[Federal Register Volume 66, Number 241 (Friday, December 14, 2001)]
[Rules and Regulations]
[Pages 64759-64768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-30820]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 152 and 156

[OPP-300890A; FRL-6752-1]
RIN 2070-AD14


Pesticide Labeling and Other Regulatory Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY:  EPA is revising certain labeling regulations for pesticide 
products for clarity. EPA is also interpreting the Federal Insecticide, 
Fungicide and Rodenticide Act as it applies to nitrogen stabilizers, 
and revising regulations that contain statutory provisions excluding 
certain types of products from regulation of pesticides. These topics 
were part of a larger proposal concerning antimicrobial products, and 
are being promulgated separately for convenience.

EFFECTIVE DATE: This rule is effective on February 12, 2002.

FOR FURTHER INFORMATION CONTACT: Jean M. Frane, Field and External 
Affairs Division (7506C), Office of Pesticide Programs, Environmental 
Protection Agency, Ariel Rios Building, 1200 Pennsylvania Ave., NW., 
Washington DC 20460; telephone: (703) 305-5944; and e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer or importer, or pesticide manufacturer. 
Potentially affected categories and entities may include but are not 
limited to:

------------------------------------------------------------------------
            Category                  NAICS Code           Examples
------------------------------------------------------------------------
Producers                         32531               Nitrogen
                                                       stabilizer
                                                       products
                                  32532               Pesticide products
                                  32561               Antimicrobial
                                                       products
Wholesalers                       42269               Antimicrobial
                                                       products
                                  42291               Pesticide products
------------------------------------------------------------------------

    This table is not exhaustive, but is intended as a guide to 
entities likely to be regulated by this action. The North American 
Industrial Classification System codes have been provided to assist you 
in determining whether this action might apply to certain entities. If 
you have questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Get Additional Information or Copies of Support Documents?

    1. Electronically. You may obtain electronic copies of this 
document and various support documents are available from the EPA Home 
page at http://www.epa.gov/. On the Home Page, select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.''
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-36195. The official records 
consists of the documents specifically referred to in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as confidential business information (CBI). The official record 
includes documents that are physically located in the docket, as well 
as documents that are referred to in those documents. The public 
version of the official record does not include any information claimed 
as CBI. The public version of this record, including printed versions 
of any electronic comments, is available for inspection in the Public 
Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 
#2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The PIRIB 
telephone number is (703) 305-5805.

II. EPA Proposal

    In the Federal Register of September 17, 1999 (64 FR 50672) (FRL-
5770-6), EPA issued a proposed rule entitled ``Registration 
Requirements for Antimicrobial Pesticide Products and Other Pesticide 
Regulatory Changes.'' The proposal was primarily directed at 
implementing provisions of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) requiring EPA to issue regulations streamlining 
its management of the registration process for antimicrobial 
pesticides, and the main body of the proposal addressed antimicrobial 
procedures and policies.
    At the same time, EPA chose to include additional proposals.
    1. EPA proposed to codify a statutory provision excluding from 
regulation under FIFRA certain liquid chemical sterilants. The effect 
of the statutory exclusion was to eliminate double jurisdiction over 
liquid chemical sterilants by EPA and the Food and Drug Administration 
(FDA).
    2. EPA proposed to exempt from FIFRA regulation under section 25(b) 
non-liquid chemical sterilants that met essentially the same criteria 
as those statutorily excluded. This proposal was intended to supplement 
the statutory exclusion to give FDA jurisdiction over all chemical 
sterilants for similar purposes.
    3. EPA proposed to permit consolidated applications for amendment 
of several products at one time, under prescribed conditions.
    4. EPA proposed to interpret a new provision of FIFRA defining 
certain nitrogen stabilizer products as pesticides, thus subjecting 
them to regulation under FIFRA.
    5. EPA proposed to reformat, clarify, and make minor revisions to 
its labeling regulations that affect all pesticide products, including 
antimicrobial pesticides.
    EPA is promulgating a final rule on the topics enumerated above 
separately from the main body of the antimicrobial proposal. EPA's 
decision is based partly on the fact that these proposals are general 
for all pesticides and are not limited to antimicrobial pesticides. 
Moreover, they were non-controversial and received little comment in 
proposal.
    With few exceptions, noted in Unit III. of this Preamble, EPA is 
adopting the changes as proposed.
    EPA is not at this time promulgating any of the core antimicrobial 
proposals, which were comprised of procedural regulations for 
registration, labeling requirements pertaining to the efficacy of 
public health products, and associated revisions to accommodate the new 
antimicrobial provisions.

