[Federal Register Volume 71, Number 45 (Wednesday, March 8, 2006)]
[Proposed Rules]
[Pages 12072-12117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-2185]



[[Page 12071]]

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Part III





Environmental Protection Agency





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40 CFR Parts 158 and 172



Pesticides; Data Requirements for Biochemical and Microbial Pesticides; 
Proposed Rule

  Federal Register / Vol. 71, No. 45 / Wednesday, March 8, 2006 / 
Proposed Rule  

[[Page 12072]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 158 and 172

[EPA-HQ-OPP-2004-0415; FRL-7763-4]
RIN 2070-AD51


Pesticides; Data Requirements for Biochemical and Microbial 
Pesticides

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to update and revise its data requirements 
for the registration of microbial and biochemical pesticide products to 
reflect current scientific knowledge. These proposed revisions are 
intended to provide EPA with data and other information necessary to 
support the registration of a biochemical and microbial pesticide 
product, and will improve the Agency's ability to make regulatory 
decisions about the human health and environmental effects of these 
pesticide products. EPA is also proposing to update the definitions of 
a biochemical pesticide and a microbial pesticide to more accurately 
describe these categories of pesticides, and to make a conforming 
change to the definition of microbial pesticide. EPA is announcing its 
policy to provide assistance to applicants when needed in determining 
what data are appropriate to support registration of a biochemical or 
microbial pesticide and encouraging applicants to request pre-
submission meetings to discuss these data issues. EPA is announcing its 
intent to provide assistance to applicants in some narrow circumstances 
in preparation of an applicant's data waiver.

DATES: Comments must be received on or before June 6, 2006.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2004-0415, by one of the following methods:
    Federal eRulemaking Portal:http://www.regulations.gov. Follow the 
on-line instructions for submitting comments.
    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. In 
addition, please mail a copy of your comments on the information 
collection provisions to the Office of Information and Regulatory 
Affairs, Office of Management and Budget (OMB), Attn: Desk Officer for 
EPA, 725 17th St. NW., Washington, DC 20503.
    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. EPA-HQ-OPP-
2006-0415. 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.regulations.gov/, 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 regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system, 
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 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 the EPA Docket Center 
homepage athttp://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the 
regulations.gov index. Although listed in the index, some information 
is not publicly available, e.g., CBI or other information whose 
disclosure is restricted by statute. Certain other material, such as 
copyrighted material, will be publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
in http://www.regulations.gov or in hard copy at the Public Information 
and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, 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: Candace Brassard or Nathanael Martin, 
U.S. Environmental Protection Agency (7506C), 1200 Pennsylvania Ave. 
NW., Washington, DC 20460, telephone: 703-305-6598 or 703-305-6475, e-
mail: [email protected] or [email protected]. Do not e-
mail your comments to these contacts. Submit your comments according to 
the instructions under ADDRESSES.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this notice if you are a producer or 
registrant of a biochemical or microbial pesticide product. This 
proposal also may affect any person or company who might petition the 
Agency for new tolerances for biochemical or microbial pesticides, or 
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 for 
biochemical or microbial pesticides. The following is intended as a 
guide to entities likely to be regulated by this action. The North 
American Industrial Classification System (NAICS) codes are provided to 
assist you in determining whether or not this action applies to you. 
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.
     Crop Production (NAICS 111).
     Animal Production (NAICS 112).
     Food Manufacturing and Processing (NAICS 311).
    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 could also be affected. If 
you have questions regarding the applicability of this action to a 
particular entity, please consult the appropriate Branch Chief in the 
U.S. EPA Biopesticides and Pollution Prevention Division of the Office 
of Pesticide Programs at 703-308-8712, fax number at 703-308-7026 or 
visit the following website: http://www.epa.gov/pesticides/biopesticides/.

[[Page 12073]]

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

     1.  Submitting CBI. Do not submit this information to EPA through 
www.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:
    i. Identify the document by docket number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. 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.
     iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns, and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Overview of EPA's Proposal

    EPA is proposing to update and revise its data requirements for the 
registration of microbial and biochemical pesticide products to reflect 
current scientific knowledge. These proposed revisions are intended to 
provide EPA with data and other information necessary to support the 
registration of a biochemical and microbial pesticide product, and will 
improve the Agency's ability to make regulatory decisions about the 
human health and environmental effects of these pesticide products.
    Since the data requirements were first codified in 1984, 
information needed to support the registration of a biochemical and 
microbial pesticide has evolved as the general scientific understanding 
of the potential hazards posed by pesticides has grown. Since 1984, EPA 
has developed new and revised data requirements with public 
participation, extensive involvement by the scientific community, and 
review by the Scientific Advisory Panel (SAP) under Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), which have been 
imposed on a case-by-case basis. By codifying these data requirements, 
the pesticide industry, along with other partners in the regulated 
community, will have a better understanding of and could better prepare 
for the registration process for biochemical and microbial pesticides. 
In addition, the Agency is proposing certain new data requirements in 
response to the need for strengthened risk assessment mandated by the 
Food Quality Protection Act (FQPA) and FIFRA.
    EPA is also proposing to update the definitions of a biochemical 
pesticide and a microbial pesticide to more accurately describe these 
categories of pesticides, and to make a conforming change to the 
definition of microbial pesticide in 40 CFR part 172. EPA is announcing 
its policy to provide assistance to applicants when needed in 
determining what data are appropriate to support registration of a 
biochemical or microbial pesticide and encouraging applicants to 
request pre-submission meetings to discuss these data issues. EPA is 
announcing its intent to provide assistance to applicants in some 
narrow circumstances in preparation of an applicant's data waiver.
    This proposed rule is one in a series of proposals to update and 
clarify pesticide data requirements. EPA proposed data requirements for 
conventional pesticides (70 FR 12276, March 11, 2005) and is developing 
data requirements specific to antimicrobial pesticides. In the future, 
EPA expects to develop data requirements for plant-incorporated 
protectants.

III. Statutory Authorities and Regulatory Framework

    EPA is authorized to regulate pesticides under two Federal 
statutes. 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 FQPA to strengthen the protections offered, 
with particular emphasis on protection of children.
    This action is issued under the authority of sections 3, 4, 5, 12, 
and 25 of FIFRA (7 U.S.C. 136-136y) and section 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

    In general, under FIFRA, every pesticide product must be registered 
(or specifically exempted from registration under FIFRA section 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 determination, as defined in the 
statute, requires the Agency to consider the risks and benefits 
associated with the use of a pesticide. 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 fate 
properties, 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. Thispost-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 the 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 40 CFR part 158 requirements of the 1984 regulations. 
Additional data for

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older pesticides were called in where gaps in the scientific data base 
occurred. The Agency has 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 exemptions, FIFRA sec. 
5 requires persons seeking experimental use of pesticides under field 
conditions to obtain an experimental use permit (EUP). An EUP allows 
limited distribution and 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 assess 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 exposure and cumulative risk 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. 
As previously mentioned, in 1996, the FQPA modified the 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. (In this preamble, references to tolerances include 
exemptions from tolerance since the standards and procedures for both 
are essentially the same.) 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 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 
prescheduled 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 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 will 
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. What is the Context for Today's Proposal?

    Under FIFRA, as previously stated, every pesticide product must be 
registered (or specifically exempted from registration under FIFRA 
section 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 registration. The establishment of tolerances, if 
appropriate, is part of the registration process.

B. 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 the product 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 the 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, nontarget insect species 
and to determine what happens to the pesticide in soil, water, and air.

C. What are the Data Requirements?

    First promulgated in 1984, the data requirements in 40 CFR part 158 
(49 FR 42856, October 24, 1984) 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,

[[Page 12075]]

 biochemical, microbial, etc.), scientific discipline (e.g., 
toxicology, etc.), and major use sites (e.g., outdoor vs. indoor, 
terrestrial, aquatic, greenhouse). Part 158 also outlines the 
associated procedures for submitting the data, requesting a waiver from 
a requirement(s), and other associated procedures. Since there is much 
variety in pesticide chemistry, exposure, and hazard, part 158 is 
designed to be flexible. Table notes (referred to as test 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.
    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. Data requirements address 
both components of a risk assessment, i.e., what hazards do the 
pesticide present, and estimated level of exposure to humans or 
nontarget species. 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 extensive hazard data may not be required 
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 EPA 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), which 
includes representation of countries throughout the world (including 
the United States). The process for developing and amending the test 
guidelines included 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 provide recognized standards for conducting 
acceptable tests, guidance on reporting data, definition of terms, 
consistent with the purpose of the data requirement and the test 
standard and recommended study protocols. As such, pesticide 
registrants may also use a nonguideline 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 is expected to fully justify the methods 
chosen in the study protocol. Nonguideline protocols may be accepted, 
provided that the study protocol meets the purpose of the data 
requirement 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 a http://www.epa.gov/opptsfrs/home/guidelin.htm. Please see the docket for the 
complete crosswalk for old guideline numbers to new guideline numbers 
(Ref. 2).

D. Why have EPA's 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. During the registration process, EPA recognized that some 
of the 1984 data requirements were becoming out of date. The Agency 
then called in additional information in order to complete the 
registration process.
    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,'' 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 and 
reproductive testing (National Research Council, 1993, pp. 152-156) 
(Ref. 3), which applies to biochemical and microbial pesticides. NRC 
also suggested adding a thyroid screen to existing subchronic and 
chronic toxicity tests and additional tests of 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

[[Page 12076]]

testing requirements recommended by the NRC have been incorporated into 
the Agency's standard evaluation requirements and practices.
    3. Scientific Advisory Panel Review of 1994. The FIFRA SAP 
completed a review of a set of scientific issues regarding the 
Environmental Protection Agency's Proposed Rule: Pesticide Registration 
Data Requirements, 40 CFR part 158 (Ref. 4). The Panel commended the 
Agency for presenting this regulation in such a clear and 
understandable manner, and generally endorsed the revisions. The Panel 
addressed individual scientific issues where necessary for both 
biochemicals and microbial pesticides and the data needed to address 
risk.
    4. The Food Quality Protection Act of 1996 (FQPA). Passage of FQPA 
in 1996 reformed the 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. Since the 
early 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 nonoccupational 
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 nonoccupational and residential exposure.
    5. Pesticide reregistration. Recognizing that pesticides registered 
in the past may not meet today's safety standards, EPA is reviewing and 
reregistering older pesticides and taking action to reduce risks where 
appropriate. On July 13, 2005, EPA published a notice of proposed 
rulemaking (NPRM) to establish procedural regulations for conducting 
registration review (70 FR 40251, July 13, 2005), as required in FIFRA 
section 3(g). Registration review will replace EPA's one-time pesticide 
reregistration and tolerance reassessment programs starting in 2006. 
The Agency will conduct a review of each pesticide at least every 15 
years to ensure that registrations continue to meet statutory standards 
for registration. EPA plans to make decisions on almost 50 registration 
review cases, or about 80 active ingredients, each year. Under the 
reregistration process required by FIFRA section 4, EPA has been 
reviewing older pesticides (those initially registered before November 
1, 1984) to consider their health and environmental effects and to make 
decisions about their future use. EPA is committed to completing the 
reregistration process by the end of fiscal 2008.

V. Scope, Purpose, and Request for Comments on this Proposal

A. General Background on the Phased Rulemaking Approach

    EPA is responsible for registration of the following categories of 
pesticides: Biochemicals, microbials and plant-incorporated 
protectants, conventional pesticides, and antimicrobial pesticides. The 
various processes include differing data requirements that registrants 
must take into account in their submittals.
    On March 11, 2005, EPA published a proposed rule to update and 
revise its data requirements for the registration of conventional 
pesticides (70 FR 12276) (Ref. 5). In addition to proposing specific 
changes to the data requirements for registration of conventional 
pesticides, EPA proposed a number of other changes to the general 
provisions of part 158. Specifically, subpart A of the proposed rule 
for conventional chemicals describes general provisions including 
definitions, format of data submissions, policies on Confidential 
Business Information (CBI), flagging criteria, waivers, and minor uses. 
Subpart B of the proposed rule for conventional chemicals describes 
expanded use patterns, clarifications on using the data tables, 
identifying data for Experimental Use Permits (EUPs), test guidelines, 
and purpose of the registration data requirements. That proposed rule 
also proposed to upgrade the structure of part 158, assigning 
biochemical data requirements to subpart L, and microbial pesticide 
data requirements to subpart M of part 158.
    Today's proposed rule proposes to update and revise the data 
requirements for the registration of biochemical and microbial 
pesticides, and to maintain the structure proposed in the earlier 
proposed rule for conventional pesticides, by placing the proposed data 
requirements for biochemical and microbials in new subparts L and M, 
respectively. When the proposed rule for conventional pesticides is 
finalized, the general provisions of subparts A and B of that rule will 
apply to the other data specific subparts, such as subparts L and M as 
proposed today, unless otherwise specified. Future rulemakings will 
address the data requirements for antimicrobials and plant-incorporated 
protectants.

B. Summary of this Proposal

    EPA is proposing a number of changes to the current data tables. 
The proposed rule would:
    1. Codify current data requirements that do not appear in part 158, 
but which are routinely required.
    2. Add new data requirements.
    3. Revise certain existing data requirements, such as by updating 
test notes.
    4. Clarify the definitions of both ``biochemical pesticide'' and 
``microbial pesticide'' to reflect our current application of those 
terms, and make a conforming change in the part 172 definition of 
``microbial pesticide.''
    5. Add additional definitions needed to apply the data requirements 
properly.
    6. Make necessary reorganizing and formatting revisions, such as 
renaming data requirements.
    EPA will retain its current tiering system for both biochemical and 
microbial pesticide data requirements.

C. What are the Purposes of this Proposal?

    EPA has a number of objectives in proposing this regulation to 
update and revise the data requirements in 40 CFR part 158.
    1. Ensuring high quality data to meet EPA's mandates. Although most 
of the specific requirements in part 158 have not changed since the 
data requirements were first published in 1984, aspects of the 
requirements may be out of date or may be unclear because the 
underlying science has advanced (e.g., National Academy of Sciences 
(NAS) in 1993 suggested changes to better protect children) or the 
Agency's legislative mandate has been broadened to address new 
concerns. For example, given the stricter mandates imposed by the 1988 
FIFRA amendments and the 1996 FQPA amendments to FIFRA and FFDCA 
(emphasis on exposure to population subgroups), 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.
    In light of this background, the primary purpose of this proposal 
is to

[[Page 12077]]

transparently identify the data EPA needs and will require to support a 
determination of ``reasonable certainty of no harm'' under FFDCA and 
``unreasonable adverse effects'' determination under FIFRA. In 
developing this proposed rule, EPA has evaluated its data needs to 
conduct the expanded risk assessments required by new statutory 
mandates. Thus, the proposed changes entail both new tests and 
broadened requirements for some current tests, reflecting the changes 
in data requirement practices that have evolved since the 1984 data 
requirement rule was promulgated and addressing data needed to meet 
requirements created by statutory amendments to FIFRA and FFDCA.
    2. Ensuring a sound scientific basis that is consistent with 
advances in scientific understanding and works toward harmonization to 
avoid duplicative data. Relatedly, these proposed revisions are 
intended to ensure that the data requirements in part 158 reflect 
current scientific understanding and scientific advances since the data 
requirements were first issued in 1984. As discussed throughout this 
document, these proposed revisions have been presented to, and reflect 
the advice and recommendations of, the NAS and FIFRA SAP. Issues and 
related materials that are brought by EPA to the FIFRA SAP undergo a 
public review and comment opportunity before the FIFRA SAP issues its 
report with recommendations to the Agency.
    To the extent feasible, the proposed revisions are a reflection of 
the scientific advances within OECD countries. The United States 
participates in OECD activities to harmonize international testing 
standards and, where appropriate, reference to the OECD testing 
standards have been included in this proposal. However, since EPA 
continues to allow applicants to submit and use their own study 
protocols consistent with the purpose of the requirement to generate 
data that they subsequently submit to EPA, and there are differences in 
the mandate and authorities between EPA and the governing authorities 
within OECD countries, the data submitted to EPA under part 158 would 
be expected to satisfy OECD testing standards under most circumstances 
for microbial testing (because OECD has agreed to use the U.S. 
microbial pesticide testing guidelines) and for a number of countries 
some of the U.S. biochemical testing guidelines would be satisfied. A 
few of the governing authorities within the OECD countries may want 
additional studies that would not normally be required in the United 
States, but protocols for these studies are generally acceptable to all 
countries.
    3. Improving the depth and transparency of 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 improve the depth and transparency of the Agency's 
understanding of the health and environmental effects of pesticides to 
which individuals and the environment may be exposed. For example, the 
proposed rule includes a test note for the human health assessment data 
requirements indicating data are not required to support straight chain 
lepidopteran pheromones when used at certain application rates. In 
addition, EPA is proposing to continue using the tiered testing system, 
as given in the current Sec. Sec.  158.690 and 158.740, since many of 
the higher tiered data will not be required unless the results from the 
lower tiered studies indicate a concern for adverse effects.
    4. Improving utility of the part 158 data tables. As described in 
the Notice of Proposed Rulemaking on Conventional Pesticides (70 FR 
12276, March 11, 2005), EPA has proposed to reorganize and reformat 
part 158 subpart A (General Provisions) and subpart B (How to Use Data 
Tables), and reorganize and redesignate subpart D (Data Requirement 
Tables) into several individual subparts (see Table 1 in Unit VI). In 
the proposed reorganization, subpart L is designated for biochemicals 
(Sec.  158.900) and subpart M (Sec.  158.1000) is designated for 
microbials. Within both subpart L and M, there are definitions, 
examples, applicability, and then the series of data requirements in 
tables addressing product chemistry, residue chemistry, human health 
assessment or toxicology, nontarget organism, and environmental fate.
    Many of the revisions proposed in this document are intended to 
improve the usefulness of part 158 data tables by better 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.
    5. Reducing burdens where consistent with need for data. In 
proposing new and revised data requirements, EPA expects that fewer 
data waivers will be needed where the issue is well resolved, e.g., 
straight chain lepidopteran pheromones (SCLPs), and physical chemical 
properties criteria outlined in test notes when data are not required. 
There are also more transparent test notes indicating when data are 
required, while providing assistance to avoid generation of data where 
unnecessary. There is also an opportunity to reduce cost of preparation 
of waiver requests by providing pre-submission/post-submission meetings 
where appropriate.

D. What are Some of the Benefits of this Proposal?

    Discussed in more detail in the document entitled ``Economic 
Analysis of the Proposed Change in Data Requirements Rule for 
Biochemical and Microbial Pesticides,'' which is available in the 
docket for this rulemaking (Ref. 6), the following briefly highlights 
the benefits anticipated from this proposal:
    1. More refined assessments mean clearer understanding of real 
risks. EPA's current applicator/user exposure data base is not 
comprehensive, especially regarding exposures to pesticides in 
nonagricultural settings. The new data that would be collected under 
this proposal would allow the Agency to conduct improved exposure 
assessments for applicators/users (i.e., especially for insect 
repellents). This will benefit growers, other workers, and consumers by 
allowing EPA to make better informed regulatory decisions that are 
neither too stringent nor too lenient.
    2. Clarity and transparency to regulated community means savings. 
The enhanced clarity and transparency of the information presented in 
part 158, subparts L and M 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, thereby registering safer pesticides sooner 
and potentially reducing risks as well as 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 and nonagricultural products and registered pesticides as 
tools for public health.
    3. Enhanced international harmonization means less duplication. EPA 
participates with OECD countries in the development of harmonized 
international standards and, to the extent possible, we have included 
these revisions in our proposal. The OECD Biopesticide Steering Group 
has agreed to use U.S. EPA Harmonized Guidelines for the conduct of 
microbial pesticide studies and we continue to work

[[Page 12078]]

together to harmonize our approach to evaluating and reviewing these 
data. However, because other OECD countries do not use the tiered 
approach to the data requirements, but instead decide on the data 
needed for registration on a case-by-case basis, there may be 
differences in the actual data required for registration for the United 
States compared with other OECD countries. We are presently working 
with key OECD biopesticide regulatory representatives to develop OECD 
guidance for waiving data, which will bring actual data requirements 
closer together. OECD has also recognized pheromones, a certain type of 
biochemical pesticide, as warranting a separate, unique set of reduced 
data requirements similar to the U.S. data requirements.
    4. 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 nontarget 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.
    5. 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/
users) 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.

E. How will this Proposal Affect Existing Registrations?

     This proposal codifies existing practices by requiring 
data that are necessary to complete a risk assessment that are not 
included in the current data requirements.
     This proposal imposes new requirements for future 
registrations, as is the case for applicator/user exposure data to 
assess impacts from insect repellents.
     In rare circumstances, the Agency may find it necessary to 
call in data on certain existing registrations, as warranted by 
emerging risk issues.

F. Request for Comments

    The Agency invites the public to provide its views on the various 
options proposed or present any data or information for the Agency to 
consider during the development of the final rule. Specifically, the 
Agency welcomes specific comments on the following topics of particular 
interest to the Agency.
    The Agency welcomes specific comments on the need for, value of, 
and any alternatives to, the data requirements described in this 
document to meet its mandates.
    The Agency welcomes comments on the scientific basis of this 
proposed rule.
    The Agency welcomes specific comments on the clarity of the 
proposed data requirements for biochemical and microbial pesticides and 
the relationship between the proposed data requirements and EPA's 
statutory determinations.
    The Agency welcomes specific comments on the transparency of the 
proposed definitions, examples, and applicability for both biochemical 
and microbial pesticides.
    The Agency welcomes comments on its economic analysis of the 
proposed rule, as well as on its underlying assumptions, economic data, 
and high- and low-cost options and alternatives. Describe any 
assumptions and provide any technical information and data used in 
preparing your comments. Explain estimates in sufficient detail to 
allow for it to be reproduced for validation. 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 
biochemical and microbial pesticide applicants.

VI. Background on Regulation of Biochemical and Microbial Pesticides 
and Preparation of this Proposed Rule

A. Background of Regulating Biochemical and Microbial Pesticides

    The Agency finalized the data requirements to support the 
registration of biochemical and microbial pesticides (49 FR 42856, 
October 24, 1984) more than 20 years ago. When promulgated in 1984, EPA 
distinguished ``biochemical and microbial pesticides'' from 
``conventional chemical pesticides'' by ``their unique modes of action, 
low use volume, target species specificity or natural occurrence.'' EPA 
recognized that biochemical pesticides are inherently different from 
conventional pesticides since they are generally naturally-occurring 
and have a non-toxic mode of action.
    As a result, biochemicals are expected to pose lower potential risk 
compared to conventional pesticides. Due to the non-toxic mode of 
action and low risk to humans, certain studies are not included in the 
Tier I data requirements for biochemical pesticides. This adjustment in 
the tiered data requirements was intended to serve as a safety 
mechanism. If Tier I testing indicates a toxic mode of action, the 
biochemical would be treated as a conventional pesticide, and virtually 
the same toxicology and residue data would be required as is required 
for a conventional pesticide.
    The Agency has confirmed in the past 20 years of regulating 
biochemical pesticides that indeed biochemical pesticides can be 
classified and regulated with the data requirement tables that have 
been designated for biochemical pesticides. The Agency recognizes that 
at the time of application for registration there are instances where a 
biochemical may not fit the biochemical category and in such cases the 
Agency evaluates the pesticide in question as a conventional pesticide. 
Ultimately, if a pesticide were to exceed the criteria established for 
a biochemical pesticide, the data requirements in the higher tiers 
would be required and the process would take longer than if the 
application were made as a conventional pesticide, since all data 
requirements would not be clearly identified from the onset.
    Microbial pesticides are living organisms and, as such, present 
much different risk concerns than chemical toxicants. The main concern 
for a microbial pesticide is whether it could survive within, and be 
pathogenic to, a nontarget species or humans. As a result, required 
studies specifically address the potential for these unique

[[Page 12079]]

risks. Some microorganisms do produce toxins. If comparisons of the 
microorganisms indicates that taxonomically similar microorganisms have 
been reported to be pathogenic, the data set is configured to allow for 
use of conventional toxicity testing if needed to evaluate any toxins.

B. History of Development of Biochemical and Microbial Pesticide Data 
Requirements and Guidelines

    1. Biochemical pesticides history for regulatory activities. The 
following provides the history in the regulatory development of the 
data requirements for biochemical pesticides since 1984.
     1984--Promulgation of 40 CFR part 158 subpart A: Sec.  
158.65 Biochemical and Microbial Pesticides and subpart D: Sec.  
158.690 Biochemical Pesticide Data Requirements and Microbial Data 
Requirements (49 FR 42856, October 24, 1984).
     1987--Report of SAP Recommendations: A Set of Issues Being 
Considered by the Agency in Connection with Proposed Revision to 
Subdivision M, Immunotoxicity Testing of Biochemical Pest Control 
Agents (Ref. 7).
     1989--Issuance of Subdivision M of the Pesticide Testing 
Guidelines Microbial and Biochemical Pest Control Agents (Ref. 8). 
Although titled as such, this guideline did not include a discussion on 
biochemical guidelines. The Agency still relies on 1982 Pesticide 
Assessment Guidelines Subdivision M Biorational Pesticides (Ref. 9) for 
the guidelines pertaining to biochemicals (880 series) if there is not 
a designated guideline in the conventional pesticide series (i.e., 870 
series and 850 series).start here next
     1994--Presentation to SAP to discuss data requirements for 
all pesticides, including biochemical and microbial pesticides (Ref. 
4). Some data requirements were presented to support conventional 
pesticides, i.e., applicator/user exposure data to support insect 
repellents (Ref. 10).
    2.  Microbial pesticides history for regulatory activities. The 
following provides the history in the regulatory development of the 
data requirements for microbials since 1984.
     1984--Promulgation of 40 CFR part 158 subpart A: Sec.  
158.65 Biochemical and Microbial Pesticides and subpart D: Sec.  
158.690 Biochemical Pesticide Data Requirements and Microbial Pesticide 
Data Requirements (49 FR 42856, October 24, 1984).
     1987--Presentation to SAP in 1987 for microbial pesticides 
in preparation for updating the guidelines (Ref. 7) on immunotoxicity 
testing.
     1989--Issuance of Subdivision M of the Pesticide Testing 
Guidelines Microbial and Biochemical Pest Control Agents (Ref. 8). This 
was a culmination of the 1987 SAP and public comments.
     1994--Presentation to SAP to discuss data requirements for 
all pesticides, including biochemical and microbial pesticides (Ref. 
4).
    This proposed rule proposes to codify the draft data requirements 
outlined and presented to the FIFRA SAP in 1994 and in subsequent 
meetings. However, EPA is proposing certain revisions for biochemicals 
that are also discussed fully in the Agency's proposal for conventional 
chemicals (70 FR 12276, March 11, 2005) (Ref. 5). The Agency developed 
a complete list of data requirements for biochemicals and microbials 
and the year each were presented to FIFRA SAP (Ref. 11). This 
reference, the SAP final reports, and relevant documents presented to 
the SAP are available in the docket for this proposed rulemaking.

