[Federal Register Volume 70, Number 47 (Friday, March 11, 2005)]
[Proposed Rules]
[Pages 12277-12353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-4466]



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Part II





Environmental Protection Agency





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40 CFR Parts 152 and 158



Pesticides; Data Requirement for Conventional Chemicals; Proposed Rule

  Federal Register / Vol. 70, No. 47 / Friday, March 11, 2005 / 
Proposed Rules  

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 152 and 158

[OPP-2004-0387; FRL-6811-2]
RIN 2070-AC12


Pesticides; Data Requirement for Conventional Chemicals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to update and revise its data requirements for 
the registration of conventional pesticide products. These data 
requirements and those already codified in part 158 of title 40 of the 
Code of Federal Regulations (CFR), are intended to provide EPA with 
data and other information necessary for the registration of a 
conventional pesticide chemical. Since the data requirements in part 
158 were first codified in 1984, information needed to support the 
registration of a pesticide chemical has evolved as the general 
scientific understanding of the potential hazards posed by pesticides 
has grown. Over the years, updated data requirements were developed by 
EPA using a process that involved public participation and extensive 
involvement by the scientific community, including peer review by the 
FIFRA Scientific Advisory Panel (SAP). Most of the data requirements 
contained in this proposal have been applied on a case-by-case basis to 
support individual applications, or imposed via Data Call-In (DCI) on 
all registrants of similar products. Although the data requirements 
imposed have progressed as scientific understanding and concerns have 
evolved, the codified data requirements have not been updated to keep 
pace. This proposal involves changes to the codified data requirements 
that pertain to product chemistry, toxicology, residue chemistry, 
applicator exposure, post-application exposure, nontarget terrestrial 
and aquatic organisms, nontarget plant protection, and environmental 
fate. Coupled with updating data requirements, EPA proposes to add a 
few new studies, reformat the requirements, and revise its general 
procedures and policies associated with data submission. By codifying 
existing data requirements which are currently applied on a case-by-
case basis, the pesticide industry, along with other partners in the 
regulated community, attain a better understanding and are better 
prepared for the pesticide registration process. This proposed rule 
does not apply to the data requirements for the registration of 
antimicrobial pesticide products; inert ingredients for pesticide 
products; spray drift, product performance (efficacy); or biochemical, 
and microbial pesticides.

DATES: Comments must be received on or before June 9, 2005.

ADDRESSES: Submit your comments, identified by Docket ID No. OPP-2004-
0387, by one of the following methods:
     Federal eRulemaking Portal. http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Agency Web Site. http://www.epa.gov/edocket. EDOCKET, 
EPA's electronic public docket and comment system, is EPA's preferred 
method for receiving comments. Follow the on-line instructions for 
submitting comments.
     E-mail. [email protected].
     Mail. Public Information and Records Integrity Branch 
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
     Hand Delivery. Public Information and Records Integrity 
Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental 
Protection Agency, Rm. 119, Crystal Mall 2, 1801 S. Bell St., 
Arlington, VA. Such deliveries are only accepted during the Docket's 
normal hours of operation, and special arrangements should be made for 
deliveries of boxed information.
    Instructions. Direct your comments to Docket ID No. OPP-2004-0387. 
EPA's policy is that all comments received will be included in the 
public docket without change and may be made available online at http://www.epa.gov/edocket, including any personal information provided, 
unless the comment includes information claimed to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Do not submit information that you consider to 
be CBI or otherwise protected through EDOCKET, regulations.gov, or e-
mail. The EPA EDOCKET and the federal regulations.gov websites are 
``anonymous access '' systems, which means EPA will not know your 
identity or contact information unless you provide it in the body of 
your comment. If you send an e-mail comment directly to EPA without 
going through EDOCKET or regulations.gov, your e-mail address will be 
automatically captured and included as part of the comment that is 
placed in the public docket and made available on the Internet. If you 
submit an electronic comment, EPA recommends that you include your name 
and other contact information in the body of your comment and with any 
disk or CD-ROM you submit. If EPA cannot read your comment due to 
technical difficulties and cannot contact you for clarification, EPA 
may not be able to consider your comment. Electronic files should avoid 
the use of special characters, any form of encryption, and be free of 
any defects or viruses. For additional information about EPA's public 
docket visit EDOCKET on-line or see the Federal Register of May 31, 
2002 (67 FR 38102). For additional instructions on submitting comments, 
go to Unit I.B. of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket. All documents in the docket are listed in the EDOCKET index 
at http://www.epa.gov/edocket. 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 in EDOCKET or in hard 
copy at the Public Information and Records Integrity Branch (PIRIB), 
Rm. 119, Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This 
docket facility 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: Vera Au, Field and External Affairs 
Division (FEAD), Office of Pesticide Programs, Mailcode: 7506C, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460; 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 affected by this action if you are a producer or 
registrant of a pesticide product, including agricultural, residential, 
and industrial pesticides, but not including antimicrobial, biochemical 
or microbial pesticides, or inert ingredients in pesticide products. 
This proposal also may 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

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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 above could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, please consult the appropriate Branch Chief in the Registration 
Division of the Office of Pesticide Programs at 703-305-5447.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
EDOCKET, regulations.gov or e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as 
CBI and then identify electronically within the disk or CD ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments, 
remember to:
     Identify the rulemaking by docket number and other 
identifying information (subject heading, Federal Register date and 
page number).
     Follow directions - The agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives 
and substitute language for your requested changes.
     Describe any assumptions and provide any technical 
information and/or data that you used.
     If you estimate potential costs or burdens, explain how 
you arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
     Provide specific examples to illustrate your concerns, and 
suggest alternatives.
     Explain your views as clearly as possible, avoiding the 
use of profanity or personal threats.
     Make sure to submit your comments by the comment period 
deadline identified.

II. Organization of Preamble

    This preamble is organized according to the outline in this unit.
I. General Information
II. Organization of Preamble
III. Statutory Authorities and Regulatory Framework
IV. Background
V. Purpose and Scope of this Proposal
VI. Overview of Proposed Changes
VII. General Provisions of Part 158 (subpart A)
VIII. How to Use the Data Tables (subpart B)
IX. Product Chemistry Data Requirements (subpart D)
X. Terrestrial and Aquatic Nontarget Organisms Data Requirements 
(subpart E)
XI. Toxicology Data Requirements (subpart F)
XII. Nontarget Plant Protection Data Requirements (subpart J)
XIII. Post-Application Exposure Data Requirements (subpart K)
XIV. Environmental Fate Data Requirements (subpart N)
XV. Residue Chemistry Data Requirements (subpart O)
XVI. Applicator Exposure Data Requirements (subpart U)
XVII. Data Requirements Not Affected by this Proposal
XVIII. Peer Review
XIX. International Harmonization of Data Requirements
XX. Research Involving Human Subjects
XXI. ILSI Work on New Toxicity Paradigm
XXII. Animal Welfare Concerns
XXIII. Summary of Changes Being Proposed
XXIV. Public Comments Sought
XXV. References
XXVI. FIFRA Review Requirements
XXVII. Statutory and Executive Order Reviews

III. Statutory Authorities and Regulatory Framework

    EPA is authorized to regulate pesticides under two federal 
statutes. The Federal Insecticide, Fungicide and Rodenticide Act 
(FIFRA) regulates the sale, distribution, and use of pesticide products 
through a licensing (registration) scheme. The Federal Food, Drug and 
Cosmetic Act (FFDCA), among other things, regulates the safety of 
pesticide residues in food and feed. Both FIFRA and FFDCA were amended 
in 1996 by the Food Quality Protection Act (FQPA) to strengthen the 
protections offered, with particular emphasis on protection of 
children.
    This action is issued under the authority of secs. 3, 4, 5, 10, 12, 
and 25 of FIFRA (7 U.S.C. 136-136y) and sec. 408 of FFDCA (21 U.S.C. 
346a). The data required for a registration, reregistration, 
experimental use permit, or tolerance are listed in 40 CFR part 158.

A. FIFRA

    Under FIFRA, every pesticide product must be registered (or 
specifically exempted from registration under FIFRA sec. 25(b)) with 
EPA before it may be sold or distributed in the United States. To 
obtain a registration, an applicant or registrant must demonstrate to 
the Agency's satisfaction that, among other things, the pesticide 
product, when used in accordance with widespread and commonly 
recognized practice, will not cause ``unreasonable adverse effects'' to 
humans or the environment. This safety determination, as defined in the 
statute, requires the Agency to consider the risk of the use of the 
pesticide and weigh this against its benefit. EPA must determine that 
the safety standard contained in FIFRA is met before granting a federal 
pesticide registration.
    1. Registration. Section 3 of FIFRA contains the requirements for 
registration. Specifically, 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. An applicant for registration must 
furnish EPA with substantial amounts of data on the pesticide, its 
composition, toxicity, potential human exposure, environmental 
properties and ecological effects, as well as information on its 
efficacy in certain cases. Although the data requirements 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 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.
    2. Reregistration. FIFRA sec. 4 requires that EPA reregister each 
pesticide product first registered before November 1984. This date was 
chosen based upon the fact that pesticides registered since 1984 were 
subject to the part 158 requirements of the 1984 regulation. Additional 
data for older

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pesticides were called in where gaps in the scientific data base 
occurred. The Agency has largely used its data call-in authority to 
require on a case-by-case basis the submission of most of the data 
requirements contained in this proposal.
    3. Experimental use permits. Subject to some exceptions, FIFRA sec. 
5 requires persons seeking experimental use of pesticides under field 
conditions to obtain an experimental use permit (EUP). An EUP allows 
limited use of a pesticide for specified experimental and data 
collection purposes intended to support future registration of the 
pesticide. Because an EUP is for limited use under controlled 
conditions, the data needed to support issuance of the permit are 
correspondingly less than those required for full registration. For 
example, when performing crop field trials, a registrant may opt to 
destroy the treated crop rather than generate the needed residue 
chemistry data to establish a temporary tolerance. The regulations 
governing the issuance of EUPs are found in 40 CFR part 172.

B. FFDCA

    FFDCA mandates EPA to determine that the level of pesticide 
chemical residues in food and feed will be safe for human consumption. 
An applicant must petition the Agency for a tolerance (maximum residue 
level) for a pesticide that is to be used in or around food or feed 
commodities, or could otherwise come in contact with food or feed. The 
safety standard set under FFDCA sec. 408(b) and (c) defines safe as ``a 
reasonable certainty that no harm '' will result from exposures to 
pesticide chemical residues. In making this determination, EPA is 
directed to consider aggregate risks from multiple sources of pesticide 
exposure, including anticipated food, drinking water, and other non-
occupational exposures for which there is reliable information. Under 
FFDCA sec. 408(b)(2)(C), EPA must make a separate finding of safety for 
infants and children. In addition, EPA must take into account a variety 
of other factors, enumerated in sec. 408(b)(2)(D), including the 
cumulative risks associated with pesticides having a common mechanism 
of toxicity. The combination of aggregate and cumulative exposure 
increases the nature and scope of EPA's risk assessment, and 
potentially the types and amounts of data needed to determine that the 
FFDCA safety standard is met.
    1. Establishing tolerances. Under FFDCA sec. 408, EPA is authorized 
to establish tolerances for pesticide residues in food and feed, or to 
exempt a pesticide from the requirement of a tolerance, if warranted. 
In this preamble, references to tolerances include exemptions from 
tolerance since the standards and procedures for both are the same. As 
previously mentioned, in 1996, FQPA modified FFDCA to establish a 
single health-based standard for tolerance-setting and enhanced the 
risk assessment process to more clearly focus on pesticide risks to 
children. The new safety standard applies to tolerances in a number of 
regulatory situations, including:
     Permanent tolerances that support registration under 
FIFRA;
     Tolerances for imported products which are established to 
allow importation of pesticide-treated commodities, but for which no 
U.S. registration is sought;
     Time-limited tolerances which are established for FIFRA 
sec. 18 emergency exemptions; and
     Temporary tolerances established for experimental use 
permits under FIFRA sec. 5.
    2. Reassessing tolerances. Under FFDCA sec. 408(q), EPA must 
reassess each tolerance established before August 3, 1996, on a 
prescribed 10-year schedule. The Agency has reassessed many tolerances 
under its reregistration program. Numerous regulatory decisions have 
been made based upon available data and information required by the 
existing data requirements, and supplemented by additional data 
provided by registrants through data call-ins or voluntary submissions.

C. Linking FIFRA and FFDCA Safety Standards

    Unless EPA is able to establish or maintain a needed tolerance or 
exemption under FFDCA, a pesticide cannot be registered under FIFRA for 
a food/feed use. FQPA created a specific linkage (FIFRA sec. 2(bb)) 
between the ``unreasonable adverse effects'' finding under FIFRA and 
the determination of pesticide residue safety of ``reasonable certainty 
of no harm'' under FFDCA. In essence, a pesticide that is inconsistent 
with, or does not meet, the FFDCA sec. 408 safety standard poses an 
unreasonable adverse effect that precludes new or continued 
registration. Thus, both FIFRA and FFDCA standards must be met for 
pesticides intended to be registered in the United States for food or 
feed uses.
    Given this linkage between registration and tolerances, it makes 
sense for EPA to define data requirements for both purposes: the data 
required to support a determination of ``reasonable certainty of no 
harm'' under FFDCA are an integral part of the data needed for an 
``unreasonable adverse effects'' determination under FIFRA. 
Consequently, when promulgated, these proposed data requirements would 
encompass the basic data requirements for both registration and 
tolerance-setting determinations. EPA will retain its authority to 
require additional data on a case-by-case basis.

IV. Background

A. Why does EPA Require Data for Pesticide Registrations?

    Under the FFDCA and the FIFRA, anyone seeking to register a 
pesticide product is required to provide information to EPA that 
demonstrates their products can be used without posing unreasonable 
risk to human health and the environment, and for food uses, that there 
is a reasonable certainty that no harm will result from exposures to 
the residues of their pesticide product. As appropriate for the 
particular pesticide product, EPA uses the information provided to 
evaluate the pesticide for a wide range of adverse human health 
effects, from eye and skin irritation to cancer and birth defects, and 
to assess how the pesticide affects animal and plant species, non-
target insect species, and what happens to the pesticide in soil, 
water, and air.

B. What are the Data Requirements?

    First promulgated in 1984, the data requirements in 40 CFR part 158 
outline the kinds of data and related information typically needed to 
register a pesticide. The data requirements are organized by major 
pesticide type (e.g., conventional, antimicrobial, biochemical/
microbial, etc.), scientific discipline (e.g., toxicology, etc.), and 
major use site (e.g., outdoor vs. indoor). Part 158 also outlines the 
associated procedures for submitting the data, requesting a waiver from 
a requirements, and other associated procedures. Since there is much 
variety in pesticide chemistry, exposure, and hazard, part 158 is 
designed to be flexible. Table notes to each data requirement explain 
under what conditions data are typically needed. The Agency also 
recognizes, however, that due to the particular nature and risk of some 
pesticides, registrants may seek to obtain data waivers or may suggest 
alternative approaches to satisfying requirements. Over the years since 
1984, other data requirements have been implemented on a case-by-case 
basis. The determination of what data or information is needed is based 
on a scientifically rigorous process that includes peer review by the 
FIFRA Scientific Advisory Panel (SAP), as well

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as a public review and comment process.
    In essence, the data requirements identify the questions that the 
registrant will need to answer regarding the safety of a pesticide 
product before the Agency can register it. The data requirements 
address both components of a risk assessment, i.e., what hazards does 
the pesticide present, and what level of exposure. The answer to one 
question may inform the kind of information needed in others. For 
example, a pesticide that is persistent and toxicologically potent may 
require more extensive exposure data to help establish a safe level of 
exposure. If there is negligible exposure then there may be generally 
less need for extensive hazard data since any conceivable risk would be 
low.
    1. The establishment of standardized data requirements. Until 1984, 
data requirements were based on longstanding requirements initially put 
in place when pesticides were regulated by the U.S. Department of 
Agriculture (USDA) and the Food and Drug Administration (FDA). However, 
because virtually all of EPA's decisions relating to the registration 
of pesticides or the establishment of tolerances depend on Agency 
evaluation of scientific studies, EPA has throughout the years 
developed standardized data requirements and test guidelines, and 
established evaluation procedures and peer review processes to ensure 
the quality and consistency of scientific studies.
    The current provisions in part 158 were originally promulgated in 
October, 1984. Prior to this, data requirements for the registration of 
pesticides were contained in a variety of guidance documents, not in 
regulatory form. Part 158 was intended to be a concise presentation of 
what data were required and under what circumstances. Once codified, 
part 158 specified standard hazard and exposure studies required for 
registration and tolerance setting and also identified conditions under 
which more specialized studies might be required. Guidelines, i.e., 
instructions and test methods on how to perform a study, had meanwhile 
been issued as a series of Pesticide Assessment Guidelines. These 
documents, updated in 1996, describe acceptable protocols, test 
conditions, and data reporting guidelines to ensure that EPA's 
regulatory decisions are based on sound scientific data.
    2. Relationship between the harmonized test guidelines and part 158 
requirements. EPA has established a unified library for test guidelines 
issued by the Office of Prevention, Pesticides and Toxic Substances 
(OPPTS) for use in testing chemical substances to develop data for 
submission to EPA under the Toxic Substances Control Act (TSCA), FFDCA 
or FIFRA. This unified library of test guidelines represents an Agency 
effort that began in 1991 to harmonize the test guidelines within 
OPPTS, as well as to harmonize the OPPTS test guidelines with those of 
the Organization for Economic Cooperation and Development (OECD) of the 
European Community. The process for developing and amending these test 
guidelines includes several opportunities for public participation and 
the extensive involvement of the scientific community, including peer 
review by the FIFRA SAP and the Science Advisory Board (SAB) and other 
expert scientific organizations.
    The purpose for harmonizing these guidelines into a single set of 
OPPTS guidelines is to minimize variations among the testing procedures 
that must be performed to meet the Agency's data requirements under 
FIFRA and TSCA. The guidelines themselves do not impose mandatory 
requirements. Instead, they present recognized standards for conducting 
acceptable tests, guidance on evaluating and reporting data, definition 
of terms, and suggested study protocols. As such, pesticide registrants 
may use a non-guideline protocol to generate the data required by part 
158. Typically the registrant will use the available guideline, in 
which case the study protocol would simply cite the relevant guideline. 
If the registrant deviates from these guidelines, or is asked to 
provide data where there isn't yet a final guideline available, the 
registrant will discuss the variation with EPA and will explain and 
justify the methods chosen in the study protocol. Non-guideline 
protocols are accepted, provided that the study protocol meets the 
purpose of the test standards specified in the guidelines, and provides 
data of suitable quality and completeness as typified by the protocols 
cited in the guidelines. More information about the unified library and 
these guidelines is available at http://www.epa.gov/opptsfrs/home/guidelin.htm.

C. Why Have the Data Needs Changed Since 1984?

    1. 1988 FIFRA amendments. In 1988, FIFRA was amended to ensure that 
older pesticides met the scientific standards of the day. Among other 
things, the amendments provided for the acceleration of the 
reregistration program by establishing statutory deadlines and new 
procedures. The 1988 changes to FIFRA are important because it was 
during this effort that EPA recognized that some of the 1984 data 
requirements were becoming out of date. The Agency then used the 
reregistration process to focus on needed changes.
    2. The National Academy of Sciences 1993 Report. With increasing 
emphasis on protecting children's health, EPA began to examine its data 
requirements relative to evaluating the potential risks from pesticides 
to sensitive subpopulations. The Agency sought the advice of the 
National Academy of Sciences' National Research Council (NRC) to assess 
its risk assessment methodologies and to provide additional information 
on the extent to which children may be at risk given emerging 
scientific information and technologies. In their 1993 report entitled, 
``Pesticides in the Diets of Infants and Children,'' (Ref. 1) NRC 
offered recommendations for further protecting infants and children 
from pesticides in their diet. The NRC called for the Agency to require 
more data and adopt better risk assessment methodologies. For example, 
the Council called for increased testing in the area of immune 
function, neurodevelopmental and reproductive testing, and 
neurotoxicity testing. NRC also suggested adding a thyroid screen to 
existing subchronic and chronic toxicity tests and additional tests on 
age-related physiological changes and pharmacokinetics in immature 
animals.
    At the time the 1993 report was released, EPA had already begun 
work on many of the recommendations to improve the quality of its risk 
assessments. New testing guidelines and protocols were developed. Since 
then, many of the testing requirements recommended by the NRC have been 
incorporated into the Agency's standard evaluation requirements and 
practices. In addition, in line with the Council's recommendations and 
the FIFRA Scientific Advisory Panel's (SAP) advice, EPA recently 
expanded its neurotoxicity and developmental neurotoxicity study 
requirements. These updated requirements are contained in this 
proposal.
    3. The Food Quality Protection Act of 1996 (FQPA). Passage of FQPA 
in 1996 reformed our nation's pesticide and food safety laws, resulting 
in changes in EPA's approach to protecting human health from risks 
associated with pesticide use. As mentioned, FQPA modified both FIFRA 
and FFDCA and established a single health-based standard for food-use 
pesticides and added protections for infants and children.

[[Page 12281]]

    Throughout the 1990s, EPA has been continually working on improving 
data requirements. Under FFDCA, as amended by FQPA, EPA must reassess 
all existing pesticide tolerances and exemptions against the expanded 
and more rigorous safety standard. Beginning in 1994, and increasingly 
since the enactment of FQPA, EPA has changed aspects of its data 
requirements and risk assessment process to improve its ability to 
assess exposure more accurately and to strengthen its understanding of 
the potential pesticide risk to children. As mentioned, risk 
assessments must now consider data relating to aggregate exposure 
(exposure to pesticides from food, drinking water, and non-occupational 
routes such as home and garden uses) and cumulative risk (effects from 
exposures to multiple pesticides that share a common mechanism of 
toxicity). These measures necessitate collection of additional data on 
drinking water and non-occupational and residential exposure.

V. Purpose and Scope of this Proposal

A. What is the Scope of this Proposal?

    This proposal applies only to conventional pesticides. In general, 
a conventional pesticide is considered as a synthetic chemical or a 
natural substance with a toxic mode of action. It is applicable to both 
manufacturing-use and end-use products. It does not include data 
requirements for antimicrobial, biochemical or microbial pesticides; 
inert ingredients; or changes to existing spray drift or product 
performance (efficacy) data requirements for conventional chemicals.

B. Why is EPA Proposing these Revisions?

    EPA has a number of objectives in proposing this regulation to 
update and revise the data requirements in 40 CFR part 158. First, this 
proposal will update the requirements in part 158 to reflect changes 
that have occurred over time and which are generally applied already.
    Second, this proposal will provide clarity on the data requirements 
themselves, with data requirements reformatted to promote efficiency in 
registration decision processes. Third, information developed in 
fulfilling these data requirements will improve the scientific basis 
supporting increasingly complex risk management decisions.
    1. Updating the 1984 requirements. Although most of the specific 
requirements in part 158 have not changed since the data requirements 
were first published in 1984, there is information that is out-of date 
or may be unclear. The underlying science has advanced (e.g., NAS in 
1993 suggested changes to better protect children). The Agency's 
legislative mandate has been broadened to address new concerns. For 
example, given the stricter mandates imposed by the 1988 FIFRA 
amendments (emphasis on exposure to population subgroups) and the 1996 
FQPA amendments to FIFRA and FFDCA, EPA finds that it is more 
frequently requesting certain data, and the Agency believes it should 
detail more specifically the conditions under which these tests will be 
required. Thus the proposed change entails both new tests and broadened 
requirements for some current tests.
    This regulation will reflect the changes in data requirement 
practices that have evolved through practice since the 1984 data 
requirement rule was promulgated and address data needed to meet 
requirements created by statutory amendments to FIFRA and FFDCA. In 
addition, the rule will eliminate redundant data submission 
requirements.
    EPA's underlying principle in development of this regulation is to 
strike an appropriate balance between the need for adequate data to 
make informed risk management decisions while minimizing the data 
collection burden.
    Until this proposal is promulgated, the Agency will continue to use 
existing authority in 40 CFR part 158, to obtain these data on a case-
by-case basis should they be necessary to support a registration.
    2. Reorganizing part 158 to improve usability. EPA proposes to 
reorganize and reformat part 158 subpart A (General Provisions), and 
subpart B (How to Use Data Tables), and reorganize and renumber subpart 
D (Data Requirement Tables) into several individual subparts (see Table 
1 in Unit VI). Each subpart would contain the data requirement tables 
for an individual scientific discipline and references to correlate 
with the Pesticide Assessment Guidelines. The Agency also proposes to 
remove from the regulations the current Appendix A, (a compendium of 
pesticide use sites and use categories), and create a separate 
Pesticide Use Index Guidance Document. Since the information contained 
in Appendix A only serves as reference material and is not being stated 
as a requirement, EPA believes that a guidance document format is 
easier to keep current and therefore better serves the regulated 
community. The information will be placed on EPA's website and made 
available to the public.
    3. Improving the scientific basis for pesticide registration 
decisions. In general, the information developed as a result of the 
revisions, if finalized as proposed today, is expected to increase 
scientific understanding of the health and environmental effects of 
pesticides to which individuals and the environment may be exposed. The 
revised requirements are expected to improve the scientific basis for 
the Agency's regulatory decisions about the human health and 
environmental risks of pesticide products. The improved scientific 
basis is also expected to benefit a wide range of parties, including 
consumers and the general public, workers, scientists, industry, 
governments, public health officials, and the medical community, as 
well as foreign parties. Discussed in more detail in the document 
entitled ``Economic Analysis of the Proposed Change in Data 
Requirements Rule for Conventional Pesticides,'' which is available in 
the public docket for this rulemaking, the following briefly highlights 
the various ways the improved data is expected to be used:
    i. Better informed regulatory decisions allow preservation of 
important pesticide uses. The proposed revisions enable the Agency to 
make better informed regulatory decisions based on more complete data 
about the potential risks of pesticides. For example, the proposed 
changes better target needed data that take into account human and 
wildlife toxicological end points or routes of exposure not now 
adequately covered. The proposed rule would also require better 
information about the potential for pesticides to cause immunotoxic or 
developmental neurotoxic effects. This information is expected to be 
valuable in assuring that pesticide residues in food or from other 
sources are safe for children as well as other consumers. These studies 
would allow the Agency to assess aggregated and cumulative risks to 
consumers, with special emphasis on children. The proposal also 
includes exposure data tailored specifically to address pesticide 
handlers is crucial in assessing their risk and thus adequately 
protecting their health.
    ii. More refined exposure assessments mean clearing understanding 
of real risks. EPA's current application and post-application exposure 
data base is not comprehensive, especially regarding exposures to 
pesticides in some agricultural or nonagricultural settings. The new 
data that would be collected under this proposal would allow the Agency 
to conduct improved exposure

[[Page 12282]]

assessments for residential sites and for bystanders in other settings. 
This will benefit farmers and other workers by allowing EPA to make 
better informed regulatory decisions that are neither too stringent nor 
too lenient.
    iii. Clarity and transparency to regulated community means savings. 
The enhanced clarity and transparency of the information presented in 
part 158 should enhance the ability of industry to avoid wasted time 
and effort. Registrants may save time and money by understanding when 
studies are needed. This should allow products to enter the market 
earlier, thus increasing profits. The addition of some data 
requirements is likely to further communicate to domestic and world-
wide marketplaces that pesticide products and items treated with them 
are safer, thus enhancing the reputation of American agricultural 
products and registered pesticides as tools for public health, etc.
    iv. Enhanced international harmonization means less duplication. 
Data generated as a result of the revised requirements in part 158 
would generally be sufficient for the needs of the OECD countries 
because EPA has harmonized the FIFRA test guidelines with those OECD. 
As a result, assessments of pesticides that are developed using data 
under the revised part 158 can be shared worldwide, allowing companies 
to avoid duplicative efforts to meet the requirements of other 
countries where the company may also manufacture and sell certain 
pesticides. This should lead to cost savings for companies that operate 
in the international market.
    However, since EPA continues to allow applicants to submit and use 
their own study protocols to generate data that they subsequently 
submit to EPA, and there are differences in the mandate and authorities 
between EPA and OECD countries, the data submitted to EPA under part 
158 would be expected to satisfy OECD standards under most 
circumstances, but perhaps not in all cases.
    v. Better informed users means informed risk-reduction choices. 
Better regulatory decisions resulting from the proposed changes should 
also mean that the label will provide better information on the use of 
the pesticide. A pesticide label is the user's direction for using 
pesticides safely and effectively. It contains important information 
about where to use, or not use, the product, health and safety 
information that should be read and understood before using a pesticide 
product, and how to dispose of that product. This benefits users by 
enhancing their ability to obtain pesticide products appropriate to 
their needs, and to use and dispose of products in a manner that is 
safe and environmentally sound. Farmers (as well as other applicators) 
may benefit from label information based on the data submitted to the 
extent it helps inform their decisions about whether or how to use 
particular pesticides to avoid potential exposure to people or the 
environment from residues on treated crops or through off-site 
movement.
    vi. EPA information assists other communities in assessing 
pesticide risks. Scientific, environmental, and health communities find 
pesticide toxicity information useful to respond to a variety of needs. 
For example, medical professionals are concerned about the health of 
patients exposed to pesticides; poison control centers make use of and 
distribute information on toxicity and treatment associated with 
poisoning; and scientists use toxicity information to characterize the 
effects of pesticides and to assess risks of pesticide exposure. 
Similarly those responsible for protection of non-target wildlife need 
reliable information about pesticides and assurance that pesticides do 
not pose an unreasonable threat. The proposed changes will help the 
scientific, environmental, and health communities by increasing the 
breadth, quality, and reliability of Agency regulatory decisions by 
improving their scientific underpinnings. In turn, the companies will 
be able to improve their ability to make appropriate decisions and take 
useful actions.

C. How Will this Proposal Affect Existing Registrations?

    This proposal concerns prospective data requirements for future 
registrations of pesticides. That is, these proposed data requirements 
would apply to all new registrations of pesticides after the rule is 
finalized. The Agency does not intend to apply these requirements 
retrospectively to all existing pesticide registrations. While the 
intended future applicability of this proposed rule is to new 
applications, 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 future 
programmatic changes and priorities on existing pesticides.

VI. Overview of Proposed Changes

A. Phased approach

    This proposal is the first in a series of revisions aimed at 
comprehensively updating EPA's pesticide data requirements. The data 
requirements discussed in this proposal pertain to conventional 
pesticides. Future proposals will address data requirements for 
antimicrobial pesticides, biochemical and microbial pesticides, inert 
ingredients in pesticide products, and product performance data 
requirements.

B. Organizational changes

    Part 158 is currently divided into four subparts:
     Subpart A, General Provisions
     Subpart B, How to Use Data Tables
     Subpart C, Product Chemistry Data Requirements
     Subpart D, Data Requirements Tables
    EPA proposes to reorganize part 158 to more closely correspond with 
the Office of Prevention, Pesticides, and Toxic Substances (OPPTS) 
Harmonized Guidelines, primarily by creating a series of new subparts 
to replace subpart D. Each subpart will address an individual 
scientific discipline or data type. In this preamble, EPA will refer to 
the proposed new subpart and section designations when discussing the 
data requirements. Table 1 below provides a cross-reference between the 
current and proposed new subparts. Future new subparts are included for 
information.

       Table 1.--Part 158: Proposed Change to Subpart Designations
------------------------------------------------------------------------
                                               Proposed Regulation and
       Current Regulation and Title                     Title
------------------------------------------------------------------------
Subpart A: 158.20 General Provisions        Subpart A: 158.1 General
                                             Provisions
-------------------------------------------
Subpart B: 158.100 How to Use Data Tables   Subpart B: 158.100 How to
                                             Use Data Tables
-------------------------------------------
Subpart C: 158.150 Product Chemistry        Subpart D: 158.300 Product
                                             Chemistry
-------------------------------------------
Subpart D: 158.240 Residue Chemistry        Subpart O: 158.1200 Residue
                                             Chemistry
-------------------------------------------
Subpart D: 158.290 Environmental Fate       Subpart N: 158.1100
                                             Environmental Fate
-------------------------------------------
Subpart D: 158.340 Toxicology               Subpart F: 158.500
                                             Toxicology
-------------------------------------------
Subpart D: 158.390 Reentry Protection       Subpart K: 158.800 Post-
                                             application Exposure
-------------------------------------------
Subpart D: 158.440 Spray Drift              Subpart R: 158.1400 Spray
                                             Drift
-------------------------------------------

[[Page 12283]]

 
Subpart D: 158.490 Wildlife and Aquatic     Subpart E: 158.400
 Organisms                                   Terrestrial and Aquatic
                                             Nontarget Organisms
Subpart D: 158.590 Nontarget Insects
-------------------------------------------
Subpart D: 158.540 Plant Protection         Subpart J: 158.700 Plant
                                             Protection
-------------------------------------------
Subpart D: 158.640 Product Performance      Subpart G: 158.600 Product
                                             Performance
-------------------------------------------
Subpart D: 158.690 Biochemical Pesticides   Subpart L: 158.900
                                             Biochemical Pesticides
-------------------------------------------
Subpart D: 158.740 Microbial Pesticides     Subpart M: 158.1000
                                             Microbial Pesticides
-------------------------------------------
                                            Subpart P: 158.1300
                                             Pesticide Management and
                                             Disposal (Reserved)
                                            Subpart U: 158.1500
                                             Applicator Exposure
                                            Subpart V: 158.1600 Inert
                                             Ingredients (Reserved)
                                            Subpart W: 158.1700
                                             Antimicrobials
------------------------------------------------------------------------

    Further, EPA proposes to remove the current Appendix A, which 
contains a compendium of pesticide use sites and use categories to help 
determine data requirements. This will be separately issued and 
maintained as a guidance document.

C. ``New Requirement'' Vs.``Newly Codified Requirement.''

    FIFRA is a licensing statute, under which regulatory decisions on 
the registrability of an individual product is based upon data specific 
to the product and its uses. EPA is authorized to require the 
submission of data that it needs to make the registration decision in 
the context of any individual application for registration, amended 
registration or reregistration. EPA may also impose a data requirement 
after registration in order to maintain the registration, using 
specific Data Call-In (DCI) authority of FIFRA sec. 3(c)(2)(B).
    Since 1984, when part 158 was first promulgated, EPA's data 
requirements have evolved as the general scientific understanding of 
the potential hazards posed by pesticides has grown. Most of the data 
requirements contained in this new proposal have been applied on a 
case-by-case basis to support individual applications, or imposed via a 
DCI on all registrants of similar products. Thus EPA's actual data 
requirements have progressed as scientific understanding and concerns 
have evolved, but part 158 data requirements have not been updated to 
keep pace.
    The result of this regulatory lag is that EPA regards many data 
requirements in today's proposal to be ``newly codified requirements,'' 
routinely applied in practice on a case-by-case basis but simply not 
codified in the CFR. However, because they have not been codified, they 
are considered to be ``new requirements'' never before imposed on the 
regulated industry. For the purposes of this proposal, EPA has 
evaluated the costs and burdens of all proposed requirements, whether 
``new'' or ``newly codified '' against the data requirements as 
originally promulgated in 1984, termed `` existing requirements.'' Many 
of these studies can be categorized as rarely to infrequently required.
    In this preamble, EPA is proposing new and revised data 
requirements that encompass all three categories of requirements:
    1. EPA is proposing ``new requirements,'' never before imposed on 
any registrant.
    2. EPA is proposing ``newly codified requirements,'' which have 
been applied on a case-by-case basis, but are not in the CFR.
    3. EPA is proposing revisions to ``existing requirements.''

D. Types of Revisions Being Proposed

    Part 158 is a massive and complex set of tables that describe 
pesticide data requirements. Each data requirement is currently 
established and its scope and applicability defined according to a 
number of parameters. Having comprehensively evaluated its data 
requirement parameters, EPA is proposing changes in all areas of data 
requirements. Some of these changes are clarifications or housekeeping 
changes without cost or burden, others have the effect of increasing or 
decreasing the burden of the data requirement. The types of changes may 
be broadly categorized as follows:
    1. Substantive changes--i. Addition of a requirement. This 
encompasses both ``new requirements'' and ``newly codified 
requirements.'' For example, EPA is proposing a ``new requirement'' for 
immunotoxicity testing. On the other hand, data requirements for 
applicator exposure (subpart U) are entirely ``newly codified.``
    ii. Elimination of a requirement, sometimes with substitution of a 
new requirement. For example, EPA is wholly eliminating the requirement 
for seed germination testing. By contrast, the existing requirement for 
a battery of mutagenicity studies is being eliminated in favor of a 
specific set of mutagenicity studies.
    iii. A change to the number or type of species that must be tested. 
For example, EPA proposes to require acute avian toxicity testing on an 
additional passerine species in some instances. EPA also proposes to 
require that certain toxicity studies be conducted routinely with two 
species instead of one.
    iv. A change in the conditionality of the test requirement. For 
example, EPA is proposing to change a number of requirements from 
conditionally required to fully required, or vice versa. In some cases, 
this change is a minor change in the actual frequency (and burden) of 
the requirement. In other cases, the change may represent a substantive 
increase in frequency of requirement.
    v. A change to the use patterns to which a data requirement 
applies. As described elsewhere, EPA proposed to increase the number of 
use pattern descriptors from 9 to 15. In some cases, EPA proposes to 
extend requirements currently limited to food uses to nonfood uses, 
e.g., prenatal developmental toxicity studies. A second example would 
be a proposed expansion of certain studies into greenhouse and indoor 
use patterns, for example, avian oral toxicity requirements.
    vi. A change to the test substance to be used. Typical test 
substances include the technical grade of active ingredient (TGAI), the 
manufacturing-use product, the end-use product, and a ``typical 
product.'' For example, EPA proposes to require primary eye and primary 
dermal irritation, and dermal sensitization testing using the TGAI in 
addition to the end-use product.
    vii. A clarification in the notes describing the test. For example, 
EPA is proposing in a test note that analytical methods for residue 
chemistry and environmental fate be validated by an independent 
laboratory.
    2. Technical changes having no substantive effect--i. Relocation of 
a requirement. For example, EPA proposes to move the magnitude of 
residues in rotational crops data requirement from environmental fate 
requirements to residue chemistry requirements.

[[Page 12284]]

    ii. A change to the title of a data requirement. For example, EPA 
proposes to rename the ``teratogenicity'' data requirement to 
``prenatal developmental toxicity'' to more accurately reflect the 
nature of the study.
    iii. Subdividing an existing requirement to create two separate 
entries. For example, EPA proposes to separately list the storage 
stability requirement for residue samples. This requirement is 
currently included in the plant and animal metabolism data requirement. 
A change of this nature is intended to highlight an aspect of a test 
requirement for the regulated community.
    iv. Merging two data requirements into a single requirement. For 
example, EPA proposes to merge the terrestrial field dissipation study 
with the long-term field dissipation study because both studies provide 
similar information.
    Each data requirement for which a revision is proposed is discussed 
in detail in subsequent units of this preamble. Readers are referred to 
the table in Unit XXIII. for a line-by-line listing of every current 
and proposed data requirement and the types of changes proposed. If no 
change is proposed, the table contains a notation to that effect.

VII. General Provisions of Part 158 (Subpart A)

A. General

    Subpart A serves as an introduction to the data requirements in 
part 158. As proposed, current material has been substantially revised 
to be more concise and easier to understand. EPA has eliminated much of 
the redundancy in current subpart A and streamlined the remaining 
material. Unless otherwise superseded by part 174, the regulations of 
this part apply to plant-incorporated protectants.
    1. New material. New content has been added to subpart A. 
Specifically, EPA has added new Sec.  158.3 containing definitions 
relevant to part 158 as a whole. In this proposal, EPA has referred to 
statutory definitions in FIFRA and FFDCA, and has included only a 
single new definition, that of ``applicant.'' This definition is 
intended to provide an inclusive term that covers all persons who 
submit data to the Agency for any purpose, including applicants for 
registration, reregistration, or experimental use permit under FIFRA, 
petitioners for tolerance or exemption under FFDCA, and registrants who 
are required to submit data to maintain registration. The term 
``applicant'' is proposed to be used for all such persons. The 
definition is drawn from the definition of ``application for research 
or marketing permit,'' in 40 CFR 160.3, which also relates to data 
development. EPA requests comment on whether additional definitions are 
needed.
    2. Disposition of current subpart A material. The following 
sections of current subpart A are proposed to be deleted or 
substantially revised. The following Table 2 explains each section.

