Pesticides; Data Requirements for Biochemical and Microbial Pesticides, 60988-61025 [E7-20828]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 72, Number 207 (Friday, October 26, 2007)]
[Rules and Regulations]
[Pages 60988-61025]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-20828]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 158

[EPA-HQ-OPP-2004-0415; FRL-8109-8]
RIN 2070-AD51


Pesticides; Data Requirements for Biochemical and Microbial 
Pesticides

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final Rule.

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SUMMARY: This is the final rule for Biochemical and Microbial Pesticide 
Data Requirements. The Agency published a proposed rule on March 8, 
2006, on the data requirements to support registration of biochemical 
and microbial pesticides and proposed to update definitions for both 
biochemical and microbial pesticides. The Agency received comments from 
20 commenters, representing State and Federal agencies, industry, and 
private consultants.

DATES: This rule is effective on December 26, 2007.

ADDRESSES: EPA has established a docket for this action under Docket 
identification number EPA-HQ-OPP-2004-0415. All documents in the docket 
are listed on the regulations.gov web site. Although listed in the 
index, some information is not publicly available, i.e., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is not placed on the Internet 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available either electronically through 
www.regulations.gov or in hard copy at the Office of Pesticide Programs 
(OPP) Regulatory Public Docket (7502P), Room S-4400, One Potomac Yard 
(South Building), 2777 S. Crystal Drive, Arlington, VA 22202. This 
Docket is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket telephone number is (703) 305-5805 
.

FOR FURTHER INFORMATION CONTACT: Candace Brassard or Nathanael Martin, 
U.S. Environmental Protection Agency (7506P), 1200 Pennsylvania Ave., 
NW., Washington, DC 20460, telephone: 703-305-6598 or 703-305-6475, e-
mail: brassard.candace@epa.gov or martin.nathanael@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are a 
producer or registrant of a biochemical or microbial pesticide product. 
This action may also affect any person or company that might petition 
the Agency for new tolerances for biochemical or microbial pesticides, 
or hold a pesticide registration with existing tolerances, any person 
or company interested in obtaining or retaining a tolerance in the 
absence of a registration. Potentially affected entities may include, 
but are not limited to:
     Crop Production (NAICS code 111).
     Animal Production (NAICS code 112).
     Food Manufacturing and Processing (NAICS code 311).
     Chemical Producers (NAICS code 32532), e.g., pesticide 
manufacturers or formulators of pesticide products, importers, or any 
person or company that seeks to register a pesticide or obtain a 
tolerance for a pesticide.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in Unit II. If you have 
any questions regarding the applicability of this action to a 
particular entity, consult the persons listed under FOR FURTHER 
INFORMATION CONTACT or visit the following Web site: https://
www.epa.gov/pesticides/biopesticides/.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    All documents in the docket are listed in the docket index at 
https://www.regulations.gov under docket number EPA-HQ-OPP-2004-0415. 
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, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available either in the electronic docket at https://
www.regulations.gov, or, if only available in hard copy, at the Office 
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One 
Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. 
The hours of operation of this docket facility are from 8:30 a.m. to 
4:00 p.m., Monday through Friday, excluding legal holidays. The Docket 
telephone number is 703-305-5805.

II. Overview of This Document

    EPA published a notice of proposed rulemaking in the Federal 
Register on March 8, 2006 (71 FR 12072) for Data Requirements for 
Biochemical and Microbial Pesticides. This document is the final rule 
and the response to comments on the proposed rule. EPA received 
comments from 20 commenters, raising 58 comments on various data 
requirement issues for biochemical and microbial pesticides. A total of 
11 comments concerning the definition of a biochemical pesticide and 5 
comments concerning the

[[Page 60989]]

definition of a microbial pesticide were received. Of the 20 
commenters, 15 were from industry or private consulting firms, 4 were 
from State/Federal/international governments, and 1 was from a public 
interest group.
    In response to comments, EPA is modifying some aspects of the rule 
relating to types of products being tested, i.e., technical grade 
active ingredient (TGAI) versus typical end-product (TEP), modifying 
some test notes where appropriate, adding or deleting some data 
requirements, and modifying the definition of a microbial pesticide.
    The final rule updates 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 172.43. The rule also informs the public 
how the Agency will assist applicants in determining what data are 
appropriate to support registration of a biochemical or microbial 
pesticide. EPA encourages applicants to request pre-submission meetings 
to discuss these data issues. The final rule also provides for 
assistance to applicants, in some narrow circumstances, in preparation 
of an applicant's data waiver.
    As an ancillary matter, this final rule is making certain technical 
changes necessitated by EPA's decision to create new part 161 to 
contain data requirements specific to antimicrobial pesticides. New 
part 161 is discussed fully in the final rule for conventional 
pesticides published elsewhere in this issue of the Federal Register. 
By transferring essentially intact the current part 158 requirements, 
EPA would also be transferring material pertaining to biochemical and 
microbial pesticides that is not intended to be covered by part 161. 
Specifically, EPA is removing Sec. Sec.  161.65, 161.690 and 161.740, 
the freestanding sections devoted exclusively to biochemical and 
microbial pesticides.
    This final rule is one in a series of proposed and final rules to 
update and clarify pesticide data requirements.

III. The Proposed Rule and Related Proposal for Conventional Chemicals

    On March 8, 2006, the Agency published a notice of proposed 
rulemaking for Biochemical and Microbial Pesticide Data Requirements 
(71 FR 12072). The Agency received submissions from 20 commenters. This 
final rule describes briefly the background of the final rule and 
responds to key issues raised by commenters.

