Guidance on COVID-19-related consumer products stirs up procedural controversy.

The Consumer Product Safety Commission (CPSC) has posted a guidance concerning COVID-19-related consumer products on its website that drew fire from one commissioner because it was developed and put up on the Internet absent formal approval by the full commission.

Commissioner Dana Baiocco, a Republican whose term ends in 2024, said, “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.’”

She also noted that no briefing, legal opinion or analysis of the Office of Management & Budget (OMB) direction was provided regarding any of the opinions or “guidance” contained in the communication, and there was no public comment or notice about it.

Failure to comply with CPSC regulations applicable to these products could expose companies to civil or criminal penalties, recalls and costly litigation. If those actions are taken in the future based on this guidance, Baiocco’s criticism could end up being cited in court by the defendants.

The guidance holds that non-medical grade personal protective equipment (PPE) sold to the public must comply with CPSC regulations, including testing, certification, labeling, and recordkeeping requirements.

Companies supplying or selling PPE for consumer use should carefully review the guidance and confirm that their products comply with CPSC and other federal regulations, recommend attorneys Alexandra B. Cunningham and Elizabeth Reese of the law firm of Hunton Andrews Kurth.

“Additionally, while the CPSC does not generally have jurisdiction over products not intended for consumer use, we recommend that companies providing PPE for employees take steps to ensure those items comply with CPSC regulations,” they stress.

The CPSC guidance says that face coverings (including cloth face masks and face shields), gowns and gloves intended for consumer use are considered items of “wearing apparel.” This means they are required to be tested for flammability tests required. Products made entirely of acrylic, modacrylic, nylon, olefin, polyester, or wool, or made entirely of plain-surface fabric weighing at least 2.6 ounces per square yard, are exempt from flammability testing.

Wearing apparel intended primarily for children ages 12 and under must also include a permanent tracking label with (1) the manufacturer’s name; (2) the location and date of production; (3) a batch number or other identifying characteristic; and (4) any other information to facilitate the identification of the source of the product.

Children’s wearing apparel also must be certified by a CPSC-recognized third-party testing laboratory as compliant with total lead content limits. If a children’s product contains paint or a similar surface coating, it must also be certified as compliant with lead in paint/similar surface coating limits.

Most wearing apparel products require either a General Certificate of Conformity (general use products) or Children’s Product Certificate (children’s products). These certificates confirm that the products have been tested and certified as compliant with all applicable CPSC regulations. Manufacturers (domestically produced products) and importers (foreign-produced products) are legally responsible for issuing these certificates and ensuring they are based on accurate test results.

Failure to issue a certificate may be considered grounds for imposing a penalty, Cunningham and Reese explain.

Other Agencies Involved

The CPSC regulates labeling for certain household cleaning solutions and ordinary soaps. The CPSC also regulates household cleaning solutions (including ordinary soaps) qualifying as “hazardous substances,” which must bear labels with certain cautionary statements specified in its regulations.

Under the Federal Hazardous Substances Act (FHSA), a product is a “hazardous substance” 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.

The Poison Prevention Packaging Act (PPPA) also requires special child-proof packaging for household products containing any of the ingredients listed in federal regulations.

Keep in mind that other federal agencies, including the Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), and the Food & Drug Administration (FDA), have jurisdiction over certain types of disinfectant and cleaning products, the attorneys note. In fact, it is the EPA that regulates anti-microbial products and surface disinfectants. Surface disinfectant products making SARS-CoV-2 efficacy claims must be registered with EPA and included on EPA’s List N as approved to make such statements. Products may not make efficacy statements beyond those approved by the EPA.

“Any company in the supply chain may be held liable for selling a product that does not comply with EPA regulations,” Cunningham and Reese emphasize, including making false or misleading claims about those products, which has become a growing concern during the COVID-19 pandemic.

When it comes to commercial cleaning products, they must comply with OSHA regulations, including Hazard Communication Standard labeling requirements.

Hand sanitizers and soaps intended to treat or prevent disease are “drugs” subject to the FDA’s jurisdiction. Devices using UV light to disinfect surfaces are considered “medical devices” that also are regulated by the FDA. In addition, soaps intended to moisturize, add fragrance to the skin, or deodorize the body qualify as “cosmetics” and fall under the FDA’s jurisdiction.

In addition to criticizing the lack of authority for the webpage, Commissioner Baiocco also expressed her disapproval of its contents, asserting that it will serve to snare well-meaning businesses in ex post facto rule making.

“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,” she pointed out. “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.”

For more information or assistance with your Environmental and Health & Safety regulatory compliance needs, contact Ralph Carito at Total Environmental & Safety, LLC (Total) at rcarito@TotalEnviron.com or 908-442-8599.

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