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[Federal Register: April 30, 2010 (Volume 75, Number 83)]
[Notices]               
[Page 22783-22785]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap10-71]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0378; FRL-8823-4]

 
FIFRA Scientific Advisory Panel; Notice of Public Meeting

 AGENCY: Environmental Protection Agency (EPA).

 ACTION: Notice.

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 SUMMARY: There will be a 1-day meeting of the Federal Insecticide, 
Fungicide, and Rodenticide Act. Scientific Advisory Panel (FIFRA SAP) 
to consider and review a set of scientific issues related to the 
Comparative Adult and Juvenile Sensitivity Toxicity Protocols for 
Pyrethroids.

 DATES: The meeting will be held on July 23, 2010, from 8:30 a.m. to 
approximately 5 p.m.
    Comments. The Agency encourages that written comments be submitted 
by July 8, 2010 and requests for oral comments be submitted by July 15, 
2010. However, written comments and requests to make oral comments may 
be submitted until the date of the meeting, but anyone submitting 
written comments after July 8, 2010 should contact the Designated 
Federal Official (DFO) listed under FOR FURTHER INFORMATION CONTACT. 
For additional instructions, see Unit I.C. of the SUPPLEMENTARY 
INFORMATION.
    Nominations. Nominations of candidates to serve as ad hoc members 
of FIFRA SAP for this meeting should be provided on or before May 14, 
2010.
     Webcasting. This meeting may be webcast. Please refer to the FIFRA 
SAP's website, http://www.epa.gov/scipoly/SAP/ for information on how 
to access the webcast. Please note that the webcast is a supplementary 
public process provided only for convenience. If difficulties arise 
resulting in webcasting outages, the meeting will continue as planned.
    Special accommodations. For information on access or services for 
individuals with disabilities, and to request accommodation of a 
disability, please contact the DFO listed under FOR FURTHER INFORMATION 
CONTACT at least 10 days prior to the meeting to give EPA as much time 
as possible to process your request.

ADDRESSES: The meeting will be held at the Environmental Protection 
Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 
2777 S. Crystal Dr., Arlington, VA 22202.
    Comments. Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2010-0378, by one of the following methods:
      Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
      Mail: Office of Pesticide Programs (OPP) Regulatory 
Public Docket (7502P), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.
    Instructions. Direct your comments to docket ID number EPA-HQ-OPP-
2010-0378. If your comments contain any information that you consider 
to be CBI or otherwise protected, please contact the DFO listed under 
FOR FURTHER INFORMATION CONTACT to obtain special instructions before 
submitting your comments. EPA's policy is that all comments received 
will be included in the docket without change and may be made available 
on-line at http://www.regulations.gov, including any personal 
information provided, unless the comment includes information claimed 
to be Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. Do not submit information 
that you consider to be CBI or otherwise protected through 
regulations.gov or e-mail. The regulations.gov website is an 
``anonymous access'' system, which means EPA will not know your 
identity or contact information unless you provide it in the body of 
your comment. If you send an e-mail comment directly to EPA without 
going through regulations.gov, your e-mail address will be 
automatically captured and included as part of the comment that is 
placed in the docket and made available on the Internet. If you submit 
an electronic comment, EPA recommends that you include your name and 
other contact information in the body of your comment and with any disk 
or CD-ROM you submit. 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. Electronic files should avoid the use of 
special characters, any form of encryption, and be free of any defects 
or viruses.
    Docket: All documents in the docket are listed in the docket index 
available at http://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is not placed on the Internet 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available either in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of 
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The Docket Facility telephone 
number is (703) 305-5805.
    Nominations, requests to present oral comments, and requests for 
special accommodations. Submit nominations to serve as ad hoc members 
of FIFRA SAP, requests for special seating accommodations, or requests 
to present oral comments to the DFO listed under FOR FURTHER 
INFORMATION CONTACT.

 FOR FURTHER INFORMATION CONTACT: Sharlene R. Matten, DFO, Office of 
Science Coordination and Policy (7201M), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; 
telephone number: (202) 564-0130; fax number: (202) 564-8382; e-mail 
address: matten.sharlene@epa.gov.

 SUPPLEMENTARY INFORMATION:

 I. General Information

 A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may, 
however, be of interest to persons who are or may be required to 
conduct testing of chemical substances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA), FIFRA, and the Food Quality Protection Act of 
1996 (FQPA). Since other entities may also 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 DFO 
listed under FOR FURTHER INFORMATION CONTACT.

[[Page 22784]]

 B. What Should I Consider as I Prepare My Comments for EPA?

    When submitting comments, remember to:
    1. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
     2. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    3. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information 
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    6. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    7. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    8. Make sure to submit your comments by the comment period deadline 
identified.

