[Federal Register Volume 77, Number 124 (Wednesday, June 27, 2012)]
[Notices]
[Pages 38282-38285]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-15540]



[[Page 38282]]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2009-0154; FRL-9333-1]


Final Test Guidelines; OCSPP 850 Series; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is announcing the availability of the final test 
guidelines for Series 850--Ecological Effects Test Guidelines, 
consisting of Groups B, C, D, and F. These test guidelines are part of 
a series of test guidelines established by Office of Chemical Safety 
and Pollution Prevention (OCSPP) for use in testing pesticides and 
chemical substances to develop data for submission to the Agency under 
the Toxic Substances Control Act (TSCA), the Federal Insecticide, 
Fungicide and Rodenticide Act (FIFRA), and section 408 of the Federal 
Food, Drug and Cosmetic Act (FFDCA). As guidance documents, the test 
guidelines are not binding on either EPA or any outside parties.

FOR FURTHER INFORMATION CONTACT: For general information contact: 
Melissa Chun, Regulatory Coordination Staff (7101M), Office of Chemical 
Safety and Pollution Prevention, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-1605; email address: chun.melissa@epa.gov.
    For technical information contact: Amy Blankinship, Environmental 
Fate and Effects Division (7507P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (703) 347-8062; email 
address: blankinship.amy@epa.gov, or Kathryn Gallagher, Risk Assessment 
Division (7403M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (202) 564-1398; email 
address: gallagher.kathryn@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Introduction

    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 TSCA (15 
U.S.C. 2601 et seq.), FIFRA (7 U.S.C. 136 et seq.), and section 408 of 
FFDCA (21 U.S.C. 346a).
    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 the 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. Alternatives to the 
recommendations described in the test guidelines may be proposed, 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. If you have any questions regarding the applicability of 
this action to a particular entity, consult the technical person listed 
under FOR FURTHER INFORMATION CONTACT.

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 Pollution 
Prevention and Toxics Docket (OPPT Docket), Environmental Protection 
Agency Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 
Constitution Ave. NW., Washington, DC. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.
    2. Electronic access to OCSPP test guidelines. To access OCSPP test 
guidelines electronically, please go to http://www.epa.gov/ocspp/pubs/frs/home/testmeth.htm. You may also access the test guidelines at 
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--Ecological Effects Test Guidelines, consisting of Groups B, 
C, D, and F:
     Group B--Terrestrial Wildlife.
     Group C--Terrestrial Beneficial Insects, Invertebrates, 
and Soil and Wastewater Microorganisms.
     Group D--Terrestrial and Aquatic Plants, Cyanobacteria, 
and Terrestrial Soil Core Microcosm.
     Group F--Field Test Data Reporting Guidelines.
    OCSPP, formerly the Office of Prevention, Pesticides and Toxic 
Substances (OPPTS), established a unified library of test guidelines 
for use in developing data for submission to EPA under TSCA, FFDCA, 
and/or 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 
involvement of the scientific community, including peer review by the 
FIFRA Scientific Advisory Panel (SAP), the Scientific Advisory Board 
(SAB), and other expert scientific organizations. With this notice, EPA 
is announcing the availability of the final test guidelines OCSPP 850 
Series, consisting of Groups B, C, D, and F dealing with ecological 
effects for use in testing chemical substances and developing data for 
submission to EPA. Test guidelines in this series were made available 
for public comment by a notice document published in the Federal 
Register issue of March 4, 1996 (61 FR 8279) (FRL-4990-3). The peer 
review on May 29, 1996 by FIFRA SAP was announced in a meeting notice 
published in the Federal Register issue of May 1, 1996 (61 FR 19276) 
(FRL-

[[Page 38283]]

