[Federal Register Volume 63, Number 22 (Tuesday, February 3, 1998)]
[Notices]
[Pages 5565-5567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2563]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Toxicology Program; Call for Public Comments; 
Substances, Mixtures and Exposure Circumstances Proposed for Listing in 
or Delisting (Removing) From the Report on Carcinogens, Ninth Edition

Background

    The National Toxicology Program (NTP) announces its intent to 
review additional substances, mixtures and exposure circumstances for 
possible listing in or delisting (removing) from the Report on 
Carcinogens, Ninth Edition. This Report (previously known as the Annual 
Report on Carcinogens) is a Congressionally-mandated listing of known 
human carcinogens and

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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 report which contains a list of all substances 
(1) which either are known to be human carcinogen or may be reasonably 
anticipated to be a human carcinogen, 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.
    The review of the substances, mixtures or exposure circumstances 
for listing in, changing the current listing from reasonably 
anticipated to be a human carcinogen to known to be a human carcinogen 
or delisting from the Ninth Report will involve a multiphased, peer 
review process involving two Federal scientific review groups and one 
non-government, scientific peer review body (a subcommittee on the NTP 
Board of Scientific Counselors) which will meet in an open, public 
meeting that will provide for public comments. All available data 
relevant to the criteria for inclusion or removal of candidate agents, 
substances, mixtures or exposure circumstances in the Report will be 
evaluated by the three scientific review committees. The criteria to be 
used in the review process and the detailed description of the review 
procedures, including the steps in the formal review process, can be 
obtained 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) 541-5096, fax: (919) 541-2242, email: 
[email protected].

Public Comment Requested

    The NTP will be considering 11 substances, mixtures and exposure 
circumstances in 1998, for either listing in or delisting (removing) 
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 substances, mixtures, or exposure circumstances 
are provided in the following table with their chemical Abstracts 
Services (CAS) Registry numbers (where available) and pending review 
action. The NTP solicits public input on these 11 substances, mixtures 
and exposure circumstances and asks for relevant information anyone may 
have on carcinogenesis from completed, ongoing, or planned studies by 
others, as well as current production data, use patterns, and human 
exposure information for any of the substances, mixtures or exposure 
circumstances listed in this announcement. Comments concerning the 
review of these substances, mixtures or exposure circumstances for 
listing in or delisting from the Ninth Report on Carcinogens will be 
accepted for a period of 45 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.

Public Nominations for Delisting or Listing Encouraged

    The NTP solicits and encourages the broadest participation from 
interested individuals or parties in nominating agents, substances, or 
mixtures for listing in or delisting from the Ninth and future Reports 
on Carcinogens. Petitions should contain a rationale for listing or 
delisting. Appropriate background information and relevant data (e.g. 
Journal articles, NTP Technical Reports, IARC listings, exposure 
surveys, release inventories, etc.) which support a petition should be 
provided or referenced when possible.
    A detailed description of listing/delisting procedures, including 
the steps in the formal review process, can be obtained by contacting 
Dr. Jameson at the address listed above.

    Dated: January 26, 1998.
Kenneth Olden,
Director, National Toxicology Program.

 Summary for Agents, Substances, Mixtures or Exposure Circumstances To Be Reviewed in 1998, for Consideration of
                          Listing in or Delisting From the Ninth Report on Carcinogens                          
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Substance or exposure circumstance/                                                                             
             CAS Number                         Primary uses or exposures                 To be reviewed for    
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Alcoholic Beverages................  Consumption of alcoholic beverages.............  Listing in the 9th Report.
Boot and Shoe Manufacture and        Workers in the boot and shoe manufacture and     Listing in the 9th Report.
 Repair.                              repair industry.                                                          
Diesel Particulates................  Diesel engine exhaust..........................  Listing in the 9th Report.
Environmental Tobacco Smoke........  ``Passive'' inhalation of tobacco smoke from     Listing in the 9th Report.
                                      environmental sources.                                                    
Ethyl Acrylate/140-88-5............  Monomer used to produce polymers and copolymers  Delisting from the Report 
                                      for use in latex paints, textiles, etc.          on Carcinogens.          
Ethylene Oxide/75-2-8..............  Industrial chemical used as an intermediate in   Change current listing to 
                                      the manufacture of other chemicals; e.g.,        the Known to be a Human  
                                      ethylene glycol and is widely used in the        Carcinogen category.     
                                      health care industry as a sterilant.                                      
Isoprene/78-79-5...................  The monomeric unit of natural rubber and         Listing in the 9th Report.
                                      naturally occurring terpenes and steroids and                             
                                      widely used in the production of isoprene-                                
                                      butadiene copolymers.                                                     
Methyl-t-Butyl Ether/1634-04-4.....  Used as an additive in unleaded gasoline in      Listing in the 9th Report.
                                      amounts up to 11%.                                                        
Nickel and Nickel Compounds/7440-02- Many industrial and commercial applications....  Change current listing to 
 0.                                                                                    the Known to be a Human  
                                                                                       Carcinogen category.     
Nickel Refining....................  Workers in the nickel refining industry........  Listing in the 9th Report.
Silica, Crystalline/7631-86-9......  Exposure from mining and quarrying of coal and   Change current listing to 
                                      other minerals, stone cutting, production of     the Known to be a Human  
                                      glass and ceramics and in occupations such as    Carcinogen category.     
                                      sandblasting, polishing and grinding.                                     
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[FR Doc. 98-2563 Filed 2-2-98; 8:45 am]
BILLING CODE 4140-01-M