USA – CALIFORNIA Trends and Developments Contributed by: Anne Marie Ellis, Marissa Alkhazov, Steven Di Saia and Christopher Van Gundy, Buchalter, LLP
controls or personal protective equipment (PPE) actu - ally prevent disease. That claim is debatable, but it cannot be debated that poor working conditions can cause genuine harm. The regulatory landscape OSHA’s 2016 Respirable Crystalline Silica Standard set a PEL with provisions for exposure assessment, medical monitoring, and recommended controls. Higher and more strict standards have been written and proposed in multiple arenas, including of course California. Plaintiffs counter that the standards are poorly enforced and that the focus on PPE and engi - neering controls cannot establish a safe exposure level. The tension between existing and proposed regulation and plaintiffs’ claims that the regulation is inadequate mirrors what is seen in other sectors: a regulatory framework exists, but the plaintiffs’ bar treats it as a floor, not a ceiling, and litigates the gap. The numbers California, predictably, is the epicentre. Roughly 550 silicosis cases have been filed in the state, most con - solidated into a Coordinated Proceeding in Los Ange - les County Superior Court covering matters from the San Francisco, Los Angeles, San Diego, and Orange County courts. With an estimated 1,300-plus fabrica - tion shops in California, and workers who have moved between multiple shops over decades, the pipeline of new filings shows no sign of slowing. The defendant pool is strikingly broad. Plaintiffs have named manufacturers of artificial and natural stone (domestic and international), wholesale distributors, big-box retailers, local and regional retailers, interior designers, and even manufacturers of the tools and PPE used in fabrication. A typical case names around 50 defendants, many of whom appear in nearly every filing. For those outside California who may take comfort in these numbers, such comfort may be misplaced. Cases have been filed in Oregon, Washington, and Nevada, with smaller numbers in other states. Those filings will grow. Plaintiffs have framed silicosis as an “epidemic” spe - cific to stone fabrication, arguing that engineered
stone products are fundamentally defective. Whether that characterisation withstands scrutiny is debated. That the litigation itself has become epidemic is not. The Modernization of Cosmetics Regulation Act: Cosmetics Regulation Without a Rulebook If the heavy metals discussion above illustrates how regulatory gaps create dual-track enforcement risk, the Modernization of Cosmetics Regulation Act (MoCRA) demonstrates something arguably worse: a single regulator building an entire oversight regime while leaving the most consequential scientific ques - tions unanswered. MoCRA provided the FDA oversight authority over the cosmetics and personal care industry for the first time, including facility registration, product listing, adverse event reporting, records access, and recall power. The FDA has yet to outline the scientific and technical benchmarks necessary to operationalise these tools. The result is a system where companies must build testing, substantiation, and documentation frame - works that can withstand scrutiny in an environment where the rules are still being written, and where regu - latory ambiguity itself has become a primary source of risk and possible litigation. Talc and asbestos This disconnect is apparent in the agency’s handling of talc and asbestos risk. Although MoCRA directed the FDA to establish standardised testing methods for asbestos in talc-containing cosmetics, the agency withdrew its proposed rule in late 2025, citing method - ological limitations and lack of consensus. The result is a regulatory minefield wherein companies remain responsible for ensuring product safety, but no uni - form federal testing standard (or ban) exists to define what “asbestos-free” means. This places the burden squarely on manufacturers to adopt defensible test - ing protocols, while simultaneously exposing those protocols to challenge in both regulatory and litigation contexts. The testing-as-defence problem described for heavy metals in food exists here in an even more acute form, because at least in food, the FDA has begun publishing action levels or toxicological refer - ence values. In talc, there is nothing.
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