81 FR 10617 - Request for Nominations for Peer Reviewers for EPA's Biologically Based Dose-Response (BBDR) Model for Perchlorate in Drinking Water
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 81, Issue 40 (March 1, 2016)
Federal Register Volume 81, Issue 40 (March 1, 2016)
| Page Range | 10617-10618 | |
| FR Document | 2016-04449 |
[Federal Register Volume 81, Number 40 (Tuesday, March 1, 2016)] [Notices] [Pages 10617-10618] From the Federal Register Online [www.thefederalregister.org] [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: [email protected] (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 [email protected] (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: [email protected]. 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 ([email protected]) (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
![Federal Register / Vol. 81, No. 40 / Tuesday, March 1, 2016 / Notices 10617
3 MassMailing: 2 letters have been sent to FERC Commissioners and staff under this docket number.
4 MassMailing: 2 letters have been sent to FERC Commissioners and staff under this docket number.
5 MassMailing: 2 letters have been sent to FERC Commissioners and staff under this docket number.
6 Mass Mailing: 8 letters have been sent to FERC Commissioners and staff under this docket number.
7 Mass Mailing: 2 letters have been sent to FERC Commissioners and staff under this docket number.
8 Senator Sheldon Whitehouse, Senator Jack Reed, House Representative James R. Langevin, and House Representative David N. Cicilline.
9 Memo forwarding letter dated January 29, 2016 from Paul A. Raber of Society for Pennsylvania Archaeology.
10 Meeting summary from February 17, 2016 telephone call with Brian Scofield of Pennsylvania Field Office of the Fish and Wildlife Service re-
garding Eastern Shore White Oak Machine Expansion Project.
11 Email Record dated February 17, 2016 between FERC Staff and Jeff Crocker of Vermont Department of Environment Conservation.
12 Conference Call Notes from February 9, 2016 call between FERC and NPS regarding the Orion Project.
Dated: February 23, 2016. ADDRESSES: Any interested person or level goal (MCLG) and a NPDWR (42
Nathaniel J. Davis, Sr., organization may nominate scientific U.S.C. 1412(e)).
Deputy Secretary. experts to be considered as peer In 2012, EPA sought guidance from
[FR Doc. 2016–04390 Filed 2–29–16; 8:45 am] reviewers. Nominations should be the SAB on how best to consider and
BILLING CODE 6717–01–P
submitted in time to arrive no later than interpret life stage information,
March 31, 2016. Self-nominations will epidemiologic and biomonitoring data,
also be accepted. Nominations should physiologically based pharmacokinetic
be submitted to the EPA contractor, (PBPK) analyses and the totality of
ENVIRONMENTAL PROTECTION Versar, Inc., using the following email perchlorate health information to derive
AGENCY address: perchlorate@versar.com (the an MCLG for perchlorate. The MCLG is
[EPA–HQ–OW–2009–0297; FRL–9942–98– subject line should read: BBDR Model the maximum level of a contaminant in
OW] Peer Review). Nominations will also be drinking water at which no known or
accepted via U.S. Postal Service mail or anticipated adverse effect on the health
Request for Nominations for Peer by an overnight/priority mail service. of persons would occur, and which
Reviewers for EPA’s Biologically Mailed nominations should be allows an adequate margin of safety.
Based Dose-Response (BBDR) Model addressed to Versar, Inc., 6850 Versar MCLGs are non-enforceable public
for Perchlorate in Drinking Water Center, Springfield, VA 22151 health goals.
(Attention: David Bottimore). In 2013, the SAB recommended that,
AGENCY: Environmental Protection ‘‘. . . EPA derive a perchlorate MCLG
Nominations should include all
Agency (EPA). that addresses sensitive life stages
nominee information outlined in section
ACTION: Notice; request for nominations II of the SUPPLEMENTARY INFORMATION through physiologically-based
for peer reviewers. section of this document. pharmacokinetic/pharmacodynamic
(PBPK/PD) modeling based upon its
SUMMARY: The U.S. Environmental FOR FURTHER INFORMATION CONTACT:
mode of action rather than the default
Protection Agency (EPA) invites the Questions concerning the nomination
MCLG approach using the reference
public to nominate scientific experts to process should be directed to the EPA
dose and specific chemical exposure
be considered as peer reviewers for the contractor, Versar, Inc., at 6850 Versar
parameters’’ (see Advice on Approaches
contractor-managed, external peer Center, Springfield, VA 22151; by email
to Derive a Maximum Contaminant
review of the draft Biologically Based to perchlorate@versar.com (the subject
Level Goal for Perchlorate, EPA–SAB–
Dose-Response model for perchlorate in line should read: BBDR Model Peer
13–004). The SAB found that ‘‘. . . this
drinking water and the draft model Review); or by phone: (703) 642–6815
data-driven approach represents a more
support document. The draft model (ask for David Bottimore). For additional
rigorous way to address differences in
predicts changes in thyroid hormones in information concerning the draft BBDR
biology and exposure between adults
sensitive life stages exposed to different model and draft model support
and sensitive life stages than is possible
dietary iodide and perchlorate levels. document, please contact Russ
with the default approach for deriving
EPA has been working with scientists at Perkinson at the U.S. Environmental
an MCLG.’’
