80_FR_51722 80 FR 51558 - Final Test Guidelines; Endocrine Disruptor Screening Program Test Guidelines (Series 890); Three Tier 2 Non-Mammalian Tests; Notice of Availability

80 FR 51558 - Final Test Guidelines; Endocrine Disruptor Screening Program Test Guidelines (Series 890); Three Tier 2 Non-Mammalian Tests; Notice of Availability

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 164 (August 25, 2015)

Page Range51558-51560
FR Document2015-21040

EPA is announcing the availability of three Office of Chemical Safety and Pollution Prevention (OCSPP) final test guidelines: Medaka Extended One-generation Reproduction Test (MEOGRT), OCSPP Test Guideline 890.2200; Larval Amphibian Growth and Development Assay (LAGDA), OCSPP Test Guideline 890.2300; and Avian Two-generation Toxicity Test in the Japanese Quail (JQTT), OCSPP Test Guideline 890.2100. These test guidelines are part of a series of test guidelines established by OCSPP for use in testing pesticides and chemical substances. The test guidelines serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions. The test guidelines provide guidance for conducting the test and are also used by EPA, the public, and companies that submit data to EPA.

Federal Register, Volume 80 Issue 164 (Tuesday, August 25, 2015)
[Federal Register Volume 80, Number 164 (Tuesday, August 25, 2015)]
[Notices]
[Pages 51558-51560]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-21040]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2014-0766; FRL-9931-05]


Final Test Guidelines; Endocrine Disruptor Screening Program Test 
Guidelines (Series 890); Three Tier 2 Non-Mammalian Tests; Notice of 
Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: EPA is announcing the availability of three Office of Chemical 
Safety and Pollution Prevention (OCSPP) final test guidelines: Medaka 
Extended One-generation Reproduction Test (MEOGRT), OCSPP Test 
Guideline 890.2200; Larval Amphibian Growth and Development Assay 
(LAGDA), OCSPP Test Guideline 890.2300; and Avian Two-generation 
Toxicity Test in the Japanese Quail (JQTT), OCSPP Test Guideline 
890.2100. These test guidelines are part of a series of test guidelines 
established by OCSPP for use in testing pesticides and chemical 
substances. The test guidelines serve as a compendium of accepted 
scientific methodologies and protocols that are intended to provide 
data to inform regulatory decisions. The test guidelines provide 
guidance for conducting the test and are also used by EPA, the public, 
and companies that submit data to EPA.

FOR FURTHER INFORMATION CONTACT: Sharlene Matten, telephone number: 
(202) 564-0130, email address: [email protected] or Jane Robbins, 
telephone number: (202) 564-6625; email address: [email protected], 
Office of Science Coordination and Policy (7201M), Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001.

SUPPLEMENTARY INFORMATION:

I. Introduction

    EPA is announcing the availability of three final test guidelines: 
Medaka Extended One-generation Reproduction Test (MEOGRT), OCSPP Test 
Guideline 890.2200; Larval Amphibian Growth and Development Assay 
(LAGDA), OCSPP Test Guideline 890.2300; and Avian Two-generation 
Toxicity Test in the Japanese Quail (JQTT), OCSPP Test Guideline 
890.2100. These test guidelines are part of a series of test guidelines 
established by OCSPP for use in testing pesticides and chemical 
substances to develop data for submission to the Agency under the 
Federal Food, Drug, and Cosmetic Act (FFDCA) section 408 (21 U.S.C. 
346a), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
(7 U.S.C. 136 et seq.), and the Toxic Substances Control Act (TSCA) (15 
U.S.C. 2601 et seq.). The test guidelines serve as a compendium of 
accepted scientific methodologies and protocols that are intended to 
provide data to inform regulatory decisions under TSCA, FIFRA, and/or 
FFDCA.
    The test guidelines provide guidance for conducting the test and 
are also used by EPA, the public, and companies that are subject to 
data submission requirements under TSCA, FIFRA, and/or FFDCA. As 
guidance documents, the test guidelines are not binding on either EPA 
or any outside parties and EPA may depart from the test guidelines 
where circumstances warrant and without prior notice. At places in this 
guidance, the Agency uses the word ``should.'' In this guidance, use of 
``should'' with regard to an action means that the action is 
recommended rather than mandatory. The procedures contained in the test 
guidelines are recommended for generating the data that are the subject 
of the test guideline, but EPA recognizes that departures may be 
appropriate in specific situations. You may propose alternatives to the 
recommendations described in the test guidelines and the Agency will 
assess them for appropriateness on a case-by-case basis.

II. General Information

A. Does this action apply to me?

    This action is directed to the public in general. Although this 
action may be of particular interest to those persons who are or may be 
required to conduct testing of pesticides and chemical substances for 
submission to EPA under TSCA, FIFRA, and/or FFDCA, the Agency has not 
attempted to describe all the specific entities that may be affected by 
this action.

