[Federal Register Volume 68, Number 63 (Wednesday, April 2, 2003)]
[Notices]
[Pages 16032-16034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7979]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0249; FRL-7296-8]


Diuron; Availability of Risk Assessments; Tolerance Reassessment 
Decision

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 diuron. In addition, EPA is 
announcing the availability of the tolerance reassessment decision for 
diuron. This notice also starts a 60-day public comment period for the 
risk assessments and tolerance reassessment decision documents. By 
allowing access and opportunity for comment on the risk assessments and 
tolerance reassessment documents, EPA is seeking to strengthen 
stakeholder involvement and help ensure decisions made under FQPA are 
transparent and based on the best available information.

DATES: Comments, identified by the docket ID number OPP-2002-0249, must 
be received on or before June 2, 2003.

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: [email protected].

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 will be interested in obtaining the risk 
assessments for diuron, including environmental, human health, and 
agricultural advocates; the chemical industry; 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 identification (ID) number OPP-2002-0249. The 
official public docket consists of the documents specifically 
referenced in this action,

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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 the EPA 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. 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 in 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-2002-0249. 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 [email protected], 
Attention: Docket ID Number OPP-2002-0249. 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 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-2002-0249.
    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-2002-0249. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

[[Page 16034]]

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 proposed rule 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 diuron, available in the individual pesticide docket.
    In addition, EPA has reassessed the risks associated with current 
and proposed food uses of the pesticide diuron, including the 81 
existing tolerances, and reached a tolerance reassessment and interim 
risk management decision. The Agency is issuing for comment the 
resulting Tolerance Reassessment Decision for diuron, known as a TRED, 
as well as the summary, overview, and risk assessment documents. It 
should be noted that for diuron, a RED document will be issued in 2003. 
The diuron RED will address any possible risk to workers and the 
environment and list any further risk mitigation and confirmatory data 
needs. During the next 60 days, EPA will accept comments on the TRED. 
All comments received during the next 60 days will be considered by the 
Agency. If any comments significantly affect the Agency's decision, EPA 
will acknowledge and address them in the final RED document. In the 
absence of substantive comments, the tolerance reassessment decisions 
reflected in this TRED will be considered final.
    EPA must review tolerances and tolerance exemptions that were in 
effect when FQPA was enacted in August 1996, to ensure that these 
existing pesticide residue limits for food and feed commodities meet 
the safety standard established by the new law. Tolerances are 
considered reassessed once the safety finding has been made or a 
revocation occurs. EPA has reviewed and made the requisite safety 
finding for the tolerances and exemptions included in the TRED.
    Although some potential risks of concern have been identified, EPA 
is able to make a determination of reasonable certainty of no harm for 
diuron, based on further characterization of these risks, the 
registrant's commitment to mitigation measures designed to reduce 
exposure to diuron and its metabolites in drinking water and the 
development of data to confirm that the mitigation measures are 
adequate. Each risk of potential concern, related to the tolerance 
reassessment, with its characterization and the mitigation designed to 
address the concern is discussed in the tolerance reassessment 
document. It should be noted that when the Agency evaluates the 
ecological and worker risks during the development of the RED later in 
2003, additional risk mitigation may be necessary.
    Included in the public version of the official record are the 
Agency's risk assessments and related documents for diuron. As 
additional comments, reviews, and risk assessment modifications become 
available, these will also be docketed. The diuron 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, Chemicals, Pesticides and pests.

    Dated: March 14, 2003.
 Betty Shackelford,
Acting Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. 03-7979 Filed 4-1-03; 8:45 am]
BILLING CODE 6560-50-S