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Proposed Chemicals for 8th Biennial Report on Carcinogens - Call for Comments
[Federal Register: April 30, 1997 (Volume 62, Number 83)]
[Notices]
[Page 23469-23470]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service National Toxicology Program; Call for Public Comments; Chemicals Proposed for the Eighth Biennial Report on Carcinogens
Background
The National Toxicology Program (NTP) announces its intent to list
additional substances in the Eighth Biennial Report on Carcinogens
(BRC). This Report is a Congressionally-mandated listing of known human
carcinogens and reasonably anticipated human carcinogens and its
preparation is delegated to the National Toxicology Program by the
Secretary, Department of Health and Human Services (HHS). Section
301(b)(4) of the Public Health Service Act, as amended, provides that
the Secretary, (HHS), shall publish a report which contains a list of
all substances (1) Which either are known to be human carcinogens or
may reasonably be anticipated to be human carcinogens; 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 new entries for the Eighth BRC have undergone a multiphased peer review process involving two Federal scientific review groups and one non-government, scientific peer review body (a subcommittee of the NTP Board of Scientific Counselors) which met in an open, public meeting that included a public comment session. All data relevant to the criteria for inclusion of candidate agents, substances or mixtures in the BRC have been evaluated by the three scientific review committees.
In the Eighth BRC, the NTP is adding 14 agents, substances or mixtures to the existing list, one of which is listed as a known human carcinogen. The 13 remaining agents, substances or mixtures are being added as reasonably anticipated to be human carcinogens. In addition, thiotepa, which is currently listed in previous Reports on Carcinogens as reasonably anticipated to be a human carcinogen is moved to the known human carcinogen list. These agents, substances or mixtures are provided in the following table with their Chemical Abstracts Services (CAS) Registry numbers and listing. The Eighth BRC also contains an appendix which is a reference to certain ``Manufacturing Processes, Occupations and Exposure Circumstances'' that have not yet been formally reviewed by the NTP for BRC listing but have been classified by IARC as sources which are known to be carcinogenic to humans because of the associated increased incidences of cancer in workers in these settings. While not formally listed in the 8th BRC, in the interest of public health and for completeness, these occupational exposures have been referenced in an appendix to the Report with the corresponding IARC citation given.
Comments concerning the addition of these substances in the Eighth BRC will be accepted for a period of 30 days from the date of the publication of this announcement in the Federal Register. Comments or questions should be directed to Dr. C.W. Jameson, National Toxicology Program, Biennial Report on Carcinogens, MD WC-05, P.O. Box 12233, Research Triangle Park, NC 27709, fax number: (919)-541-2242, email: Jameson@niehs.nih.gov.
Attachment.
Dated: April 18, 1997.
Kenneth Olden,
Director, National Institute of Environmental Health Sciences.
Summary for Agents, Substances or Mixtures to be Listed in the Eighth Biennial Report on Carcinogens ------------------------------------------------------------------------ Chemical/CAS number Primary uses To be listed as ------------------------------------------------------------------------ AZACITIDINE/320-67-2.......... Used as a cytostatic Reasonably agent in the Anticipated to treatment of acute be a Human leukemia Carcinogen. p-CHLORO-o-TOLUIDINE and its Used to produce azo Reasonably HCl salt/95-69-2. dyes for cotton, silk Anticipated to acetate and nylon and be a Human as intermediate in Carcinogen. production of Pigment Red 7 and Pigment Yellow 49. Also an impurity in and a metabolite of the pesticide chlordimeform CHLOROZOTOCIN/54749-90-5...... Used as a cytostatic Reasonably agent in the Anticipated to treatment of cancers be a Human of the stomach, large Carcinogen. intestine pancreas and lung; melanoma; and multiple myeloma CYCLOSPORIN/59865-13-3........ Used as an Known to be a immunosuppressive Human agent in the Carcinogen. prevention and treatment of graft-vs- host reactions in bone marrow transplantation and for the prevention of rejection of kidney, heart, and liver transplants DANTHRON/(1,8- Used as a laxative and Reasonably Dihydroxyanthraquinone) 117- as an intermediate in Anticipated to 10-2. the manufacture of be a Human dyes Carcinogen. 1,6-DINITROPYRENE/42397-64-8.. Not used commercially, Reasonably detected in ambient Anticipated to atmospheric samples be a Human and as a constituent Carcinogen. of diesel exhaust 1,8-DINITROPYRENE/42397-65-9.. Not used commercially, Reasonably detected in ambient Anticipated to atmospheric samples be a Human and as a constituent Carcinogen. of diesel exhaust DISPERSE BLUE 1/(1,4,5,8- Used as an Reasonably Tetraaminoanthraquinone) 2475- anthraquinone based Anticipated to 45-8. dyestuff in hair be a Human color formulations Carcinogen. and in coloring fabrics and plastics FURAN/100-00-9................ Used as an Reasonably intermediate in the Anticipated to synthesis and be a Human production of other Carcinogen. organic compounds o-NITROANISOLE/91-23-6........ Used as a precursor in Reasonably the synthesis of o- Anticipated to anisidine which is be a Human used in the Carcinogen. manufacture of over 100 azo dyes 6-NITROCHRYSENE/7495-02-8..... Not used commercially, Reasonably detected in ambient Anticipated to atmospheric samples be a Human Carcinogen. 1-NITROPYRENE/5522-43-0....... Not used commercially, Reasonably detected in ambient Anticipated to atmospheric samples be a Human and as a constituent Carcinogen. of diesel and gasoline engine exhaust 4-NITROPYRENE/57835-92-4...... Not used commercially, Reasonably detected in ambient Anticipated to atmospheric samples be a Human Carcinogen. THIOTEPA/52-24-4.............. Used as a cytostatic Known to be a agent in the Human treatment of Carcinogen. 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 1,2,3-TRICHLOROPROPANE/96-18-4 Used as a polymer Reasonably crosslinking agent, Anticipated to paint and varnish be a Human remover, solvent and Carcinogen. 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 ------------------------------------------------------------------------[FR Doc. 97-11136 Filed 4-29-97; 8:45 am]
BILLING CODE 4140-01-M
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