[Title 40 CFR ]
[Code of Federal Regulations (annual edition) - July 1, 2019 Edition]
[From the U.S. Government Publishing Office]
[[Page i]]
Title 40
Protection of Environment
________________________
Parts 150 to 189
Revised as of July 1, 2019
Containing a codification of documents of general
applicability and future effect
As of July 1, 2019
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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[[Page iii]]
Table of Contents
Page
Explanation................................................. v
Title 40:
Chapter I--Environmental Protection Agency
(Continued) 3
Finding Aids:
Table of CFR Titles and Chapters........................ 831
Alphabetical List of Agencies Appearing in the CFR...... 851
List of CFR Sections Affected........................... 861
[[Page iv]]
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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
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HOW TO USE THE CODE OF FEDERAL REGULATIONS
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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
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(b) The matter incorporated is in fact available to the extent
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(c) The incorporating document is drafted and submitted for
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this volume.
[[Page vii]]
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Oliver A. Potts,
Director,
Office of the Federal Register
July 1, 2019
[[Page ix]]
THIS TITLE
Title 40--Protection of Environment is composed of thirty-seven
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-
60.499), part 60 (60.500-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
72-79, part 80, part 81, parts 82-86, 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-
722, parts 723-789, parts 790-999, parts 1000-1059, and part 1060 to
end. The contents of these volumes represent all current regulations
codified under this title of the CFR as of July 1, 2019.
Chapter I--Environmental Protection Agency appears in all thirty-
seven volumes. OMB control numbers for title 40 appear in Sec. 9.1 of
this chapter.
Chapters IV-VIII--Regulations issued by the Environmental Protection
Agency and Department of Justice, Council on Environmental Quality,
Chemical Safety and Hazard Investigation Board, Environmental Protection
Agency and Department of Defense; Uniform National Discharge Standards
for Vessels of the Armed Forces, and the Gulf Coast Ecosystem
Restoration Council appear in volume thirty seven.
For this volume, Cheryl E. Sirofchuck was Chief Editor. The Code of
Federal Regulations publication program is under the direction of John
Hyrum Martinez, assisted by Stephen J. Frattini.
[[Page 1]]
TITLE 40--PROTECTION OF ENVIRONMENT
(This book contains parts 150 to 189)
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Part
chapter i--Environmental Protection Agency (Continued)...... 150
[[Page 3]]
CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
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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... 49
154 Special review procedures................... 50
155 Registration standards and registration
review.................................. 58
156 Labeling requirements for pesticides and
devices................................. 66
157 Packaging requirements for pesticides and
devices................................. 88
158 Data requirements for pesticides............ 93
159 Statements of policies and interpretations.. 200
160 Good laboratory practice standards.......... 214
162 State registration of pesticide products.... 226
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........ 234
165 Pesticide management and disposal........... 252
166 Exemption of Federal and State agencies for
use of pesticides under emergency
conditions.............................. 278
167 Registration of pesticide and active
ingredient producing establishments,
submission of pesticide reports......... 288
168 Statements of enforcement policies and
interpretations......................... 291
169 Books and records of pesticide production
and distribution........................ 300
170 Worker protection standard.................. 303
171 Certification of pesticide applicators...... 360
[[Page 4]]
172 Experimental use permits.................... 399
173 Procedures governing the rescission of State
primary enforcement responsibility for
pesticide use violations................ 415
174 Procedures and requirements for plant-
incorporated protectants................ 418
176 Time-limited tolerances for emergency
exemptions.............................. 428
178 Objections and requests for hearings........ 429
179 Formal evidentiary public hearing........... 433
180 Tolerances and exemptions for pesticide
chemical residues in food............... 445
181-189
[Reserved]
[[Page 5]]
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_Satisfaction of Data Requirements and Protection of Data
Submitters' Rights
152.80 General.
152.81 Applicability.
152.82 Definitions.
152.83 Definition of exclusive use study.
152.84 When materials must be submitted to the Agency.
[[Page 6]]
152.85 Formulators' exemption.
152.86 The cite-all method.
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 Claim of data gap.
152.97 Rights and obligations regarding the Data Submitters List.
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.
[[Page 7]]
(5) Requirements pertaining to pesticide devices. Refer to subpart Z
of this part.
[73 FR 75594, Dec. 12, 2008]
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;
[[Page 8]]
(2) Any aquatic, terrestrial, outdoor, or forestry use pattern, if
no product 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,
[[Page 9]]
beverages, drugs (as defined in FFDCA 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, alone or in combination
with other substances listed in table 1 of this paragraph, are exempt
from the requirements of FIFRA provided that all of the criteria of this
section are met. All listed active ingredients may be used in non-food
use products. Under section 408 of the Federal Food, Drug, and Cosmetic
Act and EPA (FFDCA) implementing regulations at part 180 of this
chapter, food and animal feed in commerce can bear pesticide residues
only for those ingredients that have tolerances or tolerance exemptions
in part 180 of this chapter. Such tolerances or exemptions may be found,
for example, in Sec. Sec. 180.950, 180.1071, 180.1087, 180.1233, and
180.1251 of this chapter.
[[Page 13]]
Table 1--Active Ingredients Permitted in Exempted Minimum Risk Pesticide Products
----------------------------------------------------------------------------------------------------------------
Label display name Chemical name Specifications CAS No.
----------------------------------------------------------------------------------------------------------------
Castor oil......................... Castor oil............ United States 8001-79-4
Pharmacopeia (U.S.P.)
or equivalent.
Cedarwood oil...................... Cedarwood oil (China). ...................... 85085-29-6
Cedarwood oil...................... Cedarwood oil (Texas). ...................... 68990-83-0
Cedarwood oil...................... Cedarwood oil ...................... 8000-27-9
(Virginia).
