[Federal Register Volume 63, Number 199 (Thursday, October 15, 1998)]
[Notices]
[Pages 55387-55388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27706]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00549; FRL-6025-7]
Pesticides; Notice to Solicit Public Comment on EPA's Proposal to
Publish the Registration Division's Fiscal Year 1999 Workplan
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is soliciting comments on its proposal to publish the
fiscal year 1999 (FY99) workplan for the Registration Division (RD) in
keeping with efforts to improve the transparency and flexibility in the
pesticide registration process. The Agency is inviting views on the
possible benefits and disadvantages of making RD's FY99 workplan
publicly available.
DATES: Written comments must be received on or before November 16,
1998.
ADDRESSES: By mail, submit written comments to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, deliver comments to:
Rm. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
Comments and data may also be submitted electronically to: opp-
[email protected]. Follow the instructions under Unit III. of this
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 will be included in the
public docket by EPA without prior notice. The public docket is
available for public inspection in Rm. 119 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: Rick Keigwin, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Rm. 713, Crystal Mall #2, 1921
[[Page 55388]]
Jefferson Davis Highway, Arlington, VA, (703) 305-7618, fax: 703-305-
6920, e-mail: [email protected].
SUPPLEMENTARY INFORMATION: This Federal Register notice announces the
Agency's proposal to make RD's FY99 workplan publicly available in a PR
Notice to be published in October 1998, and solicit comments on this
proposed action. If, after reviewing any comments, EPA determines that
changes to the PR Notice are warranted, the Agency would revise the
draft PR Notice before issuing it in final form.
The Agency proposes to increase the transparency of the
registration process by publishing the RD's proposed FY99 workplan, and
is inviting public input on the advantages as well as the disadvantages
of making this information available.
I. Background
The registration of pesticides (excluding antimicrobials and
biopesticides) is performed by the Registration Division of the Office
of Pesticide Programs (OPP). Historically, the Agency has reviewed new
registration applications and tolerance petitions based upon a system
of ``first received, first reviewed.'' In 1993, the Agency switched its
process for setting the review queue to a points based system. Under
this points based system, RD assigned priority points of differing
values depending on the type of action (e.g. Section 18s = 75 points,
Experimental Use Permits = 15 points, New Active Ingredients = 10
points). Priority points were also accrued for ``aging,'' i.e., the
longer a submission remained in the Agency before being completed, the
more priority points it accrued. Actions with the highest number of
priority points were generally the first to be completed by each of the
science review divisions. Some drawbacks to the priority point system
include: difficulty in planning and predicting priorities; some
registrant priorities have not been completed in order; little
perceived incentive for the registrants to submit comprehensive
submissions; and poor reflection of Agency resources allocated toward
registration progress.
Despite an increase in registration productivity, backlogs for some
critical registration actions remained. To address this concern and to
create a more efficient, predictable, and equitable review queue, in
June of 1995, the Agency launched a pilot priority system limiting the
registrants to five priorities of their choice. Using this method, RD
received approximately 170 priorities (designated numbers 1-5) which
were blended with Agency identified priorities (mainly IR-4 and repeat
Section 18s) and placed into review. It was generally understood that
priority number 1 would be reviewed before priority number 2, and
priority number 2 before number 3, etc. PR Notice 95-6 (October 1995)
officially announced the new priority policy and procedures, and
requested that registrants submit their second round of five priorities
(designated numbers 6-10). This round of priorities included new active
ingredients, new uses, and experimental use permits. The second round
yielded 332 registrant priorities which were blended with EPA
priorities.
In April 1997, EPA issued PR Notice 97-2 requesting a third round
of five priorities (designated numbers 11-15). The action eligibility
for this round was expanded to include inerts and non-fast track
amendments, including additional incentives to encourage more products
for minor uses, methyl bromide substitutes, and alternatives to certain
organophosphates. Changes required in the registration process by the
Food Quality Protection Act have caused delays in completing the
reviews for priorities 1-10; and delays in the scheduling of priorities
11-15. Registrants identified approximately 600 actions for
prioritization in response to PR Notice 97-2.
Review of the registration process reveals a diversity of priority
needs: there are statutory priorities such as minor use, me-too, and
reduced risk actions; registrants frequently submit their top business
priorities; the United States Department of Agriculture (USDA) submits
priorities on the basis of crop/pest combinations; priorities for
grower groups are channeled directly to EPA or revealed by trends in
section 18 requests; and priorities for public interest groups are
frequently related to contemporary issues, such as identifying methyl
bromide replacement chemicals and alternatives to certain
organophosphate pesticides.
By publishing its proposed FY99 registration workplan, the Agency
expects to extend the transparency and predictability of the
registration process. Based upon resource allocations for FY99, RD
expects to make decisions on approximately 15 new active ingredients
and 75 (non-section 18) tolerance decisions. The Agency will have set
its workplan for FY99 by September 30, 1998, and proposes to publish
the list of new chemical and new use candidates in October 1998. When
making the workplan public the Agency would exclude all confidential
business information.
II. Issues for Comment
The Agency would like to extend the transparency of the
registration process. Moreover, EPA believes that there are several
benefits from publishing its annual pesticide registration workplan and
inviting public comment. A transparent registration workplan would
allow opportunities for harmonization of registration work with other
pesticide regulatory agencies (e.g., California and Canada), to share
similar work and objectives, thereby saving precious resources. EPA
also believes that extending the transparency of its process would
provide important information to growers, crop consultants,
researchers, states, the general public, and other users. The Agency
would like to know of any other benefits of publishing its workplan and
whether there are any disadvantages to this approach.
III. Public Record and Electronic Submissions
The official record for this action, as well as the public version,
has been established for this action under docket control number ``OPP-
00549'' (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 record is located at the Virginia address in ``ADDRESSES'' at
the beginning of this document.
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 5.1/6.1 or ASCII file
format. All comments and data in electronic form must be identified by
the docket control number ``OPP-00549.'' Electronic comments on this
action may be filed online at many Federal Depository Libraries.
List of Subjects
Environmental protection, Pesticides.
Dated: October 2, 1998.
James Jones,
Director, Registration Division, Office of Pesticide Programs
[FR Doc. 98-27706 Filed 10-14-98; 8:45 am]
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