Pesticides; Data Requirements for Conventional Chemicals

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: October 26, 2007 (Volume 72, Number 207)]
[Rules and Regulations]
[Page 60933-60988]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26oc07-14]
[[Page 60934]]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 158
[EPA-HQ-OPP-2004-0387; FRL-8106-5]
RIN 2070-AC12

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: EPA is updating its data requirements in part 158 of Title 40
in the Code of Federal Regulations for the registration of conventional
pesticide products. As scientific understanding of potential hazards
posed by pesticides has evolved, some data requirements have been
imposed on a case-by-case basis but not codified since 1984. Besides
providing the regulated community with clearer and more transparent
information, the updated data requirements will enhance the development
of health and environmental data to conduct scientifically sound
chemical hazard/risk assessments to protect human health and the
environment. In a companion final rule also being promulgated today,
EPA is making technical changes arising from this final rule.

DATES: This final rule is effective on December 26, 2007.

ADDRESSES: EPA has established a docket for this action under Docket
identification number EPA-HQ-OPP-2004-0387. All documents in the docket
are listed on the regulations.gov web site. Although listed in the
index, some information is not publicly available, i.e., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either electronically through
http://www.regulations.gov or in hard copy at the Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P), Room S-4400, One Potomac Yard
(South Building), 2777 S. Crystal Drive, Arlington, VA 22202. This
Docket is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: For information on the data
requirements for ecological effects and environmental fate, contact:
Ann Stavola, Field and External Affairs Division (FEAD), Office of
Pesticide Programs (OPP) (7506P), Environmental Protection Agency, 1200
Pennsylvania Avenue NW, Washington, DC 20460; telephone number: (703)
305-5354; fax number: (703) 305-5884; e-mail address:
stavola.ann@epa.gov . For all other questions, contact: Vera Au, FEAD
(7506P), OPP, Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW., Washington, DC 20460-0001; telephone number:(703) 308-9069; fax
number: (703) 305-5884; e-mail address: au.vera@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are a
producer or registrant of a pesticide product, including agricultural,
residential, and industrial, but not including antimicrobial
pesticides, biochemical pesticides, or microbial pesticides.
This action may also affect any person or company who might
petition the Agency for new tolerances, hold a pesticide registration
with existing tolerances, or any person or company who is interested in
obtaining or retaining a tolerance in the absence of a registration,
that is, an import tolerance. This latter group may include pesticide
manufacturers or formulators, importers of food, grower groups, or any
person or company who seeks a tolerance. Potentially affected entities
may include, but are not limited to:
Chemical Producers (NAICS 32532), e.g., pesticide manufacturers or
formulators of pesticide products, importers or any person or company
who seeks to register a pesticide or to obtain a tolerance for a pesticide.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
code has been provided to assist you and others in determining whether
this action might apply to certain entities. To determine whether you
or your business may be affected by this action, you should carefully
examine the applicability provisions in Unit II.C. If you have any
questions regarding the applicability of this action to a particular
entity, consult the persons listed under FOR FURTHER INFORMATION CONTACT.

II. Background

A. What Action is the Agency Taking?

The Agency is updating and revising its data requirements for the
registration of conventional pesticide products. The data requirements
for the registration of antimicrobial products, product performance,
and biochemical and microbial pesticides are not being revised in this
action. EPA issued a proposed rule addressing data requirements for
biochemical and microbial pesticides on March 8, 2006 (71 FR 12072).
Antimicrobial data requirements have been moved to new part 161.
As scientific understanding of potential hazards posed by
pesticides has evolved, some data requirements have been imposed on a
case-by-case basis but not codified since 1984. By codifying the data
requirements that have been applied on a case-by-case basis, the Agency
believes the pesticide industry and other partners in the regulated
community will be better prepared for the pesticide registration process.

B. What is the Agency's Authority for Taking this Action?

This rule is issued under the authority of FIFRA sections 3, 4, 5,
12, and 25; and FFDCA section 408.

C. Is this Final Rule Applicable to Antimicrobial Pesticides Products?

In current part 158, the data requirements cover both conventional
and antimicrobial pesticides. Biochemical and microbial pesticides are
set apart at Sec. 158.690 and Sec. 158.740. EPA proposed to limit the
applicability of revised part 158 to conventional chemicals in
anticipation of additional revisions tailored to biochemical,
microbial, and antimicrobial pesticides. EPA received no key comments
concerning the proposed limited applicability of part 158, and
accordingly, EPA is adopting its proposed scope. Elsewhere in today's
Federal Register, EPA is promulgating a final rule establishing data
requirements for biochemical and microbial pesticides. However, EPA has
not yet issued a proposed rule that would create separate data
requirements tailored to antimicrobial pesticides.
If EPA were to maintain the proposed rule's exclusive application
to conventional pesticides, the result would be that there would be no
data requirements established by regulation for antimicrobial
pesticides. Applicants would have to rely solely on consultations with
EPA to determine the data requirements for their antimicrobial products
without the benefit of regulatory data requirements. However, EPA has
decided to preserve the current data requirements to provide regulatory
coverage for antimicrobial

[[Page 60935]]

pesticides until the Agency can propose and promulgate a final
regulation. To accomplish this, EPA has transferred intact the current
data requirements of part 158 into a new part 161, entitled Data
Requirements for Antimicrobial Pesticides. New part 161 will only apply
to antimicrobial pesticides. Part 158 as promulgated today will only
apply to conventional pesticides.
Part 161 is intended to be transitional and will be revoked upon
the effective date of a replacement regulation tailored to
antimicrobial pesticide data requirements. EPA recognizes that current
data requirements of this transitional part are not optimal for
registrants of antimicrobial pesticides. Because the 1984 data
requirements were developed primarily to address agricultural
chemicals, it has been difficult for antimicrobial registrants to
discern data requirements that apply to antimicrobial products. This
difficulty will not be corrected in simply transferring the current
requirements to a new location. As a result, applicants should continue
to routinely consult with the Agency to interpret the requirements of
new part 161 as they apply to antimicrobial products. EPA supports and
encourages the consultation process for all applicants, as the data
requirements are highly dependent on pesticide type and use pattern.
EPA is fully committed to the development of tailored data requirements
for antimicrobial pesticides and expects to issue a proposed rule by
the end of 2008.

III. Discussion of the March 11, 2005, Notice of Proposed Rulemaking (NPRM)

EPA published an NPRM on March 11, 2005 (70 FR 12275), proposing to
update and revise its data requirements for the registration of
conventional pesticide products in 40 CFR part 158. The data
requirements identify the types of information that EPA needs to:
determine that a pesticide product can be registered; issue a tolerance
or tolerance exemption for pesticide residues in food; or allow the
experimental use of the pesticide. The proposed rule was intended to:
improve the scientific basis for pesticide decisions; update the
requirements last codified in 1984; and reorganize part 158 to improve
usability. These efforts will help protect human health and the
environment by providing an up-to-date scientific framework for
identifying and assessing the risks of conventional pesticides for use
in the United States. The closing date of the 90-day comment period for
the NPRM was June 9, 2005. The comment period was extended to September
7, 2005, to allow stakeholders additional time to assess the impact of
the proposed revisions on their particular situations and prepare their
comments (40 FR 33414). One hundred seven public comments were filed in
Docket ID OPP-2004-0387. For a detailed response to comments, refer to
Docket ID OPP-2004-0387. In addition, EPA convened a 2-day public
workshop in Arlington, Virginia, to explain the provisions of the NPRM
on May 3-4, 2005. There were 126 attendees at the public workshop.

IV. Discussion of Key Comments on the Order of Subparts

EPA's proposed rule structured the subparts of part 158 to match
the original sequence of guidelines. A number of commenters found this
structure confusing, and one commenter submitted an alternative
structure, which was considered along with other alternative
structures. EPA agrees with commenters that the current relatively
random structure is not ideal for the average registrant who is seeking
to determine the data requirements that apply to his product.
Accordingly, in the final rule, EPA is restructuring the subparts to be
more user-friendly.
EPA reasons that the users most in need of clarity are the
infrequent, follow-on applicants, whose actual data requirements are in
many cases limited to end-use product data of various types. In
general, larger pesticide companies that routinely submit complex new
chemical/new use applications and petitions for tolerance are
responsible for the bulk of toxicology, residue chemistry, ecological
effects and environmental fate data developed using the pure active
ingredient (PAI), technical grade of active ingredient (TGAI) or the
typical end-use product (TEP). In the case of exposure data, a variety
of industry task forces, again primarily comprising large companies,
are developing surrogate databases, so that newly generated data may
not be necessary for many exposure scenarios.
In all these cases, FIFRA sec. 3(c)(1)(F) and its regulations in
part 152 provide for the use of data developed by others, either under
the formulators' exemption of section 3(c)(2)(D), or with appropriate
permission or compensation offers. These provisions were put in place
specifically to obviate the need for duplicate data development while
protecting the rights of data submitters. Thus, smaller follow-on or
me-too registrants often are required to generate only product-specific
chemistry data, acute toxicity data, and efficacy data (generally
designated in part 158 tables with End Use Product (EP) as the test
substance). These applicants will benefit by the restructured part 158
so that they don't have to search for applicable data requirements by
sifting through voluminous data requirements that may be satisfied by
formulators' exemption, citation or offer-to-pay procedures.
EPA believes that major registrants will not be disrupted by a
restructuring of the subparts because they are familiar with the data
requirements, and, in any case, should be able to easily find the data
requirement applicable to their product or petition in the current
structure. Accordingly, EPA has restructured the subparts to place
those data requirements applicable to the bulk of applications (new
end-use products and me-too products) towards the beginning of part 158.
The resulting order does not correspond to the previous guidelines
issued in 1982 et seq. (upon which the order of the proposed rule was
based), or the sequence of the OPPTS Harmonized Guidelines. It is not
critical that they do, as the tables refer to the appropriate
individual Guideline for each data requirement.
The structure of part 158 in the final rule proceeds from product
chemistry to efficacy to hazard/toxicity requirements of all types
(human health, ecological toxicity) then exposure data requirements of
all types (pre- and post-application human exposures, exposure to
residues in food), and environmental fate, which overlap human exposure
through drinking water, and ecological exposure, and spray drift. EPA
has reserved subparts among these various segments for future additions
on the same topic. EPA has also consolidated subparts addressing the
same topics: plant protection data requirements (proposed as subpart J)
have been incorporated into new subpart G (ecological effects data
requirements) as have terrestrial and aquatic nontarget organisms data
requirements (proposed as subpart E).
Finally, EPA intends that freestanding data requirements subparts
such as biochemical pesticides, microbial pesticides, and antimicrobial
pesticides be located at the end of the series. Product performance
requirements, which span all categories of pesticides, would at present
remain a separate subpart near the beginning of the series. In the
proposed rule, EPA had reserved subpart P for Pesticide Management and
Disposal but has removed the topic from the final rule while reserving
subpart P. At present, EPA has no plans to develop data requirements
specific to disposal. If EPA does so in the future, it will

[[Page 60936]]

determine where such requirements should be located.
EPA has placed data requirements for experimental use permits in
subpart C of part 158. EPA eliminated the current use of brackets in
each discipline to indicate which data requirements applied to an
experimental use permit (see Unit VII.).
The final structure of part 158 is as follows:
Subpart A General provisions
Subpart B How to use the data tables
Subpart C Experimental use permits
Subpart D Product chemistry
Subpart E Product performance
Subpart F Toxicology
Subpart G Ecological effects [comprising aquatic, terrestrial and
plant species]
Subparts H - I [Reserved]
Subpart J [Reserved] [Plant protection has been consolidated into subpart G]
Subpart K Human exposure [comprising pre-application and post-
application exposure]
Subpart L Spray drift
Subpart M [Reserved]
Subpart N Environmental fate
Subpart O Residue chemistry
Subparts P - T [Reserved]
Subpart U Biochemical pesticides
Subpart V Microbial pesticides
Subpart W Antimicrobial pesticides
Subparts X - Z [Reserved]

V. Discussion of Key Comments on General Provisions of Part 158 (Subpart A)

A. Subpart A

EPA proposed revising subpart A by adding new material, deleting
some portions, and revising the portions that were retained or
relocated. The new material included definitions for ``applicant'' and
``registration,'' with references to definitions in the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug and Cosmetic Act (FFDCA) that apply to part 158. Deletions
from subpart A include: timing of the imposition of data requirements;
flexibility of the data requirements; consultation with the Agency;
agricultural versus non-agricultural pesticides; and biochemical and
microbial pesticides.
EPA proposed deleting the section on minor uses but based on the
comments and subsequent review, the Agency has in the final rule
retained portions of the minor use section with an introductory
paragraph. The section on the formulators' exemption was updated and
relocated to 40 CFR part 152, subpart E.

B. Format for Data Submissions

EPA proposed minor revisions to Sec. 158.32, describing how data
are to be formatted for submission to EPA. Commenters supported
revising Pesticide Registration (PR) Notice 86-5 to clarify provisions
and avoid rejection of data for formatting reasons; one commenter also
suggested integrating formatting guidance from PR 86-5 with Sec.
158.32 in the final rule. The Agency has begun the process of updating
the guidance in PR Notice 86-5 to further clarify the submission
process. The improved guidance, together with consultation with the
Agency, should help reduce the formatting conflicts. EPA will provide
the public an opportunity to comment on the proposed revisions to PR
86-5. Since the details of the revisions are still underway, EPA has
not changed the final rule.

C. Confidential Business Information

EPA proposed a number of minor revisions to Sec. 158.33 concerning
requirements for identification of and Agency treatment of confidential
business information (CBI) under FIFRA sec. 10. These revisions were
intended to clarify the provisions governing the Agency's ability to
release information, and to bring the regulations in line with a court
decision (District Court for the District of Columbia in NCAP v.
Browner, 941 F.Supp. 197, 201 (D.D.C. 1996) supporting broader release
of information to the public.
EPA received four comments concerning these proposed revisions, all
from industry trade organizations. In general, the commenters disputed
the Agency's positions or interpretations of the status of certain
types of information as non-confidential (and therefore eligible for
disclosure). One commenter misunderstood the provisions of FIFRA sec.
10 and based his comments upon an erroneous conception. EPA disagrees
with all commenters and made no revisions in the final rule. EPA
intends to abide by the Court decision which supports the Agency's
interpretation of FIFRA sec. 10. EPA has responded to all comments in
its Response to Comments document in the docket for this rule.
There were no comments on the confidentiality claims for plant-
incorporated protectant information or on releasing information to
state and foreign governments with consent.

D. Flagging Requirements

EPA proposed to revise the flagging requirements by updating and
clarifying the criteria by:
• Reducing the number of study criteria from 11 to 7 by
combining certain studies under one criterion;
• Combining reproductive, prenatal developmental toxicity
and developmental neurotoxicity under one criterion to reflect the
focus on infants and children.
Commenters requested clarification on the criteria and suggested
the revisions would increase the burden to registrants. All of the
listed flagging criteria need not apply to a toxicology study. If any
of the criteria listed are applicable to the study, then the
corresponding criterion number is to be included in the flagging
statement submitted with the study. In the proposed rule, the Agency
acknowledged that the revisions could flag more studies but this was
expected because of the new types of toxicity studies to further
protect infants and children. EPA made no revisions to the flagging
requirements in the final rule. EPA has responded to comments in its
Response to Comments document in the docket for this rule.

E. Data Waivers

EPA proposed reformatting the waiver process while retaining the
provisions. Several commenters expressed their concerns about clarity,
timelines and organization of information for waiver requests and made
several suggestions. EPA refined data requirements and test notes to
help the registrant determine if a waiver request is in order.
Applicants are encouraged to discuss the waiver with the Agency before
developing and submitting supporting data, information, or other
materials. The Agency is committed to timely decisions and notification
of the applicant. Organizational changes that were proposed will be
retained for the final rule. EPA has responded to comments in its
Response to Comments document in the docket for this rule.

F. Formulators' Exemption

EPA proposed to remove or revise provisions in part 158 that
directly or indirectly arise from the statutory formulators' exemption
of FIFRA sec. 3(c)(2)(D). First, EPA proposed to remove language in
Sec. 158.50 pertaining to the statutory formulators' exemption.
Second, EPA proposed removing the asterisks denoting the application of
the formulators' exemption to product chemistry and toxicology data
requirements.
A number of commenters objected to the removal of formulators'
exemption language, and others were confused by the removal of the
asterisks. It is clear that commenters are confused by the distinction
between the array of data that the Agency must have to determine
whether a pesticide may be registered (the data requirements of part
158), and the means by which those data requirements are satisfied (the
data citation and compensation provisions of part 152, subpart E,
including the

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formulators' exemption). In short, part 158 specifies the ``what'' and
part 152 specifies the ``how'' of data requirements.
The primary purpose of part 158 is to specify the data requirements
pertaining to a pesticide product. Part 158 was never intended to serve
the broader purpose of specifying the various means by which an
individual applicant can legally satisfy the data requirements: that is
the purpose of the data compensation provisions of part 152. Part 152
explains all of the means of satisfying a data requirement specified in
part 158, including submitting new data, citing existing data, citing
to public literature, obtaining a waiver, or claiming eligibility for
the formulators' exemption. EPA believes that it should reinforce this
distinction by removing from part 158 what is actually incomplete
information about the formulators' exemption.
Eligibility for the formulators' exemption is not a function of a
data requirement. Rather, eligibility depends on the purchase of a
registered product for incorporation into another product. The 1984
regulations erred in attempting to apply the formulators' exemption to
specific product chemistry and acute toxicology requirements by means
of the asterisk notation. First, the manner in which the asterisks were
displayed was such that it was not clear precisely when the
formulators' exemption did and did not excuse an applicant from the
requirement to submit data. Further, it was unclear because it
potentially conveyed the notion that the data requirement need not be
satisfied. The fact that certain data need not be submitted or cited by
an applicant eligible for the formulators' exemption does not mean that
those data are not necessary to support the registration of the
product, merely that the data requirement has been satisfied by another
means. Usually the requirement has been satisfied by submission of data
by the producer of the registered TGAI or manufacturing use product
(MP) that the applicant purchases.
Additionally, maintaining information on the formulators' exemption
in two locations in the Code of Federal Regulations is administratively
cumbersome. As one commenter noted, the statute has been revised since
both of these regulations were issued, and neither Sec. 152.85 nor
Sec. 158.50 is accurate or complete. For this reason, EPA believes it
is important to consolidate the formulators' exemption language in a
single location.
All commenters correctly pointed out that although EPA indicated in
the preamble that the formulators' exemption text of Sec. 158.50 was
to be relocated to part 152, no proposed regulatory language was
included. EPA agrees that it did not include in the proposal the actual
regulatory text that would be incorporated into part 152. In a
companion final rule making technical changes, and which is published
elsewhere in this issue of the Federal Register, EPA has included the
revised language, which would incorporate the provisions of Sec.
158.50 into Sec. 152.85 with needed conforming text changes. EPA has
also corrected Sec. 152.85 to reflect current FIFRA sec. 3(c)(2)(D),
as amended in 1988. Except where required as a result of these
statutory amendments, EPA has made no substantive change to the
exemption or EPA's interpretation of its applicability.
Although EPA believes that the formulators'exemption should
properly be located in part 152 together with other provisions
concerning submission or citation of data, the Agency recognizes the
value of referring to the provisions of part 152 in part 158.
Accordingly, EPA has revised Sec. 158.70(a), by including a new
paragraph (1) which explains that the provisions of part 158 should be
read in conjunction with those of part 152, subpart E.

G. Minor Uses

EPA proposed to delete material in Sec. 158.60 concerning minor
uses. Minor use policies in existence in 1984 and information in
anticipation of reregistration needs for data were included in original
part 158. The information is by no means complete concerning EPA
policies on minor uses, which have since expanded by statute.
Nonetheless, several commenters wanted EPA to retain the information in
paragraphs (a)(2) and (3). EPA has in the final rule retained
paragraphs (a)(2) and (3), but has removed the remaining material and
renumbered those paragraphs. The paragraphs being deleted have been
superseded (the definition in paragraph (a)), are guidance only
(paragraphs (a)(1) and (b)), or are covered by regulations elsewhere
(paragraph (a)(4)).

H. Weight-of-Evidence Approach

The weight-of-evidence approach is referenced in part 158 under
several disciplines. The approach requires a critical analysis of the
entire body of available data for consistency and biological
plausibility. Some considerations in this approach are listed below:
• Sufficiency of data. Studies that completely characterize
both the effects and exposure of the agent have more credibility and
support than studies that contain data gaps.
• Quality of the data. Potentially relevant studies are
judged for quality and studies of high quality are given more weight
than those of lower quality.
• Evidence of causality. The degree of correlation between the
presence of an agent and some adverse effect is an important consideration.
• Corroborative information. Supplementary information
relevant to the conclusions reached in the assessment is incorporated,
e.g., studies demonstrating agreement between model predictions and
observed effects.
The weight-of-evidence considers the kinds of evidence available, how
they fit together in drawing conclusions, and significant issues/
strengths/limitations of the data and conclusions. Weight-of-evidence
is not to be interpreted as simply tallying the number of positive or
negative studies.
In the case of the developmental neurotoxicity (DNT) study, such a
weight of the evidence approach is used when evaluating:
1. Treatment-related neurological effects in adult animal studies,
such as:
• Clinical signs of neurotoxicity
• Neuropathology
• Functional or behavioral effects
2. Treatment-related neurological effects in developing animals,
following pre- and/or postnatal exposure, such as:
• Nervous system malformations or neuropathy
• Brain weight changes in offspring
• Functional or behavioral changes in the offspring
3. Causative association between exposures and adverse neurological
effects in human epidemiological studies
4. A mechanism that is associated with adverse effects on the
development of the nervous system, such as:
• SAR relationship to known neurotoxicants
• Altered neuroreceptor or neurotransmitter responses
A compound could be subject to a DNT requirement under a variety of
circumstances using these criteria in a weight of evidence approach
that considers dose response, logical pattern of effects, data quality,
biological plausibility, consistency of observations in the broader
toxicological database, likeness of the case to structural analogues,
and mode of action understanding. For example, the following scenarios
for 3 different chemicals (chemicals A, B, and C) describe findings
that could lead to the conclusion that a DNT study is needed. Chemical
A is found to result in

[[Page 60938]]

responses consistent with an effect on the central nervous system
(CNS): staggering (i.e., abnormal gait) at the mid and high doses and
convulsions at the high dose are seen in a study, and abnormal gait at
the mid and high doses and cortical lesions in the brain at the high
dose are seen in another study. Chemical B is a GABA (gamma-
aminobutyric acid) receptor antagonist (i.e., a CNS mode of action that
block inhibitory systems that are involved in nerve responses) and is
found to result in functional effects in the animal studies consistent
with this mode of action, such as hyperactivity, altered response to
sudden loud noises, and seizures (only at very high doses). In
developmental toxicity studies, Chemical C results in dose-related
microcephaly, a rare finding indicative of the brain neurons not
proliferating normally.
However, a single effect would not necessarily always trigger a
DNT. For example, a small decrease in brain weight at the highest dose
tested in one adult animal study but no indications of neurotoxicity,
including the lack of corresponding decreases in brain weight in other
adequate toxicity studies, would not necessarily trigger a DNT.
Similarly, a decreased response to stimuli at doses that result in
significant body weight loss and poor health of the animal may not
provide a weight-of-evidence basis for triggering the DNT.

VI. Discussion of Key Comments on the Data Tables (Subpart B)

A. Use Patterns

EPA proposed subdividing the current nine major use patterns to 15
major use patterns to fully address nonagricultural uses. Commenters
asked for definitions of the proposed major use patterns and the
phrases ``major use pattern,'' and ``pesticide use site groups.'' One
commenter suggested adding a new major use pattern in addition to the
ones proposed by EPA. Commenters also identified inconsistencies in
major use patterns between the preamble and the regulatory text. EPA
believed that the resulting use patterns from the subdivision of
existing major use patterns were fairly self-explanatory and believed
that adding the suggested terrestrial nonfood non-crop uses might
create too fine a distinction and add to the already existing
confusion. However, the Agency does appreciate the commenters'
assistance in locating inconsistencies between the regulatory text and
the preamble and believes the inconsistencies have been corrected.
One major use pattern in the proposed rule, Indoor medical, has
been eliminated from the final rule. It is a use pattern primarily
applied to antimicrobial products, not conventional pesticides, and
will be considered for subpart W when proposed for comment. There were
several variations of aquatic nonfood use patterns that commenters
found confusing. The definition of the aquatic nonfood residential
category was questioned by several commenters who assumed it referred
to indoor tropical fish aquaria or koi fish ponds in yards. A survey of
labels associated with this use category produced only a handful of
products. Therefore EPA has consolidated the various aquatic nonfood
use patterns into one aquatic nonfood use pattern, thus reducing the
number of aquatic nonfood patterns to one. The elimination of Indoor
medical and several aquatic nonfood use patterns reduced the final
number of major use patterns. Thus, the final number of major use
pattern for conventional pesticides will be 12, rather than the 15 in
the proposed rule. The final 12 use patterns are: terrestrial food
crop; terrestrial feed crop; terrestrial nonfood crop; aquatic food;
aquatic nonfood; greenhouse food crop; greenhouse nonfood crop;
forestry; residential outdoor; residential indoor; indoor food; and
indoor nonfood.
In addition, not all the general use patterns will appear in the
data table for each discipline. Some of the use patterns have been
collapsed under a larger major use pattern for ease of use. For
example, the major use patterns in the Toxicology Data Requirements
table consist of Food and Nonfood. The discussion in Sec. 158.500(b)
explains that the general use patterns of terrestrial food crop,
terrestrial feed crop, aquatic food, greenhouse food crop, and indoor
food have been placed under the major use pattern Food. The Nonfood use
patterns include products classified under terrestrial nonfood crop,
aquatic nonfood, greenhouse nonfood crop, forestry, residential outdoor
and indoor, and indoor nonfood. Therefore only two major use patterns
appear in the data requirement table for Toxicology. Similar
adjustments have been made to other disciplines as appropriate.

B. Appendix A

EPA proposed updating the current Appendix A, a compendium of
pesticide use sites associated with major use patterns to assist
registrants in determining which data requirements might apply to their
products. EPA also proposed removing the updated Appendix A from 40 CFR
part 158 and placing it on the OPP website and titled as Pesticide Use
Site Index. This change in location would allow EPA to correct and
update the pesticide use sites with some regularity without a
complicated and lengthy rulemaking. Commenters either wanted to retain
Appendix A in 40 CFR part 158 or were in favor of posting it on the OPP
website. The latter were more concerned that the information be updated
and revised more frequently. Since Appendix A is meant to be an index
of pesticide use sites and major use patterns but not a requirement for
applicants, EPA believes that it is more properly posted on the OPP
website to assist applicants in locating the relevant pesticide use
site(s) and the corresponding data requirements. Users are encouraged
to submit comments and suggestions to the contacts listed on the Web
page. OPP will update the Pesticide Use Site Index on a timely basis to
keep the information current for users. Accordingly in the final rule,
EPA has removed Appendix A from 40 CFR part 158. The information in the
current Appendix A has been updated, titled Pesticide Use Site Index,
and is available at http://www.epa.gov/pesticides/regulating/registering/
data_sources.htm.

