[Federal Register Volume 76, Number 73 (Friday, April 15, 2011)]
[Proposed Rules]
[Pages 21294-21299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-9191]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 158

[EPA-HQ-OPP-2010-0670; FRL-8857-7]
RIN 2070-AJ80


Pesticides; Microbial Pesticide Definitions and Applicability; 
Clarification and Availability of Draft Test Guideline for Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: As promulgated, EPA's regulations distinguish ``isolates'' and 
``strains'' in a confusing and non-obvious manner. This has resulted in 
significant uncertainty within the regulated industry. This proposed 
rule addresses this problem by proposing new regulatory language that 
clarifies the requirements applicable to new strains that are 
considered to be new active ingredients under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA). EPA is also soliciting comment 
on a draft microbial pesticide test guideline, explaining the 
deposition of a sample in a nationally recognized culture collection 
data requirement, for comment. The revisions proposed in this rule also 
include several other minor corrections to words and references. The 
changes should enhance the ability of industry to efficiently manage 
their microbial pesticide registration submissions.

DATES: Comments must be received on or before July 14, 2011.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2010-0670, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2010-0670. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov Web site is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form

[[Page 21295]]

of encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available at http://www.regulations.gov. 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 OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of 
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The Docket Facility telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Rose Kyprianou, Field and External 
Affairs Division (7506P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-5354; fax number: (703) 305-5884; e-
mail address: [email protected].

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 microbial pesticide product. This proposal 
also may affect any person or company who might petition the Agency for 
a tolerance or an exemption from the requirement of a tolerance for the 
residues of a microbial pesticide, holds a pesticide registration with 
an existing tolerance or tolerance exemption for a microbial pesticide, 
or is interested in obtaining or retaining a tolerance or tolerance 
exemption in the absence of a registration (i.e., an import tolerance 
or tolerance exemption for a microbial pesticide). Potentially affected 
entities may include, but are not limited to:
     Pesticide and Other Agricultural Chemical Manufacturing 
(NAICS code 325320), e.g., pesticide manufacturers or formulators of 
pesticide products, importers, or any person or company who seeks to 
register a pesticide or to obtain a tolerance or tolerance exemption 
for a pesticide.
     Crop Production (NAICS code 111).
     Animal Production (NAICS code 112).
     Food Manufacturing and Processing (NAICS 311).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed 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. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. What is EPA's authority for taking this action?

    This action is issued under the authority of sections 3, 5, 10, 12, 
and 25 of the Federal, Insecticide, Fungicide, and Rodenticide Act 
(FIFRA), as amended, and section 408 of the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

III. What action is EPA taking?

    EPA is proposing several changes and corrections to the Microbial 
Pesticides data requirements (40 CFR part 158, subpart V). Two 
revisions are proposed to be made to text found in the Microbial 
Pesticides Definition and Applicability section (40 CFR 158.2100). The 
first is a correction, replacing ``part'' with ``subpart'' in 40 CFR 
158.2100(c)(1). The other is a clarification, involving revisions to 40 
CFR 158.2100(c)(2), and is in response to recent confusion over the 
distinction between isolates and strains and exactly how EPA is 
considering both of these terms. The clarification to 40 CFR 
158.2100(c)(2) also proposes to include a requirement for the use of a 
unique identifier, as part of the microbial pesticide active ingredient 
taxonomic name, to allow for improved identification of company-
specific registered isolates.
    In conjunction with the change detailed for 40 CFR 158.2100(c)(2), 
EPA is also developing a draft microbial pesticide test guideline 
(OCSPP Guideline 885.1250) to explain the data requirement for the 
deposition of a sample in a nationally recognized culture collection, 
which is found in the tables in 40 CFR 158.2120(c) and 40 CFR 
158.2171(c); presently, there is no test guideline referenced in the 
tables for this requirement. A copy of this draft test guideline is in 
the docket for this action to solicit public comment. Additionally, to 
clarify this microbial deposition data requirement, EPA is proposing to 
add a test note to the aforementioned tables, emphasizing the need for 
the continuing maintenance of a culture deposit to ensure it remains 
available in case EPA requests a sample. Finally, EPA is proposing to 
remove incorrect references, in 40 CFR 158.2120 and 40 CFR 158.2171, to 
a paragraph (e) that does not exist.
    The improved clarity and transparency of the information proposed 
as changes to 40 CFR part 158, subpart V should enhance the ability of 
industry to efficiently manage their microbial pesticide registration 
submissions. Applicants may save time and money by understanding the

