Two Chemicals Proposed for Addition to California’s Prop 65 List
California’s Office of Environmental Health Hazard Assessment has announced its intent to list pertuzumab and vismodegib to the list of chemicals known to the state to cause reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). These substances are drugs used to treat certain types of cancer. Comments on these proposals are due no later than Jan. 3.
Beginning one year after a chemical is added to the Prop 65 list businesses are required to provide a “clear and reasonable” warning before knowingly and intentionally exposing anyone to that chemical unless they can show that the anticipated exposure level will not pose a significant risk of cancer or is significantly below levels observed to cause birth defects or other reproductive harm. This warning can be given in several ways; e.g., labeling a consumer product. However, no such warning is required if exposure to a chemical occurs at or below any established safe harbor level.
Prop 65 also prohibits companies that do business within California from knowingly discharging listed chemicals into sources of drinking water, a requirement that kicks in 20 months after a chemical is listed.