5366-3). The test guidelines were subsequently revised in response to 
FIFRA SAP and public comments.
    Based on comments from FIFRA SAP and from the public, the following 
changes were made in the final test guidelines:
    1. Group titles and organization changes. EPA is changing the title 
of Group D ``Nontarget Plants Test Guidelines'' to ``Terrestrial and 
Aquatic Plants, Cyanobacteria, and Terrestrial Soil Core Microcosm Test 
Guidelines.'' The term ``nontarget,'' which is not applicable to OPPT, 
is removed from the Group D title, broadening the scope to all test 
guidelines evaluating effects to plants. The following test guidelines 
involving plants are renumbered and moved to Group D: OCSPP 850.4500 
``Algal Toxicity'' (Public Draft OPPTS 850.5400) and OCSPP 850.4900 
``Terrestrial Soil-Core Microcosm Test'' (Public Draft OPPTS 850.2450).
    EPA is changing the title of Group C ``Beneficial Insects and 
Invertebrates Test Guidelines'' to ``Terrestrial Beneficial Insects, 
Invertebrates, and Soil and Wastewater Microorganism Test Guidelines,'' 
expanding the scope to include testing of microorganisms other than the 
aquatic algae. The following microorganism test guidelines are 
renumbered and moved to Group C: OCSPP 850.3200 ``Soil Microbial 
Community Toxicity Test'' (Public Draft OPPTS 850.5100) and OCSPP 
850.3300 ``Modified Activated Sludge, Respiration Inhibition Test'' 
(Public Draft OPPTS 850.6800).
    EPA is moving the ``Earthworm Subchronic Toxicity Test'' test 
guideline from the Public Draft Group F ``Chemical Specific Test 
Guidelines'' to Group C and renumbering it from OPPTS 850.6200 to OCSPP 
850.3100. The earthworm is being added to Group C since it is a 
beneficial soil invertebrate.
    EPA is changing the Group G designation to Group F, and the test 
guideline contained within it (Public Draft OPPTS 850.7100) is 
renumbered OCSPP 850.6100. The title for Group E is removed as it no 
longer contains any test guidelines; however, Group E and its title are 
reserved.
    2. Title change for OCSPP 850.4000. EPA is changing the title of 
OCSPP 850.4000 ``Background--Nontarget Plant Testing'' to ``Background 
and Special Considerations: Tests with Terrestrial and Aquatic Plants, 
Cyanobacteria, and Terrestrial Soil-Core Microcosms.'' The new title 
reflects the change in the Group D title.
    3. Background and special consideration test guideline addition for 
Group B and Group C and content revision of Group D. EPA is adding two 
background and special consideration test guidelines: OCSPP 850.2000 
``Background and Special Considerations: Terrestrial Wildlife'' and 
OCSPP 850.3000 ``Background and Special Considerations: Terrestrial 
Beneficial Insects, Invertebrates, and Soil and Wastewater 
Microorganisms.'' The addition of these test guidelines are in response 
to comments regarding harmonizing the organization of test guidelines 
and improving the consistency of terminology and guidance applicable 
across test guidelines in a group. These test guidelines provide 
general guidance on test methods, statistics, and data reporting and an 
overview of the use for OPPT and OPP. Such test guidelines already 
exist for Group A (OPPTS 850.1000) and Group D (OCSPP 850.4000). 
Information contained within the OCSPP 850.2000 and OCSPP 850.3000 is 
based on information extracted from the test guidelines within their 
respective group and on general statistical methods applicable to 
toxicity testing.
    With the addition of test guidelines from other groups, OCSPP 
850.4000 was updated to reflect general information applicable across 
test guidelines in Group D. This information was extracted from the 
existing test guidelines. Additionally, a description of the meaning of 
