United States: Are You Ready For The New California Prop 65 Warning Requirements?

Last Updated: May 26 2017
Article by Karen F. Lederer and Eric L. Unis

Last year, the California Office of Environmental Health Hazard Assessment (OEHHA) issued new regulations under California Proposition 65 concerning the exposure warnings required for consumer products. While the new regulations will not be fully effective until August 30, 2018, businesses should be readying their new warnings now.

California Proposition 65

By way of background, Prop 65, officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986, was enacted as a ballot initiative in November 1986. It is codified at Health and Safety Code Section 25249.5 – 25249.13 and is administered by OEHHA. The heart of Prop 65 states: "No person in the course of doing business shall knowingly or intentionally expose an individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving a clear and reasonable warning to such individual, except as provided in Section 25249.10." The list of chemicals so known to the state currently runs 800 chemicals long and contains chemicals, additives and ingredients present in many common household and office products.

Prop 65 is concerned with all types of exposures: environmental, occupational, and from consumer products. In the consumer products context, this means that the warning must be visible to consumers prior to purchase.

Exposure may occur via dermal absorption, inhalation, direct mouthing, direct ingestion, or hand-to-mouth pathway.

Prop 65 applies to all businesses with 10 or more employees. There are two sets of implementing regulations: those issued by OEHHA and those concerning private enforcement of Prop 65, which are issued by the California Attorney General's Office.

The exemptions from the warning requirement, stated in Section 25249.10, are as follows: (1) in the case of carcinogens, no warning is required if it can be proven that "no significant risk" is presented by the exposure, meaning that the level of exposure does not exceed the level that would result in not more than one excess case of cancer in 100,000 individuals exposed to the chemical over a 70-year lifetime; and (2) in the case of reproductive toxicants, no warning is required if it can be proven that there is "no observable effect" on birth defects posed to humans or laboratory animals at 1,000 times the level of exposure.em

OEHHA has provided Safe Harbor levels for many of the listed chemicals. Exposure levels that are at or below the Safe Harbor levels are exempt from Prop 65.1 For chemicals for which there is no Safe Harbor, it is up to the business to prove that the level of exposure falls within the applicable exemption formula unless the warning is provided. And that explains why Prop 65 warnings are ubiquitous in California.

Actions for violating Prop 65 may be brought by the Attorney General, by certain other municipal officials, or by individuals -- so called citizen enforcers -- acting in the public interest. This has led to the growth of a cottage industry consisting of a small group of organizations and lawyers who, working with scientists, labs and other investigators to substantiate their claims, bring most of the Prop 65 cases.

The civil penalty for violation is up to $2,500 per day per violation, with the plaintiff being entitled to keep 25% and the remaining 75% going to the California Department of Toxic Substances Control. Successful plaintiffs may also recover their reasonable attorneys' fees and costs.

Almost without exception, Prop 65 cases settle, and settlement agreements often establish a Safe Harbor level for the defendant's product going forward. The Attorney General must be given notice of all settlements. For businesses that distribute a similar product but who were not parties to the settlement agreement, the Attorney General has stated that: "Voluntary compliance with the terms of an existing settlement (e.g., providing specified warnings, or reformulating a product to the agreed-upon specifications) may or may not afford some protection against Proposition 65 litigation, or against penalties in the event of litigation." But, at a minimum, earlier settlements covering a similar product are an efficient means of structuring a settlement. Particularly relevant to the new regulations, a party to a court-ordered settlement establishing the language of the warning and the method of transmission may continue to comply with those terms

The New Warning Requirements

The new regulations, applicable to consumer products manufactured on or after August 30, 2018, significantly modify the warning language required for a consumer product exposure, provide clearer guidance on how to transmit the warning, and provide many retailers with welcome relief from compliance obligations.2

California consumers are accustomed to seeing products labeled with a warning such as "This product contains a chemical known to the State of California to cause cancer and birth defects or other reproductive harm." Under the new regulations such a warning will no longer be considered "clear and reasonable."

The new warnings must include:

  • The name of at least one chemical in the product for each type of exposure (carcinogen or reproductive toxicant)
  • A warning symbol in yellow

  • The word "WARNING" in all capital letters and bold print
  • For products causing exposure to listed carcinogens, the statement: "This product can expose you to chemicals including [name one or more chemicals], which is [are] known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov."
  • For products causing exposure to listed reproductive toxicants, the statement: "This product can expose you to chemicals including [name one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov."
  • For products causing exposure to both carcinogens and reproductive toxicants, the statement: "This product can expose you to chemicals including [name one or more chemicals], which is [are] known to the State of California to cause cancer, and [name one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov."

