[Federal Register Volume 61, Number 207 (Thursday, October 24, 1996)]
[Notices]
[Pages 55165-55166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-27325]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service


National Toxicology Program; National Toxicology Program (NTP) 
Board of Scientific Counselors' Meeting; Review of Substances for 
Listing in the 8th Biennial Report on Carcinogens

Background

    The Director, NTP, initiated a public review in 1994 of the process 
for preparation of the Biennial Report on Carcinogens (BRC) to broaden 
input to its preparation, broaden the scope of scientific review 
associated with the Report, and provide review of the criteria used for 
inclusion of substances in the BRC. As a result of an extensive public 
as well as Federal interagency review, the criteria were revised with 
the revised criteria recently approved by the Secretary, Department of 
Health and Human Services, (Federal Register Vol. 61, No. 188, 50499-
50500). The major change in the BRC which will occur as a result of the 
criteria revision will be to include consideration of all relevant 
information, including mechanistic data, in the decision to list 
substances in or delist substances from future volumes of the BRC. To 
broaden the scope of scientific review, a new standing subcommittee of 
the NTP Board of Scientific Counselors was established and held an 
organizational and informational meeting on May 8, 1996. The Biennial 
Report on Carcinogens (BRC) Subcommittee will meet once or twice a 
year, in public session, to review nominations for listing and/or 
delisting substances and to receive public comments. A November 18 and 
19, 1996, meeting will be the first where review of nominations takes 
place. Finally, to broaden input to preparation of the BRC, the NTP 
will use a number of mechanisms to communicate to the public the 
revised criteria and the process for listing and delisting substances 
in the BRC, and to solicit nominations for listing or delisting. 
Announcements will be published in the Federal Register and appropriate 
publications such as the NIEHS journal, Environmental Health 
Perspectives, and various trade publications and journals. Direct 
mailings from the NTP Liaison Office will target persons and 
organizations who have requested to be on a mailing list for NTP 
information and specifically for information regarding the BRC. A list 
of new petitions for listing or delisting, soliciting public comment, 
will be disseminated through the same media.

November 18-19 Meeting

    Pursuant to Public Law 92-463, notice is hereby given of the next 
meeting of the NTP Board of Scientific Counselors' Biennial Report on 
Carcinogens Subcommittee to be held in the Conference Center, Building 
101, South Campus, National Institute of Environmental Health Sciences 
(NIEHS), 111 Alexander Drive, Research Triangle Park, North Carolina. 
The meeting will begin at 8:30 a.m. and is open to the public. The 
agenda topic is the peer review of substances nominated for listing in 
the 8th Biennial Report on Carcinogens. Also under review will be 
revisions to the Introduction to the 8th BRC and changes to the 
structure of the report. These include a.) the addition of a table of 
substances considered, but rejected for inclusion in the BRC as known 
or reasonably anticipated human carcinogens and b.) the addition of a 
table of substances nominated but not yet reviewed for listing in a 
subsequent Report. There will also be a review of the reference in the 
draft 8th BRC Introduction to certain manufacturing processes and 
occupations which the International Agency for Research on Cancer 
(IARC) has determined are associated with increased incidences of 
cancer in workers in these settings but which do not qualify for formal 
review for BRC listing because no specific agent, substance or mixture 
has been identified with the exposures involved. This will include a 
discussion of the appropriateness of having this reference in the BRC 
and, if so, should it remain in the Introduction or be listed 
separately in an appendix in the Report.
    Tentatively scheduled to be peer reviewed on November 18-19 are 15 
substances, listed alphabetically, along with supporting information in 
the attached table. The order of review is given in the far right 
column of the table. Copies of the draft introduction for the 8th BRC, 
or copies of a draft summary document which contains the background 
data and information used to evaluate the nomination for listing a 
substance may be obtained, as available, from: Dr. C. W. Jameson, 
Biennial Report on Carcinogens, MD WC-05, P.O. Box 12233, Research 
Triangle Park, NC 27709 (919/541-4096; FAX 919/541-2242).

Public Comment

    Persons wanting to make a formal presentation concerning proposed 
changes to the BRC or regarding a particular nominated substance must 
notify the Executive Secretary, Dr. Larry G. Hart, by telephone, by 
FAX, or by mail (see contact information below) no later than November 
13, 1996. A written copy of comments is requested in advance of the 
meeting so that copies can be distributed to all Subcommittee members 
and staff and made available at the meeting. Written statements should 
supplement and may expand upon the oral presentation. Oral 
presentations must be limited to no more than five minutes. In lieu of 
an oral presentation, written statements may be submitted. These should 
be received by the Executive Secretary by November 13.
    The program would welcome receiving carcinogenesis information from 
completed, ongoing, or planned studies, as well as current production 
data, human exposure information, and use patterns for any of the 
substances listed in this announcement. Please contact Dr. C. W. 
Jameson at the address given above.
    Upon request the Executive Secretary, Dr. Larry G. Hart, P.O. Box 
12233, Research Triangle Park, North Carolina 27709 (telephone 919/541-
3971; FAX 919/541-0295), will furnish an agenda and a roster of 
Subcommittee members prior to the meeting. Summary minutes subsequent 
to the meeting will be available upon request.

Attachment

    Dated: October 16, 1996.
Kenneth Olden,
Director, National Toxicology Program.

