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• Some of the documents in the docket:

Feb 11, 2003 Overview of the Benfluralin Risk Assessment (15 pages)
Feb 11, 2003 - Benfluralin Summary (2 pages)
Oct 30, 2003 - MEMORANDUM : Benfluralin: Human Health Risk Assessment (Revised) (64 pages)
April 29, 2003 - Benfluralin: Health Effects Division (HED) Metabolism Assessment. Review Committee (MARC) Decision Document.
Dec 2001 - CANCER ASSESSMENT DOCUMENT. EVALUATION OF THE CARCINOGENIC POTENTIAL OF BENFLURALIN. Final Report.

http://www.epa.gov/fedrgstr/EPA-PEST/2004/February/Day-25/p3939.htm

[Federal Register: February 25, 2004 (Volume 69, Number 37)]
[Notices]
[Page 8640-8642]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25fe04-58]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2003-0381; FRL-7338-5]

Benfluralin; Availability of Risk Assessments (Interim Process)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the availability of risk assessments
that were developed as part of EPA's process for making pesticide
Reregistration Eligibility Decisions (REDs) and tolerance reassessments
consistent with the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act (FQPA) of 1996. These risk
assessments are the human health and environmental fate and effects
risk assessments and related documents for benfluralin. Benfluralin is
a dinitroaniline herbicide registered for use on lettuce; animal feed
crops; non-bearing fruits; and berries; commercial and residential
turf; and ornamentals. This notice also starts a 60-day public comment
period for the risk assessments. By allowing access and opportunity for
comment on the risk assessments, EPA is seeking to strengthen
stakeholder involvement and help ensure that pesticide decisions are
transparent and based on the best available information.

DATES: Comments, identified by the docket identification (ID) number
OPP-2003-0381, must be received on or before April 26, 2004.

ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Diane Isbell, Special Review and
Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8154; e-mail
address: isbell.diane@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general, nevertheless, a
wide range of stakeholders may be interested in obtaining the risk
assessments for benfluralin, including environmental, human health, and
agricultural advocates; the chemical industry;
[[Page 8641]]
pesticide users; and members of the public interested in the use of
pesticides on food. Since other entities also may be interested, 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 Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket ID number OPP-2003-0381. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related to this action.
Although a part of the official docket, the public docket does not
include Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. The official public docket
is the collection of materials that is available for public viewing at
the Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This
docket facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The docket telephone number is (703)
305-5805.

2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.

An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select ``search,''
then key in the appropriate docket ID number.

Certain types of information will not be placed in EPA's Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B.1. EPA intends to work
towards providing electronic access to all of the publicly available
docket materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or on paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the Docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.

II. How Can I Respond to this Action?

A. How and to Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.

1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.

i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/
edocket/, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPP-2003-0381. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov,
Attention: Docket ID Number OPP-2003-0381. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.

iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid
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the use of special characters and any form of encryption.

2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2003-0381.

3. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket
ID Number OPP-2003-0381. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.

B. How Should I Submit CBI to the Agency?

Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed under FOR FURTHER INFORMATION CONTACT.

C. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Offer alternative ways to improve the notice or collection
activity.
7. Make sure to submit your comments by the deadline in this document.
8. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

III. What Action is the Agency Taking?

EPA is making available to the public the risk assessments that
have been developed as part of the Agency's interim public
participation process for tolerance reassessment and reregistration.
During the next 60 days, EPA will accept comments on the human health
and environmental fate and effects risk assessments and other related
documents for benfluralin, available in the individual pesticide
docket. Benfluralin is a dinitroaniline herbicide registered for use on
lettuce; animal feed crops; non-bearing fruits and berries; commercial
and residential turf; and ornamentals. Like other REDs for pesticides
developed through the interim process, the benfluralin RED will be made
available to the public for comment.

EPA and the United States Department of Agriculture (USDA) have
been using a pilot public participation process for the assessment of
organophosphate pesticides since August 1998. In considering how to
accomplish the movement from the organophosphate pilot process to the
public participation process that will be used for non-
organophosphates, such as benfluralin, EPA and the USDA have adopted an
interim public participation process. For the past 3 years, EPA has
been using this interim process in reviewing many non-organophosphate
pesticides completing tolerance reassessment and reregistration. The
interim public participation process ensures public access to the
Agency's risk assessments while also allowing EPA to meet its
reregistration commitments. It takes into account that the risk
assessment development work on these pesticides is substantially
complete, and that related risk issues are not extremely complex. The
interim public participation process involves: A registrant error
correction period; a period for the Agency to respond to the
registrant's error correction comments; the release of the refined risk
assessments and risk characterizations to the public via the docket and
EPA's internet website; a significant effort on stakeholder
consultations, such as meetings and conference calls; and the issuance
of the risk management decision document (i.e., RED) after the
consideration of issues and discussions with stakeholders. The USDA may
hold meetings and conference calls with the public (i.e., interested
stakeholders such as growers, USDA Cooperative Extension Offices,
commodity groups, and other Federal government agencies) to discuss any
identified risks and solicit input on risk management strategies. EPA
participates in USDA's meetings and conference calls with the public.
This feedback is used to complete the risk management decisions and the
RED. EPA conducts a close-out conference call with interested
stakeholders to describe the regulatory decisions presented in the RED.
REDs for pesticides developed under the interim process may be made
available for another public comment period, depending on the
complexity of the decision and the level of stakeholder interest.
Included in the public version of the official record are the
Agency's risk assessments and related documents for benfluralin. As
additional comments, reviews, and risk assessment modifications become
available, these will also be docketed. The benfluralin risk
assessments reflect only the work and analysis conducted as of the time
they were produced and it is appropriate that, as new information
becomes available and/or additional analyses are performed, the
conclusions they contain may change.

List of Subjects
Environmental protection, Pesticides and pests.
Dated: February 17, 2004.
Peter Caulkins,
Acting Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. 04-3939 Filed 2-24-04; 8:45 am]
BILLING CODE 6560-50-S