Federal Register, Volume 77 Issue 169 (Thursday, August 30, 2012)

[Federal Register Volume 77, Number 169 (Thursday, August 30, 2012)]
[Rules and Regulations]
[Pages 52610-52614]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-21430]

[[Page 52610]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 158

[EPA-HQ-OPP-2010-0670; FRL-9338-9]
RIN 2070-AJ80

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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This final rule clarifies the distinction between ``isolates''
and ``strains,'' and clarifies the requirements applicable to new
isolates, which are considered to be new active ingredients under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Additional
revisions to regulatory text include several minor corrections to words
and references. Finally, EPA is announcing the availability of a final
microbial pesticide test guideline that further explains the existing
data requirement to deposit a sample in a nationally recognized culture
collection. Collectively, the final rule clarifications and revisions,
as well as the final microbial pesticide test guideline, are expected
to enhance the ability of industry to efficiently manage its microbial
pesticide registration submissions.

DATES: This final rule is effective October 29, 2012.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2010-0670, is available either
electronically through http://www.regulations.gov or in hard copy at
the OPP Docket in the Environmental Protection Agency Docket Center
(EPA/DC), located in EPA West, Rm. 3334, 1301 Constitution Ave. NW.,
Washington, DC 20460-0001. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is (202) 566-1744, and the
telephone number for the OPP Docket is (703) 305-5805. Please review
the visitor instructions and additional information about the docket
available at http://www.epa.gov/dockets.

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;
email address: kyprianou.rose@epa.gov.

SUPPLEMENTARY INFORMATION:

I. 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 action
also may affect any person or company who might petition EPA for a
tolerance or an exemption from the requirement of a tolerance for
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., a tolerance or
tolerance exemption for an imported microbial pesticide). 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. 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 code 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. If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.

II. Background

In the Federal Register of October 26, 2007 (72 FR 60988) (FRL-
8109-8), a final rule, entitled ``Pesticides; Data Requirements for
Biochemical and Microbial Pesticides,'' revised the data requirements
for biochemical and microbial pesticides--regulations that had
originally been promulgated in and had remained largely unchanged since
1984. In doing so, EPA established a distinct subpart for microbial
pesticides (i.e., 40 CFR part 158, subpart V) that provided a
definition for these particular pesticides and clearly identified the
data required to support their registration. Since 2007, however, EPA
has consistently encountered questions from industry stakeholders on
certain portions of 40 CFR part 158, subpart V, particularly with
regard to the language set forth in 40 CFR 158.2100(c)(2).
To address these questions, in the Federal Register of April 15,
2011 (76 FR 21294) (FRL-8857-7), EPA proposed specific revisions to the
regulatory text in 40 CFR 158.2100(c)(2) for purposes of enhanced
clarity. In addition, EPA also recognized that an existing data
requirement under 40 CFR 158.2120(c) and 40 CFR 158.2171(c), deposition
of a sample in a nationally recognized culture collection, did not have
an accompanying test guideline and that there were several minor errors
in the regulatory text of 40 CFR part 158, subpart V. Therefore, with
the proposed rule, EPA also made available for public comment a draft
test guideline, entitled ``Deposition of a Sample in a Nationally
Recognized Culture Collection'' and identified as OCSPP Test Guideline
885.1250, addressing the deposition of a sample in a nationally
recognized culture collection data requirement, and proposed to make
other minor corrections to the regulations. The public comment period
for the proposed rule closed on July 14, 2011, and EPA received no
comments on the proposed rule or the draft test guideline.

III. Final Changes

A. What action is EPA taking?

EPA is finalizing most of the changes and corrections proposed.
Although no comments were received, EPA has revised a few of the
originally proposed changes and corrections to further clarify the
regulatory text being modified. These changes are not substantive in
nature. The specific changes being promulgated with this action and the
anticipated benefits of such changes are described in this final rule
and the rationale supporting the revisions can be found in the proposed
rule (see Unit IV. of the April 15, 2011 proposed rule).
Specifically, EPA is making several changes and corrections to the
Microbial Pesticides data requirements (40 CFR part 158, subpart V).
First, EPA is revising 40 CFR 158.2100(c)(2) to reduce confusion over
the distinction between ``isolates'' and ``strains'' and exactly how
EPA views both of these terms. To this end, EPA substitutes ``active
ingredient'' for ``strain.'' The

