[Federal Register Volume 69, Number 207 (Wednesday, October 27, 2004)]
[Notices]
[Pages 62663-62666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24038]


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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: [email protected].

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

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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 [email protected], 
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

[[Page 62666]]

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