Final Test Guidelines; Endocrine Disruptor Screening Program Test Guidelines (Series 890); Three Tier 2 Non-Mammalian Tests; Notice of Availability, 51558-51560 [2015-21040]
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51558
Federal Register / Vol. 80, No. 164 / Tuesday, August 25, 2015 / Notices
General Information: The agenda will
be available at https://www2.epa.gov/
faca/gneb. General information about
the Board can be found on its Web site
at https://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
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
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(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.
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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
https://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 https://
www.epa.gov/dockets.
2. Electronic access to the OCSPP test
guidelines. To access OCSPP test
guidelines electronically, please go to
https://www.epa.gov/ocspp/pubs/frs/
home/testmeth.htm. You may also
access the test guidelines in https://
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
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Federal Register / Vol. 80, No. 164 / Tuesday, August 25, 2015 / Notices
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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.,
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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
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51559
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 https://
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 https://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 https://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
https://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 https://
www.epa.gov/ocspp/pubs/frs/
publications/Test_Guidelines/
series850.htm.
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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 https://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 https://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.
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:
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
ENVIRONMENTAL PROTECTION
pesticide manufacturer. The following
AGENCY
list of North American Industrial
Classification System (NAICS) codes is
[EPA–HQ–OPP–2015–0021; FRL–9932–68]
not intended to be exhaustive, but rather
Pesticide Product Registrations;
provides a guide to help readers
Receipt of Applications for New Active determine whether this document
Ingredients
applies to them. Potentially affected
entities may include:
AGENCY: Environmental Protection
• Crop production (NAICS code 111).
Agency (EPA).
• Animal production (NAICS code
ACTION: Notice.
112).
• Food manufacturing (NAICS code
SUMMARY: EPA has received applications
311).
to register pesticide products containing
• Pesticide manufacturing (NAICS
active ingredients not included in any
code 32532).
currently registered pesticide products.
If you have any questions regarding
Pursuant to the Federal Insecticide,
the applicability of this action to a
Fungicide, and Rodenticide Act
particular entity, consult the person
(FIFRA), EPA is hereby providing notice listed under FOR FURTHER INFORMATION
of receipt and opportunity to comment
CONTACT.
on these applications.
B. What should I consider as I prepare
DATES: Comments must be received on
my comments for EPA?
or before September 24, 2015.
1. Submitting CBI. Do not submit this
ADDRESSES: Submit your comments,
information to EPA through
identified by the Docket Identification
regulations.gov or email. Clearly mark
(ID) Number and the File Symbol of
the part or all of the information that
interest as shown in the body of this
you claim to be CBI. For CBI
document, by one of the following
information in a disk or CD–ROM that
methods:
• Federal eRulemaking Portal: https:// you mail to EPA, mark the outside of the
www.regulations.gov. Follow the online disk or CD–ROM as CBI and then
identify electronically within the disk or
instructions for submitting comments.
CD–ROM the specific information that
Do not submit electronically any
is claimed as CBI. In addition to one
information you consider to be
Confidential Business Information (CBI) complete version of the comment that
or other information whose disclosure is includes information claimed as CBI, a
copy of the comment that does not
restricted by statute.
• Mail: OPP Docket, Environmental
contain the information claimed as CBI
Protection Agency Docket Center (EPA/
must be submitted for inclusion in the
DC), (28221T), 1200 Pennsylvania Ave.
public docket. Information so marked
NW., Washington, DC 20460–0001.
will not be disclosed except in
• Hand Delivery: To make special
accordance with procedures set forth in
arrangements for hand delivery or
40 CFR part 2.
delivery of boxed information, please
2. Tips for preparing your comments.
follow the instructions at https://
When preparing and submitting your
[FR Doc. 2015–21040 Filed 8–24–15; 8:45 am]
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BILLING CODE 6560–50–P
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comments, see the commenting tips at
https://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 https://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
E:\FR\FM\25AUN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 164 (Tuesday, August 25, 2015)]
[Notices]
[Pages 51558-51560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21040]
-----------------------------------------------------------------------
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-by-case basis.