the Food and Drug Administration to Protection Agency, Office of Ground
Based on the SAB’s
develop the model recommended by Water and Drinking Water, Standards
recommendations, EPA and Food and
EPA’s Science Advisory Board for the and Risk Management Division, (Mail
Drug Administration (FDA) scientists
derivation of a maximum contaminant Code 4607M), 1200 Pennsylvania
developed a BBDR (also known as a
level goal for perchlorate in drinking Avenue NW., Washington, DC 20460;
PBPK/PD) model to determine under
water. The model integrates previous telephone: 202–564–4901; or email:
what conditions of iodine nutrition and
perchlorate and iodine models for perkinson.russ@epa.gov.
exposure to perchlorate across sensitive
thyroid hormones in formula-fed and SUPPLEMENTARY INFORMATION: life stages low serum free and total
nursing infants, as well as lactating thyroxine would result. EPA is
women. The model predicts the effects I. Information on the Draft Biologically
Based Dose-Response (BBDR) Model considering deriving a perchlorate
of perchlorate on serum thyroid MCLG by linking BBDR model output to
hormone concentrations in infants and Draft Model Support Document for
Perchlorate in Drinking Water information from literature to account
exposed via ingestion of formula mixed for adverse health outcomes.
with contaminated drinking water or EPA is developing a National Primary
asabaliauskas on DSK5VPTVN1PROD with NOTICES
breast milk. EPA anticipates releasing Drinking Water Regulation (NPDWR) for II. How to Submit Nominations for Peer
the draft model and draft model support Perchlorate in accordance with the Reviewers
document for peer review and public requirements under the Safe Drinking Expertise Sought: EPA is seeking
comment in the near future (the exact Water Act (SDWA). Among these candidates who are nationally and/or
date to be determined). requirements are that the agency must internationally recognized scientific
DATES: The nomination period for request comment from the EPA’s experts to serve as external peer
scientific experts begins on March 1, Science Advisory Board (SAB) prior to reviewers for the draft BBDR model and
2016 and ends on March 31, 2016. proposal of a maximum contaminant draft model support document for
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![10618 Federal Register / Vol. 81, No. 40 / Tuesday, March 1, 2016 / Notices
perchlorate in drinking water. Nominees also conduct an independent search for nominees will be selected from the
should possess and demonstrate candidates to assemble a balanced group following stakeholder work force
background knowledge and experience representing the expertise needed to sectors:
in one or more of the following areas: fully evaluate EPA’s draft BBDR model • Academia
(1) PBPK, PBPK/PD and/or BBDR and draft model support document for • Business and industry
modeling, (2) fetal and neonatal thyroid perchlorate in drinking water. Versar • Environmental laboratory
endocrinology (clinical and will consider and screen all candidates commercial, municipal, small, other
experimental), (3) iodide homeostasis, against the criteria previously listed. • Environmental laboratory suppliers of
and (4) perchlorate toxicology and mode Following the screening process, Versar services
of action or adverse outcome pathway. will narrow the list of potential • State and local Government agencies
Selection Criteria: Selection criteria reviewers to approximately 10–15 • Tribal governments and indigenous
for individuals nominated to serve as candidates. Prior to selecting the final groups
external peer reviewers of the draft peer reviewers, a Federal Register • Trade associations
BBDR model and draft model support notice will be published (exact date to Within these sectors, EPA is seeking
document include the following: (1) be determined) to solicit comments on nominees with knowledge in methods
Demonstrated expertise through the interim list of candidates. In that development; measurements;
relevant peer reviewed publications, (2) notice, the public will be requested to monitoring and regulatory programs;
professional accomplishments and provide relevant information or quality systems; and environmental
recognition by professional societies, (3) documentation on the nominees within accreditation. In an effort to obtain
demonstrated ability to work 30 days of the announcement of the nominations of diverse candidates, the
constructively and effectively in a interim list of candidates. Once Versar agency encourages nominations of
committee setting, (4) absence of has considered the public comments on women and men of all racial and ethnic
financial conflicts of interest, (5) no the interim list of candidates, Versar groups. All nominations will be fully
actual conflicts of interest or the will select the final list of peer considered.
