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Final Call for Public Comments - Report on Carcinogens, 9th Edition
[Federal Register: March 19, 1998 (Volume 63, Number 53)]
[Notices]
[Page 13418-13421]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
National Toxicology Program; Call for Public Comments; Agents, Substances, Mixtures and Exposure Circumstances Proposed for Listing in or Removing from the Report on Carcinogens, Ninth Edition
Background
The National Toxicology Program (NTP) solicits final public comments on its intent to recommend additional agents, substances, mixtures and exposure circumstances for listing in or delisting from the Report on Carcinogens, Ninth Edition. 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.
In 1997, 14 substances or exposure circumstances were reviewed for listing in or removal from the Ninth Report. This review included two Federal and one non-government, scientific peer reviews and public comment and review. All available data relevant to the criteria for inclusion or removal of candidate substances or exposure circumstances in the Report were evaluated by the three scientific review committees. The criteria used in the review process and the detailed description of the review procedures, including the steps in the current formal review process, 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) 541-2242, email: jameson@niehs.nih.gov.
Public Comment Requested
The NTP will be making a final recommendation for the
14 substances or exposure circumstances reviewed in 1997, for
either listing in, delisting from, or changing the current listing
from reasonably anticipated to be a human carcinogen to
the known to be a human carcinogen category in the Ninth
Report. These nominated substances or exposure circumstances are
provided in the following table with their Chemical Abstracts
Services (CAS) Registry numbers (where available) and the recommendations
from the three scientific peer reviews of the nominations.
Background documents provided to the review committees and the interested public and summary minutes of the public peer review by the NTP Board Subcommittee are available upon request. The NTP will review the recommendations of each of the review committees and consider the public comments received throughout the process in making decisions regarding the NTP recommendations to the Secretary, DHHS, for listing or removal of the nominated substances and exposure circumstances in the Ninth Edition of the Report on Carcinogens. The NTP solicits final public comment to supplement any previously submitted comments or to provide comments for the first time on any substance or exposure circumstances in the following table. Because of the different recommendations forwarded by the three scientific review groups, the NTP is especially interested in obtaining additional relevant information in support of or against the petition to delist Saccharin from the Report on Carcinogens. The critical areas identified in the earlier scientific reviews where additional input is solicited include 1) information that addresses the adequacy of existing epidemiology data, particularly as it relates to reported increased incidences of bladder tumor formation in certain small populations; 2) the levels of human exposure, especially in infants and children; 3) information addressing the mechanism of urinary bladder tumor formation in male rats as it relates to other test species (especially female rats and male and female mice) and to humans; and 4) the adequacy of data for tumor formation in laboratory animals at target sites other than the urinary bladder. Comments will be accepted for a period of 60 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 at the address listed above.
Dated: March 12, 1998
___________________________
Kenneth Olden, Ph. D.
Director
National Toxicology Program
Attachment
Agents, Substances, Mixtures or Exposure Circumstances
Reviewed in 1997 for Listing in or Delisting from
the Report on Carcinogens, 9th Edition
EXPOSURE CIRCUMSTANCE/ _CAS NUMBER___ |
SUBCOMMITTEE ____ACTION__ | |||
Dyes Metabolised to Benzidine (Benzidine Dyes as a Class) | Benzidine-based dyes are used primarily for dyeing textiles, paper and leather products. More than 250 benzidine-based dyes have been reported by the Society of Dyers and Colorists. | RG1 voted 7/1 to list as a known to be human carcinogen | RG2 voted unanimously to list as a known to be human carcinogen | The Subcommittee recommended unanimously listing as known to be human carcinogen. |
1,3-Butadiene/ 106-99-0 | Used primarily as a chemical intermediate and polymer component in the manufacture of synthetic rubber | RG1 voted 9/0 with 1 abstention to upgrade the current listing to known to be human carcinogen | RG2 voted unanimously to upgrade the current listing to known to be human carcinogen | The Subcommittee recommended (4 yes votes to 1 no vote with 1 abstention) upgrading the current listing to known to be human carcinogen |
Cadmium and Cadmium Compounds/ 7440-43-9 | Used in batteries, coating and plating, plastic and synthetic products and in alloys. | RG1 voted 7/1 to upgrade the current listing to known to be human carcinogen | RG2 voted unanimously to upgrade the current listing to known to be human carcinogen | The Subcommittee recommended unanimously upgrading the current listing to known to be human carcinogen |