           Table 2.--Disposition of Current Subpart A Material
------------------------------------------------------------------------
            Section                   Title             Disposition
------------------------------------------------------------------------
158.20                          Overview           Paragraph (a) deleted
                                                   Paragraph (b).
                                                    Content contained in
                                                    proposed Sec.
                                                    158.1, Purpose and
                                                    Scope.
                                                   Paragraph (c)
                                                    deleted.
-------------------------------
158.25                          Applicability of   Deleted as redundant
                                 data               or unnecessary.
                                 requirements       Applicability of
                                                    this part to various
                                                    regulatory actions
                                                    is contained in
                                                    proposed Sec.
                                                    158.5
-------------------------------
158.30                          Timing of the      Deleted as
                                 imposition of      unnecessary and not
                                 data               relevant. This
                                 requirements       section addresses
                                                    approval of
                                                    registration
                                                    actions, which is
                                                    properly covered in
                                                    part 152, and is not
                                                    relevant to data
                                                    requirements.
-------------------------------
158.32                          Format of data     Retained and revised.
                                 submissions.       Discussed in Unit
                                                    VII.B.
-------------------------------
158.33                          Procedures for     Retained and revised.
                                 claims of          Discussed in Unit
                                 confidentiality    VII.C.
                                 of data.
-------------------------------
158.34                          Flagging of        Retained. Criteria
                                 studies for        revised.
                                 potential
                                 adverse effects.
-------------------------------
158.35                          Flexibility of     Deleted as redundant.
                                 the data           Mainly contains
                                 requirements       cross-references to
                                                    similar material
                                                    elsewhere in part
                                                    158.
-------------------------------
158.40                          Consultation with  Deleted. Consultation
                                 the Agency.        with the Agency is
                                                    encouraged in
                                                    several sections of
                                                    proposed part 158.
-------------------------------
158.45                          Waivers            Retained and revised.
                                                    Discussed in Unit
                                                    VII.E.
-------------------------------
158.50                          Formulator's       Information to be
                                 exemption          relocated to 40 CFR
                                                    152.85, which covers
                                                    the formulator's
                                                    exemption.
-------------------------------
158.55                          Agricultural vs.   Deleted as
                                 Non-agricultural   unnecessary.
                                 pesticides         Material is covered
                                                    in individual
                                                    subparts of
                                                    proposal, which are
                                                    organized by
                                                    agricultural and no-
                                                    agricultural use
                                                    patterns.
-------------------------------
158.60                          Minor uses         Deleted as
                                                    unnecessary.
                                                    Definitions and
                                                    minor use policies
                                                    are largely governed
                                                    by statutory
                                                    mandates and
                                                    priorities, not
                                                    regulatory policies.
-------------------------------
158.65                          Biochemical and    Deleted. Material
                                 microbial          will be considered
                                 pesticides         for inclusion in
                                                    future revisions of
                                                    biochemical and
                                                    microbial data
                                                    requirements.
-------------------------------
158.70                          Acceptable         Revised.
                                 protocols
-------------------------------

[[Page 12285]]

 
158.75                          Requirements for   Paragraph (a)
                                 additional data    retained. Paragraph
                                                    (b) deleted as
                                                    unnecessary. This
                                                    material is covered
                                                    by paragraph (a).
-------------------------------
158.80                          Acceptability of   Paragraph (a) moved
                                 data               to Sec.   158.70(a)
                                                     now refers to
                                                    ``cited.'' Paragraph
                                                    (b) deleted.
                                                    Paragraph (c)
                                                    retained. Paragraph
                                                    (d) revised.
-------------------------------
158.85                          Revision of data   Deleted as
                                 requirements and   unnecessary.
                                 guidelines         Guideline references
                                                    are contained in
                                                    tables in each
                                                    subpart.
------------------------------------------------------------------------

B. Format of Data Submissions

    EPA proposes to reorganize for clarity the data submission 
requirements of Sec.  152.32. EPA would eliminate descriptions of EPA 
assignment of MRID numbers, as this internal action does not bear upon 
applicant requirements. Applicants would continue to format data 
submissions in support of regulatory actions according to current 
Agency procedures. The proposed rule makes clear that administrative 
non-data elements of a submission (forms, labels, and correspondence) 
are not subject to formatting requirements.
    The Agency also proposes to eliminate specific media and copy 
requirements from the regulatory text because these requirements are 
subject to change as the Agency implements new strategies to reduce the 
paperwork burden on data submitters and to simplify the submission 
process. The Agency intends to provide updated guidance in a new PR 
Notice that will supersede PR Notice 86-5. EPA has a web page that 
provides guidance for both paper and electronic data submission.
    After a series of pilots EPA has developed a standard for 
electronic submission of data using Adobe Acrobat Portable Document 
Format and related tools for pesticide data submitters to create 
electronic versions of documents. Extensive guidance has been developed 
and posted on the EPA web page dedicated to electronic 
submissions(http://www.epa.gov/oppfead1/edsgoals.htm). As experience is 
gained, and in consultation with stakeholders, EPA intends to refine 
its guidance.
    Registrants should note that regulations in part 159 concerning 
FIFRA sec. 6(a)(2) submissions require that such data be formatted 
according to the requirements of this section.

C. Confidential Business Information

    EPA proposes to clarify its policies on confidentiality claims 
asserted by submitters and on the release of information by the Agency. 
Section 158.33 discusses information that may be claimed as 
confidential and the procedures for asserting such a claim. It also 
discusses information that may be released by EPA, and circumstances 
under which such information can be released. Any release of 
information by EPA would be in accordance with FIFRA sec. 10, FFDCA 
sec. 408, and EPA regulations under the Freedom of Information Act (5 
U.S.C. 552) found in 40 CFR part 2. The revisions to procedures for 
asserting confidentiality claims would not apply to data submitted to 
the Agency before the date of promulgation of this rule. Further 
regulatory provisions regarding confidentiality can be found at 40 CFR 
part 2.
    1. Confidentiality of 408 information. EPA also proposes to 
implement the revised confidentiality provisions in FFDCA sec. 408(i). 
Prior to the changes made in FFDCA by FQPA in 1996, confidentiality of 
information submitted in support of a tolerance or exemption was 
governed by old sec. 408(f), which made all such information 
confidential until publication of a regulation establishing a tolerance 
or exemption (unless the submitter explicitly waived confidential 
protection). This section was replaced in 1996 by current sec. 408(i), 
which provides in part, ``Data and information that are or have been 
submitted to the Administrator under this section or sec. 348 of this 
title in support of a tolerance or an exemption from a tolerance shall 
be entitled to confidential treatment for reasons of business 
confidentiality and to exclusive use and data compensation to the same 
extent provided by secs 3 and 10 of the Federal Insecticide, Fungicide, 
and Rodenticide Act.'' EPA has never formally interpreted the meaning 
of sec. 408(i) with respect to confidential information.
    The likely intent of Congress was to accord information submitted 
in support of a tolerance or exemption the same confidentiality 
protections that apply to data submitted under FIFRA, especially 
considering the extent to which FIFRA and FFDCA were intertwined more 
closely by FQPA. Treating information submitted under the two statutes 
identically means that they are subject to the same protections (e.g., 
restrictions on disclosure of entire studies to multinational 
corporations in accordance with FIFRA sec. 10(g)) and the same 
disclosure requirements (e.g., mandatory public availability of safety 
and efficacy information in accordance with FIFRA 10(d)(1)). In fact, 
this discussion may be largely academic, because EPA expects that 
nearly all data submitted under part 158 in support of a tolerance or 
exemption will also be information submitted under FIFRA. The only 
exception would pertain to import tolerances or exemptions for 
pesticides that are not used in the United States, submissions which 
are uncommon. All references in this preamble to FIFRA sec. 10 are 
therefore intended to apply equally to information submitted pursuant 
to FFDCA 408.
    2. Safety and efficacy information. Information pertaining to the 
safety and efficacy of registered pesticides must in most cases be made 
available to the public. The existing provisions in 40 CFR 158.33 
regarding the confidentiality of safety and efficacy information have 
in some cases been unclear to registrants and applicants, resulting in 
confusion regarding what information is claimed as confidential. EPA 
seeks to clarify these provisions, and to clear up some long-standing 
misconceptions as to the eligibility of inert ingredient and process 
information for confidential treatment.
    FIFRA sec. 10(d)(1) provides that ``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

[[Page 12286]]

and fate in the environment, and metabolism'' must be made available to 
the public. EPA considers metabolites to be a form of ``degradation 
product'' within the meaning of sec. 10(d)(1).
    Excepted from that mandatory disclosure requirement is certain 
information pertaining to manufacturing and quality control processes 
and to inert ingredients, which is given qualified protection under 
FIFRA secs. 10(d)(1)(A), (B), or (C). This exception has been 
frequently misinterpreted to mean that all such information is made 
categorically confidential by sec. 10(d)(1). In fact, as decided by the 
District Court for the District of Columbia in NCAP v. Browner, 941 
F.Supp. 197, 201 (D.D.C. 1996), the statute makes information subject 
to FIFRA sections 10(d)(1)(A), (B), or (C) neither categorically 
confidential nor categorically public. Instead, the information may be 
entitled to confidential treatment, but only if it meets the 
requirements of sec. 10(b) (generally, trade secrets and information 
whose disclosure is likely to cause substantial harm to the competitive 
position of the submitter).
    EPA believes that, with the exception of information pertaining to 
a pesticide that has never been registered, all information submitted 
in accordance with part 158 (including information submitted in 
connection with an application for a tolerance or exemption) 
constitutes safety and efficacy information subject to sec. 10(d)(1). 
All of the information subject to part 158 concerns ``the effects of 
such pesticide on any organism or the behavior of such pesticide in the 
environment.'' This includes not only studies regarding hazard and 
fate, but also information such as product chemistry, which is 
collected by the Agency for the very purpose of determining the effects 
of the pesticide on organisms and its behavior in the environment.
    In addition to providing submitters with an opportunity to 
designate information as subject to one of the exceptions in FIFRA 
secs. 10(d)(1)(A), (B), or (C) (a feature also contained in the current 
version of Sec.  158.33), EPA proposes to include a provision that all 
information that has not been so designated and that pertains to a 
registered or previously registered pesticide be deemed non-
confidential by operation of law, without further notice to the 
submitter (subject to the requirements of sec. 10(g) regarding 
disclosure to multinational entities). This provision would not apply 
to information that was submitted prior to May 4, 1988, the effective 
date of the current regulation contained in Sec.  158.33, and thus the 
first time that claims under sec. 10 (d)(1)(A), (B), or (C) were 
required to be identified.
    3. Information pertaining to unregistered pesticides. Although 
safety and efficacy information (which by definition pertains only to 
registered or previously registered pesticides) is made publicly 
available by statute, if the information pertains to unregistered 
pesticides (including both applications for new active ingredients and 
import tolerances for pesticides used only outside the United States) 
it is not subject to the same mandatory disclosure requirement. Such 
information may be entitled to confidential treatment if it meets the 
requirements of sec. 10(b). In practice, EPA believes that information 
relating to the effects of unregistered pesticides that is not within 
one of the exceptions in FIFRA sec. 10(d)(1)(A), (B), or (C) will 
seldom meet this test. Much of the information in studies is valuable 
only to the extent that it can be used for registration/tolerance 
purposes, and protection from unauthorized submission or citation of a 
study by persons other than the submitter is provided by the FIFRA and 
FFDCA data compensation provisions and by FIFRA sec. 10(g). Moreover, 
because such information becomes publicly available once the pesticide 
is registered, competitors will eventually be able to get access to the 
information. Thus, confidentiality should normally be appropriate only 
when disclosure of the information prior to registration would give 
competitors an advance look at information that they could use to their 
advantage.
    At the same time, the period prior to registration is of special 
importance for public participation in the registration process. Under 
FIFRA sec. 3(c)(4), EPA publishes a Federal Register notice announcing 
receipt of an application for registration of a product involving a new 
active ingredient or changed use pattern, and gives the public an 
opportunity to comment on the application. Implicit in the opportunity 
to comment is the availability of sufficient information to evaluate 
the risks and benefits of the product. Although requests for pre-
registration information may be made under the Freedom of Information 
Act, the amount of time involved in contacting the submitter to clarify 
claims, obtaining substantiation of the confidentiality claim, and 
making a final determination on the claim make it very difficult for 
the public to get access to important information on a timely basis.
    Because of the possibility that some pre-registration information 
may be legitimately confidential, EPA does not believe that it can 
categorically determine all such information to be non-confidential. 
The provisions in this proposal requiring the submitter to specify 
which information is claimed as confidential will simplify access to 
information not so claimed, but EPA is soliciting comment on other 
mechanisms to facilitate public access to pre-registration information.
    4. Confidentiality claims for plant-incorporated protectant 
information. Part 174 was incorporated into 40 CFR effective September 
17, 2001. The regulations in part 158 apply to plant-incorporated 
protectants unless otherwise superseded by part 174. In addition to 
complying with the requirements of Sec.  158.33, 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.
    5. Disclosure of data to multinational entities. Also included is a 
proposed provision governing the release of data to foreign or 
multinational pesticide companies. Under sec. 10(g) of FIFRA, EPA 
requires that any person requesting information from the Agency affirm 
that he or she is not an ``entity engaged in the production, sale, or 
distribution of pesticides in countries other than the United States or 
in addition to the United States'' and that the information will not be 
disclosed to such an entity. The requirement for such an affirmation 
applies to all data received by the Agency under FIFRA (and FFDCA) and 
is not limited to confidential business information.
    In Class Determinations 3-85 (50 FR 48833, November 27, 1985) and 
1-99 (64 FR 70019, December 15, 1999) EPA elucidated the criteria for 
determining whether information and documents derived from studies or 
reports submitted to the agency are subject to the restrictions of 
FIFRA sec. 10(g). In order to be outside the scope of sec. 10(g), 
documents must not (1) ``contain or consist of any complete unpublished 
report submitted to EPA '' or (2) ``contain or consist of 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.'' (50 FR 48834). Although the application of these class 
determinations is limited to data reviews created by the Agency (3-85) 
and information regarding unreasonable adverse effects of

[[Page 12287]]

pesticides on the environment submitted in connection with sec. 6(a)(2) 
of FIFRA (1-99), the rationale behind the class determinations applies 
to all data which meet the criteria quoted in this paragraph. In order 
to facilitate the timely release to the public of important safety and 
efficacy information beyond that contained in data reviews and 6(a)(2) 
notices, EPA is proposing to codify these determinations with respect 
to all information submitted in accordance with part 158.
    6. Release to state and foreign governments with consent. EPA also 
is including in this proposal a provision to facilitate the release and 
exchange of information with State and foreign regulatory agencies. In 
an effort to promote harmonization and to conserve resources through 
work share programs, the exchange of data often is beneficial and 
desirable. Applicants would have the option of signing a statement 
authorizing the Agency to release information contained in their 
documents for such purposes. Although most governments provide 
protection for confidential information, EPA cannot guarantee how a 
particular government would treat specific information disclosed to it. 
Consequently, the submitter should be aware of any risk involved before 
granting consent to disclosure. However, EPA would not view disclosure 
to a government that protected confidential information as otherwise 
waiving confidential treatment for the information.

D. Flagging Criteria

    EPA proposes to revise the flagging requirements of Sec.  158.34, 
established in 1985, without changing the substance of the requirement. 
Currently, applicants for registration and amended registration, and 
submitters of data under FIFRA sec. 3(c)(2)(B) are required to flag 
certain toxicology studies that show results potentially indicating an 
adverse effect. EPA proposes to make minor revisions to update and 
clarify the criteria to encompass the new types of toxicology studies 
being proposed today. Specifically, EPA proposes to:
    1. Reduce the number of study criteria from 11 to 7 by combining 
certain studies under one criterion. The new criteria would eliminate 
distinctions between subchronic and chronic studies in most cases.
    2. Combine reproductive, prenatal developmental toxicity and 
developmental neurotoxicity studies under one criterion to better focus 
on effects on children and infants.
    3. Consolidate the criteria that address the No-Observed-Adverse-
Effect Levels (NOAEL) into a single criterion covering all studies from 
which NOAELs are derived. In so doing, EPA would change references to 
cholinesterase inhibition to ``acute toxicity.'' This change 
acknowledges that NOAELs are now derived for a number of acute toxicity 
effects, not just cholinesterase inhibition. In a similar vein, EPA 
would eliminate the specific ``less than 10X'' and ``less than 100X'' 
triggers for NOAEL study flagging in favor of a more general 
description of ``less than the current NOAEL.'' Both of these changes 
could result in more studies being flagged.
    4. Update the guidelines references, and terminology, e.g., 
teratogenicity studies are now called prenatal developmental toxicity 
studies; the ADI is now referred to as the RfD. EPA believes that these 
revisions to the criteria will simplify the application of the criteria 
by submitters, even though additional studies may be required to be 
flagged.

E. Waivers

    EPA proposes to reformat its waiver process, currently contained in 
Sec.  158.45, but to retain its provisions. This proposal retains the 
flexibility of the current provisions for applicants to request, and 
EPA to evaluate, the need for data on a case-by-case basis depending on 
individual chemicals and use patterns. One of the benefits of updating 
part 158 as proposed today is that the improvements in clarity and 
transparency of the data requirements will greatly assist both the 
Agency and applicants in addressing data waivers.
    1. Waiver requests submitted as part of an application for 
registration. Waiver requests submitted in conjunction with an 
application for registration, amended registration, experimental use 
permit, or petition for tolerance are considered in the context, and in 
the same time frame, as the application is considered, based upon the 
application review period in FIFRA sec. 33. The review periods 
currently range from 90 days for minor amendments to as much as 3 years 
for new chemical applications. Consideration of waiver requests (and 
there may be multiple requests in a single application) is done by 
Agency scientists when the application is reviewed scientifically.
    2. Waiver requests submitted in response to Data Call-Ins for 
studies that are required in part 158. In the case of DCIs for data 
requirements that are contained in part 158, EPA believes that it will 
be able to make waiver decisions in a reasonably prompt timeframe since 
the need for the data has been established, the criteria upon which the 
data are required (use pattern, exposure pattern, chemical 
characteristics, etc.) have been elaborated, and the conditionalities 
associated with its imposition have been carefully considered in the 
development of this proposal. In other words, much of the evaluative 
process associated with a data waiver has already been done. Thus EPA 
will be able to judge an adequately supported waiver request against 
these existing factors to determine whether a waiver can be granted.
    Moreover, the improved transparency of the requirements and 
conditions in new part 158 means that an applicant will be able to 
ascertain with reasonable certainty the likelihood that EPA would 
consider favorably a waiver request. EPA believes that improved clarity 
will also reduce the number of frivolous, inappropriate, or ill-
supported waiver requests. Thus, EPA believes it will be able to 
respond in a reasonable period of time to a waiver request. If EPA 
requires a lengthy period to reach a decision on a waiver request which 
is denied, the Agency will generally consider time extensions to 
accommodate legitimate and reasonable registrant needs, whether to 
define acceptable protocols, evaluate alternative tests that might 
satisfy the Agency's requirements, or allow for consideration of 
laboratory capacity.

F. Minor Uses

    Current Sec.  158.60 outlines a number of non-regulatory policies 
EPA adopted to limit the economic impact of data requirements on minor 
use products while ensuring that the Agency had adequate data to assess 
the potential risks and benefits of these pesticides. Because minor use 
policies by themselves are somewhat fluid and subject to change 
periodically, EPA proposes to remove Sec.  158.60. EPA, however, 
remains committed to the minor use program by imposing the mandates 
contained in FIFRA that relate to minor uses, such as extending 
exclusive use of minor use data, granting minor use waivers, and 
expediting minor use registrations. The Agency believes that tiered 
testing, outlined elsewhere in this proposal, coupled with its waiver 
policy in Sec.  158.45 and priority review status, limit the economic 
burden for all pesticides by ensuring that registrants are required to 
develop only those studies that are essential for an appropriate safety 
evaluation.

[[Page 12288]]

VIII. How to Use the Data Tables (Subpart B)

    EPA proposes to revise subpart B to update use patterns and clarify 
the steps needed to determine the appropriate data requirements from 
the tables in subparts, D, E, F, J, K, N, O, and U. Pesticide use 
patterns that are used to determine required testing have been revised 
for all of the data requirements tables to reflect the expanded use 
patterns contained in this proposal (see below).

A. Expanded Use Patterns

    EPA proposes to subdivide the current 9 major use patterns listed 
in Appendix A of part 158 to 15 to more fully address nonagricultural 
uses. The revised use patterns would be terrestrial food crop, 
terrestrial feed crop, and terrestrial nonfood crop; aquatic food crop, 
aquatic nonfood crop, aquatic nonfood outdoor use and aquatic nonfood 
industrial use; greenhouse food crop and greenhouse nonfood crop; 
forestry; residential outdoor; indoor food; indoor nonfood; indoor 
medical; and indoor residential use. As mentioned above, the Agency 
proposes to remove the Pesticide Use Index (Appendix A) from the 
regulations because it is not a requirement. Instead, the Index will 
become a separate guidance document and placed on EPA's website and 
made available to the public. A guidance document would be easier to 
update and would provide the regulated community with the most current 
information.

B. Clarifying How to Use the Data Tables

    Subpart B would contain a step-wise process to assist the applicant 
in determining the data needed to support its particular product. 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 proposed here as 
they relate to their specific product prior to and during the 
registration process.
    EPA is continuing its current system of identifying the 
applicability of data requirements in the data tables. Because of the 
variety of chemicals and use patterns, and because EPA must retain 
flexibility to tailor data requirements to its needs, it uses only 
qualitative descriptors in the tables. These are used for convenience 
to make the table format feasible, but serve only 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.
    The table descriptors NR (not required), R (required), and CR 
(conditionally required) can be viewed as markers along a spectrum of 
the likelihood that the data requirement applies. 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. Although only an approximation, if 
percentages were to be assigned, R could be viewed as representing the 
range of 50% to 100% and CR the range up to 50%. EPA welcomes comment 
on ways to characterize the data requirements that would better serve 
applicant needs.
    EPA is continuing its longstanding system of identifying test 
substances in the tables. The standard descriptors of test substance 
are the following:
    1. The technical grade of active ingredient (TGAI), used when 
evaluating the inherent toxicity or chemical characteristics of a 
pesticide.
    2. The manufacturing use product (MP), used in certain product 
chemistry tests, usually for labeling purposes.
    3. The pure active ingredient (PAI), used in certain product 
chemistry tests requiring extremely basic chemical properties or 
manufacturing process information.
    4. The pure active ingredient, radioactive (PAIRA), used primarily 
in residue chemistry studies when residues at very low levels (ppm) 
must be quantified in plant or animal tissue.
    5. The end-use product (EP), used as the test substance when the 
Agency wants to refine its hazard or chemical profile based on actual 
concentrations, or needs to determine the impact of added inert 
ingredients on the hazard or chemical profile.
    6. The typical end-use product (TEP), used as a representative 
product in tests that might otherwise require duplicative testing of a 
number of EPs.
    Where changes in the test substance are proposed, such changes are 
described in the discussion of each proposed revision. EPA welcomes 
comment on its test substances and how the Agency uses them in a 
testing regimen. Such comments should be made in the context of the 
specific data requirement for which changes are proposed.

C. Identifying Data for Experimental Use Permits (EUPs)

    Finally, the Agency is requesting comment on the best way to 
identify data requirements for EUPS. Some people believe that the 
brackets indicating what data requirements also apply to EUPs in the 
current data tables complicate the tables with extraneous symbols and 
codes. In an effort to make the data tables simpler and easier for an 
applicant to understand, one suggestion is to separate the EUP data 
requirements from the main data tables and make them a stand-alone 
table. Revised EUP data requirements could be housed in 40 CFR part 158 
(data requirements) or in part 172 (EUP requirements). As part of this 
proposal, EUP data requirements for each discipline have been 
identified either in the regulatory text accompanying the data table 
or, as brackets, within the body of the table, itself. In general, the 
Agency proposes to retain the existing data requirements for EUPs with 
a few minor changes in the areas of environmental fate and ecological 
effects. The Agency is soliciting opinions on this approach or other 
approaches that may prove more efficient and useful to the applicant. 
If an alternative approach is accepted, the Agency may in the final 
rule, reformat the regulatory text or data tables.

D. Test Guidelines

    The guidelines for the environmental fate series are currently 
being updated and where applicable, harmonized with the guidelines 
established by the OECD. Therefore, the Agency is showing the current 
guideline numbers in the preamble, regulatory text, and tables. If, 
before the final rule has been promulgated, these guidelines have been 
issued, EPA will insert the new guideline numbers in the Final Rule.

E. Purposes of the Registration Data Requirements

    The Agency proposes to retain the material currently in Sec.  
158.202 Purposes of the registration data requirements in subpart D, 
Data Requirements Tables. Since a series of new subparts will replace 
subpart D, this material will be moved to subpart B.

IX. Product Chemistry Data Requirements (Subpart D)

A. General

    The Agency uses product chemistry information to determine whether 
impurities of toxicological or environmental concern are present in 
pesticides and formulated products.

[[Page 12289]]

 Product chemistry data requirements are comprised of product identity 
and composition data along with the physical and chemical 
characteristics of a pesticides, plus any intentionally added 
ingredients and impurities in the final pesticide product. Included in 
this subpart are the specific, detailed requirements for product 
identity and chemical analysis. The Agency is proposing two additional 
data requirements and other minor revisions that would clarify the 
applicability of existing requirements. For example, the Agency 
proposes to revise the definition of an active ingredient and end-use 
product to include nitrogen stabilizers, which were added to the 
definition of ``pesticide'' in 1996.
    The Agency proposes to list entries in the data requirements table 
for product identification, composition, analysis, and certification of 
limits requirements. These requirements are currently contained in 
Sec.  Sec.  158.155 through 158.180, and are proposed to be retained 
unchanged as new Sec.  Sec.  158.320 through 158.355. Inclusion in the 
table for product chemistry is for the convenience of applicants--the 
requirements themselves are not affected by including them in the 
table. The test notes refer applicants to the subsequent section that 
discuss the requirements in detail.
    The Agency's current policy as described in Pesticide Registration 
Notice 98-1 (January 12, 1998) allows applicants and registrants to 
submit a summary of the physical and chemical properties of non-
integrated pesticide products, EPA Form 8570-36, rather than submit the 
studies upon which these data are based. The self-certification 
statement (EPA Form 8570-37) must be signed and dated by the applicant 
certifying that the submitted information was conducted in full 
compliance with the regulations (Attachment 2 to PR notice 98-1). The 
PR notice applies to applications for registration of manufacturing-use 
and end-use products of all pesticide products produced by a non-
integrated formulation system.

B. Proposed Product Chemistry Data Requirements

    1. Newly imposed data requirements. None.
    2. Newly codified data requirements--i. UV/visible light 
absorption. The Agency proposes to add a requirement for data on the 
ultraviolet (UV)/visible light absorption in the 200-800 nanometers 
wavelength range (guideline 830.7050) as part of the basic data in the 
characterization and identification of a compound. This information 
will be used in conjunction with the photodegradation in water study 
(Sec.  158.1100) to determine if photodegradation is a possible route 
of dissipation in the environment. In order for a pesticide to undergo 
direct photolysis in the environment, it must absorb energy in the 
wavelength range emitted by sunlight. While the UV/visible light 
absorption spectrum will indicate whether or not the chemical absorbs 
in this range and hence may potentially photodegrade, it does not 
actually measure the photodegradation rate or identify photodegradates. 
Accordingly, test note 2 for the photodegradation study states that the 
photodegradation in water study will not be 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.
    ii. Particle size, fiber length, and diameter distribution. The 
Agency proposes to add the conditional requirements for data on 
particle size, fiber length, and diameter distribution (guideline 
830.7520). This study would be conditionally required for water 
insoluble test substances (<10-\6\ g/l) and fibrous test 
substances with diameter >=0.1 [mu]m. Data from this study are needed 
in the environmental fate assessment to estimate potential chemical 
drift to nontarget areas.
    3. Revised data requirements--i. Stability to temperatures, metals, 
and metal ions. The Agency proposes to change the requirement for 
stability data (guideline 830.6313) from ``required'' to 
``conditionally required.''Data on the stability to metals and metal 
ions is required only if the active ingredient is expected to come in 
contact with either material during storage. This proposed change does 
not alter the nature of the requirement.
    ii. Explodability. The Agency proposes to change the requirement 
for explodability data (guideline 830.6316) from ``required'' to 
``conditionally required.'' Since pesticides do not typically fall 
under this category, these data are only required for products that are 
potentially explosive. This proposed change does not alter the nature 
of the requirement.
    iii. Partition coefficient (n-octanol/water). The Agency proposes 
to change the requirement from ``conditionally required'' to 
``required'' (guidelines 830.7550, 830.7560, and 830.7570). The Agency 
is requiring this study because the majority of currently registered 
pesticides are organic non-ionic chemicals that are not expected to 
significantly hydrolyze or solubilize in water. In the event a chemical 
fully hydrolyzes or is completely soluble in water, this data 
requirement would be waived. This proposed change does not alter the 
nature of the requirement nor the conditions under which it is imposed.
    iv. Density, dissociation constant, and vapor pressure. The Agency 
proposes to add test notes for the data requirements for density/
relative density/bulk density (guideline 830.7300), dissociation 
constant (guideline 830.7370), and vapor pressure (guideline 830.7950) 
to better identify when these study requirements are applicable. These 
proposed minor changes do not expand the product chemistry requirement. 
Instead, they clarify the requirements by specifying which physical 
states or chemical forms the requirements apply.

X. Terrestrial and Aquatic Nontarget Organisms Data Requirements 
(Subpart E)

A. General

    The Agency uses a tiered system of ecological effects testing to 
assess the potential risks of pesticides to aquatic and terrestrial 
vertebrates, invertebrates, and plants. These tests include studies 
arranged in a hierarchy from basic laboratory tests to applied field 
tests. The results of each tier are evaluated to determine the 
potential impacts on fish, wildlife and other nontarget organisms, and 
to indicate whether further laboratory and/or field studies are needed. 
These data requirements provide the Agency with ecological effects 
information, which, in turn, allows the Agency to determine if 
precautionary statements concerning toxicity or potential adverse 
effects to nontarget organisms are necessary.
    Higher tiered studies may be required when basic toxicity data and 
predicted exposure levels or environmental conditions suggest the 
potential for adverse effects. Field data are used to examine acute and 
chronic adverse effects on captive or monitored populations under 
natural or near-natural environments. Such studies are required only 
when the potential for adverse effects is high, based on the results of 
lower tier studies, or to confirm the need for mitigation measures. In 
some cases, the results of field studies may give rise to the need for 
further testing.

B. Proposed Requirements

    The Agency is proposing two additional data requirements as well as 
other minor revisions that would clarify the existing data 
requirements. In some cases, the proposal is to change the

[[Page 12290]]

existing test requirement from ``conditionally required'' to ``required 
'' or ``not required.'' The data requirements for nontarget insects, 
formerly in Sec.  158.590, would be moved under this proposal to 
subpart E to consolidate the data requirements for nontarget organisms. 
Other changes include changes in test substance, conditions under which 
the test is required, and clarification of test notes.
    In addition, as discussed in more detail in this section, the 
Agency proposes to require an additional test species for the avian 
oral toxicity study, because current data requirements may not 
adequately characterize the risks that pesticides pose to songbirds. 
The Agency also proposes to conditionally require sediment testing to 
better assess the effects of sediment bound pesticide residues in 
aquatic environments. The Agency is proposing to require independent 
laboratory validation of environmental chemistry methods for 
terrestrial and aquatic field testing.
    Finally, the Agency is proposing to eliminate the requirement for 
avian dietary testing for indoor and greenhouse uses, and to simplify 
the test notes for these requirements. The Agency invites comments on 
all aspects of these data requirements.
    1. Newly imposed data requirements. None.
    2. Newly codified data requirements. The Agency proposes to add 
testing of aquatic organisms exposed to treated sediment to better 
assess the effects of sediment bound pesticide residues in aquatic 
environments. Environmental risk estimates should be based on exposure 
data from the water column, sediment, and pore water (the water 
occupying space between sediment or soil particles), however, with the 
exception of field studies, the current data requirements are limited 
to water column exposures. The effects of sediment bound pesticides (or 
their degradates) on aquatic environments cannot be accurately assessed 
from bioassays on compounds suspended in the water column alone. For 
example, lipophilic or hydrophobic chemicals can dissipate from the 
water column, but may remain in the aquatic environment adsorbed to 
sediment. Sediment bound pesticides may differ significantly from 
pesticides in solution, showing different physical, chemical, and 
biological properties, chemical partitioning, bioavailability, 
concentrations in interstitial or pore water, exposure from sediment 
ingestion and possible manifestations of food chain effects. By serving 
as a potential pesticide sink, exposure to these compounds may lead to 
significant environmental risk to a wide variety of fish and aquatic 
invertebrates which live and feed at the bottom of a lake or stream. 
Sediment toxicity testing is needed to assess the bioavailability of a 
sediment bound compound and to characterize the possible impact to 
sediment dwelling organisms. The Agency does not believe these studies 
will be commonly required.
    EPA's Contaminated Sediment Management Strategy (USEPA 1998) (Ref. 
3) has been recently developed to provide a more unified approach to 
testing and risk assessment of aquatic species which inhabit and feed 
in the benthic environment. Testing would consist of whole sediment 
(spiked) tests; testing can also consist of chronic whole sediment 
toxicity tests and/or sampling for residues and biological monitoring 
of pesticides in the sediment after exposure. EPA has developed test 
protocols for chronic whole sediment tests of invertebrates. Test 
guidelines will be developed from these protocols. Protocols for 
further tests (e.g., acute pore water tests) and for vertebrate species 
are under consideration. Registrants are urged to meet with the Agency 
prior to development of their own protocols.
    i. Whole sediment: acute toxicity to invertebrates, freshwater and 
marine. The Agency is proposing to conditionally require data for acute 
invertebrate sediment testing (guidelines 850.1735 and 850.1740) for 
terrestrial uses, aquatic food and nonfood outdoor uses, and forestry 
uses. This study would be required when the soil partition coefficient 
(Kd) is >= 50 mg/L, indicating the ability to absorb to 
sediment, and if the half-life of the pesticide in the sediment is <= 
10 days in either the aerobic soil or aquatic metabolism studies. 
Registrants would need to consult with the Agency on appropriate test 
protocols.
    ii. Whole sediment: chronic toxicity to invertebrates. The Agency 
proposes to conditionally require this study for the same use patterns 
as the above sediment toxicity tests. The study would be triggered when 
the estimated environmental concentration is greater than or equal to 
the acute sediment EC50/LC50 or the soil 
partition coefficient (Kd) is >= 50 mg/L, indicating the 
ability to absorb to sediment; and if the half-life of the pesticide in 
the sediment is >10 days in either the aerobic soil or aquatic 
metabolism studies. Registrants would need to consult with the Agency 
on appropriate test protocols.
    3. Revised data requirements--Avian oral toxicity. The Agency 
proposes to require for certain uses, an additional test species for 
the acute avian oral toxicity study (guideline 850.2100), which 
currently recommends the use of mallard ducks or bobwhite quail. 
Testing on a passerine species (i.e., redwing blackbird) would be 
required for outdoor uses. The Agency is proposing to add this 
passerine species because of concern in the scientific community that 
data from tests with mallards or quail may not always adequately 
characterize the risks that pesticides pose to songbirds. Recent 
evaluation of the data collected over the past 10 years indicates 
passerines are more sensitive to pesticides than larger birds such as 
mallards and quail (which are currently the recommended test species) 
(Ref. 2) and in 1996, the SAP supported the need for testing on 
passerines. In addition to comments on the proposed addition of a 
passerine species for the acute oral toxicity study, the Agency 
requests comments on whether this species should replace the existing 
bobwhite/mallard species or otherwise be conditional, and if so what 
criteria or triggers should be used to determine when the data should 
be required.
    The Agency proposes to revise and simplify the test notes for the 
avian acute toxicity test. The single current footnote is structurally 
complex, so EPA has subdivided it into 4 test notes that are easier to 
understand and apply.
    In addition, the Agency proposes to conditionally require testing 
of the typical end-use product (TEP) of granular and non-granular end-
use products because the inherent toxicity of end-use products is 
better defined by testing the product. End-use products may contain 
chemicals that enhance efficacy by acting as solvents, stickers, and 
wetting agents. Although these chemicals are listed as inerts, their 
individual toxicity or combination with one another or the active 
ingredient (a.i.), may be more toxic than the technical grade of the 
active ingredient (TGAI).
    i. Avian dietary toxicity. In the current regulation, the Agency 
requires the subacute avian dietary toxicity study (guideline 850.2200) 
for terrestrial and aquatic (food crop and nonfood), forestry, and 
domestic outdoor uses, and conditionally requires this study for indoor 
and greenhouse (food crop and nonfood) use sites, as part of a set of 4 
basic avian (acute and dietary) and aquatic toxicity studies. The 
results are used in decisions regarding environmental hazard statements 
on product labeling. Since the avian acute oral study more accurately 
reflects the inherent exposure to birds in this scenario, the Agency is 
proposing to no

[[Page 12291]]

longer require the avian dietary study for indoor and greenhouse uses.
    This proposal would also add as a conditional requirement data on 
one avian species for aquatic nonfood residential uses if the acute 
avian oral LD50 of the TGAI is less than or equal to 100 mg 
a.i./kg. Data would be required on a second species for this use if the 
avian dietary lethal concentration to cause mortality in 50% of the 
test animals (LC50) in the first species tested is less than 
or equal to 500 ppm a.i. in the diet. The Agency is proposing to 
conditionally require the second species because the data will provide 
some assurance that EPA is not basing an assessment on a single species 
which might be highly sensitive (or the opposite) when compared to 
other birds. This particular use category (aquatic nonfood residential) 
is relatively small-scale, so the current regulations require testing 
on only one species. However, in the event that this test shows high 
toxicity, this concern is addressed by the conditional requirement for 
testing on a second species.
    ii. Wild mammal toxicity. The Agency proposes to amend this 
conditional data requirement to eliminate the requirement for aquatic 
nonfood residential uses. In splitting the current aquatic use 
category, EPA is able to tailor the requirement to those use situations 
for which the data are needed (aquatic food and nonfood uses). The 
conditionality of the requirement would be unchanged, that is, required 
on a case-by-case basis depending on the results of lower toxicology 
tier studies, such as acute and subacute testing, intended use pattern, 
and environmental fate characteristics that indicate potential 
exposure.
    iii. Avian reproduction. Because some pesticides are stable in the 
environment, or can be stored in plant tissues that may be used by 
birds as a food source, avian reproduction testing (guideline 850.2300) 
is conditionally required for pesticides to which birds are exposed 
repeatedly or continuously during or preceding the breeding season. In 
addition, research has shown that even short-term exposures to 
pesticides can lead to significant adverse reproductive effects. For 
example, several organophosphorus insecticides have been shown to 
significantly reduce egg production and lead to changes in eggshell 
quality within days of dietary exposure (Refs. 4, 5 and 6). Therefore, 
EPA proposes to require these studies for terrestrial (food crop, feed 
crop, and nonfood), aquatic food crop and nonfood outdoor, forestry, 
and residential outdoor uses.
    iv. Simulated or actual field testing for mammals and birds. 
Current part 158 conditionally requires field testing (guideline 
850.2500) for terrestrial and aquatic (food crop and nonfood), 
forestry, and domestic outdoor uses. The Agency proposes to expand this 
conditional requirement to include terrestrial feed crop and aquatic 
nonfood outdoor uses, as well. The requirement would be based on the 
results of lower tiered studies such as acute and subacute bird and 
mammal testing, intended use pattern, and environmental fate 
characteristics that indicate potential exposure. Testing would be 
required only for those products that appear to pose significant risks 
to nontarget wildlife. The Agency is also proposing to require 
independent laboratory validation of the environmental chemistry 
methods used to generate data associated with this study.
    v. Acute toxicity: freshwater fish. Currently part 158 requires the 
freshwater fish toxicity study (guideline 850.1075) for terrestrial and 
aquatic (food crop and nonfood), forestry, and domestic outdoor uses 
and conditionally requires these studies for greenhouse (food crop and 
nonfood) and indoor uses.
    Although indoor and greenhouse uses usually require only one 
species of fish to be tested, in some instances a second fish species 
may be needed. For example, a chemical may be shown to be stable in the 
environment (i.e., hydrolysis study), have moderate toxicity (1 ppm 
LC50 < 10 ppm) in the acute fish toxicity study, and may be 
released into the aquatic environment through effluent discharge. In 
such cases, the results of the two required acute aquatic toxicity 
studies (fish and invertebrates) may not be sufficient to rule out 
greater toxicity in a second species of fish. Testing on a second 
species will provide some assurance that EPA is not basing an 
assessment on a species that is highly sensitive (or the opposite) when 
compared with another species. Therefore, in these cases, the Agency 
proposes to conditionally require a third acute study on a second 
species of fish to correlate with the results of the previous two acute 
aquatic studies and to ensure that the labeling is adequate to protect 
aquatic species. The additional study increases the likelihood that 
effluent criteria and product labeling reflect the pesticide's risk and 
inherent toxicity.
    vi. Acute toxicity--estuarine and marine organisms. Acute data from 
estuarine testing enables the Agency to perform a risk assessment by 
comparing the toxic concentrations with the estimated or monitored 
levels in estuaries. The Agency proposes to change the conditional 
requirement for the acute LC50/EC50 testing 
(guidelines 850.1025, 850.1035, 850.1045, 850.1055, and 850.1075) for 
terrestrial, aquatic (food crop and nonfood outdoor), residential 
outdoor, and forestry uses to required testing, and change the aquatic 
nonfood residential use to ``not required.'' Generally, three out of 
the five studies would be needed to satisfy the data requirement. 
Registrants may request a waiver of the study if the crop is never 
associated with coastal counties or there is a geographical restriction 
for a site that would normally be of concern.
    vii. Chronic toxicity--fish early-life stage and aquatic 
invertebrate life-cycle. Currently, the Agency conditionally requires 
fish early-life stage and aquatic invertebrate life-cycle studies 
(guidelines 850.1300, 850.1350, and 850.1400) for terrestrial food and 
nonfood, aquatic food and nonfood, forestry, and domestic outdoor uses. 
These studies are not required for greenhouse food and nonfood, and 
indoor uses. The Agency is proposing several revisions that would 
clarify the applicability of the requirements. The first is to list the 
fish early-life stage and aquatic invertebrate life-cycle studies as 
separate requirements in the data table; then identify each test 
organism as a freshwater or saltwater species.
    For the freshwater fish early-life stage and invertebrate life-
cycle studies, the Agency proposes to change the conditional 
requirement for terrestrial and aquatic (food crop and nonfood) and 
forestry uses to required, and change the aquatic nonfood residential 
use to not required.
    Currently, the freshwater invertebrate life cycle and fish early 
life stage tests are conditionally required for terrestrial, aquatic 
(food crop and nonfood), and forestry uses. When promulgated in 1984, 
one basis for the conditional nature of the requirements was that only 
one of the two tests was required, depending on whether fish or 
invertebrates were more sensitive in the acute studies. However, when a 
pesticide enters the aquatic environment, both groups of organisms will 
be exposed. Moreover, acute sensitivity is not a reliable indicator of 
chronic sensitivity, whether in the same or a different group of 
organisms, so that chronic data are needed regardless of the results of 
acute testing.
    The proposed change to ``not required'' for aquatic nonfood 
residential use is due to the fact that the current ``aquatic nonfood'' 
use pattern is proposed to be split into aquatic

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nonfood outdoor and aquatic nonfood residential. As the latter 
represents a much smaller use pattern, the Agency believes that data 
requirements can be reduced or eliminated for aquatic nonfood 
residential uses.
    In addition, the Agency proposes to require both of these tests for 
all turf uses including residential, since exposure varies. This change 
is warranted because the relative sensitivity of fish and invertebrates 
can vary widely across chemicals. Currently, only the most sensitive of 
the two organisms, either fish or aquatic invertebrates, as determined 
by Tier I acute studies, is tested. However, since both organisms will 
be exposed when a pesticide enters an aquatic environment and the acute 
sensitivity of an invertebrate may not accurately predict the chronic 
sensitivity in fish and vice versa, the Agency believes that both 
species should be tested for chronic effects. The Agency cannot make 
the assumption that a chemical is not chronically toxic at much lower 
concentrations than some ratio of the LC50 value would 
suggest.
    viii. Aquatic organism bioavailability/biomagnification/toxicity 
tests. The Agency proposes to eliminate the requirement for these 
studies for aquatic nonfood residential or residential outdoor uses 
since exposure is expected to be minimal (i.e., insufficient quantities 
to accumulate in the tissues of aquatic organisms (guidelines 850.1710, 
850.1730, and 850.1850).
    ix. Simulated or actual field testing for aquatic organisms. The 
Agency is clarifying that the conditional requirement (guideline 
850.1950) applies to turf, however these studies would no longer be 
required for aquatic nonfood residential uses since exposure is 
expected to be minimal.
    x. Honeybee acute contact toxicity. EPA is proposing to require 
this study (guideline 850.3020) for terrestrial (food crop, feed crop, 
and nonfood), aquatic food crop and nonfood (outdoor), forestry, and 
residential outdoor uses. This study is being added to the battery of 
studies required to support outdoor uses when honeybees are likely to 
be exposed to pesticides. Previously, the requirement was limited to 
outdoor use patterns when the crop may be in bloom and thereby be 
attractive to honey bees. The change from ``conditionally required'' to 
`` required'' is to address those situations where blooming, pollen-
shedding, or nectar-producing parts of nontarget plants adjacent to or 
within the treated area may be attractive to honey bees. Registrants 
may request a waiver of the study if use practices significantly 
restrict exposure of the pesticide to honey bees.
    xi. Honeybee-toxicity of residues on foliage. The current 
regulation conditionally requires honeybee toxicity of residues on 
foliage studies (guideline 850.3030) for terrestrial and aquatic (food 
crop and nonfood), forestry, and domestic outdoor uses. The study is 
required when the formulation contains one or more active ingredients 
having an acute LD50 of less than 1 [mu]g/bee. The Agency 
proposes to amend the requirement to require testing on the TEP when 
the formulation contains one or more active ingredients having an acute 
LD50 of <11 [mu]g/bee, as determined in the acute contact 
study, and the use pattern indicates that honey bees may be exposed. 
The proposed data requirements rule (48 FR 53192) which was published 
in 1982, listed the correct value of <11 [mu]g/bee for the 
honeybee study.
    xii. Field testing for pollinators. The Agency proposes to include 
terrestrial (feed crop) and aquatic nonfood (aquatic outdoor and 
residential) uses where honeybees are likely to be exposed to 
pesticides as a conditional requirement (guideline 850.3040).