C. Test Substances

EPA is continuing its longstanding system of identifying test
substances in the tables as follows: Technical grade of the active
ingredient (TGAI); manufacturing-use product (MP); pure active
ingredient (PAI); pure active ingredient, radiolabeled (PAIRA); end-use
product (EP); and typical end-use product (TEP).

D. Required and Conditionally Required Data

Some commenters were confused by the explanations of R and CR in
the proposed rule and requested tighter definitions and clarification
of the test notes since the latter provided insufficient guidance. In
the proposed rule, EPA requested comment on its R/CR designation, and
received no suggestions for alternative means of presenting the data
requirements. As described in the preamble to the proposed rule, the R/
CR terminology is a general presentation of the likelihood that a data
requirement will apply. The use of R does not necessarily indicate that
a study is always required, but that it is more likely to be required
than not. The use of CR means a study is less likely to be required.
However, both R and CR designations must be read in the context of the
accompanying test notes to provide context for the R/CR in the table.
An applicant may assume that a data requirement with R will typically

[[Page 60939]]

be required all the time. The test notes accompanying that R
designation may provide supplementary information or identify some
condition(s) when the study is not required. A CR designation will
generally include more extensive test notes describing the limited
conditionality of the requirement. The final rule continues this
longstanding practice. EPA revised some of the test notes to clarify
the conditions under which the data would be required.

VII. Discussion of Key Comments on Identifying Data for Experimental
Use Permits (EUPs) (Subpart C)

EPA requested comment on a way to identify data requirements for
EUPs to replace the current bracketing system within each data table. A
commenter suggested that EPA should separate out the data requirements
applicable to experimental use permits, which have been expressed since
1984 by simply bracketing a registration data requirement in the
tables. Other commenters misunderstood the bracketing, assuming that
bracketed data requirements were somehow conditional in nature. EPA
agrees that the bracket system diminishes the visibility of the EUP
data requirements and leaves them scattered throughout the registration
data requirements, and has therefore separated out and consolidated
them. At the same time, EPA has updated the test notes to reflect those
in the subparts on registration data requirements.
Because an experimental use permit is intended to precede a full
registration, EPA has elected to place those data requirements early in
the part 158 organizational structure. An alternative location for EUP
data requirements would have been to locate them in part 172, thereby
consolidating all EUP requirements in one place. However, examination
of part 172 yielded no logical location for the data requirements
except at the very end. Accordingly EPA has placed EUP requirements in
subpart C of part 158, preferring to keep all data requirements
pertaining to conventional pesticides in one place for ease of use.
Where test notes for registration requirements have been revised based
on comments to the proposed rule, in separating out EUP requirements,
EPA has also revised those same test notes as they apply to EUPs.

VIII. Discussion of Key Comments on Product Chemistry Data Requirements
(Subpart D)

EPA proposed a few changes in product chemistry requirements and it
received a number of comments on elements of the data requirements that
EPA had not proposed changing. They include:
• certified limits
• preliminary analysis
• submittal of samples
• definition of TGAI vs. MP
• statement of formula
• grouping of products to reduce or consolidate product
chemistry requirements
• data on pesticide degradates
These comments are outside the scope of the proposal and may be
considered for future revisions of part 158. Accordingly, EPA has not
revised the final rule.

IX. Discussion of Product Performance Data Requirements (Subpart E)

EPA has transferred the contents of the product performance section
(current Sec. 158.640) essentially unchanged into the revised part
158. The regulatory text of the product performance section is
reprinted in this final rule for clarity and completeness.

X. Discussion of Key Comments on Toxicology Data Requirements (Subpart F)

A. Data Requirements

1. Immunotoxicity. EPA proposed requiring functional immunotoxicity
testing to evaluate the potential of a chemical to adversely affect the
immune system since immune system suppression has been associated with
increased incidences of infections and neoplasia. While the Agency
understands that traditional subchronic and chronic rodent studies can
provide much useful information on certain immunological endpoints such
as hematology, lymphoid organ weights and histopathology, these studies
do not provide a full and integrated evaluation of immune function. As
a result of recommendations from the National Research Council (NRC)
review and the FIFRA Scientific Advisory Panel (SAP), the Agency
proposed requiring functional immunotoxicity testing along with the
data from endpoints in other studies to assess the potential risk of
pesticides on the immune system more fully.
Fifteen commenters submitted a variety of comments on this data
requirement. All comments are addressed in the detailed Response to
Comments document in the docket. Key comments are discussed in this unit.
Two commenters requested clarification of when this testing would
be required and one commenter compared the U.S. requirement with that
of the European Union (EU). Three commenters strongly supported
including immunotoxicity testing in the toxicology data requirements
for all pesticides. Six commenters opposed the codification of this
data requirement on several bases and offered alternatives: divergence
in immunological structure and response between species that gives
animal studies limited predictive power for immunogenicity in humans;
using data from other toxicity studies as a trigger for immunotoxicity
studies; and changing from R to CR. EPA disagrees with these comments
because data and analysis have shown that functional immunotoxicity
testing, particularly when considered in conjunction with data already
required by EPA on immunotoxic endpoints, is likely to increase EPA's
ability to identify pesticides with immunotoxic effects. Additionally,
functional immunotoxicity testing allows for better characterization of
the possible effects of an immunotoxicant.
Three commenters had detailed technical questions about the test
guideline which were not appropriate for discussion in part 158 since
the latter concerns only data requirements. Their comments and
suggestions were forwarded to the appropriate scientists for review and
consideration in the context of guideline revision. While EPA agrees
that the testing protocol may need further refinement, discussions on
alternative testing paradigms will continue through the various
scientific venues (e.g., International Life Sciences Institute/Health
and Environmental Sciences Institute (ILSI/HESI) cooperative effort) as
well as through future consultation with stakeholders on the
development and validation of this test guideline.
EPA recognizes that there are a range of opinions on the necessity
of an across-the-board requirement for functional immunotoxicity
testing. However, EPA's judgment, as supported by the recommendations
of the NRC and FIFRA SAP, is that there is value-added from requiring
functional immunotoxicity testing for all pesticides. Therefore in the
final rule, EPA retains a requirement for immunotoxicity testing on all
food and nonfood pesticides on the TGAI. EPA has responded to comments
in its Response to Comments document in the docket for this rule.
2. Prenatal developmental toxicity. EPA proposed amending the name
of the requirement to correspond with the current terminology and to
require two species for all nonfood pesticides. Commenters suggested
making this requirement conditional based on results of other Tier 1
studies or on a

[[Page 60940]]

likely exposure pattern. EPA proposed requiring a second species
because it believes the data will provide some assurance that the
Agency will not be basing an assessment on a single species that might
be highly sensitive (or the opposite) when compared to another. The
final rule will maintain these changes to adequately characterize
potential hazards to pregnant women and their fetuses.
3. 21-day dermal and 90-day dermal toxicity. EPA proposed a 21- to
28-day dermal toxicity test for all food use pesticides since it is
generally needed for worker risk assessments. Analyses of exposure
information have shown that this duration of exposure is typical for
agricultural workers in various components of their job. EPA proposed
not requiring the 21- to 28-day dermal toxicity test for nonfood uses.
However, if the dermal route is the primary route of exposure for
nonfood uses, a 90-day study would be required because EPA believes the
21- to 28-day subchronic dermal toxicity test is insufficient to
identify potential hazards.
Several commenters questioned requiring a 90-day study for nonfood
uses when exposures rarely exceed 45 days. EPA considers the 21- to 28-
day dermal study insufficient for nonfood use assessment because higher
tiered oral studies (i.e., chronic or carcinogenicity studies) are not
usually required for nonfood use pesticides. While 45-day exposures are
common, EPA believes that they are not the maximum duration. For
example, professional applicators may be subjected to repeated
exposures during the 3 months of peak summer infestations. Since for
many pesticides there is increased toxicity with increased exposure,
professional applicators may not be adequately protected with 45-day
studies. Existing regulations provide flexibility to implement
alternative studies, on a case-by-case basis, as appropriate.
Registrants should consult with the Agency if there is any question
regarding the appropriate duration of the study. The highest level of
hazard evaluation available for a nonfood use pesticide is satisfied
through a subchronic toxicity test, i.e., a 90-day repeated exposure to
the nonfood pesticide. Therefore, the final rule will require the 90-
day dermal toxicity study for nonfood uses.
4. Reproduction and fertility effects. EPA proposed to require a
reproduction study for nonfood uses but emphasized that the requirement
is based on potential exposure. Commenters requested further
clarification when the study would be required. Requiring the study for
nonfood use pesticides would be based on a weight-of-evidence
consideration of the toxicology data and potential exposure in terms of
the frequency, magnitude, and/or duration. This is primarily an
exposure-based data requirement and will not always be necessary.
Registrants should consult with the Agency if there is any question
whether the study must be conducted.
5. Developmental neurotoxicity (DNT). EPA proposed that
developmental neurotoxicity testing (DNT) be conditionally required for
food and nonfood use pesticides. Thirteen commenters were unclear about
the conditionality of this requirement and requested clarification
about Test Note 27. Test Note 27 identified the effects to be
considered in the weight-of-evidence approach.
One commenter questioned whether the results of standard tests in
developing animals were sufficient to trigger a DNT test and whether
the inhibition of cholinesterase activity (ChEI) would be the most
sensitive effect for organophosphorus and N-methyl carbamate
pesticides. The Agency has completed review of 20 DNT studies conducted
with organophosphorus pesticides. In 13 out of 20 studies, ChEI was
measured in the pups; cholinesterase was the most sensitive endpoint in
those 13. Only a limited number of DNT studies are available for
carbamates, and the endpoint for only one chemical was used to assess
acute dietary risk.
Two commenters suggested amending the 2-generation reproduction
study to include findings of thyroid effects, thus providing another
criterion for DNT testing. Although such a criterion was included in
the proposed weight-of-evidence approach, experience gained with the
study resulted in the removal of this criterion. Instead, when thyroid
effects of concern are observed, the Agency may require a more specific
special study. In the final rule, EPA continues to encourage
registrants to conduct DNT studies in combination with a 2-generation
reproduction study when addressing the DNT requirement.
Ten commenters asked for clarification of Test Note 27 to indicate
whether the listed effects were part of the approach and not individual
triggers. EPA has revised this Test Note to eliminate the impression
that the items in the list were individual triggers and referred
commenters to its published Risk Assessment Guidelines for a more
detailed explanation of the terms used in the test note. Due to an
addition of a test note, Test Note 27 in the proposed rule was re-
numbered to Test Note 28 in the final rule.
Therefore, the Agency is conditionally requiring the DNT study in
the rat for food and nonfood pesticides. All available toxicology data
for the pesticide will contribute to the weight-of-evidence
determination of the need for a DNT study. The criteria for the weight-
of-evidence determination are listed in Test Note 28 and include
neurological effects from adult animal studies as well as
neurobehavioral effects after pre- and post-natal exposure of the
pesticide to young animals.
6. Scheduled-controlled operant behavior, peripheral nerve
function, and neurophysiology - sensory evoked potentials. Commenters
wondered if these tests would be commonly required and requested
specific triggers for these studies. EPA discovered upon review that
these studies were seldom required during the reregistration process
and determined the studies could be removed from the table of commonly
required studies. If the need arises in the future, the Agency may
require any of these studies on a case-by-case basis. Validated OPPTS
guidelines are in place.
7. Non-rodent chronic studies (1-year dog study). In the proposed
rule, EPA considered eliminating the requirement because evidence from
the published literature was consistent with EPA's belief from its
reviews that the study may not be needed. EPA currently requires a 90-
day dog study and a 1-year dog study for all food and nonfood uses to
fulfill the non-rodent data requirements. EPA referenced published
literature that suggested that the 1-year dog study may not be
necessary. Based on a retrospective analysis of a large body of 1-year
dog studies in its toxicology database, EPA proposed to eliminate the
1-year dog study but retain the 90-day study. EPA solicited review and
comment by the FIFRA Scientific Advisory Panel (SAP) on the results of
the preliminary analysis for reference dose (RfD) derivation on May 5-
6, 2005 [Ref. 10].
The FIFRA SAP reviewed the Agency's retrospective analysis of the
toxicity studies and encouraged the Agency to continue its analysis
with a larger database. The FIFRA SAP made the following
recommendations:
i. Increase the robustness of data analysis by including dog study
datasets that were not used for the RfD determination.
ii. Conduct an analysis more representative of a prospective
comparison through delineating the 13-week No Observed Adverse Effect
Levels (NOAELs) and Lowest Observed Adverse Effect Levels (LOAELs)

[[Page 60941]]

independent of the 1-year study and establish data review criteria.
iii. Consider data analysis for separate classes of pesticides.
iv. Include additional background information on RfD that provides
better perspectives for reviewing the Agency position paper.
v. Revise the title of the Agency position paper to reflect the
purpose of the data analysis.
The FIFRA SAP said in its report that ``if the results of the
analysis continue to indicate little added value from the 1-year dog
studies, the Agency could move toward eliminating them on a stronger
basis.''
In response, EPA conducted a more extensive analysis of dog
toxicity studies on 110 chemicals representing over 50 different
classes of pesticides [Ref. 12]. EPA concluded from this analysis that
extending a dog toxicity study beyond a 13-week duration does not
provide additional essential toxicity information; eliminating the 1-
year dog toxicity study does not compromise the data needed for the
determination of chronic RfDs and margins of exposure (MOE). Thus,
reliance on the required chronic rodent studies, 2-generation rat
reproductive study, and the 13-week dog toxicity study provides an
adequate basis for chronic RfD derivation in pesticide risk assessment.
EPA acknowledges that there may be situations where a longer
duration dog toxicity study may be warranted when a pesticide chemical
is highly bioaccumulating (e.g. builds up in body fat) and is
eliminated so slowly that it does not achieve steady state or
sufficient tissue concentrations to elicit an effect during a 90-day
study. EPA anticipates that this situation will be infrequent since
current pesticides are not usually designed to be highly persistent and
bioaccumulating. If such a chemical is encountered, EPA would require
the appropriate Tier II metabolism and pharmacokinetic studies to more
precisely evaluate bioavailability, half life, and steady state to
determine if a longer duration dog toxicity study is needed. The
circumstances that might lead to a request for the 1-year dog study are
identified in Test Note 36.

B. Alternative Testing Paradigms

In the proposed rule published March 2005, EPA discussed the work
underway on alternative testing paradigms by the International Life
Sciences Institute (ILSI)/Health and Environmental Sciences Institute
(HESI). EPA is in conceptual agreement with the ILSI/HESI philosophy of
moving toxicology testing away from a rigid guideline-based screening
approach and towards a more knowledge-based approach. The ILSI/HESI
approach was published in a series of papers in the January 2006 issue
of Critical Reviews in Toxicology.
Eleven commenters addressed the ILSI/HESI testing paradigm, all
supporting its development and early adoption. One commenter suggested
that EPA update the proposed rule with the ILSI/HESI study findings and
reissue a revised proposed rule for comment. In a similar vein, another
suggested incorporating a timetable into the final rule for modifying
subpart F (Toxicology). Another commenter believed a number of the
concepts developed in by ILSI/HESI were ripe for incorporation into
pesticide testing requirements at this time. This same commenter
suggested not finalizing the proposed rule until there was an
opportunity to consider and incorporate the important concepts
developed by Agricultural Chemical Safety Assessment (ACSA). EPA
believes that incorporating the concepts into the final rule is
premature since EPA has not had the opportunity to determine if the new
testing paradigm will meet its risk assessment needs. EPA believes that
delaying the remaining proposed changes which comprise the bulk of the
proposal would be a disservice to the regulated community. In a
differing view, a commenter was concerned about the lack of public
interest representatives in ILSI-EPA discussions and recommended that
EPA terminate its collaborative working relationship with ILSI and
industry trade groups. Since the Agency is interested in more efficient
risk assessment paradigms, it will continue to work with all
stakeholders in investigating efforts in that direction and welcomes
the participation of any public interest representatives in the
discussions.
EPA is committed to moving towards a more efficient and refined
testing/risk assessment paradigm. Given the Agency's experience with
regulating pesticides over the last 30 years, the Agency is interested
in improving certain aspects of the testing process. In particular, EPA
is more attuned to risk assessment needs (i.e., an integrated approach)
that avoids requesting data not used in risk assessment and that
reduces and refines the use of laboratory animals.
In the proposed rule, EPA discussed the relevance and importance of
the ILSI/HESI project, Agricultural Chemical Safety Assessment (ACSA):
a Tiered Approach. This project, with the participation of EPA
scientists, represents a pursuit of a more efficient and accurate
tiered testing of pesticide chemicals. A series of reports authored by
ILSI/HESI was published in a special edition of the Journal of Critical
Reviews in Toxicology in January 2006, Volume 36, Issue 1 [Refs. 1, 2,
3 and 5], summarizing their findings and initial recommendations.
ACSA represents the first comprehensive effort to scientifically
redesign the toxicology animal-testing framework for agricultural
chemicals. The ACSA proposal is consistent with EPA's direction and
goals to develop a more efficient and reliable testing paradigm. Under
the ACSA scheme, some studies would be eliminated while endpoint
coverage would be increased in redesigned studies based on responses
observed in a core set of toxicity tests. The value of the scheme is
that animals are more fully utilized and the need for some tests can be
eliminated if the core set of tests or existing knowledge does not
indicate a concern. Decisions on next steps must be made throughout the
course of the study as a thorough evaluation of all available
information, including data on the pharmacokinetics and mode of action
of the pesticide (if such data exist), could lead to different
conclusions regarding the appropriate way to approach testing.
For example, in the case of the developmental neurotoxicity study,
for some chemicals, it might be concluded that adequate testing of the
developing nervous system would be best accomplished with a standard
developmental neurotoxicity study. Refinements to the guideline study
could include, for example, changes to the route and/or duration of
exposure (e.g., initiation of dosing to maternal animals prior to
gestation day 6, or direct gavage administration to pups during
lactation), the evaluation of appropriate biomarkers of exposure or
effect, the use of more targeted functional, behavioral, or cognitive
testing in offspring, or the histopathological and/or morphometric
evaluation of particular regions of the central or peripheral nervous
system that are known to be affected by either the chemical or chemical
class. For other chemicals, the information in the toxicological
database could lead to the conclusion that an alternative test should
be performed instead of a guideline developmental neurotoxicity study.
Alternative chemical-specific methods could be identified as a
preferred option.
EPA has multiple activities underway to address the remaining
science and policy issues associated with the ACSA proposal. One
essential step towards

[[Page 60942]]

adopting the ACSA proposal will be conducting retrospective and
prospective data analyses to determine whether this new testing
paradigm will meet EPA's risk assessment needs as defined by statute.
To this end, the Office of Pesticide Programs is currently working with
EPA's National Center for Computational Toxicology (NCCT) to populate a
Toxicological Reference Database (ToxRef). The current priority is to
populate ToxRef with data from the rat 2-generation reproductive study,
prenatal toxicity, and systemic toxicity studies on hundreds of
pesticides that represent different classes, modes of action, and
toxicity profiles. EPA will use this relational database to determine
the value of endpoints currently evaluated in risk assessment (i.e.,
the F1 versus F2 responses). This analysis will provide scientific
support for EPA's adoption of the proposal as the analysis will subject
the ACSA proposal to a much broader set of chemicals than that used to
develop the proposal.
Another critical step is gaining scientific consensus on the
triggers (i.e., the points at which a concern is indicated and a higher
level of testing is needed). The retrospective analyses will also be
used to refine or confirm the ACSA proposed triggers for test
decisions. Once the analysis is complete, EPA will be able to complete
draft guidance on testing. The analyses and guidance are planned to be
subject to SAP review and public comment in 2008.
Another essential step is testing how the ACSA scheme works in
practice. There are plans to conduct several case studies using the
ACSA tiered testing proposal. From these case studies, EPA will be able
to assess the laboratory testing feasibility of such a complex study
and to evaluate the ability of the approach and its parameters to
characterize known toxicants and address risk assessment needs. Based
on early scientific reviews, EPA scientists are already working on
improvement of the ACSA tiered testing approach.
EPA will consider the results of the SAP review of the
retrospective analyses and draft guidance, issues raised by
stakeholders, and the case studies, in determining what revisions to
current data requirements and testing guidelines may be appropriate. As
the science issues are adequately vetted and crucial questions
resolved, EPA will promulgate the appropriate regulatory changes on a
timely basis. In the meantime, the existing regulations provide
flexibility to implement any updated, new or novel testing schemes, on
a case-by-case basis, as appropriate, until the changes are codified.
Case-by-case determinations would be made in consultations with the
Agency without the necessity of the waiver process.
It should be noted that ACSA is only one proposal that EPA will
consider in improving the risk assessment process of environmental
chemicals. Other relevant activities to consider include the National
Academy of Sciences (NAS) recommendations on Toxicity Testing and
Assessment of Environmental Agents expected in 2007 (Project ID BEST-U-
03-08-A at http://www8.nationalacademies.org/cp/projectview.aspx?key=74),
Organization for Economic Co-Operation and Development (OECD)
Integrated Approaches to Testing and Assessment (http://www.oecd.org/
document/42/0,2340,en_2649_34377_36283562_1_1_1_1,000.html),
as well as predictive toxicity tools (QSAR, -omics,
etc.) being developed by EPA's Office of Research and Development (ORD)
Computational Toxicology Program (http://www.epa.gov/comptox). With regard to
the OECD effort, EPA is currently playing a leadership role in planning
a workshop scheduled for December 2007. The workshop will evaluate the
current state of science and regulatory programs to evaluate pesticide
inert ingredients and active ingredients using the data derived from in
silico (performed on computer or via computer simulation), in vitro,
and short-term in vivo models and bioassay systems.
Before considering regulatory changes to reflect the results of
EPA's consideration of ACSA, NAS, and other recommendations, the Agency
will develop scientific position papers on the new approach and
recommendations for internal and external review. Internal review
includes review by the FIFRA SAP and opportunities for public comment.
External peer review as well as acceptability by other national and
international regulatory authorities are crucial before implementation
of any new testing paradigm and data requirements. Harmonization with
the data requirements of these same authorities is also an important
factor. International regulations currently require studies that were
omitted in ACSA; this would pose significant problems for registrants
if a harmonized approach is not adopted world-wide.
Lastly, EPA is committed to review part 158 data requirements
frequently to incorporate new science that has been fully documented
and peer reviewed.

XI. Discussion of Key Comments on Ecological Effects Data Requirements
(Subpart G)

A. Generic Issues

EPA received comments in several areas that were common to all
science disciplines under this subpart.
1. Data harmonization and lack of availability of current
guidelines. The Agency received several comments stating that the data
requirements for nontarget terrestrial and aquatic organisms, plants
and environmental fate testing should not be promulgated if the test
guidlines upon which the data requirements rely are not finalized. The
Agency recognizes the importance of the connection between these data
requirements and the guidance documents that provide information on how
the data requirements may be satisfied. The Agency is in the process of
updating its nontarget plant test guidelines with the OPPTS and the
OECD. The terrestrial and aquatic animal guidelines are scheduled to be
finished and available to the public by late 2007. Nonetheless,
guidelines are guidance documents only, and the promulgation of data
requirements does not depend on the availability of guidance documents.
2. Elimination of species names in the test notes. EPA eliminated
the inclusion of preferred species names from the data requirements in
subpart G. This does not represent an actual change in the
requirements. Rather, the Agency determined that the indication of
preferred species is a matter of guidance and should not be part of the
requirements document. Species names are covered in the Agency's test
guidelines, which are cited in the data requirements tables.
3. Independent laboratory validation. Concerns were raised by some
commenters that the requirement to now have independent laboratory
validation (ILV) of the chemistry methods used for residue measurements
in the ecological and environmental fate field studies would add cost
and time to these studies. They view these studies as already required
and conducted under Good Laboratory Practice Standards (GLP) in 40 CFR
part 160 for other data requirements. However, GLP Standards do not
require an ILV. The requirement for an ILV has been in effect since the
1990s and, as such, is a codification of current practice. The ILV, as
well as the original method validation, should be conducted under the GLP.

