California Proposition 65 (Prop 65) is a very significant piece of legislation that is getting some renewed attention. Known as the “Safe Drinking Water Toxic Enforcement Act of 1986,” Prop 65 states that no one shall introduce into the drinking water of the state of California any substance that may cause reproductive or carcinogenic toxicity. This legislation, however, has expanded into the consumer product area. Wherefore, dietary supplements, herbal, cosmetic and even home products, etc. have been included within the confines of this piece of legislation.
As Prop 65 currently stands, if a product or its ingredients has substances known to be carcinogenic or reproductively toxic, on the Prop 65 list and exceeds the “no significant risk levels” prescribed by law, then one of two things may be required.
- A warning label will need to be placed on the product and or advertisement stating, “This product contains [substance] a chemical known [to the state of California] to cause birth defects or other reproductive harm.”
- The manufacturer, raw ingredient supplier, distributor or retailer may provide documentation as proof that the chemical substance is not present or at levels below limits set by California Proposition 65.
Two weeks ago, California published the first set of major changes to the Proposition 65 regulations, creating another set of challenges for businesses offering products or operating facilities in California. As written in Morrison Foerster,
Under Proposition 65, businesses with 10 or more employees must give a “clear and reasonable warning” to individuals in the state before knowingly and intentionally exposing those individuals to a chemical listed as known to cause cancer or reproductive toxicity. The new regulations for Clear and Reasonable Warnings repeal and replace Title 27 of the California Code of Regulations, Article 6 (sections 25601 et seq.), except those added via an emergency rulemaking in April 2016 related to warnings for exposures to bisphenol A in canned foods and beverages (sections 25603.3(f) and (g)). In adopting the changes, the state’s Office of Environmental Health Hazard Assessment (OEHHA) determined that its existing regulations were outdated and that the warnings must be rewritten to provide more useful information about potential exposures, as well as to incorporate changes in technology and to communicate more effectively with non-English speakers.
The new regulations become operative on August 30, 2018, providing a two-year transition period. Until then, businesses may comply with either the current regulations or the new ones. Products manufactured before the operative date may continue to use the current safe harbor warning language. The new regulations also retain the provision allowing businesses to use either its new safe harbor warning language, which is deemed to be “clear and reasonable,” or other warning language that can be defended as clear and reasonable. Such other warnings may include the current safe harbor language or warnings that have been reviewed and approved by courts. Companies that are parties to a court-ordered settlement or final judgment establishing a warning method or content are deemed to be providing a clear-and-reasonable warning for that exposure, if the warning complies with the order or judgment.
Click here to see what the new safe harbor regulations will require.
Another source, Grimaldi Law Offices, recently wrote an article entitled, “Navigating Proposition 65 Consent Judgments Through The New Safe Harbor Regulations: Should Your Consent Judgment Be Modified?” The article offers valuable information for companies seeking to maintain compliance within California Prop 65 guidelines.
If your business is currently using Proposition 65 warnings pursuant to a consent judgment, take heed: You may need to modify the judgment to address business, not legal, pressure to use the new warnings recently established under the new safe harbor warning regulations that go into effect August 30, 2018.
California law has long required businesses to provide clear and reasonable warnings prior to exposing individuals to chemicals placed on the Proposition 65 list. However, recent shake-ups in what defines “clear and reasonable” are changing the liability landscape for businesses selling products in, or destined for, California. On August 30, 2016, the Office of Environmental Health Hazard Assessment (OEHHA) adopted new safe harbor warning regulations, which become effective and enforceable on August 30, 2018. As of that date, the safe harbor warnings that have been in place since 1988 will no longer provide shelter, and their continued use may subject companies to liability.
The article continues discussing a scenario that is cause for confusion: product manufacturers or distributors previously entered into a consent judgment regarding warning requirements and will now be required to reconcile those warnings with the new safe harbor regulations. If your company is covered by such a consent judgment, consider the possibility that it may be in your best interest to seek a modification of that judgment. Click here to read more.
SGS is dedicated to providing trace elemental analysis by ICP-MS. We also recognize that while it is very important to have the latest technology, having you receive your information on time is just as critical. To learn more about Prop 65, visit our website or contact us today.