A manufacturer, producer, packager, importer, supplier, or distributor may provide the warning by affixing it to the product or its packaging, or by providing notice and warning materials (such as labels, labeling, shelf signs, tags, or warning language for products sold on the Internet) to a retailer's "authorized agent" for the retailer to display.

A truncated warning may be used if the warning is an "on-product warning." The term "on-product warning" is not defined in the regulations but according to OEHHA guidance, an on-product warning would include one on "the immediate container (box, packaging) or wrapper for the product." It would not include a warning on other types of labeling, such as written printed, graphic, or electronically provided communications that accompany a product including tags at the point of sale or display of a product. For on-product warnings, the warning will be "clear and reasonable" if it consists of the yellow triangular warning symbol, the word "WARNING" in all capital letters and bold print, and, as appropriate depending on the chemicals in the product, (i) "Cancer - www.P65Warnings.ca.gov."; (ii) Reproductive Harm - www.P65Warnings.ca.gov."; or (iii) "Cancer and Reproductive Harm - www.P65Warnings.ca.gov."

For internet sales, the complete warning must be provided (i) on the product display page by displaying either the complete warning or a clearly marked hyperlink labeled "WARNING" that links to the complete warning, or (ii) by otherwise prominently displaying the warning to the purchaser prior to completing the purchase. A warning is not sufficient if the purchaser must search for it in the general content of the website, as has been a common practice.

For catalog sales, the warning must be provided in a manner that clearly associates the warning with the item being sold.

With respect to both internet and catalog sales, if an on-product warning is provided with the product, the warning provided on the website or catalog may use the same truncated content as the on-product warning.

In the case of the following products, the new regulations prescribe the specific language and method of transmission of the warning in lieu of the general requirements discussed above:

  • Food
  • Alcoholic beverages
  • Prescription drugs
  • Dental care
  • Raw wood products
  • Furniture
  • Diesel engines
  • Vehicles
  • Recreational vessels
  • Petroleum products
  • Bisphenol A exposures from canned and bottled food and beverages.

The new regulations will relieve retailers from the responsibility of providing a Prop 65 warning if certain criteria are met. Retailers have often been caught up in the broad scope of Prop 65, which until now said little about who exactly needs to provide the warning. Retailers will no longer have to provide the warning unless (a) the retailer is selling the product under a brand or trademark that is owned or licensed by the retailer or an affiliated entity; (b) the retailer has knowingly introduced a listed chemical into the product, or knowingly caused a listed chemical to be created in the product; (c) the retailer has covered, obscured or altered a warning label that has been affixed to the product; (d) the retailer has received a notice and warning materials from the manufacturer, producer, packager, importer, supplier, or distributor and the retailer has sold the product without conspicuously posting or displaying the warning; or (e) the retail seller has actual knowledge of a potential consumer product exposure requiring a warning and there is no manufacturer, producer, packager, importer, supplier or distributor who (1) meets the definition of a "person in the course of doing business," and (2) has a designated agent for service of process in California or has a place of business in California.

THE TROUTMAN TAKEAWAY: The most significant change made by the new regulations is that Prop 65 warnings will now need to identify at least one Prop 65 chemical by name and state that the product can "expose" the consumer to the chemical (unless the truncated warning allowed to be placed on products is used). No longer will the common generic warnings that a product "contains" an unidentified Prop 65 chemical be sufficient. It is advisable to consult with a laboratory that has expertise in Prop 65 so that any Prop 65 chemicals can be identified and any necessary Prop 65 warning can be fashioned in advance of the new regulations becoming effective.

Footnotes

[1] A business or trade group may request a Safe Use Determination (SUD) from OEHHA, which determines whether an exposure resulting from the average use of a specific product is at or below the Safe Harbor level.

[2] The new regulations define "consumer product" as "any article, or component part thereof, including food, that is produced, distributed, or sold for the personal use, consumption or enjoyment of a consumer." A "consumer product exposure" is defined as "an exposure that results from a person's acquisition, purchase, storage, consumption, or any reasonably foreseeable use of a consumer product, including consumption of a food."

The new regulations also amend certain requirements relating to environmental and occupational exposures.

Until August 30, 2018, a business may comply with either the existing or the new regulations.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Authors
Karen F. Lederer
Eric L. Unis
 
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