EPA names five PBT chemicals for expedited action.

Yesterday, the U.S. Environmental Protection Agency (EPA) announced that five chemicals will be subject to expedited action under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which overhauls the Toxic Substances Control Act (TSCA). The affected chemicals and their uses, as described by EPA, are:

  • Decabromodiphenyl ethers (DecaBDE), used as a flame retardant in textiles, plastics and polyurethane foam;
  • Hexachlorobutadiene (HCBD), used in the manufacture of rubber compounds and lubricants and as a solvent;
  • Pentachlorothio-phenol (PCTP), used as an agent to make rubber more pliable in industrial uses;
  • Tris (4-isopropylphenyl) phosphate, used as a flame retardant in consumer products and other industrial uses; and
  • 2,4,6-Tris(tert-butyl)phenol, used as a fuel, oil, gasoline or lubricant additive.

Last month, we wrote that as required by the Lautenberg Act, EPA would fast-track the regulation of certain persistent, bioaccumulative, and toxic (PBT) chemicals unless manufacturers nominated them for risk evaluation by September 19. Two of the seven PBT chemicals, which are used in fragrance mixtures, Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,5,5-tetramethyl-2-naphthalenyl) and Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,8,8-tetramethyl-2-naphthalenyl), were nominated for risk assessment.

Under the Lautenberg Act, EPA must skip conducting risk assessments for these five chemicals and take expedited action to reduce exposure to the extent practicable. The agency will first determine “where these chemicals are used and how people are exposed to them” before proposing limitations on use. According to agency guidance, EPA may restrict the chemicals in one or more of the following ways:

  • Prohibit or otherwise restrict manufacturing, processing, or distribution in commerce.
  • Prohibit or otherwise restrict manufacturing, processing, or distribution in commerce for particular uses or for uses in excess of a specified concentration.
  • Require minimum warning labels and instructions.
  • Require record keeping or testing.
  • Prohibit or regulate any manner or method of commercial use or disposal.
  • Direct manufacturers and processors to notify distributors and the public and replace or repurchase chemicals substances or mixtures.

EPA must propose expedited actions for these chemicals by June 22, 2019, and final rules must be issued within the following 18 months.

Ninth Circuit rules on “all natural” food claims.

Last week, the Court of Appeals for the Ninth Circuit reversed in part and affirmed in part orders issued by a district court judge in a putative class action case involving “all natural” claims made by Dole Foods. In Brazil v. Dole, No. 14-17480 (9th Cir. Sept. 30, 2016), the plaintiff, Chad Brazil, alleged that Dole’s “All Natural Fruit” labels for packaged fruit products were deceptive under the California Unfair Competition Law (UCL), California False Advertising Law (FAL), and California Consumer Legal Remedies Law (CLRA).

The plaintiff claimed that the labels were deceptive because the products contain synthetic citric and ascorbic acid, citing evidence including informal policy issued in 1993 by the federal Food and Drug Administration (FDA), as well as more recent FDA warning letters to food sellers making similar claims (“100% Natural” or “All Natural”). The FDA’s informal policy [PDF] states that a “natural” claim on a food label is truthful and non-misleading when “nothing artificial or synthetic… has been included in, or added to, a food that would not normally be expected in the food.” In the warning letters, FDA described “natural” claims as deceptive because the food products included synthetic citrus acid, among other substances.

Upon appeal, the Ninth Circuit affirmed the lower court’s order decertifying the class because the plaintiff failed to show how to calculate the price premium with proof common to the class. The Court also affirmed the dismissal of the plaintiff’s claims for the sale of “illegal products.”

However, the Ninth Circuit reversed the district court’s granting of summary judgment on the merits of Brazil’s claims. The Court held that the evidence presented “could allow a trier of fact to conclude that Dole’s description… is misleading to a reasonable consumer.” Interestingly, the Court noted that the FDA warning letters “did not always rely on the limitation that an artificial or synthetic product would ‘not normally be expected to be in the food’ – and, in fact, asserted that foods that naturally contain citric acid (such as tomatoes) may not be labeled ‘all natural’ if synthetic citric acid is added to them.”

While unpublished, the Ninth Circuit’s opinion [PDF] may prove consequential because it suggests how the Court may interpret “natural” claims in the future. In addition, a number of other cases involving “natural” claims have been stayed while this case has been pending and the plaintiff’s bar may be emboldened to pursue further litigation.

The case has been remanded to the lower court to allow the plaintiff “injunctive relief on behalf of the class and his remaining individual claim for restitution.”

California’s Department of Toxic Substances Control is Seeking Collaboration on the Next Round of Products

The Safer Consumer Products (SCP) program, under CA’s Department of Toxic Substances Control (DTSC), is using a four-step process to reduce toxic chemicals in products that consumers buy and use. One of these steps includes developing Priority Products, which are products that contain one or more Candidate Chemicals. The DTSC is now seeking stakeholder engagement for implementing its Priority Product Work Plan (PPWP) in a webinar, scheduled for November 15. 2016 from 10:30am- 12:00pm PST.

The webinar will provide an overview of DTSC’s progress towards Priority Product selection. The webinar will also focus on three topics, which the DTSC would like stakeholder engagement in:

  • Potential aquatic impacts and continued uses of nonylphenol ethoxylates (NPEs) and triclosan,
  • Nail products, and
  • Perfluoroalkyl and polyfluoroalkyl substances (PFASS) in carpets, rugs, upholstered furniture, and their care and treatment products.

Potential Aquatic Impacts and Continued Uses of Nonylphenol Ethoxylates and Triclosan:

This category contains chemicals that may adversely impact aquatic resources, or that have been observed through water quality monitoring. SCP identified NPEs, triclosan, and some of their transformation products as Candidate Chemicals that may warrant further research. A Candidate Chemical as a chemical that exhibits a “hazard trait and/or an environmental or toxicological endpoint” and is either: 1) found on one or more of the authoritative lists specified in Section 69502.2(a) of the regulations; or 2) listed by DTSC using the criteria specified in Section 69502.2(b). SCP would like to better understand the presence of these Candidate Chemicals in the aquatic environment, and would like current product use information for these Candidate Chemicals in cleaning, personal care, and clothing products.

Nail Products:

Nail salon workers have daily exposure to a variety of hazardous chemicals in nail products. Additionally, nail products in salons and at home are used by potentially sensitive subpopulations such as pregnant women and children. Three key questions being explored for this topic are:

  • What are the potentially hazardous chemicals present in nail products?
  • Why are these potentially hazardous chemicals being used in nail products?
  • What alternative chemicals are being used including products marketed as green, safer, or free of specific chemicals?

PFASS in Carpets, Rugs, Upholstered Furniture, and Their Care and Treatment Products:

DTSC is concerned about the hazard traits of PFASs and their widespread presence in the environment, humans, and other living organisms. Carpets, rugs, and upholstered furniture treated with PFASs for stain-, soil-, oil-, or water-resistance, as well as their PFASs-based care and treatment products, are potential long-term sources of widespread human and ecological exposures to this class of chemicals. DTSC is requesting public input to better understand:

  • The exposure potential from the use of PFASs in these consumer products, and
  • The hazard traits of short-chain PFASs, fluorinated ethers, and other “novel” PFASs.