the terms ``Tier I,'' ``Tier II,'' and ``Tier III,'' under TSCA in 
contrast to their definitions under FIFRA, was added.
    4. Title changes and merging and splitting of test guidelines--i. 
Removal of terms ``Tiers I, II, and III'' from test guideline titles 
and consolidation of resulting common test guidelines. The terms ``Tier 
I,'' ``Tier II,'' or ``Tier III'' used in these test guideline titles 
are not necessary and are misleading as they have different regulatory 
meanings under OPP and OPPT. These tests, though, are used by both 
programs. EPA is changing the OPPTS 850.4400 ``Aquatic Plant Toxicity 
Test Using Lemna Spp., Tiers I and II'' and OPPTS 850.5400 (now OCSPP 
850.4500) ``Algal Toxicity, Tiers I and II'' test guideline titles by 
removing ``Tiers I and II.''
    EPA is also removing the terms ``Tier I'' and ``Tier II'' and then 
consolidating and harmonizing the ``Tier I'' test guidelines with their 
``Tier II'' test guideline counterparts for the following test 
guidelines: The ``Terrestrial Plant Toxicity, Tier I (Seedling 
Emergence)'' and ``Seedling Emergence, Tier II'' test guidelines 
(Public Drafts OPPTS 850.4100 and OPPTS 850.4225, respectively). These 
test guidelines were merged and harmonized into OCSPP 850.4100 
``Seedling Emergence and Seedling Growth.'' The ``Terrestrial Plant 
Toxicity, Tier I (Vegetative Vigor)'' and ``Vegetative Vigor, Tier II'' 
test guidelines (Public Draft OPPTS 850.4150 and OPPTS 850.4250, 
respectively) were merged and harmonized into OCSPP 850.4150 
``Vegetative Vigor.'' For these test guidelines, except for the number 
of treatment levels, ``Tier I'' test conditions (referred to as limit 
tests) are essentially the same as ``Tier II'' (definitive tests) test 
conditions.
    EPA is changing the title of OPPTS 850.4450 ``Aquatic Plants Field 
Study, Tier III'' test guideline by removing the term, ``Tier III.''
    EPA is also removing the term ``Tier III'' from the OPPTS 850.4300 
``Terrestrial Plants Field Study, Tier III'' test guideline. Public 
Draft OPPTS 850.4025 ``Target Area Phytotoxicity'' was merged with 
Public Draft OPPTS 850.4300 to create a single test guideline, OCSPP 
850.4300 ``Terrestrial Plants Field Study.'' The target area test 
guideline covers a special case of a terrestrial plant field study for 
OPP, where the study area is the area intentionally treated with a 
pesticide when label use directions are followed. The OCSPP 850.4300 
``Terrestrial Plants Field Study'' provides flexibility to cover this 
special case for OPP, if needed.
    ii. Division of the Algal Toxicity Test into two separate 
guidelines. EPA split the Public Draft OPPTS 850.5400 ``Algal Toxicity, 
Tiers I and II'' test guideline into two test guidelines: OCSPP 
850.4500 ``Algal Toxicity'' and OCSPP 850.4550 ``Cyanobacteria 
(Anabaena flos-aquae) Toxicity'' (in addition to removing ``Tiers I and 
II''). This division of the unicellular species into two different test 
guidelines provides a clearer differentiation between methodological 
approaches prescribed for testing cyanobacteria and those for testing 
the unicellular algae. Additionally, this division addresses the 
reclassification of blue-green algae as cyanobacteria.
    5. Standardization of test guideline organization. The FIFRA SAP 
recommended that the ecological effects test guidelines include the 
same organizational format and that the tables summarizing test 
conditions for appropriate test guidelines contain consistent concepts 
across test guidelines. As a result of these suggestions, information 
was moved within the test guidelines, but the information remained the 
same. Tables summarizing test conditions and test validity elements 
were added to test guidelines in which species specific or