Cinnamon........................... Cinnamon.............. ...................... N/A
Cinnamon oil....................... Cinnamon oil.......... ...................... 8015-91-6
Citric acid........................ 2-Hydroxypropane-1,2,3- ...................... 77-92-9
tricarboxylic acid.
Citronella......................... Citronella............ ...................... N/A
Citronella oil..................... Citronella oil........ ...................... 8000-29-1
Cloves............................. Cloves................ ...................... N/A
Clove oil.......................... Clove oil............. ...................... 8000-34-8
Corn gluten meal................... Corn gluten meal...... ...................... 66071-96-3
Corn oil........................... Corn oil.............. ...................... 8001-30-7
Cornmint........................... Cornmint.............. ...................... N/A
Cornmint oil....................... Cornmint oil.......... ...................... 68917-18-0
Cottonseed oil..................... Cottonseed oil........ ...................... 8001-29-4
Dried blood........................ Dried blood........... ...................... 68991-49-9
Eugenol............................ 4-Allyl-2- ...................... 97-53-0
methoxyphenol.
Garlic............................. Garlic................ ...................... N/A
Garlic oil......................... Garlic oil............ ...................... 8000-78-0
Geraniol........................... (2E)-3,7-Dimethylocta- ...................... 106-24-1
2,6-dien-1-ol.
Geranium oil....................... Geranium oil.......... ...................... 8000-46-2
Lauryl sulfate..................... Lauryl sulfate........ ...................... 151-41-7
Lemongrass oil..................... Lemongrass oil........ ...................... 8007-02-1
Linseed oil........................ Linseed oil........... ...................... 8001-26-1
Malic acid......................... 2-Hydroxybutanedioic ...................... 6915-15-7
acid.
Peppermint......................... Peppermint............ ...................... N/A
Peppermint oil..................... Peppermint oil........ ...................... 8006-90-4
2-Phenylethyl propionate........... 2-Phenylethyl ...................... 122-70-3
propionate.
Potassium sorbate.................. Potassium (2E,4E)-hexa- ...................... 24634-61-5
2,4-dienoate.
Putrescent whole egg solids........ Putrescent whole egg ...................... 51609-52-0
solids.
Rosemary........................... Rosemary.............. ...................... N/A
Rosemary oil....................... Rosemary oil.......... ...................... 8000-25-7
Sesame............................. Sesame................ Includes ground sesame N/A
plant.
Sesame oil......................... Sesame oil............ ...................... 8008-74-0
Sodium chloride.................... Sodium chloride....... ...................... 7647-14-5
Sodium lauryl sulfate.............. Sulfuric acid ...................... 151-21-3
monododecyl ester,
sodium salt.
Soybean oil........................ Soybean oil........... ...................... 8001-22-7
Spearmint.......................... Spearmint............. ...................... N/A
Spearmint oil...................... Spearmint oil......... ...................... 8008-79-5
Thyme.............................. Thyme................. ...................... N/A
Thyme oil.......................... Thyme oil............. ...................... 8007-46-3
White pepper....................... White pepper.......... ...................... N/A
Zinc............................... Zinc.................. Zinc metal strips 7440-66-6
(consisting solely of
zinc metal and
impurities).
----------------------------------------------------------------------------------------------------------------
(2) Permitted inert ingredients. A pesticide product exempt under
paragraph (f)(1) of this section may only include the inert ingredients
listed in paragraphs (f)(2)(i) through (iv) of this section. All listed
inert ingredients may be used in non-food use products. Under FFDCA
section 408 and EPA implementing regulations at part 180 of this
chapter, food and animal feed in commerce can bear pesticide residues
only for those ingredients that have tolerances or tolerance exemptions
in part 180 of this chapter. Such tolerances or exemptions may be found,
for example, in Sec. Sec. 180.910, 180.920. 180.930, 180.940, 180.950,
and 180.1071 of this chapter.
(i) Commonly consumed food commodities, as described in Sec.
180.950(a) of this chapter.
(ii) Animal feed items, as described in Sec. 180.950(b) of this
chapter.
(iii) Edible fats and oils, as described in Sec. 180.950(c) of this
chapter.
(iv) Specific chemical substances, as listed in the following table.
[[Page 14]]
Table 2--Inert Ingredients Permitted in Minimum Risk Pesticide Products
------------------------------------------------------------------------
Label display name Chemical name CAS No.
------------------------------------------------------------------------
Acetyl tributyl citrate..... Citric acid, 2- 77-90-7
(acetyloxy)-,
tributyl ester.
Agar........................ Agar................ 9002-18-0
Almond hulls................ Almond hulls........ N/A
Almond oil.................. Oils, almond........ 8007-69-0
Almond shells............... Almond shells....... N/A
alpha-Cyclodextrin.......... alpha-Cyclodextrin.. 10016-20-3
Aluminatesilicate........... Aluminatesilicate... 1327-36-2
Aluminum magnesium silicate. Silicic acid, 1327-43-1
aluminum magnesium
salt.
Aluminum potassium sodium Silicic acid, 12736-96-8
silicate. aluminum potassium
sodium salt.
Aluminum silicate........... Aluminum silicate... 1335-30-4
Aluminum sodium silicate.... Silicic acid, 1344-00-9
aluminum sodium
salt.
Aluminum sodium silicate.... Silicic acid (H4 12003-51-9
SiO4), aluminum
sodium salt (1:1:1).
Ammonium benzoate........... Benzoic acid, 1863-63-4
ammonium salt.
Ammonium stearate........... Octadecanoic acid, 1002-89-7
ammonium salt.
Amylopectin, acid- Amylopectin, acid- 113894-85-2
hydrolyzed, 1- hydrolyzed, 1-
octenylbutanedioate. octenylbutanedioate.
Amylopectin, hydrogen 1- Amylopectin, 125109-81-1
octadecenylbutanedioate. hydrogen 1-
octadecenylbutanedi
oate.
