Final Test Guidelines; OCSPP Series 850 Group A-Ecological Effects Test Guidelines; Notice of Availability, 95989-95991 [2016-31447]
Download as PDF
Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
95989
the public; however, seating is limited.
All members of the public who wish to
attend the meeting must register in
advance, no later than Monday,
February 6, 2017. Registration is
required for all members of the public
to ensure an expeditious security
process.
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:
chun.melissa@epa.gov.
SUPPLEMENTARY INFORMATION:
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.
The full board meeting will be
held Tuesday, February 21, 2017 from
1:30 p.m.–5:00 p.m., and Wednesday,
February 22, 2017 from 9:00 a.m.–5:00
p.m.
ADDRESSES: District Architecture Center,
421 7th Street NW., Washington, DC
20004.
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-bycase basis.
1. Docket for this document. The
docket for this action, identified by
docket identification (ID) number EPA–
HQ–OPPT–2009–0154, is available at
https://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 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/test-guidelinespesticides-and-toxics-substances. 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.
DATES:
For
information on access or services for
individuals with disabilities, or to
request accommodations for a disability,
please contact Sandra Williams at (202)
564–4999 or williams.sandra@epa.gov,
at least 10 days prior to the meeting to
allow as much time as possible to
process your request.
FOR FURTHER INFORMATION CONTACT:
Andrew D. Sawyers,
Director, Office of Wastewater Management,
Office of Water.
[FR Doc. 2016–31448 Filed 12–28–16; 8:45 am]
BILLING CODE 6560–50–P
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
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:41 Dec 28, 2016
Jkt 241001
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
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
B. How can I get copies of this document
and other related information?
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
E:\FR\FM\29DEN1.SGM
29DEN1
asabaliauskas on DSK3SPTVN1PROD with NOTICES
95990
Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
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 lifecycle 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
VerDate Sep<11>2014
18:41 Dec 28, 2016
Jkt 241001
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.
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
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
E:\FR\FM\29DEN1.SGM
29DEN1
Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices
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
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–9957–61–OW]
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Environmental Financial Advisory
Committee; Request for Nominations
of Candidates to the Environmental
Financial Advisory Board
Environmental Protection
Agency (EPA).
ACTION: Notice of request for
nominations of candidates to the
Environmental Financial Advisory
Board.
AGENCY:
The United States
Environmental Protection Agency (EPA)
invites nominations of qualified
SUMMARY:
VerDate Sep<11>2014
18:41 Dec 28, 2016
Jkt 241001
candidates to be considered for
appointments to fill vacancies on the
Environmental Financial Advisory
Board (the Board or EFAB). The Board
seeks to maintain diverse representation
across all workforce sectors and
geographic locations.
Nominees should demonstrate
experience in any of the following areas:
Energy efficiency; regulators;
commercial banking; local utility
management and finance; resource
conservation; brownfields; green
infrastructure financing; sustainable
community partnerships; water
resiliency; water and wastewater utility
financial management; public-public;
public-private; and public-nonprofit
partnerships. Nominees who live and
work in the pacific-northwest,
northeast, and mid-west parts of the
United States are strongly encouraged to
apply.
EPA values and welcomes diversity.
In an effort to obtain a diverse pool of
candidates, EPA encourages
nominations of women and men of all
racial and ethnic groups. In addition to
this notice, other sources may be
utilized in the solicitation of nominees.
The deadline for receiving nominations
is Friday, February 10, 2017.
Appointments will be made by the
Administrator of the Environmental
Protection Agency and will be
announced in May 2017. Nominee
qualifications will be assessed under the
mandates of the Federal Advisory
Committee Act, which requires
Committees to maintain diversity across
a broad range of constituencies, sectors,
and groups.
DATES: Nominations should be
submitted in time to arrive no later than
February 10, 2017.
ADDRESSES: EPA, Office of Water, 1301
Constitution Avenue NW., (4201T),
Washington, DC 20004.
FOR FURTHER INFORMATION CONTACT:
Submit nomination materials by postal
mail or electronic mail to: Alecia F.
Crichlow, Membership Coordinator,
Environmental Financial Advisory
Board, or email crichlow.alecia@
epa.gov.
SUPPLEMENTARY INFORMATION: The
Environmental Financial Advisory
Board was chartered in 1989 under the
Federal Advisory Committee Act to
provide advice and recommendations to
EPA on the following issues: Reducing
the cost of financing environmental
facilities and discouraging polluting
behavior; creating incentives to increase
private investment in the provision of
environmental services and removing or
reducing constraints on private
involvement imposed by current
PO 00000
Frm 00036
Fmt 4703
Sfmt 9990
95991
regulations; developing new and
innovative environmental financing
approaches and supporting and
encouraging the use of cost-effective
existing approaches; identifying
approaches specifically targeted to
small/disadvantaged community
financing; increasing the capacity of
state and local governments to carry out
their respective environmental programs
under current Federal tax laws;
analyzing how new technologies can be
brought to market expeditiously; and,
increasing the total investment in
environmental protection of public and
private environmental resources to help
ease the environmental financing
challenge facing our nation.
The Board meets two times each
calendar year (two days per meeting) at
different locations within the
continental United States. Board
members typically contribute
approximately 1–3 hours per month to
the Board’s work. The Board’s
membership services are voluntary and
the Agency is unable to provide
honoraria or compensation, according to
FACA guidelines. However, Board
members may receive travel and per
diem allowances, where appropriate,
and in accordance with Federal Travel
Regulations for invitational travelers.
Evaluation Criteria: The following
criteria will be used to evaluate
nominees: residence in the continental
United States; professional knowledge
of, and experience with, environmental
financing activities; senior levelexperience that fills a gap in Board
representation, or brings a new and
relevant dimension to its deliberations;
demonstrate ability to work in a
consensus-building process with a wide
range of representatives from diverse
constituencies; and willingness to serve
a two-year term as an active and
contributing member, with possible reappointment to a second term.
Nominations for membership must
include a resume describing the
professional and educational
qualifications of the nominee, as well as
expertise/experience. Contact details
should include full name and title,
business mailing address, telephone,
fax, and email address. A supporting
letter of endorsement is encouraged, but
not required.
Dated: December 20, 2016.
Andrew Sawyer,
Director, Office of Wastewater Management,
Office of Water.
[FR Doc. 2016–31449 Filed 12–28–16; 8:45 am]
BILLING CODE 6560–50–P
E:\FR\FM\29DEN1.SGM
29DEN1
Agencies
[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 95989-95991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31447]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: chun.melissa@epa.gov.
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 https://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
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/test-guidelines-pesticides-and-toxics-substances. 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 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