C. EPA Activities in Preparation for this Proposed Rule

    1. Consideration of redesigning data requirement tables. While 
preparing for this proposed rule, the Agency considered redesigning 
data requirements based on subcategories of biochemical and microbial 
pesticides. Each subcategory was evaluated based on mode of action and 
potential for risk to human health and the environment, with each 
subcategory requiring different data to support registration. The 
subcategories for biochemical pesticides were as follows: pheromones 
(including arthropod, lepidopteran, and straight chain lepidopteran 
pheromones), growth regulators (insect and plant), repellents (insect 
and others), and other biochemicals (which includes all other 
biochemicals). The microbial pesticides includes the following 
subcategories: protozoa, viruses, bacteria, and fungi.
    In the economic analysis for this proposed rule, the Agency 
analyzed the test cost data submitted based on each subcategory to 
determine the different data requirements (Ref. 12). Based on the 
analysis, the Agency decided it was more appropriate to make the test 
notes more clear and transparent, and only update the data requirement 
tables without redesigning them based on subcategory.
    2. Consistencies between current part 158 and proposed part 158 
design of data requirement tables for biochemical and microbial 
pesticides. EPA is proposing to continue using the tiered testing 
system, as given in the current Sec.  158.690 and Sec.  158.740. For 
these specific types of pesticides, it is appropriate to ask for 
studies in a tiered scheme because many of the higher tiered data will 
not be required unless the results from the lower tiered studies 
indicate a concern for adverse effects.
    3. Consultations with stakeholders. During the pre-rulemaking 
process, the Agency actively sought consultations with industry, 
academia, and non-profit organizations (i.e., environmental groups) on 
the current regulatory requirements for data and requested input on the 
universe of possible changes to the regulatory text. For parties 
interested in discussing the development of this rule with EPA, 
consultations were held in-person, by telephone conference, and via-
email. During these pre-proposal stage consultations, the Agency did 
not request feedback on the changes being proposed today, whether the 
proposed changes are newly imposed, newly codified data, or revisions 
to existing data requirements. Feedback from these consultations 
included the following topics: existing data requirements, industry 
burden in fulfilling data requirements, tiered testing approach, and 
issuance of guidance specific to test protocols. All the stakeholder 
comments are available in the docket (Ref. 13).

D. Consultations with Applicants

    In an effort to improve transparency, increase efficiencies and 
reduce burdens, EPA is announcing a policy to provide assistance to 
applicants when needed in determining what data or information are 
appropriate to support registration of a biochemical or microbial 
pesticide. EPA is encouraging applicants to request pre-submission 
meetings to discuss these data issues. EPA is also announcing its 
intent to provide assistance to applicants in some narrow circumstances 
in preparation of an applicant's data waiver after submission of an 
application.
    EPA notes that applications for biochemical and microbial 
pesticides frequently involve substances that present low risk (i.e., 
naturally-occurring, non-toxic mode of action, minimal exposure). Data 
requirements - even as proposed--may overstate the Agency's need, or 
may be satisfied by existing data in the open literature or other 
available data or information. In some cases, the applicant may not be 
aware of a potential rationale for a waiver or be able to identify 
available data or information that may satisfy a data requirement in 
lieu of generating new data. Thus, EPA encourages applicants to seek 
pre-submission meetings to discuss the appropriate data or information 
to support their product

[[Page 12080]]

and the opportunity for requesting data waivers.
    1. Pre-submission process. During a pre-submission meeting, EPA may 
be aware that certain data requirements are already satisfied by 
available data or information. Sources of existing data include public 
literature and/or studies submitted by another registrant, which may be 
cited with data compensation procedures. EPA may also be aware of sound 
scientific rationales that certain data requirements should not be 
imposed. For example, the question the required data is intended to 
answer might be addressed by a combination of other information or 
data, and therefore might be able to be waived. In either case, during 
the pre-submission meeting, EPA would discuss with the applicant the 
grounds for citing other information or data to conclude that a data 
requirement has been met or the grounds for requesting a waiver where 
other information or data otherwise addresses the need for a specific 
piece of data required by the regulations have been satisfied. The 
applicant may then submit an application based on the discussion with 
EPA. The application should include a signed copy of the minutes of the 
pre-submission meeting listing each data requirement and the reason why 
EPA and the company believe a waiver is appropriate. The applicant is 
encouraged to submit a copy of the pre-submission meeting minutes to 
EPA for concurrence prior to submission of its application for a 
waiver.
    To some extent, EPA currently offers this assistance to applicants 
and is simply encouraging applicants to request pre-submission meetings 
and suggesting a process for ensuring consistent reflection of 
discussions at the pre-submission meeting.
    2. Post-submission process. Even after submission of an application 
for registration, EPA may find that either of these scenarios exist 
(i.e., basis for citing to other data/information or waiver of a data 
requirement). Again, EPA may discuss these issues with the applicant 
and the applicant may choose to amend its application by citing to 
other data/information or requesting a waiver.
    EPA is also announcing its intention to assist applicants in the 
actual preparation of a data waiver in some narrow circumstances. 
Specifically, in the course of reviewing an application, EPA may find 
that in its judgment, data otherwise required by part 158 would not be 
necessary to grant the application or are available from other sources. 
EPA would notify the applicant and explain the basis for its belief in 
writing. If the data are compensable or exclusive in use, the applicant 
may submit EPA's letter with the appropriate offer to pay or an 
authorization, as an amendment to its application. If the Agency 
explains in its correspondence that the data may be waived, the 
applicant may use EPA's correspondence to support a waiver request by 
signing the correspondence and submitting it as an amendment to its 
application. Because the correspondence only includes citation or 
discussion of existing data or information, EPA is proposing not to 
consider such amendments to an application to be ``data'' subject to 
the formatting provisions of Sec.  158.32(a) as proposed on March 11, 
2005 (70 FR 12276).
    This pre-submission and post-submission process for ensuring that 
the data requirements are either satisfied or waived is specific to the 
review of biochemical and microbial registration applications, due 
primarily to the specific nature and circumstances unique to these 
pesticides (e.g., information already known to the Agency) and thus the 
Agency does not anticipate this process being widely applicable to 
other types of pesticides, such as conventional or antimicrobial 
pesticides.
    EPA notes that in providing this assistance during the pre-
submission and post-submission process, it will only consider readily 
accessible information, such as information found in Agency databases, 
and will not search for applicable information, data, or literature. 
Further, although intending to help applicants in supporting their 
applications, EPA does not encourage applicants to rely on this process 
to fill informational data gaps; doing so may be at the expense of 
timely review or may ultimately result in rejection of an application 
or petition.
    Finally, providing assistance in this manner does not effectively 
allow applicants to circumvent the data requirements or the requirement 
to submit a waiver of a data requirement. The applicant must at all 
times submit the waiver request; EPA is simply providing assistance in 
what requirements are likely to be waived for a particular product or, 
in some narrow circumstances, assistance in the preparation of the 
waiver request. Throughout these mechanisms EPA is flexible in 
implementing the regulation. Thus, the waiver provisions currently 
codified and the recent proposed amendments to the waiver provisions do 
not need to be amended.
    One of the benefits of providing this pre-submission and post-
submission assistance is the reduction in burden. Prior to finalization 
of this proposed rule (e.g., codifying that some data may no longer be 
required or adding conditions that result in data not being required), 
the number of opportunities for requesting waivers or citing to 
existing data will not change. Thus, providing assistance in this 
manner prior to finalization of this proposed rule may avoid the 
generation, processing and review of unnecessary data, and thereby 
ultimately save the Agency and applicant expenses, while providing the 
same level of protection for human health and the environment. In 
addition, although this proposal attempts to refine the test notes in 
order to be more transparent when data are required and necessary to 
support registration, there will continue to be opportunities to 
reference existing data or information or request waivers based on 
information that may be readily accessible to the Agency, and again 
avoid the generation, processing, and review of unnecessary data or 
information. Thus, the Agency expects to reduce burdens on both the 
applicants and EPA during and after the rulemaking process.

E. Agency Coordination with the APHIS Permitting Process

    As a result of the comments received during the Interagency review 
process, the Agency and USDA have discussed the registration process of 
microbial pesticides and the need for coordination when an Animal and 
Plant Health Inspection Service (APHIS) movement permit under 7 CFR 
part 340 is required by USDA. USDA suggested that the registrants 
should be required to submit a copy of the applicable APHIS permits as 
part of the registration application to EPA. The Agency is seeking 
public comment on the most appropriate method to ensure APHIS 
permitting and EPA registrations are coordinated. In particular, EPA is 
interested in your specific suggestions on whether there should be a 
requirement for pesticide registration applicants to include copies or 
otherwise attest to the applicability of and their compliance with the 
APHIS requirements when they submit their registration application to 
EPA.

F. Differences Between the Proposed Biochemical Data Requirements and 
the Proposed Conventional Data Requirements

    There are several revisions that were included in the proposal to 
amend part 158 for conventional pesticides, but were considered not 
appropriate for biochemical pesticides. For example, neurotoxicity 
studies (including acute, subchronic, delayed, and developmental 
neurotoxicity studies; OPPTS Test

[[Page 12081]]

Guidelines 870.6100, 870.6200, 870.7620, etc.) are required to support 
conventional pesticides. In addition, the recent proposal (70 FR 12276, 
March 11, 2005) identifies developmental neurotoxicity to be critical 
in some cases. If the Agency identifies a biochemical pesticide to be a 
potential neurotoxicant, then the Agency would evaluate the pesticide 
as a conventional pesticide, and it would then require the 
neurotoxicity data to support registration. The Agency prepared an 
overview of the proposed data requirements for biochemical pesticides 
as compared to conventional pesticides (Ref. 14).

G. Similarities Between Both Biochemical and Microbial Proposed Rule 
Development and Proposed Rule for Conventional Pesticides

    The Agency proposes to retain certain data requirements when they 
are appropriate. For instance, biochemical pesticides data requirements 
for product chemistry are the same as is required for conventional 
pesticides (Sec.  158.320 through Sec.  158.355).
    Certain revisions for proposed conventional pesticides (70 FR 
12276, March 11, 2005) were considered appropriate for biochemicals 
and/or microbials and are included in this proposed rule, i.e., 
registrations introducing significant exposure require applicator/user 
exposure data. As previously mentioned, the consistent designation of 
CR and R within the data tables remains the same as it is in the 
current part 158 for both conventional pesticides and microbial and 
biochemical pesticides. The proposed conventionals retains the CR and R 
designation, and this proposed rule retains this designation as well, 
within the data tables.

H. Proposed Amendments and Reference to Harmonized Guidelines

    The following units VII and VIII identify the proposed revisions to 
the current data requirements for biochemicals and microbials. In each 
preamble unit, the Agency explains the basis for the proposed 
amendments and for ease of reference to the public, identifies the 
harmonized guideline that is applicable to the proposed data 
requirement. EPA is not proposing changes to these harmonized 
guidelines as they have gone through a public review. The reference is 
simply for ease in understanding the proposed revisions.

VII. Biochemical Pesticide Data Requirements (Subpart L)

A. Definition of Biochemical

    The Agency is proposing to revise the definition of biochemical. 
Although the current definition provides examples of biochemicals, it 
does not really explain what a biochemical is. The language in the 
current definition was constrained by the need for including microbial 
pesticides in the same definition that defined biochemical pesticides. 
The new format for this regulation allows for a separation of the two 
classes of pesticides. The proposed definition of biochemical is 
intended to reflect a more useful and transparent definition, in 
accordance with the original scientific rationale for creating the 
biochemical class of pesticides while being consistent with the 
examples. The current definition is listed in Sec.  158.65 and reads as 
follows:
    Biochemical and microbial pesticides are generally distinguished 
from conventional pesticides by their unique modes of action, low 
use volume, target species specificity or natural occurrence. ... 
(a) Biochemical pesticides include, but are not limited to, products 
such as semiochemicals (e.g., insect pheromones), hormones (e.g., 
insect juvenile growth hormones), natural plant and insect 
regulators, and enzymes. When necessary the Agency will evaluate 
products on an individual basis to determine whether they are 
biochemical or conventional chemical pesticides.

    EPA is proposing to relocate the definition of biochemical to Sec.  
158.900, which would immediately precede the data requirements in part 
158 for the respective categories of biochemicals. EPA is also 
proposing to amend the definition so that it would state the following:
    A biochemical pesticide is a pesticide that:
    (1) Is a naturally-occurring substance or structurally similar 
and functionally identical to a naturally-occurring substance;
    (2) has a history of exposure to humans and the environment 
demonstrating minimal toxicity, or in the case of a synthetically 
derived biochemical pesticides, is equivalent to a naturally-
occurring substance that has such a history; and
    (3) Has a non-toxic mode of action to the target pest(s).
    EPA is proposing to continue the requirement that a biochemical 
pesticide be naturally-occurring. In addition, based on a long 
established policy, EPA is proposing to include a clarification that a 
``naturally-occurring'' biochemical pesticide may be synthetically 
produced if it is ``equivalent'' (structurally similar and functionally 
identical) to the naturally-occurring chemical. A synthetically derived 
chemical may often be more pure or economically feasible to produce but 
have the same properties as its naturally-occurring equivalent. An 
example of a synthetic substance that meets the criteria for 
classification as a biochemical is an insect pheromone manufactured by 
man. These insect pheromones are structurally and functionally 
identical to the substances that are produced by the insects, but the 
currently registered products are not naturally-occurring because it 
would be very difficult to extract them directly from an insect in a 
usable form.
    Second, the current regulation does not explicitly indicate that 
inherent non-toxicity is a means of defining a biochemical. EPA is 
proposing to add a criterion to the definition of biochemical that 
requires that there be a history of exposure to the naturally-occurring 
pesticide or, for synthetically-derived pesticides, to the equivalent 
naturally-occurring pesticide, and that exposure demonstrates minimal 
toxicity. The original intent for specifying natural occurrence in 
Sec.  158.65 was to allow EPA to use information derived from the 
pesticide's natural exposure to humans and non-target species to decide 
if the pesticide is inherently toxic. This is described in the 1982 
Pesticide Assessment Guidelines, Subdivision M for Biorational 
Pesticides, section V(A)(2)(1) (Ref. 9), which states that the fact 
that the chemical is naturally-occurring is to be used to predict 
whether ``these compounds are generally not innately toxic.'' 
Therefore, the criterion for having a history of adequate exposure was 
added in order to have confidence that if the naturally-occurring 
pesticide were not ``innately'' toxic, it would have to be present in 
the environment at sufficient levels and locations to predict 
significant exposure to humans and/or non-target species. If the 
pesticide is naturally-occurring but inherently toxic, EPA would use 
the data requirements for the conventional pesticides to ensure it 
could conduct an adequate assessment of the risks from the proposed use 
of the pesticide.
    Thus, rather than giving the impression that natural occurrence 
alone defines whether the pesticide should be classified as a 
biochemical pesticide, the Agency is proposing to include the criterion 
that there be a history of exposure demonstrating minimal toxicity. In 
order to make this determination, the naturally-occurring pesticide or 
the naturally-occurring equivalent to the synthetically derived 
pesticide must be present in the environment in sufficient quantities 
so that if it is innately toxic, there would be a good chance that this 
toxicity

[[Page 12082]]

would already have been recognized because of its effect on humans or 
representative non-target organisms. EPA has often used public 
literature to demonstrate that the substance is either widely used, 
and/or widely known (supported by extensive information and low 
toxicity) as part of the decision whether a pesticide may be adequately 
reviewed using the reduced data set for biochemical pesticides. The 
natural occurrence of a pesticide does not necessarily mean that it has 
a non-toxic mode of action to the target pest. An example might be 
pyrethrins, which are naturally-occurring toxins that occur in 
chrysanthemum plants. The new criteria in the biochemical definition 
would clearly allow us to classify this as a conventional chemical 
pesticide that would be subject to the conventional pesticide data 
requirements, which is consistent with past Agency decisions.
    Third, the current regulation refers to a unique mode of action, 
which is an attempt to describe the mode of action of both microbial 
and biochemical pesticides together. EPA is proposing to add a 
criterion to the definition of biochemical to better describe that the 
unique mode of action for biochemical pesticides must be one that is 
non-toxic to the target pest(s). This was the original intent for the 
biochemical pesticide mode of action as described in the 1982 Pesticide 
Assessment Guidelines, Subdivision M for Biorational Pesticides. That 
guideline explained in section I(A)(1) (Ref. 9) that ``some of the 
characteristics that typically distinguish biorational from 
conventional pesticides are their unique non-toxic mode of action, 
...,'' and in section V(A)(2)(1) that a characteristic of biochemical 
pesticides is that ``their pesticidal action is not the result of 
target organism toxification.'' Thus, the third element of the 
definition adds that the biochemical must have a non-toxic mode of 
action to the target pest. This toxic mode of action criterion would 
preclude pyrethrins and other clearly toxic naturally-occurring 
pesticides from being classified as biochemicals.
    In addition to the proposed language noted previously, EPA is 
proposing to amend the examples provided in the current definition of 
biochemical to better represent the kinds of biochemical pesticides we 
have actually seen since the original rule was published and move the 
examples from the actual definition to a subsequent paragraph. The 
proposed definition removes hormones from the example list because 
hormones fall into the growth regulator class, which is already in the 
list. The new ``Examples'' section is proposed to read as follows:
    Biochemical pesticides include, but are not limited to: (1) 
Semiochemicals (e.g., insect pheromones and kairomones), (2) natural 
plant and insect regulators, (3) naturally-occurring repellents and 
attractants, and (4) enzymes.
    At the present time, the Agency will review requests for 
classification as a biochemical pesticide, but does not believe this 
needs to be part of the regulatory language because the proposed 
revised definition is much more definitive than the current definition.
    As a final note, although not always the case, EPA recognizes that 
biochemical pesticides tend to have a limited range of target species, 
are often effective against their target pest(s) in relatively low 
quantities, and usually decompose rapidly after application in the 
environment.

B. Applicability of Biochemical Pesticide Data Tables

    EPA is also proposing to use table descriptors NR (not required), R 
(required), and CR (conditionally required) to be used as markers along 
a spectrum of the likelihood that a data requirement applies. In other 
words, it should be assumed that a required (R) data requirement is 
required typically all the time. There may be some narrow or rare 
conditions identified in test notes when data are not required. For 
example, acute oral toxicity data are required to support registration 
for biochemical pesticides unless the proposed pesticide is a gas or 
highly volatile (which is rare). In contrast, a conditionally required 
(CR) data requirement is less likely to be triggered compared to a 
required (R) data requirement. Conditionally required data are more 
likely to include test notes indicating conditions when data are 
typically required. For example, the 90-day dermal toxicity test is 
currently conditionally required (CR) for biochemical pesticides. The 
test note indicates it is required (R) to support uses involving 
purposeful application to human skin or which would result in 
comparable prolonged human exposure to the product (e.g., insect 
repellents). Specific criteria are identified with the test note.

C. Product Chemistry Data Requirements

    1. General. The Agency uses product chemistry information to 
determine whether impurities of toxicological or environmental concern 
are present in biochemical pesticides and their formulated products. 
Product chemistry data requirements include product identity and 
composition, the physical and chemical characteristics of data on the 
pesticide, the identity of any intentionally added ingredients, and 
impurities in the final pesticide product.
    The Agency is continuing to list the data requirements in the table 
for product identification, description of starting materials, 
production and formulation process, discussion of formation of 
impurities, preliminary analysis, certified limits, and physical and 
chemical characteristics, as currently listed in Sec.  158.690. The 
following is a discussion about the changes from the current data 
requirements to support ``biochemical product analysis data 
requirements'' to the proposed ``biochemical product chemistry data 
requirements'' for biochemicals. The revised title of the proposed 
table more accurately reflects the current types of data required to 
support biochemical pesticides.
    In addition, the proposed rule for conventional pesticides (70 FR 
12276, March 11, 2005) identifies the following sections where this 
proposed rule will also require the same information/data and are 
indicated in the test notes within the proposed product chemistry data 
requirement table: Sec. Sec.  158.320, 158.325, 158.330, 158.335, 
158.340, 158.345, 158.350, 158.355.
    2. Proposed product chemistry data requirements. The Agency 
proposes to codify one study (particle size, fiber length, and diameter 
distribution) and to make minor revisions to existing data requirements 
to support product chemistry data requirements. The Agency is also 
proposing to require studies to support experimental use permits (EUPs) 
as well as registration for certain studies, (i.e., certified limits). 
In addition, certain studies (i.e., enforcement analytical method) 
would require a different test substance (for example, TGAI or both EP 
and MP). One study, which is currently required to satisfy 
environmental fate and expression data requirements, is proposed to be 
moved from environmental fate and expression to the product chemistry 
data requirements (ultraviolet (UV)/light absorption) table. The Agency 
is also proposing to delineate the physical and chemical properties 
into subcategories, depending on the formulation type (e.g., solid 
versus liquid) and provide test notes identifying conditions when data 
are required (i.e., flammability). In other words, the current product 
chemistry data requirement table lists physical and chemical properties 
as one data requirement, whereas the proposed rule identifies the 
individual studies that make up physical and chemical

[[Page 12083]]

properties (e.g., color, odor, vapor pressure, pH). Additional test 
notes concerning the physical and chemical properties identifying when 
each data requirement is required (i.e., solid versus liquid at room 
temperature, water insoluble substances (10-6 grams/liter 
(g/l)) are also included.
    i. New requirements. None.
    ii. Newly codified requirements--particle size, fiber length, and 
diameter distribution. The Agency proposes to add the conditional 
requirement (CR) for data on particle size, fiber length, and diameter 
distribution. This data requirement is proposed to be conditionally 
required (CR), the condition being that the test substance is water 
insoluble (<10-6 g/l) or fibrous with diameter >= 0.1 [mu]m 
(micrometer). Data from this study are needed to complete the 
environmental fate assessment to estimate potential pesticide drift to 
nontarget areas.
    iii. Revisions to existing requirements. a. ``Certification of 
limits'' data are currently conditionally required (CR) to support all 
proposed use patterns/applications, except for EUPs for nonfood crops. 
The Agency proposes to change the conditionally required (CR) to 
required (R) ``Certified limits'' data to support proposed use patterns 
to ensure we have proper product chemistry information on all 
registrations for enforcement purposes.start
    b. UV/visible light absorption. The Agency currently requires (R) 
these data to satisfy one of the nontarget organism, fate and 
expression data requirements. The Agency proposes to relocate this data 
requirement from environmental fate and expression data tables to the 
proposed product chemistry data table. The endpoints measured by this 
data, characterization, and identification of a compound are more 
appropriately considered product chemistry data. This is not a new data 
requirement, merely a relocation. This information will be used in 
conjunction with the ``photodegradation in water'' study 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. The UV/visible light absorption spectrum will indicate 
whether the pesticide is absorbed in this range.
    c. Revision of names. The Agency proposes to revise names of 
certain studies to correspond with OPPTS Test Guidelines (Ref. 2) and 
to synchronize with the name changes taking place in the updating of 
part 158 for conventional pesticides. The following three name changes 
are proposed in this section: (1) `` Product identity'' to ``Product 
identity and composition''; (2) ``Discussion of formation of 
unintentional ingredients'' to ``Discussion of formation of 
impurities''; and (3) ``Manufacturing process'' to ``Description of 
starting materials, production and formulation process.''