C. Data Requirements Specific to Endangered Species Assessments and 
Determinations

    Over the last several years, the Agency has been requiring, on a 
case-by-case basis for certain pesticides, data demonstrating specific 
geographic location(s) of threatened and endangered species (listed 
species), which can then be compared with areas of potential pesticide 
use. These data have been required when EPA determined that the 
estimated environmental concentration of the pesticide when applied 
according to the labeling appears to exceed the Agency's numeric 
concern levels for listed species. The specific species for which 
location information was needed, has been determined on a case-by-case 
basis based upon the use pattern of the pesticide and the sites on 
which it may be used. These special data are currently not required by 
part 158, and have only been requested on a few occasions; however, the 
Agency anticipates that they may be requested in the future in 
connection with other registration and reregistration actions. In 
response to a Data Call-In notice for data on the location of all 
listed species, an industry task force is working to develop a database 
that may partly fulfill Agency needs, i.e., geographic locations where 
potentially affected species are thought to occur. Access to the task 
force data by other registrants who may be required to provide such 
data in the future would be made available through appropriate data 
sharing mechanisms. Although the anticipated expanded burden on 
registrants is not large since it does not entail experimental or 
laboratory procedures, it is nevertheless not likely to be 
inconsequential. Consequently, the Agency is requesting comment on its 
utility and appropriateness.
    In addition, through discussions about methods to evaluate the 
potential risks of pesticides to listed species, EPA and the Fish and 
Wildlife Service and the National Marine Fisheries Service (jointly 
referred to as the Services) identified several aspects of EPA's 
current approach for which there is some scientific uncertainty. While 
the Services agreed that EPA was using the best available scientific 
and commercial information to assess risks to listed species, the 
Services and EPA also agreed that where uncertainties existed, further 
research and investigation might help to develop improved risk 
assessment approaches. The Agency recognizes that such research also 
could lead, in the long run, to additional data requirements for 
registration. Accordingly, the Agency seeks input on research areas 
that may be necessary to effectively characterize potential risks to 
listed endangered species from pesticide use. These include research to 
address the following types of uncertainties:
     Product use information by geographic location below the 
state and county levels
     Toxicity data and environmental fate measurements/exposure 
model predictions with end use products
     Toxicity data from surrogate species that quantify dose-
response relationships for effects relevant to critical life stages of 
endangered species
     Measured or estimated values of physiological, 
biochemical, and morphological characteristics of endangered species 
and surrogate species to refine chemical-specific interspecies toxicity 
extrapolations
     Toxicity, exposure, uptake and elimination data to better 
determine any differences in interspecies sensitivity of non-target and 
endangered plant species exposed to herbicides
     Toxicity data to characterize potential effects to 
freshwater mussels
     Toxicity data to characterize potential effects to 
reptiles and amphibians.
    The Agency seeks comment on:
    1. The relative value of each of these research areas in better 
refining assessments of potential risks to listed species.

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    2. Input on specific research directions in these areas, including 
methodologies, protocols etc., that would be appropriate and useful in 
assessing the potential risks to listed species.
    3. Other types of research that would be of value in refining 
potential risks of a pesticide to a listed species.
    4. The extent to which potential research areas reflect 
uncertainties that apply to pesticides generically; to chemical 
stressors generically, or to types of pesticides or chemicals 
stressors.

XI. Toxicology Data Requirements (Subpart F)

A. General

    Toxicology studies are required by the Agency to assess the hazard 
of the pesticide to humans and domestic animals. These hazard data, 
when combined with exposure data, form the basis for the human risk 
assessment. Generally, using animals as a surrogate for humans, tests 
are carried out by the oral, dermal or inhalation route depending on 
the pesticide's pattern of use and physical form. The duration of the 
toxicity study approximates the estimated duration of human exposure, 
while considering species differences in maturational milestones and 
overall life span. Typical exposures may be ``acute'' (single dose), 
``subchronic'' (intermediate), or ``chronic'' (long-term). If a 
pesticide is used on food and requires a tolerance, the dietary 
exposure may be over a lifetime, or a significant portion of a 
lifetime, and thus chronic/cancer and multi-generation reproductive 
studies would be required. Studies would be required to assess the 
hazard during a potentially susceptible stage of life, e.g., prenatal 
developmental studies and developmental neurotoxicity studies, and to 
measure end points not always observed in the basic toxicity test 
battery, e.g., acute and subchronic neurotoxicity studies.
    In addition, EPA's Risk Assessment Guidelines set forth principles 
and procedures to guide EPA scientists in the conduct of Agency risk 
assessments, and to inform Agency decision makers and the public about 
these procedures. The guidelines emphasize that risk assessments will 
be conducted on a case-by-case basis, giving full consideration to all 
relevant scientific information. This case-by-case approach means that 
Agency experts review the scientific information on each agent and use 
the most scientifically appropriate interpretation to assess risk. The 
guidelines also stress that this information will be fully presented in 
Agency risk assessment documents, and that Agency scientists will 
identify the strengths and weaknesses of each assessment by describing 
uncertainties, assumptions, and limitations, as well as the scientific 
basis and rationale for each assessment.
    This proposal includes the requirements for pesticides retained 
from the current 40 CFR 158.340 as well as proposed revisions that have 
been peer reviewed by the SAP. The basic data set proposed here 
includes toxicity studies needed to support high exposure pesticides, 
such as food use pesticides.
    1. Acute studies (oral, dermal, and inhalation toxicity tests, eye 
and skin irritation tests and dermal sensitization)
    2. Subchronic (90-day) feeding studies in rodents and nonrodents
    3. Chronic feeding studies in rodents and nonrodents
    4. Cancer studies in two species of rodents (rat and mouse 
preferred)
    5. Prenatal developmental toxicity studies in rodents and 
nonrodents (rat and rabbit preferred)
    6. Two-generation reproduction study in rodents (rat preferred)
    7. General metabolism study in rodents
    8. Mutagenicity battery
    9. Acute and subchronic neurotoxicity studies in rats
    10. Immunotoxicity study in rodents
    11. Developmental neurotoxicity study in rodents

B. Approach

    1. Options for generating data. A required sequence of 
toxicological testing for new pesticides is not specified by the 
Agency. Rather, most decisions regarding the order of testing are left 
up to the individual registrant, based upon the understanding that 
there are many factors that could affect the testing progression. It is 
recommended, however, that the development of pharmacokinetic 
information, including data relevant to developing systems, be 
initiated early in the testing process in order to aid in the 
appropriate design of the studies and the interpretation of 
toxicological findings in adult and immature (developing) animals.
    Generally, data requirements will proceed from single to multiple 
exposures, from shorter to longer duration, and from simpler to more 
complex. Different studies may be conducted simultaneously and various 
studies may be done in combination as well (an approach encouraged by 
the Agency to optimize resources and reduce the number of animals used 
in testing). Knowledge gained from results of earlier studies should be 
used to design subsequent study protocols in order to attain the 
greatest confidence in the results of the higher-order studies. For 
instance, conducting the subchronic (90-day) feeding study prior to the 
two-generation reproduction study would provide information on target 
organs that may be affected and that need to be specifically evaluated 
in the two-generation reproduction study.
    2. Options for submitting nonfood use data. In proposed Sec.  
158.510 for nonfood uses of pesticides, EPA proposes to implement two 
approaches for complying with the toxicology data requirements. The 
first option, which parallels the testing scheme in the current 
regulations, would allow registrants and applicants to submit a set of 
acute, subchronic, chronic, and other toxicological studies on the 
active ingredient, with the specific makeup of the set of study 
requirements being based upon anticipated human exposure to the 
pesticide, as determined by the Agency. The makeup of the set of 
studies required for non-food use chemicals will be determined by the 
Agency based on the use pattern and expected exposure scenarios for the 
chemical. The following two examples illustrate the Agency's 
approaches:
    i. A fairly volatile pesticide is used in the home where long-term 
exposure by both inhalation and dermal routes are expected. In this 
case, the toxicity studies required would be similar to that for a 
food-use chemical.
    ii. In another example, a termite control pesticide is buried in 
the lawn near the house. There is very little exposure to anyone 
including the applicator. In this case, only Tier 1 data would be 
needed. In general, the level of toxicity studies will be determined by 
the magnitude, frequency and duration of the estimated human exposure.
If hazards are identified based upon review of these studies, the 
Agency would decide what types of actual human exposure data (i.e., 
applicator and post-application studies) also would be required to 
evaluate risk.
    The second option would allow registrants and applicants of nonfood 
use pesticides to submit both toxicological studies and human exposure 
data simultaneously. For this option, toxicological data would be 
submitted under a tiered system. Agency review of the first-tier 
toxicological studies and the simultaneously submitted exposure data 
then would determine the need, for second- or third-tier toxicological 
studies. This option would permit flexibility in study requirements 
based on the identification and characterization of adverse treatment-

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related toxicological effects and dose-response information, and 
estimates of potential human exposure. Additional second- or third-tier 
studies would be required on a case-by-case basis.
    Under this second option, the required first-tier studies would 
consist of: Acute studies, a subchronic 90-day dermal study or a 
subchronic 90-day inhalation study, an acute and subchronic 
neurotoxicity screening battery in the rat, prenatal developmental 
toxicity studies in two species, two-generation reproduction study in 
rodents (rat preferred), immunotoxicity study in rodents, and a full 
initial battery of mutagenicity studies. The conditionally required 
second-tier studies would include both subchronic 90-day feeding 
studies, and sometimes a dermal penetration study. Depending on the 
results of completed studies, conditionally required third-tier studies 
would include both Chronic Feeding studies, both carcinogenicity 
studies, a reproduction study, and a metabolism study. In addition, 
depending upon the results in the initial neurotoxicity and 
mutagenicity batteries, further neurotoxicity or mutagenicity testing 
may be required to address possible identified risk concerns.

C. Proposed Toxicology Data Requirements

    EPA's proposed toxicology data requirements encompass studies 
expected to improve the Agency's understanding of the potential 
pesticide hazard to humans, including subpopulations such as infants 
and children. The proposed table in this subpart contains the 
toxicology data requirements EPA would rely on to identify potential 
hazards to humans and domestic animals for all conventional pesticides. 
These include acute, subchronic and chronic toxicity studies, as well 
as carcinogenicity, prenatal developmental toxicity, reproductive 
toxicity, mutagenicity, neurotoxicity and other specialized studies.
    EPA recognizes that toxicology testing represents a large economic 
burden on registrants and incorporates the use of test animals. 
Consequently, the Agency works with industry, the scientific community, 
and advocates, to ensure that data requirements are imposed only when 
needed to make a sound scientific safety finding required under the 
law. Because of this concern, the Agency has adopted guidelines whereby 
several toxicological endpoints may be derived from one study and has 
instituted other avenues for combining studies. The Agency also 
recognizes that, in general, lower exposure uses often correlate with 
lower risk. Consequently, the Agency has adopted an approach that tends 
to levy more extensive data requirements on high exposure uses like 
food uses. It is also reflected in the tiering system for data 
submissions for nonfood uses and in the layout of the data tables.
    1. Newly imposed data requirements--Immunotoxicity. The Agency 
proposes to require immunotoxicity testing for all pesticides. 
Immunotoxicity testing is necessary to evaluate the potential of a 
chemical to produce adverse effects on the immune system. Immune system 
suppression has been associated with increased incidences of infections 
and neoplasia. In 1993, the National Research Council reviewed the 
technical literature and found that some pesticides are 
immunosuppressive (NRC, 1993). Because of the potential for pesticides 
to adversely impact the immune system, the EPA has developed a test 
guideline (870.7800) for immunotoxicity. The immunotoxicity test 
guideline was reviewed and endorsed by the FIFRA Science Advisory Panel 
and EPA's Science Advisory Board in 1996, and published in 1998 as part 
of the Office of Prevention, Pesticides and Toxic Substances' 
harmonized test guidelines.
    Because the immune system is highly complex, studies not 
specifically conducted to assess immunotoxic endpoints are inadequate 
to characterize a pesticide's potential immunotoxicity, even if some 
tissues subject to immunotoxic insult are examined. While data from 
hematology, lymphoid organ weights, and histopathology of routine 
chronic or subchronic toxicity studies may offer useful information on 
potential immunotoxic effects, these endpoints alone are insufficient 
to predict immunotoxicity (Refs. 7 and 8). Therefore, the Agency is 
proposing to require functional immunotoxicity testing along with the 
data from endpoints in other studies to predict the potential risk of 
pesticides on the immune system more accurately. The Agency invites 
public comment on all aspects of its proposed data requirement for 
functional immunotoxicity.
    2. Newly codified data requirements-- i. prenatal developmental 
toxicity. The Agency proposes to change the name of this requirement 
from ``Teratogenicity'' to ``Prenatal Developmental Toxicity'' to 
correspond with the name of the guideline (870.3700). An information 
based approach to testing is preferred which utilizes the best 
available knowledge on the chemical to develop a study protocol and 
testing strategy. Currently, both studies are required for food use 
pesticides, but for nonfood uses, only one prenatal developmental 
toxicity study is required, and the results of that study may trigger 
the conditional requirement for a second species. However, the response 
to developmental insult in one species is not necessarily the same in 
another species. The pharmaceutical thalidomide, which produces severe 
malformations in rabbits (and humans) but not rats following in utero 
exposure, is a classic example of this species-related difference in 
response. Additionally, the dose at which maternal or prenatal 
developmental toxicity is observed may not be the same across species, 
and the severity of the response in dams or fetuses may also differ. 
Consequently, there is a concern that the current testing paradigm for 
non-food use pesticides may not adequately characterize potential 
hazards to pregnant women and their fetuses. Given that the prenatal 
developmental toxicity study is used extensively to establish endpoints 
and doses for acute, short-term, and intermediate-term risk assessment, 
EPA believes it necessary to require studies in two species for all 
nonfood pesticides.
    The Agency encourages registrants consider the use of combined 
study protocols in satisfying this requirement. A prenatal 
developmental toxicity study segment could be added to a two-generation 
reproduction study in rodents (guideline 870.3800). This can be 
accomplished by utilizing a second mating of the parental animals of 
either generation. The dams would undergo cesarean section at one day 
prior to expected delivery and a separate evaluation would proceed as 
specified in guideline 870.3700. By combining protocols in this manner, 
a single study would satisfy the requirement for both prenatal 
developmental and reproductive toxicity in the rodent. While it is 
recognized that the cost of the reproduction study would increase 
somewhat due to the additional work scope, the total cost of the 
combined study would be substantially less than that incurred by 
conducting the two studies separately. Moreover, a combined 
reproduction/developmental protocol would not require the purchase of 
additional animals, and would increase the efficient utilization of the 
animals being studied. The second required prenatal developmental 
toxicity study would then be performed on the rabbit.
    ii. Neurotoxicity. Neurotoxicity studies evaluate the potential of 
a substance to adversely affect the structure and function of the adult

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nervous system. Since promulgation of the toxicology data requirements 
in 1984, there has been an increasing concern on the part of the 
scientific and public health communities that some pesticides may 
produce functional or structural effects on the nervous system that are 
not readily observed or adequately characterized in standard 
toxicological studies. The Agency believes that the current set of 
neurotoxicity studies are inadequate for some chemicals in their 
observation of behavioral effects and do not use optimal methods to 
evaluate the nervous tissue structure and function. To detect and 
characterize these potential effects more fully in certain chemicals, a 
battery of more sensitive testing would be required. Several 
neurotoxicity studies are proposed to be added to the already existing 
neurotoxicity study requirements for all conventional pesticide 
registrations. The objective of the new acute and subchronic battery is 
to evaluate the incidence and severity of the functional and/or 
behavioral effects, the level of motor activity, and the histopathology 
of the nervous system following exposure to a pesticide.
    A new adult neurotoxicity test battery of seven studies would 
replace the current adult neurotoxicity test requirements. The current 
adult neurotoxicity test battery consists of three studies: acute 
delayed neurotoxicity (hen), 90-day neurotoxicity (hen), and 90-day 
neurotoxicity (mammal). In the current part 158, an adult acute 
neurotoxicity study in mammals is not listed. However, an adult 
subchronic neurotoxicity study is required if the acute oral, dermal, 
or inhalation toxicity studies show neurotoxicity or neuropathy. 
Currently, the neurotoxicity studies can be triggered either by 
statistically and/or biologically significant findings.
    Under the proposal, some of these tests would be routinely required 
and others would be conditionally required. Two studies that would be 
required are an acute and a subchronic 90-day neurotoxicity study 
(guideline 870.6200) in rats. The acute study would be required to 
detect possible effects resulting from a single exposure. The 
subchronic study is intended to detect possible effects resulting from 
repeated or longer-term exposures. The requirement for a subchronic 
neurotoxicity study also may be satisfied by incorporating the required 
neurotoxicity testing into the standard 90-day subchronic feeding study 
in rats (guideline 870.3100). The acute and subchronic neurotoxicity 
studies in adult rats, in addition to providing data on the potential 
for neurotoxicity, also provide a basis for comparison of the potential 
for age-related differences in impacts on the nervous system with 
results from the developmental neurotoxicity study, if needed, for the 
same chemical.
    A new, conditionally required, 28-day delayed neurotoxicity study 
in hens (guideline 870.6100) would be added. The 28-day delayed 
neurotoxicity test would be required if results of the acute 
neurotoxicity study (guideline 870.6100) 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. The Summary Report of the 1990 OECD Ad Hoc Meeting (Ref. 9) 
adds:
    In the assessment and evaluation of the toxic characteristics of 
organophosphorus substances, the determination of the subchronic 
delayed neurotoxicity may be carried out, usually after initial 
information on delayed neurotoxicity has been obtained by acute 
testing or by the demonstration of inhibition and aging of 
neurotoxic esterase and acetylcholinesterase in hen neural tissue.
    The Agency believes that to evaluate the specific type of delayed 
neurotoxicity associated with some organophosphorus esters and related 
substances, a subchronic 28-day study in hens, rather than a 90-day 
study, would provide sufficient data. Thus, the duration of the 
subchronic hen study has been shortened from 90 days to 28 days. This 
is based on the finding that test chemicals reach equilibrium from both 
a pharmacokinetic and pharmacodynamic perpective; that is, the levels 
that cause effects, i.e., LOAELs and NOELs, would be stable after 28 
days of exposure. Another reason is that the 28-day study is able to 
identify effects as well as the 90-day study in that it includes a 
requirement for dosing 7 days a week, while the 90-day study only doses 
5 days per week, allowing for some intermittent recovery. This change 
was recommended by a panel of experts at a 1990 OECD ad hoc meeting on 
various issues in neurotoxicity testing (Ref. 9). Hence, the 90-day 
study requirement has been deleted from the proposed table. The 
conditional testing requirement for the acute delayed neurotoxicity 
study in hens (guideline 870.6100) would be unchanged.
    The last three studies that comprise the neurotoxicity test battery 
are also new data requirements. The scheduled controlled operant 
behavior, peripheral nerve function, and sensory evoked potential 
neuropathology studies would be conditionally required if the results 
of the acute and/or the subchronic neurotoxicity studies show adverse 
effects on the central nervous system which affect learning, memory or 
performance, or adverse effects on visual, auditory, or somatosensory 
senses and/or concerns for peripheral neuropathy. The scheduled 
controlled operant behavior study (guideline 870.6500) evaluates 
substances that have been observed to produce neurotoxic signs in other 
studies (e.g., central nervous system depression or stimulation), as 
well as substances with a structural similarity to neurotoxicants which 
affect learning, memory, or performance. The peripheral nerve function 
study (guideline 870.6850) evaluates substances that have been shown to 
produce peripheral neuropathy or other neuropathological changes in 
other studies, as well as substances with a structural similarity to 
those causing such effects. The sensory evoked potential 
neurophysiology study (guideline 870.6855) evaluates substances that 
may affect the visual, auditory, or somatosensory (body sensation) 
senses. Substances tested include those expected to affect these senses 
or to detect changes based on data from other studies or based on their 
structural similarity to substances that do affect these senses. The 
scheduled controlled operant behavior, peripheral nerve function, and 
sensory evoked potential neurophysiology studies are being proposed at 
this time to be conditionally required, subject to the results of acute 
or subchronic neurotoxicity testing or for other reasons, such as 
structure activity considerations or to more fully characterize any 
neurotoxic effects seen in the acute and subchronic studies. The Agency 
believes that these three studies will be rarely required.
    iii. Developmental neurotoxicity (DNT). The Agency is proposing 
that developmental neurotoxicity testing be conditionally required for 
conventional food use and nonfood use pesticides. In implementing this 
conditional requirement, registrants are encouraged to apply what is 
known about the chemical and its toxicity to develop a rational, 
science-based approach to this testing; this is discussed in more 
detail below. A DNT would be required (Ref. 10) using a weight-of-the-
evidence approach when:
    1. The pesticide causes treatment-related neurological effects in 
adult animal studies, such as:
     Clinical signs of neurotoxicity
     Neuropathology
     Functional or behavioral effects
    2. The pesticide causes treatment-related neurological effects in

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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. The pesticide elicits a causative association between exposures 
and adverse neurological effects in human epidemiological studies
    4. The pesticide evokes 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
    In practice, EPA evaluates each pesticide using all available 
toxicological information that might indicate a need for a 
developmental neurotoxicity study. The developmental neurotoxicity 
study (guideline 870.6300) has been requested on a case-by-case basis 
for certain chemicals for food use and nonfood use registrations since 
the guideline was finalized in 1991. The Agency is proposing to 
conditionally require developmental neurotoxicity studies for all 
neurotoxic pesticides and/or when other criteria are met that indicated 
a potential for toxicity to the developing nervous system, based upon a 
weight-of-evidence evaluation of the toxicological database.
    The criteria used in this evaluation were developed through 
extensive scientific peer review, including a 1999 FIFRA SAP expert 
review (and public comment) on the use of the FQPA 10X factor in 
pesticide risk assessment (Ref. 11). The Panel concluded that these 
criteria were reasonable and useful indicators which would increase 
concern for pre-/postnatal toxicity. EPA proposes the (conditional) 
addition of the developmental neurotoxicity study to the toxicology 
testing requirements since the two developmental toxicity studies do 
not include an in-depth assessment of the development of the nervous 
system. The SAP acknowledged that the criteria were not adequate for 
identifying every potential developmental neurotoxicant, supporting the 
Agency's concern about the criteria's limitations. Accordingly, the SAP 
agreed with the Agency's approach of calling in the full range of 
neurotoxicity studies, including developmental neurotoxicity, for 
existing conventional chemistry food-use pesticides that are known 
neurotoxicants, and for all new conventional food-use pesticides.
    The prenatal developmental toxicity study (guideline 870.3700) and 
the two-generation reproduction study (guideline 870.3800), evaluate 
the potential for toxicity to offspring following pre- and/or postnatal 
exposure to a test substance. The prenatal developmental toxicity 
study, in which the maternal animals are exposed during pregnancy, is 
designed to assess fetal growth, viability, and the presence of 
structural alterations (i.e., variations and malformations that can be 
detected by careful external, visceral, and skeletal examinations of 
each fetus). The two-generation reproduction study evaluates fetal and 
pup growth and development, offspring survival, clinical observations, 
reproductive system maturation and function, and postmortem findings 
(i.e., organ weights, macro- and microscopic pathology). The 
developmental neurotoxicity study is designed to evaluate test animals 
for functional and behavioral deficiencies, as well as structural 
alterations to the nervous system, that may result from pesticide 
exposure that occurs in utero and/or during early postnatal life.
    Currently, discussions on alternative testing paradigms are 
underway by the International Life Sciences Institute (ILSI) Health and 
Environmental Sciences Institute (HESI) under the Agricultural Chemical 
Safety Assessment Technical Committee. The consensus of this effort to 
date (ILSI, 2001) (Ref. 12) is that toxicological testing should move 
away from a rigid guideline-based screening approach and towards a more 
knowledge-based approach such as is currently used for pharmaceutical 
testing (e.g., the International Committee on Harmonization, 1994). The 
Agency is in conceptual agreement with this philosophy and proposes to 
consider the basic precepts of such a toxicology testing paradigm in 
the application of the toxicology testing requirements that are used to 
support pesticide regulatory decisions (i.e., Sec.  158.500).
    Under this paradigm, both the selection of studies that would be 
required, as well as the design of the tests themselves, could be 
influenced by other substantive and reliable information about the 
pesticide. Such information could include toxicity and dose-response 
data from other guideline or non-guideline studies, structure-activity 
relationships, data on the mechanism or mode of action of the chemical, 
pharmacokinetic data, studies that examine age-related sensitivity or 
susceptibility to chemical exposure, and information on potential or 
actual exposure to humans. These data could be used to inform a more 
targeted testing approach in the design of studies or to support a 
position that the requirement for specific toxicology tests listed in 
part 158 should be waived (under the authority described in Sec.  
158.45). For example, on a chemical-by-chemical basis, the design of 
prenatal developmental toxicity and/or two-generation reproductive 
toxicity studies (both of which examine toxicological effects on 
immature animals) could be refined, or alternative tests that examine 
appropriate functional or structural endpoints would be considered. The 
proposed HESI approach to testing pesticides is anticipated to be 
published early summer 2005. Once published, the Agency would consider 
this approach and make appropriate recommendations following internal 
and external peer review.
    In the case of the developmental neurotoxicity study, 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 some chemicals, it might be concluded that 
adequate testing of the developing nervous system would be best 
accomplished with a standard developmental neurotoxicity study 
(guideline 870.6300). 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 data base 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.
    In the case of organophosphorus and n-methyl carbamate pesticides 
whose primary mode of neurotoxic action is inhibition of acetyl 
cholinesterase, a comparative cholinesterase assay could be conducted 
in lieu of the DNT given that the inhibition of cholinesterase (ChEI) 
is the most sensitive effect for these classes of chemicals. Regulation 
on a threshold (or benchmark) dose for

[[Page 12297]]

ChEI should be protective of neurotoxicity. Another example of such a 
testing scenario would be the use of a comprehensive screen of 
functional and structural thyroid perturbation (i.e., including T3, T4, 
and TSH levels) in adult and young animals, for a thyrotoxic chemical 
that has no other indications of direct nervous system toxicity. In 
such a case, it can be assumed that identification of maternal or 
offspring thyroid perturbations would signal any potential alterations 
in nervous system development, and that minimal effects on the thyroid 
would be detected at lower dose levels than would result in the types 
of frank functional, behavioral, or structural alterations that can be 
detected in the developmental neurotoxicity study. Therefore, it can be 
presumed that regulation of the chemical on the basis of threshold 
thyroid effects would be protective of any treatment-related 
alterations in neurological development that might potentially occur at 
higher doses. Alternatively, evaluation of the toxicology and exposure 
data bases for a pesticide may lead to the conclusion that there is no 
need to conduct a developmental neurotoxicity study, when there is 
reliable evidence demonstrating the lack of potential for neurotoxicity 
and/or for human exposure.
    Whenever feasible, the Agency encourages registrants to conduct 
developmental neurotoxicity studies in combination with a two-
generation reproduction study. In addition, if preliminary evidence 
indicates the need for evaluation of structural or functional toxicity 
of other organ systems in immature animals, these could also be 
examined within the context of the reproduction study. For 
developmental neurotoxicity assessment, this can be accomplished, for 
example, by utilizing the second generation (F2) offspring 
that are produced in the reproduction study to conduct the functional, 
behavioral, and neuropathological testing that is integral to the 
developmental neurotoxicity protocol. A combined reproduction/
developmental neurotoxicity protocol reduces the total number of 
animals assigned to testing (as compared to the number of animals 
required when the two studies are conducted independently), and results 
in a more efficient utilization of the animals already on test. Other 
benefits of using a combined study approach for any type of targeted 
functional testing in offspring would include the evaluation of a 
population of offspring with maximized exposure duration (i.e., that 
have been treated throughout pre- and postnatal life), greater 
assurance that steady state levels of test substance in the animals 
have been achieved prior to testing, and an evaluation of effects 
within the larger context of assessments of maternal and neonatal 
toxicity and offspring growth and development. Additionally, combined 
studies are likely to cost less and take less time, and reduce inter 
and intra-laboratory variability. The Agency invites public comment on 
all aspects of its proposed data requirements for developmental 
neurotoxicity.
    iv. Mutagenicity. A battery of mutagenic tests is currently 
required to assess the potential of the test chemical to adversely 
affect the genetic material in the cell and subsequently serve as part 
of the Agency's weight-of-the-evidence approach for classifying 
potential human carcinogens. Mutagenicity data are also used to 
evaluate potential heritable effects in humans. The Agency is proposing 
to change the specific types of tests to be performed to satisfy the 
mutagenicity testing requirement (Refs. 13, 14 and 15). Mutagenicity 
testing would no longer be subdivided into the categories of gene 
mutation, structural chromosomal aberrations, and other genotoxic 
effects, with selection from a wide range of mutagenicity tests allowed 
to satisfy these categories. A more specific initial battery of 
mutagenicity tests and relevant information would be required to 
support the registration of each pesticide product. This initial 
battery would consist of a bacterial reverse mutation assay with 
Salmonella typhimurium and Escherichia coli (guideline 870.5100), an 
assay with mammalian cells in culture (guideline 870.5300), and an in 
vivo cytogenetics assay (guidelines 870.5385 or 870.5395).
    The Agency has selected the bacterial assay because it is a primary 
test for detecting intrinsic mutagenicity of many classes of 
biologically active chemicals. The genetics of each test strain of 
Salmonella and select strains of E coli have been well-validated and 
the assay is easy to perform, is used routinely throughout the world, 
and has an extensive data base of tested chemicals. The mammalian cells 
in culture assay will detect a wider spectrum of possible genetic 
endpoints not assayed in the bacterial test. The in vivo cytogenetics 
assay provides an important examination of the potential effect a test 
compound may have on an intact mammalian system. Data from this study 
provides information on in vivo metabolism, repair capabilities, 
pharmacokinetic factors (e.g., biological half-life, absorption, 
distribution, excretion) and target organ/tissue effects.
    Since there are many different mutagenicity tests available besides 
those in the initial battery, other types of testing by the registrant 
or other investigators may have been performed in the course of product 
research and development. In addition to the initial battery, data from 
such mutagenicity tests must be submitted to the Agency, along with a 
reference list of all studies and papers known to the applicant or 
registrant concerning the mutagenicity of the test chemical. Having 
this information at the beginning of a mutagenicity assessment will 
greatly facilitate EPA's effort to provide a more accurate assessment 
of the mutagenicity of the pesticide in question.
    3. Revised data requirements--i. Acute oral and dermal toxicity. In 
addition to performing studies using the TGAI, current requirements 
give the applicant a choice of performing these studies on the end-use 
product or a diluted end-use product. However, the Agency has 
determined that studies using the end-use product (EP) provide the most 
useful data and would only require additional testing on the diluted 
form if the product met the conditions for a restricted use 
classification under Sec.  152.170(b) or special review consideration 
under Sec.  154.7(a)(1). Hence the Agency proposes to change the test 
substance to support a registration for an end-use product for these 
two studies (guidelines 870.1100 and 870.1200) to read ``TGAI, EP, and 
possibly diluted EP.'' The Agency will notify the applicant when 
additional testing using the diluted product is required. The Agency 
invites public comment on all aspects of its proposal to modify the 
current use of the TGAI to include data from the same tests using the 
EP and possibly the diluted product.
    ii. Primary eye irritation, primary dermal irritation, and dermal 
sensitization. EPA proposes to modify the existing data requirement for 
the EP to include testing with the TGAI. In order to more fully 
characterize the toxicity of the active ingredient of a pesticide, 
tests using the TGAI would now be required in addition to the test 
performed on the end-use product for these three studies (guidelines 
870.2400, 870.2500 and 870.2600) to support the end-use product. Dermal 
and eye irritation and dermal sensitization testing of the TGAI have 
not previously been required in the toxicology data requirements table 
in Sec.  158.340 for the EP. These data, however, serve to identify 
hazards from exposure to the eyes, skin, and associated mucous 
membranes to the active ingredient. The

[[Page 12298]]

Agency considers this information essential in accurately classifying 
the eye and skin irritation and the skin sensitization potential of the 
pesticide, and in determining whether any observed adverse effects are 
inherent to the active ingredient, or caused by the presence of other 
ingredients. The Agency invites public comment on all aspects of its 
proposal to modify the current use of the end-use product to include 
data from the same tests using the TGAI.
    iii. 21-day dermal and 90-day dermal. For both food and nonfood 
uses, dermal testing may be needed on the end-use product if the 
product, or any component in it, could lead to potentially toxic 
effects or could possibly increase the dermal absorption of the active 
ingredient. The Agency proposes to require a 21- to 28-day subchronic 
dermal toxicity test (guideline 870.3200) for all food use pesticides. 
This test is being changed from conditionally required to routinely 
required 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. Since not all food use applications pose worker risk, the 
requirement will be tailored to the potential for worker exposure.
    Dermal toxicity testing for nonfood uses would be required if the 
dermal route is the major route of exposure. In this latter case, a 90-
day study (guideline 870.3250) is proposed to be required, in lieu of 
the shorter, subchronic study. This proposed conditional requirement is 
necessary in order to assess potential hazards associated with dermal 
exposure. If the major route of exposure for nonfood uses is the dermal 
route, the 21- to 28-day subchronic dermal toxicity test is 
insufficient to identify potential hazards.
    iv. Carcinogenicity. The Agency proposes to change the name of the 
oncogenicity study to carcinogenicity (guideline 870.4200) to 
correspond with the name of the guideline. In addition, the Agency has 
determined that 90-day subchronic range-finding studies generally are 
needed to select appropriate doses for use in these carcinogenicity 
studies, since cancer studies with doses that are too low and do not 
cause any adverse effects can be rejected. These range-finding studies 
have been performed routinely by most investigators prior to the start 
of their cancer studies and have been submitted regularly to the Agency 
for review. Since the carcinogenicity study requires testing on rats 
and mice (which may differ in their response), the 90-day range-finding 
studies also need to include both species.
    The Agency is proposing to formalize this routine practice by 
including these studies in the part 158 data requirements. The 
requirement for the 90-day oral study (guideline 870.3100) will be 
modified to include ``two rodent species- rat and mouse preferred''. 
Both rodent species would be required for food use pesticides and 
conditionally required for nonfood uses.
    v. Reproduction. Under the current toxicology data requirements, a 
reproduction study (guideline 870.3800) is required for all food use 
pesticides, and conditionally required for nonfood use pesticides based 
on the anticipated level of exposure. The Agency proposes to amend the 
data table and require a reproduction study for nonfood uses, but 
qualify the requirement to emphasize that the requirement is based on 
potential exposure. Data on reproductive effects for a nonfood 
pesticide would be required unless there is no significant human 
exposure, as determined by the Agency, in terms of the frequency, 
magnitude, or duration of the exposure. For example, products such as 
pesticide treated fabric, diapers, or bedding; insect repellent 
lotions; or constant-release aerosols for indoor use would require 
reproductive data. This data requirement is still exposure-based and as 
such will not always be necessary.
    This change is predicated on the fact that reproductive toxicity 
testing endpoints are not assessed in any of the other required studies 
for the nonfood uses, and that these other studies do not provide 
adequate triggers which would indicate the potential for reproductive 
adverse effects.Multi-generation reproductive studies provide critical 
scientific information needed to characterize potential hazard to the 
human population during a number of sensitive life stages, e.g., during 
in utero fetal development, perinatal life, adolescence, and adulthood. 
These studies can be used to select endpoints and doses for use in risk 
assessment and are considered a primary data source for reliable 
reference dose calculations (Ref. 16).
    The need for a reproduction study in Tier 1 is bolstered by 
information developed by the Pest Management Regulatory Agency (PMRA) 
of Canada. (Ref. 17). In 1997, PMRA provided to the Agency the results 
of a preliminary study, which retrospectively evaluated reproduction 
studies as they affected risk assessment needs. The study was presented 
in the context of antimicrobial pesticides, for which a tiered 
toxicology testing scheme was being discussed. However, the results 
apply to similar tiered testing schemes across a broader spectrum of 
uses, such as what EPA is proposing for nonfood uses.
    One aspect of the PMRA study looked to determine whether a reduced 
Tier 1 set of toxicology studies (consisting of acute toxicity, 
subchronic toxicity, developmental toxicity, and mutagenicity studies, 
but not a reproduction study) would adequately identify reproductive 
endpoints or concerns for risk assessment purposes. PMRA's results are 
telling with respect to reproductive effects:
     For 67% of the evaluated chemicals (12/18) with 
reproductive endpoints of concern, the reduced Tier 1 data set would 
not have predicted reproductive effects identified in a reproduction 
study
     Reproductive effects were not limited to a particular 
class of pesticide
     Chemical structure was not useful as a predictive tool (of 
reproductive effects)
     Mutagenicity studies were not helpful (in predicting 
reproductive effects)
    EPA believes their results support the inclusion of reproduction 
studies in the Tier 1 nonfood testing regimen.
    vi. Non-rodent chronic studies. The Agency is considering 
eliminating the requirement for a 1-year dog study. Under the current 
toxicology data requirements, a 1-year non-rodent (dog) study 
(guideline 83-1) is required for all food use pesticides or for nonfood 
uses if use of the pesticide product is likely to result in repeated 
human exposure over a significant portion of the human life-span. 
Evidence in the published literature suggests that the study may not be 
needed. (Ref. 18) The Agency's impression from its reviews is 
consistent with the conclusion reached in that study. However, the 
Agency possesses a large body of dog studies submitted over the last 
three decades, and believes it appropriate to conduct a comprehensive 
and systematic analysis of those studies. EPA is in the process of 
conducting such an analysis and expects to present its preliminary 
analysis to the SAP in the spring of 2005. At that time, the analysis 
and other supporting documents would be made available for public 
review and comment. If this review confirms that the study is no longer 
needed, the Agency would in the final rule eliminate the requirement 
for the 1-year dog study. EPA specifically seeks comment on the 
possibility of eliminating the 1-year dog study.

