66 FR 135 pgs. 36767-36768 - Oak Ridge National Laboratory/DOE and Waterborne Environmental Inc.,and Summitec Corporation; Transfer of Data
Type: NOTICEVolume: 66Number: 135Pages: 36767 - 36768
Docket number: [OPP-100173; FRL-6791--3]
FR document: [FR Doc. 01-17632 Filed 7-12-01; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
ENVIRONMENTAL PROTECTION AGENCY
[OPP-100173; FRL-6791--3]
Oak Ridge National Laboratory/DOE and Waterborne Environmental Inc.,and Summitec 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 tranferred to Oak Ridge National Laboratory/Department of Energy (DOE) and its subcontractors, Waterborne Environmental, Inc., and Summitec Corporation, in accordancewith 40 CFR 2.307(h)(3) and 2.308(i)(2). Oak Ridge National Laboratory/DOE and its subcontractors, Waterborne Environmental, Inc., and Summitec Corporation, have been awarded a contract to perform work for OPP, and access to this information will enable Oak Ridge National Laboratory/DOE and its subcontractors, Waterborne Environmental, Inc.,and Summitec Corporation, to fulfill the obligations of the contract.
DATES:
Oak Ridge National Laboratory/DOE and its subcontractors, Waterborne Environmental, Inc., and Summitec Corporation, will be given access to thisinformation on or before July 18, 2001.
FOR FURTHER INFORMATION CONTACT:
By mail: Erik R.Johnson, FIFRA Security Officer, Information Resources and Services Division (7502C), Officeof Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; telephone number: (703) 305-7248; e-mail address:johnson.erik@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 todescribe all the specific entities that may be affected by this action. If you have any questionsregarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .
B. How Can I Get Additional Information, Including Copies of this Document and OtherRelated Documents?
You may obtain electronic copies of this document, and certain other relateddocuments that might be available electronically, from the EPA Internet Home Page athttp://www.epa.gov/. To access this document, on the Home Page select "Laws andRegulations,""Regulations and Proposed Rules," and then look up theentry for this document under the " Federal Register -Environmental Documents." You can also go directly to the FederalRegister listings at http://www.epa.gov/fedrgstr/.
II. Contractor Requirements
Under Contract No. DW-89-93921701, Oak Ridge National Laboratory/DOE andits subcontractors, Waterborne Environmental, Inc and Summitec Corporation, will performthe following based on the statement of work:
The purpose of this collaborative effort is to assist OPP/EPA in systematically analyzing,evaluating, simulating, and identifying data/information gaps for pesticides with complex issuesfrom the registrant's submissions to fully characterize the safe manufacture, application, reentry,and residue issues prior to a FIFRA registration or reregistration. Several major tasks have beenidentified to support the OPP/EPA mission under the FIFRA mandate.
1. Risk assessments . Assess risks of specific pesticides using the best scientific rationale and state-of-the-art information to evaluate adverse effects to exposed human and ecological populations insupport of the Food Quality Protection Act (FQPA) and ecological risk assessments conductedunder FIFRA. In addition, provide state-of-the-art risk assessment methodologies (i.e.,probabilistic risk assessment) as requested.
2. Fate and transport . Develop and evaluate environmental fate and transport data and models insupport of the Ecological Committee on FIFRA Risk Assessment Methods (ECOFRAM)Guidance. In addition, provide research in areas of uncertainty and sensitivity analyses to advancethe use and usefulness of probabilistic techniques in fate and transport modeling.
3. Geo-spatial analysis . Provide data analysis, modeling, Geographic Information System (GIS)and software programming support to enhance assessments of potential pesticide transport fromcrop areas to surface waters and drinking water intake sources. Assess potential impacts ofpesticide use at differing spatial scales and resolution.
4. Computerization of toxicology data . Systematically compile toxicity data submitted by theregistrants into an electronic format. This would enable easy access and effective retrieval ofdata that would assist in the evaluation of chemicals under current review, and makerecommendations to OPP/EPA in identifying data/information gaps for future studies.
5. Evaluations of complex toxicology studies and issues . Perform evaluations of difficult andcomplex toxicology studies, and provide assessments of the overall significance of the findings asthey relate to the expected effects and environmental persistence of a chemical. Such studies mayinclude population based dynamics in addition to those specified under Task 1. Evaluations ofdifficult and complex issues in toxicology will be performed. The Oak Ridge National Laboratory will be exploring the state-of-the-art bio-statistical and dose/response methodologies for hazard assessments, identifying datagaps for research studies, and making recommendations to OPP/EPA for handling data gapissues.
The OPP has determined that access by Oak Ridge National Laboratory/DOE andits subcontractors, Waterborne Environmental, Inc. and Summitec Corporation, toinformation on all pesticide chemicals is necessary for the performance of this contract.
Some of this information may be entitled to confidential treatment. The informationhas been submitted to EPA under sections 3, 4, 6, and 7 of FIFRA and under sections 408 and409 of FFDCA.
In accordance with the requirements of 40 CFR 2.307(h)(2), the contract with OakRidge National Laboratory/DOE and its subcontractors, Waterborne Environmental, Inc.,and Summitec Corporation, prohibits use of the information for any purpose not specified in thecontract; prohibits disclosure of the information to a third party without prior written approvalfrom the Agency; and requires that each official and employee of the contractor sign an agreementto protect the information from unauthorized release and to handle it in accordance with theFIFRA Information Security Manual. In addition, Oak Ridge National Laboratory/DOE andits subcontractors, Waterborne Environmental, Inc., and Summitec Corporation, arerequired to submit for EPA approval a security plan under which any CBI will be secured andprotected against unauthorized release or compromise. No information will be provided to OakRidge National Laboratory/DOE and its subcontractors, Waterborne Environmental, Inc.,and Summitec Corporation, until the requirements in this document have been fully satisfied.Records of information provided to Oak Ridge National Laboratory/DOE and itssubcontractors, Waterborne Environmental, Inc., and Summitec Corporation, will bemaintained by EPA Project Officers for this contract. All information supplied to Oak RidgeNational Laboratory/DOE and its subcontractors, Waterborne Environmental, Inc., andSummitec Corporation, by EPA for use in connection with this contract will be returned to EPAwhen Oak Ridge National Laboratory/DOE and its subcontractors, WaterborneEnvironmental, Inc., and Summitec Corporation, have completed their work.
List of Subjects
Environmental protection, Business and industry, Government contracts, Governmentproperty, Security measures.
Dated: June 27, 2001.
Richard D. Schmitt,
Acting Director, Information Resources and Services Division,Office of Pesticide Programs.
[FR Doc. 01-17632 Filed 7-12-01; 8:45 am]
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