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Final Test Guidelines; Notice of Availability of Several Revised Test Guidelines

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AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

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 Start Printed Page 17480data 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.

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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.

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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).Start Printed 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.

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Dated: March 10, 2009.

James Jones,

Acting Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances.

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[FR Doc. E9-8484 Filed 4-14-09; 8:45 am]

BILLING CODE: 6560-50-S