2021-02576. Battelle Memorial Institute; Transfer of Data (October 2020)

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 in accordance with the CBI regulations. Battelle Memorial Institute has been awarded a contract to perform work for OPP and access to this information will enable Battelle Memorial Institute to fulfill the obligations of the contract.

DATES:

Battelle Memorial Institute will be given access to this information on or before February 16, 2021.

FOR FURTHER INFORMATION CONTACT:

William Northern, Information Technology and Resources Management Division (7502P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 703 305-6478 email 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.

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-2019-0188, 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 [phone], and the telephone number for the OPP Docket is [phone].

Due to the public health concerns related to COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit https://www.epa.gov/​dockets.

II. Contractor Requirements

EPA requires technical and program support for the Agency's Endocrine Disruptor Screening Program (EDSP). This procurement entails services in the following areas: (1) Comprehensive toxicological and ecotoxicological testing and analysis; (2) toxicokinetics and dosimetry testing and analysis; (3) systematic literature reviews; (4) workshops/meeting support; (5) information/records management support; and (6) special studies/projects. Skills needed include, but are not limited to, technical experience and/or capability with performing Tier 1 and Tier 2 EDSP studies, in vitro toxicokinetics and dosimetry, risk assessment, development and evaluation of computational toxicity or exposure models, analytical chemical analysis, biochemical analyses, statistical analyses, information/records management, report-writing, meeting support and quality assurance/quality control support.

OPP has determined that the contracts 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 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)(3), the contracts with Battelle Memorial Institute, 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, Battelle Memorial Institute 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 Battelle Memorial Institute until the requirements in this document have been fully satisfied. Records of information provided to Battelle Memorial Institute will be maintained by EPA Project Officers for these contracts. All information supplied to Battelle Memorial Institute by EPA for use in connection with these contracts will be returned to EPA when Battelle Memorial Institute has completed its work.

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

Dated: November 18, 2020.

Delores Barber,

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