[[Page 60943]]

B. Data Requirements

1. Terrestrial organisms. i. Acute oral toxicity test with a
passerine species. EPA proposed to require a second avian acute oral
study on a passerine species (i.e., red-winged blackbird) to support
all outdoor uses, including residential outdoor uses. The other avian
acute oral study must be conducted on either a waterfowl or an upland
gamebird, which has been standard policy. This revision of the avian
acute toxicity data requirement elicited a significant number of
comments. The comments not only concerned the addition of a passerine
species to the avian acute oral data requirement, but also the test
note which specifically named the red-winged blackbird (Agelaius
phoeniceus) as the preferred passerine species. Some commenters
suggested that the passerine requirement should be based on the results
of either the mallard or bobwhite acute oral test results. They based
their concerns on the fact that the red-winged blackbird is a wild
species, and is not reared in a laboratory, unlike some commonly tested
passerines as the canary and zebra finch. Because it is a wild species,
the laboratories must request permits from the U.S. Fish and Wildlife
Service (USFWS) to trap the birds. Also, there were concerns about the
possible exposure of laboratory personnel to the avian flu virus from
the trapped birds. Others suggested that EPA continue its policy of
extrapolating the data from the mallard and bobwhite acute studies to
passerine species in its risk assessments, and reserve the passerine
study for cases when extrapolation does not significantly reduce
uncertainty. Still others requested that the Agency consider other
passerine species and provide a list of recommended species to the
regulatory community, rather than prescribing solely the red-winged
blackbird.
Based on these comments, in the final rule the Agency is no longer
specifying the red-winged blackbird as the only acceptable passerine
species for an additional avian acute oral toxicity study. However, the
passerine acute oral study is still required, in addition to one with
either the upland gamebird or the waterfowl. More than one tested
species allows for consideration of interspecies sensitivity, and
testing of a passerine addresses concerns that broad, untested avian
taxa may be more sensitive than previously required mallards and
bobwhites (Refs. 8 and 9).
EPA will consider studies using alternative species, as long as the
alternative species meet the Agency's needs. EPA also intends to revise
the avian acute oral toxicity guideline to include a passerine species,
with the red-winged blackbird listed as among the preferred species.
The Agency will revisit the issue of an acceptable species list with
this goal in mind. Testing protocols may list other acceptable species
upon reconsideration of this issue.
ii. Japanese quail. EPA did not propose to add the Japanese quail
as a test species for the acute toxicity test and as an alternate for
the avian reproduction test. Nonetheless, the Agency received two
comments requesting that EPA accept the use of the Japanese quail as a
test species, particularly as this species is accepted by OECD. The
Agency presented its rationale for not listing Japanese quail as a
preferred test species in its correspondence with OECD on March 24,
2003 (Ref. 14). Many years of domestication and artificial selection in
this species may have biased the response of this species to chemicals.
When comparing dietary study results of the same pesticide in both
species the Japanese quail responds differently to toxicants, showing
less sensitivity than the northern bobwhite quail. In addition, the EPA
has a long history of requiring testing with the bobwhite and has
accumulated a large database of acute toxicity results for this
species. Abitrarily using another test species now would increase
uncertainty and not add much value to the risk assessment process. Also
the Japanese quail has an extremely high reproduction rate that is not
representative of North American species, and therefore is not a
suitable test species for the avian reproduction study.
iii. Avian reproduction. EPA proposed to change the requirement
from conditionally required to required for terrestrial, aquatic,
forestry and residential outdoor use patterns. Two commenters stated
that the need for these data should be based on the pesticides'
properties. EPA does not agree with the comments and has not revised
the final rule. Adverse effects on avian reproduction can occur at
levels of exposure several magnitudes lower than those that can cause
acutely toxic effects. A pesticide's properties are not adequate
predictors of avian reproduction effects.
One commenter advocated the development of reproduction tests with
passerine species. Their interest was based on the fact that the
current species used in this test, the mallard and the bobwhite, are
precocial species (birds that are born covered with feathers, able to
see and leave the nest soon after hatching) and passerine birds are
altricial (birds that are born naked and blind and depend on their
parents for food). The Agency believes that addressing the potential
differences in reproduction between passerines and other birds is
scientifically appropriate. However, at this time, no protocols have
been made available to the Agency for such testing. Given the
challenges testing labs are faced with for existing reproduction tests,
protocols for passerines are not likely to be developed in the near
future. Thus, the Agency is not expanding avian reproduction testing to
passerine species at this time.
iv. Wild mammal testing. EPA did not propose to change the
conditionality of the wild mammal toxicity test, but to maintain its
requirement on a case-by-case basis. The Agency received three comments
regarding this data requirement and its test note, which referred to
some of the lower tier data that could indicate a need for the study.
One comment stated that the test note was unclear, and asked for more
specific guidance as to what avian or mammalian acute and subacute
testing, fate characteristics and use patterns could trigger this data
requirement. The second comment stated that wild mammal studies should
only be triggered when the terrestrial risk assessment triggers a
potential concern based on mammalian endpoints generated in the
toxicology data package. A third comment proposed that the test note be
revised to state that data on a wild mammal species may be required
when the terrestrial risk assessment triggers a potential concern
(acute RQ > 0.5; chronic RQ > 1.0) [RQ = Risk Quotient = exposure/
toxicity] for a given use pattern based on laboratory toxicity
endpoints and a refined exposure assessment.
The Agency evaluates the need for wild mammal toxicity on a case-
by-case basis. The results of effects testing or fate testing alone are
not the causal factor in such a determination. There may be case-
specific information that would trigger the need for additional
testing. This might include lines of information that suggest that
available toxicity data provide unsuitable surrogacy for a particular
nontarget species. Accordingly, the Agency has not revised the final rule.
v. Acute toxicity studies with reptiles. Although EPA did not
propose acute toxicity studies with reptiles as test species, one
commenter stated that effects on reptiles still are inadequately
addressed in this new regulation. They do not believe that the avian
studies adequately assess risks to reptiles.
The Agency will consider any peer-reviewed reptile testing protocols for

[[Page 60944]]

possible future addition in required testing. Information demonstrating
a biologically significant difference in sensitivity or exposure
between birds and reptiles, which would suggest that the bird risk
assessment is not adequately protective, can still be considered in
individual risk assessments.
vi. Field testing. The only changes that EPA proposed for the
simulated or actual field testing for birds and mammals were to expand
the requirement to include more use patterns under the conditional
requirement, and to ask for independent laboratory validation of the
chemistry methods. EPA did not propose to change the conditionality of
the field test, but to maintain its requirement on a case-by-case basis.
EPA received five comments regarding the data requirement for
simulated or actual field testing with terrestrial animals. One comment
stated that the information provided in the test note for this data
requirement was nebulous and asked for clarification. Three comments
stated that additional testing, particularly with wild species in the
natural environment, should only be conducted when refined risk
assessments indicate a potential concern. The fifth comment supported
the continued requirement of the study.
The Agency evaluates the need for field testing on a case-by-case
basis. Field studies have traditionally been performed to address
uncertainties in risk assessments, especially those risk assessments
predicting environmental effects of concern. However, setting a
conditional requirement that triggers such studies only when risk
assessment tools predict adverse effects ignores the possibility that
lines of information may conversely point out inadequacies of the
existing tool to provide adequate protection. To this end, the Agency
has retained the existing field testing data requirements in part 158.
One of the commenters proposed a change to the test note for the
terrestrial field study (test note 6 in the final rule). Their
rationale was that a refined risk assessment should be the basis for
requiring this higher tier study. A refined assessment may indicate
that field data are needed to resolve uncertainties in the risk
assessment. If so, then the field test is required. The Agency agrees
with the comment and changed test note 6.
vii. TEP testing. EPA proposed to expand the testing of birds in
the acute oral and dietary studies to conditionally require testing
with the TEP based on the results of these tests with the TGAI,
environmental fate data and the use patterns.
A significant number of the comments the Agency received concerned
the confusion in the data table regarding the use patterns that would
need to be supported by TEP and the conditions that would trigger TEP
testing with birds. Two commenters stated that TEP testing of birds
should only be triggered when the risk from the TGAI is high, and birds
are expected to encounter the intact end-use formulation in the field
or expected to use the formulation itself as a food source. In
contrast, a commenter recommended TEP testing for all products with
potential aquatic or terrestrial nontarget exposure.
The Agency evaluates the need for testing of TEPs on a case-by-case
basis. In such evaluations, the Agency relies on available lines of
evidence such as published literature, adverse effects information
submitted under FIFRA sec. 6(a)(2), European regulatory testing, and
confidential statements of formula. The potential for nontarget
organism exposure to TEP would naturally be a consideration as well. In
light of the number of comments received on this issue, and past
experience that shows TEP testing has only been required for granular
formulations or other special situations, the conditional requirement
has been removed from the data requirements and does not appear in the
final rule. It will remain consistent with past policy and be required
on a case-by-case basis.
2. Aquatic organisms--i. Sediments. EPA proposed to add testing of
aquatic organisms exposed to treated sediment to better assess the
effects of sediment-bound pesticides on aquatic environments. The whole
sediment tests are acute toxicity studies of freshwater and marine
invertebrates and a chronic study with invertebrates. The Agency
received many comments about these newly codified data requirements.
Most of the comments concerned the conditions for requiring these
tests. The commenters cited not only the test notes, but also the
sections of the draft preamble where the sediment data requirements
were discussed in detail. Most asked for better guidance regarding the
criteria for the studies. Several commenters also proposed alternative
criteria for both studies. Some of the comments discussed risk
assessment issues, or issues with the guidelines for the studies. These
latter two areas are not the focus of this rule, and therefore, are not
addressed in this document. The Response to Comments document has
comprehensive details regarding these issues. Once the Agency
determines or extrapolates that the use pattern has the likelihood for
chemical exposure to an aquatic system the triggers for persistence and
adsorption are reviewed. Toxicity will be taken into consideration
relative to potential exposure. EPA will not define specific use patterns
or applications that will not automatically require sediment testing.
Two criteria, the soil-binding ability and persistence of the
pesticide, were the focus of many comments. The criteria, as listed in
the proposal, are the soil partition coefficient (Kd) value >= 50
Liters/kilogram (L/kg) and the half-life of the pesticide in sediment
<= 10 days for the acute test and > 10 days for the chronic test.
Commenters asked for justification for the selection of the value of 50
for the Kd value.
The Agency's justification for selecting Kd >= 50 L/kg as a
criterion for requiring the study was that this value would capture
those chemicals with about 80% adsorption of a chemical to sediment
organic carbon (2%). In the 1980s the Agency had proposed a Kd >= 3 to
10 L/kg as a trigger for adsorption. At that time the Agency put in
place a Kd >= 50 L/kg. The Kd criterion represents the mean value
observed in the soil adsorption studies.
EPA received a comment that questioned the appropriateness of using
the Kd value as a trigger for sediment testing. They suggested that the
trigger should be based on the results of the aquatic transformation
studies, particularly the mass balance results and the half-lives in
sediments. Their method indicated that pesticides with Kd values lower
than 50 L/kg, our proposed value, could also bind to sediment.
Agency scientists re-analyzed the value for the Kd criterion with
United States Geological Survey (USGS) data (Ref. 13) and found that Kd
values for pesticides commonly detected in sediments can range as low
as 1.6 and as high as 2,095. This analysis provided EPA with an
important new perspective on Kd values, and the Agency considered
lowering the value of the criterion. However, EPA decided not to change
the Kd value from that in the proposed rule based on science and policy
considerations. First, the Kd value, which indicates binding potential
of the pesticide (unadjusted for dependency upon organic carbon) is not
the primary factor in determining the need for sediment testing (i.e.,
persistence, toxicity and exposure are the main factors). More
importantly, the Agency believes that such a change warrants input from
the scientific community along with broader public input on the Kd
trigger. The Agency

[[Page 60945]]

may consider changing the Kd value in future updates to part 158
requirements.
The criteria for persistence is determined by using the aerobic
aquatic metabolism data and the aerobic soil metabolism data. The
anaerobic soil metabolism data are not used for this purpose.
Commenters questioned the half-life value of < = 10 days for the acute
test and assumed it was a typographical error and should be >= 10 days.
They also questioned if an acute study must be done prior to conducting
the chronic study.
It appears from the above comments that the commenters
misunderstand the purpose of the persistence trigger. Refer to Test
Notes 21 and 22. EPA affirms that the intent of the triggers for the
acute and chronic sediment tests are not to determine length of test.
They were designed to determine if the sediment compartment should be
considered for testing. Once that determination is made, then problem
formulation will determine the specifics of the data required. The
Agency strongly advises that the registrant consult with EPA concerning
type of study and test organism selection. The Kd trigger is the same
for either the acute or chronic sediment test. It is the persistence
(i.e. half-life) that drives the decision regarding which study to
require. For example, if the soil or aquatic aerobic/anaerobic half-
lives are less than 10 days (Agency policy is to use the most
conservative value, unless evidence is provided to support the use of
an alternative value), then the Agency would accept the 10 day (acute)
sediment study, unless there are clear reproductive issues a priori.
For half lives greater than 10 days, a 28 to 65 day (chronic) study
would be more appropriate. Consultation with the Agency is needed if
the registrant is uncertain as to which length of study is appropriate.
Two commenters proposed that a value of log Kow > 3 is a more
commonly used value with which to judge whether a compound might have
adsorptive potential. EPA agrees that the Kow, along with the Koc, are
valid environmental fate values to use as criteria for these studies.
The log Kow of 3 is equivalent to a Koc value of 1,000. Both values are
frequently more available than either the Kd or half-life values.
Consequently, the requirement for submission of sediment studies can be
determined by either of these two values. The test notes in the final
rule have been revised to include the Kow and Koc.
One commenter wanted EPA to specify in the test notes when
freshwater or marine organisms must be tested for sediment toxicity.
Sediment toxicity data are required for marine/estuarine test species
if the product is intended for direct application to the estuarine or
marine environments, or the product is expected to enter this
environment in significant concentrations, either by runoff or erosion,
because of its expected use or mobility pattern. The test notes are
amended to clarify when marine organism testing is required.
ii. Fish acute toxicity testing. EPA proposed that indoor and
greenhouse uses would only require one fish acute toxicity test, unless
the chemical is stable in the environment, in which case, a second fish
test with a different species is required. The Agency received three
comments regarding the fish acute data requirement. The comments asked
for clarification regarding the number of freshwater fish studies that
are now required to support greenhouse and indoor uses.
With regard to greenhouse and indoor uses, the Agency requires the
testing of one fish species to adequately assess the hazards to fish.
If the LC₅₀ is < 1 ppm, no other fish species testing is
required. However, if the LC₅₀ is between 1 - 10 ppm, a
second species will be required to substantiate the potential for
hazard to aquatic organisms.
iii. Fish and invertebrate chronic toxicity testing. EPA proposed
several revisions to clarify the applicability of the requirements for
the chronic toxicity tests. The Agency received one comment requesting
more information on the fish early life stage test and the invertebrate
life cycle with saltwater organisms. Another comment suggested that the
Agency take into consideration the difficulties of using estimated
environmental concentration-based triggers for the chronic studies.
The Agency affirms that chronic studies are required to support
registration of an end-use pesticide product that is applied directly
to water or is expected to be transported to water from the intended
use site. This condition applies to estuarine as well as freshwater
environments. These study requirements reflect the uncertainty that
surrounds pesticide exposure and their potential for impact to aquatic
organisms. Since exposure is a major driving parameter in assessing
acute and/or chronic risk, this factor must be defined and addressed.
The test notes for these studies list the details.
iv. Testing with estuarine organisms. EPA proposed to change the
conditionality of the acute testing from conditionally required to
required for several use patterns. The comments regarding this set of
data requirements primarily addressed test species and TEP testing with
estuarine organisms.
The commenters stated that proposed test notes 13 and 15 were
inconsistent with regard to the preferred estuarine fish species in the
test note. As discussed in the Generic Issues unit (Unit XI.A.), the
test notes in the final rule no longer indicate the names of preferred
test species as they are fully discussed in the appropriate guidelines.
The comment regarding TEP with estuarine organisms is similar to
that for TEP testing with freshwater organisms discussed in Unit
XI.B.2.vii., except that the commenter recommended estuarine organisms
should only be tested with the TEP if testing with the TGAI indicated
that estuarine organisms are more sensitive than freshwater organisms,
or if the freshwater organism tests demonstrate that the TEP is more
toxic than the TGAI. The Agency response to the comment on TEP testing
is addressed in Unit XI.B.2.vii.
v. Testing of degradates. EPA did not specifically propose any data
requirements requiring toxicity testing with degradates of pesticides.
However, one commenter stated that degradates should be included as
they can also present significant environmental risks. The Agency
requires appropriate testing of a pesticide's degradates on a case-by-
case basis. If the environmental fate data show the degradates can
potentially persist, and subpart F toxicology data show they are toxic,
then aquatic toxicity testing is required.
vi. Bioaccumulation testing. EPA proposed to eliminate the
requirement for these studies for aquatic nonfood residential or
residential outdoor uses since the exposure is expected to be minimal.
One comment asked for clarification as to when they would, most likely,
be required. The Agency anticipates that these studies may be required
on a case-by-case basis depending on the results of lower tier
ecological toxicity tests and potential environmental fate
characteristics. The potential for accumulation is triggered when a
chemical has a half-life >= 4 days and log Kow >= 3.
EPA proposed to change the conditions under which the accumulation
in fish and accumulation in aquatic organisms would be required. EPA
received eight comments regarding the fish and nontarget organism
accumulation studies. Three of the commenters suggested that this data
requirement be placed in proposed subpart E (now subpart G),
Terrestrial and Aquatic Nontarget Organism Data Requirements, and not
proposed subpart N. There were two comments stating that test note 10
was well written, and

[[Page 60946]]

should also apply to the aquatic nontarget organism accumulation study
requirement in lieu of test note 11 in the environmental fate data
table. They suggested that this test note is also appropriate for the
three accumulation studies in proposed subpart E, bioavailability,
biomagnification and toxicity of aquatic organisms.
The Agency agrees with the comments, and has moved the two studies
under proposed subpart N, Accumulation in Fish and Accumulation in
Aquatic Nontarget Organisms to subpart G, under the data requirements
for aquatic organisms - bioavailability, biomagnification and toxicity.
Therefore, all the ecological and fate requirements related to
bioaccumulation are located solely in subpart G. We also agree with the
comment that the language of Test Note 10 (Accumulation in Fish) in the
proposed environmental fate data table is appropriate for the
Accumulation in aquatic nontarget organisms data requirement in subpart
G. Test note 10, ``Not required when the octanol/water partition
coefficients of the pesticide and its major degradates are less than
1,000; or there are no potential exposures to fish and other nontarget
aquatic organisms; or the hydrolytic half-life is less than 5 days at
pH 5, 7, and 9.'' was moved to subpart G and renumbered as test note
19. This test note replaces test note 21 in proposed subpart E (now
subpart G).
vii. Testing with TEPs. EPA proposed to require acute testing with
the TEP for freshwater and estuarine organisms based on the
introduction of the TEP directly into an aquatic environment, or the
estimated environmental concentration of pesticide equaled or exceeded
one-half the LC₅₀ of the TGAI when the end-product was used
as directed, or an ingredient in the formulation was expected to
enhance the toxicity of the active ingredient or to directly cause
toxicity to aquatic organisms. One comment recommended that TEP testing
with estuarine organisms should be conditional based on the results of
TEP testing with freshwater organisms, or if estuarine organisms were
more sensitive to the TGAI than were freshwater organisms.
The Agency requires TEP testing of freshwater and estuarine
organisms for all outdoor uses. As the environments of the estuarine
and freshwater organisms are different, how the chemical ingredients
that comprise a formulated product will react in the different aquatic
systems cannot be readily predicted. Therefore, the responses of each
group of organisms are independent of each other, necessitating testing
of both freshwater and estuarine organisms with the TEP in addition to
the TGAI, if the triggers in the test note 9 are met.
3. Nontarget plant testing. EPA proposed to eliminate the
requirement for the seed germination study because the information from
this study can also be obtained from the seedling emergence study. The
germination study has not been required for several years, so its
removal from the final rule simply codifies the current standard
practice. Commenters agreed with this change.
EPA proposed to expand Tier I and Tier II seedling emergence,
vegetative vigor and aquatic plant growth studies to include
terrestrial food and feed crops, aquatic food crops, forestry and
residential outdoor uses. The conditional requirements for Tier III
phytotoxicity terrestrial and aquatic field studies were also expanded
with the addition of the same use patterns. The use patterns were
expanded beyond terrestrial and aquatic nonfood uses and forestry uses
in order to capture scenarios which may be impacted by drift and runoff
from pesticide applications in neighboring areas.
Two comments requested explanations for including outdoor
residential uses and indoor uses among those requiring plant testing.
Outdoor residential use patterns are now included among the sites
requiring plant testing because data indicate that herbicide uses on
sites such as turf can harm nontarget plants through runoff. Turf is
classified as an outdoor residential terrestrial use, and therefore
requires nontarget plant testing. The Agency acknowledges that
including indoor uses among those requiring aquatic plant growth
testing in Table 3 in the proposed rule was an error as EPA did not
intend to propose such a requirement. Plant testing is not required for
indoor uses. Additionally, testing for aquatic nonfood residential use,
also included by error in Table 3, has been eliminated in the final rule.
i. Test substance. EPA proposed to change the test substance for
the terrestrial plant studies from TGAI to TEP. This change was made to
address Agency concerns that end-use products can contain ingredients
that enhance the bioavailability or toxicity of the active ingredient.
Seven commenters expressed concerns regarding the change in the test
material to the TEP for the terrestrial plant studies. They preferred
to continue to use the TGAI as the test substance. The most common
concern expressed by the commenters was the possibility that the final
composition of the end-use product under development may differ from
the product used in testing. EPA recognizes this may occur, but the TEP
is required as the test material because the formulations contain
adjuvants and other chemicals that aid the movement of the active
ingredient into the plant, making it more effective, and therefore,
possibly more toxic to nontarget plant species. The Agency has been
routinely requesting nontarget terrestrial plant tests with TEP for a
number of years, so this change is codifying current policy and reflects
the needs of the Agency in assessing impacts on nontarget organisms.
ii. Species testing. Recommended plant test species are not
designated in part 158, but are included in the guidelines for
conducting the studies. Species issues should be addressed in the
context of guideline development and revision and not the data
requirements. Accordingly, EPA has not revised part 158 based on
comments about the plant test species.
iii. TIER III guidelines. The only changes that EPA proposed for
the Tier III terrestrial and aquatic field studies for nontarget plants
was to expand the requirements to include more use patterns under the
conditional requirement, and to propose independent laboratory
validation of the chemistry methods. EPA did not propose to change the
conditionality of the field test, but to maintain its requirement on a
case-by-case basis. The Agency received three comments regarding the
field testing study guidelines and the process of problem formulation
and refinement of the ecological risk assessments. They recommended
that the field studies be conducted within the context of problem
formulation to characterize risks to plants under actual use
conditions. These comments relate more towards guidance about the field
studies and not to the data requirements themselves. As such, these
comments are being considered in context of revisions to guidelines and
not to this final rule.
iv. Test note revisions. The vegetative vigor studies are no longer
required for granular and bait formulations. This change acknowledges
that these formulations are not practical test materials, as the
vegetative vigor study requires the test substance to be applied
directly to the plant surface.
The Agency received one comment regarding an apparent error in the
placement of test note 3 for the Tier I and Tier II seedling emergence
studies. EPA acknowledges that test note 3 was inaccurately placed next
to the seedling emergence studies. This has been

[[Page 60947]]

corrected, and this test note now refers to the Tier I and Tier II
vegetative vigor studies.
v. Test notes 5 and 6--the conditions for moving from Tier I to
Tier II studies. EPA received one comment asking for clarification of
test notes 5 and 6 of the proposed rule. The Agency agrees that the
wording of both test notes is ambiguous, and rewrote both test notes.
Test notes 5 and 6 in Sec. 158.660 are now accurate. The draft test
notes implied that all the plants tested in the tier I studies were
also required to be tested in Tier II. We rewrote the two test notes to
clarify that only the plant species that exhibited the stated level of
the detrimental effect are required to be tested at Tier II.
Another commenter referred to the findings of the FIFRA SAP in 2001
when it convened to discuss the proposed NAFTA (North America Fair
Trade Act) Nontarget Plant Toxicity Tests. [Ref. 4] The FIFRA SAP
indicated that progression from Tier I to Tier II should be based on a
statistically significant effect > 10% relative to the control for
aquatic plants and between 50% to 25% for terrestrial plants. This
commenter recommended that, as a conservative approach, EPA should use
the 25% for progression from Tier I to Tier II for terrestrial plant
studies. For terrestrial plants, the Agency agrees that the progression
from Tier I to Tier II testing will remain 25% inhibition or greater.
However, effects seen at less than 25% may raise concerns for federally
listed threatened and endangered species, and additional testing at Tier
II may be needed to mitigate the presumption of risk to listed species.
4. Insect pollinator testing. EPA eliminated the requirement for a
honey bee subacute feeding study as the information from this test can
be covered under the field study requirement. The proposed rule listed
four requirements for testing of aquatic insects and terrestrial
predators and parasites. Even though EPA did not propose to delete
these requirements, continuing to include potential data requirements
that have not been routinely imposed and for which no guidelines have
been developed, serves no useful purpose. Therefore EPA eliminated
these four data requirements in the final rule.
The Agency also proposed to include additional use patterns and
exposure scenarios under the data requirement for the honey bee acute
contact toxicity study. Previously, the requirement was limited to
outdoor use patterns when the crop may be in bloom and thereby
attractive to honey bees. The change addresses not only blooming but
also pollen-shedding and nectar-producing parts of nontarget plants
that may be attractive to honey bees and may be in or near the site of
a pesticide application. The criteria for requiring the honey bee
residue study was corrected from an LD₅₀ value of < 1
microgram/bee for the acute contact study to < 11 micrograms/bee, as
originally published in 1982 (48 FR 53192).
There were several comments pertaining to the field study
requirement for pollinators concerning the criteria that the
requirement could be based on data from arthropods other than bees.
These commenters asked for clarification to confirm that the data
pertain solely to terrestrial and not aquatic arthropods. The test note
for the pollinator field study was modified to clarify this point.
Another comment concerned the designation of the acute contact toxicity
study as R for the aquatic uses, citing several application scenarios
or formulation types, such as direct application to water or granular
formulations, that would reduce exposure to honey bees. The Agency
agrees with the comment and changed the requirement for aquatic uses to CR.

XII. Discussion of Key Comments on Human Exposure Data Requirements
(Subpart K)

A. Applicator Exposure

A commenter recommended that EPA rely on surrogate data from other
agencies such as the Occupational Safety and Health Administration's
(OSHA) permissible exposure limits that are regulatory limits on the
amount of concentration of hazardous substances in the air. Other
commenters indicated that exposure data were available from several
reliable sources besides the Pesticide Handlers Exposure Database and
the Outdoor Residential Exposure Task Force mentioned in the proposed
rule. These commenters identified other task forces that have generated
exposure data--Indoor Residential Exposure Task Force, the Agricultural
Handlers Exposure Task Force, and the Agricultural Reentry Task Force.
The Agency assumes that the commenter is referring to Permissible
Exposure Limits (PELs) when he speaks of ``OSHA workplace exposure
limits.'' The Agency does consider regulatory levels set by other
authorities during risk assessment, including OSHA PELs; however, EPA
and OSHA have different legislative mandates. OSHA does not have the
authority under FIFRA to regulate pesticide exposures and therefore
does not set PELs for chemicals used solely for pesticides.
The Agency has a long history of relying on surrogate exposure data
and databases. To estimate occupational and residential exposures, the
Agency uses databases containing large numbers of measured values of
dermal and inhalation exposure for pesticide workers. Using these
measured data from one study/scenario as surrogate or generic data for
another study/scenario is appropriate since it is generally believed
for pesticides of low volatility that the physical parameters of the
handling and application process (e.g. the type of formulations, the
method of application, and the type of clothing), not the chemical
properties of the pesticide, control the amount of dermal and
inhalation exposure. In contrast, OSHA evaluates exposures on a site-
specific basis by collecting samples on workers and does not rely on
surrogate databases.
However, for certain types of pesticide formulations or use
scenarios, there is no exposure data, and therefore, it is not possible
to perform an occupational/residential risk assessment. This is
particularly one of the types of situations in which the Agency would
require chemical-specific exposure data.
Some commenters questioned the currency of several guidelines in
the context of dermal exposure and inhalation exposure data
requirements. EPA will consider the comments as its scientists work to
revise/update the guidelines. The Agency has reviewed and accepted many
studies that are not conducted in accordance with current guidelines,
but which serve its needs and provide suitable information for risk
assessment purposes. In addition, some guidelines have not been
finalized but are available in draft form. Notwithstanding such
flexibility, EPA intends to finalize these test draft guidelines by the
end of 2008.
EPA made no revisions in the final rule. EPA received other
comments on this topic and has responded in its Response to Comments
document in the docket for this rule.