B. How can I get copies of this document and other related information?

    1. Docket for this document. The docket for this action, identified 
by docket identification (ID) number EPA-HQ-OPPT-2014-0766 is available 
at http://www.regulations.gov or at the Office of Pollution Prevention 
and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket 
Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., 
Washington, DC. 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 OPPT Docket is (202) 566-0280. Please review the visitor 
instructions and additional information about the docket available at 
http://www.epa.gov/dockets.
    2. Electronic access to the OCSPP test guidelines. To access OCSPP 
test guidelines electronically, please go to http://www.epa.gov/ocspp/pubs/frs/home/testmeth.htm. 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.

III. Overview

A. What action is EPA taking?

    EPA is announcing the availability of three final test guidelines 
that are being added to its 890 Series, entitled ``Endocrine Disruptor 
Screening Program Test Guidelines'' and identified as follows:
    1. OCSPP Test Guideline 890.2200, entitled Endocrine Disruptor 
Screening Program Test Guidelines; Medaka Extended One-generation 
Reproduction Test.
    2. OCSPP Test Guideline 890.2300, entitled Endocrine Disruptor 
Screening Program Test Guidelines; Larval Amphibian Growth and 
Development Assay.
    3. OCSPP Test Guideline 890.2100, entitled Endocrine Disruptor 
Screening

[[Page 51559]]

Program Test Guidelines; Avian Two-generation Toxicity Test in the 
Japanese Quail.

B. How Were These Final Test Guidelines Developed?

    On January 30, 2015, the Agency released three draft non-mammalian 
test guidelines for public review and comment as described in a Federal 
Register notice (80 FR 5107) (FRL-9919-43) (Ref. 1). These three draft 
test guidelines were subsequently revised based on public comments, 
existing EPA test guidelines, and concurrent Organisation for Economic 
Co-operation and Development (OECD) test guidelines for MEOGRT (Ref. 2) 
and LAGDA (Ref. 3).
    Comments were submitted by representatives from the following 
organizations: Endocrine Policy Forum, SynTech Research Laboratory 
Services, American Petroleum Institute, Wildlife International, People 
for Ethical Treatment of Animals, the Physicians Committee for 
Responsible Medicine, and the Humane Society of the United States. 
Comments were grouped according to each test guidelines: JQTT 
(890.2100), MEOGRT (890.2200) and LAGDA (890.2300).
    EPA worked with the OECD to harmonize test guidelines for MEOGRT 
(Ref. 2) and LAGDA (Ref. 3). The OECD test guidelines were approved at 
the Working Group of National Coordinators of the Test Guidelines 
Programme (WNT) and endorsed by the Joint Meeting of the Chemicals 
Committee and the Working Party on Chemicals, Pesticides and 
Biotechnology in June 2015 prior to EPA finalizing the U.S. MEOGRT and 
LAGDA test guidelines. EPA revised the terminology, procedures, and 
statistical practices to harmonize the MEOGRT and LAGDA test guidelines 
with analogous OECD's test guidelines and at the same time incorporated 
public comments received that were not already addressed in the 
harmonization.
    A summary of the substantive changes reflected in the final U.S. 
MEOGRT and LAGDA test guidelines is provided:
    1. The option for extending the MEOGRT through F2 generation 
reproduction has been removed from the final test guideline pending 
additional data. The test will end following hatching of the F2 
offspring. This is consistent with the decision made in the draft OECD 
test guideline for MEOGRT. This test guideline may be updated as new 
information and data are considered. For example, guidance on extending 
the F2 generation through reproduction may be potentially useful under 
certain circumstances (e.g., chemicals with high bioconcentration 
potential or indications of trans-generational effects in other taxa).
    2. The mean water temperature over the duration of the MEOGRT has 
been changed to 25  2 [deg]C to be consistent with the 
analogous OECD test guideline.
    3. The LAGDA developmental stage terminology has been clarified to 
avoid confusion with what is meant by complete metamorphosis.
    4. Clarified the conduct of liver and kidney histopathology in the 
MEOGRT and LAGDA test guidelines for overt toxicity. An effort was made 
to clarify and provide more explicit guidance as to what specific 
histopathology is appropriate based on the results of the study.
    5. The rationale for use of solvent control only, dilution water 
control only, or pooled controls in the statistical analyses for the 
MEOGRT and LAGDA was clarified.
    6. The guidelines have been modified to address commenters' 
concerns that they be more flexible and less prescriptive. Examples 
have been provided as appropriate to add clarity.
    The JQTT draft test guideline (OCSPP 890.2100) was revised to 
address comments provided by the public, the draft OECD test guideline 
for the avian two-generation toxicity test in the Japanese quail (Ref. 
4), as well as the existing EPA and OECD test guidelines for avian one-
generation toxicity tests (Refs. 5 and 6). EPA revised the terminology, 
procedures, endpoints measured, figures, tables, and appendices in the 
JQTT test guideline to clarify specific points raised by public 
commenters as follows:
    1. The revised test guidelines include fewer endpoints. For 
example, the revisions eliminated behavioral endpoints to reduce the 
overall numbers of birds required for the study; eliminated endpoints 
that are difficult to obtain (i.e., hormone levels measured in embryo 
blood samples); eliminated redundant endpoints; and statistical 
analyses.
    2. For clarity, the test termination point is following measurement 
of the 14-day survival of filial 2 (F2) generation chicks. This is the 
minimum length of the study necessary to evaluate and measure a 
chemical's effect on the F1 generation's reproductive performance. If 
delayed reproduction is observed in F1 birds, a decision to extend the 
F2 generation may be made. If extended, the test should be terminated 
when F2 birds are approximately 6 weeks old when 90% of control animals 
have reached sexual maturity. The decision to limit the length of the 
JQTT is consistent with EPA's efforts to move to extended one-
generation reproduction test protocols for Tier 2 tests rather than 
multigenerational studies (Ref. 7). Extended one-generation 
reproduction tests are technically sound, save animals, and reduce 
costs.
    3. The guidelines have been modified to address commenters' 
concerns that they be more flexible and less prescriptive. Examples 
have been provided as appropriate to add clarity.

