81_FR_48937 81 FR 48794 - Federal Insecticide, Fungicide, and Rodenticide Act Scientific Scientific Advisory Panel; Notice of Public Meeting

81 FR 48794 - Federal Insecticide, Fungicide, and Rodenticide Act Scientific Scientific Advisory Panel; Notice of Public Meeting

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 143 (July 26, 2016)

Page Range48794-48796
FR Document2016-17707

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.

Federal Register, Volume 81 Issue 143 (Tuesday, July 26, 2016)
[Federal Register Volume 81, Number 143 (Tuesday, July 26, 2016)]
[Notices]
[Pages 48794-48796]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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: knott.steven@epa.gov.

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



                                                48794                           Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices

                                                II. What action is the Agency taking?                      Dated: July 1, 2016.                                If difficulties arise resulting in
                                                                                                         Robert McNally,                                       webcasting outages, the meeting will
                                                   Under section 5 of the Federal
                                                                                                         Director, Biopesticides and Pollution                 continue as planned.
                                                Insecticide, Fungicide and Rodenticide                                                                            Special accommodations. For
                                                                                                         Prevention Division, Office of Pesticide
                                                Act (FIFRA), 7 U.S.C. 136c, EPA can                      Programs.                                             information on access or services for
                                                allow manufacturers to field test                                                                              individuals with disabilities, and to
                                                                                                         [FR Doc. 2016–17533 Filed 7–25–16; 8:45 am]
                                                pesticides under development.                                                                                  request accommodation of a disability,
                                                                                                         BILLING CODE 6560–50–P
                                                Manufacturers are required to obtain an                                                                        please contact the DFO listed under FOR
                                                EUP before testing new pesticides or                                                                           FURTHER INFORMATION CONTACT at least
                                                new uses of pesticides if they conduct                   ENVIRONMENTAL PROTECTION                              10 days prior to the meeting to give EPA
                                                experimental field tests on more than 10                 AGENCY                                                as much time as possible to process
                                                acres of land or more than one acre of                                                                         your request.
                                                water.                                                   [EPA–HQ–OPP–2016–0385; FRL–9949–22]
                                                                                                                                                               ADDRESSES: Meeting: The meeting will
                                                   Pursuant to 40 CFR 172.11(a), the
                                                                                                         Federal Insecticide, Fungicide, and                   be held at the Environmental Protection
                                                Agency has determined that the
                                                                                                         Rodenticide Act Scientific Scientific                 Agency, Conference Center, Lobby
                                                following EUP application may be of
                                                                                                         Advisory Panel; Notice of Public                      Level, One Potomac Yard (South Bldg.),
                                                regional or national significance, and
                                                                                                         Meeting                                               2777 S. Crystal Dr., Arlington, VA
                                                therefore is seeking public comment on
                                                                                                                                                               22202.
                                                the EUP application:                                     AGENCY: Environmental Protection                         Comments. Submit your comments,
                                                   Submitter: Monsanto Company, 800                      Agency (EPA).                                         identified by docket identification (ID)
                                                N. Lindbergh Blvd., St. Louis, MO                        ACTION: Notice.                                       number EPA–HQ–OPP–2016–0385, by
                                                63137, (524–EUP–RNI).                                                                                          one of the following methods:
                                                   Pesticide Chemical: Bacillus                          SUMMARY:   There will be a 4-day meeting                 • Federal eRulemaking Portal: http://
                                                thuringiensis mCry51Aa2 protein and                      of the Federal Insecticide, Fungicide,                www.regulations.gov. Follow the online
                                                the genetic material necessary for its                   and Rodenticide Act Scientific Advisory               instructions for submitting comments.
                                                production (vector PV–GHIR508523) in                     Panel (FIFRA SAP) to consider and                     Do not submit electronically any
                                                MON 88702 cotton (OECD Unique                            review a set of scientific issues being               information you consider to be
                                                Identifier: MON–887;2–4).                                evaluated by the Environmental                        Confidential Business Information (CBI)
                                                   Summary of Request: Monsanto                          Protection Agency (EPA) regarding                     or other information whose disclosure is
                                                Company is proposing to test MON                         EPA’s evaluation of the carcinogenic                  restricted by statute.
                                                88702, a new plant-incorporated                          potential of glyphosate, a non-selective,                • Mail: OPP Docket, Environmental
                                                protectant (PIP) technology in cotton,                   phosphonomethyl amino acid herbicide                  Protection Agency Docket Center (EPA/
                                                alone and in combination with other                      registered to control weeds in various                DC), (28221T), 1200 Pennsylvania Ave.
