In August 2017, the California Office of Environmental Health Hazard Assessment (OEHHA) released a Questions and Answers for Businesses (Q&A) document related to its August 28, 2016, adopted revisions to its Proposition 65 (Prop 65) Article 6 regulations covering “clear and reasonable warnings” requirements.
Information related to OEHHA’s past actions modifying Prop 65 warning regulations, including the August 28, 2016, adoption and the November 27, 2015, and March 25, 2016, proposal rules, is available on our website, key phrase Proposition 65.
The Q&A document provides important guidance on issues related to those responsible for providing warnings, the methods for providing warnings via the Internet or catalogs, short-form (previously “on-product”) warnings, and issues related to occupational and environmental exposure warnings. Of particular significance, we note the following:
-
Compliance Timing: OEHHA states the following regarding the timing for when entities need to provide warnings under the new regulations:
Q6: When do I need to provide the new warnings?
The new warnings become operative on August 30, 2018, at which time the September 2008 safe harbor warning methods and content will no longer be operative. The exceptions involve consumer products manufactured prior to August 30, 2018 and labeled in compliance with the September 2008 warning regulations, and products covered by court approved settlements (Section 25600).
OEHHA clarifies that this phase-in period applies only to businesses providing warnings. With regard to new regulations at Section 25600.2(e) that set forth the circumstances when a retail seller is responsible for providing the warning for a consumer product exposure, OEHHA states that such requirements are not operative until August 30, 2018.
OEHHA also clarifies that the date the product is available for purchase does not determine whether the product should have a new warning. Instead: “A consumer product that is manufactured prior to August 30, 2018 and labeled with a warning that is compliant with the September 2008 version of the regulations is deemed to be compliant with the new regulations (Section 25600(b)).”
-
Warning Responsibility: There are potentially complicated supply chains that can raise issues regarding who is responsible for providing a warning, and the amended regulations set forth new requirements if a business intends to comply with warning requirements by providing written notice to its retail seller. The following OEHHA Q&As help frame the issues regarding how companies can comply with Prop 65 considering all the different entities that can be involved:
Q13: If a company is a manufacturer or producer of a consumer product, but does not sell it directly to retailers, how can it comply with the requirement to provide warnings to retail sellers?
A consumer product manufacturer that does not sell directly to retailers has two options for compliance: (1) Label the product with the required warning; or (2) Provide a warning notice and the warning materials to the packager, importer, supplier or distributor via their authorized agent. Manufacturers and others in the chain of commerce should take appropriate actions to ensure that the warning is passed along to the retailer and ultimately to the consumer. How that is done will vary from situation to situation. A manufacturer or producer may choose to enter into a contract with other businesses along the chain of commerce for their product to ensure that the warning is appropriately transmitted to the retailer and end consumer.
Q14: If a company manufactures component parts or ingredients that are sold in bulk to other manufacturers or formulators, how can it comply with the requirement to provide a warning, especially if the need for a warning depends on the concentration or the manner of use of the listed chemical in the final product?
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 consistent with Section 25606. 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 that the ingredient is typically used in certain types of prepared foods and could thereby result in an exposure under the Act, then the ingredient manufacturer should provide the warning notice to the product manufacturer. The product manufacturer is then responsible for determining whether the product they are manufacturing causes an 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. In such a situation, the ingredient manufacturer may also choose to work with the product manufacturer to evaluate whether the product should have a warning and may enter into a contract with product manufacturers to ensure that the warning is transmitted to the retailer and ultimately the consumer.
OEHHA also confirms that it would not meet the requirements for a business to place the warning symbol next to the product and use it as a reference to a full consumer product warning provided elsewhere in the catalog or website, as this approach is “unlikely to ensure that the warning is ‘clearly associated’ with the item being purchased.”
-
Occupational Exposure Warnings: It is important to recognize that if a substance does not trigger Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (HCS) warning/label requirements (e.g., is not present at a high enough concentration), that does not mean that there are no Prop 65 warning requirements. OEHHA provides the following Q&A regarding the interplay of HCS requirements and Prop 65 warning requirements:
Q42: Section 25606(a) states that a warning is not required on products that meet the requirements of the Hazard Communication Standard (HCS). If a product contains a Proposition 65 chemical, but the quantity is not enough to trigger classification as a carcinogen or reproductive toxicant under the HCS, does it still require a Proposition 65 warning?
Proposition 65 imposes separate warning requirements from the HCS. Section 25606 provides that a business can comply with Proposition 65 by complying with state and federal occupational training and warning requirements when a warning is required under the federal or California HCS, or the California Pesticides and Worker Safety requirements. In the event that there is an occupational exposure to a Proposition 65 listed chemical with no warning requirement for the chemical under these laws, a Proposition 65 warning may still be required. Section 25606(b) provides businesses the option to use safe harbor warning methods and content for an exposure to a Proposition 65 listed chemical in an occupational setting.
OEHHA also notes that a Safety Data Sheet (SDS) may be used to provide occupational exposure warnings, but “they are not a safe harbor warning method for other exposure types such as consumer product or environmental exposures covered by Article 6.”
[View source.]