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The Process of Listing Chemical by State’s Qualified Experts

Proposition 65 authorizes four ways for chemicals to be listed as known to cause cancer or reproductive toxicity. One of these methods is through the state’s qualified experts (SQE). SQEs are comprised of two independent committees of scientific and health experts appointed by the Governor who determine whether a chemical qualifies for listing under the statute. Through the process described further below, members of the public have opportunities to provide comments on a proposed SQE listing.

The two committees that are identified as SQEs are the Carcinogen Identification Committee (CIC) and the Developmental and Reproductive Toxicant Identification Committee (DARTIC). They both belong to the Science Advisory Board. The committees review the most current scientific data available to determine whether a certain chemical should be added to the Proposition 65 list.  Both the CIC and DARTIC are comprised of members who have completed a doctoral degree and demonstrated expertise in a relevant area of research.

California’s Office of Environmental Health Hazard Assessment (OEHHA) utilizes a specific process to select chemicals to be considered by the CIC and DARTIC. The agency maintains a database of chemicals that have been brought to its attention through searches or upon the recommendations of CIC or DARTIC. Once entered into the tracking database, these chemicals are evaluated to assess toxicity data and potential for exposure. They are then screened using various review processes, starting with an epidemiology data screen and a toxicology evaluation.

With consultation from the relevant SQE committee, selects a chemical for preparation of Hazard Identification Materials (HIMs). OEHHA then publishes a notice announcing a data call-in for that selected chemical; at that point, members of the public have 45 days within which to submit studies and other relevant information.

Following the data call-in period, OEHHA prepares the HIM, incorporating the data and other information received from the public, as appropriate. OEHHA then publishes the HIM for another 45-day public comment period and submits the HIM, along with public comments received, to the relevant SQE committee for review.

The relevant committee holds a public meeting to evaluate whether the selected chemical should be listed. During the public meeting, OEHHA scientific staff presents data and information relating to the chemical and responds to questions from the committee members. OEHHA legal staff also is present at the public meeting. Members of the public may submit oral comments; typically, each commenter is allowed five minutes to speak.

The committee then decides whether to add the chemical to the list pursuant to the applicable standard, i.e., that the chemical has been “’clearly shown through scientifically valid testimony according to generally accepted principles’ to cause cancer or reproductive harm.” The committee members vote on whether the chemical meets that standard. If a majority of the committee members vote “yes,” then the chemical is added to the Proposition 65 list, and OEHHA publishes a public notice to that effect.

Grimaldi Law Offices has been advising clients for over 20 years on chemical and product law. For knowledgeable advice and in-depth analysis on your Proposition 65 compliance obligations, contact Grimaldi Law Offices at (415) 463-5186 or email us at [email protected].

Ms. Grimaldi maintains a diverse environmental law practice focusing on chemical and product regulation and litigation defense. Her practice areas include Proposition 65, California's Safer Consumer Products Regulations, California's Rigid Plastic Packaging Container Act and the federal Toxic Substances Control Act. Ms. Grimaldi graduated from the University of California Hastings College of the Law magna cum laude and holds a Bachelor of Science Degree in Bacteriology from University of California, Davis. Prior to attending law school, she worked as a research assistant in laboratories at the University of California, San Francisco Cancer Research Institute and at the University of California, San Francisco School of Medicine.