Traditionally, the U.S. Environmental Protection Agency (“EPA”) has not regulated finished goods under the Toxic Substance Control Act (“TSCA”), but instead focused on the manufacture or import of bulk chemicals and chemical mixtures. While the agency has been empowered to regulate articles, it chose not to, finding the burden imposed on stakeholders to know the chemical identity of finished goods to be extremely difficult. Recent regulatory actions on per-and polyfluoroalkyl substances (“PFAS”) and persistent, bioaccumulative and toxic (“PBTs”) chemicals, however, are breaking from this tradition. These changes mean that importers of finished products will need to know whether these chemistries are present in their products, as steep civil and criminal penalties can be assessed for violating the TSCA.
Starting with the PBTs, the EPA has taken, or will be taking, action to ban or severely limit the commercial use of five PBTs chemicals, including their use in products that a company might make, import or distribute. These PBTs are: 1) Decabromodiphenyl ether (DecaBDE); 2) Phenol, isopropylated phosphate (3:1) (PIP (3:1)); 3) 2,4,6-Tris (tert-butyl) phenol (2,4,6-TTBP); 4) Hexachlorobutadiene (HCBD), and 5) Pentachlorothiophenol (PCTP). These agency actions prohibit the processing and distribution of these substances and products containing them (with limited exceptions). Of note, the substance PIP 3:1 is widely used as a plasticizer and flame retardant in many finished products, including electronic components, power supplies and cords, vinyl cable jacketing and wire sheathing, and gaskets, seals, and o-rings. The ban on PIP 3:1 is scheduled to be implemented on October 31, 2024 and on January 6, 2026 for 2,4,6-TTNP; the compliance dates for the other substances have already passed.
The EPA’s proposed PFAS regulations, if promulgated as drafted, will create different hurdles. As drafted, the PFAS regulations will require manufacturers and importers of articles containing PFAS to report going forward and for any year since January 1, 2011, data regarding the manufacture and import of articles containing any listed PFAS, regardless of the amount of the PFAS found in the finished product. This final rulemaking is still pending before the EPA.
Supply chain transparency is the problem faced by manufacturers, importers and distributors of products containing PBTs and PFAS. Many of these chemistries are present in the parts and components used to produce the finished, manufactured articles. Thus, the necessary information as to whether these substances are present are several levels up the supply chain and out of the immediate knowledge of the manufacturer of the finished product. The fact that a company may be distributing other manufacturers’ products, including private label products, does not insulate it from complying with the TSCA, unless exempted, for goods containing these chemistries.
Not all products are or will be covered. Products regulated by agencies other than the EPA are exempt from TSCA. For example, medical devices and drugs regulated by the U.S. Food and Drug Administration are exempt from the EPA’s laws. The FDA, however, does regulate materials in medical devices for biocompatibility so a possible scenario where the FDA uses its laws to recall medical devices containing PBTs or PFAS is not too unreasonable.
If you have any questions about importing, TSCA, or governmental treatment of chemical products, do not hesitate to contact any attorney at Barnes, Richardson & Colburn, LLP.