81_FR_12144 81 FR 12099 - FIFRA Scientific Advisory Panel; Notice of Public Meeting

81 FR 12099 - FIFRA Scientific Advisory Panel; Notice of Public Meeting

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 45 (March 8, 2016)

Page Range12099-12102
FR Document2016-05174

There will be a 3-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review Chlorpyrifos: Analysis of Biomonitoring Data.

Federal Register, Volume 81 Issue 45 (Tuesday, March 8, 2016)
[Federal Register Volume 81, Number 45 (Tuesday, March 8, 2016)]
[Notices]
[Pages 12099-12102]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-05174]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2016-0062; FRL-9942-63]


FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: There will be a 3-day meeting of the Federal Insecticide, 
Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to 
consider and review Chlorpyrifos: Analysis of Biomonitoring Data.

DATES: The meeting will be held on April 19-21, 2016, from 
approximately 9 a.m. to 5 p.m.
    Comments. The Agency encourages written comments be submitted on or 
before April 5, 2016, and requests for oral comments be submitted on or 
before April 12, 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 April 5, 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 March 23, 
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-2016-0062, 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

[[Page 12100]]

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: Fred Jenkins, DFO, Office of Science 
Coordination and Policy (7201M), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-3327; 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 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. To ensure proper receipt by EPA, it is imperative that 
you identify docket ID number EPA-HQ-OPP-2016-0062 in the subject line 
on the first page of your request.
    1. Written comments. The Agency encourages written comments be 
submitted, using the instructions in ADDRESSES and Unit I.B., on or 
before April 5, 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 April 5, 2016, should contact the DFO listed under FOR FURTHER 
INFORMATION CONTACT. Anyone submitting written comments at the meeting 
should bring 30 copies for distribution to FIFRA SAP.
    2. Oral comments. The Agency encourages each individual or group 
wishing to make brief oral comments to FIFRA SAP submit their request 
to the DFO listed under FOR FURTHER INFORMATION CONTACT on or before 
April 12, 2016, 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 30 copies of his or her comments and presentation 
for distribution to FIFRA SAP at the meeting.
    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: Human biomonitoring data and interpretation of such data; 
epidemiology (particularly reproductive/developmental, and 
environmental), exposure assessment of pesticides (residential and 
agricultural worker); route-specific pharmacokinetics (dermal, oral); 
physiologically-based pharmacokinetic modeling (PBPK); cholinergic and 
non-cholinergic mechanisms; cholinesterase inhibition; developmental 
neurotoxicity; human health risk assessment; organophosphate 
pesticides; and pharmacokinetics. [Note: In support of the U.S. 
Environmental Protection Agency's (EPA) priority of ``Making a Visible 
Difference in Communities'' across the country, the Agency is committed 
to helping minority, low-income, tribal and other vulnerable 
populations improve their health and environment. In an effort to 
ensure that the Agency's proposed actions are taking into consideration 
input from potential communities with environmental justice concerns, 
the EPA is offering an opportunity to provide input on the FIFRA SAP 
meeting to address scientific issues associated with ``Chlorpyrifos: 
Analysis of Biomonitoring Data.'' The EPA encourages all grass-roots 
organizations and residents to submit public comments on this issue 
that is being addressed during the FIFRA Scientific Advisory Panel 
meeting. The Agency also encourages community environmental justice 
advocates to give a voice to their communities by nominating candidates 
for consideration to serve on this panel.] 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 March 23, 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

[[Page 12101]]

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 8 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 
candidate's employment, stocks, and bonds, and where applicable, 
sources of research support. EPA will evaluate the candidates' 
financial disclosure form 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/scipoly/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 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 the 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 recommendation to the Agency.

