National Toxicology Program; Call for Public Comments on 9 Substances Proposed for Listing in or Delisting from the Report on Carcinogens, Tenth Edition

Download PDF
Federal RegisterApr 5, 2000
65 Fed. Reg. 17891 (Apr. 5, 2000)

Background

The National Toxicology Program (NTP) solicits final public comments on additional agents, substances, mixtures and exposure circumstances for listing in or delisting from the Report on Carcinogens, Tenth Edition. This Report (previously known as the Annual Report on Carcinogens) 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 (DHHS). Section 301 (b) (4) of the Public Health Service Act, as amended, provides that the Secretary, (HHS), shall publish a biennial 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 1999 and early 2000, nine substances were reviewed for listing in the Tenth Report. This review included two Federal and one non-government, scientific peer reviews and public comment and review. The three scientific review committees evaluated all available data relevant to the criteria for inclusion of candidate substances in the Report. 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 from the NTP Home Page web site at http://ntp-server.niehs.nih.gov/ or by contacting: Dr. C. W. Jameson, National Toxicology Program, Report on Carcinogens, 79 Alexander Drive, Room 3217, 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 nominated substances reviewed in 1999 and early 2000 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. The NTP will be making a final recommendation in 2001 for these nine substances for listing in, or changing the current listing from reasonably anticipated to be a human carcinogen to the known to be a human carcinogen category in the Tenth Report.

Background documents provided to the review committees and the public are available on the web in pdf version at the address above. Hard copies of these documents are also 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 of the nominated substances in the Tenth 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 in the following table. Comments will be accepted through June 5, 2000. Comments or questions should be directed to Dr. C. W. Jameson at the address listed above.

Dated: March 28, 2000.

Kenneth Olden,

Director, National Toxicology Program.

Summary of RG1 , RG2 and NTP Board Subcommittee Agents, Substances, Mixtures or Exposure Circumstances Reviewed in 1999-2000 for Listing Inor Delisting From the Report on Carcinogens , 10th Edition

Nomination/CAS No. Primary uses or exposures RG1 action RG2 action NTP board subcommittee action
Beryllium and Beryllium compounds/7440-41-7 Used in fiber optics and cellular network communications systems, aerospace, defense and other industry applications RG1 unanimously recommended (8/0) listing as known to be a human carcinogen RG2 recommended (5 yes votes to 4 no votes) listing as known to be a human carcinogen The Subcommittee unanimously recommended (7/0) listing as known to be a human carcinogen.
2,2-bis-(bromomethyl)-1,3-propanediol (Technical Grade) 3296-90-9 Used as a fire retardant in unsaturated polyester resins, in molded products, and in rigid polyurethane foam RG1 unanimously recommended (9/0) listing as reasonably anticipated to be a human carcinogen RG2 unanimously recommended (8/0) listing as reasonably anticipated to be a human carcinogen The Subcommittee unanimously recommended (7/0) to list as reasonably anticipated to be a human carcinogen.
2,3-Dibromo-1-Propanol/96-13-9 Used as a flame retardant, 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 RG1 unanimously recommended (9/0) listing as reasonably anticipated to be a human carcinogen RG2 unanimously recommended (9/0) listing as reasonably anticipated to be a human carcinogen The Subcommittee unanimously recommended (7/0) to list as reasonably anticipated to be a human carcinogen.
Dyes metabolized to 3,3′-Dimethylbenzidine Dyes mainly used for textile industries with other applications in paper, plastics, and rubber industries RG1 recommended (5 yes votes to 1 no vote with 1 abstention) to list as reasonably anticipated to be a human carcinogen RG2 unanimously recommended (9/0) listing as reasonably anticipated to be a human carcinogen The Subcommittee unanimously recommended (7/0) to list as reasonably anticipated to be a human carcinogen.
Dyes metabolized to 3,3′-Dimethoxybenzidine Dyes mainly used for textile industries with other applications in paper, plastics, and rubber industries RG1 unanimously recommended (9/0) listing as reasonably anticipated to be a human carcinogen RG2 recommended ( 8 yes votes to 0 no vote with 1 abstention) listing as reasonably anticipated to be a human carcinogen The Subcommittee unanimously recommended (7/0) to list as reasonably anticipated to be a human carcinogen.
IQ (2-Amino-3-methylimidazo[4,5-f]quinoline)/76180-96-6 Found in cooked meat and fish and in cigarette smoke RG1 unanimously recommended (7/0) listing as reasonably anticipated to be a human carcinogen RG2 unanimously recommended (8/0) listing as reasonably anticipated to be a human carcinogen The Subcommittee unanimously recommended (7/0 to list as reasonably anticipated to be a human carcinogen.
Styrene 7,8-oxide/96-09-3 Used mainly in the preparation of fragrances and in some epoxy resin formulations RG1 recommended (7 yes votes to 1 no votes) to list as reasonably anticipated to be a human carcinogen RG2 recommended (6 yes votes to 3 no votes) to list as reasonably anticipated to be a human carcinogen The Subcommittee recommended (6 yes votes to 0 no votes with 1 abstention) to list as reasonably anticipated to be a human carcinogen.
Vinyl Bromide/593-60-2 Used primarily in the manufacture of flame retardant synthetic fibers RG1 unanimously recommended (10/0) listing as reasonably anticipated to be a human carcinogen RG2 unanimously recommended (9/0) listing as reasonably anticipated to be a human carcinogen The Subcommittee recommended (4 yes votes to 3 no votes) listing as known to be a human carcinogen.
Vinyl Fluoride/75-02-5 Used in the production of polyvinylfluoride which is used for plastics RG1 recommended (7 yes votes to 2 no votes) to list as reasonably anticipated to be a human carcinogen RG2 unanimously recommended (9/0) listing as reasonably anticipated to be a human carcinogen The Subcommittee recommended (4 yes votes to 3 no votes) listing as known to be a human carcinogen.
The NIEHS Review Committee for the Report on Carcinogens (RG1).
The NTP Executive Committee* Interagency Working Group for the Report on Carcinogens (RG2).
* Agencies represented on the NTP Executive Committee include: Agency for Toxic Substances and Disease Registry (ATSDR), Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), National Institute for Occupational Safety and Health (NIOSH), Occupational Safety and Health Administration (OSHA), Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), National Library of Medicine (NLM), and National Institute of Environmental Health Sciences/NTP (NIEHS/NTP).
The NTP Board of Scientific Counselors Report on Carcinogens Subcommittee (the External Peer Review Group).
RoC—Report on Carcinogens.

[FR Doc. 00-8311 Filed 4-4-00; 8:45 am]

BILLING CODE 4140-01-P