

[Federal Register: October 26, 2007 (Volume 72, Number 207)]
[Rules and Regulations]               
[Page 60988-61025]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26oc07-15]                         

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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 
http://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: http://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 
http://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 http://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

[[Page 60994]]

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

[[Page 60996]]

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 
comments. EPA proposed to require testing on TGAI for various data 
requirements instead of MP, or TEP or vice versa.
    Summary of response to comments. One commenter indicated that the 
EP should be tested instead of the TGAI for physical and chemical 
properties data requirements. The Agency agrees with the commenter and 
understands that for meeting the chemical and physical properties data 
requirements, some product analyses should be done on the product 
proposed for registration, either an MP or EP. However, some product 
analyses should be done with TGAI. EPA proposed no change to the test 
substance currently being required. Rather, EPA simply broke out the 
various tests that make up the body of the product analyses data. 
Therefore, the data being required are on TGAI or

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EP just as often as before, but with the revised table, it is more 
clear when TGAI or TGAI and MP/EP data are required for each specific 
test is listed (odor, color, etc.).
    2. Analytical methods data requirement--summary of comments. EPA 
proposed to move the data requirement for analytical methods from the 
Product Analysis Data Table to the Residue Data Table. One commenter 
indicated that the analytical method should be required as a chemical 
and physical properties data requirement.
    Summary of response to comments. The Agency is continuing to 
require these data but believes it more appropriate to require the data 
as a residue chemistry data requirement where it primarily would be 
needed if the microorganism could produce residues of concern, such as 
toxins. For general analysis of less problematic microorganisms, the 
new requirement for deposition of a sample to a culture collection 
where it would be available for use with standard microbial analytical 
comparison methods is sufficient to allow post registration analysis. 
This is to ensure that the product being registered is what was tested 
and evaluated.
    3. Quality assurance/quality control issue--summary of comments. 
EPA did not propose a revision in the manufacturing process data 
requirement. One commenter indicated that a detailed description of 
quality assurance/quality control (QA/QC) program as part of the 
manufacturing/production process should be clearly specified as a data 
requirement.
    Summary of response to comments. The Agency agrees with the 
commenter that the QA/QC program is especially critical for microbial 
agents. The existing regulations address these concerns by requiring 
confirmation that QA/QC is an essential part of the manufacturing 
process description as well as the discussion on formation of 
unintentional products and impurities.
    4. Acute injection toxicity/pathogenicity data requirement--summary 
of comments. EPA proposed to eliminate the intracerebral administration 
and rely on the intravenous or intraperitoneal administration for the 
acute injection toxicity/pathogenicity study. One commenter agreed that 
elimination of the intracerebral injection assay was reasonable, but 
indicated it was unclear why the data were not required to support 
registration of viruses. Another commenter indicated that the 
pathogenicity/toxicity study via the intravenous (i.v.) or subcutaneous 
(s.c.) route should not be required for viruses.
    Summary of response to comments. The requirement for the 
intracerebral injection assay is eliminated since it is difficult to 
accomplish and has questionable utility for detecting effects given the 
high likelihood of adverse effects from the method itself.
    The Agency is not requiring pathogenicity/toxicity data for viral 
agents based on the difficulty of establishing the clearance endpoint 
for viruses. In these tests, the individual organ macerates must be 
tested for infectivity by a bioassay in the target pest. The Agency 
finds that the results from the cell culture assays are more sensitive 
and present a greater potential for the virus to express infectivity 
and cytopathic effects. The final rule is the same as the proposed rule 
for this data requirement.
    5. Hypersensitivity incidents data requirement--summary of 
comments. EPA proposed to revise the hypersensitive incident data 
requirement from ``conditionally required'' (CR) to ``required'' (R) to 
better describe the occurrence and when it is actually required. One 
commenter requested more guidance on when to report hypersensitivity 
incidents to the Agency, and indicated that the elimination of the 
sensitization study could not be supported.
    Summary of response to comments. For clarification, EPA did not 
require a ``sensitization'' study for microbial pesticides in either 
the original or the proposed rule. The original rule required a 
hypersensitivity study and reporting of hypersensitivity incidents. The 
proposed rule proposed to remove the requirement for hypersensitivity 
studies but continue the requirement for reporting of data for 
hypersensitivity incidents. The reference was changed from CR to R for 
the hypersensitivity reporting to better indicate that the data are 
required with no exceptions for all use patterns, if any 
hypersensitivity incidents occur. The Agency expects that many 
microbial pesticides may be respiratory sensitizers, although there are 
no consistently reliable laboratory tests available for this endpoint. 
Therefore, in general, the Agency requires protective equipment to 
lessen exposure to microbial agents for applicators with a high 
likelihood of repeated exposure. The requirement for reporting of human 
hypersensitivity incidents is to track microorganisms that may require 
more protective measures than those generally followed. The Agency 
agrees with the comment that more guidance on when to report would be 
helpful and is adding to the footnote the following language from the 
``when required'' section of the 1982 Subdivision M Guideline 152.37 
referenced in the original data requirements for Hypersensitivity 
Incidents and as slightly revised in the 1989 Guidelines (152A-15): 
``3. Hypersensitivity incidents, including immediate-type and delayed-
type reactions, of humans or domestic animals that occur during the 
testing or production of the TGAI, MP, or EP, or are otherwise known to 
the applicant, must be reported if they occur.'' Additional guidance is 
provided by 40 CFR 152.50(f)(3), which specifies that an applicant must 
include in a registration application any factual information of which 
he is aware regarding unreasonable adverse effects of the pesticide on 
humans or the environment.
    6. Mutagenicity data requirements--summary of comments. EPA 
proposed to no longer require mutagenicity data on the whole 
microorganism. One commenter disagreed with the Agency, and indicated 
that mutagenicity data should be required on the whole organism. The 
commenter indicated that, especially for a new microorganism, basic 
genotoxicity studies (in vitro) might indicate the presence of 
metabolites/toxins with mutagenic properties that otherwise would not 
have been detected. Thus, basic studies should be kept on the list, at 
least as conditionally required. This same commenter indicated a 
concern for immunocompromised people and the possible production of 
antibiotic substances or the spread of antibiotic resistance to human 
or animal pathogens that could occur.
    Summary of response to comments. The Agency's experience with 
standard mutagenicity testing shows that it is not appropriate for 
whole microorganisms or often even for slurries. These mixtures often 
interfere with the results from the tests. If toxins that may be 
mutagenic are identified as part of the Tier I testing and/or are known 
to be present in taxonomically related microorganisms, they can be 
tested as part of the acute testing requirements at Tier II. The 
Agency's approach is to require testing that identifies whether known 
problematic toxins are present in that isolate. The significant part of 
a microbial assessment comes from the taxonomic description of the 
organism that is used to search the literature to identify any 
problematic toxins that warrant individual assessment.
    EPA evaluates potential effects on immunocompromised people as part 
of the assessment process of a microbial pesticide, considering its 
relationship to known human pathogens, the test data, and the potential 
exposure from its use.

[[Page 60998]]

EPA agrees most naturally-occurring microorganisms have evolved some 
sort of antibiotic mechanisms to help them survive in the presence of 
other microorganisms. However, rarely would significant levels of an 
antibiotic be produced from uses of microbial pesticides that might 
produce a disease problem. If a microorganism that could produce 
significant levels of a clinically important antibiotic was proposed 
for a pesticidal use that might affect medicinal uses of that 
antibiotic, it would be handled on a case-by-case basis by 
knowledgeable EPA scientists. After careful consideration, the 
mutagenicity data requirements remain the same in the final rule as in 
the proposed rule.
    7. Infectivity/pathogenicity data requirement--summary of comments. 
EPA proposed to conditionally require infectivity/pathogencity data as 
a Tier III data requirement. One commenter was opposed to the new data 
requirement for infectivity/pathogenicity.
    Summary of response to comments. The Agency understands the 
concerns of conditionally requiring higher tiers of mammalian testing. 
EPA believes, however, that there may be instances in which a microbial 
pesticide is intended for control of a mammalian pest, and such tests 
may be needed to assure the safety for non-target mammalian species. 
This same commenter also strongly opposed the use of primates for this 
testing and oncogencity/carcinogenicity testing. The Agency doubts a 
registrant would go to the extremes of performing a primate study to 
try to support registration of a mammalian pathogen. The data 
requirements in the final rule remain the same as in the proposed rule.
    8. TEP testing for non-target ecological effects. EPA proposed some 
revisions to provide the option for testing either the TEP or TGAI for 
non-target ecological effects. One commenter recommended TEP or EP 
testing for all products with potential aquatic or terrestrial non-
target exposure.
    Summary of response to comments: The Agency agrees with the 
commenter that EP testing should be required when significant non-
target exposure is to be expected. Therefore, the Agency has added a 
new test note to require EP or TEP testing when the EP may contain 
other ingredients that may be toxic to non-target organisms. The Agency 
has added TEP to freshwater fish/pathogenicity and invertebrate/
pathogenicity testing data requirements.
    9. Honeybee toxicity testing--summary of comments. The Agency 
proposed one test note revision to the honeybee toxicity study for 
indoor use and Experimental Use Permits (EUPs). One commenter indicated 
the data requirement refers mainly to oral effects, and that the Agency 
should consider dermal/topical effects as well, suggesting it would 
improve harmonization with other data requirements, if the dermal/
topical acute toxicity test was also included as an option.
    Summary of response to comments. The data table does not specify 
the route of exposure for the honeybee toxicity testing. The route of 
exposure for this test is addressed in its OPPTS Microbial Pesticide 
Harmonized Test Guideline, 885.4380, which is available on the EPA's 
web site at http://www.epa.gov/opptsfrs/home/guidelin.htm and which is 

referenced in the data table. This guideline recommends using an oral 
dose if the microbial pesticide is expected to act by a dietary route 
of exposure or consists of particles of such a size that they might be 
carried back to the hive like pollen. However, we recognize that most 
honeybee oral dosing methods would likely also result in some dermal 
exposure. Furthermore, the guideline does not rule out using a 
conventional dermal/topical exposure as an option if the mode of action 
of the microbial pesticide indicates that it would be more appropriate.
    10. Environmental expression data requirements--summary of comments 
. EPA did not propose to change when the Tier II environmental fate, 
i.e. expression, testing would be triggered by Tier I acute toxicity 
testing. However, one commenter indicated that the data requirements on 
environmental expression are very limited. The commenter recommended, 
to improve harmonization with the European Union (EU), that EPA should 
add substantial guidance to the test notes 9, 10, and 11 (or references 
to relevant literature) on what environmental fate data should be 
collected, presented, and submitted, in case a Tier II evaluation is 
required.
    Response to comments: The guidance that the commenter recommends be 
added to the regulatory text is found in our guidelines, specifically 
guidelines 885.5200, 885.5300, and 85.5400, which are referenced in the 
data tables. Historically, EPA has provided detailed guidance on a 
case-by-case basis. The EU and the US have agreed to use the same 
microbial pesticide testing guidelines, so these would be the best 
place to address this concern. The EPA will continue to address EU 
harmonization through the OECD Biopesticides Steering Group.
    11. Reduction in number of test animals used for testing--summary 
of comments. EPA did not propose any revisions to the test guidelines 
within this proposed rule. Two commenters supported the development of 
new methods to reduce the number of animals used for pesticide testing 
while maintaining the diversity of test species.
    Summary of response to comments. The revision of the guidelines is 
a separate activity. The OPPTS Microbial Test Guidelines already 
recommends a single high dose for the initial test using a minimal 
number of test animals and provides for enough replicates with 
sufficient statistical power. Specifically, high dose tests (basically 
high dose screening tests using a low number of test animals and 
replicates) by their very nature provide sufficient statistical power 
to avoid type II (beta) errors.
    12. Non-target organisms and environmental fate testing. Both the 
original and the proposed testing for non-target effects and 
environmental fate are organized into tiers, with the effects testing 
at the Tier I level and the environmental exposure testing at the Tier 
II level. One commenter requested the Agency conduct the fate and 
exposure studies at Tier I and put the non-target studies using living 
test organisms at Tier II and higher. The commenter suggested limiting 
Tier I data requirements to strictly non-vertebrate studies, e.g., 
environmental expression studies, and substituting some in vitro 
studies such as a fish egg and a protozoan toxicity study for in vivo 
fish studies.
    Summary of response to comments. The Agency does not believe this 
suggestion would allow an adequate assessment to be done. The basis for 
the microbial pesticide ecological risk assessment is to first 
determine if there are any significant adverse effects with a maximum 
hazard approach. The maximum hazard approach to testing uses one dosing 
group of animals (mice, rats, birds, etc) tested at a very high dosage 
of the test substance on the presumption that no adverse effects will 
be seen. If no significant adverse effects are seen at the maximum 
dosage, exposure data are not required. The Agency minimizes testing as 
much as possible and often encourages the use of maximum hazard testing 
when no significant effects are expected to be seen at that level. This 
is especially pertinent to microbial pesticides which rarely show any 
significant effects in the high dose and it has dramatically reduced 
the number of test animals used and also reduced the cost of the 
testing.
    Definitive environmental expression studies are very difficult to 
perform for naturally-occurring microorganisms that can increase in 
numbers in the