B. Public Meeting

    Chlorpyrifos (0,0-diethyl-0-3,5,6-trichloro-2-pyridyl 
phosphorothioate) is a broad-spectrum, chlorinated organophosphate (OP) 
insecticide. The FIFRA SAP previously reviewed the human health effects 
of chlorpyrifos in 2008 and 2012, and the chlorpyrifos physiologically-
based pharmacokinetic/pharmacodynamic (PBPK/PD) model in 2011. At the 
2008 and 2012 SAP meetings, the Agency presented information on a 
variety of science issues such as inhibition of the enzyme 
acetylcholinesterase (AChE) in the nervous system, epidemiology studies 
in infants and children which suggest that chlorpyrifos and other OPs 
impact neurodevelopment, and a growing body of literature with 
laboratory animals (rats and mice) indicating that gestational and/or 
early postnatal exposure to chlorpyrifos may cause persistent effects 
into adulthood. Like other OPs, chlorpyrifos binds to and 
phosphorylates the enzyme acetylcholinesterase (AChE) in both the 
central (brain) and peripheral nervous systems. This can lead to 
accumulation of acetylcholine and ultimately, at sufficiently high 
doses, to clinical signs of toxicity. As recommended by the FIFRA SAP 
in 2008 and 2012, the Agency used inhibition of AChE as the critical 
effect to derive points of departure for the 2014 human health risk 
assessment. However, the 2014 human health risk assessment identified 
uncertainty in the degree to which points of departure derived from 
AChE inhibition are protective for neurodevelopmental effects in 
humans.
    In 2008 and 2012, the FIFRA SAP cautioned the Agency against using 
the biomonitoring data from epidemiology studies, particularly those 
from Columbia University in this case, to directly derive points of 
departure due to uncertainties associated with a lack of knowledge 
about timing of indoor chlorpyrifos applications and a single measure 
of exposure (cord blood) which were collected by the Columbia 
researchers. The concern is that single measures of exposure may not 
reflect the entire pregnancy or temporal exposure uncertainty coupled 
with unknown windows of susceptibility. The 2012 SAP recommended that 
the Agency consider use of a PBPK model to further characterize the 
dose estimates in the epidemiology studies. Based on human health risks 
identified in the 2014 human health risk assessment, the Agency 
published a 2015 proposed tolerance revocation for chlorpyrifos; in 
that proposal the Agency noted that the evaluation of the available 
biomonitoring was continuing. While EPA would have preferred to 
complete that analysis prior to commencing rulemaking, the timing for 
the proposal was directed by the U.S. Court of Appeals for the 9th 
Circuit, which ordered EPA to respond to an administrative petition to 
revoke all chlorpyrifos tolerances by October 31, 2015. In any case, at 
this point in time, the Agency's analysis of biomonitoring data from 
cord blood collected as part of the Columbia University epidemiology 
studies has progressed to a point where peer review would be useful. 
Specifically, the Agency has done additional characterization of the 
pharmacokinetic profile of simulated exposures from oral and dermal 
exposures using the PBPK model. Based on this evaluation, the Agency 
now believes the cord blood data are sufficiently robust for deriving 
points of departure. The Agency will solicit comment from the SAP on 
the evaluation of biomonitoring data using the PBPK model, proposed 
points of departure and extrapolation/uncertainty factors, and examples 
of a proposed approach to use the PBPK model to simulate internal doses 
from current exposure patterns from drinking water, food and worker 
exposure.

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-March. In addition, the Agency may provide additional 
background documents as the materials become

[[Page 12102]]

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/scipoly/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: February 26, 2016.
David J. Dix,
Director, Office of Science Coordination and Policy.
[FR Doc. 2016-05174 Filed 3-7-16; 8:45 am]
 BILLING CODE 6560-50-P



                                                                                   Federal Register / Vol. 81, No. 45 / Tuesday, March 8, 2016 / Notices                                           12099

