[Federal Register Volume 78, Number 36 (Friday, February 22, 2013)]
[Pages 12311-12313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-03977]

[[Page 12311]]



[EPA-HQ-OPP-2013-0075; FRL-9378-8]

FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.


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 the Endocrine Disruptor Screening Program (EDSP) 
Tier 1 Screening Assays and Battery Performance.

DATES: The meeting will be held on May 21-24, 2013, from approximately 
9 a.m. to 5 p.m.
    Comments. The Agency encourages that written comments be submitted 
by May 7, 2013 and requests for oral comments be submitted by May 14, 
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 May 7, 2013 should contact the Designated 
Federal Official (DFO) listed under FOR FURTHER INFORMATION CONTACT. 
For additional instructions, see Unit I.C. of the SUPPLEMENTARY 
    Nominations. Nominations of candidates to serve as ad hoc members 
of FIFRA SAP for this meeting should be provided on or before March 8, 
    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-2013-0075, 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 
     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 

Science Coordination and Policy (7201M), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; 
telephone number: (202) 564-3327; fax number: (202) 564-8382; email 
address: jenkins.fred@epa.gov.


 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 
    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 

 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-2013-0075 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 May 7, 
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 May 7, 2013 
should contact the DFO listed under FOR FURTHER INFORMATION CONTACT. 
Anyone submitting written comments at the meeting should bring 25 
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 May 14, 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

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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 25 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/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, and systems biology. 
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 8, 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 10 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 Federal Food, Drug, and Cosmetic Act (FFDCA), section 
408(p) and the Safe Drinking Water Act (SDWA), section 1457, the EPA is 
required to screen all pesticide chemicals (active and inert 
ingredients) and those drinking water contaminants to which a 
``substantial population'' is exposed for the potential to interact 
with the endocrine system. As recommended by a Federal Advisory 
Committee, (Endocrine Disruptor Screening and Testing Advisory 
Committee, EDSTAC), the EPA Endocrine Disruptor Screening Program 
(EDSP) established a two tiered screening and testing program to 
address the potential of chemicals to perturb the estrogen, androgen or 
thyroid (E,A or T) systems and elicit adverse human and ecological 
health outcomes. In 1999, following the EDSTAC recommendations, a joint 
subcommittee of the Agency's Science Advisory Board (SAB) and FIFRA SAP 
recommended to the Agency, after review of the initial set of Tier 1 
data, to subject that data to external scientific peer review for 
consideration to further optimize the Tier 1 screening battery.
    Tier 1 screening was recommended to include a diverse yet 
complementary suite of in vitro and in vivo assays covering multiple 
hormonal modes of action (MoA) across various taxa. To maximize 
sensitivity and reliability (i.e., minimizing false negatives) for 
determining the potential of a chemical to interact with E, A, or T, 
the suite of assays was to be conducted as a battery.

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If the results of the Tier 1 battery indicated the potential for a 
chemical to interact with the endocrine system as determined through a 
weight of evidence (WoE) analysis, various Tier 2 tests were to be 
considered for determining dose-response relationships and any 
potential adverse effects for risk assessment. The EDSP is mandated 
under FFDCA to use ``validated'' assays to screen for endocrine 
disrupting chemicals. Validation principles established by the 
Organization for Economic Co-Operation and Development (OECD) and 
Interagency Coordinating Committee on the Validation of Alternative 
Methods (ICCVAM) were followed to develop, standardize, and validate 
many of the initially proposed Tier 1 in vitro and in vivo screening 
assays as well as more novel screening assays that emerged after the 
EDSTAC final report in 1998. Subsequent to the validation process, an 
independent peer review of individual Tier 1 screening assays was 
conducted. Based on results of the validation process, comments from 
peer review, and recommendations from EDSTAC, the EDSP proposed a 
battery of screening assays that was founded on the strengths of one or 
more assays complimenting the limitations of other assays in the 
battery. Moreover, it was expected that the result(s) of each assay 
would not be considered in isolation but be inclusive of the results of 
all assays in the battery to support a WoE analysis. The FIFRA SAP 
reviewed the proposed Tier 1 screening battery and recommended a 
battery of 11 assays to EPA which the Panel indicated ``* * * as an 
appropriate starting point to detect endocrine disrupting chemicals 
based on the current state of the science.'' In addition, however, the 
SAP also expected the Agency to continue ``* * * to develop, refine, 
and review the battery.'' Notably, this latter statement concurs with a 
recommendation from the initial joint SAB/SAP who indicated EPA should 
review the initial data ``* * * with an eye towards revising the 
process and eliminating those methods that don't work.''
    This FIFRA SAP review will be focused on a subset of the initial 
Tier 1 screening data received by the Agency in response to test orders 
issued for the first list of chemicals in 2009. The SAP review will 
involve the performance of the 11 Tier 1 screening assays and 
performance of the assays as a battery that was designed to detect the 
potential of a test chemical to interact with the E, A or T hormonal 
pathways. The SAP will be asked to comment on factors that may impact 
interpretation of the assay/battery results (e.g., variability) as well 
as suggestions for increasing the efficiency of the Tier 1 screening 
approach. To illustrate assay/battery performances, case examples of 
Tier 1 data from the initial list of chemicals will be used. It should 
be noted that there will be a separate SAP meeting scheduled in the 
summer of 2013 to discuss the decision logic in a WoE approach to 
identify candidate chemicals for Tier 2 testing using EDSP Tier 1 
screening results, other scientifically relevant information (OSRI), 
and health and ecological effects data from 40 CFR part 158 studies.

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 
approximately early May 2013. 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, and Endocrine 

    Dated: February 13, 2013.
Steven M. Knott,
Acting, Director, Office of Science Coordination and Policy.
[FR Doc. 2013-03977 Filed 2-21-13; 8:45 am]