Final Test Guidelines; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of availability.

SUMMARY:

EPA has established a unified library for test guidelines issued by the Office of Prevention, Pesticides and Toxic Substances (OPPTS) for use in testing chemical substances to develop 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). These test guidelines represent an Agency effort that began in 1991 to harmonize the test guidelines within OPPTS, as well as to harmonize the OPPTS test guidelines with those of the Organization for Economic Cooperation and Development (OECD). The process for developing and amending these test guidelines includes public participation and the extensive involvement of the scientific community, including peer review by the Scientific Advisory Panel (SAP) and the Scientific Advisory Board (SAB) and other expert scientific organizations. With this notice, EPA is announcing the availability of three final test guidelines for three health effects end points. These test guidelines (and their OPPTS guideline reference) are: Repeated Dose 28-Day Oral Toxicity Study in Rodents (OPPTS 870.3050), Reproduction/Developmental Toxicity Screening Test (OPPTS 870.3550), and Combined Repeated Dose Toxicity Study With the Reproduction/Developmental Toxicity Screening Test (OPPTS 870.3650).

FOR FURTHER INFORMATION CONTACT:

For general information contact:

Toxic Substances Control Act (TSCA) information contact: TSCA Hotline at TAIS/7408, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 554-1404; fax number: (202) 554-5603; e-mail address: TSCA-Hotline@epa.gov.

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) information contact: Communications Services Branch (7506C), Field and External Affairs Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-5017; fax number: (703) 305-5558.

For technical information contact: Chemical Control Division, Office of Pollution Prevention and Toxics (7405), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 260-8130; e-mail address: ccd.citb@epa.gov.

SUPPLEMENTARY INFORMATION:

I. 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 under the Toxic Substances Control Act (TSCA), the Federal Food, Drug and Cosmetic Act (FFDCA), or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 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 in the FOR FURTHER INFORMATION CONTACT.

II. How Can I Get Additional Information, Including Copies of this Document or Other Related Documents?

A. Electronically

You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.

You may also obtain copies of test guidelines from the EPA Internet Home Page and the U.S. Government Printing Office (GPO). From the EPA Internet Home Page select “Information Resources/Test Methods/OPPTS Harmonized Test Guidelines” at http://www.epa.gov/OPPTS _— Harmonized. Paper copies and disks of the guidelines are available from GPO, Washington, DC 20402, or by calling (202) 512-0132.

B. In Person

The Agency has established an official record for this proposed guideline under docket control number OPP-00631. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch, Rm. 119, Crystal Mall ×2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Public Information and Records Integrity Branch telephone number is (703) 305-5805.

III. What Action is EPA taking?

EPA is announcing the availability of three final health effects test guidelines. These guidelines are: Repeated Dose 28-Day Oral Toxicity Study in Rodents (OPPTS 870.3050), Reproduction/Developmental Toxicity Screening Test (OPPTS 870.3550), and Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OPPTS 870.3650). These guidelines are being made available today in order to establish a set of harmonized guidelines for use in test rules and other actions under TSCA. After establishment of these guidelines today, the Agency will then establish new TSCA test guidelines in Title 40 of the Code of Federal Regulations (CFR), but in the format specified for the CFR. TSCA test guidelines for the three endpoints are not now in existence but are needed for planned regulatory actions.

In publishing these harmonized test guidelines, EPA recognizes concerns have been expressed about animal testing. EPA is committed to avoiding unnecessary or duplicative animal testing. As part of this commitment, the Agency plays a important role in the federal Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) (http://iccvam.niehs.nih.gov/home.htm) whose goals are: (1) To encourage the reduction of the number of animals used in testing; (2) to seek opportunities to replace test methods requiring animals with alternative test methods when acceptable alternative methods are available; and ( 3) to refine existing test methods to optimize animal use when there is no substitute for animal testing. Further, where testing is needed to develop scientifically adequate data, the Agency is committed to reducing the number of animals used for testing, including, whenever possible, by incorporating in vitro (non-animal) test methods or other alternative approaches that have been scientifically validated and have received regulatory acceptance. EPA considers these goals and commitments to be important considerations in developing health effects data; however, they must be balanced with the essential need to conduct scientifically sound chemical hazard/risk assessments in support of the Agency's mission. By using the test guidelines cited in today's notice, EPA believes that fewer animals will be used when it is necessary to conduct screening level testing to fill such data needs and these guidelines will yield scientifically sound data.

IV. How Were these Test Guidelines Developed?

These guidelines were adapted from the series of the Organization for Economic Cooperation and Development (OECD) Guidelines for Testing of Chemicals. The OECD guidelines which were adapted and are being announced for publication today are: OECD Guideline 407 (Repeated Dose 28-day Oral Toxicity in Rodents) for OPPTS 870.3050, OECD Guideline 421 (Reproduction/Developmental Toxicity Screening Test) for OPPTS 870.3550, and OECD Guideline 422 (Combined Repeated Dose Toxicity Study With the Reproduction/Developmental Toxicity Screening Test) for OPPTS 870.3650. EPA has retained the OECD guideline names. EPA scientists reviewed the OECD guidelines and reformatted them to the OPPTS harmonized guideline format with only minor editorial changes.

The OECD test guidelines were developed initially under the OECD Chemicals Testing Programme and are updated under the OECD Updating Programme for Test Guidelines and the OECD Test Guidelines Programme. The OECD test guideline process involves the use of multi-national panels of scientific and technical experts who develop guideline drafts which are submitted to a review panel. The review process is concluded by the endorsement of the guidelines by the OECD Chemicals Group and the OECD Environment Committee prior to the formal submission to the OECD Council. The OECD Council then adopts the guidelines and publishes them in the official OECD Guidelines for Testing of Chemicals.

V. Are there Any Applicable Voluntary Consensus Standards that EPA Should Consider?

This notice of availability does not involve a proposed regulatory action that would require the Agency to consider voluntary consensus

standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Section 12(d) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, business practices, etc.) that are developed or adopted by voluntary consensus standards bodies. The NTTAA requires EPA to provide an explanation to Congress, through OMB, when the Agency decides not to use available and applicable voluntary consensus standards when the NTTAA directs the Agency to do so.

List of Subjects

• Environmental protection
• Chemical testing
• Test guideline