A. General Background on the Phased Rulemaking Approach

    EPA is responsible for registration of the following categories of 
pesticides: biochemicals, microbials, plant-incorporated protectants, 
conventional pesticides, and antimicrobial pesticides. These 
pesticides, although regulated under the same statutory standards under 
FIFRA and FFDCA, pose different levels of risk and exposure that lead 
to significant differences in data needs. EPA has embarked on a series 
of rulemakings intended to update data requirements for the various 
types of pesticides. This final rule is the second and builds on the 
previous update for conventional chemicals.
    Elsewhere in this issue of the Federal Register EPA published a 
final rule to update and revise its data requirements for the 
registration of conventional pesticides. In addition to specific 
changes to the data requirements for registration of conventional 
pesticides, EPA made a number of other changes to the general 
provisions of part 158. Specifically, subpart A of the 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 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.
    EPA proposed to also upgrade the structure of part 158, assigning 
biochemical data requirements to subpart L and microbial pesticide data 
requirements to subpart M of part 158. As a result of the comments on 
the proposed rule for conventional pesticides, EPA has restructured 
part 158. Biochemical pesticide data requirements will now be under 
subpart U and microbial pesticide data requirements will be under 
subpart V.

B. General Provisions and Format

    As described in the final rule on Conventional Pesticides published 
elsewhere in this issue of the Federal Register, EPA has reorganized 
and reformatted part 158, subpart A (General Provisions) and subpart B 
(How to Use Data Tables), and reorganized and redesignated subpart D 
(Data Requirement Tables) into a number of individual subparts.
    Many of the revisions 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.

C. Required and Conditionally Required Data Requirements

    As with conventional pesticides, the R/CR terminology is a general 
presentation of the likelihood that a data requirement will apply. The 
use of R does not necessarily indicate that a study is always required, 
but that it is more likely to be required than not. The use of CR means 
a study is less likely to be required. However, both R and CR 
designations must be read in the context of the accompanying test notes 
to the table. An applicant may assume that a data requirement with R 
will typically be required all the time. The test notes accompanying 
that R designation may provide supplementary information or identify 
some condition(s) when the study is not required. A CR designation will 
generally include more extensive test notes describing the limited 
conditionality of the requirement. The final rule continues this 
longstanding practice. EPA revised some of the test notes to clarify 
the conditions under which the data would be required.

IV. Regulation of Biochemical and Microbial Pesticides and Response to 
Comments Discussion

A. Background of Regulating Biochemical and Microbial Pesticides

    This document is the final rule for the Biochemical and Microbial 
Pesticide Data Requirements. This document also finalizes definitions 
of both a biochemical and microbial pesticide. The Agency issued a 
Notice of Proposed Rulemaking on Biochemical and Microbial Pesticide 
Data Requirements, 71 FR 12072; March 8, 2006. This notice was an 
update of the biochemical and microbial pesticide data requirements to 
support the registration of biochemical and microbial pesticides 
originally promulgated in 1984.

B. Consultations with Applicants

    In the preamble to the proposed rule, the Agency discussed a 
process for consultations with applicants. The public responses were in 
favor of the Agency recognizing that applicants often needed assistance 
in determining what information or data are appropriate to support 
registration of a biochemical or microbial pesticide.

[[Page 60990]]

Therefore, EPA will continue to encourage applicants to request pre-
submission meetings to discuss these data issues. EPA will also 
continue to provide assistance to applicants in some narrow 
circumstances in preparation of an applicant's data waiver after 
submission of an application.
    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. During the 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 by the applicant in accordance with 
relevant data compensation procedures. EPA may also be aware of sound 
scientific rationales that render certain testing unnecessary. 
Ultimately, the applicant may submit an application based on the 
discussion with EPA, along with a signed copy of the minutes (which 
have been concurred on by the Agency) of the pre-submission meeting 
listing each data requirement and the reason why EPA and the company 
believe a waiver is appropriate.
    In addition, the Agency is offering a post-submission process. Even 
after submission of an application for registration, EPA may find that 
either of these scenarios may exist (i.e., basis for citing to other 
data or 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.
    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 this process is intended 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 request for waiver of a data requirement. The applicant 
must at all times submit the waiver request; EPA is simply providing 
assistance in identifying what requirements are likely to be waived for 
a particular product or, in some narrow circumstances, assistance in 
the preparation of the waiver request. Because we are using the pre-and 
post-submission process to assist applicants in filing their own waiver 
requests, we are not amending the existing waiver provisions at 40 CFR 
158.45.

C. Agency Coordination with the APHIS Permitting Process

    EPA requested comment on whether the Agency should coordinate with 
USDA for reviewing microbial pesticides prior to registration. The 
Agency was prompted by USDA's need for coordination when an Animal and 
Plant Health Inspection Service (APHIS) movement permit under 7 CFR 
part 340 is needed. USDA suggested that registrants be required to 
submit a copy of the applicable APHIS permits as part of the 
registration application to EPA. After discussing this issue with USDA, 
EPA is developing a process for coordinating the review of these 
applications with USDA to avoid delays.

D. Other Issues

    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 those currently used by the Agency. The 
second guideline numbers, which are in parentheses, are the draft 
guidelines that have completed peer review and will be published as EPA 
final guidelines in the near future. Guideline numbers are provided in 
part 158 as information/guidance to applicants, and both guideline 
numbers are provided for each data requirement in this rule as an 
interim measure until the draft guidelines are finalized. In general, 
draft guidelines do not represent official Agency position until 
finalized. In either case, an applicant is not compelled to use the 
cited guidelines, but may choose to use an alternative methodology that 
will provide the information needed to complete the risk assessment. In 
such cases, applicants are encouraged to consult with EPA beforehand. 
Applicants may also consult with EPA about using an alternative 
methodology in draft guideline that has completed peer review.
    As with the existing guidelines, draft guidelines are developed 
through a rigorous scientific process, including public comment and 
extensive peer review by the Scientific Advisory Panel, and many have 
been harmonized internationally. As such, they represent the Agency's 
recommended approach to developing data that will generally be likely 
to satisfy the Agency's data needs for risk assessment, and an 
applicant choosing to use the Agency guidelines may have greater 
confidence that the resulting data will adequately address our needs. 
This may also be the case for the draft guidelines referenced in 
parentheses in this rule. Once finalized, the Agency would correct the 
guideline references as appropriate.

