The Consumer Product Safety Commission (CPSC) has posted a webpage that purports to provide guidance on COVID-19-related consumer products. The CPSC’s new COVID-19 guidance covers two general categories:
- Personal protective equipment (PPE), including face coverings, gowns and gloves
- Cleaning and disinfectant products
Personal Protective Equipment
According to the webpage, face coverings (including cloth face masks and face shields), gowns and gloves are considered items of “wearing apparel.” Based on this classification, the webpage provides insight on three important considerations.
First, consumer products that are wearing apparel require written certificates of compliance (absent an applicable exemption). These certificates fall into two categories: (1) General Certificates of Conformity and (2) Children’s Product Certificates. Each of these certifies that a product meets applicable CPSC-enforced statutes and regulations.
Second, wearing apparel must comply with the Flammable Fabrics Act and be flammability tested, with some exceptions. Under this law, PPE must be tested according to either 16 CFR Part 1610 (Standard for the Flammability of Clothing Textiles), or Part 1611 (Standard for the Flammability of Vinyl Plastic Film). PPE made entirely of acrylic, modacrylic, nylon, olefin, polyester, wool or any combination of these fabrics, or made entirely of plain-surface fabric weighing at least 2.6 ounces per square yard (or 88.2 grams per square meter), is exempted from flammability testing. Under the March 25, 2016, enforcement discretion, the CPSC will not pursue compliance with the General Certificate of Conformity for such products.
Third, children’s wearing apparel (designed or sized for children ages 12 and under) must comply with the requirements of children’s products:
All children’s products, including children’s face masks, must bear permanent tracking information, meet total lead content limits, and meet lead in paint/similar surface coating limits, if either paint or a surface coating is present on the product. Testing must be conducted at a CPSC-Accepted Testing Lab[.]
The webpage makes it clear that “[f]ace masks [and face shields] that are intended for use in the diagnosis of disease or other health-related conditions, or in the cure, mitigation, treatment, or prevention of disease (such as surgical masks) are ‘medical devices’ that fall under the jurisdiction of the U.S. Food and Drug Administration” (FDA). Medical gowns and gloves also fall within the jurisdiction of the FDA.
Similarly, industrial face masks — “exclusively manufactured for commercial purposes and that are meant to protect the wearer from chemical or physical hazards” — fall outside the jurisdiction of CPSC, and guidance from the National Institute for Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA) should be considered instead.
Disinfectant and Cleaning Products
As authorized by the Federal Hazardous Substances Act (FHSA) and Poison Prevention Packaging Act (PPPA), the CPSC regulates certain household cleaning products and soaps. A household cleaning solution/soap falls under the FHSA if: “(1) the substance or mixture of substances 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 a mixture of substances is toxic, corrosive, an irritant, a strong sensitizer, is flammable or combustible, or generates pressure through decomposition, heat or other means.”
If the product falls within the scope of the FHSA, the label must conform with the requirements found at 16 CFR §1500.121. The CPSC website offers additional guidance on the FHSA.
The webpage also notes that the PPPA requires “certain household products containing any of the substances listed in 16 CFR §1700.14 to have special packaging to protect children from serious injury or illness from handling, using, or ingesting such substances.” The CPSC website also offers additional guidance on the PPPA.
Similar to PPE, the webpage does make it clear that certain types of cleaning products remain within the jurisdiction of the Environmental Protection Agency (EPA), OSHA and FDA. Specifically, the EPA still regulates surface disinfectants and hand sanitizers intended to treat or prevent disease. Commercial cleaning products must still comply with OSHA standards.
Commissioner Dana Baiocco’s Reaction
As the title of the article states, the webpage is arguably “unofficial” guidance. Commissioner Baiocco released a statement making clear her view of the “unofficial” nature of the webpage:
This is NOT an official CPSC policy position. An official CPSC policy position requires a majority vote of the Commission. No vote was taken on the information presented on the website and certainly no vote was taken on whether a “mask” crafted during the pandemic should be regulated as “apparel” or “textiles.” In fact, no briefing, legal opinion, or analysis of the recent OMB direction was provided to this Commissioner regarding any of the opinions or “guidance” contained in the communication. Furthermore, there was no public comment or notice solicited on the matter.
After criticizing the lack of authority for the webpage, Commissioner Baiocco turned her attention to her disapproval of its contents:
Many Americans stepped up during this crisis. Some manufacturers retooled their facilities and produced materials to meet the demand for hundreds of thousands of essential workers, consumers, and the American public generally. Thousands of small businesses, individuals, and volunteers with a sewing machine also contributed to the enormous gap in supplies created by the circumstances. Rather than celebrating the American spirit, this unilateral publication suggests the potential for general legal liability and/or CPSC enforcement action — retroactively — without perspective, notice, or any deliberative process.
In closing, she notes that the webpage will “serve only to create unnecessary public tension, confusion, and damage to the Agency’s credibility.”
Conclusion
Although Commissioner Baiocco has expressed her concerns with the webpage, it still remains an active, accessible link on the CPSC’s website. CPSC staff likely believe that the webpage is simply a summary of existing law. Although there appears to be disagreement within the CPSC, those who have responded to the pandemic by producing PPE, disinfectants and cleaners should be aware of the existing laws applicable to consumer products and the CPSC staff’s view that such products do not deserve special treatment, regardless of the circumstances of a pandemic.
McGuireWoods has published additional thought leadership analyzing how companies across industries can address crucial business and legal issues related to COVID-19.