Animal glue................. Animal glue......... N/A
Ascorbyl palmitate.......... Ascorbyl palmitate.. 137-66-6
Attapulgite-type clay....... Attapulgite-type 12174-11-7
clay.
Beeswax..................... Beeswax............. 8012-89-3
Bentonite................... Bentonite........... 1302-78-9
Bentonite, sodian........... Bentonite, sodian... 85049-30-5
beta-Cyclodextrin........... beta-Cyclodextrin... 7585-39-9
Bone meal................... Bone meal........... 68409-75-6
Bran........................ Bran................ N/A
Bread crumbs................ Bread crumbs........ N/A
(+)-Butyl lactate........... Lactic acid, n-butyl 34451-19-9
ester, (S).
Butyl lactate............... Lactic acid, n-butyl 138-22-7
ester.
Butyl stearate.............. Octadecanoic acid, 123-95-5
butyl ester.
Calcareous shale............ Calcareous shale.... N/A
Calcite..................... Calcite (Ca(CO3))... 13397-26-7
Calcium acetate............. Calcium acetate..... 62-54-4
Calcium acetate monohydrate. Acetic acid, calcium 5743-26-0
salt, monohydrate.
Calcium benzoate............ Benzoic acid, 2090-05-3
calcium salt.
Calcium carbonate........... Calcium carbonate... 471-34-1
Calcium citrate............. Citric acid, calcium 7693-13-2
salt.
Calcium octanoate........... Calcium octanoate... 6107-56-8
Calcium oxide silicate...... Calcium oxide 12168-85-3
silicate (Ca3
O(SiO4)).
Calcium silicate............ Silicic acid, 1344-95-2
calcium salt.
Calcium stearate............ Octadecanoic acid, 1592-23-0
calcium salt.
Calcium sulfate............. Calcium sulfate..... 7778-18-9
Calcium sulfate dihydrate... Calcium sulfate 10101-41-4
dihydrate.
Calcium sulfate hemihydrate. Calcium sulfate 10034-76-1
hemihydrate.
Canary seed................. Canary seed......... N/A
Carbon...................... Carbon.............. 7440-44-0
Carbon dioxide.............. Carbon dioxide...... 124-38-9
Carboxymethyl cellulose..... Cellulose, 9000-11-7
carboxymethyl ether.
Cardboard................... Cardboard........... N/A
Carnauba wax................ Carnauba wax........ 8015-86-9
Carob gum................... Locust bean gum..... 9000-40-2
Carrageenan................. Carrageenan......... 9000-07-1
Caseins..................... Caseins............. 9000-71-9
Castor oil.................. Castor oil.......... 8001-79-4
Castor oil, hydrogenated.... Castor oil, 8001-78-3
hydrogenated.
Cat food.................... Cat food............ N/A
Cellulose................... Cellulose........... 9004-34-6
Cellulose acetate........... Cellulose acetate... 9004-35-7
Cellulose, mixture with Cellulose, mixture 51395-75-6
cellulose carboxymethyl with cellulose
ether, sodium salt. carboxymethyl
ether, sodium salt.
Cellulose, pulp............. Cellulose, pulp..... 65996-61-4
Cellulose, regenerated...... Cellulose, 68442-85-3
regenerated.
Cheese...................... Cheese.............. N/A
Chlorophyll a............... Chlorophyll a....... 479-61-8
Chlorophyll b............... Chlorophyll b....... 519-62-0
Citric acid................. Citric acid......... 77-92-9
Citric acid, monohydrate.... Citric acid, 5949-29-1
monohydrate.
Citrus meal................. Citrus meal......... N/A
Citrus pectin............... Citrus pectin....... 9000-69-5
[[Page 15]]
Citrus pulp................. Citrus pulp......... 68514-76-1
Clam shells................. Clam shells......... N/A
Cocoa....................... Cocoa............... 8002-31-1
Cocoa shell flour........... Cocoa shell flour... N/A
Cocoa shells................ Cocoa shells........ N/A
Cod-liver oil............... Cod-liver oil....... 8001-69-2
Coffee grounds.............. Coffee grounds...... 68916-18-7
Cookies..................... Cookies............. N/A
Cork........................ Cork................ 61789-98-8
Corn cobs................... Corn cobs........... N/A
Cotton...................... Cotton.............. N/A
Cottonseed meal............. Cottonseed meal..... 68424-10-2
Cracked wheat............... Cracked wheat....... N/A
Decanoic acid, monoester Decanoic acid, 26402-22-2
with 1,2,3-propanetriol. monoester with
1,2,3-propanetriol.
Dextrins.................... Dextrins............ 9004-53-9
Diglyceryl monooleate....... 9-Octadecenoic acid, 49553-76-6
ester with 1,2,3-
propanetriol.
Diglyceryl monostearate..... 9-Octadecanoic acid, 12694-22-3
monoester with
oxybis(propanediol).
Dilaurin.................... Dodecanoic acid, 27638-00-2
diester with 1,2,3-
propanetriol.
Dipalmitin.................. Hexadecanoic acid, 26657-95-4
diester with 1,2,3-
propanetriol.
Dipotassium citrate......... Citric acid, 3609-96-9
dipotassium salt.
Disodium citrate............ Citric acid, 144-33-2
disodium salt.
Disodium sulfate decahydrate Disodium sulfate 7727-73-3
decahydrate.
Diatomaceous earth.......... Kieselguhr; 61790-53-2
Diatomite (less
than 1% crystalline
silica).
Dodecanoic acid, monoester Dodecanoic acid, 27215-38-9
with 1,2,3-propanetriol. monoester with
1,2,3-propanetriol.
