[Federal Register Volume 66, Number 43 (Monday, March 5, 2001)]
[Notices]
[Pages 13334-13338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5175]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Toxicology Program; Call for Public Comments on 8 
Nominations, Proposed for Listing in or Delisting From the Report on 
Carcinogens, Tenth Edition

Background

    The National Toxicology Program (NTP) solicits final public 
comments on agents, substances, mixtures and exposure circumstances 
reviewed in 2000 for listing in or delisting from the Report on 
Carcinogens, Tenth Edition. This 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 National Toxicology Program 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 2000, eight nominations were reviewed for listing in the Tenth 
Report. This review included two Federal and one non-government, 
scientific peer reviews and 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 
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 Home Page web site at http://ntp-server.niehs.nih.gov/ or by contacting: 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, email: [email protected].

Public Comment Requested

    The nominations reviewed in 2000 are provided in the following 
table with their Chemical Abstracts Services (CAS) Registry numbers 
(where available) and the recommendations from the three scientific 
peer reviews of the nominations. The NTP will be making a final 
recommendation in 2001 for these eight nominations for listing in, or 
changing the current listing from reasonably anticipated to be a human 
carcinogen to the known to be a human carcinogen category in the Tenth 
Report.
    Background documents provided to the review committees and the 
public are available on the web in PDF-format at the address above. 
Hard copies of these documents are also available upon request. The NTP 
will review the recommendations from each of the review committees and 
consider the public comments received throughout the process in making 
decisions regarding the NTP recommendations to the Secretary, DHHS, for 
listing of the nominated substances in the Tenth Edition of the Report 
on Carcinogens. The NTP solicits final public comment to supplement any 
previously submitted comments or to provide comments for the first time 
on any substance in the following table. Comments will be accepted for 
60 days from the publication date of this announcement and should be 
directed to Dr. C.W. Jameson at the address listed above. Individuals 
submitting public comments are asked to include relevant contact 
information [name, affiliation (if any), address, telephone, fax, and 
e-mail].
Attachment

    Dated: February 21, 2001.
Kenneth Olden,
Director, National Toxicology Program.

   Summary of RG1,9 RG2 2 and NTP Board Subcommittee 3 Recommendations for the Agents, Substances, Mixtures or
      Exposure Circumstances Reviewed in 2000 for Listing in, Delisting From, or Upgrading in the Report on
                                           Carcinogens,4 10th Edition
----------------------------------------------------------------------------------------------------------------
                                                                                                   NTP board
       Nomination/CAS No.           Primary uses or       RG1 action          RG2 action         subcommittee
                                       exposures                                                    action
----------------------------------------------------------------------------------------------------------------
Broad Spectrum UV Radiation       Solar and           Motion to list UVR  Motion list UVR as  Motion to list UVR
 (UVR) and UVA, and UVB, and UVC.  artificial          as known to be a    known to be a       as known to be a
                                   sources of          human carcinogen    human carcinogen    human carcinogen
                                   ultraviolet         passed by           passed by           passed by
                                   radiation.          unanimous vote (6/  unanimous vote (8/  unanimous vote
                                                       0).                 0).                 (10/0).
                                                      Motion to list      Motion to list      Motion to list UVA
                                                       UVA, UVB and UVC    UVA, UVB and UVC    as reasonably
                                                       as reasonably       as reasonably       anticipated to be
                                                       anticipated to be   anticipated to be   human carcinogen
                                                       human carcinogens   human carcinogens   passed by
                                                       passed by           passed by           unanimous vote
                                                       unanimous vote (6/  unanimous vote (8/  (10/0).
                                                       0).                 0).
                                                                                              Motion to list UVB
                                                                                               as reasonably
                                                                                               anticipated to be
                                                                                               human carcinogen
                                                                                               passed by vote of
                                                                                               7 yes to 3 no.
                                                                                               Negative votes
                                                                                               (3) cast because
                                                                                               members felt data
                                                                                               meets criteria to
                                                                                               list as known
                                                                                               human carcinogen.

