[Federal Register Volume 80, Number 91 (Tuesday, May 12, 2015)]
[Notices]
[Pages 27178-27179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11355]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Draft Report on Carcinogens Monograph on Cobalt and Certain 
Cobalt Compounds; Availability of Document; Request for Comments; 
Notice of Meeting

SUMMARY: The notice announces a meeting to peer review the Draft Report 
on Carcinogens (RoC) Monograph on Cobalt and Certain Cobalt Compounds. 
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 is available at http://ntp.niehs.nih.gov/go/38853.

DATES: 
    Meeting: July 22, 2015, 9:00 a.m. Eastern Daylight Time (EDT) to 
adjournment.
    Document Availability: Draft monograph will be available by June 5, 
2015, at http://ntp.niehs.nih.gov/go/38853.
    Written Public Comments Submissions: Deadline is July 8, 2015. 
Registration for Attendance and/or Oral Comments: Deadline is July 15, 
2015. 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, 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. 
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.
    Cobalt was selected as a candidate substance following solicitation 
of public comment, review by the NTP Board of Scientific Counselors on 
April 16--18, 2014, and approved by the NTP Director (http://ntp.niehs.nih.gov/go/9741). This meeting is planned for peer review of 
the Draft RoC Monograph on Cobalt and Certain Cobalt Compounds.
    Cobalt is a naturally occurring metallic element that exists in 
different forms. It occurs in the environment in ores where it is 
combined with other elements such as arsenic and sulfur. Pure cobalt is 
a grey metal and there are numerous inorganic and organic cobalt 
compounds, with varying valence states and water solubility. The RoC 
evaluation includes cobalt metal and certain cobalt compounds--both 
water soluble and poorly soluble compounds--that can release cobalt 
ions in biological fluids. One cobalt compound that releases cobalt 
ions, cobalt sulfate, is listed in the 13th RoC as reasonably 
anticipated to be a human carcinogen (http://ntp.niehs.nih.gov/go/roc13). The RoC evaluation does not include cobalt forms that have 
confounding exposures, such as cobalt carbides, alloys and radioactive 
forms of cobalt or cobalt compounds. It also does not include Vitamin 
B12, which does not release cobalt ions in vivo. Cobalt-
tungsten carbide: powders and hard metals is listed in the 13th RoC as 
reasonably anticipated to be a human carcinogen and is not included in 
this evaluation.
    Major uses of cobalt include the production of cemented carbides, 
diamond tools, and superalloys and other alloys used in a variety of 
commercial, industrial, medical and military applications. Some cobalt 
compounds are used as pigments for coloring glass, ceramics, and 
pottery. A more recent use of cobalt is in green energy (e.g., 
rechargeable batteries for electric vehicles and consumer electronics). 
People are exposed to cobalt in workplaces that process cobalt metals 
and produce cobalt alloys; exposure to cobalt in their everyday lives 
may also result from implanted medical devices, consumption of food and 
drinking water and, to a lesser extent, from breathing contaminated 
air. Additional information about the review of cobalt and certain 
cobalt compounds for the RoC is available at http://ntp.niehs.nih.gov/go/730697.
    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 July 15, 2015, 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 5, 2015. 
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. Robbin Guy at

[[Page 27179]]

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.
    Request for Comments: The NTP invites written and oral public 
comments on the draft monograph. The deadline for submission of written 
comments is July 8, 2015, to enable review by the peer-review panel and 
NTP staff prior to the meeting. Registration to provide oral comments 
is by July 15, 2015, 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 9:00 a.m. until adjournment on July 22, 
2015, 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 July 15, 2015, 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 13th 
RoC, the latest edition, was published on October 2, 2014 (available at 
http://ntp.niehs.nih.gov/go/roc13). The 14th 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.

    Dated: May 6, 2015.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2015-11355 Filed 5-11-15; 8:45 am]
 BILLING CODE 4140-01-P