[Federal Register Volume 78, Number 74 (Wednesday, April 17, 2013)]
[Notices]
[Pages 22873-22876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08921]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2013-0230; FRL-9384-1]
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 Weight-of-Evidence: Evaluating Results of EDSP Tier
1 Screening.
DATES: The meeting will be held July 30, 2013-August 2, 2013, from
approximately 8:30 a.m. to 5 p.m.
Comments. The Agency encourages that written comments be submitted
by July 16, 2013, and requests for oral comments be submitted by July
23, 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 July 16, 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 May 2,
2013.
Webcast. This meeting may be webcast. Please refer to the FIFRA
SAP's Web site at http://www.epa.gov/scipoly/
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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-2013-0230, 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.html.
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: 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; email
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) 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-2013-0230 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 16,
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 July 16,
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 July 23, 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 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 20 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: Regulatory toxicology/weight-of-evidence risk assessment,
ecotoxicology (fish and amphibian toxicology), comparative
endocrinology, reproductive physiology, developmental biology/
toxicology, thyroid physiology, in vitro models, toxicological
pathology, amphibian histopathology, morphometrics, quantitative
ecology/biostatistics, systems biology, and Baysian statistics.
Nominees should be scientists who have sufficient professional
qualifications, including training and experience, to be capable of
providing expert comments
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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 2, 2013. 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 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 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 FIFRA SAP on an ad hoc basis to assist in reviews conducted by the
FIFRA 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 developed the Endocrine Disruptor Screening Program (EDSP) in
response to FFDCA section 408(p) which requires EPA to ``develop a
screening program, using appropriate validated test systems and other
scientifically relevant information, to determine whether certain
substances may have an effect in humans that is similar to an effect
produced by a naturally occurring estrogen, or such other endocrine
effect as the Administrator may designate.'' 21 U.S.C. 346a(p)(1). In
addition, the provision in section 1457 of the Safe Drinking Water Act
(SDWA) provides that ``the Administrator may provide for testing under
the screening program * * * any other substance that may be found in
sources of drinking water if the Administrator determines that a
substantial population may be exposed to such substance.'' 42 U.S.C.
300j-17.
Based on recommendations from the Endocrine Disrupter Screening and
Testing Advisory Committee (EDSTAC) and, pursuant to the EPA
Administrator's discretionary authority, the EPA expanded the program
to encompass the estrogen, androgen, and thyroid (E, A, and T) hormonal
pathways of the endocrine system and human and ecological effects.
Subsequent to review by a joint committee of the EPA's Science Advisory
Board (SAB) and the FIFRA SAP, the EDSP embarked on a validation
process as mandated to evaluate the relevance and reliability of Tier 1
screening and Tier 2 test methods. As recommended by a FIFRA SAP, the
current EDSP Tier 1 screening battery consists of both in vitro and in
vivo assays that provide redundancy within a particular mode or pathway
of action and complementary endocrine specific-endpoints sensitive
enough to detect effects on E, A, and T signaling through different
routes of exposure and across multiple life-stages and taxa. The degree
of redundancy and complementary assays/endpoints are intended to
provide corroborating information to support an evaluation of the Tier
1 screening results.
EPA issued the first test orders of the EDSP Tier 1 screening on 67
chemicals (List 1 chemicals) between October 29, 2009, and February 26,
2010 (http://www.epa.gov/endo). As a result of these test orders, EDSP
Tier 1 data were submitted on 50 pesticide active ingredients and 2
pesticide inert ingredients. For some test orders, EPA accepted ``other
scientifically relevant information'' (OSRI) in lieu of specific study
data (http://www.epa.gov/endo).
In May 2013, the Agency will be holding a FIFIRA SAP meeting to
obtain input to ensure that individual assays and the overall battery
performed as anticipated toward understanding whether a chemical is
impacting E, A, and T pathways. A subset of the List 1 chemicals will
be presented to the Panel to evaluate whether each assay can be
consistently executed based on the performance criteria and to discuss
any issues associated with interpretation of the responses within each
assay as well
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as the anticipated complementary relationships both within and across
the assays. The advice and recommendations of the Panel from the May
FIFRA SAP will be critical in how the Agency conducts its weight-of-
evidence (WoE) evaluation of the Tier 1 screening results, which is the
topic of this FIFRA SAP.
The EPA issued its WoE guidance document in 2011 for evaluating the
results of EDSP Tier 1 screening to identify the need for Tier 2
testing. That document can be found at http://www.regulations.gov
(Docket ID number EPA-HQ-OPPT-2010-0877). Briefly, that document
presents a hypothesis-based approach that begins with an evaluation of
each study's quality and relevance in addressing the questions for the
chemical of interest, and guidance on how to assemble and integrate all
lines of evidence (EDSP Tier 1 assays and OSRI, including peer reviewed
studies) for that chemical. Thus, Tier 1 screening is combined with
other relevant evidence (e.g., 40 CFR part 158 guideline studies) using
a WoE analysis intended to determine whether or not a test chemical
requires more comprehensive Tier 2 testing or a more targeted and
tailored approach.
The Agency will present case studies based on a subset of List 1
chemicals for the Tier 1 test orders to illustrate the decision logic
for applying EPA's EDSP WoE guidance (http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2010-0877-0021) in interpreting Tier 1
screening results and OSRI. The FIFRA SAP will be asked to comment on
interpretative issues that arise during this WoE approach as well as
the decision logic that guides the determination of whether higher
level testing is needed.
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
early July. 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 Web site 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 at http://www.regulations.gov.
List of Subjects
Environmental protection, Pesticides and pests.
Dated: April 9, 2013.
Steven M. Knott,
Acting Director, Office of Science Coordination and Policy.
[FR Doc. 2013-08921 Filed 4-16-13; 8:45 am]
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