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

General Information: The agenda will 

be available at http://www2.epa.gov/

faca/gneb. General information about 

the Board can be found on its Web site 

at http://www2.epa.gov/faca/gneb. If 

you wish to make oral comments or 

submit written comments to the Board, 

please contact Ann-Marie Gantner at 

least five days prior to the meeting. 

Written comments should be submitted 

Ann-Marie Gantner at gantner.annmarie@epa.gov. 

Meeting Access: For information on 

access or services for individuals with 

disabilities, please contact Ann-Marie 

Gantner at (202) 564–4330 or email at 

gantner.ann-marie@epa.gov. To request 

accommodation of a disability, please 

contact Ann-Marie Gantner at least 10 

days prior to the meeting to give EPA as 

much time as possible to process your 

request. 

Dated: August 18, 2015. 

Ann-Marie Gantner, 

Acting Designated Federal Officer. 

[FR Doc. 2015–21016 Filed 8–24–15; 8:45 am] 

BILLING CODE 6560–50–P 

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: 

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-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. 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 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 164 / Tuesday, August 25, 2015 / Notices 51559 

Program Test Guidelines; Avian Twogeneration 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 transgenerational effects in other taxa). 

2. The mean water temperature over 

the duration of the MEOGRT has been 

changed to 25 ± 2 °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 onegeneration 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.oecdilibrary.org/environment/oecdguidelines-for-the-testing-of-chemicalssection-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.oecdilibrary.org/environment/oecdguidelines-for-the-testing-of-chemicalssection-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. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
51560 Federal Register / Vol. 80, No. 164 / Tuesday, August 25, 2015 / Notices 

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 OneGeneration 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPP–2015–0021; FRL–9932–68] 

Pesticide Product Registrations; 

Receipt of Applications for New Active 

Ingredients 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: EPA has received applications 

to register pesticide products containing 

active ingredients not included in any 

currently registered pesticide products. 

Pursuant to the Federal Insecticide, 

Fungicide, and Rodenticide Act 

(FIFRA), EPA is hereby providing notice 

of receipt and opportunity to comment 

on these applications. 

DATES: Comments must be received on 

or before September 24, 2015. 

ADDRESSES: Submit your comments, 

identified by the Docket Identification 

(ID) Number and the File Symbol of 

interest as shown in the body of this 

document, 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: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 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: 

Robert McNally, Director, Biopesticides 

and Pollution Prevention Division 

(BPPD) (7511P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; main 

telephone number: (703) 305–7090; 

email address: BPPDFRNotices@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

If you have any questions regarding 

the applicability of this action to a 

particular entity, consult the person 

listed under FOR FURTHER INFORMATION

CONTACT. 

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. 

3. Environmental justice. EPA seeks to 

achieve environmental justice, the fair 

treatment and meaningful involvement 

of any group, including minority and/or 

low-income populations, in the 

development, implementation, and 

enforcement of environmental laws, 

regulations, and policies. To help 

address potential environmental justice 

issues, EPA seeks information on any 

groups or segments of the population 

who, as a result of their location, 

cultural practices, or other factors, may 

have atypical or disproportionately high 

and adverse human health impacts or 

environmental effects from exposure to 

the pesticides discussed in this 

document, compared to the general 

population. 

II. Registration Applications 

EPA has received applications to 

register pesticide products containing 

active ingredients not included in any 

currently registered pesticide products. 

Pursuant to the provisions of FIFRA 

section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA 

is hereby providing notice of receipt and 

opportunity to comment on these 

applications. Notice of receipt of these 

applications does not imply a decision 

by EPA on these applications. For 

actions being evaluated under EPA’s 

public participation process for 

registration actions, there will be an 

additional opportunity for public 

comment on the proposed decisions. 

Please see EPA’s public participation 

Web site for additional information on 

this process http://www2.epa.gov/

pesticide-registration/publicparticipation-process-registrationactions. EPA received the following 

applications to register pesticide 

products containing active ingredients 

not included in any currently registered 

pesticide products: 

1. File Symbol: 87472–R. Docket ID 

number: EPA–HQ–OPP–2015–0547. 

Applicant: Technology Sciences Group, 

Inc., 712 Fifth St., Ste. A, Davis, CA 

95616 (on behalf of Biogents AG, 

Weissenburgstrasse 22, D–93055 

Regensburg, Germany). Product name: 

BG-Sweetscent. Active ingredient: 

Insecticide—Hexanoic acid at 0.900%. 

Proposed use: Mosquito lure. Contact: 

BPPD. 

2. File Symbol: 87978–G. Docket ID 

number: EPA–HQ–OPP–2015–0494. 

Applicant: MacIntosh and Associates, 

Inc., 1203 Hartford Ave., St. Paul, MN 

55116–1622 (on behalf of AgBiTech Pty 

Ltd, 8 Rocla Ct., Glenvale, Queensland 

4350, Australia). Product name: 

Spodoptera frugiperda Multiple 


asabaliauskas on DSK5VPTVN1PROD with NOTICES