Airborne TiO2 Of Respirable Size? Litigation Goes On Under Prop 65

In an ongoing Prop 65 case targeting sun-protection and powder-cosmetics manufacturers, the Public Interest Alliance maintains it has demonstrated likely exposure to titanium dioxide particles that are airborne, unbound and of respirable size, as characterized by the Prop 65 listing. However, defendants argue the plaintiff must conduct air-monitor testing to prove that all products named in the suit contain particles of that form, with associated exposure risks.

In ongoing Prop 65 litigation, litigants are debating whether the plaintiff has met the required burden of proof to link manufacturers of titanium-dioxide containing cosmetics to the listed ingredient form – i.e., “airborne, unbound particles of respirable size.”

Jeffrey Margulies, a partner at law firm Norton Rose Fulbright who represents companies in Prop 65 cases, and Jeffrey Judd, managing partner at the Judd Law Group and plaintiff’s counsel in the TiO2 litigation, spoke recently with “The Rose Sheet” about the case being waged in a California superior court.

Titanium dioxide is used in various personal-care products as a sunscreen active, as well as a coloring or opacifying agent. The ingredient – in formats consisting of airborne, unbound particles of respirable size – was placed on the Prop 65 list of chemicals “known to cause cancer” in September 2011 after the International Agency for Cancer Research concluded that an association between TiO2 exposure and cancer is possible (Also see "IARC Finds TiO2 Possibly Carcinogenic, Setting Stage For Prop 65 Action" - HBW Insight, 24 Jan, 2011.).

In fall 2013, following a one-year grace period for affected marketers to come into compliance, the Public Interest Alliance LLC sued nearly 100 manufacturers of powder cosmetics and sun-protection products formulated with TiO2 that allegedly had not provided proper warning to California consumers. Those defendants include L’Oreal SA, the Estee Lauder Companies and Revlon.

The specificity of the TiO2 listing under Prop 65 marks the case as an atypical one with the potential to establish significant precedent.

“In typical cases, a plaintiff need only perform a simple chemical analysis on a sample of a product, and if the analysis shows a ‘hit,’ the burden is met. But TiO2 is not a typical substance because of the physical characteristics that must be present, which requires a far more expensive type of sampling and testing.” – Plaintiff’s counsel Jeffrey Judd

California’s Safe Drinking Water and Toxic Enforcement Act, or Proposition 65, requires manufacturers to disclose to consumers the presence of chemicals identified by the state as posing potential carcinogenic or reproductive toxicity risks when exposure levels exceed limits set by the Office of Environmental Health Hazard Assessment.

The basic structure of all Prop 65 litigation is a two-step process. A plaintiff wanting to prove liability must test a sample of a product and establish that it contains a “detectable amount” of a listed chemical and that it is “more likely than not” that consumers are exposed to the chemical, Judd noted in a July 18 email.

Once a plaintiff has illustrated that, a defendant has the opportunity to show that the exposure to the substance is insignificant, as demonstrated by a quantitative risk assessment, according to the Public Interest Alliance’s attorney.

The pending TiO2 case is thornier than others under the law because it hinges on a narrow characterization of the substance of concern and a specific exposure scenario outside the realm of conventional absorption models.

Judd noted that “no powder cosmetic or personal care product ‘contains’ airborne, unbound particles of TiO2.” Rather, “the process of using/applying the powders releases TiO2 particles into the air.”

According to Judd, to proceed with the suit the Public Interest Alliance must present a prima-facie case demonstrating that it is more likely than not that use of the defendants’ various cosmetic and personal-care products exposes consumers to some airborne, unbound TiO2 particles of respirable size.

He noted that the plaintiff “believes it has already met that burden,” having submitted evidence in the form of peer-reviewed studies and samples of selected products representative of the group, “employing generally accepted scientific methods and principles,” to support a case for likely exposure across the defendants’ product spectrum.

“The principle scientific study that PIA relies on demonstrates that this is the case, and that primary particles (i.e. single particles of TiO2), primary aggregates (i.e. ‘clumps’ of more than one particle of TiO2) and secondary aggregates (i.e. ‘clumps’ of particles comprised of TiO2 and other materials, like mica) – all include some respirable-sized particles and particle aggregates,” Judd said.

However, defendants in the case argue that testing must be performed on each product from every company named in the case to prove that their TiO2 content meets the particulars of the Prop 65 listing.

According to Margulies, there is no evidence currently that TiO2 of the form targeted under Prop 65 – particles that are airborne, unbound and of respirable size – is actually present in all of the products cited.

“There is dispute over whether plaintiffs should have to do testing with an air monitor before making that argument about a particular product” containing TiO2 particles, the attorney related. “Simply being present in the product as an ingredient doesn’t establish from our perspective that the substance is airborne,” he continued, adding: “This is a very live controversy.”

Plaintiffs Face Cost Constraints

Judd held that demanding testing for every TiO2 product marketed by the defendants is impractical and seeks to exploit the plaintiff’s limited resources.

“There are hundreds, perhaps thousands of these products,” he said. “Defendants are hoping they can persuade the court that this should proceed like a typical Prop 65 case. In typical cases, a plaintiff need only perform a simple chemical analysis on a sample of a product, and if the analysis shows a ‘hit,’ the burden is met. But TiO2 is not a typical substance because of the physical characteristics that must be present. … This requires a far more expensive type of sampling and testing.”

Instead of investing $200 to $300 in sample analysis as is typical, “entirely conclusive” testing of the sort called for by defendants would require air sampling, electron microscopy and chemical analysis, which could cost anywhere from $7,000 to $12,000 per sample, Judd said, adding: “This is a classic case of deep-pocketed defendants with unlimited resources using their financial depth to overwhelm a plaintiff who will likely win on the merits if it can stay in the game long enough.”

Five defendants in the case agreed to settle in May (Also see "TiO2-Containing Cosmetic Powders Subject Of Prop 65 Settlements" - HBW Insight, 9 Jun, 2014.). Under the terms of the agreement, Dr. Hauschka Skin Care Inc., Murad Inc., Tarte Inc., Melaleuca, Inc. and affiliated companies Allure Inc. and DermaQuest agreed to remove TiO2 from their products or provide warnings on products, and to pay attorneys’ fees and fines.

Reflecting on why those companies decided to settle in light of the argument fellow defendants are pursuing in the case, Margulies speculated: “It may be that companies that settled did not have the interest in the technical scientific aspect of the case and simply decided to settle rather than wait things out.”