IV. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are in the docket, even if the 
referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the 
persons listed under FOR FURTHER INFORMATION CONTACT.
    1. EPA Draft Test Guidelines; Endocrine Disruptor Screening Program 
Test Guidelines (Series 890); Three Tier 2 Non-Mammalian Tests; Notice 
of Availability and Public Comment, Federal Register (80 FR 5107, 
January 30, 2015). It is available at http://www.thefederalregister.org/fdsys/pkg/FR-2015-01-30/pdf/2015-01836.pdf.
    2. OECD, Test No. 240: Medaka Extended One-Generation Reproduction 
Test, OECD Guidelines for the Testing of Chemicals, section 2 (2015). 
It is available at http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals-section-2-effects-on-biotic-systems_20745761.
    3. OECD, Test No. 241: Larval Amphibian Growth and Development 
Test, OECD Guidelines for the Testing of Chemicals, section 2 (2015). 
It is available at http://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals-section-2-effects-on-biotic-systems_20745761.
    4. OECD Guidelines for Testing of Chemicals. Proposal for a new 
test guideline: Avian Two-generation Toxicity Test in the Japanese 
Quail, Draft November 2005. It is available at http://www.epa.gov/endo/pubs/edmvac/2gen_guide_gd_draft1.pdf.
    5. U.S. EPA Ecological Effects Test Guidelines; OCSPP 850.2300, 
Avian Reproduction Test. January 2012. EPA 712C-023. It is available at 
http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series850.htm.

[[Page 51560]]

    6. OECD, Test No. 206: Avian Reproduction Test. OECD Guidelines for 
the Testing of Chemicals, section 2--Effect on Biotic Systems (adopted 
1984). OECD Publishing, Paris (1993) DOI: It is available at http://dx.doi.org/10.1787/9789264070028-en.
    7. OECD, Test No. 443: Extended One-Generation Reproductive 
Toxicity Study, OECD Guidelines for the Testing of Chemicals, section 
4, 28 July 2011, DOI. It is available at http://dx.doi.org/10.1787/9789264122550-en.

    Authority: 7 U.S.C. 136 et seq.; 15 U.S.C. 2601 et seq.; 21 
U.S.C. 301 et seq.

    Dated: August 18, 2015.
Louise P. Wise,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2015-21040 Filed 8-24-15; 8:45 am]
BILLING CODE 6560-50-P



