81_FR_96239 81 FR 95989 - Final Test Guidelines; OCSPP Series 850 Group A-Ecological Effects Test Guidelines; Notice of Availability

81 FR 95989 - Final Test Guidelines; OCSPP Series 850 Group A-Ecological Effects Test Guidelines; Notice of Availability

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 250 (December 29, 2016)

Page Range95989-95991
FR Document2016-31447

EPA is announcing the availability of final test guidelines, OCSPP Series 850 Group A--Ecological Effects, OCSPP Test Guidelines 850.1000, 850.1010, 850.1020, 850.1025, 850.1035, 850.1045, 850.1055, 850.1075, 850.1300, 850.1400, 850.1710, 850.1730, 850.1735, and 850.1740. These 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.

Federal Register, Volume 81 Issue 250 (Thursday, December 29, 2016)
[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 95989-95991]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-31447]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2009-0154; FRL-9955-08]


Final Test Guidelines; OCSPP Series 850 Group A--Ecological 
Effects Test Guidelines; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is announcing the availability of final test guidelines, 
OCSPP Series 850 Group A--Ecological Effects, OCSPP Test Guidelines 
850.1000, 850.1010, 850.1020, 850.1025, 850.1035, 850.1045, 850.1055, 
850.1075, 850.1300, 850.1400, 850.1710, 850.1730, 850.1735, and 
850.1740. These 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.

FOR FURTHER INFORMATION CONTACT: Melissa Chun, Regulatory Coordination 
Staff Office of Chemical Safety and Pollution Prevention, (7101M), 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (202) 564-1605; email 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Introduction

    EPA is announcing the availability of final test guidelines, OCSPP 
Series 850 Group A--Ecological Effects, OCSPP Test Guideline 850.1000, 
850.1010, 850.1020, 850.1025, 850.1035, 850.1045, 850.1055, 850.1075, 
850.1300, 850.1400, 850.1710, 850.1730, 850.1735, and 850.1740.
    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-2009-0154, is 
available at http://www.regulations.gov or at the Office of Pesticide 
Programs Regulatory Public Docket (OPP Docket) in the Environmental 
Protection Agency Docket Center (EPA/DC), West William Jefferson 
Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 
20460-0001. 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 OPP Docket is (703) 305-5805. 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/test-guidelines-pesticides-and-toxics-substances. 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 final test guidelines under 
Series 850, Group A--Ecological Effects, entitled ``Group A (850.1000 
Series)--Aquatic and Sediment-Dwelling Fauna, Aquatic Microcosm and 
Field Testing'' and identified as OCSPP Test Guidelines 850.1000, 
850.1010, 850.1020, 850.1025, 850.1035, 850.1045, 850.1055, 850.1075, 
850.1300, 850.1400, 850.1710, 850.1730, 850.1735, and 850.1740. EPA's 
OCSPP has established a unified library of test guidelines for use in 
developing data for submission to EPA under the TSCA, FFDCA, and FIFRA. 
Beginning in 1991, EPA initiated an effort to harmonize the test 
guidelines within OCSPP, as well as to harmonize the OCSPP test 
guidelines with those of the Organization for Economic Cooperation and 
Development (OECD). The process for developing and amending these test 
guidelines has included public participation and the extensive

[[Page 95990]]