Chloroprene/ 126-99-8 | Used as a monomer for neoprene elastomers, industrial rubber products, and as a component of adhesives in food packaging. | RG1 voted 7/0 with 2 abstentions to list as a reasonably anticipated human carcinogen | RG2 voted unanimously to list as a reasonably anticipated human carcinogen | The Subcommittee recommended unanimously listing as reasonably anticipated to be a human carcinogen. |
Phenolphthalein/ 77-09-8 | Used as a laboratory reagent and acid-base indicator and as a cathartic drug in over-the-counter laxative preparations. | RG1 voted 9/1 to list as reasonably anticipated to be a human carcinogen | RG2 voted 7/0 with 1 abstention to list as a reasonably anticipated to be a human carcinogen | The Subcommittee recommended unanimously listing as reasonably anticipated to be a human carcinogen. |
Saccharin/ 128-44-9 | Used primarily as a nonnutritive sweetening agent. | RG1 voted 7/3 to delist from the Report on Carcinogens | RG2 voted 6/2 to delist from the Report on Carcinogens | The Subcommittee recommended (4 yes votes to 3 no votes) not to delist from the Report, and leave saccharin listed as reasonably anticipated to be a human carcinogen. |
Smokeless Tobacco | Oral use of smokeless tobacco products. | RG1 voted unanimously to list as a known to be human carcinogen | RG2 voted unanimously to list as a known to be human carcinogen | The Subcommittee recommended unanimously listing as a known to be human carcinogen. |
| Strong Inorganic Acid Mists Containing Sulfuric Acid |
Sulfuric acid is the one of the most widely used of all industrial chemicals. Used in the manufacture of fertilizers, rayon and other fibers, pigments and colors, explosives, plastics, coal-tar products such as dyes and drugs, storage batteries, synthetic detergents, natural and synthetic rubber, pulp and paper. | RG1 voted unanimously to list as known to be a human carcinogen | RG2 voted 7/1 to list as known to be a human carcinogen | The Subcommittee recommended unanimously listing as known to be a human carcinogen. |
Tamoxifen/ 10540-29-1 | Used as an anti-estrogen drug and in the palliative treatment of breast cancer. | RG1 voted unanimously to list as known to be a human carcinogen with the added statement that there is also conclusive evidence that tamoxifen therapy reduces the risk of contralateral breast cancer in women with a previous diagnosis of breast cancer | RG2 voted 7/0 with 1 abstention to list as known to be a human carcinogen with the added statement that there is also conclusive evidence that tamoxifen therapy reduces the risk of contralateral breast cancer in women with a previous diagnosis of breast cancer | The Subcommittee recommended unanimously listing as known to be a human carcinogen, with the statement that there is also conclusive evidence that tamoxifen therapy reduces the risk of contralateral breast cancer in women with a previous diagnosis of breast cancer |
| 2,3,7,8- Tetrachlorodibenzo-p- dioxin (TCDD)/ 1746-01-6 | Not used commercially, used only as a research chemical. | RG1 voted unanimously to upgrade the current listing to known to be human carcinogen | RG2 voted unanimously to upgrade the current listing to known to be human carcinogen | The Subcommittee recommended (4 yes votes to 3 no votes with 1 abstention) upgrading the current listing to known to be human carcinogen. |
|
Tetrafluoroethylene/ 116-14-3 | Used in the production of polytetrafluoroethylene (Teflon) and other polymers. Has also been used as a propellant for food product aerosols. | RG1 voted unanimously to list as reasonably anticipated to be a human carcinogen | RG2 voted unanimously to list as reasonably anticipated to be a human carcinogen | The Subcommittee recommended unanimously listing as reasonably anticipated to be a human carcinogen. |
Tobacco Smoking | Inhalation of tobacco smoke | RG1 voted unanimously to list as known to be a human carcinogen | RG2 voted unanimously to list as known to be a human carcinogen | The Subcommittee recommended unanimously listing as known to be a human carcinogen. |
Trichloroethylene/ 79-01-6 | Used as an industrial solvent for vapor degreasing and cold cleaning of fabricated metal parts. Has also been used as a carrier solvent for the active ingredients of insecticides and fungicides, as an anesthetic for medical and dental use, and for caffeine from coffee. | RG1 voted 6/2 to list as reasonably anticipated to be a human carcinogen | RG2 voted 7/1 to list as reasonably anticipated to be a human carcinogen | The Subcommittee recommended unanimously listing as reasonably anticipated to be a human carcinogen. |
UV Radiation | Solar and artificial sources of ultraviolet radiation | RG1 voted unanimously to list Solar Radiation and use of Sunlamps and Sunbeds as known to be a human carcinogen | RG2 voted 7/1 in favor of motion to defer action on UV Radiation until the Background Document could be revised to address the full spectrum of UV Radiation, including UVA, UVB, and UVC. | The Subcommittee recommended unanimously listing Solar Radiation and use of Sunlamps and Sunbeds as known to be a human carcinogen. |
1 - The NIEHS Review Committee for the Report on Carcinogens (RG1)
2 - The NTP Interagency Executive Committee Working Group for the Report on Carcinogens (RG2)
3 - The NTP Board of Scientific Counselors Report on Carcinogens Subcommittee
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