D. Residue Chemistry Data Requirements

    1. General. The Agency is proposing to codify two data requirements 
which identify the use pattern under which they are proposed to be 
required. EPA is also proposing to consolidate the nonfood use patterns 
into the following four categories: terrestrial nonfood; greenhouse 
nonfood; forestry; and domestic outdoor, and to do so for all residue 
data requirements except for chemical identity and directions for use. 
Those will remain conditionally required (CR) for all uses. This would 
not change the number of times the data are required, but merely 
consolidate the uses that have the same data required under the same 
conditions.
    In addition, the Agency is proposing to delete the test note 
stipulating data conditionally required (CR) if the application rate of 
0.7 ounces was exceeded. This test note is no longer considered 
relevant. Therefore, all the proposed residue chemistry studies would 
be required regardless of the application rate. It was originally 
incorporated in the data requirements as explained in the October, 
1982, Subdivision M guidelines (pages 31 and 32, Section VI, Residue 
Analysis) as an estimate of a ``low application rate'' since the 
original definition for biochemical and microbial pesticides (40 CFR 
158.65) mentioned that they are generally distinguished from 
conventional pesticides by various characteristics including ``low use 
volume.'' The Agency has determined that the key to whether residue 
data (which is needed only to support a numerical tolerance) are needed 
for biochemical (and microbial) pesticides is toxicity, not exposure by 
itself.
    2. Residue data requirements-- i. New requirements. None.
    ii. Newly codified requirements--a. Nature of the residue: plants; 
livestock. These data are currently not required (NR) to support indoor 
food use. The Agency, however, proposes to conditionally require (CR) 
these studies to support registration of indoor food use. There have 
been instances where certain biochemical pesticides are applied to food 
crops indoors (e.g., for treatment of stored potatoes), and these 
potato peels are then fed to cattle for feed. Therefore, the nature of 
residues on plants is needed to determine potential residues on the 
treated crop. The 0.7 ounces per acre restriction is no longer a 
trigger for requiring the submittal of data. The Agency also proposes 
to eliminate ``Nature of residue: livestock'' to support domestic 
outdoor use, since the data are needed for potential food uses outside 
of the home, and domestic outdoor use is for porches, patios, yards, 
home gardens, etc. EPA also proposes to no longer require testing on 
Pure Active Ingredient Radio Labeled (PAIRA) but instead to use the 
TGAI because it is difficult to isolate pure active ingredient from a 
naturally-occurring substance.
    b. Residue analytical method. This data requirement is currently 
conditionally required (CR) for terrestrial, aquatic, and greenhouse 
food use with the 0.7 ounce per acre limitation (data not required if 
applied at rate less than or equal to) restriction. The Agency proposes 
these data to be required (R) for greenhouse use and continue to 
conditionally require (CR) data for terrestrial, aquatic, and indoor 
food use but without the less than 0.7 ounce active ingredient (a.i.)/
per acre/year exemption. It would remain conditionally required (CR) 
for indoor food use. The residue analytical method data are needed to 
address enforcement issues, i.e. ability to measure the pesticide.
    iii. Revisions to existing requirements--a. Chemical identity and 
Directions for use. These data are currently conditionally required 
(CR) based on a series of conditions including if the application rate 
exceeds 0.7 ounces (20 grams) active ingredient per acre per year. EPA 
proposes not to include the application rate conditions (data required 
only if application rate exceeds 0.7 ounce a.i./acre/year). EPA 
proposes test note revisions for both the chemical identity and 
directions for use, but preserves one test note addressing domestic 
outdoor use. However, EPA is proposing to continue to conditionally 
require (CR) this data only for all biochemicals for which residue data 
are required since chemical identity and directions for use are 
considered to be essential to understanding the pesticide. The Agency 
has determined that throughout the years of registration activities for 
all biochemicals, the chemical identity and the directions for use 
information are always submitted before processing the application. The 
directions for use are included as part of the labeling information 
along with the submission.
    b. Multiresidue method. Multiresidue methodology data are currently 
part of

[[Page 12084]]

the residue analytical method requirement. The Agency proposes to 
codify an existing multiresidue method study (guideline 860.1360) and 
designate it as a separate requirement. These data, which are currently 
submitted to support registration, are important in designing pesticide 
monitoring and enforcement programs. 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 allow analysis of as many pesticides as possible, it is clearer to 
list these as two separate data requirements. The test note indicates 
that any analytical methodology must be evaluated for its ability to 
detect metabolites included in the tolerance expression.
    c. Magnitude of residue data. All the studies in this category 
(guidelines 860.1400 through 860.1650) no longer have the application 
rate of 0.7 ounces a.i./per acre/ per year exemption.
    d. Submittal of analytical reference standards. The Agency 
currently conditionally requires (CR) this data as ``submittal of 
samples'' as a product analysis data requirement. The Agency is 
proposing to revise the name to ``Submittal of Analytical Reference 
Standards'' (quideline 860.1650) and continue to conditionally require 
(CR) the data. The requirement for submittal of samples was moved to 
the residue data requirements because it is considered a residue data 
requirement rather than a product analysis data requirement. 
Biochemical pesticides are generally of low toxicity because of their 
non-toxic mode of action, but, if the Agency does identify toxicity 
concerns, then an analytical reference standard requirement will be 
triggered to analyze potential residues.

E. Human Health Assessment Data Requirements

    1. General. The current ``Toxicology'' data requirement is proposed 
to be renamed from ``toxicology'' to ``human health assessment'' to 
include toxicology and applicator/user exposure data requirements. 
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 health risk 
assessment. For example, an insect repellent registration would require 
significantly more human health assessment data compared to a 
application for SCLP. The duration of the toxicity study approximates 
the estimated duration of human exposure, while considering species 
differences in maturational milestones and overall life span.
    The proposed table in subpart L (Sec.  158.950) contains the human 
health assessment data requirements EPA would rely on to identify 
potential hazards to humans and domestic animals for biochemical 
pesticides, and is expected to improve the Agency's understanding of 
the potential pesticide hazard to animals and humans, including 
subpopulations such as infants and children and possible environmental 
effects. This proposal retains the requirements for pesticides in 
current 40 CFR 158.690, as well as revisions that reflect the current 
practices due to FQPA implementation and the evaluation of regulating 
biochemical pesticides.
    The Agency is continuing to require toxicity studies where use 
patterns indicate high exposure, such as food use biochemical 
pesticides, as well as exposure studies required to support certain use 
patterns (e.g., insect repellents). The exposure data assess exposure 
to both the person to and for whom the repellent is being applied as 
well as the person who is applying the repellent (i.e., parent to 
child) and it also assesses hand to mouth contact (i.e. children), 
which often occurs under these circumstances. Other toxicity studies, 
e.g., 90-day dermal, 90-day inhalation, 90-day oral toxicity for 
nonfood use, etc., remain as conditionally required on a case-by-case 
basis, depending on the category of pesticide (e.g., SCLPs, growth 
regulators, repellents), the patterns of use (food and nonfood), and 
estimated exposure and the results of lower tiered studies.
    2. Human health assessment data requirements. The following 
identifies the revisions from the current ``Biochemical pesticides 
toxicology data requirements'' in 40 CFR 158.690 to the proposed 
``Biochemical pesticides human health assessment data requirements.'' 
The title of the data table has been revised to reflect that the 
primary use of the data is to assess the potential risk to humans. The 
proposed revised table includes the toxicology data requirements and 
exposure studies (the latter to support insect repellent uses). There 
are few new studies which are proposed which were not identified until 
the 1986 Science Advisory Panel discussing applicator/user exposure 
data requirements (Ref. 10) and conditions under which data are 
appropriate (except the companion animal safety data). The following 
lists the individual data requirements, and what the proposed rule 
requires and when it requires these data. There is also a discussion on 
why the Agency proposes companion animal safety data in this proposed 
rule as well.
    i. New requirements.--a. Exposure (applicator/user). The Agency 
proposes exposure studies (guidelines 875.1000 through 875.1500) to be 
conditionally required (CR). These data are triggered when Tier I 
toxicology data indicate that the biochemical may pose a hazard. The 
Tier II human health assessment data (toxicology and/or exposure) 
requirements are not required if the results from the Tier I toxicity 
studies indicate no expected risk. The Agency recommends that 
registrants consult with the Agency prior to study initiation to 
determine what exposure studies are appropriate based on the nature of 
the adverse effects seen in the Tier I data. The following are the 
various types of applicator/user exposure data that could be required:
    (1) Dermal exposure. The Agency proposes to conditionally require 
(CR) data 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 applicator/
user exposure studies employ passive dosimetry techniques which 
estimate the amount of a pesticide 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 using 
patches that absorb pesticides or by removing the material that has 
contacted the skin before it has been absorbed.
    (2) Inhalation exposure. To estimate inhalation exposure to 
pesticide residues, the Agency proposes to conditionally require (CR) 
both outdoor and indoor inhalation exposure studies (guideline 875.1300 
and 875.1400). It has become apparent to the Agency that insect 
repellents when applied often result in inhalation exposure to the user 
(either to the person it is being applied (e.g., child) as well as to 
the person applying the insect repellent (e.g., adult)) and therefore 
the Agency would like the flexibility to require these data for this 
use when triggered by results from lower tier studies or estimated 
exposure.
    (3) 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 to

[[Page 12085]]

satisfy, dermal or inhalation exposure data requirements provided the 
human pharmacokinetics of the pesticide residue are sufficiently 
understood to permit calculation to determine the total internal dose. 
Biological monitoring offers the advantage of assessing the actual 
internal dose, as opposed to the estimated exposure or amount of 
pesticide coming in contact with the surface of the skin or available 
for inhalation in the lungs as measured using passive dosimetry 
techniques. For example, biological monitoring could consist of 
evaluating blood for cholinesterase activity; if it is low in a blood 
sample, the person may have been exposed to a cholinesterase inhibitor 
by any route including dermal or inhalation. Also, biological 
monitoring may indicate whether a given substance has been absorbed 
through the skin or inhaled in enough quantities to be of concern.
    b. Companion animal safety data. Companion animal safety data 
(guideline 870.7200) is being proposed to be part of conditionally 
required (CR) special testing. This data would be triggered if the 
product's use would result in exposure to domestic animals through, but 
not limited to, direct application (e.g., topical application as in 
insect repellents) or consumption of treated feed. This new data 
requirement is based on recent Agency experiences with biochemical 
pesticides, specifically, that there are currently no data requirements 
addressing potential toxicity to domestic animal species from 
biochemical pesticides. Fulfillment of this conditionally required data 
would address such potential risk concerns. This is considered part of 
the human health battery of studies, as it is considered for 
conventionals.
    ii. Newly codified data requirements.--a. Hypersensitivity 
incidents. Currently, the Agency conditionally requires (CR) these data 
when they are reported. The Agency proposes to augment this data 
requirement to include incidents to be reported from conditionally 
required (CR) to required (R) for all preregistered (EUP's) and 
registered products. Incidents can occur from application of an EUP as 
well as registered products, which, if reported, would be essential to 
making a well informed finding. Registrants are reminded that FIFRA 
section 6(a)(2) requires the submission of such information for 
registered products (see 40CFR part 159).
    b. Product use information. EPA is proposing to require (R) product 
use information (guideline 875.1700) to provide information on how the 
pesticide is used and applied per day. Data would at least include: 
Typical application methods, typical values for application rates, 
timing and number of applications per season or per year, any available 
surveys that provide use information for insect repellents, and other 
use information relevant to potential exposure following a repellent 
application. Such use information enables the Agency to appropriately 
trigger other conditional data requirements, i.e., identification of 
potential exposure (risk), and conduct more accurate and realistic risk 
assessments, thus enabling the Agency to levy appropriate limitations 
on use to mitigate any potential risks. This data requirement is newly 
codified since this information is already submitted with the label and 
the Agency could not complete a risk determination (estimate exposure) 
without the information.
    c. Test note revisions and other conditions exempting data. The 
Agency is proposing to add the following conditions at the onset to 
Tier I, Tier II, and Tier III Human Health Assessment Data Tables: 
Straight chain Lepidopteran pheromones are exempt if applied at a rate 
less than or equal to 150 grams active ingredient/per acre/year (Ref. 
15). EPA is no longer requiring these data for SCLPs because the past 
20 years of scientific literature supports waiving the data. SCLP's do 
not pose a risk to human health when applied at a rate not to exceed 
150 grams active ingredient per acre. This is consistent with current 
implementation, e.g., Sec.  180.1124 requirements.
    The Agency proposes to provide a test note identifying when certain 
data are required (acute oral, acute dermal, primary dermal 
irritation), unless the test material is a gas or highly volatile 
(vapor pressure >104 torr). The current data tables do not 
specify the trigger for vapor pressure. Thus, the proposed rule 
provides criteria and clarity.
    iii. Revisions to existing requirements--a. Primary eye irritation 
and primary dermal irritation. The Agency currently requires (R) these 
data for MP or EP. The Agency is proposing to require (R) these data 
for TGAI and MP test substances since effects may result from active 
ingredient or other (inert) ingredients in the end-use product.
    b. Dermal sensitization. The Agency conditionally requires (CR) 
``Hypersensitivity study'' (152-15) in current Sec.  158.690. EPA 
proposes to substitute dermal sensitization data (guideline 870.2600) 
and to require (R) the data, since the dermal sensitization guideline 
measures the same endpoints and more accurately describes the nature of 
the type of data required in that it identifies dermal sensitivity. The 
Agency considers this information a method for accurately classifying 
the dermal sensitization potential of the pesticide and for determining 
whether any observed adverse effects are inherent to the active 
ingredient, or caused by the presence of other ingredients. In 
addition, the Agency currently requires (R) this data for MP or EP. The 
Agency is proposing to require (R) this data for TGAI and MP test 
substances since effects may result from active ingredient or other 
(inert) ingredients in the end-use product.
    c. Mutagenicity. The Agency proposes to change the name of the 
battery of studies from ``Studies to detect genotoxicity'' (152-17) to 
specific mutagenicity studies including the following: Bacterial 
Reverse Mutation Test (guideline 870.5100), In vitro Mammalian Cell 
Gene Mutation Test (guideline 870.5300), and In-vivo Cytogenetics 
(guideline 870.5385 and 870.5395) (Mammalian Bone Marrow Chromosomal 
Aberration Test and Mammalian Erythrocyte Micronucleus Test, 
respectively). The Agency proposes to split existing genotoxicity data 
requirement (152-17) into four different data requirements. The 
following are proposed as Tier I requirements: Bacterial Reverse 
Mutagenicity (guideline 870.5100) and In vitro Mammalian Cell Gene 
Mutation TEst (guideline 870.5300) are proposed to be required (R) for 
food uses and conditionally required (CR) for nonfood uses. The 
following are proposed Tier II requirements: In vivo Cytogenetics 
(guideline 870.5385 and 870.5395). Second, the proposed Tier II 
studies, mammalian spermatagonial chromosomal aberration and mammalian 
bone marrow chromosomal aberration (guideline 870.5385 and 870.5395), 
are conditionally required (CR) for food uses if Tier I data indicate 
mutagenicity. The Agency is proposing these organizational changes 
because the original genotoxicity data requirement was actually 
composed of multiple studies and the actual data requirements are more 
clearly described when separated as found in today's proposal. For 
example, the current Tier II data is required on mammals and would be 
unnecessary if the Tier I data shows no mutagenicity concerns. In 
addition, the guideline under which the old genotoxicity data 
requirement references is 152-17 in the 1982 guidelines and it says 
``Data derived from short-term microbial mutagenicity tests are 
required...'' and it mentions gene mutations, structural chromosomal 
aberrations, and direct DNA damage and

[[Page 12086]]

repair (Ref. 9). The Agency designates these as mutagenicity tests 
today and the overall way the Agency cumulatively test for mutagenicity 
has evolved since then.
    d. Prenatal developmental toxicity. The Agency proposes to change 
the name of this requirement from ``Teratogenicity'' to ``Prenatal 
developmental toxicity'' to better correspond with the focus of the 
study and current terminology. The Agency currently conditionally 
requires (CR) this study for Tier I. The Agency proposes to require (R) 
this study for Tier I for food uses since food use has the highest 
potential exposure to humans during pregnancy; this guideline will 
provide sound data if needed to address prenatal development. EPA 
encourages preregistration meetings to determine if the data 
requirement can be waived because of minimal exposure; or existing data 
on the product in the scientific literature indicating there is not a 
concern for developmental toxicity. EPA will continue to conditionally 
require (CR) these data for a nonfood use. EPA is also proposing to 
conditionally require (CR) these data on a second test species for food 
and nonfood uses as a Tier II data requirement based on the condition 
that there are reproductive effects (e.g., fetotoxicity, retarded 
development, structural abnormalities, behavioral abnormalities and/or 
death) evident in Tier I, Prenatal Developmental Toxicity (guideline 
870.3700).
    The Agency currently does not require a reproduction study as Tier 
III, and EPA is proposing to conditionally require (CR) a reproduction 
and fertility data requirement as a Tier III study depending on the 
results of the Tier I and II data requirements (i.e. subchronic 
toxicity, prenatal development, mutagenicity studies) in order to 
address potential risks that may be identified in lower tier studies.
    In summary, for biochemical pesticides, the tiered principle of 
testing requirements for developmental toxicity is as follows: identify 
the hazard potential in Tier I for one species; if that study is 
positive, another study is required (2nd species) for use in reducing 
the uncertainties of species-to-species extrapolation (Tier II). If 
positive mutagenicity or effects on reproductive organs are observed in 
subchronic (Tier II) studies, then the reproduction study (Tier III) 
would be required for greater certainty in risk characterization.
    e. Immunotoxicity. The Agency currently requires (R) Immune 
Response data (152-18). The Agency has renamed the guideline name and 
number to Immunotoxicity (guideline 880.3550) and is proposing to 
conditionally require (CR) such data as part of Tier II, with a test 
note indicating this data is required if there are effects on 
hematology, clinical chemistry, lymphoid organ weights and 
histopathology observed in the 90-day studies, or if the results of the 
Tier I mutagenicity tests are positive. The proposed change would make 
it consistent with current evaluation process for determining if a 
pesticide is expected to pose immunotoxicity. This is consistent with 
the Office of Pesticide Programs historic waiver of this requirement 
for SCLP's, as well as when there are no effects on hematology, 
clinical chemistry, lymphoid organ weights, etc. or when there is no 
evidence of mutagencity concerns in Tier I data.
    The Immunotoxicity study (guideline 880.3550) provides information 
on health hazards likely to arise from subchronic exposure to a 
pesticide, usually after dosing by the oral route (emphasis added). 
Tests are selected to provide quantitative and qualitative data on the 
capacity of a pesticide to adversely affect components of antibody-
mediated and specific and non-specific cell-mediated immunity. This 
purpose suggests that the oral route is preferred, but the conditions 
for requiring immunotoxicity testing indicate that any route that is 
relevant to each pesticide's use pattern (primary route of exposure 
under conditions of use) is acceptable. (Results from one insect 
repellent study that was done by the dermal route p-menthane-3,8-diol 
(Ref. 16) did not show any effects on the immune system.)
    EPA is also proposing to rename and move a Tier II immune response 
data requirement (152-24) to a Tier III data requirement (immune 
response guideline 880.3800). The Agency proposes to continue to 
conditionally require (CR) these data depending on the results of the 
study completed to satisfy the Tier II Immunotoxicity data requirement. 
The Agency believes these data address the endpoints more suitably then 
the results found in the Immune Response Study.
    In summary, the Agency decided to raise the level of tiers for the 
required immunotoxicity data from Tier I to II and from Tier II to Tier 
III, based on the triggers used to require the immunotoxicity data. In 
other words, the results of the 90 day studies requested under Tier I 
may trigger Tier II immunotoxicity studies, but the Agency would not be 
able to make that determination until the data from Tier I was 
reviewed. This is different from what was proposed in conventional 
pesticides (70 FR 12275, March 11, 2005), which requires the data 
(though not the same guideline (conventional pesticides requires 
guideline 870.7800)), since it is proposed to be required as Tier I. 
The Agency discussed the variability, and decided for biochemical 
pesticides, given their low risk, it was appropriate to defer until the 
data in Tier I are reviewed and determined if there was a potential for 
adverse effects to the immune system.
    f. Carcinogenicity. The Agency proposes to change the name of the 
``Oncogenicity study'' to ``Carcinogenicity study'' (guideline 
870.4200) to reflect current terminology.
    g. 90 Day-Oral Subchronic Testing. The Agency currently 
conditionally requires (CR) these data for food uses. The Agency is 
proposing to require (R) these data for food uses since people eat food 
for periods longer than one day, and since biochemicals have a non-
toxic modes of action, there is a need for some data comparable to 
dietary exposure to assure us that nothing adverse is likely to happen 
when there are higher than normal levels of the biochemical in our 
food. For instance, eating too much of a given vitamin can be toxic or 
too much of an essential element like iron can have some unpleasant 
effects.

F. Nontarget Organisms and Environmental Fate Data Requirements

    1. General. The Agency uses a tiered system of ecological effects 
and environmental fate testing to assess the potential exposure and 
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. 
Laboratory tests provide a screening tool for what can potentially 
occur in the field, whereas the field study data indicate the potential 
adverse effects in the field. 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 (e.g., Tier II, Tier III, and Tier IV) are needed. Tier I 
ecological effects testing generally consists of the basic data 
requirements that are necessary to determine the acute toxicity to 
nontarget fish, invertebrate, plant, and wildlife species. Tier II 
environmental fate data requirements (there are no Tier I environmental 
fate data requirements) revolve around the characterization of the 
pesticide in the environment, e.g., hydrolysis, soil and aquatic 
metabolism

[[Page 12087]]

rate, photodegradation rate in soil and water, etc.
    Higher tiered studies may be conditionally required when basic Tier 
I data indicate there is potential for adverse effects to nontarget 
species. Tier II data requirements include an array of environmental 
fate data requirements and subchronic/chronic ecological effects tests 
to further refine the potential for exposure and/or risk to the 
environment. Tier III data requirements include a further array of 
field studies that address ecotoxicity concerns for terrestrial and 
aquatic animal species as well as nontarget plants and insects. These 
data provide a foundation for ecological risk assessment, which allows 
the Agency to determine any appropriate precautionary statements or 
mitigation measures necessary to support registration concerning 
toxicity or potential adverse effects to nontarget organisms (including 
endangered species).
    With respect to some of the environmental fate data requirements, 
the Agency is providing two sets of guideline numbers where needed, the 
first guideline numbers are what are currently used by the Agency. The 
second set which are in (parentheses) are guidelines the Agency has in 
draft stage and hope to finalize in the near future. To avoid confusion 
on the types of data that are required, both numbers are provided for 
each data requirement as an interim measure until the guidelines are 
finalized.
    2. Nontarget organisms and environmental fate data requirements. 
The Agency is proposing to add the redwing blackbird, Agelaius 
phoenicius, to the list of species that may be substituted for the 
other species (i.e., mallard or bobwhite quail). This test species 
could be used for the avian oral toxicity study because current data 
requirements do not adequately characterize the risks that pesticides 
pose to songbirds. Other changes include revisions in the test 
substance, conditions under which the test is conducted, and 
clarification of test notes.
    i. New data requirements. None.
    ii. Newly codified data requirements. a.  Regulatory text revision. 
The current part 158 for biochemicals does not include regulatory text 
provisions within the data table section discussing the exemptions of 
data to support arthropod pheromones (Sec.  158.960(a)(2)).The Agency 
is proposing the following language to be part of the regulatory text 
in the proposed rule:
    (2) The data in this section (Sec.  158.960) are not required 
for arthropod pheromones when applied at up to a maximum use rate of 
150 grams active ingredient/acre/year except when the product is 
expected to be available to avian species (i.e. granular 
formulation).

It makes it clear from the onset under what conditions these data are 
required. Based on a survey of data and the literature since 1984, EPA 
believes that arthropod pheromones pose minimal risk to nontarget 
species when applied at this rate or less (Ref. 15). As a result of 
this finding, EPA has historically waived these data and is revising 
the test note to reflect the current practice.
    b. EP testing. Where nontarget and environmental fate data are 
required, the Agency currently requires (R) that the TGAI be used as 
the test substance, and does not generally require (R) or conditionally 
require (CR) the EP to be tested. EPA is proposing to conditionally 
require (CR) EP testing when any end-use formulation may contain other 
ingredients that may be toxic to nontarget organisms or to support 
arthropod pheromones that would be available to avian wildlife (e.g., 
granular product).
    c. Anerobic aquatic metabolism (162-3 or guideline 835.4400) and 
anerobic soil metabolism (162-2 or guideline 835.4200), are currently 
not required (NR). The Agency is proposing to conditionally require 
(CR) anerobic soil metabolism for terrestrial use and anerobic aquatic 
metabolism for both terrestrial and aquatic uses. The Agency believes 
that anerobic aquatic metabolism is necessary if the pesticide is 
intended for application to standing water and/or low oxygen 
environments, e.g., rice paddies, cranberry bogs, wetlands in natural 
areas and would already be required under these circumstances under 
typical registration practices for biochemicals.
    iii. Revisions to existing requirements. The Agency is proposing a 
reduction or clarification in following five data requirements: avian 
oral, avian dietary, freshwater fish, freshwater invertebrate, and 
plant toxicity testing. The Agency is proposing to not require (NR) 
these studies for terrestrial uses of arthropod pheromones as defined 
in Sec.  158.900. Other proposed changes are as follows:
    a. Avian acute oral (guideline 850.2100)--Redwing Blackbird. Part 
158 currently only offers two test species for testing, mallard and the 
bobwhite quail. The Agency is proposing revisions to the Avian Acute 
Oral data requirement, specifically to add an optional test species 
(i.e. redwing blackbird), in order to address potential exposure to 
passerine species in a terrestrial environment. In addition, the Agency 
is proposing to conditionally require (CR) EP testing if the 
formulation would be available to avian wildlife, e.g., granular 
formulation. Testing on a passerine species (i.e., redwing blackbird) 
may be required (R) for outdoor uses if the use pattern lends itself to 
higher exposure to passerine species compared to upland game or 
waterfowl species. EPA is requesting comments on whether this species 
should replace the existing bobwhite/mallard species for a biochemical 
pesticide, or otherwise be presented as an optional species for the 
conduct of the test. If so, comments are also sought on the specific 
criteria to be used to determine when the testing on this particular 
species would be required.
    In addition, the Agency is proposing to conditionally require (CR) 
EP testing when the following apply: when any end-use formulation may 
contain other ingredients that may be toxic to nontarget organisms or 
when the end-use formulation is used to support arthropod pheromones 
that would be available to avian wildlife (e.g., granular product).
    b. Avian dietary (guideline 850.2200). Part 158 currently requires 
(R) TGAI testing for this data requirement. In addition, the Agency is 
proposing to conditionally require (CR) EP testing when the following 
apply: when any end-use formulation may contain other ingredients that 
may be toxic to nontarget organisms or when the end-use formulation is 
used to support arthropod pheromones that would be available to avian 
wildlife (i.e., granular product).
    c. Fish acute toxicity test (freshwater) (guideline 850.1075), 
aquatic invertebrate acute toxicity (freshwater)test (guideline 
850.1010). The Agency currently requires (R) these data for all 
terrestrial, aquatic, forestry, and domestic outdoor uses. The Agency 
conditionally requires (CR) the data for greenhouse and indoor use. The 
Agency proposes to add two test notes to the current standards. The 
first proposed test note indicates when EP data are conditionally 
required (CR), the second test note does not require testing for 
compounds which are highly volatile.
    d. Seedling emergence (guideline 850.4100) and vegetative vigor 
(guideline 850.4250). Part 158 currently requires (R) these data as 
Nontarget Plant Toxicity testing to support terrestrial and aquatic 
nonfood uses and forestry uses. The Agency proposes to require (R) 
these data for all outdoor uses. Currently there is one test note with 
three conditions identifying when these data are required. The Agency 
is proposing to eliminate these test note conditions, but add a test 
note requiring

