Draft Test Guidelines; Endocrine Disruptor Screening Program Test Guidelines (Series 890); Three Tier 2 Non-Mammalian Tests; Notice of Availability and Request for Comment, 5107-5109 [2015-01836]

Download as PDF asabaliauskas on DSK5VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 20 / Friday, January 30, 2015 / Notices information unless it displays a currently valid OMB control number. DATES: Additional comments may be submitted on or before March 2, 2015. ADDRESSES: Submit your comments, referencing Docket ID Number EPA– HQ–OAR–2006–0971, to (1) EPA online using www.regulations.gov (our preferred method) or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email to oira_submission@omb.eop.gov. Address comments to OMB Desk Officer for EPA. EPA’s policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. FOR FURTHER INFORMATION CONTACT: Ms. Kaye Whitfield, Sector Policies and Programs Division (Mail Code D243– 02), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541–2509; fax number: (919) 541–5450; email address: whitfield.kaye@epa.gov. SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone number for the Docket Center is 202–566–1744. For additional information about EPA’s public docket, visit https://www.epa.gov/ dockets. Abstract: The EPA is required under section 183(e) of the Clean Air Act (CAA) to regulate volatile organic compound (VOC) emissions from the use of consumer and commercial products. Pursuant to CAA section 183(e)(3), the EPA published a list of consumer and commercial products and a schedule for their regulation (60 FR 15264). Aerosol coatings are included on the list, and the standards for such coatings are codified at 40 CFR part 59, subpart E. The reports required under the standards enable the EPA to identify coating formulations manufactured, imported or distributed in the United States, and to determine the productweighted reactivity. The ICR addresses the burden for activities conducted in 3- VerDate Sep<11>2014 18:50 Jan 29, 2015 Jkt 235001 year increments after promulgation of the national VOC emission standards for aerosol coatings. Regulated entities read instructions to determine how they are affected by the rule. They are required to submit initial notifications when an aerosol coating is manufactured and notification of changes in the initial report, to report formulation data and exemptions claimed and to maintain records. In addition, regulated entities are required to submit triennial reports that include formulation data and VOC usage. Form Numbers: None. Respondents/affected entities: Manufacturers, distributors and importers of aerosol coatings. Respondent’s obligation to respond: Mandatory under 40 CFR part 59, subpart E. Estimated number of respondents: 64 (total). Frequency of response: Annual, triennial. Total estimated burden: 12,265 hours (per year). Burden is defined at 5 CFR 1320.03(b). Total estimated cost: $1,033,626 (per year), includes no annualized capital or operation & maintenance costs. Changes in the estimates: There is no change in hours in the total estimated respondent burden compared with the ICR currently approved by OMB. Courtney Kerwin, Acting Director, Collection Strategies Division. [FR Doc. 2015–01771 Filed 1–29–15; 8:45 am] BILLING CODE 6560–50–P 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 Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: 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 SUMMARY: PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 5107 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: https:// 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 https:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/ dockets. FOR FURTHER INFORMATION CONTACT: Sharlene Matten, telephone number: (202) 564–0130, email address: matten.sharlene@epa.gov; or Steven Knott, telephone number: (202) 564– 0103, email address: knott.steven@ epa.gov. 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 E:\FR\FM\30JAN1.SGM 30JAN1 5108 Federal Register / Vol. 80, No. 20 / Friday, January 30, 2015 / Notices 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-bycase basis. II. General Information A. Does this action apply to me? asabaliauskas on DSK5VPTVN1PROD with NOTICES 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 VerDate Sep<11>2014 20:52 Jan 29, 2015 Jkt 235001 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 https://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 https://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 nonmammalian 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 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 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 2generation 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 2generation 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 2generation 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, E:\FR\FM\30JAN1.SGM 30JAN1 asabaliauskas on DSK5VPTVN1PROD with NOTICES Federal Register / Vol. 80, No. 20 / Friday, January 30, 2015 / Notices 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 1generation 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 hypothalamicpituitary-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 pathwayspecific 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 VerDate Sep<11>2014 18:50 Jan 29, 2015 Jkt 235001 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 NonMammalian 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] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [ER–FRL–9019–3] Environmental Impact Statements; Notice of Availability Office of Federal Activities, General Information (202) 564–7146 or https://www.epa.gov/compliance/nepa/. Weekly receipt of Environmental Impact Statements Filed 01/19/2015 Through 01/23/2015 Pursuant to 40 CFR 1506.9. AGENCY: Notice Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA’s comment letters on EISs are available at: https:// www.epa.gov/compliance/nepa/ eisdata.html. PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 5109 EIS No. 20150019, Draft EIS, USACE, NC, Town of Ocean Isle Beach Shoreline Management Project, Comment Period Ends: 03/09/2015, Contact: Tyler Crumbley 910–251– 4170 EIS No. 20150020, Draft EIS, NOAA, 00, PROGRAMMATIC—Habitat Restoration Activities Implemented throughout the Coastal United States, Comment Period Ends: 03/20/2015, Contact: Frederick Sutter 301–427– 8600 EIS No. 20150021, Final EIS, NMFS, 00, Recreational Red Snapper Sector Separation, Amendment 40 to the Fishery Management Plan for the Reef Fish Resources of the Gulf of Mexico, Review Period Ends: 03/02/2015, Contact: Roy Crabtree 727–824–5301 EIS No. 20150022, Draft Supplement, BOEM, 00, Gulf of Mexico Outer Continental Shelf (OCS) Oil and Gas Lease Sales 2016 and 2017, Central Planning Area Lease Sales 241 and 247; Eastern Planning Area Lease Sales 226, Comment Period Ends: 03/ 16/2015, Contact: Gary Goeke 504– 736–3233 EIS No. 20150023, Final Supplement, USN, 00, Surveillance Towed Array Sensor System Low Frequency Active (SURTASS LFA) Sonar Systems, Review Period Ends: 03/02/2015, Contact: Cynthia Morgan 703–695– 8266 EIS No. 20150024, Final EIS, FHWA, ME, I–395/Route 9 Transportation System, Review Period Ends: 03/02/2015, Contact: Mark Hasselmann 207–512–4913 EIS No. 20150025, Final EIS, FERC, 00, Algonquin Incremental Market Project, Review Period Ends: 03/02/ 2015, Contact: Maggie Suter 202–502– 6463 EIS No. 20150026, Final Supplement, USFS, WY, Long Term Special Use Authorization for Wyoming Game and Fish Commission to Use National Forest System Lands for their Winter Elk Management Activities at Alkali Creek Feedground, Review Period Ends: 03/16/2015, Contact: Pam Bode 307–739–5513 Amended Notices EIS No. 20140354, Draft EIS, USACE, FL, South Central Palm Beach Island Comprehensive Shoreline Stabilization Project, Comment Period Ends: 02/25/2015, Contact: Garett Lips 561–674–2421 Revision to FR Notice Published 12/12/ 2014; Extending Comment Period from 01/26/2015 to 2/25/2015 E:\FR\FM\30JAN1.SGM 30JAN1

Agencies

[Federal Register Volume 80, Number 20 (Friday, January 30, 2015)]
[Notices]
[Pages 5107-5109]
From the Federal Register Online via the Government Printing 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.

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

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: https://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 https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Sharlene Matten, telephone number: 
(202) 564-0130, email address: matten.sharlene@epa.gov; or Steven 
Knott, telephone number: (202) 564-0103, email address: 
knott.steven@epa.gov. 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

[[Page 5108]]

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 https://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 
https://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,

[[Page 5109]]

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]
BILLING CODE 6560-50-P
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