[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

[[Page 48795]]

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

[[Page 48796]]

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]
 BILLING CODE 6560-50-P