E. Issues Identified that Apply to Both Biochemical and Microbial 
Pesticide Data Requirements.

    The Agency did receive comments that applied to both biochemical 
and microbial pesticide data requirements. These issues are discussed 
as follows:
    1. Endangered species assessments--summary of comments. Incidental 
to its proposed data requirements for conventional pesticides, EPA 
discussed the possibility of future data and information needs to 
develop and/or refine risk assessments for endangered species. EPA did 
not propose any data requirements specific to endangered species but 
described its current level of information and data usage. EPA 
requested comment on the value and utility of location and usage 
information, and on additional types of research that might yield 
greater refinement in risk assessments for endangered species. One 
commenter questioned whether the Agency's endangered species discussion 
in the preamble applies to biochemical and microbial pesticides only, 
or for conventional pesticides as well. Two commenters indicated the 
Agency should require toxicity data for surrogate species, and in 
particular reptile and amphibian data.
     Summary of response to comments. EPA appreciates the responses it 
received from the commenter on this topic. As endangered species data 
requirements were not proposed, EPA has not responded to the comment as 
part of this final rule but will consider them in the context of its 
ongoing risk assessments. If EPA finds that it needs

[[Page 60991]]

to amend part 158 to normalize endangered species data requirements, 
the Agency will consider these comments in the development of a future 
proposed rule. The Agency has in the past and will continue to rely on 
the avian, fish, and invertebrate testing to indicate the potential 
toxicity for other non-target species.
    2. Product performance--summary of comments. Without proposing 
changes to existing product performance data requirements (Sec.  
158.640), the Agency augmented language for both biochemical and 
microbial pesticide data requirements for product performance with the 
regulatory text. One commenter indicated that the Agency requires data 
for uses other than for public health pests. Another comment was that 
EPA's language in the proposed preamble required clarification, 
indicating some products are not as efficacious as conventional 
pesticides. Another commenter indicated that the label should be 
supported by the efficacy data provided to the Agency.
    Summary of response to comments. The Agency agrees that product 
performance data are required for all uses, but are only required to be 
submitted for review at the time of registration to support public 
health claims. These provisions, i.e. new Sec. Sec.  158.2070 and 
158.2160 for biochemical and microbial pesticides, respectively, are 
not replacing the data requirement tables in Sec.  158.640, but only 
adding additional text for clarifying when submission of product 
performance data are typically necessary for biochemical and microbial 
pesticides. EPA is finalizing the language as proposed. EPA agrees with 
the commenters that the data must be submitted to support the label 
claims for registration of these public health pesticides.
    EPA did not propose to change the existing data requirements and 
neither the existing data table nor the proposed regulating text would 
require the applicant to submit data comparing product efficacy. The 
Agency agrees with the commenter that there should not have been a 
distinction between biochemical and conventional pesticides in their 
efficacy, but that the efficacy varies between all pesticides and their 
products, and with respect to public health claims, the label should 
reflect the efficacy of the product.
    3. Addition of passerine species and appropriate nomenclature of 
test species within nontarget ecological effects data requirements--
summary of comments. The Agency proposed to add another possible test 
species for the avian acute oral toxicity study, the red-winged 
blackbird, a passerine species. EPA also proposed to continue to 
include the identification of other possible avian test species 
(bobwhite quail and mallards), and for fish species (rainbow trout and 
bluegill sunfish). One commenter requested that EPA revise the word 
``songbird'' to read ``passerine.'' Another commenter indicated that 
the Agency should require historical control data on the red-winged 
blackbird for the past 5 years to develop a baseline for future testing 
on the species.
    Summary of response to comments. The Agency recommends that if the 
registrant and the Agency deem it appropriate to test a passerine 
species, the registrant meet with the Agency before initiating the 
study to determine if the passerine species is appropriate based on the 
current scientific methodology and use pattern of the proposed 
registration. This test species may be required if the use pattern 
would result in higher exposure to this order of avian species.
    In addition, after reviewing the comments submitted, the Agency 
decided to discontinue specific species designation for all non-target 
organisms. The test notes in the final rule only indicate upland game, 
waterfowl, or passerine species for avian concerns and coldwater and 
warmwater fish for fish concerns.
    In summary, passerine species data are still conditionally required 
in the final rule for both biochemical and microbial pesticides. The 
individual test notes indicate when these data would be appropriate. 
With respect to developing test data over 5 years, EPA will consider 
such protocol concerns when it revises its test guidelines. The Agency 
is finalizing the proposed addition of the passerine species.
    4. Reptile/amphibian testing--summary of comments. The Agency did 
not propose to require separate reptile testing. One commenter 
indicated that amphibian testing needed to be included in the data 
requirements for evaluating effects to non-target ecological species.
    Summary of response to comments. The Agency has in the past and 
will continue to rely on avian, fish, and invertebrate testing to 
indicate the potential toxicity for other non-target species. 
Additional information will be required as needed.
    5. New studies providing little or no practical value-- summary of 
comments. EPA proposed to require a few newly codified studies, i.e., 
applicator/user exposure data to refine data requirements, i.e., 
mutagenicity data requirements. One commenter believed the Agency was 
using a ``check box'' approach to requiring data rather than regulatory 
need.
    Summary of response to comments. The Agency reviewed the data 
typically submitted or determined to be necessary to support 
registration requests received over 7 years. EPA's proposed rule was 
based on that review. In some cases, EPA proposed new data requirements 
to codify existing practices and in other cases EPA proposed to amend 
test notes, for example, to clarify existing data requirements. EPA's 
analysis and proposed rule were based on decisions that the data and 
the modifications to the tables were necessary. Without more specific 
comment, EPA can not further respond to this comment.
    6. Providing adequate guidance when data are required/use pattern 
clarification--summary of comments. When EPA revised the proposed rule, 
there was a concerted effort to provide informative test notes, which 
would clarify when data are required. However, a commenter did not 
provide specific data requirement issues but indicated the Agency was 
not clear on the expanded use patterns. This commenter also indicated 
that the waiver policy was unclear.
    Summary of response to comments. As indicated earlier in this 
preamble, the Agency provided a section on ``Consultation with 
Applicants'' in the proposal which the commenter indicated was missing. 
It is a description of the pre-submission and post-submission process 
within the Agency encouraging the registrant to meet with the Agency as 
early as possible in the process in order to minimize delays and avoid 
unnecessary test costs. In most cases the numbers of use patterns were 
actually combined for transparency, i.e., food use and non-food use. 
The test notes provided for biochemical and microbial pesticides are 
more detailed than in the current regulation.
    7. There are no accepted protocols or guidelines for many data 
requirements--summary of comments. One commenter indicated that the 
Agency published data requirements without supporting published 
guidelines. This commenter cited the environmental fate guidelines.
    Summary of response to comments. The Agency proposed newly codified 
data data requirements guidelines for applicator/user exposure data; 
particle size, fiber length, and diameter distribution; product use 
information; and companion animal safety. There were also some new 
guideline numbers identified for environmental fate data

