[Federal Register Volume 77, Number 222 (Friday, November 16, 2012)]
[Pages 68773-68775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-27816]

[[Page 68773]]



[EPA-HQ-OPP-2012-0818; FRL-9367-9]

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 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 
    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 
     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) 564-0130; 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-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

[[Page 68774]]

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 
     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 
     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

[[Page 68775]]

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]