Pesticides; Data Requirements for Biochemical and Microbial Pesticides, 12072-12117 [06-2185]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 71, Number 45 (Wednesday, March 8, 2006)]
[Proposed Rules]
[Pages 12072-12117]
From the Federal Register Online via the Government Printing 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

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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:https://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 
https://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 athttps://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 https://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: brassard.candace@epa.gov or martin.nathanael@epa.gov. 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: https://www.epa.gov/pesticides/
biopesticides/.

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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,

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 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 https://
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 app