Document ID: EPA-HQ-OPP-2007-0639-0001
Agency: epa
Document Type: Notice
Title: Final Test Guidelines; Notice of Availability of Several Revised Test Guidelines
Posted Date: 2009-04-15T04:00Z

[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]