[[Page 12088]]

EP testing when the end-use formulation may contain other ingredients 
that may be toxic to nontarget plants.
    e. Nontarget insect testing (guideline 880.4350). Currently the 
Agency conditionally requires (CR) nontarget insect testing (154-11) 
data with two test note conditions. The Agency proposes to be more 
transparent and require (R) these data, for all uses except indoor use. 
This is because it has become apparent to the Agency throughout the 
years, that is appropriate to require insect testing especially with 
these types of biochemical pesticides, to ensure they are insect 
specific. In addition, the actual test guideline recommends that the 
guideline 850.3020 be conducted on the honeybee initially, but that 
additional nontarget insect species may be required. The honeybee study 
is required since that is what has been typically submitted and 
addresses the issues for risk assessments for biochemical pesticides.
    f. Sediment and soil adsorption/desorption for parent and 
degradates; 161-1 or guideline 835.1230, and soil column leaching ( 
163-1 or guideline 835.1240) currently designated as adsorption-
desorption. These data are currently not required (NR) for greenhouse 
use. Hydrolysis (161-1 or guideline 835.2120) and Aerobic Aquatic 
Metabolism (162-4 or guideline 835.4300) are also not required (NR) for 
greenhouse use. The Agency is proposing to conditionally require (CR) 
these data for greenhouse use. The proposed test note is also revised 
to indicate all these data are conditionally required (CR) depending on 
the results of any of the Tier I data, not limited to environmental 
fate data, since it is the experience of the Agency that there may be 
other indicators other than exposure data which would trigger the need 
for these data.
    g. Laboratory volatilization from soil (163-2 or guideline 
835.1410) designated as volatility in current data requirements, and 
Aerobic soil metabolism, 161-1 or guideline 835.4100. The Agency 
currently conditionally requires (CR) these data to support aquatic 
uses and do not require (NR) these data to support greenhouse use. The 
Agency is proposing to not require (NR) these data to support aquatic 
uses, and to conditionally require (CR) these data to support 
greenhouse use. Since the exposure is in the soil, it is appropriate 
not to require data in the water/sediment and it is appropriate to 
require these data for land type use. In other words, this revision is 
consistent with the purpose and implementation, as well as with the 
guidelines.
    h.  Photodegradation on soil (161-3 or guideline 835.2410) and 
photodegradation in water (161-2 or guideline 835.2240) identified as 
Soil photolysis and Aquatic photolysis in current guidelines. Part 158 
currently conditionally requires (CR) these data for all uses except 
greenhouse and indoor use. That study is designed to measure photolysis 
of a pesticide on the surface of the soil. Water will attenuate the 
amount of sunlight reaching underlying sediments in a water body, 
thereby making photolysis of a sediment bound pesticide unlikely. In 
that case, measuring photolysis of the pesticide in the water column 
would be more appropriate. Therefore, the Agency proposes to not 
require (NR) photodegradation of parent and degradates in soil for 
aquatic (food and nonfood), since photodegradation cannot be measured 
in the soil under the water, but the Agency is continuing to 
conditionally require (CR) the direct photolysis rate of parent and 
degradates in water, since photolysis can be measured. The Agency 
proposes to add a condition for terrestrial, greenhouse, and forestry 
uses, when the results of Tier I studies demonstrate a concern for 
toxicity, and an evaluation of potential exposure (environmental fate) 
is needed to make a risk determination. EPA also proposes to change the 
names of these studies from ``soil photolysis'' to ``photodegradation 
on soil'' as designated in (161-3 or guideline 835.2410) and from 
``aquatic photolysis'' to ``photodegradation in water'' also identified 
as direct photolysis rate of parent and degradates in water (161-2 or 
guideline 835.2240). In essence, the proposed data requirements are in 
line with the proposed use patterns, where the exposure is eminent.
    i. Partition coefficient (n-octanol/water) (guidelines 830.7550, 
830.7560, and 830.7570). Part 158 currently conditionally requires (CR) 
this study when results from Tier1 tests indicate environmental fate 
data are needed. The Agency proposes to relocate this requirement under 
the product chemistry data requirements. As further explained in that 
section of the preamble, the study would no longer be dependent on Tier 
I studies, but would be conditionally required (CR) for organic 
chemicals unless they dissociate in water or are partially or 
completely soluble in water.
    j. UV/light absorption (guideline 830.7050). Part 158 currently 
conditionally requires (CR) this study for all uses except greenhouse 
(food and nonfood) and indoor use. As explained elsewhere, the Agency 
proposes to transfer this data requirement to product chemistry data 
requirements and to require (R) this for all 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 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. The UV/visible light absorption 
spectrum will indicate whether or not the pesticide absorbs in this 
range.
    k. Dispenser-water leaching (guideline 880.4425). Part 158 
currently does not require (NR) this study to support greenhouse uses 
and indoor use. The proposed rule conditionally requires (CR) this 
study for greenhouse use and does not require (NR) for aquatic uses. 
This proposed change brings the data table in line with the guideline 
and only require the data when the pesticide is applied to land in a 
passive dispenser.
    l. Terrestrial wildlife, aquatic animal, nontarget plant, and 
insect testing. The Agency currently divides Tier III studies into four 
categories: terrestrial, aquatic animal, nontarget plant, and nontarget 
insect testing. The Agency proposes to identify individual studies and 
their respective guideline numbers that may be conditionally required 
(CR) when results from lower tiered data indicate the potential need 
for additional studies. The test notes have not been revised, therefore 
the conditions under which these data are required will not be revised. 
However, the Agency is updating the guideline numbers. As a result 
guideline 850.2300 through 850.2500 apply to various terrestrial data 
requirements (avian and mammal), guideline 850.1025 through 850.1500 
for aquatic animal data requirements (freshwater and marine fish and 
invertebrate species), and guideline 850.4225 through 850.4450 for 
nontarget plant studies.
    The Agency currently conditionally (CR) requires Tier III nontarget 
insect testing depending on the results of the lowered testing for 
nontarget insects. The Agency proposes to conditionally require (CR) 
field pollinator testing (to address risks to bees) data (guideline 
850.3040) as Tier III, if the product is expected to be transported 
during application to air, soil, or water, which is determined in the 
Tier II environmental fate studies. Based on industry information, and 
fate data indication potential for exposure, we

[[Page 12089]]

might then require some type of Tier III testing. This testing would 
have to be preceded by consultation with OPP, because it would be 
directed at the problem identified earlier. We would need to consider 
the species at risk, route of exposure, etc. Additional insect species 
may have to be tested if necessary to address issues raised by use 
patterns and potential exposure of important insect species, e.g., 
beneficial insects, endangered species. The guideline number is 
guideline 850.4030.
    m. Product performance. Currently the Agency relies on Sec.  
158.640 for product performance data requirements for biochemicals and 
microbial pesticides. The Agency is proposing to include product 
performance in the regulatory text for both biochemicals and microbial 
pesticides to improve transparency. Product performance verification 
can be important, especially for public health pests, for some of the 
biochemical and microbial pesticides since we have seen independent 
reports that some do not work as well as the conventional pesticide 
products.

VIII. Microbial Pesticides Data Requirements (Subpart M)

A. Definition of Microbial Pesticide

    Amendment to part 158. The Agency is proposing a revision in the 
definition of a microbial pesticide. The current definition at Sec.  
158.65 of microbial pesticides is:
    Biochemical and microbial pesticides are generally distinguished 
from conventional pesticides by their unique modes of action, low use 
volume, target species specificity or natural occurrence. In addition, 
microbial pesticides are living entities capable of survival, growth 
reproduction and infection. ... Microbial pesticides include microbial 
entities such as bacteria, fungi, viruses, and protozoans. The data 
requirements apply to all microbial pesticides, including those that 
are naturally-occurring as well as those that are genetically modified. 
Each ``new'' variety of subspecies, or strain of an already registered 
microbial pest control agent must be evaluated, and may be subject to 
additional data requirements.
    The definition of a microbial pesticide in the proposed rule is as 
follows:
    Microbial pesticide means a microorganism intended for 
preventing, destroying, repelling, or mitigating any pest, or 
intended for use as a plant regulator, defoliant, or desiccant, 
that: (1) Is a eucaryotic microorganism including, but not limited 
to, protozoa, algae, and fungi; (2) Is a procaryotic microorganism, 
including, but not limited to, bacteria; or (3) Is an autonomous 
replicating microscopic element, including, but not limited to, 
viruses.
    This proposed definition of microbial pesticide is based on the 
language in the current definition of microbial pesticide at Sec.  
158.65 and the class of nonexempt biological control agents in Sec.  
152.20(a)(2), but uses a structure for defining microbial pesticide 
similar to that at 40 CFR 172.43. Specifically, the proposed definition 
replicates the structure used in Sec.  172.43 that identifies the 
intent of the microbial pesticide, for example, as the prevention or 
destruction of a pest. The proposed definition also combines the 
structure and examples at Sec.  152.20 with the current regulatory 
structure to clarify the intended scope of the current regulatory 
definition and relationship to Sec.  152.20. For example, the proposed 
definition includes references to eucaryotic and procaryotic 
microorganisms, terms not found in the current definition at Sec.  
158.65 but found in Sec.  152.20(a)(3). The proposed definition also 
clarifies that microbial pesticides include viruses and other similar 
infective elements, while the ''autonomous replicating`` language is 
intended to exclude pesticide components of microscopic cells that are 
not able to replicate as separate entities, such as genetic constructs 
inserted intentionally into the cells. None of these proposed 
amendments are intended to change the scope of the current regulatory 
definitions of microbial pesticide at Sec.  158.65 or of the exemption 
provision at Sec.  152.20(a)(3).
    EPA is also proposing not to include in the definition of microbial 
pesticide the phrase from current Sec.  158.65 distinguishing microbial 
pesticides from conventional pesticides because the original definition 
was more of a description of those characteristics that might be shared 
by both biochemical pesticides and microbial pesticides. In this rule, 
we have described biochemical pesticides separately and we can now be 
more specific in defining microbial pesticides.
    EPA notes that microorganisms are known to produce many pesticidal 
substances. These pesticidal substances, when used independently of the 
microorganism, are considered to be biochemical pesticides, 
conventional chemical pesticides, or antimicrobial pesticides, 
depending on the mode of action and the use. The microorganism would 
then usually be considered part of the manufacturing process. For 
example, streptomycin, an antibiotic produced by a bacterium, 
Streptomyces griseus, is registered as a conventional chemical 
fungicide.

B. Applicability of Microbial Pesticide Data Tables

    EPA is proposing to create a new applicability provision expressly 
providing that the microbial pesticide data tables apply to microbial 
pesticides, as described previously, and to add to that paragraph 
specifics on the types of microbials subject to the subpart M data 
requirements.
    First, the language in current Sec.  158.65 states that ``each new 
variety of subspecies, or strain of an already registered microbial 
pest control agent must be evaluated, and may be subject to additional 
data requirements.'' The proposed refinement now reads ``each new 
isolate of a microbial pesticide is treated as a new strain and must be 
registered independently of any similar registered microbial pesticide 
strain and supported by data required in this subpart.'' This 
refinement is simply intended to clarify the intent of the current 
regulatory language.
    The second sentence added to the applicability provision states 
that genetically modified microbial pesticides may be subject to 
additional data or information requirements on a case-by-case basis 
depending on the particular microorganism and/or its parent 
microorganism(s), the proposed pesticide use pattern, and the manner 
and extent to which the organism has been genetically modified. That 
language is moved from current Sec.  158.65.
    The final sentence reads ``pest control organisms such as insect 
predators, nematodes, and macroscopic parasites are exempt from the 
requirements of FIFRA as authorized by section 25 (b) of FIFRA and 
specified in Sec.  152.20 (a) of this chapter.'' That sentence is moved 
from current Sec.  158.65 as well.
    In addition, the current regulatory text at Sec.  158.65 specifies 
that the microbial ``data requirements apply to all microbial 
pesticides, including those that are naturally-occurring as well as 
those that are genetically modified.'' This language is not needed in 
the definition; the use of the data requirements for microbial 
pesticides is fully described in the section immediately following the 
definition.
    Other portions of the current text at Sec.  158.65 are proposed to 
be moved to the applicability subsection of subpart M, Sec.  158.1000, 
or the other provision that seems generic Sec.  158.1010 to avoid 
confusion on the definition of microbial pesticide. Specifically, EPA 
is proposing to move current Sec.  158.65(b)(2) to proposed Sec.  
159.1010.
    EPA is also proposing to use table descriptors NR (not required), R

[[Page 12090]]

(required), and CR (conditionally required) to be used as markers along 
a spectrum of the likelihood that a data requirement applies. In other 
words, it should be assumed that a required (R) data requirement is 
required typically all the time. There may be some narrow or rare 
conditions identified in test notes when data are not required. For 
example, acute injection toxicity (intraperitoneal or intravenous) not 
required when the microbial pesticide is a virus. In contrast, a 
conditionally required (CR) data requirement is less likely to be 
triggered compared to a required (R) data requirement, but more likely 
include test notes indicating conditions when data are typically 
required. For example, the primary dermal irritation is currently 
conditionally required (CR) for microbial pesticides. The test note 
indicates it is required (R) when dermal irritation is reported from 
the acute dermal toxicity study. Specific criteria are identified with 
the test note.

C. Amendment of Part 172

    The Agency is also proposing to replace the definition for a 
microbial pesticide at 40 CFR 172.43 with the definition proposed here. 
The proposed definition is broader than the definition at Sec.  172.43 
in that it uses the term ``includes'' rather than ``means'' and 
identifies a category for autonomous replicating microscopic elements, 
rather than just including viruses. EPA is proposing a broader 
definition because it has been EPA's experience that there are 
microorganisms other than viruses that could be used as a pesticide but 
that would otherwise be excluded by the definition at Sec.  172.43.

D. Product Analysis Data Requirements

    1. General. The Agency uses product analysis information to 
determine whether impurities of toxicological or environmental concern 
are present in the pesticide and formulated products. Product analysis 
data requirements include product identity and composition data, 
physical and chemical characteristics of a pesticide, plus any 
intentionally added ingredients and impurities in the final pesticide 
product. Included in this category are the specific, detailed 
requirements for product identity and chemical analysis. The title of 
the data requirements, ``microbial pesticides product chemistry data 
requirements,'' is proposed to be revised to ``microbial pesticides 
product analysis data requirements'' to better reflect the extra 
identification procedures necessary to analyze living organisms. The 
following discussion addresses the proposed data requirements.
    2. Product analysis data requirements. Currently, the Agency groups 
all the physical and chemical properties studies under one section. The 
Agency proposes instead to list the individual studies that are 
included in the category of data requirements to support registration 
(guideline 830.6302 through 830.7300). The Agency currently requires 
(R) all product chemistry data to support registration, except for 
analysis of samples and submittal of samples, which is proposed to be 
required under residue chemistry data requirements.
    i. New requirements. None.
    ii. Newly codified requirements. None.
    iii. Revisions to existing requirements. a. Product identity, 
manufacturing process, and deposition of a sample in a nationally 
recognized culture collection. Currently these data are required as 
guideline numbers 151-20, 151-21, and 151-22. The Agency proposes that 
these data requirements would remain the same as before. However, we 
are proposing to list each as a separate study: product identity; 
manufacturing process; and, discussion of formation of unintentional 
ingredients. The Agency proposes to list them as follows: product 
identity (guideline 885.1100), manufacturing process and deposition of 
a sample in a nationally recognized culture collection (guideline 
885.1200), and discussion of formation of unintentional ingredients 
(guideline 885.1300).
    b. Physical and chemical characteristics. The Agency currently 
requires (R) physical and chemical characteristics data. The Agency 
proposes to require (R) that the same studies and same endpoints be 
evaluated, however the Agency is trying to be more clear by identifying 
the individual pieces of the data requirement and separately identify 
each in the data table. Specifically the studies are identified as: 
color, physical state, odor, stability, storage stability, miscibility, 
corrosion characteristics, pH, viscosity, and density (guidelines 
830.6302 through 870.7300).
    c. Analysis of samples. This study (guideline 885.1400) is 
currently conditionally required (CR) for EUPs and registrations. The 
Agency proposes to revise this data requirement to be required (R), 
since it is critical to have an analysis of samples to understand the 
composition of the microbial pesticide and the potential for 
contamination with other microorganisms.
    d. Certification of limits. This study is currently required (R) 
except for nonfood uses. The Agency is proposing to expand this data 
requirement to be required (R) for all uses. These studies are needed 
to confirm the claims made on the label and to validate the 
confidential statement of formula.
    e. Analytical methods. The analytical methods would typically 
assure that you could quantify the confidential statement of formula. 
This study is currently required (R), and the Agency proposes to 
continue to require (R) these data, but under product identity and 
discussion of unintentional ingredients data requirements, which 
provide these data.
    f. Submittal of samples. This provision is typically intended to 
enable EPA to identify the active ingredient and provide standards to 
governmental agencies needing to monitor chemical pesticide residues 
and is conditionally required (CR). The Agency proposes to require (R) 
these data as a product analysis requirement to be deposited in a 
nationally recognized culture collection to allow EPA to validate 
strain identity if issues arise (guideline 885.1200).
    Since the Agency does not have capacity to store the variety of 
microbial pesticides that may be submitted, EPA did not set up a 
nationally recognized culture collection. There are several nationally 
recognized culture collections in this country (and abroad) such as the 
American Type Culture Collection and a microbial collection maintained 
in Peoria, Ill., by the USDA. These facilities have a vast number of 
microbial and cell cultures that are dedicated to transferring, 
maintaining and identifying. Rather than duplicate this effort, EPA 
chose to refer microbial pesticide producers to these facilities who 
have the routine expertise to keep and distribute (or protect) 
microbial cultures. There is a certain element of required expertise 
but really the cost and small number of our microbial pesticides would 
make it prohibitively expensive for the Agency to do this collection 
rather than direct the companies to these specialized facilities.

E. Residue Chemistry Data Requirements

    1. General. The Agency uses residue chemistry information to 
determine the potential bioavailability of pesticide residues on food. 
Included in this subpart are the detailed requirements for chemical 
identity, analytical methods for plants and animals, nature of residue, 
stability, and magnitude of residue.
    2. Residue chemistry data requirements. The residue chemistry

[[Page 12091]]

data table currently requires residue data under one data requirement. 
The Agency is proposing to delineate the residue data to clearly 
identify the endpoints being measured. In other words, there is only 
one data requirement, and in the proposed rule there are several data 
requirements listed (guideline 885.2000 through 885.2350), but no more 
additional data are actually required. In addition, the current test 
note in part 158 delays the residue study requirement until Toxicology 
Tier II and Tier III data are required (R). The Agency is proposing the 
data requirement not be dependent on the Tier Data in II and III, but 
to conditionally require (CR) these data when the results of testing 
(indicated in test note).
    i. New requirements. None.
    ii. Newly codified requirements. None.
    iii. Revisions to existing requirements. Part 158 currently 
requires residue data (153-4) for microbial pesticides, but does not 
lay out clearly the various underlying studies for fulfilling the 
actual requirement. EPA proposes the following be listed to provide 
greater clarity and transparency of the data that are actually required 
(R) to support registration: Background for residue analysis of 
microbial pest control agents (guideline 885.2000), chemical identity 
(guideline 885.2100), nature of residue (guideline 885.2200, 885.2250), 
analytical methods (guideline 885.2300,885.2350), storage stability, 
magnitude of residue (guideline 885.2500, 885.2550, 885.2600). These 
data are currently required (R), therefore there is no revision in the 
proposed rule.

F. Toxicology Data Requirements

    1. General. 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, and 
domestic animals, for all microbial pesticides. These data requirements 
include acute toxicity/infectivity studies (oral, dermal, inhalation, 
pulmonary injection), a cell culture study, and hypersensitivity 
incidents (guideline 885.3050 through 885.3500) to be submitted. In 
addition, acute toxicity studies (oral, dermal, and inhalation) and the 
primary eye and dermal irritation studies (guidelines 870.1100 through 
870.2500) are also required. The Agency wants to specially note that we 
are inviting public comment as to whether or not hypersensitivity 
incidents (guideline 885.4300) is addressed adequately via the Sec.  
152.125, FIFRA section 6 (a)(2) data requirement, also discussed in the 
preamble for biochemical pesticides.
    The following identifies the revisions to the current Sec.  158.740 
for microbial toxicology data requirements. Revisions include name 
changes, test note clarifications, revisions under which use pattern 
data are triggered (e.g., food use versus non-food use), and 
clarification of other circumstances under which data are required.
    2. Toxicology data requirements. The Agency generally discourages a 
registrant from pursuing registration of a microbial pesticide that is 
a known human pathogen, even one reported to be an opportunistic human 
pathogen, because it would be difficult to support a risk assessment 
that would show no unreasonable risk to humans. However, in some cases, 
a candidate microbial pesticide may:
    (a) Be very closely related to a human pathogen but lack the toxins 
or invasive factors responsible for that disease;
    (b) Be taxonomically distinct from known human pathogens, but may 
have picked up a toxin or other factor that could cause mammalian 
disease as detected by Tier I and II studies; or,
    (c) Provide significant benefits that would offset some risk that 
might additionally be mitigated by certain use/exposure considerations.
    The Agency has encountered several cases where microbial pesticides 
are a member of a taxonomic group containing mammalian toxins. In these 
instances, data gathering beyond the codified data requirements may be 
required to account for potential human health risks. For most 
applications, this kind of testing is not needed.
    Generally, toxicology data from Tier I is sufficient to address the 
hazards related to the human health risk assessment for pathogenicity 
and infectivity of microbial pesticides. The most common reason for 
needing Tier II or higher tests is the appearance of unexplained 
toxicity, unusual persistence, lethality, or adverse effects related to 
treatment with the microbial pesticide in the Tier I studies.
    Some microbial products may be lethal to rodents at the Tier I and/
or Tier II levels, where the mode of action may not be sufficiently 
clear to allow for specific toxin or other infectivity factors to be 
analyzed. Furthermore, due to the nature of some microorganisms, the 
possibility exists that rodents may not be a truly representative test 
animal for determining effects on humans of a microbial pesticide.
    The Agency proposes to conditionally require (CR) Infectivity/ 
pathogenicity as a Tier III data requirement. This requirement allows 
for the possible use of alternative test species, including primates as 
described in the testing guidelines.
    In addition, there are ten revisions, primarily name changes to the 
data requirements.
    i. New requirements--Infectivity/pathogenicity. Currently this 
study is not required. The Agency is proposing to conditionally require 
(CR) a Tier III infectivity/pathogenicity analysis (guideline 885.3000) 
when the microbial pesticide appears to be a mammalian pathogen that 
might sufficiently affect humans or nontarget mammals. While it is 
possible that the registrant would not want to pursue a microbial 
registration if such testing were triggered, the Agency believe it is 
appropriate to establish a Tier III toxicity study requirement to 
evaluate the microbial pesticides potential effects in higher animals. 
The Agency believes this type of data would rarely be required. 
However, if all criteria established in the revised test notes has been 
exceeded, it is appropriate to require the data.
    ii. Newly codified requirements. None.
    iii. Revisions to existing requirements-- a. Acute oral toxicity/
pathogenicity. Currently this study is required (R) with no test notes. 
For clarity, the Agency is proposing a name change to the more 
descriptive one used in the updated guidelines (guideline 885.3050). 
EPA also proposes a reduction in the number of test substances required 
to be tested. Currently, part 158 requires both MP or EP and TGAI. The 
proposed rule would only require (R) the TGAI to be tested. TGAI is 
only required for the acute oral toxicity/pathogenicity and can be done 
with MP or EP to avoid the ``normal'' acute oral toxicity for the EP if 
all endpoints and dosing are confirmed. The endpoint examined in the 
toxicity/pathogenicity include clearance and immune functioning of the 
test rodent. These endpoints, once determined, are not necessary for 
more than the TGAI. The MP and the EP are not expected to dramatically 
alter the pathogenicity character of the microbe so the extra testing 
does not add to the safety assessment. The Agency is also proposing to 
add a test note, indicating the acute oral study toxicity/pathogenicity 
can be combined with the unit dose portion of acute oral toxicity study 
(guideline 870.1100) if the new protocol is designed to address the 
endpoints of concern.
    b. Acute pulmonary toxicity/pathogenicity. The Agency currently 
requires (R) the acute inhalation study

[[Page 12092]]

(152-31) under Tier I. The Agency is proposing acute pulmonary 
toxicity/pathogenicity (guideline 885.3150) to be required in lieu of 
the acute inhalation study. EPA also proposes a reduction in number of 
test substances required to be tested, currently both MP or EP and TGAI 
are required. The proposed rule would only require (R) the TGAI to be 
tested. These endpoints, once determined, are not needed for more than 
the TGAI. As discussed previously, the MP and the EP are not expected 
to dramatically alter the pathogenicity character of the microbe so the 
extra testing does not add to the safety assessment.
    c. Acute injection toxicity/pathogenicity (Intravenous or 
Intraperitoneal). The Agency currently requires (R) I.V., I.C., I.P. 
injection study. The Agency is proposing acute injection toxicity/
pathogenicity (either intraperitoneal or intravenous) to also be 
required (R), with the test note indicating the pathway under what 
conditions the intravenous or intraperitoneal would be required. 
Intracerebral is no longer required since it has been determined that 
exposure would most likely result in intravenous or intraperitoneal 
exposure. Under this revised data requirement, the data would not be 
required if the active ingredient of the pesticide product is a virus.
    d. Primary dermal irritation. The Agency currently requires (R) 
this data under Tier I. The Agency is proposing to conditionally 
require (CR) these data as Tier I, with proposed test notes better 
defining the conditions when the data requirement would apply. This 
study would be conditionally required (CR) only if dermal irritation 
was indicated in the acute dermal toxicity study, since it would be 
evident in the results of the acute dermal toxicity study if primary 
dermal toxicity effects could occur.
    e. Acute inhalation toxicity. Currently the Agency conditionally 
requires (CR) an acute inhalation study (151-41) in Tier II on MP or EP 
product when data in a Tier I acute inhalation study indicate potential 
adverse effects (e.g., survival, replication, infectivity, toxicity). 
The Agency is proposing to require (R) the acute inhalation toxicity 
study (guideline 870.1300) as a Tier I, limiting it to testing MP or 
EP, no longer requiring TGAI testing, but with a test note indicating 
data are required only if the product can be inhaled.
    f. Hypersensitivity study and hypersensitivity incidents. Currently 
the Agency requires (R) the hypersensitivity study and conditionally 
requires (CR) hypersensitivity incidents. The Agency is proposing to 
not require (NR) the hypersensitivity study and to require (R) 
hypersensitivity incident reporting data. The hypersensitivity study 
are currently submitted as part of product characterization on known 
microbial hazards such as toxins and allergens.
    As indicated, the Agency proposes to revise hypersensitivity 
incidents from the current conditionally required (CR) to proposed 
required (R), even under conditions of EUP's. While these types of data 
are already required under Sec.  152.125, FIFRA 6(a)(2), the status of 
hypersensitivity incidents reporting is unclear for microbial products 
that have not been registered or are under an EUP. Therefore, the 
Agency included a requirement for hypersensitivity incident reporting 
for EUP's in lieu of the hypersensitivity study. As previously 
indicated, EPA is inviting comment as to whether or not this study is 
needed, since the data must already be submitted to the Agency as 
6(a)(2) data.
    g. Cell culture. The Agency proposes to rename the currently 
required (R) tissue culture study for all viruses to the cell culture 
data requirement (guideline 885.3500), since this study is a more 
appropriate name for the tissue culture study and would only be 
required when the product's active ingredient is a virus.
    h. Reproductive fertility effects. The Agency currently 
conditionally requires (CR) teratogenicity data. The Agency is 
proposing to conditionally require (CR) reproductive and fertility 
effects data (guideline 885.3650). This study replaces both guidelines 
152-47 and 152-53. This is actually a replacement, since the data are 
basically assessing the same endpoints. The Agency is also proposing to 
not require these data as Tier II, but as Tier III since the triggers 
for this study rely on toxicity endpoints which are collected in Tier 
II studies, i.e., guideline 885.3600.

