[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Notices]
[Pages 36580-36583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13010]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2020-0263; FRL-10009-83]


FIFRA Scientific Advisory Panel; Notice of Public Meetings and 
Request for Nominations of Ad Hoc Expert Reviewers

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: There will be a 4-day public peer review meeting of the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific 
Advisory Panel (SAP) to consider and review the use of new approach 
methodologies (NAMs) to derive extrapolation factors and evaluate 
developmental neurotoxicity for human health risk assessment. Preceding 
the public peer review meeting, there will be a public preparatory 
virtual meeting, conducted via teleconference and webcast, to consider 
the scope and clarity of the draft charge questions for this peer 
review. In addition, EPA is requesting nominations of prospective 
candidates for service as ad hoc reviewers to assist the FIFRA SAP with 
this review. Any interested person or organization may nominate 
qualified individuals to be considered as prospective candidates for 
this review by following the instructions provided in this notice.

DATES: 
    Nominations: Submit nominations of candidates to serve as ad hoc 
reviewers on or before July 2, 2020.
    Preparatory Virtual Meeting: The preparatory virtual meeting will 
be held on August 25, 2020, from 1:00 p.m. to approximately 4:00 p.m. 
(EDT). You must register online on or before August 25, 2020, to 
receive the webcast meeting link and audio teleconference information. 
You must submit your written comments or request time to present oral 
comments for the preparatory virtual meeting on or before noon, August 
21, 2020.
    Peer Review Meeting: The 4-day public peer review meeting will be 
held September 15-18, 2020, from 9:00 a.m. to approximately 5:00 p.m. 
(EDT) (as needed, updated times for each day may be provided in the 
meeting agenda that will be posted in the docket at http://www.regulations.gov and the FIFRA SAP website at http://www.epa.gov/SAP). To make oral comments during the peer review meeting and be 
included on the meeting agenda, please register by noon on September 9, 
2020. Any written comments submitted for the peer review meeting on or 
before September 9, 2020, will be provided to the FIFRA SAP for their 
consideration before the meeting. Comments received after September 9, 
2020, and prior to the oral public comment period during the meeting 
will be available to the FIFRA SAP for their consideration during the 
meeting.
    Special accommodations: Requests for special accommodations should 
be submitted on or before August 25, 2020, to allow EPA time to process 
these requests.

ADDRESSES: 
    Nominations: Submit your nominations of candidates to the 
Designated Federal Official (DFO) listed under FOR FURTHER INFORMATION 
CONTACT.
    Preparatory Virtual Meeting: Registration is required to 
participate during the public preparatory virtual meeting. Please refer 
to the FIFRA SAP website at http://www.epa.gov/sap for information on 
how to register.
    Peer Review Meeting: The location of the 4-day public peer review 
meeting will be announced on the FIFRA SAP website at http://
www.epa.gov/sap. You may also subscribe to the following listserv for 
alerts regarding this and other SAP-related activities: https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101. This peer review meeting may also be 
viewed via webcast. Please refer to the FIFRA SAP website at http://
www.epa.gov/sap for information on how to access the webcast.
    Special accommodations: For information on access or services for 
individuals with disabilities, and to request accommodation for a 
disability, please contact the DFO listed under FOR FURTHER INFORMATION 
CONTACT.

[[Page 36581]]

    Comments: Submit requests to present oral comments to the DFO 
listed under FOR FURTHER INFORMATION CONTACT.
    Submit written comments, identified by docket identification (ID) 
number EPA-HQ-OPP-2020-0263, through the 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.
    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 SUPPLEMENTARY INFORMATION.
    Please note that due to the current COVID-19 public health 
emergency the EPA Docket Center (EPA/DC) and Reading Room were closed 
to public visitors on March 31, 2020. Our EPA/DC staff will continue to 
provide customer service via email, phone, and webform. For further 
information on EPA/DC services, docket contact information and the 
current status of the EPA/DC and Reading Room, please visit https://www.epa.gov/dockets. For questions about this docket, you may also 
contact the DFO listed under FOR FURTHER INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: Tamue Gibson, DFO, Office of Science 
Coordination and Policy (7201M), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(202) 564-7642; 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 
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. Where can I access information about the FIFRA SAP and this meeting?

