[Federal Register Volume 77, Number 124 (Wednesday, June 27, 2012)]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-15540]
ENVIRONMENTAL PROTECTION AGENCY
Final Test Guidelines; OCSPP 850 Series; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
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: firstname.lastname@example.org.
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: email@example.com, 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
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
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-
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)
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
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
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
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
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
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
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
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.
Acting Assistant Administrator, Office of Chemical Safety and Pollution
[FR Doc. 2012-15540 Filed 6-26-12; 8:45 am]
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