[[Page 60999]]

environment under varying conditions, in contrast to chemical 
pesticides for which environment fate studies are designed to determine 
only how fast they degrade and/or are transported. An environmental 
expression study on a microorganism rarely, if ever, would be 
sufficiently conclusive to allow bypassing the easier-to-perform in 
vivo effects studies. However, a careful preregistration analysis of 
the proposed uses and known environmental characteristics of the 
specific microorganism usually allows for some data waivers of the Tier 
I studies to be granted. The proposal for substituting the two in vitro 
studies to replace a study on fish is worth further study as an 
alternative to the standard fish study, but it is not clear at this 
time if it would accurately detect the potential for microbial 
infectivity and pathogenicity.
    13. Addition of other test species--summary of comments. One 
commenter suggested adding testing of freshwater algae, terrestrial 
micro-organisms, and the active micro-organisms in sewage treatment 
plants, as these may be exposed as well to general use, biochemical, or 
microbial pesticides.
    Summary of response to comments. Current knowledge indicates that 
the inherent variability in physical and biological environments, the 
adaptability of microbes, and redundant degradation pathways in 
microbial and mesofaunal communities, leads to no significant or 
lasting impact on ecosystems from introduction of pesticidal microbes 
even where changes to these populations can be meaningfully tracked. 
(Refs. 3 and 4). Moreover, microbial ecosystems are highly variable. 
Any transitory, limited, effects from the introduction of a typical 
microbial pesticide into the environment would be very difficult to 
detect and analyze. The active microorganisms in sewage treatment 
plants are also part of a complex specialized microbial community that 
is very competitive and is also very unlikely to be influenced by any 
one given microbial pesticide.

VII. Experimental Use Permits

    In promulgating its final rule on conventional pesticides, EPA 
segregated the Experimental Use Permit (EUP) data requirements into a 
separate subpart C. This was done in response to comments suggesting 
this change for clarity and to avoid confusion about the purpose of the 
brackets. For consistency and ease of use, EPA has adopted this new 
format for biochemical and microbial pesticides. Accordingly, the 
brackets have been removed from the product chemistry, residue, 
toxicology, non-target organism, and environmental fate data tables.
    The new data requirements for experimental use permits are listed 
in Sec.  158.2080 for biochemical pesticides and Sec.  158.2170 for 
microbial pesticides.

VIII. Implementation

    After the effective date, the data requirements in this final rule 
will apply to all new registrations of biochemical pesticides and 
microbial pesticides. The Agency does not intend to apply these 
requirements retroactively to all existing pesticide registrations but 
the Agency may find it necessary to call in some data on certain 
existing registrations, as warranted by emerging risks of concern on 
particular pesticides or as a result of possible programmatic changes 
and priorities on existing pesticides.
    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. Although the data requirements in part 158 are imposed 
primarily as a part of initial registration, EPA is authorized under 
FIFRA sec. 3(c)(2)(B) to require a registrant to develop and submit 
additional data to maintain a registration. This post-registration data 
call-in authority recognizes that the scientific underpinnings of risk 
assessment change, and is another means by which EPA may keep data for 
use in risk assessment current with evolving science.
    EPA will consider as part of its review of a pending application 
whether and how to apply these updated data requirements. EPA expects 
that few changes will be needed, as these updated requirements reflect 
current practice.

IX. References

    The following is a listing of the documents that are specifically 
referenced in this final rule. These documents and other supporting 
materials are included in the docket established for this rulemaking 
under docket ID No. EPA-HQ-OPP-2004-0415 at http://www.regulations.gov.

    1. Dearfield, K.L., Cimino, M.C., McCarroll, N.E., et al. 
``Genotoxicity risk assessment: a proposed classification strategy.'' 
Mutation Research 521, 121-135 (2002).
    2. December 3, 1990 EPA memo: Schneider to Hutton.
    3. Gagliardi, J.V., Buyer, J.S. Angle, J.S. and Russek-Cohen, E. 
2001a. Structural and functional analysis of whole-soil microbial 
communities for risk and efficacy testing following microbial 
inoculation of wheat roots in diverse soils. Soil Biol. Biochem. 33:25-
40.
    4. Gagliardi J.V., Angle J.S., Germida J.J., Wyndham R.C., Chanway 
C.P., Watson R.J., Greer C.W., McIntyre T, Yu H.H., Levin M.A., Russek-
Cohen E, Rosolen S, Nairn J, Seib A, Martin-Heller T, Wisse G. 2001b. 
Intact soil-core microcosms compared with multi-site field releases for 
prerelease testing of microbes in diverse soils and climates. Can J 
Microbiol. 47(3):237-52.
    5. U.S. EPA, 2006. ``Economic Analysis of the Final Data 
Requirements For Biochemical And Microbial Pesticides Rule.'' FEAD/OPP/
U.S. EPA, Washington, D.C.
    6. U.S. EPA, 2002. ``Supporting Statement for an Information 
Collection Request: Tolerance Petitions for Pesticides on Food/Feed 
Crops and New Inert Ingredients.'' OMB Control No. 2070-0024, EPA ICR 
No. 0597. OPP/U.S. EPA, Washington, D.C.
    7. U.S. EPA, 2002. ``Supporting Statement for an Information 
Collection Request: Application for New or Amended Pesticide 
Registration.'' OMB Control No. 2070-0060, EPA ICR No. 0277. OPP/U.S. 
EPA, Washington, D.C.
    8. U.S. EPA, 2001. ``Supporting Statement for an Information 
Collection Request:'' Data Generation for Reregistration; Phase 4 and 5 
Reregistration.'' OMB Control No. 2070-0107, EPA ICR No. 1504. OPP/U.S. 
EPA, Washington, D.C.
    9. U.S. EPA, 2001. ``Supporting Statement for an Information 
Collection Request: Data Call-Ins for the Special Review and 
Registration Review Programs.'' OMB Control No. 2070-0057, EPA ICR No. 
0057. OPP/U.S. EPA, Washington, D.C.
    10. U.S. EPA, 2004. ``Supporting Statement for an Information 
Collection Request: Plant-Incorporated Protectants; CBI Substantiation 
and Adverse Effects Reporting.'' OMB Control No. 2070-0142, EPA ICR No. 
1693, Washington, D.C.

X. FIFRA Review Requirements

    In accordance with FIFRA sec. 25(a), the Agency submitted a draft 
of this final rule to the FIFRA Scientific Advisory Panel (SAP), the 
Secretary of Agriculture, and the Committee on Agriculture in the House 
of Representatives, and the Committee on Agriculture, Nutrition, and 
Forestry in the United States Senate.
    The FIFRA SAP waived its review of this final rule because the 
significant scientific issues involved have already been reviewed by 
the SAP and additional review is unnecessary.

[[Page 61000]]

XI. Statutory and Executive Order Review

A. Regulatory Planning and Review

    Under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), the Office of Management and 
Budget (OMB) has determined that this action is a significant 
regulatory action because it might raise novel legal or policy issues 
arising out of legal mandates, the President's priorities, or the 
principles set forth in the Executive Order. Accordingly, EPA submitted 
this action to OMB for review under Executive Order 12866 and any 
changes made in response to OMB recommendations have been documented in 
the docket for this action as required by sec. 6(a)(3)(E) of the 
Executive Order.
    In addition, EPA has prepared an analysis of the potential costs 
and benefits associated with this action, entitled Economic Analysis of 
the Final Data Requirements For Biochemical And Microbial Pesticides 
Rule (Economic Analysis). (Ref. 4). A copy of this analysis is 
available in the docket for this rule and is briefly summarized here.
    For the proposed rule, EPA estimated that the total annual impact 
to the pesticide industry is a regulatory compliance cost reduction of 
$3.04 million per year, with an estimated average cost reduction of 
$60,000 per firm, per year. During the public comment period for the 
proposed rule, no comments were received on the economic analysis. The 
majority of the comments on the proposed rule focused on definitional 
issues; none of the clarifications made in this final rule affect the 
Agency's estimate on the total annual impact to the pesticide industry. 
Accordingly, no substantive changes have been made to the Economic 
Analysis for this rulemaking.
    As such, the likely impact of this final rule on businesses overall 
is expected to be mostly beneficial. EPA believes that the final rule 
would have no effect on the availability of pesticides to users. On 
balance, the Agency believes that cost savings resulting from the final 
changes to the data requirements presented in this final rule can be 
realized without compromising the protection of human health and the 
environment.

B. Paperwork Reduction Act (PRA)

    This final rule does not contain any new information collection 
requirements that require additional approval by OMB under the 
Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. Under the PRA, an 
agency may not conduct or sponsor, and a person is not required to 
respond to a collection of information unless it displays a currently 
valid OMB control number, or is otherwise required to submit the 
specific information by a statute. The OMB control numbers for EPA's 
regulations codified in Title 40 of the CFR, after appearing in the 
preamble of the final rule, are further displayed either by publication 
in the Federal Register or by other appropriate means, such as on the 
related collection instrument or form, if applicable. The display of 
OMB control numbers in certain EPA regulations is consolidated in a 
list at 40 CFR 9.1.
    Under the PRA, ``burden'' means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
or disclose or provide information to or for a Federal agency. This 
includes the time needed to: review instructions; develop, acquire, 
install, and utilize technology and systems for the purposes of 
collecting, validating, and verifying information, processing and 
maintaining information, and disclosing and providing information; 
adjust existing ways to comply with any previously applicable 
instructions and requirements; train personnel to be able to respond to 
a collection of information; search data sources; complete and review 
the collection of information; and transmit or otherwise disclose the 
information.
    The information collection requirements (i.e., the paperwork 
collection activities) related to the submission of data necessary to 
register a pesticide product are already approved by OMB under several 
existing information collection requests (ICR). Specifically, the 
activities that would generate a paperwork burden under this rule are 
covered by the following ICRs:
     The activities associated with the establishment of a 
tolerance are currently approved under OMB Control No. 2070-0024 (EPA 
ICR No. 0597) (Ref. 5).
     The activities associated with the application for a new 
or amended registration of a pesticide are currently approved under OMB 
Control No. 2070-0060 (EPA ICR No. 0277) (Ref. 6).
     The activities associated with the generation of data for 
reregistration are currently approved under OMB Control No. 2070-0107 
(EPA ICR No. 1504) (Ref. 7).
     The activities associated with the generation of data for 
special review or registration review are currently approved under OMB 
Control No. 2070-0057 (EPA ICR No. 0922) (Ref. 8).
     The activities associated with notification of genetically 
modified microbial pesticides are currently approved under OMB Control 
No. 2070-0142 (EPA ICR No. 1693) (Ref. 9).
    These existing ICRs cover the paperwork activities contained in 
this rule because these activities already occur as part of existing 
program activities. These program activities are an integral part of 
the Agency pesticide program, and the corresponding ICRs are regularly 
renewed as required under the PRA, such that these OMB Control Nos. are 
maintained valid.
    Based on these existing approvals, the Agency estimates that the 
total average annual public reporting burden currently approved by OMB 
for these various activities ranges from 8 hours to approximately 3,000 
hours per respondent, depending on the activity and other factors 
surrounding the particular pesticide product. Additional information 
about this estimate is provided in the Economic Analysis for this 
rulemaking.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 
5 U.S.C. 601 et seq., the Agency hereby certifies that this rule will 
not have a significant adverse economic impact on a substantial number 
of small entities. This determination is based on the Agency's Economic 
Analysis performed for this rulemaking, which is summarized in Unit 
IX.A. above, and a copy of which is available in the docket for this 
rulemaking. The following is a brief summary of the factual basis for 
this certification.
    Under the RFA, small entities include small businesses, small not-
for-profit organizations, and small governmental jurisdictions. For 
purposes of assessing the impacts of today's rule on small entities, 
small entity is defined in accordance with the RFA as: (1) A small 
business as defined by the Small Business Administration's (SBA) 
regulations at 13 CFR 121.201; (2) a small governmental jurisdiction 
that is a government of a city, county, town, school district, or 
special district with a population of less than 50,000; and (3) a small 
organization that is any not-for-profit enterprise which is 
independently owned and operated and is not dominant in its field.
    Based on the industry profile that EPA prepared using historical 
pesticide registration data as part of the Economic Analysis prepared 
for this rulemaking, EPA has determined that this rule is not expected 
to impact any small not-for-profit organizations or small governmental 
jurisdictions. The

[[Page 61001]]

historical data indicates that these types of entities do not engage in 
the activities covered by this rulemaking. As such, the small entity 
impacts analysis evaluates potentially impacted businesses that could 
be considered small businesses as defined by the Small Business 
Administration, which uses the maximum number of employees or sales for 
businesses in each industry sector, as that sector is defined by NAICS. 
For example, entities defined as Pesticide and Other Agricultural 
Chemical Manufacturing (325320) are considered to be a small business 
if they employ 500 or fewer people.
    EPA then used historical data to estimate the impacts of the rule 
on these small businesses. Of 51 firms with biochemical or microbial 
registration actions between 1997 to 2004, financial data for 
determining company size was available for 40 firms, with 23 of those 
firms classified as small businesses. According to the analysis, all of 
these small entities would realize a reduction in costs based on the 
rule changes compared to the current part 158 data requirements. Given 
these estimated impacts on small businesses, EPA concluded that the 
revisions in this rule may benefit and would not likely have a 
significant adverse economic impact on a substantial number of small 
entities.