                                                    51558                        Federal Register / Vol. 80, No. 164 / Tuesday, August 25, 2015 / Notices

                                                       General Information: The agenda will                 (202) 564–0130, email address:                        II. General Information
                                                    be available at http://www2.epa.gov/                    matten.sharlene@epa.gov or Jane
                                                                                                                                                                  A. Does this action apply to me?
                                                    faca/gneb. General information about                    Robbins, telephone number: (202) 564–
                                                    the Board can be found on its Web site                  6625; email address: robbins.jane@                      This action is directed to the public
                                                    at http://www2.epa.gov/faca/gneb. If                    epa.gov, Office of Science Coordination               in general. Although this action may be
                                                    you wish to make oral comments or                       and Policy (7201M), Environmental                     of particular interest to those persons
                                                    submit written comments to the Board,                                                                         who are or may be required to conduct
                                                                                                            Protection Agency, 1200 Pennsylvania
                                                    please contact Ann-Marie Gantner at                                                                           testing of pesticides and chemical
                                                                                                            Ave. NW., Washington, DC 20460–0001.
                                                    least five days prior to the meeting.                                                                         substances for submission to EPA under
                                                    Written comments should be submitted                    SUPPLEMENTARY INFORMATION:                            TSCA, FIFRA, and/or FFDCA, the
                                                    Ann-Marie Gantner at gantner.ann-                                                                             Agency has not attempted to describe all
                                                                                                            I. Introduction                                       the specific entities that may be affected
                                                    marie@epa.gov.
                                                       Meeting Access: For information on                      EPA is announcing the availability of              by this action.
                                                    access or services for individuals with                 three final test guidelines: Medaka                   B. How can I get copies of this document
                                                    disabilities, please contact Ann-Marie                  Extended One-generation Reproduction                  and other related information?
                                                    Gantner at (202) 564–4330 or email at                   Test (MEOGRT), OCSPP Test Guideline
                                                    gantner.ann-marie@epa.gov. To request                                                                           1. Docket for this document. The
                                                                                                            890.2200; Larval Amphibian Growth                     docket for this action, identified by
                                                    accommodation of a disability, please                   and Development Assay (LAGDA),
                                                    contact Ann-Marie Gantner at least 10                                                                         docket identification (ID) number EPA–
                                                                                                            OCSPP Test Guideline 890.2300; and                    HQ–OPPT–2014–0766 is available at
                                                    days prior to the meeting to give EPA as                Avian Two-generation Toxicity Test in                 http://www.regulations.gov or at the
                                                    much time as possible to process your
                                                                                                            the Japanese Quail (JQTT), OCSPP Test                 Office of Pollution Prevention and
                                                    request.
                                                                                                            Guideline 890.2100. These test                        Toxics Docket (OPPT Docket),
                                                     Dated: August 18, 2015.                                guidelines are part of a series of test               Environmental Protection Agency
                                                    Ann-Marie Gantner,                                      guidelines established by OCSPP for use               Docket Center (EPA/DC), EPA West
                                                    Acting Designated Federal Officer.                      in testing pesticides and chemical                    Bldg., Rm. 3334, 1301 Constitution Ave.
                                                    [FR Doc. 2015–21016 Filed 8–24–15; 8:45 am]             substances to develop data for                        NW., Washington, DC. The Public
                                                    BILLING CODE 6560–50–P                                  submission to the Agency under the                    Reading Room is open from 8:30 a.m. to
                                                                                                            Federal Food, Drug, and Cosmetic Act                  4:30 p.m., Monday through Friday,
                                                                                                            (FFDCA) section 408 (21 U.S.C. 346a),                 excluding legal holidays. The telephone
                                                    ENVIRONMENTAL PROTECTION                                the Federal Insecticide, Fungicide, and               number for the Public Reading Room is
                                                    AGENCY                                                                                                        (202) 566–1744 and the telephone
                                                                                                            Rodenticide Act (FIFRA) (7 U.S.C. 136
                                                                                                                                                                  number for the OPPT Docket is (202)
                                                    [EPA–HQ–OPPT–2014–0766; FRL–9931–05]                    et seq.), and the Toxic Substances
                                                                                                                                                                  566–0280. Please review the visitor
                                                                                                            Control Act (TSCA) (15 U.S.C. 2601 et                 instructions and additional information
