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

ENVIRONMENTAL PROTECTION AGENCY

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

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, 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

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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