[[Page 21296]]

standards and interpretations of the definitions for the data that are 
needed. Having all required studies and information available to EPA at 
the time of application may reduce potential delays in the registration 
process, thereby enabling registration of microbial pesticides sooner 
and allowing microbial pesticide products to enter the market faster.

IV. Today's Proposed Revisions

A. Correcting the Statement in 40 CFR 158.2100(c)(1)

    The Agency believes that 40 CFR 158.2100(c)(1), after replacing 
``part'' with ``subpart,'' should read as follows: ``This subpart 
applies to microbial pesticides as specified in paragraphs (c)(2), (3), 
and (4) of this section.'' This section, as currently presented, could 
be misconstrued or interpreted to mean that all of 40 CFR part 158 
applies to microbial pesticides and conflicts with the information 
presented in 40 CFR 158.1(c)(3).

B. Clarifying the Statement in 40 CFR 158.2100(c)(2)

    The preamble of the final rule (71 FR 60988, October 26, 2007), 
codifying the provision found at 40 CFR 158.2100(c)(2), explained that 
registering a new isolate of an already registered microbial strain did 
not necessarily increase the amount of data needed to obtain such a 
registration. The following language is from that preamble:

    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.

    In this action, EPA is proposing new language for 40 CFR 
158.2100(c)(2) to clarify that the use of the phrase ``is treated as a 
new strain'' was intended to illustrate that a new strain is considered 
to be a new active ingredient. EPA believes that this interpretation is 
consistent with its discussion in the 2007 final rule preamble and with 
how EPA has been implementing this regulation. Moreover, in order to 
allow for improved identification of company-specific registered 
isolates, these modifications will include a provision requiring use of 
a unique identifier as part of the microbial pesticide active 
ingredient taxonomic name (e.g., a culture collection deposit 
identification number or another unique identifier, such as company 
initials followed by a number). Currently registered microbial 
pesticide active ingredients would not have to conform to this 
identification provision until they go through the registration review 
process.

C. Clarifying Particular Information Found in 40 CFR 158.2120 and 
158.2171 Through Development of a Draft Test Guideline

    In conjunction with the proposed change detailed for 40 CFR 
158.2100(c)(2) (see Unit IV.B.), EPA is also developing a draft 
microbial pesticide test guideline (OCSPP Guideline 885.1250) to 
explain the deposition of a sample in a nationally recognized culture 
collection data requirement, which is currently found in the tables in 
40 CFR 158.2120(c) and 40 CFR 158.2171(c). Presently, there is no test 
guideline referenced in the tables for this requirement. Instead, 
information on this data requirement is briefly mentioned at the end of 
the Microbial Pesticide Test Guideline for Manufacturing Process (OPPTS 
Guideline 885.1200): ``A sample of registered [Microbial Pest Control 
Agents] MPCAs is to be maintained on deposit in a nationally recognized 
culture collection.'' In 1996, this particular statement was 
transferred from the 1989 revision of Subdivision M of the Pesticide 
Assessment Guidelines (specifically 151A-11) to the Microbial Pesticide 
Test Guideline for Manufacturing Process (OPPTS Guideline 885.1200). 
The term ``maintained'' was used because some culture collections will 
discard deposits after a certain time if they do not get subsequent 
requests to purchase samples from that deposit. In creating a distinct 
test guideline for the microbial deposition data requirement, EPA will 
provide a more easily found reference that can be added to the data 
requirement table. Furthermore, the draft test guideline will make 
clear that the deposition requirement is analogous to the submittal of 
samples data requirement (OPPTS Guideline 830.1900), which established 
that chemical pesticides must be deposited in the EPA National 
Pesticide Standard Repository. Some of this background information was 
explained in the preamble to the proposed rule for Data Requirements 
for Microbial and Biochemical Pesticides (71 FR 12072, March 8, 2006):

