[Federal Register Volume 62, Number 117 (Wednesday, June 18, 1997)]
[Notices]
[Pages 33078-33080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15980]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00485; FRL-5724-4]
Proposed Reduced-Risk Initiative Guidelines
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of availability.
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SUMMARY: EPA is soliciting comments on a proposed expedited review
policy as required by the Food Quality Protection Act of 1996. The
proposal is available in a draft Pesticide Registration (PR) Notice
entitled ``Draft Guidelines for Expedited Review of Conventional
Pesticides under the Reduced-Risk Initiative and for Biological
Pesticides'' which is available upon request.
DATES: Written comments, identified by the docket control number ``OPP-
00485,'' must be received on or before July 18, 1997.
ADDRESSES: The PR Notice is available by contacting the person whose
name appears under FOR FURTHER INFORMATION CONTACT. Submit written
comments identified by the docket control number OPP-00485 by mail to:
Public Information and Records Integrity Branch, Information Resources
and Services Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
In person, bring comments directly to the OPP docket which is located
in Rm. 1132 of Crystal Mall #2, 1921 Jefferson Davis Highway,
Arlington, VA.
Comments and data may also be submitted electronically by following
the instructions under Unit V. of this
[[Page 33079]]
document. No Confidential Business Information (CBI) should be
submitted through e-mail.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
CBI. Information so marked will not be disclosed except in accordance
with procedures set forth in 40 CFR part 2. A copy of the comment that
does not contain CBI must be submitted for inclusion in the public
record. Information not marked confidential may be disclosed publicly
by EPA without prior notice. All written comments will be available for
public inspection in Rm. 1132 at the Virginia address given above from
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Richard Keigwin (7505C),
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number, and e-mail address: Rm. 713A, CM #2,
1921 Jefferson Davis Highway, Arlington, VA, (703) 305-5447, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
Electronic Availability: Electronic copies of this document and the
draft PR Notice are available from the EPA home page at the
Environmental Sub-Set entry for this document under ``Regulations''
(http://www.epa.gov/fedrgstr/).
This Federal Register notice announces the availability of the
draft PR Notice and solicits comment on the proposed policy. If, after
reviewing any comments, EPA determines that changes to the Notice are
warranted, the Agency will revise the draft PR Notice prior to release.
I. Purpose
The Food Quality Protection Act of 1996 (FQPA) requires EPA, not
later than 1 year after enactment, to develop procedures and
guidelines, and to expedite the review of applications for registration
that meet such guidelines. An application for registration or amendment
of either a conventional or a biological pesticide shall qualify for
expedited review if the proposed use of the pesticide may reasonably be
expected to accomplish one or more of the following:
1. Reduce the risks of pesticides to human health.
2. Reduce the risks of pesticides to nontarget organisms.
3. Reduce the potential for contamination of groundwater surface
water or other valued environmental resources.
4. Broaden the adoption of integrated pest management strategies,
or make such strategies more available or more effective.
The purpose of the proposed PR Notice is to provide the process and
criteria to guide applicants in developing their reduced-risk
submissions. This proposed PR Notice will supersede the criteria
published in Federal Register Notices of July 20, 1992 (57 FR 32140)
and January 22, 1993 (58 FR 5854), and PR Notice 93-9, July 21, 1993.
The goal of the Reduced-Risked Pesticide Initiative and of the
Biopesticides and Pollution Prevention Division is to encourage the
development, registration, and use of lower-risk pesticide products
which would result in reduced risks to human health and the environment
when compared to existing alternatives. The major incentive which EPA
offers for reduced-risk pesticides is expedited registration review.
II. Applicability
The proposed PR Notice will apply to all applicants seeking any
type of registration action for a biological pesticide and to all
applicants seeking to register as reduced-risk certain chemical
pesticide products containing a new active ingredient, or a new use of
an active ingredient.
III. Contents of the PR Notice
The main sections of the proposed PR Notice address the following
topics:
1. Characteristics of acceptable and unacceptable submissions. A
review of most reduced-risk submissions received by the Agency to date
serves as the basis for guidance on what reduced-risk rationales have
been found acceptable and on what problems caused rejection of the
application.
2. Guidelines for reduced-risk rationales. In this section, the
required organization and substance of a reduced-risk application are
described in detail. Basically, a full discussion of the
characteristics and potential risks of the pesticide must be provided
in a standard format, with appropriate references to applicable data.
3. Guidelines for FQPA rationale. An explanation of how the
proposed application complies with the requirements of FQPA is
necessary. Appendix A to the notice gives additional guidance.
IV. Issues
The Agency invites comments on any issues regarding these proposed
Reduced-Risk Pesticide guidelines. In particular, the Agency invites
comments on the following issues.
1. The Agency's reduced-risk program initially sought to develop
``bright line'' criteria that clearly indicated what criteria a
pesticide had to meet to be considered safe. Instead, experience
indicated that reduced-risk was more readily defined in relative terms
through comparisons with relevant alternatives. The Agency seeks
comment on the appropriateness of determining reduced-risk status using
a weight-of-evidence approach that relies heavily on comparative
criteria rather than relying on more absolute criteria that would
define a ``safe'' pesticide.
2. While a new active ingredient may have a similar chemical
structure to chemicals already on the market, it may not necessarily
share a common mode of toxicity. Such a determination will be made
during the tolerance reassessment process over the next 10 years. In
the absence of a formal determination by the Agency on common mode of
toxicity, should the reduced-risk committee accept candidates that meet
all of the other reduced-risk criteria but may share a common mode of
toxicity with other pesticides already on the market?
3. Members of the Food Quality Protection Act Advisory Committee
expressed concerns that if the scope of the reduced-risk program is
expanded too broadly, too many applications will qualify, the program
will be overwhelmed, and the average review time will grow thereby
negating the only incentive available for companies to develop reduced-
risk pesticides. The Agency invites comments on the trade off between
expanding the scope of the program and slower registration times.
4. How should EPA measure success of its reduced-risk pesticide
initiative?
5. What other incentives beyond expedited registration should the
Agency consider to increase the development and registration of
reduced-risk pesticides, biopesticides, and other safer pest management
tools?
V. Public Record
The official record for this document, as well as the public
version, has been established for this document under docket control
number ``OPP-00485'' (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The official rulemaking record is located at the address in
``ADDRESSES'' at the beginning of this document.
[[Page 33080]]
Electronic comments can be sent directly to EPA at:
[email protected]
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comment and data
will also be accepted on disks in Wordperfect 5.1 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket control number ``OPP-00485.'' Electronic
comments on this document may be filed online at many Federal
Depository Libraries.
List of Subjects
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests.
Dated: June 12, 1997.
Stephen L. Johnson,
Acting Director, Office of Pesticide Programs.
[FR Doc. 97-15980 Filed 6-17-97; 8:45 am]
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