05-711. Response to Petition; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

On October 5, 2004, EPA received a petition filed under section 21 of the Toxic Substances Control Act (TSCA) and section 553(e) of the Administrative Procedure Act from People for the Ethical Treatment of Animals (PETA). The Physicians Committee for Responsible Medicine (PCRM) joined the petition by a letter dated November 9, 2004. The petition requests that EPA revoke the TSCA developmental neurotoxicity test guideline codified at 40 CFR 799.9630 and withdraw a harmonized test guideline issued by the Office of Prevention, Pesticides and Toxic Substances (OPPTS) titled, “Health Effects Test Guidelines: OPPTS 870.6300 Developmental Neurotoxicity Study” (EPA-712-C-98-239). Although EPA believes the petitioners' requests are outside the scope of TSCA section 21, and thus the submission in its entirety is being treated as a petition under the Administrative Procedure Act, EPA responded to the petitioners within the 90-day timeframe established in TSCA for section 21 petitions. EPA has responded to the petition by denying these requests and is announcing the public availability of this response.

FOR FURTHER INFORMATION CONTACT:

For general information contact: Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

For technical information contact: Laura Bunte, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public in general, and 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). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be interested in this action. If you have any questions regarding the applicability of this action to a particular entity, consult the technical contact 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 an official public docket for this action under docket ID number OPPT-2004-0132. The official public docket consists of the documents specifically referenced in this action, including the petitioner's request, supporting information submitted by the petitioners, and EPA's response to the petition. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the EPA Docket Center, Rm. B102-Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The EPA Docket Center Reading Room telephone number is(202) 566-1744 and the telephone number for the OPPT Docket, which is located in the EPA Docket Center, is [phone].

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the Federal Register listings at http://www.epa.gov/​fedrgstr/​. The documents referenced in Unit I.B.1 are also accessible through the EPA Internet at http://www.epa.gov/​opptintr/​chemtest/​dnt/​index.htm. To access the OPPTS Harmonized Test Guideline referenced in this document, go directly to the guideline at http://www.epa.gov/​opptsfrs/​home/​guidelin.htm/​.

In addition, an electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/​edocket/​ to access the index listing of the contents of the official public docket and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket.

II. What Action is the Agency Taking?

This action announces the availability of EPA's response to the petition. The public may access both the petition and EPA's response as described in Unit I.B. of this document.

List of Subjects

• Environmental protection
• Pesticides
• Toxic substances
• Test guidelines

Dated: January 3, 2005.

Susan B. Hazen,

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