                                                    Barone, Risk Assessment Division                        should consider for future assessment                 review Chlorpyrifos: Analysis of
                                                    (7403M), Office of Pollution Prevention                 and/or collection priorities for this                 Biomonitoring Data.
                                                    and Toxics, Environmental Protection                    chemical. Use the specific docket ID                  DATES: The meeting will be held on
                                                    Agency, 1200 Pennsylvania Ave. NW.,                     number provided in this notice to locate              April 19–21, 2016, from approximately
                                                    Washington, DC 20460–0001; telephone                    a copy of the chemical-specific                       9 a.m. to 5 p.m.
                                                    number: (202) 564–1169; email address:                  document, as well as to submit                           Comments. The Agency encourages
                                                    barone.stan@epa.gov.                                    comments via http://                                  written comments be submitted on or
                                                      For general information contact: The                  www.regulations.gov.                                  before April 5, 2016, and requests for
                                                    TSCA-Hotline, ABVI-Goodwill, 422                           Docket ID Number: EPA–HQ–OPPT–                     oral comments be submitted on or
                                                    South Clinton Ave., Rochester, NY                       2015–0084.                                            before April 12, 2016. However, written
                                                    14620; telephone number: (202) 554–                        Title: TSCA Work Plan Chemical Risk                comments and requests to make oral
                                                    1404; email address: TSCA-Hotline@                      Assessment for 1-Bromopropane (n-                     comments may be submitted until the
                                                    epa.gov.                                                Propyl Bromide): Spray adhesives, dry                 date of the meeting, but anyone
                                                    SUPPLEMENTARY INFORMATION:                              cleaning, and degreasing uses.                        submitting written comments after April
                                                                                                               Chemical Covered: 1-Bromopropane                   5, 2016, should contact the Designated
                                                    I. General Information                                  (n-Propyl Bromide) (1–BP; CASRN 106–                  Federal Official (DFO) listed under FOR
                                                    A. Does this action apply to me?                        94–5).                                                FURTHER INFORMATION CONTACT. For
                                                                                                               Summary: 1–BP is a colorless liquid                additional instructions, see Unit I.C. of
                                                       This action is directed to the public                with a sweet hydrocarbon odor that is
                                                    in general, and may be of interest to a                                                                       the SUPPLEMENTARY INFORMATION.
                                                                                                            used as a solvent in degreasing                          Nominations. Nominations of
                                                    wide range of stakeholders including                    applications, spray adhesives, and in                 candidates to serve as ad hoc members
                                                    those interested in environmental and                   dry cleaning. 1–BP is produced or                     of FIFRA SAP for this meeting should
                                                    human health; the chemical industry;                    imported to the U.S. in large quantities              be provided on or before March 23,
                                                    chemical users; consumer product                        (over 15 million pounds in 2011). This                2016.
                                                    companies and members of the public                     draft assessment focuses on human                        Webcast. This meeting may be
                                                    interested in the assessment of chemical                health risks to workers and consumers                 webcast. Please refer to the FIFRA SAP
                                                    risks. Since others also may be                         from acute (short-term) and chronic                   Web site at http://www.epa.gov/sap for
                                                    interested, the Agency has not                          inhalation exposures associated with 1–               information on how to access the
                                                    attempted to describe all the specific                  BP use in spray adhesives, dry cleaning,              meeting webcast. Please note that the
                                                    entities that may be affected by this                   and degreasing uses. EPA reviewed the                 webcast is a supplementary public
                                                    action.                                                 evidence for 1–BP toxicity and                        process provided only for convenience.
                                                    B. What should I consider as I prepare                  identified risks for cancer (in workers)              If difficulties arise resulting in
                                                    my comments for EPA?                                    and adverse developmental effects (in                 webcasting outages, the meeting will
                                                       1. Submitting CBI. Do not submit this                consumers and workers). Other health                  continue as planned.
                                                    information to EPA through                              risks identified for workers with chronic                Special accommodations. For
                                                    regulations.gov or email. Clearly mark                  1–BP exposures include adverse                        information on access or services for
                                                    the part or all of the information that                 neurologic effects, as well as kidney,                individuals with disabilities, and to
                                                    you claim to be CBI. For CBI                            liver, and reproductive effects.                      request accommodation of a disability,
                                                    information on a disk or CD–ROM that                       If you have any questions about this               please contact the DFO listed under FOR
                                                    you mail to EPA, mark the outside of the                draft risk assessment, or the Agency’s                FURTHER INFORMATION CONTACT at least
                                                    disk or CD–ROM as CBI and then                          programs in general, please contact the               10 days prior to the meeting to give EPA
                                                    identify electronically within the disk or              person listed under FOR FURTHER                       as much time as possible to process
                                                                                                            INFORMATION CONTACT.                                  your request.
                                                    CD–ROM the specific information that
                                                    is claimed as CBI. In addition to one                     Authority: 15 U.S.C. 2601 et. seq.                  ADDRESSES: Meeting: The meeting will
                                                    complete version of the comment that                      Dated: March 2, 2016.                               be held at the Environmental Protection
                                                    includes information claimed as CBI, a                  Wendy C. Hamnett,
                                                                                                                                                                  Agency, Conference Center, Lobby
                                                    copy of the comment that does not                                                                             Level, One Potomac Yard (South Bldg.),
                                                                                                            Director, Office of Pollution Prevention and
                                                    contain the information claimed as CBI                  Toxics.
                                                                                                                                                                  2777 S. Crystal Dr., Arlington, VA
                                                    must be submitted for inclusion in the                                                                        22202.
                                                                                                            [FR Doc. 2016–05176 Filed 3–7–16; 8:45 am]
                                                    public docket. Information so marked                                                                             Comments. Submit your comments,
                                                                                                            BILLING CODE 6560–50–P
                                                    will not be disclosed except in                                                                               identified by docket identification (ID)
                                                    accordance with procedures set forth in                                                                       number EPA–HQ–OPP–2016–0062, by
                                                    40 CFR part 2.                                                                                                one of the following methods:
                                                                                                            ENVIRONMENTAL PROTECTION
                                                       2. Tips for preparing your comments.                                                                          • Federal eRulemaking Portal: http://
                                                                                                            AGENCY
                                                    When preparing and submitting your                                                                            www.regulations.gov. Follow the online
                                                    comments, see the commenting tips at                                                                          instructions for submitting comments.
                                                                                                            [EPA–HQ–OPP–2016–0062; FRL–9942–63]                   Do not submit electronically any
                                                    http://www.epa.gov/dockets/
                                                    comments.html.                                          FIFRA Scientific Advisory Panel;                      information you consider to be
                                                                                                            Notice of Public Meeting                              Confidential Business Information (CBI)
                                                    II. What action is the Agency taking?                                                                         or other information whose disclosure is
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                       EPA is announcing the availability of                AGENCY: Environmental Protection                      restricted by statute.
                                                    and opening the public comment period                   Agency (EPA).                                            • Mail: OPP Docket, Environmental
                                                    for the 1-Bromopropane (1–BP) TSCA                      ACTION: Notice.                                       Protection Agency Docket Center (EPA/
                                                    Work Plan Chemical draft risk                                                                                 DC), (28221T), 1200 Pennsylvania Ave.
                                                    assessment. EPA also invites comments                   SUMMARY:  There will be a 3-day meeting               NW., Washington, DC 20460–0001.
                                                    on whether there are other uses that                    of the Federal Insecticide, Fungicide,                   • Hand Delivery: To make special
                                                    may result in high potential worker and                 and Rodenticide Act Scientific Advisory               arrangements for hand-delivery or
                                                    consumer exposures that the Agency                      Panel (FIFRA SAP) to consider and                     delivery of boxed information, please


