultural 
practices.

[66 FR 33198, June 21, 2001]



Sec. 180.1188  Gamma aminobutyric acid; exemption from the requirement of a 

tolerance.

    Gamma aminobutyric acid is exempt from the requirement of a 
tolerance on all food commodities when used in accordance with good 
agricultural practices.

[66 FR 33198, June 21, 2001]



Sec. 180.1189  Methyl salicylate; exemption from the requirement of a 

tolerance.

    The biochemical pesticide methyl salicylate is exempt from the 
requirement of a tolerance for residues in or on food or feed when used 
as an insect repellant in food packaging and animal feed packaging at an 
application rate that does not exceed 0.2 mg of methyl salicylate per 
square inch of packaging materials.

[62 FR 61639, Nov. 19, 1997]



Sec. 180.1191  Ferric phosphate; exemption from the requirement of a 

tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the biochemical pesticide, ferric phosphate 
(FePO4, CAS No. 11045-86-0) in or on all food commodities.

[62 FR 56105, Oct. 29, 1997]



Sec. 180.1193  Potassium dihydrogen phosphate; exemption from the requirement 

of a tolerance.

    Potassium dihydrogen phosphate is exempted from the requirement of a 
tolerance in or on all food commodities when applied as a fungicide in 
accordance with good agricultural practices.

[63 FR 43085, Aug. 12, 1998]



Sec. 180.1195  Titanium dioxide.

    Titanium dioxide (CAS Reg. No. 13463-67-7) is exempted from the 
requirement of a tolerance for residues in or on growing crops, when 
used as an inert ingredient (UV protectant) in microencapsulated 
formulations of the insecticide lambda cyhalothrin at no more than 3.0% 
by weight of the formulation and as an inert ingredient (UV-stabilizer) 
at no more than 5% in pesticide formulations containing the active 
ingredient napropamide.

[77 FR 44155, July 27, 2012]



Sec. 180.1196  Peroxyacetic acid; exemption from the requirement of a 

tolerance.

    (a) An exemption from the requirement of a tolerance is established 
for residues of peroxyacetic acid in or on all food commodities, when 
such residues result from the use of peroxyacetic acid as an 
antimicrobial treatment in solutions containing a diluted end use 
concentration of peroxyacetic acid up to 100 ppm per application on 
fruits, vegetables, tree nuts, cereal grains, herbs, and spices.
    (b) An exemption from the requirement of a tolerance is established 
for residues of peroxyacetic acid, in or on all food commodities when 
used in

[[Page 754]]

sanitizing solutions containing a diluted end-use concentration of 
peroxyacetic acid up to 500 ppm, and applied to tableware, utensils, 
dishes, pipelines, tanks, vats, fillers, evaporators, pasteurizers, 
aseptic equipment, milking equipment, and other food processing 
equipment in food handling establishments including, but not limited to 
dairies, dairy barns, restaurants, food service operations, breweries, 
wineries, and beverage and food processing plants.
    (c) An exemption from the requirement of a tolerance is established 
for residues of the biochemical pesticide peroxyacetic acid and its 
metabolites and degradates, including hydrogen peroxide and acetic acid, 
in or on all food commodities, when used in accordance with good 
agricultural practices.

[74 FR 26535, June 3, 2009, as amended at 76 FR 11969, Mar. 4, 2011]



Sec. 180.1197  Hydrogen peroxide; exemption from the requirement of a 

tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of hydrogen peroxide in or on all food commodities at the rate 
of <= 1% hydrogen peroxide per application on growing and postharvest 
crops.

[67 FR 41844, June 20, 2002]



Sec. 180.1198  Gliocladium catenulatum strain J1446; exemption from the 

requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticide, Gliocladium catenulatum strain 
J1446 when used in or on all food commodities.

[63 FR 37288, July 10, 1998]



Sec. 180.1199  Lysophosphatidylethanolamine (LPE); exemption from the 

requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the biochemical pesticide lysophosphatidylethanolamine in or 
on all food commodities.

[67 FR 17636, Apr. 11, 2002]



Sec. 180.1200  Pseudomonas fluorescens strain PRA-25; temporary exemption from 

the requirement of a tolerance.

    A temporary exemption from the requirement of a tolerance is 
established for residues of the microbial pesticide, pseudomonas 
fluorescens strain PRA-25 when used on peas, snap beans and sweet corn 
and will expire July 31, 2001.

[63 FR 38498, July 17, 1998]



Sec. 180.1201  Trichoderma harzianum strain T-39; exemption from the 

requirement of a tolerance.

    Trichoderma harzianum strain T-39 is exempt from the requirement of 
a tolerance on all food commodities.

[65 FR 38757, June 22, 2000]



Sec. 180.1202  Bacillus sphaericus; exemption from the requirement of a 

tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticides, Bacillus sphaericus when used in 
or on all food crops.

[63 FR 48597, Sept. 11, 1998]



Sec. 180.1204  Harpin protein; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of individual harpin proteins that meet specified 
physiochemical and toxicological criteria when used as biochemical 
pesticides on all food commodities to enhance plant growth, quality and 
yield, to improve overall plant health, and to aid in pest management. 
The physiochemical and toxicological criteria identifying harpin 
proteins are as follows:
    (a) Consists of a protein less than 100 kD in size, that is acidic 
(pI<7.0), glycine rich (10%), and contains no more than one 
cystine residue.
    (b) The source(s) of genetic material encoding the protein are 
bacterial plant pathogens not known to be mammalian pathogens.
    (c) Elicits the hypersensitive response (HR) which is characterized 
as rapid, localized cell death in plant tissue after infiltration of 
harpin into the intercellular spaces of plant leaves.

[[Page 755]]

    (d) Possesses a common secondary structure consisting of [alpha] and 
[beta] units that form an HR domain.
    (e) Is heat stable (retains HR activity when heated to 65 [deg]C for 
20 minutes).
    (f) Is readily degraded by a proteinase representative of 
environmental conditions (no protein fragments 3.5 kD after 
15 minutes degradation with Subtilisin A).
    (g) Exhibits a rat acute oral toxicity (LD50) of greater 
than 5,000 mg product/kg body weight.

[69 FR 24996, May 5, 2004]



Sec. 180.1205  Beauveria bassiana ATCC #74040; exemption from the requirements 

of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the insecticide Beauveria bassiana (ATCC 74040) in 
or on all food commodities when applied or used as ground and aerial 
foliar sprays for use only on terrestrial crops.

[64 FR 22796, Apr. 28, 1999]



Sec. 180.1206  Aspergillus flavus AF36; exemption from the requirement of a 

tolerance.

    (a) An exemption from the requirement of a tolerance is established 
for residues of the microbial pesticide Aspergillus flavus AF36 in or on 
cotton, gin byproducts; cotton, hulls; cotton, meal; cotton, refined 
oil; cotton, undelinted seed.
    (b) An exemption from the requirement of a tolerance is established 
for residues of Aspergillus flavus AF36 in or on pistachio when applied 
as an antifungal agent and used in accordance with good agricultural 
practices.
    (c) An exemption from the requirement of a tolerance is established 
for residues of Aspergillus flavus AF36 in or on corn, field, forage; 
corn, field, grain; corn, field, stover; corn, field, aspirated grain 
fractions; corn, sweet, kernel plus cob with husk removed; corn, sweet, 
forage; corn, sweet, stover; corn, pop, grain; and corn, pop, stover, 
when applied/used as an antifungal agent.

[68 FR 41541, July 14, 2003, as amended at 72 FR 28871, May 23, 2007; 72 
FR 72965, Dec. 26, 2007; 74 FR 26535, 26546, June 3, 2009; 76 FR 16301, 
Mar. 23, 2011; 77 FR 14291, Mar. 9, 2012]



Sec. 180.1207  N-acyl sarcosines and sodium N-acyl sarcosinates; exemption 

from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the following substances when used as inert ingredients 
(surfactants) at levels not to exceed 10% in pesticide formulations 
containing glyphosate:

------------------------------------------------------------------------
                                                               CAS Reg.
                            Name                                 No.
------------------------------------------------------------------------
N-acyl sarcosines..........................................
 N-cocoyl sarcosine mixture................................   68411-97-2
 N-lauroyl sarcosine.......................................      97-78-9
 N-myristoyl sarcosine.....................................   52558-73-3
 N-oleoyl sarcosine........................................     110-25-8
 N-stearoyl sarcosine......................................     142-48-3
Sodium N-acyl sarcosinates.................................
 N-cocoyl sarcosine sodium salt mixture....................   61791-59-1
 N-methyl-N-(1-oxo-9-octodecenyl) glycine..................    3624-77-9
 N-methyl-N-(1-oxododecyl) glycine.........................     137-16-6
 N-methyl-N-(1-oxooctadecyl) glycine.......................    5136-55-0
 N-methyl-N-(1-oxotetradecyl glycine.......................   30364-51-3
------------------------------------------------------------------------


[64 FR 68046, Dec. 6, 1999]



Sec. 180.1209  Bacillus subtilis strain QST 713 and strain QST 713 variant 

soil; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticides Bacillus subtilis strain QST 713 
and strain QST 713 variant soil when used in or on all food commodities.

[77 FR 73937, Dec. 12, 2012]



Sec. 180.1210  Phosphorous acid; exemption from the requirement of a 

tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of phosphorous acid and its ammonium, sodium, and potassium 
salts in or on all food commodities when used as an agricultural 
fungicide and in or on potatoes when applied as a post-harvest treatment 
at 35,600 ppm or less phosphorous acid.

[71 FR 49373, Aug. 23, 2006]



Sec. 180.1212  Pseudomonas chlororaphis Strain 63-28; exemption from the 

requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticide

[[Page 756]]

Pseudomonas chlororaphis Strain 63-28 in or on all food commodities.

[66 FR 53346, Oct. 22, 2001]



Sec. 180.1213  Coniothyrium minitans strain CON/M/91-08; exemption from the 

requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticide Coniothyrium minitans strain CON/M/
91-08 when used in or on all food commodities.

[66 FR 16874, Mar. 28, 2001]



Sec. 180.1218  Indian Meal Moth Granulosis Virus; exemption from the 

requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticide Indian Meal Moth Granulosis Virus 
when used in or on all food commodities.

[68 FR 55875, Sept. 29, 2003]



Sec. 180.1219  Foramsulfuron; exemption from the requirement of a tolerance.

    The pesticide foramsulfuron is exempted from the requirement of a 
tolerance in corn, field, grain/corn, field, forage/ corn, field, 
stover/corn, pop, grain/corn, pop, forage/corn, pop, stover; corn, 
sweet, forage; corn, sweet, kernel plus cob with husks removed; corn, 
sweet, stover when applied as a herbicide in accordance with good 
agricultural practices.

[74 FR 26535, June 3, 2009]



Sec. 180.1220  1-Methylcyclopropene; exemption from the requirement of a 

tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the 1-Methylcyclopropene in or on fruits and vegetables 
when:
    (a) Used as a post harvest plant growth regulator, i.e., for the 
purpose of inhibiting the effects of ethylene.
    (b) Applied or used outdoors for pre-harvest treatments.

[73 FR 19150, Apr. 9, 2008]



Sec. 180.1221  Pseudozyma flocculosa strain PF-A22 UL; exemption from the 

requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Pseudozyma flocculosa strain PF-A22 UL in or on all food 
commodities.

[67 FR 60966, Sept. 27, 2002]



Sec. 180.1222  Sucrose octanoate esters; exemption from the requirement of a 

tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of sucrose octanoate esters [([alpha]-D-glucopyranosyl-[beta]-
D-fructofuranosyl-octanoate), mono-, di-, and triesters of sucrose 
octanoate] in or on all food commodities when used in accordance with 
good agricultural practices.

[67 FR 60152, Sept. 25, 2002]



Sec. 180.1223  Imazamox; exemption from the requirement of a tolerance.

    The herbicide imazamox, () 2, -[4,5-dihydro-4-
methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-(methoxymethyl)-3-
pyridinecarboxylic acid, is exempt from the requirement of a tolerance 
on all food commodities when applied as a herbicide in accordance with 
good agricultural practices.

[68 FR 7433, Feb. 14, 2003]



Sec. 180.1224  Bacillus pumilus GB34; exemption from the requirement of a 

tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticide Bacillus pumilus GB34 when used as a 
seed treatment in or on all food commodities. An exemption is also 
granted for such residues on treated but unplanted soybean seeds.

[69 FR 76625, Dec. 22, 2004]



Sec. 180.1225  Decanoic acid; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of decanoic acid in or on all raw agricultural commodities and 
in processed commodities, when such residues result from the use of 
decanoic acid as

[[Page 757]]

an antimicrobial treatment in solutions containing a diluted end-use 
concentration of decanoic acid (up to 170 ppm per application) on food 
contact surfaces such as equipment, pipelines, tanks, vats, fillers, 
evaporators, pasteurizers and aseptic equipment in restaurants, food 
service operations, dairies, breweries, wineries, beverage and food 
processing plants.

[68 FR 7939, Feb. 19, 2003; 68 FR 17308, Apr. 9, 2003]



Sec. 180.1226  Bacillus pumilus strain QST2808; temporary exemption from the 

requirement of a tolerance.

    A temporary exemption from the requirement of a tolerance is 
established for residues of the microbial pesticide Bacillus pumilus 
strain QST2808 when used in or on all agricultural commodities when 
applied/used in accordance with label directions.

[68 FR 36480, June 18, 2003]



Sec. 180.1228  Diallyl sulfides; exemption from the requirement of a 

tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of diallyl sulfides when used in/on garlic, leeks, onions, and 
shallots.

[68 FR 40808, July 9, 2003]



Sec. 180.1230  Ferrous sulfate; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of ferrous sulfate.

[70 FR 33363, June 8, 2005]



Sec. 180.1231  Lime; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of lime.

[70 FR 33363, June 8, 2005]



Sec. 180.1232  Lime-sulfur; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of lime-sulfur.

[70 FR 33363, June 8, 2005]



Sec. 180.1233  Potassium sorbate; exemption from the requirement of a 

tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of potassium sorbate.

[70 FR 33363, June 8, 2005]



Sec. 180.1234  Sodium carbonate; exemption from the requirement of a 

tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of sodium carbonate.

[70 FR 33363, June 8, 2005]



Sec. 180.1235  Sodium hypochlorite; exemption from the requirement of a 

tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of sodium hypochlorite.

[70 FR 33363, June 8, 2005]



Sec. 180.1236  Sulfur; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of sulfur.

[70 FR 33363, June 8, 2005]



Sec. 180.1237  Sodium metasilicate; exemption from the requirement of a 

tolerance.

    (a) An exemption from the requirement of a tolerance is established 
for residues of sodium metasilicate in or on all food commodities when 
used in accordance with approved label rates and good agricultural 
practices as a plant desiccant, so long as the sodium metasilicate does 
not exceed 4% by weight in aqueous solution.
    (b) An exemption from the requirement of a tolerance is established 
for residues of sodium metasilicate in or on all food commodities when 
used in accordance with approved label rates and good agricultural 
practices as an insecticide and fungicide, so long as the sodium 
metasilicate does not exceed 2.41% by weight in aqueous solution.

[71 FR 19441, Apr. 14, 2006]

[[Page 758]]



Sec. 180.1240  Thymol; exemption from the requirement of a tolerance.

    (a) Time-limited exemptions from the requirement of a tolerance are 
established for residues of thymol on honey and honeycomb in connection 
with use of the pesticide under section 18 emergency exemptions granted 
by the EPA. These time-limited exemptions from the requirement of a 
tolerance for residues of thymol will expire and are revoked on June 30, 
2007.
    (b) An exemption from the requirement of a tolerance for residues of 
the thymol (as present in thyme oil) in or on food commodities when 
applied/used in/on public eating places, dairy processing equipment, 
and/or food processing equipment and utensils.

[70 FR 37696, June 30, 2005, as amended at 71 FR 2895, Jan. 18, 2006; 74 
FR 12617, Mar. 25, 2009]



Sec. 180.1241  Eucalyptus oil; exemption from the requirement of a tolerance.

    Time-limited exemptions from the requirement of a tolerance are 
established for residues of eucalyptus oil on honey and honeycomb in 
connection with use of the pesticide under section 18 emergency 
exemptions granted by the EPA. These time-limited exemptions from the 
requirement of a tolerance for residues of eucalyptus oil will expire 
and are revoked on June 30, 2007.

[70 FR 37696, June 30, 2005]



Sec. 180.1243  Bacillus subtilis var. amyloliquefaciens strain FZB24; 

exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance for residues of the 
Bacillus subtilis var. amyloliquefaciens strain FZB24 in or on all 
agricultural commodities when applied/used in accordance with label 
directions.

[68 FR 44640, July 30, 2003]



Sec. 180.1244  Ammonium bicarbonate; exemption from the requirement of a 

tolerance.

    An exemption from the requirement of tolerance is established for 
residues of ammonium bicarbonate used in or on all food commodities when 
used in accordance with good agricultural practices.

[69 FR 13745, Mar. 24, 2004]



Sec. 180.1245  Rhamnolipid biosurfactant; exemption from the requirement of a 

tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of rhamnolipid biosurfactant when used in accordance with good 
agricultural practices as a fungicide in or on all food commodities.

[69 FR 16800, Mar. 31, 2004]



Sec. 180.1246  Yeast Extract Hydrolysate from Saccharomyces cerevisiae: 

exemption from the requirement of a tolerance.

    This regulation establishes an exemption from the requirement of a 
tolerance for residues of the biochemical pesticide Yeast Extract 
Hydrolysate from Saccharomyces cerevisiae on all food commodities when 
applied/used for the management of plant diseases.

[69 FR 9958, Mar. 3, 2004]



Sec. 180.1248  Exemption of citronellol from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the biochemical pesticide citronellol in or on all food 
commodities.

[69 FR 23146, Apr. 28, 2004]



Sec. 180.1250  C8, C10, and C12 fatty acid monoesters of glycerol and 

propylene glycol; exemption from the requirement of a tolerance.

    The C8, C10, and C12 straight-chain fatty acid monoesters of 
glycerol (glycerol monocaprylate, glycerol monocaprate, and glycerol 
monolaurate) and propylene glycol (propylene glycol monocaprylate, 
propylene glycol monocaprate, and propylene glycol monolaurate) are 
exempt from the requirement of a tolerance in or on all food commodities 
when used in accordance with approved label rates and good agricultural 
practice.

[69 FR 34944, June 23, 2004]

[[Page 759]]



Sec. 180.1251  Geraniol; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the biochemical pesticide geraniol in or on all food 
commodities.

[69 FR 23151, Apr. 28, 2004]



Sec. 180.1253  Streptomyces lydicus WYEC 108; exemption from the requirement 

of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticide Streptomyces lydicus WYEC 108 when 
used in or on all agricultural commodities when applied/used in 
accordance with label directions.

[69 FR 31301, June 3, 2004]



Sec. 180.1254  Aspergillus flavus NRRL 21882; exemption from the requirement 

of a tolerance.

    (a) An exemption from the requirement of a tolerance is established 
for residues of Aspergillus flavus NRRL 21882 on peanut; peanut, hay; 
peanut, meal; and peanut, refined oil.
    (b) An exemption from the requirement of a tolerance is established 
for residues of Aspergillus flavus NRRL 21882 on corn, field, forage; 
corn, field, grain; corn, field, stover; corn, field, aspirated grain 
fractions; corn, sweet, kernel plus cob with husk removed; corn, sweet, 
forage; corn, sweet, stover; corn, pop, grain; and corn, pop, stover.

[75 FR 6576, Feb. 10, 2010]



Sec. 180.1255  Bacillus pumilus strain QST 2808; exemption from the 

requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticide Bacillus pumilus strain QST 2808 
when used in or on all agricultural commodities when applied/used in 
accordance with label directions.

[69 FR 63954, Nov. 3, 2004]



Sec. 180.1256  Alternaria destruens strain 059; exemption from the requirement 

of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticide Alternaria destruens Strain 059 when 
used in or on all raw agricultural commodities when applied/used in 
accordance with label directions.

[70 FR 28459, May 18, 2005]



Sec. 180.1257  Paecilomyces lilacinus strain 251; exemption from the 

requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticide Paecilomyces lilacinus strain 251 
when used in or on all agricultural commodities when applied/used in 
accordance with label directions.

[70 FR 19283, Apr. 13, 2005]



Sec. 180.1258  Acetic acid; exemption from the requirement of a tolerance.

    (a) An exemption from the requirement of a tolerance is established 
for residues of the biochemical pesticide acetic acid when used as a 
preservative on post-harvest agricultural commodities intended for 
animal feed, including Alfalfa, seed; alfalfa, hay; barley, grain; 
bermudagrass, hay; bluegrass, hay; bromegrass, hay; clover, hay; corn, 
field, grain; corn, pop, grain; cowpea, hay; fescue, hay; lespedeza, 
hay; lupin; oat, grain; orchardgrass, hay; peanut, hay; timothy, hay; 
vetch, hay; and wheat, grain, or commodities described as grain or hay.
    (b) An exemption from the requirement of a tolerance is established 
for residues of acetic acid in or on all food crops resulting from 
unintentional spray and drift to non-target vegetation including non-
food, food and feed crops when used as a non-selective contact herbicide 
spray.

[75 FR 40741, July 14, 2010]



Sec. 180.1259  Reynoutria sachalinensis extract; exemption from the 

requirement of a tolerance.

    Residues of the biochemical pesticide Reynoutria sachalinensis 
extract, when derived from the whole plant extract, are exempt from the 
requirement of a tolerance in or on all food commodities.

