[Federal Register Volume 68, Number 63 (Wednesday, April 2, 2003)]
[Notices]
[Pages 16030-16032]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7982]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0101; FRL-7299-5]


Carbaryl; Availability of Revised Risk Assessments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of the revised risk 
assessments and related documents for the carbamate pesticide, 
carbaryl. In addition, this notice starts a 60-day public participation 
period during which the public is encouraged to submit risk management 
ideas or proposals. These actions are in response to a joint initiative 
between EPA and the U.S. Department of Agriculture (USDA) to increase 
transparency in the tolerance reassessment process for pesticides.

DATES: Comments, identified by docket ID number OPP-2003-0101, must be 
received by EPA 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: 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; 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 revised 
risk assessments and submitting risk management comments on carbaryl, 
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. As such, the Agency has 
not attempted to specifically describe all the entities potentially 
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-2003-0101. 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 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

[[Page 16031]]

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-2003-0101. 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-2003-0101. 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 following 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-2003-0101.
    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-2003-0101. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Handle CBI Information that I Want to Submit to the 
Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
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 version of the 
official record. Information not marked confidential will be included 
in the public version of the official record 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 
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.

II. Background

A. What Action is EPA Taking in this Notice?

    EPA is making available for public viewing the revised risk 
assessments and related documents for the carbamate chemical, carbaryl. 
These documents have been developed as part of the public participation 
process that EPA and USDA are now using for involving the public in the 
reassessment of pesticide tolerances under the Food Quality Protection 
Act (FQPA), and the reregistration of individual pesticides under the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). A goal of 
the public participation process is to find a more effective way for 
the public to participate at critical junctures in the Agency's 
development of assessments and risk management decisions. EPA and USDA 
began implementing this process in August 1998, to increase 
transparency and opportunities for stakeholder consultation. The 
documents being released to the public through this notice provide 
information on the revisions that were made to the carbaryl preliminary 
risk assessments, which were released to the public August 28, 2002 (67 
FR 55233) (FRL-7194-2), through a notice in the Federal Register.

[[Page 16032]]

    In addition, this notice starts a 60-day public participation 
period during which the public is encouraged to submit risk management 
proposals or otherwise comment on risk management for carbaryl. The 
Agency is providing an opportunity, through this notice, for interested 
parties to provide written risk management proposals or ideas to the 
Agency on carbaryl. Such comments and proposals could address ideas 
about how to manage dietary, residential, occupational, or ecological 
risks on specific carbaryl use sites or crops across the U.S. or in a 
particular geographic region of the country. To address dietary risk, 
for example, commenters may choose to discuss the feasibility of lower 
application rates, increasing the time interval between application and 
harvest (``pre-harvest intervals'') modifications in use, or suggest 
alternative measures to reduce residues contributing to dietary 
exposure. For residential risk, commenters may suggest lowering 
application rates, modification in use, or other measures to reduce 
exposures to homeowners. For occupational risks, commenters may suggest 
personal protective equipment or technologies to reduce exposure to 
workers and pesticide handlers. For ecological risks, commenters may 
suggest ways to reduce environmental exposure, for example, exposure to 
birds, fish, mammals, and other non-target organisms. All comments and 
proposals must be received by EPA on or before June 2, 2003 at the 
addresses given under Unit I. Comments and proposals will become part 
of the Agency record for carbaryl.
    On February 24, 2003, EPA received from Bayer CropScience, the 
technical registrant for carbaryl, a submission titled ``Evaluation of 
Potential Aggregate Human Health Risks Associated with Agricultural and 
Consumer Uses of Carbaryl.'' In this submission, Bayer estimates the 
potential aggregate human health risks associated with dietary (food) 
and residential exposures to carbaryl. Bayer conducted the analysis 
using the Cumulative and Aggregate Risk Evaluation System (CARES), 
version 1.3., which is a software model that provides a probabilistic 
assessment of human health risks. The software has been reviewed by the 
FIFRA Science Advisory Panel (SAP), and was found to be an acceptable 
model for assessing aggregate risks. EPA is currently reviewing the 
carbaryl-specific CARES assessment submitted by the registrant.
    EPA did not receive this submission in time to completely or 
comprehensively review it prior to publishing this notice, but is 
releasing the Agency's revised human health risk assessment for 
carbaryl now to allow time for public comment before June 30, 2003, 
which is the court-ordered deadline for EPA to make a reregistration 
eligibility decision for carbaryl. Also, to allow as much time as 
possible for the public to comment on the registrant's submission, EPA 
has placed it in the official public docket for carbaryl and briefly 
discussed it in EPA's revised human health risk assessment.
    Depending on the results of the Agency's full review of the 
registrant's submission and comments received from the public, EPA 
might further amend, at some future time, its revised human health risk 
assessment for carbaryl, particularly aggregate risks from food, 
drinking water, and residential exposures. Bayer's current submission 
does not include a dietary drinking water component in its aggregate 
assessment of carbaryl's human health risks, but the registrant has 
informed the Agency that this information will be submitted shortly, 
and EPA will also endeavor to make this information publically 
available as quickly as possible. However, because this information 
will not be received until later. EPA does not believe it will be able 
to provide an analysis of this information during the comment period.

List of Subjects

    Environmental protection, Chemicals, Pesticides and pests.

    Dated: March 26, 2003.
 Lois Ann Rossi,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. 03-7982 Filed 4-1-03; 8:45 am]
BILLING CODE 6560-50-S