[Federal Register: March 8, 2006 (Volume 71, Number 45)]
[Proposed Rule]
[Page 12071-12117]
[DOCID:fr08mr06-28]

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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

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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<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Candace Brassard or Nathanael Martin,
U.S. Environmental Protection Agency (7506C), 1200 Pennsylvania Ave.
NW., Washington, DC 20460, telephone:<PHONE_NUMBER> or<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>or<EMAIL_ADDRESS>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<PHONE_NUMBER>, fax number at<PHONE_NUMBER> or
visit the following website: http://www.epa.gov/pesticides/biopesticides/
.

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

     1.  Submitting CBI. Do not submit this information to EPA through
http://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

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,

 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

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

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

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

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

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

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

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

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

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

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

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

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

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.