[Federal Register Volume 72, Number 207 (Friday, October 26, 2007)]
[Rules and Regulations]
[Pages 60934-60988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-20826]



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Part II





Environmental Protection Agency





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40 CFR Parts 9, 152, 156, 159 et al.



Pesticides; Data Requirements for Conventional Chemicals, Technical 
Amendments, and Data Requirements for Biochemical and Microbial 
Pesticides; Final Rules

  Federal Register / Vol. 72, No. 207 / Friday, October 26, 2007 / 
Rules and Regulations  

[[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


Pesticides; Data Requirements for Conventional Chemicals

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 
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: 
[email protected] . 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: [email protected].

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

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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 (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 (65 FR 67249, 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.

0
Therefore, chapter I of title 40 of the Code of Federal Regulations is 
amended as follows:

PART 9--[AMENDED]

0
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.

0
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
                                * * * * *
------------------------------------------------------------------------


0
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 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.

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

[[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.

                                                                           Table--Environmental Fate Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                  Use Pattern
                                                 ------------------------------------------------------------------------------------------------------------
       Guideline Number         Data Requirement                                                                                               Residential     Test substance     Test Note No.
                                                     Terrestrial         Aquatic         Greenhouse          Indoor           Forestry           Outdoor
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Degradation Studies - Laboratory
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.2120                      Hydrolysis        R                 R                 R                 CR                R                 R                 TGAI or PAIRA     1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.2240                      Photodegradation  R                 R                 NR                NR                R                 NR                TGAI or PAIRA     2
                                 in water
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[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