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AGENCY : Environmental Protection Agency (EPA).
Related Material
[Federal Register: December 15, 1999 (Volume 64, Number 240)]
[Notices]
[Page 70019-70020]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15de99-56]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-100152; FRL-6392-4]
Disclosure of Information Obtained Regarding Unreasonable Adverse
Effects of Pesticides on the Environment; Class Determination
AGENCY : Environmental Protection Agency (EPA).
ACTION: Notice of Availability.
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SUMMARY: This document announces a class determination by EPA that
safety and efficacy information submitted under section 6(a)(2) of the
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) is not
entitled to confidential treatment. This determination will enable EPA
offices to respond more quickly and efficiently to requests for
information submitted under section 6(a)(2).
DATES: The class determination took effect upon its issuance, on
September 28, 1999.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kathryn S. Bouve, 6(a)(2) Officer, Office of Pesticide Programs
(7502C), U.S. Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location: Information Services Branch, CM
#2, 2d floor, 1921 Jefferson Davis Hwy., Arlington, VA. Telephone:
(703) 305-5032; e-mail: bouve.kate@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Does this Action Apply to Me?
You may be potentially affected by this action if you are a
pesticide registrant, i.e., any person who holds, or ever held, a
registration for a pesticide product issued under section 3 or section
24(c) of FIFRA. Potentially affected categories and entities may
include but are not limited to:
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Examples of Potentially
Categories NAICS Affected Entities
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Industry............................. 32532 Pesticide manufacturing
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This listing is not exhaustive, but is a guide to entities likely
to be regulated by this action. The North American Industrial
Classification System (NAICS) codes will assist you in determining
whether this action applies to you. If you have questions regarding the
applicability of this action to a particular entity, consult the person
listed in the FOR FURTHER INFORMATION CONTACT section.
II. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain copies of this document and
certain other available support documents from the EPA Internet Home
Page at http://www.epa.gov/. On the Home Page select ``Laws and
Regulations'' 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/homepage/
fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number OPP-100152. The official record
consists of the documents specifically referenced in this action and
other information related to this action, including any information
claimed as confidential business information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period, is available
for inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is 703-305-5805.
3. Fax on demand. Using a faxphone call (202) 401-0527 and select
item 6045 for a copy of Class Determination 1-99.
III. What Is the Determination Announced in this Document?
On September 28, 1999, EPA issued Class Determination 1-99. In the
Class Determination the Agency determined that safety and efficacy
information submitted pursuant to FIFRA section 6(a)(2) is not entitled
to confidential treatment, and that if such information is submitted to
EPA under a claim of business confidentiality it may nonetheless be
disclosed to the public, subject to the provisions of FIFRA section
10(g). This determination covers information both currently in the
[[Page 70020]]
Agency's possession and submitted in the future.
A. What is Section 6(a)(2) of FIFRA?
On September 19, 1997, EPA published in the Federal Register (62 FR
49370) (FRL-5739-1) a rule implementing section 6(a)(2) of FIFRA. This
rule is codified at 40 CFR part 159, subpart D. As explained more fully
in the 1997 Federal Register rule, under FIFRA section 6(a)(2)
pesticide registrants are required to submit to EPA reports of adverse
effects related to product usage, product defects, or lack of product
efficacy, as well as new information derived from scientific studies
which pertain to unreasonable adverse effects of pesticides on the
environment.
B. What is Safety and Efficacy Information?
Section 10(d)(1) of FIFRA requires disclosure to the public of all
information regarding the effects of any registered or previously
registered pesticide on any organism or the behavior of any such
pesticide in the environment (subject to certain exceptions, discussed
in the class determination). EPA has used the term ``safety and
efficacy information'' as a label for the information required to be
disclosed by section 10(d)(1). Information submitted under section
6(a)(2) is largely safety and efficacy information.
C. What is Section 10(g) of FIFRA?
Section 10(g) protects the proprietary rights of pesticide
registrants and applicants in data submitted to support applications
for pesticide registration, by limiting disclosure of such data to
persons who affirm that they are not, and will not deliver the
information to, a business engaged in the production, sale or
distribution of pesticide products in countries other than the United
States (except when the data submitter has consented to such
disclosure). In Class Determination 3-85, Disclosure of Reviews of
Pesticide Test Data (50 FR 48833, November 27, 1985), EPA announced its
interpretation that section 10(g) applies to information which consists
of a complete unpublished report of a study, test, or experiment
submitted to EPA by an applicant or registrant under FIFRA, or which
consists of excerpts or restatements of any such report which reveal
the full methodology and complete results of the study, test, or
experiment, and all explanatory information necessary to understand the
methodology or interpret the results, and that section 10(g) does not
apply to information of a more summary nature.
D. Why has EPA Issued the Class Determination and Published Notice in
the Federal Register?
Under EPA confidentiality regulations at 40 CFR 2.207, the Agency
may issue determinations regarding the application of the
confidentiality regulations to an entire class, when such a
determination serves a useful purpose. In this case, a class
determination promoting expeditious processing of section 6(a)(2)
information subject to confidentiality claims will assist the Agency in
responding to requests for this information and in making the
information more widely available. Because under section 2.207 one of
the purposes of issuing a class determination is to make known the
Agency's position regarding the manner in which information within the
class will be treated, EPA is publishing notice of the class
determination in the Federal Register.
List of Subjects
Environmental protection.
Dated: December 7, 1999.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.
[FR Doc. 99-32185 Filed 12-14-99; 8:45 am]
BILLING CODE 6560-50-F
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