National Toxicology Program

[Federal Register: May 29, 1997 (Volume 62, Number 103)]
[Notices]
[Page 29145-29146]

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service

National Toxicology Program; Call For Nominations For Listing Or Delisting Substances In The Biennial Report On Carcinogens (BRC)

Background

The National Toxicology Program (NTP) has the responsibility within the US Department of Health and Human Services (DHHS) for preparation of the Biennial Report on Carcinogens. The NTP SOLICITS and ENCOURAGES the broadest participation from interested individuals or parties in nominating agents, substances or mixtures for listing in or delisting from the BRC. The criteria for listing or for removing an agent substance or mixture in the Biennial Report on Carcinogens were revisited during 1994 and 1995 in a series of open public meetings. In recognition of the advances made in understanding the biological events involved in carcinogenesis, it was recommended that the criteria for listing an agent be expanded to include a broader array of information related to the carcinogenic process. The revised criteria for listing a substance in the Biennial Report on Carcinogens were approved by the Secretary, HHS on September 13, 1996, and are as follows:

1. Known to be Human Carcinogens:

There is sufficient evidence of carcinogenicity from studies in humans which indicates a causal relationship between exposure to the agent, substance or mixture and human cancer.

2. Reasonably Anticipated to be Human Carcinogens:

There is limited evidence of carcinogenicity from studies in humans which indicates that causal interpretation is credible but that alternative explanations such as chance, bias or confounding factors could not adequately be excluded; or

There is sufficient evidence of carcinogenicity from studies in experimental animals which indicates there is an increased incidence of malignant and/or a combination of malignant and benign tumors: (1) in multiple species, or at multiple tissue sites, or (2) by multiple routes of exposure, or (3) to an unusual degree with regard to incidence, site or type of tumor or age at onset; or

There is less than sufficient evidence of carcinogenicity in humans or laboratory animals, however; the agent, substance or mixture belongs to a well defined, structurally-related class of substances whose members are listed in a previous Annual or Biennial Report on Carcinogens as either a known to be human carcinogen, or reasonably anticipated to be human carcinogen or there is convincing relevant information that the agent acts through mechanisms indicating it would likely cause cancer in humans.

Conclusions regarding carcinogenicity in humans or experimental animals are based on scientific judgment, with consideration given to all relevant information. Relevant information includes, but is not limited to dose response, route of exposure, chemical structure, metabolism, pharmacokinetics, sensitive sub populations, genetic effects, or other data relating to mechanism of action or factors that may be unique to a given substance. For example, there may be substances for which there is evidence of carcinogenicity in laboratory animals but there are compelling data indicating that the agent acts through mechanisms which do not operate in humans and would therefore not reasonably be anticipated to cause cancer in humans.

Call for Nominations

Petitions for listing or delisting an agent, substance, or mixture in the BRC may be submitted by any interested individual or party and should be sent to the National Toxicology Program, Biennial Report on Carcinogens, MD WC-05, P.O. Box 12233, Research Triangle Park, NC 27709. Petitions must contain a rationale for listing or delisting as either a "known human carcinogen" or a "reasonably anticipated human carcinogen". Appropriate background information and relevant data (e.g. Journal articles, NTP Technical Reports, IARC listings, exposure surveys, release inventories, etc.) which support a petition should be provided or referenced when possible.

A detailed description of listing/delisting procedures, including the steps in the formal review process, can be obtained by contacting: Dr. C. W. Jameson, National Toxicology Program, Biennial Report on Carcinogens, MD WC-05, P.O. Box 12233, Research Triangle Park, NC 27709; phone: (919)541-4096, fax: (919) 541-2242, email: jameson@niehs.nih.gov. Any questions regarding the process, procedures, or the information contained herein may also be directed to Dr. Jameson

The most recent Report (the 7th Annual Report on Carcinogens) was published in 1994 and may be obtained by contacting: NTP Central Data Management, P O Box 12233, MD E1-02, Research Triangle Park, NC 27709. The 8th BRC is nearing completion and will be published in 1997. All nominations received in 1997 are expected to receive consideration and review in 1997 and 1998 and any new listings or delistings would be included in the 9th BRC to be published in 1999.

Dated: May 20, 1997

____________________
Kenneth Olden, Ph.D.,Director
National Toxicology Program

[Billing Code 4140-01-P]