[Federal Register Volume 62, Number 191 (Thursday, October 2, 1997)]
[Notices]
[Pages 51674-51675]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-26169]



[[Page 51674]]

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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 or Delisting from the 9th 
Report on Carcinogens.
    Pursuant to Pub. L. 92-463, notice is hereby given of the next 
meeting of the NTP Board of Scientific Counselors' Report on 
Carcinogens Subcommittee to be held on October 30 & 31, 1997, 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. both 
days and is open to the public. The agenda are the peer review of 
substances nominated for listing in or delisting from the 9th Report on 
Carcinogens (formerly the Biennial Report on Carcinogens), and 
provision of an opportunity for public input.

Background

    Over the past three years, there was an extensive public and 
Federal interagency review of the process for the preparation of the 
Report on Carcinogens (RC) to broaden input to its preparation, broaden 
the scope of scientific review, and provide review of the criteria used 
for inclusion in or removal of substances from the Report. As a result, 
the criteria were revised and approved in September 1996 by the 
Secretary, Department of Health and Human Services. The major change in 
the RC which occurred as a result of the criteria revision was to 
include consideration of all relevant information, including 
mechanistic data, in the decision to list substances in or delist 
substances from future volumes. To broaden the scope of scientific 
review, a new standing subcommittee of the NTP Board of Scientific 
Counselors was established. A November 1996 meeting of the Report on 
Carcinogens (RC) Subcommittee was the first where public review of 
nominations took place, and using the revised criteria. Thus, the 
current review process for review of petitions considered by the NTP 
for listing in or delisting from the Report begins with initial 
scientific review by the NIEHS/NTP Report on Carcinogens Review 
Committee (RG1). The RG1 makes a formal recommendation for those 
petitions determined to contain sufficient information for listing or 
delisting in the Report. The second scientific review is done by the 
NTP Executive Committee's Working Group for the Report on Carcinogens 
(RG2). RG2 is comprised of representatives of the Federal health 
research and regulatory agencies on the NTP Executive Committee. 
Following external scientific peer review by the RC Subcommittee in 
public session and solicitation of public comments through 
announcements in the Federal Register and other media, the independent 
recommendations of the three review groups and all public comments are 
presented to the NTP Executive Committee for review and comment. The 
Director, NTP, receives the four independent recommendations and makes 
the final decision to submit the Report to the Secretary for review and 
approval.

Agenda

    Tentatively scheduled to be peer reviewed on October 30 & 31, are 
14 agents, substances, mixtures or exposure circumstances listed 
alphabetically, along with supporting information in the attached 
table. The table lists the nominations in the tentative order of their 
presentation and review, and gives their primary uses or exposures and 
the category for which they were originally nominated. Background 
summary documents on each of the substances will be provided to 
reviewers around October 1, and will be available to the public at that 
time as well. Background documents include (1) a summary of the 
background data and information used to evaluate the nomination, and 
(2) the recommendation for: listing as ``known to be a human 
carcinogen'' or as ``reasonably anticipated to be a human carcinogen''; 
the upgrading of a current listing; or the removal from the Report. 
Copies of draft background documents can be obtained, as available, 
from: the Executive Secretary, Dr. Larry G. Hart, P.O. Box 12233, 
Research Triangle Park, NC 27709 (telephone 919/541-3971; FAX 919/541-
0295; email [email protected].

Public Input Encouraged

    The entire meeting is open to the public and time will be provided 
for public comment on each of the substances being reviewed. In order 
to facilitate planning for the meeting, persons wanting to make a 
formal presentation regarding a particular nominated substance must 
notify the Executive Secretary by telephone, by FAX, by mail, or by 
email no later than October 23, 1997, and provide a written copy in 
advance of the meeting. Written statements should supplement and may 
expand on the oral presentation, or may be submitted in lieu of an oral 
presentation, and should be received by October 27 so copies can be 
made for distribution to Subcommittee members and staff and made 
available for the public. Oral presentation should be limited to no 
more than five minutes. Should the requests for time exceed the likely 
available time, the time may have to be limited to three minutes and 
presenters will be contacted.
    The program would welcome receiving carcinogenesis information from 
completed, ongoing, or planned studies by others, 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, Report on Carcinogens, MD EC-14, P.O. Box 12233, Research 
Triangle Park, NC 27709 (919/541-4096; FAX 919/541-2242).
    The Executive Secretary, Dr. Larry G. Hart, at the address given 
above, will furnish agenda and a roster of Subcommittee members prior 
to the meeting. Summary minutes subsequent to the meeting will be 
available upon request.

