[Federal Register Volume 80, Number 20 (Friday, January 30, 2015)]
[Notices]
[Pages 5107-5109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01836]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2014-0766; FRL-9919-43]
Draft Test Guidelines; Endocrine Disruptor Screening Program Test
Guidelines (Series 890); Three Tier 2 Non-Mammalian Tests; Notice of
Availability and Request for Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is announcing the availability of three draft test
guidelines for public review and comment that are being added to its
890 Series, entitled ``Endocrine Disruptor Screening Program Test
Guidelines.'' The draft guidelines relate to the following three non-
mammalian species tests identified under Tier 2 of the Endocrine
Disruptor Screening Program (EDSP): Japanese quail 2-generation
reproduction test; Medaka extended 1-generation reproduction test; and
Larval amphibian growth and development assay. These draft test
guidelines are part of a series of test guidelines established by the
Office of Chemical Safety and Pollution Prevention (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.
DATES: Comments must be received on or before March 31, 2015.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2014-0766, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), U.S. Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Sharlene Matten, telephone number:
(202) 564-0130, email address: [email protected]; or Steven
Knott, telephone number: (202) 564-0103, email address:
[email protected]. Mailing address: 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 draft test guidelines
for public review and comment that are being added to its 890 Series,
entitled ``Endocrine Disruptor Screening Program Test Guidelines.'' The
draft guidelines relate to the following three non-mammalian species
tests identified under Tier 2 of the EDSP: Japanese quail 2-generation
reproduction test; Medaka
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extended 1-generation reproduction test; and Larval amphibian growth
and development assay.
These draft 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 (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. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
III. Overview
A. What is the EDSP?
The EDSP is established under FFDCA section 408(p), which requires
EPA to develop a chemical substance screening program using appropriate
validated test systems and other scientifically relevant information to
determine whether certain chemical substances may have hormonal
effects. The EDSP consists of a two-tiered approach to screen chemical
substances for potential endocrine disrupting effects. The purpose of
Tier 1 screening is to identify chemical substances that have the
potential to interact with the estrogen, androgen, or thyroid hormone
systems using a battery of assays. Chemical substances that have the
potential to interact with the estrogen, androgen or thyroid systems
may proceed to Tier 2 testing, which is designed to identify any
adverse endocrine-related effects caused by the chemical substance, and
to establish a quantitative relationship between the dose and that
endocrine effect. Additional information about the EDSP is available at
http://www.epa.gov/endo.
1. Tests considered for EDSP Tier 2. In the December 1998 EDSP
Policy Statement (Ref. 1), the Agency explained that the purpose of the
testing stage (Tier 2) is to characterize the likelihood, nature, and
dose-response relationship of any estrogen-, androgen-, and thyroid-
related effects caused by a chemical substance in humans or wildlife.
At that time, EPA identified the following non-mammalian tests under
Tier 2 of EDSP: Amphibian reproduction and developmental toxicity,
avian reproduction, fish reproduction, and invertebrate reproduction.
EPA followed the general validation principles of the Organization
for Economic Co-Operation and Development (OECD) and the
Intergovernmental Interagency Coordinating Committee on the Validation
of Alternative Methods (ICCVAM) in the development of the four non-
mammalian Tier 2 tests. In June 2013, the FIFRA Scientific Advisory
Panel (SAP), a Federal advisory committee chartered under the Federal
Advisory Committee Act (5 U.S.C. Appendix), reviewed draft protocols
and supporting data for the four non-mammalian Tier 2 tests (Ref. 2):
Japanese quail 2-generation toxicity test; Medaka extended 1-generation
reproduction test; Larval amphibian growth and development assay; and
mysid 2-generation toxicity test.
2. Status of the mysid 2-generation toxicity test. Although the
mysid 2-generation toxicity test was generally supported by the FIFRA
SAP, the data were not considered fully reliable across all endpoints
and the results were not repeatable across laboratories without
recommended improvements (Ref. 2). The FIFRA SAP and public commenters
also stated that endpoints in the mysid 2-generation toxicity test are
also provided to a large extent by the current mysid chronic life cycle
test (Ref. 3), a test used effectively to assess the risk of chemical
substances that may disrupt invertebrate growth, development, and
reproduction, such as, insect growth regulators that disrupt
development mediated by invertebrate hormones (Ref. 2). While concerns
were expressed for certain aspects of the mysid 2-generation toxicity
test, there were advancements in other features of the assay,
particularly regarding culturing conditions and control performance.
