[Federal Register Volume 67, Number 183 (Friday, September 20, 2002)]
[Notices]
[Pages 59301-59303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-23874]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Toxicology Program (NTP) Board of Scientific Counselors' 
Meeting; Review of Nominations for Listing in the 11th Report on 
Carcinogens

    Pursuant to Public Law 92-463, notice is hereby given of the next 
meeting of the NTP Board of Scientific Counselors Report on Carcinogens 
Subcommittee (``the NTP RoC Subcommittee'') to be held on November 19 & 
20, 2002, at the Hyatt Regency Bethesda, One Bethesda Metro Center, 
7400 Wisconsin Avenue, Bethesda, MD 20814. On November 19, registration 
will begin at 9 a.m. and the meeting will begin at 9:30 a.m. On 
November 20, the meeting will begin at 8:30 a.m. Pre-registration is 
not required; however, persons requesting time to make oral, public 
comments are asked to notify Dr. Mary S. Wolfe, Executive Secretary, 
prior to the meeting (contact information given below). The agenda 
covers the peer review of 10 nominations for possible listing in the 
11th Report on Carcinogens, and includes an opportunity for public 
input.

Background

    The Department of Health and Human Services (DHHS) Report on 
Carcinogens (RoC) is a public information document prepared by the 
National Toxicology Program (NTP) in response to Section 301(b)(4) of 
the Public Health Service Act, as amended. The intent of the document 
is to provide a listing of those agents, substances, mixtures or 
exposure circumstances that are either ``known'' or ``reasonably 
anticipated'' to cause cancer in humans and to which a significant 
number of people in the United States are exposed. The process for 
preparation of the RoC has three levels of scientific peer review. 
Central to the evaluations of the review groups is the use of criteria 
for inclusion in or removal of listings from the RoC. The current 
criteria for listing in or delisting from the report is available on 
the Internet at the following website: http://ntp-server.niehs.nih.gov/NewHomeRoc/ListingCriteria.html, or can be obtained in hard copy by 
contacting Dr. Jameson at the address listed below. The review process 
for listing in or delisting from the RoC begins with initial scientific 
review by the National Institute of Environmental Health Sciences 
(NIEHS)/NTP Report on Carcinogens Review Committee (RG1), which is 
comprised of NIEHS/NTP staff scientists. The second scientific review 
group (RG2) is comprised of representatives from the Federal health 
research and regulatory agencies that are members of the NTP Executive 
Committee. The third step is external public peer review by the NTP RoC 
Subcommittee. Following completion of these reviews and solicitation of 
public comments through announcements in the Federal Register and other 
media, the independent recommendations of the three scientific peer 
review groups and all public comments are presented to the NTP 
Executive Committee for review and comment. All recommendations and 
public comments are submitted to the Director, NTP, who reviews them 
and makes a final recommendation to the Secretary, DHHS, concerning the 
listing or delisting of substances or exposure circumstances in the 
RoC. The Secretary has final review and approval for the 11th RoC.

Agenda

    The meeting of the NTP RoC Subcommittee is scheduled for November 
19 & 20, 2002. Tentatively scheduled to be peer reviewed are 10 
nominated chemicals or exposure circumstances. These nominations are 
listed alphabetically in the attached table, along with supporting 
information and a tentative order of presentation and review. 
Background summary documents for each of the nominations are available 
to the public and include a summary of the scientific data and 
information being used to evaluate the nomination. A copy of the draft 
background summary document for each of these nominations is available 
electronically through the NTP's homepage at http://ntp-server.niehs.nih.gov/ (select Report on Carcinogens) or can be obtained 
on CD or in hard copy, as available, from: Dr. C.W. Jameson, Report on 
Carcinogens, NIEHS, MD EC-14, 79 Alexander Drive, Building 4401, Room 
3118, P.O. Box 12233, Research Triangle Park, NC 27709 (919/541-4096; 
FAX 919/541-0144; email [email protected]).
    Previous announcements in the Federal Register (July 24, 2001: 
Volume 66, Number 142, Pages 38430-38432 and March 28, 2002: Volume 67, 
Number 60, Page 14957) called for public comments on the nominations to 
be reviewed for possible listing in the 11th RoC. These announcements 
identified a total of 17 nominations. This review by the NTP RoC 
Subcommittee is for the first set of 10 nominations identified in those 
Federal Register announcements that have completed review by the RG1 
and the RG2. The remaining 7 nominations for the 11th RoC will be 
reviewed by the NTP RoC Subcommittee in 2003. The date and details 
about that meeting will be published in a future Federal Register 
notice.

Solicitation of Public Comment

    The NTP RoC Subcommittee meeting is open to the public, and time 
will be provided for oral public comment on each of the nominations 
under review. In order to facilitate planning for the meeting, persons 
requesting time for an oral presentation regarding a particular 
nomination should notify the Executive Secretary, Dr. Mary S. Wolfe, 
P.O. Box 12233, A3-01, Research Triangle Park, NC 27709 (telephone 919/
541-3971; FAX 919/541-0295; email [email protected]) no later than 
November 4, 2002. Each organization is allowed one time slot for an 
oral presentation per nomination. Persons registering to make comments 
are asked to provide, if possible, a written copy of their statement by 
November 4th so copies can be made and distributed to NTP RoC 
Subcommittee members for their timely review prior to the meeting. 
Written statements can supplement and expand the oral presentation, and 
each speaker is asked to provide his/her name, affiliation, mailing 
address, phone, fax, e-mail and supporting organization (if any). At 
least 7 minutes will be allotted to each speaker, and if time permits, 
can be extended to 10 minutes. Individuals who register to make oral 
presentations by November 4th will be notified about the time available 
for their presentation at least one week prior to the meeting. 
Registration for making public comments will also be available on-site. 
Time allowed for presentation by on-site registrants may be less then 
that for preregistered speakers and will be determined by the number 
who have registered at the meeting. If registering on-site to speak and 
reading oral comments from printed copy, the speaker is asked to bring 
25 copies of the text. These copies will be distributed to the NTP RoC 
Subcommittee members and supplement the record. All comments