Dolomite.................... Dolomite............ 16389-88-1
Douglas fir bark............ Douglas fir bark.... N/A
Egg shells.................. Egg shells.......... N/A
Eggs........................ Eggs................ N/A
(+)-Ethyl lactate........... Lactic acid, ethyl 687-47-8
ester, (S).
Ethyl lactate............... Lactic acid, ethyl 97-64-3
ester.
Feldspar.................... Feldspar............ 68476-25-5
Ferric oxide................ Iron oxide (Fe2O3).. 1309-37-1
Ferrous oxide............... Iron oxide (FeO).... 1345-25-1
Fish meal................... Fish meal........... N/A
Fish oil.................... Fish oil............ 8016-13-5
Fuller's earth.............. Fuller's earth...... 8031-18-3
Fumaric acid................ Fumaric acid........ 110-17-8
gamma-Cyclodextrin.......... gamma-Cyclodextrin.. 17465-86-0
Gelatins.................... Gelatins............ 9000-70-8
Gellan gum.................. Gellan gum.......... 71010-52-1
Glue........................ Glue (as depolymd. 68476-37-9
animal collagen).
Glycerin.................... 1,2,3-Propanetriol.. 56-81-5
Glycerol monooleate......... 9-Octadecenoic acid 111-03-5
(Z)-, 2,3-
dihydroxypropyl
ester.
Glyceryl dicaprylate........ Octanoic acid, 36354-80-0
diester with 1,2,3-
propanetriol.
Glyceryl dimyristate........ Tetradecanoic acid, 53563-63-6
diester with 1,2,3-
propanetriol.
Glyceryl dioleate........... 9-Octadecenoic acid 25637-84-7
(9Z)-, diester with
1,2,3-propanetriol.
Glyceryl distearate......... Octadecanoic acid, 1323-83-7
diester with 1,2,3-
propanetriol.
Glyceryl monomyristate...... Tetradecanoic acid, 27214-38-6
monoester with
1,2,3-propanetriol.
Glyceryl monooctanoate...... Octanoic acid, 26402-26-6
monoester with
1,2,3-propanetriol.
Glyceryl monooleate......... 9-Octadecenoic acid 25496-72-4
(9Z)-, monoester
with 1,2,3-
propanetriol.
Glyceryl monostearate....... Octadecanoic acid, 31566-31-1
monoester with
1,2,3-propanetriol.
Glyceryl stearate........... Octadecanoic acid, 11099-07-3
ester with 1,2,3-
propanetriol.
Granite..................... Granite............. N/A
Graphite.................... Graphite............ 7782-42-5
Guar gum.................... Guar gum............ 9000-30-0
Gum Arabic.................. Gum arabic.......... 9000-01-5
Gum tragacanth.............. Gum tragacanth...... 9000-65-1
Gypsum...................... Gypsum.............. 13397-24-5
Hematite.................... Hematite (Fe2O3).... 1317-60-8
Humic acid.................. Humic acid.......... 1415-93-6
Hydrogenated cottonseed oil. Hydrogenated 68334-00-9
cottonseed oil.
Hydrogenated rapeseed oil... Hydrogenated 84681-71-0
rapeseed oil.
Hydrogenated soybean oil.... Hydrogenated soybean 8016-70-4
oil.
Hydroxyethyl cellulose...... Cellulose, 2- 9004-62-0
hydroxyethyl ether.
Hydroxypropyl cellulose..... Cellulose, 2- 9004-64-2
hydroxypropyl ether.
Hydroxypropyl methyl Cellulose, 2- 9004-65-3
cellulose. hydroxypropyl
methyl ether.
Iron magnesium oxide........ Iron magnesium oxide 12068-86-9
(Fe2MgO4).
Iron oxide, hydrate......... Iron oxide (Fe2O3), 12259-21-1
hydrate.
Iron oxide.................. Iron oxide (Fe3O4).. 1317-61-9
Isopropyl alcohol........... 2-Propanol.......... 67-63-0
[[Page 16]]
Isopropyl myristate......... Isopropyl myristate. 110-27-0
Kaolin...................... Kaolin.............. 1332-58-7
Lactose..................... Lactose............. 63-42-3
Lactose monohydrate......... Lactose monohydrate. 64044-51-5
Lanolin..................... Lanolin............. 8006-54-0
Latex rubber................ Latex rubber........ N/A
Lauric acid................. Lauric acid......... 143-07-7
Lecithins................... Lecithins........... 8002-43-5
Licorice extract............ Licorice extract.... 68916-91-6
Lime dolomitic.............. Lime (chemical) 12001-27-3
dolomitic.
Limestone................... Limestone........... 1317-65-3
Linseed oil................. Linseed oil......... 8001-26-1
Magnesium carbonate......... Carbonic acid, 546-93-0
magnesium salt
(1:1).
Magnesium benzoate.......... Magnesium benzoate.. 553-70-8
Magnesium oxide............. Magnesium oxide..... 1309-48-4
Magnesium oxide silicate.... Magnesium oxide 12207-97-5
silicate
(Mg3O(Si2O5)2),
monohydrate.
Magnesium silicate.......... Magnesium silicate.. 1343-88-0
Magnesium silicate hydrate.. Magnesium silicate 1343-90-4
hydrate.
Magnesium silicon oxide..... Magnesium silicon 14987-04-3
oxide (Mg2Si3O8).
Magnesium stearate.......... Octadecanoic acid, 557-04-0
magnesium salt.
Magnesium sulfate........... Magnesium sulfate... 7487-88-9
Magnesium sulfate Magnesium sulfate 10034-99-8
heptahydrate. heptahydrate.
Malic acid.................. Malic acid.......... 6915-15-7
Malt extract................ Malt extract........ 8002-48-0
Malt flavor................. Malt flavor......... N/A
Maltodextrin................ Maltodextrin........ 9050-36-6
Methylcellulose............. Cellulose, methyl 9004-67-5
ether.