[70 FR 55277, Sept. 21, 2005]

[[Page 760]]



Sec. 180.1260  Muscodor albus QST 20799 and the volatiles produced on 

rehydration; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established on 
all food/feed commodities, for residues of Muscodor albus QST 20799, and 
the volatiles produced on its rehydration, when the pesticide is used 
for all agricultural applications, including seed, propagule and post 
harvest treatments.

[70 FR 56576, Sept. 28, 2005]



Sec. 180.1261  Xanthomonas campestris pv. vesicatoria and Pseudomonas syringae 

pv. tomato specific Bacteriophages.

    An exemption from the requirement of a tolerance is established for 
residues of Xanthomonas campestris pv. vesicatoria and Pseudomonas 
syringae pv. tomato specific bacteriophages in or on pepper and tomato.

[74 FR 26536, June 3, 2009]



Sec. 180.1262  Sorbitol octanoate; exemption from the requirement of a 

tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of sorbitol octanoate in or on all food commodities when used 
in accordance with label directions.

[71 FR 4518, Jan. 27, 2006]



Sec. 180.1263  Tetrahydrofurfuryl alcohol; exemption from the requirement of a 

tolerance.

    Tetrahydrofurfuryl alcohol (THFA, CAS Reg. No. 97-99-4) is exempt 
from the requirement of a tolerance in or on all raw agricultural 
commodities when used in accordance with good agricultural practices as 
an inert ingredient applied only:
    (a) For use as a seed treatment.
    (b) For applications prior to planting and at the time of planting.
    (c) For use on cotton.
    (d) For use in herbicides with one application to wheat and barley 
prior to the pre-boot stage, and two applications to canola and soybeans 
pre-bloom.
    (e) For use in herbicides with two applications to field corn up to 
24 inches tall (V 5 stage).

[71 FR 45415, Aug. 9, 2006]



Sec. 180.1267  Pantoea agglomerans strain C9-1; exemption from the requirement 

of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Pantoea agglomerans strain C9-1 when used on apples and 
pears.

[71 FR 24596, Apr. 26, 2006]



Sec. 180.1268  Potassium silicate; exemption from the requirement of a 

tolerance.

    Potassium silicate is exempt from the requirement of a tolerance in 
or on all food commodities so long as the potassium silicate is not 
applied at rates exceeding 1% by weight in aqueous solution and when 
used in accordance with good agricultural practices.

[71 FR 34272, June 14, 2006]



Sec. 180.1269  Bacillus mycoides isolate J; exemption from the requirement of 

a tolerance.

    Bacillus mycoides isolate J is temporarily exempt from the 
requirement of a tolerance when used as a fungicide on potatoes in 
accordance with a valid Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) section 18 emergency exemption. This temporary exemption 
from the requirement of a tolerance expires and is revoked on December 
31, 2015.

[78 FR 24353, Apr. 25, 2013]



Sec. 180.1270  Isophorone; exemption from the requirement of a tolerance.

    Isophorone (CAS Reg. No. 78-59-1) is exempt from the requirement of 
a tolerance when used as an inert ingredient in pesticide formulations 
applied to beets, ginseng, rice, spinach, sugar beets, and Swiss chard.

[71 FR 45408, Aug. 9, 2006]



Sec. 180.1271  Eucalyptus oil; exemption from the requirement of a tolerance.

    An exemption from the requirement of tolerance is established for 
residues

[[Page 761]]

of eucalyptus oil in or on honey, honeycomb, and honeycomb with honey 
when used at 2g or less eucalyptus oil per hive, where the eucalyptus 
oil contains 80% or more eucalyptol.

[71 FR 53979, Sept. 13, 2006]



Sec. 180.1272  Pantoea agglomerans strain E325; exemption from the requirement 

of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Pantoea agglomerans strain E325 when used on apples and 
pears.

[71 FR 54933, Sept. 20, 2006]



Sec. 180.1273  Beauveria bassiana HF23; exemption from the requirement of a 

tolerance.

    Residues of Beauveria bassiana HF23 are exempt from the requirement 
of a tolerance on all food/feed commodities, when the pesticide is used 
for the treatment of chicken and livestock facilities, including the 
treatment of chicken and livestock manure.

[75 FR 10190, Mar. 5, 2010]



Sec. 180.1274  Tris (2-ethylhexyl) phosphate; exemption from the requirement 

of a tolerance.

    Tris (2-ethylhexyl) phosphate (TEHP, CAS Reg. No. 78-42-2) is exempt 
from the requirement of a tolerance for residues in grain, aspirated 
fractions; barley, grain, barley, hay, barley, straw; wheat, grain; 
wheat, forage; wheat, hay; wheat, straw when used under the following 
conditions:
    (a) The use is in accordance with good agricultural practices;
    (b) Tris (2-ethylhexyl) phosphate is used as an inert ingredient in 
pesticide formulations with the active ingredients pinoxaden, 
clodinafop-propargyl, and tralkoxydium;
    (c) Tris (2-ethylhexyl) phosphate is applied no more than twice per 
season; and
    (d) The applications occur no later than the pre-boot stage (prior 
to formation of edible grain).

[72 FR 5624, Feb. 7, 2007, as amended at 74 FR 26536, June 3, 2009]



Sec. 180.1275  Pythium; exception from the requirement of a tolerance.

    An exemption from the requirement of tolerance is established on all 
food/feed commodities, for residues of pythium oligandrum DV 74 when the 
pesticide is used on food crops.

[72 FR 27452, May 16, 2007]



Sec. 180.1276  Tobacco mild green mosaic tobamovirus (TMGMV); temporary 

exemption from the requirement of a tolerance.

    A temporary exemption from the requirement of a tolerance is 
established for residues of tobacco mild green mosaic tobamovirus in or 
on all grass, forage and grass, hay.

[74 FR 26536, June 3, 2009]



Sec. 180.1277  Dibasic esters; exemption from the requirement of a tolerance.

    Dibasic esters (CAS Reg. No. 95481-62-2) is exempted from the 
requirement of a tolerance for residues when used as an inert ingredient 
(solvent and/or anti-freeze) at 10% W/W or less in microencapsulated 
pesticide formulations with the active ingredient cyfluthrin.

[73 FR 10398, Feb. 27, 2008]



Sec. 180.1278  Quillaja saponaria extract (saponins); exemption from the 

requirement of a tolerance.

    Residues of the biochemical pesticide Quillaja saponaria extract 
(saponins) are exempt from the requirement of a tolerance in or on all 
food commodities.

[72 FR 41935, Aug. 1, 2007]



Sec. 180.1279  Zucchini yellow mosaic virus--weak strain; exemption from the 

requirement of a tolerance.

    An exemption from the requirement of a tolerance for residues of the 
ZYMV-WK strain in or on all raw cucurbit when applied/used in accordance 
with label directions.

[74 FR 26536, June 3, 2009]

[[Page 762]]



Sec. 180.1280  Poly(hexamethylenebiguanide) hydrochloride (PHMB); exemption 

from the requirement of a tolerance.

    Poly(hexamethylenebiguanide) hydrochloride (PHMB)(CAS Reg. No. 
32289-58-0) is exempt from the requirement of a tolerance for residues 
of the antimicrobial in or on all food commodities when the residues are 
the result of the lawful application of a food contact surface sanitizer 
containing PHMB at 550 parts per million (ppm).

[73 FR 1517, Jan. 9, 2008]



Sec. 180.1281  S-Abscisic Acid, (S)-5-(1-hydroxy-2,6,6-trimethyl-4-oxo-1-

cyclohex-2-enyl)-3-methyl-penta-(2Z,4E)-dienoic Acid; exemption from the 

requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of S-Abscisic Acid in or on all food commodities when applied 
or used preharvest as a plant regulator.

[75 FR 11744, Mar. 12, 2010]



Sec. 180.1282  Bacillus firmus I-1582; exemption from the requirement of a 

tolerance.

    An exemption from the requirement of a tolerance is established in/
on all food/feed commodities, for residues of Bacillus firmus I-1582 
when used as a soil application or seed treatment.

[73 FR 25528, May 7, 2008]



Sec. 180.1283  (Z)-7,8-epoxy-2-methyloctadecane (Disparlure); exemption from 

the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of (Z)-7,8-epoxy-2-methyloctadecane on all food and feed crops 
that occur when it is used to treat trees, shrubs, and pastures and such 
use results in unintentional spray and drift to non-target vegetation 
including non-food, food, and feed crops. This active ingredient is also 
known as Disparlure.

[73 FR 33714, June 13, 2008]



Sec. 180.1284  Ammonium salts of higher fatty acids (C8-C18 saturated; C8-C12 

unsaturated); exemption from the requirement of a tolerance.

    Ammonium salts of C8-C18 saturated and 
C8-C12 unsaturated higher fatty acids are exempted 
from the requirement of a tolerance for residues in or on all food 
commodities when used in accordance with good agricultural practice.

[74 FR 47457, Sept. 16, 2009]



Sec. 180.1285  Polyoxin D zinc salt; exemption from the requirement of a 

tolerance.

    An exemption from the requirement of a tolerance is established for 
the residues of polyoxin D zinc salt in or on all food commodities when 
applied as a fungicide and used in accordance with good agricultural 
practices.

[77 FR 56133, Sept. 12, 2012]



Sec. 180.1287  Extract of Chenopodium ambrosioides near ambrosioides; 

exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
the residues of Extract of Chenopodium ambrosioides near ambrosioides 
when used as an insecticide/acaricide on all food commodities.

[74 FR 634, Jan. 7, 2009]



Sec. 180.1288  Tristyrylphenol ethoxylates; exemption from the requirement of 

a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of poly(oxy-1,2-ethanediyl), [alpha]-[2,4,6-tris(1-
phenylethyl)phenyl]-[omega]-hydroxy-, (CAS Reg. No. 70559-25-0) and 
poly(oxy-1,2-ethanediyl), [alpha]-[tris(1-phenylethyl)phenyl]-[omega]-
hydroxy-, (CAS Reg. No. 99734-09-5) on citrus crops, group 10, when used 
as inert ingredients under the following conditions:
    (a) They are applied post-harvest;
    (b) They are used as inert ingredients in pesticide formulations 
with azoxystrobin and fludioxonil; and
    (c) They constitute no more than 10.0% of the formulated pesticide 
product.

[74 FR 12625, Mar. 25, 2009]

[[Page 763]]



Sec. 180.1289  Candida oleophila Strain O; exemption from the requirement of a 

tolerance.

    An exemption from the requirement of a tolerance is established for 
the residues of the microbial pesticide, Candida oleophila Strain O, on 
apples and pears when applied/used as a post-harvest biofungicide.

[74 FR 22464, May 13, 2009]



Sec. 180.1290  Pasteuria usgae; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Pasteuria usgae in or on all food commodities when applied 
preharvest and used as a nematicide in accordance with good agricultural 
practices.

[75 FR 37737, June 30, 2010]



Sec. 180.1291  Cold pressed neem oil; exemption from the requirement of a 

tolerance.

    Residues of the biochemical pesticide cold pressed neem oil are 
exempt from the requirement of a tolerance in or on all food 
commodities.

[74 FR 55463, Oct. 28, 2009]



Sec. 180.1292  Ulocladium oudemansii (U3 Strain); exemption from the 

requirement of a tolerance.

    An exemption from the requirement of a tolerance is established in/
on all food commodities for residues of Ulocladium oudemansii (U3 
Strain), when applied or used pre-harvest-only, excluding applications 
made post-harvest or to processed commodities, as a microbial fungicide 
in accordance with good agricultural practices.

[74 FR 55458, Oct. 28, 2009]



Sec. 180.1293  Trichoderma gamsii strain ICC 080; exemption from the 

requirement of a tolerance.

    Trichoderma gamsii strain ICC 080 is exempted from the requirement 
of a tolerance in or on all food and feed commodities when applied 
preharvest and used in accordance with good agricultural practices.

[75 FR 8507, Feb. 25, 2010]



Sec. 180.1294  Trichoderma asperellum strain ICC 012; exemption from the 

requirement of a tolerance.

    Trichoderma asperellum strain ICC 012 is exempted from the 
requirement of a tolerance in or on all food and feed commodities when 
applied pre-harvest and used in accordance with good agricultural 
practices.

[75 FR 9530, Mar. 3, 2010]



Sec. 180.1295  Laminarin; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of laminarin in or on all food commodities when laminarin is 
applied preharvest.

[75 FR 8256, Feb. 24, 2010]



Sec. 180.1296  Terpene Constituents [alpha]-terpinene, d-limonene and p-

cymene, of the Extract of Chenopodium ambrosioides near ambrosioides as 

Synthetically Manufactured; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
the residues of the biochemical pesticide Terpene Constituents [alpha]-
terpinene, d-limonene and p-cymene, of the Extract of Chenopodium 
ambrosioides near ambrosioides as Synthetically Manufactured when used 
as an insecticide/acaricide in or on all food commodities.

[75 FR 39455, July 9, 2010]



Sec. 180.1297  Homobrassinolide; exemption from the requirement of a 

tolerance.

    An exemption from the requirement of a tolerance is established for 
the residues of homobrassinolide in or on all food commodities when 
applied/used as a plant growth regulator in accordance with good 
agricultural practices.

[75 FR 39459, July 9, 2010]



Sec. 180.1298  Trichoderma hamatum isolate 382; exemption from the requirement 

of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Trichoderma hamatum isolate 382

[[Page 764]]

in or on all food commodities when applied as a fungicide and used in 
accordance with good agricultural practices.

[75 FR 43076, July 23, 2010]



Sec. 180.1299  Prohydrojasmon; temporary exemption from the requirement of a 

tolerance.

    A temporary exemption from the requirement of a tolerance is 
established for residues of prohydrojasmon, propyl-3-oxo-2-pentylcyclo-
pentylacetate, when used as a plant growth regulator on red apples 
varieties and grapes pre-harvest, in accordance with good agricultural 
practices and the terms of Experimental Use Permit No. 62097-EUP-1, and 
will expire on August 1, 2014.

[77 FR 29552, May 18, 2012]



Sec. 180.1300  Potassium hypochlorite; exemption from the requirement of a 

tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of potassium hypochlorite in or on all commodities.

[76 FR 11343, Mar. 2, 2011]



Sec. 180.1301  Escherichia coli O157:H7 specific bacteriophages; temporary 

exemption from the requirement of a tolerance.

    A temporary exemption from the requirement of a tolerance is 
established for residues of lytic bacteriophages that are specific to 
Escherichia coli O157:H7, sequence negative for shiga toxins I and II, 
and grown on atoxigenic host bacteria when used/applied on food contact 
surfaces in food processing plants in accordance with the terms of 
Experimental Use Permit (EUP) No. 74234-EUP-2. This temporary exemption 
expires on April 1, 2013.

[76 FR 20546, Apr. 13, 2011]



Sec. 180.1302  Sodium Ferric Ethylenediaminetetraacetate (EDTA); exemption 

from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of sodium ferric EDTA in or on all food commodities when 
applied as a molluscicide and used in accordance with good agricultural 
practices.

[76 FR 17561, Mar. 30, 2011]



Sec. 180.1303  Metarhizium anisopliae strain F52; exemption from the 

requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Metarhizium anisopliae strain F52 in or on all food 
commodities when applied as an insecticide, miticide, or ixodicide and 
used in accordance with good agricultural practices.

[76 FR 26198, May 6, 2011]



Sec. 180.1304  Pseudomonas fluorescens strain CL145A; exemption from the 

requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Pseudomonas fluorescens strain CL145A in or on all food 
commodities when applied as a molluscicide.

[76 FR 52875, Aug. 24, 2011]



Sec. 180.1305  Chromobacterium subtsugae strain PRAA4-1\T\; exemption from the 

requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Chromobacterium subtsugae strain PRAA4-1\T\ in or on all 
food commodities when applied as an insecticide or miticide and used in 
accordance with good agricultural practices.

[76 FR 55272, Sept. 7, 2011]



Sec. 180.1306  Isaria fumosorosea (formerly Paecilomyces fumosoroseus) Apopka 

strain 97; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Isaria fumosorosea (formerly Paecilomyces fumosoroseus) 
Apopka strain 97 in or on all food commodities when applied as an 
insecticide or miticide and used in accordance with good agricultural 
practices.

[76 FR 59905, Sept. 28, 2011]



Sec. 180.1307  Bacteriophage of Clavibacter michiganensis subspecies 

michiganensis; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of lytic bacteriophage of Clavibacter michiganensis subspecies

[[Page 765]]

michiganensis produced in Clavibacter michiganensis subspecies 
michiganensis in or on tomato when applied as a bactericide in 
accordance with good agricultural practices.

[76 FR 66192, Oct. 26, 2011]



Sec. 180.1308  Bacillus amyloliquefaciens strain D747; exemption from the 

requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticide, Bacillus amyloliquefaciens strain 
D747 in or on all food commodities when used in accordance with good 
agricultural practices.

[77 FR 749, Jan. 6, 2012. Redesignated at 77 FR 2911, Jan. 20, 2012]



Sec. 180.1309  Bacillus subtilis strain CX-9060; exemption from the 

requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticide Bacillus subtilis strain CX-9060, in 
or on all food commodities, when applied or used in accordance with good 
agricultural practices.

[77 FR 1637, Jan. 11, 2012]



Sec. 180.1310  Trichoderma virens strain G-41; exemption from the requirement 

of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Trichoderma virens strain G-41, in or on all food 
commodities, when applied as a fungicide and used in accordance with 
good agricultural practices.

[77 FR 4908, Feb. 1, 2012]



Sec. 180.1311  Pasteuria nishizawae--Pn1; exemption from the requirement of a 

tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Pasteuria nishizawae--Pn1 in or on all food commodities when 
applied as a nematicide and used in accordance with good agricultural 
practices.

[77 FR 8741, Feb. 15, 2012]



Sec. 180.1312  Aureobasidium pullulans strains DSM 14940 and DSM 14941; 

exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticides, Aureobasidium pullulans strains 
DSM 14940 and DSM 14941 in or on all food commodities when applied 
preharvest and used in accordance with good agricultural practices.

[77 FR 8736, Feb. 15, 2012]



Sec. 180.1313  Bacillus pumilus strain GHA 180; exemption from the requirement 

of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Bacillus pumilus strain GHA 180 in or on all food 
commodities when used in accordance with good agricultural practices.

[77 FR 19112, Mar. 30, 2012]



Sec. 180.1314  Killed, nonviable Streptomyces acidiscabies strain RL-110\T\; 

exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of killed, nonviable Streptomyces acidiscabies strain RL-110\T\ 
in or on all food commodities when applied as a pre- or post-emergent 
herbicide and used in accordance with good agricultural practices.

[77 FR 35295, June 13, 2012]



Sec. 180.1315  Natamycin; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of natamycin in or on mushrooms when applied as a fungistat to 
prevent the germination of fungal spores on mushrooms produced in 
enclosed mushroom production facilities.

[77 FR 29548, May 18, 2012]



Sec. 180.1316  Pasteuria spp. (Rotylenchulus reniformis nematode)--Pr3; 

exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Pasteuria spp. (Rotylenchulus reniformis nematode)--Pr3 in 
or on all

[[Page 766]]

food commodities when applied as a nematicide and used in accordance 
with label directions and good agricultural practices.

[77 FR 40276, July 9, 2012]



Sec. 180.1317  Pesticide chemicals; exemption from the requirements of a 

tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Didecyl dimethyl ammonium chloride in or on broccoli 
resulting from the use of Didecyl dimethyl ammonium chloride as a seed 
treatment at a treatment concentration of 1200 ppm prior to planting by 
immersion.

[77 FR 47296, Aug. 8, 2012]



Sec. 180.1318  3-decen-2-one; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the biochemical pesticide, 3-decen-2-one, in or on potatoes 
when applied as a potato sprout inhibitor and used in accordance with 
label directions and good agricultural practices.

[78 FR 11766, Feb. 20, 2013]



Sec. 180.1319  Banda de Lupinus albus doce (BLAD); exemption from the 

requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
the residues of Banda de Lupinus albus doce (BLAD), a naturally 
occurring polypeptide from the catabolism of a seed storage protein 
([beta]-conglutin) of sweet lupines (Lupinus albus), in or on all food 
commodities when applied as a fungicide and used in accordance with 
label directions and good agricultural practices.

[78 FR 17604, Mar. 22, 2013]



Sec. 180.1320  Methyl jasmonate; exemption from the requirement of a 

tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of methyl jasmonate in or on all food commodities when methyl 
jasmonate is applied pre-harvest.

[78 FR 22794, Apr. 17, 2013]



Sec. 180.1322  Bacillus pumilus strain BU F-33; exemption from the requirement 

of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Bacillus pumilus strain BU F-33 in or on all food 
commodities when applied to elicit induced systemic resistance in plants 
and used in accordance with label directions and good agricultural 
practices.

[78 FR 35149, June 12, 2013]



Subpart E_Pesticide Chemicals Not Requiring a Tolerance or an Exemption 

                            From a Tolerance

    Source: 66 FR 66772, Dec. 27, 2001, unless otherwise noted.



Sec. 180.2000  Scope.

    This subpart sets forth the pesticide chemicals for use in 
agricultural or other food-related settings for which neither a 
tolerance nor an exemption is deemed to be needed by EPA.



Sec. 180.2003  Definitions.

    (a) Food uses are the uses of a pesticide chemical that are likely 
to yield residues in food or feed crops, meat, milk, poultry or egg.
    (b) Non-food uses are those uses that are not likely to yield 
residues in food or feed crops, meat, milk, poultry or egg.

