Scientific & Technical Support: Proposition 65 - Risk Assessment
Under
Proposition 65, “clear and reasonable warnings” must be applied to certain
products and discharges to possibly potable water, based on risk to the
public. Estimating the degree of risk is therefore essential, and depends
partly on levels of exposure to the products or discharges.
Levels
of exposure are frequently estimated by calculation, using mathematical
models that predict chemical distribution and dissipation. However, since
most exposure scenarios are not specifically set out in regulation under
Proposition 65, proper guidance from experts with an intimate knowledge of
the law is fundamental to protecting a product from potential
litigation
under the Act.
Enforcement under Proposition 65 is by litigation, not
by Agency decision like most environmental statutes. Therefore, exposure
levels and penalties can be negotiated with plaintiffs and decided by courts
if negotiations fail. Successful risk assessments under Proposition 65
follow the history of analogous litigation under the Act.
TSG’s consultants provide the knowledge and experience to help companies
make sound decisions and avoid litigation. Our risk assessments may utilize:
▲ Use of chemicals listed under Proposition 65 as a basis for
determining relevant exposures or the
Safe Harbor Level in the absence of a
default value established by the Office of Environmental Health Hazard
Assessment (OEHHA).
▲ Conservative assumptions, calculation models and
supporting documentation in the absence of
surrogate data or product data
▲ Use of presumptions that are in-line with previous actions and
litigation under Proposition 65
Our scientist’s 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, margins above one show that warnings or discharge prohibitions
are not required, and margins in between require a variety of different
approaches, depending on many factors.
TSG provides companies with:
▲ Expertise in conducting Proposition 65 risk assessments and experience
with plaintiff's positions and tactics
▲ Guidance and documentation to
deter litigation
▲ Documentation to support customer requests
TSG’s staff has been conducting risk assessments under Proposition 65 since
the first week after voters approved the Act in November 1986. TSG’s
consultants provide underlying documentation to deter litigation and satisfy client requests. We also assist clients by assessing products
under notice of potential litigation and negotiating favorable outcomes with
a plaintiff.
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