III. Comments

    In this unit, EPA will discuss briefly the major comments received 
on the topics listed above and any resulting revisions. Of the 20 sets 
of comments received on the entire proposal, the vast majority were 
directed to the antimicrobial provisions. Most comments on the topics 
being promulgated today came from major trade associations and large 
producers of antimicrobial products. They were, by and large, editorial 
or clarifying. A

[[Page 64760]]

number of commenters also misconstrued EPA's proposals, or suggested 
revisions in areas that EPA did not propose to modify. Comments not 
discussed in the preamble are responded to in the docket.

A. Chemical Sterilants

    EPA proposed to codify the statutory provisions excluding from 
regulation liquid chemical sterilants intended for use on critical or 
semi-critical medical devices, and further proposed to exempt under the 
authority of section 25(b) FIFRA non-liquid sterilants for the same 
uses. To accommodate the statutory exclusion for liquid chemical 
sterilants, and others scattered throughout the regulations, EPA 
proposed to create a new Sec. 152.6 in which to locate all statutory 
exclusions from regulation. EPA also proposed to revise Sec. Sec. 152.8 
and 152.25 by moving existing statutory exclusions into the new 
Sec. 152.6. In addition, EPA would add the section 25(b) exemption for 
non-liquid chemical sterilants to existing Sec. 152.20, which contains 
exemptions for pesticides adequately regulated by another Federal 
agency. No comments were received on any of these proposals, and they 
are adopted as proposed.

B. Consolidation of Amendments

    EPA proposed to allow registrants of products who wish to make 
identical amendments to multiple registrations to do so with one 
application, provided that no data are needed to support the amendment. 
Although this situation occurs informally for some amendments, 
registrants had informed the Agency that it was not clear in the 
regulations that the practice was permitted. No comments were received 
on this proposal, and it is adopted as proposed.
    EPA emphasizes that consolidated amendments under this provision 
must be identical, and must not require supporting data. The types of 
amendments EPA envisions being most appropriate are labeling changes, 
such as revision of precautionary statements to add a specific type of 
statement. Another area where a consolidated application may be useful 
would be to accomplish EPA-requested changes made by notice to 
registrants. Changes in composition are unlikely to be eligible for 
consolidated applications because composition changes will generally 
not apply to multiple products.

