FDA rulemaking or guidance may be needed to clarify points in federal law amended by the Microbead-Free Waters Act of 2015, and it's possible that industry hasn't seen the last of state legislation aimed at addressing plastic microbead use in the cosmetics sector, Latham & Watkins attorneys say.

Julia Hatcher and Ann Claassen, partner and counsel, respectively, in the law firm's Washington, D.C. office, expect that "interpretive ambiguities" in the federal microbeads bill will pose compliance challenges for companies as they work to phase out and replace plastic microbeads with eco-friendlier alternatives.

Moreover, the legislation's shortcomings "may allow states to regulate certain types of products containing plastic microbeads that fall outside of H.R. 1321's scope," they suggest in an article published Jan. 19 by legal news and analysis service Law 360.

Signed into law by President Obama Dec. 28, the Microbead-Free Waters Act imposes deadlines on cosmetic manufacturers to discontinue use of plastic microbeads according to a phase-out schedule that industry has embraced as feasible compared with some timelines legislated at local levels in 2015 ([A#02151221009]).

Importantly, the federal law also includes preemption language intended to bar states from establishing or continuing restrictions on the manufacture and sale of plastic microbead-containing cosmetics that are not identical. The provision was seen as a win for industry, which otherwise was facing an increasingly convoluted patchwork of bans and restrictions at the state and local levels prior to H.R. 1321's enactment.

However, as the Latham & Watkins attorneys and other stakeholders have noted, the federal legislation is markedly compact, light on details and fails to define some key terms with bearing on the law's scope.

"Biodegradable materials such as PHAs are not only suitable to produce microbeads in all sorts of applications, but will also be key to addressing the remaining 99.9% of plastics that are the real problem," says Mango Materials CEO Morse, putting the cosmetic industry's contribution to plastic litter, and the federal ban's scope, into perspective.

The ban imposed by H.R. 1321 is expressly limited to plastic microbeads, or solid plastic particles within designated dimensions, which are intentionally added to rinse-off cosmetic products for cleansing or exfoliating purposes, and forbids conflicting state restrictions on the ingredients' use within those parameters.

Hatcher and Claassen note that "if the 'solid plastic particle' is being intentionally added so that the product will be 'used' for some other reason – such as, for example, to lubricate and fill crevices in the skin for a more pleasing visual appearance – then H.R. 1321 arguably may not apply to ban such a product."

Such gaps could represent areas that state and local lawmakers attempt to target with future bills. Already some local municipalities have crafted legislation that would prohibit plastic microbead use in categories beyond rinse-off cosmetics, even proposing that prohibitions extend beyond microbeads to include any manufactured plastic particle in a personal-care product.

Industry advocates have noted that a New York City Council bill along those lines would have impacted large numbers of personal-care products unaffected by other regulatory proposals to date ([A#02151116005]).

While the federal law is intended to provide industry with regulatory certainty and a level of closure on the issue, "environmental and consumer protection groups may continue to advocate for state regulation if they believe the scope of the federal law is too narrow, and this could lead to litigation over whether new state regulations are preempted," the attorneys say.

Lack Of 'Plastic' Definition Also Problematic

According to the Latham & Watkins attorneys, the Microbead-Free Waters Act's potentially problematic "simplicity" also is evident in the absence of a definition for "plastic."

Illinois' trendsetting microbead legislation, signed into law in June 2014 and subsequently picked up and passed by a handful of other states, defined plastic in a way that would exclude from its ban natural polymers that readily degrade in aquatic environments.

Under those terms, next-generation polyhydroxyalkanoate (PHA)-based microbeads could have been used as replacements for conventional plastic microbeads made from polyethylene, polypropylene and similarly non-biodegradable materials that escape filtration by wastewater treatment plants and end up in natural waterways, posing threats to marine life and the food chain.

In a Jan. 7 CBC radio interview, William Bardosh, CEO of Edmonton, Canada-based TerraVerdae BioWorks, provided perspective on the US ban and its implications for the company, which has been ramping up PHA microbead production with an eye toward supplying the personal-care industry.

According to the exec, TerraVerdae's PHA is naturally occurring, biodegradable and harmless to fish and other organisms, representing "a natural drop-in alternative that is totally sustainable."

He added, "Unfortunately, this [US] law sort of captures our product in its definition" ([A#02150615007]).

Hatcher and Claassen similarly recognize the challenges before bioplastic suppliers and cosmetic manufacturers that could benefit from using biodegradable plastic microbead substitutes.

"Under the circumstances, it is unclear whether H.R. 1321 covers 'naturally derived,' more readily biodegradable materials that function as plastics, such as polymers made from vegetative matter," they say.

"Arguably, if concerns about bioaccumulation of microbeads in the environment are behind H.R. 1321 … then biodegradability should be a factor in determining whether a particular material qualifies as a 'plastic' covered by the law."

Bardosh noted that significant market opportunity remains for PHA microbead use in cosmetics sold in Europe and Asia. Meanwhile, TerraVerdae is working with US Congress members to find wiggle-room for PHA under the federal ban.

"In some respects, what we have is a biopolymer and it really comes down to semantics. What is the definition of plastic? That's the real problem with the law – the law is poorly written, it's overly broad, it's literally two paragraphs, that's all it is. … So there is really some room there that we need to get clarity on," the exec said.

Mango Materials' Position: PHA Isn't Plastic

Palo Alto, Calif.-based Mango Materials is taking a similar approach after being "slightly caught off-guard" by developments at the federal legislative level as 2015 came to a close. The Microbead-Free Waters Act passed both houses of Congress in rapid succession in December after sitting idle for most of the year Also see "2015 In Review: Tension Builds At The Regulatory Cosmetic/Drug Divide" - HBW Insight, 2 January, 2016..

In a Jan. 4 email, Mango CEO Molly Morse told "The Rose Sheet" that the PHA microbead supplier plans to argue that its material "is not a plastic – it is a 'naturally occurring biopolymer.'"

As part of her education efforts, Morse also is highlighting the relatively miniscule percentage of global plastic litter that the personal-care industry contributes and the Microbead-Free Waters Act addresses.

In a Jan. 7 Facebook post, the exec puts the issue in perspective: "Even if we consider that all the microbeads in US rinse-off products are discharged directly to the marine environment (which is totally not the case by the way), only about 0.1% of the plastics that enter our waters would actually be addressed by this legislation."

She adds: "Truly innovative biodegradable materials such as PHAs are not only suitable to produce microbeads in all sorts of applications, but will also be key to addressing the remaining 99.9% of plastics that are the real problem."

Federal Microbead Ban May Not Be Final Word On Cosmetic Use

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