D. Unfunded Mandates Reform Act (UMRA)

    Under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) 
(Public Law 104-4), EPA has determined that this action does not 
contain a Federal mandate that may result in expenditures of $100 
million or more for State, local, and tribal governments, in the 
aggregate, or the private sector in any one year. As described in Unit 
XI.A., the total annual impact to the pesticide industry is estimated 
to be a regulatory compliance cost reduction of about $3.04 million per 
year.
    In addition, since State, local, and tribal governments are rarely 
pesticide applicants or registrants, the final rule is not expected to 
significantly or uniquely affect small governments. Accordingly, this 
action is not subject to the requirements of sections 202 and 205 of 
UMRA.

E. Federalism Implications

    Pursuant to Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999), EPA has determined that this rule does not 
have ``federalism implications,'' because it would not have substantial 
direct effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in the Order. Because instances in which a State is a registrant are 
extremely rare, this final rule may seldom affect a State government. 
Thus, Executive Order 13132 does not apply to this rule.

F. Tribal Implications

    As required by Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000), EPA has determined that this final rule does not have tribal 
implications because it would not have substantial direct effects on 
tribal governments, on the relationship between the Federal government 
and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes, as 
specified in the Order. At present, no tribal governments hold, or have 
applied for, a pesticide registration. Thus, Executive Order 13175 does 
not apply to this rule.

G. Protection of Children

    Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997) does not apply to this final rule because this action is not 
designated as an ``economically significant'' regulatory action as 
defined by Executive Order 12866 (see Unit XI.A.). Further, this rule 
does not establish an environmental standard that is intended to have a 
negatively disproportionate effect on children. To the contrary, this 
action would provide added protection for children from pesticide risk. 
The requirements in this rule are intended to address risks that, if 
not addressed, could have a disproportionate negative impact on 
children. EPA will use the data and information obtained by this rule 
to carry out its mandate under FFDCA to give special attention to the 
risks of pesticides to sensitive subpopulations, especially infants and 
children.

H. Energy Implications

    This rule is not subject to Executive Order 13211, entitled Actions 
Concerning Regulations that Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001), because it is not 
designated as an ``economically significant'' regulatory action under 
Executive Order 12866 (see Unit XI.A.), nor is it likely to have any 
significant adverse effect on the supply, distribution, or use of 
energy.

I. National Technology Transfer and Advancement Act (NTTAA)

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

J. Environmental Justice

    This rule does not have an adverse impact on the environmental and 
health conditions in low-income and minority communities. Therefore, 
under Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994), the Agency is not required 
to and has not considered environmental justice-related issues. 
Although not directly impacting environmental justice-related concerns, 
the Agency believes that the requirements in this rule will assist EPA 
and others in assessing potential risks associated with exposures to 
biochemical and microbial pesticides.

XII. Congressional Review Act (CRA)

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must

[[Page 61002]]

submit a rule report, which includes a copy of the rule, to each house 
of Congress and the Comptroller General of the United States. EPA will 
submit a report containing this rule and other required information to 
the U.S. Senate, the U.S. House of Representatives, and the Comptroller 
General of the United States prior to publication of the rule in the 
Federal Register. This rule is not a major rule as defined by 5 U.S.C. 
804(2).

List of Subjects in 40 CFR Part 158

    Administrative practice and procedure, Agricultural commodities, 
Pesticides and pests, Reporting and recordkeeping requirements.

    Dated: October 10, 2007.
Stephen L. Johnson,
Administrator.

0
Therefore, Title 40, chapter I, part 158 is amended as follows:
0
1. The authority citation for part 158 continues to read as follows:

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

0
2. By adding subparts U and V to part 158 to read as follows:
Subpart U--Biochemical Pesticides
Sec.
158.2000 Biochemical pesticides definition and applicability.
158.2010 Biochemical pesticides data requirements.
158.2030 Biochemical pesticides product chemistry data requirements 
table.
158.2040 Biochemical pesticides residue data requirements table.
158.2050 Biochemical pesticides human health assessment data 
requirements table.
158.2060 Biochemical pesticides nontarget organisms and 
environmental fate data requirements table.
158.2070 Biochemical pesticides product performance data 
requirements.
158.2080 Experimental use permit data requirements - biochemical 
pesticides.
158.2081 Experimental use permit biochemical pesticides product 
chemistry data requirements table.
158.2082 Experimental use permit biochemical pesticides residue data 
requirements table.
158.2083 Experimental use permit biochemical pesticides human health 
assessment data requirements table.
158.2084 Experimental use permit biochemical pesticides nontarget 
organisms and environmental fate data requirements table.
Subpart V-- Microbial Pesticides
Sec.
158.2100 Microbial pesticides definition and applicability.
158.2110 Microbial pesticides data requirements.
158.2120 Microbial pesticides product analysis data requirements 
table.
158.2130 Microbial pesticides residue data requirements table.
158.2140 Microbial pesticides toxicology data requirements table.
158.2150 Microbial pesticides nontarget organisms and environmental 
fate data requirements table.
158.2160 Microbial pesticides product performance data requirements.
158.2170 Experimental use permit data requirements-microbial 
pesticides.
158.2171 Experimental use permit microbial pesticides product 
analysis data requirements table.
158.2172 Experimental use permit microbial pesticides residue data 
requirements table.
158.2173 Experimental use permit microbial pesticides toxicology 
data requirements table.
158.2174 Experimental use permit microbial pesticides nontarget 
organisms and environmental fate data requirements table.

Subpart U--Biochemical Pesticides


Sec.  158.2000  Biochemical pesticides definition and applicability.

    This subpart applies to all biochemical pesticides as defined in 
paragraphs (a), (b), and (c) of this section.
    (a) Definitions. The following terms are defined for the purposes 
of subpart U of this part.
    (1) A biochemical pesticide is a pesticide that:
    (i) Is a naturally-occurring substance or structurally-similar and 
functionally identical to a naturally-occurring substance;
    (ii) 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
    (iii) Has a non-toxic mode of action to the target pest(s).
    (2) A Pheromone is a compound produced by a living organism or is a 
synthetically derived substance that is structurally similar and 
functionally identical to a naturally-occurring pheromone, which, alone 
or in combination with other such compounds, modifies the behavior of 
other individuals of the same species.
    (i) An Arthropod Pheromone is a pheromone produced by a member of 
the taxonomic phylum Arthropoda.
    (ii) A Lepidopteran Pheromone is an arthropod pheromone produced by 
a member of the insect order Lepidoptera.
    (iii) 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.
    (b) Examples. Biochemical pesticides include, but are not limited 
to:
    (1) Semiochemicals (insect pheromones and kairomones),
    (2) Natural plant and insect regulators,
    (3) Naturally-occurring repellents and attractants, and
    (4) Enzymes.
    (c) Applicability. The Agency may review, on a case-by-case basis, 
naturally-occurring pesticides that do not clearly meet the definition 
of a biochemical pesticide in an effort to ensure, to the greatest 
extent possible, that only the minimum testing sufficient to make 
scientifically sound regulatory decisions would be conducted. The 
Agency will review applications for registration of naturally-occurring 
pesticides to determine whether to review the pesticide under this 
subpart U.


Sec.  158.2010  Biochemical pesticides data requirements.

    (a) Sections 158.2030 through 158.2070 identify the data 
requirements that are required to support registration of biochemical 
pesticides. Sections 158.2080 through 158.2084 identify the data 
requirements that are required to support Experimental Use Permits 
(EUPs). Variations in the test conditions are identified within the 
test notes. Definitions that apply to all biochemical data requirements 
can be found in Sec.  158.2000.
    (b) Each data table includes ``use patterns'' under which the 
individual data are required, with variations including food and 
nonfood uses for terrestrial and aquatic applications, greenhouse, 
indoor, forestry, and residential outdoor applications under certain 
circumstances.
    (c) The categories for each data requirement are ``R'', which 
stands for required, and ``CR'' which stands for conditionally 
required. Generally, ``R'' indicates that the data are more likely 
required than for those data requirements with ``CR.'' However, in each 
case, the regulatory text preceding the data table and the test notes 
following the data table must be used to determine whether the data 
requirement must be satisfied.
    (d) Each table identifies the test substance that is required to be 
tested to satisfy the data requirement. Test substances may include: 
technical grade active ingredient (TGAI), manufacturing-use product 
(MP), end-use product (EP), typical end-use

[[Page 61003]]

product (TEP), residue of concern, and pure active ingredient (PAI) or 
all of the above (All). Commas between the test substances (i.e., TGAI, 
EP) indicate that data may be required on the TGAI or EP or both 
depending on the conditions set forth in the test note.
    (e) The data requirements are organized into a tier-testing system 
with specified additional studies at higher tiers being required if 
warranted by adverse effects observed in lower tier studies. The lower 
tier studies are a subset of those required for conventional 
pesticides, and the studies overall are generally selected from those 
required for conventional pesticides.
    (f) Two sets of guideline numbers are provided for some of the 
environmental fate data requirements. For ease of understanding, the 
current guidelines will be used as an interim measure until the new 
guidelines (in parentheses) are finalized.


Sec.  158.2030  Biochemical pesticides product chemistry data 
requirements table.

    (a) General. (1) Sections 158.100 through 158.130 describe how to 
use this table to determine the product chemistry data requirements for 
a particular pesticide product. Notes that apply to an individual test 
and include specific conditions, qualifications, or exceptions to the 
designated test are listed in paragraph (e) of the section.
    (2) Definitions in Sec.  158.300 apply to data requirements in this 
section.
    (b) Use patterns. Product chemistry data are required for all 
pesticide products and are not use specific.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; Residue of 
concern=the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; All=All of the above.
    (d) Table. The following table shows the data requirements for 
biochemical pesticides product chemistry. The test notes are shown in 
paragraph (e) of this section.

