[Federal Register Volume 63, Number 239 (Monday, December 14, 1998)]
[Notices]
[Pages 68783-68785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33090]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Toxicology Program; Call for Public Comments on 11 
Agents, Substances, Mixtures and Exposure Circumstances Proposed for 
Listing in or Delisting from the Report on Carcinogens, Ninth Edition

Background

    The National Toxicology Program (NTP) solicits final public 
comments on additional agents, substances, mixtures and exposure 
circumstances for listing in or delisting from the Report on 
Carcinogens, Ninth Edition. This Report is a Congressionally mandated 
listing of known human carcinogens and reasonably anticipated human 
carcinogens and the Secretary, Department of Health and Human Services 
(HHS) delegates its preparation to the National Toxicology Program. 
Section 301(b)(4) of the Public Health Service Act, as amended, 
provides that the Secretary, (HHS), shall publish a 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 decrease the risk to 
public health from exposure to these chemicals.
    In 1998, 11 substances or exposure circumstances were reviewed for 
listing in or removal from the Ninth Report. This review included two 
Federal and one non-government, scientific peer reviews and public 
comment and review. The three scientific review committee evaluated all 
available data relevant to the criteria for inclusion or removal of 
candidate substances or exposure circumstances in the Report. The 
criteria used in the review process and the detailed description of the 
review procedures, including the steps in the current formal review 
process, can be obtained by contacting: Dr. C.W. Jameson, National 
Toxicology Program, Report on Carcinogens, 79 Alexander Drive, Room 
3217, P.O. Box 12233, Research Triangle Park, NC 27709; phone: (919) 
541-4096, fax: (919) 541-2242, email: [email protected]. This 
information is also available on the NTP Home Page web site at http://
ntp-server.niehs.nih.gov/

Public Comment Requested

    The NTP will be making a final recommendation in 1999 for the 11 
substances or exposure circumstances reviewed in 1998, for either 
listing in, delisting from, or changing the current listing from 
reasonably anticipated to be a human carcinogen to the known to be a 
human carcinogen category in the Ninth Report. These nominated 
substances or exposure circumstances 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.
    Background documents provided to the review committees and the 
interested public are available upon request. The NTP will review the 
recommendations of 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 
or removal of the nominated substances and exposure circumstances in 
the Ninth 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 or exposure 
circumstances in the following table. Comments will be accepted for a 
period of 60 days from the date of the publication of this announcement 
in the Federal Register. Comments or questions should be directed to 
Dr. C.W. Jameson at the address listed above.

Attachment

    Dated: December 4, 1998.
Kenneth Olden,
Director, National Toxicology Program.

 Summary of RG1,\1\ RG2 \2\ and NTP Board Subcommittee \3\ Recommendations for the Agents, Substances, Mixtures
  or Exposure Circumstances Reviewed in 1998 for Listing in or Delisting from the Report on Carcinogens,\4\ 9th
                                                     Edition
----------------------------------------------------------------------------------------------------------------
                                                                                                   NTP board
       Nomination/CAS No.           Primary uses or       RG1 action          RG2 action         subcommittee
                                       exposures                                                    action
----------------------------------------------------------------------------------------------------------------
Alcoholic Beverages.............  Consumption of      RG1 recommended (6  RG2 unanimously     The Subcommittee
                                   alcoholic           yes votes to 1 no   recommended (7      recommended (9
                                   beverages.          vote) listing as    yes votes to 0 no   yes votes to 3 no
                                                       known to be a       votes) listing as   votes with 1
                                                       human carcinogen.   known to be a       abstention)
                                                                           human carcinogen.   listing as known
                                                                                               to be a human
                                                                                               carcinogen.
Boot and Shoe Manufacture and     Workers in the      RG1 recommended (5  RG2 recommended (6  The Subcommittee
 Repair.                           boot and shoe       yes votes to 1 no   yes votes to 1 no   unanimously
                                   manufacture and     vote) that Boot     vote) that Boot     recommended (10
                                   repair industry.    and Shoe            and Shoe            yes votes to 0 no
                                                       Manufacture and     Manufacture and     votes) to defer
                                                       Repair in the       Repair in the       action on this
                                                       United States be    United States be    nomination
                                                       included in the     included in the     because of the
                                                       RoC as having       RoC as having       lack of exposure
                                                       been reviewed but   been reviewed but   assessment
                                                       not formally        not formally        information.
                                                       listed, due to      listed, due to
                                                       inadequate data.    inadequate data.
Diesel Exhaust Particulates.....  Diesel engine       RG1 defeated a      RG2 recommended (6  The Subcommittee
                                   exhaust.            motion to list as   yes votes to 1 no   recommended (9
                                                       reasonably          vote) to list as    yes votes to 0 no
                                                       anticipated to be   reasonably          votes with 3
                                                       a human             anticipated to be   abstentions) to
                                                       carcinogen (4 yes   a human             list as
                                                       votes to 5 no       carcinogen.         reasonably
                                                       votes). RG1                             anticipated to be
                                                       recommended (5                          a human
                                                       yes votes to 4 no                       carcinogen.
                                                       votes) to list as
                                                       known to be a
                                                       human carcinogen.

