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Carcinogen Classification Criteria Patricia Richter Ph.D., DABT

Carcinogen Classification Criteria Patricia Richter Ph.D., DABT. Tobacco Products Scientific Advisory Committee June 8, 2010. National Toxicology Program. Multiple U.S. government agencies participate in the NTP, including the NIH, CDC and FDA

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Carcinogen Classification Criteria Patricia Richter Ph.D., DABT

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  1. Carcinogen Classification CriteriaPatricia Richter Ph.D., DABT Tobacco Products Scientific Advisory Committee June 8, 2010

  2. National Toxicology Program • Multiple U.S. government agencies participate in the NTP, including the NIH, CDC and FDA • In the United States, the NTP releases the Report on Carcinogens (RoC) every 2 years • The RoC identifies 2 groups of agents: • "Known to be human carcinogens" • "Reasonably anticipated to be human carcinogens“ • The RoC does not list substances that have been studied and found not to be carcinogens

  3. National Toxicology Program

  4. National Toxicology Program

  5. National Toxicology Program

  6. International Agency for Research on Cancer (IARC) • Part of the World Health Organization (WHO). • Has evaluated over 900 likely carcinogens over 30 years. • Classification system: • Group 1: Carcinogenic to humans • Group 2A: Probably carcinogenic to humans • Group 2B: Possibly carcinogenic to humans • Group 3: Unclassifiable as to carcinogenicity in humans • Group 4: Probably not carcinogenic to humans

  7. IARC: Carcinogenicity in Humans

  8. IARC: Carcinogenicity in Animals

  9. IARC: Mechanistic Data • May include data on • Preneoplastic lesions • Tumor pathology • Genetic effects • Structure-activity relationship • Metabolism and toxicokinetics • Physiochemical parameters

  10. IARC: Classification

  11. Environmental Protection Agency • The US EPA maintains the Integrated Risk Information System (IRIS), an electronic database that contains information on human health effects from exposure to various substances in the environment. • Rating system: • Group A: Carcinogenic to humans • Group B: Likely to be carcinogenic to humans • Group C: Suggestive evidence of carcinogenic potential • Group D: Inadequate information to assess carcinogenic potential • Group E: Not likely to be carcinogenic to humans

  12. EPA Classification Criteria • Weight of evidence approach: • Epidemiological human data • Results of long-term experimental animal bioassays • Other key data, including physiochemical properties, structure-activity relationships, comparative metabolism and toxicokinetics, and mode of action

  13. California EPA • The CA Safe Drinking Water and Toxic Enforcement Act requires that the state publish a list of chemicals known to cause cancer or reproductive toxicity. • Inclusion criteria: • Recommendation by the state's qualified experts. The state Science Advisory Board includes two subcommittees that review toxicity data and identify carcinogens and reproductive toxicants. • Identification by recognized authoritative bodies, including the U.S. EPA, FDA, National Institute for Occupational Safety and Health, NTP or IARC. • Requirement by state or federal government agencies that the chemical be labeled or identified as a carcinogen or reproductive toxicant.

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