[Federal Register Volume 68, Number 14 (Wednesday, January 22, 2003)]
[Notices]
[Pages 3033-3036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-1368]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Toxicology Program; Call for Public Comments on 10 
Nominations, Proposed for Listing in the Report on Carcinogens, 
Eleventh Edition

Background

    The National Toxicology Program (NTP) solicits final public 
comments on the nominations reviewed in 2002 for listing in the Report 
on Carcinogens, Eleventh Edition (``the Report''). 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 2002, ten nominations were reviewed for listing in the Eleventh 
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

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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, e-mail: 
[email protected].

Public Comment Requested

    The nominations reviewed in 2002 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. The NTP will be making a final recommendation for these 
ten 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 Eleventh Report.
    Background documents provided to the review committees and the 
public are available on the Internet in PDF-format at the address 
above. Hard copies of these documents are also available upon request 
from Dr. Jameson (contact information above). 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 Report on Carcinogens, Eleventh 
Edition. 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 provided above. 
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: January 10, 2003.
Kenneth Olden,
Director, National Toxicology Program.

 Summary of RG1,\1\ RG2 \2\ and NTP Board Subcommittee \3\ Recommendations for the Nominations Reviewed in 2002
                            for Listing in the Report on Carcinogens,\4\ 11th Edition
----------------------------------------------------------------------------------------------------------------
                                                                                                   NTP board
       Nomination/CAS No.           Primary uses or       RGI action          RG2 action         subcommittee
                                       exposures                                                    action
----------------------------------------------------------------------------------------------------------------
1-Amino-2,4-dibromoanthraquinone/ An anthraquinone-   Motion to list 1-   Motion to list 1-   Motion to list 1-
 (81-49-2).                        derived vat dye     amino-2,4-          amino-2,4-          amino-2,4-
                                   that is used in     dibromoanthraquin   dibromoanthraquin   dibromoanthraquin
                                   the textile         one as reasonably   one as reasonably   one as reasonably
                                   industry.           anticipated to be   anticipated to be   anticipated to be
                                                       a human             a human             a human
                                                       carcinogen passed   carcinogen passed   carcinogen passed
                                                       by unanimous vote   by unanimous vote   by unanimous vote
                                                       (8/0).              (8/0).              (9/0)
---------------------------------
Selected Heterocyclic Amines      MeIQ, MeIQx, and    Motion to list      Motion to list      Motion to list
 (three nominations):              PhIP are            MeIQ as             MeIQ as             MeIQ as
(1) MeIQ (2-Amino-3,4-dimethyl-    heterocyclic        reasonably          reasonably          reasonably
 imidazo- [4,5-f]quino line)/*     amines that are     anticipated to be   anticipated to be   anticipated to be
 (77094-11-2).                     formed during       a human             a human             a human
(2) MeIQx (2-Amino-3,8-dimethyl-   heating or          carcinogen passed   carcinogen passed   carcinogen passed
 imidazo[4,5-f] quinoxaline)/      cooking and are     by unanimous vote   by unanimous vote   by a vote of 8
 (77500-04-0).                     found in cooked     (6/0).              (8/0).              yes, 0 no and 1
 (3) PhIP (2-Amino-1-methyl-6-     meat and fish.                                              abstention.
 phenyl- imidazo[4,5-b]pyridine)/                                                              Abstention
 (105650-23-5).                                                                                because member
                                                                                               felt insufficient
                                                                                               data for human
                                                                                               exposure to list
                                                                                               in the RoC.
                                                      Motion to list      Motion to list      Motion to list
                                                       MeIQx as            MeIQx as            MeIQx as
                                                       reasonably          reasonably          reasonably
                                                       anticipated to be   anticipated to be   anticipated to be
                                                       a human             a human             a human
                                                       carcinogen passed   carcinogen passed   carcinogen passed
                                                       by a vote of 5      by unanimous vote   by a unanimous
                                                       yes to 1 no.        (8/0).              vote (9/0).
                                                       Negative vote
                                                       cast because
                                                       member felt data
                                                       meet criteria to
                                                       list as known
                                                       human carcinogen.
                                                      Motion to list      Motion to list      Motion to list
                                                       PhIP as             PhIP as             PhIP as
                                                       reasonably          reasonably          reasonably
                                                       anticipated to be   anticipated to be   anticipated to be
                                                       a human             a human             a human
                                                       carcinogen passed   carcinogen passed   carcinogen passed
                                                       by a vote of 5      by unanimous vote   by unanimous vote
                                                       yes to 1 no.        (8/0).              (9/0).
                                                       Negative vote
                                                       cast because
                                                       member felt data
                                                       meet criteria to
                                                       list as known
                                                       human carcinogen.
---------------------------------