    Information about the FIFRA SAP and this meeting is available on 
the FIFRA SAP website at http://www.epa.gov/scipoly/sap and in the 
docket for this meeting, identified by docket ID number EPA-HQ-OPP-
2020-0263, at http://www.regulations.gov.

C. 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 Tips for Effective Comments at http://www.epa.gov/dockets/comments.html.

II. Background

A. What is the purpose of the 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. The 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 I). 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 and the National 
Science Foundation (NSF). The FIFRA established a Science Review Board 
consisting of at least 60 scientists who are available to the FIFRA SAP 
on an ad hoc basis to assist in reviews conducted by FIFRA SAP. As a 
scientific peer review mechanism, the FIFRA SAP provides comments, 
evaluations, and recommendations to improve the effectiveness and 
quality of analyses made by Agency scientists. Members of the FIFRA SAP 
are scientists who have sufficient professional qualifications, 
including training and experience, to provide expert advice and 
recommendation to the Agency.

B. What is the purpose of this public meeting?

    In 2007, the National Research Council (NRC)'s report on Toxicity 
Testing in 21st Century: A Vision and a Strategy was published which 
encouraged a new paradigm in toxicity testing that reduces the reliance 
on laboratory animals while moving towards in vitro and in silico 
predictive approaches that are more efficient and human relevant. EPA's 
Office of Pesticide Programs (OPP) has developed a strategic vision for 
implementing the 2007 NRC report that has multiple components involving 
a combination of computational and predictive modeling approaches, in 
vitro techniques, and limited, targeted in vivo testing.
    EPA is actively engaged in numerous activities with respect to 
reducing laboratory animal use and implementing in vitro and 
computational approaches. As NAMs can provide human relevant 
information that may be challenging to obtain with whole animal 
testing. EPA is also interested in using in vitro and computational 
approaches for reducing the reliance on default assumptions for risk 
assessment, including the application of 10X uncertainty factors for 
inter- and intra-species extrapolation.
    In recent years, EPA began collaborative work with academia, and 
industry to use organophosphate pesticides (OPs) as a case study for 
the development of NAMs for purposes of using data to inform 
extrapolation/uncertainty and safety factors in lieu of reliance on 
default factors.
    The Agency is interested in using in vitro data to derive 
extrapolation factors and evaluate developmental neurotoxicity for 
human health risk assessment. Specifically, the Agency is seeking 
advice and recommendation from the FIFRA SAP on scientific issues 
associated with the evaluation and utility of NAMs as part of a weight 
of evidence evaluation of developmental neurotoxicity potential and the 
use of in vitro acetylcholinesterase inhibition data to develop 
interspecies and/or intraspecies data-derived extrapolation factors for 
organophosphate pesticides.

C. How can I access the FIFRA SAP documents and meeting minutes?

    EPA's background paper, the supporting materials, and draft charge/
questions provided to the FIFRA SAP will be available by late-June as 
described in Unit I.B. The Agency will provide additional background 
documents (e.g., the meeting agenda) as the materials become available. 
In addition, the FIFRA SAP will prepare meeting minutes summarizing its 
recommendations to the Agency approximately 90 days after the meeting. 
The meeting minutes will also be made available as described in Unit 
I.B.

[[Page 36582]]

III. Nominations for Ad Hoc Expert Reviewers

A. How do I nominate someone to be considered as an ad hoc expert 
reviewer to assist the FIFRA SAP in this peer review?

    As part of a broader process for developing a pool of candidates 
for each review, FIFRA SAP staff routinely solicits the stakeholder 
community for nominations of prospective candidates for service as ad 
hoc reviewers. Any interested person or organization may nominate 
qualified individuals to be considered as prospective candidates for a 
specific topic. Nominees should be identified by name, occupation, 
position, address, email address, and telephone number. The Agency will 
consider all nominations of prospective candidates for this review that 
are received on or before the deadline identified in the DATES section. 
Final selection of ad hoc reviewers is a discretionary function of the 
Agency.

B. Who can I nominate to be considered as an ad hoc expert reviewer to 
assist the FIFRA SAP in this peer review?

    Individuals nominated for this meeting should have expertise in one 
or more of the following areas: (i) Data derived extrapolation factors; 
(ii) Development and implementation of new approach methodologies; 
(iii) Statistics; (iv) Developmental neurotoxicity; (v) In vitro to in 
vivo extrapolation; and (vi) Organophosphate pesticides. Nominees 
should be scientists who have sufficient professional qualifications, 
including training and experience, to provide expert comments on the 
scientific issues for this review.

