[Federal Register Volume 64, Number 63 (Friday, April 2, 1999)]
[Notices]
[Pages 15983-15984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8098]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
National Toxicology Program: Call for Public Comment on 11
Substances, Mixtures and Exposure Circumstances To Be Reviewed in 1999
for Listing in or Delisting (Removing) From the Report on Carcinogens,
Tenth Edition
Background
The National Toxicology Program (NTP) announces its intent to
review additional substances, mixtures and exposure circumstances for
possible listing in or delisting (removing) from the Report on
Carcinogens, Tenth Edition which is scheduled for publication in 2001.
This Report (previously known as the Annual Report on Carcinogens) is a
Congressionally-directed listing of known human carcinogens and
reasonable anticipated human carcinogens and its preparation is
delegated to the National Toxicology Program by the Secretary,
Department of Health and Human Services (DHHS). Section 301(b)(4) of
the Public Health Service Act, as amended, provides that the Secretary,
(DHHS), shall publish a report which contains a list of all substances
(1) which either are known to be a human carcinogen or reasonable
anticipated to be a human carcinogen, 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 scientific review of the substances, mixtures or exposure
circumstances involves three separate reviews, which include two
Federal review groups and one non-government peer review body (a
subcommittee of the NTP Board of Scientific Counselors) which will meet
in an open, public meeting and provide for public comments. All
available data and public comments received that are relevant to the
application of the criteria for inclusion or removal of candidate
agents, substances, mixtures or exposure circumstances or for a change
in the classification in the Report will be evaluated. The criteria to
be used in the review process are described below:
1. Known to be Human Carcinogens:
There is sufficient evidence of carcinogenicity from studies in
humans which indicates a causal relationship between exposure to the
agent, substance or mixture and human cancer.
2. Reasonably Anticipated to be Human Carcinogens:
There is limited evidence of carcinogenicity from studies in
humans which indicates that causal interpretation is credible but
that alternative explanations such as chance, bias or confounding
factors could not adequately be excluded; or
There is sufficient evidence of carcinogenicity from studies in
experimental animals which indicates there is an increased incidence
of malignant and/or a combination of malignant and benign tumors:
(1) In multiple species, or at multiple tissue sites, or (2) by
multiple routes of exposure, or (3) to an unusual degree with regard
to incidence, site or type of tumor or age at onset; or
There is less than sufficient evidence of carcinogenicity in
humans or laboratory animals, however; the agent, substance or
mixture belongs to a well defined, structurally-related class of
substances whose members are listed in a previous Report on
Carcinogens as either a known to be human carcinogen, or reasonably
anticipated to be human carcinogen or there is convincing relevant
information that the agent acts through mechanisms indicating it
would likely cause cancer in humans.
Conclusions regarding carcinogenicity in humans or experimental
animals are based on scientific judgment, with consideration given
to all relevant information. Relevant information includes, but is
not limited to dose response, route of exposure, chemical structure,
metabolism, pharmacokinetics, sensitive sub populations, genetic
effects, or other data relating to mechanism of action or factors
that may be unique to a given substance. For example, there may be
substances for which there is evidence of carcinogenicity in
laboratory animals but there are compelling data indicating that the
agent acts through mechanisms which do not operate in humans and
would therefore not reasonably be anticipated to cause cancer in
humans.
Clarification of the Criteria
Some questions have arisen regarding information from studies
involving humans and how this is applied to the listing of a substance
determined to be a ``known human carcinogen''. The ``known human
carcinogen'' category requires evidence from studies of humans. This
can include traditional cancer epidemiology studies, data from clinical
studies, and/or data derived from the study of tissues from humans
exposed to the substance in question and useful for evaluating whether
a relevant cancer mechanism is operating in people.
[[Page 15984]]
Public Comment Requested
Nominations for the Report on Carcinogens to be reviewed in 1999
are provided in the following table with their Chemical Abstracts
Services (CAS) Registry numbers (where available) and pending review
action. NTP invites public comment on any of these nominations. In
addition, NTP requests relevant information on the carcinogenic
properties of the substances from completed or ongoing experimental
animal or human epidemiology studies, as well as current production
data, use patterns, and human exposure information. Comments received
by April 30, 1999 will allow the time for their consideration by the
initial review groups and by the NTP in the preparation of the
background document prepared for each substance. Comments or questions
should be directed to Dr. C. W. Jameson at the address listed below.
