[Federal Register Volume 62, Number 83 (Wednesday, April 30, 1997)]
[Notices]
[Pages 23469-23470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-11136]



[[Page 23469]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Toxicology Program; Call for Public Comments; Chemicals 
Proposed for the Eighth Biennial Report on Carcinogens

Background

    The National Toxicology Program (NTP) announces its intent to list 
additional substances in the Eighth Biennial Report on Carcinogens 
(BRC). 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 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 new entries for the Eighth BRC have undergone 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 met in an open, public 
meeting that included a public comment session. All data relevant to 
the criteria for inclusion of candidate agents, substances or mixtures 
in the BRC have been evaluated by the three scientific review 
committees.
    In the Eighth BRC, the NTP is adding 14 agents, substances or 
mixtures to the existing list, one of which is listed as a known human 
carcinogen. The 13 remaining agents, substances or mixtures are being 
added as reasonably anticipated to be human carcinogens. In addition, 
thiotepa, which is currently listed in previous Reports on Carcinogens 
as reasonably anticipated to be a human carcinogen is moved to the 
known human carcinogen list. These agents, substances or mixtures are 
provided in the following table with their Chemical Abstracts Services 
(CAS) Registry numbers and listing. The Eighth BRC also contains an 
appendix which is a reference to certain ``Manufacturing Processes, 
Occupations and Exposure Circumstances'' that have not yet been 
formally reviewed by the NTP for BRC listing but have been classified 
by IARC as sources which are known to be carcinogenic to humans because 
of the associated increased incidences of cancer in workers in these 
settings. While not formally listed in the 8th BRC, in the interest of 
public health and for completeness, these occupational exposures have 
been referenced in an appendix to the Report with the corresponding 
IARC citation given.
    Comments concerning the addition of these substances in the Eighth 
BRC will be accepted for a period of 30 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, National Toxicology 
Program, Biennial Report on Carcinogens, MD WC-05, P.O. Box 12233, 
Research Triangle Park, NC 27709, fax number: (919)-541-2242, email: 
J[email protected].

    Attachment.

    Dated: April 18, 1997.
Kenneth Olden,
Director, National Institute of Environmental Health Sciences.

  Summary for Agents, Substances or Mixtures to be Listed in the Eighth 
                     Biennial Report on Carcinogens                     
------------------------------------------------------------------------
      Chemical/CAS number            Primary uses        To be listed as
------------------------------------------------------------------------
AZACITIDINE/320-67-2..........  Used as a cytostatic    Reasonably      
                                 agent in the            Anticipated to 
                                 treatment of acute      be a Human     
                                 leukemia                Carcinogen.    
p-CHLORO-o-TOLUIDINE and its    Used to produce azo     Reasonably      
 HCl salt/95-69-2.               dyes for cotton, silk   Anticipated to 
                                 acetate and nylon and   be a Human     
                                 as intermediate in      Carcinogen.    
                                 production of Pigment                  
                                 Red 7 and Pigment                      
                                 Yellow 49. Also an                     
                                 impurity in and a                      
                                 metabolite of the                      
                                 pesticide                              
                                 chlordimeform                          
CHLOROZOTOCIN/54749-90-5......  Used as a cytostatic    Reasonably      
                                 agent in the            Anticipated to 
                                 treatment of cancers    be a Human     
                                 of the stomach, large   Carcinogen.    
                                 intestine pancreas                     
                                 and lung; melanoma;                    
                                 and multiple myeloma                   
CYCLOSPORIN/59865-13-3........  Used as an              Known to be a   
                                 immunosuppressive       Human          
                                 agent in the            Carcinogen.    
                                 prevention and                         
                                 treatment of graft-vs-                 
                                 host reactions in                      
                                 bone marrow                            
                                 transplantation and                    
                                 for the prevention of                  
                                 rejection of kidney,                   
                                 heart, and liver                       
                                 transplants                            
DANTHRON/(1,8-                  Used as a laxative and  Reasonably      
 Dihydroxyanthraquinone) 117-    as an intermediate in   Anticipated to 
 10-2.                           the manufacture of      be a Human     
                                 dyes                    Carcinogen.    
1,6-DINITROPYRENE/42397-64-8..  Not used commercially,  Reasonably      
                                 detected in ambient     Anticipated to 
                                 atmospheric samples     be a Human     
                                 and as a constituent    Carcinogen.    
                                 of diesel exhaust                      
1,8-DINITROPYRENE/42397-65-9..  Not used commercially,  Reasonably      
                                 detected in ambient     Anticipated to 
                                 atmospheric samples     be a Human     
                                 and as a constituent    Carcinogen.    
                                 of diesel exhaust                      
DISPERSE BLUE 1/(1,4,5,8-       Used as an              Reasonably      
 Tetraaminoanthraquinone) 2475-  anthraquinone based     Anticipated to 
 45-8.                           dyestuff in hair        be a Human     
                                 color formulations      Carcinogen.    
                                 and in coloring                        
                                 fabrics and plastics                   
FURAN/100-00-9................  Used as an              Reasonably      
                                 intermediate in the     Anticipated to 
                                 synthesis and           be a Human     
                                 production of other     Carcinogen.    
                                 organic compounds                      
o-NITROANISOLE/91-23-6........  Used as a precursor in  Reasonably      
                                 the synthesis of o-     Anticipated to 
                                 anisidine which is      be a Human     
                                 used in the             Carcinogen.    
                                 manufacture of over                    
                                 100 azo dyes                           
6-NITROCHRYSENE/7495-02-8.....  Not used commercially,  Reasonably      
                                 detected in ambient     Anticipated to 
                                 atmospheric samples     be a Human     
                                                         Carcinogen.    
1-NITROPYRENE/5522-43-0.......  Not used commercially,  Reasonably      
                                 detected in ambient     Anticipated to 
                                 atmospheric samples     be a Human     
                                 and as a constituent    Carcinogen.    
                                 of diesel and                          
                                 gasoline engine                        
                                 exhaust                                
4-NITROPYRENE/57835-92-4......  Not used commercially,  Reasonably      
                                 detected in ambient     Anticipated to 
                                 atmospheric samples     be a Human     
                                                         Carcinogen.    

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THIOTEPA/52-24-4..............  Used as a cytostatic    Known to be a   
                                 agent in the            Human          
                                 treatment of            Carcinogen.    
                                 lymphomas and a                        
                                 variety of solid                       
                                 tumors, such as                        
                                 breast and ovary. It                   
                                 has also been used at                  
                                 high doses in                          
                                 combination                            
                                 chemotherapy with                      
                                 cyclophosphamide in                    
                                 patients with                          
                                 refractory                             
                                 malignancies treated                   
                                 with autologous bone                   
                                 transplantation                        
1,2,3-TRICHLOROPROPANE/96-18-4  Used as a polymer       Reasonably      
                                 crosslinking agent,     Anticipated to 
                                 paint and varnish       be a Human     
                                 remover, solvent and    Carcinogen.    
                                 degreasing agent..                     
                                It has been found as                    
                                 an impurity in                         
                                 certain nematicides                    
                                 and soil fumigants                     
                                 and has been detected                  
                                 in drinking and                        
                                 ground water in                        
                                 various parts of the                   
                                 United States                          
------------------------------------------------------------------------

[FR Doc. 97-11136 Filed 4-29-97; 8:45 am]
BILLING CODE 4140-01-M