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                                                                                              Motion to list UVC
                                                                                               as reasonably
                                                                                               anticipated to be
                                                                                               human carcinogen
                                                                                               passed by vote of
                                                                                               9 yes to 1 no.
                                                                                               Negative vote (1)
                                                                                               cast because
                                                                                               member felt
                                                                                               insufficient
                                                                                               human data to
                                                                                               list as
                                                                                               reasonably
                                                                                               anticipated
                                                                                               carcinogen.
Chloramphenicol (56-75-7).......  Chloramphenicol     Motion to list      Motion to list      Motion to list
                                   has been used an    Chloramphenicol     Chloramphenicol     Chloramphenicol
                                   antibiotic since    as reasonably       reasonably          as reasonably
                                   the 1950s.          anticipated to be   anticipated to be   anticipated to be
                                                       human carcinogen    human carcinogen    human carcinogen
                                                       passed by           passed by vote of   passed by
                                                       unanimous vote (7/  7 yes to 0 no       unanimous vote
                                                       0).                 with 1              (10/0).
                                                                           abstention.
                                                                           Abstention (1)
                                                                           was because
                                                                           member felt data
                                                                           concerning link
                                                                           between aplastic
                                                                           anemia and
                                                                           leukemia was not
                                                                           compelling.
Estrogens, Steroidal............  Estrogens are       Motion to list      Motion to list      Motion to list
                                   widely used in      Steroidal           Steroidal           Steriodal
                                   post-menopausal     Estrogens as        Estrogens as        Estrogens as
                                   therapy and in      known to be a       known to be a       known to be a
                                   oral                human carcinogen    human carcinogen    human carcinogen
                                   contraceptives      passed by           passed by           passed by a vote
                                   for women.          unanimous vote (7/  unanimous vote (8/  of 8 yes to 1 no.
                                                       0).                 0).                 Negative vote (1)
                                                                                               cast because
                                                                                               member felt
                                                                                               insufficient
                                                                                               human data to
                                                                                               list all
                                                                                               steroidal
                                                                                               estrogens in the
                                                                                               Report.
Methyleugenol (93-15-2).........  Methyleugenol are   Motion to list      Motion to list      Motion to list
                                   flavoring agents    Methyleugenol as    Methyleugenol as    Methyleugenol as
                                   used in jellies,    reasonably          reasonably          reasonably
                                   baked goods,        anticipated to be   anticipated to be   anticipated to be
                                   nonalcoholic        human carcinogen    human carcinogen    human carcinogen
                                   beverages,          passed by           passed by           passed by a vote
                                   chewing gum,        unanimous vote (7/  unanimous vote (8/  of 9 yes to 1 no.
                                   candy, and ice      0).                 0).                 Negative vote (1)
                                   cream. Also used                                            cast because
                                   as fragrance for                                            member felt
                                   many perfumes,                                              insufficient
                                   lotions,                                                    human data to
                                   detergents and                                              list in the
                                   soaps.                                                      Report.
Nickel (metallic) and Certain     Metallic Nickel     Motion to list      Motion to list      Motion to list
 Nickel Alloys.                    and Nickel Alloys   Metallic Nickel     Metallic Nickel     Metallic Nickel
                                   have been used in   and Certain         as reasonability    as reasonability
                                   commercial          Nickel alloys as    anticipated to be   anticipated to be
                                   applications for    reasonability       human carcinogen    human carcinogen
                                   over 100 years.     anticipated to be   passed by a vote    passed by a vote
                                                       human carcinogen    of 7 yes to 1 no.   of 7 yes to 3 no.
                                                       passed by a vote    Negative vote (1)   Negative votes
                                                       of 6 yes to 2 no.   cast because        (3) cast because
                                                       Negative votes      member felt the     members felt that
                                                       (2) cast because    animal data not     the human and
                                                       members did not     persuasive to       animal data not
                                                       agree with the      list in the         persuasive to
                                                       use of term         Report as           list in the
                                                       ``certain'' in      reasonably          Report as
                                                       the listing of      anticipated human   reasonably
                                                       Nickel alloys.      carcinogens         anticipated human
                                                                           because of          carcinogens.
                                                                           inappropriate
                                                                           routes of
                                                                           exposure.

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                                                                          Motion not to list  Motion to list
                                                                           Certain Nickel      Certain Nickel
                                                                           Alloys in RoC was   Alloys as
                                                                           passed a vote of    reasonably
                                                                           6 yes to 2 no.      anticipated to be
                                                                           Negative votes      human carcinogen
                                                                           (2) cast because    was defeated by a
                                                                           members felt data   vote of 3 yes to
                                                                           meets criteria to   7 no. in RoC.
                                                                           list as             Negative votes
                                                                           reasonably          (7) cast because
                                                                           anticipated to be   members felt
                                                                           a human             available data
                                                                           carcinogen.         not persuasive to
                                                                                               list in the
                                                                                               Report as
                                                                                               reasonably
                                                                                               anticipated human
                                                                                               carcinogens.
                                                                                              Motion not to list
                                                                                               Certain Nickel
                                                                                               Alloys in RoC was
                                                                                               passed by a vote
                                                                                               of 9 yes 1 no.
                                                                                               Negative votes
                                                                                               (1) cast because
                                                                                               member felt data
                                                                                               meets criteria to
                                                                                               list as
                                                                                               reasonably
                                                                                               anticipated to be
                                                                                               a human
                                                                                               carcinogen.
Talc (14807-96-6) Abestiform and  Both Asbestiform    Motion to list      Motion to list      Motion to list
 Non-Abestiform.                   talc (i.e., talc    Talc containing     Talc containing     Talc containing
                                   containing          asbestiform         asbestiform         asbestiform
                                   asbestiform         fibers as known     fibers as known     fibers as
                                   fibers) and non-    to be a human       to be a human       reasonably
                                   asbestiform talc    carcinogen passed   carcinogen was      anticipated to be
                                   (i.e. talc not      by unanimous vote   defeated by a       a human
                                   containing          (7/0).              vote of 2 yes to    carcinogen
                                   asbestiform        Motion to list       6 no. Negative      resulted in a tie
                                   fibers) occur in    Talc not            votes (6) cast      vote (5 yes to 5
                                   various             containing          because members     no). Negatives
                                   geological          asbestiform         felt human data     votes (4) cast
                                   settings around     fibers as           were not            because members
                                   the world.          reasonably          sufficient to       felt human and
                                   Occupational        anticipated to be   list as a known     animal data not
                                   exposure to both    a human             human carcinogen    sufficient to
                                   forms occurs        carcinogen passed   because             list in Report.
                                   during mining,      by a vote of 6      asbestiform         Other negative
                                   milling, and        yes to 1 no.        fibers were not     (1) cast because
                                   processing.         Negative vote (1)   considered to       member felt
                                   Exposure to non-    cast because        include asbestos    action should be
                                   asbestiform talc    member questioned   contamination.      deferred.
                                   by the general      the biological
                                   population occurs   plausibility of
                                   through the use     talc using
                                   of products such    causing ovarian
                                   as cosmetics.       neoplasms in
                                                       women.