                                               VerDate Sep<11>2014   17:02 Mar 07, 2016   Jkt 238001   PO 00000   Frm 00035   Fmt 4703   Sfmt 4703   E:\FR\FM\08MRN1.SGM   08MRN1


                                                    12100                          Federal Register / Vol. 81, No. 45 / Tuesday, March 8, 2016 / Notices

                                                    follow the instructions at http://                      ADDRESSES and Unit I.B., on or before                 assessment; organophosphate
                                                    www.epa.gov/dockets/contacts.html.                      April 5, 2016, to provide FIFRA SAP the               pesticides; and pharmacokinetics. [Note:
                                                    Additional instructions on commenting                   time necessary to consider and review                 In support of the U.S. Environmental
                                                    or visiting the docket, along with more                 the written comments. Written                         Protection Agency’s (EPA) priority of
                                                    information about dockets generally, is                 comments are accepted until the date of               ‘‘Making a Visible Difference in
                                                    available at http://www.epa.gov/                        the meeting, but anyone submitting                    Communities’’ across the country, the
                                                    dockets.                                                written comments after April 5, 2016,                 Agency is committed to helping
                                                      Nominations, requests to present oral                 should contact the DFO listed under FOR               minority, low-income, tribal and other
                                                    comments, and requests for special                      FURTHER INFORMATION CONTACT. Anyone                   vulnerable populations improve their
                                                    accommodations. Submit nominations                      submitting written comments at the                    health and environment. In an effort to
                                                    to serve as ad hoc members of FIFRA                     meeting should bring 30 copies for                    ensure that the Agency’s proposed
                                                    SAP, requests for special                               distribution to FIFRA SAP.                            actions are taking into consideration
                                                    accommodations, or requests to present                    2. Oral comments. The Agency                        input from potential communities with
                                                    oral comments to the DFO listed under                   encourages each individual or group                   environmental justice concerns, the EPA
                                                    FOR FURTHER INFORMATION CONTACT.                        wishing to make brief oral comments to                is offering an opportunity to provide
                                                    FOR FURTHER INFORMATION CONTACT: Fred                   FIFRA SAP submit their request to the                 input on the FIFRA SAP meeting to
                                                    Jenkins, DFO, Office of Science                         DFO listed under FOR FURTHER                          address scientific issues associated with
                                                    Coordination and Policy (7201M),                        INFORMATION CONTACT on or before April                ‘‘Chlorpyrifos: Analysis of
                                                    Environmental Protection Agency, 1200                   12, 2016, to be included on the meeting               Biomonitoring Data.’’ The EPA
                                                    Pennsylvania Ave. NW., Washington,                      agenda. Requests to present oral                      encourages all grass-roots organizations
                                                    DC 20460–0001; telephone number:                        comments will be accepted until the                   and residents to submit public
                                                    (202) 564–3327; email address:                          date of the meeting and, to the extent                comments on this issue that is being
                                                    jenkins.fred@epa.gov.                                   that time permits, the Chair of FIFRA                 addressed during the FIFRA Scientific
                                                                                                            SAP may permit the presentation of oral               Advisory Panel meeting. The Agency
                                                    SUPPLEMENTARY INFORMATION:
                                                                                                            comments at the meeting by interested                 also encourages community
                                                    I. General Information                                  persons who have not previously                       environmental justice advocates to give
                                                                                                            requested time. The request should                    a voice to their communities by
                                                    A. Does this action apply to me?                        identify the name of the individual                   nominating candidates for consideration
                                                       This action is directed to the public                making the presentation, the                          to serve on this panel.] Nominees
                                                    in general. This action may, however, be                organization (if any) the individual will             should be scientists who have sufficient
                                                    of interest to persons who are or may be                represent and any requirements for                    professional qualifications, including
                                                    required to conduct testing of chemical                 audiovisual equipment. Oral comments                  training and experience, to provide
                                                    substances under the Federal Food,                      before FIFRA SAP are limited to                       expert comments on the scientific issues
                                                    Drug, and Cosmetic Act (FFDCA) and                      approximately 5 minutes unless prior                  for this meeting. Nominees should be
                                                    FIFRA. Since other entities may also be                 arrangements have been made. In                       identified by name, occupation,
                                                    interested, the Agency has not                          addition, each speaker should bring 30                position, address, email address, and
                                                    attempted to describe all the specific                  copies of his or her comments and                     telephone number. Nominations should
                                                    entities that may be affected by this                   presentation for distribution to FIFRA                be provided to the DFO listed under FOR
                                                    action.                                                 SAP at the meeting.                                   FURTHER INFORMATION CONTACT on or
                                                                                                              3. Seating at the meeting. Seating at
                                                    B. What should I consider as I prepare                                                                        before March 23, 2016. The Agency will
                                                                                                            the meeting will be open and on a first-
                                                    my comments for EPA?                                                                                          consider all nominations of prospective
                                                                                                            come basis.
                                                                                                              4. Request for nominations to serve as              candidates for this meeting that are
                                                      1. Submitting CBI. Do not submit CBI
                                                                                                            ad hoc members of FIFRA SAP for this                  received on or before that date.
                                                    information to EPA through
                                                                                                            meeting. As part of a broader process for             However, final selection of ad hoc
                                                    regulations.gov or email. If your
                                                                                                            developing a pool of candidates for each              members for this meeting is a
                                                    comments contain any information that
                                                                                                            meeting, FIFRA SAP staff routinely                    discretionary function of the Agency.
                                                    you consider to be CBI or otherwise
                                                    protected, please contact the DFO listed                solicits the stakeholder community for                   The selection of scientists to serve on
                                                    under FOR FURTHER INFORMATION                           nominations of prospective candidates                 FIFRA SAP is based on the function of
                                                    CONTACT to obtain special instructions                  for service as ad hoc members of FIFRA                the Panel and the expertise needed to
                                                    before submitting your comments.                        SAP. Any interested person or                         address the Agency’s charge to the
                                                      2. Tips for preparing your comments.                  organization may nominate qualified                   Panel. No interested scientists shall be
                                                    When preparing and submitting your                      individuals to be considered as                       ineligible to serve by reason of their
                                                    comments, see the commenting tips at                    prospective candidates for a specific                 membership on any other advisory
                                                    http://www.epa.gov/dockets/                             meeting. Individuals nominated for this               committee to a Federal department or
                                                    comments.html.                                          meeting should have expertise in one or               agency, or their employment by a
                                                                                                            more of the following areas: Human                    Federal department or agency except
                                                    C. How may I participate in this                        biomonitoring data and interpretation of              EPA. Other factors considered during
                                                    meeting?                                                such data; epidemiology (particularly                 the selection process include
                                                       You may participate in this meeting                  reproductive/developmental, and                       availability of the potential Panel
                                                    by following the instructions in this                   environmental), exposure assessment of                member to fully participate in the
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                                                    unit. To ensure proper receipt by EPA,                  pesticides (residential and agricultural              Panel’s reviews, absence of any conflicts
                                                    it is imperative that you identify docket               worker); route-specific                               of interest or appearance of lack of
                                                    ID number EPA–HQ–OPP–2016–0062 in                       pharmacokinetics (dermal, oral);                      impartiality, independence with respect
                                                    the subject line on the first page of your              physiologically-based pharmacokinetic                 to the matters under review, and lack of
                                                    request.                                                modeling (PBPK); cholinergic and non-                 bias. Although financial conflicts of
                                                       1. Written comments. The Agency                      cholinergic mechanisms; cholinesterase                interest, the appearance of lack of
                                                    encourages written comments be                          inhibition; developmental                             impartiality, lack of independence, and
                                                    submitted, using the instructions in                    neurotoxicity; human health risk                      bias may result in disqualification, the