                                                    Final Test Guidelines; Endocrine                        seq.). The test guidelines serve as a
                                                    Disruptor Screening Program Test                                                                              about the docket available at http://
                                                                                                            compendium of accepted scientific                     www.epa.gov/dockets.
                                                    Guidelines (Series 890); Three Tier 2                   methodologies and protocols that are                    2. Electronic access to the OCSPP test
                                                    Non-Mammalian Tests; Notice of                          intended to provide data to inform                    guidelines. To access OCSPP test
                                                    Availability                                            regulatory decisions under TSCA,                      guidelines electronically, please go to
                                                    AGENCY: Environmental Protection                        FIFRA, and/or FFDCA.                                  http://www.epa.gov/ocspp/pubs/frs/
                                                    Agency (EPA).                                              The test guidelines provide guidance               home/testmeth.htm. You may also
                                                    ACTION: Notice.                                         for conducting the test and are also used             access the test guidelines in http://
                                                                                                            by EPA, the public, and companies that                www.regulations.gov, grouped by series
                                                    SUMMARY:   EPA is announcing the                                                                              under docket ID numbers: EPA–HQ–
                                                                                                            are subject to data submission
                                                    availability of three Office of Chemical                                                                      OPPT–2009–0150 through EPA–HQ–
                                                    Safety and Pollution Prevention                         requirements under TSCA, FIFRA, and/
                                                                                                                                                                  OPPT–2009–0159 and EPA–HQ–OPPT–
                                                    (OCSPP) final test guidelines: Medaka                   or FFDCA. As guidance documents, the
                                                                                                                                                                  2009–0576.
                                                    Extended One-generation Reproduction                    test guidelines are not binding on either
                                                    Test (MEOGRT), OCSPP Test Guideline                     EPA or any outside parties and EPA                    III. Overview
                                                    890.2200; Larval Amphibian Growth                       may depart from the test guidelines                   A. What action is EPA taking?
                                                    and Development Assay (LAGDA),                          where circumstances warrant and
                                                                                                            without prior notice. At places in this                  EPA is announcing the availability of
                                                    OCSPP Test Guideline 890.2300; and                                                                            three final test guidelines that are being
                                                    Avian Two-generation Toxicity Test in                   guidance, the Agency uses the word
                                                                                                                                                                  added to its 890 Series, entitled
                                                    the Japanese Quail (JQTT), OCSPP Test                   ‘‘should.’’ In this guidance, use of
                                                                                                                                                                  ‘‘Endocrine Disruptor Screening
                                                    Guideline 890.2100. These test                          ‘‘should’’ with regard to an action
                                                                                                                                                                  Program Test Guidelines’’ and identified
                                                    guidelines are part of a series of test                 means that the action is recommended                  as follows:
                                                    guidelines established by OCSPP for use                 rather than mandatory. The procedures                    1. OCSPP Test Guideline 890.2200,
                                                    in testing pesticides and chemical                      contained in the test guidelines are                  entitled Endocrine Disruptor Screening
                                                    substances. The test guidelines serve as                recommended for generating the data                   Program Test Guidelines; Medaka
                                                    a compendium of accepted scientific                     that are the subject of the test guideline,
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                                                                                                                                  Extended One-generation Reproduction
                                                    methodologies and protocols that are                    but EPA recognizes that departures may                Test.
                                                    intended to provide data to inform                      be appropriate in specific situations.                   2. OCSPP Test Guideline 890.2300,
                                                    regulatory decisions. The test guidelines               You may propose alternatives to the                   entitled Endocrine Disruptor Screening
                                                    provide guidance for conducting the test                recommendations described in the test                 Program Test Guidelines; Larval
                                                    and are also used by EPA, the public,                   guidelines and the Agency will assess                 Amphibian Growth and Development
                                                    and companies that submit data to EPA.                  them for appropriateness on a case-by-                Assay.
                                                    FOR FURTHER INFORMATION CONTACT:                        case basis.                                              3. OCSPP Test Guideline 890.2100,
                                                    Sharlene Matten, telephone number:                                                                            entitled Endocrine Disruptor Screening