[[Page 12299]]

D. Further Test Guideline Development

    The data base to assess pre- and post-natal toxicity varies 
depending on the nature of the chemical. Some chemicals may need 
additional data in addition to the core data set for an adequate 
evaluation of potential hazards. The following studies may be required 
on a case-by-case basis to support the registration of particular 
pesticide products and the Agency has begun developing test guidelines 
for some of these studies. As the Agency's experience with these 
studies increases and if the studies are imposed more regularly, EPA 
may propose to include them in future revisions to part 158.
     pharmacokinetics in fetuses and/or young animals
     direct dosing of neonates prior to weaning for exposure 
through the maternal route
     specialized developmental neurotoxicity of more sensitive 
sensory and/or cognitive functions
     developmental immunotoxicity
     developmental carcinogenesis
     enhanced evaluation of potential endocrine disruption.
    EPA solicits public comment on the Agency's possible request for 
such data, including the circumstances under which such data should be 
required.

XII. Nontarget Plant Protection Data Requirements (Subpart J)

A. General

    Plant protection studies are used by the Agency to evaluate the 
potential for adverse pesticidal effects to nontarget terrestrial and 
aquatic plant species. Nontarget plants include crop plants growing 
within the target or treated area (such as crop plants which are 
growing with weeds or plants which are hosts for insects and disease 
organisms), and those growing outside the target area (adjacent crop 
plants, endangered plants, and plants that are important to fish and 
wildlife for food and cover). Data from the plant protection studies 
will be used to determine if protective measures, such as precautionary 
labeling, are needed.
    Data on plant protection include short-term acute greenhouse and 
simulated or full field studies arranged in a hierarchy from basic 
tests to applied field tests. The results of each tier of tests must be 
evaluated to determine the potential of the pesticide to cause adverse 
effects, and to determine whether further testing is required. Tier I 
and II studies are short-term and relatively inexpensive. They are 
required broadly to assess a pesticide's potential to harm plants in 
the early stages of plant growth (the first 14 to 21 days). The short-
term acute greenhouse studies provide basic toxicity data which are 
used in a deterministic risk assessment screen. These data are used to 
establish acute toxicity levels of the pesticide to the test organisms; 
to compare toxicity information with measured or estimated pesticide 
residues in the environment in order to assess potential impacts on 
plants; and to indicate whether further greenhouse and/or field studies 
are needed.
    If additional, more refined, information is needed, Tier III field 
studies would be triggered. Simulated field and full field studies may 
be required when basic data and environmental conditions suggest that 
the risk exceeds the Agency's level of concern for nontarget plants and 
the information sought is necessary to adequately refine the Agency's 
assessment of risk. Data from these studies are used to estimate the 
potential for adverse effects on plant reproduction and survival, 
taking into account the measured or estimated residues in the 
environment.

B. Proposed Plant Protection Data Requirements

    EPA is not proposing major changes to the plant protection data 
requirements from those currently listed in part 158. The proposed data 
requirements are being expanded to include use patterns where the 
potential for off-target exposure via surface run-off and spray drift 
are likely, or for uses that may result in discharges to the aquatic 
environment. The seed germination study would be eliminated.
    In addition, the Agency is proposing to require independent 
laboratory validation of the environmental chemistry methods for 
terrestrial and aquatic field testing. Other changes include changes in 
test substance, conditions under which a test is required or in some 
cases, not required, and clarification of test notes. These changes are 
not expected to increase the burden of the existing data requirements.
    1. Newly imposed data requirements. None.
    2. Newly codified data requirements. None.
    3. Revised data requirements--i. Seed germination. The Agency 
proposes to eliminate the requirement for the seed germination study 
(guideline 850.4200). The information from this study would be obtained 
from the accompanying seedling emergence study (guideline 850.4100) 
which is currently required.
    ii. Seedling emergence and vegetative vigor. Currently, Tier I 
seedling emergence (guideline 850.4100) and vegetative vigor (guideline 
850.4150) studies are required for terrestrial and aquatic nonfood and 
forestry uses. Tier II tests (guidelines 850.4225 and 850.4250) are 
conditionally required for the same use patterns and are triggered by 
the results of the Tier I studies. Due to the potential for surface 
run-off or spray drift, EPA proposes to expand the seedling emergence 
and vegetative vigor data requirements to terrestrial food and feed 
crops, aquatic food crops, and residential outdoor uses. These studies 
would not be required for aquatic residential uses since limited 
exposure is expected from this use site.
    The Agency also proposes that seedling emergence and vegetative 
vigor studies be conducted using the TEP instead of the currently 
required TGAI. The TEP that contains the highest percentage of active 
ingredient, and/or is the most commonly used, would be required. TEP 
testing eliminates the need for a separate solvent control because the 
solvent is already contained in the product formulation.
    The Agency also proposes that vegetative vigor studies with 
granular or bait formulations not be required. Since the protocol for 
this study requires that the pesticide be applied directly to the plant 
surface, tests using granular or bait formulations would not be 
practical.
    iii. Aquatic plant growth (algal and aquatic vascular plant 
toxicity). Currently the Agency requires Tier I aquatic plant growth 
studies for terrestrial and aquatic nonfood and forestry uses, and 
conditionally requires Tier II studies for these same use patterns 
using five aquatic plant species (Pseudokershneria subcapitata (green 
algae), Skeletonema costatum (marine diatom), Anabaena flos-aquae 
(blue-green cyanobacteria), Navicula sp. (freshwater diatom), and Lemna 
gibba (floating vascular macrophyte)) (guidelines 850.4400 and 
850.5400). Again, due to the potential for off-target exposure via 
surface run-off and spray drift, the Agency proposes to extend this 
requirement to terrestrial food and feed crops, aquatic food crop, and 
residential outdoor uses. Tier II aquatic plant growth studies are 
proposed to be conditionally required for aquatic nonfood residential 
uses, using either the TGAI of TEP.
    iv. Terrestrial field and aquatic field. The Agency is proposing to 
extend these Tier III conditional requirements (guideline 850.4300 and 
850.4450, respectively) from terrestrial and aquatic nonfood and 
forestry uses to terrestrial food and feed crop, aquatic food crop, and 
residential outdoor uses when off-target movement appears likely (e.g., 
use

[[Page 12300]]

patterns that readily release the pesticide into the environment). 
These phytotoxicity data are needed to evaluate the level of pesticide 
exposure to non-target terrestrial and aquatic plants and to assess the 
impact of pesticides on endangered and threatened plants. The Agency is 
also proposing to require independent laboratory validation of the 
environmental chemistry methods used to generate data associated with 
these studies. Independent laboratory validation is used to ensure the 
accuracy and reproducibility of the analytical methods that were used 
to conduct field studies. For example, independent laboratory 
validations have been required for food residue methods since 1989. EPA 
instituted this requirement because analytical protocols were often 
poorly written and incomplete in terms of the descriptions of all the 
necessary steps. The Agency scientists spent excessive amounts of time 
confirming that the methods worked properly and in some cases they 
could not duplicate the results of the studies. Since the independent 
laboratory validations have been required, a higher percentage of 
methods is successfully validated by EPA scientists and less time is 
required to do so. For laboratory tests, we rely on Good Laboratory 
Practice Standards (GLP) to assure the quality and integrity of the 
data submitted to the Agency. Ensuring reproducibility and quality of 
studies used in EPA's decision-making are also key components of EPA's 
Information Quality Guidelines.

XIII. Post-application Exposure Data Requirements (Subpart K)

A. General

    While toxicology data depict the potential hazard of a pesticide, 
residue chemistry, applicator and post-application data serve to 
estimate the potential exposure to the chemical. Residue chemistry data 
(subpart O) provide EPA with dietary exposure information, applicator 
(subpart U) and post-application (subpart K) exposure data provide 
exposure data from other routes, such as dermal, inhalation, and oral.
    The post-application data requirements are being revised because 
the existing data requirements no longer meet the needs of the Agency 
to protect human health from unreasonable adverse risks in all post-
application settings. Data to determine post-application exposure are 
essential to assess the risk to people resulting from exposure to 
pesticides after they have been applied. Results from the post-
application residue studies assess the presence of pesticide residues, 
while exposure monitoring data are used to determine the quantity of 
the pesticide and any of its potentially harmful degradates or 
metabolites to which people may be exposed. These data, in conjunction 
with appropriate toxicology information, are used to determine whether 
post-application risks are of concern at residential and occupational 
sites, and to develop, when appropriate, post-application restrictions.
    The 1984 data requirements were developed to assess the risks to 
agricultural workers and others who must enter a treated field. The 
data were, and still are, required to protect these workers from 
exposures resulting from pesticide residues remaining on crops. Over 
the years, occupational safety concerns have led to the development of 
a number of state and federal programs for agricultural worker 
protection. More recently, the Agency has become increasingly concerned 
about post-application risks to persons in occupational settings other 
than conventional food, feed and fiber crop agriculture. Additional 
studies and information are needed to assess the risks to workers in 
nurseries and greenhouses, forests, golf courses, animal facilities, 
and other settings where a person may be exposed to pesticides. 
Depending on the setting and the type of application, exposure can 
result from residues on foliage (including turf grass), soil, or indoor 
surfaces.
    The proposed data requirements also are being expanded to encompass 
potential risks from other settings where people may be exposed, such 
as golf courses, recreation areas, schools, and hospitals, regardless 
of whether they are on the job or are simple bystanders. The Agency has 
long been aware of the need for exposure data in this area. Under 
current practice, post-application exposure data are generally required 
for both occupational and residential settings. Currently, post-
application exposure studies are required on a case-by-case basis when 
specific exposure and toxicity criteria triggers have been met. 
Moreover, FFDCA now mandates that EPA perform additional scientific 
analyses which have not been a routine part of the Agency's risk 
assessment process, such as the assessment of aggregate exposures from 
multiple pathways including dietary and non-dietary routes. Such 
exposures to pesticides have been associated with a significant 
proportion of reported incidents in the record.
    Residential use sites, for data requirement purposes, encompass 
more than what would normally be considered homeowner use. A 
``resident'' is a member of the general public, and ``exposure'' from a 
residential use site includes post-application exposure to anyone who, 
in the course of their daily activities, comes in contact with a 
pesticide after it has been applied. Post-application residential 
exposure to pesticides can occur in a variety of indoor and outdoor 
environments, and a vast number of different human activities can occur 
at these sites after the pesticides has been applied. Data reflecting 
new exposure patterns are required to determine whether a product may 
be used safely in and around homes, golf courses, parks, recreation 
areas, schools, hospitals, and public buildings. Numerous pesticides 
contribute to outdoor residential exposure including lawn chemicals, 
landscaping and garden products, rodent poison, and treated lumber. 
Indoor exposures can result from ant and roach killers, termite 
treatments, pet flea and tick products, and treated paint. While use of 
some products may result in intermittent exposures, use of others can 
result in people's exposure to the pesticide or its residues on a daily 
basis. In addition to acute or episodic exposures, chronic exposure to 
pesticides used in residential settings may be of concern.
    EPA's current post-application exposure data base is not 
comprehensive, especially regarding exposures to pesticides in 
nonagricultural settings. The new data that would be collected under 
the approach outlined in this proposal would allow the Agency to 
conduct improved exposure assessments for residential and occupational 
sites. In addition, such post-application studies would allow the 
Agency to assess aggregated and cumulative risks to consumers, with 
special emphasis on children. The Agency invites public comment on all 
aspects of its proposed data requirements for post-application 
exposure.

B. Criteria for Testing

    EPA proposes to revise the toxicity and exposure criteria for post-
application exposure studies. The Agency currently requires pesticide 
post-application exposure data when it determines that risks resulting 
from post-application exposures may be a concern in occupational or 
residential settings. The criteria for requiring post-application 
exposure monitoring data would be expanded to include a wider number of 
potential exposure scenarios in both occupational and non-occupational 
settings. The

[[Page 12301]]

determination of whether or not a pesticide meets these criteria would 
be made by the Agency on a case-by-case basis.
    1. Toxicity criteria. In the 1984 regulations, EPA required post-
application exposure data if the pesticide was classified as category I 
for acute dermal toxicity. EPA, however, is proposing to modify the 
toxicity criteria for requiring post-application exposure data. While 
the Agency remains concerned about pesticides that are highly toxic by 
the dermal route or that cause other significant effects by the dermal 
route, there is also strong concern about other types of toxic effects 
such as neurotoxicity, developmental effects and general systemic 
effects which are seen in oral studies, but would be relevant to any 
risk related to post-application exposure.
    EPA is proposing that the toxicity criteria be based on all aspects 
of the toxicity of the active ingredient. Post-application exposure 
data would be required, as determined by the Agency, if the active 
ingredient meets any of the following including:
     Evidence of potentially significant adverse effects have 
been observed in applicable toxicity studies,
     Scientifically sound epidemiological or poisoning incident 
data indicate that adverse health effects may have resulted from post-
application exposure to the pesticide.
    2. Exposure criteria. EPA proposes to expand the exposure criteria 
that would trigger post-application exposure studies to include 
residential settings and certain occupational settings both indoors and 
outdoors. Specifically, EPA is proposing the following exposure 
criteria. When there is potential exposure to humans from post-
application pesticide residues from any media, typically, these 
exposures fall into the following areas.
    i. For outdoor uses:
     Occupational human post-application exposure to pesticide 
residues on plants or in soil could occur as the result of cultivation, 
pruning, harvesting, mowing or other work related activity. Such plants 
include agricultural food, feed, and fiber commodities, forest trees, 
horticultural plants in commercial greenhouses or nurseries, and turf 
grass,
     Residential human post-application exposure to pesticide 
residues on plants or in soil could occur. Such plants include turf 
grass, fruits, vegetables, and ornamentals grown at sites, including, 
but not limited to, homes, parks, and recreation areas.
    ii. For indoor uses:
     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,
     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, inside homes, daycare centers, hospitals, schools, and 
other public buildings.
    The need for data from potential exposure resulting from situations 
not covered by these examples should be discussed with the Agency.

C. Proposed Post-application Exposure Data Requirements

    At a minimum, residue dissipation, exposure studies, and selected 
toxicity data are needed to assess post-application risk and determine, 
when appropriate, entry restrictions. Product use information, 
including registrant-generated or other surveys on actual use, and 
descriptions of human activity information are also used to define and 
refine post-application exposure and risk estimates.
    The dissipation of pesticide residues may occur on foliage, soil, 
or indoor surfaces. To determine dissipation rate, the Agency uses, 
depending on the use of the pesticide, dislodgeable foliar residue 
dissipation data, turf grass transferable residue dissipation data, 
soil residue dissipation data, and/or indoor surface residue 
dissipation data. To determine the level of post-application human 
exposure, EPA may use dermal exposure, inhalation exposure, and/or 
nondietary ingestion studies. In some instances, such as exposure to 
swimmers, where passive dosimetry methods are not feasible, EPA may 
require a biological monitoring study. The Agency does not believe that 
this study will be commonly required. Certain toxicity data also are 
used in conjunction with the dissipation and exposure data. Typically, 
this information is obtained through existing toxicity data 
requirements (see Unit XI of this preamble and subpart F in the 
proposed regulatory text).
    Post-application exposure monitoring data are proposed to be 
pesticide- or formulation-specific, however, surrogate exposure data 
may be submitted, if appropriate. In general, the studies required for 
estimating post-application exposure are dependent upon the pesticide 
site and use patterns, potentially exposed populations, significant 
exposure routes, and the time duration over which the exposure occurs. 
The employment of exposure mitigating measures, such as packaging or 
use restrictions, e.g., tamper-resistant bait stations, may alleviate 
the need for some or all of the data requirements in subpart K. Data 
would be required when any of the testing criteria is met. The Agency 
does not believe that ``full'' studies will be commonly required. 
Applicants are strongly encouraged to consult with the Agency to 
determine specific data requirements for their product.
    1. Newly imposed data requirements. None.
    2. Newly codified data requirements. EPA is proposing to base its 
data requirements for post-application exposure information on two 
distinct use patterns: occupational and residential. In doing so, the 
Agency proposes to expand the data requirements for post-application 
exposure data to include residential sites, nonagricultural sites, and 
agricultural sites other than conventional food, feed and fiber crop 
agriculture, which would include greenhouses, nurseries, forests, and 
animal facilities. New data requirements include indoor surface residue 
dissipation, biological monitoring data, product use and human activity 
information, nondietary ingestion exposure, and data reporting and 
calculation methodologies.
    i. Indoor surface residue dissipation. The Agency proposes to add 
the Indoor Surface Residue Dissipation study (guideline 875.2300) as a 
new post-application exposure data requirement. These data characterize 
the pesticide residues found inside buildings on surfaces such as 
flooring, carpets, upholstery, counter tops, and other treated surfaces 
after the pesticide has been used. The measurement of indoor pesticide 
residues is particularly important for characterizing exposure to 
subpopulations that may spend a large portion of their time indoors, 
such as children or the elderly. Such data will be used to determine 
whether or not a pesticide could be safely used in an indoor 
residential or occupational setting.
    ii. Biological monitoring. Biological monitoring data (guideline 
875.2600) measure the amount of chemical to which a person has been 
internally exposed. This is done by measuring pesticide and/or 
metabolite compound concentrations in selected human tissues, fluids, 
or bodily wastes (feces and/or urine). EPA proposes to conditionally 
require biological

[[Page 12302]]

monitoring studies as an alternative to passive dosimetry techniques. 
The Agency is providing this alternative because, typically, an 
exposure assessment will be performed relying on generic passive 
dosimetry data, which measures the potential dose or amount of the 
chemical on skin or in the air. However, passive dosimetry data usually 
overestimate exposure, because they only provide estimates of potential 
exposure, not measurements of absorbed dose. A biological monitoring 
study performed under the same label use conditions as the passive 
dosimetry study will provide data on the actual absorbed dose and will 
result in more accurate and refined risk assessments. Often, biological 
monitoring studies are voluntarily submitted by registrants. Again, 
both passive dosimetry studies and biological monitoring studies are 
always performed under real-world conditions and are representative of 
actual post application activities.
    In addition, the Agency proposes to allow registrants to submit 
biological monitoring data in addition to, or in lieu of, dermal or 
inhalation passive dosimetry data provided adequate pharmacokinetic 
data are available and sufficiently understood to interpret the 
results.
    iii. Product use information. EPA is proposing to require product 
use information (guideline 870.2700) for both the occupational and 
residential use patterns. Product use information will provide EPA with 
information about how the pesticide is actually used and applied. Data 
will include major use sites, typical application methods, ranges and 
typical values for application rates, timing and number of applications 
per season or per year, geographical distribution of use, use surveys, 
post-application entry restrictions, restricted-entry intervals, any 
available surveys that provide use information, and other use 
information relevant to potential exposure following a pesticide 
application. This use information will enable the Agency to conduct 
more accurate and realistic risk assessments, thus enabling the Agency 
to levy appropriate limitations on use to mitigate potential risks.
    iv. Description of human activity. In addition to use information, 
the Agency proposes a new requirement describing the possible 
activities (guideline 875.2800) in which people may be engaged after a 
site has been treated. Human activities play a crucial role in the 
nature and magnitude of exposure to pesticides. These data are also 
useful for evaluating potential differences in exposures between 
different subpopulations (i.e., adults and children), and for 
determining how specific activity patterns affect exposure levels. Data 
would include information on types of human activities associated with 
use of the pesticide, principal source(s) of exposure, conditions (if 
any) mitigating exposure, expected frequency and duration of activities 
(including hours per day and days per year), description of exposed 
population, typical clothing worn and equipment used, any available 
surveys that provide human activity information, and other relevant use 
data.
    In many cases, product use information coupled with the description 
of human activity information are used to help the Agency determine the 
most likely route(s) of exposure, whether through the skin, through the 
lungs, or through incidental ingestion.
    v. Data reporting and calculations information. EPA proposes to 
require registrants to submit data reporting and calculation 
information whenever post-application exposure data are submitted. Data 
reporting and calculations information (guideline 875.2900) is an 
important component needed to assess the validity of the studies and 
the accuracy of the exposure calculations. Minimal information that 
must be submitted includes a description of the purpose of the study 
and what requirement(s) it is intended to satisfy, a summary of the 
study, a comprehensive section on materials, methods, and calculations, 
a section interpreting the scientific results of the study, a 
discussion of quality assurance, identification of the location of the 
raw data, and any relevant references, communications, and protocols.
    vi. Nondietary ingestion exposure. The Agency proposes to 
conditionally require a nondietary ingestion exposure study (guideline 
875.3000) to evaluate the potential oral exposures to humans, 
particularly children, from pesticide residues from sources other than 
food. Nondietary ingestion exposure would be expected in residential 
settings following applications such as:
    (1) lawns (soil that contains pesticide residues);
    (2) residential plantings (pesticide-treated foliage);
    (3) outdoor surfaces (decks);
    (4) indoor surfaces (pesticide-treated paint chips);
    (5) residential fabrics (clothing, bedding, carpets);
    (6) insect and rodent baits.
    Nondietary ingestion may also occur through hand-to-mouth orobject-
to-mouth transfer of pesticide residues during activities performedby 
children (e.g., crawling) that put them in close proximity with 
treatedsurfaces.
    Studies would address such concerns as examining behavior 
patterns,monitoring the amount of soil or residue in the rinsate from 
hand-washing,and developing science-based models or formulas to 
estimate theinadvertent exposure. The results from these studies will 
be used toassess the risks associated with the incidental ingestion of 
pesticides bychildren following pesticide applications in residential 
settings. TheAgency is primarily concerned with nondietary exposures 
immediatelyfollowing application of the pesticide, therefore 
dissipation studiesalone would not provide the information needed to 
assess risks fromnondietary ingestion exposures. This study would not 
be required foroccupational uses.
    3. Revised data requirements. In addition to newly codified test 
requirements, EPA proposes to make significant changes to the existing 
post-application exposure data requirements. The use patterns requiring 
testing would be expanded from conventional food, feed, and fiber crop 
agricultural use sites to include other use sites as well. In some 
cases, the test requirement would change from ``conditionally 
required'' to ``required,'' and/or the test notes have been reworded to 
be clearer and easier to understand.
    i. Dislodgeable foliar residue dissipation and turf transferable 
residues. The Dislodgeable Foliar Residue Dissipation study (guideline 
875.2100) is currently conditionally required for evaluation of post-
application conventional food, feed, and fiber crop agricultural 
exposure. The Agency proposes to expand this requirement to include 
testing for greenhouse, nursery, forest, and residential settings and 
change it from ``conditionally required'' to `` required'' for all use 
patterns. Applicants are encouraged to consult with the Agency to 
determine their applicable data needs. Like dislodgeable foliar 
residues, turf grass transferable residues are the amount of pesticide 
residues deposited onto the leaf surface that have not been absorbed 
into the leaf or dissipated from the surface, and that can be dislodged 
from the leaf surface. Turf grass transferable residues are pesticide 
residues on the surfaces of treated lawns, sod farms, golf courses, or 
other turf grass that are available for transfer to exposed humans 
(e.g., golf course workers and golfers, adults and children at 
residences, reentry workers on sod farms) when they contact the treated 
turf surfaces. These additional tests are necessary to evaluate dermal 
exposures

[[Page 12303]]

resulting from contact with pesticide-treated plant surfaces, whether 
residential or occupational.
    ii. Soil residue dissipation. The Agency proposes to also expand 
the Soil Residue Dissipation study (guideline 875.2200) to include 
broader agricultural (greenhouse, nursery, forest) and residential 
settings. This study would be required for occupational use sites and 
conditionally required for residential use sites. Soil residue 
dissipation data are used with toxicological endpoints of concern and 
concurrent human dermal exposure monitoring data to produce 
quantitative post-application risk assessments and to determine whether 
post-application risks from contact with treated soil are of concern at 
residential and occupational sites. TBTH and methyl parathion for use 
in nut tree plantations are examples of situations in which EPA found 
that these were exposures of concern. Without this data, the Agency 
would not be able to estimate exposure in these scenarios.
    iii. Dermal and inhalation exposure. The Agency proposes to expand 
the data requirements for Dermal and Inhalation Exposure studies 
(guidelines 875.2400 and 875.2500) to include post-application exposure 
in occupational and residential (indoor and outdoor) settings. Both 
studies would be required instead of conditionally required for all use 
patterns. Currently, EPA requires dermal post-application exposure data 
when agricultural workers are expected to have contact with pesticide-
treated food, feed, or fiber crops growing outdoors. The Agency 
proposes to expand the data requirements to include persons exposed to 
pesticide residues in residential settings and in other occupational 
settings, such as greenhouses, nurseries, forests, golf courses, and 
certain indoor environments. The Agency needs post-application dermal 
and inhalation data in order to perform the residential risk 
assessments needed to fulfill the requirements of the Food Quality 
Protection Act. In addition, the original requirements were not broad 
enough to assess risks to occupational workers in greenhouses, 
nurseries, forests, golf courses, and certain indoor environments, 
where post-application exposures may be a concern. The Agency has 
imposed two major DCI's for dermal and inhalation exposure data for 
agricultural chemicals (e.g., diazinon, iprodione, and chlorsulfuron) 
and for those applied to lawns (e.g., MCPA, triadimefon, trichlorfon, 
isofenphos, and cyfluthrin).
    4. Use of surrogate data. Surrogate data are data collected for 
another pesticide that may be applicable to the pesticide under review. 
Surrogate post-application exposure data are data generated using 
comparable methods and under similar conditions, and where contact with 
the treated surfaces is likewise similar. The assumption in the use of 
surrogate data is that in many post-application scenarios, the physical 
parameters of the contact with residues on varying surfaces (e.g., 
foliage, turf grass, soil, indoor surfaces), not the chemical 
properties of the pesticide itself, are most important in determining 
the level of residue transfer from treated surfaces to people.
    At this time, EPA generally is not allowing the use of surrogate 
data for any of the post-application residue data (guidelines 875.2100, 
875.2200, 875.2300, and 875.3000). EPA encourages applicants and 
registrants to generate needed exposure data using the pesticide 
product for which the registration is sought. Surrogate data are, 
however, accepted under certain circumstances for post-application 
exposure monitoring. The Agency recognizes the need to impose exposure 
data requirements judiciously to avoid unnecessary economic burdens on 
applicants. Surrogate exposure data estimations must have adequate 
information to address post- application exposure data requirements and 
must contain adequate replicates of acceptable quality data to reflect 
the exposure of concern, such as the type of plant or indoor surface 
and the post-application activity. When the data meet these criteria, 
the residue transfer coefficients derived from surrogate studies may be 
used to assess the occupational and residential post-application 
exposure to the pesticide. When surrogate data, however, prove 
inadequate for the Agency to estimate likely exposures, applicants and 
registrants will be required to submit the data required in subpart K.
    Surrogate data may be obtained from several reliable sources. Some 
surrogate post-application data for workers in agricultural settings is 
available through the Agricultural Reentry Task Force. The task force 
has submitted to the Agency post-application exposure data. A database 
was developed that contains transfer coefficients for various 
agricultural work tasks and crops. Some surrogate post-application data 
for pesticide applications in residential settings is available through 
the Outdoor Residential Exposure Task Force. This task force submitted 
data to the Agency on post-application exposures following the use of 
different types of pesticide formulations typically found in outdoor 
residential settings.
    In addition, the Agency may accept surrogate exposure data 
estimations from other agencies, such as the National Institute of 
Occupational Safety and Health (NIOSH), the Occupational Safety and 
Health Administration (OSHA), or the OECD to satisfy post-application 
exposure data requirements, if the data meet the basic quality 
assurance, quality control, good laboratory practice, and other 
scientific requirements set by EPA. Moreover, if EPA determines that 
industrial standards, such as the workplace standards set by OSHA, 
provide adequate protection for a particular pesticide use pattern 
exposure, data may not be required for that use pattern. The Agency 
invites public comment on all aspects of its proposal regarding the use 
of surrogate exposure data.

XIV. Environmental Fate Data Requirements (Subpart N)

A. General

    Under current part 158, EPA requires a series of individual 
laboratory studies as well as field studies to assess the behavior and 
fate of a pesticide in the environment. Controlled environmental fate 
and transport laboratory studies are used to determine the persistence, 
mobility, and bioconcentration potential of a pesticide active 
ingredient and its major degradates. The studies offer information on 
how, or by what mechanism, the pesticide degrades or dissipates, the 
rate at which it degradates or dissipates, where it goes, and what 
transformation products are formed. Data from these studies are used as 
inputs to exposure models. These models estimate the expected 
environmental concentrations of the pesticide and its degradates under 
various environmental and use conditions. The laboratory studies also 
help to focus field study design by providing information on which 
transformation products are likely to be produced, and thus need to be 
tracked, and the environmental media (e.g., soil, sediment, water, air) 
that should be sampled, including the depth to which soil/sediment 
samples should be collected.
    A conceptual model (hypothesis) is developed using assumptions 
derived from the laboratory data. Since the laboratory studies are 
controlled and evaluate specific fate and transport properties 
individually (i.e., degradation, metabolism, mobility, and 
bioconcentration), they allow for the development of a conceptual model 
that includes only those fate processes and degradates that are 
``significant'' to the pesticide in question. Although

[[Page 12304]]

laboratory data are the foundation for the hypothesis and the basis for 
the conceptual model approach, field studies provide the primary 
mechanism for testing and refining the hypothesis for the environmental 
fate and transport of a pesticide. Field studies give site-specific 
information on the fate and transport of a pesticide and its degradates 
under actual use conditions.
    The field and laboratory data are integrated to characterize the 
persistence and transport of the pesticide and its degradates in the 
environment. From these data, quantitative environmental fate and 
drinking water exposure assessments are developed. Model-estimated 
environmental concentrations of the pesticide in different media under 
various pesticide application and site scenarios are calculated. These 
estimates of exposure are used in conjunction with toxicity data to 
assess whether a pesticide has the potential to cause adverse effects 
on human health and the environment, such as, wildlife, fish, and 
plants, including endangered species.
    Persistence studies assess what happens to a pesticide when it 
interacts with water, soil, air, and sunlight. Mobility studies attempt 
to predict the potential of the pesticide to volatilize into the 
atmosphere, move into ground or surface waters, or bind to soil. 
Bioconcentration studies evaluate the potential to partition to aquatic 
biota and the degree to which bioconcentration can be reversed should 
external exposure to the active ingredient or degradates be reduced or 
eliminated. These studies are designed to help characterize how a 
pesticide active ingredient dissipates once it is released into the 
environment and to identify the major degradates that may result from 
these processes.
    Degradation studies include hydrolysis, photodegradation in water, 
photodegradation in air, and photodegradation on soil. The hydrolysis 
study determines the potential of the pesticide to degrade from the 
influence of water alone. Photodegradation studies determine the 
potential to degrade in water, soil, or air when exposed to sunlight. 
During these studies, data are also collected concerning the identity, 
formation and persistence of major degradates.
    Metabolism studies include aerobic soil metabolism, anaerobic soil 
metabolism, anaerobic aquatic metabolism, and aerobic aquatic 
metabolism. The soil microbial metabolism studies determine the 
persistence of the pesticide when it interacts with soil microorganisms 
under aerobic and anaerobic conditions. The aquatic metabolism studies 
produce similar data, but are generated by pesticide interaction with 
microorganisms in a water/sediment system. These studies also identify 
the significant degradates that result from biological degradation.
    Mobility studies, which include leaching, adsorption/desorption, 
and volatility, provide information on the mode of transport and 
eventual destination of the pesticide in the environment. Scientists 
can predict the degree of pesticide mobility in soil from data 
generated from leaching and adsorption/desorption studies.
    Bioconcentration studies in aquatic organisms are used to estimate 
the potential of a pesticide, under controlled laboratory conditions, 
to partition to the organisms from respiratory and dermal exposures. 
These studies also provide information on the degree to which 
bioconcentration of a pesticide or degradate can be reversed should 
pesticide levels in the surrounding aquatic environment be reduced.
    Field studies which identify the environmental dissipation 
processes, assess the transformation, transport, and fate of a 
pesticide under actual use conditions with typically applied pesticide 
product at representative field sites. These studies characterize the 
relative importance of each route of dissipation of the pesticide and 
its major degradates. Data generated from field dissipation studies can 
provide more realistic estimates (albeit limited in time and space) of 
the persistence and transport of an active ingredient and its 
degradates when the pesticide product is applied under actual use 
conditions.