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                                                                                   Federal Register / Vol. 81, No. 45 / Tuesday, March 8, 2016 / Notices                                            12101

                                                    absence of such concerns does not                       accordance with requirements of the                   biomonitoring data from epidemiology
                                                    assure that a candidate will be selected                Federal Advisory Committee Act (5                     studies, particularly those from
                                                    to serve on the FIFRA SAP. Numerous                     U.S.C. Appendix). FIFRA SAP is                        Columbia University in this case, to
                                                    qualified candidates are identified for                 composed of a permanent panel                         directly derive points of departure due
                                                    each Panel. Therefore, selection                        consisting of seven members who are                   to uncertainties associated with a lack of
                                                    decisions involve carefully weighing a                  appointed by the EPA Administrator                    knowledge about timing of indoor
                                                    number of factors including the                         from nominees provided by the National                chlorpyrifos applications and a single
                                                    candidates’ areas of expertise and                      Institutes of Health and the National                 measure of exposure (cord blood) which
                                                    professional qualifications and                         Science Foundation. FIFRA established                 were collected by the Columbia
                                                    achieving an overall balance of different               a Science Review Board (SRB)                          researchers. The concern is that single
                                                    scientific perspectives on the Panel. The               consisting of at least 60 scientists who              measures of exposure may not reflect
                                                    Agency anticipates selecting                            are available to the FIFRA SAP on an ad               the entire pregnancy or temporal
                                                    approximately 8 ad hoc scientists to                    hoc basis to assist in reviews conducted              exposure uncertainty coupled with
                                                    have the collective breadth of                          by FIFRA SAP. As a scientific peer                    unknown windows of susceptibility.
                                                    experience needed to address the                        review mechanism, FIFRA SAP                           The 2012 SAP recommended that the
                                                    Agency’s charge for this meeting.                       provides comments, evaluations and                    Agency consider use of a PBPK model
                                                       FIFRA SAP members are subject to                     recommendations to improve the                        to further characterize the dose
                                                    the provisions of 5 CFR part 2634—                      effectiveness and quality of analyses                 estimates in the epidemiology studies.
                                                    Executive Branch Financial Disclosure,                  made by Agency scientists. Members of                 Based on human health risks identified
                                                    Qualified Trusts, and Certificates of                   the FIFRA SAP are scientists who have                 in the 2014 human health risk
                                                    Divestiture, as supplemented by EPA in                  sufficient professional qualifications,               assessment, the Agency published a
                                                    5 CFR part 6401. In anticipation of this                including training and experience, to                 2015 proposed tolerance revocation for
                                                    requirement, prospective candidates for                 provide expert advice and                             chlorpyrifos; in that proposal the
                                                    service on FIFRA SAP will be asked to                   recommendation to the Agency.                         Agency noted that the evaluation of the
                                                    submit confidential financial                                                                                 available biomonitoring was continuing.
                                                                                                            B. Public Meeting
                                                    information which shall fully disclose,                                                                       While EPA would have preferred to
                                                    among other financial interests, the                       Chlorpyrifos (0,0-diethyl-0-3,5,6-                 complete that analysis prior to
                                                    candidate’s employment, stocks, and                     trichloro-2-pyridyl phosphorothioate) is              commencing rulemaking, the timing for
                                                    bonds, and where applicable, sources of                 a broad-spectrum, chlorinated                         the proposal was directed by the U.S.
                                                    research support. EPA will evaluate the                 organophosphate (OP) insecticide. The                 Court of Appeals for the 9th Circuit,
                                                    candidates’ financial disclosure form to                FIFRA SAP previously reviewed the                     which ordered EPA to respond to an
                                                    assess whether there are financial                      human health effects of chlorpyrifos in               administrative petition to revoke all
                                                    conflicts of interest, appearance of a                  2008 and 2012, and the chlorpyrifos                   chlorpyrifos tolerances by October 31,
                                                    lack of impartiality, or any prior                      physiologically-based pharmacokinetic/                2015. In any case, at this point in time,
                                                    involvement with the development of                     pharmacodynamic (PBPK/PD) model in                    the Agency’s analysis of biomonitoring
                                                    the documents under consideration                       2011. At the 2008 and 2012 SAP                        data from cord blood collected as part
                                                                                                            meetings, the Agency presented                        of the Columbia University
