Bromethalin. Sept 22, 2004. Availability of revised comparative ecological risk assessment. Federal Register.

FLUORIDE ACTION NETWORK PESTICIDE PROJECT

Bromethalin. September 22, 2004. Availability of Revised Comparative Ecological Risk Assessment. Federal Register.

Docket identification number OPP-2004-0033

Documents available are:
• Potential Risks of Nine Rodenticides to Birds and Nontarget Mammals: a Comparative Approach - July 2004 (230 pages)
• Update to the Overview of the Rodenticide Comparative Ecological Assessment - September 9, 2004 (4 pages)
• Analysis of Rodenticide Bait Use - September 10, 2004 (43 pages)
• EFED Response to USDA/APHIS’ “Partner Review Comments: Preliminary Analysis of Rodenticide Bait Use and Potential Risks of Nine Rodenticides to Birds and Nontarget Mammals: A Comparative Approach (June 9, 2004)” - September 7, 2004 (24 pages)
• Response to Public Comments on EFED's Risk Assessment: "Potential Risks of Nine Rodenticides to Birds and Nontarget Mammals: a Comparative Approach", dated December 19, 2002- July 17, 2004 (24 pages)
• "Potential Risks of Nine Rodenticides to Birds and Nontarget Mammals: A Comparative Approach"; revised document dated July 2004 - July 22, 2004 (2 pages)

http://www.epa.gov/fedrgstr/EPA-PEST/2004/September/Day-22/

[Federal Register: September 22, 2004 (Volume 69, Number 183)]
[Notices]
[Page 56756-56758]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22se04-51]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0033; FRL-7675-4]

Rodenticides; Availability of Revised Comparative Ecological Risk
Assessment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notices announces the availability of the revised
comparative ecological risk assessment and related documents for nine
rodenticides, which includes those addressed in the Reregistration
Eligibility Decisions (REDs) for zinc phosphide and the rodenticide
cluster (brodifacoum, bromadiolone, bromethalin, chlorophacinone, and
diphacinone), as well as three other rodenticides, warfarin,
difethialone, and cholecalciferol. This notice also opens a 60-day
public participation period during which the public is encouraged to
submit risk management ideas or proposals. These actions are designed
to further efforts to engage stakeholders in a dialogue on risk
reduction and risk management.
DATES: Comments, identified by docket identification number OPP-2004-
0033, must be received by EPA on or before November 22, 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: Kelly White, Special Review and
Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 305-8401; e-mail
address: white.kelly@epa.gov.
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 these nine
rodenticides, including environmental, human health, and agricultural
advocates; the chemical industry; pesticide users; and members of the
public interested in the use of pesticides. As such, the Agency has not
attempted to specifically describe all of 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 ID number OPP-2004-0033. 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, 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/. In addition, copies of the
revised comparative ecological risk assessment for nine rodenticides
may also be accessed at http://www.epa.gov/rodenticidecluster/.
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
[[Page 56757]]
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,'' andthen key in docket ID number
OPP-2004-0033. 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-2004-0033. 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-2004-0033.
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-2004-0033. 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.
[[Page 56758]]
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. What Action is EPA Taking in this Notice?

EPA is making available for public viewing the revised comparative
ecological risk assessment and related documents for nine rodenticides,
which includes those addressed in the Reregistration Eligibility
Decisions (REDs) for zinc phosphide and the rodenticide cluster
(brodifacoum, bromadiolone, bromethalin, chlorophacinone, diphacinone),
as well as three other rodenticides, warfarin, difethialone, and
cholecalciferol. Included among the documents being released to the
public through this notice is EPA's response to comments on the
preliminary comparative ecological risk assessment. The preliminary
assessment was released to the public through a notice in the Federal
Register on January 29, 2003 (FR 68 4468)(FRL-7280-6). Also being
published is a memorandum summarizing the revisions to the preliminary
comparative ecological risk assessment that are reflected in the
revised assessment, and a document that details the use patterns of the
nine rodenticide active ingredients.

The Agency notes that the comparative ecological risk assessment
for the rodenticides is revised; however, further refinements may be
appropriate. Risk assessment documents 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.

This notice begins a 60-day public participation period during
which the public is encouraged to submit risk management proposals or
otherwise comment on risk management for the nine rodenticides listed
in this notice. Such comments and proposals could address ideas about
how to manage ecological risks associated with particular uses of any
of the nine rodenticides. For example, commenters may suggest ways to
reduce environmental exposure, e.g., exposure to birds, fish, mammals,
and other non-target organisms. During the comment period, stakeholders
are also encouraged to comment on the document titled ``Analysis of
Rodenticide Bait Use'' and/or to provide additional information related
to the use and importance of these nine rodenticide products. The
Agency recongnizes that there are public health and other benefits
associated with the use of rodenticide baits, and will consider those
benefits in reaching a risk management decision.

During the public comment period, EPA plans to work with the United
States Department of Agriculture, the Centers for Disease Control and
Prevention, the United States Fish and Wildlife Service, the National
Marine Fisheries Service, the United States Department of Defense, and
other interested stakeholders to identify and propose mitigation
measures to reduce risks while maintaining the key benefits of the
rodenticides. If you wish to participate in this process, please
consult the person listed under FOR FURTHER INFORMATION CONTACT.
Failure to participate or comment as part of this opportunity will in
no way prejudice or limit a commenter's opportunity to participate
fully in later notice and comment processes. All comments and proposals
must be received by EPA on or before November 22, 2004 at the addresses
given under the ADDRESSES section. Comments and proposals will become
part of the Agency record for each rodenticide to which it pertains.
List of Subjects
Environmental protection, Chemicals, Pesticides and pests.
Dated: August 25, 2004.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. 04-21068 Filed 9-21-04; 8:45 am]
BILLING CODE 6560-50-S