                                                registered PIPs in cotton to generate data               agricultural and non-agricultural                     NW., Washington, DC 20460–0001.
                                                and information that is intended to                      settings.                                                • Hand Delivery: To make special
                                                support future PIP registration                                                                                arrangements for hand delivery or
                                                                                                         DATES:  The meeting will be held on
                                                applications (e.g., PIPs with multiple                                                                         delivery of boxed information, please
                                                                                                         October 18–21, 2016, from
                                                modes of action against hemipteran,                                                                            follow the instructions at http://
                                                                                                         approximately 9 a.m. to 5 p.m.
                                                thysanopteran and/or lepidopteran                                                                              www.epa.gov/dockets/contacts.html.
                                                                                                           Comments. The Agency encourages
                                                cotton pests). Monsanto Company’s                                                                                 Additional instructions on
                                                                                                         written comments be submitted on or
                                                proposed experimental program would                                                                            commenting or visiting the docket,
                                                                                                         before October 4, 2016, to provide
                                                begin on March 1, 2017, and continue                                                                           along with more information about
                                                                                                         adequate time for the FIFRA SAP to
                                                until February 28, 2019; would take                                                                            dockets generally, is available at http://
                                                                                                         review and consider the comments. The
                                                place on 2,510 acres in Alabama,                                                                               www.epa.gov/dockets.
                                                                                                         Agency encourages requests for oral                      Nominations, requests to present oral
                                                Arizona, Arkansas, California, Florida,                  comments be submitted on or before
                                                Georgia, Louisiana, Mississippi,                                                                               comments, and requests for special
                                                                                                         October 11, 2016. However, written                    accommodations. Submit nominations
                                                Missouri, New Mexico, North Carolina,                    comments and requests to make oral
                                                Oklahoma, South Carolina, Tennessee,                                                                           to serve as ad hoc members of FIFRA
                                                                                                         comments may be submitted until the                   SAP, requests for special
                                                Texas, Virginia and Puerto Rico; and                     date of the meeting, but anyone
                                                would use 8,495.3 grams of active                                                                              accommodations, or requests to present
                                                                                                         submitting written comments after                     oral comments to the DFO listed under
                                                ingredient. Trial protocols will                         October 4, 2016, should contact the
                                                concentrate on seed development and                                                                            FOR FURTHER INFORMATION CONTACT.
                                                                                                         Designated Federal Official (DFO) listed
                                                increase for future testing, nursery                                                                           FOR FURTHER INFORMATION CONTACT:
                                                                                                         under FOR FURTHER INFORMATION
                                                observations of traits in various genetic                                                                      Steven Knott, DFO, Office of Science
                                                                                                         CONTACT. For additional instructions,
                                                backgrounds, phenotypic and                                                                                    Coordination and Policy (7201M),
                                                                                                         see Unit I.C. of the SUPPLEMENTARY
                                                agronomic observations, efficacy and                                                                           Environmental Protection Agency, 1200
                                                                                                         INFORMATION.
                                                yield benefits, and product                                                                                    Pennsylvania Ave. NW., Washington,
                                                                                                           Nominations. Nominations of
                                                characterization, performance and                                                                              DC 20460–0001; telephone number:
                                                                                                         candidates to serve as ad hoc members
                                                regulatory studies.                                                                                            (202) 564–0103; email address:
                                                                                                         of FIFRA SAP for this meeting should
                                                   Following the review of the                                                                                 knott.steven@epa.gov.
                                                                                                         be provided on or before August 25,
                                                application and any comments and data                    2016.                                                 SUPPLEMENTARY INFORMATION:
srobinson on DSK5SPTVN1PROD with NOTICES




