[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Notices]
[Pages 39087-39090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16990]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2018-0517; FRL-9980-76]


FIFRA Scientific Advisory Panel; Notice of Public Meeting and 
Request for Nomination of Ad Hoc Expert Members

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: There will be a 4-day, in-person meeting of the Federal 
Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel 
(FIFRA SAP) to consider and review the Evaluation of a Proposed 
Approach to Refine the Inhalation Risk Assessment for Point of Contact 
Toxicity: A Case Study Using a New Approach Methodology (NAM). 
Preceding the in-person meeting, there will be a half-day virtual 
preparatory meeting, conducted via webinar using Adobe Connect, to 
consider and review the clarity and scope of the meeting's draft charge 
questions. In addition, EPA is requesting nominations of prospective 
candidates for service as ad hoc members of FIFRA SAP for this meeting. 
Any interested person or organization may nominate qualified 
individuals to be considered as prospective candidates

[[Page 39088]]

for this meeting by following the instructions provided in this 
document.

DATES: 
    Meeting: The 4-day, in-person meeting will be held December 4 to 
December 7, 2018, from approximately 9 a.m. to 5 p.m.
    Nominations: Nominations of candidates to serve as ad hoc members 
of the FIFRA SAP for this review should be provided on or before 
September 7, 2018.
    Special accommodations: Requests for special accommodations should 
be submitted on or before November 16, 2018, to allow EPA time to 
process your request.
    Comments: Written comments should be submitted on or before October 
19, 2018, and EPA encourages individuals and groups that wish to make 
oral comments to submit the request to make oral comments by November 
9, 2018.

ADDRESSES: 
    Meeting: The in-person 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. The virtual 
meeting will be webcast. Please refer to the following website for 
information on how to access the webcast: http://www.epa.gov/sap.
    Nominations: Submit nominations of candidates to serve as ad hoc 
members of the FIFRA SAP Meeting to the DFO listed under FOR FURTHER 
INFORMATION CONTACT.
    Special accommodations: For information on access or services for 
individuals with disabilities, and to request accommodation for a 
disability, please contact the Designated Federal Official (DFO) listed 
under FOR FURTHER INFORMATION CONTACT.
    Comments. Submit requests to present oral comments to the DFO 
listed under FOR FURTHER INFORMATION CONTACT.
    Submit your written comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2018-0517, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not 
electronically submit any information you consider to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute.
    <bullet> Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
    <bullet> 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 information on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets. For additional instructions related to this 
meeting, see Unit I.C. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Dr. Marquea D. King, DFO, Office of 
Science Coordination and Policy (7201M), Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone 
number: 202-564-3626; email address: <a href="/cdn-cgi/l/email-protection#2d4644434a03404c5f5c58484c6d485d4c034a425b"><span class="__cf_email__" data-cfemail="5f3436313871323e2d2e2a3a3e1f3a2f3e71383029">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may 
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 both meetings?

    You may participate in both meetings by following the instructions 
in this unit. To ensure proper receipt of comments, nominations or 
other requests by EPA, it is imperative that you identify docket ID 
number EPA-HQ-OPP-2018-0517 in the subject line on the first page of 
your request.
    1. Written comments. Written comments for both the in-person and 
virtual meetings should be submitted, using the instructions in 
ADDRESSES and Unit I.B., on or before October 19, 2018, to provide 
FIFRA SAP the time necessary to consider and review the written 
comments. FIFRA SAP may not be able to fully consider written comments 
submitted after October 19, 2018.
    2. Oral comments. To be included on the meeting agenda, the Agency 
encourages each individual or group wishing to make brief oral comments 
to FIFRA SAP during the in-person or virtual meetings to submit their 
request to the DFO listed under FOR FURTHER INFORMATION CONTACT on or 
before November 9, 2018. To the extent that time permits, the Chair of 
the FIFRA SAP may permit the presentation of oral comments at the 
meeting by interested persons who have not previously requested time. 
Oral comments during the virtual meeting are limited to approximately 5 
minutes due to the time constraints of this webcast. Oral comments 
during the 4-day, in-person meeting are limited to approximately 5 
minutes unless arrangements have been made prior to November 9, 2018. 
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. In addition, each 
speaker should bring 15 copies of his or her oral remarks and 
presentation slides (if required) for distribution to the FIFRA SAP at 
the meeting by the DFO.
    3. Seating at the meeting. Seating at the in-person meeting will be 
open and on a first-come basis.
    4. Request for nominations to serve as ad hoc expert 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: (i) Development and implementation of new 
approach methodologies (NAMs); (ii) inhalation alternative testing; 
(iii) inhalation toxicology; (iv) inhalation exposure assessment; (v) 
inhalation/computational fluid dynamic (CFD) modeling; and (vi) risk 
assessment. Nominees should be scientists who have sufficient 
professional qualifications, including training and experience, to 
provide 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

[[Page 39089]]

DFO listed under FOR FURTHER INFORMATION CONTACT on or before September 
7, 2018. 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 review, absence of any conflicts of 
interest or appearance of loss of impartiality, independence with 
respect to the matters under review, and lack of bias. Although 
financial conflicts of interest, the appearance of loss 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 peer review charge for this meeting, the Agency 
anticipates selecting approximately 13 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 candidate's 
financial disclosure form to assess whether there are financial 
conflicts of interest, appearance of a loss 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 and final 
report. The list of FIFRA SAP members participating at this meeting 
will be posted on the FIFRA SAP website 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

