[Federal Register Volume 85, Number 143 (Friday, July 24, 2020)]
[Notices]
[Pages 44885-44887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16048]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD-2020-0181; FRL-10011-36-ORD]
Notice of Public Comment Period on Technical Documents for
External Peer Review and the Pool of Candidate Peer Reviewers for a
Report on Physiologically Based Pharmacokinetic (PBPK) Modeling for
Chloroprene and a Supplemental Analysis of Metabolite Clearance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of public comment period and external peer review.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) is announcing a 30-
day public comment period on documents
[[Page 44886]]
associated with a Report on Physiologically Based Pharmacokinetic
(PBPK) Modeling for Chloroprene and a Supplemental Analysis of
Metabolite Clearance. These documents will undergo independent external
scientific peer review managed by Versar (https://www.versar.com/), an
EPA contractor. Public comments on the documents associated with the
PBPK modeling will be provided to the external peer reviewers. Versar
will convene a virtual meeting of the peer reviewers, which will be
open to the public and include an opportunity to provide oral comments.
In preparation for the external peer review, EPA is also announcing a
30-day public comment period on the pool of candidates to conduct the
external peer review of the documents identified above. Versar will
consider public comments on these candidates and evaluate any conflicts
of interest and/or appearance of lack of impartiality, and will then
select nine independent experts from the pool of 19 candidates.
Information on the external peer review process, including details on
how to provide comments on the proposed pool of candidates, is further
described in this notice. Once complete, the final peer review report
will be used to inform EPA's Reconsideration of a 2017 Request for
Correction related to the Integrated Risk Information System (IRIS)
assessment of chloroprene.
DATES: The 30-day public comment period on the technical documents and
the list of proposed peer review candidates begins July 24, 2020 and
ends August 24, 2020. Comments must be received on or before August 24,
2020.
ADDRESSES: Submit written comments to Docket ID No. EPA-HQ-ORD-2020-
0181 no later than August 24, 2020. Documents associated with this peer
review will be available within the docket.
Submit comments on the pool of candidate peer reviewers to Versar
no later than August 24, 2020 by one of the following methods:
[email protected] (Subject line: Chloroprene PBPK Peer
Review); or by phone (301) 304-3121 (ask for Tracey Cowen). Please be
advised that public comments are subject to release under the Freedom
of Information Act.
FOR FURTHER INFORMATION CONTACT:
For information on how to submit comments on the technical
documents contact: The EPA Headquarters Docket Center; telephone: 202-
566-1752; facsimile: 202-566-9744; or email: [email protected].
For general information contact: Dahnish Shams, CPHEA; telephone:
202-564-2758; or email: [email protected].
For information regarding the peer review contact: Versar at
[email protected] (Subject line: Chloroprene PBPK Peer
Review); or by phone (301) 304-3121 (ask for Tracey Cowen).
SUPPLEMENTARY INFORMATION:
I. Background
On June 26, 2017, the U.S. EPA received a Request for Correction
(RFC) provided on behalf of Denka Performance Elastomer LLC (DPE). In
the RFC letter, DPE claimed that the Toxicological Review of
Chloroprene (CAS NO. 126-99-8) in Support of Summary Information on the
Integrated Risk Information System (IRIS), disseminated by EPA's Office
of Research and Development (ORD) in 2010, did not reflect the ``best
available science'' or ``sound and objective scientific practices'' and
requested correction. On January 25, 2018, EPA concluded in response
that the underlying information and conclusions presented in the IRIS
chloroprene assessment are consistent with the EPA's Information
Quality Guidelines and that no evidence published since the 2010 IRIS
Assessment would change its conclusions. On July 23, 2018, DPE
submitted a Request for Reconsideration of Denial of Request for
Correction (RFR) with regard to EPA's decision, and entered into
discussions with EPA to address the uncertainties identified by EPA as
documented in the RFC response. Additional information regarding the
chloroprene RFC/RFR can be found at: https://www.epa.gov/quality/epa-information-quality-guidelines-requests-correction-and-requests-reconsideration#17002. Discussions with Denka LLC (DPE) and its
contractor, Ramboll, are summarized on the IRIS website (https://cfpub.epa.gov/ncea/iris2/events.cfm#stakeholderMeetings).
An updated PBPK model is now available in a report:
``Physiologically Based Pharmacokinetic (PBPK) Modeling for Chloroprene
(Ramboll, 2020)''. This report, and a Supplemental Analysis of
Metabolite Clearance (U.S. EPA, 2020), will undergo external peer
review to help to inform future decisions regarding the RFR.
