GeoLogics Corporation; Transfer of Data

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Federal RegisterMar 16, 2011
76 Fed. Reg. 14392 (Mar. 16, 2011)

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

DATES:

GeoLogics Corporation will be given access to this information on or before March 21, 2011.

FOR FURTHER INFORMATION CONTACT:

Mario Steadman, Information Technology and Resources Management Division (7502P), Office of Pesticide Programs, 20460-0001; telephone number: (703) 305-8338; e-mail address: 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. 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-2011-0038. 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 (703) 305-5805.

II. Contractor Requirements

Under Contract No. EP10H002173, the contractor will perform the following: The Laboratory Data Integrity Branch (LDIB) within the Office of Compliance (OC) is charged with the responsibility of conducting Good Laboratory Practice (GLP) inspections under FIFRA and the Toxic Substances Control Act (TSCA). The LDIB utilizes a database known as Laboratory lnformation and Study Audit (LISA) to aid them in targeting future inspections and tracking and documenting historical inspections. LISA maintains records of test substance chemicals and their metabolites, the registrants and sponsors of these chemicals, and the laboratories employed by the sponsors to test these chemicals. LISA also maintains EPA inspection findings, the identity of the inspection team, and the dates the inspection was conducted. LISA also aids the branch is generating end of year reports to the branch chief and correspondence.

LISA also has the ability to interface with the OPP database known as, Office of Pesticide Programs lnformation network (OPPIN). This link provides LDIB with a list of laboratories regulated by GLPS and therefore subject to GLP inspections. Information from OPP provides up-to-date information regarding studies, test facilities, sponsors, guidelines, and test substance chemicals.

The purpose of this Statement of Work is to identify, evaluate, and write new system software for the modernization of the LDIB data management system known as LISA. The LDIB utilizes LISA to aid the branch in targeting, monitoring and documenting historical GLP inspection Information. Additionally, LISA maintains historical GLP inspection findings, inspection team Information, and inspection dates. LISA also aids the LDB by generating end of year reports to the branch chief, including EPA correspondence to the regulated community. The objective of LISA modernization is to: Increase the accessibility of LISA from remote locations, i.e., Denver field office, reduce inefficiencies created by the existing antiquated software, improve the overall performance of the system, and ensure better integrity of the data stored in the database system.

This contract involves no subcontractors.

OPP 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 contract with GeoLogics Corporation, 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, GeoLogics 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 GeoLogics Corporation until the requirements in this document have been fully satisfied. Records of information provided to GeoLogics Corporation will be maintained by EPA Project Officers for the contract. All information supplied to GeoLogics Corporation by EPA for use in connection with these contract will be returned to EPA when GeoLogics Corporation has completed its work.

List of Subjects

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

Dated: March 4, 2011.

Michael Hardy,

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

[FR Doc. 2011-5974 Filed 3-15-11; 8:45 am]

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