                                                    (including previous scientific peer
                                                                                                            information on a variety of science                   epidemiology studies has progressed to
                                                    review) before the candidate is
                                                                                                            issues such as inhibition of the enzyme               a point where peer review would be
                                                    considered further for service on the
                                                                                                            acetylcholinesterase (AChE) in the                    useful. Specifically, the Agency has
                                                    FIFRA SAP. Those who are selected
                                                                                                            nervous system, epidemiology studies                  done additional characterization of the
                                                    from the pool of prospective candidates
                                                                                                            in infants and children which suggest                 pharmacokinetic profile of simulated
                                                    will be asked to attend the public
                                                                                                            that chlorpyrifos and other OPs impact                exposures from oral and dermal
                                                    meetings and to participate in the
                                                                                                            neurodevelopment, and a growing body                  exposures using the PBPK model. Based
                                                    discussion of key issues and
                                                                                                            of literature with laboratory animals                 on this evaluation, the Agency now
                                                    assumptions at these meetings. In
                                                                                                            (rats and mice) indicating that                       believes the cord blood data are
                                                    addition, they will be asked to review                  gestational and/or early postnatal
                                                    and to help finalize the meeting                                                                              sufficiently robust for deriving points of
                                                                                                            exposure to chlorpyrifos may cause                    departure. The Agency will solicit
                                                    minutes. The list of FIFRA SAP                          persistent effects into adulthood. Like
                                                    members participating at this meeting                                                                         comment from the SAP on the
                                                                                                            other OPs, chlorpyrifos binds to and                  evaluation of biomonitoring data using
                                                    will be posted on the FIFRA SAP Web                     phosphorylates the enzyme
                                                    site at http://www.epa.gov/scipoly/sap                                                                        the PBPK model, proposed points of
                                                                                                            acetylcholinesterase (AChE) in both the               departure and extrapolation/uncertainty
                                                    or may be obtained from the OPP Docket                  central (brain) and peripheral nervous
                                                    at http://www.regulations.gov.                                                                                factors, and examples of a proposed
                                                                                                            systems. This can lead to accumulation                approach to use the PBPK model to
                                                    II. Background                                          of acetylcholine and ultimately, at                   simulate internal doses from current
                                                                                                            sufficiently high doses, to clinical signs            exposure patterns from drinking water,
                                                    A. Purpose of FIFRA SAP                                 of toxicity. As recommended by the                    food and worker exposure.
                                                       FIFRA SAP serves as the primary                      FIFRA SAP in 2008 and 2012, the
                                                    scientific peer review mechanism of                     Agency used inhibition of AChE as the                 C. FIFRA SAP Documents and Meeting
                                                    EPA’s Office of Chemical Safety and                     critical effect to derive points of                   Minutes
                                                    Pollution Prevention (OCSPP) and is                     departure for the 2014 human health                      EPA’s background paper, related
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                                                    structured to provide scientific advice,                risk assessment. However, the 2014                    supporting materials, charge/questions
                                                    information and recommendations to                      human health risk assessment identified               to FIFRA SAP, FIFRA SAP composition
                                                    the EPA Administrator on pesticides                     uncertainty in the degree to which                    (i.e., members and ad hoc members for
                                                    and pesticide-related issues as to the                  points of departure derived from AChE                 this meeting), and the meeting agenda
                                                    impact of regulatory actions on health                  inhibition are protective for                         will be available by approximately mid-
                                                    and the environment. FIFRA SAP is a                     neurodevelopmental effects in humans.                 March. In addition, the Agency may
                                                    Federal advisory committee established                     In 2008 and 2012, the FIFRA SAP                    provide additional background
                                                    in 1975 under FIFRA that operates in                    cautioned the Agency against using the                documents as the materials become


