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Background on Ninth Report on Carcinogens

U.S. Department of Health and Human Services (NIEHS/NTP)


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The Secretary of Health and Human Services is under Congressional mandate, enacted in 1978, to publish this report every two years. The report is supposed to list all substances that are either "known" or "reasonably anticipated" human carcinogens, and it provides additional information on the scientific evidence evaluated and on current regulatory measures imposed by other agencies. Administration of the program has been delegated to the National Toxicology Program within the National Institute of Environmental Health Sciences. There are six levels of review for each substance: four committee reviews, including other agencies, and one of the committees is an external peer review committee under FACA. After the committee reviews, recommendations are made to the Secretary by the Director of the NTP.

There are approximately 20 substances under review for the Ninth Report. All substances have been through the four committee reviews, and the Director's recommendations are expected to be sent to the Secretary in July 1999. Decisions by the Secretary, and publication of the Report, are expected by Fall 1999. More detailed background on the Program, and on substances currently under review, can be found through the NTP Website at ntp-server.niehs.nih.gov.

The reviews for the Ninth Report involve a number of controversial substances and issues. Such substances include saccharin (proposed for delisting), alcoholic beverages (proposed for the "known" category), tamoxifen (the leading breast cancer drug, proposed for the "known" listing), dioxin (proposed to be upgraded to the "known" category), and silica (proposed for the "known" category). Some of the important issues that have arisen concern whether listing of substances as "known" to cause cancer which appear to have a net beneficial health effect are likely to be misleading to the public and harmful to the overall public health; whether the agency is adhering to its listing criteria if it allows the use of animal testing data to "upgrade" a substance to the "known" category; whether the review process is sufficiently expert and thorough; and how the Director and Secretary will make decisions for the "known" category in cases where there have been significant differences of opinion in the preceding reviews.