involvement of the scientific community, including peer review by the 
FIFRA Scientific Advisory Panel (SAP), the Science Advisory Board 
(SAB), and other expert scientific organizations. With this notice, EPA 
is announcing the availability of the final OCSPP Series 850 Group A--
Ecological Effects Test Guidelines for use in testing chemical 
substances and developing data for submission to EPA. Guidelines in 
this series were made available for public comment by notice in the 
Federal Register (61 FR 8279, March 4, 1996), peer reviewed on May 29, 
1996 by the SAP, and subsequently revised in response to SAP and public 
comments.
    Based on comments from the SAP and from the public, the following 
changes were made in the final harmonized environmental effects test 
guidelines:
    1. Guideline group series name change.
    EPA is changing the name of the Group A Series ``Aquatic Fauna'' to 
``Aquatic and Sediment-Dwelling Fauna, Aquatic Microcosm and Field 
Testing'' broadening the scope of this guideline series to all test 
guidelines evaluating effects to aquatic fauna contained in Group A.
    2. Name change for the OCSPP 850 guidelines.
    EPA is changing the name of the 850.1735 ``Whole Sediment Acute 
Toxicity Invertebrates, Freshwater'' guideline to ``Spiked Whole 
Sediment 10-Day Toxicity Test, Freshwater Invertebrates.'' Likewise, 
EPA is changing the name of the 850.1740 ``Whole Sediment Acute 
Toxicity Invertebrates, Marine'' guideline to ``Spiked Whole Sediment 
10-Day Toxicity Test, Saltwater Invertebrates.'' The new names reflect 
the understanding that a 10-day exposure is not necessarily reflective 
of an acute exposure when considering the life-cycle duration of the 
organisms, as well as identify the nature of the treated test media. In 
addition, the use of ``saltwater'' instead of ``marine'' reflects newer 
terminology. The 850.1075 ``Fish Acute Toxicity Test, Freshwater and 
Marine'' has changed to ``Freshwater and Saltwater Fish Acute Toxicity 
Test'' to also reflect newer terminology. Additionally, the 850.1020 
``Gammarid Acute Toxicity Test'' has changed to ``Gammarid Amphipod 
Acute Toxicity Test'' to better identify the test organism.
    3. Harmonization of guideline organization.
    The SAP recommended that the ecological effects guidelines include 
the same organizational format and that the tables summarizing test 
conditions for appropriate guidelines contain consistent concepts 
across guidelines. As a result of these suggestions, information was 
moved within the guidelines, but the information remained the same. 
Tables summarizing test conditions and test validity elements were 
added to guidelines in which species specific or laboratory 
measurements were defined. In all guidelines where a calculated 
response measure (e.g., reproductive output) was derived from direct 
response measures (e.g., number of offspring), equations were provided.
    4. Highlights of technical changes.
    a. Addition of a limit test option.
    Public comments indicated that a limit test could be an option to a 
definitive test in additional guidelines. A limit test provides an 
opportunity to reduce the number of animals to be tested and/or 
resources. Guidelines where a limit test is appropriate and a limit 
test option was added include the following: 850.1010 ``Aquatic 
Invertebrate Acute Toxicity Test, Freshwater Daphnids''; 850.1020 
``Gammarid Acute Toxicity Test''; 850.1025 ``Oyster Acute Toxicity Test 
(Shell Deposition)''; 850.1035 ``Mysid Acute Toxicity Test''; 850.1045 
``Penaeid Acute Toxicity Test''; 850.1055 ``Bivalve Acute Toxicity Test 
(Embyro-Larval)''; 850.1300 ``Daphnid Chronic Toxicity Test''; 850.1735 
``Whole Sediment Acute Toxicity Invertebrates, Freshwater''; 850.1740 
``Whole Sediment Acute Toxicity Invertebrates, Marine''.
    b. Modification of limit dosage or concentration ``cut-off'' 
values. The limit dosage or concentration values for tests for 
pesticides were originally set at values seen in the literature as 
``cut off'' values. It was believed that few, if any, pesticides would 
be applied at a label rate that would result in residues equal to or 
greater than these values. However, if there are cases where estimated 
environmental residue values are higher than limit values provided in 
the Public Drafts, or there are cases where actual or expected 
environmental exposure levels may be higher than the limit values for 
industrial chemicals, language was added. To address these case-by-case 
occurrences, language was added saying that the limit value should be 
adjusted upward if environmental exposure concentrations are expected 
to be higher than the limit value. In addition, the limit concentration 
for industrial chemicals was changed from ``1,000 milligrams/Liter (mg/
L)'' to ``100 mg/L'' for acute toxicity tests and ``10 mg/L'' for 
chronic tests.
    5. Public draft guidelines that were not finalized.
    The draft 850.1790 ``Chironomid Sediment Toxicity Test'' and 
850.1800 ``Tadpole/Sediment Subchronic Toxicity Test'' guidelines were 
not finalized as the 1996 FIFRA SAP report recommended dropping these 
guidelines for reasons such as another sediment guideline was available 
(i.e., 850.1735).
    The draft 850.1850 ``Aquatic Food Chain Transfer'', 850.1900 
``Generic Freshwater Microcosm Test, Laboratory'', 850.1925 ``Site-
Specific Aquatic Microcosm Test, Laboratory'', and 850.1950 ``Field 
Testing for Aquatic Organisms'' guidelines were not finalized as these 
types of tests are generally considered higher-tiered tests that are 
designed to meet specific testing needs, which may vary from study to 
study.
    The draft 850.1500 ``Fish Life Cycle Toxicity'' and 850.1350 
``Mysid Chronic Toxicity Test'' were also not finalized. The EPA 
acknowledges that a test guideline for the Endocrine Disruptor 
Screening Program (EDSP) was developed for fish (890.2200--Medaka 
Extended One Generation Reproduction Test (MEOGRT) (Ref. 1)). 
Additionally, a mysid 2-generation toxicity test was developed for the 
EDSP but was not finalized into a test guideline (Ref. 2). As such, the 
Agency intends to consider and potentially incorporate, as appropriate, 
test design features from both the EDSP MEOGRT and the mysid 2-
generation toxicity test when updating and finalizing the existing 
draft 850.1500 fish life cycle and 850.1350 mysid chronic life cycle 
test guideline.
    With regard to the 850.1085 ``Acute Fish Toxicity Mitigated by 
Humic Acid Test'', the EPA is re-evaluating how the outcomes of these 
types of tests represent natural processes in the environment, what 
chemicals are expected to be impacted by this type of process, and the 
extent to which these tests can be used to represent environments that 
vary in their level of total organic carbon.