                                               VerDate Sep<11>2014   17:10 Aug 24, 2015   Jkt 235001   PO 00000   Frm 00028   Fmt 4703   Sfmt 4703   E:\FR\FM\25AUN1.SGM   25AUN1


                                                                                 Federal Register / Vol. 80, No. 164 / Tuesday, August 25, 2015 / Notices                                         51559

                                                    Program Test Guidelines; Avian Two-                     chemicals with high bioconcentration                  EPA’s efforts to move to extended one-
                                                    generation Toxicity Test in the Japanese                potential or indications of trans-                    generation reproduction test protocols
                                                    Quail.                                                  generational effects in other taxa).                  for Tier 2 tests rather than
                                                                                                               2. The mean water temperature over                 multigenerational studies (Ref. 7).
                                                    B. How Were These Final Test                            the duration of the MEOGRT has been                   Extended one-generation reproduction
                                                    Guidelines Developed?                                   changed to 25 ± 2 °C to be consistent                 tests are technically sound, save
                                                       On January 30, 2015, the Agency                      with the analogous OECD test guideline.               animals, and reduce costs.
                                                    released three draft non-mammalian test                    3. The LAGDA developmental stage                     3. The guidelines have been modified
                                                    guidelines for public review and                        terminology has been clarified to avoid               to address commenters’ concerns that
                                                    comment as described in a Federal                       confusion with what is meant by                       they be more flexible and less
                                                    Register notice (80 FR 5107) (FRL–                      complete metamorphosis.                               prescriptive. Examples have been
                                                    9919–43) (Ref. 1). These three draft test                  4. Clarified the conduct of liver and              provided as appropriate to add clarity.
                                                    guidelines were subsequently revised                    kidney histopathology in the MEOGRT
                                                    based on public comments, existing                      and LAGDA test guidelines for overt                   IV. References
                                                    EPA test guidelines, and concurrent                     toxicity. An effort was made to clarify                  The following is a listing of the
                                                    Organisation for Economic Co-operation                  and provide more explicit guidance as                 documents that are specifically
                                                    and Development (OECD) test                             to what specific histopathology is                    referenced in this document. The docket
                                                    guidelines for MEOGRT (Ref. 2) and                      appropriate based on the results of the               includes these documents and other
                                                    LAGDA (Ref. 3).                                         study.                                                information considered by EPA,
                                                       Comments were submitted by                              5. The rationale for use of solvent
                                                                                                                                                                  including documents that are referenced
                                                    representatives from the following                      control only, dilution water control
                                                                                                                                                                  within the documents that are in the
                                                    organizations: Endocrine Policy Forum,                  only, or pooled controls in the statistical
                                                                                                                                                                  docket, even if the referenced document
                                                    SynTech Research Laboratory Services,                   analyses for the MEOGRT and LAGDA
                                                                                                                                                                  is not physically located in the docket.
                                                    American Petroleum Institute, Wildlife                  was clarified.
                                                                                                               6. The guidelines have been modified               For assistance in locating these other
                                                    International, People for Ethical
                                                                                                            to address commenters’ concerns that                  documents, please consult the persons
                                                    Treatment of Animals, the Physicians
                                                                                                            they be more flexible and less                        listed under FOR FURTHER INFORMATION
                                                    Committee for Responsible Medicine,
                                                                                                                                                                  CONTACT.
                                                    and the Humane Society of the United                    prescriptive. Examples have been
                                                    States. Comments were grouped                           provided as appropriate to add clarity.                  1. EPA Draft Test Guidelines;
                                                    according to each test guidelines: JQTT                    The JQTT draft test guideline (OCSPP               Endocrine Disruptor Screening Program
                                                    (890.2100), MEOGRT (890.2200) and                       890.2100) was revised to address                      Test Guidelines (Series 890); Three Tier
                                                    LAGDA (890.2300).                                       comments provided by the public, the                  2 Non-Mammalian Tests; Notice of
                                                       EPA worked with the OECD to                          draft OECD test guideline for the avian               Availability and Public Comment,
                                                    harmonize test guidelines for MEOGRT                    two-generation toxicity test in the                   Federal Register (80 FR 5107, January
                                                    (Ref. 2) and LAGDA (Ref. 3). The OECD                   Japanese quail (Ref. 4), as well as the               30, 2015). It is available at http://
                                                    test guidelines were approved at the                    existing EPA and OECD test guidelines                 www.gpo.gov/fdsys/pkg/FR-2015-01-30/
                                                    Working Group of National                               for avian one-generation toxicity tests               pdf/2015-01836.pdf.
                                                    Coordinators of the Test Guidelines                     (Refs. 5 and 6). EPA revised the                         2. OECD, Test No. 240: Medaka
                                                    Programme (WNT) and endorsed by the                     terminology, procedures, endpoints                    Extended One-Generation Reproduction
                                                    Joint Meeting of the Chemicals                          measured, figures, tables, and                        Test, OECD Guidelines for the Testing of
                                                    Committee and the Working Party on                      appendices in the JQTT test guideline to              Chemicals, section 2 (2015). It is
                                                    Chemicals, Pesticides and                               clarify specific points raised by public              available at http://www.oecd-
                                                    Biotechnology in June 2015 prior to EPA                 commenters as follows:                                ilibrary.org/environment/oecd-
                                                    finalizing the U.S. MEOGRT and                             1. The revised test guidelines include             guidelines-for-the-testing-of-chemicals-
                                                    LAGDA test guidelines. EPA revised the                  fewer endpoints. For example, the                     section-2-effects-on-biotic-systems_
                                                    terminology, procedures, and statistical                revisions eliminated behavioral                       20745761.
                                                    practices to harmonize the MEOGRT                       endpoints to reduce the overall numbers                  3. OECD, Test No. 241: Larval
                                                    and LAGDA test guidelines with                          of birds required for the study;                      Amphibian Growth and Development
                                                    analogous OECD’s test guidelines and at                 eliminated endpoints that are difficult               Test, OECD Guidelines for the Testing of
                                                    the same time incorporated public                       to obtain (i.e., hormone levels measured              Chemicals, section 2 (2015). It is
                                                    comments received that were not                         in embryo blood samples); eliminated                  available at http://www.oecd-
                                                    already addressed in the harmonization.                 redundant endpoints; and statistical                  ilibrary.org/environment/oecd-
                                                       A summary of the substantive changes                 analyses.                                             guidelines-for-the-testing-of-chemicals-
                                                    reflected in the final U.S. MEOGRT and                     2. For clarity, the test termination               section-2-effects-on-biotic-systems_
                                                    LAGDA test guidelines is provided:                      point is following measurement of the                 20745761.
                                                       1. The option for extending the                      14–day survival of filial 2 (F2)                         4. OECD Guidelines for Testing of
                                                    MEOGRT through F2 generation                            generation chicks. This is the minimum                Chemicals. Proposal for a new test
                                                    reproduction has been removed from                      length of the study necessary to evaluate             guideline: Avian Two-generation
                                                    the final test guideline pending                        and measure a chemical’s effect on the                Toxicity Test in the Japanese Quail,
                                                    additional data. The test will end                      F1 generation’s reproductive                          Draft November 2005. It is available at
                                                    following hatching of the F2 offspring.                 performance. If delayed reproduction is               http://www.epa.gov/endo/pubs/edmvac/
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    This is consistent with the decision                    observed in F1 birds, a decision to                   2gen_guide_gd_draft1.pdf.
                                                    made in the draft OECD test guideline                   extend the F2 generation may be made.                    5. U.S. EPA Ecological Effects Test
                                                    for MEOGRT. This test guideline may be                  If extended, the test should be                       Guidelines; OCSPP 850.2300, Avian
                                                    updated as new information and data                     terminated when F2 birds are                          Reproduction Test. January 2012. EPA
                                                    are considered. For example, guidance                   approximately 6 weeks old when 90%                    712C–023. It is available at http://
                                                    on extending the F2 generation through                  of control animals have reached sexual                www.epa.gov/ocspp/pubs/frs/
                                                    reproduction may be potentially useful                  maturity. The decision to limit the                   publications/Test_Guidelines/
                                                    under certain circumstances (e.g.,                      length of the JQTT is consistent with                 series850.htm.