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laboratory measurements were defined. In all test guidelines where a 
calculated response measure (e.g., average specific growth rate) was 
derived from direct response measures (e.g., weight), equations were 
provided.
    6. Highlights of technical changes--i. Addition of a limit test 
option. Public comments indicated that a limit test could be an option 
to a definitive test in additional test guidelines. A limit test 
provides an opportunity to reduce the number of animals to be tested 
and/or resources. Test guidelines where a limit test is appropriate and 
a limit test option was added include the following: OCSPP 850.2200 
``Avian Dietary Toxicity Test;'' OCSPP 850.2400 ``Wild Mammal Toxicity 
Test;'' OCSPP 850.3100 ``Earthworm Subchronic Toxicity Test;'' OCSPP 
850.3300 ``Modified Activated Sludge, Respiration Inhibition Test;'' 
OCSPP 850.4230 ``Early Seedling Growth Toxicity Test;'' and OCSPP 
850.4600 ``Rhizobium-Legume Toxicity.'' Although a limit test option is 
available for OCSPP 850.2100, OCSPP 850.2200, and OCSPP 850.2400, 
language was added that if sublethal effects are observed at the limit 
dose, a definitive test should be conducted.
    ii. 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. Based on current exposure models used within 
the Office of Pesticide Programs (OPP), though, there are cases where 
estimated environmental residue values are higher than limit values 
provided in the public drafts, and there are also cases where actual or 
expected environmental exposure levels may be higher than the limit 
values for industrial chemicals. 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, guidance on how to 
calculate a pesticide estimated environmental concentration for 
comparison to a typical limit value was included in each test guideline 
with a limit test option.
    iii. Group B test guidelines. In OCSPP 850.2100 ``Avian Acute Oral 
Toxicity Test,'' passerine species and alternative species were added 
as test species in response to FIFRA SAP comments for additional 
alternative test species and the new passerine 40 CFR part 158 data 
requirement published in the Federal Register issue of October 26, 2007 
(72 FR 60934-60988) (FRL-8106-5). Furthermore, the option of testing 
additional sex and age groups (including breeding females) on a case-
by-case basis, as well as confirmation of dosing solutions, were added 
to address comments. OCSPP 850.2200 ``Avian Dietary Toxicity'' was 
modified to specify that young birds cannot survive 5 days without 
feeding. Additionally, when delayed effects are observed or expected, 
the guidance extending the observation period recommends testing for at 
least 14 days but continuing until overt evidence of toxicity has 
subsided.
    There were also issues raised with the cage sizes provided in OCSPP 
850.2300 ``Avian Reproduction Test.'' In response to these comments, 
the specific cage sizes provided in OCSPP 850.2300 were removed and 
replaced with a recommendation to follow current best practices for the 
care and testing of laboratory animals, as recommended cage sizes for 
avian species for use in reproductive tests are evolving. The health 
and presence/absence of signs of stress in control animals are used to 
help evaluate housing and handling conditions. Additionally, language 
was added to increase the minimum number of replicate pens per 
treatment to 16, and the measurement endpoint of hatchling body weight 
was added. Furthermore, the initial test subject age was reduced to as 
low as 16 weeks to address comments on problems of starting with older 
test subjects and impacts on acclimation, holding, and initial 
photoperiod during the reproduction phase.
    iv. Group C test guidelines. In OCSPP 850.3020 ``Honey Bee Acute 
Contact Toxicity'' and OCSPP 850.3030 ``Honey Bee Toxicity of Residues 
on Foliage,'' the age of test bees was harmonized with that in OECD 214 
``Honeybees, Acute Contact Toxicity Test'' and with FIFRA SAP comments. 
A method for immobilizing bees using cold temperature was included and 
the wording on the source of bees was changed to an ``apparently 
disease-free colony'' in response to comments on collection techniques 
and source of bees. In addition, language regarding measurements of 
residue concentrations on the foliage was added.
    v. Group D test guidelines. In conducting ecological risk 
assessments, both hypothesis-based endpoints (No Observed Effect 
Concentration/Lowest Observed Effect Concentration (NOEC/LOEC)) and 
regression-based endpoints (e.g., inhibition concentration 
IC25 or IC50) are recommended in OCSPP 850.4100 
``Seedling Emergence and Seedling Growth,'' OCSPP 850.4150 ``Vegetative 
Vigor,'' OCSPP 850.4400 ``Aquatic Plant Toxicity Test Using Lemna 
spp.,'' OCSPP 850.4500 ``Algal Toxicity,'' and OCSPP 850.4550 
``Cyanobacteria (Anabaena flos-aquae) Toxicity.'' Within these test 
guidelines, text was modified to clarify both objectives and test 
acceptability in terms of both definitive and limit tests. A number of 
modifications to OCSPP 850.4400 were made to harmonize the test 
guideline with OECD 221 ``Lemna sp Growth Inhibition.'' A change in the 
period of testing from 14 days to 7 days was made in alignment with the 
OECD 221 guideline based on bridging data between 7-day and 14-day 
results. An evaluation of in-house toxicity data on Lemna gibba 
demonstrated no significant difference between the inhibition 
concentration endpoint values at 7 days versus 14 days.
    The minimum number of replicates has been increased to 4 for OCSPP 
850.4100 ``Seedling Emergence and Seedling Growth,'' OCSPP 850.4150 
``Vegetative Vigor,'' OCSPP 850.4400 ``Aquatic Plant Toxicity Testing 
Using Lemna spp.,'' OCSPP 850.4500 ``Algal Toxicity,'' and OCSPP 
850.4550 ``Cyanobacteria (Anabaena flos-aquae) Toxicity'' to reflect 
the objective of these tests within OPP in which a hypothesis-based no 
observable adverse effect concentration (NOAEC) in addition to the 
regression-based ICX is calculated. The NOAEC is used in 
endangered and threatened species assessments and there are cases where 
nonparametric tests, which require a minimum of 4 replicates, are 
needed to evaluate the results. Additional modifications to OCSPP 
850.4550 were made to reflect FIFRA SAP recommendations of not 
continuously shaking test vessels during the test and using 
sonification only to facilitate counting.