B. How were the final test guidelines developed?

    In 1996, draft guidelines were made available by notice in the 
Federal Register (61 FR 8279, March 4, 1996) for public comment through 
the EPA docket. These guidelines were also submitted by EPA for peer 
review by the FIFRA Scientific Advisory Panel (SAP) on May 29, 1996 (61 
FR 19276, May 1, 1996). These final guidelines incorporate changes 
recommended by the SAP and other changes resulting from the public 
comment received in response to the March 4, 1996 draft guidelines. The 
majority of comments

[[Page 95991]]

and changes dealt with the organizational structure of the guideline 
group series, consistency of organization and format across the 
ecological effects guidelines, addition of tables summarizing test 
conditions, addition of tables summarizing test validity elements, 
consistency in use of terminology, and updating of references. The 
reporting section of each guideline now provides a list of study 
specific information to include in a study report based on study 
reporting requirements specified in 40 CFR 160.185 for FIFRA and 40 CFR 
792.185 for TSCA.

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 person 
listed under FOR FURTHER INFORMATION CONTACT.

    1. EPA. Endocrine Disruptor Screening Program Test Guidelines 
890.2200: Medaka Extended One Generation Reproduction Test (MEOGRT), 
July 2015. EPA No. 740-C-15-002. 2015. Docket ID No. EPA-HQ-OPPT-
2014-0766-0001.
    2. EPA. Guidance: Endocrine Disruptor Screening Program Test 
Guidelines; Three Tier 2 Non-Mammalian Tests. 2015. Docket ID No. 
EPA-HQ-OPPT-2014-0766-0001.

    Authority: 7 U.S.C. 136 et seq.; 15 U.S.C. 2601 et seq.; 21 
U.S.C. 301 et seq.

    Dated: November 30, 2016.
James Jones,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2016-31447 Filed 12-28-16; 8:45 am]
 BILLING CODE 6560-50-P



                                                                              Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices                                           95989

