[Federal Register Volume 77, Number 222 (Friday, November 16, 2012)]
[Notices]
[Pages 68773-68775]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27816]
[[Page 68773]]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2012-0818; FRL-9367-9]
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 scientific issues associated with Prioritizing the
Universe of Endocrine Disruptor Screening Program (EDSP) Chemicals
Using Computational Toxicology Tools.
DATES: The meeting will be held on January 29-February 1, 2013, from
approximately 9 a.m. to 5:30 p.m.
Comments. The Agency encourages that written comments be submitted
by January 15, 2013 and requests for oral comments be submitted by
January 22, 2013. However, written comments and requests to make oral
comments may be submitted until the date of the meeting, but anyone
submitting written comments after January 15, 2013 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 November
30, 2012.
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-2012-0818, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.
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.
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 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; email
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) and FIFRA. 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.
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-2012-0818 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 January
15, 2013, 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
January 15, 2013 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 January 22, 2013, 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
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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). 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:
Organic and analytical chemistry (expertise focused on
developing criteria for physical chemical properties that cannot be
easily tested in in vitro systems or stable enough for human exposure
potential).
In vitro models of receptor binding (e.g., estrogen) and
gene activation.
Quantitative structural-activity relationship (QSAR)
models and estrogen receptor (ER) expert systems development.
High-throughput data generation and analysis (expertise
focused on how this methodology can be applied to assess toxicity
potential of environmental compounds with a range of potency).
Application of QSAR models and expert systems in
prioritization processes for regulatory toxicity testing programs.
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 November 30, 2012.
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 Web site at http://www.epa.gov/scipoly/sap or may be obtained from the OPP Docket or 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 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
Under the 1996 FFDCA, section 408(p), and Safe Drinking Water Act,
section 1457, EPA is required to screen all pesticide chemicals (active
and inert ingredients) and only those drinking water contaminants to
which a ``substantial population'' is exposed for the potential to
interact with the endocrine system. The combination of both pesticide
and drinking water chemicals amounts to a universe of over 10,000
chemicals. The Agency must therefore prioritize which chemicals are
listed for screening and testing in multiple biologically complex and
resource intensive assays. The Agency is developing the use of
structure-activity relationships (SARs) and high-throughput (HTP) assay
data as cost effective prioritization tools that can help focus the
generation of new data on chemicals that are more likely to have the
potential to interact with the
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estrogen, androgen, or thyroid pathways.
In 2009, EPA developed the Estrogen Receptor (ER) Expert System
(ERES) to help prioritize candidate chemicals specific to an estrogen
receptor (ER) mediated pathway for testing in the Tier 1 Endocrine
Disruptor Screening Program. The ERES was initially developed for
pesticide, food use inert ingredients and antimicrobial pesticides and
predicts ER binding affinity based on data derived from two types of in
vitro assays: ER binding and ER transcriptional assays. The FIFRA SAP
reviewed the initial ERES approach including the transparency of the
approach, biological endpoint definition, mechanistic interpretation,
and model's applicability domain (http://www.epa.gov/scipoly/sap/meetings/2009/august/082509minutes.pdf).
EPA incorporated the 2009 SAP's recommendations and is expanding
the ERES training set through the use of chemical read across
techniques (i.e., using data from a tested chemical for a particular
property or effect to a similar untested chemical) and in vitro HTP
assay data. This SAP review will seek comment on the expansion of the
ERES training set to cover a larger chemical universe and the approach
to interpreting the HTP data to inform the ERES. The SAP will also be
asked to comment on various aspects of the HTP data including
transparency of how the data were generated, processed, and analyzed.
While this SAP is focused on the estrogenic toxicity pathway, the
recommendations may be more broadly applied for additional toxicity
pathways (e.g., androgen and thyroid). In addition, this SAP review
will establish a solid foundation upon which the agency seeks to build
upon as we advance the use of these computational toxicology tools
beyond EDSP chemical prioritization and into Tier 1 data replacement.
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 at
least 15 days prior to the meeting. 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 Docket or at http://www.regulations.gov.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: November 7, 2012.
Frank Sanders,
Director, Office of Science Coordination and Policy.
[FR Doc. 2012-27816 Filed 11-15-12; 8:45 am]
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