[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 hart@niehs.nih.gov.
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
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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.
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\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
