Request for Nominations for Peer Reviewers for EPA's Biologically Based Dose-Response (BBDR) Model for Perchlorate in Drinking Water, 10617-10618 [2016-04449]
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Federal Register / Vol. 81, No. 40 / Tuesday, March 1, 2016 / Notices
10617
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8 Senator Sheldon Whitehouse, Senator Jack Reed, House Representative James R. Langevin, and House Representative David N. Cicilline.
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Dated: February 23, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016–04390 Filed 2–29–16; 8:45 am]
BILLING CODE 6717–01–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OW–2009–0297; FRL–9942–98–
OW]
Request for Nominations for Peer
Reviewers for EPA’s Biologically
Based Dose-Response (BBDR) Model
for Perchlorate in Drinking Water
Environmental Protection
Agency (EPA).
ACTION: Notice; request for nominations
for peer reviewers.
AGENCY:
The U.S. Environmental
Protection Agency (EPA) invites the
public to nominate scientific experts to
be considered as peer reviewers for the
contractor-managed, external peer
review of the draft Biologically Based
Dose-Response model for perchlorate in
drinking water and the draft model
support document. The draft model
predicts changes in thyroid hormones in
sensitive life stages exposed to different
dietary iodide and perchlorate levels.
EPA has been working with scientists at
the Food and Drug Administration to
develop the model recommended by
EPA’s Science Advisory Board for the
derivation of a maximum contaminant
level goal for perchlorate in drinking
water. The model integrates previous
perchlorate and iodine models for
thyroid hormones in formula-fed and
nursing infants, as well as lactating
women. The model predicts the effects
of perchlorate on serum thyroid
hormone concentrations in infants
exposed via ingestion of formula mixed
with contaminated drinking water or
breast milk. EPA anticipates releasing
the draft model and draft model support
document for peer review and public
comment in the near future (the exact
date to be determined).
DATES: The nomination period for
scientific experts begins on March 1,
2016 and ends on March 31, 2016.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:18 Feb 29, 2016
Any interested person or
organization may nominate scientific
experts to be considered as peer
reviewers. Nominations should be
submitted in time to arrive no later than
March 31, 2016. Self-nominations will
also be accepted. Nominations should
be submitted to the EPA contractor,
Versar, Inc., using the following email
address: perchlorate@versar.com (the
subject line should read: BBDR Model
Peer Review). Nominations will also be
accepted via U.S. Postal Service mail or
by an overnight/priority mail service.
Mailed nominations should be
addressed to Versar, Inc., 6850 Versar
Center, Springfield, VA 22151
(Attention: David Bottimore).
Nominations should include all
nominee information outlined in section
II of the SUPPLEMENTARY INFORMATION
section of this document.
FOR FURTHER INFORMATION CONTACT:
Questions concerning the nomination
process should be directed to the EPA
contractor, Versar, Inc., at 6850 Versar
Center, Springfield, VA 22151; by email
to perchlorate@versar.com (the subject
line should read: BBDR Model Peer
Review); or by phone: (703) 642–6815
(ask for David Bottimore). For additional
information concerning the draft BBDR
model and draft model support
document, please contact Russ
Perkinson at the U.S. Environmental
Protection Agency, Office of Ground
Water and Drinking Water, Standards
and Risk Management Division, (Mail
Code 4607M), 1200 Pennsylvania
Avenue NW., Washington, DC 20460;
telephone: 202–564–4901; or email:
perkinson.russ@epa.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
Jkt 238001
I. Information on the Draft Biologically
Based Dose-Response (BBDR) Model
and Draft Model Support Document for
Perchlorate in Drinking Water
EPA is developing a National Primary
Drinking Water Regulation (NPDWR) for
Perchlorate in accordance with the
requirements under the Safe Drinking
Water Act (SDWA). Among these
requirements are that the agency must
request comment from the EPA’s
Science Advisory Board (SAB) prior to
proposal of a maximum contaminant
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
level goal (MCLG) and a NPDWR (42
U.S.C. 1412(e)).
