[Federal Register Volume 75, Number 83 (Friday, April 30, 2010)]
[Notices]
[Pages 22783-22785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-10229]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: [email protected].
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