    Dated: September 23, 1997.
Samuel H. Wilson,
Deputy Director, National Toxicology Program.

[[Page 51675]]



 Summary Data for Agents, Substances, Mixtures or Exposure Circumstances Tentatively Scheduled for Review at the
 Meeting of the NTP Board of Scientific Counselors' Report on Carcinogens Subcommittee October 30, and 31, 1997 
----------------------------------------------------------------------------------------------------------------
                                                                                                       Tenative 
Substance or exposure circumstance/       Primary uses or exposures           Nominated for \1\         review  
              CAS No.                                                                                   order   
----------------------------------------------------------------------------------------------------------------
Dyes metabolized to benzidine       Benzidine-based dyes are used         Listing as Known to be a            14
 (Benzidine dyes as a class).        primarily for dyeing textiles,        Human Carcinogen in the              
                                     paper and leather products. More      9th Report.                          
                                     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          Upgrading current listing            4
                                     intermediate and polymer component    to Known to be a Human               
                                     in the manufacture of synthetic       Carcinogen in the 9th                
                                     rubber.                               Report.                              
Cadmium and cadmium compounds/7440- Used in batteries, coating and        Upgrading current listing            2
 43-9.                               plating, plastic and synthetic        to Known to be a Human               
                                     products and in alloys.               Carcinogen in the 9th                
                                                                           Report.                              
Chloroprene/126-99-8..............  Used as a monomer for neoprene        Listing as Reasonably                3
                                     elastomers, industrial rubber         Anticipated to be a                  
                                     products, and as a component of       Human Carcinogen in the              
                                     adhesives in food packaging.          9th Report.                          
Phenolphthalein/77-09-8...........  Used as a laboratory reagent and      Listing as Reasonably               10
                                     acid-base indicator and as a          Anticipated to be a                  
                                     cathartic drug in over-the-counter    Human Carcinogen in the              
                                     laxative preparations.                9th Report.                          
Saccharin/281-44-9................  Used primarily as a nonnutritive      Removal from the Report             11
                                     sweetening agent.                     on Charcinogens.                     
Smokeless tobacco.................  Oral use of smokeless tobacco         Listing as Known to be a             7
                                     products.                             Human Carcinogen in the              
                                                                           9th Report.                          
Strong inorganic acid mists         Used in the manufacture of            Listing as Known to be a             8
 containing sulfuric acid.           fertilizers, rayon, and other         Human Carcinogen in the              
                                     fibers, pigments and colors,          9th Report.                          
                                     explosives, plastics, coal-tar                                             
                                     products such as dyes and drugs,                                           
                                     storage batteries, synthetic                                               
                                     detergents, natural and synthetic                                          
                                     rubber, pulp and paper, cellophone                                         
                                     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  Listing as Known to be a             9
                                     the palliative treatment of breast    Human Carcinogen in the              
                                     cancer.                               9th Report.                          
2,3,7,8-Tetrachorodibenzo-P-Dioxin  Not used commercially, used only as   Upgrading current listing           12
 (TCDD)/1746-01-6.                   a research chemical. Potential        to Known to be a Human               
                                     exposure from municipal               Carcinogen in the 9th                
                                     incinerators, dump sites and          Report.                              
                                     contaminated soil.                                                         
Tetrafluoroethylene/116-14-3......  Used in the production of             Listing as Reasonably                1
                                     polytetrafluoroethylene (Teflon)      Anticipated to be a                  
                                     and other polymers. Has also been     Human Carcinogen in the              
                                     used as a propellant for food         9th Report.                          
                                     product aerosols.                                                          
Tobacco smoking...................  Inhalation of tobacco smoke.........  Listing as Known to be a             6
                                                                           Human Carcinogen in the              
                                                                           9th Report.                          
Tricholoroethylene/79-01-6........  Used as an industrial solvent for     Listing as Reasonably               13
                                     vapor degreasing and cold cleaning    Anticipated to be a                  
                                     of fabricated metal parts. Has also   Human Carcinogen in the              
                                     been used as a carrier solvent for    9th Report.                          
                                     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 as Known to be a            5 
                                     ultraviolent radiation.               Human Carcinogen in the              
                                                                           9th Report.                          
----------------------------------------------------------------------------------------------------------------
\1\ Nomination does not necessarily reflect the final recommendaiton of the two NTP Scientific Review Committees
  for the Report on Carcinogens.                                                                                

[FR Doc. 97-26169 Filed 10-1-97; 8:45 am]
BILLING CODE 4140-01-M