Document ID: EPA-HQ-ORD-2020-0181-0001
Agency: epa
Document Type: Notice
Title: 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
Posted Date: 2020-07-24T04:00Z

[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]

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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.

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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: 
chloroprenePBPK@versar.com (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: Docket_ORD@epa.gov.
    For general information contact: Dahnish Shams, CPHEA; telephone: 
202-564-2758; or email: shams.dahnish@epa.gov.
    For information regarding the peer review contact: Versar at 
chloroprenePBPK@versar.com (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: 
chloroprenePBPK@versar.com (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 chloroprenePBPK@versar.com (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: Docket_ORD@epa.gov.
     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]
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