In 2012, EPA sought guidance from
the SAB on how best to consider and
interpret life stage information,
epidemiologic and biomonitoring data,
physiologically based pharmacokinetic
(PBPK) analyses and the totality of
perchlorate health information to derive
an MCLG for perchlorate. The MCLG is
the maximum level of a contaminant in
drinking water at which no known or
anticipated adverse effect on the health
of persons would occur, and which
allows an adequate margin of safety.
MCLGs are non-enforceable public
health goals.
In 2013, the SAB recommended that,
‘‘. . . EPA derive a perchlorate MCLG
that addresses sensitive life stages
through physiologically-based
pharmacokinetic/pharmacodynamic
(PBPK/PD) modeling based upon its
mode of action rather than the default
MCLG approach using the reference
dose and specific chemical exposure
parameters’’ (see Advice on Approaches
to Derive a Maximum Contaminant
Level Goal for Perchlorate, EPA–SAB–
13–004). The SAB found that ‘‘. . . this
data-driven approach represents a more
rigorous way to address differences in
biology and exposure between adults
and sensitive life stages than is possible
with the default approach for deriving
an MCLG.’’
Based on the SAB’s
recommendations, EPA and Food and
Drug Administration (FDA) scientists
developed a BBDR (also known as a
PBPK/PD) model to determine under
what conditions of iodine nutrition and
exposure to perchlorate across sensitive
life stages low serum free and total
thyroxine would result. EPA is
considering deriving a perchlorate
MCLG by linking BBDR model output to
information from literature to account
for adverse health outcomes.
II. How to Submit Nominations for Peer
Reviewers
Expertise Sought: EPA is seeking
candidates who are nationally and/or
internationally recognized scientific
experts to serve as external peer
reviewers for the draft BBDR model and
draft model support document for
E:\FR\FM\01MRN1.SGM
01MRN1
asabaliauskas on DSK5VPTVN1PROD with NOTICES
10618
Federal Register / Vol. 81, No. 40 / Tuesday, March 1, 2016 / Notices
perchlorate in drinking water. Nominees
should possess and demonstrate
background knowledge and experience
in one or more of the following areas:
(1) PBPK, PBPK/PD and/or BBDR
modeling, (2) fetal and neonatal thyroid
endocrinology (clinical and
experimental), (3) iodide homeostasis,
and (4) perchlorate toxicology and mode
of action or adverse outcome pathway.
Selection Criteria: Selection criteria
for individuals nominated to serve as
external peer reviewers of the draft
BBDR model and draft model support
document include the following: (1)
Demonstrated expertise through
relevant peer reviewed publications, (2)
professional accomplishments and
recognition by professional societies, (3)
demonstrated ability to work
constructively and effectively in a
committee setting, (4) absence of
financial conflicts of interest, (5) no
actual conflicts of interest or the
appearance of lack of impartiality, (6)
willingness to commit adequate time for
the thorough review of the draft BBDR
model and draft model support
document, commencing approximately
in June 2016 (exact date to be
determined), and (7) availability to
participate in-person in a one-day peer
review meeting in the Washington, DC
metro area, projected to occur in
approximately August 2016 (exact date
will be published in the Federal
Register at least 30 days prior to the
external peer review meeting). Further
logistical information regarding the
external peer review meeting will be
announced at a later date in the Federal
Register.
Required Nominee Information: To
receive full consideration, the following
information should be submitted to
Versar (perchlorate@versar.com) (the
subject line should read: BBDR Model
Peer Review): (1) Contact information
for the person making the nomination;
(2) contact information for the nominee;
(3) the disciplinary and specific areas of
expertise of the nominee; (4) the
nominee’s curriculum vitae; and (5) a
biographical sketch of the nominee
indicating current position, educational
background, past and current research
activities, recent service on other
advisory committees, peer review
panels, editorial boards or professional
organizations, sources of recent grant
and/or contract support and other
comments on the relevance of the
nominee’s expertise to this peer review
topic. Compensation for non-federal
peer reviewers will be provided by
Versar.