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                                                    12102                          Federal Register / Vol. 81, No. 45 / Tuesday, March 8, 2016 / Notices

                                                    available. You may obtain electronic                    necessary to evaluate whether the                     required by the Paperwork Reduction
                                                    copies of these documents and certain                   lender has the capital to fund potential              Act (PRA) of 1995 (44 U.S.C. 3501–
                                                    other related documents that might be                   transactions, proper due diligence                    3520), the Federal Communications
                                                    available at http://www.regulations.gov                 procedures, and the monitoring capacity               Commission (FCC or the Commission)
                                                    and the FIFRA SAP Web site at http://                   to carry out transactions.                            invites the general public and other
                                                    www.epa.gov/scipoly/sap.                                   The information collection tool can be             federal agencies to take this opportunity
                                                       FIFRA SAP will prepare meeting                       reviewed at: http://exim.gov/sites/                   to comment on the following
                                                    minutes summarizing its                                 default/files/pub/pending/eib10_06.pdf.               information collection. Comments are
                                                    recommendations to the Agency                           DATES: Comments must be received on                   requested concerning: Whether the
                                                    approximately 90 days after the                         or before May 9, 2016 to be assured of                collection of information is necessary
                                                    meeting. The meeting minutes will be                    consideration.                                        for the proper performance of the
                                                    posted to the FIFRA SAP Web site or                     ADDRESSES: Comments may be                            functions of the Commission, including
                                                    may be obtained from the OPP Docket                     submitted electronically on                           whether the information shall have
                                                    at http://www.regulations.gov.                          WWW.REGULATIONS.GOV or by mail                        practical utility; the accuracy of the
                                                      Authority: 7 U.S.C. 136 et seq.; 21 U.S.C.            to Michele Kuester, Export-Import Bank,               Commission’s burden estimate; ways to
                                                    301 et seq.                                             811 Vermont Ave. NW., Washington, DC                  enhance the quality, utility, and clarity
                                                      Dated: February 26, 2016.                             20571                                                 of the information collected; ways to
                                                                                                            SUPPLEMENTARY INFORMATION:
                                                                                                                                                                  minimize the burden of the collection of
                                                    David J. Dix,
                                                                                                               Title and Form Number: EIB 10–06                   information on the respondents,
                                                    Director, Office of Science Coordination and                                                                  including the use of automated
                                                    Policy.                                                 Application for Approved Finance
                                                                                                            Provider.                                             collection techniques or other forms of
                                                    [FR Doc. 2016–05174 Filed 3–7–16; 8:45 am]
                                                                                                               OMB Number: 3048–0032.                             information technology; and ways to
                                                    BILLING CODE 6560–50–P                                                                                        further reduce the information
                                                                                                               Type of Review: Regular.
                                                                                                               Need and Use: The information                      collection burden on small business
                                                                                                            collected will allow EXIM Bank to                     concerns with fewer than 25 employees.
                                                    EXPORT-IMPORT BANK                                      determine compliance and content for                     The FCC may not conduct or sponsor
                                                    [Public Notice: 2016–6021]                              transaction requests submitted to the                 a collection of information unless it
                                                                                                            Export-Import Bank under its insurance,               displays a currently valid control
                                                    Agency Information Collection                           guarantee, and direct loan programs.                  number. No person shall be subject to
                                                    Activities: Comment Request                                Affected Public: This form affects                 any penalty for failing to comply with
                                                                                                            entities involved in the export of U.S.               a collection of information subject to the
                                                    AGENCY:  Export-Import Bank of the                                                                            PRA that does not display a valid Office
                                                    United States.                                          goods and services.
                                                                                                               Annual Number of Respondents: 50.                  of Management and Budget (OMB)
                                                    ACTION: Submission for OMB review and                                                                         control number.
                                                                                                               Estimated Time per Respondent: 30
                                                    comments request.                                       minutes.                                              DATES: Written PRA comments should