                                                    the public; however, seating is limited.                Staff Office of Chemical Safety and                   testing of pesticides and chemical
                                                    All members of the public who wish to                   Pollution Prevention, (7101M),                        substances for submission to EPA under
                                                    attend the meeting must register in                     Environmental Protection Agency, 1200                 TSCA, FIFRA, and/or FFDCA, the
                                                    advance, no later than Monday,                          Pennsylvania Ave. NW., Washington,                    Agency has not attempted to describe all
                                                    February 6, 2017. Registration is                       DC 20460–0001; telephone number:                      the specific entities that may be affected
                                                    required for all members of the public                  (202) 564–1605; email address:                        by this action.
                                                    to ensure an expeditious security                       chun.melissa@epa.gov.
                                                                                                                                                                  B. How can I get copies of this document
                                                    process.                                                SUPPLEMENTARY INFORMATION:                            and other related information?
                                                    DATES: The full board meeting will be                   I. Introduction                                          1. Docket for this document. The
                                                    held Tuesday, February 21, 2017 from
                                                                                                               EPA is announcing the availability of              docket for this action, identified by
                                                    1:30 p.m.–5:00 p.m., and Wednesday,
                                                                                                            final test guidelines, OCSPP Series 850               docket identification (ID) number EPA–
                                                    February 22, 2017 from 9:00 a.m.–5:00
                                                                                                            Group A—Ecological Effects, OCSPP                     HQ–OPPT–2009–0154, is available at
                                                    p.m.
                                                                                                            Test Guideline 850.1000, 850.1010,                    http://www.regulations.gov or at the
                                                    ADDRESSES: District Architecture Center,                                                                      Office of Pesticide Programs Regulatory
                                                                                                            850.1020, 850.1025, 850.1035, 850.1045,
                                                    421 7th Street NW., Washington, DC                                                                            Public Docket (OPP Docket) in the
                                                                                                            850.1055, 850.1075, 850.1300, 850.1400,
                                                    20004.                                                                                                        Environmental Protection Agency
                                                                                                            850.1710, 850.1730, 850.1735, and
                                                    FOR FURTHER INFORMATION CONTACT:     For                850.1740.                                             Docket Center (EPA/DC), West William
                                                    information on access or services for                      These test guidelines are part of a                Jefferson Clinton Bldg., Rm. 3334, 1301
                                                    individuals with disabilities, or to                    series of test guidelines established by              Constitution Ave. NW., Washington, DC
                                                    request accommodations for a disability,                OCSPP for use in testing pesticides and               20460–0001. The Public Reading Room
                                                    please contact Sandra Williams at (202)                 chemical substances to develop data for               is open from 8:30 a.m. to 4:30 p.m.,
                                                    564–4999 or williams.sandra@epa.gov,                    submission to the Agency under the                    Monday through Friday, excluding legal
                                                    at least 10 days prior to the meeting to                Federal Food, Drug and Cosmetic Act                   holidays. The telephone number for the
                                                    allow as much time as possible to                       (FFDCA) section 408 (21 U.S.C. 346a),                 Public Reading Room is (202) 566–1744,
                                                    process your request.                                   the Federal Insecticide, Fungicide and                and the telephone number for the OPP
                                                                                                            Rodenticide Act (FIFRA) (7 U.S.C. 136                 Docket is (703) 305–5805. Please review
                                                    Andrew D. Sawyers,
                                                                                                            et seq.), and the Toxic Substances                    the visitor instructions and additional
                                                    Director, Office of Wastewater Management,                                                                    information about the docket available
                                                    Office of Water.
                                                                                                            Control Act (TSCA) (15 U.S.C. 2601 et
                                                                                                            seq.). The test guidelines serve as a                 at http://www.epa.gov/dockets.
                                                    [FR Doc. 2016–31448 Filed 12–28–16; 8:45 am]
                                                                                                            compendium of accepted scientific                        2. Electronic access to the OCSPP test
                                                    BILLING CODE 6560–50–P                                                                                        guidelines. To access OCSPP test
                                                                                                            methodologies and protocols that are