II. General Information
A. Does this action apply to me?
This action is directed to the public in general. Although this
action may be of particular interest to those persons who are or may be
required to conduct testing of pesticides and chemical substances for
submission to EPA under TSCA, FIFRA, and/or FFDCA, the Agency has not
attempted to describe all the specific entities that may be affected by
this action.
B. How can I get copies of this document and other related information?
1. Docket for this document. The docket for this action, identified
by docket identification (ID) number EPA-HQ-OPPT-2014-0766 is available
at https://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
https://www.epa.gov/dockets.
2. Electronic access to the OCSPP test guidelines. To access OCSPP
test guidelines electronically, please go to https://www.epa.gov/ocspp/pubs/frs/home/testmeth.htm. You may also access the test guidelines in
https://www.regulations.gov, grouped by series under docket ID numbers:
EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159 and EPA-HQ-OPPT-
2009-0576.
III. Overview
A. What action is EPA taking?
EPA is announcing the availability of three final test guidelines
that are being added to its 890 Series, entitled ``Endocrine Disruptor
Screening Program Test Guidelines'' and identified as follows:
1. OCSPP Test Guideline 890.2200, entitled Endocrine Disruptor
Screening Program Test Guidelines; Medaka Extended One-generation
Reproduction Test.
2. OCSPP Test Guideline 890.2300, entitled Endocrine Disruptor
Screening Program Test Guidelines; Larval Amphibian Growth and
Development Assay.
3. OCSPP Test Guideline 890.2100, entitled Endocrine Disruptor
Screening
[[Page 51559]]
Program Test Guidelines; Avian Two-generation Toxicity Test in the
Japanese Quail.
B. How Were These Final Test Guidelines Developed?
On January 30, 2015, the Agency released three draft non-mammalian
test guidelines for public review and comment as described in a Federal
Register notice (80 FR 5107) (FRL-9919-43) (Ref. 1). These three draft
test guidelines were subsequently revised based on public comments,
existing EPA test guidelines, and concurrent Organisation for Economic
Co-operation and Development (OECD) test guidelines for MEOGRT (Ref. 2)
and LAGDA (Ref. 3).
Comments were submitted by representatives from the following
organizations: Endocrine Policy Forum, SynTech Research Laboratory
Services, American Petroleum Institute, Wildlife International, People
for Ethical Treatment of Animals, the Physicians Committee for
Responsible Medicine, and the Humane Society of the United States.
Comments were grouped according to each test guidelines: JQTT
(890.2100), MEOGRT (890.2200) and LAGDA (890.2300).
EPA worked with the OECD to harmonize test guidelines for MEOGRT
(Ref. 2) and LAGDA (Ref. 3). The OECD test guidelines were approved at
the Working Group of National Coordinators of the Test Guidelines
Programme (WNT) and endorsed by the Joint Meeting of the Chemicals
Committee and the Working Party on Chemicals, Pesticides and
Biotechnology in June 2015 prior to EPA finalizing the U.S. MEOGRT and
LAGDA test guidelines. EPA revised the terminology, procedures, and
statistical practices to harmonize the MEOGRT and LAGDA test guidelines
with analogous OECD's test guidelines and at the same time incorporated
public comments received that were not already addressed in the
harmonization.
A summary of the substantive changes reflected in the final U.S.
MEOGRT and LAGDA test guidelines is provided:
1. The option for extending the MEOGRT through F2 generation
reproduction has been removed from the final test guideline pending
additional data. The test will end following hatching of the F2
offspring. This is consistent with the decision made in the draft OECD
test guideline for MEOGRT. This test guideline may be updated as new
information and data are considered. For example, guidance on extending
the F2 generation through reproduction may be potentially useful under
certain circumstances (e.g., chemicals with high bioconcentration
potential or indications of trans-generational effects in other taxa).
2. The mean water temperature over the duration of the MEOGRT has
been changed to 25 2 [deg]C to be consistent with the
analogous OECD test guideline.