Mica........................ Mica................ 12003-38-2
Mica-group minerals......... Mica-group minerals. 12001-26-2
Milk........................ Milk................ 8049-98-7
Millet seed................. Millet seed......... N/A
Mineral oil................. Mineral oil (U.S.P.) 8012-95-1
1-Monolaurin................ Dodecanoic acid, 2,3- 142-18-7
dihydroxypropyl
ester.
1-Monomyristin.............. Tetradecanoic acid, 589-68-4
2,3-dihydroxypropyl
ester.
Monomyristin................ Decanoic acid, 53998-07-1
diester with 1,2,3-
propanetriol.
Monopalmitin................ Hexadecanoic acid, 26657-96-5
monoester with
1,2,3-propanetriol.
Monopotassium citrate....... Citric acid, 866-83-1
monopotassium salt.
Monosodium citrate.......... Citric acid, 18996-35-5
monosodium salt.
Montmorillonite............. Montmorillonite..... 1318-93-0
Myristic acid............... Myristic acid....... 544-63-8
Nepheline syenite........... Nepheline syenite... 37244-96-5
Nitrogen.................... Nitrogen............ 7727-37-9
Nutria meat................. Nutria meat......... N/A
Nylon....................... Nylon............... N/A
Octanoic acid, potassium Octanoic acid, 764-71-6
salt. potassium salt.
Octanoic acid, sodium salt.. Octanoic acid, 1984-06-1
sodium salt.
Oleic acid.................. Oleic acid.......... 112-80-1
Oyster shells............... Oyster shells....... N/A
Palm oil.................... Palm oil............ 8002-75-3
Palm oil, hydrogenated...... Palm oil, 68514-74-9
hydrogenated.
Palmitic acid............... Hexadecanoic acid... 57-10-3
Paper....................... Paper............... N/A
Paraffin wax................ Paraffin wax........ 8002-74-2
Peanut butter............... Peanut butter....... N/A
Peanut shells............... Peanut shells....... N/A
Peanuts..................... Peanuts............. N/A
Peat moss................... Peat moss........... N/A
Pectin...................... Pectin.............. 9000-69-5
Perlite..................... Perlite............. 130885-09-5
Perlite, expanded........... Perlite, expanded... 93763-70-3
Plaster of paris............ Plaster of paris.... 26499-65-0
Polyethylene................ Polyethylene........ 9002-88-4
Polyglyceryl oleate......... Polyglyceryl oleate. 9007-48-1
Polyglyceryl stearate....... Polyglyceryl 9009-32-9
stearate.
Potassium acetate........... Acetic acid, 127-08-2
potassium salt.
Potassium aluminum silicate, Potassium aluminum 1327-44-2
anhydrous. silicate, anhydrous.
Potassium benzoate.......... Benzoic acid, 582-25-2
potassium salt.
Potassium bicarbonate....... Carbonic acid, 298-14-6
monopotassium salt.
Potassium chloride.......... Potassium chloride.. 7447-40-7
Potassium citrate........... Citric acid, 7778-49-6
potassium salt.
Potassium humate............ Humic acids, 68514-28-3
potassium salts.
[[Page 17]]
Potassium myristate......... Tetradecanoic acid, 13429-27-1
potassium salt.
Potassium oleate............ 9-Octadecenoic acid 143-18-0
(9Z)-, potassium
salt.
Potassium ricinoleate....... 9-Octadecenoic acid, 7492-30-0
12-hydroxy-,
monopotassium salt,
(9Z, 12R)-.
Potassium sorbate........... Sorbic acid, 24634-61-5
potassium salt.
Potassium stearate.......... Octadecanoic acid, 593-29-3
potassium salt.
Potassium sulfate........... Potassium sulfate... 7778-80-5
Potassium sulfate........... Sulfuric acid, 7646-93-7
monopotassium salt.
1,2-Propylene carbonate..... 1,3-Dioxolan-2-one, 108-32-7
4-methyl-.
Pumice...................... Pumice.............. 1332-09-8
Red cabbage color........... Red cabbage color N/A
(expressed from
edible red cabbage
heads via a
pressing process
using only
acidified water).
Red cedar chips............. Red cedar chips..... N/A
Red dog flour............... Red dog flour....... N/A
Rubber...................... Rubber.............. 9006-04-6
Sawdust..................... Sawdust............. N/A
Shale....................... Shale............... N/A
Silica, amorphous, fumed.... Silica, amorphous, 112945-52-5
fumed (crystalline
free).
Silica, amorphous, Silica, amorphous, 7699-41-4
precipitate and gel. precipitate and gel.
Silica...................... Silica (crystalline 7631-86-9
free).
Silica gel.................. Silica gel.......... 63231-67-4
Silica gel, precipitated, Silica gel, 112926-00-8
crystalline-free. precipitated,
crystalline-free.
Silica, hydrate............. Silica, hydrate..... 10279-57-9
Silica, vitreous............ Silica, vitreous.... 60676-86-0
Silicic acid, magnesium salt Silicic acid 13776-74-4
(H2SiO3), magnesium
salt (1:1).
Soap........................ Soap (The water N/A
soluble sodium or
potassium salts of
fatty acids
produced by either
the saponification
of fats and oils,
or the
neutralization of
fatty acid).
Soapbark.................... Quillaja saponin.... 1393-03-9
Soapstone................... Soapstone........... 308076-02-0
Sodium acetate.............. Acetic acid, sodium 127-09-3
salt.
Sodium alginate............. Sodium alginate..... 9005-38-3
Sodium benzoate............. Benzoic acid, sodium 532-32-1
salt.
Sodium bicarbonate.......... Sodium bicarbonate.. 144-55-8
Sodium carboxymethyl Cellulose, 9004-32-4
cellulose. carboxymethyl
ether, sodium salt.
