[Federal Register Volume 81, Number 143 (Tuesday, July 26, 2016)]
[Notices]
[Pages 48794-48796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17707]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2016-0385; FRL-9949-22]
Federal Insecticide, Fungicide, and Rodenticide Act Scientific
Scientific Advisory Panel; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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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 a set of scientific issues being evaluated by the
Environmental Protection Agency (EPA) regarding EPA's evaluation of the
carcinogenic potential of glyphosate, a non-selective, phosphonomethyl
amino acid herbicide registered to control weeds in various
agricultural and non-agricultural settings.
DATES: The meeting will be held on October 18-21, 2016, from
approximately 9 a.m. to 5 p.m.
Comments. The Agency encourages written comments be submitted on or
before October 4, 2016, to provide adequate time for the FIFRA SAP to
review and consider the comments. The Agency encourages requests for
oral comments be submitted on or before October 11, 2016. However,
written comments and requests to make oral comments may be submitted
until the date of the meeting, but anyone submitting written comments
after October 4, 2016, 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 August
25, 2016.
Webcast. This meeting may be webcast. Please refer to the FIFRA SAP
Web site at http://www.epa.gov/sap for information on how to access the
meeting 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-2016-0385, 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: Steven Knott, DFO, Office of Science
Coordination and Policy (7201M), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-0103; 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
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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.
1. Written comments. To ensure proper receipt by EPA, it is
imperative that you identify docket ID number EPA-HQ-OPP-2016-0385 in
the subject line on the first page of your request. The Agency
encourages written comments be submitted, using the instructions in
ADDRESSES and Unit I.B., on or before October 4, 2016, 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 October 4, 2016, should contact the
DFO listed under FOR FURTHER INFORMATION CONTACT. Anyone submitting
written comments at the meeting should bring 15 copies for distribution
to FIFRA SAP by the DFO.
2. Oral comments. The Agency encourages each individual or group
wishing to make brief oral comments to FIFRA SAP to submit their
request to the DFO listed under FOR FURTHER INFORMATION CONTACT on or
before October 11, 2016, 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 before FIFRA SAP
are limited to approximately 5 minutes unless prior arrangements have
been made. In addition, each speaker should bring 15 copies of his or
her comments and presentation for distribution to FIFRA SAP at the
meeting by the DFO.
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: Carcinogenicity (mammalian), cancer biostatistics, rodent cancer
bioassays, epidemiology (cancer/occupational), genotoxicity/genetic
toxicology/mutagenicity (related to human cancer risk), risk
assessment, weight of evidence analysis, and mode of action/human
relevance/adverse outcome pathway frameworks. 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 DFO listed under FOR FURTHER
INFORMATION CONTACT on or before August 25, 2016. 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 the 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. The Agency anticipates selecting
approximately eight ad hoc scientists to have the collective breadth of
experience needed to address the Agency's charge for this meeting.
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
candidates' employment, stocks, bonds, and where applicable, sources of
research support. EPA will evaluate the candidates' financial
disclosure forms 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 the 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/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
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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 the FIFRA SAP are scientists who
have sufficient professional qualifications, including training and
experience, to provide expert advice and recommendations to the Agency.
B. Public Meeting
Glyphosate is a non-selective, phosphonomethyl amino acid herbicide
registered to control weeds in various agricultural and non-
agricultural settings. Labeled uses of glyphosate include over 100
terrestrial food crops as well as other non-agricultural sites, such as
greenhouses, aquatic areas, and residential areas. Use of glyphosate in
the United States and globally has increased overtime, particularly
with the introduction of glyphosate-resistant crops; however, usage has
stabilized in recent years due to the increased number of weed species
becoming resistant to glyphosate. Glyphosate is currently undergoing
Registration Review, which is a program where all registered pesticides
are reviewed at least every 15 years as mandated by the Federal
Insecticide, Fungicide, and Rodenticide Act.
Recently, several international agencies have evaluated the
carcinogenic potential of glyphosate. In March 2015, the International
Agency for Research on Cancer (IARC), a subdivision of the World Health
Organization (WHO), determined that glyphosate was a probable
carcinogen (group 2A). Later, in November 2015, the European Food
Safety Authority (EFSA) determined that glyphosate was unlikely to pose
a carcinogenic hazard to humans. In May 2016, the Joint Food and
Agriculture Organization (FAO)/WHO Meeting on Pesticide Residues
(JMPR), another subdivision of the WHO, concluded that glyphosate was
unlikely to pose a carcinogenic risk to humans from exposure through
the diet.
Recently, EPA collected and analyzed a substantial amount of data
informing the carcinogenic potential of glyphosate and utilized its
draft ``Framework for Incorporating Human Epidemiological & Incident
Data in Health Risk Assessment'' to assess the potential carcinogenic
hazard. The draft framework provides the foundation for evaluating
multiple lines of scientific evidence and includes two key components:
Problem formulation and use of the mode of action/adverse outcome
pathway (MOA/AOP) frameworks. A comprehensive analysis of data on
glyphosate from submitted guideline studies and the open literature was
performed. This includes epidemiological, animal carcinogenicity,
genotoxicity, metabolism, and mechanistic studies. Guideline studies
were collected for consideration from the toxicological databases for
glyphosate and glyphosate salts. A fit-for-purpose systematic review
was executed to obtain relevant and appropriate open literature studies
with the potential to inform the human carcinogenic potential of
glyphosate. Furthermore, the list of studies obtained from the
toxicological databases and systematic review was cross-referenced with
recent internal reviews, review articles from the open literature, and
international agency evaluations (i.e., IARC, EFSA, JMPR).
Available data from epidemiological, animal carcinogenicity, and
genotoxicity studies were reviewed and evaluated for study quality and
results to inform the human carcinogenic potential of glyphosate.
Additionally, as described in the draft ``Framework for Incorporating
Human Epidemiological & Incident Data in Health Risk Assessment,'' the
multiple lines of evidence were integrated in a weight-of-evidence
analysis using the modified Bradford Hill Criteria considering
concepts, such as strength, consistency, dose response, temporal
concordance, and biological plausibility. The agency will solicit
advice from the SAP on the evaluation and interpretation of the
available data for each line of evidence and the weight-of-evidence
analysis, as well as how the available data inform cancer
classification descriptors according to the agency's 2005 Guidelines
for Carcinogen Risk Assessment.
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 mid-September. 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/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 to 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: July 19, 2016.
Stanley Barone,
Acting Director, Office of Science Coordination and Policy.
[FR Doc. 2016-17707 Filed 7-25-16; 8:45 am]
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