In a win for the cosmetics and personal care products industry, a California court dismissed the Public Interest Alliance’s Proposition 65 complaint that nearly 100 firms failed to warn that their products could expose consumers to a specific form of titanium dioxide.

The consumer advocacy group filed the suit in 2013 after California's Office of Environmental Health Hazard Assessment added TiO2 "in unbound, airborne particles of respirable size" to Prop 65, which followed the International Agency for Cancer Research's 2011 conclusion that TiO2 is "possibly carcinogenic" Also see "IARC Finds TiO2 Possibly Carcinogenic, Setting Stage For Prop 65 Action" - HBW Insight, 24 January, 2011..

The suit alleged the firms were in violation of Prop 65, which requires manufacturers to disclose to consumers that they may be exposed to chemicals with suspected carcinogenic or reproductive toxicity risks.

However, in a July ruling Alameda County Superior Court Judge George Hernandez Jr. disagreed, affirming that only unbound, airborne particles of respirable TiO2 are subject to Prop 65 labeling mandates and the presence of TiO2 in products does not require a warning.

According to the ruling, the Public Interest Alliance had no evidence that cited products contained the form of TiO2 listed under Prop 65.

The summary judgment said the Public Interest Alliance’s failure to support its certificates of merit more thoroughly "brings to mind the 'shakedown' cases concerning other aspects of defective Prop 65 litigation notices."

Michael Steel, a partner with Morrison & Foerster LLP in San Francisco representing the manufacturers targeted in the complaint, said the dismissal illustrates the importance of getting involved early in the Prop 65 listing process.

When TiO2 was proposed for addition to the Prop 65 list, the substance was nominated based on studies exposing rodents to an inhalable mist of pure, very fine TiO2 that was not bound to other particles such as micas or colorants found in cosmetics and personal care products, Steel said in an interview.

The fine, respirable size particles can get into the deep lung, where they have the potential to cause cancer.

In contrast, "larger particles get trapped either in the upper respiratory tract in the nose and throat, or in the middle respiratory tract, but in those areas they don't have an adverse health effect," Steel explained.

So the industry pushed for the Prop 65 listing to include only the form of TiO2 studied and linked to cancer risks, unbound, airborne particles of respirable TiO2.

"The agency was persuaded that this was scientifically valid, and so it limited [the listing] to that particular set of circumstances," Steel said.

While other chemicals on the Prop 65 list "are presumed to cause the adverse health effect whether you inhale it, whether you eat it, whether you rub it on your skin – for TiO2 it's inhalation only, and then it has to be respirable particles and they have to be unbound. So, it's a very narrow listing," he said.

"Early action on the listing of chemicals and trying to make sure the listing is tailored to the science is really important."

Shallow Evidence Prompts 'Shakedown' Comparison

According to the Personal Care Products Council’s CosmeticsInfo.org, TiO2 is used in cosmetic products as an opacifying agent and colorant, and in cosmetic/drug combination products, such as sun-protective makeup, as a UV filter.

Steel said manufacturers conducted a study to ensure their TiO2-containing, powder-based cosmetic products targeted by the suit fell outside the narrow range of the Prop 65 listing.

The study included a woman in a sealed, controlled room, who applied products in question liberally while air collectors next to her face assessed the particles in her breathing zone.

The collectors "did not contain any detectable amounts of respirable-size particles of TiO2," Steel said, affirming that the products contained TiO2 particles that are bound with other ingredients, making them too large to be of concern.

Public Interest Alliance did not submit results from its own air-sampling tests on products cited in the suit, which led manufactures to challenge the validity of the alliances certificates of merit, required for private enforcement under Prop 65.

The industry specifically questioned whether the alliance had the required "credible factual basis for the certifier's belief that an exposure to a listed chemical had occurred or was threatened."

In a 2014 interview, plaintiff attorney Jeffrey Judd of the Judd Law Group expressed confidence in the alliance’s evidence, including peer-reviewed studies and samples of selected products representative of the group, suggesting that the "generally accepted scientific methods and principles" employed supported a claim of likely exposure across the industry’s product spectrum Also see "Airborne TiO2 Of Respirable Size? Litigation Goes On Under Prop 65" - HBW Insight, 23 July, 2014..

However, Steel maintains targeted air-sampling testing is the only way to determine if TiO2 particles in targeted products are of respirable size. Further, the alliance admitted during proceedings that containing TiO2 does not mean a product will cause exposure to unbound, airborne particles.

Given that the cited studies were not specific to products claimed to be violative, "it was clear [the alliance] didn't have any evidence to support its claim and there's no point in going to trial," Steel said.