appearance of lack of impartiality, (6) reviewers, based on who, collectively, Any interested person or organization
willingness to commit adequate time for will best provide expertise spanning the may nominate qualified persons to be
the thorough review of the draft BBDR disciplines previously listed and (to the considered for appointment to this
model and draft model support extent feasible) best provide a balance of advisory committee. Individuals may
document, commencing approximately perspectives. self-nominate. Nominees should possess
in June 2016 (exact date to be the following qualifications:
determined), and (7) availability to Dated: February 21, 2016. • Demonstrated experience with
participate in-person in a one-day peer Joel Beauvais, environmental measurement programs
review meeting in the Washington, DC Deputy Assistant Administrator. and environmental accreditation;
metro area, projected to occur in [FR Doc. 2016–04449 Filed 2–29–16; 8:45 am] • Willingness to commit time to the
approximately August 2016 (exact date BILLING CODE 6560–50–P committee, and demonstrated ability to
will be published in the Federal work constructively and effectively on
Register at least 30 days prior to the committees;
external peer review meeting). Further ENVIRONMENTAL PROTECTION • Excellent interpersonal, oral, and
logistical information regarding the AGENCY written communication and consensus-
external peer review meeting will be [FRL–9943–11–ORD]
building skills; and
announced at a later date in the Federal • Ability to serve a 2-year
Register. Environmental Laboratory Advisory appointment and volunteer
Required Nominee Information: To Board (ELAB) Membership approximately 5–7 hours per month to
receive full consideration, the following support the Board’s activities.
information should be submitted to AGENCY: U.S. Environmental Protection How to Submit Nominations:
Versar (perchlorate@versar.com) (the Agency (EPA). Nominations can be submitted in
subject line should read: BBDR Model ACTION: Notice soliciting nominations electronic format (preferred) to Ms. Lara
Peer Review): (1) Contact information for membership. P. Phelps, Designated Federal Officer,
for the person making the nomination; US EPA, MC E243–05, 109 T. W.
(2) contact information for the nominee; SUMMARY: The U.S. Environmental Alexander Drive, Research Triangle
(3) the disciplinary and specific areas of Protection Agency’s (EPA) invites Park, NC 27709, or email to
expertise of the nominee; (4) the nominations from a diverse range of phelps.lara@epa.gov and should be
nominee’s curriculum vitae; and (5) a qualified candidates to be considered received by April 1, 2016 for October
biographical sketch of the nominee for appointment to its Environmental 2016 appointment. To be considered, all
indicating current position, educational Laboratory Advisory Board (ELAB). The nomination packages should include:
background, past and current research ELAB is a multi-stakeholder federal • Current contact information for the
activities, recent service on other advisory committee that provides nominee, including the nominee’s
advisory committees, peer review independent advice and name, organization (and position within
panels, editorial boards or professional recommendations to the EPA that organization), current business
organizations, sources of recent grant Administrator, Science Advisor, and address, email address, and daytime
and/or contract support and other Forum on Environmental Measurements
asabaliauskas on DSK5VPTVN1PROD with NOTICES
telephone number.
comments on the relevance of the (FEM) about cross-cutting issues related • Brief statement describing the
nominee’s expertise to this peer review to enhancing EPA’s measurement nominee’s interest in serving on the
topic. Compensation for non-federal programs, and facilitating the operation ELAB.
peer reviewers will be provided by and expansion of national • Resume describing the professional
Versar. environmental accreditation. and educational qualifications of the
Selection Process: EPA’s contractor, This notice solicits nominations to fill nominee, including a list of relevant
Versar, will notify candidates of eight–nine (8–9) new vacancies. To activities, and any current or previous
selection or non-selection. Versar may maintain diverse representation, service on advisory committees.
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Document Created: 2018-02-02 15:00:14
Document Modified: 2018-02-02 15:00:14
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice; request for nominations for peer reviewers. | |
| Dates | The nomination period for scientific experts begins on March 1, 2016 and ends on March 31, 2016. | |
| 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 [email protected] (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: [email protected] | |
| FR Citation | 81 FR 10617 |
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