                                                received in response to this solicitation,                 Webcast. This meeting may be                        I. General Information
                                                EPA will decide whether to issue or                      webcast. Please refer to the FIFRA SAP
                                                deny the EUP request, and if issued, the                 Web site at http://www.epa.gov/sap for                A. Does this action apply to me?
                                                conditions under which it is to be                       information on how to access the                        This action is directed to the public
                                                conducted. Any issuance of an EUP will                   meeting webcast. Please note that the                 in general. This action may, however, be
                                                be announced in the Federal Register.                    webcast is a supplementary public                     of interest to persons who are or may be
                                                   Authority: 7 U.S.C. 136 et seq.                       process provided only for convenience.                required to conduct testing of chemical


                                           VerDate Sep<11>2014   20:28 Jul 25, 2016   Jkt 238001   PO 00000   Frm 00059   Fmt 4703   Sfmt 4703   E:\FR\FM\26JYN1.SGM   26JYN1


                                                                                Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices                                           48795

                                                substances under the Federal Food,                       audiovisual equipment. Oral comments                  to the matters under review, and lack of
                                                Drug, and Cosmetic Act (FFDCA) and                       before FIFRA SAP are limited to                       bias. Although financial conflicts of
                                                FIFRA. Since other entities may also be                  approximately 5 minutes unless prior                  interest, the appearance of lack of
                                                interested, the Agency has not                           arrangements have been made. In                       impartiality, lack of independence, and
                                                attempted to describe all the specific                   addition, each speaker should bring 15                bias may result in disqualification, the
                                                entities that may be affected by this                    copies of his or her comments and                     absence of such concerns does not
                                                action.                                                  presentation for distribution to FIFRA                assure that a candidate will be selected
                                                                                                         SAP at the meeting by the DFO.                        to serve on the FIFRA SAP. Numerous
                                                B. What should I consider as I prepare                      3. Seating at the meeting. Seating at
                                                my comments for EPA?                                                                                           qualified candidates are identified for
                                                                                                         the meeting will be open and on a first-              each Panel. Therefore, selection
                                                  1. Submitting CBI. Do not submit CBI                   come basis.                                           decisions involve carefully weighing a
                                                information to EPA through                                  4. Request for nominations to serve as             number of factors including the
                                                regulations.gov or email. If your                        ad hoc members of FIFRA SAP for this                  candidates’ areas of expertise and
                                                comments contain any information that                    meeting. As part of a broader process for             professional qualifications and
                                                you consider to be CBI or otherwise                      developing a pool of candidates for each              achieving an overall balance of different
                                                protected, please contact the DFO listed                 meeting, FIFRA SAP staff routinely                    scientific perspectives on the Panel. The
                                                under FOR FURTHER INFORMATION                            solicits the stakeholder community for                Agency anticipates selecting
                                                CONTACT to obtain special instructions                   nominations of prospective candidates                 approximately eight ad hoc scientists to
                                                before submitting your comments.                         for service as ad hoc members of FIFRA                have the collective breadth of
                                                  2. Tips for preparing your comments.                   SAP. Any interested person or                         experience needed to address the
                                                When preparing and submitting your                       organization may nominate qualified                   Agency’s charge for this meeting.
                                                comments, see the commenting tips at                     individuals to be considered as                          FIFRA SAP members are subject to
                                                http://www.epa.gov/dockets/                              prospective candidates for a specific                 the provisions of 5 CFR part 2634—
                                                comments.html.                                           meeting. Individuals nominated for this               Executive Branch Financial Disclosure,
                                                C. How may I participate in this                         meeting should have expertise in one or               Qualified Trusts, and Certificates of
                                                meeting?                                                 more of the following areas:                          Divestiture, as supplemented by EPA in
                                                                                                         Carcinogenicity (mammalian), cancer                   5 CFR part 6401. In anticipation of this
                                                   You may participate in this meeting                   biostatistics, rodent cancer bioassays,
                                                by following the instructions in this                                                                          requirement, prospective candidates for
                                                                                                         epidemiology (cancer/occupational),                   service on FIFRA SAP will be asked to
                                                unit.                                                    genotoxicity/genetic toxicology/
                                                   1. Written comments. To ensure                                                                              submit confidential financial
                                                                                                         mutagenicity (related to human cancer                 information which shall fully disclose,
                                                proper receipt by EPA, it is imperative                  risk), risk assessment, weight of
                                                that you identify docket ID number                                                                             among other financial interests, the
                                                                                                         evidence analysis, and mode of action/                candidates’ employment, stocks, bonds,