3. The LAGDA developmental stage terminology has been clarified to
avoid confusion with what is meant by complete metamorphosis.
4. Clarified the conduct of liver and kidney histopathology in the
MEOGRT and LAGDA test guidelines for overt toxicity. An effort was made
to clarify and provide more explicit guidance as to what specific
histopathology is appropriate based on the results of the study.
5. The rationale for use of solvent control only, dilution water
control only, or pooled controls in the statistical analyses for the
MEOGRT and LAGDA was clarified.
6. The guidelines have been modified to address commenters'
concerns that they be more flexible and less prescriptive. Examples
have been provided as appropriate to add clarity.
The JQTT draft test guideline (OCSPP 890.2100) was revised to
address comments provided by the public, the draft OECD test guideline
for the avian two-generation toxicity test in the Japanese quail (Ref.
4), as well as the existing EPA and OECD test guidelines for avian one-
generation toxicity tests (Refs. 5 and 6). EPA revised the terminology,
procedures, endpoints measured, figures, tables, and appendices in the
JQTT test guideline to clarify specific points raised by public
commenters as follows:
1. The revised test guidelines include fewer endpoints. For
example, the revisions eliminated behavioral endpoints to reduce the
overall numbers of birds required for the study; eliminated endpoints
that are difficult to obtain (i.e., hormone levels measured in embryo
blood samples); eliminated redundant endpoints; and statistical
analyses.
2. For clarity, the test termination point is following measurement
of the 14-day survival of filial 2 (F2) generation chicks. This is the
minimum length of the study necessary to evaluate and measure a
chemical's effect on the F1 generation's reproductive performance. If
delayed reproduction is observed in F1 birds, a decision to extend the
F2 generation may be made. If extended, the test should be terminated
when F2 birds are approximately 6 weeks old when 90% of control animals
have reached sexual maturity. The decision to limit the length of the
JQTT is consistent with EPA's efforts to move to extended one-
generation reproduction test protocols for Tier 2 tests rather than
multigenerational studies (Ref. 7). Extended one-generation
reproduction tests are technically sound, save animals, and reduce
costs.
3. The guidelines have been modified to address commenters'
concerns that they be more flexible and less prescriptive. Examples
have been provided as appropriate to add clarity.
IV. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are in the docket, even if the
referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
persons listed under FOR FURTHER INFORMATION CONTACT.
1. EPA Draft Test Guidelines; Endocrine Disruptor Screening Program
Test Guidelines (Series 890); Three Tier 2 Non-Mammalian Tests; Notice
of Availability and Public Comment, Federal Register (80 FR 5107,
January 30, 2015). It is available at https://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 https://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals-section-2-effects-on-biotic-systems_20745761.
3. OECD, Test No. 241: Larval Amphibian Growth and Development
Test, OECD Guidelines for the Testing of Chemicals, section 2 (2015).
It is available at https://www.oecd-ilibrary.org/environment/oecd-guidelines-for-the-testing-of-chemicals-section-2-effects-on-biotic-systems_20745761.
4. OECD Guidelines for Testing of Chemicals. Proposal for a new
test guideline: Avian Two-generation Toxicity Test in the Japanese
Quail, Draft November 2005. It is available at https://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
https://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series850.htm.
[[Page 51560]]
6. OECD, Test No. 206: Avian Reproduction Test. OECD Guidelines for
the Testing of Chemicals, section 2--Effect on Biotic Systems (adopted
1984). OECD Publishing, Paris (1993) DOI: It is available at https://dx.doi.org/10.1787/9789264070028-en.
7. OECD, Test No. 443: Extended One-Generation Reproductive
Toxicity Study, OECD Guidelines for the Testing of Chemicals, section
4, 28 July 2011, DOI. It is available at https://dx.doi.org/10.1787/9789264122550-en.
Authority: 7 U.S.C. 136 et seq.; 15 U.S.C. 2601 et seq.; 21
U.S.C. 301 et seq.
Dated: August 18, 2015.
Louise P. Wise,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2015-21040 Filed 8-24-15; 8:45 am]
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