
[Federal Register Volume 79, Number 104 (Friday, May 30, 2014)]
[Notices]
[Pages 31111-31113]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12593]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2014-0331; FRL-9910-22]


FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: There will be a 3-day meeting of the Federal Insecticide, 
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to 
consider and review New High Throughput Methods to Estimate Chemical 
Exposure.

DATES: The meeting will be held on July 29 to August 1, 2014, from 
approximately 9:00 a.m. to 5:00 p.m.
    Comments. The Agency encourages that written comments be submitted 
by July 15, 2014 and requests for oral comments be submitted by July 
22, 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 July 15, 2014 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 June 13, 
2014.
    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-2014-0331, 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.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 
INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: Fred Jenkins, DFO, Office of 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.

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.

[[Page 31112]]

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-2014-0331 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 15, 
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 July 15, 2014 
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 22, 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 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 
areas: Computational exposure modeling, Mathematical modeling of 
environmental and biological systems and their interactions, 
Toxicokinetics, Pharmacokinetics, Environmental fate and transport, 
Modeling of chemical concentrations in water sources, Bioinformatics, 
Biomathematics, Statistics, Environment and health risk/impact 
assessment, including vulnerable and/or susceptible populations, 
Ecological risk assessment, Human exposure assessment, Ecological 
exposure assessment, Pharma, Monitoring of environmental contaminants--
surface water and groundwater. Note: In support of the US 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 ``New High Throughput Methods 
to Estimate Chemical Exposure''. 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 June 13, 2014. 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 11 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.

[[Page 31113]]

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

    EPA has made many recent advances in high throughput bioactivity 
testing. However, concurrent advances in rapid, quantitative prediction 
of human and ecological exposures have been lacking, despite the clear 
importance of both measures for a risk-based approach to prioritizing 
and screening chemicals. A recent report by the National Research 
Council of the National Academies, Exposure Science in the 21st 
Century: A Vision and a Strategy (NRC 2012) laid out a number of 
applications in chemical evaluation of both toxicity and risk in 
critical need of quantitative exposure predictions, including screening 
and prioritization of chemicals for targeted toxicity testing, focused 
exposure assessments or monitoring studies, and quantification of 
population vulnerability. Despite these significant needs, for the 
majority of chemicals (e.g. non-pesticide environmental compounds) 
there are no or limited estimates of exposure. For example, exposure 
estimates exist for only 7% of the ToxCast Phase II chemical list. In 
addition, the data required for generating exposure estimates for large 
numbers of chemicals is severely lacking (Egeghy et al. 2012).
    This SAP will review the use of EPA's ExpoCast model to rapidly 
estimate potential chemical exposures for prioritization and screening 
purposes. The focus will be on bounded chemical exposure values for 
people and the environment for the Endocrine Disruptor Screening 
Program (EDSP) Universe of Chemicals. In addition to exposure, the SAP 
will review methods to extrapolate an in vivo dose from in vitro dose 
data. This will involve presenting pharmacokinetic (PK) data for 
chemicals that have been run through a battery of high throughput 
endocrine screening assays and the methodology to use that PK 
information to estimate an in vivo dose. This exposure and RTK 
information along with high throughput in vitro bioactivity data will 
allow the EPA to assign a risk ranking to chemicals and prioritize them 
accordingly.
    ExpoCast is an EPA initiative to develop the necessary approaches 
and tools for rapidly prioritizing and screening thousands of chemicals 
based on the potential for human exposure. This focus for ExpoCast is 
distinct from many existing exposure tools that support regulatory risk 
assessment. Traditional exposure tools are lower throughput, requiring 
considerable data to make predictions of sufficient precision for a 
full risk assessment. ExpoCast efforts have focused on empirically 
assessing the uncertainty in forecasts made with limited available 
data, finding that in some cases even highly uncertain forecasts may be 
useful for prioritization and screening.
    In order to relate high throughput bioactivity data and rapid 
exposure predictions, an in vitro-in vivo extrapolation (IVIVE) via PK 
is needed. This IVIVE relates the in vitro compound concentrations 
([micro]M) found to be bioactive to the in vivo doses needed to produce 
serum concentrations equal to the in vitro concentrations. Without the 
time and resources necessary to generate in vivo PK data for the 
thousands of chemicals in the EDSP universe, high throughput 
pharmacokinetics (HTPK) can serve as a useful surrogate. HTPK methods 
were developed for pharmaceuticals to estimate therapeutic doses for 
clinical studies. HTPK technologies have been effective for 
pharmaceutical compounds and predicted concentrations are typically on 
the order of the measured in vivo concentrations. For non-therapeutic 
compounds in humans, PK data is not available and so it is essential to 
carefully characterize the predictive ability of the HTPK models and 
define the domain of applicability.
    High throughput exposure prediction and high throughput PK, when 
taken together with in vitro bioactivity profiling as a surrogate for 
hazard, will allow for a risk-based, rapid prioritization and screening 
of chemicals in the EDSP universe and beyond.

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 July 9, 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 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, Environmental 
justice.

    Dated: May 20, 2014.
David J. Dix,
Director, Office of Science Coordination and Policy.
[FR Doc. 2014-12593 Filed 5-29-14; 8:45 am]
BILLING CODE 6560-50-P