[[Page 60992]]

requirements. All of these data requirements have guidelines available. 
At the time of the publication of the proposed rule, the environmental 
fate guidelines were not finalized. The Agency did provide the existing 
guideline numbers that denoted the test methods at that time. The 
environmental fate guidelines (835 series) are anticipated to be 
published this year. In the interim, we have provided the current 
guideline numbers and the proposed guideline numbers in the data table. 
Once the final guidelines are published, the Agency will amend the 
Guideline references in the datea tables, as appropriate. As indicated 
previously, the guideline references are provided in part 158 as 
information/guidance to applicants. As with existing guidelines, an 
applicant is not compelled to use the cited draft guidelines, but may 
choose to use an alternative methodology that will provide the 
information needed to complete the risk assessment. (See Unit IV.D.).
    8. Codifying existing practice--summary of comments. EPA made 
revisions, which included codified, newly codified, or new data 
requirements. One commenter stated that the Agency was mistaken in its 
distinction between ``new requirements'' and ``newly codified 
requirements.'' The commenter provided the example that the 
immunotoxicity study (guideline 885.3550), is a new requirement, as no 
such data requirement previously existed, regardless of whether the 
guideline was available.
    Summary of response to comments. In developing this rule, the 
Agency received the data typically submitted or determined to be 
necessary to support registration requests received over the last 7 
years. If the data had never been submitted to support registration, 
then the data requirement would be considered new. However, if the data 
had been submitted or required to support recent registrations, and 
were not listed in the 1984 promulgated rule, then the Agency would 
classify that data requirement as newly codified.
    As for the specific example of immunotoxicity, these data are 
currently required and are being submitted to support existing 
registrations and is currently required in 40 CFR 158.690. EPA has been 
requiring or applicants have been submitting immunotoxicity data based 
on specific conditions, consistent with the 880.3550 guideline in more 
recent years, so the Agency classified this as a newly codified data 
requirement as a Tier II and Tier III data requirement.
    9. Animal welfare concerns--summary of comments. The Agency 
received comment on individual studies suggesting alternative 
approaches to substitute for them. This comment was designed to 
recommend reducing the number of animals used in studies.
    Summary of response to comments. All new studies required under 
today's rule for biochemical and microbial pesticides were all standard 
guideline studies that are also part of the data requirements for 
conventional pesticides. The EPA's Biopesticides and Pollution 
Prevention Division (BPPD) uses, where possible, the same studies that 
are used for conventional pesticides to allow for similar risk 
assessment procedures; to support the validated, time-tried, methods; 
to reduce the complexity of studies that testing laboratories must 
provide; to avoid excessive expenses for the typically small businesses 
that market these biopesticides; and to avoid instituting novel, non-
validated procedures for a relatively small group of pesticides. As 
discussed in the preamble to the final rule for the data requirements 
for the registration of conventional pesticide products, Unit XIII, 
Discussion of Comments on Animal Welfare Concerns, the Agency is 
committed to avoiding unnecessary animal testing, while taking into 
consideration principles of sound science and the requirements of FIFRA 
to protect humans and the environment. The complete Unit XIII response 
to these comments also applies to microbial and biochemical pesticide 
data requirements. BPPD will consider test methods that do not use 
animals and is working with the rest of the Agency to move towards 
these goals. In addition, BPPD will continue to be available for pre 
and post submission meetings to allow an applicant to submit only those 
data needed to support that particular product.

V. Biochemical Pesticide Data Requirements (new Subpart U)

A. Definition of Biochemical (Sec.  158.2000)

    Summary of proposed definition. EPA proposed to revise the 
definition of biochemical pesticide and received 11 comments on the 
definition. EPA's proposed definition was as follows:
    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 pesticide, 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).
    As explained in the proposed rule, EPA proposed to clarify the 
``naturally-occurring'' clause of the prior definition by adding a 
criterion that the pesticide have a history of exposure demonstrating 
minimal toxicity. EPA believes that if a pesticide is present in the 
environment in sufficient quantities, there would be a good chance that 
any innate toxicity would already have been recognized due to observed 
effects on humans or representative non-target organisms. A pesticide 
that meets this, as well as other specified criteria, is more 
appropriate for the tiering data structure that EPA uses for 
biochemicals than a pesticide that does not have such history of 
exposure or a pesticide that has a history of exposure in which such 
exposure has revealed toxicity concerns.
    The tiering structure can be beneficial if data submitted to 
satisfy the early tiers allow EPA to determine that the pesticide does 
not cause unreasonable adverse effects on the environment. This 
determination at the early tiered stage can reduce the total amount of 
data generated to satisfy registration as compared to pesticides that 
do not meet the biochemical definition.
    If the pesticide is naturally occurring but otherwise does not 
clearly meet the biochemical definition, EPA is not likely to use the 
biochemical pesticides tiering structure for testing; instead, EPA 
would likely apply the data requirements for conventional pesticides 
for an adequate assessment of the risks from the proposed use of such a 
pesticide. However, note that in some limited cases, EPA may assess a 
pesticide under the biochemical pesticide tiering structure even though 
the pesticide is not a biochemical pesticide. Specifically, EPA added 
paragraph (c) to 40 CFR 158.2000 to allow some limited use of the 
biochemical tiering structure for pesticides not clearly meeting the 
biochemical definition but for which only minimal additional data would 
be necessary. Please refer to the preamble of the proposed rule for 
further explanation.
    EPA also proposed that to meet the definition of ``biochemical'' 
the pesticide must have a non-toxic mode of action to the target pest. 
EPA proposed this criterion to conform to the original intent for 
defining biochemical, that the term describes a pesticide that is ``not 
the result of target organism