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Environmental Tobacco Smoke.....  ``Passive''         RG1 recommended (7  RG2 recommended (5  The Subcommittee
                                   inhalation of       yes votes to 0 no   yes votes to 2 no   unanimously
                                   tobacco smoke       vote with 1         votes) to list as   recommended (13
                                   from                abstention) to      known to be a       yes votes to 0 no
                                   environmental       list as known to    human carcinogen.   votes) listing as
                                   sources.            be a human                              known to be a
                                                       carcinogen.                             human carcinogen.
Ethyl Acrylate/140-88-5.........  Monomer used to     RG1 recommended (7  RG2 recommended (6  The Subcommittee
                                   produce polymers    yes votes to 2 no   yes votes to 1 no   recommended (8
                                   and copolymers      votes) to delist    vote) to delist     yes votes to 2 no
                                   for use in latex    from RoC.           from RoC.           votes with 2
                                   paints, textiles,                                           abstentions) to
                                   etc.                                                        delist from the
                                                                                               RoC.
Ethylene Oxide/75-21-8..........  Industrial          RG1 recommended (6  RG2 unanimously     The Subcommittee
                                   chemical used as    yes votes to 1 no   recommended (7      recommended (6
                                   an intermediate     vote) to upgrade    yeas votes to 0     yes votes to 5 no
                                   in the              to a known human    no votes) to        votes with 1
                                   manufacture of      carcinogen.         upgrade to a        abstention) to
                                   other chemicals;                        known human         upgrade to a
                                   e.g., ethylene                          carcinogen.         known human
                                   glycol and is                                               carcinogen.
                                   widely used in
                                   the health care
                                   industry as a
                                   sterilant.
Isoprene/78-79-5................  The monomeric unit  RG1 unanimously     RG2 recommended (6  The Subcommittee
                                   of natural rubber   recommended (6      yes votes to 0 no   unanimously
                                   and naturally       yes votes to 0 no   votes with 1        recommended (13
                                   occurring           votes) to list as   abstention) to      yes votes to 0 no
                                   terpenes and        reasonably          list as             votes) to list as
                                   steroids and        anticipated to be   reasonably          reasonably
                                   widely used in      a human             anticipated to be   anticipated to be
                                   the production of   carcinogen.         a human             a human
                                   isoprene-                               carcinogen.         carcinogen.
                                   butadiene
                                   copolymers.
Methyl-t-Butyl Ether/1634-04-4..  Used as an          RG1 recommended (4  RG2 voted against   The Subcommittee
                                   additive in         yes votes to 3 no   motion to list as   voted against
                                   unleaded gasoline   votes) to list as   reasonably          motion to list as
                                   in amounts up to    reasonably          anticipated to be   reasonably
                                   11%.                anticipated to be   a human             anticipated to be
                                                       a human             carcinogen (3 yes   a human
                                                       carcinogen.         votes to 4 no       carcinogen (5 yes
                                                                           votes).             votes to 6 no
                                                                                               votes with 1
                                                                                               abstention).
Nickel Compounds................  Many industrial     RG1 unanimously     RG2 recommended (4  The Subcommittee
                                   and commercial      recommended (7      yes votes to 3 no   unanimously
                                   applications.       yes votes to 0 no   votes with 1        recommended (12
                                                       votes) to upgrade   abstention to       yes votes to 0 no
                                                       to a known human    upgrade to a        votes) to upgrade
                                                       carcinogen.         known human         to a known human
                                                                           carcinogen.         carcinogen.
Silica, Crystalline (Respirable   Exposure from       RG1 unanimously     RG2 recommended (5  The subcommittee
 Size)/7631-86-9.                  mining and          recommended (9      yes votes to 2 no   recommended (11
                                   quarrying of coal   yes votes to 0 no   votes) to upgrade   yes votes to 1 no
                                   and other           votes) to upgrade   to a known human    vote) to upgrade
                                   minerals, stone     to a known human    carcinogen.         to a known human
                                   cutting,            carcinogen.                             carcinogen.
                                   production of
                                   glass and
                                   ceramics and in
                                   occupations such
                                   as sandblasting,
                                   polishing and
                                   grinding.
2,3,7,8-TETRACHLORODIBENZ O-P-    Not used            RG1 unanimously     RG2 unanimously     The Subcommittee
 DIOXIN (TCDD)/1746-01-6.          commercially,       recommended (10     recommended (8      voted against
                                   found as a          yes votes to 0 no   yes votes to 0 no   motion to upgrade
                                   contaminant in      votes) to upgrade   votes) to upgrade   current listing
                                   the production of   to a known human    to a known human    to known human
                                   some pesticides     carcinogen.         carcinogen.         carcinogen. (5
                                   and other                                                   yes votes to 7 no
                                   commercial                                                  votes with 1
                                   products.                                                   abstention).
----------------------------------------------------------------------------------------------------------------
\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 represented on the NTP Executive Committee include: Agency for Toxic Substances and Disease Registry
  (ATSDR), Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), Food and Drug
  Administration (FDA), National Center for Toxicological Research (NCTR), National Institute for Occupational
  Safety and Health (NIOSH), Occupational Safety and Health Administration (OSHA), Department of Health and
  Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), National Library
  of Medicine (NLM), and National Institute of Environmental Health Sciences/NTP (NIEHS/NTP).
\3\ The NTP Board of Scientific Counselor Report on Carcinogens Subcommittee (the External Peer Review Group).
\4\ RoC-Report on Carcinogens.


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[FR Doc. 98-33090 Filed 12-11-98; 8:45 am]
BILLING CODE 4140-01-M