[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]


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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