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Law360 (October 27, 2020, 9:01 PM EDT ) A commissioner of the Consumer Product Safety Commission on Monday said that the agency recently issued guidance on face masks on its website, but she didn't know where it came from and that no vote had been taken on how masks created during the coronavirus pandemic should be regulated.
Commissioner Dana Baiocco said that the CPSC recently issued "guidance" on masks and other other pandemic products, like gloves and disinfectants, but she doesn't know who is responsible for publishing it. She said in a statement that the publication is not an official CPSC policy position, as an official policy needs a majority vote by 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,'" Baiocco said.
She also said that she hadn't received any briefing, legal opinion or analysis from the Office of Management and Budget about the publication. Additionally, Baiocco said that there was no public comment or notice on the matter.
Baiocco told Law360 on Tuesday that she didn't know when the publication was posted but that she first noticed it on Monday.
During the pandemic, manufacturers have adjusted their facilities and made materials to meet the demand for the gap in personal protective equipment supplies, as well as small businesses and volunteers with sewing machines, Baiocco said.
"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," Baiocco said. "Enough with the unilateral communications and publications."
The post Baiocco referred to in her statement lists four main categories of pandemic products: face coverings, gowns, gloves, and disinfectant and cleaning products.
Consumer face masks for adults are considered "wearing apparel" under the CPSC's jurisdiction and must comply with the flammability requirements of the Flammable Fabrics Act, according to the post. Children's face masks must also be tested for lead, the post states.
Medical face masks, such as surgical masks and N95 respirators, are considered medical devices under the U.S. Food and Drug Administration's jurisdiction, according to the post. Face shields are also medical devices.
Similarly, gowns and gloves for consumers are under the CPSC's jurisdiction and gowns and gloves used in medical settings are under the FDA's, according to the post.
As for cleaning products, those used in households are under the jurisdiction of the CPSC if they are a hazardous substance under the Federal Hazardous Substances Act, the post states.
The CPSC also has jurisdiction over "ordinary" soaps made from fats and alkalis for consumers.
Soaps that moisturize or prevent disease by killing germs are regulated by the FDA, according to the post.
And disinfectants and antimicrobial products are regulated by the U.S. Environmental Protection Agency under the Toxic Substances Control Act, which mandates reporting, record-keeping and testing requirements, according to the post.
CPSC Acting Chairman Robert Adler said in a statement on Wednesday that he values Baiocco's input, but in this case he has a different take on the guidance document posted by the CPSC's Small Business Ombudsman.
"In response to a number of inquiries from small businesses, the SBO, after careful consultation with the agency's technical staff, produced a fact sheet about face coverings, gowns, gloves, and disinfectants and cleaners to help small businesses with their inquiries. No one has shown me any errors in the SBO's guidance, which I consider to be useful and timely," Adler said. "This is the type of information that the SBO shares routinely all the time – involving no particular policy issues that would require formal Commission approval. I'm sorry that we disagree on the issue, but continue my appreciation for her comments."
--Editing by Michael Watanabe.
Update: This article was updated to include comment from CPSC Acting Chairman Adler.
For a reprint of this article, please contact reprints@law360.com.
