There are high-stakes changes on the horizon for the well-known California regulation that will likely and more deeply impact food packaging and food packagers.
Most United States citizens even outside of California are aware at least in a general sense of that state’s Proposition 65 regulation from warnings and cautions on the labels of many common products that states “WARNING: This product contains chemicals known to the State of California to cause cancer and birth defects and other reproductive harm.”
Although the label warning now seems ubiquitous when used across such a diverse range of consumer products, it can still give users pause before buying or continuing use of a product.
There are forthcoming changes to the regulation that will more strongly impact food packaging, which is the topic that’s part of an upcoming conference session during WestPack 2018 (February 6-8, Anaheim, CA). Presenter Mitzi Ng Clark, partner, Keller and Heckman LLP, provides an executive summary of her talk in this exclusive Packaging Digest Q&A.
What’s the backdrop to the regulation relative to food packaging?
Clark: When it comes to packaging, California’s Proposition 65, formally known as the Safe Drinking Water and Toxic Enforcement Act of 1986, is one of the state’s most well-known regulations. The law requires California to publish a list of chemicals “known to the State to cause cancer or reproductive toxicity” and prohibits a company from knowingly exposing any individual to a listed chemical without first providing a “clear and reasonable warning” to such individual unless the exposure is below a "safe harbor"—that is, a no significant risk level (NSRL) for a carcinogen or a Maximum Allowable Dose Level (MADL) for a reproductive toxicant. There is the potential for Proposition 65 enforcement to affect packaging materials due to the presence of bisphenol-a, lead, acrylamide, styrene, polycyclic aromatic hydrocarbons, vinyl chloride and other listed chemicals that may be present in packaging materials.
What’s upcoming that packaging professionals should know about?
Clark: New regulations on Clear and Reasonable Warnings becomes effective this year on August 30. The most significant change is a revision of the warning language to define “clear and reasonable” that requires the identification of at least one carcinogen and at least one reproductive toxicant present in the given product and refer consumers to a Lead Agency Website for additional information. Unlike the existing warning regulations, the new regulations present the possibility of manufacturers to face liability even when a warning is provided because there is, arguably, a lot of potential for error.
What about the impending changes is surprising or worth pointing out?
Clark: Perhaps the most interesting aspect of Proposition 65 is its enforcement. Any private individual can enforce Proposition 65. Even if you have a scientifically sound, conservative assessment to support the conclusion that no warning is necessary, the plaintiff need not accept any of your reasonable assumptions—and you may still end up paying damages. In other words, having a sound compliance narrative does not necessarily protect companies from liability. It’s important for companies to understand their Proposition 65 liability, how to assess that liability and how to interpret the regulations. The stakes are high—out of 333 judgments in 2017, total penalties amounted to more than $167 million. Given that California represents the sixth largest economy in the world, it is hard to deny the reach of the law to all businesses, even if not located in the state.
Mitzi Ng Clark will touch on key aspects of Proposition 65 and how it impacts the food packaging industry in her presentation at WestPack 2018 on Thurs., Feb. 8, 1:30 p.m. - 2:15 p.m. You will find more information about the tradeshow and the on-site packaging conference through the WestPack 2018 website.