B. Post-Application Exposure

EPA proposed changing several existing post-application data
requirements from CR to R, expanding the use sites that those data
requirements cover to include residential uses sites, and codifying
certain data that had been previously sought on a case-by-case basis.
Currently, EPA frequently conducts post-application exposure
assessments, particularly with regard to residential

[[Page 60948]]

exposures, based upon conservative extrapolations from generic data.
The new data will ensure that EPA can more realistically assess post-
application exposure. The possibility of using generic task force data
or modeling for dermal and inhalation exposure was suggested by many
commenters because some of the studies might place additional testing
burdens on formulators as to products that did not raise safety
concerns under very conservative modeling. EPA believes that modeling
and generic task force data would be acceptable absent any specific
problems. Registrants who are not members of task forces need to submit
their own data or otherwise satisfy the data requirements. Comments
about surrogate exposure data and the Task Forces that generate them
arose in the following data requirements: Product use information;
description of human activity; nondietary ingestion exposure; and
dislodgeable foliar residue dissipation and turf transferable residues.
Commenters also identified test guidelines that still exist only in
draft form and are absent from the list of OPPTS harmonized guidelines.
EPA agrees that these test guidelines need to be finalized and intends
to finalize them by the end of 2008.
EPA made no revisions in the final rule. EPA received other
comments on this topic and has responded to comments in its Response to
Comments document in the docket for this rule.

XIII. Discussion on Spray Drift Data Requirements (Subpart L)

EPA has transferred the contents of the spray drift section
(current Sec. 158.440) essentially unchanged into subpart L of part
158. The regulatory text of the spray drift sections is reprinted in
this final rule for clarity and completeness.

XIV. Discussion of Key Comments on Environmental Fate Data Requirements
(Subpart N)

A. Generic Issues

1. Data harmonization and lack of availability of current
guidelines. The Agency received several comments stating that the data
requirements for nontarget terrestrial and aquatic organisms, plants
and environmental fate testing should not be promulgated if the test
guidelines upon which the data requirements rely are not finalized. The
Agency recognizes the importance of the connection between these data
requirements and the guidance documents that provide information on how
the data requirements may be satisfied. Guidelines are scheduled to be
finished and available to the public by late 2007. Nonetheless,
Guidelines are guidance documents only, and the promulgation of data
requirements does not depend on the availability of guidance documents
for each group of guidelines.
2. Independent laboratory validation (ILV). Concerns were raised by
some commenters that the requirement to now have ILV of the chemistry
methods used for residue measurements in the ecological and
environmental fate field studies would add cost and time to these
studies. They view these studies as already required and conducted
under GLP 40 CFR part 160 for other data requirements. The requirement
for an ILV has been in effect since the 1990s. The ILV, as well as the
original method validation, is subject to the GLP.
3. Data requirements--i. Hydrolysis. The Agency received three
comments on the hydrolysis data requirement. Two comments questioned
the addition of indoor uses to the use patterns that require this
study. EPA included several sites that are considered indoor, but where
environmental exposure may be likely. These sites include agricultural
premises, in or around farm buildings, barnyards, beehives, and fish or
seafood processing premises. The expansion of the use patterns
requiring this study reflects concern about the potential movement of
pesticides and their degradates into the environment.
ii. Photodegradation, laboratory volatility and field volatility.
EPA proposed to expand the data requirement for photodegradation in air
adding all terrestrial, greenhouse, forestry and residential outdoor
use patterns. The Agency's rationale relates to the potential for
exposure to highly volatile pesticides in greenhouses, residential and
certain outdoor use situations. The Agency received three comments on
the expansion of the use patterns for this data requirement, asking for
additional guidance on the conditions that would trigger this data
requirement. EPA uses the measured vapor pressure of a chemical
compound or the chemical's Henry's Law Constant, as guides to the
chemical's volatility and the probability of its movement into the
atmosphere. Pesticides with vapor pressures >= 3.9 x 10-5 mm
Hg are considered to be of intermediate to high volatility under field
conditions and may become airborne and enter the environment [Ref. 7].
EPA received two comments on the test note for the photodegradation
in water data requirement which provided values for the electronic
absorption spectra for the pesticide at which the study is not
required. One comment asked for more specific guidance regarding the
absorbance of the hydrolysis mixture, and the other comment asked for
clarification about the structural identities of the hydrolysis
products. EPA believes the test note is clear, but the commenters
detailed concerns that could be addressed on an individual basis.
EPA proposed to change the designation of the requirement for the
photodegradation on soil study from conditionally required (CR) to
required (R) for terrestrial food crop and forestry uses patterns. The
Agency received one comment about this photodegradation requirement
that questioned the proposed change in classification as stated in the
proposed rule. EPA is codifying a long-standing practice of requiring
this study for terrestrial and forestry use patterns. The test note
explaining that the study is not required when the chemical is to be
applied only by soil injection or is incorporated in the soil has been
retained.
iii. Aerobic soil and aerobic aquatic metabolism. EPA proposed to
expand the use patterns that require the aerobic soil metabolism study
by including aquatic uses if the pesticide is applied to aquatic sites
that are intermittently dry. The aerobic aquatic metabolism study
requirements were expanded to include all terrestrial and forestry use
patterns, and to clarify its requirement for aquatic residential use
patterns. The Agency received five comments regarding the data
requirements for the aerobic soil metabolism study and the aerobic
aquatic metabolism study. The comments questioned the inclusion of
aquatic use sites such as rice paddies and cranberry bogs that are
intermittently dry for the soil metabolism study, and the inclusion of
all terrestrial and forestry uses patterns for the aquatic metabolism
study. They asked for further explanation of these changes. EPA
categorizes uses such as cranberry bogs and rice paddies as aquatic,
but such sites can be considered both aquatic and terrestrial depending
on timing and agronomic practices. As explained in the proposed rule,
both the aerobic aquatic and terrestrial studies are needed to better
characterize the fate of chemicals applied to aquatic sites that are
intermittently dry. Aquatic metabolism studies are needed for
pesticides applied terrestrially since these chemicals can be
transported, e.g., through run-off or spray drift, to water bodies.
Since the degradation or dissipation rates and pathways of pesticides
in aquatic systems can be different from those of terrestrial

[[Page 60949]]

systems, both soil metabolism and aquatic metabolism studies are needed
to fully describe the fate of pesticides that may be found in both
terrestrial and aquatic environments. In addition to being useful for
developing ecological risk assessments, this study is also valuable in
refining drinking water exposure estimates.
iv. Anaerobic soil and anaerobic aquatic metabolism. EPA proposed
to correct a technical error in current part 158 by reinstating the
requirement for the anaerobic soil metabolism study. The requirement
appeared in 40 CFR 158.290 prior to 1991, but a simple printing error
led to its omission from the CFR in 1991 and subsequent CFRs. The
twelve comments that the Agency received about the anaerobic metabolism
studies generally asserted that the anaerobic soil metabolism
requirement in the proposed rule constituted a new data requirement.
This data requirement was never intentionally removed from the CFR by
notice and comment rulemaking, and therefore is not considered a new
requirement.
EPA has continued to require the anaerobic soil study as needed,
notwithstanding its inadvertent omission from the CFR, but has also
upon occasion accepted the anaerobic aquatic study in lieu of the
anaerobic soil study. However, with the harmonization of the OPP
environmental fate guidelines with those of the OECD and with PMRA
under NAFTA agreements, and with the technical correction and
clarification of the requirements in this rule, this practice of
substituting the anaerobic aquatic study is no longer appropriate. In
the harmonized guidelines, the two studies use different test media and
redox conditions, so the results of these two studies will not
necessarily be comparable. Continuing to use the anaerobic aquatic
study when the Agency requires the anaerobic soil study will not fully
address Agency risk assessment needs.
The commenters were also concerned about the expansion of the
anaerobic aquatic metabolism requirement to include all terrestrial use
patterns, such that the applicants would be required to conduct two
anaerobic studies. This added requirement, in their estimate, would
have a significant impact, doubling the time of the anaerobic system
requirement. With this rule EPA now requires both anaerobic studies for
terrestrial uses where the pesticide is likely to move from the site of
application to nearby aquatic systems. Since the degradation or
dissipation rates and pathways of pesticides in aquatic systems can be
different from those of terrestrial systems, soil metabolism studies
alone may not be adequate to cover these terrestrial use patterns.
v. Soil mobility. EPA did not propose any changes to the data
requirement for soil mobility studies. However, the Agency received
three comments asking for clarification about which test type we prefer
to fulfill this data requirement. Therefore, in the final rule, we
added a new test note for the leaching and absorption/desorption data
requirement that explains which test procedure is preferred.
vi. Terrestrial, aquatic and forestry field dissipation studies.
EPA proposed to expand the use patterns that require the terrestrial
field dissipation study to include aquatic food crops and aquatic
nonfood uses when the pesticide is applied to aquatic sites that are
intermittently dry (rice and cranberries were given as examples).
Likewise, EPA proposed to expand the requirement for an aquatic field
dissipation study from solely aquatic use patterns to conditionally
include terrestrial use patterns as well. The third change the Agency
proposed with the field dissipation studies was to merge the long-term
field dissipation study into the terrestrial field dissipation study.
Instead of a separate long-term study, the field dissipation study
would be extended in duration for persistent pesticides to characterize
their decline curves. A number of commenters were very concerned about
the changes in the conditions and requirements for the dissipation
studies. One issue raised by several commenters pertained to the
likelihood that some chemicals and use patterns would now require two
separate field dissipation studies instead of just one, as was the
policy in the past. Several of the commenters asked for greater
justification and clarification of the test notes from the Agency to
explain the expansion of the data requirements. They also asked for
additional guidance on the triggers and endpoints of the long-term study.
EPA acknowledges that some pesticides, based on their environmental
fate profile and uses, may require both the aquatic and the terrestrial
field dissipation studies, but we estimated that the frequency of this
occurring is low. The Agency expanded the terrestrial field dissipation
data requirement to gain a better understanding of the patterns of a
pesticide's fate and transport when applied to crops that grow in both
flooded and dry conditions in one growing season. This decision was
endorsed by the FIFRA SAP in 1994. The data provided by the aquatic
field study for terrestrial applications will provide data necessary to
understand the fate of a terrestrially applied pesticide that has a
high potential to enter aquatic environments. Data from these studies
can reduce potential overestimation of exposure and risk and can
confirm assumptions of low levels of toxic degradates. The test note
for the aquatic study is based on harmonized language with PMRA under
NAFTA, and provides the details that must be considered to determine if
an aquatic (sediment) dissipation study is necessary for a terrestrial use.
One commenter recommended that to be consistent with the
terrestrial field dissipation data requirement, the Agency should state
that aquatic food crops, like rice and cranberry uses, which are
managed to have a dry-land period for production, now must be conducted
under the Terrestrial Field Dissipation (TFD) requirement. EPA agrees
with this comment and has amended the test note for this study. The TFD
guideline is available on the websites of EPA and PMRA.
EPA changed the requirement for the forestry dissipation study from
required to conditionally required for pesticides used in forests. The
Agency received five comments expressing the concern that with this
change it is no longer clear what conditions of pesticide use in
forestry would trigger this requirement. The Agency made the change
because these studies are very difficult to conduct and very difficult
to interpret. The trend over the past few years has been to rely on the
terrestrial field dissipation studies for forestry uses. If this
terrestrial dissipation study cannot assess all of the major routes of
dissipation, the forestry study will be required.
The Agency did not propose any changes in the requirement for a
field dissipation study for combination and tank mixes. Three comments
identified the test note for this study as vague and with no useful
information. They suggested that the test note be revised to clarify
when this data requirement is needed, and the relevance of this data.
EPA took their recommendation and rewrote this test note to clarify
that this study may be triggered if there is specific evidence that the
presence of one pesticide can affect the dissipation characteristics of
another pesticide when applied simultaneously or serially.
vii. Accumulation studies. EPA proposed to change the conditions
under which the accumulation in fish and accumulation in aquatic
organisms would be required. EPA received eight

[[Page 60950]]

comments regarding the fish and nontarget organism accumulation
studies. Three of the commenters suggested that this data requirement
be placed in proposed subpart E (now subpart G), Terrestrial and
Aquatic Nontarget Organism Data Requirements, and not subpart N. There
were two comments stating that test note 10 was well written, and
should also apply to the aquatic nontarget organism accumulation study
requirement in lieu of test note 11, in the environmental fate data
table. They suggested that this test note is also appropriate for the
three accumulation studies in proposed subpart E, bioavailability,
biomagnification and toxicity of aquatic organisms.
The Agency agrees with the comments, and moved the two studies
under proposed subpart N, Accumulation in Fish and Accumulation in
Aquatic Nontarget Organisms to subpart G, under the data requirement
for aquatic organisms - bioavailability, biomagnification and toxicity.
Therefore, all the ecological and fate requirements related to
bioaccumulation are located solely in subpart G. We also agree with the
comment that the language of Note 10 (Accumulation in Fish) in the
proposed environmental fate data table is appropriate for the
Accumulation in aquatic nontarget organisms data requirement in subpart
G. Test note 10, ``Not required when the octanol/water partition
coefficients of the pesticide and its major degradates are less than
1,000; or there are no potential exposures to fish and other nontarget
aquatic organisms; or the hydrolytic half-life is less than 5 days at
pH 5, 7, and 9.'' was moved to subpart G and renumbered as test note
19. This test note replaces draft test note 21 in proposed subpart E
(now G).
viii. Ground water monitoring. EPA proposed to conditionally
require a groundwater monitoring study for all terrestrial and forestry
uses. EPA received six comments on the proposed new data requirement
for ground water monitoring. This study is conditionally required for
all terrestrial uses patterns and all forestry uses patterns. Because
of the newness of this data requirement we received several comments
questioning the conditions that would trigger this requirement. Three
additional commenters asked for better guidance in the test note for
this requirement. One of the commenters additionally expressed the
opinion that the conditions in the test note for this study should
focus on the results of the field dissipation studies rather than
laboratory studies. The Agency affirms that the conditions described in
the test note include both laboratory and field data, but points out
that this test note also describes many factors that must be considered
to determine if this requirement is triggered. It is quite complex and
difficult to fully explain all possible scenarios that could trigger a
groundwater monitoring study. In summary, EPA uses a weight-of-evidence
approach that incorporates the results of the other environmental fate
studies plus use patterns along with factors specific to the pesticide
of concern.
In addition to these use patterns, one commenter recommended that
the ground water monitoring data requirement be conditionally required
(CR) for residential outdoor uses. We agree that there may be certain
cases where a ground water monitoring study would be needed to inform a
risk management decision for residential outdoor use pesticides. In the
final rule, EPA made this study CR, but we expect that the need for
this study is likely to be rare.
ix. Degradates. EPA received six comments regarding the need and
potential triggers to test degradate substances in the laboratory
studies. They all asked for clarification of the potential requirement.
The Agency does not require degradate substances to undergo the set of
fate data requirements as it requires of the active ingredients. The
set of fate studies as currently designed and conducted with the TGAI
provide adequate information on the formation, decline and mobility of
the major degradates. Testing with degradates as the primary test
substance is not required for the environmental fate data requirements.

XV. Discussion of Key Comments on Residue Chemistry Data Requirements
(Subpart O)

EPA proposed codifying the residue chemistry data requirements that
have arisen since the 1984 regulations were issued and clarifying and
simplifying the 1984 data requirements. EPA has responded to comments
in its Response to Comments document in the docket for this rule.
Some commenters viewed the proposed residential outdoor use pattern
as an expansion of requirements for home garden uses and believed such
uses do not fall under the scope of the FFDCA. EPA did not intend to
expand the data requirement for residential uses; the current practice
is to require data based on residential use only if the corresponding
agricultural use on that crop is not approved or if the residential use
is likely to have higher residues based on increased application rates
or shorter preharvest intervals. EPA agrees that FFDCA does not apply
to commodities that are not introduced into interstate commerce and
tolerances are not established for residues on home garden crops. EPA
does assess under FIFRA whether any adverse effects (e.g. dietary
risks) could occur.
Some commenters requested a definition of indoor food use. EPA
considers indoor food uses to be primarily pesticide treatment in food
areas of food handling establishments (FHEs). FHEs include food
servicing, food manufacturing, and food processing. Crack, crevice and
space treatments are examples of application areas where pests hide or
through which they enter a building. The FHE uses described above fall
under the auspices of FFDCA and generally require residue data and
tolerances (or exemptions from tolerances) for residues of conventional
pesticides in food.
1. Tolerances and tolerance exemptions. A commenter requested a
more complete definition of tolerance because the proposed definition
implies that all the data requirements apply to applications for a
tolerance exemption. EPA agrees with the commenter that the proposed
rule implies that all the residue chemistry data requirements and
conditions apply to tolerance exemptions, which is not the case. In
many instances such data are not needed for an exemption due to the low
toxicity of the pesticide or the ability to make a safety finding using
theoretical dietary exposure estimates. The Agency added Test Note 25
to most of the data requirements to clarify when a residue chemistry
data requirement may not be required for an exemption from a tolerance.
2. Storage stability. EPA proposed separately identifying the
requirement to validate the Magnitude of the Residue studies.
Commenters believed that requiring an explicit storage stability study
was too rigid and suggested the registrant retain the option to include
this data in a stand-alone report or in the magnitude of residue (MOR)
report. As explained in the proposed rule, the separation of the
storage stability regime was intended solely to give visibility to a
requirement often overlooked in the residue studies. The Agency would
not object to the storage stability data being in the MOR report in
cases where the data were actually generated concurrently as part of
the MOR study.
3. Multiresidue methods. There were no comments on the proposed
codification of the multiresidue methods data requirement as a separate
requirement; multiresidue methodology

[[Page 60951]]

data are currently part of the Residue Analytical Method requirement.
4. Nature of the residue in livestock. A commenter questioned EPA's
basis for requiring this study when residues are not found in livestock
feed. The primary reason for requiring the livestock metabolism study
when measurable residues are not found on feed items from labeled uses
is to assess the potential bioconcentration of the pesticides and
metabolites of concern in animal products. Although residues in feed
may not be quantifiable, EPA needs assurance that residues do not
concentrate to measurable levels when livestock ingest the treated feeds.
5. Residue analytical methods. EPA proposed changing the test
substance from TGAI and metabolites to residue of concern and proposed
requiring an ILV; the latter is a policy that has been in place since
1988. Commenters varied on the value of the ILV of tolerance
enforcement methods. EPA believes that the ILV requirement helps ensure
that methods are clearly written and include detailed descriptions of
all necessary steps. Due to resource limitations, EPA chemists can
validate only a limited number of methods so the Agency relies greatly
on the ILV as part of the review process to determine whether an
adequate tolerance enforcement method is available.
A commenter felt that it would be appropriate to address
radiovalidation under both the Nature of the Residue and the Analytical
Method entries. While EPA views radiovalidation as an element of the
Analytical method requirement, EPA believes the issue may be addressed
in either the metabolism study report or the method validation report.
Radiovalidation would not be necessary when the extraction procedures
in the method and metabolism studies are identical or very similar and
the metabolism study was deemed acceptable in terms of the levels of
residues extracted and characterized/identified.
6. Magnitude of the residue in processed food and feed, potable
water, fish, and irrigated crops. EPA proposed changing the test
substance from EP to TEP because it believes that, in general,
variations of the formulation will not affect the behavior of the
active ingredient. Commenters believed that changing the test substance
from EP to TEP would cause an increase in the residue data as each
formulation type would need to be tested. EPA notes that the existing
EP requirement from the 1984 rule would require residue data for each
end-use product if it were to be implemented. In actual practice, EPA
has been administratively following a TEP-based approach of grouping
EPs into formulation classes that requires considerably less data than
an EP approach. The rule revision merely codifies this current practice.
7. Magnitude of the residue in meat, milk, poultry, and eggs. A
verbal request for clarification at the May 3-4, 2005, workshop on the
proposed rule prompted EPA review of the test note pertaining to the
nature of the residue in livestock. As a result, the test note was
revised to indicate that data are required if pesticide residue are
present in or on livestock feed items or intentionally added to
drinking water. These studies may not be required if the metabolism
studies show negligible transfer of the residues of concern at the
maximum expected exposure.
A commenter questioned the necessity of conducting separate feeding
studies for separate metabolites. Only when the chemical structure of
the plant metabolite raises concerns over potential bioconcentration
and/or increased toxicity would EPA require additional animal studies
dosing with the plant metabolite. The study is rarely requested, but
EPA prefers to maintain the proposed test substance and footnote to
alert applicants to the possibility of such data.
8. Confined and field rotational crops. EPA proposed moving the
data requirements for confined and field rotational crops from an
environmental fate requirement to residue chemistry requirement since
these are primarily a dietary risk assessment concern. Commenters
suggested EPA describe in detail the triggers for progressing to the
Tier II and Tier III studies and explain the data needed to establish
tolerances for inadvertent residues in rotational crops. Upon further
consideration, Test Notes 7 and 23 were revised to put the focus on
residue uptake in rotational crops as opposed to residues in food. In
addition, Test Note 24 was added to the crop field trial study to
address situations where tolerances are needed on rotational crops.

XVI. Discussion of Data Requirements Not Affected by this Final Rule

This final rule does not apply to the data requirements for the
registration of: biochemical pesticide products; microbial pesticide
products; or antimicrobial pesticide products. EPA proposed to limit
the applicability of revised part 158 to conventional pesticides in
anticipation of additional revisions tailored to biochemical,
microbial, and antimicrobial pesticides. Elsewhere in today's Federal
Register, EPA is promulgating a final rule establishing data
requirements for biochemical and microbial pesticides. For a discussion
of the applicability of part 158 data requirements to antimicrobial
pesticides, see Unit II.C. One commenter believed that the promulgation
of data requirements for antimicrobial pesticides should precede the
promulgation of data requirements for conventional pesticides. Because
EPA believes that a revised part 158 provides an important and crucial
framework for the other types of pesticides, EPA is adopting its
proposal to limit the applicability of revised part 158 to conventional
chemicals.
EPA has transferred the contents of the sections that were not
addressed in the proposal essentially unchanged into the revised part
158, i.e., spray drift (subpart L) and product performance (subpart E).
The regulatory text of the sections for which no changes were proposed
is reprinted in this final rule for clarity and completeness.

XVII. Discussion of Key Comments on International Harmonization of Data
Requirements

The preamble to the proposed rule discussed the Agency's extensive
consultation and harmonization efforts with Canada and the OECD. Both
the Pest Management Regulatory Agency (PMRA) and the EU submitted
comments in response to the Agency's proposed rule. Both provided
extensive comparisons of data requirements between the United States
and their respective requirements. The PMRA stated that, in virtually
every scientific discipline, the requirements exhibit a high degree of
harmonization with the Canadian requirements. The EU, whose comments
were based on their draft data requirements, noted that the U.S.
requirements are not completely compatible with the corresponding EU
data requirements. Nonetheless, the data requirements of the United
States and the EU are comparable in many cases, with some exceptions.
Both PMRA and the EU highlighted areas where continued collaboration
toward development of a common testing strategy would be useful. EPA
will continue to work with Canada and the EU through the OECD to
harmonize data requirements, testing protocols and methodologies, and
to promote work-sharing opportunities.

XVIII. Discussion of Key Comments on Animal Welfare Concerns

EPA received 53 comments, primarily from individuals, supporting
its proposal to eliminate the 1-year dog study from the core toxicology
data requirements and urging increased minimization of animal testing,

[[Page 60952]]

adoption of alternative non-animal testing, and revision of test
strategies to incorporate innovations such as the one developed by
ILSI/HESI.
The Agency is committed to avoiding unnecessary animal testing
while taking into consideration principles of sound science and the
requirements of FIFRA to protect humans and the environment. For
example, chemicals with a demonstrated pH indicating a strongly acidic
or alkaline substance need not be tested in animals to screen for eye
or skin corrosivity potential. EPA will consider data from a validated
in vitro corrosivity assay as a screen to judge whether a chemical may
be corrosive to the eye or skin. Making this determination may reduce
or avoid subsequent actual testing on animals. EPA is considering how
the number of longer term studies might be reduced by examining the
possibility to combine toxicological endpoints from more than one
study. The Agency already has bridging and batching policies in place
to allow the use of acute toxicity, sensitization, or irritation test
data on products to be used to support other products.
EPA is working closely with 15 other U.S. agencies to advance the
validation and adoption of alternative test methods through the Federal
Interagency Coordinating Committee on Validation of Alternative Methods
(ICCVAM) (http://iccvam.niehs.nih.gov), established by the National
Institute of Environmental Health Sciences. ICCVAM works towards:
1. Encouraging the reduction of the number of animals used in
testing, where possible.
2. Seeking opportunities to replace test methods requiring animals
with alternative test methods when validated acceptable alternative
methods are available.
3. Optimizing animal use by test method refinement.
ICCVAM, together with the National Toxicology Program Interagency
Center for the Evaluation of Alternative Toxicological Methods
(NICEATM), convenes independent peer review panels, as appropriate, to
evaluate the validation status of proposed test methods and coordinates
expert panel meetings or workshops for validation or test method-
related activities. ICCVAM has developed guidelines for the nomination
and submission of new, revised, and alternative test methods
(http://iccvam.niehs.nih.gov/SuppDocs/submission.htm).
The Agency has also co-sponsored a number of major workshops to
advance alternative test method activities. EPA, ICCVAM, and NICEATM
collaborated in the development of performance standard concepts for
validated alternative tests (May 2004 NIH Publication No. 04-4510 [Ref.
6]. Recently, at the request of EPA, ICCVAM/NICEATM coordinated the
review of four in vitro test methods for identifying ocular corrosives
and severe irritants. EPA is incorporating new alternative tests and
testing strategies into its programs to reduce animal use (e.g. in
assessing acute oral toxicity [guideline 870.1000 revised and 870.1100
revised], dermal sensitization [guideline 870.2600 revised], and dermal
irritation/corrosion).
The Agency also recognizes the need for timely periodic review,
revision and/or supplementation, as applicable, of its test guidelines.
As new tests and test batteries are validated, the Agency can present
them to the FIFRA SAP to review their applicability in meeting
regulatory needs. EPA can seek comment from the SAP on test guideline
or other test method-related issues, depending on the circumstances. As
other appropriate alternative or in vitro methods become available,
they will be considered for addition to the Agency's test guidelines.
Finally, the Agency is committed to a more hypothesis-based testing
paradigm by advancing in silico, in vitro, and efficient focused in
vivo testing so that chemicals are tested in animals for those
endpoints most relevant to each chemical's exposure or intended use.
The Agency acknowledges that substantial work remains to achieve this
long term goal, but the Agency is also working on the important short-
term goal to make the existing animal testing paradigm more efficient,
reliable, and responsive to its risk assessment and management needs.
The Agency has undertaken several activities to move towards a more
efficient animal paradigm, including analyzing and updating the current
data requirements. As evidenced by this final rule, the Agency has
completed its analysis of dog toxicity studies and determined that the
1-year dog study can now be omitted as a core data requirement for
pesticides.
EPA is committed to revise part 158 data requirements to
incorporate new science. In the meantime, the existing regulations
provide flexibility to implement any updated, new or novel testing
schemes, on a case-by-case basis, as appropriate, until the changes are
codified.