                                                      Form Title: EIB 10–06 Application for                    Annual Burden Hours: 25 hours.                     be submitted on or before May 9, 2016.
                                                    Approved Finance Provider.                                 Frequency of Reporting of Use: On                  If you anticipate that you will be
                                                    SUMMARY: The Export-Import Bank of                      occasion.                                             submitting comments, but find it
                                                    the United States (EXIM Bank), as part                     Government Expenses:                               difficult to do so within the period of
                                                    of its continuing effort to reduce                         Reviewing time per year: 25 hours.                 time allowed by this notice, you should
                                                    paperwork and respondent burden,                           Average Wages per Hour: $42.50.                    advise the contact listed below as soon
                                                    invites the general public and other                       Average Cost per Year: $1,062.50.                  as possible.
                                                                                                               (time*wages)                                       ADDRESSES: Direct all PRA comments to
                                                    Federal Agencies to comment on the
                                                                                                               Benefits and Overhead: 20%.                        Cathy Williams, FCC, via email PRA@
                                                    proposed information collection, as                        Total Government Cost: $1,275.
                                                    required by the Paperwork Reduction                                                                           fcc.gov and to Cathy.Williams@fcc.gov.
                                                    Act of 1995.                                            Bonita Jones-McNeil,                                  FOR FURTHER INFORMATION CONTACT: For
                                                      Financial institutions interested in                  Program Analyst, Agency Clearance Officer,            additional information about the
                                                    becoming an Approved Finance                            Office of the Chief Information Officer.              information collection, contact Cathy
                                                    Provider (AFP) with EXIM Bank must                      [FR Doc. 2016–05102 Filed 3–7–16; 8:45 am]            Williams at (202) 418–2918.
                                                    complete this application in order to                   BILLING CODE 6690–01–P                                SUPPLEMENTARY INFORMATION:
                                                    obtain approval to make loans under                                                                              OMB Control Number: 3060–0261.
                                                    EXIM Bank insurance policies and/or                                                                              Title: Section 90.215, Transmitter
                                                    enter into one or more Master Guarantee                 FEDERAL COMMUNICATIONS                                Measurements.
                                                    Agreements (MGA) with EXIM Bank. An                     COMMISSION                                               Form No.: Not applicable.
                                                    AFP may participate in the Medium-                                                                               Type of Review: Extension of a
                                                    Term Insurance, Bank Letter of Credit,                  [OMB 3060–0261]
                                                                                                                                                                  currently approved collection.
                                                    and Financial Institution Buyer Credit                                                                           Respondents: Business or other for-
                                                                                                            Information Collection Being Reviewed
                                                    programs as an insured lender, while                                                                          profit, not-for-profit institutions and
                                                                                                            by the Federal Communications
                                                    AFPs approved for an MGA may apply                                                                            state, local or tribal Government.
                                                                                                            Commission Under Delegated
                                                    for multiple loan or lease transactions to
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                                                                                                                                                                     Number of Respondents: 19,570
                                                                                                            Authority
                                                    be guaranteed by EXIM Bank.                                                                                   respondents; 25,558 responses.
                                                      EXIM Bank uses the information                        AGENCY: Federal Communications                           Estimated Time per Response: .034
                                                    provided in the form and the                            Commission.                                           hours.
                                                    supplemental information required to be                 ACTION: Notice and request for                           Frequency of Response:
                                                    submitted with the form to determine                    comments.                                             Recordkeeping requirement.
                                                    whether the lender qualifies to                                                                                  Obligation to Respond: Required to
                                                    participate in its lender insurance and                 SUMMARY:  As part of its continuing effort            obtain or retain benefits. Statutory
                                                    guarantee programs. The details are                     to reduce paperwork burdens, and as                   authority for this information collection


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Document Created: 2018-02-02 15:10:13
Document Modified: 2018-02-02 15:10:13
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 April 19-21, 2016, from approximately 9 a.m. to 5 p.m.
ContactFred Jenkins, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
FR Citation81 FR 12099 

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