That was the basis of the industry’s motion for summary judgment, filed April 24, and the court agreed. In the summary judgment, Judge Hernandez concluded the alliance's certificates of merit were based on "probability and conjecture" and were therefore invalid.

The decision offers a cue for defending other Prop 65 cases on the level of deficient certificates of merit, which are filed when a party gives notice of intent to take action under Prop 65. The submissions must show “not only documentation of exposure to a listed chemical, but a reasonable basis for concluding that the entire action has merit."

According to Steel, the TiO2 case is significant because it shows the courts are willing to look into the legitimacy of Prop 65 violation claims, to consider the merits of pre-trial evidence and "and if there's not [evidence], then to put a stop to it."

The development may signal a shift in industry's favor in Prop 65 litigation. In the summary judgment, the judge suggests that alliance’s failure to support its certificates of merit more thoroughly "brings to mind the 'shakedown' cases concerning other aspects of defective Prop 65 litigation notices."

The shakedown reference "shows that the courts are increasingly aware that Prop 65 is subject to widespread abuse," Steel said.

"That probably won’t stop these abuses, but it is good to know that the courts are onto them," he added.

Other groups are not likely to see the alliance’s complaint as an opportunistic grab at low-hanging fruit, and its attorney makes a point in an Aug. 17 write-up at ChemicalWatch that may drive further action.

According to Judd, pre-trial discovery revealed that none of the manufacturers assessed their powder products to determine if use would expose consumers to the form of TiO2 listed under Prop 65. The testing companies undertook was performed as a reaction to the lawsuit, he indicated.

The ruling could lower the likelihood of additional claims about TiO2 exposure profiles of cosmetic and personal care products sold in California and other states. Potential plaintiffs will need to test products themselves – a costly if not wholly impractical prospect – or pressure companies into testing via a lawsuit bound to lose.

"The court's ruling makes clear that no enforcement action will be brought until a sufficiently deep-pocketed plaintiff does the toxic exposure assessment that, in our view, is something any responsible manufacturer should do before it offers a product for sale to the public," Judd told ChemicalWatch.

Industry maintains that UART is not present in cosmetics products. The study leading to UART's Prop 65 listing exposed rodents to "something that does not actually exist in the real world," Michele Corash, a senior partner with Morrison & Foerster, said at the American Conference Institute's Legal, Regulatory and Compliance Forum on Cosmetics in March.

"Your products don’t contain [unbound, airborne TiO2 particles], nobody’s do, because nobody sells as a consumer product pure titanium dioxide," Corash said.

Firms Should 'Push Back' Against Suits

Manufacturers with business in California have been hard hit by Prop 65 litigation and many companies reformulated away from listed ingredients rather than adding warning labels to products or risk incurring costly lawsuits.

The high volume of suits against manufacturers that fail to comply with warning requirements within allotted grace periods essentially has made "hostages" of companies, attorneys say, with litigants often seeking settlements from companies that lack the resources to mount an aggressive defense Also see "Cosmetics Firms Held “Hostage” By Prop 65 Litigators; Law Changes Possible" - HBW Insight, 23 September, 2013..

While California OEHHA floated potential reforms to the regulation in 2014, cosmetics and personal care product industry stakeholders decried the proposal as potentially more debilitating to businesses, suggesting that contrary to its intent, it could open a new frontier of litigation ([A#02140707004]).

The department in January issued a notice of proposed rulemaking it said took into account industry feedback, though some legal experts were quick to voice enduring concerns Also see "OEHHA Prop 65 Website Proposal Is Mixed Bag For Industry" - HBW Insight, 29 January, 2015..

Steel said one of the main takeaways from the Public Interest Alliance litigation is that firms should not be afraid to push back against Prop 65 lawsuits. Although the ruling benefits the industry, around 20 firms settled with the alliance and are bound by the settlements, he said.

Under settlements in May and October 2014, companies agreed to remove TiO2 from products, feature a proper Prop 65 warning label on products or withdraw products from the market Also see "TiO2-Containing Cosmetic Powders Subject Of Prop 65 Settlements" - HBW Insight, 9 June, 2014..

"So they're stuck with that decision. You shouldn't be bashful about pushing back and getting the court to take a hard look at this," Steel said.

Around 98% of Prop 65 cases settle, he added.

[Editor’s note: “The Rose Sheet” also published this article. "The Tan Sheet" brings selected complementary coverage from our sister publications to our subscribers.]

TiO2 Prop 65 Dismissal Offers Lessons, Renews Hope For Industry

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