                                               VerDate Sep<11>2014   17:10 Aug 24, 2015   Jkt 235001   PO 00000   Frm 00029   Fmt 4703   Sfmt 4703   E:\FR\FM\25AUN1.SGM   25AUN1


                                                    51560                        Federal Register / Vol. 80, No. 164 / Tuesday, August 25, 2015 / Notices

                                                      6. OECD, Test No. 206: Avian                          www.epa.gov/dockets/contacts.html.                    comments, see the commenting tips at
                                                    Reproduction Test. OECD Guidelines for                  Additional instructions on commenting                 http://www.epa.gov/dockets/
                                                    the Testing of Chemicals, section 2—                    or visiting the docket, along with more               comments.html.
                                                    Effect on Biotic Systems (adopted 1984).                information about dockets generally, is                  3. Environmental justice. EPA seeks to
                                                    OECD Publishing, Paris (1993) DOI: It is                available at http://www.epa.gov/                      achieve environmental justice, the fair
                                                    available at http://dx.doi.org/10.1787/                 dockets.                                              treatment and meaningful involvement
                                                    9789264070028-en.                                       FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                                  of any group, including minority and/or
                                                      7. OECD, Test No. 443: Extended One-                  Robert McNally, Director, Biopesticides               low-income populations, in the
                                                    Generation Reproductive Toxicity                        and Pollution Prevention Division                     development, implementation, and
                                                    Study, OECD Guidelines for the Testing                  (BPPD) (7511P), Office of Pesticide                   enforcement of environmental laws,
                                                    of Chemicals, section 4, 28 July 2011,                                                                        regulations, and policies. To help
                                                                                                            Programs, Environmental Protection
                                                    DOI. It is available at http://dx.doi.org/                                                                    address potential environmental justice
                                                                                                            Agency, 1200 Pennsylvania Ave. NW.,
                                                    10.1787/9789264122550-en.                                                                                     issues, EPA seeks information on any
                                                                                                            Washington, DC 20460–0001; main
                                                                                                                                                                  groups or segments of the population
                                                      Authority: 7 U.S.C. 136 et seq.; 15 U.S.C.            telephone number: (703) 305–7090;
                                                    2601 et seq.; 21 U.S.C. 301 et seq.                                                                           who, as a result of their location,
                                                                                                            email address: BPPDFRNotices@
                                                                                                                                                                  cultural practices, or other factors, may
                                                      Dated: August 18, 2015.                               epa.gov.
                                                                                                                                                                  have atypical or disproportionately high
                                                    Louise P. Wise,                                         SUPPLEMENTARY INFORMATION:                            and adverse human health impacts or
                                                    Assistant Administrator, Office of Chemical                                                                   environmental effects from exposure to
                                                                                                            I. General Information
                                                    Safety and Pollution Prevention.                                                                              the pesticides discussed in this
                                                                                              A. Does this action apply to me?
                                                    [FR Doc. 2015–21040 Filed 8–24–15; 8:45 am]                                                                   document, compared to the general
                                                    BILLING CODE 6560–50–P                       You may be potentially affected by                               population.
                                                                                              this action if you are an agricultural                              II. Registration Applications
                                                                                              producer, food manufacturer, or
                                                    ENVIRONMENTAL PROTECTION                  pesticide manufacturer. The following                                  EPA has received applications to
                                                    AGENCY                                    list of North American Industrial                                   register pesticide products containing
                                                                                              Classification System (NAICS) codes is                              active ingredients not included in any
                                                    [EPA–HQ–OPP–2015–0021; FRL–9932–68]
                                                                                              not intended to be exhaustive, but rather                           currently registered pesticide products.
                                                    Pesticide Product Registrations;          provides a guide to help readers                                    Pursuant to the provisions of FIFRA
                                                    Receipt of Applications for New Active determine whether this document                                        section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA
                                                    Ingredients                               applies to them. Potentially affected                               is hereby providing notice of receipt and
                                                                                              entities may include:                                               opportunity to comment on these
                                                    AGENCY: Environmental Protection                                                                              applications. Notice of receipt of these
