Regulatory Developments

Proposition 65:  OEHHA Repeals and Re-Proposes Revisions to Proposition 65 Warning Regulations

December 11, 2015 PRINT

On November 27, 2015, the California Office of Environmental Health Hazard Assessment (OEHHA) took two actions: (1) it withdrew its proposed rule issued on January 16, 2015, that would have repealed and replaced the existing Article 6 regulations regarding the all-important "clear and reasonable warnings" requirements under Proposition 65 (Prop 65); and (2) it replaced it with a new proposed rule that will repeal and replace the Prop 65 Article 6 regulations (Proposed Rule), posted with an accompanying Initial Statement of Reasons (ISOR).

OEHHA states it is withdrawing and re-proposing the regulations because of extensive revisions it made to the proposed regulatory language based upon a review of stakeholder comments and its review of the results of a survey conducted by the University of California Davis Extension Collaboration Center to assess the effectiveness of the existing and proposed new warnings (UC Davis Survey). Despite the changes in the Proposed Rule, several controversial proposed changes remain, including but not limited to proposed warning language that a product "can expose" a person to the Prop 65-listed substances. Other proposed changes that would have required listing specific chemicals in the warning have been replaced with requirements to include the "name of one or more of the listed chemicals." Information regarding the Proposed Rule and ISOR regarding Prop 65 warnings is available on OEHHA's website. A public hearing on the Proposed Rule will be held in Sacramento, California, on January 13, 2016. Comments on the Proposed Rule are due by January 22, 2016.

Bergeson & Campbell, P.C. (B&C®) prepared a memorandum discussing OEHHA's January 16, 2015, proposed rule, Proposition 65: OEHHA Proposes Revisions to Proposition 65 Warning Regulations. OEHHA also previously released, on March 7, 2014, a Pre-Regulatory Proposal for Prop 65 warning requirements; B&C's memorandum discussing this proposal is available at Proposition 65: OEHHA Releases Pre-Regulatory Proposal for Revised Proposition 65 Warning Regulations.

Below we discuss OEHHA's Proposed Rule and the proposed changes to the warnings, including the ways in which the Proposed Rule differs from the January 2015 proposed rule.

General (Section 25600)

As with the January 2015 proposed rule, OEHHA re-proposes several general provisions, including a two-year delayed effective date to allow businesses time to comply with new requirements and provisions allowing an "interested party" to request OEHHA to adopt additional regulations that address exposures to listed chemicals in products or the environment, to the extent they are not already sufficiently covered by the regulations.

A new provision at Section 25600(b) states: "A warning for a consumer product manufactured prior to the effective date of this article is deemed to be clear and reasonable if it complies with the September 2008 revision of this article." OEHHA states the following in the ISOR (page 11) regarding this proposal:

OEHHA is sympathetic to the concerns expressed by some manufacturers regarding the change over from the old to the new safe harbor labels on durable goods. In order to avoid the difficulties involved for manufacturers and retailers to locate all products bearing the old warnings, the proposed regulation allows the old safe harbor to remain and be considered compliant if the product was manufactured prior to the effective date of the new regulation. Specifically, during the earlier phases of the development of this regulation, many stakeholders expressed concern over anticipated logistical and economic costs associated with changing the warnings on products already produced and distributed to the marketplace; this was of particular concern to businesses dealing in durable goods with compliant warnings and a long shelf-life. In order to address these concerns and mitigate potential cost impact on businesses, subsection (b) provides that a warning provided on products manufactured prior to the effective date of the revised Article 6 is deemed to be clear and reasonable if it complies with the September 2008 version of Article 6.

This is potentially very helpful language to businesses that have struggled with compliance based on the effective date of warning requirements.

OEHHA also has proposed language that was present in the Pre-Regulatory Proposal but removed from the January 2015 proposed rule regarding the sufficiency of warnings covered by court-ordered settlements or final judgments establishing a method or content for a consumer product or environmental warning. Regarding the re-introduction of this language, OEHHA states: "While this is simply a statement of existing law, many stakeholders requested that it be expressly included in the regulation. The provision was narrowly tailored in order to maintain consistency with the proposed regulations and avoid perpetuating potentially vague warnings." ISOR page 13.