    f. Submittal of samples. This provision is typically intended to 
enable EPA to identify the active ingredient and provide standards 
to governmental agencies needing to monitor chemical pesticide 
residues and is conditionally required (CR). The Agency proposes to 
require (R) these data as a product analysis requirement to be 
deposited in a nationally recognized culture collection to allow EPA 
to validate strain identity if issues arise (guideline 885.1200).
    Since the Agency does not have capacity to store the variety of 
microbial pesticides that may be submitted, EPA did not set up a 
nationally recognized culture collection. There are several 
nationally recognized culture collections in this country (and 
abroad) such as the American Type Culture Collection and a microbial 
collection maintained in Peoria, Ill., by the USDA. These facilities 
have a vast number of microbial and cell cultures that [the 
facilities] are dedicated to transferring, maintaining and 
identifying. Rather than duplicate this effort, EPA chose to refer 
microbial pesticide producers to these facilities who have the 
routine expertise to keep and distribute (or protect) microbial 
cultures. There is a certain element of required expertise but 
really the cost and small number of our microbial pesticides would 
make it prohibitively expensive for the Agency to do this collection 
rather than direct the companies to these specialized facilities.

    To clarify this microbial deposition data requirement, the Agency 
is proposing to add a test note to the tables in 40 CFR 158.2120 and 40 
CFR 158.2171, emphasizing the need for the continuing maintenance of a 
culture deposit to ensure it remains available in case the Agency 
requests a sample.

D. Correcting Statements in 40 CFR 158.2120 and 158.2171

    The current paragraphs (a) and (b) of both 40 CFR 158.2120 and 
158.2171 incorrectly reference a paragraph (e) that does not exist. EPA 
proposes to remove these incorrect references. Specifically, EPA 
proposes to do the following in 40

[[Page 21297]]

CFR 158.2120 and 158.2171: (1) Revise the last sentence of paragraph 
(a) for each of these sections to read as ``Notes that apply to an 
individual test and include specific conditions, qualifications, or 
exceptions to the designated test are identified in paragraph (d) of 
this section'' and (2) remove the last sentence in paragraph (b) for 
each of these sections.

V. FIFRA Review Requirements

    Pursuant to FIFRA sections 25(a) and (d), EPA has submitted a draft 
of this proposed rule to the Committee on Agriculture in the House of 
Representatives, the Committee on Agriculture, Nutrition, and Forestry 
in the United States Senate, and the U.S. Department of Agriculture 
(USDA).
    The FIFRA Scientific Advisory Panel (SAP) and the USDA waived 
review of this proposed rule. The FIFRA SAP waived its review of this 
proposed rule because the significant scientific issues involved have 
already been reviewed by the SAP and additional review is not 
necessary. The SAP waived its review of this proposed rule on August 
17, 2010.

