Final Test Guidelines; Availability

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

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.

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:

1. General Information

   1. 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.

   2. 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.

2. 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.

3. 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.

   1. 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.

   2. 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 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--CO2in 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 CO2Production

      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