[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.


[[Page 33205]]


    Dated: June 4, 2014.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2014-13481 Filed 6-9-14; 8:45 am]
BILLING CODE 4140-01-P