2010-15456. Dynamac Corporation; 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 Dynamac Corporation in accordance with 40 CFR 2.307(h)(3) and 2.308(i)(2). Dynamac Corporation has been awarded a contract to perform work for OPP, and access to this information will enable Dynamac Corporation to fulfill the obligations of the contract.

DATES:

Dynamac Corporation will be given access to this information on or before July 6, 2010.

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?

EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2010-0194. 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].

II. Contractor Requirements

Under this contract number, the contractor will perform the following:

Under Contract No. EP10H001452, the contractor shall review and/or update approximately 280 Data Evaluation Records (DERs) per contract period to address the evaluation of endocrine-related effects cited in the Other Scientifically Relevant Information (OSRI). The contractor shall retrieve some or all of an estimated 6,000 journal articles cited in the OSRI that provide information on the endocrine disruption potential of the chemicals under consideration.

The Test Order Recipients may submit journal articles that will require review of published mammalian literature submitted as OSRI. Journal articles may by submitted for nine Tier 1 Assays. It is estimated that the submission may include up to 10 articles/assays x 9 per chemical x 67 chemicals for a total of 6,000 journals articles.

The contractor shall review some or all of the journal articles retrieved and prepare a Journal Article Review summary (JARs) containing the parameters/endpoints evaluated in the studies.

The contractor shall perform expert analyses of difficult and complex toxicological issues as defined in written technical direction from the Contracting Officer Representative (COR). The technical direction will provide key scientific questions and data sets, as appropriate, that the contractor shall analyze and answer. These analyses shall assess the overall significance of the findings as they relate to the expected human health effects. Such studies may focus on endocrinology (including endocrine disruption), epidemiology, immunology, cholinesterase inhibition, synergistic interaction, behavioral pharmacology biostatics, mode of action studies, and risk assessment. To conduct these complex analyses, the contractor shall identify expert scientists in the required scientific disciplines, convene and/or attend work groups or meeting to conduct coordinated reviews, conduct the workgroup or meetings, and prepare draft reports.

This contract involves no subcontractors.

OPP has determined that the contract described in this document involves 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 contract with Dynamac Corporation, prohibits use of the information for any purpose not specified in this 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, Dynamac Corporation 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 Dynamac Corporation until the requirements in this document have been fully satisfied. Records of information provided to Dynamac Corporation will be maintained by EPA Project Officers for this contract. All information supplied to Dynamac Corporation by EPA for use in connection with this contract will be returned to EPA when Dynamac Corporation has completed its work.

List of Subjects

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

Dated: June 21, 2010.

Oscar Morales,

Acting Director, Office of Pesticide Programs.