03-1368. National Toxicology Program; Call for Public Comments on 10 Nominations, Proposed for Listing in the Report on Carcinogens, Eleventh Edition

Background

The National Toxicology Program (NTP) solicits final public comments on the nominations reviewed in 2002 for listing in the Report on Carcinogens, Eleventh Edition (“the Report”). 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, (DHHS), 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 2002, ten nominations were reviewed for listing in the Eleventh 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 nominations in the Report. The criteria used in the review process and a 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, MD EC-14, P.O. Box 12233, Research Triangle Park, NC 27709; phone: [phone], fax: [phone], e-mail: [e-mail].

Public Comment Requested

The nominations reviewed in 2002 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. The NTP will be making a final recommendation for these ten nominations 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 Eleventh Report.

Background documents provided to the review committees and the public are available on the Internet in PDF-format at the address above. Hard copies of these documents are also available upon request from Dr. Jameson (contact information above). The NTP will review the recommendations from 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 Report on Carcinogens, Eleventh Edition. 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 for 60 days from the publication date of this announcement and should be directed to Dr. C. W. Jameson at the address provided above. Individuals submitting public comments are asked to include relevant contact information [name, affiliation (if any), address, telephone, fax, e-mail, and sponsoring organization (if any)].

Dated: January 10, 2003.

Kenneth Olden,

Director, National Toxicology Program.

Summary of RG1,¹ RG2 ² and NTP Board Subcommittee ³ Recommendations for the Nominations Reviewed in 2002 for Listing in the Report on Carcinogens,⁴ 11th Edition