[[Page 52611]]

clarification to 40 CFR 158.2100(c)(2) also includes 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. The clarification also
mentions the possibility for data citation, in lieu of data generation,
should sufficient similarity be established between isolates. Moreover,
after further consideration, EPA has decided against including the
proposed explanatory text (i.e., ``Because of the potential for
variation in microorganisms'') at the beginning of the first sentence
in 40 CFR 158.2100(c)(2). This phrase is not necessary or appropriate
as regulatory text because it does not add anything to the regulatory
provision.
Second, in conjunction with the changes detailed for 40 CFR
158.2100(c)(2), EPA is announcing the availability of a final microbial
pesticide test guideline under Series 885, entitled ``Deposition of a
Sample in a Nationally Recognized Culture Collection'' and identified
as OCSPP Test Guideline 885.1250. This OCSPP test guideline is intended
to explain the existing data requirement to deposit a sample in a
nationally recognized culture collection found in the tables in 40 CFR
158.2120(c) and 40 CFR 158.2171(c). Additionally, to clarify this
microbial deposition data requirement, EPA is adding a test note to 40
CFR 158.2120(d) and 40 CFR 158.2171(d), emphasizing the need for the
continuing maintenance of a culture deposit to ensure that it remains
available for the duration of an associated registration or
experimental use permit in case EPA requests a sample. This requirement
already applies to all isolates; thus, the reference to ``new
isolates'' in the proposed rulemaking was an oversight and is just
``isolates'' in this final rule.
Finally, to correct several minor errors, EPA is replacing ``part''
with ``subpart'' in 40 CFR 158.2100(c)(1) and removing references to a
non-existing paragraph (e) that appears in 40 CFR 158.2120 and 40 CFR
158.2171.
The improved clarity and transparency resulting from the insertion
of this information in 40 CFR part 158, subpart V, are expected to
enhance the ability of industry to efficiently manage its microbial
pesticide registration submissions. Applicants may save time and money
from an improved understanding of the 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
also reduce potential delays in the registration process, thereby
enabling registration of microbial pesticides sooner and allowing
microbial pesticide products to enter the market sooner.

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

This final rule is issued under the authority of FIFRA sections 3,
5, 10, 12, and 25 (7 U.S.C. 136 et seq.), and section 408 of the
Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a).

C. Electronic Access to the OCSPP Test Guidelines

To access the OSCPP test guidelines referenced in this final rule
electronically, please go to http://www.epa.gov/ocspp and select ``Test
Methods and Guidelines.'' You may also access the test guidelines in
http://www.regulations.gov grouped by Series under Docket ID numbers:
EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159 and EPA-HQ-OPPT-
2009-0576.

IV. FIFRA Review Requirements

Pursuant to FIFRA sections 25(a) and (d), EPA has submitted a draft
of this final rule to the Committee on Agriculture in the House of
Representatives; the Committee on Agriculture, Nutrition, and Forestry
in the United States Senate; the United States Department of
Agriculture (USDA); and the FIFRA Scientific Advisory Panel (SAP).
FIFRA SAP and USDA waived review of this final rule.

V. Statutory and Executive Order Reviews

This action only clarifies existing regulatory text to allow EPA
and stakeholders a clearer understanding of 40 CFR part 158, subpart V.
It does not otherwise impose any other requirements, involve any
significant policy or legal issues, or increase existing costs. As
such, EPA is not required to make special considerations or evaluations
under the following statutory and Executive Order review requirements.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

This is not a ``significant regulatory action'' under Executive
Order 12866 (58 FR 51735, October 4, 1993) and was therefore not
reviewed by the Office of Management and Budget (OMB) under Executive
Orders 12866 and 13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

This action does not impose or change any information collection
burden that requires additional review by OMB under the provisions of
PRA (44 U.S.C. 3501 et seq.). Burden is defined at 5 CFR 1320.3(b). An
agency may not conduct or sponsor, and a person is not required to
respond to a collection of information that requires OMB approval under
PRA, unless it has been approved by OMB and displays a currently valid
OMB control number. The OMB control numbers for EPA's regulations in
title 40 of the CFR, after appearing in the Federal Register, are
listed in 40 CFR part 9, and included on the related collection
instrument, or form, if applicable.
The revisions in this final rule involve existing information
collection activities that are already approved by OMB under PRA.
Specifically, the submission of data to EPA in order to establish a
tolerance or an exemption from the requirement of a tolerance are
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 are currently approved under OMB Control
No. 2070-0060 (EPA ICR No. 0277); the activities associated with the
application for an experimental use permit are 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
are currently approved under OMB Control No. 2070-0174 (EPA ICR No.
2288).

C. Regulatory Flexibility Act (RFA)

Pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), EPA hereby
certifies that this final rule does not have a significant adverse
economic impact on a substantial number of small entities. Under RFA,
small entities include small businesses, small organizations, and small
governmental jurisdictions. In making this determination, the impact of
concern is any significant adverse economic impact on small entities
because the primary purpose of regulatory flexibility analysis is to
identify and address regulatory alternatives ``which minimize any
significant economic impact of the rule on small entities.'' 5 U.S.C.
603 and 604. Thus, an agency may certify under RFA when the rule
relieves regulatory burden, or otherwise has no expected economic
impact on small entities subject to the rule.
This action only clarifies existing regulatory text to allow EPA
and stakeholders a clearer understanding of

[[Page 52612]]

40 CFR part 158, subpart V. It does not otherwise amend or impose any
other requirements. As such, this final rule will not have any adverse
economic impact on any entities, large or small.

