The Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) is a California right-to-know law with a notoriously high enforcement rate. To comply, companies must provide “clear and reasonable warnings” on products containing substances known by the state of California to cause cancer or reproductive harm.

Because it is enforced entirely through litigation with no repercussions for inaccurate accusations, “bounty hunter” law firms are incentivized to file as many lawsuits as possible.

While some businesses selling into California call for “common-sense reforms” to scale back the enforcement mechanism, recent changes and proposed amendments to the regulation further complicate product sales. As a result, the number of lawsuits continues to increase.

Although companies are given a one-year grace period after updates to implement changes, this is a relatively tight timeline to create specialized packaging or other communications for products sold in a single region, or test product composition to verify ingredients.

To keep pace, companies must pay close attention to new or proposed changes.

Proposed Amendments to Clarify Proposition 65

In response to stakeholder comments, on January 31, 2020, California’s Office of Environmental Health Hazard Assessment (OEHHA) proposed several amendments to clarify ambiguous language in Article 6 of Proposition 65. Article 6 outlines requirements for content and transmission methods in addition to revised warning language. These amendments would make the following explicit:

  • Mobile device sales are included in current article 6 requirements for “internet sales.”
  • The option to provide warnings by way of an automatic electronic device or processes to warn purchasers before or during the purchase of a product applies only to “physical retail locations.”
  • Product-specific safe harbor warning provisions are applicable to all products subject to specific safe harbor warnings under Proposition 65.
  • Online or physical catalogs must contain product-specific warnings.
  • Product-specific warnings must be included in foreign language translations.
  • Product-specific warnings may be included under the existing regulation on catalog warnings.

Further warnings specifically speak to alcoholic beverages.

The OEHHA is currently accepting public comments on the proposed amendments until March 16, 2020.

Find out if your company is in-scope of Proposition 65 with our Proposition 65 Scoping Knowledge Article.

THC Added to Proposition 65 List

Effective January 3, 2020, the OEHHA has listed cannabis (marijuana), cannabis smoke and delta-9-tetrahydrocannabinol (THC) as reproductive toxicants on the constantly evolving list of Proposition 65 substances. Due to the one-year grace period to implement changes, enforcement will begin on January 3, 2021.

This action will likely impact companies that manufacture or sell cannabidiol (CBD) products, which tend to retain a percentage of THC during processing. While CBD products with a THC concentration of 0.3 percent or less are exempt from the definition of marijuana under the 2018 Farm Bill, this does not directly apply to Proposition 65, which does not recognize a safe harbor level. As a result, companies with any detectable THC could be exposed to risks under Proposition 65.

Lawsuits Filed Against Talc Manufacturers

On January 30, 2020, a Proposition 65 lawsuit was filed against more than a dozen major talc product manufacturers, alleging the producers knowingly exposed consumers to carcinogens and reproductive toxicants without appropriate warning for decades. Although talc is not a Proposition 65 substance, “talc containing asbestiform fibres” has been listed for 30 years.

The complaint also alleges that these talc products contained several other Proposition 65 substances — including arsenic (inorganic oxides), chromium (hexavalent compounds) and lead — and that the industry has taken steps to mislead the public and conceal the presence of these chemicals from consumers.

In cases like these, once a plaintiff detects even trace amounts of a chemical in a product, the burden of proof falls on the defendant to show that the chemical is not present or will not result in exposure. Fighting these claims can be arduous and expensive, leading most companies to settle.

How Assent Can Help

As the leader in supply chain data management technology, Assent Compliance can help you collect and organize the information you need to demonstrate due diligence in accordance with regulations such as Proposition 65. With better insight into the composition of your products, labelling becomes more straightforward and supporting evidence is available in case a complaint is filed. To learn more about how Assent can help you protect your business, contact our experts.

Dr. Bruce Jarnot
Regulatory & Sustainability Expert, Product Sustainability

Bruce is a board certified toxicologist with over 30 years of industry experience managing product safety and global materials compliance programs with large organizations,  Read More

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