[Federal Register Volume 68, Number 48 (Wednesday, March 12, 2003)]
[Notices]
[Pages 11837-11839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5477]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0333; FRL-7292-2]


Imazalil; Tolerance Reassessment Decisions; Notice of 
Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's tolerance 
reassessment decision and related documents for imazalil including the 
imazalil overview, imazalil summary, imazalil tolerance decision 
document: Tolerance Reassessment Progress and Interim Risk Management 
Decision (TRED), and supporting risk assessment tolerance documents. 
EPA has reassessed the 32 tolerances, or legal limits, for residues of 
imazalil in or on raw agricultural commodities. These tolerances are 
now considered safe under the Federal Food, Drug, and Cosmetic Act 
(FFDCA), as amended by the Food Quality Protection Act (FQPA) of 1996.

DATES: Comments, identified by docket ID number OPP-2002-0333, must be 
received on or before April 11, 2003. In the absence of substantive 
comments, the tolerance reassessment decision will be considered final.

ADDRESSES: Comments may be submitted electronically, by mail or through 
hand delivery/courier. Follow the detailed instructions for each method 
as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket ID 
number OPP-2002-0333 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  Cecelia Watson, Special Review and 
Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-4329; 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, but will be of 
interest to a wide range of stakeholders, including environmental, 
human health, and agricultural advocates; the chemical industry; 
pesticide users; and members of the public interested in the use of 
pesticides. The Agency has not attempted to describe all the persons or 
entities who may be interested in or affected by this action. If you 
have questions in this regard, consult the persons listed under FOR 
FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2002-0333. The 
official public docket consists of the documents

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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. 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.

C. 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-2002-0333. 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-2002-0333. 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), Office of Pesticide Programs (OPP), 
Environmental Protection Agency (7502C), 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2002-0333.
    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-2002-0333. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.A.1.

[[Page 11839]]

D. How Should I Handle CBI That I Want to Submit 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.

E. 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 
control 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.

II. Background

A. What Action is the Agency Taking?

    This notice announces the availability of the TRED for imazalil. 
This decision has been developed as part of the public participation 
process that EPA and the U.S. Department of Agriculture (USDA) are 
using to involve the public in the reassessment of pesticide tolerances 
under FFDCA. EPA must review tolerances and tolerance exemptions that 
were in effect when FQPA was enacted in August 1996, to ensure these 
existing pesticide residues limits for food and feed commodities meet 
the safety standard of the new law.
    FFDCA requires EPA to review all the tolerances for registered 
chemicals in effect on or before the date of the enactment. In 
reviewing these tolerances, the Agency must consider, among other 
things, aggregate risks from non-occupational sources of pesticide 
exposure, whether there is increased susceptibility to infants and 
children, and the cumulative effects of pesticides with a common 
mechanism of toxicity. The tolerances are considered reassessed once 
the safety finding has been made or a revocation occurs.
    FFDCA requires that the Agency, when considering whether to 
establish, modify, or revoke a tolerance, consider ``available 
information'' concerning the cumulative effects of a particular 
pesticide's residues and ``other substances that have a common 
mechanism of toxicity.''
    As indicated above, the Agency will also evaluate the cumulative 
risk, if necessary, posed by the entire group of chemicals with which a 
common mechanism of toxicity is shared, and issues a final tolerance 
reassessment decision once the cumulative assessment for that group is 
completed. At this time, imazalil has not been identified as sharing a 
common mechanism of toxicity and is not scheduled for a cumulative risk 
assessment.
    The tolerance reassessment program is being conducted under 
Congressionally mandated time frames, and EPA recognizes both the need 
to make timely tolerance decisions and to involve the public. 
Therefore, EPA is issuing the TRED as a final document with a 30-day 
comment period. All comments will be carefully considered by the 
Agency. If any comment significantly affects a TRED, EPA will amend the 
TRED by publishing the amendment in the Federal Register.
    Imazalil is currently in the reregistration process. The imazalil 
preliminary risk assessment was made available for public comment on 
March 27, 2002 (67 FR 14710) (FRL-6824-7). The Agency is currently 
reviewing public comments and anticipates a reregistration decision 
this fall.

B. What is the Agency's Authority for Taking this Action?

    The authority for this TRED is found in section 408(q) of the 
FFDCA, 21 U.S.C. 346a(q). Section 408(q) requires EPA to review 
tolerances and exemptions for pesticide chemical residues in effect of 
August 2, 1996, to determine whether the tolerance or exemption meets 
the requirements of 408(b)(2) or (c)(2). This review is to be completed 
by August 3, 2006.

List of Subjects

    Environmental protection, Chemicals, Pesticides and Tolerances.

    Dated: February 14, 2003.
Betty Shackleford,
Acting Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. 03-5477 Filed 3-11-03; 8:45 am]
BILLING CODE 6560-50-S