                                                                                                 • Crop production (NAICS code 111).
                                                    Agency (EPA).                                • Animal production (NAICS code                                  applications does not imply a decision
                                                    ACTION: Notice.                           112).                                                               by EPA on these applications. For
                                                                                                 • Food manufacturing (NAICS code                                 actions being evaluated under EPA’s
                                                    SUMMARY: EPA has received applications                                                                        public participation process for
                                                                                              311).
                                                    to register pesticide products containing    • Pesticide manufacturing (NAICS                                 registration actions, there will be an
                                                    active ingredients not included in any    code 32532).                                                        additional opportunity for public
                                                    currently registered pesticide products.     If you have any questions regarding                              comment on the proposed decisions.
                                                    Pursuant to the Federal Insecticide,      the applicability of this action to a                               Please see EPA’s public participation
                                                    Fungicide, and Rodenticide Act            particular entity, consult the person                               Web site for additional information on
                                                    (FIFRA), EPA is hereby providing notice listed under FOR FURTHER INFORMATION                                  this process http://www2.epa.gov/
                                                    of receipt and opportunity to comment     CONTACT.                                                            pesticide-registration/public-
                                                    on these applications.                                                                                        participation-process-registration-
                                                    DATES: Comments must be received on       B. What should I consider as I prepare                              actions. EPA received the following
                                                    or before September 24, 2015.             my comments for EPA?                                                applications to register pesticide
                                                    ADDRESSES: Submit your comments,             1. Submitting CBI. Do not submit this                            products containing active ingredients
                                                    identified by the Docket Identification   information to EPA through                                          not included in any currently registered
                                                    (ID) Number and the File Symbol of        regulations.gov or email. Clearly mark                              pesticide products:
                                                    interest as shown in the body of this     the part or all of the information that                                1. File Symbol: 87472–R. Docket ID
                                                    document, by one of the following         you claim to be CBI. For CBI                                        number: EPA–HQ–OPP–2015–0547.
                                                    methods:                                  information in a disk or CD–ROM that                                Applicant: Technology Sciences Group,
                                                      • Federal eRulemaking Portal: http:// you mail to EPA, mark the outside of the                              Inc., 712 Fifth St., Ste. A, Davis, CA
                                                    www.regulations.gov. Follow the online disk or CD–ROM as CBI and then                                         95616 (on behalf of Biogents AG,
                                                    instructions for submitting comments.     identify electronically within the disk or                          Weissenburgstrasse 22, D–93055
                                                    Do not submit electronically any          CD–ROM the specific information that                                Regensburg, Germany). Product name:
                                                    information you consider to be            is claimed as CBI. In addition to one                               BG-Sweetscent. Active ingredient:
                                                    Confidential Business Information (CBI) complete version of the comment that                                  Insecticide—Hexanoic acid at 0.900%.
                                                    or other information whose disclosure is includes information claimed as CBI, a                               Proposed use: Mosquito lure. Contact:
                                                                                              copy of the comment that does not                                   BPPD.
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    restricted by statute.
                                                      • Mail: OPP Docket, Environmental       contain the information claimed as CBI                                 2. File Symbol: 87978–G. Docket ID
                                                    Protection Agency Docket Center (EPA/     must be submitted for inclusion in the                              number: EPA–HQ–OPP–2015–0494.
                                                    DC), (28221T), 1200 Pennsylvania Ave.     public docket. Information so marked                                Applicant: MacIntosh and Associates,
                                                    NW., Washington, DC 20460–0001.           will not be disclosed except in                                     Inc., 1203 Hartford Ave., St. Paul, MN
                                                      • Hand Delivery: To make special        accordance with procedures set forth in                             55116–1622 (on behalf of AgBiTech Pty
                                                    arrangements for hand delivery or         40 CFR part 2.                                                      Ltd, 8 Rocla Ct., Glenvale, Queensland
                                                    delivery of boxed information, please        2. Tips for preparing your comments.                             4350, Australia). Product name:
                                                    follow the instructions at http://        When preparing and submitting your                                  Spodoptera frugiperda Multiple


                                               VerDate Sep<11>2014   17:10 Aug 24, 2015   Jkt 235001   PO 00000   Frm 00030   Fmt 4703   Sfmt 4703   E:\FR\FM\25AUN1.SGM   25AUN1



Document Created: 2018-02-23 11:02:59
Document Modified: 2018-02-23 11:02:59
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactSharlene Matten, telephone number:
FR Citation80 FR 51558 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR