[Federal Register Volume 76, Number 88 (Friday, May 6, 2011)]
[Notices]
[Pages 26287-26290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-11027]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2011-0399; FRL- 8872-8]
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 Non-Cancer
Effects, Drinking Water Monitoring Frequency, and Cancer Epidemiology.
DATES: The meeting will be held on July 26-29, 2011, from approximately
8:30 a.m. to 5 p.m.
Comments. The Agency encourages that written comments be submitted
by July 12, 2011 and requests for oral comments be submitted by July
19, 2011. 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 12, 2011 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 20,
2011.
Webcast. This meeting may be webcast. Please refer to the FIFRA
SAP's Web site, 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-2011-0399, 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-
2011-0399. 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 Web site 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: Joseph 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:
[[Page 26288]]
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-2011-0399 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 12,
2011, 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 12,
2011should contact the DFO listed under FOR FURTHER INFORMATION
CONTACT. Anyone submitting written comments at the meeting should bring
30 copies for distribution to the FIFRA SAP.
2. Oral comments. The Agency encourages that each individual or
group wishing to make brief oral comments to the FIFRA SAP submit their
request to the DFO listed under FOR FURTHER INFORMATION CONTACT no
later than July 19, 2011, 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, environmental epidemiology, exposure assessment
(particularly pesticide applicators), mammary gland development, mode
of action analysis (particularly those with MOA framework experience),
frameworks to evaluate human relevance, prostate development,
pharmacokinetics, physiologically-based pharmacokinetic modeling,
neuroendocrinology, hormone-mediated health effects, HPA axis
(corticosterone), 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 May 20, 2011. 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 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 candidate's financial disclosure
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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 Web site
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 Chemical Safety and Pollution Prevention (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
EPA is undertaking a re-evaluation of the human health effects of
atrazine. The human health re-evaluation has involved three SAP
meetings in 2010 and one in 2011. The first meeting was held in
February 2010 during which 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
second meeting in April 2010 SAP meeting focused on:
1. A preliminary review of experimental toxicology studies from
laboratory mammals and in vitro studies and recent advancements in
understanding atrazine's mode of action along with;
2. Statistical and modeling approaches for evaluating monitoring
frequency in community water systems (CWS). The September 2010 meeting
built on the scientific analysis and SAP feedback from the April
meeting. Specifically, the Agency presented scientific analyses on an
empirical approach for estimating internal dosimetry, and calculation
of benchmark dose estimates for purposes of deriving points of
departure. In addition, EPA presented a general strategy for designing
a monitoring study to characterize drinking water exposures and
discussed different methods for analyzing and interpreting monitoring
data collected at different sampling frequencies. The September 2010
meeting also provided proposals for updating the critical durations of
exposure based on the new science, and a preliminary evaluation of
potential susceptibility of the young. In addition, the September 2010
meeting included evaluation of non-cancer epidemiology studies, a
weight of the evidence evaluation of the non-cancer epidemiology
studies with experimental laboratory studies, and a proposal to use the
non-cancer epidemiology studies qualitatively in evaluating the human
relevance of experimental toxicology findings.
The July 2011 SAP meeting will build on the scientific analyses and
SAP feedback from the previous three SAP meetings by proposing a
conceptual framework for the evaluation of atrazine human health non-
cancer effects. This proposed conceptual framework will integrate
information on mode of action and adverse outcome pathways, potentially
susceptible lifestages/subpopulations, drinking water exposure,
internal dosimetry, and water monitoring sampling uncertainty. The
Agency will solicit comment on the overall integrative approach
proposed for atrazine along with technical considerations for each
scientific component. To illustrate the conceptual framework, a case
study will be provided that demonstrates an approach for estimating
non-cancer risk to atrazine based on an internal dose metric for
temporally, spatially, and demographically explicit information. The
Agency will use feedback received from the SAP at the July 2011 meeting
as it completes the scientific analysis for determining whether or not
adjustments may be necessary in the sampling frequency of CWS
monitoring. The evaluation of non-cancer effects will include studies
available up through April 29, 2010.
In the 2003 Interim Reregistration Eligibility Decision (IRED) for
atrazine, the Agency noted that it would convene another SAP meeting
concerning atrazine and its possible association with carcinogenic
effects, particularly as new information from the National Cancer
Institute's (NCI) Agricultural Health Study (AHS) is made available.
The Agency believes it is appropriate at this time to re-evaluate the
cancer epidemiology literature on atrazine in a SAP meeting; EPA notes
that the evidence of atrazine carcinogenicity based upon experimental
animal data were evaluated by the SAP in April 2010. As such, at the
July 2011 meeting, the Agency will provide a preliminary review of
cancer epidemiology studies and a draft weight of the evidence (WOE)
analysis on cancer that integrates mode of action, experimental
toxicology information, and epidemiology. This draft WOE analysis will
follow the Draft Framework for Incorporating Epidemiologic and Human
Incident Data in Health Risk Assessment, which was reviewed by the SAP
in February 2010. The Agency will include epidemiological studies on
the cancer effects of atrazine available up through April 29, 2010. The
Agricultural Health Study is anticipated to be published in spring 2011
and will be part of this review given that this study is considered to
be a pivotal line of evidence.
At the February 2010 SAP, the Agency presented a proposed plan for
a collaborative project with investigators from the AHS to evaluate
approaches for estimating exposure to pesticide applicators. At the
July 2011 meeting, the Agency will discuss the status of the
collaborative project (which includes a case study involving atrazine)
and solicit comment from the Panel on the overall direction of the
project and the methods development aspects of this effort. This
project is part of a larger effort by OPP to improve the incorporation
of epidemiology in human health risk assessment. The feedback from the
SAP may not be used for atrazine risk assessment per se but
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will inform EPA's continued efforts to improve risk assessment
approaches and methodologies.
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 after the meeting.
The meeting minutes will be posted on the FIFRA SAP Web site 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, 2011.
Frank Sanders,
Director, Office of Science Coordination and Policy.
[FR Doc. 2011-11027 Filed 5-5-11; 8:45 am]
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