[66 FR 66772, Dec. 27, 2001, as amended at 73 FR 60158, Oct. 10, 2008]



Sec. 180.2010  Threshold of regulation determinations.

    The following pesticide chemical uses on food or feed, or food or 
feed crops, do not need a tolerance or exemption from the requirement of 
a tolerance, and may be registered under the Federal Insecticide, 
Fungicide, and Rodenticide Act, 7 U.S.C. 136 et seq., without obtaining 
such tolerance or exemption, based on EPA's determination that the uses 
are below the threshold of regulation.

[[Page 767]]



----------------------------------------------------------------------------------------------------------------
         Pesticide Chemical                 CAS Reg. No.               Use/Limits            Analytical Method
----------------------------------------------------------------------------------------------------------------
Thiabendazole.......................                 148-79-8  As a seed treatment for    High Performance
                                                                dry pea (including field   Liquid Chromatography/
                                                                pea, pigeon pea,           Florescence Detector
                                                                chickpea or lentil),       method \1\;
                                                                using a maximum            Modification of Ion-
                                                                application rate of        Pairing Liquid
                                                                0.075 pounds of active     Chromatographic
                                                                ingredient per 100         Determination of
                                                                pounds of seed. Vines or   Benzimidazole
                                                                hay grown from treated     Fungicides in Foods,
                                                                seed may not be fed to     Gilvydis and Walters,
                                                                livestock..                JAOAC, vol. 73, no.
                                                                                           5, 1990.
----------------------------------------------------------------------------------------------------------------
\1\Available from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade,
  MD 20755-5350; telephone number: (410) 305-2905; e-mail address: [email protected]


[73 FR 1978, Jan. 11, 2008]



Sec. 180.2020  Non-food determinations.

    The following pesticide chemical uses do not need a tolerance or 
exemption from the requirement of a tolerance based on EPA's 
determination that they are not likely to result in residues in or on 
food.

----------------------------------------------------------------------------------------------------------------
         Pesticide Chemical                 CAS Reg. No.                 Limits                    Uses
----------------------------------------------------------------------------------------------------------------
Methyl bromide                        74-83-9                  When applied as a pre-     All pre-plant soil
                                                                plant soil fumigant        uses
Potassium triiodide (KI3)             12298-68-9               When applied to growing    Bananas, grapes, and
                                                                crops in foreign           melons
                                                                countries
Rhodamine B                           81-88-9                  Not to exceed 2% by        Dye for seed treatment
                                                                weight of the formulated
                                                                product and 60 ppm on
                                                                the treated seed
----------------------------------------------------------------------------------------------------------------


[66 FR 66772, Dec. 27, 2001, as amended at 70 FR 40201, July 13, 2005; 
71 FR 45402, Aug. 9, 2006]

                        PARTS 181-189 [RESERVED]


[[Page 769]]



                              FINDING AIDS




  --------------------------------------------------------------------

  A list of CFR titles, subtitles, chapters, subchapters and parts and 
an alphabetical list of agencies publishing in the CFR are included in 
the CFR Index and Finding Aids volume to the Code of Federal Regulations 
which is published separately and revised annually.

  Table of CFR Titles and Chapters
  Alphabetical List of Agencies Appearing in the CFR
  List of CFR Sections Affected

[[Page 771]]



                    Table of CFR Titles and Chapters




                      (Revised as of July 1, 2013)

                      Title 1--General Provisions

         I  Administrative Committee of the Federal Register 
                (Parts 1--49)
        II  Office of the Federal Register (Parts 50--299)
       III  Administrative Conference of the United States (Parts 
                300--399)
        IV  Miscellaneous Agencies (Parts 400--500)

                    Title 2--Grants and Agreements

            Subtitle A--Office of Management and Budget Guidance 
                for Grants and Agreements
         I  Office of Management and Budget Governmentwide 
                Guidance for Grants and Agreements (Parts 2--199)
        II  Office of Management and Budget Circulars and Guidance 
                (200--299)
            Subtitle B--Federal Agency Regulations for Grants and 
                Agreements
       III  Department of Health and Human Services (Parts 300-- 
                399)
        IV  Department of Agriculture (Parts 400--499)
        VI  Department of State (Parts 600--699)
       VII  Agency for International Development (Parts 700--799)
      VIII  Department of Veterans Affairs (Parts 800--899)
        IX  Department of Energy (Parts 900--999)
        XI  Department of Defense (Parts 1100--1199)
       XII  Department of Transportation (Parts 1200--1299)
      XIII  Department of Commerce (Parts 1300--1399)
       XIV  Department of the Interior (Parts 1400--1499)
        XV  Environmental Protection Agency (Parts 1500--1599)
     XVIII  National Aeronautics and Space Administration (Parts 
                1800--1899)
        XX  United States Nuclear Regulatory Commission (Parts 
                2000--2099)
      XXII  Corporation for National and Community Service (Parts 
                2200--2299)
     XXIII  Social Security Administration (Parts 2300--2399)
      XXIV  Housing and Urban Development (Parts 2400--2499)
       XXV  National Science Foundation (Parts 2500--2599)
      XXVI  National Archives and Records Administration (Parts 
                2600--2699)
     XXVII  Small Business Administration (Parts 2700--2799)
    XXVIII  Department of Justice (Parts 2800--2899)

[[Page 772]]

       XXX  Department of Homeland Security (Parts 3000--3099)
      XXXI  Institute of Museum and Library Services (Parts 3100--
                3199)
     XXXII  National Endowment for the Arts (Parts 3200--3299)
    XXXIII  National Endowment for the Humanities (Parts 3300--
                3399)
     XXXIV  Department of Education (Parts 3400--3499)
      XXXV  Export-Import Bank of the United States (Parts 3500--
                3599)
    XXXVII  Peace Corps (Parts 3700--3799)
     LVIII  Election Assistance Commission (Parts 5800--5899)

                        Title 3--The President

         I  Executive Office of the President (Parts 100--199)

                           Title 4--Accounts

         I  Government Accountability Office (Parts 1--199)
        II  Recovery Accountability and Transparency Board (Parts 
                200--299)

                   Title 5--Administrative Personnel

         I  Office of Personnel Management (Parts 1--1199)
        II  Merit Systems Protection Board (Parts 1200--1299)
       III  Office of Management and Budget (Parts 1300--1399)
         V  The International Organizations Employees Loyalty 
                Board (Parts 1500--1599)
        VI  Federal Retirement Thrift Investment Board (Parts 
                1600--1699)
      VIII  Office of Special Counsel (Parts 1800--1899)
        IX  Appalachian Regional Commission (Parts 1900--1999)
        XI  Armed Forces Retirement Home (Parts 2100--2199)
       XIV  Federal Labor Relations Authority, General Counsel of 
                the Federal Labor Relations Authority and Federal 
                Service Impasses Panel (Parts 2400--2499)
        XV  Office of Administration, Executive Office of the 
                President (Parts 2500--2599)
       XVI  Office of Government Ethics (Parts 2600--2699)
       XXI  Department of the Treasury (Parts 3100--3199)
      XXII  Federal Deposit Insurance Corporation (Parts 3200--
                3299)
     XXIII  Department of Energy (Parts 3300--3399)
      XXIV  Federal Energy Regulatory Commission (Parts 3400--
                3499)
       XXV  Department of the Interior (Parts 3500--3599)
      XXVI  Department of Defense (Parts 3600-- 3699)
    XXVIII  Department of Justice (Parts 3800--3899)
      XXIX  Federal Communications Commission (Parts 3900--3999)
       XXX  Farm Credit System Insurance Corporation (Parts 4000--
                4099)
      XXXI  Farm Credit Administration (Parts 4100--4199)

[[Page 773]]

    XXXIII  Overseas Private Investment Corporation (Parts 4300--
                4399)
     XXXIV  Securities and Exchange Commission (Parts 4400--4499)
      XXXV  Office of Personnel Management (Parts 4500--4599)
    XXXVII  Federal Election Commission (Parts 4700--4799)
        XL  Interstate Commerce Commission (Parts 5000--5099)
       XLI  Commodity Futures Trading Commission (Parts 5100--
                5199)
      XLII  Department of Labor (Parts 5200--5299)
     XLIII  National Science Foundation (Parts 5300--5399)
       XLV  Department of Health and Human Services (Parts 5500--
                5599)
      XLVI  Postal Rate Commission (Parts 5600--5699)
     XLVII  Federal Trade Commission (Parts 5700--5799)
    XLVIII  Nuclear Regulatory Commission (Parts 5800--5899)
      XLIX  Federal Labor Relations Authority (Parts 5900--5999)
         L  Department of Transportation (Parts 6000--6099)
       LII  Export-Import Bank of the United States (Parts 6200--
                6299)
      LIII  Department of Education (Parts 6300--6399)
       LIV  Environmental Protection Agency (Parts 6400--6499)
        LV  National Endowment for the Arts (Parts 6500--6599)
       LVI  National Endowment for the Humanities (Parts 6600--
                6699)
      LVII  General Services Administration (Parts 6700--6799)
     LVIII  Board of Governors of the Federal Reserve System 
                (Parts 6800--6899)
       LIX  National Aeronautics and Space Administration (Parts 
                6900--6999)
        LX  United States Postal Service (Parts 7000--7099)
       LXI  National Labor Relations Board (Parts 7100--7199)
      LXII  Equal Employment Opportunity Commission (Parts 7200--
                7299)
     LXIII  Inter-American Foundation (Parts 7300--7399)
      LXIV  Merit Systems Protection Board (Parts 7400--7499)
       LXV  Department of Housing and Urban Development (Parts 
                7500--7599)
      LXVI  National Archives and Records Administration (Parts 
                7600--7699)
     LXVII  Institute of Museum and Library Services (Parts 7700--
                7799)
    LXVIII  Commission on Civil Rights (Parts 7800--7899)
      LXIX  Tennessee Valley Authority (Parts 7900--7999)
       LXX  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 8000--8099)
      LXXI  Consumer Product Safety Commission (Parts 8100--8199)
    LXXIII  Department of Agriculture (Parts 8300--8399)
     LXXIV  Federal Mine Safety and Health Review Commission 
                (Parts 8400--8499)
     LXXVI  Federal Retirement Thrift Investment Board (Parts 
                8600--8699)
    LXXVII  Office of Management and Budget (Parts 8700--8799)
      LXXX  Federal Housing Finance Agency (Parts 9000--9099)
    LXXXII  Special Inspector General for Iraq Reconstruction 
                (Parts 9200--9299)

[[Page 774]]

   LXXXIII  Special Inspector General for Afghanistan 
                Reconstruction (Parts 9300--9399)
    LXXXIV  Bureau of Consumer Financial Protection (Parts 9400--
                9499)
    LXXXVI  National Credit Union Administration (9600--9699)
     XCVII  Department of Homeland Security Human Resources 
                Management System (Department of Homeland 
                Security--Office of Personnel Management) (Parts 
                9700--9799)
     XCVII  Council of the Inspectors General on Integrity and 
                Efficiency (Parts 9800--9899)

                      Title 6--Domestic Security

         I  Department of Homeland Security, Office of the 
                Secretary (Parts 1--99)
         X  Privacy and Civil Liberties Oversight Board (Parts 
                1000--1099)

                         Title 7--Agriculture

            Subtitle A--Office of the Secretary of Agriculture 
                (Parts 0--26)
            Subtitle B--Regulations of the Department of 
                Agriculture
         I  Agricultural Marketing Service (Standards, 
                Inspections, Marketing Practices), Department of 
                Agriculture (Parts 27--209)
        II  Food and Nutrition Service, Department of Agriculture 
                (Parts 210--299)
       III  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 300--399)
        IV  Federal Crop Insurance Corporation, Department of 
                Agriculture (Parts 400--499)
         V  Agricultural Research Service, Department of 
                Agriculture (Parts 500--599)
        VI  Natural Resources Conservation Service, Department of 
                Agriculture (Parts 600--699)
       VII  Farm Service Agency, Department of Agriculture (Parts 
                700--799)
      VIII  Grain Inspection, Packers and Stockyards 
                Administration (Federal Grain Inspection Service), 
                Department of Agriculture (Parts 800--899)
        IX  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Fruits, Vegetables, Nuts), Department 
                of Agriculture (Parts 900--999)
         X  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Milk), Department of Agriculture 
                (Parts 1000--1199)
        XI  Agricultural Marketing Service (Marketing Agreements 
                and Orders; Miscellaneous Commodities), Department 
                of Agriculture (Parts 1200--1299)
       XIV  Commodity Credit Corporation, Department of 
                Agriculture (Parts 1400--1499)
        XV  Foreign Agricultural Service, Department of 
                Agriculture (Parts 1500--1599)

[[Page 775]]

       XVI  Rural Telephone Bank, Department of Agriculture (Parts 
                1600--1699)
      XVII  Rural Utilities Service, Department of Agriculture 
                (Parts 1700--1799)
     XVIII  Rural Housing Service, Rural Business-Cooperative 
                Service, Rural Utilities Service, and Farm Service 
                Agency, Department of Agriculture (Parts 1800--
                2099)
        XX  Local Television Loan Guarantee Board (Parts 2200--
                2299)
       XXV  Office of Advocacy and Outreach, Department of 
                Agriculture (Parts 2500--2599)
      XXVI  Office of Inspector General, Department of Agriculture 
                (Parts 2600--2699)
     XXVII  Office of Information Resources Management, Department 
                of Agriculture (Parts 2700--2799)
    XXVIII  Office of Operations, Department of Agriculture (Parts 
                2800--2899)
      XXIX  Office of Energy Policy and New Uses, Department of 
                Agriculture (Parts 2900--2999)
       XXX  Office of the Chief Financial Officer, Department of 
                Agriculture (Parts 3000--3099)
      XXXI  Office of Environmental Quality, Department of 
                Agriculture (Parts 3100--3199)
     XXXII  Office of Procurement and Property Management, 
                Department of Agriculture (Parts 3200--3299)
    XXXIII  Office of Transportation, Department of Agriculture 
                (Parts 3300--3399)
     XXXIV  National Institute of Food and Agriculture (Parts 
                3400--3499)
      XXXV  Rural Housing Service, Department of Agriculture 
                (Parts 3500--3599)
     XXXVI  National Agricultural Statistics Service, Department 
                of Agriculture (Parts 3600--3699)
    XXXVII  Economic Research Service, Department of Agriculture 
                (Parts 3700--3799)
   XXXVIII  World Agricultural Outlook Board, Department of 
                Agriculture (Parts 3800--3899)
       XLI  [Reserved]
      XLII  Rural Business-Cooperative Service and Rural Utilities 
                Service, Department of Agriculture (Parts 4200--
                4299)

                    Title 8--Aliens and Nationality

         I  Department of Homeland Security (Immigration and 
                Naturalization) (Parts 1--499)
         V  Executive Office for Immigration Review, Department of 
                Justice (Parts 1000--1399)

                 Title 9--Animals and Animal Products

         I  Animal and Plant Health Inspection Service, Department 
                of Agriculture (Parts 1--199)

[[Page 776]]

        II  Grain Inspection, Packers and Stockyards 
                Administration (Packers and Stockyards Programs), 
                Department of Agriculture (Parts 200--299)
       III  Food Safety and Inspection Service, Department of 
                Agriculture (Parts 300--599)

                           Title 10--Energy

         I  Nuclear Regulatory Commission (Parts 0--199)
        II  Department of Energy (Parts 200--699)
       III  Department of Energy (Parts 700--999)
         X  Department of Energy (General Provisions) (Parts 
                1000--1099)
      XIII  Nuclear Waste Technical Review Board (Parts 1300--
                1399)
      XVII  Defense Nuclear Facilities Safety Board (Parts 1700--
                1799)
     XVIII  Northeast Interstate Low-Level Radioactive Waste 
                Commission (Parts 1800--1899)

                      Title 11--Federal Elections

         I  Federal Election Commission (Parts 1--9099)
        II  Election Assistance Commission (Parts 9400--9499)

                      Title 12--Banks and Banking

         I  Comptroller of the Currency, Department of the 
                Treasury (Parts 1--199)
        II  Federal Reserve System (Parts 200--299)
       III  Federal Deposit Insurance Corporation (Parts 300--399)
        IV  Export-Import Bank of the United States (Parts 400--
                499)
         V  Office of Thrift Supervision, Department of the 
                Treasury (Parts 500--599)
        VI  Farm Credit Administration (Parts 600--699)
       VII  National Credit Union Administration (Parts 700--799)
      VIII  Federal Financing Bank (Parts 800--899)
        IX  Federal Housing Finance Board (Parts 900--999)
         X  Bureau of Consumer Financial Protection (Parts 1000--
                1099)
        XI  Federal Financial Institutions Examination Council 
                (Parts 1100--1199)
       XII  Federal Housing Finance Agency (Parts 1200--1299)
      XIII  Financial Stability Oversight Council (Parts 1300--
                1399)
       XIV  Farm Credit System Insurance Corporation (Parts 1400--
                1499)
        XV  Department of the Treasury (Parts 1500--1599)
       XVI  Office of Financial Research (Parts 1600--1699)
      XVII  Office of Federal Housing Enterprise Oversight, 
                Department of Housing and Urban Development (Parts 
                1700--1799)
     XVIII  Community Development Financial Institutions Fund, 
                Department of the Treasury (Parts 1800--1899)

[[Page 777]]

               Title 13--Business Credit and Assistance

         I  Small Business Administration (Parts 1--199)
       III  Economic Development Administration, Department of 
                Commerce (Parts 300--399)
        IV  Emergency Steel Guarantee Loan Board (Parts 400--499)
         V  Emergency Oil and Gas Guaranteed Loan Board (Parts 
                500--599)

                    Title 14--Aeronautics and Space

         I  Federal Aviation Administration, Department of 
                Transportation (Parts 1--199)
        II  Office of the Secretary, Department of Transportation 
                (Aviation Proceedings) (Parts 200--399)
       III  Commercial Space Transportation, Federal Aviation 
                Administration, Department of Transportation 
                (Parts 400--1199)
         V  National Aeronautics and Space Administration (Parts 
                1200--1299)
        VI  Air Transportation System Stabilization (Parts 1300--
                1399)

                 Title 15--Commerce and Foreign Trade

            Subtitle A--Office of the Secretary of Commerce (Parts 
                0--29)
            Subtitle B--Regulations Relating to Commerce and 
                Foreign Trade
         I  Bureau of the Census, Department of Commerce (Parts 
                30--199)
        II  National Institute of Standards and Technology, 
                Department of Commerce (Parts 200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  Foreign-Trade Zones Board, Department of Commerce 
                (Parts 400--499)
       VII  Bureau of Industry and Security, Department of 
                Commerce (Parts 700--799)
      VIII  Bureau of Economic Analysis, Department of Commerce 
                (Parts 800--899)
        IX  National Oceanic and Atmospheric Administration, 
                Department of Commerce (Parts 900--999)
        XI  Technology Administration, Department of Commerce 
                (Parts 1100--1199)
      XIII  East-West Foreign Trade Board (Parts 1300--1399)
       XIV  Minority Business Development Agency (Parts 1400--
                1499)
            Subtitle C--Regulations Relating to Foreign Trade 
                Agreements
        XX  Office of the United States Trade Representative 
                (Parts 2000--2099)
            Subtitle D--Regulations Relating to Telecommunications 
                and Information
     XXIII  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                2300--2399)

[[Page 778]]

                    Title 16--Commercial Practices

         I  Federal Trade Commission (Parts 0--999)
        II  Consumer Product Safety Commission (Parts 1000--1799)

             Title 17--Commodity and Securities Exchanges

         I  Commodity Futures Trading Commission (Parts 1--199)
        II  Securities and Exchange Commission (Parts 200--399)
        IV  Department of the Treasury (Parts 400--499)

          Title 18--Conservation of Power and Water Resources

         I  Federal Energy Regulatory Commission, Department of 
                Energy (Parts 1--399)
       III  Delaware River Basin Commission (Parts 400--499)
        VI  Water Resources Council (Parts 700--799)
      VIII  Susquehanna River Basin Commission (Parts 800--899)
      XIII  Tennessee Valley Authority (Parts 1300--1399)

                       Title 19--Customs Duties

         I  U.S. Customs and Border Protection, Department of 
                Homeland Security; Department of the Treasury 
                (Parts 0--199)
        II  United States International Trade Commission (Parts 
                200--299)
       III  International Trade Administration, Department of 
                Commerce (Parts 300--399)
        IV  U.S. Immigration and Customs Enforcement, Department 
                of Homeland Security (Parts 400--599)

                     Title 20--Employees' Benefits

         I  Office of Workers' Compensation Programs, Department 
                of Labor (Parts 1--199)
        II  Railroad Retirement Board (Parts 200--399)
       III  Social Security Administration (Parts 400--499)
        IV  Employees' Compensation Appeals Board, Department of 
                Labor (Parts 500--599)
         V  Employment and Training Administration, Department of 
                Labor (Parts 600--699)
        VI  Office of Workers' Compensation Programs, Department 
                of Labor (Parts 700--799)
       VII  Benefits Review Board, Department of Labor (Parts 
                800--899)
      VIII  Joint Board for the Enrollment of Actuaries (Parts 
                900--999)
        IX  Office of the Assistant Secretary for Veterans' 
                Employment and Training Service, Department of 
                Labor (Parts 1000--1099)

[[Page 779]]

                       Title 21--Food and Drugs

         I  Food and Drug Administration, Department of Health and 
                Human Services (Parts 1--1299)
        II  Drug Enforcement Administration, Department of Justice 
                (Parts 1300--1399)
       III  Office of National Drug Control Policy (Parts 1400--
                1499)