Although the Proposed Rule contains similar language from prior proposals specifying that a person can provide supplemental information so long as it does not contradict the warning, OEHHA provides additional guidance on this issue in the ISOR. Specifically, OEHHA states that persons are not permitted to provide information "intended to reduce the effectiveness of the warnings by essentially contradicting it and providing other inaccurate information about the law." ISOR page 12. In the ISOR, OEHHA provides an example of information potentially not allowed: where there are statements regarding the amount of exposure as a key factor in determining health risks, the company has no alternative but to place warnings whether the product ends up in California or not. ISOR page 13.

Definitions (Section 25600.1)

The Proposed Rule proposes to re-adopt many of the definitions in the existing regulations. The Proposed Rule also re-proposes new definitions from the January 2015 proposed rule, including definitions for "Food," "Knowingly," and "Retail Seller" (previously termed "Retailer"). The Proposed Rule modifies the definitions for "Consumer Product Exposure," "Environmental Exposure," "Label," "Labeling," and "Sign" consistent with the January 2015 proposed rule, although OEHHA is no longer proposing to change the term from "Consumer Product Exposure" to "Product Exposure."

In the Proposed Rule, OEHHA proposes a new term "Authorized Agent," defined as "the person or entity designated by a retail seller to receive notices from product manufacturers, suppliers, and distributors under this article."

The Proposed Rule also proposes a modification to the term "Affected Area" by deleting the phrase "is reasonably calculated to occur at": "the area in which an exposure to a chemical known to the state to cause cancer or birth defects or other reproductive harm is reasonably calculated to occur at a level that requires a warning."

The Proposed Rule also modifies the definition for "sign" to clarify that a sign can include shelf signs and must be conspicuous by being "clearly visible under all lighting conditions normally encountered during business hours."

Responsibility to Provide Consumer Product Exposure Warnings (Section 25600.2)

The Proposed Rule's Section 25600.2 is not in the existing regulations but was proposed in January 2015, with some revisions. This section sets forth the circumstances under which the manufacturer, producer, packager, importer, or distributor has primary responsibility for providing the warning, and the more limited circumstances when the retailer is responsible for providing the warning. Specifically, proposed Section 25600.2 is intended to clarify that the primary responsibility for providing warnings for consumer products, including foods, is with the manufacturer, importer, distributor, producer, or packager of those products. Retail sellers would only be responsible for providing warnings when specific conditions are satisfied, for example, when the retailer seller is selling the product under a brand or trademark that is owned or licensed by the retail seller, or when the retail seller has "actual knowledge" of the potential consumer product exposure and there is no manufacturer, importer, distributor, producer, or packager to comply with the warning requirements.

The Proposed Rule clarifies that such a manufacturer, importer, distributor, producer, or packager is one who is not a "person in the course of doing business" in California, does not have a designated agent for service of process in California, and does not have a place of business in California. The Proposed Rule also modifies the definition of "actual knowledge" to clarify that the notice provided "must provide a description of the product with sufficient specificity for the retail seller to readily identify the product."

Another difference between the Proposed Rule and the January 2015 proposed rule regards the circumstances under which the manufacturer, importer, distributor, producer, or packager provides written notice to a retail seller of its warning requirements. The January 2015 proposed rule would have required the manufacturer, importer, distributor, producer, or packager to ensure that the notice had been received and acknowledged in writing by the retailer and that the acknowledgement is renewed at least every 180 days during the period in which the product is sold in California by the retailer. Under the Proposed Rule, OEHHA has modified this requirement so that the renewal is at least every 180 days for the first year after the effective date of the regulation, and then annually during the period in which the product is sold in California by the retailer. An additional notice is required within 90 days if a new chemical name or endpoint (i.e., cancer or reproductive toxicity) is required to be included in the warning.

Safe Harbor Clear and Reasonable Warnings -- Methods and Content (Section 25601)

Section 25601 in the Proposed Rule is similar to the January 2015 proposed rule as it states that a warning is considered "clear and reasonable" when it complies with all applicable requirements of this Article.

A major change in the Proposed Rule is in the new Section 25601(c), which states:

Except as provided in Section 25603(c), a warning meets the requirements of this article if the name of one or more of the listed chemicals for which the warning is being provided is included in the text of the warning, to the extent that an exposure to that chemical or chemicals is at a level that requires a warning.

