In a keynote speech at the Product Stewardship Society’s annual meeting on September 28, 2021, Michal Freedhoff, head of the EPA chemical program, “clearly articulated an intent by the Agency to reverse course and aggressively seek to regulate finished articles under the Toxic Substances Control Act (TSCA),” according to an analysis in JD Supra by law firm Jenner & Block LLP. “Historically, U.S. EPA has focused on the manufacture or import of chemicals and chemical mixtures as opposed to finished articles. However, in her written remarks, Freedhoff focused on articles, stating that the ‘law is very clear that when a chemical enters the United States, or is distributed or processed in the United States—whether in bulk form or in an article—it can be subject to regulation under TSCA.’”
TSCA’s regulations define “finished articles” as final products that are not categorized as firearms, food, food additives, pesticides, devices, or cosmetics.
Traditionally, the EPA has agreed with industry stakeholders in holding that determining every chemical substance in a finished product would be too costly and time-consuming for manufacturers, processers, and importers. The Agency appears to be contemplating a very different stance.
“It’s simply not tenable for industry to complain about a rule regulating articles because they don’t know what’s in them,” Freedhoff said. She also stressed that “companies are already required to know what is in their products in order to comply with European Union regulations, which require reporting for products which contain chemicals identified as a ‘substance of very high concern.’”
While her speech did not contain an announcement of new regulatory actions, industry analysts believe her comments contain an important warning signal industry would be negligent to overlook.
Her comments strongly suggest the EPA may be moving to a position that requires manufacturers, processors, and importers offering commercial sales of a “finished article” to provide documentation on every chemical contained in those products.
“Freedhoff did, however, refer to existing regulatory actions for phenol, isopropylated phosphate (3:1) (PIP (3:1)) and Per- and polyfluoroalkyl substances (PFAS) that may be a model [for regulating all chemicals in finished products],” states The Nickel Report, a blog by environmental and energy law firm Hunton Andrews Kurth LLP. “In three recent regulatory actions, EPA has required, or proposed to require, that importers of articles (including finished products) know whether or not PFAS chemistries or PIP (3:1) are in any product that is imported or processed. These high-profile regulatory actions had already caught the attention of many industry stakeholders who manufacture or import finished goods—and Freedhoff’s remarks should prompt all potentially affected companies to take steps to prepare for compliance now.”
Industry challenges to address
To be ahead of regulatory challenges, The Nickel Report advises:
- “Addressing future regulatory actions broadly applicable to ‘articles.’ The priority chemicals EPA is likely to take future action on include: 1) the first 10 chemicals where EPA has completed risk evaluations and will be moving to risk management; 2) the 20 chemicals where EPA has released scoping documents and will be preparing risk evaluations; and 3) those chemicals where manufacturers have requested risk evaluations. The full list of these chemicals, and their review status, can be found here. … In addition to these chemistries where EPA is already considering risk management or actively working on a risk evaluation, EPA will likely look to the 2014 TSCA workplan for the next set of chemistries it will evaluate under TSCA.
- Complying with the proposed PFAS reporting rule. If the PFAS reporting rule is finalized as-is, it will require manufacturers and importers of articles to report 10 years’ worth of data regarding the manufacture and import of articles containing PFAS. The data required to be reported includes information related to chemical identity, categories of use, volumes manufactured and processed, by-products, environmental and health effects, worker exposure, and disposal. Many—if not most—finished goods manufacturers and importers will not have ready access to this information. In fact, they may not even know that their products even contain PFAS, especially if it is present in low amounts. However, the proposed rule does not currently have exemptions for low levels or impurities—nor does it have an exemption for ignorance. Companies will need to invest significant time and resources investigating their historical supply chains in order to rule in or rule out the need to report, and then even further resources will be needed for actually reporting.
- Navigating concurrent jurisdiction with the Consumer Product Safety Commission (CPSC). Many companies are already familiar with the CPSC, which has authority over consumer products, or any products produced and distributed for ultimate consumer use (and not industrial use). Should EPA move forward with regulating ‘articles,’ it will be regulating many goods over which the CPSC will have concurrent authority. The CPSC and EPA have equal authority to ban chemicals from consumer products. If EPA issues a final rule banning a chemical—as it did with the PBT chemicals—there may be questions as to whether the presence of the chemical in a consumer product should immediately be construed to be a ‘substantial product hazard’ for which products must be recalled. This could trigger an obligation to recall products already on the market even if EPA’s ban does not become effective until several years in the future. Further, EPA action in the finished product space could significantly constrain the CPSC from issuing its own rules concerning chemicals in consumer products for fear of creating compliance conflicts.”
To forecast what may lie ahead, industry should carefully consider recent EPA actions regarding persistent, bioaccumulative and toxic (PBT) chemicals, particularly phenol, PIP (3:1), and PFAS. In January 2021, the EPA took action to remove PBT chemicals from certain products. When stakeholders complained about the burdens of this type of compliance, the EPA issued a 6-month “No Action Assurance” enforcement deferral and extended the compliance deadline to March 8, 2022. While the EPA may yet again extend the compliance deadline, the Agency has been very clear that industry is expected to document the “concrete steps” it has taken to work toward compliance with these new regulations.