                      Title 22--Foreign Relations

         I  Department of State (Parts 1--199)
        II  Agency for International Development (Parts 200--299)
       III  Peace Corps (Parts 300--399)
        IV  International Joint Commission, United States and 
                Canada (Parts 400--499)
         V  Broadcasting Board of Governors (Parts 500--599)
       VII  Overseas Private Investment Corporation (Parts 700--
                799)
        IX  Foreign Service Grievance Board (Parts 900--999)
         X  Inter-American Foundation (Parts 1000--1099)
        XI  International Boundary and Water Commission, United 
                States and Mexico, United States Section (Parts 
                1100--1199)
       XII  United States International Development Cooperation 
                Agency (Parts 1200--1299)
      XIII  Millennium Challenge Corporation (Parts 1300--1399)
       XIV  Foreign Service Labor Relations Board; Federal Labor 
                Relations Authority; General Counsel of the 
                Federal Labor Relations Authority; and the Foreign 
                Service Impasse Disputes Panel (Parts 1400--1499)
        XV  African Development Foundation (Parts 1500--1599)
       XVI  Japan-United States Friendship Commission (Parts 
                1600--1699)
      XVII  United States Institute of Peace (Parts 1700--1799)

                          Title 23--Highways

         I  Federal Highway Administration, Department of 
                Transportation (Parts 1--999)
        II  National Highway Traffic Safety Administration and 
                Federal Highway Administration, Department of 
                Transportation (Parts 1200--1299)
       III  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 1300--1399)

                Title 24--Housing and Urban Development

            Subtitle A--Office of the Secretary, Department of 
                Housing and Urban Development (Parts 0--99)
            Subtitle B--Regulations Relating to Housing and Urban 
                Development
         I  Office of Assistant Secretary for Equal Opportunity, 
                Department of Housing and Urban Development (Parts 
                100--199)

[[Page 780]]

        II  Office of Assistant Secretary for Housing-Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 200--299)
       III  Government National Mortgage Association, Department 
                of Housing and Urban Development (Parts 300--399)
        IV  Office of Housing and Office of Multifamily Housing 
                Assistance Restructuring, Department of Housing 
                and Urban Development (Parts 400--499)
         V  Office of Assistant Secretary for Community Planning 
                and Development, Department of Housing and Urban 
                Development (Parts 500--599)
        VI  Office of Assistant Secretary for Community Planning 
                and Development, Department of Housing and Urban 
                Development (Parts 600--699) [Reserved]
       VII  Office of the Secretary, Department of Housing and 
                Urban Development (Housing Assistance Programs and 
                Public and Indian Housing Programs) (Parts 700--
                799)
      VIII  Office of the Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Section 8 Housing Assistance 
                Programs, Section 202 Direct Loan Program, Section 
                202 Supportive Housing for the Elderly Program and 
                Section 811 Supportive Housing for Persons With 
                Disabilities Program) (Parts 800--899)
        IX  Office of Assistant Secretary for Public and Indian 
                Housing, Department of Housing and Urban 
                Development (Parts 900--1699)
         X  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Interstate Land Sales 
                Registration Program) (Parts 1700--1799)
       XII  Office of Inspector General, Department of Housing and 
                Urban Development (Parts 2000--2099)
        XV  Emergency Mortgage Insurance and Loan Programs, 
                Department of Housing and Urban Development (Parts 
                2700--2799)
        XX  Office of Assistant Secretary for Housing--Federal 
                Housing Commissioner, Department of Housing and 
                Urban Development (Parts 3200--3899)
      XXIV  Board of Directors of the HOPE for Homeowners Program 
                (Parts 4000--4099)
       XXV  Neighborhood Reinvestment Corporation (Parts 4100--
                4199)

                           Title 25--Indians

         I  Bureau of Indian Affairs, Department of the Interior 
                (Parts 1--299)
        II  Indian Arts and Crafts Board, Department of the 
                Interior (Parts 300--399)
       III  National Indian Gaming Commission, Department of the 
                Interior (Parts 500--599)
        IV  Office of Navajo and Hopi Indian Relocation (Parts 
                700--799)
         V  Bureau of Indian Affairs, Department of the Interior, 
                and Indian Health Service, Department of Health 
                and Human Services (Part 900)

[[Page 781]]

        VI  Office of the Assistant Secretary-Indian Affairs, 
                Department of the Interior (Parts 1000--1199)
       VII  Office of the Special Trustee for American Indians, 
                Department of the Interior (Parts 1200--1299)

                      Title 26--Internal Revenue

         I  Internal Revenue Service, Department of the Treasury 
                (Parts 1--End)

           Title 27--Alcohol, Tobacco Products and Firearms

         I  Alcohol and Tobacco Tax and Trade Bureau, Department 
                of the Treasury (Parts 1--399)
        II  Bureau of Alcohol, Tobacco, Firearms, and Explosives, 
                Department of Justice (Parts 400--699)

                   Title 28--Judicial Administration

         I  Department of Justice (Parts 0--299)
       III  Federal Prison Industries, Inc., Department of Justice 
                (Parts 300--399)
         V  Bureau of Prisons, Department of Justice (Parts 500--
                599)
        VI  Offices of Independent Counsel, Department of Justice 
                (Parts 600--699)
       VII  Office of Independent Counsel (Parts 700--799)
      VIII  Court Services and Offender Supervision Agency for the 
                District of Columbia (Parts 800--899)
        IX  National Crime Prevention and Privacy Compact Council 
                (Parts 900--999)
        XI  Department of Justice and Department of State (Parts 
                1100--1199)

                            Title 29--Labor

            Subtitle A--Office of the Secretary of Labor (Parts 
                0--99)
            Subtitle B--Regulations Relating to Labor
         I  National Labor Relations Board (Parts 100--199)
        II  Office of Labor-Management Standards, Department of 
                Labor (Parts 200--299)
       III  National Railroad Adjustment Board (Parts 300--399)
        IV  Office of Labor-Management Standards, Department of 
                Labor (Parts 400--499)
         V  Wage and Hour Division, Department of Labor (Parts 
                500--899)
        IX  Construction Industry Collective Bargaining Commission 
                (Parts 900--999)
         X  National Mediation Board (Parts 1200--1299)
       XII  Federal Mediation and Conciliation Service (Parts 
                1400--1499)
       XIV  Equal Employment Opportunity Commission (Parts 1600--
                1699)

[[Page 782]]

      XVII  Occupational Safety and Health Administration, 
                Department of Labor (Parts 1900--1999)
        XX  Occupational Safety and Health Review Commission 
                (Parts 2200--2499)
       XXV  Employee Benefits Security Administration, Department 
                of Labor (Parts 2500--2599)
     XXVII  Federal Mine Safety and Health Review Commission 
                (Parts 2700--2799)
        XL  Pension Benefit Guaranty Corporation (Parts 4000--
                4999)

                      Title 30--Mineral Resources

         I  Mine Safety and Health Administration, Department of 
                Labor (Parts 1--199)
        II  Bureau of Safety and Environmental Enforcement, 
                Department of the Interior (Parts 200--299)
        IV  Geological Survey, Department of the Interior (Parts 
                400--499)
         V  Bureau of Ocean Energy Management, Department of the 
                Interior (Parts 500--599)
       VII  Office of Surface Mining Reclamation and Enforcement, 
                Department of the Interior (Parts 700--999)
       XII  Office of Natural Resources Revenue, Department of the 
                Interior (Parts 1200--1299)

                 Title 31--Money and Finance: Treasury

            Subtitle A--Office of the Secretary of the Treasury 
                (Parts 0--50)
            Subtitle B--Regulations Relating to Money and Finance
         I  Monetary Offices, Department of the Treasury (Parts 
                51--199)
        II  Fiscal Service, Department of the Treasury (Parts 
                200--399)
        IV  Secret Service, Department of the Treasury (Parts 
                400--499)
         V  Office of Foreign Assets Control, Department of the 
                Treasury (Parts 500--599)
        VI  Bureau of Engraving and Printing, Department of the 
                Treasury (Parts 600--699)
       VII  Federal Law Enforcement Training Center, Department of 
                the Treasury (Parts 700--799)
      VIII  Office of International Investment, Department of the 
                Treasury (Parts 800--899)
        IX  Federal Claims Collection Standards (Department of the 
                Treasury--Department of Justice) (Parts 900--999)
         X  Financial Crimes Enforcement Network, Department of 
                the Treasury (Parts 1000--1099)

                      Title 32--National Defense

            Subtitle A--Department of Defense
         I  Office of the Secretary of Defense (Parts 1--399)

[[Page 783]]

         V  Department of the Army (Parts 400--699)
        VI  Department of the Navy (Parts 700--799)
       VII  Department of the Air Force (Parts 800--1099)
            Subtitle B--Other Regulations Relating to National 
                Defense
       XII  Defense Logistics Agency (Parts 1200--1299)
       XVI  Selective Service System (Parts 1600--1699)
      XVII  Office of the Director of National Intelligence (Parts 
                1700--1799)
     XVIII  National Counterintelligence Center (Parts 1800--1899)
       XIX  Central Intelligence Agency (Parts 1900--1999)
        XX  Information Security Oversight Office, National 
                Archives and Records Administration (Parts 2000--
                2099)
       XXI  National Security Council (Parts 2100--2199)
      XXIV  Office of Science and Technology Policy (Parts 2400--
                2499)
     XXVII  Office for Micronesian Status Negotiations (Parts 
                2700--2799)
    XXVIII  Office of the Vice President of the United States 
                (Parts 2800--2899)

               Title 33--Navigation and Navigable Waters

         I  Coast Guard, Department of Homeland Security (Parts 
                1--199)
        II  Corps of Engineers, Department of the Army (Parts 
                200--399)
        IV  Saint Lawrence Seaway Development Corporation, 
                Department of Transportation (Parts 400--499)

                          Title 34--Education

            Subtitle A--Office of the Secretary, Department of 
                Education (Parts 1--99)
            Subtitle B--Regulations of the Offices of the 
                Department of Education
         I  Office for Civil Rights, Department of Education 
                (Parts 100--199)
        II  Office of Elementary and Secondary Education, 
                Department of Education (Parts 200--299)
       III  Office of Special Education and Rehabilitative 
                Services, Department of Education (Parts 300--399)
        IV  Office of Vocational and Adult Education, Department 
                of Education (Parts 400--499)
         V  Office of Bilingual Education and Minority Languages 
                Affairs, Department of Education (Parts 500--599)
        VI  Office of Postsecondary Education, Department of 
                Education (Parts 600--699)
       VII  Office of Educational Research and Improvement, 
                Department of Education (Parts 700--799) 
                [Reserved]
            Subtitle C--Regulations Relating to Education
        XI  National Institute for Literacy (Parts 1100--1199)
       XII  National Council on Disability (Parts 1200--1299)

[[Page 784]]

                          Title 35 [Reserved]

             Title 36--Parks, Forests, and Public Property

         I  National Park Service, Department of the Interior 
                (Parts 1--199)
        II  Forest Service, Department of Agriculture (Parts 200--
                299)
       III  Corps of Engineers, Department of the Army (Parts 
                300--399)
        IV  American Battle Monuments Commission (Parts 400--499)
         V  Smithsonian Institution (Parts 500--599)
        VI  [Reserved]
       VII  Library of Congress (Parts 700--799)
      VIII  Advisory Council on Historic Preservation (Parts 800--
                899)
        IX  Pennsylvania Avenue Development Corporation (Parts 
                900--999)
         X  Presidio Trust (Parts 1000--1099)
        XI  Architectural and Transportation Barriers Compliance 
                Board (Parts 1100--1199)
       XII  National Archives and Records Administration (Parts 
                1200--1299)
        XV  Oklahoma City National Memorial Trust (Parts 1500--
                1599)
       XVI  Morris K. Udall Scholarship and Excellence in National 
                Environmental Policy Foundation (Parts 1600--1699)

             Title 37--Patents, Trademarks, and Copyrights

         I  United States Patent and Trademark Office, Department 
                of Commerce (Parts 1--199)
        II  Copyright Office, Library of Congress (Parts 200--299)
       III  Copyright Royalty Board, Library of Congress (Parts 
                300--399)
        IV  Assistant Secretary for Technology Policy, Department 
                of Commerce (Parts 400--599)

           Title 38--Pensions, Bonuses, and Veterans' Relief

         I  Department of Veterans Affairs (Parts 0--199)
        II  Armed Forces Retirement Home (Parts 200--299)

                       Title 39--Postal Service

         I  United States Postal Service (Parts 1--999)
       III  Postal Regulatory Commission (Parts 3000--3099)

                  Title 40--Protection of Environment

         I  Environmental Protection Agency (Parts 1--1099)
        IV  Environmental Protection Agency and Department of 
                Justice (Parts 1400--1499)
         V  Council on Environmental Quality (Parts 1500--1599)
        VI  Chemical Safety and Hazard Investigation Board (Parts 
                1600--1699)

[[Page 785]]

       VII  Environmental Protection Agency and Department of 
                Defense; Uniform National Discharge Standards for 
                Vessels of the Armed Forces (Parts 1700--1799)

          Title 41--Public Contracts and Property Management

            Subtitle A--Federal Procurement Regulations System 
                [Note]
            Subtitle B--Other Provisions Relating to Public 
                Contracts
        50  Public Contracts, Department of Labor (Parts 50-1--50-
                999)
        51  Committee for Purchase From People Who Are Blind or 
                Severely Disabled (Parts 51-1--51-99)
        60  Office of Federal Contract Compliance Programs, Equal 
                Employment Opportunity, Department of Labor (Parts 
                60-1--60-999)
        61  Office of the Assistant Secretary for Veterans' 
                Employment and Training Service, Department of 
                Labor (Parts 61-1--61-999)
   62--100  [Reserved]
            Subtitle C--Federal Property Management Regulations 
                System
       101  Federal Property Management Regulations (Parts 101-1--
                101-99)
       102  Federal Management Regulation (Parts 102-1--102-299)
  103--104  [Reserved]
       105  General Services Administration (Parts 105-1--105-999)
       109  Department of Energy Property Management Regulations 
                (Parts 109-1--109-99)
       114  Department of the Interior (Parts 114-1--114-99)
       115  Environmental Protection Agency (Parts 115-1--115-99)
       128  Department of Justice (Parts 128-1--128-99)
  129--200  [Reserved]
            Subtitle D--Other Provisions Relating to Property 
                Management [Reserved]
            Subtitle E--Federal Information Resources Management 
                Regulations System [Reserved]
            Subtitle F--Federal Travel Regulation System
       300  General (Parts 300-1--300-99)
       301  Temporary Duty (TDY) Travel Allowances (Parts 301-1--
                301-99)
       302  Relocation Allowances (Parts 302-1--302-99)
       303  Payment of Expenses Connected with the Death of 
                Certain Employees (Part 303-1--303-99)
       304  Payment of Travel Expenses from a Non-Federal Source 
                (Parts 304-1--304-99)

                        Title 42--Public Health

         I  Public Health Service, Department of Health and Human 
                Services (Parts 1--199)
        IV  Centers for Medicare & Medicaid Services, Department 
                of Health and Human Services (Parts 400--599)

[[Page 786]]

         V  Office of Inspector General-Health Care, Department of 
                Health and Human Services (Parts 1000--1999)

                   Title 43--Public Lands: Interior

            Subtitle A--Office of the Secretary of the Interior 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Lands
         I  Bureau of Reclamation, Department of the Interior 
                (Parts 400--999)
        II  Bureau of Land Management, Department of the Interior 
                (Parts 1000--9999)
       III  Utah Reclamation Mitigation and Conservation 
                Commission (Parts 10000--10099)

             Title 44--Emergency Management and Assistance

         I  Federal Emergency Management Agency, Department of 
                Homeland Security (Parts 0--399)
        IV  Department of Commerce and Department of 
                Transportation (Parts 400--499)

                       Title 45--Public Welfare

            Subtitle A--Department of Health and Human Services 
                (Parts 1--199)
            Subtitle B--Regulations Relating to Public Welfare
        II  Office of Family Assistance (Assistance Programs), 
                Administration for Children and Families, 
                Department of Health and Human Services (Parts 
                200--299)
       III  Office of Child Support Enforcement (Child Support 
                Enforcement Program), Administration for Children 
                and Families, Department of Health and Human 
                Services (Parts 300--399)
        IV  Office of Refugee Resettlement, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 400--499)
         V  Foreign Claims Settlement Commission of the United 
                States, Department of Justice (Parts 500--599)
        VI  National Science Foundation (Parts 600--699)
       VII  Commission on Civil Rights (Parts 700--799)
      VIII  Office of Personnel Management (Parts 800--899)
         X  Office of Community Services, Administration for 
                Children and Families, Department of Health and 
                Human Services (Parts 1000--1099)
        XI  National Foundation on the Arts and the Humanities 
                (Parts 1100--1199)
       XII  Corporation for National and Community Service (Parts 
                1200--1299)
      XIII  Office of Human Development Services, Department of 
                Health and Human Services (Parts 1300--1399)

[[Page 787]]

       XVI  Legal Services Corporation (Parts 1600--1699)
      XVII  National Commission on Libraries and Information 
                Science (Parts 1700--1799)
     XVIII  Harry S. Truman Scholarship Foundation (Parts 1800--
                1899)
       XXI  Commission on Fine Arts (Parts 2100--2199)
     XXIII  Arctic Research Commission (Part 2301)
      XXIV  James Madison Memorial Fellowship Foundation (Parts 
                2400--2499)
       XXV  Corporation for National and Community Service (Parts 
                2500--2599)

                          Title 46--Shipping

         I  Coast Guard, Department of Homeland Security (Parts 
                1--199)
        II  Maritime Administration, Department of Transportation 
                (Parts 200--399)
       III  Coast Guard (Great Lakes Pilotage), Department of 
                Homeland Security (Parts 400--499)
        IV  Federal Maritime Commission (Parts 500--599)

                      Title 47--Telecommunication

         I  Federal Communications Commission (Parts 0--199)
        II  Office of Science and Technology Policy and National 
                Security Council (Parts 200--299)
       III  National Telecommunications and Information 
                Administration, Department of Commerce (Parts 
                300--399)
        IV  National Telecommunications and Information 
                Administration, Department of Commerce, and 
                National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 400--499)

           Title 48--Federal Acquisition Regulations System

         1  Federal Acquisition Regulation (Parts 1--99)
         2  Defense Acquisition Regulations System, Department of 
                Defense (Parts 200--299)
         3  Health and Human Services (Parts 300--399)
         4  Department of Agriculture (Parts 400--499)
         5  General Services Administration (Parts 500--599)
         6  Department of State (Parts 600--699)
         7  Agency for International Development (Parts 700--799)
         8  Department of Veterans Affairs (Parts 800--899)
         9  Department of Energy (Parts 900--999)
        10  Department of the Treasury (Parts 1000--1099)
        12  Department of Transportation (Parts 1200--1299)
        13  Department of Commerce (Parts 1300--1399)
        14  Department of the Interior (Parts 1400--1499)

[[Page 788]]

        15  Environmental Protection Agency (Parts 1500--1599)
        16  Office of Personnel Management, Federal Employees 
                Health Benefits Acquisition Regulation (Parts 
                1600--1699)
        17  Office of Personnel Management (Parts 1700--1799)
        18  National Aeronautics and Space Administration (Parts 
                1800--1899)
        19  Broadcasting Board of Governors (Parts 1900--1999)
        20  Nuclear Regulatory Commission (Parts 2000--2099)
        21  Office of Personnel Management, Federal Employees 
                Group Life Insurance Federal Acquisition 
                Regulation (Parts 2100--2199)
        23  Social Security Administration (Parts 2300--2399)
        24  Department of Housing and Urban Development (Parts 
                2400--2499)
        25  National Science Foundation (Parts 2500--2599)
        28  Department of Justice (Parts 2800--2899)
        29  Department of Labor (Parts 2900--2999)
        30  Department of Homeland Security, Homeland Security 
                Acquisition Regulation (HSAR) (Parts 3000--3099)
        34  Department of Education Acquisition Regulation (Parts 
                3400--3499)
        51  Department of the Army Acquisition Regulations (Parts 
                5100--5199)
        52  Department of the Navy Acquisition Regulations (Parts 
                5200--5299)
        53  Department of the Air Force Federal Acquisition 
                Regulation Supplement (Parts 5300--5399) 
                [Reserved]
        54  Defense Logistics Agency, Department of Defense (Parts 
                5400--5499)
        57  African Development Foundation (Parts 5700--5799)
        61  Civilian Board of Contract Appeals, General Services 
                Administration (Parts 6100--6199)
        63  Department of Transportation Board of Contract Appeals 
                (Parts 6300--6399)
        99  Cost Accounting Standards Board, Office of Federal 
                Procurement Policy, Office of Management and 
                Budget (Parts 9900--9999)

                       Title 49--Transportation

            Subtitle A--Office of the Secretary of Transportation 
                (Parts 1--99)
            Subtitle B--Other Regulations Relating to 
                Transportation
         I  Pipeline and Hazardous Materials Safety 
                Administration, Department of Transportation 
                (Parts 100--199)
        II  Federal Railroad Administration, Department of 
                Transportation (Parts 200--299)
       III  Federal Motor Carrier Safety Administration, 
                Department of Transportation (Parts 300--399)
        IV  Coast Guard, Department of Homeland Security (Parts 
                400--499)

[[Page 789]]

         V  National Highway Traffic Safety Administration, 
                Department of Transportation (Parts 500--599)
        VI  Federal Transit Administration, Department of 
                Transportation (Parts 600--699)
       VII  National Railroad Passenger Corporation (AMTRAK) 
                (Parts 700--799)
      VIII  National Transportation Safety Board (Parts 800--999)
         X  Surface Transportation Board, Department of 
                Transportation (Parts 1000--1399)
        XI  Research and Innovative Technology Administration, 
                Department of Transportation (Parts 1400--1499) 
                [Reserved]
       XII  Transportation Security Administration, Department of 
                Homeland Security (Parts 1500--1699)

