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A carcinogen is an agent, mixture, or exposure that increases the occurrence of cancer. Carcinogen identificationisanactivitybasedontheevaluationofthe results of scientific research. Pertinent data for carcinogen identification include human epidemiologic studies, long-term bioassays in experimental animals, and other relevant data on toxicokinetics and cancer mechanisms. Several classification systems exist to identify the degree of carcinogenicity of agents. The most widely used system is developed by the International Agency for Research on Cancer (IARC), which is part of the World Health Organization.

Most of the existing data about whether an agent might cause cancer originate from laboratory (cell culture and animal) studies. Although it is not possible to predict with certainty which substances will cause cancer in humans based on animal studies alone, virtually all known human carcinogens that have been adequately tested have been found to produce cancer in lab animals. In many cases, carcinogens are first found to cause cancer in lab animals and are later found to cause cancer in humans. For most carcinogens, it is assumed that those that cause cancer at larger doses in animals will also cause cancer in humans.

Another source of data about carcinogens comes from epidemiologic studies, which provide evidence of a carcinogenic hazard but often are not sufficiently sensitive to identify a carcinogenic hazard except when the risk is high or when it involves an unusual form of cancer. In addition, it is difficult to single out any particular exposure as having a definite link to cancer. For these reasons, laboratory studies generally provide the best means of assessing potential risks to humans.

The IARC Classification System for Carcinogens

The most widely used system for classifying carcinogens originates from IARC. This agency releases the IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, which are scientific evaluations developed by international working groups of expert scientists. Agents are selected for evaluation on the basis of evidence of human exposure and some evidence or suspicion of carcinogenicity. The IARC Monographs include a critical review of the pertinent peer-reviewed scientific literature as the basis for an evaluation of the weight of the evidence that an agent may be carcinogenic to humans. Published continuously since 1972, the scope of the IARC Monographs has expanded beyond chemicals to include complex mixtures, occupational exposures, lifestyle factors, physical and biologic agents, and other potentially carcinogenic exposures. In the past 30 years, IARC has evaluated the cancer-causing potential of about 900 likely candidates. These evaluations provide the scientific support for public health measures implemented by many national and international health agencies around the world. IARC categorizes agents into the following five potential categories.

Group 1: Carcinogenic to Humans

If a substance is classified as belonging to Group 1, it is labeled ‘carcinogenic to humans.’ This category is used when there is sufficient evidence of carcinogenicity in humans. An agent may be placed in this category when evidence of carcinogenicity in humans is less than sufficient but there is sufficient evidence of carcinogenicity in experimental animals and strong evidence in exposed humans that the agent acts through a relevant mechanism of carcinogenicity. Only 91 agents have been characterized as ‘carcinogenic to humans.’

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