B. Proposed Environmental Fate Data Requirements

    The Agency is proposing to revise the environmental fate data 
requirements. The Agency is proposing to expand the applicable use 
pattern for the aerobic soil metabolism, terrestrial field dissipation, 
and aquatic field dissipation studies. The ground water monitoring 
study would be added as a separate requirement in the table.
    The Agency is also proposing to require independent laboratory 
validation of the environmental chemistry methods used to generate data 
associated with the dissipation studies. Two residue studies, confined 
and field rotational crops, would be moved to the residue chemistry 
data requirements (subpart O). The long-term soil field dissipation 
study would be merged with the terrestrial field dissipation study. The 
accumulation study in irrigated crops would be eliminated. Other 
changes include conditions under which the tests are required or in 
some circumstances not required, and clarification of test notes.
    1. Newly imposed data requirements--aerobic soil metabolism. The 
Agency is proposing to conditionally require this test (guideline 
835.4100) for aquatic food crop and aquatic nonfood uses in cases where 
the pesticide is applied to aquatic sites that are intermittently dry. 
Such sites include, but are not limited to cranberry bogs and rice 
paddies. EPA is proposing this change because pesticides which are 
applied to these sites are more likely to follow degradative pathways 
that resemble terrestrial rather than aquatic systems. This change was 
presented to the SAP in 1994, which endorsed the change.
    2. Newly codified data requirements--i.Terrestrial field 
dissipation. The Agency is clarifying that this requirement (guideline 
835.6100) also applies to terrestrial feed crop uses, and is proposing 
to conditionally require this study for aquatic uses involving 
application to aquatic sites that are intermittently dry. Such sites 
include, but are not limited to cranberry bogs and rice paddies. This 
change was endorsed by the SAP in 1994. While the laboratory studies 
are designed to address one dissipation process at a time, terrestrial 
field dissipation studies address pesticide loss as a combined result 
of chemical and biological processes (e.g., hydrolysis, photolysis, 
microbial transformation) and physical migration (e.g., volatilization, 
leaching, plant uptake). Pesticide dissipation may proceed at different 
rates under field conditions and may result in formation of degradates 
at levels different from those observed in laboratory studies. Data 
from these studies can reduce potential overestimation of exposure and 
risk and can confirm assumptions of low levels of toxic degradates. 
Results can be used to propose scenario-specific effective risk 
mitigation. The Agency also proposes to merge this requirement with the 
long-term field dissipation study (formerly guideline 164-5). The 
current regulations specify that the long-term field dissipation study 
is required for pesticides that do not readily dissipate in soil. The 
field dissipation study would be extended in duration for pesticides 
that are persistent so that the decline curves for the parent chemical 
and important degradates can be fully characterized. Since the expanded 
applicability only applies to uses where the cultural practice of the 
crop includes periods where the soil is deliberately kept covered with 
water

[[Page 12305]]

then dried, such as in rice or cranberries, the frequency of requesting 
this study will be quite low. The Agency is also proposing to require 
independent laboratory validation of environmental chemistry methods 
for this study to ensure the accuracy and reproducibility of the data, 
as previously discussed.
    ii. Aquatic field dissipation. EPA proposes to conditionally 
require the aquatic field dissipation study (guideline 835.6200) for 
terrestrial food crop, feed crop, and nonfood uses. The conditions for 
requiring the study would be:
    a. high persistence;
    b. high mobility;
    c. high potential to bioaccumulate;
    d. high acute toxicity to aquatic organisms;
    e. high potential for aquatic exposure.
Factors such as environmental fate properties, target crops and 
application methods which are taken into account when determining if 
the potential for aquatic exposure is high. For example, a persistent 
and mobile pesticide that is aerially applied is more likely to runoff, 
drift, and persist in surface water compared to one that degrades 
rapidly by hydrolysis and is soil incorporated. Since the expanded 
applicability only applies to uses where the cultural practice of the 
crop includes periods where the soil is deliberately kept covered with 
water then dried, such as in rice or cranberries, the frequency of 
requesting this study will be quite low. The Agency also proposes to 
require independent laboratory validation for test methods used to 
generate data associated with this study to ensure the accuracy and 
reproducibility of the data, as previously discussed.
    iii. Ground water monitoring. Ground water monitoring studies are 
designed to determine or confirm the potential of a pesticide or its 
degradates to reach ground water. The Agency proposes to add a ground 
water monitoring study (guideline 835.7100) as a conditional 
requirement for all of the terrestrial uses and for forestry uses. The 
requirement for ground water monitoring is conditional upon 
consideration of the toxicological characteristics of the pesticides 
and its potential to leach into ground water. This study would be 
triggered if the weight of the evidence of available data indicates 
that the pesticide and/or its degradates may leach into ground water. 
Ground water monitoring data may also be requested by the Agency if the 
existing data base is found to be inadequate to support decisions that 
are protective of ground water resources.
    The likelihood of a pesticide to leach to ground water is initially 
evaluated by considering the persistence and mobility of the chemical 
indicated in environmental fate laboratory studies and the field 
dissipation study required under part 158, and through use of a 
screening-level simulation model. When the potential for environmental 
risk is indicated, or cannot be evaluated definitively by this 
screening assessment, monitoring is used to evaluate the potential of a 
pesticide to contaminate ground water resources. The results of 
prospective ground water monitoring studies can provide evidence not 
available from laboratory studies that natural factors cause a 
pesticide to degrade without contamination of water resources. 
Alternatively, they can provide evidence to indicate that ground water 
contamination could result from use according to the pesticide label, 
and they can help to quantify the levels at which that can occur.
    In providing answers about the potential of a pesticide to leach 
into ground water and the magnitude of contamination under the most 
environmentally vulnerable and typical use conditions, ground water 
monitoring data give risk managers the information they need to make 
appropriate regulatory decisions. Measured concentrations of pesticides 
in ground water from prospective ground water monitoring studies are 
used as screening estimates of potential drinking water exposure for 
human dietary risk assessments. These studies are also often the best 
tool with which to estimate pesticide concentrations in drinking water 
drawn from shallow private wells. Monitoring of private drinking water 
wells is not required under the Safe Drinking Water Act, and data are 
therefore scarce for most pesticides.
    Under certain circumstances, the Agency also requires ground water 
monitoring in specified use areas in order to investigate the extent of 
ground water contamination from previous pesticide use. The use-
specific and soil-specific data from field scale monitoring studies 
also are intended to provide verification for estimates from modeling 
used to predict the impact of long-term pesticide use on water quality 
in other use areas. The results of prospective ground water monitoring 
studies have been and will be used to develop and improve models which 
allow the Agency to better evaluate the leaching potential of 
pesticides when data are scarce.
    If a pesticide is determined to have a strong potential to leach 
into ground water and in doing so, poses a risk to human health or the 
environment, the Agency intends to work with industry to develop the 
appropriate risk reduction and mitigation measures. Thus, in some 
cases, ground water monitoring would be required to confirm the 
effectiveness of these mitigation actions or any other regulatory 
measures and to elicit appropriate regulatory responses that 
effectively prevent pollution of ground water resources. The Agency 
believes that this study will be rarely required.
    The Agency is also proposing to require independent laboratory 
validation of the environmental chemistry methods used to generate data 
associated with this study. As previously discussed, this evaluation 
will be used by the Agency reviewers to verify the results of the data 
submitted.
    3. Revised data requirements--i. Hydrolysis. EPA proposes to 
clarify that the requirement for this study applies to terrestrial feed 
crop and aquatic residential uses. In addition, EPA would conditionally 
require hydrolysis testing for indoor food and nonfood uses. Hydrolysis 
testing (guideline 835.2120) may be required to support products for 
indoor food and nonfood uses for which environmental exposure is 
likely. Such use sites include, but are not limited to, agricultural 
premises, in or around farm buildings, barnyards, beehives, and fish or 
seafood processing premises. The proposed changes reflect concern about 
the potential movement of pesticides and their degradates into the 
environment.
    ii. Photodegradation in water. The Agency is clarifying the 
applicability of the photodegradation in water study (guideline 
835.2240) to reduce the frequency of the requirement, based upon the 
UV/visible absorption spectrum data submitted as part of the product 
chemistry data. (Sec.  158.310) The Agency proposes to indicate in a 
test note that data on photodegradation in water would not be required 
in cases where the electronic absorption spectra, measured at pHs 5, 7, 
and 9 of the chemical and its hydrolysis products, if any, do not show 
absorption or tailing between 290 and 800 nanometers. These testing 
parameters were announced in an Environmental Fate and Effects Division 
Policy Note in March 1992, as well as the 1993 Pesticide Reregistration 
Rejection Rate Analysis - Environmental Fate (EPA 738-R-93-010).
    iii. Photodegradation on soil. Currently, photodegradation on soil 
studies (guideline 835.2410) are conditionally required for terrestrial 
food crop and forestry uses, with the test note indicating that studies 
are not required if the use involves application to soils solely by 
injection of the product into the soil or by incorporation

[[Page 12306]]

of the product into the soil upon application. The Agency is proposing 
to change the designation of the requirement for this study from 
conditionally required for terrestrial food crop and forestry uses to 
required, expand the use patterns to include terrestrial nonfood uses, 
and retain the test note indicating when the studies will not be 
required. This change represents current practice and is in accord with 
international harmonization efforts under NAFTA.
    iv. Photodegradation in air. Data from photodegradation in air 
studies (guideline 835.2370) provide information about the potential of 
the pesticide to degrade in air when it interacts with sunlight. 
Because of the potential for exposure to highly volatile pesticides in 
greenhouses, residential, and certain outdoor settings, EPA is 
proposing to expand the requirement from terrestrial food crop to 
terrestrial feed crop and nonfood, greenhouse food crop and nonfood, 
forestry, and residential outdoor uses on a conditional basis. This 
requirement is based on use patterns and other pertinent factors 
including but not limited to Henry's law constant (the solubility of a 
gas is directly proportional to the partial pressure exerted by the 
gas). In combination with volatility studies, this information is 
needed to develop a profile of the pesticide in the atmosphere. In view 
of methodological difficulties with the study, including, but not 
limited to, wall effects, the test note has been amended to recommend 
consultation with the Agency before tests are performed.
    v. Anaerobic aquatic metabolism. EPA proposes to require this study 
(guideline 835.4400) for terrestrial food crop, feed crop, and 
terrestrial nonfood uses where the pesticide is likely to move from the 
site of application to nearby aquatic systems. Anaerobic aquatic 
metabolism studies measure the formation of pesticide residues in water 
and hydrosoil under anaerobic or oxygen-poor conditions. 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 use 
patterns.
    vi. Aerobic aquatic metabolism. The Agency is clarifying that this 
requirement (guideline 835.4300) applies to aquatic residential uses, 
and is proposing to expand this requirement to include terrestrial food 
crop, feed crop, and nonfood, and forestry uses. Aerobic aquatic 
metabolism studies measure the formation of pesticide residues under 
aerobic or oxygen-rich conditions in water or sediment while the 
pesticide is dispersed in aquatic environments. 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 use patterns.
    Note also that the Agency is reasserting that Anaerobic Soil 
Metabolism studies (guideline 835.4200) are required for terrestrial 
food crop, feed crop, and terrestrial nonfood uses. Due to a printing 
error, this data requirement was inadvertently omitted from the data 
tables in 1991 and subsequent publications of the CFR. This action 
would restore the data requirement in the table. The scope and nature 
of the requirement would not change.
    vii. Forestry field dissipation. EPA is proposing to change the 
status of the forestry dissipation study (guideline 835.6300) from 
required to conditionally required. Forestry use patterns are broad in 
scope, range from the application of pesticides to individual trees, to 
aerial applications covering very large areas, and may apply to tree 
farms or reforestation efforts. As a result, it is difficult to 
extrapolate data from tests in particular forestry systems to other 
forests of regulatory interest. Therefore, this study would need to be 
tailored to address exposures of concern for particular uses. When the 
Agency determines that a study is needed, a suggested protocol would 
need to be submitted and approved by the Agency prior to initiation of 
the study. The Agency believes that this study will be rarely required. 
The Agency also proposes to require independent laboratory validation 
for test methods used to generate data associated with this study to 
ensure the accuracy and reproducibility of the data, as previously 
discussed.
    viii. Accumulation in fish. EPA is proposing minor clarifications 
to this study requirement (guideline 850.1730). As such, the revised 
data tables would indicate that this conditional requirement applies to 
terrestrial feed crop and aquatic residential uses. Further, the Agency 
proposes to indicate in the test note that studies are required unless:
    a. The octanol/water partition coefficients of the pesticide/major 
degradates are less than 1,000 (indicative of a relatively low 
potential for accumulation in fish),
    b. There are no potential exposures to fish and other nontarget 
aquatic organisms, or
    c. The hydrolytic half-life is less than 5 days at pH 5, 7, and 9.
    ix. Accumulation in aquatic nontarget organisms. EPA is proposing 
to expand the conditional requirement for a nontarget aquatic organism 
accumulation study to terrestrial food crop, feed crop, and nonfood 
uses; and aquatic food and aquatic nonfood residential uses (guideline 
850.1950). The study would be triggered if significant concentrations 
of the active ingredient and/or its principal degradation products are 
likely to occur in aquatic environments and may potentially accumulate 
in aquatic organisms. The Agency proposes to require this study in 
situations involving direct application of the pesticide to aquatic 
systems, from various terrestrial sites where run-off or other movement 
of the pesticide into nearby aquatic systems is likely, or in 
intercropping situations involving aquatic animal species and 
traditional aquatic plant crops, e.g., crayfish and rice. The Agency 
believes that this study will be rarely required.
    x. Confined and field rotational crops. Because the presence of 
residues in rotational crops is primarily a dietary risk concern, the 
Agency proposes to move the data requirements for confined and field 
rotational crops (guidelines 860.1850 and 860.1900) from environmental 
fate data requirements to residue chemistry data requirements (subpart 
O).
    xi. Accumulation studies in irrigated crops. The Agency proposes to 
eliminate the environmental fate requirement for the accumulation 
studies in irrigated crops (formerly guideline 165- 3). Pesticide 
residue data and information to address the potential for pesticides to 
be present in crops irrigated with treated water may be obtained from 
the Magnitude of the Residue in Irrigated Crops study (guideline 
860.1540) in subpart O.

XV. Residue Chemistry Data Requirements (Subpart O)

A. General

    Residue chemistry data are used by the Agency to estimate people's 
dietary exposure to pesticide residues from food. The residue chemistry 
data base is designed to determine the composition of the pesticide 
residue and how much of that residue is present in the food people eat. 
Residue chemistry studies include those which define the nature of the 
residue, i.e., metabolism studies, and those which measure how much of

[[Page 12307]]

the residue of concern is present in food, feed, and water, i.e., 
magnitude of the residue studies. Most food use pesticides require both 
types of studies. Both plant and livestock metabolism studies are 
needed to determine the breakdown of the pesticide in a living system, 
that is, whether the parent compound stays intact or is converted into 
metabolites. Occasionally, the metabolites are toxic and, as such, are 
included in the analyses as a residue of concern. Magnitude of the 
residue studies, also called residue field trials, are done for all 
foods, such as, fruit and vegetable crops, processed foods, meat and 
poultry products (including milk and eggs), potable water, fish, and 
other instances where food may be exposed to pesticide treatment.
    In addition to dietary risk assessments, residue chemistry data are 
used to establish pesticide tolerances which, in turn, are used for 
enforcement purposes (see Unit XV.B. below). Therefore, methods for 
detecting the presence and amount of the residue are needed. Detection 
methods are used by EPA for study validation purposes, and by FDA, 
USDA, and the states for food inspection purposes.
    EPA is proposing changes to the residue chemistry data requirements 
to better estimate dietary exposure to pesticide residues in or on food 
or feed, to more accurately assess and reassess tolerances and 
tolerance exemptions, and to provide additional tools for the 
enforcement of pesticide residue tolerances to ensure that food 
entering the commercial market meets the ``reasonable certainty of no 
harm'' standard under FFDCA. The Agency is proposing to codify data 
needs that have evolved since the 1984 regulations were issued, and 
clarify and simplify existing data requirements.

B. Tolerances

    1. Residue chemistry data. Residue chemistry data are used to 
assess human dietary exposure and establish tolerances (or tolerance 
exemptions) for pesticide residues present in food and feed. Pesticide 
tolerances are listed in 40 CFR part 180. Tolerances are used primarily 
for enforcement purposes and represent the maximum legal amount of 
pesticide residue allowed in or on food or animal feed in interstate 
commerce. Results from data generated from crop field trials are used 
to set the tolerance for that particular crop. A tolerance or exemption 
from tolerance must be established for a pesticide to be registered 
under FIFRA for uses on the food or feed, and for food or feed bearing 
pesticide residues to be imported into the United States. Wherever 
possible, EPA tries to harmonize its tolerances with Maximum Residue 
Levels (MRLs) established by other countries.
    2. Import tolerances. In cases where a pesticide is not registered 
in the United States, interested persons may submit a petition 
requesting that EPA establish a tolerance or tolerance exemption for 
residues of a pesticide in or on a commodity to allow that treated 
commodity to be legally imported. These tolerances, called import 
tolerances, can be established for any food or feed commodity, but are 
usually established for foods grown outside the United States and its 
territories, such as bananas or coffee. For new tolerances with no 
accompanying U.S. registration, part 158 will require that tolerance 
petitioners provide the information and/or data necessary to make the 
required safety finding under FFDCA. While there is generally no 
distinction in data requirements between an import tolerance and any 
other tolerance issued by EPA, some important differences occur in the 
way data is generated. This usually includes residue data 
representative of the pesticide's use in the exporting country. EPA 
issued proposed guidance for registrants of import tolerances in June 
2000 (65 FR 35069). EPA expects to issue its final guidance on import 
tolerances in the near future.

C. Proposed Residue Chemistry Data Requirements

    The residue chemistry data table has been modified to include 
general use patterns that include food uses, plus the residential 
outdoor use pattern. EPA is not proposing significant changes to the 
residue chemistry data requirements from those currently listed in part 
158. Two data requirements would be added as separate requirements in 
the data table. These data (storage stability and multiresidue methods) 
have been imposed by the Agency on a case-by-case basis. The Reduction 
In Residue study is now called ``anticipated residues;'' a longstanding 
independent method validation is being proposed; and two residue 
studies, confined and field rotational crops, which were formerly 
environmental fate data requirements, would be moved to the residue 
chemistry data requirements. Other changes include changes in test 
substance, conditions under which the test is required, and 
clarification of test notes. These are not expected to substantively 
increase the nature or burden of the existing data requirement.
    1. Newly imposed data requirements. None.
    2. Newly codified data requirements--i. Storage stability. The 
Agency proposes to add a storage stability study (guideline 860.1380) 
as an explicit requirement to validate the Magnitude of the Residue 
studies. Magnitude of the residue studies address how levels of 
pesticide residues in samples of human foods and livestock feeds are 
determined. These samples are often stored for extended periods of time 
prior to analysis. Since tolerances are based on residues at the time 
of harvest (or sample collection) and the residues may be lost by 
processes such as degradation and volatilization during storage prior 
to analysis, storage stability data depicting the presence of residues 
during this period are critical to validation of the results of the 
field trial studies. Such data have been required previously as a part 
of the magnitude of the residue studies, but will now be codified as a 
separate requirement in the data tables.
    ii. Multiresidue methods. The Agency also proposes to codify a 
multiresidue methods study (guideline 860.1360) as a separate 
requirement. Multiresidue methodology data are currently part of the 
residue analytical method requirement. These data are important in 
designing pesticide monitoring and enforcement programs, and as such, 
multiresidue methodology data is being proposed as a separate 
requirement. In food monitoring programs, it is not practical or 
feasible to test for individual pesticides. Since the residue 
analytical method requirement is intended to refer to a method that is 
specific for one pesticide (sometimes called a ``single residue 
method'') and the multiresidue procedures currently used are designed 
to measure as many pesticides as possible, it is clearer to list these 
as two separate data requirements. The Agency will amend the test note 
to stress that any analytical methodology must be evaluated for its 
ability to detect metabolites included in the tolerance expression.
    3. Revised data requirements--i.  Nature of the residue in 
livestock. Also called an animal metabolism study, EPA is proposing 
several small changes to the Nature of the Residue in Livestock Study 
(guideline 860.1300). First, the Agency proposes to require livestock 
metabolism studies whenever a pesticide is applied to crops used for 
livestock feed and would indicate this change in the test note for this 
study. In 1984, livestock metabolism studies were conditionally 
required and were triggered by the presence of residues in the 
livestock feed. The Agency changed its policy in July 1989 and now 
proposes to incorporate it by regulation. The data provides essential 
information

[[Page 12308]]

on the potential transfer and bioconcentration of residues in meat and 
milk for all pesticides applied to feed items. Therefore, in cases 
where pesticide misuse results in residues on feed items not expected 
to have residues from approved uses, the Agency will have data from 
which to estimate the potential residues in the affected animal 
commodities.
    The Agency is also proposing to change the test substance for this 
study from the pure active ingredient, radio-labeled (PAIRA) ``and 
plant metabolites'' to the PAIRA ``or plant metabolite.'' The test 
substance ``metabolites'' will be changed to ``metabolite'' to prevent 
dosing with more than one compound in any one study. This is needed 
because in studies involving simultaneous dosing with both the active 
ingredient and plant metabolites, it is impossible to determine the 
amount of metabolite due to active metabolism from that introduced 
through dosing. Simultaneous dosing with the active ingredient and any 
metabolites may not produce useful results, because the active 
ingredient and metabolites may have different metabolic pathways that 
cannot be differentiated. In most cases dosing with only the parent 
compound is necessary. However, in cases where plant and animal 
metabolites are found to differ, a separate study in which livestock 
are dosed with a unique plant metabolite may also be required.
    The livestock metabolism study would be required when a pesticide 
is applied to livestock premises or is used in livestock drinking 
water. Such applications may result in both oral and dermal exposure of 
animals to the pesticide and, depending on the results, may precipitate 
magnitude of the residue studies to quantify the residues in meat, 
milk, poultry, and eggs. Finally, the Agency proposes to delete the 
conditional requirement for the nature of the residue in livestock 
study for residential outdoor uses since livestock are not found in 
this use pattern.
    ii. Residue analytical methods. Residue analytical methods are used 
to validate the residue field trial studies in plant and animal 
commodities and as a means of enforcement of established tolerances. 
The Agency proposes to change the test substance for residue analytical 
methods (guideline 860.1340) from the ``TGAI and metabolites'' to the 
``residue of concern.'' This will focus the study on only those 
chemicals with potential toxicity, typically the pure active ingredient 
and other compounds of concern (i.e., metabolites and degradates), and 
not on the other components of the TGAI.
    As part of this data requirement, the Agency is also proposing to 
require an independent laboratory validation of residue analytical 
methods to ensure the accuracy and reproducibility of data used for 
tolerance enforcement purposes. As previously discussed, this policy 
has been in place since 1988.
    iii. Magnitude of the residue in processed food and feed. The 
Agency proposes to change the test substance for processing studies 
(guideline 860.1520) from an end-use product (EP) to a ``typical'' end-
use product (TEP). A processing study is needed for only one 
representative end-use product proposed for use on a given commodity or 
site. For a given active ingredient, the Agency believes that, in 
general, variations of the formulation will not affect the behavior of 
the active ingredient with respect to processing a raw agricultural 
commodity bearing residues of that chemical. This change would codify a 
longstanding practice in EPA.
    iv. Magnitude of the residue in meat, milk, poultry, and eggs. In 
line with the livestock metabolism study, the Agency proposes to change 
the test substance for the meat/milk/poultry/egg study (guideline 
860.1480). Due to the difficulties in interpreting results of studies 
in which a mixture is fed, the Agency is currently discouraging the 
feeding of mixtures and is instead requesting the feeding of isolated 
compounds in livestock studies. Hence, the test substance will be 
changed to read a single plant metabolite instead of metabolites in the 
plural. Provided that plant and animal metabolites are the same, the 
parent compound must be the test substance in livestock feeding 
studies. If any plant metabolite exists that is not also an animal 
metabolite, a separate feeding study may be required involving dosing 
with that unique plant metabolite. The Agency will inform the applicant 
when this additional testing is required. It is rare that this study is 
requested.
    Unlike the livestock metabolism studies, however, livestock feeding 
studies are generally not required when residues are not demonstrated 
to be present in the feed. The Agency proposes to clarify that data 
generally are not required when:
    1. Residues are not found on feed items or
    2. Livestock metabolism studies indicate minimal transfer of the 
pesticide residue to tissues, milk or eggs. For those pesticides which 
leave non-detectable or low residues in feed items and for which the 
livestock metabolism study shows little transfer of radioactivity to 
tissues, the Agency may be able to conclude that data on the level of 
residues in livestock and their byproducts are not necessary.
    v. Magnitude of the residue in potable water, fish, and irrigated 
crops. Like the study for processed food and feed commodities, the 
Agency proposes to change the test substance from an EP to a TEP to 
determine pesticide residues in potable water, fish, and irrigated 
crops (guideline 860.1400). Residue data are needed for only one 
representative end-use product of each formulation type proposed for 
use on a given commodity or site. For each formulation type for a given 
active ingredient, the Agency believes that, in general, variations of 
the formulation will not affect the behavior of the active ingredient.
    vi. Anticipated residues. The Agency proposes to change the title 
of the Reduction of Residue study to Anticipated Residues. The new 
title emphasizes the Agency's intent to use, where appropriate and 
feasible, data showing the actual residues in food as consumed, as 
opposed to residues in crops at harvest. For example, market basket 
surveys can be one way of generating better dietary exposure estimates. 
The Agency also proposes to indicate in the test note that alternative 
data, such as market basket surveys, may be required.
    The Agency also proposes to add a test note to this study to 
address the need for residue data on acutely toxic pesticides in single 
servings of raw agricultural commodities. Most residue data provided to 
the Agency are based on composited samples. For example, 20 apples 
collected from different trees may be blended together prior to 
determining the pesticide residues. This procedure is adequate for 
estimating dietary risk from pesticides whose toxic effects arise from 
exposure over a long time period; however, data on composited samples 
may not be adequate for assessing acute risk from ingestion of single 
servings of a raw agricultural commodity bearing pesticide residues 
(e.g., one apple). This proposed analysis of single serving sizes will 
allow the Agency to more accurately assess acute dietary risks. This 
additional study would be required only where commodities are consumed 
in single serving amounts. Historically, the Agency has only asked for 
this study once. EPA expects that the utility of this study would be 
for old chemicals with risk concerns. However, for newer chemicals 
(e.g., reduced risk chemicals) which are the focus of these data 
requirements, this requirement would rarely be invoked.
    vii. Confined and field rotational crops. Because the presence of 
residues

[[Page 12309]]

in rotational crops is primarily a dietary risk concern, the Agency 
proposes to move the data requirements for confined and field 
rotational crops (guidelines 860.1850 and 860.1900) from an 
environmental fate requirement (subpart N) to subpart O. The Agency 
also proposes to revise the test note addressing the requirement for 
the Field Rotational Crop study. Currently, a Field Rotational Crop 
study is required when significant pesticide residues are found in the 
soil at the time of planting. The use of soil residues alone to predict 
crop residues does not take into account the metabolites of chemicals 
in the soil and the differing abilities of plants to take up such 
residues. Since the confined study involves the actual measurement of 
residues in rotational crops under worst-case conditions, the Agency 
believes that it is more appropriate to use the results of the Confined 
Rotational Crop study as a screen for potential residues in crops grown 
under field conditions and the footnote for the field study will be 
revised to reflect this approach.

XVI. Applicator Exposure Data Requirements (Subpart U)

A. General

    Individuals who handle pesticides are subject to potential risks 
stemming from pesticide exposure. Because of this, exposure data 
tailored specifically to address pesticide handlers are crucial. 
Pesticide handlers (i.e., applicators) are persons who mix, load, 
apply, or otherwise come into contact with pesticides during the 
application process. An applicator can be a professional or a 
homeowner. The risks to applicators is evaluated based upon the results 
of the toxicity and human exposure studies. Monitoring data are used to 
quantify the exposure. The proposed data requirements for applicator 
exposure would allow the Agency to conduct improved exposure 
assessments for those who handle pesticides.
    The current data requirements in part 158 do not contain studies to 
determine applicator exposure from pesticide use. The Agency, however, 
has long been aware of the necessity for applicator data to assess the 
risks from handling pesticides and has frequently asked for such data. 
In 1987, the Agency published guidelines for such studies. Since that 
time, applicator exposure studies have been requested when specific 
exposure and toxicity criteria triggers were met. Since EPA believes 
these data are essential for fulfilling its mandate to protect human 
health from pesticide risk, including aggregated and cumulative risks, 
it is proposing to make the applicator exposure studies a standard part 
of its regulatory data requirements.
    EPA proposes to codify requirements for application exposure data 
in part 158 as a new subpart U. The purpose of codifying these data 
requirements is to assist pesticide registrants and others in 
determining which studies are required, and aid them in designing and 
conducting field studies that measure potential dermal and respiratory 
exposure to pesticides during handling activities. These test 
requirements cover exposure monitoring studies for people involved in 
mixing, loading, and applying pesticides; flagging during aerial 
applications; and other tasks, such as cleaning of equipment and spill 
cleanup that result in direct contact with pesticides. The requirements 
cover not only agricultural applicators, but other occupational 
applicators and residential applicators as well.

B. Criteria for Testing

    The Agency proposes to establish toxicity and exposure criteria for 
applicator exposure studies. These criteria are based on the toxicity 
of the active ingredient and the proposed exposure pattern of the 
product.
    1. Toxicity criteria. EPA proposes that applicator exposure data be 
required for occupational and residential exposures for pesticide 
active ingredients that indicate potential adverse effects from 
toxicity studies, such as developmental toxicity, carcinogenicity, 
neurotoxicity, reproductive toxicity, immunotoxicity, 90-day oral 
toxicity, 21-day dermal toxicity, 90-day inhalation toxicity, and 
chronic feeding.
    Specifically, EPA is proposing that the toxicity criteria be based 
on the toxicity of the active ingredient. Applicator exposure 
monitoring data would be required, as determined by the Agency, if the 
active ingredient meets any of the following criteria:
    i. Evidence of potentially significant adverse effects have been 
observed in applicable toxicity studies. For example, toxicity studies 
may indicate that the active ingredient is a possible or likely human 
carcinogen and that carcinogenic risk can be assessed using a linear 
extrapolation approach with a Q1*. Or, toxicity studies may 
indicate that the active ingredient may cause developmental, 
neurotoxic, reproductive, or immunotoxic effects or may inhibit 
cholinesterase and establish a toxicological endpoint of concern that 
can be used to assess risks to applicators and other handlers.
    ii. Scientifically sound epidemiological or poisoning incident data 
indicate that adverse health effects may have resulted from handling of 
the pesticide. For example, EPA reviews data in the:
    a. Office of Pesticide Programs Incident Data System reports of 
incidents from various sources, including registrants, other federal 
and state health and environmental agencies and individual consumers);
    b. Toxic Exposure Surveillance System (a national data collection 
system of Poison Control Center data);
    c. National Pesticide Information Center database (NPIC is a toll-
free information service supported by the Office of Pesticide Programs 
that fields calls about human and animal incidents); and
    d. California Department of Pesticide Regulation exposure incident 
database. California physicians are required, by statute, to report to 
their local health officer all occurrences of illness suspected of 
being related to exposure to pesticides. The majority of the incidents 
involve workers. CDPR has collected uniform data on suspected pesticide 
poisonings since 1982.
    2. Exposure criteria. EPA proposes to establish exposure criteria 
that would trigger applicator exposure studies. In determining what 
studies are required, EPA considers the product's use patterns, use 
surveys, application methods, whether the product is for indoor or 
outdoor use, whether the exposure is expected to be occupational or 
residential, the duration of the exposure (i.e., short-term, 
intermediate-term, or long-term), whether sensitive subpopulations 
might be exposed, and other criteria. Applicator exposure monitoring 
studies would be required if either dermal or respiratory exposure is 
likely to occur during the prescribed use. Applicants are strongly 
encouraged to consult with the Agency to determine applicable data 
needs.
    Specifically, EPA is proposing the following exposure criteria. 
Data would be required, as determined by the Agency, if either of the 
following conditions is met:
    i. Dermal exposure is likely to occur when used as directed on the 
label,
    ii. Respiratory exposure is likely to occur when used as directed 
on the label.
    Because these exposure scenarios are covered under the broad 
categories of occupational and residential, the table in Sec.  158.1520 
lists only these two use patterns.
    The Agency may also require data when exposure is likely, when the 
pesticide is used in a commonly recognized and widespread manner. Thus, 
if the Agency knows that a

[[Page 12309]]

particular product or class of products is frequently used in a manner 
that isn't directed on the label, the Agency can still require data.

C. Proposed Applicator Exposure Data Requirements

    1. Newly imposed data requirements. None.
    2. Newly codified data requirements. EPA is proposing seven 
separate data elements for applicator exposure data.
    i. Dermal exposure studies. The Agency proposes to add data 
requirements for both outdoor and indoor dermal exposure studies 
(guidelines 875.1100 and 875.1200) in order to estimate the dermal 
exposure to persons directly handling pesticides. Dermal exposures can 
and do occur at levels that can cause adverse effects. Dermal 
applicator exposure studies employ passive dosimetry techniques which 
estimate the amount of a chemical impinging on the surface of the skin. 
The amount of pesticide potentially available for absorption through 
the skin can be estimated by trapping the material before it contacts 
the skin or by removing the material that has contacted the skin before 
it has been absorbed.
    ii Inhalation exposure studies. To estimate occupational and 
residential human post-application inhalation exposure to pesticide 
residues, the Agency proposes to add data requirements for both outdoor 
and indoor inhalation exposure studies (guidelines 875.1300 and 
875.1400). Inhalation exposures can and do occur at levels that can 
cause adverse effects. Protocols must be submitted for approval prior 
to initiation of the study. Details for developing protocols are 
available from the Agency.
    iii. Biological monitoring. Data from biological monitoring studies 
(guideline 875.1500) provide the Agency with estimates of the internal 
dose or amount of a pesticide in the body. EPA proposes to allow the 
submission of biological monitoring data in addition to, or in lieu of, 
dermal or inhalation exposure data provided the human pharmacokinetics 
of the pesticide residue is sufficiently understood to permit the back 
calculation to determine the total internal dose. Biological monitoring 
offers the advantage of assessing the internal dose, as opposed to the 
exposure or amount of chemical coming in contact with the surface of 
the skin or available for inhalation in the lungs as measured using 
passive dosimetry techniques. Biological monitoring is being proposed 
as a conditional requirement.
    iv. Data reporting and calculations information. EPA proposes to 
require registrants to submit data reporting and calculation 
information (guideline 875.1600) whenever handler exposure data are 
submitted. Data reporting and calculations information is important 
because it allows EPA to assess the quality of an applicator exposure 
study and the accuracy of the exposure calculations derived from the 
study. Information that must be submitted includes a description of the 
purpose of the study and what requirement(s) it is intended to satisfy, 
a summary of the study, a comprehensive section on materials, methods, 
and calculations, a section interpreting the scientific results of the 
study, a discussion of quality assurance, identification of the 
location of the raw data, and any references, communications, and 
protocols relevant to the conduct of the study.
    v. Product use information. EPA is proposing to require product use 
information (guideline 875.1700) for both the occupational and 
residential use patterns. Product use information assists EPA to more 
accurately assess pesticide exposure to applicators by describing how 
the pesticide is actually used and applied in occupational and 
residential settings. EPA requires this information because differences 
in use can translate to significant differences in exposure, and thus 
risk. The required information is to encompass a description of the 
application of the pesticide and include the range and typical values 
for: Application rates; amount of formulated product or active 
ingredient handled per day and per year or season; acreage or area 
treated per day and per year or season; timing of and number of 
treatments per year or season for private and commercial handlers; 
exposure time per activity; types of handling equipment used, 
geographical distribution of usage; any available surveys that provide 
use information, and other relevant use data.
    3. Use of surrogate data. To support the registration of a 
pesticide product, EPA encourages applicants and registrants to 
generate needed exposure data with the particular pesticide product. 
However, the Agency recognizes the need to impose exposure data 
requirements judiciously to minimize the economic burdens on 
applicants, and at the same time, obtain sufficient data and 
information for exposure and risk assessments. Therefore, whenever 
possible, surrogate data will be used to assess the occupational and 
residential exposure to pesticides. Because the Agency does not 
commonly require these studies and because surrogate data is often 
available, the Agency does not expect that ``full'' studies will often 
be needed. However, when surrogate data prove inadequate for the Agency 
to estimate likely exposures, applicants and registrants would be 
required to submit the additional data proposed in subpart U.
    Surrogate applicator exposure data may adequately satisfy these 
data requirements under certain circumstances. Surrogate applicator 
data must be generated using comparable methods and under similar usage 
conditions as the product under review. Surrogate exposure data 
estimations must have adequate information to address handler exposure 
data requirements and must contain adequate replicates of acceptable 
quality data to reflect the specific use prescribed by the label, 
including formulation type, application equipment, methods and rates, 
personal protective equipment, engineering controls and other pertinent 
use directions or restrictions.
    Surrogate data may be obtained from several reliable sources. For 
many years, the Agency has been expanding its Pesticide Handlers 
Exposure Database (PHED) which provides surrogate data for a wide 
variety of handler exposure scenarios. PHED is a generic database 
containing measured exposure data for persons involved in the handling 
or application of pesticides in the field and contains data for over 
2000 monitored exposure events. Users can select data from each major 
PHED file (e.g., mixer/loader, applicator, flagger, or mixer/loader/
applicator) and construct exposure scenarios that are representative of 
the use of the chemical. Although the PHED database was originally 
developed for the agricultural workplace, it now contains information 
that is applicable to other pesticide use scenarios, including 
residential settings. In general, PHED is not appropriate for assessing 
highly volatile or gaseous pesticides (e.g., fumigants). EPA, Health 
Canada, pesticide registrants, and other interested entities are 
participating in a task force to update, refine, and expand the handler 
exposure database.
    Some surrogate data for outdoor pesticide applications in 
residential settings (occupational and residential handlers) also is 
available through the Outdoor Residential Exposure Task Force. The Task 
Force has submitted data to the Agency on mixer, loader, and applicator 
exposures during use of several types of equipment typically found in 
residential settings. The Agency may accept surrogate exposure data 
estimations from NIOSH, OSHA,

[[Page 12310]]

and OECD to satisfy handler exposure data requirements, if the data 
meet the basic quality assurance, quality control, good laboratory 
practice, and other scientific requirements set by EPA. Moreover, if 
EPA determines that industrial standards, such as the workplace 
standards set by OSHA, provide adequate protection under the standard 
set by FIFRA for a particular pesticide use pattern, applicator 
exposure data may not be required for that use pattern.

XVII. Data Requirements Not Affected by this Proposal

    EPA is proposing today a major restructuring of current part 158 
for clarity and comprehensibility, but is not proposing substantive 
revisions to all portions of current part 158. Several specific 
sections of part 158 may be revised in the future, including the 
following:
     Section 158.440 Spray drift data requirements
     Section 158.640 Product performance data requirements
     Section 158.690 Biochemical pesticide data requirements
     Section 158.740 Microbial pesticide data requirements
    In addition, the Agency intends later to propose other changes to 
current part 158, including the creation of separate subparts to 
address data requirements for the registration of antimicrobial 
pesticide products and biochemical and microbial pesticide products.
    In order to accommodate the restructuring of part 158 without 
creating confusion for readers of this proposal, EPA proposes to revise 
the Table of Contents for part 158 to include the future subpart 
designations for these sections, and to add and reserve the appropriate 
subparts in the revised part 158. The regulatory text of the sections 
for which no change is proposed is not reprinted in this proposal, and 
EPA is not requesting comment on any aspect of those unchanged data 
requirements.
    If EPA does not issue these other proposals before this proposal is 
issued in final form, EPA will transfer the contents of the current 
part 158 that are not specifically addressed in this proposal into 
their new subparts, essentially unchanged. This step will be necessary 
because at that time subpart D which currently contains the sections 
will be redesignated to contain only product chemistry data 
requirements.
    At the same time, EPA expects to make needed technical revisions to 
accommodate the new structure of part 158, without changing the 
substance of the data requirements. For example, section numbers will 
be assigned within the new subpart; cross-references will be updated; 
and footnotes will be restructured as test notes and given Arabic 
numerals, e.g., footnote (iv) would become test note (4). EPA believes 
these minor technical revisions can be accommodated within the final 
rule without specific proposal at this time.

XVIII. Peer Review

A. National Research Council Recommendations

    In 1988, Congress directed the National Academy of Sciences to 
study the vulnerability of infants and children to dietary pesticides. 
The National Research Council was charged with ``examining scientific 
and policy issues faced by government agencies, particularly EPA, in 
regulating pesticide residues in foods consumed by infants and 
children.'' In so doing, the NRC was asked to:
     Examine the adequacy of current risk assessment policies 
and methods;
     Assess information on the dietary intakes of infants and 
children;
     Evaluate data on pesticide residues in the food supply;
     Identify toxicological issues; and
     Develop relevant research priorities.
    The Council reviewed current EPA practices and data requirements 
related to dietary risk assessment as well as testing modifications 
planned by the Agency. In 1993, the NRC issued a report (Ref. 1) 
entitled, ``Pesticides in the Diets of Infants and Children.'' The 
panel of experts concluded that, at that time, EPA approaches to data 
requirements and risk assessments emphasized the evaluation of the 
effects of pesticides in mature animals and, in general, there was a 
lack of data on pesticide toxicity in developing organisms.
    The Council was not specifically charged with evaluating the data 
requirements as proposed today. Nonetheless, the Council made 
recommendations with respect to regulatory needs for data development 
that EPA is today proposing:
     The report stated the need to investigate the effects of 
pesticide exposure on immunotoxic responses in infants and children. 
``Analysis of the impact or toxicity of agricultural chemicals on the 
immune system is essential. Regulatory development of a battery of 
consensus tests is critical to protect the developing immune system.'' 
(Ref. 1, p. 110).
     The report supported the Agency's proposed requirement for 
acute and subchronic neurotoxicity testing for pesticides and 
``encourages the agency to make this a general requirement for all 
food-use pesticides.'' (Ref. 1, p. 156).
     The report strongly encouraged further work in the area of 
developmental neurotoxicity. ``Neurodevelopmental effects must be part 
of the battery of end points evaluated for toxicants.... Regulatory 
development of a battery of consensus tests will be .... necessary to 
ensure public confidence.'' (Ref. 1, p. 110).
     The report suggested that the Agency impose a requirement 
for developmental toxicity for all classes of pesticides registered for 
food uses. ``A modified reproductive/developmental toxicity study in 
the rat is suggested for registration of all food-use pesticides.... 
the committee recommends that this study be made a requirement for 
registration for all food-use pesticides.'' (Ref. 1, p. 155)
    Other recommendations by the Council included an in utero chronic 
toxicity/carcinogenicity test and the inclusion of thyroid function 
into existing tests. The Council also recommended a conditional 
requirement for visual system toxicity testing, especially for 
cholinesterase-inhibiting compounds. These recommendations were brought 
to the SAP and are discussed in Unit XVIII.B. Other recommendations 
arising from the NRC report are still being considered for use on a 
case-by-case basis, as summarized in the list of potential data 
requirements in Unit XI.D.