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

[[Page 61004]]


830.7220                             Boiling point/boiling   CR                      TGAI                   TGAI                   8, 14
                                      range
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7300                             Density/relative        R                       TGAI and MP            TGAI and EP            8, 18
                                      density/bulk density
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7520                             Particle size, fiber    CR                      TGAI                   TGAI                   8, 15
                                      length, and diameter
                                      distribution
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7550                             Partition coefficient   CR                      TGAI                   TGAI                   16
830.7560...........................   (n-Octanol /Water)
830.7570...........................
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7840                             Water solubility        R                       TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7950                             Vapor pressure          R                       TGAI                   TGAI                   8, 19
--------------------------------------------------------------------------------------------------------------------------------------------------------

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


Sec.  158.2040  Biochemical pesticides residue data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the biochemical pesticides residue data 
requirements for a particular pesticide product and the substance that 
needs to be tested. These data requirements apply to all biochemical 
pesticides, i.e. naturally occurring insect repellents and attractants, 
semiochemicals (e.g., insect pheromones), natural and plant growth 
regulators. Notes that apply to an individual test and include specific 
conditions, qualifications, or exceptions to the designated test are 
listed in paragraph (e) of this section.
    (b) Use patterns. (1) Data are required or conditionally required 
for all pesticides used in or on food and for residential outdoor uses 
where food crops are grown. Food use patterns include products 
classified under the general use patterns of terrestrial food crop use, 
terrestrial feed crop use, aquatic food crop use, greenhouse food crop 
use, and indoor food use. Data are also conditionally required for 
aquatic nonfood use if there is direct application to water that could 
subsequently result in exposure to food.
    (2) Data are conditionally required for nonfood uses if pesticide 
residues may occur in food or feed as a result of the use. Data 
requirements for these nonfood uses would be determined on a case-by-
case basis. For example, most products used in or near kitchens require 
residue data for risk assessment purposes even though tolerances may 
not be necessary in all cases.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing end-use product; EP=End-use product; TEP=Typical end-
use product; TGAI=Technical grade of the active ingredient; Residue of 
concern=the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; All=All of the above. Specific 
conditions, qualifications, or exceptions to the designated test 
procedures appear in paragraph (e) of this section, and apply to the 
individual tests in the following table:
    (d) Data requirements table. The following table shows the data 
requirements for biochemical pesticides residue. The test notes are 
shown in paragraph (e) of this section.

[[Page 61005]]



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

    (e) Test notes. The following test notes are applicable to the data 
requirements for biochemical pesticides product chemistry and are in 
the last column of the table contained in paragraph (d) of this 
section.
    1. Residue chemistry data requirements apply to biochemical 
pesticide products when Tier II or Tier III toxicology data are 
required, as specified for biochemical agents in the biochemical 
human health assessment data requirements, Sec. 158.2050.
    2. The same chemical identity data are required for biochemical 
product chemistry data requirements, Sec. 158.2030, with an emphasis 
on impurities.
    3. Required information includes crops to be treated, rate of 
application, number and timing of applications, preharvest 
intervals, and relevant restrictions.
    4. Required for residential outdoor uses on food crops if the 
corresponding agricultural use is not approved or the residential 
use is expected to produce higher residues based on the label 
directions .
    5. Required unless it is an arthropod pheromone applied at a 
rate less than or equal to 150 grams active ingredient per acre.
    6. Required for indoor uses where the pesticide is applied 
directly to food, in order to determine metabolites and/or 
degradates. Not required when only indirect contact with food would 
occur (e.g., crack and crevice treatments).
    7. Required when a pesticide is to be applied directly to 
livestock, to livestock premises, to livestock drinking water, or to 
crops used for livestock feed.
    8. If results from the plant metabolism study show differing 
metabolites in plants from those found in animals, an additional 
livestock metabolism study involving dosing with the plant 
metabolite(s) may also be required.
    9. A residue analytical method suitable for enforcement of 
tolerances is required whenever a numeric tolerance (including 
temporary and time-limited tolerances) is proposed.
    10. Required if indoor use could result in pesticide residues in 
or on food or feed.
    11. Data are required to determine whether FDA/USDA multiresidue 
methodology would detect and identify the pesticides and any 
metabolites.

[[Page 61006]]

    12. Data are required whenever a pesticide may be applied 
directly to water, unless it can be demonstrated that the treated 
water would not be available for human or livestock consumption.
    13. Data on fish are required for all pesticides applied 
directly to water inhabited, or which will be inhabited by fish that 
may be caught or harvested for human consumption .
    14. Data are required when a pesticide is to be applied directly 
to water that could be used for irrigation or to irrigation 
facilities such as irrigation ditches.
    15. Data are required whenever a pesticide may be used in food/
feed handling establishments.
    16. Data on the nature and level of residue in processed food/
feed are required when detectible residues could potentially 
concentrate on processing thus requiring the establishment of a 
separate tolerance higher than that of the raw agricultural 
commodity.
    17. Required when residues at the tolerance level may result in 
risk of concern. These data may include washing, cooking, 
processing, or degradation studies as well as market basket surveys 
for a more precise residue determination.
    18. The proposed tolerance must reflect the maximum residue 
likely to occur in crops, in meat, milk, poultry, or eggs.
    19. Required when a residue analytical method is required.


Sec.  158.2050  Biochemical pesticides human health assessment data 
requirements table.

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

                                         Table--Biochemical Pesticides Human Health Assessment Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Use Patterns                           Test Substance
        Guideline Number           Data Requirement  --------------------------------------------------------------------------------     Test Notes
                                                             Food               Nonfood               MP                  EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Acute Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1100                          Acute oral          R                   R                   TGAI and MP         TGAI and EP         1
                                   toxicity - rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1200                          Acute dermal        R                   R                   TGAI and MP         TGAI and EP         1, 2
                                   toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1300                          Acute inhalation    R                   R                   TGAI and MP         TGAI and EP         3
                                   toxicity - rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2400                          Primary eye         R                   R                   TGAI and MP         TGAI and EP         2
                                   irritation -
                                   rabbit
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2500                          Primary dermal      R                   R                   TGAI and MP         TGAI and EP         1, 2
                                   irritation
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2600                          Dermal              R                   R                   TGAI and MP         TGAI and EP         2, 4
                                   sensitization
--------------------------------------------------------------------------------------------------------------------------------------------------------
none                              Hypersensitivity    R                   R                   All                 All                 5
                                   incidents
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Subchronic Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3100                          90-day oral (one    R                   CR                  TGAI                TGAI                6
                                   species)
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3250                          90-day dermal -     CR                  CR                  TGAI                TGAI                7
                                   rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3465                          90-day inhalation - CR                  CR                  TGAI                TGAI                8
                                    rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Developmental Toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3700                          Prenatal            R                   CR                  TGAI                TGAI                9
                                   developmental -
                                   rat preferably
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Mutagenicity Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 61007]]


870.5100                          Bacterial reverse   R                   CR                  TGAI                TGAI                10
                                   mutation test
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5300                          In vitro mammalian  R                   CR                  TGAI                TGAI                10, 11
870.5375........................   cell assay
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier II
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Mutagenicity Testing (In vivo cytogenetics)
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5385                          In vivo Mammalian   CR                  CR                  TGAI                TGAI                13
870.5895........................   Cytogenetics
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Developmental Toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3700                          Prenatal            CR                  CR                  TGAI                TGAI                9
                                   developmental
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Special Tests
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.3550                          Immunotoxicity      CR                  CR                  TGAI                TGAI                12, 13
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Applicator/User Exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1100                          Dermal outdoor      CR                  CR                  TGAI                TGAI                15
                                   exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1200                          Dermal indoor       CR                  CR                  TGAI                TGAI                15
                                   exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1300                          Inhalation outdoor  CR                  CR                  TGAI                TGAI                15
                                   exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1400                          Inhalation indoor   CR                  CR                  TGAI                TGAI                15
                                   exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1500                          Biological          CR                  CR                  TGAI                TGAI                15
                                   monitoring
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier III
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Chronic Testing/Special Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.3800                          Immune response     CR                  CR                  TGAI                TGAI                14
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3800                          Reproduction and    CR                  CR                  TGAI                TGAI                16
                                   fertility effects
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.4100                          Chronic oral -      CR                  CR                  TGAI                TGAI                17
                                   rodent and
                                   nonrodent
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.4200                          Carcinogenicity -   CR                  CR                  TGAI                TGAI                18
                                   two species - rat
                                   and mouse
                                   preferred
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5380                          Mammalian           CR                  CR                  TGAI                TGAI                19
                                   spermatogonial
                                   chromosome
                                   aberration test
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Special Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.7200                          Companion animal    CR                  CR                  NR                  TGAI or EP          20
                                   safety
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for biochemical pesticides human health assessment as 
referenced in the last column of the table in paragraph (d) of this 
section.

    1. Required unless the test material is a gas or highly volatile 
(vapor pressure >10-4torr (mm/Hg)).
    2. Required unless the test material is corrosive to skin or has 
pH <2 or >11.5.
    3. Required when the pesticide, under conditions of use, would 
result in respirable material (e.g., gas, volatile substance or 
aerosol/particulate), unless it is a straight chain lepidopteran 
pheromone.
    4. Required if repeated contact with human skin is likely to 
occur under conditions of use.
    5. Hypersensitivity incidents must be reported as adverse 
effects data.
    6. Required for non-food uses that are likely to result in 
repeated oral exposure to humans.
    7. Required to support uses involving purposeful application to 
the human skin or which would result in comparable prolonged human 
exposure to the product (e.g., insect repellents) and if any of the 
following criteria are met:
    i. Data from a 90-day oral study are not required.
    ii. The active ingredient is known or expected to be metabolized 
differently by the dermal route of exposure than by the oral route 
and the metabolite is of toxicological concern.
    iii. The use pattern is such that the dermal route would be the 
primary route of exposure.
    8. Required if there is a likelihood of significant levels of 
repeated inhalation exposure to the pesticide as a gas, vapor, or 
aerosol.
    9. Required if the use of the product under widespread and 
commonly recognized practice may reasonably be expected to result in 
significant exposure to female humans (e.g., occupational exposure 
or repeated application of insect repellents directly to the skin). 
Tier II data is required on a different test species from Tier I 
data when

[[Page 61008]]

developmental effects are observed in the first study and 
information on species-to-species extrapolation is needed.
    10. Required to support nonfood uses if either:
    i. The use is likely to result in significant human exposure; or
    ii. The active ingredient (or its metabolites) is structurally 
related to a known mutagen or belongs to any chemical class of 
compounds containing a known mutagen. Additional mutagenicity tests 
that may have been performed plus a complete reference list must 
also be submitted. Subsequent testing may be required based on the 
available evidence.
    11. Choice of assay using either:
    i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene 
locus, maximizing assay conditions for small colony expression or 
detection;
    ii. Chinese hamster ovary (CHO) or Chinese hamster lung 
fibroblast (V79) cells, hypoxanthine-guanine phosphoribosyl 
transferase (hgprt) gene locus, accompanied by an appropriate in 
vitro test for clastogenicity; or
    iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl 
transferase (xprt) gene locus.
    12. Required if there are effects on hematology, clinical 
chemistry, lymphoid organ weights, and histopathology are observed 
in the 90-day studies.
    13. The micronucleus rodent bone marrow assay is preferred; 
however, rodent bone marrow assays using metaphase analysis 
(aberrations) are acceptable.
    14. Required if adverse effects are observed in the Tier II 
immunotoxicity study. The protocol for evaluating adverse effects to 
the immune response should be developed after evaluating the effects 
noted in the immunotoxicity study.
    15. These data are required when the data used for the human 
health assessment indicates that the biochemical may pose a 
potential hazard to the applicator/user.
    16. Required if there is evidence of:
     i. Endocrinological effects from the subchronic toxicity 
studies.
    ii. Developmental effects in the prenatal developmental toxicity 
study(s), or
    iii. Genotoxicity to mammals based on results from the 
mutagenicity tests.
The use of a combined study that utilizes the two-generation 
reproduction study in rodents (guideline 870.3800) as a basic 
protocol for the addition of other endpoints or functional 
assessments in the immature animal is encouraged.
    17. Required if the potential for adverse chronic effects is 
indicated based on any of the following:
    i. The subchronic effect level established in the following Tier 
I studies: 90-day oral toxicity study, 90-day dermal toxicity study, 
or 90-day inhalation toxicity study.
    ii. The pesticide use pattern (e.g., rate, frequency, and site 
of application).
    iii. The frequency and level of repeated human exposure that is 
expected.
    18. Required if the product meets either of the following 
criteria:
    i. The active ingredient (or any of its metabolites, degradation 
products, or impurities) produce(s) in Tier I subchronic studies a 
morphologic effect (e.g., hyperplasia or metaplasia) in any organ 
that potentially could lead to neoplastic change.
    ii. Adverse cellular effects suggesting carcinogenic potential 
are observed in Tier II immunotoxicity and Tier III immune response 
study or in Tier II mammalian mutagenicity assays.
    In addition, a 90-day range finding study in both rats and mice 
is required to determine the dose levels if carcinogenicity studies 
are required. If the mouse carcinogenicity study is not required, 
the 90-day mouse subchronic study is likewise not required.
    19. Required if results from lower tiered mutation or 
reproductive studies indicate there is potential for chromosomal 
aberration to occur.
    20. May be required if the product's use will result in exposure 
to domestic animals through, but not limited to, direct application 
or consumption of treated feed.