Sodium chloride............. Sodium chloride..... 7647-14-5
Sodium citrate.............. Sodium citrate...... 994-36-5
Sodium humate............... Humic acids, sodium 68131-04-4
salts.
Sodium oleate............... Sodium oleate....... 143-19-1
Sodium ricinoleate.......... 9-Octadecenoic acid, 5323-95-5
12-hydroxy-,
monosodium salt,
(9Z,12R)-.
Sodium stearate............. Octadecanoic acid, 822-16-2
sodium salt.
Sodium sulfate.............. Sodium sulfate...... 7757-82-6
Sorbitol.................... D-glucitol.......... 50-70-4
Soy protein................. Soy protein......... N/A
Soya lecithins.............. Lecithins, soya..... 8030-76-0
Soybean hulls............... Soybean hulls....... N/A
Soybean meal................ Soybean meal........ 68308-36-1
Soybean, flour.............. Soybean, flour...... 68513-95-1
Stearic acid................ Octadecanoic acid... 57-11-4
Sulfur...................... Sulfur.............. 7704-34-9
Syrups, hydrolyzed starch, Syrups, hydrolyzed 68425-17-2
hydrogenated. starch,
hydrogenated.
Tetraglyceryl monooleate.... 9-Octadecenoic acid 71012-10-7
(9Z)-, monoester
with tetraglycerol.
Tricalcium citrate.......... Citric acid, calcium 813-94-5
salt (2:3).
Triethyl citrate............ Citric acid, 77-93-0
triethyl ester.
Tripotassium citrate........ Citric acid, 866-84-2
tripotassium salt.
Tripotassium citrate Citric acid, 6100-05-6
monohydrate. tripotassium salt,
monohydrate.
Trisodium citrate........... Citric acid, 68-04-2
trisodium salt.
Trisodium citrate dehydrate. Citric acid, 6132-04-3
trisodium salt,
dehydrate.
Trisodium citrate Citric acid, 6858-44-2
pentahydrate. trisodium salt,
pentahydrate.
Ultramarine blue............ C.I. Pigment Blue 29 57455-37-5
Urea........................ Urea................ 57-13-6
Vanillin.................... Benzaldehyde, 4- 121-33-5
hydroxy-3-methoxy-.
Vermiculite................. Vermiculite......... 1318-00-9
Vinegar..................... Vinegar (maximum 8% 8028-52-2
acetic acid in
solution).
Vitamin C................... L-Ascorbic acid..... 50-81-7
Vitamin E................... Vitamin E........... 1406-18-4
Walnut flour................ Walnut flour........ N/A
Walnut shells............... Walnut shells....... N/A
Wheat....................... Wheat............... N/A
Wheat flour................. Wheat flour......... N/A
[[Page 18]]
Wheat germ oil.............. Wheat germ oil...... 8006-95-9
Wheat oil................... Oils, wheat......... 68917-73-7
Whey........................ Whey................ 92129-90-3
White mineral oil........... White mineral oil 8042-47-5
(petroleum).
Wintergreen oil............. Wintergreen oil..... 68917-75-9
Wollastonite................ Wollastonite 13983-17-0
(Ca(SiO3)).
Wool........................ Wool................ N/A
Xanthan gum................. Xanthan gum......... 11138-66-2
Yeast....................... Yeast............... 68876-77-7
Zeolites.................... Zeolites (excluding 1318-02-1
erionite (CAS Reg.
No. 66733-21-9)).
Zeolites, NaA............... Zeolites, NaA....... 68989-22-0
Zinc iron oxide............. Zinc iron oxide..... 12063-19-3
Zinc oxide.................. Zinc oxide (ZnO).... 1314-13-2
Zinc stearate............... Octadecanoic acid, 557-05-1
zinc salt.
------------------------------------------------------------------------
(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 label display name and percentage (by weight) of each
active ingredient as listed in table 1 in paragraph (f)(1) of this
section. Each product must also list all inert ingredients by the label
display name listed in table 2 in paragraph (f)(2)(iv) of this section.
(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) Company name and contact information.
(A) The name of the producer or the company for whom the product was
produced must appear on the product label. If the company whose name
appears on the label in accordance with this paragraph is not the
producer, the company name must be qualified by appropriate wording such
as ``Packed for [insert name],'' ``Distributed by [insert name], or
``Sold by [insert name]'' to show that the name is not that of the
producer.
(B) Contact information for the company specified in accordance with
paragraph (f)(3)(iii)(A) of this section must appear on the product
label including the street address plus ZIP code and the telephone phone
number of the location at which the company may be reached.
(C) The company name and contact information must be displayed
prominently on the product label.
(iv) The product must not include any false and misleading labeling
statements, including those listed in 40 CFR 156.10(a)(5)(i) through
(viii).
(4) Providing guidance. Guidance on minimum risk pesticides is
available at http://www2.epa.gov/minimum-risk-pesticides or successor
Web pages.
[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; 80 FR 80660, Dec. 28, 2015]
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,
[[Page 19]]
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 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 significance, 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.
[[Page 20]]
(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.
(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
[[Page 21]]
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 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
[[Page 22]]
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 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_Satisfaction of Data Requirements and 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
[[Page 23]]
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, the
requirements of this subpart apply to:
(1) Each application for registration of a new product.
(2) Each application for amended registration of a currently
registered product.
(3) Each submission in response to a Data Call-In under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(c)(2)(B)
for an existing registration, including but not limited to, a product
subject to reregistration under FIFRA section 4 or registration review
under FIFRA section 3(g). If the Data Call-In establishes procedures for
protection of data submitters' rights, recipients must comply with the
specific requirements of the Data Call-In rather than the generic
procedures set forth in Sec. Sec. 152.85 through 152.96.
(b) This subpart does not apply to any of the following:
(1) An application for registration submitted to a State under FIFRA
section 24(c).
