80 FR 15598 - FIFRA Scientific Advisory Panel; Notice of Public Meeting

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 56 (March 24, 2015)

There will be a 3-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review research to evaluate the potential for juvenile sensitivity to pyrethroids.

[Federal Register Volume 80, Number 56 (Tuesday, March 24, 2015)]
[Notices]
[Pages 15598-15600]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-06689]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2015-0130; FRL-9923-73]


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 research to evaluate the potential for juvenile 
sensitivity to pyrethroids.

DATES: The meeting will be held on May 19-21, 2015, from approximately 
9:00 a.m. to 5:00 p.m.
    Comments. The Agency encourages written comments be submitted on or 
before May 5, 2015, and requests for oral comments be submitted on or 
before May 12, 2015. 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 5, 2015, 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 April 7, 
2015.
    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: Meeting: 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-2015-0130, 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.html.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.
    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 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

[[Page 15599]]

Coordination and Policy (7201M), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-3327; email address: [email protected].

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?

    1. Submitting CBI. Do not submit CBI information to EPA through 
regulations.gov or email. 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.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

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-2015-0130 in the subject line 
on the first page of your request.
    1. Written comments. The Agency encourages written comments be 
submitted, using the instructions in ADDRESSES and Unit I.B., on or 
before May 5, 2015, 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 5, 2015, 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 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 on or before 
May 12, 2015, 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. Oral comments given before the 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 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: In vitro to in vivo extrapolation (IVIVE), Risk assessment, 
Toxicokinetics, Quantitative modeling and analyses of complex data, 
Pyrethroid pesticides, Age-dependent pharmacokinetics and metabolism, 
Enzyme maturation profiles in rodents and humans, Voltage-gated sodium 
channels, Ontogeny of metabolizing enzymes (e.g., carboxylesterase and 
P450), Clinical observations of neurotoxicology in animals (adult and 
neonate). 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, email address, and telephone number. Nominations should be 
provided to the DFO listed under FOR FURTHER INFORMATION CONTACT on or 
before April 7, 2015. 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 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, 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. 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

[[Page 15600]]

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 (5 U.S.C. Appendix). 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 scientific 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

    The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
authorizes EPA to register pesticides and the FFDCA gives the agency 
the authority to establish tolerances for residues resulting on food 
and/or feed resulting from use of a pesticide. The studies required to 
allow the agency to make the appropriate statutory safety findings 
under both of these acts are stipulated under 40 CFR part 158. There is 
flexibility, however, in implementing Part 158. Additional data can be 
required (Sec.  158.75), alternative approaches can be accepted, and 
studies can be waived (Sec.  158.45). The 2007 National Research 
Council (NRC) report from the National Academy of Sciences (NAS) on 
Toxicity Testing in the 21st Century describes this new vision for 
toxicity testing. In response to the NRC report, EPA's Office of 
Pesticide Programs (OPP) developed a Strategic Direction for New 
Pesticide Testing and Assessment Approaches http://www.epa.gov/pesticides/science/testing-assessment.html which describes OPP's 
approach to implementing the NAS vision. One of the key components of 
OPP's Strategic Direction is improved approaches to more traditional 
toxicity tests to minimize the number of animals used while expanding 
the amount of information obtained. OPP also has a recent document, 
Guiding Principles for Data Requirements (http://www.epa.gov/pesticides/regulating/data-require-guide-principle.pdf) which describes 
the principles for requiring toxicology data for pesticides, 
specifically to ``only require data that adequately inform regulatory 
decision making and thereby avoid unnecessary use of time and 
resources, data generation costs, and animal testing.''
    OPP is actively working on a reevaluation of the human health 
effects of the pyrethroids and pyrethrins under the OPP registration 
review program (http://www.epa.gov/oppsrrd1/registration_review/index.htm), required under FIFRA.
    Until late 2009, OPP requested developmental neurotoxicity (DNT) 
studies for pyrethroids. However, the agency determined that the DNT 
studies were not providing adequate data to evaluate the potential for 
post-natal sensitivity to pyrethroids. In July, 2010, the FIFRA 
Scientific Advisory Panel (SAP) reviewed a proposed research strategy 
to assess the potential for juvenile sensitivity consistent with the 
recommendations of the NAS in its report on Toxicity Testing in the 
21st Century using a combination of in vitro studies, targeted in vivo 
studies, and physiologically-based pharmacokinetic (PBPK) models.
    Based on feedback from the SAP and the agency, the industry 
research proposal was revised. Since late 2010, the Council for the 
Advancement of Pyrethroid Human Health Risk Assessment (CAPHRA) has 
worked with industry and academic scientists to develop assays and 
models to assess the potential for juvenile post-natal sensitivity to 
pyrethroids. The on-going research effort is organized around the 
adverse outcome pathway (AOP) for pyrethroids: Alterations with 
voltage-gated sodium channels (VGSC), leading to alterations in 
membrane excitability and firing potentials and ultimately to in vivo 
clinical syndromes. Specifically, the CAPHRA is evaluating the potency 
of pyrethroids to human sodium channels and transplantation of adult 
and juvenile rat synaptic membrane into oocytes. In addition, the 
CAPHRA is conducting targeted in vivo studies on behavioral metrics and 
developing PBPK models. The research, thus far, has focused on 
development of the overall approach using data for deltamethrin and 
permethrin (Type II and Type I pyrethroids, respectively). The CAPHRA 
research is at a point where feedback on extending this research to the 
other pyrethroids would be constructive. The CAPHRA proposal is to use 
the knowledge gained with deltamethrin and permethrin to develop more 
targeted datasets using read across and computational approaches (i.e., 
less data generation) for other pyrethroids. As such, the agency will 
be seeking the SAP's advice on the current state of the science with 
the CAPHRA research effort and proposals for next steps which include 
extension of data on deltamethrin and permethrin to other pyrethroids.

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 4 weeks before 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 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.

    Authority:  7 U.S.C. 136 et seq.; 21 U.S.C. 301 et seq.

    Dated: March 13, 2015.
David J. Dix,
Director, Office of Science Coordination and Policy.
[FR Doc. 2015-06689 Filed 3-23-15; 8:45 am]
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