Sec.  158.2060  Biochemical pesticides nontarget organisms and 
environmental fate data requirements table.

    (a) General. (1) Sections 158.100 through 158.130 describe how to 
use this table to determine the terrestrial and aquatic nontarget 
organisms and fate data requirements for a particular biochemical 
pesticide product. Notes that apply to an individual test including 
specific conditions, qualifications, or exceptions to the designated 
test are listed in paragraph (e) of this section. In general, for all 
outdoor end-use products including turf, the following studies are 
required: one avian acute oral, one avian dietary, one acute freshwater 
fish, one acute freshwater invertebrate study, plant toxicity testing, 
and a honeybee acute contact study.
    (2) The data in this section are not required for arthropod 
pheromones when applied at up to a maximum use rate of 150 grams active 
ingredient/acre/year except when the product is expected to be 
available to avian species (i.e., granular formulation).
    (b) Use patterns. The terrestrial use pattern includes products 
classified under the general use patterns of terrestrial food crop, 
terrestrial feed crop, and terrestrial nonfood/nonfeed crop. The 
greenhouse use pattern includes products classified under the general 
use patterns of greenhouse food crop and greenhouse nonfood crop. The 
indoor use pattern includes products classified under the general use 
patterns of indoor food and nonfood use. The remaining terrestrial uses 
include: forestry and residential outdoor use. Data are also required 
for the general use patterns of aquatic food and nonfood crop use.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; Residue of 
concern=the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; All=All of the above. Specific 
conditions, qualifications, or exceptions to the designated test 
procedures appear in paragraph (e) of this section, and apply to the 
individual tests in the following table:
    (d) Table. The following table shows the data requirements for 
biochemical pesticides nontarget organisms and environmental fate. The 
test notes are shown in paragraph (e) of this section.

                                                   Table--Biochemical Pesticides Nontarget Organisms and Environmental Fate Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                     Use Patterns
                                                      ---------------------------------------------------------------------------------------------------------
        Guideline Number            Data Requirement       Terrestrial            Aquatic             Greenhouse                                  Indoor          Test Substance     Test Notes
                                                      ---------------------------------------------------------------      Forestry,      ---------------------
                                                        Food/Feed/Nonfood       Food/Nonfood         Food/Nonfood     Residential Outdoor      Food/Nonfood
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Avian Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2100                          Avian acute oral     R..................  R..................  CR.................  R..................  CR.................  TGAI, EP..........   1, 2, 3, 4
                                   toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 61009]]


850.2200                          Avian dietary        R..................  R..................  CR.................  R..................  CR.................  TGAI, EP..........   1, 2, 3, 4
                                   toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Aquatic Organism Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1075                          Fish acute           R..................  R..................  CR.................  R..................  CR.................  TGAI, EP..........   2, 3, 4, 5
                                   toxicity,
                                   freshwater
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1010                          Aquatic              R..................  R..................  CR.................  R..................  CR.................  TGAI, EP..........      2, 3, 5
                                   invertebrate acute
                                   toxicity,
                                   freshwater
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Nontarget Plant Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4100                          Terrestrial Plant    R..................  R..................  NR.................  R..................  NR.................  TGAI, EP..........            5
                                   Toxicity, Seedling
                                   emergence
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4150                          Terrestrial Plant    R..................  R..................  NR.................  R..................  NR.................  TGAI, EP..........            5
                                   Toxicity,
                                   Vegetative vigor
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Insect Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
880.4350                          Nontarget Insect     R..................  R..................  R..................  R..................  NR.................  TGAI..............           14
                                   Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier II
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Environmental Fate Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
163-1 (835.1230)                  Sediment and soil    CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   adsorption/
                                   desorption for
                                   parent and
                                   degradates
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
163-1 (835.1240)                  Soil column          CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   leaching
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
163-2 (835.1410)                  Laboratory           CR.................  NR.................  CR.................  CR.................  NR.................  TEP...............            7
                                   volatilization
                                   from soil
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
161-1 (835.2120)                  Hydrolysis           CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
161-1 (835.4100)                  Aerobic soil         CR.................  NR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   metabolism
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
161-2 (835.2240)                  Photodegradation in  CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   water
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
161-3 (835.2410)                  Photodegradation on  CR.................  NR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   soil
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
162-2 (835.4200)                  Anaerobic soil       CR.................  NR.................  NR.................  NR.................  NR.................  TGAI..............            6
                                   metabolism
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
162-4 (835.4300)                  Aerobic aquatic      CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   metabolism
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
162-3 (835.4400)                  Anaerobic aquatic    CR.................  CR.................  NR.................  NR.................  NR.................  TGAI..............            6
                                   metabolism
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
880.4425                          Dispenser - water    CR.................  NR.................  CR.................  CR.................  NR.................  EP................            8
                                   leaching
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Nontarget Plant
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4225                          Seedling emergence   R..................  R..................  NR.................  R..................  NR.................  TGAI..............            9
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4250                          Vegetative vigor     R..................  R..................  NR.................  R..................  NR.................  TGAI..............            9
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier III
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Aquatic Fauna Chronic, Life Cycle, and Field Studies
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1300                          Freshwater fish/     CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           10
850.1400........................   invertebrate
850.1500........................   testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 61010]]


850.1025                          Marine/Estuarine     CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           10
850.1035........................   fish/invertebrate
850.1045........................   animal testing
850.1055........................
850.1350........................
850.1400........................
850.1500........................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1950                          Aquatic field fish/  CR.................  CR.................  NR.................  CR.................  NR.................  EP................           10
                                   invertebrate
                                   testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Terrestrial Wildlife
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2300                          Avian Reproduction   CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           11
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2400                          Wild mammal acute    CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           11
                                   toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2500                          Terrestrial field    CR.................  CR.................  NR.................  CR.................  NR.................  EP................           11
                                   testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Beneficial Insects
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.3040                          Field testing for    CR.................  CR.................  NR.................  CR.................  NR.................  TEP...............           12
                                   Pollinators
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Nontarget Plants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4225                          Nontarget plant      CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           13
850.4250........................
850.4300........................
850.4450........................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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


Sec.  158.2070  Biochemical pesticides product performance data 
requirements.

    Product performance data must be developed for all biochemical

[[Page 61011]]

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


Sec.  158.2080   Experimental use permit data requirements--biochemical 
pesticides.

    (a) Sections 158.2081 through 158.2084 describe the experimental 
use permit (EUP) data requirements for biochemical pesticides. 
Variations in the test conditions are identified within the test notes. 
Definitions that apply to all biochemical data requirements can be 
found in Sec.  158.2000.
    (b) For general information on the data requirement tables, see 
Sec.  158.2010(b)-(f).


Sec.  158.2081  Experimental use permit biochemical pesticides product 
chemistry data requirements table.

    (a) General. (1) Sections 158.100 through 158.130 describe how to 
use this table to determine the product chemistry data requirements for 
a particular biochemical pesticide product. Notes that apply to an 
individual test and include specific conditions, qualifications, or 
exceptions to the designated test are listed in paragraph (e) of the 
section.
    (2) Depending on the results of the required product chemistry 
studies, appropriate use restrictions, labeling requirements, or 
special packaging requirements may be imposed.
    (b) Use patterns. Product chemistry data are required for all 
pesticide products and are not use specific.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; Residue of 
concern=the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; All=All of the above. Specific 
conditions, qualifications, or exceptions to the designated test 
procedures appear in paragraph (e) of this section, and apply to the 
individual tests in the following table:
    (d) Table. The following table shows the data requirements for 
experimental use permit biochemical pesticides product chemistry. The 
test notes are shown in paragraph (e) of this section .

                                          Table--EUP Biochemical Pesticides Product Chemistry Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Test Substance
          Guideline Number              Data Requirement        All Use Patterns    ----------------------------------------------       Test Notes
                                                                                               MP                     EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product Identity and Composition
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.1100                             Product identity and    R                       TGAI, MP               TGAI, EP               1, 2
                                      composition
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.1200                             Description of          R                       TGAI, MP               TGAI, EP               2, 3
                                      starting materials,
                                      production and
                                      formulation process
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.1400                             Discussion of           R                       TGAI and MP            TGAI and EP            4
                                      formation of
                                      impurities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Analysis and Certified Limits
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.1700                             Preliminary analysis    CR                      TGAI and MP            TGAI and EP            5, 8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.1750                             Certified limits        R                       MP                     EP                     6
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.1800                             Enforcement analytical  R                       MP                     EP                     7
                                      method
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physical and Chemical Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6302                             Color                   R                       TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6303                             Physical state          R                       TGAI and MP            TGAI and EP            8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6304                             Odor                    R                       TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6313                             Stability to normal     R                       TGAI                   TGAI                   8, 17
                                      and elevated
                                      temperatures, metals
                                      and metal ions
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6315                             Flammability            CR                      MP                     EP                     9
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6317                             Storage stability       R                       MP                     EP                     --
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6319                             Miscibility             CR                      MP                     EP                     10
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6320                             Corrosion               R                       MP                     EP                     --
                                      characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 61012]]


830.7000                             pH                      CR                      TGAI and MP            TGAI and EP            8, 11
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7050                             UV/Visible light        R                       TGAI                   TGAI                   --
                                      absorption
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7100                             Viscosity               CR                      MP                     EP                     12
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7200                             Melting point/melting   CR                      TGAI                   TGAI                   8, 13
                                      range
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7220                             Boiling point/boiling   CR                      TGAI                   TGAI                   8, 14
                                      range
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7300                             Density/relative        R                       TGAI and MP            TGAI and EP            8, 18
                                      density/bulk density
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7520                             Particle size, fiber    CR                      TGAI                   TGAI                   8, 15
                                      length, and diameter
                                      distribution
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7550                             Partition coefficient   CR                      TGAI                   TGAI                   16
830.7560...........................   (n-Octanol /Water)
830.7570...........................
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7840                             Water solubility        R                       TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7950                             Vapor pressure          R                       TGAI                   TGAI                   8, 19
--------------------------------------------------------------------------------------------------------------------------------------------------------

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


Sec.  158.2082  Experimental use permit biochemical pesticides residue 
data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the biochemical pesticides residue data 
requirements for a particular pesticide product and the substance that 
needs to be tested. These data requirements apply to all biochemical 
pesticides, i.e. naturally occurring insect repellents and attractants, 
semiochemicals (e.g., insect pheromones), natural and plant growth 
regulators. Notes that apply to an individual test and include specific 
conditions, qualifications, or exceptions to the designated test are 
listed in paragraph (e) of this section.
    (b) Use patterns. (1) Data are required or conditionally required 
for all pesticides used in or on food and for residential outdoor uses 
where food crops are grown. Food use patterns include products 
classified under the general use patterns of terrestrial food crop use, 
terrestrial feed crop use, aquatic food crop use, greenhouse food crop 
use, and indoor food use. Data are also conditionally required for 
aquatic nonfood use if there is direct application to water that could 
subsequently result in exposure to food.
    (2) Data are conditionally required for nonfood uses if pesticide 
residues may occur in food or feed as a result of the use. Data 
requirements for these nonfood uses would be determined on a case-by-
case basis. For example, most products used in or near kitchens require 
residue data for risk assessment purposes even though tolerances may 
not be necessary in all cases.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing end-use product; EP=End-use product; TEP=Typical end-
use product; TGAI=Technical grade of the active ingredient; Residue of 
concern=the active ingredient and its metabolites, degradates,and 
impurities of toxicological concern. All=All of the above. Specific 
conditions, qualifications, or exceptions to the designated test 
procedures appear in paragraph (e) of this section, and apply to the 
individual tests in the following table:
    (d) Data table. The following table shows the data requirements for 
biochemical pesticides residue. The test notes are shown in paragraph 
(e) of this section.