                   Title 50--Wildlife and Fisheries

         I  United States Fish and Wildlife Service, Department of 
                the Interior (Parts 1--199)
        II  National Marine Fisheries Service, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 200--299)
       III  International Fishing and Related Activities (Parts 
                300--399)
        IV  Joint Regulations (United States Fish and Wildlife 
                Service, Department of the Interior and National 
                Marine Fisheries Service, National Oceanic and 
                Atmospheric Administration, Department of 
                Commerce); Endangered Species Committee 
                Regulations (Parts 400--499)
         V  Marine Mammal Commission (Parts 500--599)
        VI  Fishery Conservation and Management, National Oceanic 
                and Atmospheric Administration, Department of 
                Commerce (Parts 600--699)

                      CFR Index and Finding Aids

            Subject/Agency Index
            List of Agency Prepared Indexes
            Parallel Tables of Statutory Authorities and Rules
            List of CFR Titles, Chapters, Subchapters, and Parts
            Alphabetical List of Agencies Appearing in the CFR

[[Page 791]]





           Alphabetical List of Agencies Appearing in the CFR




                      (Revised as of July 1, 2013)

                                                  CFR Title, Subtitle or 
                     Agency                               Chapter

Administrative Committee of the Federal Register  1, I
Administrative Conference of the United States    1, III
Advisory Council on Historic Preservation         36, VIII
Advocacy and Outreach, Office of                  7, XXV
Afghanistan Reconstruction, Special Inspector     22, LXXXIII
     General for
African Development Foundation                    22, XV
  Federal Acquisition Regulation                  48, 57
Agency for International Development              2, VII; 22, II
  Federal Acquisition Regulation                  48, 7
Agricultural Marketing Service                    7, I, IX, X, XI
Agricultural Research Service                     7, V
Agriculture Department                            2, IV; 5, LXXIII
  Advocacy and Outreach, Office of                7, XXV
  Agricultural Marketing Service                  7, I, IX, X, XI
  Agricultural Research Service                   7, V
  Animal and Plant Health Inspection Service      7, III; 9, I
  Chief Financial Officer, Office of              7, XXX
  Commodity Credit Corporation                    7, XIV
  Economic Research Service                       7, XXXVII
  Energy Policy and New Uses, Office of           2, IX; 7, XXIX
  Environmental Quality, Office of                7, XXXI
  Farm Service Agency                             7, VII, XVIII
  Federal Acquisition Regulation                  48, 4
  Federal Crop Insurance Corporation              7, IV
  Food and Nutrition Service                      7, II
  Food Safety and Inspection Service              9, III
  Foreign Agricultural Service                    7, XV
  Forest Service                                  36, II
  Grain Inspection, Packers and Stockyards        7, VIII; 9, II
       Administration
  Information Resources Management, Office of     7, XXVII
  Inspector General, Office of                    7, XXVI
  National Agricultural Library                   7, XLI
  National Agricultural Statistics Service        7, XXXVI
  National Institute of Food and Agriculture      7, XXXIV
  Natural Resources Conservation Service          7, VI
  Operations, Office of                           7, XXVIII
  Procurement and Property Management, Office of  7, XXXII
  Rural Business-Cooperative Service              7, XVIII, XLII, L
  Rural Development Administration                7, XLII
  Rural Housing Service                           7, XVIII, XXXV, L
  Rural Telephone Bank                            7, XVI
  Rural Utilities Service                         7, XVII, XVIII, XLII, L
  Secretary of Agriculture, Office of             7, Subtitle A
  Transportation, Office of                       7, XXXIII
  World Agricultural Outlook Board                7, XXXVIII
Air Force Department                              32, VII
  Federal Acquisition Regulation Supplement       48, 53
Air Transportation Stabilization Board            14, VI
Alcohol and Tobacco Tax and Trade Bureau          27, I
Alcohol, Tobacco, Firearms, and Explosives,       27, II
     Bureau of
AMTRAK                                            49, VII
American Battle Monuments Commission              36, IV
American Indians, Office of the Special Trustee   25, VII

[[Page 792]]

Animal and Plant Health Inspection Service        7, III; 9, I
Appalachian Regional Commission                   5, IX
Architectural and Transportation Barriers         36, XI
     Compliance Board
Arctic Research Commission                        45, XXIII
Armed Forces Retirement Home                      5, XI
Army Department                                   32, V
  Engineers, Corps of                             33, II; 36, III
  Federal Acquisition Regulation                  48, 51
Bilingual Education and Minority Languages        34, V
     Affairs, Office of
Blind or Severely Disabled, Committee for         41, 51
     Purchase from People Who Are
Broadcasting Board of Governors                   22, V
  Federal Acquisition Regulation                  48, 19
Bureau of Ocean Energy Management, Regulation,    30, II
     and Enforcement
Census Bureau                                     15, I
Centers for Medicare & Medicaid Services          42, IV
Central Intelligence Agency                       32, XIX
Chemical Safety and Hazardous Investigation       40, VI
     Board
Chief Financial Officer, Office of                7, XXX
Child Support Enforcement, Office of              45, III
Children and Families, Administration for         45, II, III, IV, X
Civil Rights, Commission on                       5, LXVIII; 45, VII
Civil Rights, Office for                          34, I
Council of the Inspectors General on Integrity    5, XCVIII
     and Efficiency
Court Services and Offender Supervision Agency    5, LXX
     for the District of Columbia
Coast Guard                                       33, I; 46, I; 49, IV
Coast Guard (Great Lakes Pilotage)                46, III
Commerce Department                               2, XIII; 44, IV; 50, VI
  Census Bureau                                   15, I
  Economic Analysis, Bureau of                    15, VIII
  Economic Development Administration             13, III
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 13
  Foreign-Trade Zones Board                       15, IV
  Industry and Security, Bureau of                15, VII
  International Trade Administration              15, III; 19, III
  National Institute of Standards and Technology  15, II
  National Marine Fisheries Service               50, II, IV
  National Oceanic and Atmospheric                15, IX; 50, II, III, IV, 
       Administration                             VI
  National Telecommunications and Information     15, XXIII; 47, III, IV
       Administration
  National Weather Service                        15, IX
  Patent and Trademark Office, United States      37, I
  Productivity, Technology and Innovation,        37, IV
       Assistant Secretary for
  Secretary of Commerce, Office of                15, Subtitle A
  Technology Administration                       15, XI
  Technology Policy, Assistant Secretary for      37, IV
Commercial Space Transportation                   14, III
Commodity Credit Corporation                      7, XIV
Commodity Futures Trading Commission              5, XLI; 17, I
Community Planning and Development, Office of     24, V, VI
     Assistant Secretary for
Community Services, Office of                     45, X
Comptroller of the Currency                       12, I
Construction Industry Collective Bargaining       29, IX
     Commission
Consumer Financial Protection Bureau              5, LXXXIV; 12, X
Consumer Product Safety Commission                5, LXXI; 16, II
Copyright Office                                  37, II
Copyright Royalty Board                           37, III
Corporation for National and Community Service    2, XXII; 45, XII, XXV
Cost Accounting Standards Board                   48, 99
Council on Environmental Quality                  40, V
Court Services and Offender Supervision Agency    5, LXX; 28, VIII
   for the District of Columbia
[[Page 793]]

Customs and Border Protection                     19, I
Defense Contract Audit Agency                     32, I
Defense Department                                2, XI; 5, XXVI; 32, 
                                                  Subtitle A; 40, VII
  Advanced Research Projects Agency               32, I
  Air Force Department                            32, VII
  Army Department                                 32, V; 33, II; 36, III, 
                                                  48, 51
  Defense Acquisition Regulations System          48, 2
  Defense Intelligence Agency                     32, I
  Defense Logistics Agency                        32, I, XII; 48, 54
  Engineers, Corps of                             33, II; 36, III
  National Imagery and Mapping Agency             32, I
  Navy Department                                 32, VI; 48, 52
  Secretary of Defense, Office of                 2, XI; 32, I
Defense Contract Audit Agency                     32, I
Defense Intelligence Agency                       32, I
Defense Logistics Agency                          32, XII; 48, 54
Defense Nuclear Facilities Safety Board           10, XVII
Delaware River Basin Commission                   18, III
District of Columbia, Court Services and          5, LXX; 28, VIII
     Offender Supervision Agency for the
Drug Enforcement Administration                   21, II
East-West Foreign Trade Board                     15, XIII
Economic Analysis, Bureau of                      15, VIII
Economic Development Administration               13, III
Economic Research Service                         7, XXXVII
Education, Department of                          2, XXXIV; 5, LIII
  Bilingual Education and Minority Languages      34, V
       Affairs, Office of
  Civil Rights, Office for                        34, I
  Educational Research and Improvement, Office    34, VII
       of
  Elementary and Secondary Education, Office of   34, II
  Federal Acquisition Regulation                  48, 34
  Postsecondary Education, Office of              34, VI
  Secretary of Education, Office of               34, Subtitle A
  Special Education and Rehabilitative Services,  34, III
       Office of
  Vocational and Adult Education, Office of       34, IV
Educational Research and Improvement, Office of   34, VII
Election Assistance Commission                    2, LVIII; 11, II
Elementary and Secondary Education, Office of     34, II
Emergency Oil and Gas Guaranteed Loan Board       13, V
Emergency Steel Guarantee Loan Board              13, IV
Employee Benefits Security Administration         29, XXV
Employees' Compensation Appeals Board             20, IV
Employees Loyalty Board                           5, V
Employment and Training Administration            20, V
Employment Standards Administration               20, VI
Endangered Species Committee                      50, IV
Energy, Department of                             2, IX; 5, XXIII; 10, II, 
                                                  III, X
  Federal Acquisition Regulation                  48, 9
  Federal Energy Regulatory Commission            5, XXIV; 18, I
  Property Management Regulations                 41, 109
Energy, Office of                                 7, XXIX
Engineers, Corps of                               33, II; 36, III
Engraving and Printing, Bureau of                 31, VI
Environmental Protection Agency                   2, XV; 5, LIV; 40, I, IV, 
                                                  VII
  Federal Acquisition Regulation                  48, 15
  Property Management Regulations                 41, 115
Environmental Quality, Office of                  7, XXXI
Equal Employment Opportunity Commission           5, LXII; 29, XIV
Equal Opportunity, Office of Assistant Secretary  24, I
     for
Executive Office of the President                 3, I
  Administration, Office of                       5, XV
  Environmental Quality, Council on               40, V

[[Page 794]]

  Management and Budget, Office of                2, Subtitle A; 5, III, 
                                                  LXXVII; 14, VI; 48, 99
  National Drug Control Policy, Office of         21, III
  National Security Council                       32, XXI; 47, 2
  Presidential Documents                          3
  Science and Technology Policy, Office of        32, XXIV; 47, II
  Trade Representative, Office of the United      15, XX
       States
Export-Import Bank of the United States           2, XXXV; 5, LII; 12, IV
Family Assistance, Office of                      45, II
Farm Credit Administration                        5, XXXI; 12, VI
Farm Credit System Insurance Corporation          5, XXX; 12, XIV
Farm Service Agency                               7, VII, XVIII
Federal Acquisition Regulation                    48, 1
Federal Aviation Administration                   14, I
  Commercial Space Transportation                 14, III
Federal Claims Collection Standards               31, IX
Federal Communications Commission                 5, XXIX; 47, I
Federal Contract Compliance Programs, Office of   41, 60
Federal Crop Insurance Corporation                7, IV
Federal Deposit Insurance Corporation             5, XXII; 12, III
Federal Election Commission                       5, XXXVII; 11, I
Federal Emergency Management Agency               44, I
Federal Employees Group Life Insurance Federal    48, 21
     Acquisition Regulation
Federal Employees Health Benefits Acquisition     48, 16
     Regulation
Federal Energy Regulatory Commission              5, XXIV; 18, I
Federal Financial Institutions Examination        12, XI
     Council
Federal Financing Bank                            12, VIII
Federal Highway Administration                    23, I, II
Federal Home Loan Mortgage Corporation            1, IV
Federal Housing Enterprise Oversight Office       12, XVII
Federal Housing Finance Agency                    5, LXXX; 12, XII
Federal Housing Finance Board                     12, IX
Federal Labor Relations Authority                 5, XIV, XLIX; 22, XIV
Federal Law Enforcement Training Center           31, VII
Federal Management Regulation                     41, 102
Federal Maritime Commission                       46, IV
Federal Mediation and Conciliation Service        29, XII
Federal Mine Safety and Health Review Commission  5, LXXIV; 29, XXVII
Federal Motor Carrier Safety Administration       49, III
Federal Prison Industries, Inc.                   28, III
Federal Procurement Policy Office                 48, 99
Federal Property Management Regulations           41, 101
Federal Railroad Administration                   49, II
Federal Register, Administrative Committee of     1, I
Federal Register, Office of                       1, II
Federal Reserve System                            12, II
  Board of Governors                              5, LVIII
Federal Retirement Thrift Investment Board        5, VI, LXXVI
Federal Service Impasses Panel                    5, XIV
Federal Trade Commission                          5, XLVII; 16, I
Federal Transit Administration                    49, VI
Federal Travel Regulation System                  41, Subtitle F
Financial Crimes Enforcement Network              31, X
Financial Research Office                         12, XVI
Financial Stability Oversight Council             12, XIII
Fine Arts, Commission on                          45, XXI
Fiscal Service                                    31, II
Fish and Wildlife Service, United States          50, I, IV
Food and Drug Administration                      21, I
Food and Nutrition Service                        7, II
Food Safety and Inspection Service                9, III
Foreign Agricultural Service                      7, XV
Foreign Assets Control, Office of                 31, V
Foreign Claims Settlement Commission of the       45, V
     United States
Foreign Service Grievance Board                   22, IX
Foreign Service Impasse Disputes Panel            22, XIV

[[Page 795]]

Foreign Service Labor Relations Board             22, XIV
Foreign-Trade Zones Board                         15, IV
Forest Service                                    36, II
General Services Administration                   5, LVII; 41, 105
  Contract Appeals, Board of                      48, 61
  Federal Acquisition Regulation                  48, 5
  Federal Management Regulation                   41, 102
  Federal Property Management Regulations         41, 101
  Federal Travel Regulation System                41, Subtitle F
  General                                         41, 300
  Payment From a Non-Federal Source for Travel    41, 304
       Expenses
  Payment of Expenses Connected With the Death    41, 303
       of Certain Employees
  Relocation Allowances                           41, 302
  Temporary Duty (TDY) Travel Allowances          41, 301
Geological Survey                                 30, IV
Government Accountability Office                  4, I
Government Ethics, Office of                      5, XVI
Government National Mortgage Association          24, III
Grain Inspection, Packers and Stockyards          7, VIII; 9, II
     Administration
Harry S. Truman Scholarship Foundation            45, XVIII
Health and Human Services, Department of          2, III; 5, XLV; 45, 
                                                  Subtitle A,
  Centers for Medicare & Medicaid Services        42, IV
  Child Support Enforcement, Office of            45, III
  Children and Families, Administration for       45, II, III, IV, X
  Community Services, Office of                   45, X
  Family Assistance, Office of                    45, II
  Federal Acquisition Regulation                  48, 3
  Food and Drug Administration                    21, I
  Human Development Services, Office of           45, XIII
  Indian Health Service                           25, V
  Inspector General (Health Care), Office of      42, V
  Public Health Service                           42, I
  Refugee Resettlement, Office of                 45, IV
Homeland Security, Department of                  2, XXX; 6, I; 8, I
  Coast Guard                                     33, I; 46, I; 49, IV
  Coast Guard (Great Lakes Pilotage)              46, III
  Customs and Border Protection                   19, I
  Federal Emergency Management Agency             44, I
  Human Resources Management and Labor Relations  5, XCVII
       Systems
  Immigration and Customs Enforcement Bureau      19, IV
  Transportation Security Administration          49, XII
HOPE for Homeowners Program, Board of Directors   24, XXIV
     of
Housing and Urban Development, Department of      2, XXIV; 5, LXV; 24, 
                                                  Subtitle B
  Community Planning and Development, Office of   24, V, VI
       Assistant Secretary for
  Equal Opportunity, Office of Assistant          24, I
       Secretary for
  Federal Acquisition Regulation                  48, 24
  Federal Housing Enterprise Oversight, Office    12, XVII
       of
  Government National Mortgage Association        24, III
  Housing--Federal Housing Commissioner, Office   24, II, VIII, X, XX
       of Assistant Secretary for
  Housing, Office of, and Multifamily Housing     24, IV
       Assistance Restructuring, Office of
  Inspector General, Office of                    24, XII
  Public and Indian Housing, Office of Assistant  24, IX
       Secretary for
  Secretary, Office of                            24, Subtitle A, VII
Housing--Federal Housing Commissioner, Office of  24, II, VIII, X, XX
     Assistant Secretary for
Housing, Office of, and Multifamily Housing       24, IV
     Assistance Restructuring, Office of
Human Development Services, Office of             45, XIII
Immigration and Customs Enforcement Bureau        19, IV
Immigration Review, Executive Office for          8, V

[[Page 796]]

Independent Counsel, Office of                    28, VII
Indian Affairs, Bureau of                         25, I, V
Indian Affairs, Office of the Assistant           25, VI
     Secretary
Indian Arts and Crafts Board                      25, II
Indian Health Service                             25, V
Industry and Security, Bureau of                  15, VII
Information Resources Management, Office of       7, XXVII
Information Security Oversight Office, National   32, XX
     Archives and Records Administration
Inspector General
  Agriculture Department                          7, XXVI
  Health and Human Services Department            42, V
  Housing and Urban Development Department        24, XII, XV
Institute of Peace, United States                 22, XVII
Inter-American Foundation                         5, LXIII; 22, X
Interior Department                               2, XIV
  American Indians, Office of the Special         25, VII
       Trustee
  Bureau of Ocean Energy Management, Regulation,  30, II
       and Enforcement
  Endangered Species Committee                    50, IV
  Federal Acquisition Regulation                  48, 14
  Federal Property Management Regulations System  41, 114
  Fish and Wildlife Service, United States        50, I, IV
  Geological Survey                               30, IV
  Indian Affairs, Bureau of                       25, I, V
  Indian Affairs, Office of the Assistant         25, VI
       Secretary
  Indian Arts and Crafts Board                    25, II
  Land Management, Bureau of                      43, II
  National Indian Gaming Commission               25, III
  National Park Service                           36, I
  Natural Resource Revenue, Office of             30, XII
  Ocean Energy Management, Bureau of              30, V
  Reclamation, Bureau of                          43, I
  Secretary of the Interior, Office of            2, XIV; 43, Subtitle A
  Surface Mining Reclamation and Enforcement,     30, VII
       Office of
Internal Revenue Service                          26, I
International Boundary and Water Commission,      22, XI
     United States and Mexico, United States 
     Section
International Development, United States Agency   22, II
     for
  Federal Acquisition Regulation                  48, 7
International Development Cooperation Agency,     22, XII
     United States
International Joint Commission, United States     22, IV
     and Canada
International Organizations Employees Loyalty     5, V
     Board
International Trade Administration                15, III; 19, III
International Trade Commission, United States     19, II
Interstate Commerce Commission                    5, XL
Investment Security, Office of                    31, VIII
Iraq Reconstruction, Special Inspector General    5, LXXXVII
     for
James Madison Memorial Fellowship Foundation      45, XXIV
Japan-United States Friendship Commission         22, XVI
Joint Board for the Enrollment of Actuaries       20, VIII
Justice Department                                2, XXVIII; 5, XXVIII; 28, 
                                                  I, XI; 40, IV
  Alcohol, Tobacco, Firearms, and Explosives,     27, II
       Bureau of
  Drug Enforcement Administration                 21, II
  Federal Acquisition Regulation                  48, 28
  Federal Claims Collection Standards             31, IX
  Federal Prison Industries, Inc.                 28, III
  Foreign Claims Settlement Commission of the     45, V
       United States
  Immigration Review, Executive Office for        8, V
  Offices of Independent Counsel                  28, VI
  Prisons, Bureau of                              28, V
  Property Management Regulations                 41, 128
Labor Department                                  5, XLII
  Employee Benefits Security Administration       29, XXV

[[Page 797]]