Nomination/CAS No.	Primary uses or exposures	RGI action	RG2 action	NTP board subcommittee action
1-Amino-2,4-dibromoanthraquinone/(81-49-2)	An anthraquinone-derived vat dye that is used in the textile industry	Motion to list 1-amino-2,4-dibromoanthraquinone as reasonably anticipated to be a human carcinogen passed by unanimous vote (8/0)	Motion to list 1-amino-2,4-dibromoanthraquinone as reasonably anticipated to be a human carcinogen passed by unanimous vote (8/0)	Motion to list 1-amino-2,4-dibromoanthraquinone as reasonably anticipated to be a human carcinogen passed by unanimous vote (9/0)
Selected Heterocyclic Amines (three nominations): (1) MeIQ (2-Amino-3,4-dimethyl- imidazo- [4,5-f]quino line)/* (77094-11-2) (2) MeIQx (2-Amino-3,8-dimethyl- imidazo[4,5-f] quinoxaline)/(77500-04-0) (3) PhIP (2-Amino-1-methyl-6-phenyl- imidazo[4,5-b]pyridine)/(105650-23-5)	MeIQ, MeIQx, and PhIP are heterocyclic amines that are formed during heating or cooking and are found in cooked meat and fish	Motion to list MeIQ as reasonably anticipated to be a human carcinogen passed by unanimous vote (6/0)	Motion to list MeIQ as reasonably anticipated to be a human carcinogen passed by unanimous vote (8/0)	Motion to list MeIQ as reasonably anticipated to be a human carcinogen passed by a vote of 8 yes, 0 no and 1 abstention. Abstention because member felt insufficient data for human exposure to list in the RoC.
		Motion to list MeIQx as reasonably anticipated to be a human carcinogen passed by a vote of 5 yes to 1 no. Negative vote cast because member felt data meet criteria to list as known human carcinogen	Motion to list MeIQx as reasonably anticipated to be a human carcinogen passed by unanimous vote (8/0)	Motion to list MeIQx as reasonably anticipated to be a human carcinogen passed by a unanimous vote (9/0).
		Motion to list PhIP as reasonably anticipated to be a human carcinogen passed by a vote of 5 yes to 1 no. Negative vote cast because member felt data meet criteria to list as known human carcinogen	Motion to list PhIP as reasonably anticipated to be a human carcinogen passed by unanimous vote (8/0)	Motion to list PhIP as reasonably anticipated to be a human carcinogen passed by unanimous vote (9/0).
Cobalt Sulfate/(10026-2401)	Cobalt sulfate is used in electroplating and electrochemical industries. It is also used as a coloring agent for ceramics, a drying agent in inks, paints, varnishes and linoleum, and has been added to animal feed as a mineral supplement	Motion to list cobalt sulfate as reasonably anticipated to be a human carcinogen passed by unanimous vote (9/0)	Motion to list cobalt sulfate as reasonably anticipated to be a human carcinogen passed by a vote of 8 yes and 1 no. Negative vote cast because member felt exposure data in background document needed to be more specific for cobalt sulfate	Motion to list cobalt sulfate as reasonably anticipated to be a human carcinogen passed by a vote of 8 yes to 1 no. Negative vote cast because member felt human exposure data not specific for cobalt sulfate.
Diethanolamine (DEA)/(111-42-2)	DEA is used in the preparation of surfactants used in liquid laundry, dishwashing detergents, cosmetics, shampoos, and hair conditioners; as a surface-active agent and corrosion inhibitor in metalworking fluids and as a dispersant in agricultural chemical formulations	Motion not to list DEA in the RoC passed by a vote of 7 yes to 2 no. Negative votes cast because members felt data sufficient to list as reasonably anticipated to be a human carcinogen	Motion not to list DEA in the RoC passed by unanimous vote (9/0)	Motion not to list DEA in the RoC passed by a vote of 8 yes to 1 no. Negative vote cost because member felt data sufficient to list as reasonably anticipated to be a human carcinogen.
Naphthalene (91-20-3)	Naphthalene is used as a intermediate in the synthesis of many industrial chemicals, and has been used as an ingredient in some moth repellants and toilet bowl deodorants, and to control lice on livestock and poultry	Motion to list naphthalene as reasonably anticipated to be a human carcinogen passed by a vote of 6 yes to 1 no. Negative vote cast because member felt data not sufficient to list in the RoC	The RG2 could not make a majority recommendation for either listing or not listing naphthalene in the RoC	Motion to list naphthalene as reasonably anticipated to be a human carcinogen passed by unanimous vote (9/0).
Nitrobenzne (98-95-3)	Nitrobenzene is used mainly in the production of aniline, itself a major chemical intermediate in the production of dyes	Motion to list nitrobenzene as reasonably anticipated to be a human carcinogen passed by unanimous vote (7/0)	Motion to list nitrobenzene as reasonably anticipated to be a human carcinogen passed by unanimous vote (7/0)	Motion to list nitrobenzene as reasonably anticipated to be a human carcinogen passed by unanimous vote (9/0).
Nitromethane (75-52-5)	Nitromethane is used in specialized fuels, in explosives and in the synthesis of nitromethane derivatives, pharmaceuticals, agricultural soil fumigants and industrial antimicrobials	Motion to list nitromethane as reasonably anticipated to be a human carcinogen passed by unanimous vote (8/0)	Motion to list nitromethane as reasonably anticipated to be a human carcinogen passed by unaimous vote (9/0)	Motion to list nitromethane as reasonably anticipated to be a human carcinogen passed by unanimous vote (9/0).
4,4′-Thiodianiline (139-65-1)	4,4′-Thiodianiline has been produced commercially since the early 1940's as an intermediate of several diazo dyes	Motion to list 4,4′-thiodianiline as reasonably anticipated to be a human carcinogen passed by a vote of 6 yes to 2 no. Negative votes cast because members felt there was not sufficient exposure to list in the RoC	Motion to list 4,4′-thiodianiline as reasonably anticipated to be a human carcinogen passed by a vote of 6 yes to 3 no. Negative votes cast because members felt there was not sufficient exposure to list in the RoC	Motion to list 4,4′-thiodianiline as reasonably anticipated to be a human carcinogen passed by a vote of 5 yes to 2 no with 2 abstentions. Negative votes and abstentions cast because members felt there was not sufficient exposure to list in the RoC.
1 The NIEHS Review Committee for the Report on Carcinogens (RG1).
2 The NTP Executive Committee * Interagency Working Group for the Report on Carcinogens (RG2).
* Agencies from NTP Executive Committee represented on RG2 include: Agency for Toxic Substances and Disease Registry (ATSDR), Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), National Center for Environmental Health of the Centers for Disease Control and Prevention (NCEH/CDC), National Center for Toxicological Research of the Food and Drug Administration (NCTR/FDA), National Institute for Occupational Safety and Health/CDC (NIOSH/CDC), Occupational Safety and Health Administration (OSHA), National Cancer Institute of the National Institutes of Health (NCI/NIH), and National Institute of Environmental Health Sciences/NIH (NIEHS/NIH).
3 The NTP Board of Scientific Counselors Report on Carcinogens Subcommittee (the External Peer Review Group).
4 RoC—Report on Carcinogens.