XIX. Water Quality Issues

EPA received comments from four California water treatment
authorities and two California cities' environmental agencies. The
comments centered on their strong recommendations that FIFRA data
requirements meet the needs of the Clean Water Act (CWA) regulatory
program and should consider urban water quality issues. California
water-treatment authorities questioned the adequacy of the Agency's
assessment of risks with regard to water quality considerations
including: use of aquatic toxicity data, surface water quality studies,
and urban uses of pesticides, particularly when these uses result in
pesticide residues in receiving waters from storm sewers or sewage
treatment plants.
The goal of the 158 data requirements is to require the registrants
to submit scientifically sound data, conducted according to recommended
guidelines to enable the scientists in the Pesticide Program to conduct
ecological risk assessments on a national scale. EPA believes the 158
data requirements are sufficient to conduct high quality risk
assessments. EPA's evaluation and registration of pesticides under
FIFRA take into account impacts on the aquatic environment. Also, under
FIFRA, EPA has the authority to impose a specific restriction on the
use of a pesticide in a particular geographic location. Such a
restriction will appear in or be referenced on the labeling of all
products distributed anywhere in the United States, but will affect the
use of the pesticide only when it occurs within the identified
geographic area. Although EPA has not routinely imposed labeling
restrictions on pesticides to prevent degradation of high quality
water, it could do so. As part of its reregistration and registration
review programs, EPA's Pesticide and Water Offices are working more
closely together to identify sites where water quality standards are
not being met as a result of the presence of unacceptable levels of
pesticide residues, and the Pesticide Office considers those issues in
its reviews. OPP provides State and Tribal pesticide lead agencies with
water quality grant funds in order to develop and carry out management
programs to protect ground and surface water resources from pesticide risks.

XX. Endangered Species

Incidental to its proposed data requirements for conventional
pesticides, EPA discussed the possibility of future data and
information needs to develop and/or refine risk assessments for
endangered species. EPA did not propose any data requirements specific
to endangered species, but described its current level of information
and data usage. EPA requested comment on the value and

[[Page 60953]]

utility of location and usage information, and on additional types of
research that might yield greater refinement in risk assessments for
endangered species.
EPA appreciates the response it received from commenters on these
topics, primarily from industry task forces and associations. As
endangered species data requirements were not proposed, EPA has not
responded to the comments as part of this final rule, but will consider
them in the context of its ongoing risk assessments. If EPA finds that
it needs to amend part 158 to normalize endangered species data
requirements, it will consider these comments in the development of a
future proposed rule.

XXI. Implementation

After the effective date, the data requirements in this final rule
will apply to all new registrations of conventional pesticides. The
Agency does not intend to apply these requirements retroactively to all
existing pesticide registrations, but the Agency may find it necessary
to call in some data on certain existing registrations, as warranted by
emerging risks of concern on particular pesticides or as a result of
possible programmatic changes and priorities on existing pesticides.
FIFRA sec. 3(c)(2) provides EPA broad authority, before and after
registration, to require scientific testing and submission of the
resulting data to the Agency by registrants and applicants of pesticide
products. Although the data requirements in part 158 are imposed
primarily as a part of initial registration, EPA is authorized under
FIFRA sec. 3(c)(2)(B) to require a registrant to develop and submit
additional data necessary to maintain a registration. This post-
registration data call-in authority recognizes that the scientific
underpinnings of risk assessment change, and is another means by which
EPA may keep data for use in risk assessment current with evolving science.
EPA will consider as part of its review of a pending application
whether and how to apply these updated data requirements. EPA expects
that few changes will be needed, as these updated requirements reflect
current practice.
Some commenters believed the revised data requirements in 40 CFR
part 158 had to be finalized before registration review could be
implemented. While the part 158 data requirements and registration
review are related, they are not inextricably linked but rather proceed
along parallel tracks. The Agency makes case-by-case data
determinations as standard program practice so the registration review
program now being implemented can operate effectively in the absence of
updated data requirements. The updated data requirements in this final
rule will provide applicants with more clarity and transparency in the
information presented in part 158.

XXII. References

The Agency established an official docket for this rulemaking under
Docket ID No. OPP-2004-0387. All of the documents that have been
included in that docket are available at http://www.fdms.gov. The
following is a list of the documents that are specifically referenced
in this final rule. Not all docket materials are available
electronically but all publicly available docket materials are
available through the Docket facility described under ADDRESSES.
1. Barton, H.A., Pastoor, T.P., Baetcke, K., Chambers, J.E.,
Diliberto, J., Doerrer, N.G.,Driver, J.H., Hastings, C.E., Iyengar, S.,
Krieger, R., Stahl, B., and Timchalk, C. The acquisition and
application of absorption, distribution, metabolism, and excretion
(ADME) data in agricultural chemical safety assessments. January 2006.
Critical Reviews in Toxicology, v. 36, 9-35.
2. Carmichael, N.G., Barton, H.A., Boobis, A.R., Cooper, R.L.,
Dellarco, V.L., Doerrer, N.G., Fenner-Crisp, P.A., Doe, J.E., Lamb,
J.C., and Pastoor, T.P. Agricultural chemical safety assessment: a
multi-sector approach to the modernization of human safety
requirements. January 2006. Critical Reviews in Toxicology. v. 36, 1-7.
3. Cooper, R.L., Lamb, J.C., Barlow, S.M., Bentley, K., Brady,
A.M., Doerrer, N.G., Eisenbrandt, D.L., Fenner-Crisp, P.A., Hines,
R.N., Irvine, L., Kimmel, C.A., Koeter, H., Li, A.A., Makris, S.L.,
Sheets, L., Speijers, G.J.A., and Whitby, K. A tiered approach to life
stages testing for agricultural chemical safety assessment. January
2006. Critical Reviews in Toxicology. v. 36, 69-98.
4. Davy, M., Petrie, R., Smrchek, J., Kuchnicki, T., and Francois,
D. Proposal to Update Nontarget Plant Toxicity Testing under NAFTA:
Scientific Advisory Panel Briefing. Washington, DC: Office of
Prevention, Pesticides, and Toxic Substances, U.S. Environmental
Protection Agency and Health Canada - Pest Management Regulatory
Agency. June 27-29, 2001.
http://www.epa.gov/scipoly/sap/meetings/2001/june/sap14.pdf.
5. Doe, J.E., Boobis, A.R., Blacker, A., Dellarco, V.L., Doerrer,
N.G., Franklin, C., Goodman, J.I., Kronenberg, J.M., Lewis, R.,
McConnell, E.E., Mercier, T., Moretto, A., Nolan, C., Padilla, S.,
Phang, W., Solecki, R., Tilbury, L., van Ravenswaay, B., and Wolf, D.C.
A tiered approach to systemic toxicity testing for agricultural
chemical safety assessment. January 2006. Critical Reviews in
Toxicology. v. 36, 37-68.
6. Interagency Coordinating Committee on the Validation of
Alternative Methods and the National Toxicology Program Interagency
Center for the Evaluation of Alternative Toxicological Methods.
Recommended Performance Standards for In Vitro Test Methods for Skin
Corrosion. NIH Publication No. 04-4510. May 2004.
http://iccvam.niehs.nih.gov/dermal/epiderm/ps/ps044510.pdf.
7. Kennedy, J.M. and Talbert, R.E. Comparative persistence of
dinitroaniline-type herbicides on the soil surface. 1977. Weed Science,
v. 25(5), 373-381.
8. Mineau, P., Baril, A., Collins, B.T., Duffe, J., Joerman, G. and
Luttik, R. Pesticide acute toxicity reference values for birds. 2001.
Review of Environmental and Contamination Toxicology, v. 170, 13-74.
9. Schafer, E.W. and Brunton, R.B. Indicator bird species for
toxicity determinations: is the technique usable in test method
development? 1979. Vertebrate Pest Control and Management Materials
(American Society for Testing and Materials Special Technical
Publication 680), pp. 157-168.
10. U.S. Environmental Protection Agency. A Comparison of the
Results of Studies on Pesticides from 1- or 2-Year Dog Studies with Dog
Studies of Shorter Duration; a set of scientific issues being
considered by the EPA, May 5 and 6, 2005, FIFRA Scientific Advisory
Panel Meeting, held at the Holiday Inn-Rosslyn at Key Bridge,
Arlington, Virginia. Washington, DC: U.S. Environmental Protection
Agency. May 2005.
11. U.S. Environmental Protection Agency. Economic Analysis of the
Change in the Data Requirements Rule for Conventional Pesticides.
Washington, DC: Biological and Economic Analysis Division, Office of
Pesticide Programs, U.S. Environmental Protection Agency. November 7, 2006.
12. U.S. Environmental Protection Agency. Length of Dog Toxicity
Study(ies) that is Appropriate for Chronic RfD Determinations of
Pesticide Chemicals. Washington, DC: Health Effects Division, Office of
Pesticide Programs, U.S. Environmental Protection Agency. March 20,
2006.
13. U.S. Geological Survey. Pesticides in stream sediment and
aquatic biota: current understanding of distribution

[[Page 60954]]

and major influences. (Fact Sheet 092-00) August 24, 2000.
http://ca.water.usgs.gov/pnsp/rep/fs09200/.
14. Letter from Dr. Maurice Zeeman, U.S. National Coordinator, OECD
Test Guidelines Program, to Dr. Eisaku Toda, Environment, Health, and
Safety Division, OECD/Environment Directorate, regarding the U.S.
comments received in response to requested review of the proposed OECD
Test Guideline 223: Avian Acute Oral Toxicity Test. March 24, 2003.

XXIII. FIFRA Review Requirements

In accordance with FIFRA sec. 25(a), a draft of this final rule was
submitted to the FIFRA SAP, the Secretary of Agriculture and
appropriate Congressional Committees. The FIFRA SAP waived its review
of this final rule because the significant scientific issues involved
have already been reviewed by the SAP and additional review isn't
necessary.

XXIV. Statutory and Executive Order Reviews

A. Executive Order 12866

Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), the Office of Management and
Budget (OMB) has determined that this action is a significant
regulatory action because it might raise novel legal or policy issues
arising out of legal mandates, the President's priorities, or the
principles set forth in the Executive Order. Accordingly, EPA submitted
this action to OMB for review under Executive Order 12866 and any
changes made in response to OMB recommendations have been documented in
the docket for this action as required by sec. 6(a)(3)(E) of the
Executive Order.
In addition, EPA prepared an analysis of the potential costs and
benefits associated with this action, entitled ``Economic Analysis of
the Changes in the Data Requirements Rule for Conventional Pesticides''
[Ref. 11]. A copy of the analysis is available in the docket for this
action.
This final rule is similar to the proposed rule except that some
data requirements will no longer be required. As such, the estimated
annual cost of this final rule will be less than the estimated annual
cost of the proposed rule. The estimated costs for the data
requirements that will no longer be required are:
1. Chronic oral-non-rodent. This test was required as part of the
baseline requirements. The cost of this test is approximately $950,000
and was recently required an average of almost 18 times per year for
the entire industry. Since this test will no longer be required, the
estimated cost of this rule decreased from the proposed estimate by
almost $16.6 million per year.
2. Special toxicity tests. Three special toxicity tests, which were
expected to be required about 1% of the time, will no longer be
required. These tests are:
• Scheduled Controlled Operant Behavior,
• Peripheral Nerve Function,
• Neurophysiology: Sensory Evoked Potentials.
In addition, some of the test notes associated with the Ecological
Effects data requirements have been revised. These revisions will
slightly reduce the percent of time these data requirements may be
imposed, resulting in a slight reduction of the cost of the rule.
However, these costs were not re-estimated because of the expected
minimal impact. As a result of these changes, the estimated annual
incremental cost of the final rule is expected to be about $33.6
million for the industry. The elimination of the toxicity tests as
described above reduces the estimated cost of the rule by almost $17
million.
This cost reduction also applies to the high-cost option (require
data 100% of the time). The low-cost option (codification of current
practice) is the same in the proposed and final rule. It is no longer
the lowest cost option under the final rule because current practice
retains the data requirements that were eliminated in the final rule.
Since the expected overall impact of this final rule on businesses is
expected to be small, the Agency believes that the effect on the
availability of pesticides to users is not likely a deleterious one. On
balance, the Agency believes that the cost of the rule is justified by
the benefits from the enhanced protection of human health and the
environment.

B. Paperwork Reduction Act

The information collection activities related to the submission of
data to EPA in order to register a conventional pesticide product are
already approved by OMB under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq. This action does not impose any new information
collection burden. The information collection activities are already
approved by OMB under the following existing ICRs:
1. The activities associated with the establishment of a tolerance
are currently approved under OMB Control No. 2070-0024 (EPA ICR No. 0597);
2. The activities associated with the application for a new or
amended registration of a pesticide are currently approved under OMB
Control No. 2070-0060 (EPA ICR No. 0277);
3. The activities associated with the generation of data for
reregistration are currently approved under OMB Control No. 2070- 0107
(EPA ICR No. 1504); and
4. The activities associated with the generation of data for
experimental use permits are currently approved under OMB Control No.
2070-0040 (EPA ICR No. 0276).
Copies of these OMB-approved Information Collection Request (ICR)
may be obtained from Susan Auby, Collection Strategies Division; U.S.
Environmental Protection Agency (2822T); 1200 Pennsylvania Ave., NW,
Washington, DC 20460 or by calling (202) 566-1672.
Under the PRA, ``burden'' means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.
An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number, or is otherwise required to submit
the specific information by a statute. The OMB control numbers for
EPA's regulations codified in Title 40 of the Code of Federal
Regulations, after appearing in the preamble of the final rule, are
further displayed either by publication in the Federal Register or by
other appropriate means, such as on the related collection instrument
or form, if applicable. The display of OMB control numbers in certain
EPA regulations is consolidated in a list at 40 CFR 9.1.
For the ICR activity contained in this final rule, in addition to
displaying the applicable OMB control number in this Unit, the Agency
is amending the table in 40 CFR 9.1 to list the OMB control number
assigned to the collection activities in this rulemaking. Due to the
technical nature of the table, EPA finds that further notice and
comment about amending the table is unnecessary. As a result, EPA finds
that there is good

[[Page 60955]]

cause under section 553(b)(B) of the Administrative Procedures Act
(APA), 5 U.S.C. 553(b)(B), to amend the table in 40 CFR 9.1 without
further notice and comment.

C. Regulatory Flexibility Act

Pursuant to section 605(b) of the Regulatory Flexibility (RFA), 5
U.S.C. 601 et seq., the Agency hereby certifies that this rule will not
have a significant adverse economic impact on a substantial number of
small entities. Small entities include small businesses, small
organizations, and small governmental jurisdictions. For purposes of
assessing the impacts of today's rule on small entities, small entity
is defined as: (1) a small business engaged in the manufacture of
pesticide and other agricultural chemicals with 500 employees or fewer
as defined by NAIC code 325320; (2) a small governmental jurisdiction
that is a government of a city, county, town, school district or
special district with a population of less than 50,000; and (3) a small
organization that is any not-for-profit enterprise which is
independently owned and operated and is not dominant in its field. EPA
has determined that this final rule does not impact any small
governmental jurisdictions or any small not-for-profit enterprise
because these entities are rarely pesticide applicants or registrants.
The small entities directly regulated by this final rule are small
manufacturers of pesticides and other agricultural chemicals.
Since the expected incremental cost of the final rule is about
$33.6 million, which is about 33% less (almost 17 million less) than
what was estimated for the proposed rule, the potential impacts on
small businesses in the final rule would be less than what was
estimated for the proposed rule. The small business impacts for the
final rule were not re-estimated since they were not significant under
the proposed rule and will therefore be even less significant under the
final rule.
Based on the Economic Analysis for the proposed rule, of the 61
firms that might be impacted by this final rule, EPA had estimated that
2.4% are likely to experience a cost increase of 1% or more of gross
sales. A cost increase of 3% or more of gross sales is expected to be
experienced by 1.6% of the potentially impacted small firms.
Although this final rule will not have a significant economic
impact on a substantial number of small entities, EPA nonetheless has
tried to reduce the impact of this rule on small entities. EPA believes
that the users most in need of clarity are the infrequent, generally
small applicants, whose data requirements are in many cases limited to
enduse product data of various types. Smaller follow-on or me-too
registrants are often required to generate only product-specific
chemistry data, acute toxicity data, and efficacy data. These
applicants will benefit by the restructured part 158 so they don't have
to search for applicable data requirements by sifting through
voluminous data requirements that may be satisfied by the formulators'
exemption, citation, or offer-to-pay procedures. EPA has restructured
the subparts to place the data requirements applicable to the bulk of
applications (new end-use and me-too products) towards the beginning of
part 158 to make the regulation more user-friendly.

D. Unfunded Mandates Reform Act

Under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA),
Public Law 104-4, EPA has determined that this action does not contain
a Federal mandate that may result in expenditures of $100 million or
more for State, local or tribal governments, in the aggregate, or on
the private sector in any 1 year. The annual costs associated with this
action are estimated to total about $33.6 million to applicants and
registrants. These costs represent the incremental costs due to the
additional or modified data requirements contained in this action.
Since State, local, and tribal governments are rarely pesticide
applicants or registrants, this rule is not expected to affect small
governments. Thus, today's rule is not subject to the requirements of
sections 202 and 205 of the UMRA.

E. Executive Order 13132

Under Executive Order 13132, entitled Federalism (64 FR 43255,
August 10, 1999), EPA has determined that this final rule does not have
federalism implications because 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 government, as specified
in Executive Order 13132. Since States or local governments are rarely
pesticide applicants or registrants, this final rule may seldom affect
a State or local government. Thus, Executive Order 13132 does not apply
to this rule.
In the spirit of Executive Order 13132, and consistent with EPA
policy to promote communications between EPA and State and local
governments, EPA specifically solicited comment on the proposed rule
from State and local officials. EPA did not receive comments on
federalism. EPA did receive comments on substantive parts of the rule
from State governments and these are addressed elsewhere.

F. Executive Order 13175

Under Executive Order 13175, entitled Consultation and Coordination
with Indian Tribal Governments (59 FR 22951, November 6, 2000), EPA has
concluded that this rule does not have tribal implications because it
will not have any affect on tribal governments, on the relationship
between the Federal government and the Indian tribes, or on the
distribution of power and responsibilities between the Federal
government and Indian tribes, as specified in the Executive Order. At
present, no tribal government holds, or has applied for, a pesticide
registration. Thus, Executive Order 13175 does not apply to this rule.

G. Executive Order 13045

Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997) does not apply to this action because it is not economically
significant as defined in Executive Order 12866, and because the Agency
does not have reason to believe the environmental health or safety
risks addressed by this action present a disproportionate risk to
children. This rule does not establish an environmental standard that
will have a negatively disproportionate effect on children. This rule
is intended to provide added protection for children from pesticide
risk. EPA will use the data and information obtained by this action to
carry out its mandate under FFDCA to give special attention to the
risks of pesticides to sensitive subpopulations, especially infants and
children.

H. Executive Order 13211

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
designated as an ``economically significant'' regulatory action under
Executive Order 12866, nor is it likely to have any adverse effect on
the supply, distribution, or use of energy.

I. National Technology Transfer and Advancement Act

As noted in the proposed rule, Section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law No.
104-113, 12(d) (15 U.S.C. 272 note)

[[Page 60956]]

directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g. materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. The NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards.
This rulemaking involves environmental monitoring or measurement.
Consistent with the Agency's Performance Based Measurement System
(PBMS), EPA has decided not to require the use of specific, prescribed
analytic methods. Rather, the rule will allow the use of any methods
that meets the prescribed performance criteria. The PBMS approach is
intended to be more flexible and cost-effective for the regulated
community; it is also intended to encourage innovation in analytical
technology and improved data quality. EPA is not precluding the use of
any method, whether it constitutes a voluntary consensus standard or
not, as long as it meets the performance criteria specified.

J. Executive Order 12898

This rule does not have an adverse impact on the environmental and
health conditions in low-income and minority communities. Therefore,
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 does not need
to consider environmental justice-related issues.

XXV. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit 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 United States prior
to the publication of the rule in the Federal Register. A major rule
cannot take effect until 60 days after it is published in the Federal
Register. This action is not a major rule as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 9

Reporting and recordkeeping requirements.

List of Subjects in 40 CFR Part 158

Environmental protection, Confidential business information,
Pesticides and pests, Reporting and recordkeeping requirements.

Dated: October 4, 2007.
Stephen L. Johnson,
Administrator.

• Therefore, chapter I of title 40 of the Code of Federal Regulations is
amended as follows:

PART 9--[AMENDED]

• 1. The authority citation for part 9 continues to read as follows:

Authority: 7 U.S.C. 135 et seq., 136 136y; 15 U.S.C. 2001,
2003, 2005, 2006, 2601 2671; 21 U.S.C. 331j, 346a, 31 U.S.C. 9701;
33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971 1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g 1, 300g 2, 300g 3, 300g 4, 300g 5, 300g 6, 300j 1, 300j 2, 300j
3, 300j 4, 300j 9, 1857 et seq., 6901 6992k, 7401 7671q, 7542, 9601
9657, 11023, 11048.

• 2. In Sec. 9.1, the table is amended by revising the entries under the
centerheading ``Data Requirements for Registration'' and by adding the
centerheading ``Data Requirements for Registration of Antimicrobial
Pesticides'' and its entries immediately before the existing centerheading
``State Registration of Pesticide Products.'' to read as follows:

Sec. 9.1 OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
OMB control
40 CFR citation No.
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
Data Requirements for Registration
------------------------------------------------------------------------
158.32.................................................. 2070-0040,
2070-0053,
2070-0057,
2070-0060,
2070-0107
158.34.................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
158.45.................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
158.75.................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
158.110................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
158.200................................................. 2070-0040
158.310................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
158.320................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
158.325................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
158.330................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
158.335................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
158.340................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
158.345................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
158.350................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
158.355................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
158.400................................................. 2070-0057,
2070-0060,
2070-0107
158.500................................................. 2070-0057,
2070-0060,
2070-0107
158.630................................................. 2070-0057,
2070-0060,
2070-0107
158.660................................................. 2070-0057,
2070-0060,
2070-0107
158.630................................................. 2070-0057,
2070-0060,
2070-0107
158.1050................................................ 2070-0057,
2070-0060,
2070-0107
158.1100................................................ 2070-0057,
2070-0060,
2070-0107
158.1300................................................ 2070-0057,
2070-0060,
2070-0107
158.1410................................................ 2070-0057,
2070-0060,
2070-0107
158.2000................................................ 2070-0057,
2070-0060,
2070-0107

[[Page 60957]]

158.2100................................................ 2070-0057,
2070-0060,
2070-0107
* * * * * * *
------------------------------------------------------------------------
Data Requirements for Registration of Antimicrobial Pesticides
------------------------------------------------------------------------
161.30.................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107

161.32.................................................. 2070-0040,
2070-0053,
2070-0057,
2070-0060,
2070-0107
161.34.................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
161.45.................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
161.75.................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
161.101................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
161.150................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
161.160................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
161.162................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
161.165................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
161.167................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
161.170................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
161.175................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
161.180................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
161.190................................................. 2070-0040,
2070-0057,
2070-0060,
2070-0107
161.240................................................. 2070-0057,
2070-0060,
2070-0107
161.290................................................. 2070-0057,
2070-0060,
2070-0107
161.340................................................. 2070-0057,
2070-0060,
2070-0107
161.390................................................. 2070-0057,
2070-0060,
2070-0107
161.440................................................. 2070-0057,
2070-0060,
2070-0107
161.490................................................. 2070-0057,
2070-0060,
2070-0107
161.540................................................. 2070-0057,
2070-0060,
2070-0107
161.590................................................. 2070-0057,
2070-0060,
2070-0107
161.640................................................. 2070-0057,
2070-0060,
2070-0107
161.740................................................. 2070-0057,
2070-0060,
2070-0107
* * * * *
------------------------------------------------------------------------

• 3. By adding new part 158 to read as follows:

PART 158--DATA REQUIREMENTS FOR PESTICIDES

Subpart A--General Provisions
Sec.
158.1 Purpose and scope.
158.3 Definitions.
158.5 Applicability.
158.30 Flexibility.
158.32 Format of data submissions.
158.33 Confidential data.
158.34 Flagging of studies for potential adverse effects.
158.45 Waivers.
158.60 Minor use data policies.
158.70 Satisfying data requirements.
158.75 Requirements for additional data.
158.80 Use of other data.
Subpart B--How to Use Data Tables
158.100 Pesticide use patterns.
158.110 Required and conditionally required data.
158.120 Determining data requirements.
158.130 Purposes of the registration data requirements.
Subpart C--Experimental Use Permits
158.200 Experimental use permit data requirements tables.
158.210 Experimental use permit data requirements for product chemistry
158.220 Experimental use permit data requirements for product performance.
158.230 Experimental use permit data requirements for toxicology.
158.240 Experimental use permit data requirements for ecological effects.
158.243 Experimental use permit data requirements for terrestrial
and aquatic nontarget organisms.
158.250 Experimental use permit data requirements for human exposure.
158.260 Experimental use permit data requirements for environmental fate.
158.270 Experimental use permit data requirements for residue chemistry.
158.280 - 158.290 [Reserved]
Subpart D--Product Chemistry
158.300 Definitions.
158.310 Product chemistry data requirements table.
158.320 Product identity and composition.
158.325 Description of materials used to produce the product.
158.330 Description of production process.
158.335 Description of formulation process.
158.340 Discussion of formation of impurities.
158.345 Preliminary analysis.
158.350 Certified limits.
158.355 Enforcement analytical method.
Subpart E--Product Performance
158.400 Product performance data requirements.
Subpart F--Toxicology
158.500 Toxicology data requirements table.
158.510 Tiered testing options for nonfood pesticides.
Subpart G--Ecological Effects
158.630 Terrestrial and aquatic nontarget organisms data
requirements table.
158.660 Nontarget plant protection data requirements table.
Subparts H-J [Reserved]
158.700 - 158.900 [Reserved]
Subpart K--Human Exposure
158.1000 Applicator exposure--general requirements.
158.1010 Applicator exposure--criteria for testing.
158.1020 Applicator exposure data requirements table.
158.1050 Post-application exposure--general requirements.
158.1060 Post-application exposure--criteria for testing.
158.1070 Post-application exposure data requirements table.
Subpart L--Spray Drift
158.1100 Spray drift data requirements table.
Subpart M [Reserved]
158.1200 - 158.1299 [Reserved]
Subpart N--Environmental Fate
158.1300 Environmental fate data requirements table.
Subpart O--Residue Chemistry
158.1400 Definitions.
158.1410 Residue chemistry data requirements table.
Subparts P-T [Reserved]
158.1500 - 158.1900 [Reserved]
Subpart U--Biochemical Pesticides [Reserved]
158.2000 [Reserved]

[[Page 60958]]

Subpart V--Microbial Pesticides [Reserved]
158.2100 [Reserved]
Subpart W--Antimicrobial Pesticides [Reserved]
158.2200 [Reserved]
Subpart X-Z [Reserved]
158.2300 - 158.2500 [Reserved]

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

Subpart A--General Provisions

Sec. 158.1 Purpose and scope.

