[Federal Register Volume 63, Number 53 (Thursday, March 19, 1998)]
[Notices]
[Pages 13418-13421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7183]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


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

Background

    The National Toxicology Program (NTP) solicits final public 
comments on its intent to recommend 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 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 report 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 1997, 14 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. All available data relevant to the criteria for 
inclusion or removal of candidate substances or exposure circumstances 
in the Report were evaluated by the three scientific review committees. 
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, MD EC-14, 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 making a final recommendation for the 14 substances 
or exposure circumstances reviewed in 1997, 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 and summary minutes of the public peer review by the 
NTP Board Subcommittee 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

[[Page 13419]]

comments or to provide comments for the first time on any substance or 
exposure circumstances in the following table. Because of the different 
recommendations forwarded by the three scientific review groups, the 
NTP is especially interested in obtaining additional relevant 
information in support of or against the petition to delist Saccharin 
from the Report on Carcinogens. The critical areas identified in the 
earlier scientific reviews where additional input is solicited include 
(1) information that addresses the adequacy of existing epidemiology 
data, particularly as it relates to reported increased incidences of 
bladder tumor formation in certain small populations; (2) the levels of 
human exposure, especially in infants and children; (3) information 
addressing the mechanism of urinary bladder tumor formation in male 
rats as it relates to other test species (especially female rats and 
male and female mice) and to humans; and (4) the adequacy of data for 
tumor formation in laboratory animals at target sites other than the 
urinary bladder. 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: March 12, 1998.
Kenneth Olden,
Director, National Toxicology Program.

 Summary of RG1 \1\, RG2 \2\ and NTP Board Subcommittee \3\ Recommendations for the Agents, Substances, Mixtures
   of Exposure Circumstances Reviewed in 1997 for Listing in or Delisting From the Report on Carcinogens, 9th   
                                                     Edition                                                    
----------------------------------------------------------------------------------------------------------------
                                                                                                   NTP Board    
      Substance or exposure         Primary uses or       RG1 action          RG2 action         Subcommittee   
      circumstance/CAS No.             exposures                                                    action      
----------------------------------------------------------------------------------------------------------------
DYES METABOLIZED TO BENZIDINE     Benzidine-based     RG1 voted 7/1 to    RG2 voted           The Subcommittee  
 (BENZIDINE DYES AS A CLASS).      dyes are used       list as known to    unanimously to      recommended      
                                   primarily for       be human            list as a known     unanimously      
                                   dyeing textiles,    carcinogen.         to be human         listing as known 
                                   paper and leather                       carcinogen.         to be human      
                                   products. More                                              carcinogen.      
                                   than 250                                                                     
                                   benzidine-based                                                              
                                   dyes have been                                                               
                                   reported by the                                                              
                                   Society of Dyers                                                             
                                   and Colorists.                                                               
1,3-BUTADIENE/106-99-0..........  Used primarily as   RG1 voted 9/0 with  RG2 voted           The Subcommittee  
                                   a chemical          1 abstention to     unanimously to      recommended (4   
                                   intermediate and    upgrade the         upgrade the         yes votes to 2 no
                                   polymer component   current listing     current listing     votes with 1     
                                   in the              to known to be      to known to be      abstention)      
                                   manufacture of      human carcinogen.   human carcinogen.   upgrading the    
                                   synthetic rubber.                                           current listing  
                                                                                               to known to be   
                                                                                               human carcinogen.
CADMIUM and CADMIUM COMPOUNDS/    Used in batteries,  RG1 voted 7/1 to    RG2 voted           The Subcommittee  
 7740-43-9.                        coating and         upgrade the         unanimously to      recommended      
                                   plating, plastic    current listing     upgrade the         unanimously      
                                   and synthetic       to known to be      current listing     upgrading the    
                                   products and in     human carcinogen.   to known to be      current listing  
                                   alloys.                                 human carcinogen.   to known to be a 
                                                                                               human carcinogen.
CHLOROPRENE/126-99-8............  Used as monomer     RG1 voted 7/0 with  RG2 voted           The Subcommittee  
                                   for neoprene        2 abstentions to    unanimously to      recommended      
                                   elastomers,         list as a           list as a           unanimously      
                                   industrial rubber   reasonably          reasonably          listing as       
                                   products, and as    anticipated human   anticipated human   reasonably       
                                   a component of      carcinogen.         carcinogen.         anticipated to be
                                   adhesives in food                                           a human          
                                   packaging.                                                  carcinogen.      
PHENOLPHTHALEIN/77-09-8.........  Used as a           RG1 voted 9/1 to    RG2 voted 7/0 with  The Subcommittee  
                                   laboratory          list as             1 abstention to     recommended      
                                   reagent and acid-   reasonably          list as a           unanimously      
                                   base indicator      anticipated to be   reasonably          listing as       
                                   and as a            a human             anticipated to be   reasonably       
                                   cathartic drug in   carcinogen.         a human             anticipated to be
                                   over-the-counter                        carcinogen.         a human          
                                   laxative                                                    carcinogen.      
                                   preparations.                                                                
SACCHARIN/218-44-9..............  Used primarily as   RG1 voted 7/3 to    RG2 voted 6/2 to    The Subcommittee  
                                   a nonnutritive      delist from the     delist from the     recommended (4   
                                   sweetening agent.   Report on           Report on           yes votes to 3 no
                                                       Carcinogens.        Carcinogens.        votes) not to    
                                                                                               delist from the  
                                                                                               Report, and leave
                                                                                               saccharin listed 
                                                                                               as reasonably    
                                                                                               anticipated to be
                                                                                               a human          
                                                                                               carcinogen.      
SMOKELESS TOBACCO...............  Oral use of         RG1 voted           RG2 voted           The Subcommittee  
                                   smokeless tobacco   unanimously to      unanimously to      recommended      
                                   products.           list as a known     list as a known     unanimously      
                                                       to be human         to be human         listing as a     
                                                       carcinogen.         carcinogen.         known to be human
                                                                                               carcinogen.      

