03-19358. Tetrahedron, Inc.; Transfer of Data

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces that pesticide related information submitted to EPA's Office of Pesticide Programs (OPP) pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA), including information that may have been claimed as Confidential Business Information (CBI) by the submitter, will be transferred to Tetrahedron, Inc. in accordance with 40 CFR 2.307(h)(3) and 2.308(i)(2). Tetrahedron, Inc. has been awarded multiple contracts to perform work for EPA, and access to this information will enable Tetrahedron, Inc. to fulfill the obligations of the contracts.

DATES:

Tetrahedron, Inc. will be given access to this information on or before August 4, 2003.

FOR FURTHER INFORMATION CONTACT:

Erik Johnson, FIFRA Security Officer, Information Resources and Services Division (7502C), Office of Pesticide Programs, 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 applies to the public in general. As such, 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 Information?

1. Docket. EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0258. 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 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 Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number 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/​.

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 submit or view public comments, 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.

II. Contractor Requirements

Under contract number 68-W-03-039, the contractor will perform the following:

The purpose of this contract is to support EPA and Agency position documents, reviews, and scientific technical assessments of potential hazards and risks of pesticides to human health and the environment. The contractor shall create Data Evaluation Reports which involve converting the studies supplied into a format specified by the program office and shall include secondary and Quality Assurance contractor reviews as specified:

• Review and evaluation of biopesticide, mammalian, non-target organisms toxicity, environmental fate, and product chemistry data.
• Review of confidential statement of formulations, manufacturing process, and labels
• Statements for compliance with United States Department of Agriculture National Organic Program Standards.
• Preliminary risk assessment for biopesticides.
• General assistance-biopesticide registration package review.

This contract involves no subcontractors.

EPA has determined that the contract described in this document involve work that is being conducted in connection with FIFRA, in that pesticide chemicals will be the subject of certain evaluations to be made under this contract. These evaluations may be used in subsequent regulatory decisions under FIFRA.

Some of this information may be entitled to confidential treatment. The information has been submitted to EPA under sections 3, 4, 6, and 7 of FIFRA and under sections 408 and 409 of FFDCA.

In accordance with the requirements of 40 CFR 2.307(h)(3), the contracts with Tetrahedron, Inc., prohibits use of the information for any purpose not specified in these contracts; prohibits disclosure of the information to a third party without prior written approval from the Agency; and requires that each official and employee of the contractor sign an agreement to protect the information from unauthorized release and to handle it in accordance with the FIFRA Information Security Manual. In addition, Tetrahedron, Inc. is required to submit for EPA approval a security plan under which any CBI will be secured and protected against unauthorized release or compromise. No information will be provided to Tetrahedron, Inc. until the requirements in this document have been fully satisfied. Records of information provided to Tetrahedron, Inc. will be maintained by EPA Project Officers for these contracts. All information supplied to Tetrahedron, Inc. by EPA for use in connection with these contracts will be returned to EPA when Tetrahedron, Inc. has completed its work.

List of Subjects

• Environmental protection
• Business and industry
• Government contracts
• Government property
• Security measures

Dated: July 21, 2003.

Arnold E. Layne,

Director, Information Resources and Services Division, Office of Pesticide Programs.