II. Information About this Peer Review
Versar is considering a list of candidates from which to select the
independent, external, peer review panel. The List of Candidates (LoC)
document has been posted to the docket at https://www.regulations.gov
(Docket ID No. EPA-HQ-ORD-2020-0181) and is included below. After
review and consideration of public comments, Versar will select from
this pool the final list of nine (9) peer reviewers in a manner
consistent with EPA's Peer Review Handbook 4th Edition, 2015 (EPA/100/
B-15/001). Versar will independently conduct a conflict of interest
(COI) screening of candidates to ensure that the selected experts have
no COI. EPA will announce the peer review panel meeting date, location,
and registration details, along with the final list of peer reviewers
selected by Versar, at least 30 days prior to the peer review meeting,
on the EPA IRIS website (https://www.epa.gov/iris). Teleconference and
webinar information regarding this public meeting will be provided
through the IRIS website (https://www.epa.gov/iris) and via EPA's IRIS
listserv. To register for the IRIS listserv, visit IRIS website at
https://www.epa.gov/iris/forms/staying-connected-integrated-risk-information-system#connect. Specific questions or comments on the peer
review process should be directed to Versar by email:
[email protected] (Subject line: Chloroprene PBPK Peer
Review); or by phone (301) 304-3121 (ask for Tracey Cowen). Comments or
questions regarding the peer review candidates must be provided to
Versar by August 24, 2020.
1. Guohua An, M.D., Ph.D., Iowa State University
2. Leslie Z. Benet, Ph.D., University of California San Francisco
3. James V. Bruckner, Ph.D., University of Georgia
4. Michael J. Daniels, Ph.D., University of Florida
5. Stephen S. Ferguson, Ph.D., National Institute of Environmental
Health Sciences (NIEHS),
National Toxicology Program Division (DNTP)
6. Bernard T. Golding, Ph.D., Newcastle University, UK
7. Jeffrey Heys, Ph.D., P.E., Montana State University
8. Nan-Hung Hsieh, Ph.D., Texas A&M University
9. Zhoumeng Lin, BMed, Ph.D., D.A.B.T., Kansas State University
10. Jochem Louisse, Ph.D., Wageningen Food Safety Research (WFSR),
part of Wageningen University and Research, the Netherlands
11. Annie Lumen, Ph.D., Food and Drug Administration (FDA), National
Center for Toxicological Research (NCTR)
12. Kenneth M. Portier, Ph.D., Independent Consultant
13. Dhaval K. Shah, Ph.D., University of Buffalo
14. Kan Shao, Ph.D., Indiana University
15. Jordan Ned Smith, Ph.D., Pacific Northwest National Laboratory
(PNNL)
[[Page 44887]]
16. Gong Tang, Ph.D., University of Pittsburgh, Graduate School of
Public Health
17. Raymond S. H. Yang, Ph.D., Colorado State University
18. Qiang Zhang, Ph.D., Emory University
19. Yiliang Zhu, Ph.D., University of New Mexico School of Medicine
III. How to Submit Technical Comments to the Docket
Please note that questions or comments regarding the peer review
process, including comments on the candidate pool of peer reviewers,
should be directed to [email protected] (Subject line:
Chloroprene PBPK Peer Review); or by phone (301) 304-3121 (ask for
Tracey Cowen). Comments on the technical documents related to the PBPK
modeling should be submitted to Docket ID No. EPA-HQ-ORD-2020-0181, by
one of the following methods:
Online: https://www.regulations.gov. Follow the online
instructions for submitting comments.
Email: [email protected].
Fax: 202-566-9744. Due to COVID-19, there may be a delay
in processing comments submitted by fax.
Mail: U.S. Environmental Protection Agency, EPA Docket
Center (ORD Docket), Mail Code: 28221T, 1200 Pennsylvania Avenue NW,
Washington, DC 20460. The phone number is 202-566-1752. Due to COVID-
19, there may be a delay in processing comments submitted by mail.
Note: The EPA Docket Center and Reading Room is currently closed
to public visitors to reduce the risk of transmitting COVID-19.
Docket Center staff will continue to provide remote customer service
via email, phone, and webform. The public can submit comments via
www.Regulations.gov or email. No hand deliveries are currently being
accepted.
Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2020-0181. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available online at
www.regulations.gov, including any personal information provided,
unless a comment includes information claimed to be Confidential
Business Information (CBI) or other information for which disclosure is
restricted by statute. Do not submit information through
www.regulations.gov or email that you consider to be CBI or otherwise
protected. The www.regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to EPA without going through
www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at www.epa.gov/epahome/dockets.htm.
Docket: Documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the ORD Docket in the EPA
Headquarters Docket Center.
Wayne E. Cascio,
Director, Center for Public Health & Environmental Assessment.
[FR Doc. 2020-16048 Filed 7-23-20; 8:45 am]
BILLING CODE 6560-50-P