California continues on the PFAS regulatory vanguard by banning PFAS in Cosmetics

On October 1, 2020, California passed a law identified as the Toxic Free Cosmetics Act. The Act will prohibit, beginning on January 1, 2025, the manufacturing or selling of any cosmetic product with any intentionally added amount of 24 specified chemicals. The specific list of chemicals includes certain phthalates, formaldehyde, mercury, and PFAS (certain per- and polyfluoroalkyl substances). Although some states have previously passed legislation banning some of the specified chemicals in cosmetic products (e.g., in children’s products), California is the first state to pass such a broad band as to cosmetics in general, and specifically to PFAS.

This is not the first time the cosmetics industry has had to respond to environmental regulatory developments in California. Under California’s Proposition 65 law (“Prop 65”), cosmetics have been a frequent target for consumer bounty hunter actions. The cosmetics industry has generally taken steps to comply with Prop 65 by reducing the concentrations of Prop 65 chemicals or providing the required Prop 65 warnings under law. Nevertheless, the Toxic Free Cosmetics Act will no longer allow the option of a Prop 65 warning, which will require the cosmetics industry to now eliminate (not reduce) the 24 listed chemicals (excepting unavoidable trace quantities).

The inclusion of PFAS on the list of 24 chemicals is of particular interest, as California has also been on the forefront of other environmental regulatory actions concerning PFAS. PFAS includes over 5000 different compounds that have been used in a wide variety of industries. PFAS has recently been reported by the US Department of Health and Human Service’s Agency for Toxic Substances and Disease Registry (“ATSDR”), based on various publications, as potentially causing reproductive and developmental effects in animals, and the EPA has identified limited epidemiological findings concerning possible immune system and thyroid disruption, as well as cancer. Nevertheless, the epidemiological evidence concerning PFAS is very limited and currently developing.

PFAS has been used in many common consumer and industrial products, such as carpet, paints, food packaging, stain resistant sprays, and non-stick cookware. PFAS was also used as a fire-fighting compound in aqueous film forming foam, which served as a very effective fire extinguisher, and has been widely used by the military, airports, and other firefighters throughout the country. The broad uses of PFAS has resulted in detections in soil and drinking water aquifers throughout the United States.

The regulatory framework for addressing PFAS is evolving rapidly. For better or worse, California has stepped to the forefront. For example, on September 29, 2020, California passed a law banning the manufacture, sale and use of PFAS firefighting foam in most applications starting on January 1, 2022. In July 2020, the California Department of Toxic Substances Control released a proposal to regulate plant fiber-based food packaging containing PFAS and has been holding public workshops to develop such regulations.

California’s aggressive regulation of PFAS has also extended to the environmental presence of PFAS in drinking water. The EPA has not yet set a maximum contaminant level (“MCL”) in drinking water for PFAS. Instead of setting MCLs, EPA established health advisory levels for PFAS, which equate to 70 parts per trillion (ppt) in drinking water. As the threshold is advisory, it is not mandated; however, many states have adopted the EPA’s advisory level of 70 ppt.

California, nevertheless, stepped out in front of both the EPA and all other states. In February 2020, California’s State Water Resources Control Board reduced the response levels for PFOA and PFOS to 10 ppt and 40 ppt, respectively. Response levels are advisory levels above which California recommends taking a water source out of service. As day follows night, the removal of drinking water sources from service has resulted in environmental litigation concerning the recovery of associated costs, as a wave of PFAS litigation concerning both environmental releases and products liability is beginning to roll across the country.

California’s Proposition 65 Runs Amok with Addition of BPA

plastic-bottlesOn May 11, 2015, the California Office of Environmental Health Hazard Assessment (OEHHA) listed Bisphenol A (BPA) as a reproductive toxicant to be added to the list of chemicals subject to Proposition 65.  Given the widespread use of BPA in numerous consumer applications (e.g., plastics, adhesives, sealants, epoxy resin liners in food containers, and thermal paper such as the paper used to print cash register receipts), the addition of BPA is a significant development for a large number of businesses evaluating compliance with Proposition 65 with respect to BPA in products.

Proposition 65 provides a 12-month period from the date of listing before warnings are required.  Thus, warnings for exposures to BPA will be required starting on May 11, 2016, unless a person in the course of doing business can show that exposures are below the Maximum Allowable Dose Level (MADL) safe harbor limit for BPA.

OEHHA Takes Action with Deadline Approaching

As the deadline for the warning requirement is quickly approaching, OEHHA recently took emergency action with respect to the listing of BPA.  The first action was the issuance of a notice of proposed rulemaking to establish a MADL for dermal exposures from solid materials containing BPA.  The second was an emergency action to allow for the temporary use of a standard point-of-sale warning for BPA exposures from canned and bottled foods and beverages.

Proposed MADL

The warning requirements under Proposition 65 do not apply if a business can show that exposures from a product are less than the MADL established by OEHHA, which puts the business in a “safe harbor.”  Based on OEHHA’s review of the scientific studies, it has proposed a MADL of 3 micrograms/day (dermal exposure from solid materials) for BPA.  Significantly, the proposed MADL of 3 micrograms/day is a level believed to be above that which most people would encounter from a product in normal use.Bisphenol_A

Comments on the proposed MADL are due to OEHHA by May 16, 2016.  Note that this means that the proposed MADL will not be finalized until after the May 11, 2016 trigger date for warnings.

OEHHA Allows Uniform Point-of-Sale Warnings for Canned and Bottled Food and Beverages

OEHHA attempted to develop a MADL for oral exposure (as opposed to the dermal exposures discussed above) that could have precluded the need for an emergency action on the warnings.  However, OEHHA was unable to work through the technical, practical, and timing issues associated with adopting an oral exposure MADL.  Consequently, to avoid potential removal of many food products from the shelves in markets, OEHHA’s proposed solution, as presented in the emergency action, is to amend the regulations to provide for the temporary use of a standard point-of-sale warning as a compliance option.

The compliance option contemplates signs no smaller than 5 x 5 inches with the following warning language:

WARNING: Many cans containing foods and beverages sold here have epoxy linings used to avoid microbial contamination and extend shelf life. Lids on jars and caps on bottles may also have epoxy linings. Some of these linings can leach small amounts of bisphenol A (BPA) into the food or beverage. BPA is a chemical known to the State of California to cause harm to the female reproductive system.  For more information go to:  www.P65Warnings.ca.gov/BPA.

OEHHA’s actions will have a significant impact on businesses seeking to comply with Proposition 65 for products carrying the potential for exposures to BPA.