Regulatory Developments

Proposition 65: OEHHA Releases Q&A Regarding Proposition 65 Regulations for Clear and Reasonable Warnings

October 19, 2017

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.

  • Consumer Product Exposure Warnings -- Content: OEHHA provides helpful guidance related to several aspects of the new requirements related to the content of the warning language.
     
    • Regarding the 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 while “if a business does not use the color yellow for other information provided on the label or sign.”
       
    • Regarding the requirement to identify the name of one or more of the listed chemicals for which the warning is being provided, OEHHA provides the following example:

      If, for example, there are five possible chemical exposures from a given product, and all five chemicals are listed only as carcinogens, then 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. If there are exposures to both carcinogens and reproductive toxicants, a business would be required to name one of the chemicals that is a carcinogen and one of the chemicals that is a reproductive toxicant, but the business could choose to identify more chemicals in the warning. If the warning covers exposure to a chemical that is listed as both a carcinogen and a reproductive toxicant, the warning would only need to name that one chemical, however both endpoints would need to be included in the warning. The business could choose to identify more chemicals covered by the warning.
       
    • Regarding the requirement to provide the warning in languages other than English, OEHHA states: 

      Safe harbor consumer product warnings (Section 25602), environmental warnings (Section 25604), and “tailored” warnings (Section 25607.1, et seq.) require warning content to be provided in other languages under certain circumstances. Specifically, if a consumer product label or packaging contains consumer information in a language other than English, the warning must be provided in that language in addition to English. If signage at a business or facility is in a language other than English, then an environmental warning provided by that business or facility must be in that other language in addition to English.
       
  • Consumer Product Exposure Warnings -- Short-Form Label: Regarding the short-form (previously called “on-product”) label option,OEHHA confirms that this option 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 further notes that there is no requirement that the short-form warning content fit on one line, so it can be placed on two or more lines so long as it is legible. In response to a question whether a business providing a short-form warning on a consumer product can also provide the same warning on its website, OEHHA states:

    Yes, a consumer product warning provided on a website pursuant to Section 25602(b) 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.
     
  • Consumer Product Exposure Warnings -- Method of Transmission: The new regulations set forth four methods for transmitting consumer product warnings: (1) warning on a posted sign, shelf tag, or shelf sign; (2) warning via electronic device; (3) warning on a label complying with Section 25603(a); and (4) warning via the short-form complying with Section 25603(b). OEHHA’s Q&A provides the following guidance regarding consumer product exposure warning methods:
     
    • With regard to using an owner’s manual to provide the warning, OEHHA states: “A standalone warning in an owner’s manual is not a safe harbor warning method for consumer product exposures.” OEHHA caveats its response by noting: “For some products (specifically diesel engines, passenger vehicles and recreational vessels), owner’s manuals are included as part of a safe harbor warning method used in conjunction with another warning method (Sections 25607.14, 25607.16, and 25607.18).”
       
    • With regard to Internet and catalog warnings, OEHHA states: 

      Q21: Must warnings be provided for internet purchases? Must a product sold over the internet have a warning in order to meet the safe harbor requirements?

      Yes, under the safe harbor provisions of the regulations, warnings are required for purchases made over the internet following the methods in Section 25602(b). Warnings must be provided to the consumer prior to completing the purchase, and a warning must be provided via any one of the four methods for consumer products in Section 25602, subsections (a)(1)-(4). For a website warning, if a label is used for a product warning, a business may opt to provide a hyperlink to the warning or a picture of the warning label used on the product. In addition, if an on-product (short-form) warning is provided on the product label, the website warning may use the same content.

      Q22: Must warnings be provided for catalog purchases? Must a product sold through a catalog also have a warning in order to meet the safe harbor requirements?

      Yes, under the safe harbor provisions of the regulations, warnings meeting the requirements of Section 25602(c) are required to be provided for purchases made through catalogs prior to completing the purchase, and a warning must be provided via any one of the four methods for consumer products in Section 25602, subsections (a)(1)-(4). In addition, if an on-product (short-form) warning is provided on the product label, the catalog warning may use the same content.

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.”


 
BERGESON & CAMPBELL, P.C.
2200 Pennsylvania Ave, N.W. Suite 100W
Washington, D.C. 20037
(202) 557-3800 • (202) 557-3836 (fax) | lawbc.com
Contact • Twitter
 
Privacy and Terms of Use | Attorney Advertising | Trademarks
©2017 Bergeson & Campbell, P.C.
All Rights Reserved.