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

Sec. 158.3 Definitions.

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

Sec. 158.5 Applicability.

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

Sec. 158.30 Flexibility.

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

Sec. 158.32 Format of data submissions.

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

[[Page 60959]]

submitted study, full identification of the other study with which it
should be associated in review.
(vi) If the study is a reprint of a published document, all
relevant facts of publication, such as the journal title, volume,
issue, inclusive page numbers, and date of publication.
(2) The appropriate statement(s) regarding any data confidentiality
claims as described in Sec. 158.33.
(3) A statement of compliance or non-compliance with respect to
Good Laboratory Practice Standards as required by 40 CFR 160.12, if
applicable.
(4) A complete and accurate English translation must be included
for any information that is not in English.
(5) A flagging statement as prescribed by Sec. 158.34, if applicable.

Sec. 158.33 Confidential data.

(a) Definitions. For the purposes of this section:
(1) Registered or previously registered pesticide means any
pesticide containing an active ingredient contained in a product that
is, or has ever been, an active ingredient in a product registered
under sec. 3 of FIFRA. A registered pesticide that is the subject of an
application for a new use falls within the category of ``registered or
previously registered pesticide.''
(2) Safety and efficacy information means information concerning
the objectives, methodology, results, or significance of any test or
experiment performed on or with a registered or previously registered
pesticide or its separate ingredients, impurities, or degradation
products, and any information concerning the effects of such pesticide
on any organism or the behavior of such pesticide in the environment,
including, but not limited to, data on safety to fish and wildlife,
humans and other mammals, plants, animals, and soil, and studies on
persistence, translocation and fate in the environment, and metabolism.
(b) Applicability. (1) This section applies to information
submitted pursuant to this part. It supplements the general
confidentiality procedures in 40 CFR part 2, subpart B, including FIFRA
confidentiality procedures at 40 CFR 2.307. To the extent that
provisions in this section conflict with those in 40 CFR part 2,
subpart B, the provisions in this section take precedence. The
provisions of 40 CFR 2.308 do not apply to information to which this
section applies. In addition to complying with the requirements of this
section, any confidentiality claims for information subject to 40 CFR
part 174 (plant-incorporated protectants) must be substantiated at the
time of submission as described in Sec. 174.9 of this chapter.
(2) FFDCA sec. 408(i) protects confidential information submitted
in connection with an application for a tolerance or exemption to the
same extent as FIFRA sec. 10. References in this section to FIFRA sec.
10 are deemed to apply equally to information submitted pursuant to
FFDCA sec. 408, pursuant to the authority in sec. 408(i).
(c) Method of asserting business confidentiality claims--(1) Claim
required. Information to which this section applies (and which is
submitted on or after the effective date of this regulation) will be
deemed as not subject to a confidentiality claim unless a claim for
that information is made in accordance with the procedures specified in
this paragraph. Information not subject to a confidentiality claim may
be made available to the public without further notice, subject to the
requirements of FIFRA sec. 10(g).
(2) Statement required. Upon submission to EPA, each document must
be accompanied by a signed and dated document containing either the
statements in paragraph (c)(2)(i) or (ii) of this section. No claims or
markings on the document or any attachments, other than these
statements and attachments submitted in accordance with paragraph
(c)(3) of this section, will be recognized as asserting a claim of
confidentiality. The format of data submissions is set forth in Sec.
158.32.
(i) No claim of confidentiality.
No claim of confidentiality, on any basis whatsoever, is made
for any information contained in this document. I acknowledge that
information not designated as within the scope of FIFRA sec.
10(d)(1)(A), (B), or (C) and which pertains to a registered or
previously registered pesticide is not entitled to confidential
treatment and may be released to the public, subject to the
provisions regarding disclosure to multinational entities under
FIFRA sec. 10(g).
(ii) Claim of confidentiality.
Information claimed as confidential has been removed to a
confidential attachment.
(3) Confidential attachment. (i) All information claimed as
confidential must be submitted in a separate confidential attachment to
the document and cross referenced to the specific location in the
document from which it was removed. The confidential attachment must
have its own title page and be paginated separately from the non-
confidential document.
(ii) All information in the confidential attachment that consists
of (or whose disclosure would in turn disclose) manufacturing or
quality control processes must be individually identified in the
confidential attachment as a claim for information within the scope of
FIFRA sec. 10(d)(1)(A).
(iii) All information in the confidential attachment that consists
of (or whose disclosure would in turn disclose) the details of any
methods for testing, detecting, or measuring the quantity of any
deliberately added inert ingredient of a pesticide, must be
individually identified in the confidential attachment as a claim for
information within the scope of FIFRA sec. 10(d)(1)(B).
(iv) All information in the confidential attachment that consists
of (or whose disclosure would in turn disclose) the identity or
percentage quantity of any deliberately added inert ingredient of a
pesticide must be individually identified in the confidential
attachment as a claim for information within the scope of FIFRA sec.
10(d)(1)(C).
(v) Information in the confidential attachment that is designated
in accordance with paragraphs (c)(3)(ii) - (iv) of this section must be
on a separate page from information that is not so designated.
(4) Voluntary release of information to States and foreign
governments. (i) Submitters are encouraged to include with the
statement required under paragraph (c)(2) of this section an additional
statement to allow EPA to share information with State and foreign
governments. EPA will not consider such a statement to be a waiver of
confidentiality or proprietary claims for the information. The
statement is as follows:
I authorize the Environmental Protection Agency to release any
information contained in this document to State or foreign
governments, without relinquishing proprietary rights or any
confidentiality claims asserted above.
(ii) Information designated as releasable to state or foreign
governments in accordance with this section may be released to such a
government without further notice to the submitter. EPA will inform the
State or foreign government of any of the confidentiality claims
associated with the information.
(d) Release of information. (1) Safety and efficacy information
that was submitted to EPA on or after May 4, 1988 and that has not been
designated by the submitter as FIFRA sec. 10(d)(1)(A), (B), or (C)
information in accordance with the applicable requirements of this
section is not entitled to confidential treatment and may be disclosed
to the public without further notice to the submitter, in accordance
with paragraph (d)(2) of this section. Safety and efficacy information

[[Page 60960]]

which has been designated by the submitter as FIFRA sec. 10(d)(1) (A),
(B), or (C) information is entitled to confidential treatment only to
the extent provided by FIFRA sec. 10(b), this section, and 40 CFR 2.208.
(2) Information that is not entitled to be protected as
confidential in accordance with FIFRA sec. 10(b), this section and with
EPA confidentiality regulations at 40 CFR part 2, subpart B, may be
released to the public without the affirmation of non-multinational
status provided under FIFRA sec. 10(g), provided that the information
does not contain or consist of any complete unpublished report
submitted to EPA, or excerpts or restatements of any such report which
reveal the full methodology and complete results of the study, test, or
experiment, and all explanatory information necessary to understand the
methodology or interpret the results.

Sec. 158.34 Flagging of studies for potential adverse effects.

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

Table--Flagging Criteria
----------------------------------------------------------------------------------------------------------------
Criteria: Treated animals show Criteria
Study Type(s) Guideline No. any of the following: No.
----------------------------------------------------------------------------------------------------------------
Carcinogenicity or combined carcinogenicity/ 870.4200 An incidence of neoplasms in 1
chronic feeding study 870.4300 males or females which increases
with dose (positive trend p< =
0.05); or

A statistically significant 2
(pairwise p< = 0.05) increase of
any type of neoplasm in any test
group, males or females at any
dose level, compared to
concurrent control animals of
the same sex; or

An increase in any type of 3
uncommon or rare neoplasms in
any test group, males or females
animals at any dose level,
compared to concurrent controls
of the same sex; or

A decrease in the time to 4
development of any type of
neoplasms in any test group,
males or females at any dose
level, compared to concurrent
controls of the same sex.
----------------------------------------------------------------------------------------------------------------
Prenatal developmental toxicity 870.3700 When compared to concurrent 5
Reproduction and fertility..................... 870.3800 controls, treated offspring show
Developmental neurotoxicity.................... 870.6300 a dose-related increase in
malformations, pre- or post-
natal deaths, or persistent
functional or behavioral changes
on a litter basis in the absence
of significant maternal toxicity
at the same dose level.
----------------------------------------------------------------------------------------------------------------
Neurotoxicity 870.6100 When compared to concurrent 6
870.6200 controls, treated animals show a
statistically or biologically
significant increase in
neuropathological lesions or
persistent functional or
behavioral changes.
----------------------------------------------------------------------------------------------------------------
Chronic feeding 870.4100 The no observed adverse effect 7
Carcinogenicity................................ 870.4200 level (NOAEL) from one of these
Reproduction and fertility..................... 870.3800 studies is less than the NOAEL
Prenatal developmental toxicity................ 870.3700 currently used by the Agency as
Developmental neurotoxicity.................... 870.6300 the basis for either the acute
Acute or 90-day neurotoxicity.................. 870.6200 or chronic reference dose.
----------------------------------------------------------------------------------------------------------------

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

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

Sec. 158.45 Waivers.

(a) The data requirements specified in this part as applicable to a
category of products will not always be appropriate for every product
in that category. Some products may have unusual physical, chemical, or
biological properties or atypical use patterns which would make
particular data requirements inappropriate, either because it would not
be possible to generate the required data or because the data would not
be useful in the Agency's evaluation of the risks or benefits of the
product. The Agency will waive data requirements it finds are
inappropriate, but will ensure that sufficient data are available to
make the determinations required by the applicable statutory standards.
(b)(1) Applicants are encouraged to discuss a data waiver request
with the Agency before developing and submitting supporting data,
information, or other materials.
(2) All waiver requests must be submitted to the Agency in writing.
The request must clearly identify the data requirement(s) for which a
waiver is sought along with an explanation and supporting rationale why
the applicant

[[Page 60961]]

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

Sec. 158.60 Minor use data policies.

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

Sec. 158.70 Satisfying data requirements.

(a) General policy. The Agency will determine whether the data
submitted or cited to fulfill the data requirements specified in this
part are acceptable. This determination will be based on the design and
conduct of the experiment from which the data were derived, and an
evaluation of whether the data fulfill the purpose(s) of the data
requirement. In evaluating experimental design, the Agency will
consider whether generally accepted methods were used, sufficient
numbers of measurements were made to achieve statistical reliability,
and sufficient controls were built into all phases of the experiment.
The Agency will evaluate the conduct of each experiment in terms of
whether the study was conducted in conformance with the design, good
laboratory practices were observed, and results were reproducible. The
Agency will not reject data merely because they were derived from
studies which, when initiated, were in accordance with an Agency-
recommended protocol, even if the Agency subsequently recommends a
different protocol, as long as the data fulfill the purposes of the
requirements as described in this paragraph.
(1) The provisions in this part 158 should be read in conjunction
with the provisions in Sec. 152.85 to claim eligibility for the
formulators' exemption.
(2) [Reserved]
(b) Good laboratory practices. Applicants must adhere to the good
laboratory practice (GLP) standards described in 40 CFR part 160 when
conducting studies. Applicants must also adhere to GLP standards when
conducting a study in support of a waiver request of any data
requirement which is within the scope of the GLP requirements.
(c) Agency guidelines. EPA has published Test Guidelines that
contain standards for conducting acceptable tests, guidance on the
evaluation and reporting of data, definition of terms, and suggested
study protocols. Copies of the Test Guidelines may be obtained by
visiting the agency's website at http://www.epa.gov/pesticides.
(d) Study protocols--(1) General. Any appropriate protocol may be
used to generate the data required by this part, provided that it meets
the purpose of the test standards specified in the pesticide assessment
guidelines, and provides data of suitable quality and completeness as
typified by the protocols cited in the guidelines. Applicants should
use the test procedure which is most suitable for evaluation of the
particular ingredient, mixture, or product. Accordingly, failure to
follow a suggested protocol will not invalidate a test if another
appropriate methodology is used.
(2) Organization for Economic Co-Operation and Development (OECD)
protocols. Tests conducted in accordance with the requirements and
recommendations of the applicable OECD protocols can be used to develop
data necessary to meet the requirements specified in this part.
Applicants should note, however, that certain of the OECD recommended
test standards, such as test duration and selection of test species,
are less restrictive than those recommended by EPA. Therefore, when
using OECD protocols, care should be taken to observe the test
standards in a manner such that the data generated by the study will
satisfy the requirements of this part.
(e) Combining studies. Certain toxicology studies may be combined
to satisfy data requirements. For example, carcinogenicity studies in
rats may be combined with the rat chronic toxicity study. Combining
appropriate studies may be expected to reduce usage of test animals as
well as reduce the cost of studies. EPA encourages this practice by
including standards for acceptable combined tests in the Pesticide
Assessment Guidelines. Registrants and applicants are encouraged to
consider combining other tests when practical and likely to produce
scientifically acceptable results. Registrants and applicants, however,
must consult with the EPA before initiating combined studies.

Sec. 158.75 Requirements for additional data.

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

Sec. 158.80 Use of other data.

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

Subpart B--How to Use Data Tables

Sec. 158.100 Pesticide use patterns.

(a) General use patterns. There are six broad use categories used
in the data tables. The six broad categories include terrestrial
outdoor uses, aquatic outdoor uses, greenhouse uses, forestry uses,
residential outdoor uses, and indoor

[[Page 60962]]

uses of all types. The 6 broad use categories are further subdivided
into 12 general use patterns which are the bases for data requirements
established by use pattern. Within the data tables, general use
patterns have been combined into single columns when the data
requirements are the same for the combined uses. If there are no data
requirements for a specific use, the column for that use is not
included in the table. The 12 general use pattern groups used in the
data table in this part are:
(1) Terrestrial food crop use.
(2) Terrestrial feed crop use.
(3) Terrestrial nonfood crop use.
(4) Aquatic food crop use.
(5) Aquatic nonfood use.
(6) Greenhouse food crop use.
(7) Greenhouse nonfood crop use.
(8) Forestry use.
(9) Residential outdoor use.
(10) Residential indoor use.
(11) Indoor food use.
(12) Indoor nonfood use.
(b) Pesticide use site index. The Pesticide Use Site Index is a
comprehensive list of specific pesticide use sites. The index is
alphabetized separately by site for all agricultural and all
nonagricultural uses. The Pesticide Use Site Index associates each
pesticide use site with one or more of the 12 general use patterns. It
may be used in conjunction with the data tables to determine the
applicability of data requirements to specific uses. The Pesticide Use
Site Index, which will be updated periodically, is available from the
Agency or may be obtained from the Agency's website at
http://www.epa.gov/pesticides.
(c) Applicants unsure of the correct use pattern for their
particular product should consult the Agency.

Sec. 158.110 Required and conditionally required data.

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

Sec. 158.120 Determining data requirements.

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

Sec. 158.130 Purposes of the registration data requirements.

(a) General. The data requirements for registration are intended to
generate data and information necessary to address concerns pertaining
to the identity, composition, potential adverse effects and
environmental fate of each pesticide.

[[Page 60963]]

(b) Product chemistry--(1) Product composition. Data on product
composition are needed:
(i) To support the conclusions expressed in the statement of formula;
(ii) To compare to the composition of materials used in required
testing under this part; and
(iii) To determine whether a product is ``identical or
substantially similar''to another product, a determination that
involves the comparison of product composition.
(2) Nominal concentration and certified limits. The nominal
concentration of a product, defined as that concentration that is
expected to be present in a product as a result of the production or
formulation process, is used to gauge the acceptability of the
certified limits, which define the outer limits of the range of the
product's ingredients. The certified limits are used to enforce the
composition of the product and to ensure the accuracy of hazard assessments.
(3) Physical and chemical characteristics. The physical and
chemical characteristics of an active ingredient or product are used:
(i) To confirm or provide supportive information on the identity
and composition of the product;
(ii) To assess the hazards of the ingredient or product; and
(iii) To trigger or evaluate certain other studies required by this
part.
(c) Product performance. Requirements to develop data on product
performance provide a mechanism to ensure that pesticide products will
perform as intended and that unnecessary pesticide exposure to the
environment will not occur as a result of the use of ineffective
products. Specific performance standards are used to validate the
efficacy data in the public health areas, including disinfectants used
to control microorganisms infectious to man in any area of the
inanimate environment and those pesticides used to control vertebrates
(such as rodents, birds, bats and skunks) that may directly or
indirectly transmit diseases to humans.
(d) Toxicology-humans and domestic animals. Data required to assess
hazards to humans and domestic animals are derived from a variety of
acute, subchronic and chronic toxicity tests, and tests to assess
mutagenicity and pesticide metabolism.
(1) Acute studies. Determination of acute oral, dermal and
inhalation toxicity is usually the initial step in the assessment and
evaluation of the toxic characteristics of a pesticide. These data
provide information on health hazards likely to arise soon after, and
as a result of, short-term exposure. Data from acute studies serve as a
basis for classification and precautionary labeling. For example, acute
toxicity data are used to calculate farmworker reentry intervals and to
develop precautionary label statements pertaining to protective
clothing requirements for applicators. They also provide information
used in establishing the appropriate dose levels in subchronic and
other studies; provide initial information on the mode of toxic
action(s) of a substance; and determine the need for child resistant
packaging. Information derived from primary eye and primary dermal
irritation studies serves to identify possible hazards from exposure of
the eyes, associated mucous membranes and skin.
(2) Subchronic studies. Subchronic tests provide information on
health hazards that may arise from repeated exposures over a limited
period of time. They provide information on target organs and
accumulation potential. The resulting data are also useful in selecting
dose levels for chronic studies and for establishing safety criteria
for human exposure. These tests are not capable of detecting those
effects that have a long latency period for expression (e.g.,
carcinogenicity).
(3) Chronic studies. Chronic toxicity studies (usually conducted by
feeding the test substance to the test species) are intended to
determine the effects of a substance in a mammalian species following
prolonged and repeated exposure. Under the conditions of this test,
effects which have a long latency period or are cumulative should be
detected. The purpose of long-term carcinogenicity studies is to
observe test animals over most of their life span for the development
of neoplastic lesions during or after exposure to various doses of a
test substance by an appropriate route of administration.
(4) Developmental toxicity and reproduction studies. The
developmental toxicity study is designed to determine the potential of
the test substance to induce structural and/or other abnormalities to
the fetus as the result of exposure of the mother during pregnancy.
Two-generation reproduction testing is designed to provide information
concerning the general effects of a test substance on gonadal function,
estrus cycles, mating behavior, conception, parturition, lactation,
weaning, and the growth and development of the offspring. The study may
also provide information about the effects of the test substance on
neonatal morbidity, mortality, and preliminary data on prenatal
developmental toxicity and serve as a guide for subsequent tests.
(5) Mutagenicity studies. For each test substance a battery of
tests is required to assess the potential to affect the mammalian
cell's genetic components. The objectives underlying the selection of a
battery of tests for mutagenicity assessment are:
(i) To detect, with sensitive assay methods, the capacity of a
chemical to alter genetic material in cells.
(ii) To determine the relevance of these mutagenic changes to mammals.
(iii) When mutagenic potential is demonstrated, to incorporate
these findings in the assessment of heritable effects, carcinogenicity,
and, possibly, other health effects.
(6) Metabolism studies. Data from studies on the absorption,
distribution, metabolism, and excretion of a pesticide aid in the
valuation of test results from other toxicity studies and in the
extrapolation of data from animals to man. The main purpose of
metabolism studies is to produce data which increases the Agency's
understanding of the behavior of the chemical when considering the
human exposure anticipated from intended uses of the pesticide.
(e) Hazards to nontarget organisms--(1) General. The information
required to assess hazards to nontarget organisms is derived from tests
to determine pesticidal effects on birds, mammals, fish, terrestrial
and aquatic invertebrates and plants. These tests include short-term
acute, subacute, reproduction, simulated field, and full field studies
arranged in a hierarchical or tier system which progresses from the
basic laboratory tests to the applied field tests. The results of each
tier of testing must be evaluated to determine the potential of the
pesticide to cause adverse effects, and to determine whether further
testing is required. A purpose common to all data requirements is to
provide data which determine the need for (and appropriate wording for)
precautionary label statements to minimize the potential adverse
effects to nontarget organisms.
(2) Short-term studies. The short-term acute and subchronic
laboratory studies provide basic toxicity information which serves as a
starting point for the hazard assessment. These data are used: To
establish acute toxicity levels of the active ingredient to the test
organisms; to compare toxicity information with measured or estimated
pesticide residues in the environment in order to assess potential
impacts on fish, wildlife and other nontarget organisms; and to
indicate whether further laboratory and/or field studies are needed.
(3) Long-term and field studies. Additional studies (i.e., avian,
fish, and

[[Page 60964]]

invertebrate reproduction, life cycle studies and plant field studies)
may be required when basic data and environmental conditions suggest
possible problems. Data from these studies are used to: Estimate the
potential for chronic effects, taking into account the measured or
estimated residues in the environment; and to determine if additional
field or laboratory data are necessary to further evaluate hazards.
Simulated field and/or field data are used to examine acute and chronic
adverse effects on captive or monitored fish and wildlife populations
under natural or near-natural environments. Such studies are required
only when predictions as to possible adverse effects in less extensive
studies cannot be made, or when the potential for adverse effects is high.
(f) Applicator and post-application exposure. Data are used to
evaluate exposures to persons in occupational and non-occupational
settings, including agricultural, residential, commercial,
institutional and recreational sites. Data include oral, dermal and
inhalation exposure data, post-application residue data, post-
application monitoring data, use information, and human activity
information. These data, together with toxicology data, are used to
determine whether application or post-application risks are of concern,
and, where appropriate, to develop post-application restrictions such
as reentry restrictions.
(g) Pesticide spray drift evaluation. Data required to evaluate
pesticide spray drift are derived from studies of droplet size spectrum
and spray drift field evaluations. These data contribute to the
development of the overall exposure estimate and, along with data on
toxicity for humans, fish and wildlife, or plants, are used to assess
the potential hazard of pesticides to these organisms. A purpose common
to all these tests is to provide data which will be used to determine
the need for (and appropriate wording for) precautionary labeling to
minimize the potential adverse effect to nontarget organisms.
(h) Environmental fate--(1) General. The data generated by
environmental fate studies are used to: Assess the toxicity to man
through exposure of humans to pesticide residues remaining after
application, either upon reentering treated areas or from consuming
inadvertantly-contaminated food; assess the presence of widely
distributed and persistent pesticides in the environment which may
result in loss of usable land, surface water, ground water, and
wildlife resources; and, assess the potential environmental exposure of
other nontarget organisms, such as fish and wildlife, to pesticides.
Another specific purpose of the environmental fate data requirements is
to help applicants and the Agency estimate expected environmental
concentrations of pesticides in specific habitats where threatened or
endangered species or other wildlife populations at risk are found.
(2) Degradation studies. The data from hydrolysis and photolysis
studies are used to determine the rate of pesticide degradation and to
identify pesticides that may adversely affect nontarget organisms.
(3) Metabolism studies. Data generated from aerobic and anaerobic
metabolism studies are used to determine the nature and availability of
pesticides to rotational crops and to aid in the evaluation of the
persistence of a pesticide.
(4) Mobility studies. These data requirements pertain to leaching,
adsorption/desorption, and volatility of pesticides. They provide
information on the mode of transport and eventual destination of the
pesticide in the environment. This information is used to assess
potential environmental hazards related to: Contamination of human and
animal food; loss of usable land and water resources to man through
contamination of water (including ground water); and habitat loss of
wildlife resulting from pesticide residue movement or transport in the
environment.
(5) Dissipation studies. The data generated from dissipation
studies are used to assess potential environmental hazards (under
actual field use conditions) related to: Reentry into treated areas;
hazards from residues in rotational crops and other food sources; and
the loss of land as well as surface and ground water resources.
(i) Residue chemistry. (1) Residue chemistry data are used by the
Agency to estimate the exposure of the general population to pesticide
residues in food and for setting and enforcing tolerances for pesticide
residues in food or feed.
(2) Information on the chemical identity and composition of the
pesticide product, the amounts, frequency and time of the pesticide
application, and results of tests on the amount of residues remaining
on or in the treated food or feed, are needed to support a finding as
to the magnitude and identity of residues which result in food or
animal feed as a consequence of a proposed pesticide usage.
(3) Residue chemistry data are also needed to support the adequacy
of one or more methods for the enforcement of the tolerance, and to
support practicable methods for removing residues that exceed any
proposed tolerance.
(4) Accumulation studies. Accumulation studies indicate pesticide
residue levels in food supplies that originate from wild sources or
from rotational crops. Rotational crop studies are necessary to
establish realistic crop rotation restrictions and to determine if
tolerances may be needed for residues on rotational crops. Data from
irrigated crop studies are used to determine the amount of pesticide
residues that could be taken up by representative crops irrigated with
water containing pesticide residues. These studies allow the Agency to
establish label restrictions regarding application of pesticides on
sites where the residues can be taken up by irrigated crops. These data
also provide information that aids the Agency in establishing any
corresponding tolerances that would be needed for residues on such
crops. Data from pesticide accumulation studies in fish are used to
establish label restrictions to prevent applications in certain sites
so that there will be minimal residues entering edible fish or
shellfish. These residue data are also used to determine if a tolerance
or action level is needed for residues in aquatic animals eaten by humans.

Subpart C--Experimental Use Permits

Sec. 158.200 Experimental use permit data requirements tables.

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

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

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

Sec. 158.220 Experimental use permit data requirements for product
performance.

All product performance data, as described in paragraph (c) of this
section, must be submitted to support a request for an experimental use
permit.
(a) Use patterns. (1) The terrestrial use pattern includes products
classified under the general use patterns of terrestrial food crop and
terrestrial nonfood crop. The aquatic use pattern includes products
classified under the general use patterns of aquatic food crop

[[Page 60965]]

and aquatic nonfood crop. The greenhouse use pattern includes products
classified under the general use patterns of greenhouse food crop and
greenhouse nonfood crop. The indoor use pattern includes products
classified under the general use patterns of indoor food and indoor
nonfood use.
(2) Data are also required for forestry and residential outdoor uses.
(b) Key. CR=Conditionally required; NR=Not required; R=Required;
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use
product.
(c) Table. The following table shows the experimental use data
requirements for product performance. The test notes are shown in
paragraph (d) of this section.
Table--Data Requirements for Product Performance
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Use Pattern Test substance to
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- support
Guideline No. Data Requirement Terrestrial Aquatic Greenhouse ------------------------ Test Note
--------------------------------------------------------------------------------------------------------------------------- Forestry Residential Indoor No.
Food Crop Nonfood Crop Food Crop Nonfood Crop Food Crop Nonfood Crop Outdoors MP EP
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy of antimicrobial agents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
91-8 Products for NR NR CR NR NR NR NR NR NR NR EP 1
treating water
systems
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy of fungicides and nematicides
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
93-16 Products for CR NR CR NR CR NR NR NR NR NR EP 1
control of
organisms
producing
mycotoxins
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy of vertebrate control agents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
96-5 Avian toxicants R R NR NR NR NR NR R R NR EP 1
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
96-6 Avian repellents R R NR NR NR NR NR R NR NR EP 1
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
96-7 Avian frightening R R NR NR NR NR NR R NR NR EP 1
agents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
96-9 Bat toxicants and NR NR NR NR NR NR NR NR R NR EP 1
repellents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
96-10 Commensal R R NR NR NR NR NR R R TEP EP 1
rodenticides
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
96-12 Rodenticides on R R NR NR NR NR NR R NR NR EP 1
farm and
rangelands
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
95-13 Rodent fumigants R R NR NR NR NR NR R R NR EP 1
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
95-16 Rodent R R NR NR NR NR NR R R NR EP 1
reproductive
inhibitors
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
95-17 Mammalian R R NR NR NR NR NR R NR NR EP 1
predacides
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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

[[Page 60966]]

Sec. 158.230 Experimental use permit data requirements for toxicology.

