[Federal Register: April 15, 2009 (Volume 74, Number 71)]
[Notices]
[Page 17479-17481]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ap09-72]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-0639; FRL-8352-8]
Final Test Guidelines; Notice of Availability of Several Revised
Test Guidelines
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: With this notice, EPA is announcing the availability of
several revised or updated test guidelines for the unified library of
harmonized test guidelines issued by the Office of Prevention,
Pesticides and Toxic Substances (OPPTS). The OPPTS Harmonized Test
Guidelines are for use in the testing of chemical substances or
pesticides where appropriate to develop
[[Page 17480]]
data for submission to EPA under the Toxic Substances Control Act
(TSCA), the Federal Food, Drug, and Cosmetic Act (FFDCA), or the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Specifically, EPA is announcing the availability of revised test
guidelines under Series 830-Product Performance Test Guidelines, Series
835-Fate, Transport and Transformation Test Guidelines, and Series 860-
Residue Chemistry Test Guidelines.
FOR FURTHER INFORMATION CONTACT: For general information contact:
Melissa Chun, Regulatory Coordination Staff (7101M), Office of
Prevention, Pesticides and Toxic Substances, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001;
telephone number: (202) 564-1605; e-mail address: chun.melissa@epa.gov.
For technical information contact: Dana Spatz, Environmental Fate
and Effects Division (7507P), Office of Pesticide Programs, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-6063; e-mail address: spatz.dana@epa.gov or Robert S.
Boethling, Economics, Exposure, and Technology Division (7406M), Office
of Pollution Prevention and Toxics, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (202) 564-8533; e-mail address: boethling.bob@epa.gov.
SUPPLEMENTARY INFORMATION:
I. 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 chemical substances or pesticides where
appropriate under TSCA, FIFRA, 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 appropriate person listed
under FOR FURTHER INFORMATION CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established a docket for this document under
docket identification (ID) number EPA-HQ-OPP-2007-0639. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal
Dr., Arlington, VA. The hours of operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The Docket Facility telephone number is (703) 305-5805.
2. Electronic access. For additional information about OPPTS
Harmonized Guidelines and to access the test guidelines, please go to
http://www.epa.gov/oppts and select ``Test Methods & Guidelines'' on
the left side menu. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.
II. Background
The Office of Prevention, Pesticides and Toxic Substances (OPPTS)
has a unified library of harmonized test guidelines that are made
available for use in the testing of pesticides and toxic substances,
and 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 be used to generate data to
support the registration of a pesticide, setting of a tolerance or
tolerance exemption for pesticide residues, or the decisionmaking
process for an industrial chemical. These 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. The
test guidelines may also be useful for satisfying FIFRA data
requirements in 40 CFR part 158, data-call-ins issued pursuant to FIFRA
section 3(c)(2)(B), 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 bases for test
standards under TSCA (15 U.S.C. 2601) are typically promulgated in 40
CFR part 799, or may be written into specific TSCA rules (such as test
rules under TSCA section 4). The test guidelines may also be used 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 may be found at 40 CFR part 799, subparts E and H.
III. What Action is EPA Taking?
EPA is announcing the availability of several revised or updated
test guidelines for the OPPTS unified library of harmonized test
guidelines. Specifically, EPA is announcing the availability of revised
test guidelines under Series 830-Product Performance Test Guidelines,
Series 835-Fate, Transport and Transformation Test Guidelines, and
Series 860-Residue Chemistry Test Guidelines.
A. Updated Delivery Address in OPPTS Test Guidelines 830.1900 and
860.1650
The Agency is correcting the mailing addresses that appear in OPPTS
Test Guideline 830.1900-Submittal of Samples and OPPTS Test Guideline
860.1650-Submittal of Analytical Reference Standards because the test
guidelines, which were issued in August 1996, reference addresses that
have since changed due to facility moves.
B. Supplemental Guidance for OPPTS Test Guideline 860.1000
In June 2008, the Agency announced the release of revisions of
Table 1 feedstuffs of OPPTS Test Guideline 860.1000-Background and the
availability of guidance to aid reviewers in the construction of
livestock diets adjusted for today's commercial practices. The changes
in Table 1 include revised definitions of reference animals, updated
percentages of feedstuffs in livestock diets, reduction of the ``Nu
(not used)'' level to <5% of the diet, a list of alternative
feedstuffs, and classification of feedstuffs into three categories
(roughage [R], carbohydrate concentrate [CC], protein concentrate
[PC]). The guidance on ``maximum reasonably balanced diets'' (MRBD)
represents a shift from the past practice of using ``maximum
theoretical dietary burdens'' (MTDB) to assess maximum potential
residues in livestock commodities. The revised data for Table 1
feedstuffs and use of MRBD are to be implemented immediately. If this
revised table is referenced in any memorandum, it should be cited as:
``Table 1 Feedstuffs (June 2008).'' There have been no changes made
with regard to the human foods in Table 1 as of this time. Therefore,
the raw agricultural commodities (RACs) and processed commodities which
are not livestock feeds remain as specified in Table 1 of OPPTS Test
Guideline 860.1000 (published in 1996).
