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Proposition 65

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CALIFORNIA'S PROPOSITION 65: RISK ASSESSMENT

“Clear and reasonable warnings” for products and discharge prohibition requirements under Proposition 65 are based on risk assessments that determine whether the potential exposure levels within California are significant . However:

  • Most exposure scenarios are not specifically set out in regulation under Proposition 65. Without these guidance, a knowledge of this history of successful assessment under Prop 65 is essential. After over 20 of performing these assessments, TSG is in a unique position to provide solid guidance under Proposition 65. This includes the development of “Safe Harbor Levels” where levels have not been established by OEHHA.
  • Enforcement under Proposition 65 is by litigation, not by agency decision like most environmental statutes. Thus, exposure levels and penalties can be negotiated with plaintiffs and decided by courts if negotiations fail. Successful risk assessments under Prop 65 follow the history of analogous litigation under the Act.

TSG provides the knowledge and experience to help companies make sound decisions and avoid litigation.

Our risk assessments may utilize:

  • The bases for the listing of a chemical under Proposition 65 for determination of relevant exposures or the Safe Harbor Level in the absence of a default value established by OEHHA .
  • Conservative assumptions, calculation models, and supporting documentation in the absence of surrogate data or product data .

TSG risk assessments generate an exposure level that we use to calculate a value TSG terms the “Margin of Comfort” (= Exposure Level ÷ Safe Harbor Level) for protection from litigation under Proposition 65. Margins below one are subject to warnings or discharge prohibitions, high margins show that warnings or discharge prohibitions are not required, and margins in between require a variety of different approaches depending on many factors.

We provide companies with:

  • Expertise in conducting Proposition 65 risk assessments and the experience with plaintiff's positions and tactics.
  • Guidance and documentation to deter litigation.
  • Documentation to support customer requests.

TSG staff have been conducting risk assessments under Proposition 65 since the first week after voters approved the Act in November 1986. TSG provides underlying documentation to deter litigation and satisfying customer requests. TSG is also experienced at assessing products under notice of potential litigation and negotiating favorable outcomes with a plaintiff.