VI. Statutory and Executive Order Reviews

    This action only proposes to clarify the existing regulatory text 
to allow EPA and stakeholders a clearer understanding of 40 CFR part 
158, subpart V. It does not otherwise propose to amend or impose any 
other requirements. The proposed rule will not otherwise involve any 
significant policy or legal issues and will not increase existing 
costs. As such, this action is not subject to review by the Office of 
Management and Budget (OMB) as a ``significant regulatory action'' 
under Executive Order 12866, entitled Regulatory Planning and Review 
(58 FR 51735, October 4, 1993). Nor does it impose or change any 
information collection burden that requires additional review by OMB 
under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501 et seq.).
    The information collection activities contained in the regulation 
are already approved under Information Collection Request (ICR) 
instruments related to the submission of data to EPA in order to 
establish a tolerance or an exemption from the requirement of a 
tolerance currently approved under OMB Control No. 2070-0024 (EPA ICR 
No. 0597), the activities associated with the application for a new or 
amended registration of a pesticide currently approved under OMB 
Control No. 2070-0060 (EPA ICR No. 0277), the activities associated 
with the application for an experimental use permit currently approved 
under OMB Control No. 2070-0040 (EPA ICR No. 0276), and the activities 
associated with the generation of data for regulatory review programs 
currently approved under OMB Control No. 2070-0174 (EPA ICR No. 2288). 
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. The OMB control numbers for EPA's regulations 
in 40 CFR are listed in 40 CFR part 9.
    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), EPA hereby certifies that this proposed rule 
does not have a significant adverse economic impact on a substantial 
number of small entities. This action only proposes to clarify the 
existing regulatory text to allow EPA and stakeholders a clearer 
understanding of 40 CFR part 158, subpart V. It does not otherwise 
propose to amend or impose any other requirements. In general, EPA 
strives to minimize potential adverse impacts on small entities when 
developing regulations to achieve the environmental and human health 
protection goals of the statute and the Agency. EPA solicits comments 
specifically about potential small business impacts.
    State, local, and Tribal governments are rarely pesticide 
applicants or registrants, so this proposed rule is not expected to 
affect these governments. Accordingly, pursuant to Title II of the 
Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1531-1538), EPA has 
determined that this action is not subject to the requirements in 
sections 202 and 205 because it 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 for the private sector in 
any one year. In addition, this action does not significantly or 
uniquely affect small governments or impose a significant 
intergovernmental mandate, as described in sections 203 and 204 of 
UMRA. For the same reasons, EPA has determined that this proposed rule 
does not have ``federalism implications'' as specified in Executive 
Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), 
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. Thus, Executive Order 13132 
does not apply to this proposed rule. Nor does it have ``Tribal 
implications'' as specified in Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
22951, November 9, 2000). EPA is not aware of any Tribal governments 
that are pesticide registrants. Thus, Executive Order 13175 does not 
apply to this action.
    Since this action is not economically significant under Executive 
Order 12866, it is not subject to Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997), and Executive Order 13211, entitled 
Actions Concerning Regulations that Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). In addition, EPA 
interprets Executive Order 13045 as applying only to those regulatory 
actions that concern health or safety risks, which is not the case in 
this proposed rule.
    This action does not involve technical standards that would require 
the consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act (NTTAA) 
(15 U.S.C. 272).
    This action does not have an adverse impact on the environmental 
and health conditions in low-income and minority communities. 
Therefore, this action does not involve special consideration of 
environmental justice related issues as specified in Executive Order 
12898, entitled Federal Actions to Address Environmental Justice in 
Minority Populations and Low-Income Populations (59 FR 7629, February 
16, 1994).

List of Subjects in 40 CFR Part 158

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

    Dated: April 7, 2011.
Lisa P. Jackson,
Administrator.

    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 158--[AMENDED]

    1. The authority citation for part 158 continues to read as 
follows:

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

    2. Amend Sec.  158.2100 as follows:
    a. Revise paragraph (c)(1).
    b. Revise paragraph (c)(2).
    The revised text reads as follows:

[[Page 21298]]

Sec.  158.2100  Microbial pesticides definition and applicability.