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

Table--Toxicology Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Use Pattern Test substance to support
Guideline Number Data Requirement -------------------------------------------------------------------------------- Test Note No.
Food Nonfood MP EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1100 Acute oral R R MP and TGAI TGAI, EP 1
toxicity - rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1200 Acute dermal R R MP and TGAI TGAI, EP 1, 2
toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1300 Acute inhalation R R MP and TGAI TGAI and EP 3
toxicity - rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2400 Primary eye R R MP TGAI and EP 2
irritation -
rabbit
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2500 Primary dermal R R MP TGAI and EP 1, 2
irritation
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2600 Dermal R R MP TGAI and EP 2, 4
sensitization
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.6100 Delayed CR CR TGAI TGAI 5
neurotoxicity
(acute) - hen
--------------------------------------------------------------------------------------------------------------------------------------------------------
Subchronic Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3100 90-day Oral - R NR TGAI TGAI --
rodent
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3150 90-day Oral - non- R NR TGAI TGAI --
rodent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chronic Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.4100 Chronic oral - R NR TGAI TGAI 6
rodent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Developmental Toxicity and Reproduction
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3700 Prenatal R NR TGAI TGAI 7, 8
Developmental
toxicity - rat
and rabbit,
preferred
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3800 Reproduction R NR TGAI TGAI 6
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mutagenicity Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5100 Bacterial reverse R NR TGAI TGAI 9
mutation assay
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5300 In vitro R NR TGAI TGAI 9, 10
870.5375...................... mammalian cell
assay
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5385 In vivo R NR TGAI TGAI 9, 11
870.5395...................... cytogenetics
--------------------------------------------------------------------------------------------------------------------------------------------------------

(d) Test notes. The following test notes apply to the data
requirements in the table to paragraph (c) of this section.
1. Not required if test material is a gas or a highly volatile liquid.
2. Not required if test material is corrosive to skin or has a
pH of less than 2 or greater than 11.5.
3. Required if the product consists of, or under conditions of
use will result in, a respirable material (e.g., gas, vapor,
aerosol, or particulate).
4. Required if repeated dermal exposure is likely to occur under
conditions of use.
5. Required if the test material is an organophosphorus
substance, which includes uncharged organophosphorus esters,
thioesters, or anhydrides of organophosphoric, organophosphonic, or
organophosphoramidic acids, or of related phosphorothioic,
phosponothioic, or phosphorothioamidic acids, or is structurally
related to other substances that may cause the delayed neurotoxicity
sometimes seen in this class of chemicals.
6. These studies are seldom required to support EUPs. They may
be required if the dietary exposure for these EUPs occupies a large
part, e.g., greater than 50%, of the reference dose.

[[Page 60967]]

7. The oral route, by oral intubation, is preferred unless the
chemical or physical properties of the test substance or the pattern
of exposure suggests a more appropriate route of exposure.
8. May be combined with the 2-generation reproduction study in
rodents by utilizing a second mating of the parental animals in
either generation.
9. At a minimum, an initial battery of mutagenicity tests with
possible confirmatory testing is required. Other relevant
mutagenicity tests that may have been performed, plus a complete
reference list must also be submitted.
10. Choice of assay using either:
i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene
locus, maximizing assay conditions for small colony expression or detection;
ii. Chinese hamster ovary (CHO) or Chinese hamster lung
fibroblast (V79) cells, hypoxanthine-guanine phosphoribosyl
transferase (hgprt) gene locus, accompanied by an appropriate in
vitro test for clastogenicity; or
iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl
transferase (xprt) gene locus.
11. The micronucleus rodent bone marrow assay is preferred;
however, rodent bone marrow assays using metaphase analysis
(aberrations) are acceptable.

Sec. 158.240 Experimental use permit data requirements for ecological
effects.

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

Sec. 158.243 Experimental use permit data requirements for
terrestrial and aquatic nontarget organisms.

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

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

(d) Test notes. The following test notes apply to the data
requirements in the table to paragraph (c) of this section.
1. Data using the TGAI are required to support all outdoor end-
use product uses including, but not limited to, turf. Data are
generally not required to support end-use products in the form of a
gas, a highly volatile liquid, a highly reactive solid, or a highly
corrosive material.
2. For greenhouse and indoor end-use products, data using the
TGAI are required to support manufacturing-use products to be
reformulated into these same end-use products or to support end-use
products when there is no registered manufacturing-

[[Page 60968]]

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

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

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

Sec. 158.260 Experimental use permit data requirements for
environmental fate.

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

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

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

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

All residue chemistry data, as described in Sec. 158.1410, are
required for an experimental use permit for which a temporary tolerance
under FFDCA

[[Page 60969]]

section 408(r) is sought. Residue chemistry data are not required for
an experimental use permit issued on a crop-destruct basis.

Sec. Sec. 158.280 - 158.290 [Reserved]

Subpart D--Product Chemistry

Sec. 158.300 Definitions.

The following terms are defined for the purposes of this subpart:
Active ingredient means any substance (or group of structurally
similar substances, if specified by the Agency) that will prevent,
destroy, repel or mitigate any pest, or that functions as a plant
regulator, desiccant, defoliant, or nitrogen stabilizer, within the
meaning of FIFRA sec. 2(b).
End-use product means a pesticide product whose labeling:
(1) Includes directions for use of the product (as distributed or
sold, or after combination by the user with other substances) for
controlling pests or defoliating, desiccating or regulating growth of
plants, or as a nitrogen stabilizer, and
(2) does not state that the product may be used to manufacture or
formulate other pesticide products.
Formulation means:
(1) The process of mixing, blending, or dilution of one or more
active ingredients with one or more other active or inert ingredients,
without an intended chemical reaction, to obtain a manufacturing-use
product or an end-use product, or
(2) The repackaging of any registered product.
Impurity means any substance (or group of structurally similar
substances if specified by the Agency), in a pesticide product other
than an active ingredient or an inert ingredient, including unreacted
starting materials, side reaction products, contaminants, and
degradation products.
Impurity associated with an active ingredient means:
(1) Any impurity present in the technical grade of active
ingredient; and
(2) Any impurity which forms in the pesticide product through
reactions between the active ingredient and any other component of the
product or packaging of the product.
Inert ingredient means any substance (or group of structurally
similar substances if designated by the Agency), other than the active
ingredient, which is intentionally included in a pesticide product.
Integrated system means a process for producing a pesticide product
that:
(1) Contains any active ingredient derived from a source that is
not an EPA-registered product; or
(2) Contains any active ingredient that was produced or acquired in
a manner that does not permit its inspection by the Agency under FIFRA
sec. 9(a) prior to its use in the process.
Manufacturing-use product means any pesticide product other than an
end-use product. A product may consist of the technical grade of active
ingredient only, or may contain inert ingredients, such as stabilizers
or solvents.
Nominal concentration means the amount of an ingredient which is
expected to be present in a typical sample of a pesticide product at
the time the product is produced, expressed as a percentage by weight.
Starting material means a substance used to synthesize or purify a
technical grade of active ingredient (or the practical equivalent of
the technical grade ingredient if the technical grade cannot be
isolated) by chemical reaction.
Technical grade of active ingredient means a material containing an
active ingredient:
(1) Which contains no inert ingredient, other than one used for
purification of the active ingredient; and
(2) Which is produced on a commercial or pilot plant production
scale (whether or not it is ever held for sale).

Sec. 158.310 Product chemistry data requirements table.

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

Product Chemistry Data Requirements
----------------------------------------------------------------------------------------------------------------
Use Pattern Test substance to support
Guideline Number Data Requirement -------------------------------------------------- Test Note
All MP EP No.
----------------------------------------------------------------------------------------------------------------
Product Identity and Composition................................................................................
----------------------------------------------------------------------------------------------------------------
830.1550 Product identity R MP EP 1
and composition
----------------------------------------------------------------------------------------------------------------
830.1600 Description of R MP EP 2
materials used
to produce the
product
----------------------------------------------------------------------------------------------------------------
830.1620 Description of R MP EP 3
production
process
----------------------------------------------------------------------------------------------------------------
830.1650 Description of R MP EP 4
formulation
process
----------------------------------------------------------------------------------------------------------------
830.1670 Discussion of R MP, and possibly EP, and possibly 5
formulation of TGAI TGAI
impurities
----------------------------------------------------------------------------------------------------------------
830.1700 Preliminary CR MP, and possibly EP, and possibly 6, 9, 10
analysis TGAI TGAI
----------------------------------------------------------------------------------------------------------------

[[Page 60970]]

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

(f) Test notes. The following test notes are applicable to the
product chemistry data requirements in the table to paragraph (e) of
this section:
1. Data must be provided in accordance with Sec. 158.320.
2. Data must be provided in accordance with Sec. 158.325.
3. Data must be provided in accordance with Sec. 158.330.
4. Data must be provided in accordance with Sec. 158.335.
5. Data must be provided in accordance with Sec. 158.340.
6. Data must be provided in accordance with Sec. 158.345.
7. Data must be provided in accordance with Sec. 158.350.
8. Data must be provided in accordance with Sec. 158.355.
9. If the TGAI cannot be isolated, data are required on the
practical equivalent of the TGAI.
10. Data are required if the product is produced by an
integrated system.
11. Basic manufacturers are required to provide the Agency with
a sample of each TGAI used to formulate a product produced by an
integrated system when the new TGAI is first used as a formulating
ingredient in products registered under FIFRA. A sample of the
active ingredient (PAI) suitable for use as an analytical standard
is also required at this time. Samples of end-use products produced
by an integrated system must be submitted on a case-by-case basis.
12. Data on the stability to metals and metal ions are required
only if the TGAI is

[[Page 60971]]

expected to come into contact with either material.
13. Required when the product contains an oxidizing or reducing agent.
14. Required when the product contains combustible liquids.
15. Required when the product is potentially explosive.
16. Required when the product is an emulsifiable liquid and is
to be diluted with petroleum solvent.
17. Required when the EP is a liquid and is to be used around
electrical equipment.
18. Required when the test substance is soluble or dispersible
in water.
19. Required when the product is a liquid.
20. Required when the TGAI is solid at room temperature.
21. Required when the TGAI is liquid at room temperature.
22. Required when the test substance contains an acid or base
functionality (organic or inorganic) or an alcoholic functionality (organic).
23. Required for water insoluble test substances
(>10-6 g/l) and fibrous test substances with diameter of
>=0.1 [mu]m.
24. Required if technical chemical is organic and non-polar.
25. Not required for salts.
26. Data on stability of the MP and TGAI to storage at normal
temperatures are required. Data on the stability of the TGAI to high
temperatures are required if the TGAI is expected to be subjected to
temperatures >50[deg] C (122[deg] F) during production or storage.

Sec. 158.320 Product identity and composition.

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

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

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

[[Page 60972]]

him), concerning the composition (and if requested by the Agency,
chemical or physical properties) of the starting material, including a
copy of all technical specifications, data sheets, or other documents
describing it.
(3) The information required by paragraph (a)(2) of this section
concerning each inert ingredient.
(c) Additional information. On a case-by-case basis, the Agency may
require additional information on substances used in the production of
the product.

Sec. 158.330 Description of production process.

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

Sec. 158.335 Description of formulation process.

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

Sec. 158.340 Discussion of formation of impurities.

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

Sec. 158.345 Preliminary analysis.

(a) If the product is produced by an integrated system, the
applicant must

[[Page 60973]]

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

Sec. 158.350 Certified limits.

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

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

(c) Applicant proposed limits. (1) The applicant may propose a
certified limit for an active or inert ingredient that differs from the
standard certified limit calculated according to paragraph (b)(2) of
this section.
(2) If certified limits are required for impurities, the applicants
must propose a certified limit. The standard certified limits may not
be used for such substances.
(3) Certified limits should:
(i) Be based on a consideration of the variability of the
concentration of the ingredient in the product when good manufacturing
practices and normal quality control procedures are used.
(ii) Allow for all sources of variability likely to be encountered
in the production process.
(iii) Take into account the stability of the ingredient in the
product and the possible formation of impurities between production and
sale or distribution.
(4) The applicant may include an explanation of the basis of his
proposed certified limits, including how the certified limits were
arrived at (e.g., sample analysis, quantitative estimate based on
production process), and its accuracy and precision. This will be
particularly useful if the range of the certified limit for an active
or inert ingredient is greater than the standard certified limits.
(d) Special cases. If the Agency finds unacceptable any certified
limit (either standard, or applicant proposed), the Agency will inform
the registrant or applicant of its determination and will provide
supporting reasons. The Agency may also recommend alternative limits to
the applicant. The Agency may require, on a case-by-case basis, any or
all of the following:
(1) More precise limits.
(2) More thorough explanation of how the certified limits were
determined.
(3) A narrower range between the upper and lower certified limits
than that proposed.
(e) Certification statement. The applicant must certify the
accuracy of the information presented, and that the certified limits of
the ingredients will be maintained. The following statement, signed by
the authorized representative of the company, is acceptable:
I hereby certify that, for purposes of FIFRA sec. 12(a)(1)(C),
the description of the composition of [insert product name], EPA
Reg. No. [insert registration number], refers to the composition set
forth on the Statement of Formula and supporting materials. This
description includes the representations that: (1) no ingredient
will be present in the product in an amount greater than the upper
certified limit or in an amount less than the lower certified limit
(if required) specified for that ingredient in a currently approved
Statement of Formula (or as calculated by the Agency); and (2) if
the Agency requires that the source of supply of an ingredient be
specified, that all quantities of such ingredient will be obtained
from the source specified in the Statement of Formula.

Sec. 158.355 Enforcement analytical method.

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

Subpart E--Product Performance

Sec. 158.400 Product performance data requirements table.

(a) General. Sections 158.100 through 158.130 describe how to use
this table to determine the product performance data requirements for a
particular pesticide product. Notes that apply to an individual test,
including specific conditions, qualifications, or exceptions to the
designated test are listed in paragraph (e) of this section.
(b) Use patterns. The terrestrial use pattern includes products
classified under the general use patterns of terrestrial food crop and
terrestrial nonfood crop. The aquatic use pattern includes products
classified under the general use patterns of aquatic food crop

[[Page 60974]]

and aquatic nonfood. The greenhouse use pattern includes products
classified under the general use patterns of greenhouse food crop and
greenhouse nonfood crop. Data are also required for the general use
patterns of forestry use, residential outdoor use, and indoor use,
which includes both food and nonfood uses.
(c) Key. CR=Conditionally required; NR=Not required; R=Required;
EP=End-use product; MP=Manufacturing-use product; TEP=Typical end-use
product.
(d) Table. The following table lists the data requirements that
pertain to product performance. The table notes are shown in paragraph
(e) of this section.
Table--Product Performance Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Use Pattern Test substance to
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- support
Guideline Number Data Requirement Terrestrial Aquatic Greenhouse ------------------------ Test Note
--------------------------------------------------------------------------------------------------------------------------- Forestry Residential Indoor No.
Food Crop Nonfood Crop Food Nonfood Food Crop Nonfood Crop Outdoor MP EP
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy of antimicrobial agents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
91-2 Products for use NR NR NR NR NR NR NR NR CR NR EP 1
on hard surfaces
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
91-3 Products requiring NR NR NR NR NR NR NR NR CR NR EP 1
confirmatory data
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
91-4 Products for use NR NR NR NR NR NR NR NR CR NR EP 1
on fabrics and
textiles
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
91-5 Air sanitizers NR NR NR NR NR NR NR NR CR NR EP 1
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
91-7 Products for NR NR NR NR NR NR NR NR CR NR EP 1
control of
microbial pests
associated with
human and animal
wastes
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
91-8 Products for NR NR CR NR NR NR NR NR CR NR EP 1
treating water
systems
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy of fungicides and nematicides
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
93-16 Products for CR NR CR NR CR NR NR NR NR NR EP 1
control of
organisms
producing
mycotoxins
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy of vertebrate control agents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
96-5 Avian toxicants R R NR NR NR NR NR R R NR EP 1
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
96-6 Avian repellents R R NR NR NR NR NR R NR NR EP 1
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
96-7 Avian frightening R R NR NR NR NR NR R NR NR EP 1
agents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
96-9 Bat toxicants and NR NR NR NR NR NR NR NR R NR EP 1
repellents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 60975]]

96-10 Commensal R R NR NR NR NR NR R R TEP EP 1
rodenticides
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
96-12 Rodenticides on R R NR NR NR NR NR R NR NR EP 1
farm and
rangelands
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
95-13 Rodent fumigants R R NR NR NR NR NR R R NR EP 1
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
95-16 Rodent R R NR NR NR NR NR R R NR EP 1
reproductive
inhibitors
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
95-17 Mammalian R R NR NR NR NR NR R NR NR EP 1
predacides
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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

Subpart F--Toxicology

Sec. 158.500 Toxicology data requirements table.

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

[[Page 60976]]

870.2500 Primary dermal R R TGAI and MP TGAI and EP 1, 3
irritation
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2600 Dermal R R TGAI and MP TGAI and EP 3, 5
sensitization
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.6100 Delayed CR CR TGAI TGAI 6
neurotoxicity
(acute) - hen
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.6200 Acute R R TGAI TGAI 7
neurotoxicity -
rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
Subchronic Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3100 90-day Oral - R CR TGAI TGAI 8, 9
rodent
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3150 90-day Oral - non- R CR TGAI TGAI 36
rodent
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3200 21/28-day Dermal R NR TGAI TGAI and EP 10, 11
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3250 90-day Dermal CR R TGAI TGAI and EP 11, 12
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3465 90-day Inhalation - CR CR TGAI TGAI 13, 14
rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.6100 28-day Delayed CR CR TGAI TGAI 6, 15
neurotoxicity-hen
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.6200 90-day R R TGAI TGAI 7, 16
Neurotoxicity -
rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chronic Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.4100 Chronic oral - R CR TGAI TGAI 17, 18, 19
rodent
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.4200 Carcinogenicity - R CR TGAI TGAI 9, 17, 18, 19, 20,
two rodent 21
species - rat and
mouse preferred
--------------------------------------------------------------------------------------------------------------------------------------------------------
Developmental Toxicity and Reproduction
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3700 Prenatal R R TGAI TGAI 22, 23, 24, 25, 26
Developmental
toxicity - rat
and rabbit,
preferred
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3800 Reproduction and R R TGAI TGAI 26, 27, 29
fertility effects
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.6300 Developmental CR CR TGAI TGAI 27, 28, 29
neurotoxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mutagenicity Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5100 Bacterial reverse R R TGAI TGAI 30
mutation assay
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5300 In vitro mammalian R R TGAI TGAI 30, 31
870.5375...................... cell assay
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5385 In vivo R R TGAI TGAI 30, 32
870.5395...................... cytogenetics
--------------------------------------------------------------------------------------------------------------------------------------------------------
Special Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.7485 Metabolism and R CR PAI or PAIRA PAI or PAIRA 33
pharmacokinetics
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.7200 Companion animal CR CR NR TGAI or EP 34
safety
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.7600 Dermal penetration CR CR Choice Choice 35
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.7800 Immunotoxicity R R TGAI TGAI
--------------------------------------------------------------------------------------------------------------------------------------------------------

(e) Test notes. The following test notes apply to the requirements
in the table to paragraph (d) of this section:
1. Not required if test material is a gas or a highly volatile
liquid.
2. Diluted EP testing is required to support the end product
registration if results using the EP meet the criteria for
restricted use classification under Sec. 152.170(b) or special
review consideration under Sec. 154.7(a)(1).
3. Not required if the test material is corrosive to skin or has
a pH of less than 2 or greater than 11.5.

[[Page 60977]]

4. Required if the product consists of, or under conditions of
use will result in, a respirable material (e.g., gas, vapor,
aerosol, or particulate).
5. Required if repeated dermal exposure is likely to occur under
conditions of use.
6. Required if the test material is an organophosphorus
substance, which includes uncharged organophosphorus esters;
thioesters or anhydrides of organophosphoric, organophosphonic, or
organophosphoramidic acids; or of related phosphorothioic,
phosponothioic, or phosphorothioamidic acids; or is structurally
related to other substances that may cause the delayed neurotoxicity
sometimes seen in this class of chemicals.
7. As determined by the Agency, additional measurements may also
be required, such as cholinesterase activity for certain pesticides,
e.g., organophosphates and some carbamates. The route of exposure
must correspond with the primary route of exposure.
8. Required for nonfood use pesticides if oral exposure could occur.
9. The 90-day study is required in the rat for hazard
characterization (possibly endpoint selection) and dose-setting for
the chronic/carcinogenicity study. It is not required in the mouse,
but the Agency would strongly encourage the registrant to conduct a
90-day range finding for the purposes of dose selection for the
mouse carcinogenicity study to achieve adequate dosing and an
acceptable study. The registrant is also encouraged to consult with
the Agency on the results of the 90-day mouse study prior to
conducting the carcinogenicity study.
10. Required for agricultural uses or if repeated human dermal
exposure may occur. Not required if an acceptable 90-day dermal
toxicity study is performed and submitted.
11. EP testing is required if the product, or any component of
it, may increase dermal absorption of the active ingredient(s) as
determined by testing using the TGAI, or increase toxic or
pharmacologic effects.
12. Required for food uses if either of the following criteria is met:
(i) The use pattern is such that the dermal route would be the
primary route of exposure; or
(ii) The active ingredient is known or expected to be
metabolized differently by the dermal route of exposure than by the
oral route, and a metabolite is the toxic moiety.
13. Required if there is the likelihood of significant repeated
inhalation exposure to the pesticide as a gas, vapor, or aerosol.
14. Based on estimates of the magnitude and duration of human
exposure, studies of shorter duration, e.g., 21- or 28-days, may be
sufficient to satisfy this requirement. Registrants should consult
with the Agency to determine whether studies of shorter duration
would meet this requirement.
15. Required if results of acute neurotoxicity study indicate
significant statistical or biological effects, or if other available
data indicate the potential for this type of delayed neurotoxicity,
as determined by the Agency.
16. All 90-day subchronic studies in rats can be designed to
simultaneously fulfill the requirements of the 90-day neurotoxicity
study using separate groups of animals for testing. Although the
subchronic guidelines include the measurement of neurological
endpoints, they do not meet the requirement of the 90-day
neurotoxicity study.
17. Required if either of the following are met:
(i) The use of the pesticide is likely to result in repeated
human exposure over a considerable portion of the human lifespan, as
determined by the Agency;
(ii) The use requires a tolerance or an exemption from the
requirement of a tolerance.
18. Based on the results of the acute and subchronic
neurotoxicity studies, or other available data, a combined chronic
toxicity and neurotoxicity study may be required.
19. Studies which are designed to simultaneously fulfill the
requirements of both the chronic oral and carcinogenicity studies
(i.e., a combined study) may be conducted. Minimum acceptable study
durations are:
(i) Chronic rodent feeding study (food use) - 24 months.
(ii) Chronic rodent feeding study (nonfood use) - 12 months.
(iii) Mouse carcinogenicity study - 18 months.
(iv) Rat carcinogenicity study - 24 months.
20. Required if any of the following, as determined by the
Agency, are met:
(i) The use of the pesticide is likely to result in significant
human exposure over a considerable portion of the human life span
which is significant in terms of either frequency, duration, or
magnitude of exposure;
(ii) The use requires a tolerance or an exemption from the
requirement of a tolerance; or
(iii) The active ingredient, metabolite, degradate, or impurity
(a) is structurally related to a recognized carcinogen, (b) causes
mutagenic effects as demonstrated by in vitro or in vivo testing, or
(c) produces a morphologic effect in any organ (e.g., hyperplasia,
metaplasia) in subchronic studies that may lead to a neoplastic change.
21. If this study is modified or waived, a subchronic 90-day
oral study conducted in the same species may be required.
22. Testing in two species is required for all uses.
23. The oral route, by oral intubation, is preferred unless the
chemical or physical properties of the test substance or the pattern
of exposure suggests a more appropriate route of exposure.
24. Additional testing by other routes may be required if the
pesticide is determined to be a prenatal developmental toxicant
after oral dosing.
25. May be combined with the 2-generation reproduction study in
rodents by utilizing a second mating of the parental animals in
either generation.
26. Required to support products intended for food uses and to
support products intended for nonfood uses if use of the product is
likely to result in significant human exposure over a portion of the
human life span in terms of frequency, magnitude or duration of exposure.
27. An information-based approach to testing is preferred, which
utilizes the best available knowledge on the chemical (hazard,
pharmacokinetic, or mechanistic data) to determine whether a
standard guideline study, an enhanced guideline study, or an
alternative study should be conducted to assess potential hazard to
the developing animal, or in some cases to support a waiver for such
testing. Registrants should submit any alternative proposed testing
protocols and supporting scientific rationale to the Agency prior to
study initiation.
28. Study required using a weight-of-evidence approach considering:
(i) The pesticide causes treatment-related neurological effects
in adult animal studies (i.e., clinical signs of neurotoxicity,
neuropathology, functional or behavioral effects).
(ii) The pesticide causes treatment-related neurological effects
in developing animals, following pre- and postnatal exposure (i.e.
nervous system malformations or neuropathy, brain weight changes in
offspring, functional or behavioral changes in the offspring).
(iii) The pesticide elicits a causative association between
exposures and adverse neurological effects in human epidemiological studies.
(iv) The pesticide evokes a mechanism that is associated with
adverse effects on the development of the nervous system (e.g., SAR
relationship to known neurotoxicants, altered neuroreceptor or
neurotransmitter responses).
29. The use of a combined study that utilizes the 2-generation
reproduction study in rodents as a basic protocol for the addition
of other endpoints or functional assessments in the immature animal
is encouraged.
30. At a minimum, an initial battery of mutagenicity tests with
possible confirmatory testing is required. Other relevant
mutagenicity tests that may have been performed, plus a complete
reference list must also be submitted.
31. Choice of assay using either:
(i) Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene
locus, maximizing assay conditions for small colony expression or
detection;
(ii) Chinese hamster ovary (CHO) or Chinese hamster lung
fibroblast (V79) cells, hypoxanthine-guanine phosphoribosyl
transferase (hgprt) gene locus, accompanied by an appropriate in
vitro test for clastogenicity; or
(iii) CHO cells strains AS52, xanthine-guanine phosphoribosyl
transferase (xprt) gene locus.
32. The micronucleus rodent bone marrow assay is preferred;
however, rodent bone marrow assays using metaphase analysis
(aberrations) are acceptable.
33. Required when chronic or carcinogenicity studies are
required. May be required if significant adverse effects are seen in
available toxicology studies and these effects can be further
elucidated by metabolism studies.
34. May be required if the product's use will result in exposure
to domestic animals through, but not limited to, direct application.
35. A risk assessment assuming that dermal absorption is equal
to oral absorption must be

[[Page 60978]]

performed to determine if the study is required, and to identify the
doses and duration of exposure for which dermal absorption is to be
quantified.
36. A 1-year non-rodent study (i.e., 1-year dog study) would be
required if the Agency finds that a pesticide chemical is highly
bioaccumulating and is eliminated so slowly that it does not achieve
steady state or sufficient tissue concentrations to elicit an effect
during a 90-day study. EPA would require the appropriate tier II
metabolism and pharmacokinetic studies to evaluate more precisely
bioavailability, half-life, and steady state to determine if a
longer duration dog toxicity study is needed.