                                                                                                            intended to provide data to inform                    guidelines electronically, please go to
                                                                                                            regulatory decisions under TSCA,                      http://www.epa.gov/test-guidelines-
                                                    ENVIRONMENTAL PROTECTION                                                                                      pesticides-and-toxics-substances. You
                                                                                                            FIFRA, and/or FFDCA.
                                                    AGENCY                                                                                                        may also access the test guidelines in
                                                                                                               The test guidelines provide guidance
                                                    [EPA–HQ–OPPT–2009–0154; FRL–9955–08]                    for conducting the test, and are also                 http://www.regulations.gov, grouped by
                                                                                                            used by EPA, the public, and companies                series under docket ID numbers: EPA–
                                                    Final Test Guidelines; OCSPP Series                     that are subject to data submission                   HQ–OPPT–2009–0150 through EPA–
                                                    850 Group A—Ecological Effects Test                     requirements under TSCA, FIFRA, and/                  HQ–OPPT–2009–0159 and EPA–HQ–
                                                    Guidelines; Notice of Availability                      or FFDCA. As guidance documents, the                  OPPT–2009–0576.
                                                    AGENCY: Environmental Protection                        test guidelines are not binding on either
                                                                                                                                                                  III. Overview
                                                    Agency (EPA).                                           EPA or any outside parties, and EPA
                                                                                                            may depart from the test guidelines                   A. What action is EPA taking?
                                                    ACTION: Notice.
                                                                                                            where circumstances warrant and                          EPA is announcing the availability of
                                                    SUMMARY:   EPA is announcing the                        without prior notice. At places in this               final test guidelines under Series 850,
                                                    availability of final test guidelines,                  guidance, the Agency uses the word                    Group A—Ecological Effects, entitled
                                                    OCSPP Series 850 Group A—Ecological                     ‘‘should.’’ In this guidance, use of                  ‘‘Group A (850.1000 Series)—Aquatic
                                                    Effects, OCSPP Test Guidelines                          ‘‘should’’ with regard to an action                   and Sediment-Dwelling Fauna, Aquatic
                                                    850.1000, 850.1010, 850.1020, 850.1025,                 means that the action is recommended                  Microcosm and Field Testing’’ and
                                                    850.1035, 850.1045, 850.1055, 850.1075,                 rather than mandatory. The procedures                 identified as OCSPP Test Guidelines
                                                    850.1300, 850.1400, 850.1710, 850.1730,                 contained in the test guidelines are                  850.1000, 850.1010, 850.1020, 850.1025,
                                                    850.1735, and 850.1740. These test                      recommended for generating the data                   850.1035, 850.1045, 850.1055, 850.1075,
                                                    guidelines are part of a series of test                 that are the subject of the test guideline,           850.1300, 850.1400, 850.1710, 850.1730,
                                                    guidelines established by the Office of                 but EPA recognizes that departures may                850.1735, and 850.1740. EPA’s OCSPP
                                                    Chemical Safety and Pollution                           be appropriate in specific situations.                has established a unified library of test
                                                    Prevention (OCSPP) for use in testing                   You may propose alternatives to the                   guidelines for use in developing data for
                                                    pesticides and chemical substances. The                 recommendations described in the test                 submission to EPA under the TSCA,
                                                    test guidelines serve as a compendium                   guidelines, and the Agency will assess                FFDCA, and FIFRA. Beginning in 1991,
                                                    of accepted scientific methodologies                    them for appropriateness on a case-by-                EPA initiated an effort to harmonize the
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    and protocols that are intended to                      case basis.                                           test guidelines within OCSPP, as well as
                                                    provide data to inform regulatory                       II. General Information                               to harmonize the OCSPP test guidelines
                                                    decisions. The test guidelines provide                                                                        with those of the Organization for
                                                    guidance for conducting the test, and                   A. Does this action apply to me?                      Economic Cooperation and
                                                    are also used by EPA, the public, and                     This action is directed to the public               Development (OECD). The process for
                                                    companies that submit data to EPA.                      in general. Although this action may be               developing and amending these test
                                                    FOR FURTHER INFORMATION CONTACT:                        of particular interest to those persons               guidelines has included public
                                                    Melissa Chun, Regulatory Coordination                   who are or may be required to conduct                 participation and the extensive


