National Toxicology Program

We are pleased to update you on the status of the National Toxicology Program's Biennial Report on Carcinogens (BRC)

• Eighth Biennial Report on Carcinogens

• Ninth Biennial Report on Carcinogens -- Call for Nominations

We are pleased to update you on the status of the National Toxicology Program's Biennial Report on Carcinogens (BRC), formerly known as the Annual Report on Carcinogens (ARC).

Background

The National Toxicology Program (NTP) has the responsibility within the US Department of Health and Human Services for preparation of the BRC.

The Report 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 (HHS). Section 301 (b)(4) of the Public Health Service Act, as amended, provides that the Secretary (HHS), shall publish a 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 of 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.

The attached procedures and criteria for listing or delisting agents, substances, or mixtures in the BRC have been recently revised and were used in developing the Eighth BRC. The most recently published report, the 7th Annual Report on Carcinogens, was published in 1994. Copies of the 7th Report may be obtained by contacting NTP Central Data Management, PO Box 12233, Research Triangle Park, NC 27709.

Eighth Biennial Report on Carcinogens

The 8th BRC is nearing completion and will be published in the fall of 1997. In the 8th BRC, the NTP announces its intent to add 14 agents, substances or mixtures to the existing list, one of which is listed as a known human carcinogen. The 13 remaining agents, substances or mixtures are being added as reasonably anticipated to be human carcinogens. In addition, thiotepa, which is currently listed in previous Reports on Carcinogens as reasonably anticipated to be a human carcinogen is moved to the known human carcinogen list. These agents, substances or mixtures are provided in the attached table with their Chemical Abstracts Services (CAS) Registry numbers and listing.

The Eighth BRC will also contain an appendix which is a reference to certain "Manufacturing Processes, Occupations and Exposure Circumstances" that have not yet been formally reviewed by the NTP for BRC listing but have been classified by IARC as sources which are known to be carcinogenic to humans because of the associated increased incidences of cancer in workers in these settings. While not formally listed in the 8th BRC, in the interest of public health and for completeness, these occupational exposures have been referenced in an appendix to the Report with the corresponding IARC citation given.

The new entries for the Eight BRC have undergone a multiphased peer review process involving two Federal scientific review groups and one non-government, scientific peer review body (a subcommittee of the NTP Board of Scientific Counselors) which met in an open, public meeting that included a public comment session. All data relevant to the criteria for inclusion of candidate agents, substances or mixtures in the BRC have been evaluated by the three scientific review committees.

Comments concerning the addition of these substances in the Eighth BRC will be accepted through May 30, 1997. Comments or questions should be directed to Dr. C.W. Jameson, National Toxicology Program, Biennial Report on Carcinogens, MD WC-05, P.O. Box 12233, Research Triangle Park, NC 27709, fax number:(919)-541-2242, email:Jameson@niehs.nih.gov.

Ninth Biennial Report on Carcinogens -- Call for Nominations

The NTP encourages the nomination of agents, substances, or mixtures for listing or delisting in the ninth BRC. The procedures and criteria for listing or delisting are described in the attached pages.

All nominations received in 1997 are expected to receive consideration and review in 1997 and 1998 and any new listing or delisting would be included in the 9th BRC to be published in 1999.

Petitions for listing or delisting an agent, substance or mixture in the BRC may be submitted by any interested party and should be sent to Dr. Jameson as shown above.

Attachments (2)
-Listing/Delisting Procedures and Criteria
-Summary for Agents, Substances or Mixtures to be Listed in the Eighth BRC