[[Page 61013]]



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

    (e) Test notes. The following test notes are applicable to the data 
requirements for biochemical pesticides product chemistry and are 
referenced referenced in the last column of the table contained in 
paragraph (d) of this section.
    1. Residue chemistry data requirements apply to biochemical 
pesticide products when Tier II or Tier III toxicology data are 
required, as specified for biochemical agents in the biochemical 
human health assessment data requirements, Sec. 158.2050.
    2. The same chemical identity data are required for biochemical 
product chemistry data requirements,Sec. 158.2030 with an emphasis 
on impurities.
    3. Required information includes crops to be treated, rate of 
application, number and timing of applications, preharvest 
intervals, and relevant restrictions.
    4. Required for residential outdoor uses on food crops if the 
corresponding agricultural use is not approved or the residential 
use is expected to produce higher residues based on the label 
directions.
    5. Required unless it is an arthropod pheromone applied at a 
rate less than or equal to 150 grams active ingredient per acre.
    6. Required for indoor uses where the pesticide is applied 
directly to food, in order to determine metabolites and/or 
degradates. Not required when only indirect contact with food would 
occur (e.g., crack and crevice treatments).
    7. Required when a pesticide is to be applied directly to 
livestock, to livestock premises, to livestock drinking water, or to 
crops used for livestock feed. If results from the plant metabolism 
study show differing metabolites in plants form those found in 
animals, an additional livestock metabolism study involving dosing 
with the plant metabolite(s) may also be required.
    8. Livestock feeding studies are required whenever a pesticide 
residue is present in livestock feed or when direct application to 
livestock uses occurs.
    9. Required if indoor use could result in pesticide residues in 
or on food or feed.
    10. Data are required to determine whether FDA/USDA multiresidue 
methodology would detect and identify the pesticides and any 
metabolites.
    11. Data are required whenever a pesticide may be applied 
directly to water, unless it can be demonstrated that the treated 
water would not be available for human or livestock consumption.
    12. Data on fish are required for all pesticides applied 
directly to water inhabited, or which will be inhabited, by fish 
that may be caught or harvested for human consumption.
    13. Data are required when a pesticide is to be applied directly 
to water that could be used for irrigation or to irrigation 
facilities such as irrigation ditches.
    14. Data are required whenever a pesticide may be used in food/
feed handling establishments.
    15. Data on the nature and level of residue in processed food/
feed are required when detectible residues could potentially 
concentrate on processing thus requiring the

[[Page 61014]]

establishment of a separate tolerance higher than that of the raw 
agricultural commodity.
    16 Anticipated residue data are required when the assumption of 
tolerance level residues would result in predicted exposure at an 
unsafe level of exposure. Data, using single serving samples of a 
raw agricultural commodity, on the level or residue in food as 
consumed would be used to obtain a more precise estimate of 
potential dietary exposure. These data may also include washing, 
cooking, processing or degradation studies as well as market basket 
surveys for a more precise residue determination.
    17. The proposed tolerance must reflect the maximum residue 
likely to occur in crops, in meat, milk, poultry, or eggs.
    18. Required when a residue analytical method is required.


Sec.  158.2083  Experimental use permit biochemical pesticides human 
health assessment data requirements table.

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

                                       Table--EUP Biochemical Pesticides Human Health Assessment Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Use Patterns                           Test Substance
        Guideline Number           Data Requirement  --------------------------------------------------------------------------------     Test Notes
                                                             Food               Nonfood               MP                  EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Acute Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1100                          Acute oral          R                   R                   TGAI and MP         TGAI and EP         1
                                   toxicity - rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1200                          Acute dermal        R                   R                   TGAI and MP         TGAI and EP         1, 2
                                   toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1300                          Acute inhalation    R                   R                   TGAI and MP         TGAI and EP         3
                                   toxicity - rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2400                          Primary eye         R                   R                   TGAI and MP         TGAI and EP         2
                                   irritation -
                                   rabbit
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2500                          Primary dermal      R                   R                   TGAI and MP         TGAI and EP         1, 2
                                   irritation
--------------------------------------------------------------------------------------------------------------------------------------------------------
none                              Hypersensitivity    R                   R                   All                 All                 4
                                   incidents
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Subchronic Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3100                          90-day oral (one    R                   NR                  TGAI                TGAI                --
                                   species)
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Developmental Toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3700                          Prenatal            R                   CR                  TGAI                TGAI                5
                                   developmental -
                                   rat preferably
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Mutagenicity Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5100                          Bacterial reverse   R                   CR                  TGAI                TGAI                6
                                   mutation test
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5300                          In vivo mammalian   R                   CR                  TGAI                TGAI                6, 7
                                   cell assay
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier II
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Developmental Toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3700                          Prenatal            CR                  CR                  TGAI                TGAI                5
                                   developmental
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 61015]]

    (e) Test notes. The following test notes are applicable to the data 
requirements for experimental use permit biochemical pesticides human 
health assessment as referenced in the last column of the table in 
paragraph (d) of this section.
    1. Required unless the test material is a gas or highly volatile 
(vapor pressure > 10-4torr (mm/Hg)).
    2. Required unless the test material is corrosive to skin or has 
pH <2 or >11.5.
    3. Required when the pesticide, under conditions of use, would 
result in respirable material (e.g., gas, volatile substance or 
aerosol/particulate), unless it is a straight chain lepidopteran 
pheromone.
    4. Hypersensitivity incidents must be reported as adverse 
effects data.
    5. Required if the use of the product under widespread and 
commonly recognized practice may reasonably be expected to result in 
significant exposure to female humans (e.g., occupational exposure 
or repeated application of insect repellents directly to the skin). 
Tier II data is required on a different test species from Tier I 
data when developmental effects are observed in the first study and 
information on species-to-species extrapolation is needed.
    6. Required to support nonfood uses if either:
    i. The use is likely to result in significant human exposure; or
    ii. The active ingredient (or its metabolites) is structurally 
related to a known mutagen or belongs to any chemical class of 
compounds containing a known mutagen.

     Additional mutagenicity tests that may have been performed plus 
a complete reference list must also be submitted. Subsequent testing 
may be required based on the available evidence.
    7. Choice of assay using either:
    i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene 
locus, maximizing assay conditions for small colony expression or 
detection;
    ii. Chinese hamster ovary (CHO) or Chinese hamster lung 
fibroblast (V79) cells, hypoxanthine-guanine phosphoribosyl 
transferase (hgprt) gene locus, accompanied by an appropriate in 
vivo test for clastogenicity; or
    iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl 
transferase (xprt) gene locus.


Sec.  158.2084  Experimental use permit biochemical pesticides 
nontarget organisms and environmental fate data requirements table.

    (a) General. (1) Sections 158.100 through 158.130 describe how to 
use this table to determine the terrestrial and aquatic nontarget 
organisms and fate data requirements for a particular biochemical 
pesticide product. Notes that apply to an individual test including 
specific conditions, qualifications, or exceptions to the designated 
test are listed in paragraph (e) of this section. In general, for all 
outdoor end-use products including turf, the following studies are 
required: one avian acute oral, one avian dietary, one acute freshwater 
fish, and one acute freshwater invertebrate study.
    (2) The data in this section are not required for arthropod 
pheromones when applied at up to a maximum use rate of 150 grams active 
ingredient/acre/year except when the product is expected to be 
available to avian species (i.e., granular formulation).
    (b) Use patterns. The terrestrial use pattern includes products 
classified under the general use patterns of terrestrial food crop, 
terrestrial feed crop, and terrestrial nonfood/nonfeed crop. The 
greenhouse use pattern includes products classified under the general 
use patterns of greenhouse food crop and greenhouse nonfood crop. The 
indoor use pattern includes products classified under the general use 
patterns of indoor food and nonfood use. The remaining terrestrial uses 
include forestry and residential outdoor use. Data are also required 
for the general use patterns of aquatic food and nonfood crop use.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; Residue of 
concern=the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; All=All of the above. Specific 
conditions, qualifications, or exceptions to the designated test 
procedures appear in paragraph (e) of this section, and apply to the 
individual tests in the following table:
    (d) Table. The following table shows the data requirements for 
experimental use permit biochemical pesticides nontarget organisms and 
environmental fate. The test notes are shown in paragraph (e) of this 
section.

                                                 Table--EUP Biochemical Pesticides Nontarget Organisms and Environmental Fate Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                     Use Patterns
                                                      ---------------------------------------------------------------------------------------------------------
        Guideline Number            Data Requirement       Terrestrial            Aquatic             Greenhouse                                  Indoor          Test Substance     Test Notes
                                                      ---------------------------------------------------------------      Forestry,      ---------------------
                                                        Food/Feed/Nonfood       Food/Nonfood         Food/Nonfood     Residential Outdoor      Food/Nonfood
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Avian Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2100                          Avian acute oral     R..................  R..................  NR.................  R..................  NR.................  TGAI, EP..........      1, 2, 3
                                   toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2200                          Avian dietary        R..................  R..................  NR.................  R..................  NR.................  TGAI, EP..........      1, 2, 3
                                   toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Aquatic Organism Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1075                          Fish acute           R..................  R..................  NR.................  R..................  NR.................  TGAI, EP..........      2, 3, 4
                                   toxicity,
                                   freshwater
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1010                          Aquatic              R..................  R..................  NR.................  R..................  NR.................  TGAI, EP..........         2, 4
                                   invertebrate acute
                                   toxicity,
                                   freshwater
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 61016]]

    (e) Test notes. The following test notes are applicable to the data 
requirements for experimental use permit biochemical pesticides 
nontarget organisms and environmental fate as referenced in the last 
column of the table contained in paragraph (d) of this section.
    1. Required for the EP when any end-use formulation may contain 
other ingredients that may be toxic to nontarget organisms or to 
support arthropod pheromones that would be available to avian 
wildlife, (e.g., a granular product).
    2. Not required for any use groups if the pesticide is highly 
volatile (estimated volatility >5 X 10-5atm 
m3/mol).
    3. Preferred test species are: upland game, waterfowl, or 
passerine for avian acute oral toxicity studies; upland game or 
waterfowl for avian dietary studies; and coldwater fish for acute 
freshwater fish studies.
    4. Required for the EP when the end-use formulation may contain 
other ingredients that may be toxic to nontarget organisms.

Subpart V--Microbial Pesticides


Sec.  158.2100  Microbial pesticides definition and applicability.

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


Sec.  158.2110  Microbial pesticides data requirements.

    (a) For all microbial pesticides. (1) The following Sec.  158.2120 
through Sec.  158.2150 identify the data requirements that are required 
to support registration of microbial pesticides. The variations in the 
test conditions are identified within the test notes.
    (2) Each data table includes ``use patterns'' under which the 
individual data are required, with variations including all use 
patterns, food and nonfood uses for terrestrial and aquatic 
applications, greenhouse, indoor, forestry, and residential outdoor 
applications under certain circumstances.
    (3) The categories for each data requirement are ``R,'' which 
stands for required, and ``CR'' which stands for conditionally 
required. If a bracket appears around the ``R'' or ``CR,'' the data are 
required for both the registration and experimental use permit 
requests. Generally, ``R'' indicates that the data are more likely 
required than for those data requirements with ``CR.'' However, in each 
case, the regulatory text preceding the data table and the test notes 
following the data table must be used to determine whether the data 
requirement must be satisfied.
    (4) Each table identifies the test substance that is required to be 
tested to satisfy the data requirement. Test substances may include: 
technical grade active ingredient (TGAI), manufacturing-use product 
(MP), end-use product (EP), typical end-use product (TEP), residue of 
concern, and pure active ingredient (PAI) or all of the above (All). 
Commas between the test substances (i.e., TGAI, EP) indicate that data 
may be required on the TGAI or EP or both depending on the conditions 
set forth in the test note. Data requirements which list two test 
substances (i.e., TGAI and EP) indicate that both are required to be 
tested. Data requirements that list only MP as the test substance apply 
to products containing solely the technical grade of the active 
ingredient and manufacturing-use products to which other ingredients 
have been intentionally added. Data requirements listing the EP as the 
test substance apply to any EP with an ingredient in the end-use 
formulation other than the active ingredient that is expected to 
enhance the toxicity of the product.
    (b) Additional data requirements for genetically modified microbial 
pesticides. Additional requirements for genetically modified microbial 
pesticides may include but are not limited to: genetic engineering 
techniques used; the identity of the inserted or deleted gene segment 
(base sequence data or enzyme restriction map of the gene); information 
on the control region of the gene in question; a description of the 
``new'' traits or characteristics that are intended to be expressed; 
tests to evaluate genetic stability and exchange; and selected Tier II 
environmental expression and toxicology tests.


Sec.  158.2120  Microbial pesticides product analysis data requirements 
table.