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                                                    95990                     Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices

                                                    involvement of the scientific                           consistent concepts across guidelines.                   The draft 850.1790 ‘‘Chironomid
                                                    community, including peer review by                     As a result of these suggestions,                     Sediment Toxicity Test’’ and 850.1800
                                                    the FIFRA Scientific Advisory Panel                     information was moved within the                      ‘‘Tadpole/Sediment Subchronic
                                                    (SAP), the Science Advisory Board                       guidelines, but the information                       Toxicity Test’’ guidelines were not
                                                    (SAB), and other expert scientific                      remained the same. Tables summarizing                 finalized as the 1996 FIFRA SAP report
                                                    organizations. With this notice, EPA is                 test conditions and test validity                     recommended dropping these
                                                    announcing the availability of the final                elements were added to guidelines in                  guidelines for reasons such as another
                                                    OCSPP Series 850 Group A—Ecological                     which species specific or laboratory                  sediment guideline was available (i.e.,
                                                    Effects Test Guidelines for use in testing              measurements were defined. In all                     850.1735).
                                                    chemical substances and developing                      guidelines where a calculated response                   The draft 850.1850 ‘‘Aquatic Food
                                                    data for submission to EPA. Guidelines                  measure (e.g., reproductive output) was               Chain Transfer’’, 850.1900 ‘‘Generic
                                                    in this series were made available for                  derived from direct response measures                 Freshwater Microcosm Test,
                                                    public comment by notice in the                         (e.g., number of offspring), equations                Laboratory’’, 850.1925 ‘‘Site-Specific
                                                    Federal Register (61 FR 8279, March 4,                  were provided.                                        Aquatic Microcosm Test, Laboratory’’,
                                                    1996), peer reviewed on May 29, 1996                       4. Highlights of technical changes.                and 850.1950 ‘‘Field Testing for Aquatic
                                                    by the SAP, and subsequently revised in                    a. Addition of a limit test option.                Organisms’’ guidelines were not
                                                    response to SAP and public comments.                       Public comments indicated that a                   finalized as these types of tests are
                                                       Based on comments from the SAP and                   limit test could be an option to a                    generally considered higher-tiered tests
                                                    from the public, the following changes                  definitive test in additional guidelines.             that are designed to meet specific testing
                                                    were made in the final harmonized                       A limit test provides an opportunity to               needs, which may vary from study to
                                                    environmental effects test guidelines:                  reduce the number of animals to be                    study.
                                                       1. Guideline group series name                                                                                The draft 850.1500 ‘‘Fish Life Cycle
                                                                                                            tested and/or resources. Guidelines
                                                    change.                                                                                                       Toxicity’’ and 850.1350 ‘‘Mysid Chronic
                                                       EPA is changing the name of the                      where a limit test is appropriate and a
                                                                                                                                                                  Toxicity Test’’ were also not finalized.
                                                    Group A Series ‘‘Aquatic Fauna’’ to                     limit test option was added include the
                                                                                                                                                                  The EPA acknowledges that a test
                                                    ‘‘Aquatic and Sediment-Dwelling                         following: 850.1010 ‘‘Aquatic
                                                                                                                                                                  guideline for the Endocrine Disruptor
                                                    Fauna, Aquatic Microcosm and Field                      Invertebrate Acute Toxicity Test,
                                                                                                                                                                  Screening Program (EDSP) was
                                                    Testing’’ broadening the scope of this                  Freshwater Daphnids’’; 850.1020
                                                                                                                                                                  developed for fish (890.2200—Medaka
                                                    guideline series to all test guidelines                 ‘‘Gammarid Acute Toxicity Test’’;
                                                                                                                                                                  Extended One Generation Reproduction
                                                    evaluating effects to aquatic fauna                     850.1025 ‘‘Oyster Acute Toxicity Test                 Test (MEOGRT) (Ref. 1)). Additionally,
                                                    contained in Group A.                                   (Shell Deposition)’’; 850.1035 ‘‘Mysid                a mysid 2-generation toxicity test was
                                                       2. Name change for the OCSPP 850                     Acute Toxicity Test’’; 850.1045                       developed for the EDSP but was not
