[Federal Register Volume 68, Number 215 (Thursday, November 6, 2003)]
[Notices]
[Pages 62825-62827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-27892]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Toxicology Program; Call for Public Comments on Seven 
Nominations Proposed for Listing in the Report on Carcinogens, Eleventh 
Edition

Summary

    The National Toxicology Program (NTP) solicits final public 
comments on the nominations reviewed in 2003 for listing in the Report 
on Carcinogens, Eleventh Edition. Comments will be accepted for 60 days 
from the publication date of this announcement and should be directed 
to Dr. C. W. Jameson (contact information below).

Background

    The Report on Carcinogens (``the Report'') (previously known as the 
Annual Report on Carcinogens) is a Congressionally mandated listing of 
known human carcinogens and reasonably anticipated human carcinogens, 
and its preparation is delegated to the NTP by the Secretary, 
Department of Health and Human Services (DHHS). Section 301 (b) (4) of 
the Public Health Service Act, as amended, provides that the Secretary, 
DHHS, shall publish a biennial report which contains a list of all 
substances (1) which either are known to be human carcinogens or may 
reasonably be anticipated to be human carcinogens; and (2) to which a 
significant number of persons residing in the United States (US) are 
exposed. The law also states that the reports should provide available 
information on the nature of exposures, the estimated number of persons 
exposed and the extent to which the implementation of Federal 
regulations decreases the risk to public health from exposure to these 
chemicals.
    In 2003, seven nominations were reviewed by three scientific 
committees, two Federal and one non-government, for listing in the 
Eleventh Report. This review included public comment and review. The 
three scientific review committees evaluated all available data 
relevant to the criteria for inclusion of candidate nominations in the 
Report. The seven nominations along with their Chemical Abstract 
Services (CAS) Registry numbers (where available) and the 
recommendations from the three scientific peer reviews are provided in 
the table below. The NTP will review the recommendations from each of 
the review committees and consider all public comments received 
throughout the review process. Based upon this information, the NTP 
Director will make a recommendation to the Secretary, DHHS, regarding 
the listing of each nominated substance in the Eleventh Report.
    The criteria used in the review process and a detailed description 
of the review procedures, including the steps in the current formal 
review process, can be obtained from the NTP Web site at http://ntp-server.niehs.nih.gov/ (choose Report on Carcinogens) or by contacting 
Dr. C. W. Jameson (contact information below). Background documents on 
the nominations are also available on the NTP Report on Carcinogens Web 
site in PDF-format and in hard copy or on CD upon request from Dr. 
Jameson.

Public Comment Requested

    The NTP solicits final public comments on the seven nominations 
reviewed in 2003 for listing in the Eleventh Report. The public is 
invited to submit comments that supplement any previously submitted 
comments or to provide comments for the first time on any nomination. 
Comments will be accepted for 60 days from the publication date of this 
announcement and should be directed to Dr. C. W. Jameson (National 
Toxicology Program, Report on Carcinogens, MD EC-14, P.O. Box 12233, 
Research Triangle Park, NC 27709; phone: (919) 541-4096, fax: (919) 
541-0144, e-mail: [email protected]). Individuals submitting public 
comments are asked to include relevant contact information (name, 
affiliation (if any), address, telephone, fax, e-mail, and sponsoring 
organization (if any)).

    Dated: October 28, 2003.
Kenneth Olden,
Director, National Toxicology Program.

[[Page 62826]]