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Cobalt Sulfate/(10026-2401).....  Cobalt sulfate is   Motion to list      Motion to list      Motion to list
                                   used in             cobalt sulfate as   cobalt sulfate as   cobalt sulfate as
                                   electroplating      reasonably          reasonably          reasonably
                                   and                 anticipated to be   anticipated to be   anticipated to be
                                   electrochemical     a human             a human             a human
                                   industries. It is   carcinogen passed   carcinogen passed   carcinogen passed
                                   also used as a      by unanimous vote   by a vote of 8      by a vote of 8
                                   coloring agent      (9/0).              yes and 1 no.       yes to 1 no.
                                   for ceramics, a                         Negative vote       Negative vote
                                   drying agent in                         cast because        cast because
                                   inks, paints,                           member felt         member felt human
                                   varnishes and                           exposure data in    exposure data not
                                   linoleum, and has                       background          specific for
                                   been added to                           document needed     cobalt sulfate.
                                   animal feed as a                        to be more
                                   mineral                                 specific for
                                   supplement.                             cobalt sulfate.
---------------------------------
Diethanolamine (DEA)/(111-42-2).  DEA is used in the  Motion not to list  Motion not to list  Motion not to list
                                   preparation of      DEA in the RoC      DEA in the RoC      DEA in the RoC
                                   surfactants used    passed by a vote    passed by           passed by a vote
                                   in liquid           of 7 yes to 2 no.   unanimous vote (9/  of 8 yes to 1 no.
                                   laundry,            Negative votes      0).                 Negative vote
                                   dishwashing         cast because                            cost because
                                   detergents,         members felt data                       member felt data
                                   cosmetics,          sufficient to                           sufficient to
                                   shampoos, and       list as                                 list as
                                   hair                reasonably                              reasonably
                                   conditioners; as    anticipated to be                       anticipated to be
                                   a surface-active    a human                                 a human
                                   agent and           carcinogen.                             carcinogen.
                                   corrosion
                                   inhibitor in
                                   metalworking
                                   fluids and as a
                                   dispersant in
                                   agricultural
                                   chemical
                                   formulations.
---------------------------------
Naphthalene (91-20-3)...........  Naphthalene is      Motion to list      The RG2 could not   Motion to list
                                   used as a           naphthalene as      make a majority     naphthalene as
                                   intermediate in     reasonably          recommendation      reasonably
                                   the synthesis of    anticipated to be   for either          anticipated to be
                                   many industrial     a human             listing or not      a human
                                   chemicals, and      carcinogen passed   listing             carcinogen passed
                                   has been used as    by a vote of 6      naphthalene in      by unanimous vote
                                   an ingredient in    yes to 1 no.        the RoC.            (9/0).
                                   some moth           Negative vote
                                   repellants and      cast because
                                   toilet bowl         member felt data
                                   deodorants, and     not sufficient to
                                   to control lice     list in the RoC.
                                   on livestock and
                                   poultry.
---------------------------------
Nitrobenzne (98-95-3)...........  Nitrobenzene is     Motion to list      Motion to list      Motion to list
                                   used mainly in      nitrobenzene as     nitrobenzene as     nitrobenzene as
                                   the production of   reasonably          reasonably          reasonably
                                   aniline, itself a   anticipated to be   anticipated to be   anticipated to be
                                   major chemical      a human             a human             a human
                                   intermediate in     carcinogen passed   carcinogen passed   carcinogen passed
                                   the production of   by unanimous vote   by unanimous vote   by unanimous vote
                                   dyes.               (7/0).              (7/0).              (9/0).
---------------------------------
Nitromethane (75-52-5)..........  Nitromethane is     Motion to list      Motion to list      Motion to list
                                   used in             nitromethane as     nitromethane as     nitromethane as
                                   specialized         reasonably          reasonably          reasonably
                                   fuels, in           anticipated to be   anticipated to be   anticipated to be
                                   explosives and in   a human             a human             a human
                                   the synthesis of    carcinogen passed   carcinogen passed   carcinogen passed
                                   nitromethane        by unanimous vote   by unaimous vote    by unanimous vote
                                   derivatives,        (8/0).              (9/0).              (9/0).
                                   pharmaceuticals,
                                   agricultural soil
                                   fumigants and
                                   industrial
                                   antimicrobials.
---------------------------------
4,4'-Thiodianiline (139-65-1)...  4,4'-Thiodianiline  Motion to list      Motion to list      Motion to list
                                   has been produced   4,4'-               4,4'-               4,4'-
                                   commercially        thiodianiline as    thiodianiline as    thiodianiline as
                                   since the early     reasonably          reasonably          reasonably
                                   1940's as an        anticipated to be   anticipated to be   anticipated to be
                                   intermediate of     a human             a human             a human
                                   several diazo       carcinogen passed   carcinogen passed   carcinogen passed
                                   dyes.               by a vote of 6      by a vote of 6      by a vote of 5
                                                       yes to 2 no.        yes to 3 no.        yes to 2 no with
                                                       Negative votes      Negative votes      2 abstentions.
                                                       cast because        cast because        Negative votes
                                                       members felt        members felt        and abstentions
                                                       there was not       there was not       cast because
                                                       sufficient          sufficient          members felt
                                                       exposure to list    exposure to list    there was not
                                                       in the RoC.         in the RoC.         sufficient
                                                                                               exposure to list
                                                                                               in the RoC.
----------------------------------------------------------------------------------------------------------------
\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).

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\*\ Agencies from 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 (the External Peer Review Group).
\4\ RoC--Report on Carcinogens.

[FR Doc. 03-1368 Filed 1-21-03; 8:45 am]
BILLING CODE 4140-01-P