This is a significant change from the existing regulations that do not require identification of any chemical, and a significant departure from the January 2015 proposed rule, that would have required disclosure only for 12 specific chemicals. OEHHA states it proposed this change based on the results of the UC Davis Survey, which found that "66% of the people surveyed selected the sign with the specific chemical names as being more helpful than the sign that generally referred to chemicals." ISOR page 23. OEHHA states that if a business is already providing a warning for a listed chemical, the identity of that chemical should be known. OEHHA further states that if "the warning is being provided with no knowledge of exposure to a listed chemical, then no warning is required and 'over-warning' is occurring." Id. This proposed requirement is striking in that it includes all listed Prop 65 substances, not specific substances selected based on certain criteria (e.g., widespread prevalence, potential for significant exposure, recent enforcement activity). The requirement also will impact companies that have been complying with Prop 65 requirements when it suspects a warning is required but may not have all the information it needs to specifically list a substance.

Consumer Product Exposure Warnings -- Methods of Transmission (Section 25602)

Prop 65 regulations currently provide several methods of transmission for warning messages, including signs, notices, stickers, or labels. The Proposed Rule expands (as did the Pre-Regulatory Proposal and the January 2015 proposed rule) the list of acceptable methods for providing a warning for an exposure to a listed chemical from a product to incorporate warnings via electronic means. The specific listed methods of transmission, and additional changes in the Proposed Rule, are:

  • Shelf Tag or Shelf Sign: A product-specific warning provided on a shelf tag or on a shelf sign for the consumer product at each point of display of the product. The entire warning message must be in a type size no smaller than one half the largest type size used for other information on the shelf tag or shelf sign for the same or similar consumer products. The Proposed Rule additionally specifies that in no case shall the warning appear in a type size smaller than 8-point type.
     
  • Electronic Device or Process: A product-specific warning provided via any electronic device or process that automatically provides the warning to the purchaser prior to or during the purchase of the product, without requiring the purchaser to seek out the warning.
     
  • Label: A label on the product that includes all the elements specified in Section 25603(a). The Proposed Rule additionally specifies that the "warning must be in a type size no smaller than the largest type size used for other consumer information on the product. In no case shall the warning appear in a type size smaller than 8-point type."
     
  • Short Version On-Product Label: For on-product label that complies with the content requirements in Section 25603(b), the Proposed Rule specifies that the entire warning must be in a type size no smaller than the largest type size used for other consumer information on the product, and in no case shall the warning appear in a type size smaller than 6-point type.
     
  • Internet Purchases: For internet purchases, the warning message must be provided by a clearly marked hyperlink on the product display page, or otherwise prominently displayed to the purchaser before the purchaser completes his or her purchase of the product. The Proposed Rule adds that the warning must use the word "WARNING" on the product display page, and that the warning must be in a type size no smaller than the largest type size used for other consumer information on the page.
     
  • Catalog Purchases: For catalog purchases, the warning message must be provided in the catalog in a manner that clearly associates it with the item being purchased. The Proposed Rule additionally requires that the entire warning must be in a type size no smaller than the largest type size used for other consumer information in the catalog for the same or similar consumer products.

Consumer Product Exposure Warnings -- Content (Section 25603)

Some of the most significant proposed revisions from the January 2015 proposed rule are retained in the Proposed Rule regarding the mandatory elements required for a warning to be considered "clear and reasonable."

  • Warning Symbol: The Proposed Rule requires the inclusion of a warning symbol, consisting of a black exclamation point in a yellow equilateral triangle with a bold black outline:
    OEHHA states that while some commenters had voiced concern that this warning symbol was "confusing, alarming, and meaningless," the UC Davis Survey results indicated that "[f]ew people expressed confusion or fear when viewing the symbol." ISOR page 28.
     
  • "WARNING" Signal Word: As in the Pre-Regulatory Proposal and the January 2015 proposed rule, the Proposed Rule would require that the signal word "WARNING" appear in all capital letters and bold print.
     
  • "Can Expose": As in the January 2015 proposed rule, the Proposed Rule would require a change in the test of the warning to state "This product can expose you to [name of one or more chemicals], a chemical known to the State of California to cause [cancer or birth defects or other reproductive harm]. For more information go to www.P65Warnings.ca.gov/product." (emphasis added). In the ISOR (page 29), OEHHA states the following regarding this requirement (emphasis in original):
    Some stakeholders have objected to the use of the word "expose" in product warnings because they are concerned that it will cause unnecessary alarm and because they allege that an exposure may not actually occur. These concerns are anecdotal and are contrary to the data generated in the UC Davis Warnings Regulations Study. Further, Proposition 65 is a right-to-know law. The purpose of the statute is to provide people with notice concerning their exposures to listed chemicals.
  • On-Product Labels: The Proposed Rule retains the ability for businesses to use a more truncated warning on product labels "to accommodate some product manufacturers' stated concern that a longer warning message will simply not fit on the labeling or packaging of some small products." ISOR page 31. Under this method, the warning must use the "WARNING" symbol and website reference noted above, but with only the words "Cancer," "Reproductive Harm," or "Cancer and Reproductive Harm," depending on the reason the chemical(s) requires a warning. Of particular significance, the Proposed Rule states that businesses providing a warning under this requirement do not need to name the Prop 65-listed chemical. While the January 2015 proposed rule also included this exception, that proposal only affected the 12 chemicals requiring disclosure, while this exception is arguably broader since it applies to all warnings.
     
