California’s Proposition 65 (Prop 65) has been a keen area of client interest for years. One question repeatedly asked is “what is a clear and reasonable warning?” The California Office of Environmental Health Hazard Assessment (OEHHA) released a Questions and Answers for Businesses (Q&A) document specifically covering “clear and reasonable warnings” requirements. The Q&A aims to help companies comply with new Prop 65 notice requirements that become effective next August. This column explains the significance of this Q&A document.
The Q&A provides important guidance for those providing Prop 65 warnings, the methods for providing warnings via the Internet or catalogs, short-form (previously “on-product”) warnings, and occupational and environmental exposure warnings. The new warnings become effective August 30, 2018, at which time the existing warning methods and content no longer will suffice. It’s none too soon to think about how best to comply with the new requirements.
Complicated supply chain issues can arise regarding who is responsible for providing a warning. The regulations set forth new requirements if a business intends to comply with warning requirements by providing written notice to its retail seller. For example, a consumer product manufacturer that doesn’t sell directly to retailers has two options for compliance: label the product with the required warning; or provide a warning notice and the warning materials to the packager, importer, supplier or distributor via its authorized agent.
Similarly, a company that manufactures component parts or ingredients that include listed chemicals can comply with the obligation to warn persons who can be occupationally exposed to the bulk product by providing warnings. The company would only have responsibility for a consumer warning if it has knowledge that the end use of the component part or ingredient can expose a consumer to a listed chemical.
For example, if a manufacturer of a food ingredient knows the ingredient typically is used in certain types of prepared foods and could result in an exposure, then the ingredient manufacturer should provide the warning notice to the product manufacturer. The product manufacturer is then responsible for determining whether the product it is manufacturing causes exposure to the chemical at a level that requires a warning. If so, the product manufacturer is responsible for passing the information along to its customers or the product retailer.
OEHHA provides helpful guidance on aspects of the new requirements related to the content of the warning language. There’s a new requirement to include a symbol of a black exclamation point in a yellow equilateral triangle with a bold black outline. OEHHA states that the symbol can be provided in just black and white “if a business does not use the color yellow for other information provided on the label or sign.”
Other issues addressed include situations where a product contains multiple listed chemicals. If, for example, there are five possible chemical exposures from a given product, and all five chemicals are listed only as carcinogens, the guidance clarifies that the business would only be required to name one of those five chemicals in the warning. However, the business may identify any or all of the remaining four chemicals if it chooses to do so.
Regarding the short-form label option, OEHHA confirms in the Q&A that this applies regardless of the size of the product, and can be “affixed to or printed on a product or its immediate container or wrapper.” OEHHA also clarifies that a consumer product warning provided on a website can use the same short-form warning content that the business is providing on the product. The business may also use a picture of the label on the product for the website warning.
The new warning requirements are complicated and extensive. Regulated entities need to focus on coming into compliance with them now, and not wait until August of next year. The Q&A document is quite useful; stakeholders are urged to review it.
LYNN L. BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at email@example.com
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006). The views expressed herein are solely those of the author. This column is not intended to provide, nor should be construed as, legal advice.