[Federal Register Volume 79, Number 179 (Tuesday, September 16, 2014)]
[Pages 55475-55477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22044]



[EPA-HQ-OPP-2014-0614; FRL-9915-55]

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 Integrated Endocrine Activity and Exposure-based 
Prioritization and Screening.

DATES: The meeting will be held on December 2-5, 2014, from 
approximately 9 a.m. to 5 p.m.
    Comments. The Agency encourages that written comments be submitted 
by November 18, 2014, and requests for oral comments be submitted by 
November 25, 2014. However, written comments and requests to make oral 
comments may be submitted until the date of the meeting, but anyone 
submitting written comments after November 18, 2014, 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 September 
30, 2014.
    Webcast. This meeting may be webcast. Please refer to the FIFRA SAP 
Web site at 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-2014-0614, 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 

FOR FURTHER INFORMATION CONTACT: Alva Daniels, DFO, Office of Science 
Coordination and Policy (7201M), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-2661; email address: [email protected].


[[Page 55476]]

 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-2014-0614 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 November 
18, 2014, 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 
November 18, 2014, should contact the DFO listed under FOR FURTHER 
INFORMATION CONTACT. Anyone submitting written comments at the meeting 
should bring 20 copies for distribution to FIFRA SAP.
    2. Oral comments. The Agency encourages that each individual or 
group wishing to make oral comments to FIFRA SAP submit their request 
to the DFO listed under FOR FURTHER INFORMATION CONTACT no later than 
November 25, 2014, 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 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: High Throughput Screening (HTS) in vitro assay technology and 
applications, QSAR methodology, Tier 1 assays (Uterotrophic and 
Hershberger), In vitro assays (Estrogen, Androgen, Thyroid or 
Steriodogenesis), reproductive biology and toxicology, endocrinology. 
Mathematical modeling of biological Systems, Bioinformatics, 
Biomathematics, Statistics, Quantitative modeling and analysis of 
complex data including Curve-fitting and Outlier detection, 
Computational exposure modeling, Near-field and far-field exposure 
modeling, Toxicokinetics and Pharmacokinetics, Environmental fate and 
transport, Human exposure assessment (including vulnerable or 
susceptible populations), Ecological exposure assessment. Note: In 
support of the U.S. Environmental Protection Agency's (EPA) priority of 
``Making a Visible Difference in Communities'' across the country, the 
Agency is committed to helping minority, low income, tribal and other 
vulnerable populations improve their health and environment. In an 
effort to ensure that actions being proposed by the Agency are taking 
into consideration input from potential communities with environmental 
justice concerns, the EPA is offering an opportunity to provide input 
on the FIFRA SAP meeting to address scientific issues associated with 
``Integrated Endocrine Activity and Exposure-based Prioritization and 
Screening''. The EPA encourages all grass-root organizations and 
residents to submit public comments on this issue which is being 
addressed during the FIFRA Scientific Advisory Panel meeting. The 
Agency also encourages community environmental justice advocates to 
give a voice to their communities by nominating candidates for 
consideration to serve on this panel. 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 September 30, 2014. The Agency will consider all 
nominations of prospective candidates for this meeting that are 
received on or before that 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

[[Page 55477]]

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 8 ad 
hoc scientists.
    FIFRA SAP members are subject to the provisions of 5 CFR Part 
2634--Executive Branch Financial Disclosure, Qualified Trusts, and 
Certificates of Divestiture, as supplemented by EPA in 5 CFR part 6401. 
In anticipation of this requirement, prospective candidates for service 
on 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 candidate's 
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 (SRB) consisting of at least 60 scientists who are 
available to FIFRA SAP on an ad hoc basis to assist in reviews 
conducted by 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

    This FIFRA SAP meeting will review methods using computational 
toxicology and exposure tools (i.e., high throughput screening (HTS) 
assays, and computational models), and other data streams for 
integrated bioactivity and exposure based prioritization and screening 
of the universe of EDSP chemicals. Endocrine bioactivity of chemicals 
will be quantified using HTS in vitro estrogen, androgen, and thyroid 
receptor assays, along with other potential molecular targets, and 
compared with Tier 1 screening and other in vivo assay results obtained 
from published and publically available peer-reviewed studies. While 
technical advances in high-throughput toxicity testing of chemicals 
were presented at a FIFRA SAP meeting in 2013, this SAP will review 
further advances in computational toxicology exposure science for 
prioritization and screening of the EDSP universe of chemicals. The 
ability of the agency to screen the thousands of environmental 
chemicals in the EDSP universe is substantially limited by the capacity 
of the current Tier 1 screening methods. Rapid screening of 1000s of 
chemicals using EPA's ToxCast high throughput assays allows the agency 
to focus attention on chemicals with the greatest potential endocrine 
bioactivity. In addition, high throughput models of human and 
ecological exposure (e.g. ExpoCast) allows the agency to identify 
chemicals with the greatest potential for exposures that could result 
in bioactive concentrations. This shift in the EDSP framework allows 
focus to be placed on chemicals that pose the greatest likelihood of 
exposures leading to endocrine bioactivity in humans or wildlife. The 
FIFRA SAP will be requested to respond to charge questions regarding 
EPA's proposed integrated bioactivity exposure based approach for 
ranking chemicals in the EDSP universe for further screening and 

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 October 27, 2014. 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 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, Environmental 

    Dated: September 2, 2014.
David J. Dix,
Director, Office of Science Coordination and Policy.
[FR Doc. 2014-22044 Filed 9-15-14; 8:45 am]