G. Nontarget Organisms and Environmental Fate Data Requirements

    1. General. The Agency uses a tiered system of ecological effects 
testing to assess the potential risks of pesticides to nontarget 
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, or whether the 
pesticide should be registered for certain use patterns at all.
    Higher tiered nontarget organisms and environmental fate studies 
may be required when basic human health assessment 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 would be required only when the 
potential for adverse effects is indicated by the results of lower tier 
studies, or to confirm the need for mitigation measures. In some cases, 
the results of field studies may also give rise to the need for further 
testing.
    2. Nontarget organisms and environmental fate data requirements. 
The proposed nontarget organisms and environmental fate data table 
reflects the data that are currently required to support registration 
of new microbials. Conditions under which data may be required are 
stipulated in the test notes. In addition, there are a few studies that 
would be replaced by more appropriate studies to measure the endpoint 
of concern, and other studies would be deleted. These data revisions 
are not be expected to substantively increase the nature or burden of 
the existing data requirements.
    i. New requirements. None.
    ii. Newly codified requirements. None.
    iii. Revisions to existing requirements. a. Avian Inhalation 
Toxicity/Pathogenicity. The Agency currently requires (R) an avian 
injection test. The Agency proposes to replace the avian injection test 
(154-17) with the avian inhalation test (guideline 885.4100) to provide 
a more appropriate endpoint to assess risks to avian species. The 
Agency is also proposing to conditionally require (CR) this data only 
when the microbial pesticide appears to have toxins that indicate 
potential pathogenicity. The inhalation study models a more realistic 
route of exposure in the wild than intraperitoneal injection.
    b.  Fish life-cycle study and aquatic invertebrate range testing. 
The Agency proposes to replace conditionally required (CR) aquatic 
embryo larvae and life cycle studies (154-28) with conditionally 
required (CR) fish life-cycle studies (guideline 885.4700) and 
definitive aquatic animal tests (154-27) with aquatic invertebrate 
range testing (guideline 885.4650) to provide more appropriate 
endpoints for assessing risks to aquatic species (fish and

[[Page 12093]]

invertebrates). The ``fish'' life cycle study is more appropriate 
because it identifies a particular taxonomic class to be tested as 
opposed to ``aquatic embryo and life cycle studies'' which do not 
identify the taxonomic class or species to be tested. ``Definitive 
aquatic animal tests'' does not say what animal group (species) is to 
be tested and does not say what test is to be done (``definitive'' is 
not a test name), whereas ``aquatic invertebrate range testing'' is 
more appropriate because it specifically instructs the registrant to 
determine which aquatic invertebrate species are susceptible to the 
pesticide and which are not susceptible. In summary, the Agency is 
proposing to revise the titles of the data requirements in order to 
account for species and life cycles being tested.
    c. Simulated or actual field testing for plants (guideline 
850.2500). The Agency currently conditionally requires (CR) nontarget 
plant studies (154-31) as Tier III when data in Tier II indicate there 
is a concern. The Agency proposes to rename the data requirement to 
simulated or actual field testing for plants (guideline 850.2500), 
which is currently conditionally required (CR) on a case-by-case basis. 
The test notes associated with the proposed requirement are more 
explicit as to when the conditions would be met. In addition, these 
data are proposed to be conditionally required (CR) as Tier IV.
    d. Product performance. Currently the Agency relies on Sec.  
158.640 for product performance data requirements for biochemicals and 
microbial pesticides. The Agency is proposing to include product 
performance in the regulatory text for both biochemicals and microbial 
pesticides to improve transparency. Product performance verification 
can be important for some of the biochemical and microbial pesticides 
since we have seen independent reports that some do not work as well as 
the conventional pesticide products. It is particularly useful to have 
product performance data for those products that want to be considered 
as presenting less risk than a conventional pesticide product.
    e. Subchronic toxicity/pathogenicity. The Agency proposes to change 
the name of the subchronic oral toxicity study (152-42) to correspond 
with the current name of the test guideline.
    f. Carcinogenicity. The Agency proposes to change the name of the 
oncogenicity study to carcinogenicity study (guideline 870.4200) to 
correspond with the current name of the test guideline.

IX. Peer Review

A. National Research Council Recommendations

    As discussed in Unit V.A.3, the National Academy of Sciences issued 
a report in 1993 entitled, ``Pesticides in the Diets of Infants and 
Children.'' The study, conducted by the National Research Council, was 
initiated to address the question of whether the current regulatory 
system adequately protected infants and children from pesticide 
residues in food. The Council reviewed current EPA practices and data 
requirements related to dietary risk assessment as well as testing 
modifications planned by the Agency. 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 also expressed the need 
to investigate the effects of pesticide exposure on immunotoxic 
responses in infants and children (Ref. 3).

B. FIFRA Scientific Advisory Panel

    1. 1994 SAP Review. In 1994, EPA held a two 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. 
While these data requirements were presented to SAP to support 
conventional pesticides, the majority of changes to the data 
requirements presented in this notice were submitted for review as 
subpart M: Microbial and Biochemical Pesticides Data Requirements. 
These revisions were generally endorsed by the SAP (Ref. 4). A copy of 
the 1994 SAP final report can be found in the docket for this 
rulemaking (docket ID number EPA-HQ-OPP-2004-0415).
    The limited issues that were addressed in1994 Panel's specific 
comments are as follows:
     Intraperitoneal study. The issue revolved around whether 
an intraperitoneal study is appropriate to use when microbial size or 
physical properties preclude the use of intravenous study. At that 
time, SAP believed the intraperitoneal study was appropriate to use 
when microbial size or physical properties preclude the use of 
intravenous study. This option is included in the proposed rule.
     Bird species. The issue revolved around whether the second 
bird study gives significant additional information for microbial 
effects, i.e., are the two birds species likely to respond differently 
to typical biocontrol microbials. At the time, SAP suggested that it 
was appropriate to use only the more sensitive bird species (the quail) 
for data requirements. This recommendation has been included in the 
test note.
     Fish species. The issue revolved around whether the second 
fish study was likely to provide significant information for 
microbials. At the time, SAP suggested that it was appropriate to use 
the more sensitive fish species (trout) for data requirements. The SAP 
recommendation was incorporated into the test note.
    Additionally, SAP encouraged the Agency to carefully evaluate the 
data requirements for genetically engineered microbials. The SAP 
believed this emerging technology was still, in many respects, an 
unknown entity. In the future, EPA will develop data requirements for 
plant-incorporated protectants.
    2. 1987 SAP Review--Immunotoxicity testing of biochemical pest 
control agents (BPCAs) (Ref. 7). Proposed Guidelines for Immunotoxicity 
Testing of Biochemical Pest Control Agents were presented to the SAP. 
In particular the issues revolved around the use of a single sex of 
test animal in the lower tiered studies. At that time, the 1987 SAP 
decided that there was no scientific rationale for examining both male 
and female animals, though this may not apply to compounds that 
demonstrate estrogenic activity. In this case females may be the sex of 
choice since they would be more sensitive to immunotoxic effects than 
males by this class of compounds. A second issue raised at this meeting 
was the inclusion of a limit test in Tier I, in which no adverse 
immunological effects are observed at a single high dose, then no 
further testing is required. The Agency was seeking advice on the 
scientific criteria that would support the inclusion or exclusion of a 
limit test in Tier I studies. At that time, the SAP deemed it 
appropriate for all assays in Tier I to be included since no single 
test can fully evaluate all cellular or functional components of the 
immune system. A dose that produces a large amount of general toxicity 
would be of concern since the general toxicity might indirectly 
contribute to the immunotoxicity. Immunotoxicity data

[[Page 12094]]

should be cautiously evaluated in this context.
    3. 1986 SAP Review--Applicator/user exposure monitoring guidelines. 
The Series 875, Group A, Applicator/User Exposure Monitoring Guidelines 
were presented to SAP in January 1986. After EPA addressed SAP 
comments, the guidelines were finalized. The guidelines were published 
by the National Technical Information Service (NTIS) in 1987 (Ref. 10).
    A comprehensive listing of data requirements and the year that each 
specific data requirement was reviewed by SAP is available in the 
docket for this proposed rule (Ref. 11). Additionally, copies of 
documents reviewed by SAP and the final reports can be found on EPA's 
website at http:// www.epa.gov/scipoly/sap.

X. 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. 
The Agency believes it has taken steps, based on current scientific 
knowledge and experience, to minimize testing on biochemical and 
microbial pesticides. With respect to these types of pesticides, the 
Agency has implemented a tiered testing approach, thereby potentially 
reducing the number of studies required for registration. 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 pesticide 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 pesticide as a screen to judge whether the 
pesticide 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.
    The Agency plays an important role in the Federal Interagency 
Coordinating Committee on 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; and (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 pesticide 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 would continue to be added to the test guidelines.

XI. 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 (mostly conventional chemical 
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 site on which it was authorized to be 
used.
    In general, a biochemical pesticide is not expected to pose 
endangered species concerns because it is a naturally-occurring 
chemical or a synthetically-derived equivalent; has a history of 
exposure to humans and the environment demonstrating minimal toxicity; 
and has a non-toxic mode of action to the target pest(s). However, the 
Agency has occasionally required such data for microbial pesticides 
(e.g., Metarhizium anisopliae). The microbial pesticides typically have 
a limited host range and affect only certain species limiting the 
potential of such pesticides to pose endangered species concerns. The 
Agency anticipates that these data could be requested in the future in 
connection with other registration and reregistration actions for both 
biochemical and microbial pesticides if lower tier studies show 
potential adverse effects to nontarget organisms.
    In response to a Data Call-In notice on certain conventional 
pesticides for data on the location of all listed species, an industry 
taskforce 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. Thus, the Agency is 
requesting comment on its utility and appropriateness.
    While EPA is using the best available scientific and commercial 
information to assess risks to listed species, uncertainties still 
exist. 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

[[Page 12095]]

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 nontarget and 
endangered plant species exposed to herbicides.
     Toxicity data to characterize potential effects to aquatic 
invertebrates (i.e., 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.
    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.

XII. Research Involving Human Subjects

    This proposed rule (see proposed Sec.  158.950) would establish 
data requirements for applicator/user exposure studies for biochemical 
pesticides proposed as insect repellents. This data requirement is 
consistent with Sec.  158.500 of the proposed rule for conventional 
pesticides (70 FR 12275, March 11, 2005).
    On January 26, 2006, the EPA Administrator signed a final rule 
entitled Protections for Humans Subjects in Research (71 FR 6138, 
February 6, 2006), (Ref. 23) that significantly strengthens and expands 
the protections for subjects of ``third-party'' human research (i.e., 
research that is not conducted or supported by EPA) by (1) prohibiting 
new research involving intentional exposure of pregnant women or 
children that is intended for submission to EPA under the pesticide 
laws; (2) extending the provisions of the Federal Policy for the 
Protection of Human Subjects of Research (the ``Common Rule'') to other 
human research involving intentional exposure of non-pregnant adults 
that is intended for submission to EPA under the pesticide laws; (3) 
requiring submission to EPA of protocols and related information about 
covered human research before it is initiated; and (4) establishing an 
independent Human Studies Review Board to review both proposals for new 
research and reports of covered human research on which EPA proposes to 
rely under the pesticide laws.
    This rule forbids EPA to rely, in its actions under the pesticide 
laws, on intentional-exposure human research that either involves 
pregnant women or children as subjects or is otherwise considered 
unethical, except in narrowly defined circumstances. Some studies 
required under this part will also be subject to subparts K, L, and M 
of 40 CFR part 26--the newly promulgated final rule for the protection 
of human subjects of research. Subpart K extends the substantive 
provisions of the ``Common Rule''--the ethical standard that governs 
research with human subjects conducted or supported by EPA and other 
Federal departments and agencies to third-party research that involves 
intentional exposure of non-pregnant adults as subjects, and that is 
intended for submission to EPA under the pesticide laws. Subpart K also 
requires submission to EPA of proposals for any covered research, at 
least 90 days before it is initiated, for review by EPA staff and the 
Human Studies Review Board. Subpart L categorically prohibits any 
third-party research that involves intentional exposure of pregnant 
women, fetuses, or children as subjects, and that is intended for 
submission to EPA. Subpart M specifies the range of information 
required to be submitted along with reports of completed research with 
human subjects to document the ethical conduct of the research.

XIII. Summary of Proposed Changes

    The Agency has prepared a document, entitled Summary of the 
Proposed Changes (Ref. 1), to compare the current data requirements to 
support the registration of biochemicals and microbials, respectively, 
with the revised data requirements presented in this proposed rule. The 
changes include: revision in test notes, revision in guideline names, 
revisions in tiering the various data requirements, etc. Along with the 
proposed changes to the data required, the Agency also proposes to 
revise the definitions of biochemical pesticides and microbial 
pesticides and to add definitions of pheromones, arthropod pheromones, 
and straight chain lepidopteran pheromones.

XIV. Summary of Options

    What Options did the Agency Evaluate?
    The Agency evaluated three regulatory options to revising the 
existing data requirements. The three options are generally 
characterized by estimated annual cost or regulatory burden reduction 
and frequency of requiring data. The options as presented are intended 
to reflect broad conceptual approaches, and within each broad option 
there are other options for requiring or reducing data requirements. In 
addition, whether considered broadly or more narrowly, EPA's approach 
is based on the primary need for sufficient information to make the 
FIFRA/FFDCA findings while at the same time being mindful of 
opportunities to reduce burden and testing where data is not value 
added. Again, as noted previously, the point is to emphasize first the 
need to meet statutory mandates.
    This section will briefly cover these three options. The specific 
cost differences between these three regulatory options are discussed 
in the executive summary of the Economic Analysis for this rulemaking 
(Ref. 6). Overviews of estimated annual cost or regulatory burden 
reduction for the proposed rulemaking as a whole may be found in Unit 
XVI., Regulatory Assessment.
    1. Option 1 (reduced regulatory burden, potential risk). This low-
cost approach was designed to maximize burden reduction based upon the 
specific nature of biochemical and microbial pesticides. Based on the 
non-toxic mode of action and naturally-occurring characteristics of 
many of these compounds, the Agency could perform a complete risk 
assessment based on a minimal amount of nontarget organisms and 
environmental fate data. For biochemical pesticides, the Agency would 
not require Tier I nontarget organisms and Tier II environmental fate 
data. For example, under this approach, the Agency would not receive 
any exposure or infectivity/pathogenicity data for biochemical 
pesticides. For microbial pesticides, the Agency would significantly 
reduce the

[[Page 12096]]

frequency of time (up to 50 percent) that proposed Tier I nontarget 
organisms and Tier II environmental fate data are required. The 
nontarget organism tests monitor the effects of proposed pesticides on 
nontarget birds, wild mammals, fish, insects and plants. The 
environmental fate tests are used to assess the persistence of 
biochemicals and microbial pesticides in the environment. This option 
would only minimally reduce the regulatory burden as compared to the 
changes being proposed today (described in Option 3). The Agency does 
not believe the decrease in burden outweighs the loss in benefits to 
public health and the environment from reduced availability of data for 
assessing environmental hazard and risk through registration decisions. 
The cost savings realized in this option are only marginally lower than 
the savings realized in the proposed option.
    2. Option 2 (significant regulatory burden, adequate risk 
assessment). This high-cost approach was evaluated based on an Agency 
approach of maximizing the completeness of the database. Under this 
approach, the Agency would require Tier I human health and 
environmental data requirements 100 percent of the time. For example, 
under this approach, the Agency would receive all exposure and 
infectivity/pathogenicity data, with immunotoxicity required as Tier II 
and Tier III data. This approach would result in significantly higher 
costs to pesticide registrants and increased burden to the Agency 
compared to the proposed approach. Additionally, unlike Option 1 and 
the proposed option, EPA believes that this high-cost approach would 
substantially raise the cost of registering a biochemical or microbial 
pesticide, resulting in fewer products being registered and reducing 
the potential for these biopesticides (generally lower risk) to compete 
in the marketplace to provide alternatives to conventional pesticides 
(generally higher risk). The extra cost and time required to register a 
biochemical or microbial pesticide under this option may discourage use 
of these safer pesticides, resulting in more, not less environmental 
risk.
    3. Option 3 (proposed option). The proposed option provides the 
Agency with flexibility and is a middle ground between Option 1, 
representing a minimal cost but potentially significant loss of 
environmental hazard information, and Option 2, representing the 
maximum availability of information, but at significantly higher cost. 
The Agency would require, under certain conditions, human health and 
environmental data from all tiering levels (I, II, III, IV). The 
frequency that data is required would be based on current scientific 
knowledge and conditions specific to the active ingredient and use 
patterns. For example, the Agency proposes to require immunotoxicity as 
Tier II and Tier III data, conditionally require infectivity/
pathogenicity data, and conditionally require exposure data for insect 
repellents. The proposed option is a codification of current practice, 
and is a balance that provides sufficient data for Agency to complete 
an environmental risk assessment while ensuring the lowest feasible 
cost and burden to applicants and the Agency.
    The Agency believes the changes proposed today best serve to 
protect human health and the environment and allow for a complete and 
accurate assessment of risks, while benefitting a large number of 
parties, including the regulated industry, pesticide users, the general 
public, other Federal, State, and foreign governments, and others who 
are affected by or interested in pesticide use or regulation. 
Additionally, the net benefit of the proposed changes is expected to 
include a cost savings for existing and future biochemical and 
microbial pesticide registrants versus the current codified 
requirements.
    Comparing the proposed option to Option 1 (low cost option), EPA 
believes that the modified and newly-imposed nontarget organisms and 
environmental fate Tier I data requirements contained in the proposed 
approach are needed to ensure informed risk assessment and risk 
management decisions on biochemical and microbial pesticide 
registrations.
    Comparing the proposed option to Option 2 (high cost option), EPA 
believes that the cost and burden of requiring the Tier I human health 
and environmental data for all biochemical and microbial registrations 
would not warrant the modest benefits of marginally valuable 
information. EPA believes that Option 2 would reduce the adverse 
externalities of pesticides and unknown risks to consumers only 
slightly more than the proposed approach. However, the benefits of this 
additional data are speculative. Based on the specific nature and 
scientific knowledge of biochemical and microbial pesticides, these 
additional data (over and above what the proposed option requires) 
would most likely inform registration decisions very little.

XV. References

    The Agency has established a docket for this rulemaking under 
docket ID number EPA-HQ-OPP-2004-0415. 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. 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 as described under ADDRESSES.
    1. U.S. EPA, 2005. ``Summary of Proposed Changes to Biochemical and 
Microbial Pesticide Data Requirements.'' FEAD/OPP/U.S. EPA, Washington, 
D.C.
    2. U.S. EPA, 2003. ``OPPTS Test Guidelines.'' OPP/U.S. EPA, 
Washington, D.C.
    3. National Research Council, ``Pesticides in the Diets of Infants 
and Children,'' National Academy Press, Washington, D.C., 1993. Excerpt 
pp. 152-156.
    4. FIFRA Scientific Advisory Panel (SAP). 1994 SAP Final, November 
29, 1994 FIFRA Scientific Advisory Panel Meeting, November 29-30, 1994, 
held in Arlington, Virginia.
    5. U.S. EPA. 2005. Part II. Environmental Protection Agency. 
Pesticides; Data Requirements for Conventional Pesticides; Proposed 
Rule. (70 FR 12276, March 11, 2005).
    6. U.S. EPA, 2005. ``Economic Analysis of the Proposed Rule 
Changing Data Requirements for Biochemical and Microbial Pesticides.'' 
FEAD/OPP/U.S. EPA, Washington, D.C.
    7. FIFRA Scientific Advisory Panel (SAP). ``A Set of Scientific 
Issues Being Considered by the Agency in Connection with Proposed 
Revision to Subdivision M, Immunotoxicity Testing of Biochemical Pest 
Control Agents (BPCA's).'' Review from open meeting on March 24, 1987 
in Arlington, Virginia.
    8. U.S. EPA, 1989. ``Subdivision M of the Pesticide Testing 
Guidelines, Microbial and Biochemical Pest Control Agents.'' EFED/OPP/
U.S. EPA, Washington, D.C.
    9. U.S. EPA, 1982. ``Pesticide Assessment Guidelines, Subdivision 
M, Biorational Pesticides.'' HED/OPP/U.S. EPA, Washington, D.C.
    10. U.S. EPA, 1986. ``Series 875, Group A, Applicator/user Exposure 
Monitoring Guidelines.'' Presented to the FIFRA Scientific Advisory 
Panel (SAP), January, 1986. OPP/U.S. EPA, Washington, D.C.
    11. U.S. EPA, 2005. ``Overview of Proposed Data Requirements and 
FIFRA SAP Review.'' FEAD/OPP/U.S. EPA, Washington, D.C.
    12. U.S. EPA, 2005. ``Analysis of Data Requirements for Biochemical 
and

[[Page 12097]]

Microbial Pesticides from 1997-2004.'' FEAD/OPP/U.S. EPA, Washington, 
D.C.
    13. U.S. EPA, 2005. ``Data Requirements for Biochemical and 
Microbial Pesticides; Proposed Rule; Consultations.'' FEAD/OPP/U.S. 
EPA, Washington, D.C.
    14. U.S. EPA, 2005. ``Comparison between Current Conventional 
Pesticides Data Requirements and Proposed Biochemical and Microbial 
Pesticide Data Requirements.'' FEAD/OPP/U.S. EPA, Washington, D.C.
    15. OECD [2002-a] Guidance for Registration Requirements for 
Pheromones and Other Semiochemicals Used for Arthropod Pest Control. 
OECD Series on Pesticides, Number 12. Organization for Economic 
Cooperation and Development. February 26, 2002.
    16. U.S. EPA, 2000. ``p-Menthane-3,8-diol (011550) Biopesticide 
Registration Eligibility Document.'' BPPD/OPP/U.S. EPA, Washington, 
D.C. Issued May, 2000.
    17. OECD [2002-b] Registration of Agricultural Pesticides, 
Biological Pesticides--Progress on Development of Dossier/Monograph 
Guidance for Microbials and Pheromones. Working Group on Pesticides. 
Organization for Economic Cooperation and Development. January 3, 2002.
    18. U.S. EPA, 2002. ``Supporting Statement for an Information 
Collection Request: Tolerance Petitions for Pesticides on Food/Feed 
Crops and New Inert Ingredients.'' OMB Control No. 2070-0024, EPA ICR 
No. 0597. OPP/U.S. EPA, Washington, D.C.
    19. U.S. EPA, 2002. ``Supporting Statement for an Information 
Collection Request: Application for New or Amended Pesticide 
Registration.'' OMB Control No. 2070-0060, EPA ICR No. 0277. OPP/U.S. 
EPA, Washington, D.C.
    20. U.S. EPA, 2001. ``Supporting Statement for an Information 
Collection Request: ''Data Generation for Reregistration; Phase 4 and 5 
Reregistration.`` OMB Control No. 2070-0107, EPA ICR No. 1504. OPP/U.S. 
EPA, Washington, D.C.
    21. U.S. EPA, 2001. ``Supporting Statement for an Information 
Collection Request: Data Call-Ins for the Special Review and 
Registration Review Programs.'' OMB Control No. 2070-0057, EPA ICR No. 
0057. OPP/U.S. EPA, Washington, D.C.
    22.U.S. EPA, 2004. ``Supporting Statement for an Information 
Collection Request: Plant- Incorporated Protectants; CBI Substantiation 
and Adverse Effects Reporting.'' OMB Control No. 2070-0142, EPA ICR No. 
1693, Washington, D.C.
    23. U.S. EPA, 2005. Protections for Subjects in Human Research: 
Final Rule. (71 FR 6138, February 6, 2006). Document ID No. OPP-2003-
0132.