                                                    guidelines.                                             ‘‘Penaeid Acute Toxicity Test’’;                      finalized into a test guideline (Ref. 2).
                                                       EPA is changing the name of the                      850.1055 ‘‘Bivalve Acute Toxicity Test                As such, the Agency intends to consider
                                                    850.1735 ‘‘Whole Sediment Acute                         (Embyro-Larval)’’; 850.1300 ‘‘Daphnid                 and potentially incorporate, as
                                                    Toxicity Invertebrates, Freshwater’’                    Chronic Toxicity Test’’; 850.1735                     appropriate, test design features from
                                                    guideline to ‘‘Spiked Whole Sediment                    ‘‘Whole Sediment Acute Toxicity                       both the EDSP MEOGRT and the mysid
                                                    10-Day Toxicity Test, Freshwater                        Invertebrates, Freshwater’’; 850.1740                 2-generation toxicity test when updating
                                                    Invertebrates.’’ Likewise, EPA is                       ‘‘Whole Sediment Acute Toxicity                       and finalizing the existing draft
                                                    changing the name of the 850.1740                       Invertebrates, Marine’’.                              850.1500 fish life cycle and 850.1350
                                                    ‘‘Whole Sediment Acute Toxicity                            b. Modification of limit dosage or                 mysid chronic life cycle test guideline.
                                                    Invertebrates, Marine’’ guideline to                    concentration ‘‘cut-off’’ values. The                    With regard to the 850.1085 ‘‘Acute
                                                    ‘‘Spiked Whole Sediment 10-Day                          limit dosage or concentration values for              Fish Toxicity Mitigated by Humic Acid
                                                    Toxicity Test, Saltwater Invertebrates.’’               tests for pesticides were originally set at           Test’’, the EPA is re-evaluating how the
                                                    The new names reflect the                               values seen in the literature as ‘‘cut off’’          outcomes of these types of tests
                                                    understanding that a 10-day exposure is                 values. It was believed that few, if any,             represent natural processes in the
                                                    not necessarily reflective of an acute                  pesticides would be applied at a label                environment, what chemicals are
                                                    exposure when considering the life-                     rate that would result in residues equal              expected to be impacted by this type of
                                                    cycle duration of the organisms, as well                to or greater than these values. However,             process, and the extent to which these
                                                    as identify the nature of the treated test              if there are cases where estimated                    tests can be used to represent
                                                    media. In addition, the use of                          environmental residue values are higher               environments that vary in their level of
                                                    ‘‘saltwater’’ instead of ‘‘marine’’ reflects            than limit values provided in the Public              total organic carbon.
                                                    newer terminology. The 850.1075 ‘‘Fish                  Drafts, or there are cases where actual or
                                                                                                            expected environmental exposure levels                B. How were the final test guidelines
                                                    Acute Toxicity Test, Freshwater and
                                                                                                            may be higher than the limit values for               developed?
                                                    Marine’’ has changed to ‘‘Freshwater
                                                    and Saltwater Fish Acute Toxicity Test’’                industrial chemicals, language was                       In 1996, draft guidelines were made
                                                    to also reflect newer terminology.                      added. To address these case-by-case                  available by notice in the Federal
                                                    Additionally, the 850.1020 ‘‘Gammarid                   occurrences, language was added saying                Register (61 FR 8279, March 4, 1996) for
                                                    Acute Toxicity Test’’ has changed to                    that the limit value should be adjusted               public comment through the EPA
                                                    ‘‘Gammarid Amphipod Acute Toxicity                      upward if environmental exposure                      docket. These guidelines were also
                                                                                                            concentrations are expected to be higher              submitted by EPA for peer review by the
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                                                    Test’’ to better identify the test
                                                    organism.                                               than the limit value. In addition, the                FIFRA Scientific Advisory Panel (SAP)
                                                       3. Harmonization of guideline                        limit concentration for industrial                    on May 29, 1996 (61 FR 19276, May 1,
                                                    organization.                                           chemicals was changed from ‘‘1,000                    1996). These final guidelines
                                                       The SAP recommended that the                         milligrams/Liter (mg/L)’’ to ‘‘100 mg/L’’             incorporate changes recommended by
                                                    ecological effects guidelines include the               for acute toxicity tests and ‘‘10 mg/L’’              the SAP and other changes resulting
                                                    same organizational format and that the                 for chronic tests.                                    from the public comment received in
                                                    tables summarizing test conditions for                     5. Public draft guidelines that were               response to the March 4, 1996 draft
                                                    appropriate guidelines contain                          not finalized.                                        guidelines. The majority of comments