  Employees' Compensation Appeals Board           20, IV
  Employment and Training Administration          20, V
  Employment Standards Administration             20, VI
  Federal Acquisition Regulation                  48, 29
  Federal Contract Compliance Programs, Office    41, 60
       of
  Federal Procurement Regulations System          41, 50
  Labor-Management Standards, Office of           29, II, IV
  Mine Safety and Health Administration           30, I
  Occupational Safety and Health Administration   29, XVII
  Office of Workers' Compensation Programs        20, VII
  Public Contracts                                41, 50
  Secretary of Labor, Office of                   29, Subtitle A
  Veterans' Employment and Training Service,      41, 61; 20, IX
       Office of the Assistant Secretary for
  Wage and Hour Division                          29, V
  Workers' Compensation Programs, Office of       20, I
Labor-Management Standards, Office of             29, II, IV
Land Management, Bureau of                        43, II
Legal Services Corporation                        45, XVI
Library of Congress                               36, VII
  Copyright Office                                37, II
  Copyright Royalty Board                         37, III
Local Television Loan Guarantee Board             7, XX
Management and Budget, Office of                  5, III, LXXVII; 14, VI; 
                                                  48, 99
Marine Mammal Commission                          50, V
Maritime Administration                           46, II
Merit Systems Protection Board                    5, II, LXIV
Micronesian Status Negotiations, Office for       32, XXVII
Millennium Challenge Corporation                  22, XIII
Mine Safety and Health Administration             30, I
Minority Business Development Agency              15, XIV
Miscellaneous Agencies                            1, IV
Monetary Offices                                  31, I
Morris K. Udall Scholarship and Excellence in     36, XVI
     National Environmental Policy Foundation
Museum and Library Services, Institute of         2, XXXI
National Aeronautics and Space Administration     2, XVIII; 5, LIX; 14, V
  Federal Acquisition Regulation                  48, 18
National Agricultural Library                     7, XLI
National Agricultural Statistics Service          7, XXXVI
National and Community Service, Corporation for   2, XXII; 45, XII, XXV
National Archives and Records Administration      2, XXVI; 5, LXVI; 36, XII
  Information Security Oversight Office           32, XX
National Capital Planning Commission              1, IV
National Commission for Employment Policy         1, IV
National Commission on Libraries and Information  45, XVII
     Science
National Council on Disability                    34, XII
National Counterintelligence Center               32, XVIII
National Credit Union Administration              5, LXXXVI; 12, VII
National Crime Prevention and Privacy Compact     28, IX
     Council
National Drug Control Policy, Office of           21, III
National Endowment for the Arts                   2, XXXII
National Endowment for the Humanities             2, XXXIII
National Foundation on the Arts and the           45, XI
     Humanities
National Highway Traffic Safety Administration    23, II, III; 47, VI; 49, V
National Imagery and Mapping Agency               32, I
National Indian Gaming Commission                 25, III
National Institute for Literacy                   34, XI
National Institute of Food and Agriculture        7, XXXIV
National Institute of Standards and Technology    15, II
National Intelligence, Office of Director of      32, XVII
National Labor Relations Board                    5, LXI; 29, I
National Marine Fisheries Service                 50, II, IV
National Mediation Board                          29, X
National Oceanic and Atmospheric Administration   15, IX; 50, II, III, IV, 
                                                  VI

[[Page 798]]

National Park Service                             36, I
National Railroad Adjustment Board                29, III
National Railroad Passenger Corporation (AMTRAK)  49, VII
National Science Foundation                       2, XXV; 5, XLIII; 45, VI
  Federal Acquisition Regulation                  48, 25
National Security Council                         32, XXI
National Security Council and Office of Science   47, II
     and Technology Policy
National Telecommunications and Information       15, XXIII; 47, III, IV
     Administration
National Transportation Safety Board              49, VIII
Natural Resources Conservation Service            7, VI
Natural Resource Revenue, Office of               30, XII
Navajo and Hopi Indian Relocation, Office of      25, IV
Navy Department                                   32, VI
  Federal Acquisition Regulation                  48, 52
Neighborhood Reinvestment Corporation             24, XXV
Northeast Interstate Low-Level Radioactive Waste  10, XVIII
     Commission
Nuclear Regulatory Commission                     2, XX; 5, XLVIII; 10, I
  Federal Acquisition Regulation                  48, 20
Occupational Safety and Health Administration     29, XVII
Occupational Safety and Health Review Commission  29, XX
Ocean Energy Management, Bureau of                30, V
Offices of Independent Counsel                    28, VI
Office of Workers' Compensation Programs          20, VII
Oklahoma City National Memorial Trust             36, XV
Operations Office                                 7, XXVIII
Overseas Private Investment Corporation           5, XXXIII; 22, VII
Patent and Trademark Office, United States        37, I
Payment From a Non-Federal Source for Travel      41, 304
     Expenses
Payment of Expenses Connected With the Death of   41, 303
     Certain Employees
Peace Corps                                       2, XXXVII; 22, III
Pennsylvania Avenue Development Corporation       36, IX
Pension Benefit Guaranty Corporation              29, XL
Personnel Management, Office of                   5, I, XXXV; 45, VIII
  Human Resources Management and Labor Relations  5, XCVII
       Systems, Department of Homeland Security
  Federal Acquisition Regulation                  48, 17
  Federal Employees Group Life Insurance Federal  48, 21
       Acquisition Regulation
  Federal Employees Health Benefits Acquisition   48, 16
       Regulation
Pipeline and Hazardous Materials Safety           49, I
     Administration
Postal Regulatory Commission                      5, XLVI; 39, III
Postal Service, United States                     5, LX; 39, I
Postsecondary Education, Office of                34, VI
President's Commission on White House             1, IV
     Fellowships
Presidential Documents                            3
Presidio Trust                                    36, X
Prisons, Bureau of                                28, V
Private and Civil Liberties Oversight Board       6, X
Procurement and Property Management, Office of    7, XXXII
Productivity, Technology and Innovation,          37, IV
     Assistant Secretary
Public Contracts, Department of Labor             41, 50
Public and Indian Housing, Office of Assistant    24, IX
     Secretary for
Public Health Service                             42, I
Railroad Retirement Board                         20, II
Reclamation, Bureau of                            43, I
Recovery Accountability and Transparency Board    4, II
Refugee Resettlement, Office of                   45, IV
Relocation Allowances                             41, 302
Research and Innovative Technology                49, XI
     Administration
Rural Business-Cooperative Service                7, XVIII, XLII, L
Rural Development Administration                  7, XLII
Rural Housing Service                             7, XVIII, XXXV, L

[[Page 799]]

Rural Telephone Bank                              7, XVI
Rural Utilities Service                           7, XVII, XVIII, XLII, L
Saint Lawrence Seaway Development Corporation     33, IV
Science and Technology Policy, Office of          32, XXIV
Science and Technology Policy, Office of, and     47, II
     National Security Council
Secret Service                                    31, IV
Securities and Exchange Commission                5, XXXIV; 17, II
Selective Service System                          32, XVI
Small Business Administration                     2, XXVII; 13, I
Smithsonian Institution                           36, V
Social Security Administration                    2, XXIII; 20, III; 48, 23
Soldiers' and Airmen's Home, United States        5, XI
Special Counsel, Office of                        5, VIII
Special Education and Rehabilitative Services,    34, III
     Office of
State Department                                  2, VI; 22, I; 28, XI
  Federal Acquisition Regulation                  48, 6
Surface Mining Reclamation and Enforcement,       30, VII
     Office of
Surface Transportation Board                      49, X
Susquehanna River Basin Commission                18, VIII
Technology Administration                         15, XI
Technology Policy, Assistant Secretary for        37, IV
Tennessee Valley Authority                        5, LXIX; 18, XIII
Thrift Supervision Office, Department of the      12, V
     Treasury
Trade Representative, United States, Office of    15, XX
Transportation, Department of                     2, XII; 5, L
  Commercial Space Transportation                 14, III
  Contract Appeals, Board of                      48, 63
  Emergency Management and Assistance             44, IV
  Federal Acquisition Regulation                  48, 12
  Federal Aviation Administration                 14, I
  Federal Highway Administration                  23, I, II
  Federal Motor Carrier Safety Administration     49, III
  Federal Railroad Administration                 49, II
  Federal Transit Administration                  49, VI
  Maritime Administration                         46, II
  National Highway Traffic Safety Administration  23, II, III; 47, IV; 49, V
  Pipeline and Hazardous Materials Safety         49, I
       Administration
  Saint Lawrence Seaway Development Corporation   33, IV
  Secretary of Transportation, Office of          14, II; 49, Subtitle A
  Surface Transportation Board                    49, X
  Transportation Statistics Bureau                49, XI
Transportation, Office of                         7, XXXIII
Transportation Security Administration            49, XII
Transportation Statistics Bureau                  49, XI
Travel Allowances, Temporary Duty (TDY)           41, 301
Treasury Department                               5, XXI; 12, XV; 17, IV; 
                                                  31, IX
  Alcohol and Tobacco Tax and Trade Bureau        27, I
  Community Development Financial Institutions    12, XVIII
       Fund
  Comptroller of the Currency                     12, I
  Customs and Border Protection                   19, I
  Engraving and Printing, Bureau of               31, VI
  Federal Acquisition Regulation                  48, 10
  Federal Claims Collection Standards             31, IX
  Federal Law Enforcement Training Center         31, VII
  Financial Crimes Enforcement Network            31, X
  Fiscal Service                                  31, II
  Foreign Assets Control, Office of               31, V
  Internal Revenue Service                        26, I
  Investment Security, Office of                  31, VIII
  Monetary Offices                                31, I
  Secret Service                                  31, IV
  Secretary of the Treasury, Office of            31, Subtitle A
  Thrift Supervision, Office of                   12, V
Truman, Harry S. Scholarship Foundation           45, XVIII
United States and Canada, International Joint     22, IV
   Commission
[[Page 800]]

United States and Mexico, International Boundary  22, XI
     and Water Commission, United States Section
Utah Reclamation Mitigation and Conservation      43, III
     Commission
Veterans Affairs Department                       2, VIII; 38, I
  Federal Acquisition Regulation                  48, 8
Veterans' Employment and Training Service,        41, 61; 20, IX
     Office of the Assistant Secretary for
Vice President of the United States, Office of    32, XXVIII
Vocational and Adult Education, Office of         34, IV
Wage and Hour Division                            29, V
Water Resources Council                           18, VI
Workers' Compensation Programs, Office of         20, I
World Agricultural Outlook Board                  7, XXXVIII

[[Page 801]]



List of CFR Sections Affected



All changes in this volume of the Code of Federal Regulations (CFR) that 
were made by documents published in the Federal Register since January 
1, 2008 are enumerated in the following list. Entries indicate the 
nature of the changes effected. Page numbers refer to Federal Register 
pages. The user should consult the entries for chapters, parts and 
subparts as well as sections for revisions.
For changes to this volume of the CFR prior to this listing, consult the 
annual edition of the monthly List of CFR Sections Affected (LSA). The 
LSA is available at www.fdsys.gov. For changes to this volume of the CFR 
prior to 2001, see the ``List of CFR Sections Affected, 1949-1963, 1964-
1972, 1973-1985, and 1986-2000'' published in 11 separate volumes. The 
``List of CFR Sections Affected 1986-2000'' is available at 
www.fdsys.gov.

                                  2008

40 CFR
                                                                   73 FR
                                                                    Page
Chapter I
152.1 Revised......................................................75594
152.3 Amended...............................................64224, 75594
152.6 (a)(2) revised...............................................75594
152.10 Heading revised.............................................75594
152.20 Heading revised.............................................75594
152.50 (i) revised; (j) added......................................75594
152.80 Revised.....................................................75594
152.83 Amended.....................................................75595
152.86 Amended.....................................................75595
152.93 (b)(2) introductory text, (iii) and (3) revised.............75595
152.94 Amended.....................................................75595
152.95 Amended.....................................................75595
152.98 Amended.....................................................75595
152.99 Amended.....................................................75595
152.110 Revised....................................................75595
152.112 (d) revised; (g) amended...................................75595
152.116 Amended....................................................75595
152.125 Revised....................................................75595
152.135 Amended....................................................75595
154 Authority citation revised.....................................75595
154.3 Revised......................................................75595
155 Authority citation revised.....................................75595
155.40 (a) introductory text revised...............................75595
155.52 (a) and (c) revised.........................................75596
156.3 Added........................................................64224
156.10 (i)(2)(ix), (x)(D) introductory text and (j) introductory 
        text revised...............................................75596
156.140 (a) introductory text and (b) introductory text revised; 
        (a)(5), (c), (d) and (e) added.............................64224
156.144 (a) revised; (e), (f) and (g) added........................64224
156.159 Revised....................................................64224
156.200 (c) revised................................................75596
156.203 Amended....................................................75596
156.204 (b) revised................................................75596
156.206 (e) amended................................................75596
156.208 (c)(1) amended.............................................75596
156.210 (b)(1) amended.............................................75596
156.212 (d)(2) amended.............................................75596
157.21 Amended.....................................................75596
158.220 (c) table amended..........................................75596
158.230 (c) table amended..........................................75596
158.243 (c) table amended..........................................75596
158.260 (c) table amended..........................................75596
159.153 (b) introductory text revised..............................75596
159.160 (b)(4) revised.............................................75596
159.165 (a)(2) and (d)(2) introductory text amended................75597
160 Authority citation revised.....................................75597
160.1 Revised......................................................75597
160.3 Amended......................................................75597
162.151 Revised....................................................75597
162.152 (b)(1)(i) revised..........................................75597
162.153 (a)(6) redesignated as (j); (c)(2) amended.................75597
164.2 (l)(2) and (s) revised.......................................75597
165.3 Amended......................................................64224
165.20 (c) revised.................................................64225
165.23 (d) heading revised.........................................64225

[[Page 802]]

165.25 (a), (b) and (f)(2) revised.................................64225
165.27 (b) introductory text and (5) introductory text revised; 
        (b)(4)(iii) and (5)(iii) added.............................64225
165.40 (b)(3) added; (c) revised...................................64226
165.43 (c) introductory text, (d) introductory text, (e) heading, 
        (1), (f) and (g) revised...................................64226
165.45 (a)(1), (b), (e), (f) introductory text and (2) revised.....64226
165.60 (c) revised.................................................64227
165.63 (d)(1) revised..............................................64227
165.65 (i)(2)(iii) revised.........................................64227
165.67 (b)(2)(ii) and (d) revised..................................64227
165.70 (b)(2)(ii), (e)(5)(i) and (j)(2)(iii) revised...............64227
165.80 (b)(1) revised..............................................64227
165.85 (a)(3), (c) introductory text, (1), (2), (d) and (f) 
        revised....................................................64227
165.87 (a)(3), (c) introductory text, (1), (d) and (f) revised.....64228
165.90 (a)(2), (5), (b)(1), (2) and (3) revised....................64228
165.97 (b)(1) revised..............................................64228
166 Authority citation revised.....................................75597
166.3 Revised......................................................75597
168.65 (b)(1)(ii) amended; (b)(1)(vii) revised.....................75598
170.5 Removed......................................................75598
170.104 (b)(2)(iii) amended; (c) removed...........................75598
170.112 (e)(7)(i) and (iv) removed; (e)(7)(ii) and (iii) 
        redesignated as (e)(7)(i) and (ii).........................75598
170.130 (a)(3)(i) and (d)(3) revised; (a)(3)(iii) removed..........75598
170.204 (c) removed................................................75599
171 Authority citation revised.....................................75599
171.2 (a) introductory text and (b)(4) revised.....................75599
172.1 Revised......................................................75599
172.3 (d) amended..................................................75599
172.4 (b)(2)(i) and (ii) revised...................................75599
172.21 Revised.....................................................75599
172.24 (b)(3), (d)(1)(i) and (ii) revised..........................75599
172.26 (c)(1)(iii) revised.........................................75599
172.46 (c) introductory text amended...............................75600
174.501 Revised....................................................45624
174.502 Revised....................................................40760
174.503 Removed....................................................37850
174.519 Revised....................................................37850
174.528 Removed....................................................45624
174.529 Added......................................................40764
174.530 Added......................................................52594
180 Order.............................................5439, 42683, 64229
    Actions on petitions............................................7472
    Technical correction...........................................44156
    Heading revised................................................75600
180.1 (g) table revised............................................60153
    Undesignated center heading removed............................75600
180.3 (d)(13) removed; (d)(14) redesignated as (d)(13).............54958
180.4 (a) revised..................................................54976
180.7 Undesignated center heading removed; (b)(1), (d) and (f) 
        amended....................................................75600
180.29 Two undesignated center headings removed....................75600
180.34 (e) introductory text revised...............................75600
180.41 (c)(15)(ii) table 1 and (22)(ii) table amended.................52
180.106 (a) and (c) table revised..................................54958
180.108 (a)(1), (2) introductory text and (c) revised...............5108
180.111 (a)(1) table amended.........................54959, 60155, 60156
180.116 (a) table revised..........................................54959
180.117 Table amended..............................................60156
180.121 (a) table revised..........................................54959
    (e) table amended..............................................60156
180.122 (a) table amended..........................................60156
180.128 (a) revised.................................................5108
180.129 Revised....................................................54960
180.142 (a) table amended..........................................53737
180.153 (a) and (c) revised........................................52611
    (c) table amended..............................................60156
    (a) table amended..............................................71945
180.154 (a) table amended..........................................60156
180.167 Removed....................................................54960
180.169 (a)(1), (2) and (c) revised................................52611
180.172 (a) table amended..........................................45634
180.173 (a) table amended..........................................60156
180.176 (a) table amended..........................................60156
180.183 (a) table revised..........................................54960
180.184 (b) revised................................................51727
180.185 (a) table and (d) table amended............................53737
    (a) table amended..............................................80302
180.204 Heading, (a) table and (c) revised.........................53737
180.205 (a) table amended...................................54960, 60156
180.206 (a) revised................................................53738
180.208 Heading and (a) revised....................................52613
180.215 (a)(1) table amended.......................................60156
180.220 (d) added..................................................37852
180.227 (a)(1) table amended.......................................17918

[[Page 803]]

    (a)(1) table, (2) table and (3) table revised..................54960
180.229 Revised....................................................52613
180.231 (a) table amended..........................................50570
180.241 Heading, (a) and (c) revised...............................53738
180.245 (a)(1) revised.............................................54960
180.252 (a) revised................................................53738
180.253 (a) table amended..........................................60156
180.258 (a) table revised; (c) removed.............................54961
180.259 (a) table revised..........................................54961
180.262 (a) table amended...................................53731, 54961
180.269 (a) table amended..........................................54961
180.275 (a)(1) table and (c) table amended; (b) revised............73585
180.276 (b) added...................................................9232
    (a) table revised..............................................52613
180.288 (a) table amended..........................................60156
180.299 Revised....................................................52613
180.303 Revised....................................................54961
180.314 (c) table amended....................................5109, 53738
180.316 (a) table and (d) revised..................................52614
180.318 (a) redesignated as (a)(1); (a)(2) added...................66785
180.319 Table amended..............................................52614
180.328 Revised....................................................52614
180.331 Revised....................................................54961
180.339 (a)(1) table amended........................................5109
180.342 (a)(1) and (c) revised; (a)(2) removed; (a)(3) and (4) 
        redesignated as (a)(2) and (3).............................53739
180.349 (a) and (c) table revised..................................53739
180.352 Revised....................................................53740
180.353 (a) table amended; (b) removed.............................53740
180.356 (a) table amended..........................................52615
180.361 (a) table amended..........................................54968
180.362 (a)(1) table amended........................................5109
180.364 (a) table revised..........................................52615
    (a) table amended..............................................60156
    (a) table amended; (a) introductory text and table 
redesignated as (a)(1); (a)(2) added...............................73592
180.368 (a)(1) table amended.......................................52616
    Revised........................................................53740
    (a)(2) table amended...........................................60156
180.370 (a) table amended..........................................54961
180.372 Revised....................................................54961
180.377 (b) table amended..........................................72357
180.379 (a)(1) table amended.......................................60156
180.381 (a) table amended...................................54962, 60156
180.399 (a)(1) table and (c) table amended.........................60156
180.406 (a) table revised..........................................54962
180.408 (a) table amended..........................................60156
180.410 Revised....................................................54962
180.411 (c)(2) table amended.......................................60156
180.412 (a) table amended...................................39261, 80302
    (a) table revised; (c) amended.................................53741
180.414 (a)(1) table amended.......................................60156
180.418 (a)(2) table amended; (b) removed...........................1525
180.419 (a)(2) table amended.......................................60156
180.420 (c) table amended..........................................60156
180.427 Heading and (a) revised....................................52616
180.428 (a)(1) table amended.......................................60156
180.430 (b) added..................................................33718
180.431 (a) table amended..........................................60156
180.435 (a)(1) table amended.......................................60156
180.436 (a)(1) table amended; (c) removed..........................10396
    (a)(1) table amended....................................44164, 60157
    Heading and (a)(1) table revised; (a)(4) added.................54972
180.438 (a)(2) table amended; (a)(3) revised.......................39264
    (a)(1) table and (2) table amended.............................60157
180.439 (a) table amended..........................................47075
180.442 (a)(1) table amended; (b) revised..........................33024
180.443 (a) table and (b) table amended............................15936
180.448 (c) table amended..........................................30503
    (a) table amended.......................................52597, 60157
180.449 (b) table amended..........................................66780
180.450 Revised....................................................54962
    (a) table amended..............................................60157
180.451 (a) table amended..........................................47065
180.466 (a) table amended..........................................60157
180.474 (a)(1) table amended.......................................27756
    (a)(1) introductory text revised; (a)(1) table amended; (b) 
removed; (c) added.................................................47072
    (a)(1) table amended....................................51738, 60157
180.475 (a) revised.................................................1508
    (b) added......................................................45629
180.480 (a)(2) removed; (a)(1) redesignated as (a); new (a) 
        introductory text and (b) revised; (a) table amended;......50562
180.484 (a)(1) heading and (2) removed; (a)(1) redesignated as 
        (a); (d) revised...........................................33017
180.485 (a) revised; (b) removed...................................27760
180.491 (a)(1) table and (2) table revised.........................54963
180.498 (a)(2) table amended.......................................60157
180.503 (a) introductory text revised; (a) table amended...........58885

[[Page 804]]

