E6-7930. Access to Confidential Business Information by the Food and Drug Administration

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA has authorized the Food and Drug Administration (FDA) access to information which has been submitted to EPA under all sections of the Toxic Substances Control Act (TSCA). Some of the information may be claimed or determined to be Confidential Business Information (CBI).

DATES:

Access to the confidential data will occur no sooner than May 31, 2006.

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; telephone number: [phone]; e-mail address: TSCA-Hotline@.epa.gov.

For technical information contact: Scott M. Sherlock, TSCA Security Staff, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: [phone]; e-mail address: [e-mail]

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Notice Apply to Me?

This action is directed to the public in general. This action may, however, be of interest to those persons who are or may be required to conduct testing of chemical substances under TSCA. Since other entities may also be interested, 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 person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Documents?

1. Docket. EPA has established an official public docket for this action under docket identification (ID) number EPA-HQ-OPPT-2003-0004. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include 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 [phone], and the telephone number for the OPPT Docket, which is located in 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/​.

II. What Action is the Agency Taking?

On March 22, 2006, in accordance with 40 CFR 2.209, the Associate Director for Research Policy and Implementation, of the Food and Drug Administration requested access to information collected through the authority of TSCA. Some of this information has been treated as CBI. FDA needs this information in connection to carrying out a pilot study with EPA by providing toxicology data and chemical structures for substances tested in genetic toxicity studies. FDA will supplement and enhance its battery Quantitative Structural Activity Relationship (QSAR) modules with the genetic toxicity data. The enhanced predictive genotoxicity QSAR modules will be made available to EPA to augment and improve EPA's capability to identify potentially genotoxic chemicals.

EPA is issuing this notice to inform all submitters of information under all sections of TSCA that the Agency will be providing FDA access to these CBI materials on a need-to-know basis only. All access to TSCA CBI under this arrangement will take place at EPA Headquarters and FDA Headquarters located at 10903 New Hampshire Ave., Building 21, Room 1525, Silver Spring, Maryland 20993-0002.

Clearance for access to TSCA CBI under this arrangement may continue until June 1, 2011.

FDA personnel will be required to sign non-disclosure agreements and be briefed on appropriate security procedures before they are permitted access to the CBI.

List of Subjects

• Environmental protection
• Confidential business information

Dated: May 18, 2006.

Vicki Simons,

Acting Director, Information Management Division, Office of Pollution Prevention and Toxics.