B. How were these test guidelines developed?

    OCSPP has developed a unified library of test guidelines, which are 
used in the testing of pesticides and toxic substances, and in the 
development of test data to meet the data requirements of the Agency or 
for voluntary testing purposes. Test guidelines are documents that 
specify methods that EPA recommends for generating data to support the 
registration of a pesticide, for setting of a tolerance or tolerance 
exemption for pesticide residues, or for the decisionmaking process for 
an industrial chemical. These test data are used by the Agency to 
perform risk assessments and make regulatory decisions. Studies 
conducted according to these test guidelines may be required

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under FIFRA (7 U.S.C. 136) for pesticide registration, pursuant to 40 
CFR part 158. Test guideline studies may also be useful for satisfying 
FIFRA data requirements either in data call-ins issued pursuant to 
FIFRA section 3(c)(2)(B) or as needed to satisfy data requirements 
appropriate for specific pesticide registration applications, or for 
satisfying data requirements to demonstrate the safety of a tolerance 
or tolerance exemption under FFDCA section 408 (21 U.S.C. 346a).
    Test guidelines used in regulatory actions as the basis for test 
standards under TSCA (15 U.S.C. 2601) are typically promulgated in 40 
CFR part 799. They may also be written into specific TSCA rules such as 
TSCA section 4 test rules or consent orders or they may be used as 
recommended test guidelines as part of voluntary testing. Note that 
where data will be required under a TSCA rule, such as a test rule 
under TSCA section 4, a TSCA-specific version of the applicable test 
guideline may be promulgated as a rule. Examples of specific chemical 
test rules and consent orders may be found in 40 CFR part 799, subparts 
B and C.
    The availability of public draft test guidelines for public comment 
was announced in a March 4, 1996 Federal Register notice. The public 
draft test guidelines were placed in the EPA Docket for public access. 
These public draft test guidelines were also submitted by EPA to FIFRA 
SAP on May 29, 1996, for peer review and was announced in a May 1, 1996 
Federal Register notice. These final test guidelines incorporate 
changes recommended by FIFRA SAP and other changes resulting from the 
public comments received in response to the 1996 public draft test 
guidelines. The majority of comments and changes dealt with the 
organizational structure of the test guideline groups, 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 test 
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.

List of Subjects

    Environmental protection, Chemical testing, Test guideline.

    Dated: June 19, 2012.
James Jones,
Acting Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2012-15540 Filed 6-26-12; 8:45 am]
BILLING CODE 6560-50-P