[Federal Register: October 27, 2004 (Volume 69, Number 207)]
[Notices]
[Page 62663-62666]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27oc04-57]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2003-0376; FRL-7679-9]
Carbaryl Interim Reregistration Eligibility Decision; Notice of
Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the availability of EPA's Interim
Reregistration Eligibility Decision (IRED) for the N-methyl carbamate
pesticide carbaryl, and opens a public comment period on this decision.
The Agency's risk assessments and other related documents also are
available in the Carbaryl Docket. Carbaryl is an insecticide registered
for use on agricultural crops, ornamentals, and turf (sod farms).
Carbaryl is used by the U.S. Department of Agriculture (USDA) for
grasshopper control. Carbaryl is also registered for residential use
for flea control on pets and for use in homes and gardens. EPA has
reviewed carbaryl through the public participation process that the
Agency uses to involve the public in developing pesticide
reregistration and tolerance reassessment decisions. Through these
programs, EPA is ensuring that all pesticides meet current health and
safety standards.
DATES: Comments, identified by docket identification (ID) number OPP-
2003-0376, must be received on or before December 27, 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: Anthony Britten, Special Review and
Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8179; fax
number: (703) 308-8005; e-mail address: britten.anthony@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general, and may 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 sale, distribution,
or use of pesticides. Since others 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-2003-0376. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related
[[Page 62664]]
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, 1801 S. Bell St.,
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.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 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-2003-0376. 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-2003-0376. 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-2003-0376.
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, 1801 S. Bell St., Arlington, VA, Attention: Docket ID
Number OPP-2003-0376. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
D. 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
[[Page 62665]]
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 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 your estimate.
5. Provide specific examples to illustrate your concerns.
6. Offer alternatives.
7. Make sure to submit your comments by the comment period
deadline identified.
8. To ensure proper receipt by EPA, identify the appropriate
docket ID number in the subject line on the first page of your
response. It would also be helpful if you provided the name, date, and
Federal Register citation related to your comments.
II. Background
A. What Action is the Agency Taking?
Under section 4 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), EPA is reevaluating existing pesticides to
ensure that they meet current scientific and regulatory standards. EPA
completed an IRED for the N-methyl carbamate pesticide carbaryl on June
30, 2003, and is now issuing this document for public comment. Carbaryl
is an insecticide registered for use on agricultural crops, sod, and
for residential use on pets and in homes and gardens. Carbaryl is also
used by USDA for grasshopper control. The Carbaryl IRED presents the
Agency's conclusions on the risks posed by exposure to carbaryl alone;
however, section 408(b)(2)(D)(v) of the Federal Food, Drug, and
Cosmetic Act (FFDCA) directs the Agency also to consider available
information on the cumulative risk from substances sharing a common
mechanism of toxicity. Because the N-methyl carbamate pesticides share
a common mechanism of toxicity, cholinesterase inhibition, the Agency
will evaluate the cumulative risk posed by this group before making
final reregistration eligibility decisions on individual N-methyl
carbamates.
During the pendency of the carbamate cumulative assessment, the
Agency is proceeding with risk assessments and interim risk management
for individual carbamate pesticides. EPA has determined that, but for
the cumulative risk assessment, the data base to support carbaryl
reregistration is substantially complete and that products containing
carbaryl will be eligible for reregistration, provided the risks are
mitigated in the manner described in the IRED. Upon submission of any
required product specific data under section 4(g)(2)(B) of FIFRA and
any necessary changes to the registration and labeling (either to
address concerns identified in the IRED or as a result of product
specific data), and after assessing N-methyl carbamate cumulative
risks, EPA will make a final reregistration decision under section
4(g)(2)(C) of FIFRA for products containing carbaryl. When the Agency
finalizes decisions for carbaryl and other N-methyl carbamate
pesticides, further risk mitigation may be required for carbaryl.
Although the Carbaryl IRED was signed on June 30, 2003, certain
components of the document, which did not affect the final regulatory
decision, were undergoing final editing at that time. These components,
including the list of additional generic data requirements, summary of
labeling changes, appendices, and other relevant information, have been
added to the Carbaryl IRED document. In addition, subsequent to
signature, EPA identified several minor errors and ambiguities in the
document. Therefore, for the sake of accuracy, EPA also has included
the appropriate error corrections, amendments, and clarifications. All
of these changes are described in detail in an errata memorandum which
is included in the public docket for carbaryl.
Following signature of the IRED, EPA received new pharmacokinetic
data from BayerCrop Science to refine the risk estimates from
residential lawn broadcast applications of carbaryl liquid
formulations. They also submitted a proposed method for using the data
in a deterministic calculation of the risks. EPA is planning to seek
independent scientific review of this information through a Scientific
Advisory Panel meeting in December 2004. The new data and EPA's
preliminary review of the data are included in the docket also.
The reregistration program is being conducted under
Congressionally mandated time frames, and EPA recognizes the need both
to make timely reregistration decisions and to involve the public in
finding ways to effectively mitigate pesticide risks. Through the
Agency's public participation process, EPA worked extensively with
stakeholders and the public to reach the regulatory decisions for
carbaryl. The Agency is issuing the carbaryl IRED for public comment.
The comment period is intended to provide an additional opportunity for
public input and a mechanism for initiating any necessary amendments to
the IRED. All comments should be submitted using the methods in Unit I.
of the SUPPLEMENTARY INFORMATION, and must be received by EPA on or
before the closing date. These comments will become part of the Agency
docket for carbaryl. Comments received after the close of the comment
period will be marked ``late.'' EPA is not required to consider these
late comments.
The Agency will carefully consider all comments received by the
closing date. If any comment significantly affects the document, EPA
will publish an amendment to the IRED in the Federal Register. In the
absence of substantive comments requiring changes, the risk management
decisions reflected in the carbaryl IRED will be implemented without
further notice. These decisions may be supplemented by further risk
mitigation measures when EPA considers its cumulative assessment of the
N-methyl carbamate pesticides.
B. What is the Agency's Authority for Taking this Action?
Section 4(g)(2) of FIFRA, as amended in 1988 and 1996, directs
that, after submission of all data concerning a pesticide active
ingredient, ``the Administrator shall determine whether pesticides
containing such active ingredient are eligible for reregistration,''
before calling in product
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specific data on individual end-use products and either reregistering
products or taking other ``appropriate regulatory action.''
Section 408(q) of FFDCA, 21 U.S.C. 346a(q), requires EPA to review
tolerances and exemptions for pesticide residues in effect as of August
2, 1996, to determine whether the tolerance or exemption meets the
requirements of section 408(b)(2) or (c)(2) of FFDCA. This review is to
be completed by August 3, 2006.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: October 21, 2004.
Peter Caulkins,
Acting Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. 04-24038 Filed 10-26-04; 8:45 am]
BILLING CODE 6560-50-S