Notice of Release of an 2008 Report on Proposition 65 Safe Harbor Levels Adopted in Regulation and Under Development
The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is the lead agency for the implementation of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or the Act). In order to provide compliance assistance for persons subject to the requirements of the Act, OEHHA develops Proposition 65 safe harbor levels - no significant risk levels (NSRLs) for carcinogens and maximum allowable dose levels (MADLs) for chemicals that cause reproductive toxicity. The NSRL is the daily intake level calculated to result in one excess case of cancer in an exposed population of 100,000, assuming lifetime (70-year) exposure at the level in question. The MADL is the level at which chemicals listed for reproductive toxicity would have no observable effect assuming exposure at 1,000 times that level. The NSRLs and MADLs are promulgated in Title 22, California Code of Regulations, sections 12705 and 12805 respectively. These levels assist interested parties in determining whether warnings are required for exposures to chemicals listed under Proposition 65, and whether certain discharges of listed chemicals to sources of drinking water are prohibited.
Today OEHHA is releasing an update of the document, “Proposition 65 Safe Harbor Levels: No Significant Risk Levels for Carcinogens and Maximum Allowable Dose Levels for Chemicals Causing Reproductive Toxicity.” The document lists current NSRLs and MADLs adopted in or proposed for adoption into regulation. The document also lists the priority for development of NSRLs and MADLs for listed chemicals. OEHHA anticipates proposing NSRLs or MADLs for the chemicals in the first priority group within the next year, and for second-priority chemicals within the next two to five years. It is unlikely that safe harbors would be released for chemicals in a lower group within the next five years.
Priority levels are based on the availability and quality of scientific data for dose-response assessments, potential for exposure, resources available to perform the assessment, need expressed by interested parties, and input from the public and Attorney General’s Office. In the future, OEHHA plans to propose regulatory levels for most chemicals within a year after they are added to the Proposition 65 list.
Any interested party may submit recommendations to OEHHA for revising the priority assignment for any listed chemicals, preferably with supporting rationale for the change.
Recommendations for revising priority assignments for safe harbor development should be submitted to:
Office of Environmental Health Hazard Assessment
Street Address: 1001 I Street, MS-19B
Sacramento, California 95814
Mailing Address: P.O. Box 4010
Sacramento, California 95812-4010
Fax No.: (916) 323-8803
Telephone: (916) 445-6900
Email: sam.delson@oehha.ca.gov