  • Uniform Resource Locator (URL): The Proposed Rule, as with the January 2015 proposed rule, would require the inclusion of a URL in all warnings so that the information on OEHHA's website can be accessed by consumers. OEHHA notes that the UC Davis Survey found that over half of the study participants stated they were "very likely" or "somewhat likely" to visit the website. ISOR page 31. OEHHA further states: "OEHHA believes that this approach will allow businesses to continue to provide a short warning message that complies with the Act, while pointing interested persons to a location where they can obtain more information." Id.

Environmental Exposure Warnings -- Methods of Transmission and Content (Sections 25604 and 25605)

In the Proposed Rule, as with the January 2015 proposed rule, OEHHA generally retains the same requirements for the methods of transmission for environmental exposure warnings, with some updates to reflect changes in technology. With regard to the ability to provide a warning in a newspaper at least once every three months, OEHHA clarifies that that this requirement is "not intended to refer to general-circulation newspapers with a state-wide or national audience in English or other languages," but rather to "refer to local and regional newspapers that serve the affected area, including local and regional foreign language newspapers where the affected area contains a significant number of non-English speaking households." ISOR at 32.

OEHHA is proposing the same changes to the content of environmental exposure warnings to those proposed for product exposure warnings (e.g., symbol, "WARNING," "can expose," OEHHA website reference).

Occupational Exposure Warnings (Section 25606)

The Proposed Rule warnings regarding the methods of transmission and content for occupational warnings is the same as that set forth in the Pre-Regulatory Proposal and the January 2015 proposed rule.

Specific Product, Chemical and Area Exposure Warnings (Section 25607)

Proposed Sections 25607 through 25608.29 provide tailored methods for transmission of warnings and warning language for the following products, chemicals, and area exposures:

  • Food (including dietary supplements);
     
  • Alcoholic beverages;
     
  • Food and non-alcoholic beverages in restaurants;
     
  • Prescription drugs;
     
  • Dental care and emergency medical care (emergency medical care new in Proposed Rule);
     
  • Raw wood;
     
  • Furniture;
     
  • Diesel engines;
     
  • Passenger vehicles or off-road vehicles (off-road vehicles new in Proposed Rule);
     
  • Recreational vessels (new in Proposed Rule);
     
  • Parking garages;
     
  • Amusement parks;
     
  • Petroleum products;
     
  • Service stations and vehicle-repair facilities; and
     
  • Designated smoking areas.

Commentary

Although OEHHA formally withdrew its January 2015 proposed rule, OEHHA has retained many provisions from that rule in its current Proposed Rule. There were significant comments submitted with regard to several of these provisions, including the warning symbol, the change in warning language from "will expose" to "can expose," and the OEHHA URL. The fact that OEHHA commissioned the UC Davis Survey to assess the impact of these changes, and that OEHHA stated in the ISOR that the survey results seemingly support such changes, indicate that these provisions are likely to remain in this and any future proposals.

Although OEHHA has eliminated the disclosure of the chemical identity for the 12 specific substances, the Proposed Rule now includes an important new requirement that all warnings identify at least one Prop 65-listed chemical, unless the short form on-product label criteria are satisfied. OEHHA does not provide examples of acceptable means by which to identify at least one chemical, and there may be some confusion to be addressed regarding the exact language by which chemical(s) are identified specifically. What OEHHA refers to as "over-warning" (warning being provided with no knowledge of exposure to a listed chemical, then no warning is required) is sometimes a pro-active or protective measure taken by companies that are not capable of confirming the presence of chemicals, particularly when there is no safe harbor level below which warnings are not required.

Companies should review carefully the proposal and how the significant changes to the warning requirements will affect its cost and compliance capabilities. Comments should be submitted by January 22, 2016.


 
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