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Proposition 65

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PROP 65 TOXICOLOGY EVALUATIONS

There are numerous processes within Proposition 65 that require the toxicological evaluation of chemicals, their uses, and the significance of the potential exposures they may cause. These evaluations are performed both for the understandings of companies doing business within California as well as in support of litigation or at the request of the government. California 's Office of Environmental Health Hazard Assessment (OEHHA), the lead agency overseeing implementation of Proposition 65, accepts public comments and re-evaluates proposed positions prior to rulemaking. TSG has the expertise and experience required to affect changes in Proposition 65 listings and regulations.

TSG provides toxicology support for interactions with OEHHA including:

  • Presentations at public hearings including those of the state's Scientific Advisory Panels (DART committee for developmental and reproductive toxins and CIC for carcinogens)
  • Petitions to OEHHA staff concerning proposed actions

Toxicology support often involves the following input:

  • Listing decisions. TSG input includes:
    • Test species relevancy to humans for observed effects
    • Test protocol relevancy ( e.g., method or extent of dosing)
    • Test data appropriateness (including equivocal data)
    • “Authoritative Body” listing basis (including intent and scope of authoritative body documents)
  • Listing language ( e.g., limiting scope). TSG input includes:
    • Form ( e.g., particle size, gas phase, or binding status)
    • Route of exposure ( e.g., inhalation only)
    • Grade or mixture ( e.g., effects of other chemicals)
  • Safe Harbor Levels. TSG input includes:
    • Data selection as basis of Safe Harbor Level
    • Calculation procedures
  • Delisting hearings. TSG input includes:
    • Data quality forming basis of the listing
    • Revised interpretations based on new data
    • New Authoritative Body decisions

TSG extensive expertise in Prop 65, from within industry and in public forums. TSG staff have been assessing the toxicological consequences of Prop 65 since a few days following its approval by voters in November 1986. TSG assembles detailed and influential petitions and presentation. TSG also has the experience with OEHHA staff and the state's panels that is required to target petitions and presentations in ways most likely to succeed.