XVI. FIFRA Review Requirements

    In accordance with FIFRA section 25(a), the Agency submitted a 
draft of this proposed regulation to the FIFRA SAP, the USDA, the 
Committee on Agriculture in the House of Representatives, and the 
Committee on Agriculture, Nutrition, and Forestry in the United States 
Senate.
    The FIFRA SAP waived its review of this proposal because the 
significant scientific issues involved have already been reviewed by 
the SAP and additional review isn't necessary. USDA participated fully 
in the interagency review process under Executive Order 12866, during 
which EPA and USDA discussed the registration process of microbial 
pesticides and the need for a coordination process when an APHIS 
movement permit under 7 CFR part 340 is required by USDA. As a part of 
related comments, USDA suggested that the Agency consider requiring the 
registrants to submit a copy of the applicable APHIS permits as part of 
the registration application for a microbial pesticide because it would 
facilitate coordination and improve compliance with the applicable USDA 
requirements. As discussed in Unit IIX., the Agency is specifically 
seeking public comment on the most appropriate method to ensure APHIS 
permitting and EPA registrations are properly coordinated.

XVII. Regulatory Assessment

A. Regulatory Planning and Review

    Under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), the Office of Management and 
Budget (OMB) has determined that this proposed rule is a ``significant 
regulatory action'' because the proposed revision of the existing 
regulation to update the data requirements may raise novel legal or 
policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in the Executive Order. 
Accordingly, EPA submitted this proposed rulemaking to OMB for review 
under Executive Order 12866 and any changes made in response to OMB 
comments have been documented in the docket for this rulemaking as 
required by sec. 6(a)(3)(E) of the Executive Order.
    In addition, EPA has prepared an economic analysis of the potential 
costs, benefits, and impacts associated with this proposed action, 
which is contained in a document entitled Economic Analysis of the 
Proposed Rule Changing Data Requirements for Biochemical and Microbial 
Pesticides (Ref. 6). A copy of this Economic Analysis is available in 
the docket for this action, and is briefly summarized here.
    The economic analysis considered the incremental effects between 
the baseline and future biochemical and microbial pesticide 
registration activity based on the proposed rule and two alternatives. 
All costs associated with presently codified 40 CFR part 158 data 
requirements applicable to biochemical and microbial pesticides were 
considered in the baseline. Future biochemical and microbial 
registration activity and associated costs were calculated based on a 
historical examination of actual pesticide registration actions between 
1997 and 2004 combined with anticipated effects of new, revised, or 
modified 40 CFR part 158 subparts L and M data requirements. Review of 
1997 to 2004 registration activity considered the type and frequency of 
the various biochemical and microbial pesticide registration actions 
that occurred, the related applicability of the various data 
requirements for those actions, the type and regularity of waivers 
granted by EPA for certain data requirements, and information about the 
applicants involved in those actions. Where applicable, these trends 
and patterns were used to predict future registration activity. 
Additional effects of the proposed rule due to newly proposed, revised, 
or modified 40 CFR part 158 subparts L and M data requirements were 
estimated based on EPA experience and best judgment.
    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 proposed revisions 
include newly codified data requirements (i.e., data requirements that 
are not currently in part 158, but have been, in practice, required on 
a case-by-case basis), changes to existing requirements (i.e., a 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, or a change in use pattern for an existing requirement), 
and newly imposed data requirements (i.e., data requirement have never 
been previously imposed).
    To calculate the potential costs associated with this proposal, EPA 
first identified the tests necessary to generate the data required, and 
then gathered information on the prices that laboratories typically 
charge a firm to conduct these tests. The prices varied

[[Page 12098]]

depending on conditions specific to the substance tested. Variations 
can be related to differences in the assumptions about the test 
performed (e.g., protocol, species used), or can simply be a difference 
in the price charged by the laboratory. Average, high, and low cost 
estimates were obtained for each test where possible. EPA assumed that 
the data required would always need to be newly generated, but often 
the data are already available because the registrant generated it for 
its own use. In such cases, the firm would simply need to submit those 
data to EPA, which involves less burden than generating it.
    EPA then used historical data on pesticide registration actions 
that occurred over an eight year period (1997-2004) to identify the 
entities that sought pesticide registration actions in the past (Ref. 
12). 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) and use pattern (how the product will be 
used). To estimate the average incremental cost of a new registration, 
a baseline testing rate (i.e., the percentage of time a particular test 
was historically required under the current rule) was estimated by EPA 
scientists based on their past experience with biochemical and 
microbial pesticide registrations and their involvement in developing 
the new data requirements. This baseline data requirement rate was 
compared with the percentage of time each test was required for 
registrations between 1997 and 2004. EPA assumes that under the 
proposed rule, data requirements would be imposed at the same frequency 
they have been required from 1997 to 2004. Additionally, EPA scientists 
estimated the frequency that newly imposed data requirements would be 
required.
    Part of the Economic Analysis included preparation of 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 
XVII.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. 6).
    Using the currently codified requirements as the baseline for the 
impact analysis, the total annual impact to the pesticide industry is 
estimated to be a regulatory compliance cost reduction of about $3.04 
million per year, with an estimated average cost reduction of $60,000 
per firm per year.
    EPA also considered a low cost alternative and a high cost 
alternative to the proposed rule. The low cost alternative would waive 
certain data requirements for biochemical pesticides and reduce the 
rate at which certain data requirements are required for microbial 
pesticides. The estimated impact of the low cost alternative is 
estimated to be a regulatory compliance cost reduction approximately 
$3.20 million, with an estimated average cost reduction of $63,000 per 
firm per year. The high cost alternative would require certain groups 
of data requirements 100 percent of the time, removing the discretion 
of Agency scientists to decide if the data are needed for a specific 
registration. This alternative would result in an estimated annual cost 
increase over current rule requirements of approximately $3.44 million 
per year, or an estimated cost increase of $67,000 per firm.
    The estimated potential costs of the proposed rule acknowledges 
registrant is likely to request that the Agency waive certain data 
requirements if the registrant believes that the data are not necessary 
for determining the effects of a pesticide on human health and the 
environment. EPA estimated the annual cost savings due to waived data 
requirements based on both the historical rate and type of waivers 
granted for the period from 1997-2004, and on an analysis of how the 
proposed rule is expected to modify the rate at which waivers are 
granted. EPA estimated that the annual cost savings due to waived data 
requirements based on the historic waiver rates to be approximately 
$29.6 million, or $580,000 per firm per year. At the modified waiver 
rates predicted under the proposed rule, EPA estimated an annual cost 
savings of $23.96 million, or $470,000 per firm per year.
    Since the likely impact of the proposed rule on businesses overall 
is expected to be mostly beneficial, the Agency believes that the rule 
would have no effect on the availability of pesticides to users. On 
balance, the Agency believes that cost savings resulting from the 
proposed changes to 40 CFR part 158 subparts L and M can be realized 
without compromising the protection of human health and the 
environment.

B. Paperwork Reduction Act

    This proposed rule does not contain any information collection 
requirements that require additional approval by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act, 44 
U.S.C. 3501 et seq. 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 contained in Title 40 of the CFR, after 
appearing in the preamble of the final rule, may be listed in 40 CFR 
part 9, 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 additional 
information collection and paperwork burden. The information collection 
requirements, i.e., the paperwork collection activities, contained in 
this proposal related to the new data necessary to register a pesticide 
product are already approved by OMB under several existing information 
collection requests (ICR). Specifically, the program activities which 
would generate a paperwork burden under this proposal are covered by 
the following ICRs:
    The activities associated with the establishment of a tolerance are 
currently approved under OMB Control No. 2070-0024 (EPA ICR No. 0597) 
(Ref. 18);
    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) (Ref. 19);
    The activities associated with the generation of data for 
reregistration are currently approved under OMB Control

[[Page 12099]]

No. 2070-0107 (EPA ICR No. 1504) (Ref. 20);
    The activities associated with the generation of data for special 
review or registration review are currently approved under OMB Control 
No. 2070-0057 (EPA ICR No. 0922) (Ref. 21); and
    Notification of genetically modified microbial pesticides. OMB 
Control No. 2070-0142 (EPA ICR No. 1693) (Ref. 22).
    These existing ICRs cover the paperwork activities contained in 
this proposal because these activities already occur as part of 
existing program activities. These program activities are an integral 
part of the Agency pesticide program and the corresponding ICRs are 
regularly renewed as required under the PRA, such that these OMB 
Control Nos. are maintained valid. The approved burden in these ICRs 
were increased in 1996 to accommodate the potential increased burden 
related to the implementation of the new safety standard imposed in 
1996 by FQPA and additional burden revisions related to the proposed 
rule are not necessary.
    Based on these existing approvals, the Agency estimates that the 
total 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.
    Direct your comments on the Agency's need for this information, the 
accuracy of the provided burden estimates, and any suggested methods 
for minimizing respondent burden, including the use of automated 
collection techniques, to EPA using the docket that has been 
established for this proposed rule (docket ID number EPA-HQ-OPP-2004-
0415) at http://www.epa.gov/edocket/.
    The Agency will consider and address comments received on the 
information collection requirements contained in this proposal when it 
develops the final rule.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 
5 U.S.C. 601 et seq., after considering the potential economic impacts 
of today's proposed rule on small entities, 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 XVII.A., and a copy of which is available in the 
docket for this rulemaking. The following is a brief summary of the 
factual basis for this certification.
    Small entities include small businesses, small organizations, and 
small governmental jurisdictions. For purposes of assessing the impacts 
of today's proposed rule on small entities, small entity is defined in 
accordance with the RFA as: (1) A small business as defined by the 
Small Business Administration's (SBA) regulations at 13 CFR 121.201; 
(2) a small governmental jurisdiction that is a government of a city, 
county, town, school district, or special district with a population of 
less than 50,000; and (3) a small organization that is any not-for-
profit enterprise which is independently owned and operated and is not 
dominant in its field.
    Based on the industry profile that EPA prepared using historical 
data as part of the Economic Analysis prepared for this rulemaking, EPA 
has 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 impacts 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.
    EPA then used historical data to estimate the impacts of the 
proposed rule on these small businesses. Out of 51 firms with 
biochemical or microbial registration actions between 1997 to 2004, 
financial data for determining company size was available for 40 firms, 
with 23 of those firms classified as small businesses. According to the 
analysis, all of these small entities would have realized a reduction 
in costs based on the proposed rule changes compared to the current 
part 158 data requirements. Given these estimated impacts on small 
businesses, EPA concluded that the proposed revisions may benefit and 
would not likely have a significant adverse economic impact on a 
substantial number of small entities.
    Nonetheless, EPA is particularly interested in receiving comment 
from small businesses as to the estimated cost savings, expected 
benefits, and overall impacts of this proposed rule. Any comments 
regarding the economic impacts that this proposed regulatory action may 
impose on small entities should be submitted to the Agency in the 
manner specified in the ADDRESSES section.

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 
XVII, the total annual impact to the pesticide industry is estimated to 
be a regulatory compliance cost reduction of about $3.04 million per 
year. 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 
sections 202 and 205 of UMRA.

E. Federalism Implications

    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 would 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. Because instances where a State is a registrant 
are extremely rare, 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. Tribal Implications

    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 would not have substantial direct effects on 
tribal governments, on the relationship between the Federal government 
and the Indian tribes, or on the distribution

[[Page 12100]]

of power and responsibilities between the Federal government and Indian 
tribes, as specified in the Order. 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 tribal governments, EPA specifically solicits comment on 
this proposed rule from tribal officials.

G. Protection of Children

    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 XVII.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 would 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 would 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. Energy Implications

    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. Environmental Justice

    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.

List of Subjects

40 CFR Part 158
    Administrative practice and procedure, Agricultural commodities, 
Pesticides and pests, Reporting and recordkeeping requirements.
40 CFR Part 172
    Confidential business information, Pesticides and pests, Reporting 
and recordkeeping requirements, Administrative practice and procedure, 
Agricultural commodities, Intergovernmental relations, Labeling.


    Dated: March 1, 2006.
Stephen L. Johnson,
Administrator.
    Therefore, it is proposed that 40 CFR chapter I, parts 158 and 172 
be amended as follows:

PART 158--[AMENDED]

    1. By revising the authority citation for part 158 to read as 
follows:

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

    2. By adding Sec.  158.3 to part 158, subpart A to read as follows:


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:
     Active ingredient means any substance (or group of structurally 
similar substances, if specified by the Agency) that would prevent, 
destroy, repel or mitigate any pest, or that functions as a plant 
regulator, desiccant, defoliant, or nitrogen stabilizer, within the 
meaning of FIFRA section 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

[[Page 12101]]

ingredient only, or may contain inert ingredients, such as stabilizers 
or solvents.
    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.  158.65  [Removed]

    3. By removing Sec.  158.65.
    4. By adding subparts L and M to part 158 to read as follows:
Subpart L--Biochemical Pesticides
Sec.
158.900 Biochemical pesticides subject to subpart L.
158.910 Biochemical pesticides data requirements.
158.930 Product chemistry data requirements table.
158.940 Residue data requirements table.
158.950 Human health assessment data requirements table.
158.960 Nontarget organisms and environmental fate data requirements 
table.
158.970 Biochemical pesticides product performance data 
requirements.
Subpart M-- Microbial Pesticides
Sec.
158.1000 Definition and applicability.
158.1010 Microbial pesticide data requirements.
158.1020 Product analysis data requirements table.
158.1030 Residue data requirements table.
158.1040 Toxicology data requirements table.
158.1050 Nontarget organisms and environmental fate data 
requirements table.
158.1060 Microbial pesticides product performance data requirements.

Subpart L--Biochemical Pesticides


Sec.  158.900  Biochemicalpesticides subject to subpart L.

    (a) This subpart applies to all biochemical pesticides as defined 
in paragraphs (b), (c) and (d) of this section.
    (b) Definition. A biochemical pesticide is a pesticide that:
    (1) Is a naturally-occurring substance or structurally-similar and 
functionally identical to a naturally-occurring substance;
    (2) Has a history of exposure to humans and the environment 
demonstrating minimal toxicity, or in the case of a synthetically-
derived biochemical pesticides, is equivalent to a naturally-occurring 
substance that has such a history; and
    (3) Has a non-toxic mode of action to the target pest(s).
    (c) Pheromone is a compound produced by a living organism which, 
alone or in combination with other such compounds, modifies the 
behavior of other individuals of the same species.
    (1) Arthropod pheromone is a pheromone produced by a member of the 
taxonomic phylum Arthropoda.
    (2) Lepidopteran pheromone is an arthropod pheromone produced by a 
member of the insect order Lepidoptera.
    (3) Straight Chain Lepidopteran pheromone is a lepidopteran 
pheromone designated by an unbranched aliphatic chain (between 9 and 18 
carbons) ending in an alcohol, aldehyde, or acetate functional group 
and containing up to three bonds in the aliphatic backbone.
    (d) Examples. Biochemical pesticides include, but are not limited 
to:
    (1) Semiochemicals (insect pheromones and kairomones),
    (2) Natural plant and insect regulators,
    (3) Naturally-occurring repellents and attractants, and
    (4) Enzymes
    (e) Applicability. The Agency may review on a case-by-case basis, 
naturally-occurring pesticides that do not clearly meet the definition 
of a biochemical in an effort, to ensure, to the greatest extent 
possible, that only the minimum testing sufficient to make 
scientifically sound regulatory decisions would be conducted. The 
Agency will reviewapplications for registration of naturally-occurring 
pesticides to determine whether to review the pesticide under this 
subpart L.


Sec.  158.910   Biochemicalpesticides data requirements.

    (a) Sections 158.930 through 158.970 identify the data requirements 
that are required to support registration of biochemical pesticides. 
Variations in the test conditions are identified within the test notes. 
Definitions that apply to all biochemical data requirements can be 
found inSec.  158.930.
    (b) Each data table includes ``use patterns'' under which the 
individual data are required, with variations including food and 
nonfood uses for terrestrial and aquatic applications, greenhouse, 
indoor, forestry, and residential outdoor applications under certain 
circumstances.
    (c) The categories for each data requirement are ``R'', which 
stands for required, and ``CR'' which stands for conditionally 
required. If a bracket appears around the R or CR, the data are 
required for both the registration and experimental use permit 
requests. Generally, ``R'' indicates that the data are more likely 
required than forthose data requirements with CR. However, in each 
case, the regulatory text preceding the data table and the test notes 
following the data table must be used to determine whether the data 
requirement must be satisfied.
    (d) Each table identifies the test substance that is required to be 
tested to satisfy the data requirement. Test substances may include: 
technical grade active ingredient (TGAI), manufacturing-use product 
(MP), end-use product (EP), typical end-use product (TEP), residue of 
concern, and pure active ingredient (PAI) or (All) indicating all of 
the above. Commasbetween the test substances (i.e., TGAI, EP) indicate 
that data may be required on the TGAI or EP or both depending on the 
conditions set forth in the test note. Data requirements which list two 
test substances (i.e., TGAI and EP) indicate that both are required to 
be tested. Data requirements that list only the manufacturing product 
(MP) as the test substance apply toproducts containing solely the 
technical grade of the active ingredient and manufacturing-use products 
to which other ingredients have been intentionally added. Data 
requirements listing the EP as the test substance apply to any EP with 
an ingredient in the end-use formulation other than the active 
ingredient that is expected to enhance the toxicity of the product.
    (e) The data requirements are organized into a tier-testing system 
with specified additional studies at higher tiers being required if 
warranted by adverse effects observed in lower tier studies. The lower 
tier studies are a subset of those required for conventional 
pesticides, and the studies overall are generally selected from those 
required for conventional pesticides.
    (f) Two sets of guideline numbers are provided for some of the 
environmental fate data requirements. For ease of understanding, the 
current guidelines will be used as an interim measure until the new 
guidelines (in parentheses) are finalized.

[[Page 12102]]

Sec.  158.930   Product chemistrydata 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 (e) 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) Key. R=Required; [R]=Required for registrations andexperimental 
use permits; CR=Conditionally required; [CR]=Conditionally required for 
registrations and experimental use permits; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; Residue of 
concern= the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; All= all of the above. Specific 
conditions, qualifications, or exceptions to the designated test 
procedures appear in paragraph (e) of this section, and apply to the 
individual tests in the following table:
    (d) Table. The following table shows the data requirements for 
biochemical product chemistry. The test notes are shown in paragraph 
(e) of this section .

                                                 Table--Biochemical Product Chemistry Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                               Test Substance  to support
          Guideline Number               Data Requirement       All Use  Patterns   ----------------------------------------------       Test notes
                                                                                               MP                     EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product Identity and Composition
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.1100                              Product identity and   [R]                      TGAI, MP               TGAI, EP               1,2
                                      composition
--------------------------------------------------------------------------------------------------------------------------------------------------------
 880.1200                             Description of         [R]                      TGAI, MP               TGAI, EP               2,3
                                      starting materials,
                                      production and
                                      formulation process
--------------------------------------------------------------------------------------------------------------------------------------------------------
 880.1400                             Discussion of          [R]                      TGAI and MP            TGAI and MP            4
                                      formation of
                                      impurities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Analysis and Certified Limits
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.1700                             Preliminary analysis   [CR]                     TGAI and MP            TGAI and MP            5,8
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.1750                             Certified limits       [R]                      MP                     EP                     6
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.1800                             Enforcement            [R]                      MP                     EP                     7
                                      analytical method
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physical and Chemical Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.6302                             Color                  [R]                      TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.6303                             Physical state         [R]                      TGAI                   TGAI and EP            8
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.6304                             Odor                   [R]                      TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.6313                             Stability to normal    [R]                      TGAI                   TGAI                   8,17
                                      and elevated
                                      temperatures, metals
                                      and metal ions
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.6315                             Flammability           [CR]                     MP                     EP                     9
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.6317                             Storage stability      [R]                      MP                     EP                    --
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.6319                             Miscibility            [CR]                     MP                     EP                     10
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.6320                             Corrosion              [R]                      MP                     EP                    --
                                      characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.7000                             pH                     [CR]                     TGAI and MP            TGAI and EP            8,11
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.7050                             UV/Visible light       [R]                      TGAI                   TGAI                  --
                                      absorption
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.7100                             Viscosity              [CR]                     MP                     EP                     12
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.7200                             Melting point/melting  [CR]                     TGAI                   TGAI                   8,13
                                      range
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.7220                             Boiling point/boiling  [CR]                     TGAI                   TGAI                   8,14
                                      range
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 12103]]

 
 830.7300                             Density/relative       [R]                      TGAI and MP            TGAI and EP            8,18
                                      density/bulk density
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.7520                             Particle size, fiber   [CR]                     TGAI                   TGAI                   8,15
                                      length, and diameter
                                      distribution
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.7550                             Partition coefficient  [CR]                     TGAI                   TGAI                   16
830.7560...........................   (n-Octanol /Water)
830.7570...........................
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.7840                             Water solubility       [R]                      TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.7950                             Vapor pressure         [R]                      TGAI                   TGAI                   8,19
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for biochemical product chemistry and are referenced in 
the last column of the table in paragraph (d) of this section.
    1. Data must be provided in accordance with Sec.  158.320.
    2. If the MP and EP are produced by an integrated formulation 
system(non-registered source), these data are also required on TGAI.
    3. Data must be provided in accordance with Sec.  158.325,Sec.  
158.330, and Sec.  158.335.
    4. Data must be provided in accordance with Sec.  158.340.
    5. Data must be provided in accordance with Sec.  158.345. Also, 
required to support the registration of each manufacturing-use 
product (including registered TGAIs) and end-use products produced 
by an integrated formulation system. Data on other end-use products 
would be required on a case-by-case basis. For pesticides in the 
production stage, a preliminary product analytical method and data 
would suffice to support an experimental use permit.
    6. Data must be provided in accordance with Sec.  158.350.
    7. Data must be provided in accordance with Sec.  158.355.
    8. If the TGAI cannot be isolated, data are required on the 
practical equivalent of the TGAI. EP testing may also be 
appropriate.
    9. Required if the product contains combustible liquids.
    10. Required if the product is an emulsifiable liquid and is to 
be diluted with petroleum solvents.
    11. Required if the test substance is soluble or dispersible in 
water.
    12. Required if the product is a liquid.
    13. Required when the technical chemical is a solid at room 
temperature.
    14. Required when the technical chemical is a liquid at room 
temperature.
    15. Required for water insoluble test substances 
(<10-6 g/l) andfibrous test substances with diameter 
>=0.1 [mu]m.
    16. Required for organic chemicals unless they dissociate in 
water or are partially or completely soluble in water.
    17. 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.
    18. True density or specific density are required for all test 
substances. Data on bulk density is required for MPs or EPs that are 
solid at room temperature.
    19. Not required for salts.


Sec.  158.940  Residue datarequirements table.

    (a) General. Sections 158.100 through Sec.  158.130 describe how to 
use this table to determine the biochemical pesticides residue data 
requirements for a particular pesticide product and the substance that 
needs to be tested. These data requirements apply to all biochemicals, 
e.g., semiochemicals, natural plant and insect regulators, naturally-
occurring repellents and attractants, and enzymes. Notes that apply to 
an individual test and include specific conditions, qualifications, or 
exceptions to the designated test are listed in paragraph (e) of this 
section.
    (b) Use patterns. (1) Data are required or conditionally required 
for all pesticides used in or on food and for residential outdoor uses 
where food crops are grown. Food use patterns include products 
classified under the general use patterns of terrestrial food crop use, 
terrestrial feed crop use, aquatic food crop use, greenhouse food crop 
use, and indoor food use. Data are also conditionally required for 
aquatic nonfood use if there is direct application to water.
    (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 would 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 and aquatic food use, greenhouse food use, indoor food use, 
and indoor residential use.
    (c) Key. R=Required; [R]=Required for registrations andexperimental 
use permits; CR=Conditionally required; [CR]=Conditionally required for 
registrations and experimental use permits; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; Residue of 
concern= the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; All= all of the above. Specific 
conditions, qualifications, or exceptions to the designated test 
procedures appear in paragraph (e) of this section, and apply to the 
individual tests in the following table:
    (d) Table. The following table shows the data requirements for 
biochemical residue for specific uses. The test notes are shown in 
paragraph (e) of this section.

[[Page 12104]]



                                             Table--Biochemical Residue Data Requirements for Specific Uses
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Use patterns containing data requirements
                                                -----------------------------------------------------------------------
       Guideline Number        Data Requirement     Terrestrial         Aquatic                                          Test Substance     Test notes
                                                ------------------------------------  Greenhouse Food     Indoor Food
                                                     Food/Feed            Food
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supporting Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1100                     Chemical          [CR]              [CR]              [CR]              [CR]             TGAI             1,2,4
                                identity
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1200                     Directions for    [CR]              [CR]              [CR]              [CR]             TGAI             1,3,4
                                use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nature of Residue
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1300                     Nature of the     [CR]              [CR]              [CR]              [CR]             TGAI             1,4,5,6
                                residue in
                                plants
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1300                     Nature of the     [CR]              [CR]              [CR]              [CR]             TGAI             1,7,8,10
                                residue in
                                livestock
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1340                     Residue           CR                CR                R                 [CR]             Residue of       4,9,10
                                analytical                                                                               concern
                                method- plants
                               Residue
                                analytical
                                method-
                                livestock.
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1360                     Multiresidue      CR                CR                R                 CR               Residue of       10,11
                                method                                                                                   concern
--------------------------------------------------------------------------------------------------------------------------------------------------------
Magnitude of the Residue
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                     Potable water     NR                [CR]              NR                NR               TGAI             1,12
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                     Fish              NR                [CR]              NR                NR               TGAI             1,13
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                     Irrigated crops   NR                [CR]              NR                NR               TGAI             1,14
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1460                     Food handling     NR                NR                NR                [CR]             TGAI             1,15
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1480                     Meat/milk/        [CR]              [CR]              [CR]              [CR]             TGAI or plant    1,7,8,10
                                poultry/eggs                                                                             metabolites
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1500                     Crop field        [CR]              [CR]              [CR]              [CR]             TGAI             1,3,4
                                trials
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1520                     Processed food/   [CR]              [CR]              [CR]              [CR]             TGAI             1,16
                                feed
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1540                     Anticipated       [CR]              [CR]              [CR]              [CR]             Residue of       1,10,17
                                residues                                                                                 concern
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1550                     Proposed          [CR]              [CR]              [CR]              [CR]             Residue of       1,18
                                tolerances                                                                               concern
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1560                     Reasonable        [CR]              [CR]              [CR]              [CR]             Residue of       1,10
                                grounds in                                                                               concern
                                support of the
                                petition
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1650                     Submittal of      [CR]              [CR]              [CR]              [CR]             TGAI             10,19
                                analytical
                                reference
                                standards
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for biochemical residue for specific uses as referenced in 
the last column of the table contained in paragraph (d) of this 
section.
    1. Residue chemistry data requirements apply to biochemical 
pesticide products when Tier II or Tier III toxicology data are 
required, as specified for biochemical agents in the biochemical 
human health assessment data requirements, Sec.  158.950.
    2. The same chemical identity data are required for biochemical 
product chemistry data requirements,Sec.  158.930 with an emphasis 
on impurities.
    3. Required information includes crops to be treated, rate of 
application, number and timing of applications, preharvest 
intervals, and relevant restrictions.
    4. Residue data for outdoor residential uses are required if 
home gardens are to be treated and the home garden use pattern is 
different from use patterns where tolerances have been established.
    5. Required unless it is an arthropod pheromone applied at a 
rate less than or equal to 150 grams active ingredient per acre.
    6. Required for indoor uses where the pesticide is applied 
directly to food, in order to determine metabolites and/or 
degradates.
    7. Data on metabolism in livestock are required when residues 
occur on a livestock feed or if the pesticide is to be applied 
directly to livestock. 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.
    8. Livestock feeding studies are required whenever a pesticide 
residue is present in livestock feed or when direct application to 
livestock uses occurs.
    9. A residue method suitable for enforcement of tolerances is 
required whenever a numeric tolerance is proposed.
    10. Required for indoor uses if the indoor use could result in 
pesticide residues in or on food or feed.