B. FIFRA Science Advisory Panel

    In 1994, EPA held a 2-day meeting of the SAP to review the Agency's 
proposed amendments to the data requirements for pesticide 
registrations contained in 40 CFR part 158. The SAP was asked to 
comment on each data requirement and identify, in their opinion, which 
ones were necessary to fully and thoroughly evaluate the potential 
hazard of a chemical compound and which ones were not intrinsically 
useful in providing practical scientific information. The revisions 
presented to the Panel, i.e., the changes to the data requirements 
presented in this notice, were generally endorsed. Data requirements, 
as they related to the application of the newly mandated FFDCA safety 
factor, were also presented to the SAP in 1998 and 1999. No new issues 
of a scientific nature have surfaced since these meetings that would 
warrant SAP review. Copies of documents prepared for the SAP and the 
final reports from each of the meetings can be found on EPA's web site 
at http://www.epa.gov/scipoly/sap. A copy of the 1994 final report also 
can be found in the public

[[Page 12311]]

docket for this rulemaking. The Panel's comments and conclusions are 
summarized below.
    1. Terrestrial and aquatic nontarget organisms. In 1994, EPA 
requested comment from the SAP on the merits of requiring sediment and 
pore water toxicity testing to its data requirements for pesticides and 
whether the Agency's proposed tiered approach is appropriate. The 
Agency also requested comment on proposals to add additional testing 
requirements. The Panel believed that the addition of sediment and pore 
water testing would provide additional useful information and the 
proposed tiered approach appeared to provide a reasonable sequence of 
tests. Further, the Panel supported the requirement of both fish early 
lifestage and invertebrate life-cycle tests for certain aquatic and 
terrestrial uses and the addition of granular and other typical end-use 
products in avian oral testing. The SAP agreed that the avian 
reproduction test be expanded to include all outdoor uses, but the test 
protocol should be flexible in order to reflect more accurately the 
environmental fate of the chemical.
    2. Toxicology. At the 1994 meeting, EPA put forth the revisions to 
part 158 that included acute and subchronic neurotoxicity studies, as 
well as immunotoxicity studies in adults as first tier tests. The 
Agency also included in its presentation several studies recommend by 
the NRC in their 1993 report. In its final report the SAP offered 
comments and cited some specific recommendations for improvement.
    For the few studies the SAP did not endorse, the Panel could not 
find a significant scientific justification for the routine use of the 
data. For example, due to increased concerns about the potential 
effects of pesticides on the visual system, special visual system 
testing was suggested by the NRC as a data requirement. The Panel, 
however, concluded that there was insufficient scientific evidence to 
require special visual system testing. After reviewing its toxicology 
data base, at that time, for visual effects, i.e., pathological damage 
to the eye, EPA found that only five organophosphates and one carbamate 
exhibited visual effects. Cholinesterase-inhibition was considered the 
more sensitive endpoint and using this as an endpoint would be 
protective of the supposed visual system effects. Therefore, since the 
Agency already was regulating these pesticides at much lower doses than 
those expected to produce adverse effects on visual systems, it 
concluded that there was already adequate protection from any possible 
visual effects.
    Similarly, the SAP did not recommend additional testing on in utero 
exposure in carcinogenicity studies, a 90-day drinking water study, nor 
testing for thyroid function or other endocrine effects in routine 
chronic studies. Regarding the need to examine the potential perinatal 
or postnatal toxicity from pesticide residues in the diets of children, 
the Panel did not believe a special new study was warranted. In each of 
these instances the SAP thought it was premature to include a data 
requirement in part 158 until methods have been scientifically 
validated and guidelines developed, and the data could be 
scientifically evaluated to yield meaningful results.
    In 1998, EPA presented the SAP an issues paper on the use of the 
FQPA safety factor to address the special sensitivity of infants and 
children to pesticides. Here the Agency presented the Panel another, 
and more detailed, discussion of the toxicology data base, especially 
in regard to developmental neurotoxicity testing criteria and 
requirements. The developmental neurotoxicity study specifically was 
put in the context of the appropriateness of a possible additional 
safety factor. At that time, the SAP did not reach a consensus on 
whether this study should be routinely or conditionally required. The 
issue of what is a complete and reliable data set was brought before 
the SAP again in May 1999. The majority of the Panel supported the 
Agency's approach to applying data requirements but advised the Agency 
to revisit the first tier toxicology data base every few years to 
update data requirements as needed. The Panel also agreed with the 
Agency in the need to require the neurotoxicity battery of studies, 
including developmental neurotoxicity testing, for new conventional 
high exposure, i.e., food use, pesticide registrations.
    3. Nontarget plant protection. In 1994, EPA presented the SAP with 
its plant protection data requirements. The SAP was asked to provide 
specific information or guidance on a number of issues. The SAP 
supported the elimination of the seed germination test. In addition, 
the Panel recommended changing the test substance from the technical 
grade active ingredient to the typical end-use product for terrestrial 
plant studies and eliminating Tier I testing of phytotoxins on 
terrestrial plants.
    4. Occupational and residential exposure. Data requirements for 
exposure assessment for both applicators and those exposed to 
pesticides post-application were presented to the SAP in 1994. The 
Agency did not present any specific questions on exposure assessment 
for application or post-application exposure, and, by comparison to 
other subparts addressed in the response, the SAP had relatively few 
comments on data revisions for exposure monitoring and assessment. 
Several areas of clarification were advised, especially with regard to 
what data would be needed for what use patterns. It was also suggested 
that the Agency work with representatives from industry to develop a 
clear set of guidelines for both residential and occupational settings.
    Working in collaboration with Health Canada, and OECD, EPA drafted 
guidelines for post-application exposures studies. They were peer-
reviewed by EPA's Office of Research and Development, the California 
Department of Pesticide Regulation, representatives from academia, and 
the American Crop Protection Association. The Agency presented its 
post-application exposure guidelines and standard operating procedures 
to the SAP in 1998 and again in 1999. In 1999, the SAP approved and 
commended the Agency for making significant strides toward developing 
scenario-based residential and non-occupational exposure assessments 
that are sufficiently conservative as to not underestimate exposures. 
(Ref. 11)
    5. Environmental fate. Three of the significant changes that the 
Agency is proposing for the environmental fate data requirements, i.e., 
conditionally requiring aerobic soil metabolism and terrestrial field 
dissipation for aquatic uses involving sites that are intermittently 
dry, and conditionally requiring ground water monitoring for 
terrestrial and forestry use, were presented to the SAP at the 1994 
meeting. The SAP endorsed these changes as well as the independent 
laboratory validation of analytical methods.
    6. Residue chemistry. In 1994, EPA presented the SAP with its 
residue chemistry data requirements. While no specific questions were 
directly posed to the Panel, the SAP made a few comments. The SAP 
endorsed the independent laboratory validation of analytical methods, 
the establishment of a separate data requirement for multiresidue 
methodology, and a requirement for storage stability data. In addition, 
the Panel supported the Agency's efforts to identify the circumstances 
under which single serving analyses would be needed for acutely toxic 
pesticides.

[[Page 12312]]

XIX. International Harmonization of Data Requirements

    EPA is working closely with other countries toward greater 
uniformity in testing, reviewing and evaluating pesticides. The 
benefits of international regulatory cooperation on pesticides are 
potentially great: improved science through greater information 
exchange, and reduced regulatory and resource burdens on national 
governments and regulated parties through harmonized pesticide 
registration review. Over the last several years, substantial progress 
has been made toward international cooperation on pesticide regulatory 
review. Member countries of the OECD, including the United States, have 
agreed upon harmonized guidance for the formats of industry data 
submissions (dossiers) and country data review reports (monographs). 
Countries now frequently exchange pesticide reviews or consult with one 
another on key technical aspects of a review. EPA has worked jointly 
with Canada, dividing up detailed evaluation work on a number of 
pesticides. The Agency has entered into information exchange and 
comparative review arrangements on a pilot basis with other countries, 
as well. The objective of these work sharing arrangements has been to 
pool scientific knowledge and to use resources in the most efficient 
way possible.
    As the international regulatory community works toward greater 
harmonization on pesticide review, attention has turned to data 
requirements, how they compare from one country to another and what can 
or should be done to establish common requirements. To the extent that 
data requirements for pesticide registration are similar, sharing 
reviews and comparing evaluations is easier and more meaningful. 
Establishing similar requirements also can reduce the resources that 
must be spent to conduct testing. Requirements that differ considerably 
from one country to another can mean that registrants who are looking 
to register a pesticide in more than one country must conduct many 
different studies to satisfy all the various national requirements.
    The United States and Canada have worked together to harmonize data 
requirements across all disciplines. Data requirements and protocols 
for the two countries have been carefully compared. The data 
requirements proposed in this document represent U.S. national 
requirements but they reflect extensive consultation with Canada and 
are harmonized with Canada's requirements to a high degree. The two 
countries plan to continue to work together to keep data requirements 
for all disciplines as similar as possible.
    OECD Member countries have had discussions about harmonizing data 
requirements within the OECD community. The pesticide industry took on 
the complex task of looking at data requirement differences among 
Member countries to identify areas that might benefit from 
harmonization. They presented their preliminary findings to the OECD 
Working Group on Pesticides meeting in June 2001. They reported, 
consistent with the positions of scientific reviewers in OECD Member 
countries, that toxicology data requirements are quite similar across 
countries. Issues can arise sometimes, however, because study protocols 
or guidelines used to generate the studies to meet the requirements are 
not always harmonized. In other words, a particular study requirement 
might be the same from one country to the next, but the study submitted 
to meet the requirement can run into problems if done according to a 
protocol that is acceptable in one country but not another. Overall, 
however, it appears that reasonable harmonization has been achieved for 
toxicology studies done according to OECD Guidelines revised since 
1997. This does not mean that there is no room for additional 
harmonization work on toxicology data requirements and study 
guidelines, but rather that there are other testing areas where there 
is much less consistency on data requirements and study protocols 
across countries.
    Ecotoxicological and environmental fate studies present a 
particular challenge for harmonization. Data requirements in these 
areas can differ considerably from one country to another depending 
upon how countries' tiered approaches to data requirements are applied. 
National data requirements have to be tied to national use patterns and 
environmental and ecological conditions. A reliable environmental 
hazard assessment, for example, must be based on studies that 
accurately reflect the climate, soil types and agricultural practices 
of the country doing the assessment. Because ecological and 
environmental studies must be representative of national conditions to 
adequately support national risk assessments, harmonization of data 
requirements and study protocols for these types of studies can be 
difficult. Harmonization can require extensive dialogue between 
scientists to determine which data requirements can act as common 
requirements. Harmonization can also involve protocol/guideline 
development or revisions in order for the studies produced to meet 
common data requirements to be widely accepted.

XX. Research Involving Human Subjects

    In the United States, all research with human subjects conducted or 
supported by the Federal government is governed by a set of regulations 
referred to as the Common Rule. The Common Rule contains requirements 
designed to protect human subjects of research and to ensure that they 
are treated ethically. EPA, along with 16 other federal departments and 
agencies, promulgated the Common Rule in 1991. See 40 CFR part 26 
(EPA's Common Rule). In all of the scientific research with human 
subjects conducted or supported by EPA, the Agency has been and remains 
committed to full compliance with the Common Rule
    Both the current version of part 158 and the version of part 158 
being proposed contain requirements for the conduct of studies that 
involve testing with human participants. These studies include: 
metabolism and pharmacokinetic studies, biological monitoring studies, 
human exposure studies, and insect repellent efficacy studies. It 
should be noted that neither the current nor proposed version of the 
part 158 contains a provision that requires testing of human 
participants in a study designed to identify or quantify a toxic 
endpoint. If studies required under part 158 were conducted or 
supported by EPA (or another Federal agency), they would be subject to 
the Common Rule. Although the Common Rule applies only to research 
conducted or supported by Federal agencies, EPA recognizes that many 
public and private research and academic institutions and private 
companies, both in the United States and in other countries, including 
non-federal U.S. and non-U.S. governmental organizations, have their 
own specific policies related to the protection of human participants 
in research.
    EPA has been considering its policies and rules regarding the 
conduct of studies involving human participants by organizations that 
are not part of the Federal government and that do not receive support 
from a Federal agency. (These are referred to as ``third party'' 
researchers). On February 8, 2005 (70 FR 6661)(FRL-7695-4), EPA issued 
a Federal Register Notice announcing that it plans to conduct 
rulemaking to make the provisions of the Common Rule, 40 CFR part 26, 
applicable to certain newly conducted third-party human studies. The 
Notice also indicated that EPA may propose to adopt some or all of the 
Department of Health and Human

[[Page 12313]]

Services' (DHHS) protections for research with vulnerable populations. 
The DHHS rules are contained in 45 CFR part 46, subparts B (pregnant 
women, human fetuses, and neonates), C (prisoners), and D (children) 
and apply when members of these groups are being considered as 
potential participants in covered research.

XXI. ILSI Work on New Toxicity Paradigm

    The Health and Environmental Sciences Institute (HESI)/
International Life Sciences Institute initiated a project in 2001 
titled ``Developing Strategies for Agricultural Safety Evaluation.'' 
The purpose of this project was to bring together scientific experts 
from government, academia and industry, including the international 
community to determine whether the current testing paradigm for 
pesticide chemicals could be made more efficient and accurate. Agency 
scientists from EPA's Office of Pesticide Programs and Office of 
Research and Development are involved in this project. The HESI 
technical work groups have developed a tiered approach that takes into 
account the toxicological properties and the use pattern of the 
chemicals, and attempts to minimize the number of animals necessary to 
produce a thorough health assessment of the chemicals of interest. The 
HESI reports are anticipated to be submitted for publication in the 
Journal Critical Reviews and Toxicology, April 2005. The draft HESI 
papers can currently be viewed in PDF format at http://hesi.ilsi.org/publications/pubslist.cfm?publicationid=578. Once the reports are 
published (anticipated for summer 2005), the Agency will consider the 
HESI tier approach, as well as other available proposals on toxicology 
testing including the ongoing National Academy of Sciences project on 
the future of toxicology testing, to determine what revisions to 
current testing guidelines and data requirements may be appropriate. 
Before considering regulatory approaches, the Agency will need to 
develop scientific position papers concerning the new approach for 
Agency internal and external review (including review by the FIFRA 
Science Advisory Panel), and public comment. Regulatory changes will be 
made, as needed, to keep the data requirements current, as stated in 
proposed Sec.  158.30(b).
    Information on the HESI project can be found at the following 
website: http://hesi.ilsi.org/index.cfm?pubentityid=55. Information on 
the NAS project can be found at the following website: http://www4.nas.edu/webcr.nsf/5c50571a75df494485256a95007 a091e/
f6b42dd0563b352e85256e5d0007281e.

XXII. Animal Welfare Concerns

    The Agency is committed to the development and use of alternative 
approaches to animal testing. The Agency understands many people's 
concern about the use of animals for research and data development 
purposes. EPA has received comments concerning the use of new and 
revised test methods which would reduce the number of test animals in 
studies, or refine procedures to make them less stressful to animals. 
Where testing is needed to develop scientifically adequate data, the 
Agency is committed to reducing or replacing, wherever possible, the 
number of animals used for testing by incorporating in vitro (non-
animal) test methods or other alternative approaches that have been 
scientifically validated and have received regulatory acceptance. EPA 
considers these goals and commitments to be important considerations in 
developing health effects data, consistent with the essential need to 
conduct scientifically sound chemical hazard/risk assessments in 
support of the Agency's mission.
    Taking into consideration principles of sound science and the 
requirements of FIFRA to protect humans (including sensitive 
subpopulations) and the environment from unreasonable uncertainty of no 
harm from pesticide exposure, the Agency is committed to avoiding 
unnecessary or duplicative animal testing. For example, currently EPA 
accepts data on the pH of a chemical as a screen to judge whether the 
chemical may be corrosive to the eye or skin. Making this determination 
avoids actual testing on animals. Many long-term studies can be 
combined so that several toxicological end-points can be discerned from 
fewer studies. 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. At EPA's 
initiative, these policies have been incorporated into the new Globally 
Harmonized System for Classification and Labeling.
    The Agency plays an important role in the Federal Interagency 
Committee for the Validation of Alternative Methods (ICCVAM) (http://iccvam.niehs.nih.gov/home.htm). ICCVAM, a standing committee made up of 
15 federal agencies and established through the National Institute of 
Environmental Health Sciences, which works to:
    1. Encourage the reduction of the number of animals used in 
testing.
    2. Seek opportunities to replace test methods requiring animals 
with alternative test methods when acceptable alternative methods are 
available.
    3. Refine existing test methods to optimize animal use when there 
is no substitute for animal testing.
ICCVAM convenes independent peer review panels to evaluate specific 
proposed test methods and has developed consensus criteria for judging 
the validation status of test methods.
    Guideline 870.1100 references the use of appropriate alternative 
test protocols as a means of reducing the number of animals used to 
evaluate acute effects of chemical exposure. Yet the Agency and the 
scientific community also recognize that test guidelines are designed 
to be updated and supplemented frequently. As new tests and test 
batteries are validated, the Agency presents them to the SAP. The 
Agency considers the SAP's determination of the reliability of the test 
guidelines and their applicability to meeting its regulatory needs 
under FIFRA. After SAP review, the Agency is planning to incorporate 
validated in vitro screening data for skin corrosion to its test 
guidelines. As other appropriate alternative or in vitro methods become 
available, they will continue to be added to the test guidelines.

XXIII. Summary of Changes Being Proposed

    Table 3 contains a line-by-line listing of every data requirement 
contained in current part 158, as well as new requirements proposed 
today, organized in the order of the proposed new subparts D through U. 
Columns 1 and 2 contain Pesticide Assessment Guideline numbers and 
current titles, respectively. Columns 3 and 4 contain OPPTS Harmonized 
Guidelines numbers and proposed titles, respectively. Column 5 contains 
an explanation of the changes proposed for each requirement, or that no 
change is proposed.

[[Page 12314]]



                          Table 3.--Part 158: Proposed Changes to Data Requirements\1\
----------------------------------------------------------------------------------------------------------------
                                                                             Proposed
         Guideline No.            Current requirement    Guideline No.      requirement            Change
----------------------------------------------------------------------------------------------------------------
                                 Subpart D--Product Chemistry and Guideline No.
----------------------------------------------------------------------------------------------------------------
Product Identity and Composition................................................................................
----------------------------------------------------------------------------------------------------------------
  61-1                           Product composition          830.1550  Product identity    No changes.
                                                                         and composition
----------------------------------------------------------------------------------------------------------------
  61-2                           Description of               830.1600  Description of      No changes.
                                  materials used to                      materials used to
                                  produce the product                    produce the
                                                                         product
----------------------------------------------------------------------------------------------------------------
  61-2                           Description of               830.1620  Description of      No changes.
                                  production process                     production
                                                                         process
----------------------------------------------------------------------------------------------------------------
  61-2                           Description of               830.1650  Description of      No changes.
                                  formulation process                    formulation
                                                                         process
----------------------------------------------------------------------------------------------------------------
  61-2                           Discussion of                830.1670  Discussion of       No changes.
                                  formulation of                         formulation of
                                  impurities                             impurities
----------------------------------------------------------------------------------------------------------------
  62-1                           Preliminary analysis         830.1700  Preliminary         No changes.
                                                                         analysis
----------------------------------------------------------------------------------------------------------------
  62-2                           Certified limits             830.1750  Certified limits    No changes.
----------------------------------------------------------------------------------------------------------------
  62-3                           Enforcement                  830.1800  Enforcement         No changes.
                                  analytical method                      analytical method
----------------------------------------------------------------------------------------------------------------
  64-1                           Submittal of samples         830.1900  Submittal of        No changes.
                                                                         samples
----------------------------------------------------------------------------------------------------------------
Physical and Chemical Properties................................................................................
----------------------------------------------------------------------------------------------------------------
   63-2                          Color                        830.6302  Color               No changes.
----------------------------------------------------------------------------------------------------------------
  63-3                           Physical state               830.6303  Physical state      No changes.
----------------------------------------------------------------------------------------------------------------
  63-4                           Odor                         830.6304  Odor                No changes.
----------------------------------------------------------------------------------------------------------------
  63-5                           Melting point                830.7200  Melting point/      No changes.
                                                                         melting range
----------------------------------------------------------------------------------------------------------------
  63-6                           Boiling point                830.7220  Boiling point/      No changes.
                                                                         boiling range
----------------------------------------------------------------------------------------------------------------
  63-7                           Density, bulk                830.7300  Density/relative    Clarified test note
                                  density, or specific                   density/bulk        to better identify
                                  gravity                                density             when this test
                                                                                             requirement is
                                                                                             applicable.
  63-8                           Solubility                   830.7840  Water solubility    No changes.
                                                              830.7860
----------------------------------------------------------------------------------------------------------------
  63-9                           Vapor pressure               830.7950  Vapor pressure      Clarified test note
                                                                                             to better identify
                                                                                             when this test
                                                                                             requirement is
                                                                                             applicable.
----------------------------------------------------------------------------------------------------------------
  63-10                          Dissociation constant        830.7370  Dissociation        Clarified test note
                                                                         constants in        to better identify
                                                                         water               when this test
                                                                                             requirement is
                                                                                             applicable.
----------------------------------------------------------------------------------------------------------------
  63-11                          Octanol/water                830.7550  Partition           Changed from
                                  partition                   830.7560   coefficient (n-     ``conditionally
                                  coefficient                 830.7570   octanol/water)      required'' to
                                                                                             ``required.''
----------------------------------------------------------------------------------------------------------------
  63-12                          pH                           830.7000  pH                  No changes.
----------------------------------------------------------------------------------------------------------------
  63-13                          Stability                    830.6313  Stability to        Changed from
                                                                         normal and          ``required'' to
                                                                         elevated            ``conditionally
                                                                         temperatures,       required.''
                                                                         metals, and metal
                                                                         ions
----------------------------------------------------------------------------------------------------------------
  63-14                          Oxidizing or reducing        830.6314  Oxidation/          No changes.
                                  action                                 reduction:
                                                                         chemical
                                                                         incompatability
----------------------------------------------------------------------------------------------------------------
  63-15                          Flammability                 830.6315  Flammability        No changes.
----------------------------------------------------------------------------------------------------------------
  63-16                          Explodability                830.6316  Explodability       Changed from
                                                                                             ``required'' to
                                                                                             ``conditionally
                                                                                             required.''
----------------------------------------------------------------------------------------------------------------

[[Page 12315]]

 
  63-17                          Storage stability            830.6317  Storage stability   No changes.
----------------------------------------------------------------------------------------------------------------
  63-18                          Viscosity                    830.7100  Viscosity           No changes.
----------------------------------------------------------------------------------------------------------------
  63-19                          Miscibility                  830.6319  Miscibility         No changes.
----------------------------------------------------------------------------------------------------------------
  63-20                          Corrosion                    830.6320  Corrosion           No changes.
                                  characteristics                        characteristics
----------------------------------------------------------------------------------------------------------------
  63-21                          Dielectric breakdown         830.6321  Dielectric          No changes.
                                  voltage                                breakdown voltage
----------------------------------------------------------------------------------------------------------------
                                 None                         830.7050  UV/visible light    Proposed
                                                                         absorption          requirement.
----------------------------------------------------------------------------------------------------------------
                                 None                         830.7520  Particle size,      Proposed conditional
                                                                         fiber length, and   requirement.
                                                                         diameter
                                                                         distribution
----------------------------------------------------------------------------------------------------------------
                                 Subpart E--Nontarget Organisms Data Requirements
----------------------------------------------------------------------------------------------------------------
Avian and Mammalian Testing.....................................................................................
----------------------------------------------------------------------------------------------------------------
  71-1                           Avian oral LD50              850.2100  Avian oral          Added testing on a
                                                                         toxicity            second species
                                                                                             (passerine) for
                                                                                             some uses. Expanded
                                                                                             requirement to
                                                                                             include testing
                                                                                             with the TEP.
                                                                                             Clarified test note
                                                                                             to better identify
                                                                                             when this test
                                                                                             requirement is
                                                                                             applicable.
----------------------------------------------------------------------------------------------------------------
  71-2                           Avian dietary LC50           850.2200  Avian dietary       Changed from
                                                                         toxicity            ``conditionally
                                                                                             required'' to ``not
                                                                                             required'' for
                                                                                             greenhouse and
                                                                                             indoor uses. Added
                                                                                             a conditional
                                                                                             requirement for
                                                                                             testing one avian
                                                                                             species for aquatic
                                                                                             nonfood residential
                                                                                             uses. Data on a
                                                                                             second avian
                                                                                             species may also be
                                                                                             required.
----------------------------------------------------------------------------------------------------------------
  71-3                           Wild mammal toxicity         850.2400  Wild mammal         Clarified test note
                                                                         toxicity            to better identify
                                                                                             when this test is
                                                                                             applicable.
----------------------------------------------------------------------------------------------------------------
  71-4                           Avian reproduction           850.2300  Avian reproduction  Changed from
                                                                                             ''conditionally
                                                                                             required'' to
                                                                                             ``required'' for
                                                                                             terrestrial,
                                                                                             aquatic food,
                                                                                             aquatic nonfood
                                                                                             outdoor, forestry,
                                                                                             and residential
                                                                                             outdoor uses.
----------------------------------------------------------------------------------------------------------------
  71-5                           Simulated or actual          850.2500  Simulated or        Expanded conditional
                                  field testing-                         actual field        requirement to
                                  mammals and birds                      testing             terrestrial feed
                                                                                             and aquatic nonfood
                                                                                             outdoor uses. Added
                                                                                             independent
                                                                                             laboratory
                                                                                             validation of
                                                                                             methods.
----------------------------------------------------------------------------------------------------------------
Sediment Testing................................................................................................
----------------------------------------------------------------------------------------------------------------
                                 None                         850.1735  Whole sediment--    Proposed conditional
                                                              850.1740   acute               requirement.
                                                                         invertebrates
                                                                         (freshwater and
                                                                         marine)
----------------------------------------------------------------------------------------------------------------
                                 None                             None  Whole sediment--    Proposed conditional
                                                                         chronic             requirement.
                                                                         invertebrates
                                                                         (freshwater and
                                                                         marine)
----------------------------------------------------------------------------------------------------------------
 Nontarget Insect Testing.......................................................................................
----------------------------------------------------------------------------------------------------------------
   141-1                         Honey bee acute              850.3020  Honey bee acute     Changed from
                                  contact LD50                           contact toxicity    ``conditionally
                                                                                             required'' to
                                                                                             ``required'' for
                                                                                             all terrestrial,
                                                                                             aquatic food,
                                                                                             aquatic nonfood
                                                                                             outdoor, forestry,
                                                                                             and residential
                                                                                             outdoor uses.
----------------------------------------------------------------------------------------------------------------
  141-2                          Honey bee--toxicity          850.3030  Honey bee--         Clarified test note.
                                  of residues on                         toxicity of
                                  foliage                                residues on
                                                                         foliage
----------------------------------------------------------------------------------------------------------------
  141-4                          Honey bee subacute              141-4  Honey bee subacute  Eliminated
                                  feeding study                          feeding study       requirement.
----------------------------------------------------------------------------------------------------------------

[[Page 12316]]

 
  141-5                          Field testing for            850.3040  Field testing for   Expanded conditional
                                  pollinators                            pollinators         requirement to
                                                                                             terrestrial feed
                                                                                             and aquatic nonfood
                                                                                             (outdoor and
                                                                                             residential) uses.
----------------------------------------------------------------------------------------------------------------
  142-1                          Acute toxicity to               142-1  Acute toxicity to   No changes.
                                  aquatic insect                         aquatic insect
----------------------------------------------------------------------------------------------------------------
  142-1                          Aquatic insect life-            142-1  Aquatic insect      No changes.
                                  cycle study                            life-cycle study
----------------------------------------------------------------------------------------------------------------
  142-3                          Simulated or actual             142-3  Simulated or        No changes.
                                  field testing for                      actual field
                                  aquatic insects                        testing for
                                                                         aquatic insects
----------------------------------------------------------------------------------------------------------------
  143-1                          Nontarget insect                143-1  Nontarget insect    No changes.
  143-2........................   testing--predators             143-2   testing--predator
  143-3........................   and parasites                  143-3   s and parasites
----------------------------------------------------------------------------------------------------------------
 Aquatic Organism Testing.......................................................................................
----------------------------------------------------------------------------------------------------------------
   72-1                          Freshwater fish LC50         850.1075  Freshwater fish     Added conditional
                                                                         toxicity            requirement for a
                                                                                             second species of
                                                                                             fish for greenhouse
                                                                                             and indoor uses.
                                                                                             Added testing
                                                                                             requirement using
                                                                                             the TEP.
----------------------------------------------------------------------------------------------------------------
  72-2                           Acute LC50 freshwater        850.1010  Acute toxicity      No changes
                                  invertebrates                          freshwater
                                                                         invertebrates
----------------------------------------------------------------------------------------------------------------
  72-3                           Acute LC50 estuarine         850.1025  Acute toxicity      Changed from
                                  and marine organisms        850.1035   estuarine and       ``conditionally
                                                              850.1045   marine organisms    required'' to
                                                              850.1055                       ``required'' for
                                                              850.1075                       terrestrial,
                                                                                             aquatic (food and
                                                                                             nonfood outdoor),
                                                                                             residential
                                                                                             outdoor, and
                                                                                             forestry uses;
                                                                                             changed the aquatic
                                                                                             nonfood residential
                                                                                             use to ``not
                                                                                             required.''
----------------------------------------------------------------------------------------------------------------
  72-4                           Fish early-life stage        850.1300  Aquatic             Changed from
                                  and Aquatic                            invertebrate life-  ``conditionally
                                  invertebrate life-                     cycle               required'' to
                                  cycle                                  (freshwater)        ``required'' for
                                                                                             terrestrial,
                                                                                             aquatic (food and
                                                                                             nonfood outdoor),
                                                                                             and forestry uses.
                                                                                             Changed the aquatic
                                                                                             nonfood residential
                                                                                             use to ``not
                                                                                             required.''
----------------------------------------------------------------------------------------------------------------
  72-4                           None                         850.1350  Aquatic             Expanded the
                                                                         invertebrate life-  conditional
                                                                         cycle (saltwater)   requirement to
                                                                                             include terrestrial
                                                                                             feed and aquatic
                                                                                             nonfood outdoor
                                                                                             uses. Changed the
                                                                                             aquatic nonfood
                                                                                             residential use to
                                                                                             ``not required.''
----------------------------------------------------------------------------------------------------------------
  72-4                           None                         850.1400  Fish early-life     Changed from
                                                                         stage               ``conditionally
                                                                         (freshwater)        required'' to
                                                                                             ``required'' for
                                                                                             terrestrial,
                                                                                             aquatic (food and
                                                                                             nonfood outdoor),
                                                                                             and forestry uses.
                                                                                             Changed the aquatic
                                                                                             nonfood residential
                                                                                             use to ``not
                                                                                             required.''
----------------------------------------------------------------------------------------------------------------
  72-4                           None                         850.1400  Fish early-life     Expanded the
                                                                         stage (saltwater)   conditional
                                                                                             requirement to
                                                                                             include terrestrial
                                                                                             feed and aquatic
                                                                                             nonfood outdoor
                                                                                             uses. Changed the
                                                                                             aquatic nonfood
                                                                                             residential use to
                                                                                             ``not required.''
----------------------------------------------------------------------------------------------------------------
  72-5                           Fish life-cycle              850.1500  Fish life-cycle     No changes.
----------------------------------------------------------------------------------------------------------------
  72-6                           Aquatic organism             850.1710  Aquatic organisms   Changed from
                                  accumulation                850.1730   bioavailability/    ``conditionally
                                                              850.1850   biomagnification/   required'' to ``not
                                                                         toxicity tests      required'' for
                                                                                             aquatic nonfood
                                                                                             residential and
                                                                                             residential outdoor
                                                                                             uses.
----------------------------------------------------------------------------------------------------------------
  72-7                           Simulated or actual          850.1950  Simulated or        Changed from
                                  field testing--                        actual field        ``conditionally
                                  aquatic organisms                      testing--aquatic    required'' to ``not
                                                                         organisms           required'' for
                                                                                             aquatic nonfood
                                                                                             residential uses.
                                                                                             Clarified that the
                                                                                             conditional
                                                                                             requirement applies
                                                                                             to turf use.
----------------------------------------------------------------------------------------------------------------
 
[[Page 12317]]

 
                                     Subpart F--Toxicology Data Requirements
----------------------------------------------------------------------------------------------------------------
 Acute Testing..................................................................................................
----------------------------------------------------------------------------------------------------------------
   81-1                          Acute oral toxicity--        870.1100  Acute oral          Modified test
                                  rat                                    toxicity--rat       substance.
----------------------------------------------------------------------------------------------------------------
  81-2                           Acute dermal toxicity        870.1200  Acute dermal        Modified test
                                                                         toxicity            substance.
----------------------------------------------------------------------------------------------------------------
  81-3                           Acute inhalation             870.1300  Acute inhalation    No changes.
                                  toxicity--rat                          toxicity--rat
----------------------------------------------------------------------------------------------------------------
  81-4                           Primary eye                  870.2400  Primary eye         Added testing using
                                  irritation--rabbit                     irritation--rabbi   the TGAI to support
                                                                         t                   end-use products.
----------------------------------------------------------------------------------------------------------------
  81-5                           Primary dermal               870.2500  Primary dermal      Added testing using
                                  irritation                             irritation          the TGAI to support
                                                                                             end-use products.
----------------------------------------------------------------------------------------------------------------
  81-6                           Dermal sensitization         870.2600  Dermal              Added testing using
                                                                         sensitization       the TGAI to support
                                                                                             end-use products.
----------------------------------------------------------------------------------------------------------------
  81-7                           Acute delayed                870.6100  Delayed             No changes.
                                  neurotoxicity--hen                     neurotoxicity
                                                                         (acute)--hen
----------------------------------------------------------------------------------------------------------------
                                 None                         870.6200  Acute               Replaces current
                                                                         neurotoxicity--ra   neurotoxicity
                                                                         t                   battery.
----------------------------------------------------------------------------------------------------------------
 Subchronic Testing.............................................................................................
----------------------------------------------------------------------------------------------------------------
   82-1                          90-day Feeding--             870.3100  90-day Feeding--    Requirement modified
                                  rodent                                 rodent              to include 2 rodent
                                                                                             species.
----------------------------------------------------------------------------------------------------------------
  82-1                           90-day Feeding--non-         870.3150  90-day Feeding--    No changes.
                                  rodent                                 non-rodent
----------------------------------------------------------------------------------------------------------------
  82-2                           21-day Dermal                870.3200  21-day Dermal       Changed from
                                                                                             ``conditionally
                                                                                             required'' to
                                                                                             ``required'' for
                                                                                             all food uses. Not
                                                                                             required for
                                                                                             nonfood uses.
----------------------------------------------------------------------------------------------------------------
  82-3                           90-day Dermal                870.3250  90-day Dermal       Changed from
                                                                                             ``conditionally
                                                                                             required'' to
                                                                                             ``required'' for
                                                                                             all nonfood uses.
----------------------------------------------------------------------------------------------------------------
  82-4                           90-day Inhalation--          870.3465  90-day inhalation-- No changes.
                                  rat                                    rat
----------------------------------------------------------------------------------------------------------------
  82-5                           90-day Neurotoxicity--       870.6200  90-day              Changed from
                                  mammal                                 Neurotoxicity--ra   ``conditionally
                                                                         t                   required'' to
                                                                                             ``required.''
----------------------------------------------------------------------------------------------------------------
  82-5                           90-day Neurotoxicity--       870.6100  28-day              Proposed conditional
                                  hen                                    Neurotoxicity--he   requirement.
                                                                         n                   Replaces 90-day
                                                                                             neurotoxicity hen
                                                                                             study.
----------------------------------------------------------------------------------------------------------------
 Chronic Testing................................................................................................
----------------------------------------------------------------------------------------------------------------
   83-1                          Chronic feeding--            870.4100  Chronic feeding--   No changes.
                                  rodent and non-                        rodent and non-
                                  rodent                                 rodent
----------------------------------------------------------------------------------------------------------------
  83-2                           Oncogenicity--rat and        870.4200  Carcinogenicity--r  Changed name.
                                  mouse, preferred                       at and mouse,      Proposed requirement
                                                                         preferred           to perform range
                                                                                             finding studies.
----------------------------------------------------------------------------------------------------------------
 Developmental Toxicity and Reproduction........................................................................
----------------------------------------------------------------------------------------------------------------
   83-3                          Teratogenicity--2            870.3700  Prenatal            Changed name.
                                  species                                developmental      Testing required on
                                                                         toxicity--rat and   a 2nd species for
                                                                         rabbit, preferred   food and nonfood
                                                                                             uses.
----------------------------------------------------------------------------------------------------------------
83-4                             Reproduction--2              870.3800  Reproduction        Changed from
                                  generation                                                 ``conditionally
                                                                                             required'' to
                                                                                             ``required'' for
                                                                                             nonfood uses based
                                                                                             on potential
                                                                                             exposure.
----------------------------------------------------------------------------------------------------------------

[[Page 12318]]

 
                                 None                         870.6300  Developmental       Proposed conditional
                                                                         neurotoxicity       requirement. To
                                                                                             conduct
                                                                                             developmental
                                                                                             neurotoxicity
                                                                                             testing utilizing
                                                                                             information about
                                                                                             the chemical and
                                                                                             its toxicity to
                                                                                             develop a science--
                                                                                             based approach to
                                                                                             testing.
----------------------------------------------------------------------------------------------------------------
 Mutagenicity Testing...........................................................................................
----------------------------------------------------------------------------------------------------------------
   84-2                          Gene mutation                870.5100  Bacterial reverse   Replaces current
                                                                         mutation assay      mutagenicity
                                                                                             battery.
----------------------------------------------------------------------------------------------------------------
  84-2                           Structural chromosome        870.5300  In vitro mammalian  Replaces current
                                  aberration                  870.5375   cell assay          mutagenicity
                                                                                             battery.
----------------------------------------------------------------------------------------------------------------
  84-4                           Other genotoxic              870.5385  In vivo             Replaces current
                                  effects                     870.5395   cytogenetics        mutagenicity
                                                                                             battery.
----------------------------------------------------------------------------------------------------------------
                                                                        Other mutagenicity  No changes.
                                                                         studies
----------------------------------------------------------------------------------------------------------------
 Special Testing................................................................................................
----------------------------------------------------------------------------------------------------------------
   85-1                          General metabolism           870.7485  General metabolism  No changes.
----------------------------------------------------------------------------------------------------------------
  85-2                           Dermal penetration           870.7600  Dermal penetration  No changes.
----------------------------------------------------------------------------------------------------------------
  86-1                           Domestic animal              870.7200  Companion animal    No changes.
                                  safety                                 safety
----------------------------------------------------------------------------------------------------------------
                                 None                         870.6500  Scheduled           Replaces current
                                                                         controlled          neurotoxicity
                                                                         operant behavior    battery.
----------------------------------------------------------------------------------------------------------------
                                 None                         870.6850  Peripheral nerve    Replaces current
                                                                         function            neurotoxicity
                                                                                             battery.
----------------------------------------------------------------------------------------------------------------
                                 None                         870.6855  Neurophysiology:    Replaces current
                                                                         sensory evoked      neurotoxicity
                                                                         potentials          battery.
----------------------------------------------------------------------------------------------------------------
                                 None                         870.7800  Immunotoxicity      New requirement.
                                                                                             Required for food
                                                                                             uses and nonfood
                                                                                             uses.
                                      Subpart J--Nontarget Plant Protection
----------------------------------------------------------------------------------------------------------------
   121-1                         Target area                  850.4025  Target area         No changes.
                                  phytotoxicity                          phytotoxicity
----------------------------------------------------------------------------------------------------------------
 Nontarget area phytotoxicity--Tier I...........................................................................
----------------------------------------------------------------------------------------------------------------
   122-1                         Seed germination/            850.4200  Seed germination    Eliminated
                                  seedling emergence                                         requirement.
----------------------------------------------------------------------------------------------------------------
  122-1                          Seed germination/            850.4100  Seedling emergence  Expanded requirement
                                  Seedling emergence                                         to include
                                                                                             terrestrial food
                                                                                             and feed, aquatic
                                                                                             food, and
                                                                                             residential outdoor
                                                                                             uses. Changed test
                                                                                             substance from TGAI
                                                                                             to TEP.
----------------------------------------------------------------------------------------------------------------
  122-1                          Vegetative vigor             850.4150  Vegetative vigor    Expanded requirement
                                                                                             to include
                                                                                             terrestrial food
                                                                                             and feed, aquatic
                                                                                             food, and
                                                                                             residential outdoor
                                                                                             uses. Changed test
                                                                                             substance from TGAI
                                                                                             to TEP.
                                                                                            Eliminated
                                                                                             requirement for
                                                                                             data on granular
                                                                                             and bait
                                                                                             formulations.
----------------------------------------------------------------------------------------------------------------
  122-2                          Aquatic plant growth         850.4400  Aquatic plant       Expanded requirement
                                                              850.5400   growth              to include
                                                                                             terrestrial food
                                                                                             and feed, aquatic
                                                                                             food, and
                                                                                             residential outdoor
                                                                                             uses.
----------------------------------------------------------------------------------------------------------------
 Nontarget area phytotoxicity--Tier II..........................................................................
----------------------------------------------------------------------------------------------------------------
   123-1                         Seed germination             850.4200  Seed germination    Eliminated
                                                                                             requirement.
----------------------------------------------------------------------------------------------------------------

[[Page 12319]]

