[Federal Register Volume 75, Number 43 (Friday, March 5, 2010)]
[Notices]
[Pages 10255-10258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-4540]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2010-0125; FRL-8812-2]
FIFRA Scientific Advisory Panel; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: There will be a 4-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 Re-
Evaluation of Human Health Effects of Atrazine: Review of Experimental
Animal and In Vitro Studies and Drinking Water Monitoring Frequency.
DATES: The meeting will be held on April 26-29, 2010, and will begin
on Monday, April 26, 2010 at 1 p.m. On April 27-29, 2010, the meeting
will be held from approximately 8:30 a.m. to 5 p.m.
Comments. The Agency encourages that written comments be submitted
by April 12, 2010 and requests for oral comments be submitted by April
19, 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 April 12, 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 March 19,
2010.
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 Hamilton Crowne Plaza
Hotel, located at 1001 14th St., NW., Washington, DC, 20005.
The telephone number for the Hamilton Crowne Plaza Hotel is (202) 682-
0111.
Comments. Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2010-0125; 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-
2010-0125. 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
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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: Joseph E. Bailey, DFO, Office of
Science Coordination and Policy (7201M), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001;
telephone number: (202) 564-2045; 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.
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-2010-0125; 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 April 12,
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 April 12,
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 April 19, 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: Risk assessment, mode of action analysis (particularly those
with MOA framework experience), frameworks to evaluate human relevance,
pharmacokinetics, neuroendocrinology (hormone-mediated health effects),
HPA axis (corticosterone), immuno- toxicology, epidemiology,
reproductive/developmental biology and environmental sampling and
statistical modeling. 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 March
19, 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
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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 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.
II. Background
A. Purpose of FIFRA SAP
FIFRA SAP serves as the primary scientific peer review mechanism of
EPA's Office of Prevention, Pesticides and Toxic Substances (OPPTS) 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
EPA is undertaking a re-evaluation of the human health effects of
atrazine. The re-evaluation plan was presented to the FIFRA Scientific
Advisory Panel (SAP) in November 2009 and involves three SAP meetings
in 2010. The first was held in February 2010 where the Agency presented
its preliminary reviews of several atrazine epidemiology studies on
birth outcomes and described a project plan to evaluate atrazine
epidemiology data from the Agricultural Health Study (http://aghealth.nci.nih.gov/). The April 2010 SAP meeting will focus on:
1. A preliminary review of mammalian in vivo as well as in vitro
studies on toxicological effects and modes of action.
2. Statistical approaches for evaluating monitoring frequency in
community water systems (CWS).
For the April SAP meeting, the Agency's scientific review of
toxicology studies will focus on those studies used to support the
reregistration of atrazine and new studies available up to January 30,
2010. Any studies that become available after January 30, 2010 will be
integrated into the Agency's weight-of-the-evidence (WOE) analysis
scheduled for review by the FIFRA SAP in September 2010. This WOE
analysis will integrate in vivo and in vitro laboratory studies along
with epidemiologic data and other human information.
At the April meeting, the Agency plans to solicit comment from the
SAP on the toxicological importance and human relevance of a variety of
effects including findings on the hypothalamic-pituitary-adrenal (HPA)
axis, immune system, prostate, brain, and the enzyme, aromatase. In
addition, the Agency plans to discuss the scientific issues associated
with lifestage susceptibility and linking a chemically-induced
activation of the HPA axis to other health outcomes and possible
approaches to use key events in a mode of action in risk assessment.
The Agency will not be proposing updated points of departure or a
complete scientific analysis relevant to the FQPA Safety Factor for
protection of infants and children at the April SAP meeting. The Agency
will consider the advice of the April SAP, however, to help inform
these issues which will be presented to the September SAP. Following
the April SAP, the Agency will continue to review the scientific
literature with particular emphasis on the potential for differential
lifestage susceptibility and the temporal aspects of pharmacokinetic
and pharmacodynamic events. This temporality is an important scientific
issue for the assessment of the health effects of atrazine because the
duration of exposure leading to adverse effects is a critical aspect of
determining the appropriate frequency of water monitoring in CWS, which
will also, be discussed in September.
As a condition of reregistration of atrazine, EPA required the
registrants to implement a monitoring program in selected CWS,
generally in the corn and sorghum growing area of the midwest. In
implementing a monitoring program, the frequency of sampling is closely
linked to the health effects of concern. If the health effects of
concern relate to long-term chronic exposures, a yearly average
concentration is sufficient. Less frequent sampling may provide
sufficient data for EPA to be reasonably confident that the results are
representative of a yearly average concentration. However, for effects
that can occur after shorter exposure durations, more frequent sampling
may be needed in order to be confident that the sampling has not missed
a high-end or peak exposure that could significantly affect the
estimate of short term exposure. The Agency will be
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evaluating the temporality of toxic effects as it conducts this
reevaluation of atrazine and at the April SAP will also discuss
proposed statistical approaches to determine the appropriate monitoring
frequency for different durations of interest.
The Agency will consider the advice and recommendations received
from the SAP at the April 2010 meeting as it develops the WOE analysis
integrating experimental toxicology and epidemiology studies with
statistical analysis for determining the frequency of water monitoring
scheduled for review by the SAP in September.
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
mid-March. 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 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: February 17, 2010.
Frank Sanders,
Director, Office of Science Coordination and Policy.
[FR Doc. 2010-4540 Filed 3-4-10; 8:45 a.m.]
BILLING CODE 6560-50-S