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National Toxicology Program; Call for Public Comments on Seven Nominations Proposed for Listing in the Report on Carcinogens, Eleventh Edition

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Summary

The National Toxicology Program (NTP) solicits final public comments on the nominations reviewed in 2003 for listing in the Report on Carcinogens, Eleventh Edition. Comments will be accepted for 60 days from the publication date of this announcement and should be directed to Dr. C. W. Jameson (contact information below).

Background

The Report on Carcinogens (“the 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 NTP 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 2003, seven nominations were reviewed by three scientific committees, two Federal and one non-government, for listing in the Eleventh Report. This review included 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 seven nominations along with their Chemical Abstract Services (CAS) Registry numbers (where available) and the recommendations from the three scientific peer reviews are provided in the table below. The NTP will review the recommendations from each of the review committees and consider all public comments received throughout the review process. Based upon this information, the NTP Director will make a recommendation to the Secretary, DHHS, regarding the listing of each nominated substance in the Eleventh 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 Web site at http://ntp-server.niehs.nih.gov/​ (choose Report on Carcinogens) or by contacting Dr. C. W. Jameson (contact information below). Background documents on the nominations are also available on the NTP Report on Carcinogens Web site in PDF-format and in hard copy or on CD upon request from Dr. Jameson.

Public Comment Requested

The NTP solicits final public comments on the seven nominations reviewed in 2003 for listing in the Eleventh Report. The public is invited to submit comments that supplement any previously submitted comments or to provide comments for the first time on any nomination. Comments will be accepted for 60 days from the publication date of this announcement and should be directed to 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) 541-0144, e-mail: jameson@niehs.nih.gov). 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)).

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Dated: October 28, 2003.

Kenneth Olden,

Director, National Toxicology Program.

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Summary of RG1, 1 RG 2 and NTP Board Subcommittee 3 Recommendations for the Nominations Reviewed in 2003 for Listing in the Report on Carcinogens, 11th Edition

Nomination/CAS numberPrimary uses or exposuresRG1 actionRG2 actionNTP board subcommittee action
Diazoaminobenzene (DAAB)/136-35-6DAAB is used as an intermediate in the production of dyes and to promote adhesion of natural rubber to steelMotion to list DAAB as reasonably anticipated to be a human carcinogen passed by unanimous vote (5/0)Motion to list DAAB as reasonably anticipated to be a human carcinogen passed by majority vote (8/1). Negative vote cast because member felt there was not sufficient evidence for DAAB to list in the Report on Carcinogens.Motion to list DAAB as reasonably anticipated to be a human carcinogen passed by majority vote (6/4) with 1 abstention. Negative votes: 3 members felt nominations did not meet criteria for listing and 1 member felt that because DAAB is metabolized to benzene, it should be listed as known to be a human carcinogen. Abstention—member felt if DAAB is metabolized to benzene, it should be listed as known to be a human carcinogen; however, not convinced chemical is metabolized to benzene in humans.
Hepatitis B Virus (HBV)HBV is a small DNA-enveloped virus that along with Hepatitis C Virus causes most parentally transmitted viral hepatitisMotion to list HBV as known to be a human carcinogen passed by unanimous vote (4/0)Motion to list HBV as known to be a human carcinogen passed by unanimous vote (8/0)Motion to list HBV as known to be a human carcinogen passed by unanimous vote (12/0).
Hepatitis C Virus (HCV)HCV is an RNA-enveloped virus that along with Hepatitis B Virus causes most parenterally transmitted viral hepatitisMotion to list HCV as known to be a human carcinogen passed by unanimous vote (7/0)Motion to list HCV as known to be a human carcinogen passed by unanimous vote (8/0)Motion to list HCV as known to be a human carcinogen passed by unanimous vote (12/0).
Human Papillomaviruses (HPVs), Genital-Mucosal TypesHPVs are small, non-enveloped viruses that infect genital skin, and genital and non-genital mucosa. HPV infections are common throughout the worldMotion to list HPVs as known to be a human carcinogen passed by unanimous vote (7/0)Motion to list HPVs as known to be a human carcinogen passed by unanimous vote (8/0)Motion to list HPVs as known to be a human carcinogen passed by unanimous vote (12/0).
Lead and Lead CompoundsMajor use of metal is in making lead-acid storage batteries. Other common uses include ammunition and cable covering. Lead compounds are used in paint, glass, ceramics, fuel additives, and some traditional cosmeticsMotion to list Lead and Lead Compounds as known to be human carcinogens passed by unanimous vote (8/0)Motion to list Lead and Lead Compounds as reasonably anticipated to be human carcinogens passed by majority vote (4/3). Negative votes cast because members felt that human data were sufficient to list lead and lead compounds as known to be human carcinogensMotion to list Lead and Lead Compounds as reasonably anticipated to be human carcinogens passed by majority vote (11/0).
NeutronsExposure to neutrons normally occurs from a mixed irradiation field in which neutrons are a minor component. The exceptions are exposure of patients to neutron radiotherapy beams and exposures of aircraft passengers and crewMotion to list Neutrons as known to be a human carcinogen passed by unanimous vote (7/0)Motion to list Neutrons as known to be a human carcinogen passed by unanimous vote (8/0)Motion to list Neutrons as known to be a human carcinogen passed by unanimous vote (11/0).
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X-Radiation and Gamma (γ)-RadiationExposure to these forms of ionizing radiation comes from a variety of natural (environmental exposure) and anthropogenic sources, including exposure for military, medical, and occupational purposesMotion to list X-Radiation and γ-Radiation as known to be human carcinogens passed by unanimous vote (7/0)Motion to list X-Radiation and γ-Radiation as known to be human carcinogens passed by unanimous vote (8/0)Motion to list X-Radiation and γ-Radiation as known to be human carcinogens passed by unanimous vote (11/0).
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 the 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 (a standing subcommittee of the NTP Board of Scientific Counselors that serves as an external peer review group).
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[FR Doc. 03-27892 Filed 11-5-03; 8:45 am]

BILLING CODE 4140-01-P