Selection Process: EPA’s contractor,
Versar, will notify candidates of
selection or non-selection. Versar may
VerDate Sep<11>2014
20:18 Feb 29, 2016
Jkt 238001
also conduct an independent search for
candidates to assemble a balanced group
representing the expertise needed to
fully evaluate EPA’s draft BBDR model
and draft model support document for
perchlorate in drinking water. Versar
will consider and screen all candidates
against the criteria previously listed.
Following the screening process, Versar
will narrow the list of potential
reviewers to approximately 10–15
candidates. Prior to selecting the final
peer reviewers, a Federal Register
notice will be published (exact date to
be determined) to solicit comments on
the interim list of candidates. In that
notice, the public will be requested to
provide relevant information or
documentation on the nominees within
30 days of the announcement of the
interim list of candidates. Once Versar
has considered the public comments on
the interim list of candidates, Versar
will select the final list of peer
reviewers, based on who, collectively,
will best provide expertise spanning the
disciplines previously listed and (to the
extent feasible) best provide a balance of
perspectives.
Dated: February 21, 2016.
Joel Beauvais,
Deputy Assistant Administrator.
[FR Doc. 2016–04449 Filed 2–29–16; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–9943–11–ORD]
Environmental Laboratory Advisory
Board (ELAB) Membership
U.S. Environmental Protection
Agency (EPA).
ACTION: Notice soliciting nominations
for membership.
AGENCY:
The U.S. Environmental
Protection Agency’s (EPA) invites
nominations from a diverse range of
qualified candidates to be considered
for appointment to its Environmental
Laboratory Advisory Board (ELAB). The
ELAB is a multi-stakeholder federal
advisory committee that provides
independent advice and
recommendations to the EPA
Administrator, Science Advisor, and
Forum on Environmental Measurements
(FEM) about cross-cutting issues related
to enhancing EPA’s measurement
programs, and facilitating the operation
and expansion of national
environmental accreditation.
This notice solicits nominations to fill
eight–nine (8–9) new vacancies. To
maintain diverse representation,
SUMMARY:
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
nominees will be selected from the
following stakeholder work force
sectors:
• Academia
• Business and industry
• Environmental laboratory
commercial, municipal, small, other
• Environmental laboratory suppliers of
services
• State and local Government agencies
• Tribal governments and indigenous
groups
• Trade associations
Within these sectors, EPA is seeking
nominees with knowledge in methods
development; measurements;
monitoring and regulatory programs;
quality systems; and environmental
accreditation. In an effort to obtain
nominations of diverse candidates, the
agency encourages nominations of
women and men of all racial and ethnic
groups. All nominations will be fully
considered.
Any interested person or organization
may nominate qualified persons to be
considered for appointment to this
advisory committee. Individuals may
self-nominate. Nominees should possess
the following qualifications:
• Demonstrated experience with
environmental measurement programs
and environmental accreditation;
• Willingness to commit time to the
committee, and demonstrated ability to
work constructively and effectively on
committees;
• Excellent interpersonal, oral, and
written communication and consensusbuilding skills; and
• Ability to serve a 2-year
appointment and volunteer
approximately 5–7 hours per month to
support the Board’s activities.
How to Submit Nominations:
Nominations can be submitted in
electronic format (preferred) to Ms. Lara
P. Phelps, Designated Federal Officer,
US EPA, MC E243–05, 109 T. W.
Alexander Drive, Research Triangle
Park, NC 27709, or email to
phelps.lara@epa.gov and should be
received by April 1, 2016 for October
2016 appointment. To be considered, all
nomination packages should include:
• Current contact information for the
nominee, including the nominee’s
name, organization (and position within
that organization), current business
address, email address, and daytime
telephone number.
• Brief statement describing the
nominee’s interest in serving on the
ELAB.
• Resume describing the professional
and educational qualifications of the
nominee, including a list of relevant
activities, and any current or previous
service on advisory committees.