[[Page 17481]]
C. Updated OPPTS Test Guidelines for Series 835
EPA is announcing the availability of updated test guidelines for
the OPPTS Test Guideline Series 835-Fate, Transport and Transformation
Test Guidelines. Many of these guidelines are based upon, and bring up
to date, the 1982 Pesticide Assessment Guidelines-Subdivision N
protocols that were presented to the Scientific Advisory Panel (SAP) in
the late 1970s and are currently being used to perform environmental
fate testing to support the registration of pesticides under FIFRA.
These test guidelines are a [non-regulatory] companion to 40 CFR Part
158-Pesticides; Data Requirement for Conventional Chemicals. Eight such
Subdivision N guidelines have been reformatted, including insertion of
clarifying guidance, and assigned an OPPTS 835 designation. The test
guidelines in this group are:
835.2240-Photodegradation in Water.
835.2410-Photodegradation in Soil.
835.2370-Photodegradation in Air.
835.1410-Laboratory Volatility.
835.8100-Field Volatility.
835.6200-Aquatic (Sediment) Field Dissipation.
835.6300-Forestry Dissipation.
835.6400-Combination and Tank Mixes Field Dissipation.
One Subdivision N guideline, 835.1240-Leaching Studies, has been
updated based on the test guideline harmonization efforts of the
Organization for Economic Cooperation and Development (OECD). The
Office of Pesticide Programs (OPP) played a major role in the OECD
harmonization effort.
Six test guidelines were harmonized at OECD for use with pesticides
or industrial chemicals: Both OPP and the Office of Pollution
Prevention and Toxics (OPPT) played major roles in the OECD
harmonization effort. The test guidelines in this group are:
835.2120-Hydrolysis.
835.4100-Aerobic Soil Metabolism.
835.4200-Anaerobic Soil Metabolism.
835.4300-Aerobic Aquatic Metabolism.
835.4400-Anaerobic Aquatic Metabolism.
835.1230-Adsorption/Desorption (Batch Equilibrium).
OPPTS 835.2120 supersedes OPPTS 835.2110-Hydrolysis as a Function
of pH.
The test guideline for Terrestrial Field Dissipation (OPPTS
835.6100) is the result of a harmonization effort with Canada's Pest
Management Regulatory Agency (PMRA) and was completed under the
auspices of the North American Free Trade Agreement (NAFTA) Technical
Working Group on Pesticides, established under NAFTA. This guideline
was peer-reviewed by FIFRA SAP.
OPPT has played a key role in the OECD harmonization effort
responsible for eight other OPPTS 835 Series guidelines, for testing of
industrial chemicals. The eight test guidelines are:
835.0001-Principles and Strategies Related to
Biodegradation Testing of Organic Chemicals under the Toxic Substances
Control Act (TSCA).
835.3140-Ready Biodegradability--CO2 in Sealed
Vessels (Headspace Test).
835.3190-Aerobic Mineralization in Surface Water--
Simulation Biodegradation Test.
835.3215-Inherent Biodegradability--Concawe Test.
835.3240-Simulation Test--Aerobic Sewage Treatment: A.
Activated Sludge Units.
835.3260-Simulation Test--Aerobic Sewage Treatment: B.
Biofilms.
835.3280-Simulation Tests to Assess the Primary and
Ultimate Biodegradability of Chemicals Discharged to Wastewater.
835.3420-Anaerobic Biodegradability of Organic Compounds
in Digested Sludge: By Measurement of Gas Production.
Of these eight test guidelines, three are updated versions that
supersede existing OPPTS guidelines. The three are OPPTS 835.3140
(supersedes OPPTS 835.3120-Sealed-Vessel CO2 Production
Test); OPPTS 835.3240 (supersedes OPPTS 835.3220-Porous Pot Test); and
OPPTS 835.3420 (supersedes OPPTS 835.3400-Anaerobic Biodegradability of
Organic Chemicals). The other five test guidelines are also based on
the test guideline harmonization efforts of OECD, but reflect the
development of new test methods that has occurred since the OPPTS 835
Series guidelines for industrial chemicals were last updated in the
1990s. In addition to these five, OPPTS 835.4100, 835.4200, 835.4300,
and 835.4400 are similarly based on OECD test methods developed and
adopted since the mid 1990s.
List of Subjects
Environmental protection, Chemical testing, Test guideline.
Dated: March 10, 2009.
James Jones,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.
[FR Doc. E9-8484 Filed 4-14-09; 8:45 am]