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                                                                              Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices                                                95991

                                                    and changes dealt with the                              candidates to be considered for                       regulations; developing new and
                                                    organizational structure of the guideline               appointments to fill vacancies on the                 innovative environmental financing
                                                    group series, consistency of organization               Environmental Financial Advisory                      approaches and supporting and
                                                    and format across the ecological effects                Board (the Board or EFAB). The Board                  encouraging the use of cost-effective
                                                    guidelines, addition of tables                          seeks to maintain diverse representation              existing approaches; identifying
                                                    summarizing test conditions, addition of                across all workforce sectors and                      approaches specifically targeted to
                                                    tables summarizing test validity                        geographic locations.                                 small/disadvantaged community
                                                    elements, consistency in use of                            Nominees should demonstrate                        financing; increasing the capacity of
                                                    terminology, and updating of references.                experience in any of the following areas:             state and local governments to carry out
                                                    The reporting section of each guideline                 Energy efficiency; regulators;                        their respective environmental programs
                                                    now provides a list of study specific                   commercial banking; local utility
                                                                                                                                                                  under current Federal tax laws;
                                                    information to include in a study report                management and finance; resource
                                                                                                                                                                  analyzing how new technologies can be
                                                    based on study reporting requirements                   conservation; brownfields; green
                                                                                                            infrastructure financing; sustainable                 brought to market expeditiously; and,
                                                    specified in 40 CFR 160.185 for FIFRA                                                                         increasing the total investment in
                                                    and 40 CFR 792.185 for TSCA.                            community partnerships; water
                                                                                                            resiliency; water and wastewater utility              environmental protection of public and
                                                    IV. References                                          financial management; public-public;                  private environmental resources to help
                                                       The following is a listing of the                    public-private; and public-nonprofit                  ease the environmental financing
                                                    documents that are specifically                         partnerships. Nominees who live and                   challenge facing our nation.
                                                    referenced in this document. The docket                 work in the pacific-northwest,                           The Board meets two times each
                                                    includes these documents and other                      northeast, and mid-west parts of the                  calendar year (two days per meeting) at
                                                    information considered by EPA,                          United States are strongly encouraged to              different locations within the
                                                    including documents that are referenced                 apply.                                                continental United States. Board
                                                    within the documents that are in the                       EPA values and welcomes diversity.                 members typically contribute
                                                    docket, even if the referenced document                 In an effort to obtain a diverse pool of              approximately 1–3 hours per month to
                                                    is not physically located in the docket.                candidates, EPA encourages                            the Board’s work. The Board’s
                                                    For assistance in locating these other                  nominations of women and men of all                   membership services are voluntary and
                                                    documents, please consult the person                    racial and ethnic groups. In addition to              the Agency is unable to provide
                                                    listed under FOR FURTHER INFORMATION                    this notice, other sources may be                     honoraria or compensation, according to
                                                    CONTACT.                                                utilized in the solicitation of nominees.
                                                                                                                                                                  FACA guidelines. However, Board
                                                                                                            The deadline for receiving nominations
                                                      1. EPA. Endocrine Disruptor Screening                                                                       members may receive travel and per
                                                    Program Test Guidelines 890.2200: Medaka
                                                                                                            is Friday, February 10, 2017.
                                                                                                                                                                  diem allowances, where appropriate,
                                                    Extended One Generation Reproduction Test               Appointments will be made by the
                                                                                                            Administrator of the Environmental                    and in accordance with Federal Travel
                                                    (MEOGRT), July 2015. EPA No. 740–C–15–                                                                        Regulations for invitational travelers.
                                                    002. 2015. Docket ID No. EPA–HQ–OPPT–                   Protection Agency and will be
                                                    2014–0766–0001.                                         announced in May 2017. Nominee                           Evaluation Criteria: The following
                                                      2. EPA. Guidance: Endocrine Disruptor                 qualifications will be assessed under the             criteria will be used to evaluate
                                                    Screening Program Test Guidelines; Three                mandates of the Federal Advisory                      nominees: residence in the continental
                                                    Tier 2 Non-Mammalian Tests. 2015. Docket                Committee Act, which requires                         United States; professional knowledge
                                                    ID No. EPA–HQ–OPPT–2014–0766–0001.
                                                                                                            Committees to maintain diversity across               of, and experience with, environmental
                                                      Authority: 7 U.S.C. 136 et seq.; 15 U.S.C.            a broad range of constituencies, sectors,             financing activities; senior level-
                                                    2601 et seq.; 21 U.S.C. 301 et seq.                     and groups.                                           experience that fills a gap in Board
                                                      Dated: November 30, 2016.                             DATES: Nominations should be                          representation, or brings a new and
                                                    James Jones,                                            submitted in time to arrive no later than             relevant dimension to its deliberations;
                                                    Assistant Administrator, Office of Chemical             February 10, 2017.                                    demonstrate ability to work in a
                                                    Safety and Pollution Prevention.                        ADDRESSES: EPA, Office of Water, 1301                 consensus-building process with a wide
                                                    [FR Doc. 2016–31447 Filed 12–28–16; 8:45 am]            Constitution Avenue NW., (4201T),                     range of representatives from diverse
                                                    BILLING CODE 6560–50–P                                  Washington, DC 20004.                                 constituencies; and willingness to serve
                                                                                                            FOR FURTHER INFORMATION CONTACT:                      a two-year term as an active and
                                                                                                            Submit nomination materials by postal                 contributing member, with possible re-
                                                    ENVIRONMENTAL PROTECTION                                mail or electronic mail to: Alecia F.                 appointment to a second term.
                                                    AGENCY                                                  Crichlow, Membership Coordinator,                        Nominations for membership must
                                                    [FRL–9957–61–OW]                                        Environmental Financial Advisory                      include a resume describing the
                                                                                                            Board, or email crichlow.alecia@                      professional and educational
                                                    Environmental Financial Advisory                        epa.gov.                                              qualifications of the nominee, as well as
                                                    Committee; Request for Nominations                      SUPPLEMENTARY INFORMATION: The                        expertise/experience. Contact details
                                                    of Candidates to the Environmental                      Environmental Financial Advisory                      should include full name and title,
                                                    Financial Advisory Board                                Board was chartered in 1989 under the                 business mailing address, telephone,
                                                    AGENCY: Environmental Protection                        Federal Advisory Committee Act to                     fax, and email address. A supporting
                                                                                                            provide advice and recommendations to                 letter of endorsement is encouraged, but
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                                                    Agency (EPA).
                                                    ACTION: Notice of request for                           EPA on the following issues: Reducing                 not required.
                                                    nominations of candidates to the                        the cost of financing environmental                     Dated: December 20, 2016.
                                                    Environmental Financial Advisory                        facilities and discouraging polluting
                                                                                                            behavior; creating incentives to increase             Andrew Sawyer,
                                                    Board.
                                                                                                            private investment in the provision of                Director, Office of Wastewater Management,
                                                    SUMMARY:  The United States                             environmental services and removing or                Office of Water.
                                                    Environmental Protection Agency (EPA)                   reducing constraints on private                       [FR Doc. 2016–31449 Filed 12–28–16; 8:45 am]
                                                    invites nominations of qualified                        involvement imposed by current                        BILLING CODE 6560–50–P




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Document Created: 2016-12-29 01:59:14
Document Modified: 2016-12-29 01:59:14
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactMelissa Chun, Regulatory Coordination Staff Office of Chemical Safety and Pollution Prevention, (7101M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-1605; email
FR Citation81 FR 95989 

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