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STRONG INORGANIC ACID MISTS       Sulfuric acid is    RG1 voted           RG2 voted 7/1 to    The Subcommittee  
 CONTAINING SULFURIC ACID.         the one of the      unanimously to      list as known to    recommended      
                                   most widely used    list as known to    be a human          unanimously      
                                   of all industrial   be a human          carcinogen.         listing as known 
                                   chemicals. Used     carcinogen.                             to be a human    
                                   in the                                                      carcinogen.      
                                   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.                                                              
TAMOXIFEN/10540-29-1............  Used as an anti-    RG1 voted           RG2 voted 7/0 with  The Subcommittee  
                                   estrogen drug and   unanimously to      1 abstention to     recommended      
                                   in the palliative   list as known to    list as known to    unanimously      
                                   treatment of        be human            be a human          listing as known 
                                   breast cancer.      carcinogen with     carcinogen with     to be a human    
                                                       the added           the added           carcinogen, with 
                                                       statement that      statement that      the statement    
                                                       there is also       there is also       that there is    
                                                       conclusive          conclusive          also conclusive  
                                                       evidence that       evidence that       evidence that    
                                                       tamoxifen therapy   tamoxifen therapy   tamoxifen therapy
                                                       reduces the risk    reduces the risk    reduces the risk 
                                                       of contralateral    of contralateral    of contralateral 
                                                       breast cancer in    breast cancer in    breast cancer in 
                                                       women with a        women with a        women with a     
                                                       previous            previous            previous         
                                                       diagnosis of        diagnosis of        diagnosis of     
                                                       breast cancer.      breast cancer.      breast cancer.   
2,3,7,8-TETRACHLORODIBENZO-P-     Not used            RG1 voted           RG2 voted           The Subcommittee  
 DIOXIN (TCDD)/1746-01-6.          commercially,       unanimously to      unanimously to      recommended (4   
                                   used only as a      upgrade the         upgrade the         yes votes to 3 no
                                   research chemical.  current listing     current listing     votes with 1     
                                                       to known to be      to known to be      abstention)      
                                                       human carcinogen.   human carcinogen.   upgrading the    
                                                                                               current listing  
                                                                                               to known to be   
                                                                                               human carcinogen.
TETRAFLUOROETHYLENE/116-14-3....  Used in the         RG1 voted           RG2 voted           The Subcommittee  
                                   production of       unanimously to      unanimously to      recommended      
                                   polytetrafluoroet   list as             list as             unanimously      
                                   hylene (Teflon)     reasonably          reasonably          listing as       
                                   and other           anticipated to be   anticipated to be   reasonably       
                                   polymers. Has       a human             a human             anticipated to be
                                   also been used as   carcinogen.         carcinogen.         a human          
                                   a propellant for                                            carcinogen.      
                                   food product                                                                 
                                   aerosols.                                                                    
TOBACCO SMOKING.................  Inhalation of       RG1 voted           RG2 voted           The Subcommittee  
                                   tobacco smoke.      unanimously to      unanimously to      recommended      
                                                       list as known to    list as known to    unanimously      
                                                       be a human          be a human          listing as known 
                                                       carcinogen.         carcinogen.         to be a human    
                                                                                               carcinogen.      
TRICHLOETHYLENE/79-01-6.........  Used as an          RG1 voted 6/2 to    RG2 voted 7/1 to    The Subcommittee  
                                   industrial          list as             list as             recommended      
                                   solvent for vapor   reasonably          reasonably          unanimously      
                                   degreasing and      anticipated to be   anticipated to be   listing as       
                                   cold cleaning of    a human             a human             reasonably       
                                   fabricated metal    carcinogen.         carcinogen.         anticipated to be
                                   parts. Has also                                             a human          
                                   been used as a                                              carcinogen.      
                                   carrier solvent                                                              
                                   for the active                                                               
                                   ingredients of                                                               
                                   insecticides and                                                             
                                   fungicides, as an                                                            
                                   anesthetic for                                                               
                                   medical and                                                                  
                                   dental use, and                                                              
                                   for caffeine from                                                            
                                   coffee.                                                                      
UV RADIATION....................  Solar and           RG1 voted           RG2 voted 7/1 in    The Subcommittee  
                                   artificial          unanimously to      favor of motion     recommended      
                                   sources of          list Solar          to defer action     unanimously      
                                   ultraviolet         Radiation and use   on UV Radiation     listing Solar    
                                   radiation.          of Sunlamps and     until the           Radiation and use
                                                       Sunbeds as known    Background          of Sunlamps and  
                                                       to be a human       Document could be   Sunbeds as know  
                                                       carcinogen.         revised to          to be a human    
                                                                           address the full    carcinogen.      
                                                                           spectrum of UV                       
                                                                           Radiation,                           
                                                                           including UVA,                       
                                                                           UVB, and UVC.                        
----------------------------------------------------------------------------------------------------------------
\1\ The NIEHS Review Committee for the Report on Carcinogens (RG1).                                             
\2\ The NTP Interagency Executive Committee Working Group for the Report on Carcinogens (RG2).                  
\3\ The NTP Board of Scientific Counselors Report on Carcinogens Subcommittee.                                  


[[Page 13421]]

[FR Doc. 98-7183 Filed 3-18-98; 8:45 am]
BILLING CODE 4140-01-M