                                                EPA–HQ–OPP–2016–0385 in the subject                      human relevance/adverse outcome
                                                line on the first page of your request.                                                                        and where applicable, sources of
                                                                                                         pathway frameworks. Nominees should                   research support. EPA will evaluate the
                                                The Agency encourages written                            be scientists who have sufficient
                                                comments be submitted, using the                                                                               candidates’ financial disclosure forms to
                                                                                                         professional qualifications, including                assess whether there are financial
                                                instructions in ADDRESSES and Unit I.B.,                 training and experience, to provide
                                                on or before October 4, 2016, to provide                                                                       conflicts of interest, appearance of a
                                                                                                         expert comments on the scientific issues              lack of impartiality, or any prior
                                                FIFRA SAP the time necessary to                          for this meeting. Nominees should be
                                                consider and review the written                                                                                involvement with the development of
                                                                                                         identified by name, occupation,
                                                comments. Written comments are                                                                                 the documents under consideration
                                                                                                         position, address, email address, and
                                                accepted until the date of the meeting,                                                                        (including previous scientific peer
                                                                                                         telephone number. Nominations should
                                                but anyone submitting written                                                                                  review) before the candidate is
                                                                                                         be provided to the DFO listed under FOR
                                                comments after October 4, 2016, should                                                                         considered further for service on the
                                                                                                         FURTHER INFORMATION CONTACT on or
                                                contact the DFO listed under FOR                                                                               FIFRA SAP. Those who are selected
                                                                                                         before August 25, 2016. The Agency
                                                FURTHER INFORMATION CONTACT. Anyone                                                                            from the pool of prospective candidates
                                                                                                         will consider all nominations of
                                                submitting written comments at the                                                                             will be asked to attend the public
                                                                                                         prospective candidates for this meeting
                                                meeting should bring 15 copies for                                                                             meetings and to participate in the
                                                                                                         that are received on or before that date.
                                                distribution to FIFRA SAP by the DFO.                                                                          discussion of key issues and
                                                                                                         However, final selection of ad hoc
                                                   2. Oral comments. The Agency                          members for this meeting is a                         assumptions at these meetings. In
                                                encourages each individual or group                      discretionary function of the Agency.                 addition, they will be asked to review
                                                wishing to make brief oral comments to                      The selection of scientists to serve on            and to help finalize the meeting
                                                FIFRA SAP to submit their request to                     FIFRA SAP is based on the function of                 minutes. The list of FIFRA SAP
                                                the DFO listed under FOR FURTHER                         the Panel and the expertise needed to                 members participating at this meeting
                                                INFORMATION CONTACT on or before                         address the Agency’s charge to the                    will be posted on the FIFRA SAP Web
                                                October 11, 2016, in order to be                         Panel. No interested scientists shall be              site at http://www.epa.gov/sap or may
                                                included on the meeting agenda.                          ineligible to serve by reason of their                be obtained from the OPP Docket at
                                                Requests to present oral comments will                   membership on any other advisory                      http://www.regulations.gov.
                                                be accepted until the date of the meeting                committee to a federal department or                  II. Background
                                                and, to the extent that time permits, the                agency, or their employment by a
                                                Chair of FIFRA SAP may permit the                        federal department or agency except                   A. Purpose of FIFRA SAP
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                                                presentation of oral comments at the                     EPA. Other factors considered during                     FIFRA SAP serves as the primary
                                                meeting by interested persons who have                   the selection process include                         scientific peer review mechanism of
                                                not previously requested time. The                       availability of the potential Panel                   EPA’s Office of Chemical Safety and
                                                request should identify the name of the                  member to fully participate in the                    Pollution Prevention (OCSPP) and is
                                                individual making the presentation, the                  Panel’s reviews, absence of any conflicts             structured to provide scientific advice,
                                                organization (if any) the individual will                of interest or appearance of lack of                  information and recommendations to
                                                represent, and any requirements for                      impartiality, independence with respect               the EPA Administrator on pesticides


