Fact sheet: the Report on Carcinogens - 9th edition

May 14, 2000

Today the Department of Health and Human Services released the Report on Carcinogens 9th edition. Prepared by the National Toxicology Program, which is headquartered at the National Institute of Environmental Health Sciences, the Report identifies substances -- such as metals, pesticides, drugs, and natural and synthetic chemicals -- and mixtures or exposure circumstances that are "known" or are "reasonably anticipated" to cause cancer, and to which a significant number of Americans are exposed. The Report is published every two years.

The Report is a scientific and public health document first ordered by Congress in 1978 to educate both the public and health professionals in the recognition that many cancers are apparently induced by chemicals in the home, workplace, general environment and from the use of certain drugs. It is important to understand that the Report identifies potential cancer hazards. A listing in the Report does not by itself establish that a substance presents a cancer risk to an individual in daily life. It is also important to note that the Report does not address or attempt to balance potential benefits of exposures to certain carcinogenic substances in special situations. For example, numerous drugs used to treat cancer have been shown to increase the occurrence of secondary cancers. In these instances, the benefits of exposure to the drugs for treatment or prevention of a specific disease have been determined by the FDA to outweigh the additional cancer risks associated with their use. People should not make decisions concerning the use of a given drug, or any other listed agent, based solely on the information contained in the Report. Decisions of this type should be made only after consulting with a physician or other appropriate specialist about both risks and benefits.

An agent, substance, mixture or exposure circumstance can be listed in the Report either as "known to be a human carcinogen" or as "reasonably anticipated to be a human carcinogen."

The "known" category is reserved for those substances for which there is sufficient evidence of carcinogenicity from studies in humans that indicates a cause and effect relationship between the exposure and human cancer.

The "reasonably anticipated" category includes those substances for which there is limited evidence of carcinogenicity in humans and/or sufficient evidence of carcinogenicity in experimental animals.

Conclusions regarding carcinogenicity in humans or experimental animals are based on expert, scientific judgment, with consideration given to all relevant information.

The 9th edition of the Report contains 218 entries. Fourteen of the listings are new. Eight of the new entries are listed as "known to be human carcinogens" and the other six entries as "reasonably anticipated to be human carcinogens." This Report also reclassifies six current listings from "reasonably anticipated" to "known to be human carcinogens".

2,3,7,8-Tetrachlorodibenzo-p-dioxin (TCDD) has been proposed for upgrade to the "known to be a human carcinogen" category. The proposed listing is currently in litigation. Depending on the outcome of the litigation, an addendum may be published following the court's ruling. Two additional substances have been removed or delisted from the Report: saccharin and ethyl acrylate.

The new listings in the 9th edition include some agents and substances to which large numbers of people are exposed including environmental tobacco smoke, tobacco smoking, oral use of smokeless tobacco products, alcoholic beverage consumption, diesel exhaust particulates, UV solar radiation, and use of sun lamps and sun beds. The Report's findings are based on three years of study that included three scientific reviews and public comment from scientists, consumers and other interested parties.

The listing of a substance in the Report is not a regulatory action, but listing may prompt regulatory agencies to consider limiting exposures or uses of a substance. In addition, the U.S. Congress, Federal and State Agencies, businesses, unions and the general public all use the Report to ensure that reasonable precautions or regulations are in place.

The following briefly describes the additions and/or changes made to the 9th edition of the Report:

Added as "known human carcinogens" or upgraded to that category in the 9th Report:Added as "reasonably anticipated to be human carcinogens" in the 9th Report:
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