C. Nitrogen Stabilizers

    FIFRA, as amended in 1996, generally subjected nitrogen stabilizers 
to FIFRA regulation by defining them as pesticides. EPA proposed an 
interpretation of the term ``nitrogen stabilizer'' that would codify 
the statutory definition and explain how the Agency would determine 
that a product was or was not a nitrogen stabilizer subject to FIFRA 
regulation. In proposed Sec. 152.6, EPA structured the requirement as 
an exclusion from regulation, since the statutory definition of 
nitrogen stabilizer is a loosely framed set of exclusions.
    In the final rule, EPA has incorporated all of the exclusion 
criteria that were clearly delineated in section 2(hh) of FIFRA, 
including specific chemicals that were excluded, and dates of 
commercial introduction of the nitrogen stabilizer. In the area of 
claims, where the statute was not explicit, EPA proposed a common sense 
interpretation of the types of claims that EPA would regard as nitrogen 
stabilization claims. EPA received two comments on its interpretation.
    The first commenter noted that, while the regulatory text is clear, 
EPA's preamble appeared to imply that products that make ammonia 
volatilization claims might be considered nitrogen stabilizers even 
though they do not act upon soil bacteria. The commenter requested 
clarification in the final rule. EPA emphasizes that unless a product 
functions by acting upon soil bacteria, it would not be regarded as a 
nitrogen stabilizer product upon examination by EPA. This point is 
clear in Sec. 152.6, so EPA has not revised the text.
    However, with the complex interactions affecting nitrogen uptake 
and utilization, it is not always possible to discern the mechanism of 
action of a product, particularly if a product makes claims that could 
otherwise be construed as nitrogen stabilizer claims. In its proposal, 
EPA identified types of claims that it would deem to be nitrogen 
stabilizer claims. Claims alone would not definitively identify a 
product as a nitrogen stabilizer, but in the absence of confirmation 
that the product does not act upon soil bacteria, claims that appear to 
be nitrogen stabilization claims would be a trigger for EPA evaluation 
of the product's pesticide status. By considering the claims along with 
the composition and mode of action of a product, EPA ultimately would 
be able to determine whether a product bearing such claims was a 
nitrogen stabilizer.
    Any product that makes what appear to be nitrogen stabilization 
claims as listed in Sec. 152.6 will be presumed in the first instance 
to be a nitrogen stabilizer. The producers of such products bear the 
burden of demonstrating that the product accomplishes the claimed 
effect without having an effect on soil bacteria.
    The second commenter noted that some vitamin-hormone horticultural 
products currently make claims that EPA might regard as nitrogen 
stabilization claims. The result, it was asserted, would be that 
products specifically excluded from FIFRA would be drawn in by virtue 
of the nitrogen-related claims. With respect to vitamin-hormone 
products, EPA believes such products do not contain ingredients that 
would achieve the effects of a nitrogen stabilizer, i.e, an effect upon 
soil bacteria leading to greater nitrogen availability to plants. EPA 
plant pathologists believe, based upon their experience, that vitamin-
hormone products contain no more than their names suggest--vitamins and 
hormones, which are not known to function as nitrogen stabilizers via 
effects upon soil bacteria. EPA has not revised the rule as a result of 
this comment.
    This same commenter raised a second concern, which EPA agrees has 
merit. Certain fungi known as mycorrhizae have a symbiotic relationship 
with plant roots in the soil and are believed to have an effect on 
macronutrient uptake into plants. Products containing mycorrhizae are 
sold to enhance such uptake, which might include nitrogen uptake. The 
effect is believed not to result from action on soil bacteria, although 
EPA has not evaluated such products. The significant difference between 
mycorrhizae and a nitrogen stabilizer as defined in Sec. 152.6 is that 
a mycorrhizae is a living organism, while a nitrogen stabilizer is a 
chemical substance. EPA has in the final rule revised Sec. 152.6(b)(1) 
to exclude living organisms, which should ensure that the presence of 
mycorrhizae does not itself make a product a nitrogen stabilizer within 
the meaning of the Act.

D. Labeling Revisions

    EPA proposed a number of minor revisions to its pesticide labeling 
regulations in 40 CFR part 156. EPA views these revisions as 
``housekeeping'' provisions, intended primarily to improve the 
structure of the regulations to make them more understandable to users, 
and to clarify some requirements currently in effect but not stated in 
the regulations. With one exception, EPA is adopting its proposal 
unchanged.
    1. First aid heading. The single area that EPA is revising as a 
result of comments concerns first aid statements. EPA proposed to 
require that the heading ``First Aid'' be used for all

[[Page 64761]]

products, instead of the current ``Statement of Practical Treatment.'' 
Agricultural product registrants who commented were concerned that they 
might be compelled to revise their labels for what they viewed as an 
unnecessarily rigid requirement They noted that the current ``Statement 
of Practical Treatment'' heading has been in use since 1975, and that 
agricultural users are familiar with the heading. EPA's research under 
the Consumer Labeling Initiative, on which its proposal was based, was 
limited to consumer products such as household cleaners, insecticides, 
and garden products. EPA agrees that the results may not be 
representative of agricultural product users, and has revised 
Sec. 156.68 to allow the use of either heading. EPA encourages the use 
of ``First Aid'' as the heading on consumer and residential/household 
products, because research conducted under the Agency's Consumer 
Labeling Initiative revealed that consumers understood the phrase 
``First Aid'' better than ``Statement of Practical Treatment.''
    2. Proposals adopted without change. Table 1 in this unit lists the 
EPA proposed revisions, which, after consideration of comments, the 
Agency is adopting without change.