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                                                48796                           Federal Register / Vol. 81, No. 143 / Tuesday, July 26, 2016 / Notices

                                                and pesticide-related issues as to the                   WHO, concluded that glyphosate was                    to FIFRA SAP, FIFRA SAP composition
                                                impact of regulatory actions on health                   unlikely to pose a carcinogenic risk to               (i.e., members and ad hoc members for
                                                and the environment. FIFRA SAP is a                      humans from exposure through the diet.                this meeting), and the meeting agenda
                                                federal advisory committee established                      Recently, EPA collected and analyzed               will be available by approximately mid-
                                                in 1975 under FIFRA that operates in                     a substantial amount of data informing                September. In addition, the Agency may
                                                accordance with requirements of the                      the carcinogenic potential of glyphosate              provide additional background
                                                Federal Advisory Committee Act (5                        and utilized its draft ‘‘Framework for                documents as the materials become
                                                U.S.C. Appendix). FIFRA SAP is                           Incorporating Human Epidemiological &                 available. You may obtain electronic
                                                composed of a permanent panel                            Incident Data in Health Risk                          copies of these documents, and certain
                                                consisting of seven members who are                      Assessment’’ to assess the potential                  other related documents that might be
                                                appointed by the EPA Administrator                       carcinogenic hazard. The draft                        available at http://www.regulations.gov
                                                from nominees provided by the National                   framework provides the foundation for                 and the FIFRA SAP Web site at http://
                                                Institutes of Health and the National                    evaluating multiple lines of scientific               www.epa.gov/sap.
                                                Science Foundation. FIFRA established                    evidence and includes two key                            FIFRA SAP will prepare meeting
                                                a Science Review Board (SRB)                             components: Problem formulation and                   minutes summarizing its
                                                consisting of at least 60 scientists who                 use of the mode of action/adverse                     recommendations to the Agency
                                                are available to FIFRA SAP on an ad hoc                  outcome pathway (MOA/AOP)                             approximately 90 days after the
                                                basis to assist in reviews conducted by                  frameworks. A comprehensive analysis                  meeting. The meeting minutes will be
                                                FIFRA SAP. As a scientific peer review                   of data on glyphosate from submitted                  posted to the FIFRA SAP Web site or
                                                mechanism, FIFRA SAP provides                            guideline studies and the open literature             may be obtained from the OPP Docket
                                                comments, evaluations, and                               was performed. This includes                          at http://www.regulations.gov.
                                                recommendations to improve the                           epidemiological, animal
                                                                                                                                                                 Authority: 7 U.S.C. 136 et seq.; 21 U.S.C.
                                                effectiveness and quality of analyses                    carcinogenicity, genotoxicity,
                                                                                                                                                               301 et seq.
                                                made by Agency scientists. Members of                    metabolism, and mechanistic studies.
                                                the FIFRA SAP are scientists who have                    Guideline studies were collected for                    Dated: July 19, 2016.
                                                sufficient professional qualifications,                  consideration from the toxicological                  Stanley Barone,
                                                including training and experience, to                    databases for glyphosate and glyphosate               Acting Director, Office of Science
                                                provide expert advice and                                salts. A fit-for-purpose systematic                   Coordination and Policy.
                                                recommendations to the Agency.                           review was executed to obtain relevant                [FR Doc. 2016–17707 Filed 7–25–16; 8:45 am]
                                                                                                         and appropriate open literature studies               BILLING CODE 6560–50–P
                                                B. Public Meeting                                        with the potential to inform the human
                                                  Glyphosate is a non-selective,                         carcinogenic potential of glyphosate.
                                                phosphonomethyl amino acid herbicide                     Furthermore, the list of studies obtained             FEDERAL COMMUNICATIONS
                                                registered to control weeds in various                   from the toxicological databases and                  COMMISSION
                                                agricultural and non-agricultural                        systematic review was cross-referenced