[[Page 13337]]

 
                                                                          Motion to list      Motion not to list
                                                                           Talc containing     talc not
                                                                           asbestiform         containing
                                                                           fibers as           asbestiform
                                                                           reasonably          fibers as
                                                                           anticipated to be   reasonably
                                                                           a human             anticipated to be
                                                                           carcinogen passed   a human
                                                                           by a vote of 6      carcinogen passed
                                                                           yes to 2 no.        by a vote of 7
                                                                           Negative vote (1)   yes to 3 no.
                                                                           cast because        Negative votes
                                                                           member felt data    cast either
                                                                           sufficient to       because the
                                                                           list as a known     member felt that
                                                                           human carcinogen.   data meets
                                                                           Other negative      criteria to list
                                                                           vote (1) cast       talc not
                                                                           because member      containing
                                                                           felt evidence not   asbestiform
                                                                           adequate to list    fibers as
                                                                           in the Report.      reasonability
                                                                          Motion to list       anticipated to be
                                                                           Talc not            a human
                                                                           containing          carcinogen or
                                                                           asbestiform         that ovarian
                                                                           fibers as           cancer studies
                                                                           reasonably          should have been
                                                                           anticipated to be   considered in the
                                                                           human carcinogen    evaluation. The
                                                                           passed by a vote    Subcommittee did
                                                                           of 7 yes to 1 no.   not consider the
                                                                           Negative vote (1)   ovarian cancer
                                                                           cast because        studies in the
                                                                           member felt         evaluation of
                                                                           animal data not     talc not
                                                                           sufficient and      containing
                                                                           human data          asbestiform
                                                                           confounded          fibers because it
                                                                           because of the      was unclear if
                                                                           uncertainty of      the talc used in
                                                                           possible            these studies
                                                                           contamination of    might have been
                                                                           talc with           contaminated with
                                                                           asbestos.           asbestos.
Trichloroethylene (TCE) (79-01-   Trichloroethylene   Motion to list TCE  Motion to list TCE  Motion that the
 6).                               is widely used as   as known to be a    as known to be a    listing of TCE
                                   a solvent with 80-  human carcinogen    human carcinogen    should remain as
                                   90% used            passed by           was defeated by a   reasonably
                                   worldwide for       unanimous vote (7/  vote of 3 yes to    anticipated to be
                                   degreasing metals.  0).                 4 no. Negative      a human
                                                                           votes (4) cast      carcinogen passed
                                                                           because members     by a vote of 9
                                                                           felt the human      yes to 1 no.
                                                                           data did not meet   Negative vote (1)
                                                                           the criteria for    because member
                                                                           listing as a        felt human data
                                                                           known human         sufficient to
                                                                           carcinogen          list as a known
                                                                           because the         human carcinogen.
                                                                           exposures in the
                                                                           human studies may
                                                                           not have been
                                                                           specific for TCE.
Wood Dust.......................  It is estimated     Motion to list      Motion to list      Motion to list
                                   that at least two   Wood Dust as        Wood as known to    Wood Dust as
                                   million people      known to be a       be a human          known to be a
                                   are routinely       human carcinogen    carcinogen passed   human carcinogen
                                   exposed             passed by           by unanimous vote   passed by
                                   occupationally to   unanimous vote      (\70\).             unanimous vote
                                   wood dust           (\80\).                                 (\80\).
                                   worldwide. Non-
                                   occupational
                                   exposure also
                                   occurs. The
                                   highest exposures
                                   have generally
                                   been reported in
                                   wood furniture
                                   and cabinet
                                   manufacture,
                                   especially during
                                   machine sanding
                                   and similar
                                   operations..
----------------------------------------------------------------------------------------------------------------
1 The NIEHS Review Committee for the Report on Carcinogens (RG1).
2 The NTP Executive Committee (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) Interagency Working Group for the Report on
  Carcinogens (RG2).
3 The NTP Board of Scientific Counselors Report on Carcinogens Subcommittee (the External Peer Review Group).
4 RoC--Report on Carcinogens.


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[FR Doc. 01-5175 Filed 3-2-01; 8:45 am]
BILLING CODE 4140-01-P