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Oak Ridge National Laboratory/DOE and Waterborne Environmental Inc., and Summitec Corporation; Transfer of Data

 
[Federal Register: July 13, 2001 (Volume 66, Number 135)]
[Notices]
[Page 36767-36768]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jy01-46]

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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.

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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 accordance with 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 this information on or before July 18, 2001.

FOR FURTHER INFORMATION CONTACT: By mail: Erik R. Johnson, FIFRA 
Security Officer, Information Resources and Services Division (7502C), 
Office of 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 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 Additional Information, Including Copies of this 
Document and Other Related Documents?

    You may obtain electronic copies of this document, and certain 
other related documents that might be available electronically, from 
the EPA Internet Home Page at http://www.epa.gov/. To access this 
document, on the Home Page select ``Laws and 
Regulations,''``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register-- Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.

II. Contractor Requirements

    Under Contract No. DW-89-93921701, Oak Ridge National Laboratory/
DOE and its subcontractors, Waterborne Environmental, Inc and Summitec 
Corporation, will perform the 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 issues from 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 been identified to

[[Page 36768]]

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 in support 
of the Food Quality Protection Act (FQPA) and ecological risk 
assessments conducted under 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 in support of the Ecological Committee on 
FIFRA Risk Assessment Methods (ECOFRAM) Guidance. In addition, provide 
research in areas of uncertainty and sensitivity analyses to advance 
the 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 from crop areas to 
surface waters and drinking water intake sources. Assess potential 
impacts of pesticide use at differing spatial scales and resolution.
    4. Computerization of toxicology data. Systematically compile 
toxicity data submitted by the registrants into an electronic format. 
This would enable easy access and effective retrieval of data that 
would assist in the evaluation of chemicals under current review, and 
make recommendations to OPP/EPA in identifying data/information gaps 
for future studies.
    5. Evaluations of complex toxicology studies and issues. Perform 
evaluations of difficult and complex toxicology studies, and provide 
assessments of the overall significance of the findings as they relate 
to the expected effects and environmental persistence of a chemical. 
Such studies may include population based dynamics in addition to those 
specified under Task 1. Evaluations of difficult 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 data gaps for 
research studies, and making recommendations to OPP/EPA for handling 
data gap issues.
    The OPP has determined that access by Oak Ridge National 
Laboratory/DOE and its subcontractors, Waterborne Environmental, Inc. 
and Summitec Corporation, 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 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)(2), the 
contract with Oak Ridge National Laboratory/DOE and its subcontractors, 
Waterborne Environmental, Inc., and Summitec 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, Oak Ridge National 
Laboratory/DOE and its subcontractors, Waterborne Environmental, Inc., 
and Summitec Corporation, 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 
Oak Ridge 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 its subcontractors, 
Waterborne Environmental, Inc., and Summitec Corporation, will be 
maintained by EPA Project Officers for this contract. All information 
supplied to Oak Ridge National Laboratory/DOE and its subcontractors, 
Waterborne Environmental, Inc., and Summitec Corporation, by EPA for 
use in connection with this contract will be returned to EPA when Oak 
Ridge National Laboratory/DOE and its subcontractors, Waterborne 
Environmental, Inc., and Summitec Corporation, have completed their 
work.

List of Subjects

    Environmental protection, Business and industry, Government 
contracts, Government property, 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]
BILLING CODE 6560-50-S

 
 

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