Cal Biz Lit

Proposition 65 Compliance is Often Not About What Chemicals a Product Contains

A lot of our posts on this blog are about changes in the law, recent happenings in litigation, or conclusions we draw from looking at litigation activity. This post is different in that it is focused on explaining a concept that is and has been important for Proposition 65 compliance since the law and its enacting regulations first took effect.
Proposition 65 compliance and enforcement is often discussed in terms of whether a product contains a listed chemical, but chemical content is not what Proposition 65 requires a warning for. Proposition 65 requires a warning for exposures to listed chemicals. Some products that do not contain a listed chemical will require a warning because people using the products will be exposed to a listed chemical when the product is used as intended. Conversely, some products that contain a listed chemical do not require a warning because people are not exposed to the chemical the product contains. Wood dust is a listed chemical and provides a good way to illustrate this distinction. A wood table necessarily contains wood dust, but a wood table would not require a Proposition 65 warning for wood dust. By contrast, in a case brought by California’s attorney general, People of the State of California v. Ace Hardware Corporation, San Francisco Superior Court Case No. 995893, makers and sellers of saws were required to provide a warning for wood dust, despite the fact saws do not contain wood dust. No warning is required for the table that contains wood dust because users of the tables sitting and eating at it are not exposed to wood dust. A warning is required for the saw because a saw is used to cut wood, exposing the user to wood dust. That said, there are some products where the mere fact that the product contains a listed chemical is enough to know that an exposure is taking place. The types of products that most often would fit this category are food products. If the bread contains the listed chemical acrylamide, consumer are going to be exposed to acrylamide because they ingest the bread.
So what does the fact that mere presence of the chemical is not enough to require a warning mean in a practical sense? It means that determining whether a product is in compliance, or whether allegations of a violation of Proposition 65 are defensible, requires more than just a test from a commercial lab for the presence of a listed chemical. Yes, in the vast majority of instances a lab test for the listed chemical is the place to start. But the ultimate question that must be answered is does use of the product result in an exposure to the listed chemical? Is the listed chemical contained in the product in such a way that the user would come into contact with the listed chemical when using the product, or does use of the product create an exposure to a listed chemical when it is used as intended with certain other material? When the alleged exposure is to a chemical contained within the product, the discussion is put in terms of whether the listed chemical is “accessible.” If it is ultimately determined that the chemical is accessible, and an exposure results, then it becomes a question of how much of an exposure. Proposition 65 puts the burden of establishing that the exposure is below a level for which a warning is required on the party defending the claim. Generally, if you get to the question of how much of an exposure occurs, that usually means that the claim will have to be litigated, or a settlement paid out to dispose of it, along with an agreement to reformulate the product or provide a warning going forward. Whether to defend or settle a claim is a business decision that is informed by the advice of counsel, and heavily influenced by the reasonableness of the enforcer bringing the claim.

Acrylamide, Further Proposition 65 Drama

As was discussed in Ahead of the Curve, here (https://scalirasmussen.com/news/2021/05/13/court-orders-cessation-of-enforcement-of-acrylamide-related-cases) and here (https://scalirasmussen.com/news/2021/08/06/update-on-proposition-65-cases-concerning-acrylamide) acrylamide, a chemical that results from roasting or cooking foods, has become perhaps the most visibly and highly litigated chemical in Proposition 65. This attention dates back to the litigation involving coffee roasters and retailers, and has since then primarily carried by the California Chamber of Commerce (see those articles noted above).

Much like glyphosate, discussed recently in Cal Biz Lit, the defendants in cases concerning acrylamide are objecting that requiring warnings are a violation of their First Amendment Rights, in that it would require them to state that the chemical in their product increases the risk of cancer, something they vehemently deny.
A further objection to the requirement of Proposition warnings has been that certain safe food products cannot be made without the development of acrylamide. In order to address that issue, last fall OEHHA published proposed “safe harbor” limits setting forth acrylamide levels specific to different prepared foods, below which a Proposition 65 warning would not be required.

