[Federal Register Volume 63, Number 206 (Monday, October 26, 1998)]
[Notices]
[Pages 57132-57133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-28606]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Toxicology Program (NTP) Board of Scientific Counselors' 
Meeting; Review of Nominations for Listing in or Delisting From the 9th 
Report on Carcinogens

    Pursuant to Public Law 92-463, notice is hereby given of the next 
meeting of the NTP Board of Scientific Counselors' Report on 
Carcinogens (RoC) Subcommittee to be held on December 2 & 3, 1998, 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 topics are the peer review 
of substances, mixtures, or exposure circumstances nominated for 
listing in or delisting from the 9th Report on Carcinogens, and the 
provision of the opportunity for public input.

Background

    The process for preparation of the Report on Carcinogens (RoC) has 
three levels of scientific peer review. Central to the evaluations of 
the review groups is the use of revised criteria, for inclusion in or 
removal of substances from the Report, which were approved by the 
Secretary, Department of Health and Human Services (DHHS), in September 
1996. The major change in the RoC 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 in or 
delist from future volumes. To broaden the scope of scientific review 
and broaden input to preparation of the Report, a new standing 
subcommittee of the NTP Board of Scientific Counselors was established 
in 1996. The meeting on December 2 & 3 will be the third meeting at 
which the RoC Subcommittee has conducted public review of nominations. 
The current review process for review of petitions considered by the 
NTP for listing in or delisting from the RoC begins with initial 
scientific review by the NIEHS/NTP Report on Carcinogens Review 
Committee (RG1). The RG1 is comprised of NIEHS/NTP staff scientists. 
The second scientific review phase 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

[[Page 57133]]

Executive Committee. The third level of review is the external public 
review by the RoC Subcommittee and includes time for public comments. 
The independent recommendations of the three scientific peer 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 NTP recommendations regarding 
listing or delisting to the Secretary, DHHS.

Agenda

    Tentatively scheduled to be peer reviewed on December 2 & 3 are 11 
nominations. An alphabetical listing of the nominations with supporting 
information follows this announcement. The table notes the tentative 
order of presentation and review in the right hand column, and gives 
primary uses or exposures and the category for which they were 
originally nominated. Draft background documents on each of the 
nominations will be provided to Board Subcommittee reviewers around 
November 1. Paper copies of draft background documents can be obtained, 
as available, from: the Board Executive Secretary, Dr. Larry G. Hart, 
P.O. Box 12233, Research Triangle Park, NC 27709 (telephone 919/541-
3971; FAX 919/541-0295; [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 nominations being reviewed. In order 
to facilitate planning for the meeting, persons wanting to make a 
formal presentation regarding a particular nomination must notify the 
Executive Secretary by telephone, by FAX, by mail, or by email no later 
than November 30, 1998, and, if possible, provide a written copy of 
their statement 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 November 30 
so copies can be made for distribution to Subcommittee members and 
staff and made available for the public. All attempts will be made to 
send statements received by November 24 to Subcommittee members in 
advance of the meeting. Oral presentations must be limited to no more 
than five minutes.
    Upon request, the Executive Secretary, Dr. Larry G. Hart, at the 
address given above, will furnish the 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, 1998.
Kenneth Olden,
Director, National Toxicology Program.

   Summary Data for Nominations Tentatively Scheduled for Review at the Meeting of the NTP Board of Scientific
                       Counselors' Report on Carcinogens Subcommittee December 2 & 3, 1998
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                                                                                                      Tentative
           Nomination/CAS No.               Primary uses or exposures         To be reviewed for        review
                                                                                                        order
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Alcoholic Beverages....................  Consumption of alcoholic         Listing in the 9th Report            3
                                          beverages.
Boot and Shoe Manufacture and Repair...  Workers in the boot and shoe     Listing in the 9th Report           11
                                          manufacture and repair
                                          industry.
Diesel Particulates....................  Diesel engine exhaust..........  Listing in the 9th Report            7
Environmental Tobacco Smoke............  ``Passive'' inhalation of        Listing in the 9th Report            4
                                          tobacco smoke from
                                          environmental sources.
Ethyl Acrylate/140-88-5................  Monomer used to produce          Delisting from the Report            9
                                          polymers and copolymers for      on Carcinogens.
                                          use in latex paints, textiles,
                                          etc.
Ethylene Oxide/75-21-8.................  Industrial chemical used as an   Change current listing to            6
                                          intermediate in the              the Known to be a Human
                                          manufacture of other             Carcinogen category.
                                          chemicals; e.g., ethylene
                                          glycol and is widely used in
                                          the health care industry as a
                                          sterilant.
Isoprene/78-79-5.......................  The monomeric unit of natural    Listing in the 9th Report            2
                                          rubber and naturally occurring
                                          terpenes and steroids and
                                          widely used in the production
                                          of isoprene-butadiene
                                          copolymers.
Methyl-t-Butyl Ether/1634-04-4.........  Used as an additive in unleaded  Listing in the 9th Report            8
                                          gasoline in amounts up to 11%.
Nickel Compounds.......................  Many industrial and commercial   Change current listing to           10
                                          applications.                    the Known to be a Human
                                                                           Carcinogen category.
Silica, Crystalline/7631-86-9..........  Exposure from mining and         Change current listing to            5
                                          quarrying of coal and other      the Known to be a Human
                                          minerals, stone cutting,         Carcinogen category.
                                          production of glass and
                                          ceramics and in occupations
                                          such as sandblasting,
                                          polishing and grinding.
2,3,7,8-Tetrachloro-dibenzo-p-dioxin     Not used commercially, used      Change current listing to            1
 (TCDD)/1746-01-6.                        only as a research chemical.     the Known to be a Human
                                          Potential exposure from          Carcinogen category.
                                          municipal incinerators, dump
                                          sites and contaminated soil.
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[FR Doc. 98-28606 Filed 10-23-98; 8:45 am]
BILLING CODE 4140-01-M