[Federal Register Volume 62, Number 133 (Friday, July 11, 1997)]
[Notices]
[Pages 37272-37273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18141]


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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 reasonably anticipated human carcinogens and its 
preparation is delegated to the National Toxicology Program by the 
Secretary, Department of Health and Human Services (HHS). 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 decreases the risk to public health from exposure to these 
chemicals.
    The review of the substances, mixtures or exposure circumstances 
for listing in 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 of 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 WC-05, P.O. Box 12233, 
Research Triangle Park, NC 27709; phone: (919) 541-4096, fax: (919) 
541-2242, email: [email protected].

Public Comment Requested

    The NTP will be considering 14 substances, mixtures and exposure 
circumstances in 1997, for either listing or delisting (removing) from, 
or changing the current listing from reasonably anticipated to be a 
human carcinogen to the known 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 14 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 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.

    Attachment:
Kenneth Olden,
Director, National Toxicology Program.

Summary for Substances, Mixtures or Exposure Circumstances 
Nominated for Consideration of Listing in or Delisting From the 
Ninth Report on Carcinogens

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 Substance or exposure circumstance/CAS                                                                         
                   No.                             Primary uses or exposures              To be reviewed for    
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BENZIDINE-BASED DYES AS A CLASS.........  Benzidine-based dyes are used primarily     Listing in the 9th Report.
                                           for dyeing textiles, paper and leather                               
                                           products. More than 250 benzidine-based                              
                                           dyes have been reported by the Society of                            
                                           Dyers and Colorists.                                                 
1,3-BUTADIENE/106-99-0..................  Used primarily as a chemical intermediate   Change current listing to 
                                           and polymer component in the manufacture    the Known to be a Human  
                                           of synthetic rubber.                        Carcinogen category.     
CADMIUM and CADMIUM COMPOUNDS/7440-43-9.  Used in batteries, coating and plating,     Change current listing to 
                                           plastic and synthetic products and in       the Known to be a Human  
                                           alloys.                                     Carcinogen category.     
CHLOROPRENE/126-99-8....................  Used as a monomer for neoprene elastomers,  Listing in the 9th Report.
                                           industrial rubber products, and as a                                 
                                           component of adhesives in food packaging.                            

[[Page 37273]]

                                                                                                                
PHENOLPHTHALEIN/77-09-8.................  Used as a laboratory reagent and acid-base  Listing in the 9th Report.
                                           indicator and as a cathartic drug in over-                           
                                           the-counter laxative preparations.                                   
SACCHARIN/218-44-9......................  Used primarily as a nonnutritive            Delisting from the Report 
                                           sweetening agent.                           on Carcinogens.          
SMOKELESS TOBACCO.......................  Oral use of smokeless tobacco products....  Listing in the 9th Report.
SULFURIC ACID MIST/7664-93-9............  Sulfuric acid is the one of the most        Listing in the 9th Report.
                                           widely used of all industrial chemicals.                             
                                           Used in the manufacture of fertilizers,                              
                                           rayon and other fibers, pigments and                                 
                                           colors, explosives, plastics, coal-tar                               
                                           products such as dyes and drugs, storage                             
                                           batteries, synthetic detergents, natural                             
                                           and synthetic rubber, pulp and paper,                                
                                           cellophane and catalysts. It is also used                            
                                           in petroleum refining, pickling iron,                                
                                           steel and other metals and in ore                                    
                                           concentration.                                                       
TAMOXIFEN/10540-29-1....................  Used as an anti-estrogen drug and in the                              
                                           palliative treatment of.                                             
 2,3,7,8-TETRACHLORODIBENZO-............  breast cancer.............................  Listing in the 9th Report.
P-DIOXIN (TCDD)/1746-01-6...............  Not used commercially, used only as a       Change current listing to 
                                           research chemical.                          the Known to be a Human  
                                                                                       Carcinogen category.     
TETRAFLUOROETHYLENE/116-14-3............  Used in the production of                   Listing in the 9th Report.
                                           polytetrafluoroethylene (Teflon) and                                 
                                           other polymers. Has also been used as a                              
                                           propellant for food product aerosols.                                
TOBACCO SMOKE...........................  Inhalation of tobacco smoke...............  Listing in the 9th Report.
TRICHLOROETHYLENE/79-01-6...............  Used as an industrial solvent for vapor     Listing in the 9th Report.
                                           degreasing and cold cleaning of                                      
                                           fabricated metal parts. Has also been                                
                                           used as a carrier solvent for the active                             
                                           ingredients of insecticides and                                      
                                           fungicides, as a solvent for waxes, fats,                            
                                           resins, and oils, as an anesthetic for                               
                                           medical and dental use, and as an                                    
                                           extractant for spice oleoresins and for                              
                                           caffeine from coffee.                                                
UV RADIATION............................  Solar and artificial sources of             Listing in the 9th Report.
                                           ultraviolet radiation.                                               
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[FR Doc. 97-18141 Filed 7-10-97; 8:45 am]
BILLING CODE 4140-01-P