* * * * *
    (c) Applicability. (1) This subpart applies to microbial pesticides 
as specified in paragraphs (c)(2), (3) and (4) of this section.
    (2) Because of the potential for variation in microorganisms, each 
new isolate of a microbial pesticide is treated as a new active 
ingredient and must be registered independently of any similarly 
designated and already registered microbial pesticide active 
ingredient. Each new isolate for which registration is sought must have 
a unique identifier following the taxonomic name of the microorganism, 
and the registration application must be supported by data required in 
this subpart. This does not preclude the possibility of using data from 
another isolate, provided sufficient similarity is established, to 
support registration.
* * * * *
    3. Amend Sec.  158.2120 as follows:
    a. Revise paragraph (a).
    b. Revise paragraph (b).
    c. Revise paragraph (c).
    d. In paragraph (d), redesignate test notes 1 through 4 as 2 
through 5, respectively, and add new test note 1.
    The revised and added text reads as follows:


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. Notes that 
apply to an individual test and include specific conditions, 
qualifications, or exceptions to the designated test are identified 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.
    (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.

                         Table--Microbial Pesticides Product Analysis Data Requirements
----------------------------------------------------------------------------------------------------------------
                                                                    Test substance
   Guideline No.      Data requirement     All use    ------------------------------------------    Test notes
                                           patterns             MP                   EP
----------------------------------------------------------------------------------------------------------------
                                        Product Chemistry and Composition
----------------------------------------------------------------------------------------------------------------
885.1100...........  Product identity.  R              MP                   EP                   ...............
885.1200...........  Manufacturing      R              TGAI and MP          TGAI and EP          ...............
                      process.
885.1250...........  Deposition of a    R              TGAI                 TGAI                               1
                      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        R              TGAI and MP          TGAI and EP                        2
                      samples.
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       R              TGAI                 TGAI                 ...............
                      normal and
                      elevated
                      temperatures,
                      metals and metal
                      ions.
830.6317...........  Storage stability  R              TGAI and MP          TGAI and EP          ...............
830.6319...........  Miscibility......  R              MP                   EP                                 3
830.6320...........  Corrosion          R              MP                   EP                                 4
                      Characteristics.
830.7000...........  pH...............  R              TGAI                 TGAI                 ...............
830.7100...........  Viscosity........  R              MP                   EP                                 5
830.7300...........  Density/relative   R              TGAI                 TGAI                 ...............
                      density/bulk
                      density
                      (specific
                      gravity).
----------------------------------------------------------------------------------------------------------------

     (d) * * *
    1. Required for each isolate of a microbial pesticide. New isolates 
must be deposited with an agreement to ensure that the sample will be 
maintained and will not be discarded for the duration of the associated 
registration(s).
* * * * *
    4. Amend Sec.  158.2171 as follows:
    a. Revise paragraph (a).
    b. Revise paragraph (b).
    c. Revise paragraph (c).
    d. In paragraph (d), redesignate test notes 3 through 6 as 4 
through 7, respectively and add a new test note 3.
    The revised and added text reads as follows:


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. Notes that 
apply to an individual test and include specific conditions, 
qualifications, or exceptions to the designated test are identified 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.
    (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.

[[Page 21299]]



                             Table--EUP Microbial Product Analysis Data Requirements
----------------------------------------------------------------------------------------------------------------
                                                                     Test substance
   Guideline No.       Data requirement       All use   ----------------------------------------    Test notes
                                             patterns            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
885.1250..........  Deposition of a        R             TGAI                TGAI                              3
                     sample 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, 4
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                                5
830.6320..........  Corrosion              R             MP                  EP                                6
                     characteristics.
830.7000..........  pH...................  R             TGAI                TGAI                ...............
830.7100..........  Viscosity............  R             MP                  EP                                7
830.7300..........  Density/relative       R             TGAI                TGAI                ...............
                     density/bulk density
                     (specific gravity).
----------------------------------------------------------------------------------------------------------------

     (d) * * *
    3. Required for each isolate of a microbial pesticide. New isolates 
must be deposited with an agreement to ensure that the sample will be 
maintained and will not be discarded for the duration of the associated 
experimental use permit(s).
* * * * *
[FR Doc. 2011-9191 Filed 4-14-11; 8:45 am]
BILLING CODE 6560-50-P