[[Page 60993]]

toxification.'' As EPA explained in the proposed rule, 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. See the proposed preamble and regulatory text for 
a more complete discussion of the proposed definition.
    Summary of comments. Eleven commenters identified concerns for the 
revised definition of a biochemical pesticide. In particular, the 
commenters believed in most cases that the proposed definition was more 
restrictive than the current definition. Of particular concern was the 
addition of the criterion that a biochemical pesticide must have a non-
toxic mode of action. A suggestion was made that the definition be 
reworded to include the phrase ``mitigating mode of action'' as in 
``Has a non-toxic or mitigating mode of action to the target pest.'' 
The commenters suggested that this would allow inclusion of a physical 
mode of action. Another commenter indicated that the new definition 
would not allow pesticides that cause suffocation.
    In addition, most of these commenters believed that the proposed 
definition, which included the language ``Has a history of exposure ... 
demonstrating minimal toxicity'' and ``Has a non-toxic mode of action 
to the target pest(s),'' would also make the criteria for defining a 
biochemical more restrictive, possibly disallowing insect pheromones, 
juvenile growth hormones, and most plant and animal extracts to be 
classified as biochemical pesticides. One commenter indicated that the 
definition should include both natural occurrence and non-toxic mode of 
action as part of the definition for low risk.
    One commenter generally supported the new definition but suggested 
that EPA also consider setting some limits to exposure since some 
naturally-occurring substances may be much more toxic if their use 
patterns result in high exposure levels. Another commenter expressed a 
concern that saponins would not be considered as biochemical pesticides 
under the proposed definition.
    Summary of response to comments. EPA disagrees with the general 
comment that the proposed definition is more restrictive than EPA's 
operation under the prior definition. EPA reviewed all 180 biochemical 
pesticide registrations since 1948 and determined that only two 
pesticides currently evaluated as biochemicals would not fit the 
definition of a biochemical pesticide as proposed. Though these two 
have been evaluated as biochemical pesticides, the data required were 
equivalent to what was required to support conventional pesticides. 
Based on this survey of biochemical pesticides, the Agency expects that 
there will be no significant differences in the scope of pesticides EPA 
evaluated as biochemical pesticides prior to the effect of this rule 
and the scope of those EPA evaluates as biochemical pesticides under 
this new definition. This applies equally to the scope of insect 
pheromones, juvenile growth hormones, and plant and animal extracts 
evaluated under the prior definition and that would be evaluated under 
the new definition.
    The Agency would like to clarify that the provision that a 
biochemical pesticide is a naturally-occurring substance as well as a 
compound that is structurally-similar and functionally identical to a 
naturally-occurring substance, also applies to pheromones. The 
pheromone definition in today's rule has been modified to make this 
explicit. In addition, the straight chain lepidopteran pheromone 
definition will be slightly corrected to correspond with the 
internationally-recognized definition as used in the tolerance 
exemption at Sec.  180.1153. The word ``double'' is added to ``three 
bonds'' to read as ``three double bonds''. The Agency is also replacing 
``designated by'' with ``consisting of'' in order to make the 
definition more transparent. The revised definition will read: `` A 
straight chain lepidopteran pheromone is a lepidopteran pheromone 
consisting of an unbranched aliphatic chain (between 9 and 18 carbons) 
ending in an alcohol, aldehyde, or acetate functional group and 
containing up to three double bonds in the aliphatic backbone.''
    EPA does not believe that the recommended inclusion of a 
``mitigating mode of action'' is needed. First, the Agency interprets 
the phrase ``non-toxic mode of action'' to include such pest control 
mechanisms as attraction, repellency (including irritants), growth 
regulation/development changes, induction of systemic acquired 
resistance, and physical modes of action such as desiccation, coatings, 
or smothering, e.g., by naturally-occurring oils. The Agency recognizes 
that physical modes of action, e.g. suffocation, may be lethal to the 
target pest, but since they do not involve toxic chemical/poison-
induced effects in the context of this program, they are considered to 
be a non-toxic mode of action. This is how EPA has interpreted ``unique 
modes of action'' as used in the prior definition. EPA notes that the 
Biochemical Classification Committee (consisting of EPA scientists) was 
formed in 1995 and has been responsible for determining whether a 
proposed pesticide is eligible to be evaluated as a biochemical 
pesticide and has consistently applied this interpretation of the 
existing definition. EPA proposed to include the phrase ``non-toxic 
mode of action'' instead of the phrase ``unique modes of action'' 
because EPA believes the former and proposed phrase better/more 
accurately describes our historical approach for defining ``biochemical 
pesticides,'' and intended no change in the scope of the term 
historically applied. In addition, to the fact that the proposed phrase 
captures commenter's concern, commenters did not adequately define the 
word ``mitigate'' as it would apply to pesticidal modes of action. 
Thus, EPA believes using a reference to mitigating mode of action is 
unnecessary and may only add confusion in implementation.
    Finally, for practical reasons, EPA does not believe that setting a 
limit based on the amount of existing exposure as compared to that 
contemplated by the proposed use pattern is necessary as recommended by 
the commenter. Implementation of this concept would be very difficult 
since the classification of the product would depend on the uses 
proposed with the initial application, which often change subsequent to 
the risk assessment process. It would be impractical to have to 
reclassify an active ingredient from a biochemical pesticide to a 
chemical pesticide based on use patterns. In practice, EPA will 
initially classify a pesticide as a biochemical pesticide, but will 
apply additional data requirements, up to and including those for 
conventional pesticides, to adequately assess the risk. In no case will 
an initial determination of biochemical status preclude the Agency from 
requiring data not specifically included in subpart U if necessary.
    Another commenter stated the belief that saponins (naturally-
occurring glycosides within plants) should be considered biochemical 
pesticides and that the new definition precludes such a finding. The 
Agency believes not all saponins would necessarily be registered as 
biochemical pesticides. Each one has to be evaluated carefully. This 
illustrates the importance of having sufficient exposure of naturally 
occurring chemicals to determine if any unreasonable toxicity is 
observed. Some saponins are known to be poisonous to people if 
swallowed, and some saponins can cause severe dermal irritation, and 
others may not be absorbed at low levels in the diet. Many saponins are

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especially toxic to fish. Any changes in the application or scope of 
the definition would be addressed through notice and comment 
rulemaking.

