[Federal Register Volume 77, Number 169 (Thursday, August 30, 2012)]
[Rules and Regulations]
[Pages 52610-52614]
From the Federal Register Online via the Government Publishing 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: [email protected].

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.

    (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 experimental use permit microbial pesticides product analysis. The 
test notes are shown in paragraph (d) of this section.

                       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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