Document ID: EPA-HQ-OPPT-2014-0766-0018
Agency: epa
Document Type: Notice
Title: Endocrine Disruptor Screening Program Test Guidelines: Three Tier 2 Non-Mammalian Tests
Posted Date: 2015-08-25T04:00Z

[Federal Register Volume 80, Number 164 (Tuesday, August 25, 2015)]
[Notices]
[Pages 51558-51560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21040]

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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.

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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: matten.sharlene@epa.gov or Jane Robbins, 
telephone number: (202) 564-6625; email address: robbins.jane@epa.gov, 
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.gpo.gov/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]
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