[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]
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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.
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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
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Proposed revision Change
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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.)
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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.
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CFR part or section number Title Action
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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.
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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