B. Individual Biochemical Data Requirements

    As noted in Unit II, 20 commenters responded to the proposal. The 
following sections are responses to comments raised:
    1. TEP and EP testing versus TGAI testing--summary of comments. 
Many commenters raised concerns about the variability in test material 
used for testing typical end-use product (TEP) or end-use product (EP) 
or technical grade active ingredient (TGAI) and whether to require the 
use of the same test material as that required for conventional 
pesticide data requirements.
    Summary of response to comments. The Agency compared the test 
materials required for conventional pesticides and determined that 
requiring the same testing material (i.e., TEP, EP, or TGAI) for 
biochemical pesticides to be used is appropriate in some circumstances. 
However, upon review EPA determined that there are instances where the 
types of testing material should not be the same. This difference is 
because there usually is no ``typical end-use product'' for biochemical 
pesticides. Most biochemical pesticide EPs are difficult to replicate. 
Therefore, TGAI is being required for many instances in which the 
conventional pesticide regulations require TEP or EP. EPA has made 
revisions where appropriate in the final rule.
    2. Particle size, fiber length, and diameter distribution--summary 
of comments. EPA proposed to add a new requirement for particle size, 
fiber length and diameter distribution, due to spray drift concerns. 
This new data requirement is consistent with conventional pesticides 
data requirements with the exception of the test material to be used; 
the Agency is requiring TGAI data for biochemical pesticides given the 
difficulties of producing a replicated TEP or EP. One commenter 
questioned the need for this data requirement.
    Summary of response to comments. As indicated in the proposed 
preamble, the data from these studies are needed to complete the 
environmental fate assessment to estimate the potential pesticide drift 
to non-target areas. The Agency should have included in the 
justification that these data are also useful for determining the 
potential for acute inhalation toxicity to human health and the 
environment. The Agency is being consistent with its assessment, since 
it reached the same conclusion in response to comments for conventional 
pesticides.
    Specifically, particle size is generally expressed as mean mass 
aerodynamic diameter (MMAD), which is a practical way to account for 
the different possible shapes such as fibers, clumps, etc. The particle 
size distribution is used as a set of criteria to determine 
respirability for purposes of establishing the need and/or the 
acceptability of inhalation toxicity studies (acute and, if the main 
route of exposure is inhalation, subchronic toxicity studies), and 
again, these data can also be used for spray drift evaluation.
    3. Immunotoxicity data requirements--summary of comment. EPA 
proposed to move the immune response requirements from Tier I and Tier 
II to Tier II and Tier III and added two test notes indicating when the 
data are required. One commenter stated immunotoxicity tier II data are 
difficult to interpret. Another commenter believed that this should be 
identified as a ``new requirement'' rather than as ``codifying an 
existing data requirement.''
    Summary of response to comments. EPA is finalizing the amendments 
as proposed. The name of this study has changed, but the 
``immunotoxicity testing'' data requirement is identical to the 
original ``immune response'' testing. To provide more guidance on when 
the studies are actually required, the final rule includes two test 
notes. As a result the data will be conditionally required as Tier II 
and Tier III data requirements.
    4. Companion animal safety data requirement--summary of comments. 
The Agency proposed to add companion animal safety data requirements 
based on past experiences indicating the data were needed for a risk 
assessment. One commenter requested that the Agency define companion 
animal species and surrogate species to be tested.
    Summary of response to comments. The Agency did not define the 
species to be tested in a test note since it relies on the Pesticide 
Assessment Guidelines (870.7200) to identify various appropriate 
species, which traditionally have been required to support flea and 
tick treatments for pets (i.e., dogs and cats). EPA has not changed the 
final rule as a result of the comments received, except we provided 
more specific guidance on test substance, (i.e., TGAI instead of 
choice).
    5. Applicator/user exposure data requirements--summary of comments. 
EPA proposed to add data requirements to address applicator/user 
exposure. EPA proposed a series of data requirements within this 
category to be tested on TGAI. EPA proposed to require background 
information as part of the applicator/user exposure monitoring data 
requirements. One commenter requested that EPA clarify its expectation 
that applicator exposure data requirements are primarily intended to 
generate data to support evaluation of insect repellents. One commenter 
indicated these data were not needed for all use patterns.
    Summary of response to comments. EPA has decided to not finalize 
its proposal to require background information for the applicator/user 
exposure monitoring test (guideline 875.1000) since the same data are 
already required to be submitted under the various other data 
requirements, i.e., dermal outdoor exposure, dermal indoor exposure, 
etc. (guidelines 875.1100 through 875.1500). EPA has made no further 
revisions to any other proposals on this series of data requirements.
    The final rule conditionally requires the data to be submitted when 
the use of the biochemical pesticide could result in exposure levels 
that might exceed those historically encountered, and if so, other 
additional information would be necessary (e.g., directions for use, 
application rates, or other exposure information) to determine 
potential risks.
    Thus, in general, when the use of any biochemical pesticide can be 
expected to exceed historical exposure to humans or the environment, 
the Agency would require exposure information to assure minimal risk 
associated with that use. Although it is true that insect repellents 
are typically applied at levels that can be expected to exceed those 
historically encountered, many other pesticide use patterns may also 
result in exposure levels exceeding these historically encountered use 
patterns. Again, these data requirements are not limited to insect 
repellents.
    6. Product use information data requirement--summary and Response 
to comments. The Agency proposed to require product use information 
(guideline 875.1700). EPA received comments that this information was 
not necessary because this same basic use information is available as 
part of the registration or experimental use permit application. EPA 
agrees with the commenters and has removed this requirement from the 
final rule.
    7. Mutagenicity data requirements--summary of comments . EPA 
proposed to provide more guidance for mutagenicity testing by 
specifying what kinds of studies would be required at Tier I and Tier 
II. This information was previously described in the 1982 published 
Subdivision M guidelines that indicated that Tier I would be in