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

[[Page 61017]]



                                             Table--Microbial Pesticides Product Analysis Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                     Test Substance
          Guideline Number               Data Requirement        All Use Patterns   ----------------------------------------------       Test Notes
                                                                                               MP                     EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product Chemistry and Composition
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1100                            Product Identity       R                        MP                    EP                     --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1200                            Manufacturing process  R                       TGAI and MP            TGAI and EP            --
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      Deposition of a        R                       TGAI                   TGAI                   --
                                      sample in a
                                      nationally recognized
                                      culture collection
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1300                            Discussion of          R                       TGAI and MP            TGAI and EP            --
                                      formation of
                                      unintentional
                                      ingredients
--------------------------------------------------------------------------------------------------------------------------------------------------------
Analysis and Certified Limits
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1400                            Analysis of samples    R                       TGAI and MP            TGAI and EP            1
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1500                            Certification of       R                       MP                     EP                     --
                                      limits
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physical and Chemical Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6302                            Color                  R                       TGAI                   TGAI                   --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6303                            Physical state         R                       TGAI                   TGAI                   --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6304                            Odor                   R                       TGAI                   TGAI                   --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6313                            Stability to normal    R                       TGAI                   TGAI                   --
                                      and elevated
                                      temperatures, metals
                                      and metal ions
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6317                            Storage stability      R                       TGAI and MP            TGAI and EP            --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6319                            Miscibility            R                       MP                     EP                     2
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6320                            Corrosion              R                       MP                     EP                     3
                                      Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.7000                            pH                     R                       TGAI                   TGAI                   --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.7100                            Viscosity              R                       MP                     EP                     4
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.7300                            Density/relative       R                       TGAI                   TGAI                   --
                                      density/bulk density
                                      (specific gravity)
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test notes are applicable to the data 
requirements for microbial pesticides product analysis as referenced in 
the last column of the table contained in paragraph (c) of this 
section.
    1. Required to support registration of each manufacturing-use 
product and end-use product. This analysis must be conducted at the 
point in the production process after which there would be no 
potential for microbial contamination or microbial regrowth. For 
full registration, generally an analysis of samples is a compilation 
of batches, over a period of time, depending on the frequency of 
manufacturing.
    2. Only required for emulsifiable liquid forms of microbial 
pesticides.
    3. Required when microbial pesticides are packaged in metal, 
plastic, or paper containers.
    4. Only required for liquid forms of microbial pesticides.


Sec.  158.2130  Microbial pesticides residue data requirements table.

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

[[Page 61018]]



                              Table--Microbial Pesticides Residue Data Requirements
----------------------------------------------------------------------------------------------------------------
                                                                             Test Substance
        Guideline Number            Data Requirement    All Use Patterns  Data to Support MP       Test Notes
                                                                                 or EP
----------------------------------------------------------------------------------------------------------------
885.2100                           Chemical Identity   CR                  EP                  1
----------------------------------------------------------------------------------------------------------------
885.2200                           Nature of the       CR                  EP                  1
                                   Residue in plants
----------------------------------------------------------------------------------------------------------------
885.2250                           Nature of the       CR                  EP                  1
                                   Residue in
                                   animals
----------------------------------------------------------------------------------------------------------------
885.2300                           Analytical          CR                  TGAI                1
                                   methods - plants
----------------------------------------------------------------------------------------------------------------
885.2350                           Analytical          CR                  TGAI                1
                                   methods - animals
----------------------------------------------------------------------------------------------------------------
885.2400                           Storage Stability   CR                  EP                  1
----------------------------------------------------------------------------------------------------------------
885.2500                           Magnitude of        CR                  EP                  1
                                   residue in plants
----------------------------------------------------------------------------------------------------------------
885.2550                           Magnitude of        CR                  EP                  1
                                   residues in meat,
                                   milk, poultry,
                                   eggs
----------------------------------------------------------------------------------------------------------------
885.2600                           Magnitude of        CR                  EP                  1
                                   residues in
                                   potable water,
                                   fish, and
                                   irrigated crops
----------------------------------------------------------------------------------------------------------------

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


Sec.  158.2140  Microbial pesticides toxicology data requirements 
table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the toxicology data requirements for a 
particular pesticide product. Notes that apply to an individual test 
and include specific conditions, qualifications, or exceptions to the 
designated test are listed in paragraph (d) of this section.
    (b) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; All=All of the 
above. Specific conditions, qualifications, or exceptions to the 
designated test procedures appear in paragraph (d) of this section, and 
apply to the individual tests in the following table:
    (c) Table. The following table shows the data requirements for 
microbial pesticides toxicology. The test notes are shown in paragraph 
(d) of this section.

                            Table--Microbial Pesticides Toxicology Data Requirements
----------------------------------------------------------------------------------------------------------------
        Guideline Number           Data Requirement    All Use Patterns     Test Substance        Test Notes
----------------------------------------------------------------------------------------------------------------
Tier I
----------------------------------------------------------------------------------------------------------------
885.3050                           Acute oral         R                    TGAI                1
                                   toxicity/
                                   pathogenicity
----------------------------------------------------------------------------------------------------------------
885.3150                           Acute pulmonary    R                    TGAI               --
                                   toxicity/
                                   pathogenicity
----------------------------------------------------------------------------------------------------------------
885.3200                           Acute injection    R                    TGAI                2
                                   toxicity/
                                   pathogenicity/
                                   (intravenous)
                                   Acute injection
                                   toxicity/
                                   pathogenicity/
                                   (intraperitoneal).
----------------------------------------------------------------------------------------------------------------
885.3400                           Hypersensitivity   R                    All                 3
                                   incidents
----------------------------------------------------------------------------------------------------------------
885.3500                           Cell culture       R                    TGAI                4
----------------------------------------------------------------------------------------------------------------
870.1100                           Acute oral         R                    MP , EP             1, 5
                                   toxicity
----------------------------------------------------------------------------------------------------------------
870.1200                           Acute dermal       R                    MP , EP             5
                                   toxicity
----------------------------------------------------------------------------------------------------------------
870.1300                           Acute inhalation   R                    MP , EP             5, 6
                                   toxicity
----------------------------------------------------------------------------------------------------------------
870.2400                           Acute eye          R                    MP , EP             5
                                   irritation
----------------------------------------------------------------------------------------------------------------
870.2500                           Primary dermal     R                    MP , EP             5
                                   irritation
----------------------------------------------------------------------------------------------------------------
Tier II
----------------------------------------------------------------------------------------------------------------
885.3550                           Acute toxicology    CR                  TGAI                7
----------------------------------------------------------------------------------------------------------------
885.3600                           Subchronic          CR                  TGAI                8
                                   toxicity/
                                   pathogenicity
----------------------------------------------------------------------------------------------------------------

[[Page 61019]]


Tier III
----------------------------------------------------------------------------------------------------------------
885.3650                           Reproductive        CR                  TGAI                9, 13
                                   fertility effects
----------------------------------------------------------------------------------------------------------------
870.4200                           Carcinogenicity     CR                  TGAI                10, 13
----------------------------------------------------------------------------------------------------------------
870.7800                           Immunotoxicity      CR                  TGAI                11, 13
----------------------------------------------------------------------------------------------------------------
885.3000                           Infectivity/        CR                  TGAI                12, 13
                                   pathogenicity
                                   analysis
----------------------------------------------------------------------------------------------------------------

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


Sec.  158.2150  Microbial pesticides nontarget organisms and 
environmental fate data requirements table.

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

[[Page 61020]]



                                                                        Table--Microbial Pesticides Nontarget Organisms and Environmental Fate Data Requirements
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                      Use Patterns
                                                  ---------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Aquatic                                                                 Terrestrial
        Guideline Number         Data Requirement ---------------------------------------------------------------------------------------------------------------------------------------------------   Test Substance      Test Notes
                                                                                                                                 Residential        Greenhouse          Indoor
                                                        Food/Feed           Nonfood          Food/Feed/          Forestry    ------------------------------------------------------     Industrial
                                                                                              Nonfood                              Outdoor         Food/Nonfood     Food/Nonfood
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4050                         Avian oral        R                   R                  R                  R                 R                 CR               CR                CR                TGAI              1, 2
                                 toxicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4100                        Avian inhalation    CR                CR                 CR                 CR                CR                CR                CR                CR                TGAI              1, 2, 3
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4150                        Wild mammal         CR                CR                 CR                 CR                CR                NR                NR                CR                TGAI              1, 4
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4200                        Freshwater fish     R                  R                  R                  R                 CR               CR                CR                CR                TGAI or TEP       1, 2, 5
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4240                        Freshwater         R                   R                  R                  R                 CR               CR                CR                CR                TGAI or TEP       1, 2, 5
                                 invertebrate
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4280                        Estuarine/Marine    CR                CR                 CR                 CR                CR                NR                NR                CR                TGAI              1, 6
                                 fish testing
                                Estuarine and
                                 marine
                                 invertebrate
                                 testing.
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4300                        Nontarget plant     CR                CR                 CR                 R                  CR               NR                CR                CR                TEP                1, 7
                                testing..........
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4340                        Nontarget insect   R                   R                  R                  R                 R                 CR               NR                CR                TGAI              1, 8
                                 testing
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4380                        Honey bee testing  R                  R                   R                  R                 R                 CR               NR                CR                TGAI              1
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier II
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.5200                        Terrestrial         CR                CR                 CR                 CR                CR                NR                NR                CR                TGAI or TEP        9
                                 environmental
                                 expression tests
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.5300                        Freshwater          CR                CR                 CR                 CR                CR                NR                NR                CR                TGAI or TEP        10
                                 environmental
                                 expression tests
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.5400                        Marine or           CR                CR                 CR                 CR                CR                NR                NR                CR                TGAI or TEP        11, 12
                                 estuarine
                                 environmental
                                 expression tests
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier III
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4600                        Avian chronic      CR                  CR                CR                 CR                CR                NR                NR                CR                TGAI              12, 13
                                 pathogenicity
                                 and reproduction
                                 test
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4650                        Aquatic             CR                CR                 CR                 CR                CR                NR                NR                CR                TGAI              12, 14
                                 invertebrate
                                 range testing
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4700                        Fish life cycle     CR                CR                 CR                 CR                CR                NR                NR                CR                TGAI              12, 14
                                 studies
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4750                        Aquatic ecosystem  CR                  CR                CR                 CR                CR                NR                NR                CR                TGAI              15
                                 test
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier IV
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2500                        Field testing for   CR                CR                 CR                 CR                CR                NR                NR                CR                TGAI or TEP        11, 16
850.1950......................   terrestrial
                                 wildlife and
                                 Field testing
                                 for aquatic
                                 organisms
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2500                        Simulated or       CR                  CR                CR                 CR                CR                NR                NR                CR                TEP               16, 17, 20
                                 actual field
                                 tests (birds,
                                 mammals)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 61021]]