                Table1.--Proposals Adopted Without Change
------------------------------------------------------------------------
             Proposed revision                         Change
------------------------------------------------------------------------
Reformatting and upgrading structure of     Human hazard and
 part 156                                    precautionary statements
                                             will be located in subpart
                                             D (Sec.  Sec.  156.60-
                                             156.79). Environmental
                                             hazard and precautionary
                                             statements will be located
                                             in subpart E(Sec.  Sec.
                                             156.80-156.99).
Signal word                                 Products in Toxicity
                                             Category IV will no longer
                                             be required to bear a
                                             signal word. The Child
                                             Hazard Warning is still
                                             required on such products.
Signal word                                 A product may not bear a
                                             signal word reflecting
                                             higher or lower toxicity
                                             than demonstrated by
                                             testing of the product as
                                             distributed and sold
Child Hazard Warning (Keep Out of Reach of  Variations on the standard
 Children)                                   statement may be approved
                                             or required by EPA
Use dilution statements                     Products may bear additional
                                             information in the
                                             precautionary statements
                                             and in the first aid
                                             instructions concerning the
                                             product as diluted for use.
                                             These instructions augment,
                                             but do not replace,
                                             statements concerning the
                                             product as sold or
                                             distributed.
First Aid Statement                         All products assigned to
                                             Toxicity Category I by any
                                             route of exposure would be
                                             required to bear a First
                                             Aid or Statement of
                                             Practical Treatment on the
                                             front panel of the label.
                                             (Products assigned to
                                             Toxicity Category II or III
                                             could bear the statement on
                                             any panel of the label.)
------------------------------------------------------------------------

    3. Additional comments received. In proposing to upgrade the 
codified structure, EPA included the entire content of the new subparts 
for convenience, including many provisions for which no substantive 
change was proposed. Nonetheless, some commenters suggested changes in 
addition to those EPA proposed. EPA has not changed the rule based on 
those comments. Detailed responses to all comments are contained in the 
public docket for this rulemaking, OPP-36195, at the location given 
under ADDRESSES.
    The thrust of several comments was that EPA regulations should be 
made consistent with the Agency's Label Review Manual (LRM). Commenters 
generally ascribed to the LRM more regulatory standing than it has.
    Because of the variety of pesticide products, purposes and uses, it 
is impossible for EPA to describe in regulatory form the majority of 
the individual labeling decisions that are required under the licensing 
scheme of FIFRA. EPA's labeling regulations in part 156 are of 
necessity general, serving as a framework for individual decisions and 
allowing flexibility for both the Agency and applicants to tailor 
actual labeling to the extent practicable to a particular product and 
its uses. The labeling regulations clearly specify in many cases that 
the statements provided are examples-- representative or typical of the 
types of statements that EPA may require.
    The LRM is a non-regulatory guidance document to assist applicants 
and the Agency in developing and reviewing labeling submitted for 
approval. It reflects, but does not supersede or change the underlying 
regulations. Its purpose is to elaborate on how the labeling 
regulations in part 156 can be applied in individual product decisions. 
EPA does not revise its regulations to conform to the LRM; rather, the 
LRM reflects the regulations.

IV. Correction

    In its proposal, EPA intended to reorganize existing material 
concerning statutory exceptions, now scattered both in FIFRA and its 
regulations, into a single location, new Sec. 152.6. To accomplish 
this, EPA proposed to move material from existing Sec. Sec. 152.8, 
152.20, and 152.25 to the new section. However, EPA inadvertently 
proposed to remove material from Sec. 152.8 without concurrently 
including it in new Sec. 152.6. The text in question concerned the 
statutory exclusion as ``plant regulators'' of plant nutrients, trace 
elements, plant inoculants and soil amendments. In this final rule, EPA 
has corrected this omission. Former paragraphs 152.8(c)(1), (2) and (3) 
now appear in Sec. 152.6(g).

V. Summary of Sections Affected

    Table 2 in this unit summarizes the sections in the Code of Federal 
Regulation that are affected by this final rule, and the nature of the 
change.

