[Federal Register Volume 78, Number 162 (Wednesday, August 21, 2013)]
[Notices]
[Pages 51733-51734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-19928]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Draft Report on Carcinogens Monographs for ortho-Toluidine and 
Pentachlorophenol and By-Products of Its Synthesis; Availability of 
Documents; Request for Comments; Notice of Meeting

SUMMARY: The notice announces a meeting to peer review the Draft Report 
on Carcinogens (RoC) Monographs for ortho-Toluidine and 
Pentachlorophenol and By-products of its Synthesis (hereafter referred 
to as ``pentachlorophenol''). These documents were prepared by the 
Office of the Report on Carcinogens (ORoC), Division of the National 
Toxicology Program (DNTP), National Institute of Environmental Health 
Sciences (NIEHS).

DATES: Meeting: October 7, 2013, 8:30 a.m. to approximately 5:00 p.m. 
Eastern Daylight Time (EDT) and October 8, 2013, from 8:30 a.m. until 
adjournment, approximately 11:30 a.m.
    Document Availability: Draft monographs will be available by August 
28, 2013, at http://ntp.niehs.nih.gov/go/38853.
    Public Comments Submissions: Deadline is September 25, 2013.
    Pre-Registration for Meeting and/or Oral Comments: Deadline is 
September 30, 2013.

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 meeting will be available via webcast at http://www.niehs.nih.gov/news/video/index.cfm.

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 Report on Carcinogens (RoC) is a congressionally 
mandated, science-based, public health report that identifies agents, 
substances, 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. 
Pentachlorophenol and ortho-toluidine were selected as 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 a (1) 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 Monographs for ortho-toluidine and 
pentachlorophenol.
    ortho-Toluidine (CASRN 95-53-4) is an arylamine used (directly or 
as an intermediate) to manufacture herbicides, dyes, pigments, and 
rubber chemicals. It is currently listed as reasonably anticipated to 
be a human carcinogen in the 12th RoC. Additional information about the 
review of ortho-toluidine for the RoC is available at http://ntp.niehs.nih.gov/go/37898.
    Pentachlorophenol (CASRN 87-86-5) is a general biocide that has 
been used extensively as a fungicide, bactericide, herbicide, and 
insecticide by agriculture and other industries. In 1987, over-the-
counter use was banned and other uses restricted. Currently, 
pentachlorophenol is defined in the United States as a `heavy duty' 
wood preservative that is used primarily in the treatment of utility 
poles and cross arms. The candidate substance is defined as 
``pentachlorophenol and by-products of its synthesis.'' During 
synthesis of pentachlorophenol, several additional chlorinated 
molecules are formed as by-products. In addition, biomonitoring studies 
have found that people who are exposed to pentachlorophenol or 
pentachlorophenol-containing products are always exposed to the 
combination of pentachlorophenol and its by-products. Additional 
information about the review of pentachlorophenol for the RoC is 
available at http://ntp.niehs.nih.gov/go/37897.
    Meeting and Registration: The meeting is open to the public with 
time set aside for oral public comment; attendance at the NIEHS is 
limited only by the space available. The meeting is scheduled for 
October 7, 2013, 8:30 a.m. to approximately 5:00 p.m. EDT and October 
8, 2013, from 8:30 a.m. until adjournment, approximately 11:30 a.m. Two 
days are set aside for the meeting; however, it may adjourn sooner if 
the panel completes its peer review of the draft monographs. Pre-
registration to attend the meeting and/or provide oral comments is by 
September 30, 2013, at http://ntp.niehs.nih.gov/go/38853. 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. Robbin 
Guy at phone: (919) 541-4363 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.
    The preliminary agenda and draft monographs should be posted on the 
NTP Web site (http://ntp.niehs.nih.gov/go/38853) by August 28, 2013. 
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.
    Request for Comments: The NTP invites written and oral public 
comments on the draft monographs. The deadline for submission of 
written comments is September 25, 2013, to enable review by the peer-
review panel

[[Page 51734]]

and NTP staff prior to the meeting. Pre-registration to provide oral 
comments is by September 30, 2013, 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 monographs. 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 approximately 5:00 p.m. EDT 
on October 7 and from 8:30 a.m. EDT until adjournment on October 8, and 
oral comments will be received only during the formal public comment 
periods indicated on the preliminary agenda. Each organization is 
allowed one time slot per monograph. 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 September 30, 2013, 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 oral comments will also be available at the meeting, 
although time allowed for presentation by on-site registrants may be 
less than that for pre-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 vitae 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.

    Dated: August 14, 2013.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2013-19928 Filed 8-20-13; 8:45 am]
BILLING CODE 4140-01-P