[Federal Register Volume 62, Number 103 (Thursday, May 29, 1997)]
[Notices]
[Pages 29145-29146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14040]


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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 U.S. 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

[[Page 29146]]

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: 
[email protected]. 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,
Director, National Toxicology Program.
[FR Doc. 97-14040 Filed 5-28-97; 8:45 am]
BILLING CODE 4140-01-M