

[Federal Register: December 28, 2005 (Volume 70, Number 248)]
[Notices]               
[Page 76818-76820]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28de05-111]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2005-0293; FRL-7752-4]

 
Cypermethrin Risk Assessments; Notice of Availability and Risk 
Reduction Options

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's risk 
assessments and related documents for the pyrethroid pesticide 
cypermethrin, and opens a 60 day public comment period on these 
documents. The public is encouraged to suggest risk management ideas or 
proposals to address the risks identified. EPA is developing a RED for 
cypermethrin through a modified, 4-Phase 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 EPA-
HQ-OPP-2005-0293, must be received on or before February 27, 2006.

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: Yan Donovan, Special Review and 
Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; Phone: (703) 605-0194; fax number: (703) 
308-8041; e-mail address: donovan.yan@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 EPA-HQ-OPP-2005-0293. 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/.

    EDOCKET, EPA's electronic public docket and comment system was 
replaced on November 25, 2005, by an enhanced Federal-wide electronic 
docket management and comment system located at http://www.regulations.gov/.
 Follow the on-line instructions.

    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Docket 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

[[Page 76819]]

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 
EPA-HQ-OPP-2005-0293. 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 EPA-HQ-OPP-2005-0293. 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 EPA-HQ- OPP-
2005-0293.
    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 EPA-HQ-OPP-2005-0293. 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 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?

    EPA is releasing for public comment its human health and 
environmental fate and effects risk assessments and related documents 
for cypermethrin, a pyrethroid pesticide, and soliciting public comment 
on risk management ideas or proposals. EPA developed the risk 
assessments and risk characterization for cypermethrin through a 
modified version of its public process for making pesticide 
reregistration eligibility and tolerance reassessment decisions. 
Through these programs, EPA is ensuring that pesticides meet current 
standards under the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act of 1996 (FQPA).
    The majority of cypermethrin use is non-agricultural. Cypermethrin 
is registered for indoor and outdoor use on industrial, commercial, and 
residential sites, including use by homeowners. When applied indoors, 
cypermethrin is used to control insect pests such as ants, cockroaches, 
termites, spiders. Other non-food-contact uses include outdoor 
application to structures and lawns (e.g., as a soil residual 
termiticide), application to commercial storage facilities (indoor and 
outdoor), eating establishments (indoor and outdoor, non food contact 
only), dairy facilities (indoor and outdoor, non food contact only), 
food stores or processing plants (indoor and outdoor, non food contact 
only), poultry processing facilities (indoor and outdoor, non food 
contact only), motor vehicles, and swimming pool water systems. In 
agriculture, cypermethrin is applied as a foliar spray to control 
insect pests primarily in cotton, with lesser use on pecans, cole 
crops, lettuce, onions, and other minor

[[Page 76820]]

crops. Cypermethrin can be applied directly to cattle (ear tags) and 
horses, and to pet (dog, horse) sleeping quarters.
    EPA is providing an opportunity, through this notice, for 
interested parties to provide comments and input on the Agency's risk 
assessments for cypermethrin. Such comments and input could address, 
for example, the availability of additional data to further refine the 
risk assessments, such as information on indoor and outdoor residential 
and other non-agricultural uses, including typical application rates 
and total pounds of active ingredient applied, methods of application, 
and frequency of re-application.
    From the human health effects assessment, there is the potential 
for short-term risk to toddlers exposed to cypermethrin following 
indoor crack and crevice treatments. From the environmental fate 
assessment, there is the potential for acute and chronic risk to 
aquatic invertebrates and fish from agricultural applications, with the 
highest potential acute risk to estuarine/marine invertebrates. 
Although exposure to aquatic organisms from outdoor, non-agricultural 
uses of cypermethrin could not be assessed at this time, data recently 
submitted to EPA from a study of an urban creek in California suggest 
the potential for aquatic exposure and risk from urban runoff, as well. 
In targeting these risks of concern, the Agency solicits information on 
effective and practical risk reduction measures, such as specific 
application procedures and other measures to reduce runoff from outdoor 
applications to structures and lawns.
    EPA seeks to achieve environmental justice, the fair treatment and 
meaningful involvement of all people, regardless of race, color, 
national origin, or income, in the development, implementation, and 
enforcement of environmental laws, regulations, and policies. To help 
address potential environmental justice issues, the Agency seeks 
information on any groups or segments of the population who, as a 
result of their location, cultural practices, or other factors, may 
have atypical, unusually high exposure to cypermethrin, compared to the 
general population.
    EPA is applying the principles of public participation to all 
pesticides undergoing reregistration and tolerance reassessment. The 
Agency's Pesticide Tolerance Reassessment and Reregistration; Public 
Participation Process, published in the Federal Register on May 14, 
2004, (69 FR 26819)(FRL-7357-9) explains that in conducting these 
programs, the Agency is tailoring its public participation process to 
be commensurate with the level of risk, extent of use, complexity of 
the issues, and degree of public concern associated with each 
pesticide. For cypermethrin, a modified, 4-Phase process with one 
comment period and ample opportunity for public consultation seems 
appropriate. However, if as a result of comments received during this 
comment period EPA finds that additional issues warranting further 
discussion are raised, the Agency may lengthen the process and include 
a second comment period, as needed.
    Cypermethrin is a member of the pyrethroid class of pesticides. 
Although all pyrethroids alter nerve function by modifying the normal 
biochemistry and physiology of nerve membrane sodium channels, EPA is 
not currently following a cumulative risk approach based on a common 
mechanism of toxicity for the pyrethroids. Although all pyrethroids 
interact with sodium channels, there are multiple types of sodium 
channels and it is currently unknown whether the pyrethroids have 
similar effects on all channels. The Agency does not have a clear 
understanding of effects on key downstream neuronal function e.g., 
nerve excitability, nor do we understand how these key events interact 
to produce their compound specific patterns of neurotoxicity. There is 
ongoing research by EPA's Office of Research and Development and 
pyrethroid registrants to evaluate the differential biochemical and 
physiological actions of pyrethroids in mammals. This research is 
expected to be completed by 2007. When available, the Agency will 
consider this research and make a determination of common mechanism as 
a basis for assessing cumulative risk. Information regarding EPA's 
procedures for assessing cumulative effects of substances found to have 
a common mechanism of toxicity is available on EPA's website at http://www.epa.gov/pesticides/cumulative/.
 The decisions presented in the 

Reregistration Eligibility Decision (RED) may be supplemented by 
further risk mitigation measures when EPA considers the cumulative 
risks of the pyrethroid pesticides.
    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. Comments will become part of the Agency Docket for 
cypermethrin. Comments received after the close of the comment period 
will be marked ``late.'' EPA is not required to consider these late 
comments.

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

    Section 4(g)(2) of FIFRA as amended 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 
specific data on individual end-use products and either reregistering 
products or taking other ``appropriate regulatory action.''
    Section 408(q) of the 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: December 15, 2005.
Peter Caulkins,
Acting Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
[FR Doc. 05-24407 Filed 12-27-05; 8:45 am]

BILLING CODE 6560-50-S