 
  123-1                          Seedling emergence           850.4225  Seedling emergence  Expanded conditional
                                                                                             requirement to
                                                                                             include terrestrial
                                                                                             food and feed,
                                                                                             aquatic food, and
                                                                                             residential outdoor
                                                                                             uses. Changed test
                                                                                             substance from TGAI
                                                                                             to TEP.
----------------------------------------------------------------------------------------------------------------
  123-1                          Vegetative vigor             850.4250  Vegetative vigor    Expanded conditional
                                                                                             requirement to
                                                                                             include terrestrial
                                                                                             food and feed,
                                                                                             aquatic food, and
                                                                                             residential outdoor
                                                                                             uses. Changed test
                                                                                             substance from TGAI
                                                                                             to TEP.
                                                                                            Eliminated
                                                                                             requirement for
                                                                                             data on granular
                                                                                             and bait
                                                                                             formulations.
----------------------------------------------------------------------------------------------------------------
  123-2                          Aquatic plant growth         850.4400  Aquatic plant       Expanded conditional
                                                              850.5400   growth              requirement to
                                                                                             include terrestrial
                                                                                             food and feed,
                                                                                             aquatic food,
                                                                                             residential
                                                                                             outdoor, aquatic
                                                                                             nonfood
                                                                                             residential, and
                                                                                             indoor uses.
----------------------------------------------------------------------------------------------------------------
Nontarget area phytotoxicity -
 Tier III
----------------------------------------------------------------------------------------------------------------
  124-1                          Terrestrial field            850.4300  Terrestrial field   Expanded conditional
                                                                                             requirement to
                                                                                             include terrestrial
                                                                                             food and feed,
                                                                                             aquatic food, and
                                                                                             residential outdoor
                                                                                             uses. Added
                                                                                             requirement for
                                                                                             independent method
                                                                                             validation.
----------------------------------------------------------------------------------------------------------------
  124-2                          Aquatic field                850.4450  Aquatic field       Expanded conditional
                                                                                             requirement to
                                                                                             include terrestrial
                                                                                             food and feed,
                                                                                             aquatic food, and
                                                                                             residential outdoor
                                                                                             uses. Added
                                                                                             requirement for
                                                                                             independent method
                                                                                             validation.
----------------------------------------------------------------------------------------------------------------
                                       Subpart K--Post-application Exposure
----------------------------------------------------------------------------------------------------------------
   132-1                         Foliar dissipation           875.2100  Dislodgeable        Revised testing
                                                                         foliar residue      criteria. Expanded
                                                                         dissipation and     use sites to
                                                                         turf transferable   include testing for
                                                                         residues            greenhouses,
                                                                                             nurseries, forests,
                                                                                             residential
                                                                                             settings, and turf
                                                                                             grass. Changed from
                                                                                             ``conditionally
                                                                                             required'' to
                                                                                             ``required''.
----------------------------------------------------------------------------------------------------------------
  132-2                          Soil dissipation             875.2200  Soil residue        Revised testing
                                                                         dissipation         criteria. Expanded
                                                                                             use sites to
                                                                                             include testing for
                                                                                             greenhouses,
                                                                                             nurseries, forests,
                                                                                             and residential
                                                                                             (conditionally
                                                                                             required) settings.
----------------------------------------------------------------------------------------------------------------
                                 None                         875.2300  Indoor surface      Proposed
                                                                         residue             requirement.
                                                                         dissipation         Subject to revised
                                                                                             testing criteria.
----------------------------------------------------------------------------------------------------------------
  133-3                          Dermal exposure              875.2400  Dermal exposure     Revised testing
                                                                                             criteria. Expanded
                                                                                             use sites to
                                                                                             include testing for
                                                                                             greenhouses,
                                                                                             nurseries, forests,
                                                                                             residential
                                                                                             settings, and turf
                                                                                             grass. Changed from
                                                                                             ``conditionally
                                                                                             required'' to
                                                                                             ``required''.
----------------------------------------------------------------------------------------------------------------
  133-4                          Inhalation exposure          875.2500  Inhalation          Revised testing
                                                                         exposure            criteria. Expanded
                                                                                             use sites to
                                                                                             include testing for
                                                                                             greenhouses,
                                                                                             nurseries, forests,
                                                                                             residential
                                                                                             settings, golf
                                                                                             courses, and
                                                                                             certain indoor
                                                                                             environments.
                                                                                             Changed from
                                                                                             ``conditionally
                                                                                             required'' to
                                                                                             ``required.''
----------------------------------------------------------------------------------------------------------------

[[Page 12320]]

 
                                 None                         875.2600  Biological          Proposed conditional
                                                                         monitoring          requirement.
                                                                                            Subject to revised
                                                                                             testing criteria
----------------------------------------------------------------------------------------------------------------
                                 None                         875.2700  Product use         Proposed
                                                                         information         requirement.
                                                                                             Subject to revised
                                                                                             testing criteria.
----------------------------------------------------------------------------------------------------------------
                                 None                         875.2800  Description of      Proposed
                                                                         human activity      requirement.
                                                                                             Subject to revised
                                                                                             testing criteria.
----------------------------------------------------------------------------------------------------------------
                                 None                         875.2900  Data reporting and  Proposed
                                                                         calculations        requirement.
                                                                                             Subject to revised
                                                                                             testing criteria.
----------------------------------------------------------------------------------------------------------------
                                 None                         875.3000  Nondietary          Proposed requirement
                                                                         ingestion           for residential
                                                                         exposure            uses. Not required
                                                                                             for occupational
                                                                                             uses. Subject to
                                                                                             revised testing
                                                                                             criteria
----------------------------------------------------------------------------------------------------------------
                                           Subpart N-Environmental Fate
----------------------------------------------------------------------------------------------------------------
 Degradation Testing............................................................................................
----------------------------------------------------------------------------------------------------------------
   161-1                         Hydrolysis                   835.2120  Hydrolysis          Expanded conditional
                                                                                             requirement to
                                                                                             include indoor food
                                                                                             and nonfood, and
                                                                                             residential indoor
                                                                                             uses.
----------------------------------------------------------------------------------------------------------------
  161-2                          Photo degradation in         835.2240  Photodegradation    Clarified conditions
                                  water                                  in water            for when study is
                                                                                             required.
----------------------------------------------------------------------------------------------------------------
  161-3                          Photodegradation on          835.2410  Photodegradation    Changed from
                                  soil                                   on soil             ``conditionally
                                                                                             required'' to
                                                                                             ``required'' for
                                                                                             terrestrial food
                                                                                             and forestry uses.
                                                                                             Expanded
                                                                                             requirement to
                                                                                             include terrestrial
                                                                                             nonfood uses.
----------------------------------------------------------------------------------------------------------------
  161-4                          Photodegradation in          835.2370  Photodegradation    Expanded conditional
                                  air                                    in air              requirement to
                                                                                             include all
                                                                                             terrestrial,
                                                                                             greenhouse,
                                                                                             forestry, and
                                                                                             residential outdoor
                                                                                             uses.
----------------------------------------------------------------------------------------------------------------
 Metabolism Testing
----------------------------------------------------------------------------------------------------------------
  162-1                          Aerobic soil                 835.4100  Aerobic soil        New expanded
                                  metabolism                             metabolism          conditional
                                                                                             requirement to
                                                                                             include aquatic
                                                                                             uses where the
                                                                                             pesticide is
                                                                                             applied to aquatic
                                                                                             sites that are
                                                                                             intermittently dry.
--------------------------------
  162-2                          Anaerobic soil               835.4200  Anaerobic soil      Reinserted.
                                  metabolism                             metabolism          Erroneously omitted
                                                                                             from published CFR.
--------------------------------
  162-4                          Aerobic aquatic              835.4300  Aerobic aquatic     Expanded requirement
                                  metabolism                             metabolism          to include all
                                                                                             terrestrial and
                                                                                             forestry uses.
--------------------------------
  162-3                          Anaerobic aquatic            835.4400  Anaerobic aquatic   Expanded requirement
                                  metabolism                             metabolism          to include all
                                                                                             terrestrial uses.
--------------------------------
Mobility Testing................................................................................................
----------------------------------------------------------------------------------------------------------------
  163-1                          Leaching and                 835.1230  Leaching and        No changes.
                                  adsorption/                 835.1240   adsorption/
                                  desorption                             desorption
--------------------------------
  163-2                          Volatility (Lab)             835.1410  Laboratory          No changes.
                                                                         volatility
--------------------------------
  163-3                          Volatility (Field)           835.8100  Field volatility    No changes.
--------------------------------
Dissipation Testing.............................................................................................
----------------------------------------------------------------------------------------------------------------

[[Page 12321]]

 
  164-1                          Soil                         835.6100  Terrestrial field   Expanded conditional
                                                                         dissipation         requirement to
                                                                                             include aquatic
                                                                                             uses involving
                                                                                             application to
                                                                                             aquatic sites that
                                                                                             are intermittently
                                                                                             dry. Merged with
                                                                                             the long-term field
                                                                                             dissipation study.
                                                                                             Added independent
                                                                                             laboratory
                                                                                             validation of
                                                                                             methods.
--------------------------------
  164-2                          Aquatic (sediment)           835.6200  Aquatic field       Expanded conditional
                                                                         dissipation         requirement to
                                                                                             include all
                                                                                             terrestrial uses.
                                                                                             Clarified
                                                                                             conditions for when
                                                                                             study is required.
                                                                                             Added independent
                                                                                             laboratory
                                                                                             validation of
                                                                                             methods.
--------------------------------
  164-3                          Forestry                     835.6300  Forestry            Changed from
                                                                         dissipation         ``required'' to
                                                                                             ``conditionally
                                                                                             required.'' Added
                                                                                             independent
                                                                                             laboratory
                                                                                             validation of
                                                                                             methods.
--------------------------------
  164-4                          Combination and tank         835.6400  Combination and     No changes.
                                  mixes                                  tank mixes
--------------------------------
  164-5                          Soil, long term                        None                Merged with the
                                                                                             terrestrial field
                                                                                             dissipation study.
--------------------------------
Accumulation Testing............................................................................................
----------------------------------------------------------------------------------------------------------------
  165-1                          Confined rotational                    None                Moved to Subpart O--
                                  crops                                                      Residue Chemistry.
--------------------------------
  165-2                          Field rotational                       None                Moved to Subpart O--
                                  crops                                                      Residue Chemistry.
--------------------------------
  165-3                          Accumulation in                        None                Eliminated
                                  irrigated crops                                            requirement.
--------------------------------
  165-4                          Accumulation in fish         850.1730  Accumulation in     Clarified conditions
                                                                         fish                for when study is
                                                                                             required.
--------------------------------
  165-5                          Accumulation in              850.1950  Accumulation in     Expanded conditional
                                  aquatic nontarget                      aquatic nontarget   requirement to
                                  organisms                              organisms           include all
                                                                                             terrestrial uses.
--------------------------------
                                 None                         835.7100  Ground water        Proposed conditional
                                                                         monitoring          requirement. Added
                                                                                             independent
                                                                                             laboratory
                                                                                             validation of
                                                                                             methods.
--------------------------------
                                          Subpart O--Residue Chemistry
----------------------------------------------------------------------------------------------------------------
Supporting Information
----------------------------------------------------------------------------------------------------------------
  171-2                          Chemical identity            860.1100  Chemical identity   No changes.
--------------------------------
  171-3                          Directions for use           860.1200  Directions for use  No changes.
--------------------------------
  171-6                          Proposed tolerance           860.1550  Proposed tolerance  No changes.
--------------------------------
  171-7                          Reasonable grounds in        860.1560  Reasonable grounds  No changes.
                                  support of the                         in support of the
                                  petition                               petition
--------------------------------
  171-13                         Submittal of                 860.1650  Submittal of        No changes.
                                  analytical reference                   analytical
                                  standards                              reference
                                                                         standards
--------------------------------
Nature of the Residue...........................................................................................
----------------------------------------------------------------------------------------------------------------
  171-4                          Nature of the residue        860.1300  Nature of the       No changes.
                                  in plants                              residue in plants
--------------------------------

[[Page 12322]]

 
  171-4                          Nature of the residue        860.1300  Nature of the       Clarified test
                                  in animals                             residue in          substance.
                                                                         animals            Expanded requirement
                                                                                             to include:
                                                                                            1. Testing whenever
                                                                                             treated crops used
                                                                                             for feed.
                                                                                            2. Cases when a
                                                                                             pesticide is
                                                                                             applied to
                                                                                             livestock premises
                                                                                             or is used in
                                                                                             livestock drinking
                                                                                             water.
                                                                                            Eliminated
                                                                                             requirement for
                                                                                             residential outdoor
                                                                                             use.
--------------------------------
Analytical Methods..............................................................................................
----------------------------------------------------------------------------------------------------------------
  171-4                          Residue analytical           860.1340  Residue analytical  Clarified test
                                  method                                 method              substance. Added
                                                                                             independent
                                                                                             laboratory
                                                                                             validation
                                                                                             requirement.
--------------------------------
                                 None                         860.1360  Multiresidue        Previously part of
                                                                         method              the residue
                                                                                             analytical method
                                                                                             study.
--------------------------------
Magnitude of the Residue Testing................................................................................
----------------------------------------------------------------------------------------------------------------
                                 None                         860.1380  Storage stability   Previously part of
                                                                         data                the magnitude of
                                                                                             the residue
                                                                                             studies.
--------------------------------
  171-4                          Crop field trials            860.1500  Crop field trials   No changes.
--------------------------------
  171-4                          Processed food/feed          860.1520  Processed food/     Clarified test
                                                                         feed                substance.
--------------------------------
  171-4                          Meat/milk/poultry/           860.1480  Meat/milk/poultry/  Clarified test
                                  eggs                                   eggs                substance.
                                                                                            Clarified conditions
                                                                                             for when study is
                                                                                             required.
--------------------------------
  171-4                          Potable water                860.1400  Potable water       Clarified test
                                                                                             substance.
--------------------------------
  171-4                          Fish                         860.1400  Fish                Clarified test
                                                                                             substance.
--------------------------------
  171-4                          Irrigated crops              860.1400  Irrigated crops     Clarified test
  165-3........................                                                              substance.
--------------------------------
  171-4                          Food handling                860.1460  Food handling       No changes.
--------------------------------
  171-5                          Reduction in Residues                  Anticipated         Name change.
                                                                         residues            Expanded
                                                                                             requirement to
                                                                                             include testing on
                                                                                             a single serving.
--------------------------------
  165-1                          Confined rotational          860.1850  Confined            Moved from
                                  crops                                  rotational crops    Environmental Fate
                                                                                             data requirements.
--------------------------------
  165-2                          Field rotational             860.1900  Field rotational    Moved from
                                  crops                                  crops               Environmental Fate
                                                                                             data requirements.
                                                                                            Modified conditions
                                                                                             for when study is
                                                                                             required.
--------------------------------
                                         Subpart U--Applicator Exposure
----------------------------------------------------------------------------------------------------------------
                                 None                         875.1100  Dermal outdoor      Proposed
                                                              875.1600   exposure            requirement.
                                                                                            Subject to new
                                                                                             testing criteria.
--------------------------------
                                 None                         875.1200  Dermal indoor       Proposed
                                                              875.1600   exposure            requirement.
                                                                                            Subject to new
                                                                                             testing criteria.
--------------------------------
                                 None                         875.1300  Inhalation outdoor  Proposed
                                                              875.1600   exposure            requirement.
                                                                                            Subject to new
                                                                                             testing criteria.
--------------------------------
                                 None                         875.1400  Inhalation indoor   Proposed
                                                              875.1600   exposure            requirement.
                                                                                            Subject to new
                                                                                             testing criteria.
--------------------------------

[[Page 12323]]

 
                                 None                         875.1500  Biological          Proposed conditional
                                                              875.1600   monitoring          requirement.
                                                                                            Subject to new
                                                                                             testing criteria.
--------------------------------
                                 None                         875.1600  Data reporting and  Proposed
                                                                         calculations        requirement.
                                                                                            Subject to new
                                                                                             testing criteria.
--------------------------------
                                 None                         875.1700  Product use         Proposed
                                                                         information         requirement.
                                                                                            Subject to new
                                                                                             testing criteria.
----------------------------------------------------------------------------------------------------------------
\1\ If the study requirement is not identified as a ``new requirement,'' then the change has been required on a
  case-by-case basis.

XXIV. Public Comments Sought

    EPA invites you to provide your views on the various options as 
proposed, other approaches, the potential impacts of the various 
options (including possible unintended consequences), and any data or 
information that you would like the Agency to consider during the 
development of the final rule. In addition, the Agency welcomes 
specific comments on the following topics of particular interest to the 
Agency:
    1. Ensuring high quality data to meet EPA's mandates. These 
proposed revisions to the pesticide data requirements in part 158 are 
intended to ensure that the Agency has the data required to support a 
determination of ``reasonable certainty of no harm'' under FFDCA and 
are an integral part of the data needed for an ``unreasonable adverse 
effects'' determination under FIFRA. In developing this proposed rule, 
EPA has evaluated its data needs to conduct the significantly expanded 
risk assessments required by new statutory mandates. EPA believes that 
this proposal describes the data needed (and only the data needed) for 
this purpose. The Agency welcomes your specific comments on the need 
for, value of, and any alternatives to, the data requirements described 
in this document to meet its mandates.
    2. Ensuring a sound scientific basis that is consistent with 
advances in scientific understanding. These proposed revisions are 
intended to ensure that the data requirements in part 158 reflect 
current scientific understanding and scientific advances since they 
were issued in 1984. As discussed throughout this document, and 
summarized in Unit XVIII, many of these proposed revisions have been 
presented to, and reflect the advice and recommendations of the NRC or 
SAP. Issues and related materials that are brought by EPA to the SAP 
undergo a public review and comment opportunity before the SAP issues 
its report with recommendations to the Agency. The Agency welcomes your 
comments on the scientific basis of this proposed rule.
    3. Improving the transparency and usefulness of part 158. Many of 
the revisions proposed in this document are intended to improve the 
usefulness of part 158 in identifying the specific data requirements 
that could apply to a particular pesticide application. As with the 
original design of part 158 in 1984, given the variety in pesticide 
chemistry, exposure, and hazard, these revisions are intended to retain 
a fair amount of flexibility in their application, while improving 
clarity and transparency to the regulated community. In future efforts 
to improve clarity and usefulness, EPA intends to issue separate 
revisions addressing antimicrobial pesticides, biochemical and 
microbial pesticides, which will highlight data requirements that apply 
to those pesticides. The Agency welcomes your specific comments on the 
Agency's efforts in this respect as described in this document and your 
specific suggestions for further improvements. In particular, the 
Agency welcomes public comment on the clarity of the proposed data 
requirements and the relationship between the proposed data 
requirements and EPA's statutory determinations.
    4. Estimating costs and benefits. As summarized in Unit XXVII.A., 
the Agency has prepared a qualitative assessment of the benefits of the 
proposed rule, and estimates the potential annual costs to the 
regulated community of approximately $50 million more than current data 
requirements as described in part 158. The Agency believes that the 
costs of the rule are justified by the benefits from enhanced 
protection of human health and the environment. The Agency welcomes 
comments on its economic analysis of the proposed rule, as well as on 
its underlying assumptions and economic data. Describe any assumptions 
and provide any technical information and/or data that you used. If you 
estimate potential costs or burdens, explain how you arrived at your 
estimate in sufficient detail to allow for it to be reproduced. As 
indicated in Unit V.B.1, EPA's underlying principle in developing the 
proposed revisions has been to strike an appropriate balance between 
the need for adequate data to make the statutorily mandated 
determinations and informed risk management decisions, while minimizing 
data collection burdens on pesticide applicants. The Agency welcomes 
your specific comments on the Agency's efforts described in this 
document and your specific suggestions for further improvements.
    5. Enhancing international harmonization. EPA is active in a number 
of scientific harmonization and regulatory coordination efforts through 
international and regional organizations, and directly with other 
countries, in order to develop common or compatible international 
approaches to pesticide review and registration. In addition, EPA has 
encouraged registrants to coordinate data submissions in the three 
NAFTA countries to facilitate joint reviews. The Agency believes that 
these proposed revisions reflect these efforts, and welcomes your 
comments on this specific point.
    6. Reducing, replacing and refining the use of animals in 
generating required data. As discussed in Unit XXII, where testing is 
needed to develop scientifically adequate data, the Agency is committed 
to reducing or replacing, wherever possible, the number of animals used 
for testing by incorporating in vitro (non-animal) test methods or 
other alternative approaches that have been scientifically validated 
and have received regulatory acceptance. The Agency understands that 
many people remain concerned about the use of animals for research and 
data development purposes, and has received several requests for more 
expeditious adoption of alternate methods. The Agency plays an 
important role in the Federal interagency efforts to encourage the

[[Page 12324]]

reduction of the number of animals used in testing; seek opportunities 
to replace test methods requiring animals with alternative test methods 
when acceptable alternative methods are available; and refine existing 
test methods to optimize animal use when there is no substitute for 
animal testing. Recognizing the different roles of data requirements 
and test guidelines, the Agency welcomes your specific comments on its 
efforts to ensure that the data requirements continue to provide 
sufficient flexibility to allow for the use of alternative approaches 
that have been scientifically validated and have received regulatory 
acceptance. The Agency welcomes specific recommendations on ways to 
reduce the number of animals tested while still allowing the Agency to 
meet its statutory obligations.

XXV. References

    The Agency has 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 listed in the ``EDOCKET'' index available 
at http://www.epa.gov/edocket. Select ``Quick Search'' and then use the 
Docket ID No. to access the index. The following is a listing of the 
documents that are specifically referenced in this proposed rule. These 
documents, and other supporting materials, are included in the docket 
index. Please note that the official docket includes the documents 
located in the docket as well as the documents that are referenced in 
those documents. As indicated previously, not all docket materials are 
available electronically, but all publicly available docket materials 
are available through the Docket facility as described under ADDRESSES.
    1. National Research Council, ``Pesticides in the Diets of Infants 
and Children,'' National Academy Press, Washington, D.C., 1993.
    2. Mineau et al., 2001. Pesticide Acute Toxicity Reference Values 
for Birds, Review of Environmental Contamination and Toxicology, 170: 
13-74.
    3. U.S. Environmental Protection Agency. 1998. EPA's Contaminated 
Sediment Management Strategy. EPA-823-R-98-001. Office of Water, 4305, 
Washington, D.C. http://www.epa.gov/waterscience/cs/stratndx.html.
    4. Bennett et al., Overview of Methods for Evaluating Effects of 
Pesticides on Reproduction in Birds., U.S. EPA, Environmental Research 
Laboratory, Corvalis, OR., EPA 600/3-91/048.
    5. Bennet et al., 1990. Effects on the Duration and Timing of 
Dietary Methyl Parathion Exposure on Bobwhite Reproduction, 
Environmental Toxicology and Chemistry, 9: 1473-1480.
    6. Bennett et al., 1991. Effects of Dietary Exposure to Methyl 
Parathion on Egg-laying and Incubation in Mallards, Environmental 
Toxicology and Chemistry, 10: 501-507.
    7. Luster et al., 1992. Risk Assessment in Immunotoxicology I. 
Sensitivity and Predictability of Immune tests, Fundam. Appl. Toxicol, 
18: 200-210.
    8. Luster et al., 1993. Risk Assessment in Immunotoxicology II. 
Relationships Between Immune and Host Resistance Tests, Fundamental amd 
Applied Toxicology, 21: 71-82.
    9. USEPA (1990) 1990 OECD Ad Hoc Meeting on Neurotoxicity Testing. 
Summary Report. September 1990. Eastern Research Group, MA.
    10. Determination of the Appropriate FQPA Safety Factor(s) in 
Tolerance Assessment. Office of Pesticide Programs, U.S. Environmental 
Protection Agency, Washington D.C, February, 2002.
    11. FIFRA Scientific Advisory Panel. SAP Report No. 99-03, May 25, 
1999 FIFRA Scientific Advisory Panel Meeting, May 25-27, 1999, held at 
the Sheraton Crystal City Hotel, Arlington, Virginia.
    12. ILSI (2001) Developing strategies for agricultural chemical 
safety evaluation, a report from an April 22-23, 2001 workshop. ILSI 
Health and Environmental Sciences Institute. http://hesi.ilsi.org/activities/actslist.cfm?pubentityid=8&pubactivityid=261 2001 draft).
    13. USEPA (U.S. Environmental Protection Agency), Pesticide 
Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and 
Domestic Animals, Series 84, Mutagenicity, Addendum 9, Office of 
Pesticides and Toxic Substances, EPA-540/09-91-122, NTIS Publication 
No. PB91-158394, Washington, DC, 1991.
    14. K. Dearfield, A. Auletta, M. Cimino and M. Moore, 
Considerations in the U.S. Environmental Protection Agency's testing 
approach for mutagenicity, Mutation Research 258 (1991) 259-283.
    15. USEPA (U.S. Environmental Protection Agency), Guidelines for 
mutagenicity risk assessment, 51 FR 34006-34012 (1986).
    16. Dourson, M.L., Knauf, L.A., and Swartout, J.C. (1972). On 
Reference Dose (RfD) and its underlying toxicity data base. Toxicology 
and Industrial Health 8:171-189.
    17. Health Canada, Pesticide Management Regulatory Agency (1997) 
Reproductive Toxicity Testing in Proposed 40 CFR part 158, Subdivision 
W - Data Requirements for Antimicrobial Pesticides. November 1997 
draft. Attachment to memorandum from Don Grant (PMRA) to Norm Cook/Tim 
McMahon/Sue Makris (USEPA/OPP), December 1, 1997.
    18. Spielmann, H., and Gerbracht, U. (2001). The use of dogs as 
second species in regulatory testing of pesticides. Part II: subacute, 
subchronic and chronic studies in the dog. Archives of Toxicology 
75(1): 1-21.
    19. U. S. EPA, 2004. ``Economic Analysis of the Proposed Rule 
Changing Data Requirements for Conventional Pesticides,'' BEAD/OPP/
USEPA, Washington, DC. Document ID No. 2004-0387-00.

XXVI. FIFRA Review Requirements

    In accordance with FIFRA sec. 25(a), this proposal was submitted to 
the FIFRA SAP, the Secretary of Agriculture, and appropriate 
Congressional Committees. The SAP has waived its review of this 
proposal, and no comments were received from any of the Congressional 
Committees. USDA participated fully in the OMB interagency review 
process, and where warranted, changes were made to the proposal based 
upon its comments.

XXVII. 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) determined that this proposed rule is a ``significant 
regulatory action'' under sec. 3(f) of the Executive Order because this 
action might raise novel legal or policy issues or otherwise have a 
potentially significant impact on pesticide producers or registrants of 
pesticide products. As a result of this OMB determination, EPA 
submitted this proposed rulemaking to OMB for review under Executive 
Order 12866 and any changes made in response to OMB comments have been 
documented in the public docket for this rulemaking as required by sec. 
6(a)(3)(E) of the Executive Order.
    EPA has prepared an economic analysis of the potential costs 
associated with this proposed action, which is contained in a document 
entitled ``Economic Analysis of the Proposed Rule Changing Data 
Requirements for Conventional Pesticides'' (Ref. 19). A copy of this 
Economic Analysis is available in the public docket for this action, 
and is briefly summarized here.
    The cost of the proposed rule is calculated as the estimated costs 
for the

[[Page 12325]]

proposed changes to the existing data requirements as currently 
codified in 40 CFR part 158. Since most of the data requirements 
contained in this proposal have been applied on a case-by-case basis 
over the years to reflect the evolution of scientific understanding and 
concerns, the Agency further categorizes the proposed revisions that 
are not currently codified as either newly codified (i.e., data 
requirements that are not currently in part 158, but are, in practice, 
required on a case-by-case basis) or expanded existing requirements 
(i.e., change in frequency with which a currently codified data 
requirement would be imposed. For example, a change from conditionally-
required to required, or visa versa. Another example is a change in use 
pattern for an existing requirement) or newly imposed (i.e., data 
requirement have not been previously imposed).
    Using the currently codified requirements as the baseline for the 
impact analysis, the total annual impact to the pesticide industry is 
estimated to be about $51 million. Of this estimated total annual 
impact, about $28.9 million per year represents the cost of new data 
requirements that were imposed over the years but were not specified in 
the existing part 158, and about $21.6 million represents the cost of 
modified or expanded existing data requirements (i.e., data 
requirements for certain tests and use patterns in the CFR that are 
changing from conditionally required (CR) to required (R)). As they 
have been applied to an increasing number of registrations, these data 
requirements have become more regularly required and are now being 
proposed. Included in the $51 million is about $1.9 million that is 
attributable to newly imposed requirements. The costs of the newly 
imposed requirements represents the increase costs over current 
practices, and therefore provide the estimated practical impact of this 
proposed rule to the pesticide industry.
    To calculate the potential costs associated with this proposal, EPA 
first identified the test necessary to generate the data required, and 
then gathered information on the price that laboratories might charge a 
firm to conduct that test for the firm. We assumed that the data 
required would always need to be generated, but often the data are 
already available because the firm generated it for their own use. In 
such cases, the firm would simply need to submit those data to EPA, 
which involves less burden and cost than generating it. Some firms may 
have surrogate data that could be used, while others may qualify for a 
waiver. Both of which also involve less costs than generating the data 
anew. For each test identified, we averaged the low and high cost 
estimates provided by the various laboratories. Variations can be 
related to differences in the assumptions about the test performed 
(e.g., protocol, species used), or it could simply be a difference in 
the price charged by the laboratory.
    EPA then used historical data on pesticide registration actions 
that occurred over a 7 year period (1996-2002) to identify the entities 
that sought pesticide registration actions in the past. The data 
required for each registration action depends on several factors, 
including the type of registration action (e.g., registration of a new 
active ingredient food use, registration of a new active ingredient 
non-food use, registration and amendments to registrations involving a 
major new use); data category or discipline (e.g., toxicology, residue 
chemistry, human exposure), and use pattern (how the product will be 
used). To estimate the average incremental cost of each type of 
registration action, the percentage of time a particular test was 
required was estimated by EPA scientists, based on their past 
experience in the program and their involvement in developing the new 
data requirements.
    The Agency prepared an industry profile using the same historical 
data on pesticide registration actions to identify the companies 
involved in those actions, and based it on public information gathered 
about those companies. EPA also used this industry profile to analyze 
the potential impacts of the proposed rule on small businesses, the 
results of which are summarized in Unit XXVII.C. The incremental costs, 
and a more detailed discussion of the estimating methodology employed 
in the analysis are presented in the economic impact analysis prepared 
for this proposed rule (Ref. 19).
    Since the likely overall impact of this proposal on businesses is 
small, the Agency believes that a deleterious effect on the 
availability of pesticides to users is unlikely. On balance, the Agency 
believes that the costs of the rule are justified by the benefits from 
enhanced protection of human health and the environment.
    The data requirements in part 158 potentially apply to new 
pesticides submitted for registration, to new uses of currently 
registered pesticides, and to existing chemicals whose databases are 
subject to Agency review to determine if they continue to meet 
registration standards. For these existing chemicals, part 158 data 
requirements are potentially relevant to three review programs.
    Reregistration (mandated in 1988) and tolerance reassessment 
(mandated in 1996) are well underway. Data requirements under those 
programs have largely been imposed on registrants of existing 
chemicals, and the data have been submitted. EPA anticipates that by 
the time this proposed rule is promulgated, few of the data 
requirements will remain to be imposed for existing chemicals. Only 
those that are ``new'' or ``newly codified '' (e.g., developmental 
neurotoxicity, immunotoxicity, sediment testing) have not been broadly 
required and may be imposed in the future under the reregistration or 
tolerance reassessment programs. Continued data needs for existing 
chemicals must be imposed under the Agency's Data Call-In (DCI) 
program.
    Should such data be needed for reregistration or tolerance 
reassessment after promulgation of this rule, EPA anticipates that it 
will articulate the specific burden and costs associated with each DCI 
pursuant to the appropriate Information Collection Request (ICR) 
approvals under the Paperwork Reduction Act (PRA). Since the approval 
process for the PRA requires that EPA characterize the information 
collection burdens and costs incurred by registrants to comply with a 
DCI, a complete estimate of the burden and costs for the DCIs will be 
provided at that time. EPA believes that the public process associated 
with the PRA approval for the DCI related ICRs is a reasonable way to 
account for the data costs without double counting the burden. 
Accordingly, in this proposal EPA has not evaluated the potential 
burden of the proposed data requirements on registrants of existing 
chemicals.
    A third program, registration review, mandated in 1996, requires 
that EPA establish a program for the periodic review of existing 
chemicals (goal is every 15 years). Any data requirements to be levied 
under that program will also be imposed under a DCI. At this time, EPA 
is developing a proposed rule to establish procedures for this program. 
An Advance Notice of Proposed Rulemaking was published in the Federal 
Register on April 26, 2000 (65 FR 24585)(FRL-6488-9).
    The data requirements in this proposed rule are expected to apply 
to all chemicals subject to registration review (i.e., all existing 
chemicals), depending on the conditions expressed in both final rules 
(this part 158 and the future registration review rule). At this time 
EPA has not determined how the

[[Page 12326]]

registration review program will function. Until the registration 
review program is better defined, any estimates of burden/cost will be 
unreliable and highly speculative. Moreover, since the requirements 
will also be imposed via DCIs, such burdens will also be characterized 
under PRA procedures described earlier.
    Accordingly, EPA intends to describe generally the burden and costs 
of potential data requirements at the time the registration review rule 
is proposed, and ultimately, to more accurately and fully characterize 
the individual DCI burden and costs during the public process 
associated with PRA approval.

B. Paperwork Reduction Act (PRA)

    Pursuant to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., an agency may not conduct or sponsor, and a person is not 
required to respond to an information collection request unless it 
displays a currently valid OMB control number. The OMB control numbers 
for EPA's regulations, after appearing in the preamble of the final 
rule, are listed in 40 CFR part 9 and 48 CFR chapter 15, and included 
on the related collection instrument (e.g., form or survey). 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.
    EPA has determined that this proposed rule imposes no significant 
additional information collection and paperwork burden. The information 
collection activity contained in this proposed rule, i.e., the 
paperwork collection activities related to the submission of data to 
EPA in order to register a conventional pesticide product, are already 
approved by OMB under several existing ICRs. Specifically, the program 
activities which would generate a paperwork burden under this proposal 
are covered by the following 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 
special review are currently approved under OMB Control No. 2070-0057 
(EPA ICR No. 0922).
    These existing ICRs cover the paperwork activities contained in 
this proposal because these activities already occur as part of the 
Agency's existing program activities. These program activities are an 
integral part of the Agency pesticide program and the corresponding 
ICRs will continue to be regularly renewed pursuant to the PRA. The 
approved burden in these ICRs were already increased in 1996 to 
accommodate the potential increased burden related to the 
implementation of the new safety standard imposed in 1996 by FQPA.
    The total estimated average annual public reporting burden 
currently approved by OMB for these various activities ranges from 8 
hours to approximately 3,000 hours per respondent, depending on the 
activity and other factors surrounding the particular pesticide 
product. Additional information about this estimate is provided in the 
Economic Analysis for this rulemaking.
    Comments are requested on the Agency's need for this information, 
the accuracy of the burden estimates, and any suggested methods for 
minimizing respondent burden, including through the use of automated 
collection techniques. The Agency is particularly interested in 
receiving comment on the estimated testing costs and burdens that are 
presented in the Economic Analysis, as well as suggestions for how the 
Agency might best be able to provide updated and more detailed 
estimates in the context of the individual ICRs during the regular 
renewals of those ICRs every 3 years. Send comments to EPA as part of 
your overall comments on this proposed action in the manner specified 
in Unit I.C. In the final rule, the Agency will address any comments 
received regarding the information collection requirements contained in 
this proposal.

C. Regulatory Flexibility Act

    Pursuant to sec. 605(b) of the Regulatory Flexibility Act (RFA), 5 
U.S.C. 601 et seq., the Agency hereby certifies that this proposal will 
not have a significant adverse economic impact on a substantial number 
of small entities. This determination is based on the Agency's economic 
analysis performed for this rulemaking, which is summarized in Unit 
XXVII.A., and a copy of which is available in the public docket for 
this rulemaking. The following is a brief summary of the factual basis 
for this certification.
    As part of the economic analysis prepared for this rulemaking, EPA 
used historical data to prepare an industry profile of potentially 
impacted entities prepared for the economic analysis for this 
rulemaking, EPA determined that this proposed rule is not expected to 
impact any small not-for-profit organizations or small governmental 
jurisdictions. As such, the small entity impact analysis prepared as 
part of the economic analysis evaluated potentially impacted businesses 
that could be considered small businesses as defined by the Small 
Business Administration, which uses the maximum number of employees or 
sales for businesses in each industry sector, as that sector is defined 
by NAICS. For example, entities defined as Pesticide and Other 
Agricultural Chemical Manufacturing (325320) are considered to be a 
small business if they employ 500 or fewer people.
    Although, as illustrated by the industry profile, the conventional 
pesticide industry is primarily composed of large, multi-national 
corporations, EPA used historical data to evaluate potential impacts on 
small firms that could be subject to the proposed requirements.
    To determine the universe of small entities that could be subject 
to the proposed requirements, the Agency used workforce data to 
determine the size for 565 firms for which financial data had been 
gathered for the economic analysis. Based on that data, EPA determined 
that 449 qualified as small businesses using the SBA definition. Using 
the resulting ratio of 79%, the Agency estimated that out of the total 
1804 firms in the pesticide industry, approximately 1434 firms might 
qualify as small and could make up the universe of small entities that 
could be subject to the proposed requirements.
    EPA then used historical data to estimate the number of small 
entities potentially impacted, and the extent of that potential impact. 
EPA used workforce data gathered on 120 firms identified as impacted by 
the proposal using historical data to determine the size of 97 firms. 
Based on that data, we determined that 49 firms of the 97 firms (51%) 
qualified as small businesses.

[[Page 12327]]

 Data was unavailable for 23 firms, but using the same ratio (51%), EPA 
estimated that a total of 61 small firms could be potentially impacted 
by the proposal. Out of the universe of 1434 small firms that could be 
subject to the proposed requirements, or out of the 61 small firms 
potentially impacted, only 35 small firms are expected to experience a 
cost increase representing 1% or more of gross sales, of which only 23 
small firms are expected to experience a cost increase representing 3% 
or more of gross sales. Given these estimated impacts on small 
businesses, EPA has concluded that the proposed revisions will not have 
a significant adverse economic impact on a substantial number of small 
entities.
    EPA is particularly interested in receiving comment from small 
businesses as to the benefits, costs and impacts of this proposed rule. 
Any comments regarding the estimated potential small entity economic 
impacts that this proposed regulatory action may impose on small 
entities should be submitted to the Agency in the manner specified in 
Unit I.

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, and tribal governments, in the 
aggregate, or the private sector in any one year. As described in Unit 
XXVII.A., the annual costs associated with this action are estimated to 
total $51 million. This cost represents the incremental cost to 
applicant and registrants attributed to the additional or modified data 
requirements contained in this proposal. In addition, since State, 
local, and tribal governments are rarely a pesticide applicant or 
registrant, the proposed rule is not expected to significantly or 
uniquely affect small governments. Accordingly, this action is not 
subject to the requirements of secs. 202 and 205 of UMRA.

E. Executive Order 13132

    Pursuant to Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999), EPA has determined that this proposed 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 the Order. As indicated above, instances where a state is 
a registrant are extremely rare. Therefore, this proposed rule may 
seldom affect a state government. Thus, Executive Order 13132 does not 
apply to this proposed rule. In the spirit of the Order, and consistent 
with EPA policy to promote communications between the Agency and State 
and local governments, EPA specifically solicits comment on this 
proposed rule from State and local officials.

F. Executive Order 13175

    As required by Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000), EPA has determined that this proposed rule does not have tribal 
implications because it will not have substantial direct effects 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 Order. As indicated above, at present, no tribal 
governments hold, or have applied for, a pesticide registration. Thus, 
Executive Order 13175 does not apply to this proposed rule. In the 
spirit of the Order, and consistent with EPA policy to promote 
communications between the Agency and State and local governments, EPA 
specifically solicits comment on this proposed rule from tribal 
officials.

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 proposed rule because this action is not 
designated as an ``economically significant'' regulatory action as 
defined by Executive Order 12866 (see Unit XXVII.A.). Further, this 
proposal does not establish an environmental standard that is intended 
to have a negatively disproportionate effect on children. To the 
contrary, this action will provide added protection for children from 
pesticide risk. The proposed data requirements are intended to address 
risks that, if not addressed, could have a disproportionate negative 
impact on children. EPA will use the data and information obtained by 
this proposed rule 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 
likely to have any significant adverse effect on the supply, 
distribution, or use of energy.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), 15 U.S.C. 272 note) directs EPA to use voluntary 
consensus standards in its regulatory activities unless to do so would 
be inconsistent with applicable law or impractical. Voluntary consensus 
standards are technical standards (e.g., materials specifications, test 
methods, sampling procedures, etc.) that are developed or adopted by 
voluntary consensus standards bodies. NTTAA directs EPA to provide 
Congress, through OMB, explanations when the Agency decides not to use 
available and applicable voluntary consensus standards. This regulation 
proposes the types of data to be required to support conventional 
pesticide registration but does not propose to require specific methods 
or standards to generate those data. Therefore, this proposed 
regulation does not impose any technical standards that would require 
Agency consideration of voluntary consensus standards. The Agency 
invites comment on its conclusion regarding the applicability of 
voluntary consensus standards to this rulemaking.

J. Executive Order 12898

    This proposed 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 has 
not considered environmental justice-related issues. Although not 
directly impacting environmental justice-related concerns, the 
collection of the information contained in this proposed rule will 
enable the Agency to protect human health and the environment by being 
better able to prioritize chemical substances of concern.

List of Subjects in 40 CFR Parts 152 and 158

    Administrative practice and procedure, Agricultural commodities,

[[Page 12328]]

Pesticides and pests, Reporting and recordkeeping requirements.

