E8-10289. Battelle Memorial Institute and Toxicology Excellence for Risk Assessment, Quality Environmental Professional Associate, and Horn Engineering Services, 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 Battelle Memorial Institute and its subcontractor, Toxicology Excellence for Risk Assessment, Quality Environmental Professional Associate, and Horn Engineering Services, Inc., in accordance with 40 CFR 2.307(h)(3) and 2.308(i)(2) Battelle Memorial Institute and its subcontractor, Quality Environmental Professional Associate, and Horn Engineering Services, Inc., have been awarded a contract to perform work for OPP, and access to this information will enable Battelle Memorial Institute and its subcontractor, Toxicology Excellence for Risk Assessment, Quality Environmental Professional Associate, and Horn Engineering Services, Inc., to fulfill the obligations of the contract.

DATES:

Battelle Memorial Institute and its subcontractor, Toxicology Excellence for Risk Assessment, Quality Environmental Professional Associate, and Horn Engineering Services, Inc., will be given access to this information on or before May 19, 2008.

FOR FURTHER INFORMATION CONTACT:

Felicia Croom, Information Technology and Resources Management Division (7502P), 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 a docket for this action under docket identification (ID) number EPA-HQ-OPP-2008-0002. 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 [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. Contractor Requirements

Under Contract No. EP-C-04-027, Battelle Memorial Institute and its subcontractor, Toxicology Excellence for Risk Assessment, Quality Environmental Professional Associate, and Horn Engineering Services, Inc. will perform the task to review and analyze published and unpublished studies of six conazoles: Fenbuconazole, Diniconazole, Cyproconazole, Uniconazole, Hexaconazole, and Propiconazole. Under this task the contractor shall:

1. Search the scientific literature from 1950 forward for dermal absorption studies of Fenbuconazole, Diniconazole, Cyproconazole, Uniconazole, Hexaconazole, and Propiconazole.

2. Obtain the dermal absorption studies for Fenbuconazole, Diniconazole, Cyproconazole, Uniconazole, Hexaconazole, and Propiconazole submitted to OPP from the OPP Registration Division.

3. Critically evaluate the studies obtained in IIA and IIB to determine the physical and chemical factors that govern dermal absorption and the influence of measurement methods on the reported dermal absorption values.

The OPP has determined that access by Battelle Memorial Institute and its subcontractor, Toxicology Excellence for Risk Assessment, Quality Environmental Professional Associate, and Horn Engineering Services, Inc., to information on all pesticide chemicals is necessary for the performance of this contract.

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)(2), the contract with Battelle Memorial Institute and its subcontractor, Toxicology Excellence for Risk Assessment, Quality Environmental Professional Associate, and Horn Engineering Services, Inc., prohibits use of the information for any purpose not specified in the contract; 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, Battelle Memorial Institute and its subcontractor, Toxicology Excellence for Risk Assessment, Quality Environmental Professional Associate, and Horn Engineering Services, Inc., are 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 Battelle Memorial Institute and its subcontractor, Toxicology Excellence for Risk Assessment, Quality Environmental Professional Associate, and Horn Engineering Services, Inc., until the requirements in this document have been fully satisfied. Records of information provided to Battelle Memorial Institute and its subcontractor, Toxicology Excellence for Risk Assessment, Quality Environmental Professional Associate, and Horn Engineering Services, Inc., will be maintained by EPA Project Officers for this contract. All information supplied to Battelle Memorial Institute and its subcontractor, Toxicology Excellence for Risk Assessment, Quality Environmental Professional Associate, and Horn Engineering Services, Inc., by EPA for use in connection with this contract will be returned to EPA when Battelle Memorial Institute and its subcontractor, Toxicology Excellence for Risk Assessment, Quality Environmental Professional Associate, and Horn Engineering Services, Inc., have completed their work.

List of Subjects

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

Dated: May 1, 2008.

Kathryn S. Bouve,

Acting Director, Office of Pesticide Programs.