E:\FR\FM\01MRN1.SGM
01MRN1
Agencies
[Federal Register Volume 81, Number 40 (Tuesday, March 1, 2016)]
[Notices]
[Pages 10617-10618]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04449]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OW-2009-0297; FRL-9942-98-OW]
Request for Nominations for Peer Reviewers for EPA's Biologically
Based Dose-Response (BBDR) Model for Perchlorate in Drinking Water
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice; request for nominations for peer reviewers.
-----------------------------------------------------------------------
SUMMARY: The U.S. Environmental Protection Agency (EPA) invites the
public to nominate scientific experts to be considered as peer
reviewers for the contractor-managed, external peer review of the draft
Biologically Based Dose-Response model for perchlorate in drinking
water and the draft model support document. The draft model predicts
changes in thyroid hormones in sensitive life stages exposed to
different dietary iodide and perchlorate levels. EPA has been working
with scientists at the Food and Drug Administration to develop the
model recommended by EPA's Science Advisory Board for the derivation of
a maximum contaminant level goal for perchlorate in drinking water. The
model integrates previous perchlorate and iodine models for thyroid
hormones in formula-fed and nursing infants, as well as lactating
women. The model predicts the effects of perchlorate on serum thyroid
hormone concentrations in infants exposed via ingestion of formula
mixed with contaminated drinking water or breast milk. EPA anticipates
releasing the draft model and draft model support document for peer
review and public comment in the near future (the exact date to be
determined).
DATES: The nomination period for scientific experts begins on March 1,
2016 and ends on March 31, 2016.
ADDRESSES: Any interested person or organization may nominate
scientific experts to be considered as peer reviewers. Nominations
should be submitted in time to arrive no later than March 31, 2016.
Self-nominations will also be accepted. Nominations should be submitted
to the EPA contractor, Versar, Inc., using the following email address:
perchlorate@versar.com (the subject line should read: BBDR Model Peer
Review). Nominations will also be accepted via U.S. Postal Service mail
or by an overnight/priority mail service. Mailed nominations should be
addressed to Versar, Inc., 6850 Versar Center, Springfield, VA 22151
(Attention: David Bottimore). Nominations should include all nominee
information outlined in section II of the SUPPLEMENTARY INFORMATION
section of this document.
FOR FURTHER INFORMATION CONTACT: Questions concerning the nomination
process should be directed to the EPA contractor, Versar, Inc., at 6850
Versar Center, Springfield, VA 22151; by email to
perchlorate@versar.com (the subject line should read: BBDR Model Peer
Review); or by phone: (703) 642-6815 (ask for David Bottimore). For
additional information concerning the draft BBDR model and draft model
support document, please contact Russ Perkinson at the U.S.
Environmental Protection Agency, Office of Ground Water and Drinking
Water, Standards and Risk Management Division, (Mail Code 4607M), 1200
Pennsylvania Avenue NW., Washington, DC 20460; telephone: 202-564-4901;
or email: perkinson.russ@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Information on the Draft Biologically Based Dose-Response (BBDR)
Model and Draft Model Support Document for Perchlorate in Drinking
Water
EPA is developing a National Primary Drinking Water Regulation
(NPDWR) for Perchlorate in accordance with the requirements under the
Safe Drinking Water Act (SDWA). Among these requirements are that the
agency must request comment from the EPA's Science Advisory Board (SAB)
prior to proposal of a maximum contaminant level goal (MCLG) and a
NPDWR (42 U.S.C. 1412(e)).
In 2012, EPA sought guidance from the SAB on how best to consider
and interpret life stage information, epidemiologic and biomonitoring
data, physiologically based pharmacokinetic (PBPK) analyses and the
totality of perchlorate health information to derive an MCLG for
perchlorate. The MCLG is the maximum level of a contaminant in drinking
water at which no known or anticipated adverse effect on the health of
persons would occur, and which allows an adequate margin of safety.
MCLGs are non-enforceable public health goals.