      Table 2.--CFR Parts and Sections Affected by this Final Rule.
------------------------------------------------------------------------
   CFR part or section number            Title              Action
------------------------------------------------------------------------
152.6                             Substances          New. Material
                                   excluded from       incorporated from
                                   regulation by       Sec.  Sec.  152.8
                                   FIFRA               , 152.20 and
                                                       152.25; Chemical
                                                       sterilants added;
                                                       nitrogen
                                                       stabilizers
                                                       added.
152.8                             Products that are   Material moved to
                                   not pesticides      Sec.  152.6.
                                   because they are
                                   not for use
                                   against pests

[[Page 64762]]

 
152.20                            Exemptions for      Material moved to
                                   pesticides          Sec.  152.6;
                                   regulated by        chemical
                                   another Federal     sterilants added
                                   agency
152.25                            Exemptions for      Material moved to
                                   pesticides of a     Sec.  152.6
                                   character not
                                   requiring FIFRA
                                   regulation
152.44                            Application for     Clarification and
                                   amended             reformatting
                                   registration
156.10                            Labeling            Material moved to
                                   requirements        new subparts D
                                                       and E; conforming
                                                       changes
Part 156, subpart D (Sec.  Sec.   Human Hazard and    Reorganized
 156.60-156.78)                    Precautionary       material from
                                   Statements          Sec.  156.10. New
                                                       material added.
Part 156, subpart E (Sec.  Sec.   Environmental       Reorganized
 156.80-156 85)                    Hazards and         material from
                                   Precautionary       Sec.  156.10. No
                                   Statements          change in
                                                       substance.
------------------------------------------------------------------------

VI. Implementation of this Rule

    The revisions being promulgated today will be (or have been) 
implemented as described in this unit. Portions of the regulations 
being promulgated today have been in place for some time, and are 
included to provide context for the reorganized and reformatted 
elements and for the convenience of readers.
    The exclusion for liquid chemical sterilants was effective on 
August 3, 1996, when FIFRA was amended by the Food Quality Protection 
Act (FQPA). Since August 3, 1996, FDA has been responsible for the 
regulation of liquid chemical sterilants described by Sec. 152.6. 
Codifying the exclusion is merely for the convenience of sterilant 
producers, and is not required for the exclusion to be effective.
    The companion exemption for non-liquid chemical sterilants is self-
implementing. The exemption removes the dual jurisdiction which has 
existed for these products, and which is being relinquished by EPA. 
After the effective date of this rule, non-liquid chemical sterilants 
described in Sec. 152.20 will be regulated solely by FDA.
    The provisions pertaining to nitrogen stabilizers were effective on 
August 3, 1996, when nitrogen stabilizers were made subject to FIFRA 
regulation. Although EPA is unaware of any products currently being 
marketed that are subject to this rule, it will identify such products 
through its compliance and inspection initiatives in the marketplace, 
and will apply the interpretation in Sec. 152.6 to determine whether 
the products are subject to FIFRA regulation.
    The provision for consolidated amendment applications is self-
implementing. Applications that meet the criteria for consolidated 
amendments in Sec. 152.44 may be submitted at any time.
    Labeling provisions will be implemented by the Agency on a case-by-
case basis, as applications for registration, amended registration, or 
reregistration are submitted. No specific action by any registrant is 
required because of the issuance of this final rule. Registrants who 
wish to avail themselves of any of the provisions must submit an 
application for amended registration to the Agency, in accordance with 
normal application procedures.

VII. Statutory Requirements

    In accordance with section 25 of FIFRA, a draft of this final rule 
was provided to the Secretary of Agriculture and to appropriate 
Committees of Congress. Neither had comments on the final rule. The 
FIFRA Scientific Advisory Panel previously had waived its review of the 
proposed and final rules.

VIII. Regulatory Assessment Requirements

A. Executive Order 12866

    Under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), this action is not a 
``significant regulatory action'' subject to review by the Office of 
Management and Budget (OMB). There are no costs or burdens associated 
with this rule. In most cases, this final rule provides regulatory 
relief or flexibility for pesticide producers. In the case of nitrogen 
stabilizer products, where the statute and this final rule potentially 
subject products to FIFRA regulation, EPA is not aware of any affected 
entities, and consequently has not identified or evaluated any costs. 
The Economic Analysis for the proposed rule identified costs and 
burdens solely associated with the antimicrobial provisions, which are 
being promulgated separately.