 C. How May I Participate in this Meeting?

    You may participate in this meeting by following the instructions 
in this unit. To ensure proper receipt by EPA, it is imperative that 
you identify docket ID number EPA-HQ-OPP-2010-0378 in the subject line 
on the first page of your request.
    1. Written comments. The Agency encourages that written comments be 
submitted, using the instructions in ADDRESSES, no later than July 8, 
2010, to provide FIFRA SAP the time necessary to consider and review 
the written comments. Written comments are accepted until the date of 
the meeting, but anyone submitting written comments after July 8, 2010 
should contact the DFO listed under FOR FURTHER INFORMATION CONTACT. 
Anyone submitting written comments at the meeting should bring 30 
copies for distribution to FIFRA SAP.
    2. Oral comments. The Agency encourages that each individual or 
group wishing to make brief oral comments to FIFRA SAP submit their 
request to the DFO listed under FOR FURTHER INFORMATION CONTACT no 
later than July 15, 2010, in order to be included on the meeting 
agenda. Requests to present oral comments will be accepted until the 
date of the meeting and, to the extent that time permits, the Chair of 
FIFRA SAP may permit the presentation of oral comments at the meeting 
by interested persons who have not previously requested time. The 
request should identify the name of the individual making the 
presentation, the organization (if any) the individual will represent, 
and any requirements for audiovisual equipment (e.g., overhead 
projector, 35 mm projector, chalkboard). Oral comments before FIFRA SAP 
are limited to approximately 5 minutes unless prior arrangements have 
been made. In addition, each speaker should bring 30 copies of his or 
her comments and presentation slides for distribution to the FIFRA SAP 
at the meeting.
    3. Seating at the meeting. Seating at the meeting will be open and 
on a first-come basis.
    4. Request for nominations to serve as ad hoc members of FIFRA SAP 
for this meeting. As part of a broader process for developing a pool of 
candidates for each meeting, FIFRA SAP staff routinely solicits the 
stakeholder community for nominations of prospective candidates for 
service as ad hoc members of FIFRA SAP. Any interested person or 
organization may nominate qualified individuals to be considered as 
prospective candidates for a specific meeting. Individuals nominated 
for this meeting should have expertise in one or more of the following 
areas: pyrethroid pesticides, rodent and human metabolic enzymes and 
their related ontogeny, in vitro pharmacokinetic studies, particularly 
when used in risk assessment; voltage-gated sodium channels, ontogeny 
and specificity; mode of action and risk assessment, and tissue 
dosimetry. Nominees should be scientists who have sufficient 
professional qualifications, including training and experience, to be 
capable of providing expert comments on the scientific issues for this 
meeting. Nominees should be identified by name, occupation, position, 
address, and telephone number. Nominations should be provided to the 
DFO listed under FOR FURTHER INFORMATION CONTACT on or before May 14, 
2010. The Agency will consider all nominations of prospective 
candidates for this meeting that are received on or before this date. 
However, final selection of ad hoc members for this meeting is a 
discretionary function of the Agency.
     The selection of scientists to serve on FIFRA SAP is based on the 
function of the panel and the expertise needed to address the Agency's 
charge to the panel. No interested scientists shall be ineligible to 
serve by reason of their membership on any other advisory committee to 
a Federal department or agency or their employment by a Federal 
department or agency except the EPA. Other factors considered during 
the selection process include availability of the potential panel 
member to fully participate in the panel's reviews, absence of any 
conflicts of interest or appearance of lack of impartiality, 
independence with respect to the matters under review, and lack of 
bias. Although financial conflicts of interest, the appearance of lack 
of impartiality, lack of independence, and bias may result in 
disqualification, the absence of such concerns does not assure that a 
candidate will be selected to serve on FIFRA SAP. Numerous qualified 
candidates are identified for each panel. Therefore, selection 
decisions involve carefully weighing a number of factors including the 
candidates' areas of expertise and professional qualifications and 
achieving an overall balance of different scientific perspectives on 
the panel. In order to have the collective breadth of experience needed 
to address the Agency's charge for this meeting, the Agency anticipates 
selecting approximately 12-15 ad hoc scientists.
    FIFRA SAP members are subject to the provisions of 5 CFR part 2634, 
Executive Branch Financial Disclosure, as supplemented by the EPA in 5 
CFR part 6401. In anticipation of this requirement, prospective 
candidates for service on the FIFRA SAP will be asked to submit 
confidential financial information which shall fully disclose, among 
other financial interests, the candidate's employment, stocks and 
bonds, and where applicable, sources of research support. The EPA will 
evaluate the candidates financial disclosure form to assess whether 
there are financial conflicts of interest, appearance of a lack of 
impartiality or any prior involvement with the development of the 
documents under consideration (including previous scientific peer 
review) before the candidate is considered further for service on FIFRA 
SAP. Those who are selected from the pool of prospective candidates 
will be asked to attend the public meetings and to participate in the 
discussion of key issues and assumptions at these meetings. In 
addition, they will be asked to review and to help finalize the meeting 
minutes. The list of FIFRA SAP members participating at this meeting 
will be posted on the FIFRA SAP website at http://epa.gov/scipoly/sap 
or may be obtained from the OPP Regulatory Public Docket at http://www.regulations.gov.