In 2013, the SAB recommended that, ``. . . EPA derive a perchlorate
MCLG that addresses sensitive life stages through physiologically-based
pharmacokinetic/pharmacodynamic (PBPK/PD) modeling based upon its mode
of action rather than the default MCLG approach using the reference
dose and specific chemical exposure parameters'' (see Advice on
Approaches to Derive a Maximum Contaminant Level Goal for Perchlorate,
EPA-SAB-13-004). The SAB found that ``. . . this data-driven approach
represents a more rigorous way to address differences in biology and
exposure between adults and sensitive life stages than is possible with
the default approach for deriving an MCLG.''
Based on the SAB's recommendations, EPA and Food and Drug
Administration (FDA) scientists developed a BBDR (also known as a PBPK/
PD) model to determine under what conditions of iodine nutrition and
exposure to perchlorate across sensitive life stages low serum free and
total thyroxine would result. EPA is considering deriving a perchlorate
MCLG by linking BBDR model output to information from literature to
account for adverse health outcomes.
II. How to Submit Nominations for Peer Reviewers
Expertise Sought: EPA is seeking candidates who are nationally and/
or internationally recognized scientific experts to serve as external
peer reviewers for the draft BBDR model and draft model support
document for
[[Page 10618]]
perchlorate in drinking water. Nominees should possess and demonstrate
background knowledge and experience in one or more of the following
areas: (1) PBPK, PBPK/PD and/or BBDR modeling, (2) fetal and neonatal
thyroid endocrinology (clinical and experimental), (3) iodide
homeostasis, and (4) perchlorate toxicology and mode of action or
adverse outcome pathway.
Selection Criteria: Selection criteria for individuals nominated to
serve as external peer reviewers of the draft BBDR model and draft
model support document include the following: (1) Demonstrated
expertise through relevant peer reviewed publications, (2) professional
accomplishments and recognition by professional societies, (3)
demonstrated ability to work constructively and effectively in a
committee setting, (4) absence of financial conflicts of interest, (5)
no actual conflicts of interest or the appearance of lack of
impartiality, (6) willingness to commit adequate time for the thorough
review of the draft BBDR model and draft model support document,
commencing approximately in June 2016 (exact date to be determined),
and (7) availability to participate in-person in a one-day peer review
meeting in the Washington, DC metro area, projected to occur in
approximately August 2016 (exact date will be published in the Federal
Register at least 30 days prior to the external peer review meeting).
Further logistical information regarding the external peer review
meeting will be announced at a later date in the Federal Register.
Required Nominee Information: To receive full consideration, the
following information should be submitted to Versar
(perchlorate@versar.com) (the subject line should read: BBDR Model Peer
Review): (1) Contact information for the person making the nomination;
(2) contact information for the nominee; (3) the disciplinary and
specific areas of expertise of the nominee; (4) the nominee's
curriculum vitae; and (5) a biographical sketch of the nominee
indicating current position, educational background, past and current
research activities, recent service on other advisory committees, peer
review panels, editorial boards or professional organizations, sources
of recent grant and/or contract support and other comments on the
relevance of the nominee's expertise to this peer review topic.
Compensation for non-federal peer reviewers will be provided by Versar.
Selection Process: EPA's contractor, Versar, will notify candidates
of selection or non-selection. Versar may also conduct an independent
search for candidates to assemble a balanced group representing the
expertise needed to fully evaluate EPA's draft BBDR model and draft
model support document for perchlorate in drinking water. Versar will
consider and screen all candidates against the criteria previously
listed. Following the screening process, Versar will narrow the list of
potential reviewers to approximately 10-15 candidates. Prior to
selecting the final peer reviewers, a Federal Register notice will be
published (exact date to be determined) to solicit comments on the
interim list of candidates. In that notice, the public will be
requested to provide relevant information or documentation on the
nominees within 30 days of the announcement of the interim list of
candidates. Once Versar has considered the public comments on the
interim list of candidates, Versar will select the final list of peer
reviewers, based on who, collectively, will best provide expertise
spanning the disciplines previously listed and (to the extent feasible)
best provide a balance of perspectives.
Dated: February 21, 2016.
Joel Beauvais,
Deputy Assistant Administrator.
[FR Doc. 2016-04449 Filed 2-29-16; 8:45 am]
BILLING CODE 6560-50-P