850.1950                        Simulated or       CR                  CR                CR                 CR                CR                NR                NR                CR                TEP               16, 18, 19, 20
                                 actual field
                                 test (aquatic
                                 organisms)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2500                        Simulated or       CR                  CR                CR                 CR                CR                NR                NR                CR                TEP               16, 18, 19, 20
                                 actual field
                                 tests (insect
                                 predators,
                                 parasites)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.3040                        Simulated or       CR                  CR                CR                 CR                CR                NR                NR                CR                TEP               16, 18, 19, 20
                                 actual field
                                 tests (insect
                                 pollinators)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4300                        Simulated or       CR                  CR                CR                 CR                CR                NR                NR                CR                TEP               16, 18, 19, 20
                                 actual field
                                 tests (plants)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for microbial pesticides nontarget organism and 
environmental fate as referenced in the last column of the table 
contained in paragraph (d) of this section.
    1. Tests for pesticides intended solely for indoor application 
would be required on a case-by-case basis, depending on use pattern, 
production volume, and other pertinent factors.
    2. The preferred species for the avian oral study is either the 
upland game or waterfowl. The preferred species for the avian 
inhalation toxicity/pathogenicity study and the avian chronic 
toxicity/pathogenicity study is the upland game. There is also the 
option to test the passerine if there is a concern. The coldwater 
fish is preferred for freshwater fish testing. However, two species 
(coldwater and warmwater fish species are the preferred species) 
must be tested for uses involving direct freshwater exposure. 
Freshwater invertebrate testing is also required.
    3. Data required when the nature of the microbial pesticide and/
or its toxins indicates potential pathogenicity to birds.
    4. Required on a case-by-case basis if results of tests required 
by Sec.  158.2140 are inadequate or inappropriate for assessment of 
hazards to wild mammals.
    5. Required when there will be significant exposure to aquatic 
organisms (fish and invertebrates).
    6. Required if the product is intended for direct application 
into the estuarine or marine environment or expected to enter this 
environment in significant concentrations because of expected use or 
mobility pattern.
    7. Required if the microbial pesticide is taxonomically related 
to a known plant pathogen.
    8. Data are not required unless an active microbial ingredient 
controls the target insect pest by a mechanism of infectivity; i.e. 
may create an epizootic condition in nontarget insects.
    9. Required if toxic or pathogenic effects are observed in one 
or more of the following tests for microbial pesticides:
    i. Avian acute oral or avian inhalation studies.
    ii. Wild mammal studies.
    iii. Nontarget plant studies (terrestrial).
    iv. Honey bee studies.
    v. Nontarget insect studies.
    10. Required when toxic or pathogenic effects are observed in 
any of the following Tier I tests for microbial pest control agents:
    i. Freshwater fish studies.
    ii. Freshwater invertebrate studies.
    iii. Nontarget plant studies (aquatic).
    11. Required if product is applied on land or in fresh water or 
marine/estuarine environments and toxic or pathogenic effects are 
observed in any of the following Tier I tests for microbial 
pesticides:
    i. Estuarine and marine animal toxicity and pathogenicity.
    ii. Plant studies - estuarine or marine species.
    12. An appropriate dose-response toxicity test is required when 
toxic effects on nontarget terrestrial wildlife or aquatic organisms 
(including plants) are reported in one or more Tier I tests and 
results of Tier II tests indicate exposure of the microbial agent to 
the affected nontarget terrestrial wildlife or aquatic organisms. 
The protocols for these tests may have to be modified in accordance 
with results from the nontarget organism and environmental 
expression studies.
    13. Required when one or more of the following are present:
    i. Pathogenic effects are observed in Tier I avian studies.
    ii. Tier II environmental expression testing indicate that long-
term exposure of terrestrial animals is likely.
    14. Required when product is intended for use in water or 
expected to be transported to water from the intended use site, and 
when pathogenicity or infectivity was observed in Tier I aquatic 
studies.
    15. Required if, after an analysis of the microbial pesticide's 
ability to survive and multiply in the environment and what 
ecological habitat it would occupy, the intended use patterns, and 
the results of previous nontarget organisms and environmental 
expression tests, it is determined that use of the microbial agent 
may result in adverse effects on the nontarget organisms in aquatic 
environments. Testing is to determine if applications of the 
microbial pest control would be expected to disrupt the balance of 
populations in the target ecosystem.
    16. Tier IV studies may be conducted as a condition of 
registration as post-registration monitoring if the potential for 
unreasonable adverse effects appears to be minimal during that 
period of use due to implementation of mitigation measures.
    17. Required when both of the following conditions occur:
    i. Pathogenic effects observed at actual or expected field 
residue exposure levels are reported in Tier III; and
    ii. The Agency determines that quarantine methods would not 
prevent the microbial pesticide from contaminating areas adjacent to 
the test area.
    18. Short term simulated or actual field studies are required 
when it is determined that the product is likely to cause adverse 
short-term or acute effects, based on consideration of available 
laboratory data, use patterns, and exposure rates.
    19. Data from a long-term simulated field test (e.g., where 
reproduction and growth of confined populations are observed) and/or 
an actual field test (e.g., where reproduction and growth of natural 
populations are observed) are required if laboratory data indicate 
that adverse long-term, cumulative, or life-cycle effects may result 
from intended use.
    20. Since test standards would be developed on a case-by-case 
basis, consultation with the Agency and development of a protocol is 
advised before performing these Tier IV studies.

[[Page 61022]]

Sec.  158.2160  Microbial pesticides product performance data 
requirements.

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


Sec.  158.2170  Experimental use permit data requirements--microbial 
pesticides.

    (a) For all microbial pesticides. (1) The following Sec.  158.2171 
through Sec.  158.2174 identify the data requirements that are required 
to support experimental use permits for microbial pesticides. The 
variations in the test conditions are identified within the test notes.
    (2) For general information on the data requirement tables, see 
Sec.  158.2110(a)(2)-(4).
    (b) Additional data requirements for genetically modified microbial 
pesticides. Additional requirements for genetically modified microbial 
pesticides may include but are not limited to: genetic engineering 
techniques used; the identity of the inserted or deleted gene segment 
(base sequence data or enzyme restriction map of the gene); information 
on the control region of the gene in question; a description of the 
``new'' traits or characteristics that are intended to be expressed; 
tests to evaluate genetic stability and exchange; and selected Tier II 
environmental expression and toxicology tests.


Sec.  158.2171  Experimental use permit microbial pesticides product 
analysis data requirements table.

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

                                                 Table--EUP Microbial Product Analysis Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Test Substance
          Guideline Number              Data Requirement        All Use Patterns    ----------------------------------------------       Test Notes
                                                                                               MP                     EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product Chemistry and Composition
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1100                           Product Identity        R                       MP                     EP                     --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1200                           Manufacturing process   R                       TGAI and MP            TGAI and EP            1, 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                     Deposition of a sample  R                       TGAI                   TGAI                   --
                                      in a nationally
                                      recognized culture
                                      collection
                                    --------------------------------------------------------------------------------------------------------------------
  885.1300                           Discussion of           R                       TGAI and MP            TGAI and EP            2
                                      formation of
                                      unintentional
                                      ingredients
--------------------------------------------------------------------------------------------------------------------------------------------------------
Analysis and Certified Limits
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1400                           Analysis of samples     R                       TGAI and MP            TGAI and EP            2, 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1500                           Certification of        R                       MP                     EP                     --
                                      limits
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physical and Chemical Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6302                           Color                   R                       TGAI                   TGAI                   --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6303                           Physical state          R                       TGAI                   TGAI                   --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6304                           Odor                    R                       TGAI                   TGAI                   --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6313                           Stability to normal     R                       TGAI                   TGAI                   --
                                      and elevated
                                      temperatures, metals
                                      and metal ions
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6317                           Storage stability       R                       TGAI and MP            TGAI and EP            --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6319                           Miscibility             R                       MP                     EP                     4
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 61023]]


  830.6320                           Corrosion               R                       MP                     EP                     5
                                      Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.7000                           pH                      R                       TGAI                   TGAI                   --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.7100                           Viscosity               R                       MP                     EP                     6
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.7300                           Density/relative        R                       TGAI                   TGAI                   --
                                      density/bulk density
                                      (specific gravity)
--------------------------------------------------------------------------------------------------------------------------------------------------------

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


Sec.  158.2172  Experimental use permit microbial pesticides residue 
data requirements table.

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

                            Table--EUP Microbial Pesticides Residue Data Requirements
----------------------------------------------------------------------------------------------------------------
                                                                            Test Substance
        Guideline Number           Data Requirement    All Use Patterns   Data to Support MP      Test Notes
                                                                                 or EP
----------------------------------------------------------------------------------------------------------------
885.2100                          Chemical Identity   CR                  EP                  1
----------------------------------------------------------------------------------------------------------------
885.2200                          Nature of the       CR                  EP                  1
                                   Residue in plants
----------------------------------------------------------------------------------------------------------------
885.2250                          Nature of the       CR                  EP                  1
                                   Residue in
                                   animals
----------------------------------------------------------------------------------------------------------------
885.2300                          Analytical methods  CR                  TGAI                1
                                   - plants
----------------------------------------------------------------------------------------------------------------
885.2350                          Analytical methods- CR                  TGAI                1
                                   animals
----------------------------------------------------------------------------------------------------------------
885.2400                          Storage Stability   CR                  EP                  1
----------------------------------------------------------------------------------------------------------------
885.2500                          Magnitude of        CR                  EP                  1
                                   residue in plants
----------------------------------------------------------------------------------------------------------------
885.2550                          Magnitude of        CR                  EP                  1
                                   residues in meat,
                                   milk, poultry,
                                   eggs
----------------------------------------------------------------------------------------------------------------
885.2600                          Magnitude of        CR                  EP                  1
                                   residues in
                                   potable water,
                                   fish, and
                                   irrigated crops
----------------------------------------------------------------------------------------------------------------

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


Sec.  158.2173  Experimental use permit microbial pesticides toxicology 
data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the toxicology data requirements for a 
particular microbial pesticide product. Notes that apply to

[[Page 61024]]

an individual test and include specific conditions, qualifications, or 
exceptions to the designated test are listed in paragraph (d) of this 
section.
    (b) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; All=All of the 
above. Specific conditions, qualifications, or exceptions to the 
designated test procedures appear in paragraph (d) of this section, and 
apply to the individual tests in the following table:
    (c) Table. The following table shows the data requirements for 
microbial pesticide toxicology. The test notes are shown in paragraph 
(d) of this section.

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

    (d) Test notes. The following test notes are applicable to the data 
requirements for experimental use permit microbial pesticides 
toxicology as referenced in the last column of the table contained in 
paragraph (c) of this section:
    1. The acute oral toxicity/pathogenicity study is required to 
support the TGAI. However, it can be combined with the unit dose 
portion of the acute oral toxicity study, with an EP or MP test 
material to fulfill the requirement for the TGAI and the MP or EP in 
a single study, if the new protocol is designed to address the 
endpoints of concern.
    2. Data not required for products whose active ingredient is a 
virus. For test materials whose size or consistency may prevent use 
of an intravenous injection, the intraperitoneal injection procedure 
may be employed.
    3. Hypersensitivity incidents, including immediate type and 
delayed type reactions of humans or domestic animals occur during 
the testing or production of the TGAI, MP, or EP, or are otherwise 
known to the applicant must be reported if they occur.
    4. Data must be submitted only for products whose active 
ingredient is a virus.
    5. The 870 series studies for the MP and EP are intended to 
provide data on the acute toxicity of the product. Waivers for any 
or all of these studies may be granted when the applicant can 
demonstrate that the combination of inert ingredients is not likely 
to pose any significant human health risks. Where appropriate, the 
limit dose approach to testing is recommended.
    6. Required when the product consists of, or under conditions of 
use that would result in an inhalable material (e.g., gas, volatile 
substances, or aerosol particulate).


Sec.  158.2174  Experimental use permit microbial pesticides nontarget 
organisms and environmental fate data requirements table.

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

[[Page 61025]]



                                                                      Table--EUP Microbial Pesticides Nontarget Organisms and Environmental Fate Data Requirements
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                      Use Patterns
                                                  ---------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Aquatic                                                                Terrestrial
       Guideline Number          Data Requirement ---------------------------------------------------------------------------------------------------------------------------------------------------  Test Substance      Test Notes
                                                                                                                                 Residential       Greenhouse          Indoor
                                                       Food/Feed           Nonfood       Food/Feed/Nonfood      Forestry     ------------------------------------------------------    Industrial
                                                                                                                                   Outdoor        Food/Nonfood      Food/Nonfood
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4050                        Avian oral         NR                 R                  R                  R                 R                 NR                NR                NR                TGAI              1, 2
                                toxicity.........
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4200                        Freshwater fish    NR                 R                  R                  R                 NR                NR                NR                NR                TGAI              1, 2, 3
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4240                        Freshwater         NR                 R                  R                  R                 NR                NR                NR                NR                TGAI              1, 2, 3
                                 invertebrate
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4300                        Nontarget plant    NR                 NR                 NR                 R                 NR                NR                NR                NR                TEP               1, 4
                                testing..........
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4340                        Nontarget insect   R                  R                  R                  R                 NR                NR                NR                NR                TGAI              1, 5
                                 testing
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4380                        Honey bee testing  R                  R                  R                  R                 NR                NR                NR                NR                TGAI              1
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for microbial pesticides nontarget organism and 
environmental fate as referenced in the last column of the table 
contained in paragraph (d) of this section.
    1. Tests for pesticides intended solely for indoor application 
would be required on a case-by-case basis, depending on use pattern, 
production volume, and other pertinent factors. Tests to support 
EUP's are based on the application timing and acreage.
    2. The preferred species for the avian oral study is either the 
upland game or waterfowl. The preferred species for the avian 
inhalation toxicity/pathogenicity study and the avian chronic 
toxicity/pathogenicity study is the upland game. There is also the 
option to test a passerine species if there is a concern. The 
coldwater fish is preferred for freshwater fish testing. However, 
two species (coldwater and warmwater fish are the preferred species) 
must be tested for uses involving direct freshwater exposure. 
Freshwater invertebrates are preferred for invertebrate testing.
    3. Required when there will be significant exposure to aquatic 
organisms (fish and invertebrates).
    4. Required if the microbial pesticide is taxonomically related 
to a known plant pathogen.
    5. Data are not required unless an active microbial ingredient 
controls the target insect pest by a mechanism of infectivity; i.e. 
may create an epizootic condition in nontarget insects.

[FR Doc. E7-20828 Filed 10-25-07; 8:45 am]

BILLING CODE 6560-50-S