C. How will EPA select ad hoc expert reviewers to assist the FIFRA SAP 
in this peer review?

    The selection of scientists to serve on a FIFRA SAP review 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 
reviewer 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 a FIFRA SAP review. Numerous 
qualified candidates are identified for each review; 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 review, the 
Agency anticipates selecting approximately twelve ad hoc scientists.
    FIFRA SAP members and ad hoc reviewers are subject to the 
provisions of the Standards of Ethical Conduct for Employees of the 
Executive Branch at 5 CFR part 2635, conflict of interest statutes in 
Title 18 of the United States Code and related regulations. In 
anticipation of these requirements, 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, 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.
    EPA plans to make a list of candidates under consideration as 
prospective ad hoc panelists for this meeting available for a 15-
calendar day public comment period in July 2020. The list of the FIFRA 
SAP members and ad hoc reviewers participating at this meeting will be 
available as described in Unit I.B.
    Those who are selected from the pool of prospective candidates will 
be asked to attend the preparatory and peer review 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.

IV. Public Participation

A. How may I participate in the public peer review meeting?

    You may participate in the public peer review meeting 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-2020-0263 in the subject line on 
the first page of your request.
    1. Written comments. The Agency encourages written comments for the 
peer review meeting be submitted using the instructions in ADDRESSES 
and Unit I.B. and C, on or before the date set in the DATES section. 
Comments received after this date and prior to the end of the oral 
public comment period during the meeting will still be provided to the 
FIFRA SAP for their consideration. Anyone submitting written comments 
after this date, should contact the DFO listed under FOR FURTHER 
INFORMATION CONTACT. Anyone submitting written comments during the 
meeting should email the DFO prior to the meeting to arrange for 
distribution of their comments to the FIFRA SAP.
    2. Oral comments. The Agency encourages each individual or group 
wishing to make brief oral comments to the FIFRA SAP during the peer 
review meeting to submit their request to the DFO listed under FOR 
FURTHER INFORMATION CONTACT on or before the date set in the DATES 
section in order to be included on the meeting agenda. Requests to 
present oral comments will be accepted until the date of the peer 
review meeting and, to the extent that time permits, the Chair of the 
FIFRA SAP may permit the presentation of oral comments at the peer 
review 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 before 
the FIFRA SAP during the peer review meeting are limited to 5 minutes 
unless arrangements have been made prior to the date set in the DATES 
section. In addition, each speaker should email a copy of his/her 
comments to the DFO prior to the meeting for distribution to the FIFRA 
SAP.
    3. Webcast. This meeting may also be viewed via webcast. Please 
refer to the FIFRA SAP website at http://www.epa.gov/sap for 
information on how to access the webcast.

B. How may I participate in the preparatory virtual meeting?

    Registration for the preparatory virtual meeting is required. To 
participate by listening or making a comment during this meeting, 
please visit: http://www.epa.gov/sap to register. Registration online 
will be confirmed by

[[Page 36583]]

email that will include the webcast meeting link and audio 
teleconference information.
    1. Written comments. Written comments for the preparatory virtual 
meeting should be submitted, using the instructions in ADDRESSES and 
Unit I.B. and C, on or before the date set in the DATES section.
    2. Oral comments. Registration is required to participate in the 
preparatory virtual meeting. Please visit the FIFRA SAP website at 
http://www.epa.gov/sap to register online. Each individual or group 
wishing to make brief oral comments to the FIFRA SAP during the 
preparatory virtual meeting should submit their request when 
registering online or with the DFO listed under FOR FURTHER INFORMATION 
CONTACT on or before the date set in the DATES section. Oral comments 
before the FIFRA SAP during the preparatory virtual meeting are limited 
to approximately 5 minutes due to the time constraints of this meeting.
    3. Webcast. The preparatory meeting will be webcast only. Please 
refer to the FIFRA SAP website at http://www.epa.gov/sap for 
information on how to access the webcast. Registration is required.

    Authority: 5 U.S.C. App. I; 7 U.S.C. 136 et seq.; 21 U.S.C. 301 
et seq.

    Dated: June 8, 2020.
Hayley Hughes,
Director, Office of Science Coordination and Policy.
[FR Doc. 2020-13010 Filed 6-16-20; 8:45 am]
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