Sec. 158.510 Tiered testing options for nonfood pesticides.

For nonfood use pesticides only, applicants have two options for
generating and submitting required toxicology (Sec. 158.500) and human
exposure (Sec. 158.1020, Sec. 158.1070, and Sec. 158.1410) studies.
Applicants are to select one of the following:
(a) Acute, subchronic, chronic, and other toxicological studies on
the active ingredient must be submitted together. The specific makeup
of the set of toxicology study requirements is based on the anticipated
exposure to the pesticide as determined by the Agency. If hazards are
identified based upon review of these studies, specific exposure data
will be required to evaluate risk.
(b) Certain toxicological and exposure studies must be submitted
simultaneously with the toxicology data submitted in a tiered system.
Exposure data must be submitted along with first tier toxicology data.
The requirement for additional second and third level toxicology
testing will be determined by the Agency based on the results of the
first tiered studies.
(1) The required first-tier toxicology studies consist of:
(i) Battery of acute studies.
(ii) A subchronic 90-day dermal study or a subchronic 90-day
inhalation study.
(iii) An acute and subchronic neurotoxicity screening battery in
the rat.
(iv) Prenatal developmental toxicity studies in both the rat and rabbit.
(v) Reproduction and fertility studies in rats.
(vi) Battery of mutagenicity studies.
(vii) Immunotoxicity study.
(2) The conditionally required second-tier studies include:
(i) Subchronic 90-day feeding studies in both the rodent and nonrodent.
(ii) Dermal penetration study.
(3) The conditionally required third-tier studies include:
(i) Chronic feeding studies in the rodent.
(ii) Carcinogenicity.
(iii) Metabolism study.
(iv) Additional mutagenicity testing.

Subpart G-- Ecological Effects

Sec. 158.630 Terrestrial and aquatic nontarget organisms data
requirements table.

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

Terrestrial and Aquatic Nontarget Organism Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Use Pattern
------------------------------------------------------------------------------------------------------------
Guideline Number Data Requirement Residential Test substance Test Note No.
Terrestrial Aquatic Forestry Outdoor Greenhouse Indoor
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Avian and Mammalian Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2100 Avian oral R R R R CR CR TGAI 1, 2, 3
toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2200 Avian dietary R R R R NR NR TGAI 1, 4
toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2400 Wild mammal CR CR CR CR NR NR TGAI 5
toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2300 Avian R R R R NR NR TGAI 1, 4
reproduction
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2500 Simulated or CR CR CR CR NR NR TEP 6, 7
actual field
testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Aquatic Organisms Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 60979]]

850.1075 Freshwater fish R R R R CR CR TGAI, TEP 1, 2, 8, 9, 26
toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1010 Acute toxicity R R R R CR CR TGAI, TEP 1, 2, 9, 10, 26
freshwater
invertebrates
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1025 Acute toxicity R R R R NR NR TGAI, TEP 1, 9, 11, 12, 26
850.1035.................... estuarine and
850.1045.................... marine
850.1055.................... organisms
850.1075....................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1300 Aquatic R R R R NR NR TGAI 1, 10, 12
invertebrate
life cycle
(freshwater)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1350 Aquatic CR CR CR CR NR NR TGAI 12, 14, 15
invertebrate
life cycle
(saltwater)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1400 Fish early-life R R R R NR NR TGAI 1, 12, 13
stage
(freshwater)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1400 Fish early-life CR CR CR CR NR NR TGAI 12, 15, 16
stage
(saltwater)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1500 Fish life cycle CR CR CR CR NR NR TGAI 17, 18
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1710 Aquatic CR CR CR CR NR NR TGAI, PAI, 19
850.1730.................... organisms degradate
850.1850.................... bioavailability
,
biomagnificatio
n, toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1950 Simulated or CR CR CR CR NR NR TEP 7, 20
actual field
testing for
aquatic
organisms
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Sediment Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1735 Whole sediment: CR CR CR CR NR NR TGAI 21
acute
freshwater
invertebrates
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1740 Whole sediment: CR CR CR CR NR NR TGAI 21, 23
acute marine
invertebrates
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Whole sediment: CR CR CR CR NR NR TGAI 22, 23
chronic
invertebrates
freshwater and
marine
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Insect Pollinator Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.3020 Honeybee acute R CR R R NR NR TGAI 1
contact
toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.3030 Honey bee CR CR CR CR NR NR TEP 24
toxicity of
residues on
foliage
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.3040 Field testing CR CR CR CR NR NR TEP 25
for pollinators
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 60980]]

(e) Test notes. The following test notes apply to terrestrial and
aquatic nontarget organisms data requirements in the table to paragraph
(d) of this section:
1. Data using the TGAI are required to support all outdoor end-
use product uses including, but not limited to turf. Data are
generally not required to support end-use products in the form of a
gas, a highly volatile liquid, a highly reactive solid, or a highly
corrosive material.
2. For greenhouse and indoor end-use products, data using the
TGAI are required to support manufacturing-use products to be
reformulated into these same end-use products or to support end-use
products when there is no registered manufacturing-use product.
Avian acute oral data are not required for liquid formulations for
greenhouse and indoor uses. The study is not required if there is no
potential for environmental exposure.
3. Data are required on one passerine species and either one
waterfowl species or one upland game bird species for terrestrial,
aquatic, forestry, and residential outdoor uses. Data are preferred
on waterfowl or upland game bird species for indoor and greenhouse uses.
4. Data are required on waterfowl and upland game bird species.
5. Tests are required based on the results of lower tier
toxicology studies, such as the acute and subacute testing, intended
use pattern, and environmental fate characteristics that indicate
potential exposure.
6. Higher tier testing may be required for a specific use
pattern when a refined risk assessment indicates a concern based on
laboratory toxicity endpoints and refined exposure assessments.
7. Environmental chemistry methods used to generate data
associated with this study must include results of a successful
confirmatory method trial by an independent laboratory. Test
standards and procedures for independent laboratory validation are
available as addenda to the guideline for this test requirement.
8. Data are required on one coldwater fish and one warmwater
fish for terrestrial, aquatic, forestry, and residential outdoor
uses. For indoor and greenhouse uses, testing with only one of
either fish species is required.
9. EP or TEP testing is required for any product which meets any
of the following conditions:
i. The end-use pesticide will be introduced directly into an
aquatic environment (e.g., aquatic herbicides and mosquito
larvicides) when used as directed.
ii. The maximum expected environmental concentration (MEEC) or
the estimated environmental concentration (EEC) in the aquatic
environment is >= one-half the LC₅₀ or EC₅₀ of
the TGAI when the EP is used as directed.
iii. An ingredient in the end-use formulation other than the
active ingredient is expected to enhance the toxicity of the active
ingredient or to cause toxicity to aquatic organisms.
10. Data are required on one freshwater aquatic invertebrate species.
11. Data are required on one estuarine/marine mollusk, one
estuarine/marine invertebrate and one estuarine/marine fish species.
12. Data are generally not required for outdoor residential
uses, other than turf, unless data indicate that pesticide residues
from the proposed use(s) can potentially enter waterways.
13. Data are required on one freshwater fish species. If the
test species is different from the two species used for the
freshwater fish acute toxicity tests, a 96-hour LC₅₀ on
that species must also be provided.
14. Data are required on one estuarine/marine invertebrate species.
15. Data are required on estuarine/marine species if the product
meets any of the following conditions:
i. Intended for direct application to the estuarine or marine
environment.
ii. Expected to enter this environment in significant
concentrations because of its expected use or mobility patterns.
iii. If the acute LC₅₀ or EC₅₀ < 1
milligram/liter (mg/l).
iv. If the estimated environmental concentration (EEC) in water
is >= 0.01 of the acute EC₅₀ or LC₅₀ or if any
of the following conditions exist:
A. Studies of other organisms indicate the reproductive
physiology of fish and/or invertebrates may be affected.
B. Physicochemical properties indicate bioaccumulation of the
pesticide.
C. The pesticide is persistent in water (e.g., half-life in
water > 4 days).
16. Data are required on one estuarine/marine fish species.
17. Data are required on estuarine/marine species if the product
is intended for direct application to the estuarine or marine
environment, or the product is expected to enter this environment in
significant concentrations because of its expected use or mobility
patterns.
18. Data are required on freshwater species if the end-use
product is intended to be applied directly to water, or is expected
to be transported to water from the intended use site, and when any
of the following conditions apply:
i. If the estimated environmental concentration (EEC) is >= 0.1
of the no-observed-effect level in the fish early-life stage or
invertebrate life cycle test;
ii. If studies of other organisms indicate that the reproductive
physiology of fish may be affected.
19. Not required when:
i. The octanol/water partition coefficients of the pesticide
and its major degradates are < 1,000; or
ii. There are no potential exposures to fish and other
nontarget aquatic organisms; or
iii. The hydrolytic half-life is < 5 days at pH 5, 7 and 9.
20. Data are required based on the results of lower tier studies
such as acute and chronic aquatic organism testing, intended use
pattern, and environmental fate characteristics that indicate
significant potential exposure.
21. Data are required if:
i. The half-life of the pesticide in the sediment is < = 10 days
in either the aerobic soil or aquatic metabolism studies and if any
of the following conditions exist:
A. The soil partition coefficient (Kd) is >= 50.
B. The log Kow is >= 3.
C. The Koc >= 1,000.
ii. Registrants must consult with the Agency on appropriate test
protocols prior to designing the study.
22. Data are required if:
i. The estimated environmental concentration (EEC) in sediment
is > 0.1 of the acute LC₅₀/EC₅₀ values and
ii. The half-life of the pesticide in the sediment is > 10 days
in either the aerobic soil or aquatic metabolism studies and if any
of the following conditions exist:
A. The soil partition coefficient (Kd) is >= 50.
B. The log Kow is >= 3.
C. The Koc >= 1,000.
iii. Registrants must consult with the Agency on appropriate
test protocols prior to designing the study.
23. Sediment testing with estuarine/marine test species is
required if the product is intended for direct application to the
estuarine or marine environment or the product is expected to enter
this environment in concentrations which the Agency believes to be
significant, either by runoff or erosion, because of its expected
use or mobility pattern.
24. Data are required only when the formulation contains one or
more active ingredients having an acute LD₅₀ of < 11
micrograms per bee as determined in the honey bee acute contact
study and the use pattern(s) indicate(s) that honey bees may be
exposed to the pesticide.
25. Required if any of the following conditions are met:
i. Data from other sources (Experimental Use Permit program,
university research, registrant submittals, etc.) indicate potential
adverse effects on colonies, especially effects other than acute
mortality (reproductive, behavioral, etc.);
ii. Data from residual toxicity studies indicate extended
residual toxicity.
iii. Data derived from studies with terrestrial arthropods other
than bees indicate potential chronic, reproductive or behavioral effects.
26. The freshwater fish test species for the TEP testing is the
most sensitive of the species tested with the TGAI. Freshwater
invertebrate and acute estuarine and marine organisms must also be
tested with the EP or TEP using the same species tested with the TGAI.

Sec. 158.660 Nontarget plant protection data requirements table.

(a) General. Sections 158.100 through158.130 describe how to use
this table to determine the nontarget plant data requirements for a
particular pesticide product. Notes that apply to an individual test
and include specific conditions, qualifications, or exceptions to the
designated test are listed in paragraph (e) of this section.

[[Page 60981]]

(b) Use patterns. (1) The terrestrial use pattern includes products
classified under the general use patterns of terrestrial food crop,
terrestrial feed crop, and terrestrial nonfood. The aquatic use pattern
includes only the general use patterns of aquatic food crops and
aquatic nonfood.
(2) Data are also required for the general use patterns of forestry
use and residential outdoor use.
(c) Key. R=Required; CR=Conditionally required; NR=Not required;
TGAI=Technical grade of the active ingredient; TEP=Typical end-use product.
(d) Table. The following table shows the nontarget plant protection
data requirements. The table notes are shown in paragraph (e) of this
section.

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

(e) Test notes. The following test notes apply to the table in
paragraph (d) of this section.
1. Not required for contained pesticide treatments such as bait
boxes and pheromone traps unless adverse effects reports are
received by the Agency.
2. Not required for known phytotoxicants.
3. Generally not required for granular formulations. May be
requested on a case-by-case basis.
4. Required for known phytotoxicants such as herbicides,
desiccants and defoliants.
5. Required if a tested terrestrial species exhibits a 25
percent or greater detrimental effect in the Tier I study. When Tier
II testing is required, the test species should be the species that
showed detrimental effects in the Tier I testing.
6. Required if the tested aquatic species exhibits a 50 percent
or greater detrimental effect in the Tier I study. When Tier II
testing is required, the test species should be the species that
showed detrimental effects in the tier I testing.
7. Not required for aquatic residential uses.
8. Environmental chemistry methods used to generate data must
include the results of a successful confirmatory method trial by an
independent laboratory.
9. Tests are required on a case-by-case basis based on the
results of lower tier phytotoxicity studies, adverse incident
reports, intended use pattern, and environmental fate
characteristics that indicate potential exposure.
10. Registrants must consult with the Agency on appropriate test
protocols prior to designing the study.

Subparts H - J [Reserved]

Sec. Sec. 158.700 - 158.900 [Reserved]

Subpart K--Human Exposure

Sec. 158.1000 Applicator exposure--general requirements.

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

[[Page 60982]]

Sec. 158.1010 Applicator exposure--criteria for testing .

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

Sec. 158.1020 Applicator exposure data requirements table.

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

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

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

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

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

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

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

[[Page 60983]]

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

Sec. 158.1070 Post-application exposure data requirements table .

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

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

(e) Test notes. The following test notes apply to the data
requirements in the table to paragraph (d) of this section:
1. Protocols must be submitted for approval prior to the
initiation of the study. Details for developing protocols are
available from the Agency.
2. Bridging applicable residue dissipation data to dermal
exposure data is required.
3. Turf grass transferable residue dissipation data are required
when pesticides are applied to turf grass. Dislodgeable foliar
residue dissipation data are required when pesticides are applied to
the foliage of plants other than turf grass.
4. Data are required for occupational sites if (i) there are
uses on turf grass or other plant foliage, and (ii) the human
activity data indicate that workers are likely to have post-
application dermal contact with treated foliage while participating
in typical activities.
5. Data are required for residential sites if there are uses on
turf grass or other plant foliage.
6. Data are required for occupational sites, if (i) there are
outdoor or greenhouse uses to or around soil or other planting
media, and (ii) the human activity data indicate that workers are
likely to have post-application dermal contact with treated soil or
planting media while participating in typical activities.
7. Data are required for residential sites if the pesticide is
applied to or around soil or other planting media both outdoors and
indoors, e.g., residential greenhouse or houseplant uses.
8. Data are required for occupational sites if the pesticide is
applied to or around on non-plant surfaces, e.g., flooring or
countertops, and if the human activity data indicate that workers
are likely to have post-application dermal contact with treated
indoor surfaces while participating in typical activities.
9. Data are required for residential sites if the pesticide is
applied to or around non-plant surfaces, e.g., flooring and countertops.
10. Data are required for occupational sites if the human
activity data indicate that workers are likely to have post-
application exposures while participating in typical activities.
11. Data are required for residential sites if post-application
exposures are likely.
12. Biological monitoring data may be submitted in addition to,
or in lieu of, dermal and inhalation exposure data provided the
human pharmocokinetics of the pesticide and/or metabolite/analog
compounds (i.e., whichever method is selected as an indicator of
body burden or internal dose) allow for a back-calculation to the
total internal dose.

[[Page 60984]]

13. Data are required when passive dosimetry techniques are not
applicable for a particular exposure scenario, such as a swimmer
exposure to pesticides.
14. Data reporting and calculations are required when any post-
application exposure monitoring data are submitted.
15. The selection of a sampling method will depend on the
nondietary pathway(s) of interest. Data must be generated to
consider all potential pathways of nondietary ingestion exposure
that are applicable (e.g., soil ingestion, hand-to-mouth transfer,
and object-to-mouth transfer of surface residues).

Subpart L--Spray Drift

Sec. 158.1100 Spray drift data requirements table.

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

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

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

Subpart M--[Reserved]

Sec. Sec. 158.1200 - 158.1299 [Reserved]

Subpart N--Environmental Fate

Sec. 158.1300 Environmental fate data requirements table.

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

[[Page 60985]]

835.2410 Photodegradation R NR NR NR R NR TGAI or PAIRA 3
on soil
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.2370 Photodegradation CR NR CR NR CR CR TGAI or PAIRA 4
in air
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Metabolism Studies - Laboratory
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.4100 Aerobic soil R CR R NR R R TGAI or PAIRA 5
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.4200 Anaerobic soil R NR NR NR NR NR TGAI or PAIRA --
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.4300 Aerobic aquatic R R NR NR R NR TGAI or PAIRA --
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.4400 Anaerobic R R NR NR R NR TGAI or PAIRA --
aquatic
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Mobility Studies
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.1230 Leaching and R R R NR R R TGAI or PAIRA 6
835.1240.................... adsorption/
desorption
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.1410 Volatility - CR NR CR NR NR NR TEP 4
laboratory
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.8100 Volatility - CR NR CR NR NR NR TEP --
field
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Dissipation Studies - Field
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.6100 Terrestrial R CR NR NR CR R TEP 5, 7, 12
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.6200 Aquatic CR R NR NR NR NR TEP 7, 8
(sediment)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.6300 Forestry NR NR NR NR CR NR TEP 7, 9, 12
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.6400 Combination and CR CR NR NR NR NR TEP 10
tank mixes
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Ground Water Monitoring
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
835.7100 Ground water CR NR NR NR CR CR TEP 7, 9, 11
monitoring
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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

[[Page 60986]]

10. This study may be triggered if there is specific evidence
that the presence of one pesticide can affect the dissipation
characteristics of another pesticide when applied simultaneously or
serially.
11. Required if the weight-of-evidence indicates that the
pesticide and/or its degradates is likely to leach to ground water,
taking into account other factors such as the toxicity of the
chemicals(s), available monitoring data, and the vulnerability of
ground water resources in the pesticide use area.
12. If the terrestrial dissipation study cannot assess all of
the major routes of dissipation, the forestry study will be required.

Subpart O--Residue Chemistry

Sec. 158.1400 Definitions.

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

Sec. 158.1410 Residue chemistry data requirements table.

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

Table--Residue Chemistry Data Requirements for Food Uses
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Use Pattern
----------------------------------------------------------------------------------------------------
Guideline Number Data Requirement Terrestrial Food Residential Test substance Test Note No.
or Feed Aquatic Food Greenhouse Food Indoor Food Outdoor
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Supporting Information
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
860.1100 Chemical identity R R R R R TGAI --
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
860.1200 Directions for use R R R R R -- --
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
860.1550 Proposed tolerance R R R CR NR -- 1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
860.1560 Reasonable grounds R R R CR NR -- 1
in support of
petition
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
860.1650 Submittal of R R R CR NR PAI and residue of 1, 2, 25
analytical concern
reference
standards
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Nature of the residue
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
860.1300 Nature of the R R R CR CR PAIRA 3, 4, 25
residue in plants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
860.1300 Nature of the CR CR CR CR NR PAIRA or 1, 6, 25
residue in radiolabeled
livestock plant metabolite
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
860.1850 Confined CR CR NR NR NR PAIRA 7
rotational crops
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Analytical methods
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
860.1340 Residue analytical R R R CR CR Residue of concern 1, 3, 8, 9, 10, 25
methods
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
860.1360 Multiresidue R R R CR NR Residue of concern 1, 11, 25
method
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 60987]]

Magnitude of the residue
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
860.1380 Storage stability R R R CR CR TEP or residue of 1, 3, 10, 12, 25
concern
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
860.1500 Crop field trials R R R CR CR TEP 3, 10, 14, 24, 25
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
860.1520 Processed food or CR CR CR CR NR TEP 1, 15, 25
feed
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
860.1480 Meat/milk/poultry/ CR CR CR CR NR TGAI or plant 1, 16, 17, 18, 25
eggs metabolite
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
860.1400 Potable water NR R NR NR NR TEP 19, 25
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
860.1400 Fish NR R NR NR NR TEP 5, 25
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
860.1400 Irrigated crops NR CR NR NR NR TEP 20, 25
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
860.1460 Food handling NR NR NR CR NR TEP 1, 21, 25
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
860.1540 Anticipated CR CR CR CR NR Residue of concern 1, 13, 22, 26
residues
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
860.1900 Field rotational CR CR NR NR NR TEP 23, 25
crops
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

(e) Test notes. The following test notes apply to the data
requirements in the table to paragraph (d) of this section.
1. Required if indoor use could result in pesticide residues in
or on food or feed.
2. Material safety data sheets must accompany standards as
specified by OSHA in 29 CFR 1910.1200.
3. Required for residential outdoor uses on food crops if the
corresponding agricultural use is not approved or the residential
use is expected to produce higher residues based on the label directions.
4. Required for indoor uses where the pesticide is applied
directly to food, in order to determine metabolites and/or
degradates. Not required when only indirect contact with food would
occur (e.g., crack and crevice treatments).
5. Data for fish are required for all pesticides applied
directly to water inhabited, or which will be inhabited, by fish
that may be caught or harvested for human consumption.
6. Required when a pesticide is to be applied directly to
livestock, to livestock premises, to livestock drinking water, or to
crops used for livestock feed. If results from the plant metabolism
study show differing metabolites in plants from those found in
animals, an additional livestock metabolism study involving dosing
with the plant metabolite(s) may also be required.
7. Required when the Agency determines that it is reasonably
foreseeable that a food or feed crop could be subsequently planted
on the site of pesticide application after harvest or failure of the
treated crop. Typically not required for pesticide uses in permanent
food crops (e.g., various tree crops, vines) or semi-permanent crops
(e.g., asparagus, pineapples).
8. A residue analytical method suitable for enforcement purposes
is required whenever a numeric tolerance (including temporary and
time-limited tolerances) is proposed.
9. New analytical methods to be used for enforcement purposes
must include results from an independent laboratory validation.
10. A residue method, storage stability data, and crop field
trials are required for the nonfood crop tobacco (green, freshly
harvested). Depending on the level of residues found on the green
tobacco, additional data may be required on cured/dried tobacco and
pyrolysis products.
11. Data are required to determine whether FDA/USDA multiresidue
methodology would detect and identify the pesticides and any metabolites.
12. Data are required for any magnitude of the residue study
unless analytical samples are stored frozen for 30 days or less, and
the active ingredient is not known to be volatile or labile.
13. Studies using single serving samples of a raw agricultural
commodity may be needed for acutely toxic pesticides and/or their
metabolites. These residue studies must be conducted using a
statistical design accepted by the Agency.
14. Required for indoor uses which are direct postharvest
treatments of raw agricultural commodities (e.g., fungicidal waxes
or stored grain fumigants).
15. Data on the nature and level of residues in processed food/
feed are required if residues could potentially concentrate on
processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity.
16. Required when the pesticide use is a direct application to
livestock.
17. Data are required if pesticide residues are present in or on
livestock feed items or intentionally added to drinking water. These
studies, however, may not be required in cases where the livestock
metabolism studies indicate negligible transfer of the pesticide's
residues of concern to tissues, milk, and eggs at the maximum
expected exposure level for the animals.
18. If results from the plant metabolism study show differing
metabolites in plants from those found in animals, an additional
livestock feeding study involving dosing with the plant
metabolite(s) may also be required.
19. Data are required whenever a pesticide may be applied
directly to water, unless it can be demonstrated that the treated
water would not be available for human or livestock consumption.
20. Data are required when a pesticide is to be applied directly
to water that could be used for irrigation or to irrigation
facilities such as irrigation ditches.
21. Data are required whenever a pesticide may be used in a food
handling or feed handling establishment.
22. Required when residues at the tolerance level may result in
a risk of concern. These data may include washing, cooking,
processing or degradation studies as well as market basket surveys
for a more precise residue determination.
23. Typically required if pesticide residues of concern greater
than 0.01 ppm are found

[[Page 60988]]

in crops at the appropriate plant back intervals (taking into
account plant back restrictions on product labels) in the confined
rotational crop study. If residues of concern in the confined study
are greater than 0.01 ppm but less than the limit of quantitation of
the analytical method to be used on field trial samples, the Agency
will consider not requiring, on a case-by-case basis, the limited
field trials. If there are particular toxicological concerns with
the parent pesticide or any metabolites, limited field studies may
be needed if such residues are identified at levels below 0.01 ppm
in the confined study.
24. Crop field trials are required to establish tolerances on
rotational crops when quantifiable residues of concern are observed
in the field rotational crops study.
25. Not required for an exemption from a tolerance provided that
dietary exposure estimates are not needed due to low toxicity or
that theoretical estimates of exposure are adequate to assess
dietary risk.
26. Not required for an exemption from a tolerance.

Subparts P - T [Reserved]

Sec. Sec. 158.1500 - 158.1900 [Reserved]

Subpart U--Biochemical Pesticides [Reserved]

Sec. 158.2000 [Reserved]

Subpart V--Microbial Pesticides [Reserved]

Sec. 158.2100 [Reserved]

Subpart W--Antimicrobial Pesticides [Reserved]

Sec. 158.2200 [Reserved]

Subparts X - Z [Reserved]

Sec. Sec. 158.2300 - 158.2500 [Reserved]

[FR Doc. E7-20826 Filed 10-25-07; 8:45 am]
BILLING CODE 6560-50-S

Notices For
2009
2008
2007
2006
2005
2004
2003
2002
2001
2000
1999
1998
1997
1996
1995
1994

Pesticides; Data Requirements for Conventional Chemicals

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