Federal Register / Vol. 80, No. 20 / Friday, January 30, 2015 / Notices 5107 

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 http://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- 

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 

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: 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: 

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 


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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? 

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 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 

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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Federal Register / Vol. 80, No. 20 / Friday, January 30, 2015 / Notices 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 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 

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 

AGENCY: Office of Federal Activities, 

General Information (202) 564–7146 or 

http://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. 

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: http://

www.epa.gov/compliance/nepa/

eisdata.html. 

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 


asabaliauskas on DSK5VPTVN1PROD with NOTICES