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vitro testing and Tier II would be in vivo testing. EPA proposed to add 
two of the three in vitro studies to the table for mutagenicity Tier I 
testing, and the two in vivo studies were added to the data table for 
mutagenicity Tier II testing. Three comments were received. One 
commenter mistakenly thought we had an in vivo study at Tier I but did 
urge us to use non-animal methods at Tier I referencing an EPA tiered 
testing proposal by Dearfield, et al. (Ref. 1). Another commenter 
recommended that we include an in vitro chromosome aberration test at 
Tier I to better address chromosomal endpoints. The third commenter was 
concerned that an in vivo chromosomal aberration or clastogenicity 
study was moved to Tier II and recommended an in vivo test be included 
at Tier I.
     Summary of response to comments. Although the commenters were not 
totally accurate about the presence of in vivo chromosome studies being 
at the Tier I level (they were not actually at Tier I in the original 
nor the proposed guidelines, although the original table was not 
definitive by itself), the Agency believes the recommendation of the 
second commenter will address all these concerns. Therefore, the in 
vitro mammalian chromosome aberration study, guideline 870.5375, will 
be included in the Tier I Mutagenicity Testing battery of acceptable 
tests to better address chromosomal endpoints. This will correspond 
better to the mutagenicity testing description for the conventional 
pesticide data requirements, and will provide a more complete Tier I 
assessment.
    8. Primary eye, dermal and skin sensitization data requirements--
summary of comments. The Agency proposed to require both TGAI and EP 
testing, for EPs and TGAI and MP testing for MPs. The prior rule did 
not require TGAI testing. One commenter did not understand why the 
Agency expanded the data requirements to add the TGAI as the requisite 
test material.
    Summary of response to comments. The Agency indicated in the 
preamble of the proposed rule that inert ingredients as well as active 
ingredients could cause adverse effects not necessarily noted by TGAI 
alone. Therefore, testing on both TGAI and EP or MP is necessary to 
determine the safety of the pesticide for these endpoints. As a result, 
EPA is finalizing both TGAI and EP or MP testing.
    9. Limit testing--summary and response to comments. The Agency did 
not propose any revisions on limit testing for avian acute toxicity 
testing, but one commenter indicated support for the new methods in 
reducing the number of test animals used for conducting the study. The 
Agency minimizes testing as much as possible and often encourages the 
use of maximum hazard testing using only the high dose level, 
anticipating that no significant effects will be seen.
    10. Sediment/soil adsorption/desorption data--summary of comments. 
EPA proposed a revision in the sediment toxicity data requirement in 
Tier I from ``not required'' to ``conditionally required'' for 
greenhouse use. The Agency also revised the test note. One commenter 
requested that the Agency clarify why these data would be required for 
greenhouse use.
    Summary of response to comments. The Agency indicated the data may 
be conditionally required for greenhouse use to determine if the parent 
compound remains bound while grown in greenhouse conditions and is 
available for uptake in the plant. Likewise, it may need to be 
determined how rapidly the parent degrades in the growing medium, into 
what forms it may degrade, and whether the degradates are bound in the 
growing medium or taken up by the plant.

VI. Microbial Pesticides Data Requirements (Subpart V)

A. Definition of Microbial Pesticide

    1. Summary of proposal. The Agency proposed to revise the 
definition of a microbial pesticide as follows:
    Microbial pesticide means a microorganism intended for preventing, 
destroying, repelling, or mitigating any pest, or intended for use as a 
plant regulator, defoliant, or desiccant, that:
    i. Is a eucaryotic microorganism including, but not limited to, 
protozoa, algae, and fungi.
    ii. Is a procaryotic microorganism, including, but not limited to 
bacteria.
    iii. Is an autonomous replicating microscopic element, including, 
but not limited to, viruses.
    EPA proposed this revision to 40 CFR 158.65 to better conform to 
the description of the class of non-exempt biological control agents in 
152.20(a)(3), and to use a structure for defining microbial pesticide 
similar to that at 40 CFR 172.43. EPA explained that the proposed 
revisions are not intended to change, and in EPA's view does not 
change, the scope of the previous regulatory definitions and 
descriptions of microbial pesticides at Sec. Sec.  158.65, 
152.20(a)(3), or Sec.  172.43. EPA also proposed changes to Sec.  
172.43 so that the definition would conform to the newly proposed 
definition of microbial pesticide, but did not intend to change the 
scope of that provision. These revisions are intended to include all 
microorganisms as microbial pesticides based on the currently accepted 
taxonomic nomenclature as of the date of publication of this rule.
    EPA also proposed to refine the current regulatory text relating to 
the need to separately register new species or isolates and to separate 
that provision from the definition section to avoid confusion on the 
definition of microbial pesticide.
    In the preamble to the proposed rule, EPA noted that microorganisms 
are known to produce many chemical pesticidal substances. These 
pesticidal substances, when distributed or sold independently of the 
microorganism, are considered to be biochemical pesticides, 
conventional chemical pesticides, or antimicrobial pesticides, 
depending on the mode of action and the use. The microorganism would 
then usually be considered part of the manufacturing process. For 
example, streptomycin, an antibiotic produced by a bacterium, 
Streptomyces griseus, is registered as a conventional chemical 
fungicide.
    See Unit VIII.A. of the preamble to the proposed rule (71 FR 12072, 
March 8, 2006) for a more complete discussion of the changes proposed 
for the definition of microbial pesticide.
    2. Summary of comments. The Agency received a total of five 
comments on the proposed definition of a microbial pesticide. Some 
commenters expressed concerns that the microbial pesticide definition 
might not adequately describe all microbial pesticides. One recommended 
including bacteriophages. Another commenter asked if nematodes (which 
may have symbiotic microorganisms living in them) are covered by the 
definition. Several commenters generally agreed with the provision in 
EPA's prior definition that specifies that each new isolate of a 
microorganism should be evaluated as a new strain. However, one of 
these commenters was concerned that, particularly for baculoviruses, 
there may be a few cases in which some microorganisms could be 
evaluated at a family or genus level for some test data requirements 
such as for human health toxicity/pathogenicity testing, even if each 
microorganism is a different strain, while in other cases an isolate 
might not ``always meet the definition for a strain.'' The commenter is 
concerned that maintaining the provision from the prior definition 
might require more testing than is necessary.
    3. Summary of response to comments. To address the concerns about 
the adequacy of the microbial pesticide definition, the Agency added 
the

