[Federal Register Volume 79, Number 111 (Tuesday, June 10, 2014)]
[Notices]
[Pages 33203-33205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-13481]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Draft Report on Carcinogens Monograph on Trichloroethylene;
Availability of Documents; Request for Comments; Notice of Meeting
SUMMARY: The notice announces a meeting to peer review the Draft Report
on Carcinogens (RoC) Monograph on Trichloroethylene (TCE). This
document was prepared by the Office of the Report on Carcinogens
(ORoC), Division of the National Toxicology Program (DNTP), National
Institute of Environmental Health Sciences (NIEHS). The peer-review
meeting is open to the public. Registration is requested for both
public attendance and oral comment and required to access the webcast.
Information about the meeting and registration are available at http://ntp.niehs.nih.gov/go/38853.
DATES:
Meeting: August 12, 2014, 8:30 a.m. Eastern Daylight Time (EDT) to
adjournment. Document Availability: Draft monograph will be available
by June 30, 2014, at http://ntp.niehs.nih.gov/go/38853.
Written Public Comments Submissions: Deadline is July 30, 2014.
Registration for Meeting, Oral Comments, and/or to View Webcast:
Deadline is August 5, 2014. Registration to view the meeting via the
webcast is required.
ADDRESSES:
Meeting Location: Rodbell Auditorium, Rall Building, NIEHS, 111
T.W. Alexander Drive, Research Triangle Park, NC 27709.
Agency Meeting Web page: The draft monographs, draft agenda,
registration, and other meeting materials will be posted at http://ntp.niehs.nih.gov/go/38853.
Webcast: The URL for viewing the webcast will be provided to those
who register.
FOR FURTHER INFORMATION CONTACT: Dr. Lori White, NTP Designated Federal
Official, Office of Liaison, Policy and Review, DNTP, NIEHS, P.O. Box
12233, MD K2-03, Research Triangle Park, NC 27709. Phone: (919) 541-
9834, Fax: (301) 480-3272, Email: [email protected]. Hand Delivery/
Courier: 530 Davis Drive, Room 2136, Morrisville, NC 27560.
SUPPLEMENTARY INFORMATION:
Background
The RoC is a congressionally mandated, science-based, public health
report that identifies agents, substances,
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mixtures, or exposures (collectively called ``substances'') in our
environment that pose a cancer hazard for people in the United States.
The NTP prepares the RoC on behalf of the Secretary of Health and Human
Services.
The NTP follows an established, four-part process for preparation
of the RoC (http://ntp.niehs.nih.gov/go/rocprocess). A RoC monograph is
prepared for each candidate substance selected for review for the RoC.
Trichloroethylene was selected as a candidate substances following
solicitation of public comment, review by the NTP Board of Scientific
Counselors on June 21-22, 2012, and approved by the NTP Director
(http://ntp.niehs.nih.gov/go/9741). A draft RoC monograph consists of
(1) a cancer evaluation component that reviews all information that may
bear on a listing decision, assesses its quality and sufficiency for
reaching a listing decision, applies the RoC listing criteria to the
relevant scientific information, and recommends a listing status for
the candidate substance in the RoC and (2) a substance profile that
contains the NTP's preliminary listing recommendation and a summary of
the scientific evidence considered key to reaching that recommendation.
This meeting is planned for peer review of the draft RoC Monograph on
TCE.
Trichloroethylene (CASRN 79-01-6) is a halogenated alkene used
primarily in the past as a degreaser for metal parts and more currently
as an intermediate for hydrofluorocarbon (e.g., refrigerant)
production. It is a common drinking water contaminant and has also been
found in contaminated air and soil, and is an ingredient in many
consumer products (e.g., aerosols or degreasers for hobbies, crafts and
home and automobile maintenance). It is currently listed as reasonably
anticipated to be a human carcinogen in the 12th RoC. Additional
information about the review of TCE for the RoC is available at http://ntp.niehs.nih.gov/go/37899.
Meeting and Registration
This meeting is open to the public with time set aside for oral
public comment. The public may attend the meeting at NIEHS, where
attendance is limited only by the space available, or view the webcast.