[[Page 22785]]

 II. Background

 A. Purpose of FIFRA SAP

    FIFRA SAP serves as the primary scientific peer review mechanism of 
EPA's Office of Chemical Safety and Pollution (OCSPP) and is structured 
to provide scientific advice, information and recommendations to the 
EPA Administrator on pesticides and pesticide-related issues as to the 
impact of regulatory actions on health and the environment. FIFRA SAP 
is a Federal advisory committee established in 1975 under FIFRA that 
operates in accordance with requirements of the Federal Advisory 
Committee Act. FIFRA SAP is composed of a permanent panel consisting of 
seven members who are appointed by the EPA Administrator from nominees 
provided by the National Institutes of Health and the National Science 
Foundation. FIFRA, as amended by FQPA, established a Science Review 
Board consisting of at least 60 scientists who are available to the SAP 
on an ad hoc basis to assist in reviews conducted by the SAP. As a peer 
review mechanism, FIFRA SAP provides comments, evaluations and 
recommendations to improve the effectiveness and quality of analyses 
made by Agency scientists. Members of FIFRA SAP are scientists who have 
sufficient professional qualifications, including training and 
experience, to provide expert advice and recommendation to the Agency.

 B. Public Meeting

    The Office of Pesticide Programs (OPP) is actively working on a 
reevaluation of the human health effects of the pyrethroids and 
pyrethrins under the OPP registration review program http://www.epa.gov/oppsrrd1/reevaluation/pyrethroids-pyrethrins.html required 
under FIFRA. As directed by FQPA, the Agency is to make special 
considerations for pre- and post-natal exposures concerning the 
susceptibility of infants and children. Guideline studies submitted to 
the Agency for pesticide registration address a variety of routes, 
toxicity endpoints, and durations. These studies, however, generally do 
not provide direct measures of relative sensitivity between adult and 
juvenile laboratory animals. Moreover, the guideline studies often do 
not adequately quantify pyrethroid toxicity due to their rapid 
pharmacokinetic time course and mode-of-action (i.e., sodium channel 
disruption leading to alterations in membrane excitability and firing 
potentials, ultimately resulting in signs of neurotoxic behavior). In a 
February 16, 2010 letter to the public, EPA asked interested parties to 
voluntarily submit study protocols to better understand the juvenile 
sensitivity for synthetic pyrethroids and naturally-occurring 
pyrethrins (see pyrethroid docket, EPA-HQ-OPP-2008-0331).
    Pyrethroids exert toxicity by interfering with the voltage-gated 
sodium channels in the nervous system. Ideally, an in vivo measure of 
sodium channel disruption could be evaluated in laboratory animals to 
assess the initiating event in the toxicity pathway of this class. 
However, a rapid and practical in vivo metric is not likely to be 
available within the Agency's registration review schedule for the 20+ 
pyrethroids that are currently registered. The Agency believes that a 
well-designed set of in vivo and in vitro studies, and possibly in 
silico studies, would provide the Agency with the necessary scientific 
information to conduct a risk assessment. The Agency has identified 
some key scientific issues which are important in considering 
comparative age sensitivity for this class of pesticides such as, 1) 
the ontogeny of hydrolytic and oxidative metabolic enzymes; 2) the 
ontogeny and differentiation of sodium channels; 3) dose-dependent 
(high vs. low) effects; and 4) rodent to human concordance and species 
sensitivity.
    Proposals submitted by May 21, 2010 will be reviewed by the Agency 
and presented to the FIFRA SAP for their independent evaluation. The 
Agency is asking the SAP to comment on the relevance and reliability, 
as well as the strengths and limitations of the proposal studies in 
addressing age-specific sensitivity to pyrethroids. Based on the 
recommendations of the SAP and comments from the public, the Agency 
will develop a scientifically-based study design for use in pyrethroid 
risk characterization.

C. FIFRA SAP Documents and Meeting Minutes

    EPA's background paper, related supporting materials, charge/
questions to FIFRA SAP, FIFRA SAP composition (i.e., members and ad hoc 
members for this meeting), and the meeting agenda will be available by 
late June. In addition, the Agency may provide additional background 
documents as the materials become available. You may obtain electronic 
copies of these documents, and certain other related documents that 
might be available electronically, at http://www.regulations.gov and 
the FIFRA SAP homepage at http://www.epa.gov/scipoly/sap.
    FIFRA SAP will prepare meeting minutes summarizing its 
recommendations to the Agency approximately 90-days days after the 
meeting. The meeting minutes will be posted on the FIFRA SAP website or 
may be obtained from the OPP Regulatory Public Docket at http://www.regulations.gov.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: April 27, 2010.
 Frank Sanders,
Director, Office of Science Coordination and Policy.

[FR Doc. 2010-10229 Filed 4-29-10; 8:45 am]
BILLING CODE 6560-50-S
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