The Consumer Product Safety Commission (CPSC) has released COVID-19 guidance confirming that certain personal protective equipment (PPE) must comply with CPSC regulations, including testing, certification, labeling, and recordkeeping requirements. The guidance, summarized below, also provides a concise overview of other federal regulations that may apply to these products.
The CPSC’s new COVID-19 guidance covers four major categories of products:
- Face coverings
- Cleaning and disinfectant products
Failure to comply with CPSC regulations applicable to these products could expose companies to civil or criminal penalties, recalls, and costly litigation.
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. 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.
Face Coverings, Gowns, and Gloves
Face coverings (including cloth face masks and face shields), gowns, and gloves intended for consumer use are considered items of “wearing apparel.”
- Flammability tests required. Wearing apparel must comply with the Flammable Fabrics Act and be tested according to 16 CFR Part 1610 (Standard for the Flammability of Clothing Textiles) or 16 CFR Part 1611 (Standard for the Flammability of Vinyl Plastic Film). 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.
- Special labeling and testing requirements for children’s wearing apparel. 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 must also be certified by a CPSC-recognized third-party testing laboratory as compliant with total lead content limits (15 U.S.C. §1278a). 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 (16 CFR Part 1303).
- Written compliance certificate required. 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 grounds for a penalty.
Disinfectant and Cleaning Products
The CPSC regulates common household cleaning solutions under the authority of the Federal Hazardous Substances Act (FHSA) and the Poison Prevention Packaging Act (PPPA):
- Labeling required for certain household cleaning solutions and ordinary soaps. The CPSC regulates household cleaning solutions (including ordinary soaps) qualifying as “hazardous substances” must bear labels with certain cautionary statements specified in 16 CFR § 1500.121. Under the 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.
- Special packaging for products containing certain ingredients. The PPPA requires special child-proof packaging for household products containing any of the ingredients listed in 16 CFR § 1700.14.
Other federal agencies, including the Environmental Protection Agency (EPA), OSHA, and FDA, have jurisdiction over certain types of disinfectant and cleaning products:
- Surface disinfectants. EPA 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. More information on EPA’s regulations and guidance concerning surface disinfectants and SARS-CoV-2 is available here.
- Commercial cleaning products. Commercial use products must comply with OSHA regulations, including Hazard Communication Standard labeling requirements.
- Hand sanitizers, cosmetic soaps, and ultraviolet (UV) disinfecting devices. 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 “medical devices” regulated by the FDA. Soaps intended to moisturize, add fragrance to the skin, or deodorize the body qualify as “cosmetics” and fall under the FDA’s jurisdiction.
The CPSC’s full COVID-19 guidance is available here.