Registration is required to view the webcast; the URL for the webcast
will be provided in the email confirming registration. Individuals who
plan to provide oral comments (see below) are encouraged to register
online at the meeting Web site (http://ntp.niehs.nih.gov/go/38853) by
August 5, 2014, to facilitate planning for the meeting.
The preliminary agenda and draft monograph should be posted on the
NTP Web site (http://ntp.niehs.nih.gov/go/38853) by June 30, 2014.
Additional information will be posted when available or may be
requested in hardcopy, see FOR FURTHER INFORMATION CONTACT. Following
the meeting, a report of the peer review will be prepared and made
available on the NTP Web site. Registered attendees are encouraged to
access the meeting Web page to stay abreast of the most current
information regarding the meeting.
Visitor and security information is available at http://www.niehs.nih.gov/about/visiting/index.cfm. Individuals with
disabilities who need accommodation to participate in this event should
contact Ms. Danica Andrews at phone: (919) 541-2595 or email:
[email protected]. TTY users should contact the Federal TTY Relay
Service at (800) 877-8339. Requests should be made at least five
business days in advance of the event.
Request for Comments
The NTP invites written and oral public comments on the draft
monograph. The deadline for submission of written comments is July 30,
2014, to enable review by the peer-review panel and NTP staff prior to
the meeting. Registration to provide oral comments is by August 5,
2014, at http://ntp.niehs.nih.gov/go/38853. Public comments and any
other correspondence on the draft monographs should be sent to the FOR
FURTHER INFORMATION CONTACT. Persons submitting written comments should
include their name, affiliation, mailing address, phone, email, and
sponsoring organization (if any) with the document. Written comments
received in response to this notice will be posted on the NTP Web site,
and the submitter will be identified by name, affiliation, and/or
sponsoring organization.
Public comment at this meeting is welcome, with time set aside for
the presentation of oral comments on the draft monograph. In addition
to in-person oral comments at the meeting at the NIEHS, public comments
can be presented by teleconference line. There will be 50 lines for
this call; availability will be on a first-come, first-served basis.
The lines will be open from 8:30 a.m. until adjournment on August 12,
2014, and oral comments will be received only during the formal public
comment period indicated on the preliminary agenda. Each organization
(sponsoring organization or affiliation) is allowed one time slot. At
least 7 minutes will be allotted to each speaker, and if time permits,
may be extended to 10 minutes at the discretion of the chair.
Persons wishing to make an oral presentation are asked to register
online at http://ntp.niehs.nih.gov/go/38853 by August 5, 2014, and if
possible, to send a copy of their slides and/or statement or talking
points at that time. Written statements can supplement and may expand
the oral presentation. Registration for in-person oral comments will
also be available at the meeting, although time allowed for
presentation by on-site registrants may be less than that for
registered speakers and will be determined by the number of speakers
who register on-site.
Background Information on the RoC
Published biennially, each edition of the RoC is cumulative and
consists of substances newly reviewed in addition to those listed in
previous editions. The 12th RoC, the latest edition, was published on
June 10, 2011 (available at http://ntp.niehs.nih.gov/go/roc12). The
13th RoC is under development. For each listed substance, the RoC
contains a substance profile, which provides information on: Cancer
studies that support the listing--including those in humans, animals,
and studies on possible mechanisms of action--information about
potential sources of exposure to humans, and current Federal
regulations to limit exposures.
Background Information on NTP Peer-Review Panels
NTP panels are technical, scientific advisory bodies established on
an ``as needed'' basis to provide independent scientific peer review
and advise the NTP on agents of public health concern, new/revised
toxicological test methods, or other issues. These panels help ensure
transparent, unbiased, and scientifically rigorous input to the program
for its use in making credible decisions about human hazard, setting
research and testing priorities, and providing information to
regulatory agencies about alternative methods for toxicity screening.
The NTP welcomes nominations of scientific experts for upcoming panels.
Scientists interested in serving on an NTP panel should provide a
current curriculum vita to the FOR FURTHER INFORMATION CONTACT. The
authority for NTP panels is provided by 42 U.S.C. 217a; section 222 of
the Public Health Service (PHS) Act, as amended. The panel is governed
by the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix
2), which sets forth standards for the formation and use of advisory
committees.
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Dated: June 4, 2014.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2014-13481 Filed 6-9-14; 8:45 am]
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