                                                settings. Labeled uses of glyphosate                     with recent internal reviews, review                  Radio Broadcasting Services; AM or
                                                include over 100 terrestrial food crops                  articles from the open literature, and                FM Proposals To Change the
                                                as well as other non-agricultural sites,                 international agency evaluations (i.e.,               Community of License
                                                such as greenhouses, aquatic areas, and                  IARC, EFSA, JMPR).
                                                residential areas. Use of glyphosate in                     Available data from epidemiological,               AGENCY: Federal Communications
                                                the United States and globally has                       animal carcinogenicity, and                           Commission.
                                                increased overtime, particularly with                    genotoxicity studies were reviewed and                ACTION: Notice.
                                                the introduction of glyphosate-resistant                 evaluated for study quality and results
                                                crops; however, usage has stabilized in                  to inform the human carcinogenic                      SUMMARY:   The following applicants filed
                                                recent years due to the increased                        potential of glyphosate. Additionally, as             AM or FM proposals to change the
                                                number of weed species becoming                          described in the draft ‘‘Framework for                community of License: Agape
                                                resistant to glyphosate. Glyphosate is                   Incorporating Human Epidemiological &                 Educational Media, Inc., Station
                                                currently undergoing Registration                        Incident Data in Health Risk                          WOWB, Facility ID 40428, BPED–
                                                Review, which is a program where all                     Assessment,’’ the multiple lines of                   20160329AER, from Brewton, AL, to
                                                registered pesticides are reviewed at                    evidence were integrated in a weight-of-              Jay; Capstar, TX, LLC, Station WKZP,
                                                least every 15 years as mandated by the                  evidence analysis using the modified                  Facility ID 4674, BPH–20160606AAG,
                                                Federal Insecticide, Fungicide, and                      Bradford Hill Criteria considering                    from Bethany Beach, DE, to West Ocean
                                                Rodenticide Act.                                         concepts, such as strength, consistency,              City; Citicasters Licenses, Inc., Station
                                                  Recently, several international                        dose response, temporal concordance,                  WRDG, Facility ID 61142, BPH–
                                                agencies have evaluated the                              and biological plausibility. The agency               20160513AEF, from Peachtree City, GA,
                                                carcinogenic potential of glyphosate. In                 will solicit advice from the SAP on the               to Union City; Jeff Andrulonis, Station
                                                March 2015, the International Agency                     evaluation and interpretation of the                  WEAF, Facility ID 24146, BP–
                                                for Research on Cancer (IARC), a                         available data for each line of evidence              20160426AAV, from Camden, SC, to
                                                subdivision of the World Health                          and the weight-of-evidence analysis, as               Saint Stephen; Max Radio Of Denver
                                                Organization (WHO), determined that                      well as how the available data inform                 LLC, Station KJHM, Facility ID 38629,
                                                glyphosate was a probable carcinogen                     cancer classification descriptors                     BPH–20160614AAD, from Strasburg,
                                                (group 2A). Later, in November 2015,                                                                           CO, to Watkins; Minerva R. Lopez,
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                                                                                                         according to the agency’s 2005
                                                the European Food Safety Authority                       Guidelines for Carcinogen Risk                        Station KOUL, Facility ID 28074, BPH–
                                                (EFSA) determined that glyphosate was                    Assessment.                                           20160216ABP, from Benavides, TX, to
                                                unlikely to pose a carcinogenic hazard                                                                         Agua Dulce, TX; Radio Partners, LLC,
                                                to humans. In May 2016, the Joint Food                   C. FIFRA SAP Documents and Meeting                    Station WKNB, Facility ID 34929, BPH–
                                                and Agriculture Organization (FAO)/                      Minutes                                               20160429ABC, from Clarendon, PA, to
                                                WHO Meeting on Pesticide Residues                          EPA’s background paper, related                     Sheffield; Radio Partners, LLC, Station
                                                (JMPR), another subdivision of the                       supporting materials, charge/questions                WLSF, Facility ID 190374, BPH–


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Document Created: 2018-02-08 08:01:08
Document Modified: 2018-02-08 08:01:08
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThe meeting will be held on October 18-21, 2016, from approximately 9 a.m. to 5 p.m.
ContactSteven Knott, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
FR Citation81 FR 48794 

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