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procaryotic class Archaea as an example to the class Bacteria since 
this is another division of procaryotes that is on the level of 
bacteria, at least according to some taxonomic schemes. Although this 
does not change the scope of the definition as implemented and proposed 
by EPA, this will ensure that this part of the definition is much 
clearer by explicitly including that entire group of microscopic living 
organisms. EPA also considered including bacteriophages in the 
``autonomous replicating'' class under the revised microbial 
definition, which, as proposed, only included ``viruses'' as an 
example. However, EPA decided that it would not be appropriate from a 
taxonomic viewpoint. Bacteriophages are viruses that infect 
prokaryotes. Including a subcategory of viruses, i.e. the 
bacteriophages, as well as ``viruses'' would tend to confuse the 
language in the regulation and adds nothing to the scope of the 
definition. In addition, the original language in the preamble to the 
proposed rule was not quite accurate in describing viruses, i.e. ``the 
autonomous replicating language is intended to exclude pesticide 
components of microscopic cells that are not able to replicate as 
separate entities, such as genetic constructs.'' Because viruses 
replicate utilizing some components of a host cell, the ``autonomous 
replicating'' language would not accurately capture the relevant 
biology or the viruses we have registered. Therefore, EPA is changing 
the phrase ``autonomous replicating microscopic element'' to 
``parasitically replicating microscopic element'' in part 3 of the 
definition. Under this definition, genetic constructs inserted 
intentionally into a microbial agent to provide pesticidal traits are 
not included because they do not parasitically replicate; however, the 
genetically altered microbial agent itself would be regulated as a 
microbial pesticide. We also changed the language in the definition 
from ``microorganism'' to ``microbial agent.'' This better agrees with 
the language in 40 CFR 152.20(a) which exempts ``Certain biological 
control agents'' from regulation under FIFRA.
    In response to the comment concerning nematodes, EPA will offer 
some general guidance on nematodes here. Nematodes have been identified 
as a macroscopic biocontrol organism that is exempt from regulation in 
accordance with Sec.  152.20(a) on the basis that another Federal 
regulatory agency is adequately regulating them. However, EPA is aware 
that the insecticidal activity of some commercially marketed nematodes 
is due to insecticidal microorganisms that live in a symbiotic 
relationship inside the nematode gut, (e.g., Xenorhabdus spp. and 
Photorhabdus spp., entomopathogenic bacteria associated with nematodes 
of the families Steinernematidae and Heterorhabditidae). In response to 
previous inquiries from researchers working with these biocontrol 
organisms, EPA determined that these symbiotic bacteria are considered 
a part of the mode of action of the exempt nematodes and are therefore 
covered by the exemption in Sec.  152.20. Many exempt biocontrol 
organisms have naturally-occurring microbial flora living within them. 
However, if these bacteria were isolated, grown separately, and 
reinoculated into the nematodes as a delivery system, EPA has 
determined that the exemption does not apply and, thus, a registration 
would be required (USEPA, 1990)(Ref. 2). Likewise, genetic engineering 
of the symbiotic insecticidal microorganisms would also require them to 
be regulated as microbial pesticides.
    EPA carefully considered the comment raising the issue of whether 
an isolate occasionally could be evaluated to satisfy a subset of data 
requirements at a higher taxonomic level than strain level and whether 
an isolate might sometimes be included as part of a very similar 
strain. EPA believes the proposed microbial pesticide definition 
applicability provision is sufficiently flexible to ensure adequate 
consideration and data on new isolates, while allowing use of existing 
data to support registration if similar to an existing strain that is 
already registered. The wording of the provision relating to 
applicability of the microbial data requirements reads, ``each new 
isolate of a microbial pesticide is treated as a new strain and must be 
registered independently of any similar registered microbial pesticide 
strain and supported by data required in this subpart.'' This wording 
does not preclude the possibility of using data from another isolate to 
support the assessment if it can be shown that the two isolates are 
sufficiently closely related. In this way it ensures that each isolate 
will be independently considered for registration purposes. The 
differences in taxonomy between different microorganism 
classifications, particularly for baculoviruses, would make any attempt 
to further clarify this provision very complex and potentially 
confusing as the systematic nomenclature of these organisms change over 
time. The Agency intends to use its best scientific judgment in each 
instance to determine if one isolate is sufficiently closely related to 
another isolate to allow sharing of data or waiving of data 
requirements.

B. Amendment of Parts 172 and 152

    The definition of a microbial pesticide has been revised as 
follows:
    (1) ``Microbial agent'' replaces ``microorganism;''
    (2) ``Eubacteria and Archaebacteria'' replaces bacteria; and 
lastly,
    (3) ``parasitically'' replaces ``autonomous''.
These revisions were incorporated and were also replaced in other 
sections of 40 CFR. To better coordinate the regulations, EPA proposed 
to replace the definition for a microbial pesticide at 40 CFR 172.43 
with an updated definition. In addition, the Agency has also identified 
Sec.  152.403 as another location in 40 CFR where the definition of a 
microbial pesticide is cross-referenced. Accordingly, this provision 
also needs to be corrected to reference the new Sec.  158.2000 and 
Sec.  158.2100. EPA has also proposed to delete Sec.  158.65 in the 
proposed rule for conventional pesticides. EPA received no comments on 
this change to parts 152 and 172.

C. Individual Issues Submitted on Microbial Pesticides Data 
Requirements

    A number of issues were identified that were focused on the 
guidelines, i.e., number of applications, maximum dosing of pesticides 
during testing, etc. These issues are outside the scope of this rule 
and EPA will consider them in the context of guideline development.
    The following issues were identified for specific data requirements 
for microbial pesticides. The Agency responds to these comments in this 
preamble. When appropriate, the Agency has revised the regulatory text.
    1. EP versus TGAI testing for data requirements--summary of 
co