    Dated: February 28, 2005.
Stephen L. Johnson,
Acting Administrator.
    Therefore, it is proposed that chapter I of title 40 of the Code of 
Federal Regulations be amended as follows:

PART 152--[AMENDED]

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

    Authority: 7 U.S.C. 136-136y. Subpart U is also issued under 31 
U.S.C. 9701.
    b. In Sec.  152.50, by amending paragraph (f)(1) by revising the 
reference ``FIFRA sec. 3(c)(1)(D)'' to read ``FIFRA sec. 3(c)(1)(F),'' 
and by revising paragraph (f)(2) to read as follows:


Sec.  152.50  Contents of application.

* * * * *
    (f) * * *
    (2) An applicant must furnish any data specified in part 158 of 
this chapter that are required by the Agency to determine that the 
product meets the registration standard of FIFRA sec. 3(c)(5) or 
3(c)(7), as applicable, and FIFRA sec. 10. An applicant may request a 
waiver of any data requirement by following the procedures in Sec.  
158.45 of this chapter. Each study must comply with:
    (i) Section 158.32 of this chapter, with respect to format of 
submission.
    (ii) Section 158.33 of this chapter, with respect to studies for 
which a claim of trade secret or confidential business information is 
made.
    (iii) Section 158.34 of this chapter, with respect to flagging for 
potential adverse effects.
    (iv) Section 160.12 of this chapter, with respect to a statement 
whether studies were conducted in accordance with Good Laboratory 
Practices of part 160.
* * * * *

PART 158--[AMENDED]

    2. In part 158:
    a. By revising the authority citation to read as follows:

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

    b. By revising the table of contents for part 158 to read as 
follows:
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.
158.70 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 categories.
158.110 Required and conditionally required data.
158.120 Determining data requirements.
158.130 Purposes of the registration data requirements.
Subpart C [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--Terrestrial and Aquatic Nontarget Organisms
158.400 Terrestrial and aquatic nontarget organisms data 
requirements table.
Subpart F--Toxicology
158.500 Toxicology data requirements table.
158.510 Tiered testing options for nonfood pesticides.
Subpart G--Product Performance
158.610 Product performance data requirements.
Subparts H-I [Reserved]
Subpart J--Nontarget Plant Protection
158.700 Nontarget plant protection data requirements table.
Subpart K--Post-application Exposure
158.800 General requirements.
158.810 Criteria for testing.
158.820 Post-application exposure data requirements table.
Subpart L--Biochemical Pesticides
158.910 Biochemical pesticide data requirements.
Subpart M--Microbial Pesticides
158.1010 Microbial pesticide data requirements.
Subpart N--Environmental Fate
158.1100 Environmental fate data requirements table.
Subpart O--Residue Chemistry
158.1200 Definitions.
158.1210 Residue chemistry data requirements table.
Subpart P--Pesticide Management and Disposal
158.1300 [Reserved]
Subpart R--Spray Drift
158.1410 Spray drift data requirements.
Subpart U--Applicator Exposure
158.1500 General requirements.
158.1510 Criteria for testing.
158.1520 Applicator exposure data requirements table.
Subpart V--Inert Ingredients
158.1600 [Reserved]
Subpart W--Antimicrobial Pesticides
158.1700 [Reserved]
    c. By revising subpart A to read as follows:

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 
judgements 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; or establish or maintain a tolerance or exemption from the 
requirement 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.


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 that applies to the Agency 
for:
    (1) An application for registration, amended registration, or 
reregistration

[[Page 12329]]

of a pesticide product under FIFRA secs. 3, 4 or 24(c).
    (2) An application for an experimental use permit under FIFRA sec. 
5.
    (3) An application for an exemption under FIFRA sec. 18.
    (4) A petition or other request for establishment or modification 
of a tolerance, for an exemption for the need for a tolerance, or for 
other clearance under FFDCA sec. 408.
    (5) A submission of data in response to a notice issued by EPA 
under FIFRA sec. 3(c)(2)(B).
    (6) Any other application, petition, or submission sent to EPA 
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.
    (7) For the purposes of this part, an applicant includes a 
registrant.
    Registration includes a new registration, amended registration and 
reregistration, unless stated otherwise.


Sec.  158.5  Applicability.

    (a) This subpart describes the data that are required to support 
the registration of each pesticide product. The information specified 
in this part must be submitted with each application for new or amended 
registration or for reregistration, if it has not been submitted 
previously or if the previously submitted information is not complete 
and accurate.
    (b) The requirements of this part apply to the following 
applicants:
    (1) Any person who submits an application for a new or amended 
registration in accordance with FIFRA sec. 3.
    (2) Any person who submits an application for an experimental use 
permit in accordance with FIFRA sec. 5.
    (3) Any person who petitions the Agency to establish, modify, or 
revoke a tolerance or exemption from a tolerance in accordance with 
FFDCA sec. 408.
    (4) Any person who submits data or information to support the 
continuation of a registration in accordance with FIFRA sec. 3 or 4.


Sec.  158.30  Flexibility.

    (a) FIFRA provides EPA flexibility to require, or not require, data 
and information for the purposes of making regulatory judgements for 
pesticide products. EPA maintains its authority to tailor data needs to 
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) The requirements of this section apply to any data 
submitted or cited to EPA in support of any new, pending, or existing 
regulatory action under FIFRA or FFDCA, including, but not limited to:
    (i) Registration, amended registration or reregistration.
    (ii) Experimental use permit.
    (iii) Data Call-in.
    (iv) Establishment, modification or revocation of a tolerance or 
exemption.
    (v) Submission of adverse effects information under FIFRA sec. 
6(a)(2).
    (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 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

[[Page 12330]]

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 one of the 
following statements:
    (i) Statement 1.
    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 
FIFRAsec. 10(g).
    (ii) Statement 2.
    Information claimed as confidential has been removed to 
aconfidential attachment.

No claims or markings on the document or any attachments, other than 
these statements and attachments submitted per 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.
    (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. Submitters are encouraged to include with the statement 
required under paragraph (c)(2) of this section the following 
additional statement to allow EPA to share information with State and 
foreign governments:
    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.

EPA will not consider such a statement to be a waiver of 
confidentiality or proprietary claims for 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 
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.
    (3) Information designated as releasable to state or foreign 
governments in accordance with paragraph (c)(4) of 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.


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.

[[Page 12331]]



                                            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                                870.3100,    males or females which increases
                                                       870.3150    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 (or registrant in the 
case of information submitted under FIFRA sec. 3(c)(2)(B)) 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. Statement 1.
    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. Statement 2.
    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 the request with the 
Agency before developing and submitting supporting data, information, 
or other materials.
    (2) All waiver requests must be submitted to the Agency in writing. 
The request must clearly identify the data requirement(s) for which a 
waiver is sought along with an explanation and supporting rationale why 
the applicant believes the data requirement should be waived. In 
addition, the applicant must describe any unsuccessful attempts to 
generate the required data, furnish any other information which the 
applicant(s) believes 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.  158.70  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

[[Page 12332]]

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.
    (b) Good laboratory practices. Applicants must adhere to the good 
laboratory practice (GLP) standards described in 40 CFR part 160 when 
conducting studies to support the registration, amended registration or 
reregistration of a pesticide product. 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 Pesticide Assessment 
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 Pesticide Assessment 
Guidelines may be obtained through the National Service Center for 
Environmental Publications (NSCEP), or by visiting the agency's website 
at www.epa.gov/pesticides. EPA publications can be ordered online 
(www.epa.gov/ncepihom/nepishom), or by telephone at 1-800-490-9198.
    (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 Cooperation 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 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 assure 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.
    d. By revising subpart B to read as follows:

Subpart B--How to Use the Data Tables


Sec.  158.100  Pesticide use categories.

    (a) General use categories. There are six broad use categories used 
in the data tables. The six broad categories include terrestrial 
outdoor uses, aquatic outdoor uses, greenhouse uses, forestry uses, 
residential outdoor uses, and indoor uses of all types. The 6 broad use 
categories are further subdivided into 15 general use categories which 
are the basis for data requirements established by use pattern. Within 
the data tables, general use categories 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 15 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 residential use.
    (6) Aquatic nonfood outdoor use.
    (7) Aquatic nonfood industrial use.
    (8) Greenhouse food crop use.
    (9) Greenhouse nonfood crop use.
    (10) Forestry use.
    (11) Residential outdoor use.
    (12) Residential indoor use.
    (13) Indoor food use.
    (14) Indoor nonfood use.
    (15) Indoor medical use.
    (b) Use pattern index. The Use Pattern Index is a comprehensive 
list of specific pesticide use patterns. The use index is alphabetized 
separately by site for all agricultural and all nonagricultural uses. 
The Use Pattern Index associates each pesticide use pattern with one or 
more of the 15 general use categories. It should be used in conjunction 
with the data tables to determine the applicability of data 
requirements to specific uses. The Pesticide Use Pattern 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 category for their 
particular product should consult the Agency.


Sec.  158.110  Required and conditionally required data.

    Some data and information specified in this part are required (R) 
for the evaluation of some or all types of products. However, other 
data and

[[Page 12333]]

information specified as conditionally required (CR) are required only 
if the product's pattern of use, results of other tests, or other 
pertinent factors meet the criteria specified in those sections.
    (a) Data designated as ``required'' (R) for products with a given 
use pattern are required by EPA to evaluate the risks or benefits of a 
product having that use pattern. Further clarification of the 
applicability of the data requirement often is located in the test 
notes accompanying the table.
    (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.


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, J, K, N, O, and U 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 L and M 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. Brackets indicate which 
data requirements also apply to experimental use permits (EUPS).
    (b) Identifying required studies. To determine the specific kinds 
of data needed to support the registration use of each pesticide 
product, the applicant should:
    (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 covers 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. For toxicology 
studies, if the data are intended to support a manufacturing-use 
product, use the first column. If the data are intended to support an 
end-use product, use the information listed in the second column.
    (ii) The test substances columns specify which substance is to be 
subjected to testing. Applicants should note that the substance that 
should 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 last column. See Sec.  158.70(c) for 
information pertaining to the guidelines and how to obtain copies.


Sec.  158.130  Purposes of the registration data requirements.

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

[[Page 12334]]

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.
    (6) 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 pesticides 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 shell 
fish. These residue data are also used to determine if a tolerance or 
action level is needed for residues in aquatic animals eaten by humans.
    (e) Hazards to 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 (usually conducted by feeding 
the test substance to the test species) studies 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 oncogenicity 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 teratogenesis 
and serve as a guide for subsequent tests.
    (5) Mutagenicity studies. For each test substance a battery of 
tests are required to assess 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, oncogenicity, 
and possibly, other health effects.
    (6) Metabolism studies. Data from studies on the absorption, 
distribution, excretion, and metabolism 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 increase the Agency's 
understanding of the behavior of the chemical in its consideration of 
the human exposure anticipated from intended uses of the pesticide.
    (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

[[Page 12335]]

appropriate wording for) precautionary labeling to minimize the 
potential adverse effect to nontarget organisms.
    (h) Hazards to nontarget organisms--(1) General. The information 
required to assess hazards to nontarget organisms are 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 hierarchial or tier system which progresses 
from the basic laboratory tests to the applied field tests. The results 
of each tier of test 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 determines the need for (and appropriate 
wording for) precautionary label statements to minimize the potential 
adverse effects to nontarget organisms.
    (2) Short-term studies. The short-term acute and subchronic 
laboratory studies provide basic toxicity information which serves as a 
starting point for the hazard assessment. These data are used: to 
establish acute toxicity levels of the active ingredient to the test 
organisms; to compare toxicity information with measured or estimated 
pesticide residues in the environment in order to assess potential 
impacts on fish, wildlife and other nontarget organisms; and to 
indicate whether further laboratory and/or field studies are needed.
    (3) Long-term and field studies. Additional studies (i.e., avian, 
fish, and invertebrate reproduction, lifecycle 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.
    (i) Product performance. Requirements to develop data on product 
performance provide a mechanism to ensure that pesticide products will 
control the pests listed on the label 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.

Subpart C [Removed and Reserved]

    e. By removing and reserving subpart C.
    f. By revising subpart D to read as follows:

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. (1) 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.
    (2) Depending on the results of the required product chemistry 
studies, appropriate use restrictions, labeling requirements, or 
special packaging requirements may be imposed.
    (3) All product chemistry data, as described in this section, are 
required to be submitted to support a request for an experimental use 
permit.
    (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

[[Page 12336]]

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
-------------------------------
  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       TGAI                        9
-------------------------------
  830.6303                      Physical state              R   MP and TGAI       EP and TGAI                 9
-------------------------------
   830.6304                     Odor                        R   MP and TGAI       TGAI                        9
-------------------------------
   830.6313                     Stability to                R   TGAI              TGAI                    9, 12
                                 normal and
                                 elevated
                                 temperatures,
                                 metals, and
                                 metal ions
-------------------------------
  830.6314                      Oxidation/                   CR MP                EP                         13
                                 reduction:
                                 chemical
                                 incompatability
-------------------------------
  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              TGAI
                                 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, 22
                                 density/bulk
                                 density
-------------------------------
  830.7370                      Dissociation                R   TGAI or PAI       TGAI or PAI             9, 23
                                 constants in
                                 water
-------------------------------
  830.7520                      Particle size,               CR TGAI or PAI       TGAI or PAI                24
                                 fiber length,
                                 and diameter
                                 distribution
-------------------------------

[[Page 12337]]

 
  830.7550                      Partition                    CR TGAI or PAI       TGAI or PAI                25
  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, 26
----------------------------------------------------------------------------------------------------------------

    (f) Test notes. The following test notes are applicable to the 
product chemistry data requirements in the table to paragrpah (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 is required 
only if the active ingredient is expected to come in contact with 
either material during storage.
    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. True density or specific density are required for all test 
substances. Data on bulk density is required for MPs that are solid 
at room temperature.
    23. Required when the test substance contains an acid or base 
functionality (organic or inorganic) or an alcoholic functionality 
(organic).
    24. Required for water insoluble test substances 
(<10-\6\ g/l) and fibrous test substances with diameter 
>=0.1 [mu]m.
    25. Required for all organic chemicals unless they dissociate in 
water or are partially or completely soluble in water.
    26. Not required for salts.


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 contains 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 in the product.
    (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

[[Page 12338]]

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 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 form 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.

[[Page 12339]]

    (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 of 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 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, unless the product label 
bears a statement prohibiting use after a certain date, in which case 
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.

[[Page 12340]]

    (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.
    g. By adding subpart E to read as follows:

Subpart E--Terrestrial and Aquatic Nontarget Organisms


Sec.  158.400  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 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 aquatic 
food crop, aquatic nonfood residential, aquatic nonfood outdoor, 
forestry and residential outdoor use.
    (3) In general, for all outdoor end-use products 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, oyster, and mysid. 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; [ 
]=Required or conditionally required for an experimental use permit; 
TGAI=Technical grade of the active ingredient; TEP=Typical end-use 
product; PAI=Pure active ingredient; 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
                                                 ------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           Aquatic
       Guideline Number         Data Requirement                   ------------------------------------------------------                                                                          Test substance       Test Note No.
                                                     Terrestrial                                    Nonfood                   Forestry         Residential       Greenhouse          Indoor
                                                                          Food       ------------------------------------                        Outdoor
                                                                                           Outdoor         Residential
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Avian and Mammalian Testing
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.2100                      Avian oral        [R]               [R]               [R]               R                 [R]               [R]               CR                CR                TGAI, TEP                  1, 2, 3, 4
                                 toxicity
-------------------------------
  850.2200                       Avian dietary    [R]               [R]               [R]               CR                [R]               [R]               NR                NR                TGAI                       1, 3, 5, 6
                                 toxicity
-------------------------------
  850.2400                      Wild mammal       CR                CR                CR                NR                CR                CR                NR                NR                TGAI                                7
                                 toxicity
-------------------------------
  850.2300                       Avian            R                 R                 R                 NR                R                 R                 NR                NR                TGAI                             1, 5
                                 reproduction
-------------------------------
  850.2500                      Simulated or      CR                CR                CR                NR                CR                CR                NR                NR                TEP                              8, 9
                                 actual field
                                 testing
-------------------------------
Aquatic Organisms Testing
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 12341]]

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

[[Page 12342]]

 
Nontarget Insect Testing
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  142-1                         Acute toxicity    --                --                --                --                --                --                --                --                TGAI                               27
                                 to aquatic
                                 insects
-------------------------------
  142-1                          Aquatic insect   --                --                --                --                --                --                --                --                TEP                                27
                                 life-cycle
-------------------------------
  142-3                         Simulated or      --                --                --                --                --                --                --                --                TEP                                27
                                 actual field
                                 testing for
                                 aquatic insects
-------------------------------
  143-1                         Predators and     --                --                --                --                --                --                --                --                TEP                                27
  143-2.......................   parasites
  143-3.......................
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (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 not required for liquid formulations for greenhouse 
and indoor uses. Study not required if there is no potential for 
environmental exposure.
    3. Data using the TEP are conditionally required based on the 
results of the avian acute oral (TGAI) and avian subacute dietary 
tests, intended use pattern, and environmental fate characteristics 
that indicate potential exposure.
    4. Data are preferred on redwing blackbird (Agelaius phoneiceus) 
and either mallard or bobwhite quail for terrestrial, aquatic, 
forestry, and residential outdoor uses. Data are preferred on 
mallard or bobwhite quail for indoor and greenhouse uses.
    5. Data are preferred on mallard and bobwhite quail.
    6. For aquatic nonfood residential uses, data are required to 
support liquid and solid formulated products on one species if the 
avian oral LD50 of the TGAI is less than or equal to 100 
mg a.i./kg. Data on a second species are required if the avian 
dietary LC50 in the first species tested is less than or 
equal to 500 ppm a.i. in the diet.
    7. 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.
    8. Tests are required based on the results of lower tier studies 
such as acute, subacute or reproduction bird and mammal testing, 
intended use pattern, and environmental fate characteristics that 
indicate potential exposure.
    9. 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.
    10. Data are preferred on rainbow trout and bluegill for 
terrestrial, aquatic, forestry, and residential outdoor uses. For 
indoor and greenhouse uses, testing with only one of either fish 
species is required. Generally, a second species will not be 
required for indoor and greenhouse use if the selected species 
LC50 is 1 ppm or less. However, if the TGAI is stable in 
the hydrolysis study, and the LC50 value of the first 
fish tested is between 1 ppm and 10 ppm, then testing with both 
species is required.
    11. Freshwater fish LC50 (the most sensitive of the 
species tested) using the TGAI, freshwater invertebrate 
EC50 (preferably Daphnia), and acute LC50/
EC50 estuarine and marine organisms studies using the EP 
or TEP are 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 in the aquatic environment 
is equal to or greater than 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.
    12. Data are preferred on Daphnia magna.
    13. Data are preferred on eastern oyster (Crassostrea virginica) 
and oppossum shrimp (America mysis) formerly (Mysidopsis bahia) and 
silver side (Menidia sp. )
    14. Data are generally not required for other, non-turf, outdoor 
residential uses, i.e., gardens and ornamentals.
    15. Data are preferred on rainbow trout. If fathead minnow 
(Pimephales promelus) is used, a 96 hour LC50 on that 
species must also be provided.
    16. Data are preferred on oppossum shrimp (America mysis) 
formerly (Mysidopsis bahia).
    17. Data are required on estuarine species if the product is:
    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 mg/l.
    iv. If the estimated environmental concentration in water is 
equal to or greater than 0.01 of the acute EC50 or 
LC50 and 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 greater than 4 days).
    18. Data are preferred on sheepshead minnow (Cypinodon 
variegatus).
    19. Data are required on estuarine 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.
    20. Data are required 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:

[[Page 12343]]

    i. If the estimated environmental concentration [See Hazard 
Evaluation Division Standard Evaluation Procedure Ecological Risk 
Assessment (EPA-540/09-86-167)] is greater than or equal to 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.
    21. Required based on the results of fish or aquatic nontarget 
organism accumulation studies (guidelines 850.1730 and 850.1950).
    22. Tests 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.
    23. Testing is required if the soil partition coefficient 
(Kd) is equal to or greater than 50 and the half-life of 
the pesticide in the sediment is equal to or less than 10 days in 
either the aerobic soil or aquatic metabolism studies. Registrants 
should consult with the Agency on appropriate test protocols.
    24. Testing is required if:
    i. The estimated environmental concentration is equal to or 
greater than the acute sediment EC50/LC50.
    ii. The soil partition coefficient (Kd) is equal to 
or greater than 50.
    (iii) The half-life of the pesticide in the sediment is greater 
than 10 days in either the aerobic soil or aquatic metabolism 
studies. Registrants should consult with the Agency on appropriate 
test protocols.
    25. Data required only when the formulation contains one or more 
active ingredients having an acute LD50 of <11 [mu]g/bee 
as determined in the honey bee acute contact study (guideline 
850.3020) and the use pattern(s) indicate(s) that honey bees may be 
exposed to the pesticide.
    26. 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 arthropods other than bees 
that indicate potential chronic, reproductive, or behavioral 
effects.
    27. This requirement is reserved pending further evaluation by 
EPA to determine what and when data should be required, and to 
develop appropriate test methods.

    h. By adding subpart F to read as follows:

Subpart F--Toxicology


Sec.  158.500  Toxicology data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table 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 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 
crop use, aquatic nonfood outdoor use, greenhouse nonfood crop use, 
forestry use, residential outdoor use, indoor nonfood use, and indoor 
residential use.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; [ 
]=Required or conditionally required for an experimental use permit; 
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 shows 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]                 MP and TGAI         TGAI, EP, and       1, 2
                                   toxicity--rat                                                                   possibly diluted
                                                                                                                   EP
---------------------------------
  870.1200                        Acute dermal        [R]                 [R]                 MP and TGAI         TGAI, EP, and       1, 2, 3
                                   toxicity                                                                        possibly diluted
                                                                                                                   EP
---------------------------------
  870.1300                        Acute inhalation    [R]                 [R]                 MP and TGAI         TGAI and EP         4
                                   toxicity - rat
---------------------------------
  870.2400                        Primary eye         [R]                 [R]                 MP                  TGAI and EP         3
                                   irritation -
                                   rabbit
---------------------------------
  870.2500                        Primary dermal      [R]                 [R]                 MP                  TGAI and EP         1, 3
                                   irritation
---------------------------------
  870.2600                        Dermal              [R]                 [R]                 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
---------------------------------

[[Page 12344]]

 
  870.3150                        90-day Oral - non-  [R]                 CR                  TGAI                TGAI                8
                                   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                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 and non-
                                   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        [R]                 R                   TGAI                TGAI                26, 27, 28
---------------------------------
  870.6300                        Developmental       CR                  CR                  TGAI                TGAI                26, 27, 28
                                   neurotoxicity
---------------------------------
Mutagenicity Testing....................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5100                          Bacterial reverse   [R]                 R                   TGAI                TGAI                29
                                   mutation assay
870.5300                          In vitro mammalian  [R]                 R                   TGAI                TGAI                29, 30
870.5375........................   cell assay
---------------------------------
870.5385                          In vivo             [R]                 R                   TGAI                TGAI                29, 31
870.5395........................   cytogenetics
---------------------------------
Special Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.7485                        Metabolism and      R                   CR                  PAI or PAIRA        PAI or PAIRA        32
                                   pharmacokinetics
---------------------------------
  870.7200                        Companion animal    CR                  CR                  --                  Choice              33
                                   safety
---------------------------------
  870.7600                        Dermal penetration  CR                  CR                  Choice              Choice              34
---------------------------------
  870.6500                        Scheduled           CR                  CR                  TGAI                TGAI                35
                                   controlled
                                   operant behavior
---------------------------------
  870.6850                        Peripheral nerve    CR                  CR                  TGAI                TGAI                35
                                   function
---------------------------------
  870.6855                        Neurophysiology:    CR                  CR                  TGAI                TGAI                35
                                   sensory evoked
                                   potentials
---------------------------------
  870.7800                        Immunotoxicity      R                   R                   TGAI                TGAI
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to 
toxicological data requirements in 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 test material is corrosive to skin or has a 
pH of less than 2 or greater than 11.5.
    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. Additional measurements such as cholinesterase activity for 
certain pesticides, e.g., organophosphates and some carbamates, will 
also be required. The route of exposure must correspond with the 
primary route of exposure.

[[Page 12345]]

    8. Required in rat for nonfood use pesticides if oral exposure 
could occur, such as through drinking water.
    9. A 90-day range-finding study in both rats and mice is 
required to determine dose levels if carcinogenicity studies are 
required. If the mouse carcinogenicity study is not required, the 
90-day mouse subchronic study is likewise not required.
    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.
    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 (guideline 
870.6100) 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 (guideline 870.6200).
    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 be established.
    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 under guideline 870.4300) 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. Chronic nonrodent feeding study - 12 months.
    iv. Mouse carcinogenicity study - 18 months.
    v. 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 time, duration, or magnitude 
of exposure.
    ii. The use requires a tolerance or an exemption from the 
requirement of a tolerance be established.
    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 (guideline 870.3100) conducted in the same species may be 
required.
    22. Testing in two species is required for all uses.
    23. Unless the chemical or physical properties of the test 
substance, or the pattern of exposure, suggest a more appropriate 
route of exposure, the oral route, by oral intubation, is preferred.
    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 two-generation reproduction study 
in rodents (870.3800) by utilizing a second mating of the parental 
animals in either generation. The dams are to undergo a cesarean 
section at one day prior to expected delivery date and evaluated 
separately as specified in guideline 870.3700.
    26. 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.
    27. A DNT would be required using a weight-of-the-evidence 
approach when:
    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/or 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 (i.e., SAR 
relationship to known neurotoxicants, altered neuroreceptor or 
neurotransmitter responses).
    28. The use of a combined study that utilizes the two-generation 
reproduction study in rodents (870.3800) as a basic protocol for the 
addition of other endpoints or functional assessments in the 
immature animal is encouraged.
    29. 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.
    30. 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.
    ii.) CHO cells strains AS52, xanthine-guanine phosphoribosyl 
transferase (xprt) gene locus.
    31. Choice of assays. Assays using rodent bone marrow, using 
either metaphase analysis (aberrations), or micronucleus assay are 
preferred.
    32. 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.
    33. May be required if the product's use will result in exposure 
to domestic animals through, but not limited to, direct application 
or consumption of treated feed.
    34. Required if toxic effects are identified in the oral or 
inhalation study. A risk assessment assuming that dermal absorption 
is equal to oral absorption must be performed to determine if the 
study is required, and to identify the doses and duration of 
exposure for which dermal absorption is to be quantified.
    35. May be required based on adverse effects seen in the acute 
or subchronic neurotoxicity screening studies, or other studies, or 
if the test substance is structurally related to a chemical known to 
cause effects best assessed by these studies.


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.  158.820, Sec.  158.1110, and Sec.  158.1420) studies. 
The options in this paragraph do not apply to pesticides used in or on 
food. 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

[[Page 12346]]

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 (guidelines 870.1100 - 870.2600)
    (ii) A subchronic 90-day dermal study (guideline 870.3250) or a 
subchronic 90-day inhalation study (guideline 870.3465)
    (iii) An acute and subchronic neurotoxicity screening battery in 
the rat (guidelines 870.6100 and 870.6200); a developmental 
neurotoxicity study in the rat (guideline 870.6300)
    (iv) Prenatal developmental toxicity studies in both the rat and 
rabbit (guideline 870.3700).
    (v) Reproduction and fertility studies in rats (guideline 870.3800)
    (vi) Battery of mutagenicity studies (guideline 870.5100 - 
870.5395)
    (vii) Immunotoxicity study (guideline 870.7800)
    (2) The conditionally required second-tier studies include:
    (i) Subchronic 90-day feeding studies in both the rodent and 
nonrodent (guidelines 870.3100 and 870.3150)
    (ii) Dermal penetration study (guideline 870.7600)
    (3) The conditionally required third-tier studies include:
    (i) Chronic feeding studies in both the rodent and nonrodent 
(guideline 870.4100)
    (ii) Carcinogenicity (guidelines 870.4200)
    (iii) Metabolism study (guideline 870.7485)
    (iv) Additional mutagenicity testing (no guideline number)

Subpart G--Product Performance

    i. By adding subpart G entitled ``Product Performance''.


Sec.  158.610  [Redesignated from Sec.  158.640]

    j. By redesignating Sec.  158.640 as Sec.  158.610 and adding 
redesignated Sec.  158.610 to subpart G.

Subparts H-I [Reserved]

    k. By adding and reserving subparts H and I.
    l. By adding subpart J to read as follows:

Subpart J--Nontarget Plant Protection


Sec.  158.700  Nontarget plant protection data requirements Table.

    (a) General. Sections 158.100 through 158.130 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 
include 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. The aquatic use pattern 
includes the general use patterns of aquatic food crop, aquatic nonfood 
residential, and aquatic nonfood outdoors.
    (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 emergence  R                   R                   R                   TEP                 1, 2, 3
---------------------------------
  850.4150                        Vegetative vigor    R                   R                   R                   TEP                 1, 2
---------------------------------
  850.4400                        Aquatic plant       R                   R                   R                   TEP or TGAI         1, 2
  850.5400......................   growth (algal and
                                   aquatic vascular
                                   plant toxicity)
---------------------------------
Nontarget Area Phytotoxicity - Tier II
--------------------------------------------------------------------------------------------------------------------------------------------------------
  850.4225                        Seedling emergence  CR                  CR                  CR                  TEP                 1, 3, 4, 5
---------------------------------
  850.4250                        Vegetative vigor    CR                  CR                  CR                  TEP                 1, 4, 5
---------------------------------
  850.4400                        Aquatic plant       CR                  CR                  CR                  TEP or TGAI         1, 4, 6
  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
---------------------------------
  850.4450                        Aquatic field       CR                  CR                  CR                  TEP                 1, 8
---------------------------------
Target Area Phytotoxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
  850.4025                        Target area         CR                  CR                  CR                  TEP                 1, 7, 9
                                   phytotoxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 12347]]

    (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. Required for all outdoor pesticide uses except for known 
phytotoxicants (such as herbicides, desiccants, defoliants).
    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, defoliants, and plant growth regulators.
    5. Required if a terrestrial species exhibits a 25 percent or 
greater detrimental effect in Tier I.
    6. Required if an aquatic species exhibits a 50 percent or 
greater detrimental effect in Tier I.
    7. Not required for aquatic residential uses.
    8. Environmental chemistry methods used to generate data must 
include results of a successful confirmatory method trial by an 
independent laboratory.
    9. Tests are required based on the results of lower tier 
phytotoxicity studies, adverse incident reports, intended use 
pattern, and environmental fate characteristics that indicate 
potential exposure.
    m. By adding subpart K to read as follows:

Subpart K--Post-application Exposure


Sec.  158.800  General requirements.

    (a) Certain measures taken to reduce or mitigate exposure may 
affect the need for data. Where label, formulation, or packaging and 
use restrictions, e.g., child-resistant bait stations, are expected to 
significantly decrease or eliminate exposure, these data requirements 
may not be required.
    (b) If EPA determines that industrial standards, such as the 
workplace standards set by 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.
    (c) 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.  158.810  Criteria for testing

    Exposure data described in Sec.  158.820(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 
studies.
    (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. When there is potential exposure to humans 
from post-application pesticide residues from any media, typically, 
these exposures fall into the following areas.
    (1) For outdoor uses. (i) Occupational human post-application 
exposure to pesticide residues on plants or in soil could occur as the 
result of cultivation, pruning, harvesting, mowing or other work 
related activity. Such plants 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 plants 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, inside homes, daycare centers, hospitals, schools, and 
other public buildings.

The need for data from potential exposure resulting from situations not 
covered by these examples should be discussed with the Agency.


Sec.  158.820  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 crop, 
aquatic nonfood use, aquatic nonfood outdoor, aquatic nonfood 
industrial, 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.  158.810. The table notes are shown in paragraph (e) of this 
section.

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

[[Page 12348]]

 
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.
    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--Biochemical Pesticides

    n. By adding subpart L entitled ``Biochemical Pesticides.''


Sec.  158.910  [Redesignated from Sec.  158.690]

    o. By redesignating Sec.  158.690 as Sec.  158.910 and adding Sec.  
158.910 to subpart L.

Subpart M--Microbial Pesticides

    p. By adding subpart M entitled ``Microbial Pesticides.''


Sec.  158.1010  [Redesignated from 158.740]

    q. By redesignating Sec.  158.740 as Sec.  158.1010 and adding 
redesignated Sec.  158.1010 to subpart M.
    r. By adding subpart N to read as follows:

Subpart N--Environmental Fate


Sec.  158.1100  Environmental Fate Data Requirements Table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the environmental fate 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. 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.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
[]=Required or conditionally required for an experimental use permit; 
TGAI=Technical grade of the active ingredient; TEP=Typical end-use 
product; PAIRA=Pure active ingredient radio-labeled.
    (d) Table.The following table list the data requirements that 
pertain to environmental fate. The table notes are shown in paragraph 
(e) of this section.

[[Page 12349]]



                                                                              Environmental Fate Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                  Use pattern
                                                 ------------------------------------------------------------------------------------------------------------
       Guideline Number         Data requirement                                                                                               Residential     Test substance     Test Note No.
                                                     Terrestrial         Aquatic         Greenhouse          Indoor           Forestry          Outdoors
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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
-------------------------------
  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     --
  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                NR                R                 TEP               5, 6
-------------------------------
  835.6200                      Aquatic           CR                R                 NR                NR                NR                NR                TEP               6, 7
                                 (sediment)
-------------------------------
  835.6300                      Forestry          NR                NR                NR                NR                CR                NR                TEP               6, 8
-------------------------------
  835.6400                      Combination and   CR                CR                NR                NR                NR                NR                TEP               9
                                 tank mixes
-------------------------------
Accumulation Studies
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1730                      Fish              [CR]              [CR]              NR                NR                [CR]              NR                TGAI or PAIRA     10
-------------------------------
  850.1950                      Aquatic           CR                CR                NR                NR                CR                NR                TEP               11
                                 nontarget
                                 organisms
-------------------------------
Ground Water Monitoring
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.7100                      Ground water      CR                NR                NR                NR                CR                NR                TEP               6, 8, 12
                                 monitoring
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes apply to the data 
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, Henry's Law Constant. 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.

[[Page 12350]]

    6. Environmental chemistry methods used to generate data 
associated with this study must include results of a successful 
confirmatory method trial by an independent laboratory. The 
environmental chemistry methods must include a statement of no data 
confidentiality claims, i.e., non-CBI. Test standards and procedures 
for independent laboratory validation are available as addenda to 
the guideline for this test requirement.
    7. 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.
    8. Agency approval of a protocol is necessary prior to 
initiation of the study.
    9. Requirement based on use patterns and other environmental 
factors that indicate potential exposure.
    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.
    11. Required if significant concentrations of the active 
ingredient and/or its principal degradation products are likely to 
occur in aquatic environments and may accumulate in aquatic 
organisms.
    12. 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.

    s. Subpart O is added to read as follows:

Subpart O--Residue Chemistry


Sec.  158.1200  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.  158.1210  Residue chemistry data requirements table.

    (a) General. (1) 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.
    (2) All residue chemistry data requirements, as described in this 
section, are required for an experimental use permit.
    (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. Food uses in general require a more extensive 
database to characterize the extent of the exposure, whereas nonfood 
uses which are of shorter duration, may require fewer studies. Uses 
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, indoor nonfood 
use, and indoor residential use.
    (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
                                   analytical                                                                                                              concern
                                   reference
                                   standards
---------------------------------
Nature of the residue
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1300                        Nature of the       R                   R                   R                   CR                  CR                  PAIRA               3, 4
                                   residue in plants
---------------------------------

[[Page 12351]]

 
  860.1300                        Nature of the       CR                  CR                  CR                  CR                  NR                  PAIRA or            1, 5, 6
                                   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
                                   methods
---------------------------------
  860.1360                        Multiresidue        R                   R                   R                   CR                  NR                  Residue of concern  1, 11
                                   method
---------------------------------
Magnitude of the residue
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1380                        Storage stability   R                   R                   R                   CR                  CR                  TEP or residue of   1, 3, 10, 12
                                                                                                                                                           concern
---------------------------------
  860.1500                        Crop field trials   R                   R                   R                   CR                  CR                  TEP                 3, 10, 14
---------------------------------
  860.1520                        Processed food or   CR                  CR                  CR                  CR                  NR                  TEP                 1, 15
                                   feed
---------------------------------
  860.1480                        Meat/milk/poultry/  CR                  CR                  CR                  CR                  NR                  TGAI or plant       1, 16, 17, 18
                                   eggs                                                                                                                    metabolite
---------------------------------
  860.1400                        Potable water       NR                  R                   NR                  NR                  NR                  TEP                 19
---------------------------------
  860.1400                        Fish                NR                  R                   NR                  NR                  NR                  TEP                 5
---------------------------------
  860.1400                        Irrigated crops     NR                  CR                  NR                  NR                  NR                  TEP                 20
---------------------------------
  860.1460                        Food handling       NR                  NR                  NR                  CR                  NR                  TEP                 1, 21
---------------------------------
  860.1540                        Anticipated         CR                  CR                  CR                  CR                  NR                  Residue of concern  1, 13, 22
                                   residues
---------------------------------
  860.1900                        Field rotational    CR                  CR                  NR                  NR                  NR                  TEP                 23
                                   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 use on food crops if home 
gardens are to be treated or the home garden use is different from 
the agricultural use pattern on which the tolerance is established.
    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 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 it is reasonably foreseeable that a food or 
feed crop could be subsequently planted on the site of the pesticide 
application.
    8. A residue analytical method suitable for enforcement purposes 
is required whenever a numeric tolerance (including temporary and 
time-limited tolerance) is proposed, and may be required for a 
tolerance exemption.
    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 (guideline 860.1000).
    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

[[Page 12352]]

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. Studies, 
however, may be waived if it can be demonstrated that residues do 
not concentrate on processing.
    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. These studies, however, may be waived by the 
Agency in cases where the residue levels are low or the animal 
metabolism studies indicate negligible transfer of the pesticide 
and/or metabolite(s) to tissues, milk, and eggs.
    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. Required if pesticide or metabolite residues of 
toxicological concern are found in crops at the appropriate plant 
back intervals from a confined rotational crop study (guideline 
860.1850).

Subpart P--Pesticide Management and Disposal

    t. By adding subpart P consisting of Sec.  158.1300 which is 
reserved.

Subpart R--Spray Drift

    u. By adding subpart R entitled ``Spray Drift.''


Sec.  158.1410  [Redesignated from 158.440]

    v. By redesignating Sec.  158.440 as Sec.  158.1410 and adding 
redesignated Sec.  158.1410 to subpart R.
    w. Subpart U is added to read as follows:

Subpart U--Applicator Exposure


Sec.  158.1500  General requirements.

    (a) If EPA determines that industrial standards, such as the 
workplace standards set by 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.


Sec.  158.1510  Criteria for testing.

    Applicator exposure data 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 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 studies.
    (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.  158.1520  Applicator exposure data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the application data monitoring 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 crop, 
aquatic nonfood use, aquatic nonfood outdoor, aquatic nonfood 
industrial, forestry, greenhouse food, greenhouse nonfood, indoor food 
use, indoor nonfood use, and indoor medical 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 
indoor residential 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.  158.1510. The 
table notes are shown in paragraph (e) of this section.

                                                          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, 4
                                      exposure
------------------------------------
875.1200                             Dermal indoor exposure  R                       R                      TEP                    1, 2, 5, 6
------------------------------------
875.1300                             Inhalation outdoor      R                       R                      TEP                    1, 2, 3, 4
                                      exposure
------------------------------------

[[Page 12353]]

 
875.1400                             Inhalation indoor       R                       R                      TEP                    1, 2, 5, 6
                                      exposure
------------------------------------
875.1500                             Biological monitoring   CR                      CR                     TEP                    1, 2
------------------------------------
875.1600                             Data reporting and      R                       R                      TEP                    7
                                      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 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 the back calculation to 
actual dose.
    3. Data are required for outdoor occupational site if the 
product is applied outdoors.
    4. Data are required for residential use sites if the product is 
applied outdoors.
    5. Data are required for occupational sites if the product is 
applied indoors.
    6. Data are required for residential use sites if the product is 
applied indoors.
    7. Data reporting and calculations are required when handler 
exposure data are submitted.

Subpart V--Inert Ingredients

    x. By adding subpart V consisting of Sec.  158.1600 which is 
reserved.

Subpart W--Antimicrobial Pesticides

    y. By adding subpart W consisting of Sec.  158.1700 which is 
reserved.


Appendix A  [Removed]

    z. By removing Appendix A.

[FR Doc. 05-4466 Filed 3-10-05; 8:45 am]
BILLING CODE 6560-50-S