[[Page 12105]]

    11. Data are required to determine whether FDA/USDA multiresidue 
methodology would detect and identify the pesticides and any 
metabolites.
    12. Data on residues in potable water are required whenever a 
pesticide is to be applied directly to water, unless it can be 
determined that the treated water would not be used (eventually) for 
drinking purposes, by man or animals.
    13. Data on residues in fish are required whenever a pesticide 
is to be applied directly to water inhabited, or that will be 
inhabited, by fish that may be caught or harvested for human 
consumption.
    14. Data on residues in irrigated crops 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.
    15. Data on residues in food/feed in food handling 
establishments are required whenever a pesticide is to be used in 
food/feed handling establishments.
    16. Data on the nature and level of residue in processed food/
feed are required when detectible residues could concentrate on 
processing.
    17. Anticipated residue data are required when the assumption of 
tolerance level residues would result in predicted exposure at an 
unsafe level of exposure. Data on the level or residue in food as 
consumed would be used to obtain a more precise estimate of 
potential dietary exposure.
    18. The proposed tolerance must reflect the maximum residue 
likely to occur in crops in meat, milk, poultry, or eggs.
    19. Required when a residue analytical method is required.


Sec.  158.950  Human healthassessment data dequirements table.

    (a) General. (1) Sections 158.100 through 158.130 describe how to 
use this table to determine the human health assessment data 
requirements for a particular pesticide product.
    (2) The data in this section (158.950) are not required for 
straight chain lepidopteran pheromones when applied up to a maximum use 
rate of 150 grams active ingredient/acre/year.
    (b) Use patterns. (1) Food use patterns, in general, include 
products classified under the following general uses: terrestrial food 
crop use; terrestrial feed crop use; aquatic food crop use; greenhouse 
food crop use.
    (2) Nonfood use patterns include products classified under the 
general use patterns of terrestrial nonfood crop use; aquatic nonfood 
residential use; aquatic nonfood outdoor use; aquatic nonfood 
industrial use; greenhouse nonfood crop use; forestry use; residential 
outdoor use; residential indoor use; indoor food use; indoor nonfood 
use; indoor medical use.
    (c) Key. R=Required; [R]=Required for registrations and 
experimental use permits; CR=Conditionally required; [CR]=Conditionally 
required for registrations and experimental use permits; NR=Not 
required; MP=Manufacturing-use product; EP=End-use product; TEP=Typical 
end-use product; TGAI=Technical grade of the active ingredient; Residue 
of concern= the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; All= all of the above. Specific 
conditions, qualifications, or exceptions to the designated test 
procedures appear in paragraph (e) of this section, and apply to the 
individual tests in the following table:
    (d) Table. The following table shows the data requirements for 
biochemical human health assessment. The test notes are shown in 
paragraph (e) of this section.

                                              Table--Biochemical Human Health Assessment Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Use Patterns                      Test substance to support
        Guideline Number           Data Requirement  --------------------------------------------------------------------------------     Test notes
                                                             Food               Nonfood               MP                  EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Acute Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1100                          Acute oral          [R]                 [R]                 TGAI and MP>        TGAI and EP         1
                                   toxicity-rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1200                          Acute dermal        [R]                 [R]                 TGAI and MP         TGAI and EP         1,2
                                   toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1300                          Acute inhalation    [R]                 [R]                 TGAI and MP         TGAI and EP         3
                                   toxicity--rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2400                          Primary eye         [R]                 [R]                 TGAI and MP         TGAI and EP         2
                                   irritation--rabbi
                                   t
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2500                          Primary dermal      [R]                 [R]                 TGAI and MP         TGAI and EP         1,2
                                   irritation
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2600                          Dermal               R                   R                  TGAI and MP         TGAI and EP         2,4
                                   sensitization
--------------------------------------------------------------------------------------------------------------------------------------------------------
none                              Hypersensitivity    [R]                 [R]                 All                 All                 5
                                   incidents
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Subchronic Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3100                          90-day oral (one    [R]                 CR                  TGAI                TGAI                6
                                   species)
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3250                          90-day dermal--rat  CR                  CR                  TGAI                TGAI                7
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3465                          90-day inhalation-- CR                  CR                  TGAI                TGAI                8
                                   rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Developmental Toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 12106]]

 
870.3700                          Prenatal            [R]                 [CR]                TGAI                TGAI                9
                                   developmental--ra
                                   t preferably
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Mutagenicity Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5100                          Bacterial reverse   [R]                 [CR]                TGAI                TGAI                10
                                   mutation test
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5300                          In vitro mammalian  [R]                 [CR]                TGAI                TGAI                10,11
                                   cell gene
                                   mutation test
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier II
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Mutagenicity Testing (In vivo cytogenetics)
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5385                          Mammalian bone      CR                  CR                  TGAI                TGAI                13
                                   marrow
                                   chromosomal
                                   aberration
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5395                          Mammalian           CR                  CR                  TGAI                TGAI                13
                                   erythrrocyte
                                   micronucleus
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Developmental Toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3700                          Prenatal            [CR]                [CR]                TGAI                TGAI                9
                                   developmental
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Special Tests
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.3550                          Immunotoxicity      CR                  CR                  TGAI                TGAI                12,13
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Applicator/User Exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1000                          Background for      CR                  CR                  TGAI                TGAI                15
                                   application
                                   exposure
                                   monitoring test
                                   guidelines
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1100                          Dermal outdoor      CR                  CR                  TGAI                TGAI                15
                                   exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1200                          Dermal indoor       CR                  CR                  TGAI                TGAI                15
                                   exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1300                          Inhalation outdoor  CR                  CR                  TGAI                TGAI                15
                                   exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1400                          Inhalation indoor   CR                  CR                  TGAI                TGAI                15
                                   exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1500                          Biological          CR                  CR                  TGAI                TGAI                15
                                   monitoring
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1700                          Product use         [R]                 [R]                  TGAI               TGAI                --
                                   information
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier III
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Chronic Testing/Special Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.3800                          Immune response     CR                  CR                  TGAI                TGAI                14
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3800                          Reproduction and    CR                  CR                  TGAI                TGAI                16
                                   fertility effects
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.4100                          Chronic oral--      CR                  CR                  TGAI                TGAI                17
                                   rodent and
                                   nonrodent
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.4200                          Carcinogenicity--t  CR                  CR                  TGAI                TGAI                18
                                   wo species--rat
                                   and mouse
                                   preferred
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 12107]]

 
870.5380                          Mammalian           CR                  CR                  TGAI                TGAI                19
                                   spermatogonial
                                   chromosome
                                   aberration test
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Special Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.7200                          Companion animal    CR                  CR                  Choice              Choice              20
                                   safety
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for biochemical human health assessment as referenced in 
the last column of the table in paragraph (d) of this section.
    1. Required unless the test material is a gas or highly volatile 
(vapor pressure >104torr).
    2. Required unless the test material is corrosive to skin or has 
pH <2 or >11.5.
    3. Required when the pesticide, under conditions of use, would 
result in respirable material (e.g., gas, volatile substance or 
aerosol/particulate), unless it is a straight chain lepidopteran 
pheromone.
    4. Required if repeated contact with human skin is likely to 
occur under conditions of use.
    5. Hypersensitivity incidents must be reported as adverse 
effects data.
    6. Required for non-food uses that are likely to result in 
repeated oral exposure to humans.
    7. Required to support uses involving purposeful application to 
the human skin or which would result in comparable prolonged human 
exposure to the product (e.g., insect repellents) and if any of the 
following criteria are met:
    (i) Data from a 90-day oral study are not required.
    (ii) The active ingredient is known or expected to be 
metabolized differently by the dermal route of exposure than by the 
oral route and the metabolite is of toxicological concern.
    (iii) The use pattern is such that the dermal route would be the 
primary route of exposure.
    8. Required if there is a likelihood of significant levels of 
repeated inhalation exposure to the pesticide as a gas, vapor, or 
aerosol.
    9. Required if the use of the product under widespread and 
commonly recognized practice may reasonably be expected to result in 
significant exposure to female humans (e.g., occupational exposure 
or repeated application of insect repellents directly to the skin). 
Tier II data is required on a different test species from Tier I 
data when developmental effects are observed in the first study and 
information on species-to-species extrapolation is needed.
    10. It is required to support nonfood uses if either (i) the use 
is likely to result in significant human exposure; or (ii) if the 
active ingredient (or its metabolites) is structurally related to a 
known mutagen or belongs to any chemical class of compounds 
containing a known mutagen. Additional mutagenicity tests that may 
have been performed plus a complete reference list must also be 
submitted. Subsequent testing may be required based on the available 
evidence.
    11. Choice of assay using either (1) mouse lymphoma L5178Y 
cells, thymidine kinase (tk) gene locus, maximizing assay conditions 
for small colony expression or detection; (2) Chinese hamster ovary 
(CHO) or Chinese hamster lung fibroblast (V79) cells, hypoxanthine-
guanine phosphoribosyl transferase (hgprt) gene locus, accompanied 
by an appropriate in vivo test for clastogenicity; or (3) CHO cells 
strains AS52, xanthine-guanine phosphoribosyl transferase (xprt) 
gene locus.
    12. Required if there are effects on hematology, clinical 
chemistry, lymphoid organ weights and histopathology are observed in 
the 90-day studies.
    13. Required if results from the Tier I mutagenicity tests are 
positive. Allowed choice of assays, initial considerations usually 
given to rodent bone marrow, using either metaphase analysis 
(aberrations) or micronucleus assay.
    14. Required if adverse effects are observed in the Tier II 
immunotoxicity study. The protocol for evaluating adverse effects to 
the immune response should be developed after evaluating the effects 
noted in the immunotoxicity study.
    15. These data are required when any human health effects 
assessment data indicate that the biochemical may pose a potential 
hazard to the applicator/user. It is recommended that the Agency be 
consulted prior to study initiation to determine what studies are 
appropriate based on the nature of the adverse effects seen in the 
human health assessment data and the available exposure data. 
Studies performed to support registration of insect repellents may 
require modifications to these guidelines.
    16. Required if there is evidence of: (a) endocrinological 
effects from the subchronic toxicity studies, (b) developmental 
effects in the prenatal developmental toxicity study(s), or (c) 
genotoxicity to mammals based on results from the mutagenicity 
tests. The use of a combined study that utilizes the two-generation 
reproduction study in rodents (guideline 870.3800) as a basic 
protocol for the addition of other endpoints or functional 
assessments in the immature animal is encouraged.
    17. Required if the potential for adverse chronic effects is 
indicated based on any of the following:
    (i) The subchronic effect level established in the following 
Tier I studies: 90-day feeding toxicity study, the 90-day dermal 
toxicity study, or the 90-day inhalation toxicity study.
    (ii) The pesticide use pattern (e.g., rate, frequency, and site 
of application).
    (iii) The frequency and level of repeated human exposure that is 
expected.
    18. Required if the product meets either of the following 
criteria:
    (i) The active ingredient (or any of its metabolites, 
degradation products, or impurities) produce(s) in Tier I subchronic 
studies a morphologic effect (e.g., hyperplasia or metaplasia) in 
any organ that potentially could lead to neoplastic change.
    (ii) Adverse cellular effects suggesting carcinogenic potential 
are observed in Tier II immunotoxicity and Tier III immune response 
study or in Tier II mammalian mutagenicity assays.
    In addition, a 90-day range finding study in both rats and mice 
is required to determine the 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.
    19. Required if results from lower tiered mutation or 
reproductive studies indicate there is potential for chromosomal 
aberration to occur.
    20. 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.


Sec.  158.960  Nontarget organismsand environmental fate data 
requirements table.

    (a) General. (1) Sections 158.100 through 158.130 describe how to 
use this table to determine the terrestrial and aquatic nontarget 
organisms and 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. In general,

[[Page 12108]]

for all outdoor end-use products including turf, the following studies 
are required: one avian acute oral, one avian dietary, one acute 
freshwater fish, one acute freshwater invertebrate study, plant 
toxicity testing and a honeybee acute contact study.
    (2) The data in this section are not required for arthropod 
pheromones when applied at up to a maximum use rate of 150 grams active 
ingredient/acre/year except when the product is expected to be 
available to avian species (i.e., granular formulation).
    (b) Use patterns. The terrestrial use pattern includes products 
classified under the general use patterns of terrestrial food crop, 
terrestrial feed crop, and terrestrial nonfood/nonfeed 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 nonfood use. The remaining terrestrial uses 
include: forestry and residential outdoor use. Data are also required 
for the general use patterns of aquatic food and nonfood crop use.
    (c) Key. R=Required; [R]=Required for registrations and 
experimental use permits; CR=Conditionally required; [CR]=Conditionally 
required for registrations and experimental use permits; NR=Not 
required; MP=Manufacturing-use product; EP=End-use product; TEP=Typical 
end-use product; TGAI=Technical grade of the active ingredient; Residue 
of concern= the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; All= all of the above. Specific 
conditions, qualifications, or exceptions to the designated test 
procedures appear in paragraph (e) of this section, and apply to the 
individual tests in the following table:
    (d) Table. The following table shows the data requirements for 
biochemical nontarget organisms and environmental fate. The test notes 
are shown in paragraph (e) of this section.

                                                         Table--Biochemical Nontarget Organisms and Environmental Fate Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                        Use Groups containing data requirements
                                                      ---------------------------------------------------------------------------------------------------------
         Guideline Number           Data Requirement        Terrestrial            Aquatic            Greenhouse                                  Indoor           Test Substance     Test notes
                                                      ---------------------------------------------------------------       Forestry,     ---------------------
                                                        Food/feed, nonfood      Food, nonfood        Food, nonfood    residential outdoor      Food, nonfood
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Avian Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 850.2100                         Avian acute oral     [R]................  [R]................  CR.................  [R]................  CR.................  TGAI, EP..........      1,2,3,4
                                   toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 850.2200                         Avian dietary        [R]................  [R]................  CR.................  [R]................  CR.................  TGAI, EP..........      1,2,3,4
                                   toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Aquatic Organism Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 850.1075                         Fish acute           [R]................  [R]................  CR.................  [R]................  CR.................  TGAI, EP..........      2,3,4,5
                                   toxicity,
                                   freshwater
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 850.1010                         Aquatic              [R]................  [R]................  CR.................  [R]................  CR.................  TGAI, EP..........      2,3,4,5
                                   invertebrate acute
                                   toxicity,
                                   freshwater
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Nontarget Plant Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 850.4100                         Terrestrial Plant     R.................   R.................  NR.................   R.................  NR.................  TGAI, EP..........            5
                                   Toxicity, Seedling
                                   emergence
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 850.4150                         Terrestrial Plant     R.................   R.................  NR.................   R.................  NR.................  TGAI, EP..........            5
                                   Toxicity,
                                   Vegetative vigor
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Insect Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 880.4350                         Nontarget Insect      R.................   R.................   R.................   R.................  NR.................  TGAI..............           14
                                   Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier II
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Environmental Fate Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 163-1 (835.1230)                 Sediment and soil    CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   adsorption/
                                   desorption for
                                   parent and
                                   degradates
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 163-1 (835.1240)                 Soil column          CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   leaching
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 163-2 (835.1410)                 Laboratory           CR.................  NR.................  CR.................  CR.................  NR.................   TEP..............            7
                                   volatilization
                                   from soil
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 12109]]

 
 161-1 (835.2120)                 Hydrolysis           CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 161-1 (835.4100)                 Aerobic soil         CR.................  NR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   metabolism
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 161-2 (835.2240)                 Photodegradation in  CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   water
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 161-3 (835.2410)                 Photodegradation on  CR.................  NR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   soil
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 162-2 (835.4200)                 Anerobic soil        CR.................  NR.................  NR.................  NR.................  NR.................  TGAI..............            6
                                   metabolism
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 162-4 (835.4300)                 Aerobic aquatic      CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   metabolism
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 162-3(835.4400)                  Anerobic aquatic     CR.................  CR.................  NR.................  NR.................  NR.................  TGAI..............            6
                                   metabolism
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 880.4425                         Dispenser -water     CR.................  NR.................  CR.................  CR.................  NR.................  EP................            8
                                   leaching
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Nontarget Plant
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 850.4225                         Seedling emergence    R.................   R.................  NR.................   R.................  NR.................  TGAI..............            9
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 850.4250                         Vegetative vigor      R.................   R.................  NR.................   R.................  NR.................  TGAI..............            9
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier III
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Aquatic Fauna Chronic, Life Cycle, and Field Studies
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1300                          Freshwater fish/     CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           10
850.1400........................   invertebrate
850.1500........................   testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 850.1025                         Marine/Estuarine     CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           10
850.1035........................   fish/invertebrate
850.1045........................   animal testing
850.1055........................
850.1350........................
850.1400........................
850.1500........................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 850.1950                         Aquatic field fish/  CR.................  CR.................  NR.................  CR.................  NR.................   EP...............           10
                                   invertebratetestin
                                   g
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Terrestrial Wildlife
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 850.2300                         Avian Reproduction   CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           11
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 850.2400                         Wild mammal acute    CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           11
                                   toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 850.2500                         Terrestrial field    CR.................  CR.................  NR.................  CR.................  NR.................  EP................           11
                                   testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Beneficial Insects
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.3040                          Field testing for    CR.................  CR.................  NR.................  CR.................  NR.................   TEP..............           12
                                   Pollinators
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Nontarget Plants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 12110]]

 
 850.4225                         Nontarget plant      CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           13
850.4250........................
850.4300........................
850.4450........................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for biochemical nontarget organisms and environmental fate 
as referenced in the last column of the table contained in paragraph 
(d) of this section.
    1. Required for the EP when any end-use formulation may contain 
other ingredients that may be toxic to nontarget organisms or to 
support arthropod pheromones that would be available to avian 
wildlife, (e.g., a granular product).
    2. Tests for pesticides intended solely for indoor application 
would be required on a case-by-case basis, depending on use pattern, 
physical/chemical properties, production volume, and other pertinent 
factors.
    3. Not required for any use groups if the pesticide is highly 
volatile (estimated volatility >5 X 10-5 atm 
m3/mol).
    4. Preferred test species are bobwhite quail, mallard, or 
redwing blackbird for avian acute oral toxicity studies; bobwhite 
quail or mallard for avian dietary studies, rainbow trout for acute 
freshwater fish studies; and Daphnia magna for acute freshwater 
invertebrate studies.
    5. Required for the EP when the end-use formulation may contain 
other ingredients that may be toxic to nontarget organisms.
    6. Required on a case-by-case basis when results from Tier I 
studies indicate adverse effects.
    7. Required when results of any one or more of the nontarget 
organism studies in Tier I indicate potential adverse effects on 
nontarget organisms and the pesticide is to be applied on land.
    8. Required when results of any one or more of the nontarget 
organism studies in Tier I indicate potential adverse effects on 
nontarget organisms and the pesticide is to be applied in a passive 
dispenser.
    9. Required to support registration of known phytotoxicants, 
i.e. herbicides, desiccants, defoliants, and plant growth 
regulators.
    10. Required if environmental fate characteristics indicate that 
the estimated environmental concentration of the pesticide in the 
aquatic environment is >0.01 of any EC50 or 
LC50 determined in the aquatic nontarget organism 
testing.
    11. Required if either of the following criteria are met:
    (i) Environmental fate characteristics indicate that the 
estimated concentration of the pesticide in the terrestrial 
environment is >0.20 the avian dietary LC50 or equal to 
or >0.20 the avian oral single dose LD50 (converted to 
ppm).
    (ii) The pesticide or any of its metabolites or degradation 
products are stable in the environment to the extent that 
potentially toxic amounts may persist in the avian or mammalian 
feed.
    12. Required when results of Tier I nontarget organism studies 
indicate potential adverse effects on nontarget insects and results 
of Tier II tests indicate exposure of nontarget insects. Additional 
insect species may have to be tested if necessary to address issues 
raised by use patterns and potential exposure of important nontarget 
insect species, (e.g., threatened or endangered species).
    13. Required if the product is expected to be transported from 
the site of application by air, soil, or water. The extent of 
movement would be determined by the results of the Tier II 
environmental fate studies.
    14. Required depending on pesticide mode of action, method and 
timing of application, and results of any available efficacy data. 
Typically the honeybee acute toxicity guideline (guideline 850.3020) 
satisfies this requirement, however additional nontarget insect 
species may have to be tested if necessary to address issues raised 
by use patterns and potential exposure of important nontarget insect 
species, e.g., endangered species.


Sec.  158.970  Biochemicalpesticides product performance data 
requirements.

    Product performance data must be developed for all biochemical 
pesticides. However, the Agency typically does not require applicants 
to submit such efficacy data unless the pesticide product bears a claim 
to control public health pests, such as pest microorganisms infectious 
to man in any area of the inanimate environment or a claim to control 
vertebrates (including but not limited to: rodents, birds, bats, 
canids, and skunks) or invertebrates (including but not limited to: 
mosquitoes and ticks) that may directly or indirectly transmit diseases 
to humans. However, each registrant must ensure through testing that 
his products are efficacious when used in accordance with label 
directions and commonly accepted pest control practices. The Agency 
reserves the right to require, on a case-by-case basis, submission of 
efficacy data for any pesticide product registered or proposed for 
registration.

Subpart M--Microbial Pesticides


Sec.  158.1000  Definition andApplicability.

    (a) This subpart applies to all living or dead microbial pesticides 
as described in paragraphs (b) and (c) of this section.
    (b) Definition. Microbial pesticide is a microorganism intended for 
preventing, destroying, repelling, or mitigating any pest, or intended 
for use as a plant regulator, defoliant, or desiccant, that:
    (1) Is a eucaryotic microorganism including, but not limited to, 
protozoa, algae, and fungi;
    (2) Is a procaryotic microorganism, including, but not limited to, 
bacteria; or
    (3) Is an autonomous replicating microscopic element, including, 
but not limited to, viruses.
    (c) Applicability. (1) In addition to the definition above, the 
definitions in Sec.  158.3 also apply to this subpart.
    (2) Each new isolate of a microbial pesticide is treated as a new 
strain and must be registered independently of any similar registered 
microbial pesticide strain and supported by data required in this 
subpart.
    (3) Genetically modified microbial pesticides, may be subject to 
additional data or information requirements on a case-by-case basis 
depending on the particular microorganism and/or its parent 
microorganism(s), the proposed pesticide use pattern, and the manner 
and extent to which theorganism has been genetically modified. 
Additional requirements may be required on a case-by-case basis.
    (4) Pest control organisms such as insect predators, nematodes, and 
macroscopic parasites are exempt from the requirements of FIFRA as 
authorized by section 25(b) of FIFRA and specified in Sec.  152.20 (a) 
of this chapter.

[[Page 12111]]

Sec.  158.1010  Microbial pesticidedata requirements.

    (a) For all microbial pesticides. (1) The following Sec.  Sec.  
158.1010 through 158.1050 identify the data requirements that are 
required to support registration of microbial pesticides. The 
variations in the test conditions are identified within the test notes.
    (2) Each data table includes ``use patterns'' under which the 
individual data are required, with variations including all use 
patterns, food and nonfood uses for terrestrial and aquatic 
applications, greenhouse, indoor, forestry, and residential outdoor 
applications under certain circumstances.
    (3) The categories for each data requirement are ``R'', which 
stands for required, and ``CR'' which stands for conditionally 
required. If a bracket appears around the R or CR, the data are 
required for both the registration and experimental use permit 
requests. Generally, ``R'' indicates that the data are more likely 
required than for those data requirements with CR. However, in each 
case, the regulatory text preceding the data table and the test notes 
following the data table must be used to determine whether the data 
requirement must be satisfied.
    (4) Each table identifies the test substance that is required to be 
tested to satisfy the data requirement. Test substances may include: 
technical grade active ingredient (TGAI), manufacturing-use product 
(MP), end-use product (EP), typical end-use product (TEP), residue of 
concern, and pure active ingredient (PAI) or (All) indicating all of 
the above. Commas between the test substances (i.e., TGAI, EP) indicate 
that data may be required on the TGAI or EP or both depending on the 
conditions set forth in the test note. Data requirements which list two 
test substances (i.e., TGAI and EP) indicate that both are required to 
be tested. Data requirements that list only the manufacturing product 
(MP) as the test substance apply to products containing solely the 
technical grade of the active ingredient and manufacturing-use products 
to which other ingredients have been intentionally added. Data 
requirements listing the EP as the test substance apply to any EP with 
an ingredient in the end-use formulation other than the active 
ingredient that is expected to enhance the toxicity of the product.
    (b) Additional data requirements for genetically modified microbial 
pesticides. Additional requirements for genetically modified microbial 
pesticides may include but are not limited to: genetic engineering 
techniques used; the identity of the inserted or deleted gene segment 
(base sequence data or enzyme restriction map of the gene); information 
on the control region of the gene in question; a description of the 
``new'' traits or characteristics that are intended to be expressed; 
tests to evaluate genetic stability and exchange; and selected Tier II 
environmental expression and toxicology tests.


