California's Proposition 65

What is Proposition 65?
California’s Safe Drinking Water and Toxic Enforcement Act of 1986, better known as Proposition 65, was approved by voters to address the growing concerns about exposure to toxic chemicals. Proposition 65 requires California to publish a list of chemicals, updated at least once a year, known to cause cancer, birth defects or other reproductive harm. Proposition 65 also requires California businesses to post notification about significant amounts of chemicals in the products they sell in California, use in their homes or workplaces, or that are released into the environment.

Who is affected by Proposition 65?
California businesses and anyone that sells their product in California.

What types of chemicals are on the Proposition 65 list?
The list contains a wide range of naturally occurring and synthetic chemicals that are known to cause cancer or birth defects or other reproductive harm. These chemicals include additives or ingredients in pesticides, common household products, food, drugs, dyes or solvents. Listed chemicals may also be used in manufacturing and construction, or they may be byproducts of chemical processes, such as motor vehicle exhaust.

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Current Proposition 65 List: View PDF version here

How can a compound be added to the Proposition 65 list?
Under Proposition 65, there are several mechanisms by which a compound can find itself added to the list of “chemicals known to the state of California” to cause either cancer or reproductive toxicity. Compounds can be added to the list by the panels of the State’s qualified experts, either the Cancer Identification Committee (CIC) or the Developmental and Reproductive Toxicant Identification Committee (DART-IC). Alternatively, compounds can be added onto the Proposition 65 list administratively, either because another regulatory agency (an “Authoritative Body” such as the EPA, FDA, NTP, IARC or NIOSH) has classified the compound as a carcinogen or reproductive toxicant, or the compound triggers warnings of product labels.

Can a compound be removed from the Proposition 65 list?
Once a compound has been added to the Proposition 65 list, it can be removed, but only under conditions established in regulation, and only if the OEHHA staff are convinced these conditions have been met. The process required for delisting is complex, multi-staged, and time consuming, but worth the effort if the intended goal is met.

Who enforces Proposition 65?
The California Attorney General's Office enforces Proposition 65. In addition, any individual acting in the public interest may enforce Proposition 65 by filing a lawsuit against a business alleged to be in violation of this law. Lawsuits have been filed by the Attorney General’s Office, district attorneys, consumer advocacy groups, private citizens and law firms. Proposition 65 is enforced by litigation with the burden of proof placed on businesses rather the plaintiff.

How is a business notified that they may be in violation of Proposition 65?
A notice of the alleged violation must be sent to the business 60 days before filing a suit. This is known as a 60-day notice letter. In the interim, the Attorney General may take over the case. Public prosecutors do not need to send 60-day notices.

Because Proposition 65 is not enforced by a government agency, such as OSHA, a business should seek legal advice upon receiving a 60-day notice letter.

How can TSG help me?
TSG provides the technical expertise to support our own risk assessments, evaluate third-party risk assessments, and examine the calculations and models used by plaintiffs. In this way, plaintiffs can be prevented from obtaining judgments and settlements through the use of unrealistic models or assumptions.

Our team is often retained to provide technical expertise in negotiations with plaintiffs. As a result, our staff is familiar with approaches used by plaintiffs to generate risk assessments, which allows us to develop a plaintiff's approach in order to ensure that our assessments will withstand hostile examination and litigation. We also provide alternative or counter approaches that establish the validity of our models, and to question and discredit those used by plaintiffs, which are often excessively conservative.

TSG’s scientists have the expertise required to develop, explain and apply sound exposure models. Our scientists also examine and call into question other approaches to risk assessment that are excessively conservative or unwarranted. Our consultants work as a team to provide the knowledge, experience, technical expertise and guidance to deter litigation if possible. The same resources are applied to defend against inappropriate assumptions that are often the basis of a plaintiff's claims.

Contact TSG to learn how we can help.

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