Summitec Corporation, Versar, Inc., and CDM/CSS-Dynamac Joint Venture; Transfer of Data

Download PDF
Federal RegisterAug 10, 2016
81 Fed. Reg. 52852 (Aug. 10, 2016)

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 Summitec Corporation and its subcontractors, Versar, Inc., and CDM/CSS-Dynamac Joint Venture in accordance with the CBI regulations. Summitec Corporation and its subcontractors, Versar, Inc., and CDM/CSS-Dynamac Joint Venture have been awarded a contract to perform work for OPP, and access to this information will enable Summitec Corporation and its subcontractors Versar, Inc., and CDM/CSS-Dynamac Joint Venture to fulfill the obligations of the contract.

DATES:

Summitec Corporation and its subcontractors Versar, Inc., and CDM/CSS-Dynamac Joint Venture will be given access to this information on or before August 15, 2016.

FOR FURTHER INFORMATION CONTACT:

Mario Steadman, Information Technology and Resources Management Division (7502P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 305-8338, email: steadman.mario@epa.gov.

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.

B. How can I get copies of this document and other related information?

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2016-0445, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

II. Contractor Requirements

Under Contract No. EP-W-16-019, Summitec Corporation and its subcontractors, Versar, Inc., and CDM/CSS-Dynamac Joint Venture, will perform critical reviews of EPA designated studies submitted by the registrants and/or from the open literature. These reviews will be provided to the contract officer's representative in data evaluation records or other similar study data evaluation records or systems, as applicable. A template of the data evaluation records format provided to the contractor will be followed in the preparation of data evaluation records. See the data evaluation records templates for test guidelines at http://www.epa.gov/pesticide-registration/study-profile-templates. Specific guidance for completing each section is provided in the data evaluation records templates. Each review will encompass all items in the study that contribute to the overall knowledge of the pesticide, and will include the following:

  • An evaluation of the accuracy, credibility and scientific validity of that study;
  • its suitability for meeting specific data requirements;
  • any necessary graphic displays of data, and/or summary tables illustrating results of the study;
  • sound scientific rationale for the conclusions reached on specific studies; and
  • clarity in data presentation and adherence to the template and overall guidance.

OPP has determined that access by Summitec Corporation and its subcontractors, Versar, Inc., and CDM/CSS-Dynamac Joint Venture 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 FIFRA sections 3, 4, 6, and 7 and under FFDCA sections 408 and 409.

In accordance with the requirements of 40 CFR 2.307(h)(2) the contract with Summitec Corporation and its subcontractors, Versar, Inc., and CDM/CSS-Dynamac Joint Venture, 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, Summitec Corporation and its subcontractors, Versar, Inc., and CDM/CSS-Dynamac Joint Venture 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 Summitec Corporation and its subcontractors, Versar, Inc., and CDM/CSS-Dynamac Joint Venture until the requirements in this document have been fully satisfied. Records of information provided to Summitec Corporation and its subcontractors, Versar, Inc., and CDM/CSS-Dynamac Joint Venture will be maintained by EPA project officers for this contract. All information supplied to Summitec Corporation and its subcontractors, Versar, Inc., and CDM/CSS-Dynamac Joint Venture by EPA for use in connection with this contract will be returned to EPA when Summitec Corporation and its subcontractors, Versar, Inc., and CDM/CSS-Dynamac Joint Venture have completed their work.

Authority: 7 U.S.C. 136 et seq.; 21 U.S.C. 301 et seq.

Dated: August 3, 2016.

Delores Barber,

Acting Director, Information Technology and Resources Management Division, Office of Pesticide Programs.

[FR Doc. 2016-18896 Filed 8-9-16; 8:45 am]

BILLING CODE 6560-50-P