[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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