Those proposed levels are applicable, inter alia, to almond butter, as well as roasted and chocolate almonds; bread, including rolls, buns and baguettes; cookies (differentiating between animal, thin, crackers and sandwich wafers); potato products (hash browns, sweet potatoes, potato puffs and french fries); prune juice and waffles.

While there has not been a noted opposition to the proposed Regulation, they have not as yet been enacted.
In the meantime, OEHHA has proposed new Warning language for those products that contain acrylamide that do exceed the proposed chemical levels. That new Section, subsection (b) to Section 25607.2 of the OEHHA regulations, would state as follows:

"b) A warning for food exposures to acrylamide meets the requirements of this subarticle if it is provided: (i) in accordance with subsection (a), or, (ii) via one or more of the methods specified in Section 25607.1 and includes both elements (1) and (2) below.
(1) The words 'CALIFORNIA WARNING:' in all capital letters and bold print.
(2) The words, “Consuming this product can expose you to acrylamide, a probable human carcinogen formed in some foods during cooking or processing at high temperatures. Many factors affect your cancer risk, including the frequency and amount of the chemical consumed. For more information including ways to reduce your exposure, see www.P65Warnings.ca.gov/acrylamide."
Readers of this blog will note that, as with glyphosate, OEHHA is trying to avoid objections the required warnings results in a First Amendment conflict.

The public comment period for the proposed Regulation as to acrylamide is open until November 8th; the public comment period for the proposed glyphosate has just closed. We will keep you apprised as new warnings regulations come into effect.

Glyphosate In the Trial Courts – Liability for Failure to Warn, Cancer Causation

As noted in CalBizLit on September 22nd, Proposition 65 warning requirements regarding the chemical glyphosate are currently being litigated. As it happens, aside from Proposition 65, glyphosate is also a subject of civil litigation, and is also in signficant dispute in that realm.
Let’s take a moment to be clear, because this is not actually universally understood: A company can be liable for a violation of Proposition 65 without any allegation (let alone proof) that anyone was injured as a result of that product’s sale or use in California. If Californians have been exposed to a potentially cancer causing or reproduction injury-inducing chemical without providing warning to California citizens, there is potential liability.
In contrast, liability under products liability theories in civil litigation requires that there be a finding that the given chemical not only was a potential cause of injury, but rather that it actually did cause (was “a substantial factor” in causing) an injury to the Plaintiff (or their decedent.)
The contrast between the two theories of liability is currently well illustrated when considering glyphosate. As noted in the September 22, 2021 edition of CalBizLit, there is a Court Order coming from the US District Court holding that the maker or user of glyphosate cannot be found liable under Proposition 65 for failure to have warnings about cancer risks on their products. The rationale is that it is a violation of the First Amendment to require such a warning because there is a substantial dispute in the scientific literature as to whether the product is actually a cancer causing substance.
In contrast, Bayer, the current manufacturer of the pesticide Round Up, which includes glyphosate as an active ingredient, is facing substantial civil liability. Most recently, the California Court of Appeals upheld a verdict that was rendered in 2019 favor of the Pilliod family. The husband and wife both claimed use of Round Up had caused them to develop non-Hodgkin’s Lymphoma. The jury had awarded them a total of $55 million in general damages, and $2 billion in punitive damages. The trial court reduced that number of $81 million total, including punitive damages, and the Pilliods agreed to accept that amount.
Bayer did not agree to even the reduced damages. In upholding the Judgment the Court of Appeals specifically approved the punitive damages by noting “Monsanto’s conduct evidenced reckless disregard of the health and safety of unsuspecting consumers it kept in the dark”.
Quite a contrast with a finding that companies that use glyphosate cannot be forced to put a Proposition 65 warning on the product. And this verdict is not an isolated one:: Bayer has paid out some 411 billion to settle cases pending against it for damages allegedly result in from glyphosate exposure. Bayer is, however, pursuing in the US Supreme Court a preemption defense based on 7 U.S.C. § 136 et seq., which requires that prior to distributing a pesticide in commerce, a manufacturer must register the pesticide with the United States Environmental Protection Agency (USEPA) by submitting scientific data regarding efficacy and health and environmental impacts, as well as proposed product labeling.