180.507 (a)(1) table amended; (b) removed..........................39246
180.509 Revised....................................................74977
180.511 (a) revised................................................19161
180.515 (a) table amended....................................9221, 60157
180.516 (b) table revised..........................................42718
    (a) table amended.......................................52602, 60157
180.518 (a)(1) table, (2) table and (3) table amended..............64251
180.523 Revised....................................................54963
180.532 (a)(2) removed; (a)(1) redesignated as (a); new (a) table 
        amended....................................................50552
180.537 (a) revised................................................75608
180.540 Revised....................................................54963
180.544 (a)(1) table amended; (b) removed; (d)(1) table and (2) 
        table revised..............................................11826
180.553 (a) table amended..........................................19154
180.555 (a) table amended.............................................57
180.557 (a) table amended..........................................67406
180.560 (a) revised................................................11820
180.564 (a) table amended..........................................60157
180.565 (a) table amended...................................21048, 60157
180.567 (a)(2) table amended.......................................60157
180.568 (a) table and (b) amended..................................11831
    (a) table amended.......................................39251, 60157
180.569 (a)(1) table amended; (a)(2) table revised.................47846
180.571 (a) table amended.....................................1512, 9226
180.572 (a)(1) table amended.......................................11837
180.573 (a)(1) table amended.......................................60157
180.575 (a)(1) table amended.......................................60157
180.578 (a)(1) table amended........................................2811
180.579 (a)(1) table amended.......................................60157
180.582 (a)(1) table amended.........................15431, 44167, 60157
    (b) text added.................................................21842
180.584 (a) table amended..........................................60157
180.585 (a) revised................................................51743
180.586 (a) table amended...........................................6856
180.589 (a)(1) table amended; (b) revised..........................16558
180.598 (a) introductory text revised; (a) table and (b) table 
        amended....................................................74982
180.599 (a) table amended..........................................17910
180.601 (a) table amended..........................................21839
180.607 (a)(1) table amended; (a)(2) table revised.................13140
    (a)(1) table amended...........................................52606
180.608 (a)(1) table amended.......................................25539
180.613 (a)(1) table amended; (a)(2) table revised.................17923
180.615 (d) table amended..........................................60157
180.617 (a) table amended; (b) removed.............................22828
180.620 (a) revised................................................75605
180.626 (a)(1) table amended.......................................14719
180.627 (a) revised.................................................5455
    (a) table amended..............................................30498
180.628 (a) table revised; (b) added...............................25523
    (b) table amended..............................................51731
180.635 (a) introductory text correctly revised....................14714
180.636 Added.......................................................8218
180.637 Added.......................................................2816
180.638 Added......................................................10402
180.639 Added......................................................47062
180.640 Added......................................................25533
180.641 Added......................................................39256
180.642 Added......................................................44162
180.643 Added......................................................51736
180.644 Added......................................................60974
180.645 Added......................................................60968
180.646 Added......................................................69559
180.910 Table amended........................................9217, 17913
    Regulation at 71 FR 45421 eff. date delayed in part to 8-9-09 
                                                                   45316
180.920 Regulation at 71 FR 45421 eff. date delayed in part to 8-
        9-09.......................................................45316
    Table amended..................................................67400
180.930 Regulation at 71 FR 45422 eff. date delayed in part to 8-
        9-09.......................................................45316
180.940 (a) table amended............................37858, 49107, 53725
    Regulation at 71 FR 45421 eff. date delayed in part to 8-9-09 
                                                                   45316
180.950 (e) table amended..........................................53725
180.960 Table amended...................9214, 31756, 41286, 52619, 65742
180.1111 Revised...................................................50556
180.1220 Revised...................................................19150
180.1254 (b) revised...............................................56998
180.1277 Added.....................................................10398
180.1280 Added......................................................1517
180.1281 Added.....................................................16562
180.1282 Added.....................................................25528
180.1283 Added.....................................................33714
180.1284 Added.....................................................39268
180.1285 Added.....................................................69564
180.2003 (a) and (b) amended.......................................60158
180.2010 Added......................................................1978

[[Page 805]]

                                  2009

40 CFR
                                                                   74 FR
                                                                    Page
Chapter I
161 Heading revised................................................29958
174.502 Revised....................................................23639
    Correctly revised..............................................39543
180 Order..........................................................59608
180.3 (d)(7) removed; (d)(8) through (13) redesignated as new 
        (d)(7) through (12)........................................46696
180.110 (b) table amended............................................636
    (a) table amended..............................................46371
180.111 (a)(1) table amended.......................................46371
    (a)(2) through (5) redesignated as (a)(4) through (7); new 
(a)(2) and (3) added; (a)(1) table and new (6) revised.............47455
180.121 (a) table and (e) table amended............................46372
180.132 (a) revised................................................48391
180.136 Removed....................................................47456
180.142 (a) table amended..........................................48411
180.149 (a)(2) table amended.......................................46372
    Removed........................................................47456
180.151 (a)(1) table and (2) revised...............................46696
180.153 (a) table amended..........................................17406
180.154 Heading and (a) table revised..............................46697
180.155 (a) and (b) redesignated as (a)(1) and (2); new (a) 
        heading, (b), (c) and (d) added............................40517
    Revised........................................................46697
180.169 (a)(3) and (4) removed.....................................10490
180.176 (a) table amended..........................................46372
180.183 (a) and (c) revised........................................46697
180.185 (a) table amended..........................................14744
180.205 (a) table amended..........................................46372
180.222 (a) table amended..........................................46372
    (a) table and (d) revised......................................47456
    (a) table and (c) table amended................................67108
180.225 (a)(1) table amended.......................................46372
180.235 (a)(2) revised.............................................46373
180.242 (a)(1) table revised.......................................46697
180.253 (a) table amended..........................................46373
180.254 (a) table and (c) table revised; eff. 8-13-09..............23094
    (a) table amended..............................................46373
180.258 (a) table revised..........................................47456
180.261 (a) table amended..........................................46373
    (a) table revised..............................................46698
180.262 (a) table amended..........................................46373
180.263 Revised....................................................46698
180.275 (a)(1) table amended........................................9367
    (c) table amended..............................................46373
180.276 (b) table amended............................................636
180.284 (a) table amended..........................................46373
180.287 (a) table amended..........................................47456
180.288 (a) table amended..........................................46374
180.291 Revised....................................................47456
180.293 (d) revised................................................67097
180.309 Removed....................................................46698
180.314 (a) revised................................................29963
180.315 (a) table amended..........................................57081
180.319 Amended....................................................47457
180.331 (a) table amended..........................................46374
180.361 (b) revised................................................11494
    (a) introductory text revised; (a) table amended...............46382
180.364 (a)(1) table amended.......................................29966
    (a)(1) table and (2) table amended.............................67132
180.368 (a)(1) table, (2) table, (d)(1) table and (2) table 
        revised....................................................48411
180.371 (b) table amended............................................636
180.377 (b) table amended..........................................46374
180.379 (a)(1) table amended.......................................46374
    Revised........................................................46698
180.408 (a) table and (d) table amended............................46374
180.411 Heading, (a) and (c) revised................................9372
    (a) table amended.......................................46374, 47457
180.419 (a)(2) table revised.......................................46374
180.421 (a) table amended..........................................68173
180.429 Revised....................................................10494
    (a) introductory text revised; (a) table amended...............67087
180.431 (a) table amended..........................................46375
180.434 (a) table amended..........................................12613
180.435 (a)(1) table amended.......................................46375
180.436 (a)(1) table amended.......................................46375
180.440 (a) table amended..........................................46375
180.442 (a)(1) table amended.......................................46375
180.443 (b) table amended............................................636
    (a) table amended..............................................46375
180.446 (a)(1) table amended.......................................46375
180.448 (c) table amended..........................................63074
180.449 (a) table amended..........................................39551
180.450 (a) table revised..........................................47457
180.451 (a) introductory text revised; (a) table amended...........67128
180.452 (a) table amended...................................46375, 46699
180.454 Table amended..............................................46375
180.457 Revised....................................................47457
180.462 (a) table amended..........................................46376
180.463 (b) revised................................................51490
    (a) table amended..............................................67090
180.466 (a) table amended; (b) removed.............................12606
180.469 (a) table amended..........................................37623
180.470 (a) table amended..........................................29969

[[Page 806]]

    (a) introductory text and (d) introductory text revised; (a) 
table and (d) table amended........................................47450
180.472 (a) table amended..........................................46376
180.474 (a)(1) table amended........................................9358
180.476 (a)(1) introductory text and (2) introductory text 
        revised; (a)(1) table and (b) table amended................26543
    (a)(1) table amended...........................................46376
180.478 (a) introductory text revised; (a) table amended...........67137
180.479 (a)(1) introductory text and (2) introductory text 
        revised; (a)(2) table amended..............................48401
180.481 Revised....................................................67118
180.482 (a)(1) table and (2) table amended.........................46376
180.493 (a) introductory text and (c) revised; (a) table amended 
                                                                    9356
180.495 (a) table amended...................................46376, 48408
180.505 (a)(1) table and (2) table amended..........................2873
180.507 (a)(1) introductory text and (2) introductory text 
        revised; (a)(1) table amended..............................53179
180.510 (a)(1) table amended; (b) revised..........................55467
180.511 (a) introductory text revised; (a) table amended...........33158
    (a) table amended..............................................48412
180.515 (a) table amended..........................................46376
180.517 (a) table amended..........................................46377
180.518 (a)(1) table amended.......................................32448
180.533 (a) revised; (c) added.....................................46699
180.538 Removed....................................................47457
180.544 (b) added..................................................22468
    (a)(1) table amended; (c) revised..............................45335
180.554 (a)(1) table amended.......................................46377
180.561 (a) revised; (b) table amended.............................24710
180.564 (a) introductory text revised; (a) table amended...........33165
180.565 (a) introductory text revised; (a) table amended; (b) 
        removed....................................................15875
    (a) introductory text revised; (a) table amended...............50145
180.566 (a)(1) introductory text, table, (2) introductory text and 
        (3) introductory text amended..............................37617
    (a)(1) table amended...........................................63079
180.571 (a) introductory text revised; (a) table amended...........67123
180.572 (a) table amended..........................................48412
    (a)(1) introductory text, (2) introductory text and (b) 
introductory text revised; (a)(1) table amended....................68167
180.576 (a) table revised..........................................15880
180.579 (a)(1) table and (d) table amended; (b) removed; (c) 
        revised....................................................34257
180.580 (a) table amended..........................................23644
180.582 (b) table amended..........................................11499
    (a)(1) table amended...........................................51496
180.586 Revised....................................................65028
180.587 (a) table amended...........................................9364
180.588 (a) table amended; (b) removed.............................14743
180.589 (a)(1) table amended.......................................47445
180.590 (a) revised................................................66579
180.593 (a) table amended..........................................25160
180.598 (b) removed..................................................637
    (b) added......................................................20891
    (a) introductory text and (b) introductory text revised; (a) 
table amended......................................................65033
180.600 (a)(1) table amended........................................9377
180.601 (a) table amended; (c) revised.............................32453
180.603 (b) revised................................................12601
    (a)(1) introductory text and (2) introductory text revised; 
(a)(1) table amended...............................................67104
180.605 (a) table amended..........................................18648
180.607 (a)(1) table amended........................................8492
    (a)(1) table and (2) table amended; (b) added..................15886
180.609 Revised....................................................67113
180.615 (d) table amended..........................................46377
180.617 (a) redesignated as (a)(1); (a)(2) added; (b) revised......21266
180.626 (a)(1) table amended................................14749, 46699
180.628 (a) table amended; (d) revised.............................30474
180.634 (a) introductory text revised and redesignated as (a)(1); 
        new (a)(1) table amended; (a)(2) added.....................47894
180.635 (a) table amended..........................................40759
180.637 (a) table amended..........................................33169
180.647 Added......................................................32443
180.648 Added......................................................48396
180.649 Added......................................................46689

[[Page 807]]

180.910 Table amended...22460, 32460, 37577, 37597, 37604, 37612, 38943, 
                                              38969, 51474, 51480, 57078
    Regulation at 71 FR 45421 eff. date delayed in part.....39545, 52151
180.920 Table amended...12620, 20887, 28623, 32437, 37570, 37577, 37584, 
                  37590, 38935, 38952, 38955, 38962, 40513, 41798, 51485
180.930 Table amended...28623, 37578, 37597, 37605, 37612, 38935, 38943, 
                                                                   38970
    Regulation at 71 FR 45421 eff. date delayed in part.....39545, 52151
180.940 (a) table amended............................27454, 38944, 40509
180.960 Table amended...10501, 10504, 10507, 10510, 10513, 11502, 12596, 
                  29972, 29975, 29978, 29982, 32456, 38944, 57084, 67826
180.1011 (b) revised...............................................26533
180.1019 (b) revised...............................................26533
180.1020 (a) amended; (b) table revised............................26533
    Revised........................................................47457
180.1021 (a) introductory text revised.............................26534
    (b) revised....................................................47457
180.1022 Revised...................................................26534
180.1023 (a) and (b) revised.......................................26534
180.1027 (c) revised...............................................26534
180.1035 Revised...................................................26534
180.1037 Revised...................................................26534
180.1043 Revised...................................................26534
180.1054 (b) revised...............................................26534
180.1057 Revised...................................................26534
180.1058 Revised...................................................26534
180.1070 Revised...................................................26534
180.1073 Revised...................................................26534
180.1075 Amended...................................................26534
180.1076 (b) revised...............................................26535
180.1083 (a) and (b) revised.......................................26535
180.1087 Revised...................................................26535
180.1092 Revised...................................................26535
180.1097 Revised...................................................26535
180.1103 Revised...................................................26535
180.1113 Revised...................................................26535
180.1128 Revised...................................................15869
180.1178 Revised...................................................26535
180.1196 Revised...................................................26535
180.1206 (a) and (c) revised.......................................26535
    (b) revised....................................................26546
180.1219 Revised...................................................26535
180.1240 (b) revised...............................................12617
180.1254 Revised...................................................26535
180.1258 Revised...................................................26536
180.1261 Revised...................................................26536
180.1269 Revised...................................................10498
180.1274 Introductory text revised.................................26536
180.1276 Revised...................................................26536
180.1279 Revised...................................................26536
180.1281 Revised...................................................37621
180.1284 Revised...................................................47457
180.1287 Added.......................................................634
180.1288 Added.....................................................12625
180.1289 Added.....................................................22464
180.1290 Added.....................................................38974
180.1291 Added.....................................................55463
180.1292 Added.....................................................55458

                                  2010

40 CFR
                                                                   75 FR
                                                                    Page
Chapter I
156.159 Revised; eff. 8-16-10......................................33708
    Revised........................................................62326
174.531 Added......................................................29435
174.532 Added......................................................34045
180 Actions on petitions...........................................38417
    Policy statement...............................................47465
    Order...................................................47475, 55997
180.1 (g) table amended; (h) removed; (i) through (o) redesignated 
        as new (h) through (n).....................................76289
180.40 (b) amended.................................................56014
180.41 (b) amended; (c)(10) through (22) redesignated as (c)(11) 
        through (23); (c)(9) heading and new (c)(12) heading 
        revised; new (c)(13) through (23) redesignated as (c)(14) 
        through (24); new (c)(15) through (24) redesignated as 
        (c)(16) through (25); new (c)(25) redesignated as (c)(26); 
        new (c)(10), new (13), new (15) and new (25) added.........76289
180.106 (c) introductory text amended..............................56014
180.108 (a)(1) introductory text, table footnote 1, (2) and (c) 
        revised; (a)(3) added......................................60237
180.111 (a)(1) table revised.......................................60238
180.117 Revised....................................................60239
180.123 (c) introductory text amended..............................56014
    (a)(1) table revised...........................................60239
180.145 (c) introductory text amended..............................56014
180.155 (b) correctly added........................................37739
180.176 (b) table amended............................................770

[[Page 808]]

    (a) introductory text and (b) introductory text revised; (a) 
table and (b) table amended........................................50913
180.183 Heading, (a) and (c) revised...............................60240
180.200 (a)(1) revised.............................................60241
180.205 (c) introductory text amended..............................56014
180.222 (c) introductory text amended..............................56014
180.226 (a)(1) table amended; (a)(2)(i) and (3) revised; (a)(4) 
        removed; (a)(5) redesignated as new (a)(4).................29441
    (a)(1) table amended...........................................60241
180.227 (a)(1), (2) introductory text and (3) introductory text 
        revised....................................................60241
180.242 (a)(1) table amended.......................................54040
180.243 Revised....................................................60242
180.253 (c) introductory text amended..............................56014
    (a) table amended..............................................60242
180.254 (c) introductory text amended..............................56014
180.259 (c) introductory text amended..............................56014
180.261 (c) introductory text amended..............................56014
    Heading, (a) and (c) revised...................................60242
180.262 (a) revised; (a) table footnote added......................60242
180.275 (c) introductory text amended..............................56014
180.284 (c) introductory text amended..............................56014
180.292 (a) revised................................................60243
180.294 (c) introductory text amended..............................56014
180.298 (c) introductory text amended..............................56015
180.300 (c) amended................................................56015
180.304 (c) introductory text amended..............................56015
180.311 (a) revised................................................60243
180.315 (b) introductory text amended..............................56015
    Revised........................................................60243
180.349 (c) introductory text amended..............................56015
    (a) and (c) revised............................................60243
180.355 (c) introductory text amended..............................56015
180.361 (b) table amended............................................770
    (a) table amended...............................................4283
    (a) introductory text revised; (a) table amended...............17573
180.367 (a) revised................................................60243
180.368 (a)(2) introductory text, (c)(2) introductory text and 
        (d)(2) introductory text revised; (a)(2) table amended.....56903
180.371 Revised....................................................60244
180.396 (c) introductory text amended..............................56015
    (a) and (c) revised............................................60244
180.399 (c) introductory text amended..............................56015
180.401 (b) introductory text amended..............................56015
180.407 (a) table amended..........................................60245
180.408 (c) introductory text amended..............................56015
180.414 (a)(1) table amended.......................................22256
180.415 (c) introductory text amended..............................56015
180.421 (a) introductory text revised; (a) table amended...........56897
180.430 (b) table amended..........................................80346
180.431 (a) introductory text revised; (a) table amended...........14091
180.432 (c) introductory text amended..............................56015
180.434 (b) table amended..........................................80346
180.439 (a) introductory text and (c) revised......................19277
180.441 (c) introductory text amended..............................56015
180.442 (b) table amended............................................770
180.447 (c) introductory text amended..............................56015
180.448 (b) table amended...........................................5517
    (a) introductory text, (b) introductory text and (c) 
introductory text revised; (a) table amended.......................12695
    (a) table amended..............................................40745
    (c) introductory text amended..................................56015
180.449 (b) table amended.....................................770, 80346
180.451 (c) introductory text amended..............................56015
180.454 Existing text designated as (a); (b) added..................8260
    Revised........................................................17578
180.458 (a)(2) removed; (a)(3) and (4) redesignated as new (a)(2) 
        and (3); new (a)(2) amended................................26678
180.472 Revised....................................................22251

[[Page 809]]

180.474 (a)(1) introductory text, (2) introductory text and (c) 
        introductory text revised; (a)(1) table amended............24428
180.475 (a)(1) and (2) introductory text revised; (b) removed......22262
180.479 (a)(1) introductory text and (2) introductory text 
        revised; (a)(2) table amended..............................46853
180.484 Heading, (a) introductory text and (d) revised; (a) table 
        amended....................................................17570
    (a) table amended..............................................80350
180.494 (c) introductory text amended..............................56015
180.495 (a) table amended..........................................60327
180.498 (b) table amended..........................................80346
180.503 (c) introductory text amended..............................56015
180.517 (b) table amended..........................................80346
180.532 (a) table amended..........................................22245
180.555 (a) introductory text and (b) revised; (a) table amended 
                                                                   33195
180.560 (a) revised................................................16020
180.565 (a) table amended..........................................35660
180.566 (b) table amended..........................................80346
180.567 (b) table amended............................................770
180.568 (a) introductory text revised; (a) table amended............8265
    (a) table amended..............................................69009
180.572 (a)(1) table amended; (b) table revised....................53593
    (b) table amended..............................................80346
180.573 (c) introductory text amended..............................56015
180.574 (a)(1) introductory text and (2) introductory text 
        revised; (a)(1) table amended..............................26667
180.578 (a)(1) introductory text, (2) introductory text and (c) 
        revised; (a)(1) table amended...............................6582
180.582 (b) table amended.....................................770, 80346
    (a)(1) introductory text revised; (a)(1) table and (2) table 
amended............................................................42329
180.583 (a) table revised...........................................4288
180.587 (c) introductory text amended..............................56015
180.589 (b) table amended.....................................770, 80346
    (a)(1) introductory text, (2) introductory text, (b) and (d) 
introductory text revised; (a)(1) table, (2) table and (d) table 
amended............................................................29907
180.598 (a) table amended....................................4278, 29447
180.599 (a) introductory text revised; (a) table amended...........70148
180.601 (a) introductory text and (c) introductory text revised; 
        (a) table amended..........................................40751
180.602 (a) introductory text revised; (a) table amended...........74640
180.603 (b) table amended............................................770
180.607 (d) table amended...........................................5526
    (a)(1) introductory text, (2) introductory text, (b) 
introductory text and (d) introductory text revised; (a)(1) table 
amended............................................................53586
180.608 (a)(1) table amended.......................................24434
180.609 (a)(1) table and (2) table amended.........................60333
180.610 (a)(1) introductory text and (2) introductory text 
        revised; (a)(1) table amended..............................17584
180.614 (b) revised................................................19272
180.621 Revised.....................................................5522
180.624 (a) revised................................................75393
180.626 (a)(1) introductory text and (2) introductory text 
        revised; (a)(1) table amended..............................29914
180.628 Revised.....................................................5532
    (d) table amended..............................................17566
180.629 Revised....................................................26673
180.639 Revised....................................................50919
    (a)(1) table correctly amended.................................68214
180.650 Added......................................................69360
180.651 Added......................................................81884
180.905 Revised....................................................60245
180.910 Regulation at 71 FR 45421 eff. date delayed in part.........6316
    Table amended.......14086, 27442, 27451, 28492, 34048, 43082, 50896, 
                                              51387, 51392, 71556, 74634
    Table correctly amended........................................20785
180.920 Table amended.......763, 767, 19267, 22240, 42323, 50890, 50902, 
                                                            53581, 55996
180.930 Regulation at 71 FR 45421 eff. date delayed in part.........6316
    Table amended........8504, 19268, 27443, 34049, 50896, 51388, 51392, 
                                                                   71556
180.940 (a) table amended..........................................40735
180.960 Table amended........773, 4291, 4294, 6586, 12698, 31715, 40754, 
                                              44920, 50930, 52272, 71559
180.1254 Revised....................................................6576
180.1258 Revised...................................................40741
180.1273 Revised...................................................10190
180.1281 Revised...................................................11744
180.1290 Revised...................................................37737
180.1293 Added......................................................8507