D. Unfunded Mandates Reform Act (UMRA)

State, local, and Tribal governments are rarely pesticide
applicants or registrants, so this final rule is not expected to affect
these governments and is not expected to adversely affect the private
sector. Accordingly, pursuant to Title II of UMRA (2 U.S.C. 1531-1538),
EPA has determined that this action is not subject to the requirements
in UMRA 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 1 year. In addition, this action does not
significantly or uniquely affect small governments or impose a
significant intergovernmental mandate, as described in UMRA sections
203 and 204.

E. Executive Order 13132: Federalism

This action will not have federalism implications because it is not
expected to have a substantial direct effect on 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 Executive Order 13132 (64 FR 43255, August
10, 1999). Thus, Executive Order 13132 does not apply to this action.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

EPA is not aware of any Tribal governments that are pesticide
registrants. This action will not, therefore, have Tribal implications
because it is not expected to have substantial direct effects on Indian
Tribes, will not significantly or uniquely affect the communities of
Indian Tribal governments, and does not involve or impose any
requirements that affect Indian Tribes, as specified in Executive Order
13175 (65 FR 67249, November 9, 2000). Accordingly, the requirements of
Executive Order 13175 do not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying only to those regulatory actions that concern health or
safety risks, such that the analysis required under section 5-501 of
the Executive Order has the potential to influence the regulation. This
action is not subject to Executive Order 13045 because it does not
establish an environmental standard intended to mitigate health or
safety risks, nor is it an ``economically significant regulatory
action'' as defined by Executive Order 12866.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001) because it is not a significant regulatory action under
Executive Order 12866, nor will it affect energy supply, distribution,
or use.

I. National Technology Transfer and Advancement Act (NTTAA)

This action does not involve technical standards that would require
the consideration of voluntary consensus standards pursuant to NTTAA
section 12(d) (15 U.S.C. 272 note).

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

This action does not have disproportionately high and adverse human
health or environmental effects on minority or low-income populations
because it does not affect the level of protection provided to human
health or the environment. Therefore, this action does not involve
special consideration of environmental justice-related issues as
specified in Executive Order 12898 (59 FR 7629, February 16, 1994).

VI. Congressional Review Act (CRA)

Pursuant to CRA (5 U.S.C. 801 et seq.), 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 action is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 158

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

Dated: August 24, 2012.
James Jones,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.

Therefore, 40 CFR chapter I is amended as follows:

PART 158--[AMENDED]

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. In Sec. 158.2100, revise paragraphs (c)(1) and (2) to read as
follows:

Sec. 158.2100 Microbial pesticides definition and applicability.

* * * * *
(c) * * *
(1) This subpart applies to microbial pesticides as specified in
paragraphs (c)(2), (c)(3), and (c)(4) of this section.
(2) Each new isolate of a microbial pesticide is 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.
* * * * *

0
3. In Sec. 158.2120:
0
a. Revise paragraphs (a), (b), and (c).
0
b. Redesignate in paragraph (d), test notes 1 through 4 as test notes 2
through 5 and add new test note 1.
The amendments read 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 table in this paragraph shows the data requirements
for microbial pesticides product analysis.

[[Page 52613]]

The test notes are shown in paragraph (d) of this section.

Table--Microbial Pesticides Product Analysis Data Requirements
----------------------------------------------------------------------------------------------------------------
Test substance
Test guideline No. Data requirement All use ---------------------------------------- Test
patterns MP EP notes
----------------------------------------------------------------------------------------------------------------
Product Chemistry and Composition
----------------------------------------------------------------------------------------------------------------
885.1100............ Product identity....... R MP................ EP................ .......
885.1200............ Manufacturing process.. R TGAI and MP....... TGAI and EP....... .......
885.1250............ Deposition of a sample R TGAI.............. TGAI.............. 1
in a nationally
recognized culture
collection.
885.1300............ Discussion of formation R TGAI and MP....... TGAI and EP....... .......
of unintentional
ingredients.
----------------------------------------------------------------------------------------------------------------
Analysis and Certified Limits
----------------------------------------------------------------------------------------------------------------
885.1400............ Analysis of samples.... R TGAI and MP....... TGAI and EP....... 2
885.1500............ Certification of limits R MP................ EP................ .......
----------------------------------------------------------------------------------------------------------------
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 and R TGAI.............. TGAI.............. .......
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. 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).
* * * * *

0
4. In Sec. 158.2171:
0
a. Revise paragraphs (a), (b), and (c).
0
b. Redesignate in paragraph (d), test notes 3 through 6 as test notes 4
through 7 and add new test note 3.
The amendments read as follows:

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

Table--EUP Microbial Pesticides Product Analysis Data Requirements
----------------------------------------------------------------------------------------------------------------
Test substance
Test guideline No. Data requirement All use patterns ---------------------------------------- Test
MP EP notes
----------------------------------------------------------------------------------------------------------------
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 sample R TGAI.............. TGAI.............. 3
in a nationally
recognized culture
collection.
885.1300............ Discussion of formation R TGAI and MP....... TGAI and EP....... 2
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 limits R MP................ EP................ .......
----------------------------------------------------------------------------------------------------------------

[[Page 52614]]

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 and R TGAI.............. TGAI.............. .......
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. 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. 2012-21430 Filed 8-29-12; 8:45 am]
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