As the COVID-19 pandemic continues, and with an incoming Biden administration that is expected to step up efforts to control the spread of the virus, use of personal protective equipment (“PPE”) and cleaning/disinfectant products has never been more important or widespread among the public. However, in late October, the Consumer Product Safety Commission (“CPSC”) issued guidance on its website asserting that certain consumer protection rules within its jurisdiction apply to PPE, and reminding consumers of the CPSC laws that apply to cleaning/disinfectant products (the “COVID Guidance”).
The CPSC commissioners disagree about the import or official applicability of the COVID Guidance, and questions abound as to how it interplays with FDA regulations issued by the U.S. Food and Drug Administration (“FDA”), including Emergency Use Authorizations (“EUA”), as well as EPA regulations on disinfectant products – not to mention how or whether the COVID Guidance impacts the protections afforded by the Public Readiness and Emergency Preparedness Act (the “PREP Act”). But in any case, the guidance unquestionably heightens scrutiny around COVID-related products, and likely will give consumer plaintiffs’ attorneys additional lawsuit fodder – so manufacturers should understand it.
Broadly, the COVID Guidance covers two broad categories of products: face coverings, gowns, gloves (i.e., PPE), and cleaning/disinfectant products.
Under the COVID Guidance, face coverings, gowns, and gloves designed for consumer use are considered “articles of wearing apparel” and therefore must (1) comply with the flammability requirements of the Flammable Fabrics Act; and (2) be tested to either 16 C.F.R. Part 1610 (Standard for the Flammability of Clothing Textiles) or Part 1611 (Standard for the Flammability of Vinyl Plastic Film), depending on the materials used for construction. Further, U.S. manufacturers and importers of these products must issue a General Certificate of Conformity (“GCC”) certifying that these clothing articles meet all applicable requirements.
The COVID Guidance imposes additional requirements for PPE apparel designed specifically for children’s use (i.e., ages 12 and under). Under the Consumer Product Safety Act (“CPSA”), all children’s products must bear permanent tracking information, meet total lead content limits, and meet lead in paint or similar surface coating limits (if either a paint or surface coating is present on the product). Product testing must take place at a CPSC-accepted testing lab, and U.S. manufacturers/importers of these products must also issue a Children’s Product Certificate.
Household cleaning solutions – for example, hand sanitizers and soaps – are primarily regulated by the FDA, but also fall under the jurisdiction of the CPSC if they constitute a “hazardous substance” under the Federal Hazardous Substances Act (“FHSA”). Generally, the FHSA defines a “hazardous substance” as (1) a substance (or mixture of substances) that may cause substantial personal injury or substantial illness during customary or reasonably foreseeable handling or use, including reasonably foreseeable ingestion by children; and (2) the substance (or mixture of substances) is toxic, corrosive, an irritant, a strong sensitizer, is flammable or combustible, or generates pressure through decomposition, heat, or other means. The FHSA requires that hazardous substances bear prominent warnings on their labels – for example, “KEEP OUT OF REACH OF CHILDREN,” “DANGER”, and “HARMFUL OR FATAL IF SWALLOWED,” among others.
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Although the COVID Guidance remains posted on the CPSC website, some of the Agency’s commissioners have taken issue with the manner in which the guidance was issued. In an October 27 statement, Commissioner Dana Baiocco expressed concern that the COVID Guidance was issued unilaterally by only one of the commissioners and did not represent the agency’s official policy position, noting that “[n]o [Commissioner] vote was taken on whether a ‘mask’ crafted during the pandemic should be regulated as ‘apparel’ or ‘textiles.’” Commissioner Peter Feldman expressed similar concerns, noting that he “wasn’t even offered a courtesy briefing” on the COVID Guidance. In response, acting CPSC Chairman Robert Adler – who recently announced that he will not seek re-nomination when his current term ends in October 2021 – characterized the COVID Guidance as a “fact sheet” intended to respond to inquiries from small businesses, and which involves “no particular policy issue that would require formal Commission approval.”
Official or not, the COVID Guidance evinces a growing trend of enhanced scrutiny around consumer products during the COVID-19 pandemic. On November 10, U.S. Senators Amy Klobuchar (D-MN) and Jerry Moran (R-KS) introduced the COVID-19 Home Safety Act (S. 4884), which responds to recent reports indicating that pediatricians and emergency room physicians have seen an uptick during the pandemic of home injuries, such as accidental hand sanitizer poisoning in children. Bipartisan companion legislation in the U.S. House of Representatives (H.R. 8121) passed the Energy and Commerce Subcommittee on Consumer Protection and Commerce in September. The legislation directs the CPSC to study injuries and deaths caused by consumer products during the pandemic, and to collaborate with the media to distribute information – such as the CPSC’s Home Safe Checklists – to help improve home safety. We expect the regulatory trend to continue after the transition to the Biden administration in January.
We have previously written that the PREP Act protects certain “covered persons,” including manufacturers of PPE, from civil tort liability for injuries causes by those products if they constitute “covered countermeasures,” as well as about how the FDA has made certain exceptions to its regulatory requirements for PPE and issued guidance for other products used to combat the pandemic. Now we must understand whether and how those PREP Act protections and FDA exceptions impact regulatory scrutiny from the CPSC.