B. Regulatory Flexibility Act

    Under section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 
601 et seq.), the Agency hereby certifies that this action will not 
have a significant economic impact on a substantial number of small 
entities. Today's rule for the most part clarifies and reformats 
existing labeling requirements. The provisions addressing nitrogen 
stabilizers potentially affect small businesses, but EPA is not aware 
of any business entities that currently produce nitrogen stabilizer 
products subject to regulation under the provisions of the rule.
    Information relating to this determination is provided upon request 
to the Chief Counsel for Advocacy of the Small Business Administration, 
and is included in the docket for this rulemaking. No comments were 
received on this determination in response to the proposal.

C. Paperwork Reduction Act

    This regulatory action does not contain any information collection 
requirements requiring approval by the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

D. Unfunded Mandates Reform Act

    Under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) 
(Pub. L. 104-4). This action does not contain a Federal mandate that 
may result in expenditures of $100 million or more for State, local, 
and tribal governments, in the aggregate, or the private sector in any 
one year. The cost associated with this action are described in Unit 
VI.A. Therefore, this action is not subject to the requirements of 
sections 202 and 205 of the UMRA.

E. Environmental Justice

    Under Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994), the Agency has considered 
environmental justice related issues with regard to the potential 
impacts of this action on the environmental and health conditions in 
low-income and

[[Page 64763]]

minority communities. This rule does not affect minority or low income 
populations.

F. Children's Health Protection

    This action is not an economically significant action (i.e., it is 
not expected to have an annual adverse impact of $100 million or more) 
that would require additional OMB review under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997).

G. Federalism

    Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999), requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.''
    This final rule does not have federalism implications. It will not 
have substantial direct effects on the States, on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of governments 
specified in Executive Order 13132. Thus, Executive Order 13132 does 
not apply to this rule.

H. Consultation and Coordination with Indian Tribal Governments

    This rule does not have tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This does 
not significantly or uniquely affect the communities of Indian trial 
governments, nor does it involve or impose any requirements that affect 
Indian Tribes. Accordingly, the requirements of section 3(b) of 
Executive Order 13084, entitled Consultation and Coordination with 
Indian Tribal Governments (63 FR 276755, May 19, 1998), do not apply to 
this rule. Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000), which took effect on January 6, 2001, revokes Executive Order 
13084 as of that date. EPA developed this rulemaking, however, during 
the period when Executive Order 13084 was in effect; thus, EPA 
addressed tribal considerations under Executive Order 13084. For the 
same reasons stated for Executive Order 13084, the requirements of 
Executive Order 10175 do not apply to this rule either.

I. Energy Effects

    This rule is not subject to Executive Order 13211, entitled Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001) because it is not a 
significant regulatory action under Executive Order 12866.

IX. Submission to Congress and the General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business 
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a 
report containing this rule and other required information to the U.S. 
Senate, the U.S. House of Representatives, and the Comptroller General 
of the General Accounting Office prior to publication of this rule in 
today's Federal Register. This is not a major rule as defined by 5 
U.S.C. 804(2).

List of Subjects

40 CFR Part 152

    Environmental protection, Administrative practice and procedure, 
Pesticides and pests, Reporting and recordkeeping requirements

40 CFR Part 156

    Environmental protection, Labeling, Occupational safety and health, 
Pesticides and pests, Reporting and recordkeeping requirements


    Dated: November 29, 2001.
Christine T. Whitman,
Administrator.

    Therefore, 40 CFR chapter I, subchapter E is amended as follows:

PART 152--[AMENDED]

    1. In part 152:
    a. The authority citation for part 152 continues to read as 
follows:

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


    b. Section 152.6 is added, to read as follows:


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. ``Sterilant'' is 
defined in Sec. 156.441 of this chapter.
    (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.

[[Page 64764]]

    (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
    (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.


