[Federal Register Volume 70, Number 168 (Wednesday, August 31, 2005)]
[Notices]
[Pages 51790-51792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17365]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0385 FRL-7734-4]


Permethrin; Notice of Availability of Risk Assessments and 
Opening of Docket

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's preliminary 
human health and ecological risk assessments and related documents for 
permethrin, a synthetic pyrethroid insecticide, and opens a public 
comment period on these documents. The public is encouraged to provide 
information to refine assessed risks, and suggest risk management ideas 
or proposals to address the risks identified. At this time, EPA is 
intending to develop a Reregistration Eligibility Decision (RED) for 
permethrin through a modified 4-phase public participation process that 
the Agency uses to involve the public in developing pesticide 
reregistration and tolerance assessment decisions. For permethrin, a 
modified 4-Phase process with one public comment period and ample 
opportunity for public consultation seems appropriate in view of the 
number and level of risk concerns identified in the preliminary risk 
assessment. 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 consider an additional comment 
period, as needed. Through this program, EPA is ensuring that all 
pesticides meet current health and safety standards. This notice is 
phase-3 of the 4-phase process.

DATES: Comments, identified by docket identification (ID) number OPP-
2004-0385 must be received on or before October 31, 2005.

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: Jacqueline Guerry, Chemical Review 
Manager, Special Review and Reregistration Division (7508C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-0024; 
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-2004-0385. 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/.
    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

[[Page 51791]]

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-2004-0385. 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-2004-0385. 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-2004-0385.
    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-2004-0385. 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?

    We invite you to provide your views on the various options we 
propose, new approaches we have not considered, the potential impacts 
of the various options (including possible unintended consequences), 
and any data or information that you would like the Agency to consider 
during the development of the final action. 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 rule or collection 
activity.
    7. Make sure to submit your comments by the deadline in this 
notice.
    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 the Agency Taking?

    EPA is releasing for public comment its preliminary human health 
and environmental fate and effects risk assessments and related 
documents for the synthetic pyrethroid insecticide,

[[Page 51792]]

permethrin, and is encouraging the public to provide information to 
refine identified risks, and suggest risk management ideas or 
proposals. 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). Permethrin is registered for use 
on sites in agricultural, commercial, and residential settings. In 
addition to its pesticidal uses, permethrin also has non-FIFRA 
pharmaceutical use as a pediculicide for the treatment of head lice and 
scabies. The Food and Drug Administration (FDA) approves use of the 
pesticidal-containing pharmaceutical products under FFDCA.
    The preliminary risk assessments have identified potential 
residential postapplication noncancer chronic risks of concerns for 
toddlers; residential handlers and postapplication cancer risks; 
occupational handler and postapplication noncancer chronic and cancer 
risks; and potential acute and chronic ecological risks of concern. EPA 
is providing an opportunity, through this notice, for interested 
parties to provide comments and input on the Agency's risk assessments 
for permethrin. Such comments and input could address the potential 
risks of concern.
    All elements of the Agency's risk assessments for permethrin are 
open for public comment; however, we are particularly seeking public 
comment and input on data that could help refine those scenarios where 
uncertainties exists and risk estimates exceed the level of concern, 
which are identified in the Agency's risk assessments available in the 
docket. Specifically, there is uncertainly regarding the residential 
handler and postapplication cancer risks. In order to identify the 
residential exposure scenarios that may pose risks of concern, the 
Agency is seeking public comment on the typical number of applications 
associated with those homeowner scenarios assessed. Additionally, the 
Agency is looking for consumer information on the market segments that 
utilize impregnated clothing and the use pattern of these products 
(i.e. types of impregnated clothing purchased and worn, number of times 
the article of clothing is worn and washed, etc.). Refer to the 
Permethrin Overview document available in the docket for further 
discussion of uncertainties and data needs regarding residential uses. 
Further, the only occupational risks of concern identified resulted 
from use of permethrin in mushroom houses. The Agency is seeking 
typical use information on permethrin applied in mushroom houses (i.e. 
current level of personal protective equipment worn, application rate, 
and percent crop treated, etc.), as well as benefits of this use, and 
potential risk mitigation ideas. Additionally, the Agency is interested 
in obtaining data or information that would assist in refining the 
risks identified in the ecological assessment, such as the typical use 
of buffer zones in areas where permethrin is applied close to bodies of 
water. Finally, additional data are being requested regarding the 
potential ecological risk resulting from permethrin formulations that 
contain the synergist piperponyl butoxide (PBO). Few toxicity studies 
are available on formulations of permethrin/PBO. In order to assess any 
increased toxicity of permethrin active ingredient when formulated with 
a synergist, the Agency is requesting the submission of existing 
permethrin/PBO toxicity studies, and public comment on additional 
studies that may need to be generated to address this issue. Refer to 
the Overview document for more discussion of this matter.
    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 permethrin, compared to the 
general population.
    EPA is releasing for public comment its risk assessments for 
permethrin, to provide an opportunity for interested parties to also 
provide risk management proposals or otherwise comment on risk 
management. Such comments and proposals should further discuss ways to 
manage permethrin's occupational, residential, and/or ecological risks 
resulting from its many uses, as discussed in the Agency's risk 
assessments.
    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, 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. At this time for 
permethrin, a modified 4-Phase process with one public comment period 
and ample opportunity for public consultation seems appropriate in due 
to the number and level of risk concerns. 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 
consider an additional comment period, as needed.
    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 
permethrin. 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: August 25, 2005.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of 
Pesticide Programs
[FR Doc. 05-17365 Filed 8-30-05; 8:45 am]
BILLING CODE 6560-50-S