[[Page 59302]]

received in response to this Federal Register notice will be posted on 
the NTP RoC web site.
    Written comments, in lieu of making oral comments, are welcome. All 
comments must include name, affiliation, mailing address, phone, fax, 
e-mail and sponsoring organization (if any) and should be received by 
November 4, 2002 for distribution to the NTP RoC Subcommittee. Written 
comments received after November 4th will not be considered by NTP RoC 
Subcommittee members in their reviews.

Solicitation of Additional Information

    The NTP would welcome receiving information from completed human or 
experimental animal cancer studies or studies of mechanism of cancer 
formation, as well as current production data, human exposure 
information, and use patterns for any of the nominations listed in this 
announcement. Organizations or individuals that wish to provide 
information should contact Dr. C.W. Jameson at the address given above.
    The agenda and a roster of NTP RoC Subcommittee members will be 
available prior to the meeting on the NTP homepage at http://ntp-server.niehs.nih.gov/ and upon request from Dr. Wolfe. Following the 
meeting, summary minutes will also be available on the NTP web site 
(http://ntp-server.niehs.nih.gov, select Meetings) and upon request 
from Dr. Wolfe.

    Dated: September 12, 2002.
Samuel Wilson,
Deputy Director, National Institute of Environmental Health Sciences.

   Summary Data for Nominations Tentatively Scheduled for Review at the Meeting of the NTP Board of Scientific
                     Counselors Report on Carcinogens Subcommittee November 19 and 20, 2002
----------------------------------------------------------------------------------------------------------------
                                                                                                      Tentative
   Nomination to be reviewed CAS      Primary uses or exposures         To be reviewed for--            review
               number                                                                                   order
----------------------------------------------------------------------------------------------------------------
1-Amino-2,4-dibromoanthraquinone/..  1-Amino-2,4-                Listing in the 11th RoC...........            1
(81-49-2)..........................   dibromoanthraquinone is
                                      an anthraquinone-derived
                                      vat dye that is used in
                                      the textile industry.
Cobalt Sulfate/(10124-43-3)........  Cobalt sulfate is used in   Listing in the 11th RoC...........            6
                                      electroplating and
                                      electrochemical
                                      industries. It is also
                                      used as a colorinig agent
                                      for ceramics, a drying
                                      agent in inks, paints,
                                      varnishes and linoleum,
                                      and has been added to
                                      animal feed as a mineral
                                      supplement.
Diethanolamine (DEA)/(111-42-2)....  DEA is used in the          Listing in the 11th RoC...........            5
                                      preparation of
                                      surfactants used in
                                      liquid laundry,
                                      dishwishing detergents,
                                      cosmetics, shampoos, and
                                      hair conditioners.
                                     DEA is also used in metal
                                      working fluids, in
                                      textile processing,
                                      industrial gas
                                      purification and as an
                                      anticorrosin agent.
Naphthalene/(91-20-3)..............  Naphthalene is used as an   Listing in the 11th RoC...........            2
                                      intermediate in the
                                      synethesis of many
                                      industrial chemicals, an
                                      ingredient in some moth
                                      repellants and toilet
                                      bowl deodorants, as an
                                      antiseptics for
                                      irragatinig animal wounds
                                      and to control lice on
                                      livestock and poultry.
Nitrobenzene/(98-95-3).............  Nitrobenzene is used        Listing in the 11th RoC...........            8
                                      mainly in the produdction
                                      of aniline, itself a
                                      major chemical
                                      intermediate in the
                                      production of dyes.
Nitromethane/(75-52-5).............  Nitromethane is used in     Listing in the 11th RoC...........            4
                                      specialized fuels, in
                                      explosives and in the
                                      synthesis of nitromethane
                                      derivatives,
                                      pharmaceuticals,
                                      agricultural soil
                                      fumigants and industrial
                                      antimicrobials. In the
                                      past it was used as a
                                      chemical stabilizer to
                                      prevent the decomposition
                                      of various halogenated
                                      hydrocarbons such as
                                      metal degreasers and
                                      aerosol propellants.
Selected Heterocyclic Animes         MeIQ, MeIQx, and PhIP are   Listing in the 11th RoC...........         \1\3
(Three Nominations):                  heterocyclic amines that
(1) 2-Amino-3,4-dimethylimidazo[4,5-  are formed during heating
 f]                                   or cooking and are found
quinoline (meIQ)/(77094-11-2)         in cooked meats and fish.
(2) 2-Amino-3,8-dimethylimidazo[4,5-
 f]
quinoxaline (MeIQx)/(77500-04-0)
(3) 2-Amino-1-methyl-6-
 phenylimidazo[4,5-b]
pyridine (PhIP)/(105650-23-5)
4,4'-Thiodianiline/(139-65-1)        4,4'-Thiodianiline has      Listing in the 11th RoC...........           7
                                      been produced
                                      commercially since the
                                      early 1940s as an
                                      intermediate of several
                                      diazo dyes.
----------------------------------------------------------------------------------------------------------------
\1\ These three nominations will be reviewed together.


[[Page 59303]]

[FR Doc. 02-23874 Filed 9-19-02; 8:45 am]
BILLING CODE 4140-01-P