[[Page 810]]

180.1294 Added......................................................9530
180.1295 Added......................................................8256
180.1296 Added.....................................................39455
180.1297 Added.....................................................39459
180.1298 Added.....................................................43076
180.1299 Added.....................................................50926

                                  2011

40 CFR
                                                                   76 FR
                                                                    Page
Chapter I
158 Notification to USDA and HHS Secretaries.......................22044
161 Notification to USDA and HHS Secretaries.......................22044
174.532 Revised....................................................14293
    Revised........................................................57657
180 Order...................................................38037, 49318
    Technical correction...........................................40628
180.106 (b) revised; (c) amended...................................34885
180.110 (b) revised................................................34885
    (a) table revised..............................................40814
180.114 (c) amended................................................34885
180.121 (a) revised................................................56652
180.122 Removed....................................................56653
180.123 (c) amended................................................34885
180.142 (c) amended................................................34885
    (a) introductory text, (c) introductory text and (d) 
introductory text revised; (a) table amended.......................55817
180.145 (a)(2) removed; (a)(3) redesignated as new (a)(2); (c) 
        amended....................................................34885
180.153 (c) amended................................................34885
180.169 (c) amended................................................34885
180.176 (a) table amended..........................................18915
180.182 (a) and (c) revised........................................56653
180.184 (c) amended................................................34885
    (b) table amended..............................................81396
180.185 (c) amended................................................34885
180.190 (d) revised................................................34885
180.191 (c) amended................................................34885
180.204 (c) amended................................................34885
180.205 (c) amended................................................34885
180.217 Heading and (a) revised....................................23891
180.220 (a) table revised..........................................56654
180.222 (c) amended................................................34885
180.227 (a)(1) introductory text, (2) introductory text and (3) 
        introductory text revised; (a)(1) table amended............55806
180.228 Removed....................................................34885
180.232 (a) introductory text revised..............................23493
180.241 (c) amended................................................34885
180.242 (b) revised................................................34885
180.252 Revised....................................................57659
180.253 (c) amended................................................34885
180.257 (a) revised................................................56654
180.259 (c) amended................................................34885
180.275 (c) amended................................................34885
180.276 (b) revised................................................34885
180.284 (b) revised; (c) amended...................................34885
180.291 (c) amended................................................34885
180.294 Removed....................................................34885
180.296 Removed....................................................34885
180.298 (a) and (c) revised........................................56655
180.304 (c) amended................................................34885
180.312 Removed....................................................34885
180.314 (c) amended................................................34885
180.317 (a) introductory text, (c) introductory text and (d) 
        introductory text revised; (b) removed.....................23493
180.319 Revised....................................................56656
180.324 (a)(1) introductory text and (2) introductory text 
        revised; (a)(1) table and (2) table amended................31491
180.325 Removed....................................................34885
180.328 (a) table amended; (c) revised.............................34885
180.330 (c) amended................................................34885
180.337 Revised....................................................23493
180.342 (c) amended................................................34885
    (a)(1) table amended...........................................56656
180.345 (c) amended................................................34885
180.362 Heading, (a)(1) introductory text, (2) introductory text 
        and (c) introductory text revised..........................23494
180.364 (a)(1) introductory text and (2) introductory text 
        revised; (a)(1) table and (2) table amended................19706
    (a)(2) table amended...........................................27271
180.368 (c)(1) amended.............................................34885
180.377 (b) table amended...................................34885, 81396
180.378 (c) amended................................................34885
180.379 Removed....................................................34885
180.399 (c) amended................................................34885
180.401 (b) redesignated as (c); new (c) amended; (a) heading, new 
        (b) and (d) added..........................................34885
180.406 Removed....................................................34885
180.410 (a) table amended; (c) revised.............................34885
180.411 (a) introductory text and (c) introductory text revised; 
        (a) table amended...........................................5703
    (a) table amended..............................................59908

[[Page 811]]

180.412 (b) revised; (c) amended...................................34885
180.414 (a)(1) introductory text, (2) and (d) introductory text 
        revised....................................................23494
180.415 (a) and (c) introductory text revised......................23494
180.420 Revised....................................................23495
180.425 (a) introductory text revised..............................23495
180.430 (a) introductory text and (b) introductory text revised....23495
180.432 (a) introductory text and (c) introductory text revised....23496
180.433 (a) introductory text revised; (a) table amended...........12882
180.434 (a) table and (b) table amended............................27268
    (c) amended....................................................34885
180.438 (b) revised................................................34885
180.443 (b) revised................................................34885
180.444 Existing text designated as (a) and amended; (b), (c) and 
        (d) added..................................................56648
180.446 (a)(1) introductory text and (2) introductory text revised
                                                                   23496
180.447 (c) amended................................................34885
180.448 (c) table amended..........................................18899
    (c) amended....................................................34885
    (a) table and (b) table amended................................77708
180.449 (a) introductory text and (b) revised; (a) table amended 
                                                                   69659
180.450 (a) table amended..........................................34885
180.451 (c) amended................................................34885
180.456 Removed....................................................34885
180.458 Revised....................................................23496
180.462 (a) introductory text revised..............................23496
180.463 (a) introductory text and (b) introductory text revised....23497
180.468 Revised....................................................23497
180.469 (a) revised................................................16310
180.473 (a) introductory text and (d) introductory text revised....23497
180.474 (a)(1) introductory text revised; (a)(1) table amended.....54133
180.475 (a)(1) table amended.......................................11349
    (a)(1) table and (2) table amended; (a)(2) introductory text 
revised............................................................34883
    (a)(1) table amended...........................................82163
180.476 (b) revised................................................34885
180.477 (a) introductory text revised..............................23497
180.479 (b) revised................................................34886
180.480 (b) revised................................................34886
180.482 (a)(1) introductory text, (2) introductory text and (d) 
        introductory text revised; (b) removed.....................23497
180.483 Removed....................................................34886
180.486 Revised....................................................23498
180.491 (a)(1) table and (2) table amended.........................38037
180.492 Heading and (a) introductory text revised; (a) table 
        amended....................................................22625
180.493 (d) revised................................................34886
180.497 Revised....................................................56656
180.498 (a)(1) introductory text, (2) introductory text, (b) and 
        (d) introductory text revised; (a)(2) table amended.........5710
180.503 (c) amended................................................34885
180.509 (a) revised; (d) added.....................................23903
180.515 (b) revised................................................34886
180.516 (b) table amended...........................................7712
180.532 (a) revised.................................................5695
180.537 (a) introductory text revised; (a) table amended...........76314
180.541 (a) revised................................................23498
180.544 (d) revised................................................34886
180.546 (a) introductory text revised; (a) table amended............4548
180.547 (a) introductory text revised; (a) table amended...........71464
180.549 (a)(2) removed; (a)(1) redesignated as (a).................34886
180.555 (a) table amended..........................................69652
180.557 (a) introductory text revised; (a) table amended...........53648
180.558 Removed....................................................56657
180.560 (a) introductory text revised..............................38035
180.561 (b) revised................................................34886
180.565 (a) table amended..........................................50913
180.571 (b) revised................................................34886
180.573 (c) amended................................................34885
    (a)(1) introductory text, (2) introductory text and (c) 
revised; (a)(1) table amended......................................82152
180.574 (a)(1) table amended; (a)(3) added..........................3029
180.576 (a) revised................................................82157
180.577 (a) introductory text revised; (a) table amended............5716

[[Page 812]]

180.579 (c) amended................................................34885
    (a)(1) introductory text, (2) introductory text, (c) 
introductory text and (d) revised..................................70895
180.582 (b) table amended..........................................81396
180.585 (a) introductory text revised; (a) table amended...........31484
180.586 (a) redesignated as (a)(1); (a)(2) added....................7718
    (a)(1) table amended...........................................25246
    (b) revised....................................................34886
180.587 (c) amended................................................34885
180.593 (a) introductory text revised; (a) table amended...........20542
180.596 (a) introductory text revised..............................23498
180.598 (a) table amended..........................................55814
180.607 (b) table amended..........................................81396
180.609 (a)(1) table amended.......................................50898
180.617 (a) revised................................................50904
    (b) table amended..............................................81396
180.620 Revised....................................................23498
180.626 (a)(1) table revised.......................................61592
180.627 (a) introductory text and (d) revised; (a) table amended 
                                                                   22054
180.628 (a) table and (d) table amended............................44821
    (a) table amended..............................................59909
180.629 (a) table amended; (d) revised.............................69647
180.631 Introductory text and (a) table revised....................23898
180.637 (b) revised................................................55804
180.639 Revised....................................................16307
    (a)(2) table amended...........................................55273
180.641 (a) revised................................................28681
180.649 (a)(1) table revised; (a)(3) table amended.................27261
    (a)(1) table amended...........................................76309
180.652 Added......................................................18921
180.653 Added......................................................18905
180.654 Added......................................................61596
180.656 Added......................................................59914
180.910 Table amended........5691, 6341, 6346, 6351, 8899, 12876, 25239, 
                                              31478, 36348, 36362, 69641
180.920 Table amended.............6347, 7707, 31479, 36356, 38033, 44815
180.930 Table amended..............5691, 6341, 8900, 12877, 25240, 36348
180.940 (a) table amended..........................................55267
180.960 Table amended...........41138, 52878, 69662, 69665, 70899, 77712
180.1196 (c) added.................................................11969
180.1206 (c) revised...............................................16301
180.1300 Added.....................................................11343
180.1301 Added.....................................................20546
180.1302 Added.....................................................17561
180.1303 Added.....................................................26198
180.1304 Added.....................................................52875
180.1305 Added.....................................................55272
180.1306 Added.....................................................59905
180.1307 Added.....................................................66192

                                  2012

40 CFR
                                                                   77 FR
                                                                    Page
Chapter I
150.17 Revised.....................................................46291
158.2100 (c)(1) and (2) revised....................................52612
158.2120 (a), (b) and (c) revised; (d) amended.....................52612
158.2171 (a), (b) and (c) revised; (d) amended.....................52613
164.2 (l)(2) amended; (s) revised..................................46292
171.11 (e) revised.................................................39642
174.530 Revised.....................................................6475
174.532 Revised....................................................47291
178.3 Amended......................................................46292
179.3 Amended......................................................46292
179.24 (b)(1), (2) and (3) amended.................................46292
179.42 (a) amended.................................................46292
179.83 (a)(2), (3), (4) and (b) introductory text amended..........46292
179.117 (a) amended................................................46292
180 Order.....................................13499, 23135, 54402, 75037
180.41 (c)(17) through (26) redesignated as (c)(18) through (27); 
        new (c)(17) added; new (c)(21) through (27) redesignated 
        as (c)(22) through (28); new (c)(21) added.................50620
180.116 (a) table revised..........................................59123
180.124 Added......................................................35298
180.133 Removed....................................................59123
180.144 Removed....................................................59123
180.155 (a) table amended..........................................26959
    (b) table revised..............................................74118
180.157 Removed....................................................12207
180.163 Heading and (a) revised....................................59124
180.172 (a) introductory text revised; (a) table amended...........72237
180.173 Removed....................................................59124
180.180 Removed....................................................59124
180.200 Revised....................................................40815
180.205 (a) table amended..........................................47544
180.214 Removed....................................................59124
180.215 (a)(1) table amended.......................................59124
180.221 Removed....................................................59125
180.232 (a) table revised..........................................59125

[[Page 813]]

180.235 (a)(1) table amended.......................................59125
180.239 Removed....................................................59125
180.253 (a) and (c) revised........................................59125
180.276 Revised....................................................40815
180.289 (a) revised................................................59126
180.308 Added........................................................749
    Correctly redesignated as 180.1308..............................1911
180.319 Revised....................................................59126
180.361 (a) table amended..........................................52246
180.368 (a)(2) table amended.......................................48906
    (a)(1) table amended...........................................59127
180.418 (a)(2) introductory text revised; (a)(2) table amended.....72984
180.420 (b) revised................................................66720
180.422 (a) revised................................................59127
180.431 (a) table amended..........................................58050
180.434 (a) table amended..........................................38204
    (a) introductory text revised; (a) table amended...............75044
180.439 (a) table amended..........................................52240
180.441 (a)(1), (2) introductory text and (c) introductory text 
        revised; (a)(3) and (4) removed............................23630
180.442 (a)(1) introductory text, (b) and (c) revised; (a)(1) 
        table amended..............................................56790
180.452 (a) table amended..........................................59128
180.458 (a) table amended..........................................59128
180.463 (a) table amended..........................................75566
180.466 (a) introductory text revised; (a) table amended...........70908
180.473 (a) introductory text and (d) introductory text revised; 
        (a) table amended..........................................59113
180.475 (a)(1) table amended.......................................42439
180.478 (a) table amended....................................3625, 46306
180.479 (a)(1) table revised; (a)(2) table amended.................71561
180.491 (a)(1) and (2) revised.....................................28495
180.493 (a) table and (c) table amended' (d) revised...............26466
180.498 (a)(2) table amended; (b) and (c) revised..................41087
    (a)(2) table amended...........................................59560
180.507 (a)(1) table revised.......................................41291
180.510 (a)(1) introductory text revised; (a)(1) table amended.....73956
180.511 (a) table amended...................................63751, 72985
180.515 (a) introductory text revised; (a) table amended...........26461
180.516 (a) and (b) revised........................................48914
180.518 (a)(1) introductory text, (2) introductory text and (3) 
        introductory text revised; (a)(1) table amended............45503
180.532 (a)(1) table revised.......................................49738
180.536 Removed....................................................59128
180.544 (a)(1) introductory text, (2) introductory text, (b) 
        introductory text, (c) and (d) revised; (a)(1) table 
        amended....................................................40812
180.550 Removed....................................................59128
180.555 (a) table amended............................12731, 42658, 65831
180.559 (a) introductory text revised; (a) table amended...........72226
180.561 (a) revised................................................21676
    (a) redesignated as (a)(1); (a)(2) added.......................30406
180.564 Existing text after (a) heading designated as (a)(1); 
        (a)(2) added................................................8749
180.565 (a) revised................................................12739
    (a) table corrected............................................25904
180.566 (a)(1), (2) introductory text, (3) introductory text and 
        (b) introductory text revised..............................73951
180.568 (a) table amended..........................................58499
180.574 (a)(1) table amended.......................................66729
180.578 (a)(1) introductory text, (2) introductory text and (c) 
        introductory text revised; (a)(1) table amended; (a)(3) 
        added......................................................18716
    (a)(1) table amended...........................................43529
180.579 (d) table amended..........................................32401
180.585 (a) table amended..........................................75861
180.586 (a)(1) introductory text revised; (a)(1) table amended.....52252
180.590 (a) revised................................................32406
180.593 (a) table amended...........................................3621
180.599 (a) table amended..........................................25909
180.601 (b) revised.................................................4252
    (a) table and (b) table amended................................59119
180.603 (a)(1) table amended.......................................56138
    (b) revised....................................................67285
    (a)(1) table and(2) table amended; (b) revised.................70913
180.608 (a)(1) introductory text revised; (a)(1) table amended.....73939
180.609 (a)(1) table amended.......................................26471
    (a)(1) table and (2) table amended.............................64915
180.613 (a)(1) introductory text and (2) introductory text 
        revised; (a)(1) table amended..............................67776

[[Page 814]]

180.614 (b) table revised..........................................74119
180.617 (a) table amended...................................26456, 66723
180.628 (a) table and (d) table amended............................60315
    (a) table amended..............................................75561
180.629 (a) table and (d) table amended............................47301
    (b) revised....................................................48901
180.637 (b) table revised..........................................74119
180.639 (a)(1) introductory text and (d) introductory text 
        revised; (a)(1) table amended..............................73945
180.641 (b) revised.................................................8746
    (b) table amended..............................................75859
180.655 Added......................................................10968
180.657 Added......................................................10386
180.658 Added......................................................14297
180.659 Added......................................................12213
180.660 Added......................................................13506
180.661 Added......................................................10975
180.662 Added......................................................12745
    (a) table amended..............................................60919
180.663 Added......................................................27134
180.664 Added......................................................28281
180.665 Added......................................................36924
180.666 Added......................................................28275
    (a) table amended..............................................46307
180.667 Added......................................................38210
180.668 Added......................................................59565
180.669 Added......................................................72231
180.905 Revised....................................................59128
180.910 Table amended................................20726, 27129, 27631
180.920 Table amended................................61517, 65827, 72752
180.930 Table amended................................20726, 27130, 28270
    Table amended..................................................61518
180.940 (a) table amended............................45498, 50617, 53150
    (a) table and (c) table amended................................68692
180.960 Table amended..................20317, 21679, 30410, 65834, 65837
180.1035 Removed...................................................59128
180.1142 Revised...................................................68697
180.1195 Revised...................................................44155
180.1206 (b) revised...............................................14291
180.1209 Revised...................................................73937
180.1285 Revised...................................................56133
180.1299 Revised...................................................29552
180.1308 Correctly redesignated from 180.308........................1911
180.1309 Added......................................................1637
180.1310 Added......................................................4908
180.1311 Added......................................................8741
180.1312 Added......................................................8736
180.1313 Added.....................................................19112
180.1314 Added.....................................................35295
180.1315 Added.....................................................29548
180.1316 Added.....................................................40276
180.1317 Added.....................................................47296

                                  2013

   (Regulations published from January 1, 2013, through July 1, 2013)

40 CFR
                                                                   78 FR
                                                                    Page
Chapter I
152.5 (d) revised..................................................13507
158.1 (c)(4) revised; eff. 7-8-13..................................26978
158.100 (c) redesignated as (e); (a) heading, (b) and new (e) 
        revised; new (c) and (d) added; eff. 7-8-13................26978
158.400 (d) table amended..........................................13507
    (d) table amended; eff. 7-8-13.................................26978
158.2200--158.2290 (Subpart W) Added; eff. 7-8-13..................26978
161 Removed; eff. 7-8-13...........................................26993
161.640 Heading and (a) table amended..............................13507
168.65--168.85 (Subpart D) Heading revised..........................4077
168.65 Removed......................................................4077
168.66 Added........................................................4077
168.67 Added........................................................4077
168.68 Added........................................................4077
168.69 Added........................................................4077
168.70 Added........................................................4077
168.71 Added........................................................4077
174.533 Added.......................................................9321
180.155 Revised....................................................30218
180.182 (a) introductory text and table redesignated as (a)(1); 
        (a)(2) added................................................8409
180.245 (b) added..................................................29055
180.252 (a) table revised..........................................15882
180.287 (a) introductory text revised; (a) table amended...........17130
180.364 (a)(1) table amended.......................................25400
180.369 Removed....................................................32157
180.418 (a)(3) added................................................7275
180.434 (a) table amended..........................................23503
180.448 (a) table and (c) table amended.............................9327
180.449 Introductory text revised; Table amended...................18525
180.470 (d) table amended..........................................13268
180.472 (a) table amended; (b) added...............................33743

[[Page 815]]

180.485 (a)(1) introductory text, (2) introductory text and (3) 
        introductory text revised; (a)(1) table amended............37473
180.499 Heading, (a) introductory text and (c) revised.............33736
180.505 (a)(1) introductory text and (a)(2) introductory text 
        revised; (a)(1) table amended..............................18511
180.507 (a)(1) table amended; (a)(2) introductory text revised.....24099
    (a)(1) table amended...........................................32575
180.535 (a) introductory text revised; (a) table amended............3333
180.565 (a) table amended..........................................18518
180.566 (a)(1) table amended.......................................36097
180.568 (a) table amended..........................................20466
180.578 (a)(1) and (2) amended.....................................36676
180.585 (a) revised................................................13263
180.586 (a)(1) amended.............................................19136
180.594 (a) introductory text revised; (a) table amended............8416
180.603 (a)(3) added...............................................21272
    (b) revised....................................................24683
180.607 (a)(1) table amended........................................3337
180.641 (a)(1) table amended; (b) and (c) revised..................28512
180.659 (a)(2) table amended; (a)(3) added.........................13257
180.665 (a) table amended..........................................33748
180.668 (a) correctly added; (b) correctly removed.................38227
180.670 Added......................................................29049
    Correctly removed..............................................38227
180.671 Added......................................................14465
180.673 Redesignated from 180.1321.................................36677
180.910 Table amended................................32161, 33753, 35147
180.920 Table amended..............................................32155
180.940 (a) table amended..........................................35147
180.960 Table amended.....................4795, 6215, 7278, 20032, 20034
180.1269 Revised...................................................24353
180.1318 Added.....................................................11766
180.1319 Added.....................................................17604
180.1320 Added.....................................................22794
180.1321 Added.....................................................32151
180.1321 Redesignated as 180.673...................................36677
180.1322 Added.....................................................35149


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