Sec.  158.1020  Product analysisdata requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the product analysis data requirements and the 
substance to be tested for a particular microbial pesticide. Specific 
conditions, qualifications, or exceptions to the designated test are 
identified in (d) of this section, and the test notes appear in 
paragraph (e) of this section.
    (b) Key. R=Required; [R]=Required for registrations andexperimental 
use permits; CR=Conditionally required; [CR]=Conditionally required for 
registrations and experimental use permits; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; All= all of the 
above. Specific conditions, qualifications, or exceptions to the 
designated test procedures appear in paragraph (e) of this section, and 
apply to the individual tests in the following table:
    (c) Table. The following table shows the data requirements for 
microbial product analysis. The test notes are shown in paragraph (d) 
of this section.

                                                   Table--Microbial Product Analysis Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  All Use patterns                   Test substances to support
         Guideline Number           Data Requirement --------------------------------------------------------------------------------      Test notes
                                                            Food Use          Nonfood Use              MP                  EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product Chemistry and Composition
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1100                         Product Identity   [R]                 [R]                  MP                 EP                  --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1200                         Manufacturing      [R]                 [R]                 TGAI and MP         TGAI and EP          1,2
                                   process
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                   Deposition of a    [R]                 [R]                 TGAI                TGAI                --
                                   sample in a
                                   nationally
                                   recognized
                                   culture
                                   collection
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1300                         Discussion of      [R]                 [R]                 TGAI and MP         TGAI and EP          2
                                   formation of
                                   unintentional
                                   ingredients
--------------------------------------------------------------------------------------------------------------------------------------------------------
Analysis and Certified Limits
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1400                         Analysis of        [R]                 [R]                 TGAI and MP         TGAI and EP          2,3
                                   samples
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1500                         Certification of   [R]                 R                   MP                  EP                  --
                                   limits
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physical and Chemical Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6302                         Color              [R]                 [R]                 TGAI                TGAI                --
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 12112]]

 
  830.6303                         Physical state     [R]                 [R]                 TGAI                TGAI                --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6304                         Odor               [R]                 [R]                 TGAI                TGAI                --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6313                         Stability to       [R]                 [R]                 TGAI                TGAI                --
                                   normal and
                                   elevated
                                   temperatures,
                                   metals and metal
                                   ions
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6317                         Storage stability  [R]                 [R]                 TGAI and MP         TGAI and EP         --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6319                         Miscibility        [R]                 [R]                 MP                  EP                  4
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6320                         Corrosion          [R]                 [R]                 MP                  EP                  5
                                   Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.7000                         pH                 [R]                 [R]                 TGAI                TGAI                --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.7100                         Viscosity          [R]                 [R]                 MP                  EP                  6
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.7300                         Density/relative   [R]                 [R]                 TGAI                TGAI                --
                                   density/bulk
                                   density (specific
                                   gravity)
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test notes are applicable to the 
data requirements for microbial product analysis as referenced in 
the last column of the table contained in paragraph (c) of this 
section.
    1. If an experimental use permit is being sought, and if the 
pesticide is not already under full-scale production, a schematic 
diagram and/or description of the manufacturing process suffices.
    2. If an experimental use permit is being sought, and if the 
product is not already under full-scale production, a discussion of 
unintentional ingredients is required to be submitted to the extent 
this information is available.
    3. Required to support registration of each manufacturing-use 
product and end-use product. This analysis must be conducted at the 
point in the production process after which there would be no 
potential for microbial contamination or microbial regrowth. For 
pesticides in the production stage, a preliminary product analytical 
method and data would suffice to support an experimental use permit. 
For full registration, generally an analysis of samples is a 
compilation of batches, over a period of time, depending on the 
frequency of manufacturing.
    4. Only required for emulsifiable liquid forms of microbial 
pesticides.
    5. Required when microbial pesticides are packaged in metal, 
plastic, or paper containers.
    6. Only required for liquid forms of microbial pesticides.


Sec.  158.1030  Residue datarequirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the residue chemistry data requirements and the 
substance to be tested for a particular microbial pesticide. Specific 
conditions, qualifications, or exceptions to the designated test appear 
in (d) of this section, and the procedures appear in paragraph (e) of 
this section.
    (b) Key. R=Required; [R]=Required for registrations and 
experimental use permits; CR=Conditionally required; [CR]=Conditionally 
required for registrations and experimental use permits; NR=Not 
required; MP=Manufacturing-use product; EP=End-use product; TEP=Typical 
end-use product; TGAI=Technical grade of the active ingredient; All= 
all of the above. Specific conditions, qualifications, or exceptions to 
the designated test procedures appear in paragraph (d) of this section, 
and apply to the individual tests in the following table:
    (c) Table. The following table shows the data requirements for 
microbial residue. The test notes are shown in paragraph (d) of this 
section.

                                   Table--Microbial Residue Data Requirements
----------------------------------------------------------------------------------------------------------------
                                                                             Test Substance
        Guideline Number            Data Requirement    All Use Patterns  Data to support MP       Test notes
                                                                                 or EP
----------------------------------------------------------------------------------------------------------------
885.2000                           Background for      [CR]                EP                  1
                                   Residue analysis
                                   of microbial pest
                                   control agents
----------------------------------------------------------------------------------------------------------------
885.2100                           Chemical Identity   [CR]                EP                  1
----------------------------------------------------------------------------------------------------------------
885.2200                           Nature of the       [CR]                EP                  1
                                   Residue in plants
----------------------------------------------------------------------------------------------------------------
885.2250                           Nature of the       [CR]                EP                  1
                                   Residue in
                                   animals
----------------------------------------------------------------------------------------------------------------

[[Page 12113]]

 
885.2300                           Analytical          [CR]                TGAI                1
                                   methods--plants
----------------------------------------------------------------------------------------------------------------
885.2350                           Analytical          [CR]                TGAI                1
                                   methods-animals
----------------------------------------------------------------------------------------------------------------
885.2400                           Storage Stability   [CR]                EP                  1
----------------------------------------------------------------------------------------------------------------
885.2500                           Magnitude of        [CR]                EP                  1
                                   residue in plants
----------------------------------------------------------------------------------------------------------------
885.2550                           Magnitude of        [CR]                EP                  1
                                   residues in meat,
                                   milk, poultry,
                                   eggs
----------------------------------------------------------------------------------------------------------------
885.2600                           Magnitude of        [CR]                EP                  1
                                   residues in
                                   potable water,
                                   fish, and
                                   irrigated crops
----------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test note is applicable to the data 
requirements for microbial residue as referenced in the last column of 
the table contained in paragraph (c) of this section.
    1. Required when the results of testing:
    i. Indicate the potential to cause adverse human health effects 
or the product characterization indicates the microbial pesticide 
has a significant potential to produce a mammalian toxin; andii. The 
use pattern is such that residues may be present in or on food or 
feed crops.


Sec.  158.1040  Toxicology datarequirements 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) This category includes products classified 
under the following general uses: terrestrial food and nonfood crop 
use; terrestrial feed crop use; aquatic food and nonfood crop use; 
greenhouse food and nonfood crop use; forestry; residential outdoor and 
indoor; and indoor food use.
    (2) Nonfood use patterns include products classified under the 
general use patterns of terrestrial nonfood crop use; aquatic nonfood 
residential use; aquatic nonfood outdoor use; aquatic nonfood 
industrial use; greenhouse nonfood crop use; forestry use; residential 
outdoor use; residential indoor use; indoor food use; indoor nonfood 
use.
    (c) Key. R=Required; [R]=Required for registrations andexperimental 
use permits; CR=Conditionally required; [CR]=Conditionally required for 
registrations and experimental use permits; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; All= all of the 
above. Specific conditions, qualifications, or exceptions to the 
designated test procedures appear in paragraph (e) of this section, and 
apply to the individual tests in the following table:
    (d) Table. The following table shows the data requirements for 
microbial toxicology. The test notes are shown in paragraph (e) of this 
section.

                                  Table--Microbial Toxicology Data Requirements
----------------------------------------------------------------------------------------------------------------
        Guideline Number           Data Requirement    All Use  patterns    Test  substance       Test notes
----------------------------------------------------------------------------------------------------------------
Tier I
----------------------------------------------------------------------------------------------------------------
885.3050                           Acute oral         [R]                  TGAI                1
                                   toxicity/
                                   pathogenicity
----------------------------------------------------------------------------------------------------------------
885.3150                           Acute pulmonary    [R]                  TGAI               --
                                   toxicity/
                                   pathogenicity
----------------------------------------------------------------------------------------------------------------
885.3200                           Acute injection    [R]                  TGAI                2
                                   toxicity/
                                   pathogenicity/
                                   (intravenous)
                                   Acute injection
                                   toxicity/
                                   pathogenicity /
                                   (intraperitoneal).
----------------------------------------------------------------------------------------------------------------
885.3400                           Hypersensitivity   [R]                  All                 3
                                   incidents
----------------------------------------------------------------------------------------------------------------
885.3500                           Cell culture       [R]                  TGAI                4
----------------------------------------------------------------------------------------------------------------
870.1100                           Acute oral         [R]                  MP , EP             1,5
                                   toxicity
----------------------------------------------------------------------------------------------------------------
870.1200                           Acute dermal       [R]                  MP , EP             5
                                   toxicity
----------------------------------------------------------------------------------------------------------------
870.1300                           Acute inhalation   [R]                  MP , EP             5,7
                                   toxicity
----------------------------------------------------------------------------------------------------------------
870.2400                           Acute eye          [R]                  MP , EP             5
                                   irritation
----------------------------------------------------------------------------------------------------------------
870.2500                           Primary dermal     [CR]                 MP , EP             5,6
                                   irritation
----------------------------------------------------------------------------------------------------------------

[[Page 12114]]

 
Tier II
----------------------------------------------------------------------------------------------------------------
885.3550                           Acute toxicology    CR                  TGAI                8
----------------------------------------------------------------------------------------------------------------
885.3600                           Subchronic          CR                  TGAI                9
                                   toxicity/
                                   pathogenicity
----------------------------------------------------------------------------------------------------------------
Tier III
----------------------------------------------------------------------------------------------------------------
885.3650                           Reproductive        CR                  TGAI                10,14
                                   fertility effects
----------------------------------------------------------------------------------------------------------------
870.4200                           Carcinogenicity     CR                  TGAI                11,14
----------------------------------------------------------------------------------------------------------------
870.7800                           Immunotoxicity      CR                  TGAI                12,14
----------------------------------------------------------------------------------------------------------------
885.3000                           Infectivity/        CR                  TGAI                13,14
                                   pathogenicity
                                   analysis
----------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for microbial toxicology as referenced in the last column 
of the table contained in paragraph (d) of this section:
    1. The acute oral toxicity/pathogenicity study is required to 
support the TGAI. However, it can be combined with the unit dose 
portion of the acute oral toxicity study, with an EP or MP test 
material to fulfill the requirement for the TGAI and the MP or EP in 
a single study, if the new protocol is designed to address the 
endpoints of concern.
    2. Data not required for products whose active ingredient is a 
virus. For test materials whose size or consistency may prevent use 
of an i.v. injection, the i.p. injection procedure may be employed.
    3. Hypersensitivity incidents for registered products must be 
reported if they occur.
    4. Data must be submitted only for products whose active 
ingredient is a virus.
    5. The 870 series studies for the MP and EP are intended to 
provide data on the acute toxicity of the product. Waivers for any 
or all of these studies may be granted when the applicant can 
demonstrate that the combination of inert ingredients is not likely 
to pose any significant human health risks. Where appropriate, the 
limit dose approach to testing is recommended.
    6. Data are required only if dermal irritation is found after 
dosing in acute dermal toxicity study.
    7. Required when the product consists of, or under conditions of 
use would result in, an inhalable material (e.g., gas, volatile 
substances, or aerosol particulate).
    8. Data required when significant toxicity, in the absence of 
pathogenicity and significant infectivity, is observed in acute 
oral, injection, or pulmonary studies (Tier I). Route(s) of exposure 
correspond to routes where toxicity was observed in Tier I studies. 
The toxic component of the TGAI is to be tested.
    9. Data required when significant infectivity and/or unusual 
persistence is observed in the absence of pathogenicity or toxicity 
in Tier I studies. Routes of exposure (oral and/or pulmonary) 
correspond to routes in Tier I studies where adverse effects were 
noted. Data may also be required to evaluate adverse effects due to 
microbial contaminants or to toxic byproducts.
    10. Data are required when any of the following criteria are 
met:
    (i) Significant infectivity of the microbial pest control agent 
(MPCA) was observed in test animals in the Tier II subchronic study 
and in which no significant signs of toxicity or pathogenicity were 
observed.
    (ii) The microbial pesticide is a virus which can persist or 
replicate in mammalian cell culture lines.
    (iii) The microbial pesticide is not amenable to thorough 
taxonomic classification, and is related to organisms known to be 
parasitic for mammalian cells.
    (iv) The microbial pesticide preparation is not well purified, 
and may contain contaminants which are parasitic for mammals.
    11. Data may be required for products known to contain or 
suspected to contain carcinogenic viruses or for microbial 
components that are identified as having significant toxicity in 
Tier II testing.
    12. Data may be required for products known to contain or 
suspected to contain viruses that can interact in an adverse manner 
with components of mammalian immune system.
    13. An analysis of human infectivity/pathogenicity potential 
using scientific literature, genomic analysis, and/or actual 
specific cell culture/animal data may be required for products known 
to contain or suspected of containing intracellular parasites of 
mammalian cells for products that exhibit pathogenic characteristics 
in Tier I and/or Tier II, for products which are closely related to 
known human pathogens based on the Product Analysis data, or for 
known human pathogens that have been ``disarmed'' or rendered non-
pathogenic for humans.
    14. Test standards may have to be modified depending on the 
characteristics of the microorganism. Requirements may vary for 
these studies depending on the active ingredient being tested. 
Consultation with the Agency is advised before performing these Tier 
III studies.


Sec.  158.1050  Nontarget organismsand environmental fate data 
requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the terrestrial and aquatic nontarget organisms 
data requirements for a particular microbial 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. Aquatic uses include: food and feed, nonfood uses 
(e.g., outdoor, residential, and industrial). Terrestrial uses include: 
Food, Feed, Non-Food, Forestry, Residential outdoor, greenhouse (food 
and food), Indoor (food and nonfood), and Industrial.
    (c) Key. R=Required; [R]=Required for registrations and 
experimental use permits; CR=Conditionally required; [CR]=Conditionally 
required for registrations and experimental use permits; NR=Not 
required; MP=Manufacturing-use product; EP=End-use product; TEP=Typical 
end-use product; TGAI=Technical grade of the active ingredient; All= 
all of the above. Specific conditions, qualifications, or exceptions to 
the designated test procedures appear in paragraph (e) of this section, 
and apply to the individual tests in the following table:
    (d) Table. The following table shows the data requirements for 
microbial nontarget organisms and environmental fate. The test notes 
are shown in paragraph (e) of this section.

[[Page 12115]]



                                                                              Table--Microbial Nontarget Organisms and Environmental Fate Data Requirements
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Aquatic                                                                 Terrestrial
                                                  ---------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Non-Food
        Guideline Number         Data Requirement                    --------------------                                                                                                               Test Substance      Test notes
                                                       Food, Feed             Out          Food, Feed, Non-      Forestry        Residential        Greenhouse       Indoor Food,       Industrial
                                                                       door,Residential,        food                               outdoor       Food, Non-Food       Non-Food
                                                                          Industrial
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4050                         Avian oral        R                   [R]                 [R]               [R]               [R]               CR               CR                CR                TGAI              1,2
                                toxicity.........
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4100                        Avian inhalation    CR                CR                  CR                CR                CR                CR                CR                CR                TGAI              1,2,3
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4150                        Wild mammal         CR                CR                  CR                CR                CR                NR                NR                CR                TGAI              1,4
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4200                        Freshwater fish     R                  [R]                 [R]               [R]               CR               CR                CR                CR                TGAI              1, 2,5
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4240                        Freshwater         R                   [R]                 [R]               [R]               CR               CR                CR                CR                TGAI              1, 2,5
                                 invertebrate
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4280                        Estuarine/Marine    CR                CR                  CR                CR                CR                NR                NR                CR                TGAI              1,6
                                 fish testing
                                Estuarine and
                                 marine
                                 invertebrate
                                 testing.
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4300                        Nontarget plant     CR                CR                  CR                [R]                CR               NR                CR                CR                TE                 1,7
                                testing..........
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4340                        Nontarget insect   [R]                 [R]                 [R]               [R]               R                 CR               NR                CR                TGAI              1,8
                                 testing
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4380                        Honey bee testing  [R]                [[R]                 [R]               [R]               R                 CR               NR                CR                TGAI              1
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier II
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.5200                        Terrestrial         CR                CR                  CR                CR                CR                NR                NR                CR                TGAI or TEP        9
                                 environmental
                                 expression tests
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.5300                        Freshwater          CR                CR                  CR                CR                CR                NR                NR                CR                TGAI or TEP        10
                                 environmental
                                 expression tests
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.5400                        Marine or           CR                CR                  CR                CR                CR                NR                NR                CR                TGAI or TEP        11,12
                                 estuarine
                                 environmental
                                 expression tests
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier III
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4600                        Avian chronic      CR                  CR                 CR                CR                CR                NR                NR                CR                TGAI              12, 13
                                 pathogenicity
                                 and reproduction
                                 test
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4650                        Aquatic             CR                CR                  CR                CR                CR                NR                NR                CR                TGAI              12, 14
                                 invertebrate
                                 range testing
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4700                        Fish life cycle     CR                CR                  CR                CR                CR                NR                NR                CR                TGAI              12, 14/ROW>
                                 studies
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4750                        Aquatic ecosystem  CR                  CR                 CR                CR                CR                NR                NR                CR                TGAI              15
                                 test                                                                                                                                                                                   ................
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier IV
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 12116]]

 
850.2500                        Field testing for   CR                CR                  CR                CR                CR                NR                NR                CR                TGAI or TEP        11, 16
850.1950......................   terrestrial
                                 wildlife and
                                 Field testing
                                 for aquatic
                                 organisms
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2500                        Simulated or       CR                  CR                 CR                CR                CR                NR                NR                CR                TEP               16, 17, 20
                                 actual field
                                 tests (birds,
                                 mammals)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1950                        Simulated or       CR                  CR                 CR                CR                CR                NR                NR                CR                TEP               16, 18, 19, 20
                                 actual field
                                 test (aquatic
                                 organisms)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2500                        Simulated or       CR                  CR                 CR                CR                CR                NR                NR                CR                TEP               16, 18,19, 20
                                 actual field
                                 tests (insect
                                 predators,
                                 parasites)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.3040                        Simulated or       CR                  CR                 CR                CR                CR                NR                NR                CR                TEP               16, 18,19, 20
                                 actual field
                                 tests (insect
                                 pollinators)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4300                        Simulated or       CR                  CR                 CR                CR                CR                NR                NR                CR                TEP               16, 18, 19, 20
                                 actual field
                                 tests (plants)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for microbial nontarget organism and environmental fate as 
referenced in the last column of the table contained in paragraph (d) 
of this section.
    1. Tests for pesticides intended solely for indoor application 
would be required on a case-by-case basis, depending on use pattern, 
production volume, and other pertinent factors. Tests to support 
EUP's are based on the application timing and acreage.
    2. The preferred species for the avian oral study is either the 
bobwhite quail or mallard duck. The preferred species for the avian 
inhalation toxicity/pathogenicity study and the avian chronic 
toxicity/pathogenicity study is the bobwhite quail. There is also 
the option to test the redwing black bird if there is a concern for 
passerine species. The rainbow trout is preferred for freshwater 
fish testing. However, two species (rainbow trout and bluegill 
sunfish are the preferred species) must be tested for uses involving 
direct freshwater exposure. Daphnia magna is the preferred species 
for freshwater invertebrate testing.
    3. Data required when the nature of the microbial pesticide and/
or its toxins indicates potential pathogenicity to birds.
    4. Required on a case-by-case basis if results of tests required 
bySec.  158.1040 are inadequate or inappropriate for assessment of 
hazards to wild animals.
    5. Required when there will be significant exposure to aquatic 
organisms (fish and invertebrates).
    6. Required if the product is intended for direct application 
into the estuarine or marine environment or expected to enter this 
environment in significant concentrations because of expected use or 
mobility pattern.
    7. Required if the microbial pesticide is taxonomically related 
to a known plant pathogen.
    8. Data are not required unless an active microbial ingredient 
controls the target insect pest by a mechanism of infectivity; i.e. 
may create an epizootic condition in nontarget insects.
    9. Required if toxic or pathogenic effects are observed in any 
of the following tests for microbial pesticides:
    (i) Avian acute oral or avian inhalation studies.
    (ii) Wild mammal studies.
    (iii) Nontarget plant studies (terrestrial).
    (iv) Honey bee studies.
    (v) Nontarget insect studies.
    10. Required when toxic or pathogenic effects are observed in 
any of the following Tier I tests for microbial pest control agents:
    (i) Freshwater fish studies.
    (ii) Freshwater aquatic invertebrate studies.
    (iii) Nontarget plant studies (aquatic).
    11. Required if product is applied on land or in fresh water or 
marine/estuarine environments and toxic or pathogenic effects are 
observed in any of the following Tier I tests for microbial 
pesticides:
    (i) Estuarine and marine animal toxicity and pathogenicity.
    (ii) Plant studies--estuarine or marine species.
    12. An appropriate dose-response toxicity test is required when 
toxic effects on nontarget terrestrial wildlife or aquatic organisms 
(including plants) are reported in one or more Tier I tests and 
results of Tier II tests indicate exposure of the microbial agent to 
the affected nontarget terrestrial wildlife or aquatic organisms. 
The protocols for these tests may have to be modified in accordance 
with results from the nontarget organism and environmental 
expression studies.
    13. Required when one or more of the following are present:
    (i) Pathogenic effects are observed in Tier I avian studies.
    (ii) Tier II environmental expression testing indicate that 
long-term exposure of terrestrial animals is likely.
    14. Required when product is intended for use in water or 
expected to be transported to water from the intended use site, and 
when pathogenicity or infectivity was observed in Tier I aquatic 
studies.
    15. Required if, after an analysis of the microbial pesticide's 
ability to survive and multiply in the environment and what 
ecological habitat it would occupy, the intended use patterns, and 
the results of previous nontarget organisms and environmental 
expression tests, it is determined that use of the microbial agent 
may result in adverse effects on the nontarget organisms in aquatic 
environments. Testing is to determine if applications of the 
microbial pest control would be expected to disrupt the balance of 
populations in the target ecosystem.
    16. Tier IV studies may be conducted as a condition of 
registration aspost-registration monitoring if the potential for 
unreasonable

[[Page 12117]]

adverse effects appears to be minimal during that period of use due 
to implementation of mitigation measures.
    17. Required when both of the following conditions occur:
    (i) Pathogenic effects at actual or expected field residue 
exposure levels are reported in Tier III; and
    (ii) The Agency determines that quarantine methods would not 
prevent the microbial pesticide from contaminating areas adjacent to 
the test area.
    18. Short term simulated or actual field studies are required 
when it is determined that the product is likely to cause adverse 
short-term or acute effects, based on consideration of available 
laboratory data, use patterns, and exposure rates.
    19. Data from a long-term simulated field test (e.g., where 
reproduction and growth of confined populations are observed) and/or 
an actual field test (e.g., where reproduction and growth of natural 
populations are observed) are required if laboratory data indicate 
that adverse long-term, cumulative, or life-cycle effects may result 
from intended use.
    20. Since test standards would be developed on a case-by-case 
basis, consultation with the Agency and development of a protocol is 
advised before performing these Tier IV studies.


Sec.  158.1060  Microbial pesticidesproduct performance data 
requirements.

    Product performance data must be developed for all microbial 
pesticides. However, the Agency has waived all requirements to submit 
efficacy data unless the pesticide product bears a claim to control 
public health pests, such as pest microorganisms infectious to man in 
any area of the inanimate environment or a claim to control vertebrates 
(including but not limited to: rodents, birds, bats, canids, and 
skunks) or invertebrates (including but not limited to: mosquitoes and 
ticks) that may directly or indirectly transmit diseases to humans. 
However, each registrant must ensure through testing that his products 
are efficacious when used in accordance with label directions and 
commonly accepted pest control practices. The Agency reserves the right 
to require, on a case-by-case basis, submission of efficacy data for 
any pesticide product registered or proposed for registration.

PART 172--[AMENDED]

    5. The authority citation continues to read as follows:

    Authority:  7 U.S.C. 136c, 136w. Section 172.4 is also issued 
under 31 U.S.C. 9701.

    6. In Sec.  172.43 revise the definition for ``microbial 
pesticide'' to read as follows:


Sec.  172.43  Definitions.

* * * * *
     Microbial pesticide means a microorganism intended for preventing, 
destroying repelling, or mitigating any pest, or intended for use as a 
plant regulator, defoliant, or desiccant, that:
    (1) Is a eucaryotic microorganism including, but not limited to, 
protozoa, algae and fungi;
    (2) Is a procaryotic microorganism, including, but not limited to, 
bacteria; or
    (3) Is an autonomous replicating microscopic element, including, 
but not limited to, viruses.
* * * * *

[FR Doc. 06-2185 Filed 3-7-06; 8:45 am]
BILLING CODE 6560-50-S