Public Nominations for Delisting or Listing Encouraged
The NTP solicits and encourages the broadest participation form
interested individuals or parties in nominating agents, substances,
mixtures or exposure circumstances for listing in or delisting from the
Reports on Carcinogens. Nominations from the public should contain a
rationale for listing or delisting. Appropriate background information
and relevant data (e.g. Journal articles, NTP Technical Reports, IARC
listings, exposure surveys, release inventories, etc.) which support a
nomination should be provided or referenced when possible.
A detailed description of the review procedures, including the
steps in the formal review process, is available at http://ntp-
server.niehs.nih.gov and can be obtained by contacting: Dr. C. W.
Jameson, National Toxicology Program, Report on Carcinogens, MD EC-14,
P.O. Box 12233, Research Triangle Park, NC 27709; phone: (919) 541-
4096, fax: (919) 541-0947, email: jameson@niehs.nih.gov.
Dated: March 22, 1999.
Kenneth Olden,
Director, National Toxicology Program.
Summary for Agents, Substances, Mixtures or Exposure Circumstances to be Reviewed in 1999, for Consideration of
Listing in or Delisting from the Tenth Report on Carcinogens
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Nomination to be reviewed/CAS No. Primary uses or exposures To be reviewed for
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Beryllium and Beryllium Compounds/ Fiber optics and cellular Possible updating of current listing of
7440-41-7. network communications beryllium and certain beryllium compounds to a
systems, aerospace, known human carcinogen.
defense and other
industry applications.
2,2-bis-(bromomethyl) -1,3- Used as a fire retardant Listing in the 10th Report.
propanediol/3296-90-9. in unsaturated polyester
resins, in molded
products, and in rigid
polyurethane foam.
2,3-Dibromo-1-Propanol/96-13-9..... Used as a flame retardant, Listing in the 10th Report.
as an intermediate in the
preparation of the flame
retardant tris(2,3-
dibromopropyl) phosphate,
and as an intermediate in
the manufacture of
pesticides and
pharmaceutical
preparations.
Dyes Metabolized to Dyes widely used for Listing in the 10th Report.
Dimethoxybenzidine leather, paper, plastics,
(Dimethoxybenzidine Dyes as a rubber, and textile
Class). industries.
Dyes Metabolized to Dyes widely used for Listing in the 10th Report.
Dimethoxybenzidine leather, paper, plastics,
(Dimethoxybenzidine Dyes as a rubber, and textile
Class). industries.
IQ (2-Amino-3-methylimidazo[4,5- Found in cooked meat and Listing in the 10th Report.
f]quinoline)/76180-96-6. fish.
Styrene=7,8=oxide/96-09-3.......... Used mainly in the Listing in the 10th Report.
preparation of fragrances
and in some epoxy resin
formulations.
Toluene Diisocyanate/26471-62-5.... Commercially produced as Delisting from the Report on Carcinogens.
an approximately 80:20
mixture of the 2,4- and
2,6-isomers it is
primarily for use in the
manufacture of flexible
polyurethane foams.
UV Radiation/separate consideration Soloar and artifical Listing in the 10th Report.
of three segments of the sources of ultraviolet
wavelength spectrum; UVA (315-400 radiation.
nm), UVB (280-315 nm), and UVC
(100-280 nm).
Vinyl Bromide/593-60-2............. Used commercial since Listing in the 10th Report.
1968, primarily in the
manufacture of flame
retardant synthetic
fibers.
Vinyl Fluoride/75-02-5............. Used commercially since Listing in the 10th Report.
the 1960's, in the
production of
polyvinylfuoride which is
used for plastics.
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[FR Doc. 99-8098 Filed 4-1-99; 8:45 am]
BILLING CODE 4140-01-M