 Summary of RG1, \1\ RG \2\ and NTP Board Subcommittee \3\ Recommendations for the Nominations Reviewed in 2003
                             for Listing in the Report on Carcinogens, 11th Edition
----------------------------------------------------------------------------------------------------------------
                                                                                                   NTP board
      Nomination/CAS number         Primary uses or       RG1 action          RG2 action         subcommittee
                                       exposures                                                    action
----------------------------------------------------------------------------------------------------------------
Diazoaminobenzene (DAAB)/136-35-  DAAB is used as an  Motion to list      Motion to list      Motion to list
 6.                                intermediate in     DAAB as             DAAB as             DAAB as
                                   the production of   reasonably          reasonably          reasonably
                                   dyes and to         anticipated to be   anticipated to be   anticipated to be
                                   promote adhesion    a human             a human             a human
                                   of natural rubber   carcinogen passed   carcinogen passed   carcinogen passed
                                   to steel.           by unanimous vote   by majority vote    by majority vote
                                                       (5/0).              (8/1). Negative     (6/4) with 1
                                                                           vote cast because   abstention.
                                                                           member felt there   Negative votes: 3
                                                                           was not             members felt
                                                                           sufficient          nominations did
                                                                           evidence for DAAB   not meet criteria
                                                                           to list in the      for listing and 1
                                                                           Report on           member felt that
                                                                           Carcinogens..       because DAAB is
                                                                                               metabolized to
                                                                                               benzene, it
                                                                                               should be listed
                                                                                               as known to be a
                                                                                               human carcinogen.
                                                                                               Abstention--membe
                                                                                               r felt if DAAB is
                                                                                               metabolized to
                                                                                               benzene, it
                                                                                               should be listed
                                                                                               as known to be a
                                                                                               human carcinogen;
                                                                                               however, not
                                                                                               convinced
                                                                                               chemical is
                                                                                               metabolized to
                                                                                               benzene in
                                                                                               humans.
Hepatitis B Virus (HBV).........  HBV is a small DNA- Motion to list HBV  Motion to list HBV  Motion to list HBV
                                   enveloped virus     as known to be a    as known to be a    as known to be a
                                   that along with     human carcinogen    human carcinogen    human carcinogen
                                   Hepatitis C Virus   passed by           passed by           passed by
                                   causes most         unanimous vote (4/  unanimous vote (8/  unanimous vote
                                   parentally          0).                 0).                 (12/0).
                                   transmitted viral
                                   hepatitis.
Hepatitis C Virus (HCV).........  HCV is an RNA-      Motion to list HCV  Motion to list HCV  Motion to list HCV
                                   enveloped virus     as known to be a    as known to be a    as known to be a
                                   that along with     human carcinogen    human carcinogen    human carcinogen
                                   Hepatitis B Virus   passed by           passed by           passed by
                                   causes most         unanimous vote (7/  unanimous vote (8/  unanimous vote
                                   parenterally        0).                 0).                 (12/0).
                                   transmitted viral
                                   hepatitis.
Human Papillomaviruses (HPVs),    HPVs are small,     Motion to list      Motion to list      Motion to list
 Genital-Mucosal Types.            non-enveloped       HPVs as known to    HPVs as known to    HPVs as known to
                                   viruses that        be a human          be a human          be a human
                                   infect genital      carcinogen passed   carcinogen passed   carcinogen passed
                                   skin, and genital   by unanimous vote   by unanimous vote   by unanimous vote
                                   and non-genital     (7/0).              (8/0).              (12/0).
                                   mucosa. HPV
                                   infections are
                                   common throughout
                                   the world.
Lead and Lead Compounds.........  Major use of metal  Motion to list      Motion to list      Motion to list
                                   is in making lead-  Lead and Lead       Lead and Lead       Lead and Lead
                                   acid storage        Compounds as        Compounds as        Compounds as
                                   batteries. Other    known to be human   reasonably          reasonably
                                   common uses         carcinogens         anticipated to be   anticipated to be
                                   include             passed by           human carcinogens   human carcinogens
                                   ammunition and      unanimous vote (8/  passed by           passed by
                                   cable covering.     0).                 majority vote (4/   majority vote (11/
                                   Lead compounds                          3). Negative        0).
                                   are used in                             votes cast
                                   paint, glass,                           because members
                                   ceramics, fuel                          felt that human
                                   additives, and                          data were
                                   some traditional                        sufficient to
                                   cosmetics.                              list lead and
                                                                           lead compounds as
                                                                           known to be human
                                                                           carcinogens.
Neutrons........................  Exposure to         Motion to list      Motion to list      Motion to list
                                   neutrons normally   Neutrons as known   Neutrons as known   Neutrons as known
                                   occurs from a       to be a human       to be a human       to be a human
                                   mixed irradiation   carcinogen passed   carcinogen passed   carcinogen passed
                                   field in which      by unanimous vote   by unanimous vote   by unanimous vote
                                   neutrons are a      (7/0).              (8/0).              (11/0).
                                   minor component.
                                   The exceptions
                                   are exposure of
                                   patients to
                                   neutron
                                   radiotherapy
                                   beams and
                                   exposures of
                                   aircraft
                                   passengers and
                                   crew.

[[Page 62827]]

 
X-Radiation and Gamma ([gamma])-  Exposure to these   Motion to list X-   Motion to list X-   Motion to list X-
 Radiation.                        forms of ionizing   Radiation and       Radiation and       Radiation and
                                   radiation comes     [gamma]-Radiation   [gamma]-Radiation   [gamma]-Radiation
                                   from a variety of   as known to be      as known to be      as known to be
                                   natural             human carcinogens   human carcinogens   human carcinogens
                                   (environmental      passed by           passed by           passed by
                                   exposure) and       unanimous vote (7/  unanimous vote (8/  unanimous vote
                                   anthropogenic       0).                 0).                 (11/0).
                                   sources,
                                   including
                                   exposure for
                                   military,
                                   medical, and
                                   occupational
                                   purposes.
----------------------------------------------------------------------------------------------------------------
\1\ --The NIEHS Review Committee for the Report on Carcinogens (RG1).
\2\ --The NTP Executive Committee* Interagency Working Group for the Report on Carcinogens (RG2).
 *Agencies from the NTP Executive Committee represented on RG2 include: Agency for Toxic Substances and Disease
  Registry (ATSDR), Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), National
  Center for Environmental Health of the Centers for Disease Control and Prevention (NCEH/CDC), National Center
  for Toxicological Research of the Food and Drug Administration (NCTR/FDA), National Institute for Occupational
  Safety and Health/CDC (NIOSH/CDC), Occupational Safety and Health Administration (OSHA), National Cancer
  Institute of the National Institutes of Health (NCI/NIH), and National Institute of Environmental Health
  Sciences/NIH (NIEHS/NIH).
\3\ --The NTP Board of Scientific Counselors Report on Carcinogens Subcommittee (a standing subcommittee of the
  NTP Board of Scientific Counselors that serves as an external peer review group).

[FR Doc. 03-27892 Filed 11-5-03; 8:45 am]
BILLING CODE 4140-01-P