(2) An application for an experimental use permit (EUP) under FIFRA
section 5.
(3) An application for an emergency exemption under FIFRA section
18.
(4) A request for cancellation of a registration, or a request for
deletion of one or more existing uses, under FIFRA section 6(f).
(5) A modification to registration of a currently registered product
that may be accomplished under the notification or non-notification
provisions of Sec. 152.46 and any procedures issued thereunder.
Notwithstanding the preceding sentence, compliance with this subpart is
required if the Administrator has, by written notice under Sec. 152.46,
determined that the modification may not be accomplished by notification
or non-notification.
(6) Any type of amendment if the Administrator determines, by
written finding, that Agency consideration of data would not be
necessary in order to approve the amendment under FIFRA section 3(c)(5).
(7) 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 canceled, 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.
[79 FR 6824, Feb. 5, 2014]
Sec. 152.82 Definitions.
For the purposes of this subpart, the definitions set forth in the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), in Sec.
152.3, and in this section apply. In addition, the term ``exclusive use
study'' shall have the meaning set forth in Sec. 152.83.
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.
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 24]]
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.
Redesignated and amended at 79 FR 6825, Feb. 5, 2014]
Sec. 152.83 Definition of exclusive use study.
A study is an exclusive use study if it meets the conditions of
either paragraph (a) or paragraph (b) of this section.
(a) Initial exclusive use period. A study submitted to support the
registration of a product containing a new active ingredient (new
chemical) or a new combination of active ingredients (new combination)
is an exclusive use study if all the following conditions are met:
(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, or an
application to amend such registration to add a new use.
(3) Less than 10 years have passed (or up to 13 years, if the period
of exclusive use protection has been extended under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) section
3(c)(1)(F)(ii)) since the issuance of the registration for which the
data were submitted.
(4) The study was not submitted to satisfy a data requirement
imposed under FIFRA section 3(c)(2)(B).
(b) Exclusive use period for certain minor use data. A study
submitted by an applicant or registrant to support an amendment adding a
new minor use to an existing registration that does not retain any
period of exclusive use under paragraph (b)(1) of this section is an
exclusive study under FIFRA section 3(c)(1)(F)(vi) if all the following
conditions are met:
(1) The study relates solely to a minor use of a pesticide.
(2) The applicant or registrant at the time the new use is requested
has notified the Administrator that any exclusive use period for the
pesticide has expired and that the study is eligible for exclusive use
treatment.
(3) Less than 10 years have passed since the study was submitted to
EPA.
(4) The study was not submitted to satisfy a data requirement
imposed under FIFRA section 3(c)(2)(B).
(5) The minor use supported by the data has not been voluntarily
canceled nor have such data been used to support a non-minor use.
[79 FR 6825, Feb. 5, 2014]
Sec. 152.84 When materials must be submitted to the Agency.
Information and materials required by this subpart must be submitted
at the time of application, unless the application is determined not to
be subject to the requirements of this subpart.
[79 FR 6825, Feb. 5, 2014]
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.
[[Page 25]]
(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 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:
[[Page 26]]
(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) The applicant's name, address, and contact information,
including telephone number and email address.
(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; 79
FR 6825, Feb. 5, 2014]
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 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 claiming a data gap.
(a) List of data requirements. (1) 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 the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) section 3(c)(5) for the first time.
(2) The applicant must list the applicable requirements, as
prescribed by part 158 of this chapter, 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 need not list data requirements pertaining
to any ingredient which qualifies for the formulators' exemption.
(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,
[[Page 27]]
with any necessary written authorizations or offers to pay. Refer to
Sec. 152.95.
(6) Claim of data gap. Refer to Sec. 152.96.
[49 FR 30903, Aug. 1, 1984, as amended at 72 FR 61028, Oct. 26, 2007; 79
FR 6825, Feb. 5, 2014]
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 an extension of an existing waiver. An applicant may
claim that a waiver previously granted by the Agency also applies to a
data requirement for the 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 Reregistration Eligibility Decision (RED) document or
registration review decision document, and explain why that waiver
should apply to the 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. A decision by the Agency to
deny a written request for a new waiver or an extension of an existing
waiver is a final Agency action. Following denial, 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; 79
FR 6825, Feb. 5, 2014]
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 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:
[[Page 28]]
(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 contact information,
including a telephone number and email address.
(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; 79
FR 6825, Feb. 5, 2014]
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]
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
to 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 contact information,
including a telephone number and email address.
(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
[[Page 29]]
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; 79
FR 6825, Feb. 5, 2014]
Sec. 152.96 Claim of data gap.
(a) When a data gap may be claimed. Except as provided in paragraph
(b) of this section, an applicant may defer his obligation to satisfy an
applicable data requirement until the Agency requires the data if no
other person has previously submitted to the Agency a valid study that
would satisfy the data requirement in question.
(b) When a data gap may not be claimed--(1) Product containing a new
active ingredient. An applicant for registration of a product containing
a new active ingredient may not defer his obligation by claiming a data
gap 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 the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) section 3(c)(7)(C).
(2) Product not containing a new active ingredient. An applicant for
registration of a product under FIFRA sections 3(c)(7)(A) or (B) (a
product not containing a new active ingredient) may not defer his
obligation by claiming a data gap if the data are:
(i) Data needed to determine whether the product is identical or
substantially similar to another currently registered product or differs
only in ways that would substantially increase the risk of unreasonable
adverse effects on the environment.
(ii) Efficacy data specific to the product, if required to be
submitted to the Agency.
(iii) If a new use is proposed for a product that is identical or
substantially similar to an existing product, data to demonstrate
whether the new use would substantially increase the risk of
unreasonable adverse effects on the environment.