   Summary Data for Substances Tentatively Scheduled for Review at the Meeting of the NTP Board of Scientific   
                  Counselors' Biennial Report on Carcinogens Subcommittee, November 18-19, 1996                 
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Azacitidine.........................  CAS Number 320-67-2..........................  Review order: 3.           
Primary Uses........................  Used as a cytostatic agent in the treatment                               
                                       of acute leukemia.                                                       
Nominated as........................  Reasonably Anticipated to be a Human                                      
                                       Carcinogen.                                                              
p-Chloro-o-Toluidine and its HCl      CAS Number 95-69-2...........................  Review order: 4.           
 salt.                                                                                                          
Primary Uses........................  Used to produce azo dyes for cotton, silk                                 
                                       acetate and nylon and as intermediate in                                 
                                       production of Pigment Red 7 and Pigment                                  
                                       Yellow 49. Also an impurity in and a                                     
                                       metabolite of the pesticide chlordimeform.                               

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Nominated as........................  Reasonably Anticipated to be a Human                                      
                                       Carcinogen.                                                              
Chlorozotocin.......................  CAS Number 54749-90-5........................  Review order: 5.           
Primary Uses........................  Used as a cytostatic agent in the treatment                               
                                       of cancers of the stomach, large intestine                               
                                       pancreas and lung; melanoma; and multiple                                
                                       myeloma.                                                                 
Nominated as........................  Reasonably Anticipated to be a Human                                      
                                       Carcinogen.                                                              
Cyclosporin.........................  CAS Number 59865-13-3........................  Review order: 1.           
Primary Uses........................  Used as an immunosuppressive agent in the                                 
                                       prevention and treatment of graft-vs-host                                
                                       reactions in bone marrow transplantation and                             
                                       for the prevention of rejection of kidney,                               
                                       heart, and liver transplants.                                            
Nominated as........................  Known to be a Human Carcinogen...............                             
Danthron (1,8-                        CAS Number 117-10-2..........................  Review order: 12.          
 Dihydroxyanthraquinone).                                                                                       
Primary Uses........................  Used as a laxative and as an intermediate in                              
                                       the manufacture of dyes.                                                 
Nominated as........................  Reasonably Anticipated to be a Human                                      
                                       Carcinogen.                                                              
1,6-Dinitropyrene...................  CAS Number 42397-64-8........................  Review order: 9.           
Primary Uses........................  Not used commercially, detected in ambient                                
                                       atmospheric samples and as a constituent of                              
                                       diesel exhaust.                                                          
Nominated as........................  Reasonably Anticipated to be a Human                                      
                                       Carcinogen.                                                              
1,8-Dinitropyrene...................  CAS Number 42397-65-9........................  Review order: 10.          
Primary Uses........................  Not used commercially, detected in ambient                                
                                       atmospheric samples and as a constituent of                              
                                       diesel exhaust.                                                          
Nominated as........................  Reasonably Anticipated to be a Human                                      
                                       Carcinogen.                                                              
Disperse Blue 1 (1,4,5,8-             CAS Number 2475-45-8.........................  Review order: 13.          
 Tetraaminoanthraquinone).                                                                                      
Primary Uses........................  Used as an anthraquinone based dyestuff in                                
                                       hair color formulations and in coloring                                  
                                       fabrics and plastics.                                                    
Nominated as........................  Reasonably Anticipated to be a Human                                      
                                       Carcinogen.                                                              
Furan...............................  CAS Number 100-00-9..........................  Review order: 6.           
Primary Uses........................  Used as an intermediate in the synthesis and                              
                                       production of other organic compounds..                                  
Nominated as........................  Reasonably Anticipated to be a Human                                      
                                       Carcinogen.                                                              
o-Nitroanisole......................  CAS Number 91-23-6...........................  Review order: 14.          
Primary Uses........................  Used as a precursor in the synthesis of o-                                
                                       anisidine which is used in the manufacture                               
                                       of over 100 azo dyes.                                                    
Nominated as........................  Reasonably Anticipated to be a Human                                      
                                       Carcinogen.                                                              
6-Nitrochrysene.....................  CAS Number 7495-02-8.........................  Review order: 11.          
Primary Uses........................  Not used commercially, detected in ambient                                
                                       atmospheric samples.                                                     
Nominated as........................  Reasonably Anticipated to be a Human                                      
                                       Carcinogen.                                                              
1-Nitropyrene.......................  CAS Number 5522-43-0.........................  Review order: 7.           
Primary Uses........................  Not used commercially, detected in ambient                                
                                       atmospheric samples and as a constituent of                              
                                       diesel and gasoline engine exhaust.                                      
Nominated as........................  Reasonably Anticipated to be a Human                                      
                                       Carcinogen.                                                              
4-Nitropyrene.......................  CAS Number 57835-92-4........................  Review order: 8.           
Primary Uses........................  Not used commercially, detected in ambient                                
                                       atmospheric samples.                                                     
Nominated as........................  Reasonably Anticipated to be a Human                                      
                                       Carcinogen.                                                              
Thiotepa............................  CAS Number 52-24-4...........................  Review order: 2.           
Primary Uses........................  Used as a cytostatic agent in the treatment                               
                                       of 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.                            
Nominated as........................  Known to be a Human Carcinogen...............                             
1,2,3-Trichloropropane..............  CAS Number 96-18-4...........................  Review order: 15.          
Primary Uses........................  Used as a polymer crosslinking agent, paint                               
                                       and varnish remover, solvent and 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.                             
Nominated as........................  Reasonably Anticipated to be a Human                                      
                                       Carcinogen.                                                              
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[FR Doc. 96-27325 Filed 10-23-96; 8:45 am]
BILLING CODE 4140-01-M