[Federal Register Volume 78, Number 74 (Wednesday, April 17, 2013)]
[Pages 22873-22876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08921]



[EPA-HQ-OPP-2013-0230; FRL-9384-1]

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 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 
    Nominations. Nominations of candidates to serve as ad hoc members 
of FIFRA SAP for this meeting should be provided on or before May 2, 
    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 
     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 

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].


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-2013-0230 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 
    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. 
    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]