(c) Approval of application with a data gap claim--(1) In accordance
with Sec. 152.115(a), any registration that is approved based upon a
data gap claim shall be conditioned on the submission of the data no
later than the time that the data are required to be submitted for
similar products already registered.
(2) Notwithstanding paragraph (c)(1) of this section, the Agency
will not approve an application if it determines that the data for which
a data gap claim has been made are needed to determine if the product
meets the requirements of FIFRA sections 3(c)(5) or (7).
[79 FR 6826, Feb. 5, 2014]
Sec. 152.97 Rights and obligations regarding the Data Submitters List.
(a) Each original data submitter shall have the right to be included
on the Agency's Data Submitters List.
(b) 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:
(1) Name and current address.
(2) Chemical name, common name (if any) and Chemical Abstracts
Service (CAS) number (if any) of the active ingredients(s), with respect
to which he is an original data submitter.
(3) For each such active ingredient, the type(s) of study he has
previously submitted (identified by reference to data/information
requirements listed in part 158 of this chapter), the date of
submission, and the EPA registration number, file symbol, or other
identifying reference for which it was submitted.
(c) Each applicant not already included on the Data Submitters List
for a particular active ingredient must inform the Agency at the time of
the submission of a relevant study whether he wishes to be included on
the Data Submitters List for that pesticide.
[79 FR 6826, Feb. 5, 2014]
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.
[[Page 30]]
(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.
(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
[[Page 31]]
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 falsely or improperly claimed that a data gap
existed at the time of his application.
(v) 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, the petitioner shall send
a copy to the affected applicant or registrant by certified mail or by
any other method that provides evidence of delivery. The affected
applicant or registrant shall have 60 days from the date of 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; 79
FR 6826, Feb. 5, 2014]
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
[[Page 32]]
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. 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
[[Page 33]]
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]
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
[[Page 34]]
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 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
[[Page 35]]
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 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
[[Page 36]]
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.
(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
[[Page 37]]
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 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
[[Page 38]]
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 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
[[Page 39]]
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 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
[[Page 40]]
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;
(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
[[Page 41]]
(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 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
[[Page 42]]
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.
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.
[[Page 43]]
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.
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.
[[Page 44]]
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.
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.
[[Page 45]]
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]
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]
[[Page 46]]
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
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
[[Page 47]]
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 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
[[Page 48]]
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 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
[[Page 49]]
(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. 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
[[Page 50]]
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.
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
[[Page 51]]
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.
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,
[[Page 52]]
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.
(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
[[Page 53]]
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 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.
[[Page 54]]
(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 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.
[[Page 55]]
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
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
[[Page 56]]
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.
(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.
[[Page 57]]
(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.
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
[[Page 58]]
(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.
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
[[Page 59]]
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 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
[[Page 60]]
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 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;
[[Page 61]]
(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 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
[[Page 62]]
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
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
[[Page 63]]
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 (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
[[Page 64]]
(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.
(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]
[[Page 65]]
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 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.
[[Page 66]]
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 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]
[[Page 67]]
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.
(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''
[[Page 68]]
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 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
[[Page 69]]
(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.
(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
[[Page 70]]
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
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
[[Page 71]]
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.''
(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
[[Page 72]]
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. x 5 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 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
[[Page 73]]
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.
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
[[Page 74]]
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).
(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.''
[[Page 75]]
(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.]
----------------------------------------------------------------------------------------
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
[[Page 76]]
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 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
[[Page 77]]
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.
(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
[[Page 78]]
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.
(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
[[Page 79]]
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]
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
[[Page 80]]
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 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
[[Page 81]]
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 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.
[[Page 82]]
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 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
[[Page 83]]
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 ``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
[[Page 84]]
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.
(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.
[[Page 85]]
(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 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
[[Page 86]]
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.
(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
[[Page 87]]
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 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--
[[Page 88]]
(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.
(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.
[[Page 89]]
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 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.
[[Page 90]]
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 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
[[Page 91]]
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 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.
[[Page 92]]
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.
(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]
[[Page 93]]
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.
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.
[[Page 94]]
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.
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.
[[Page 95]]
(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. Subparts A, B, C, D, and W of this
part apply to antimicrobial pesticides.
[72 FR 60957, Oct. 26, 2007, as amended at 78 FR 26978, May 8, 2013]
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.
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,
[[Page 96]]
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.
(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
[[Page 97]]
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 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.
[[Page 98]]
(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
(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.
----------------------------------------------------------------------------------------------------------------
[[Page 99]]
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 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.
[[Page 100]]
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 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
[[Page 101]]
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 for conventional, biochemical, and
microbial pesticides. 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.
(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 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
[[Page 102]]
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.
[72 FR 60957, Oct. 26, 2007, as amended at 78 FR 26978, May 8, 2013]
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.
(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.
[[Page 103]]
(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.
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
[[Page 104]]
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,
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
[[Page 105]]
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 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
[[Page 106]]
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 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
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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.
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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 109]]
(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 110]]
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 111]]
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 112]]
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 113]]
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:
[[Page 114]]
(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.
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................................................................................
----------------------------------------------------------------------------------------------------------------
[[Page 115]]
830.1550 Product identity R MP EP 1
and composition
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
[[Page 116]]
830.7950 Vapor pressure R TGAI or PAI TGAI or PAI 9, 25
----------------------------------------------------------------------------------------------------------------
(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:
[[Page 117]]
(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 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
[[Page 118]]
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:
(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.
[[Page 119]]
(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 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.
[[Page 120]]
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 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
[[Page 121]]
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.
(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 122]]
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
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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 123]]
(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;
78 FR 26978, May 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 124]]
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.
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.
[[Page 125]]
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.
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.
[[Page 126]]
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 Agency. If hazards are
identified based upon review of these studies, specific exposure data
will be required to evaluate risk.
[[Page 127]]
(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 128]]
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 129]]
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 130]]
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