    The FIFRA SAP serves as one of the primary scientific peer review 
mechanisms of EPA's Office of Chemical Safety and Pollution Prevention 
(OCSPP) and is structured to provide independent scientific advice, 
information and recommendations to the EPA Administrator on pesticides 
and pesticide-related issues as to the impact of regulatory actions on 
human 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). The 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 (NIH) and the National 
Science Foundation (NSF). 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

    EPA conducts human health risk assessments to evaluate the 
potential health effects of pesticides and toxic chemicals in 
residential and occupational settings based on the use pattern or 
conditions of use. For evaluating effects via the inhalation route, 
registrants and manufacturers conduct subchronic inhalation toxicity 
studies according to test guideline requirements (OPPTS 870.3465, 40 
CFR part 798, OECD TG 412 and 413). In these studies, several groups of 
experimental animals are exposed daily for a defined period to 
graduated concentrations of test substance as a gas or aerosol/
particulate. These studies are used to determine a no observed adverse 
effect concentration (NOAEC) for effects following repeated inhalation 
exposure that may be used for human health risk assessment.
    The anatomy and physiology of human and animal respiratory tracts 
differ in several ways that can impact changes in airflow and 
deposition of inhaled substances and, therefore, influence the animal 
to human dose response extrapolation. Furthermore, traditional in vivo 
toxicity tests used to extrapolate from test species to humans are 
expensive, time-consuming, and can cause stress to laboratory animals. 
As a result, efforts to develop alternative methods and strategies for 
evaluating toxic effects from inhaled chemicals using in vitro test 
systems with human tissues combined with human dosimetry modeling 
provide inherent advantages over using in vivo animal studies. These 
alternatives are also consistent with the National Research Council's 
(NRC) long-range vision to advance toxicity testing in the 21st 
century, as well as the strategic roadmap released by Interagency 
Coordinating Committee on the Validation of Alternative Methods 
(ICCVAM) to accomplish NRC's vision in the United States.
    New approach methodologies (NAMs) has been adopted as a broadly 
descriptive reference to any non-animal technology, methodology, 
approach, or combination thereof that can be used to provide 
information on chemical hazard and risk assessment. An example of a NAM 
for refining inhalation risk assessment has been submitted to the 
Agency for the pesticide chlorothalonil. Chlorothalonil is a contact 
irritant that has been found to be toxic via the inhalation route. Due 
to the irritant nature of chlorothalonil and animal welfare concerns, 
the registrant (Syngenta Crop Protection) indicated that a 90-day 
inhalation toxicity study was not feasible to fulfill the regulatory 
requirement of a subchronic inhalation study. Subsequently, Syngenta 
proposed an alternative approach using an in vitro assay 
(MucilAir<SUP>TM</SUP> using human nasal tissue) to characterize the 
hazard of chlorothalonil and derive a point of departure (POD) for use 
in human health risk assessment. In order to calculate human equivalent 
concentrations for the purposes of human health risk assessment, an in

[[Page 39090]]

vitro POD has been proposed in conjunction with surface concentrations 
of deposited chlorothalonil particles from a computational fluid 
dynamic (CFD) model for the upper airway of a human. As a proof of 
concept, Syngenta also used the calculated human equivalent 
concentrations for pesticide operators/applicators to provide potential 
risk estimates supported by this proposed approach.
    The Agency is soliciting advice from the FIFRA Scientific Advisory 
Panel (SAP) on the derivation of the POD from the in vitro assay and 
the integration of the in vitro POD for calculation of human equivalent 
concentrations for the inhalation risk assessment. Chlorothalonil will 
be presented as a case study to solicit advice on the proposed overall 
approach expected to be applied to other pesticides or industrial 
chemicals in the future.
    The 4-day, in-person FIFRA SAP meeting may also be webcast. You may 
refer to the FIFRA SAP website at http://www.epa.gov/sap for 
information on how to access the webcast. Please note that the webcast 
for the in-person meeting is a supplementary public process provided 
only for convenience. If difficulties arise resulting in webcasting 
outages, the in-person meeting will continue as planned.

C. Virtual Preparatory Meeting

    Preceding the in-person meeting, there will be a half-day virtual 
preparatory meeting, conducted via webinar using Adobe Connect, to 
consider and review the clarity and scope of the meeting's draft charge 
questions. The virtual preparatory meeting will be webcast only, and 
registration is required to attend this virtual meeting. The date and 
registration instructions will be announced in a future Federal 
Register Notice and on the FIFRA SAP website (http://www.epa.gov/sap) 
by mid-September.

D. FIFRA SAP Documents and Meeting Minutes

    EPA's background paper, charge/questions to FIFRA SAP, and related 
supporting materials will be available by early September 2018. In 
addition, a list of candidates under consideration as prospective ad 
hoc panelists for this meeting will be available for a 15-day public 
comment period by early to mid-September 2018. You may obtain 
electronic copies of most meeting documents, including FIFRA SAP 
composition (i.e., members and ad hoc members for this meeting) and the 
meeting agenda, at http://www.regulations.gov and the FIFRA SAP website 
at http://www.epa.gov/scipoly/sap.
    FIFRA SAP will prepare the meeting minutes and final report 
approximately 90 calendar days after the in-person meeting. The meeting 
minutes and final report will be posted on the FIFRA SAP website: 
https://www.epa.gov/sap and may be accessed in the docket at https://www.regulations.gov.

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

    Dated: July 12, 2018.
Stanley Barone, Jr.,
Acting Director, Office of Science Coordination and Policy.
[FR Doc. 2018-16990 Filed 8-7-18; 8:45 am]
 BILLING CODE 6560-50-P


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