Based on all of these factors, the Agency intends to consider and
potentially incorporate, as appropriate, test design features from the
mysid 2-generation toxicity test when updating and finalizing the
existing draft mysid chronic life cycle test guideline (Ref. 4)
assessing development, growth, reproductive, and toxicity endpoints.
This may include the option of extending the mysid chronic life cycle
test to a second generation. Expansion of the mysid chronic life cycle
test was one of the Agency's options discussed in the December 1998
EDSP Policy Statement (Ref. 1). The existing OCSPP Test Guideline
850.1350 is intended to meet current and future testing requirements
for data submitted to EPA under FFDCA, FIFRA, and TSCA (Ref. 4).
B. How were the draft test guidelines developed?
The FIFRA SAP supported the scientific rationale and purpose,
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representative species chosen, biological and toxicological relevance
of the major endpoints selected and measured, and the validation
process used by EPA for all four Tier 2 non-mammalian tests (Ref. 2).
Based on the FIFRA SAP's recommendations and public comments received,
the EPA revised the test protocols (Ref. 3) and developed draft test
guidelines for the following three tests: Japanese quail 2-generation
toxicity test, Medaka extended 1-generation reproduction test, and
Larval amphibian growth and development assay.
The Japanese quail 2-generation reproduction test features
a number of core apical endpoints related to survival, growth,
reproduction and, potentially, behavior, as well as more pathway-
specific endpoints (e.g., histopathology). See draft OCSPP Test
Guideline 890.2100, entitled ``Endocrine Disruptor Screening Program
Test Guidelines; Avian Two-generation Toxicity Test in the Japanese
Quail.''
The Medaka extended 1-generation reproduction test,
developed and evaluated primarily by scientists from the United States
and Japan, starts with F0 adults, proceeds through the entire F1
generation, and provides an option for an entire life cycle exposure of
the F2 generation. The test, which features both pathway-specific
(e.g., histopathology) and apical (e.g., growth, reproduction)
endpoints, has been successfully evaluated using several chemical
substances expected to have different effects on the hypothalamic-
pituitary-gonadal (HPG) axis. See draft OCSPP Test Guideline 890.2200,
entitled ``Endocrine Disruptor Screening Program Test Guidelines;
Medaka Extended One Generation Reproduction Test (MEOGRT).''
The Larval amphibian growth and development assay is
designed to assess possible risks of both HPG- and hypothalamic-
pituitary-thyroid (HPT)-active toxicants. The assay, which was also
developed through a joint effort between the United States and Japan,
is initiated with Nieuwkoop-Faber (NF) stage 8 embryos and proceeds
through NF stage 62 (complete metamorphosis). The amphibian test
considers a variety of both apical and more pathway-specific endpoints.
See draft OCSPP Test Guideline 890.2300, entitled ``Endocrine Disruptor
Screening Program Test Guidelines; Larval Amphibian Growth and
Development Assay (LAGDA).''
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. Endocrine Disruptor Screening Program; Proposed Statement of
Policy; Notice. Federal Register (63 FR 71542, December 28, 1998) (FRL-
6052-9).
2. FIFRA SAP. SAP Minutes No. 2013-04. A Set of Scientific Issues Being
Considered by the Environmental Protection Agency Regarding: Proposed
Endocrine Disruptor Screening Program (EDSP) Tier 2 Ecotoxicity Tests,
June 25-28, 2013. 2013. Docket ID No. EPA-HQ-OPP-2013-0182-0084.
3. EPA. Summary of EPA's Responses to Recommendations of the June 25-
28, 2013 FIFRA SAP Regarding Proposed EDSP Tier 2 Non-Mammalian Tests.
2014.
4. EPA. OCSPP Harmonized Ecological Effects Test Guideline 850.1350
(Public Draft): Mysid Chronic Toxicity Test, April 1996. EPA 712-C-96-
166. 1996. Docket ID No. EPA-HQ-OPPT-2009-0154.
Authority: 7 U.S.C. 136 et seq.; 15 U.S.C. 2601 et seq.; 21
U.S.C. 346a.
Dated: December 23, 2014.
Louise P. Wise,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2015-01836 Filed 1-29-15; 8:45 am]
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