Sec. 152.8  [Amended]

    c. In Sec. 152.8, by removing paragraphs (a), (b), (c) introductory 
text, (c)(2), (c)(3) and (c)(4), and redesignating paragraph (c)(1) as 
paragraph (a) and paragraph (d) as paragraph (b).

    d. In Sec. 152.20, by revising paragraph (b) to read as follows:


Sec. 152.20  Exemptions for pesticides regulated by another Federal 
agency.

* * * * *
    (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.


Sec. 152.25  [Amended]

    e. Section 152.25 is amended by removing paragraph (d) and 
redesignating paragraphs (e) through (g) as (d) through (f).

    f. Section 152.44 is amended by removing paragraph (b)(3), 
redesignating paragraph (b)(4) as paragraph (b)(3), and adding new 
paragraph (c), to read as follows:


Sec. 152.44  Application for amended registration.

* * * * *
    (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.

PART 156--[AMENDED]

    2. In part 156:

    a. The authority citation for part 156 continues to read as 
follows:

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

    b. In Sec. 156.10, by revising paragraph (a)(1)(vii) and removing 
paragraph (h), to read as follows:


Sec. 156.10  Labeling requirements.

    (a) * * *
    (1) * * *
    (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.
* * * * *

    c. By adding new subpart D, to read as follows:
Subpart D--Human Hazard and Precautionary Statements
Sec.
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.

[[Page 64765]]

Subpart D--Human Hazard and Precautionary Statements


Sec. 156.60  General.

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

              Type Sizes for Front Panel Warning Statements
------------------------------------------------------------------------
                                                Point Size
    Size of Label Front Panel    ---------------------------------------
         (Square Inches)           Signal Word (All      Child Hazard
                                   Capital Letters)         Warning
------------------------------------------------------------------------
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 mg/kg  >500 thru 5,000 mg/ >5,000 mg/kg
                                   including 50 mg/                        kg
                                   kg
Dermal LD50.....................  Up to and           >200 thru 2000 mg/  >2000 thru 20,000   >20,000 mg/kg
                                   including 200 mg/   kg                  mg/kg
                                   kg
Inhalation LC50.................  Up to and           >0.2 thru 2 mg/     >2 thru 20 mg/      >20 mg/liter
                                   including 0.2 mg/   liter               liter
                                   liter
Eye irritation..................  Corrosive; corneal  Corneal opacity     No corneal          No irritation
                                   opacity not         reversible within   opacity;
                                   reversible within   7 days;             irritation
                                   7 days              irritation          reversible within
                                                       persisting for 7    7 days
                                                       days
Skin irritation.................  Corrosive           Severe irritation   Moderate            Mild or slight
                                                       at 72 hours         irritation at 72    irritation at 72
                                                                           hours               hours
----------------------------------------------------------------------------------------------------------------

Sec. 156.64  Signal word.

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

[[Page 64766]]

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.''
    (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.
----------------------------------------------------------------------------------------------------------------


[[Page 64767]]

Sec. 156.78  Precautionary statements for physical or chemical hazards.

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

            Flammability Statements for Pressurized Products
------------------------------------------------------------------------
  Flash point/flame extension of product     Required labeling statement
------------------------------------------------------------------------
--Flash point at or below 20 deg. F         Extremely flammable.
                                             Contents under pressure.
                                             Keep away from fire,
                                             sparks, and heated
                                             surfaces. Do not puncture
                                             or incinerate container.
                                             Exposure to temperatures
                                             above 130 deg. F may cause
                                             bursting.
      OR
 
--Flashback at any valve opening
------------------------------------------------------------------------
--Flash point >20 deg. F to 80 deg. F       Flammable. Contents under
                                             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

    d. By adding new subpart E, to read as follows:
Subpart E--Environmental Hazard and Precautionary Statements
Sec.
156.80  General.
156.85  Non-target organisms.

Subpart E--Environmental Hazard and Precautionary Statements


Sec. 156.80  General.

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


Sec. 156.85  Non-target organisms.

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

[[Page 64768]]

    (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.''

[FR Doc. 01-30820 Filed 12-13-01; 8:45 am]
BILLING CODE 6560-50-S