In a speech at the Product Stewardship Society’s annual meeting on September 28, 2021, Michal Freedhoff, EPA’s chemical program manager, “clearly expressed the Agency’s intention to back off and seek aggressively. to regulate finished articles as part of the control of toxic substances. Law (TSCA) ”, according to analysis in JD Supra by law firm Jenner & Block LLP. “Historically, the US EPA has focused on the manufacture or import of chemicals and chemical mixtures as opposed to finished items. However, in his written remarks, Freedhoff focused on the 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 into bulk or in an article, it may be subject to regulation under the TSCA. “
TSCA regulations define “finished articles” as finished products that are not classified as firearms, foods, food additives, pesticides, appliances, or cosmetics.
Traditionally, the EPA has agreed with industry stakeholders that determining each chemical in a finished product would be too expensive and time consuming for manufacturers, processors and importers. The Agency appears to be considering a very different position.
“It’s just not tenable for the industry to complain about a rule regulating items 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 the declaration of products containing chemicals identified as a ‘substance of very high concern'”.
While his speech did not contain an announcement of new regulatory measures, industry analysts believe his comments contain an important warning signal that the industry would be remiss to overlook.
His comments strongly suggest that the EPA may evolve into a position that requires manufacturers, processors and importers offering commercial sales of a “finished article” to provide documentation for each chemical contained in those products.
“Freedhoff did however refer to existing regulatory measures for phenol, isopropyl phosphate (3: 1) (PIP (3: 1)) and per- and polyfluoroalkyl substances (PFAS) which could 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, the EPA has required, or proposed to require, that importers of articles (including finished products) know whether PFAS or PIP (3: 1) chemicals are present in any imported or processed product. These high-profile regulatory actions had already caught the attention of many industry players who manufacture or import finished products, and Freedhoff’s remarks should prompt all potentially affected companies to take action to prepare for compliance now. .
The challenges facing the industry
To stay ahead of regulatory challenges, The Nickel Report advises:
- “Address future regulatory actions broadly applicable to” articles “. Priority chemicals on which the EPA may take action in the future include: 1) the top 10 chemicals for which the EPA has completed risk assessments and will move to risk management; 2) the 20 chemicals for which the EPA has published scoping documents and will prepare risk assessments; and 3) chemicals for which manufacturers have requested risk assessments. The full list of these chemicals and their review status can be viewed here. … In addition to those chemistries where the EPA is already considering risk management or actively working on a risk assessment, the EPA will likely be looking at 2014 TSCA work plan for the next round of chemistries, it will be evaluated under the TSCA.
- Comply with the proposed PFAS reporting rule. If the PFAS declaration rule is finalized as is, it will oblige manufacturers and importers of articles to declare 10 years of data concerning the manufacture and import of articles containing PFAS. The data to be reported include information on chemical identity, categories of use, volumes manufactured and processed, by-products, environmental and health effects, worker exposure and disposal. . Many, if not most, manufacturers and importers of finished products will not have easy 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 currently has no exemptions for low levels or impurities, nor an exemption for ignorance. Companies will need to invest significant time and resources to investigate their historical supply chains to exclude or exclude the need to report, and additional resources will then be required to actually report.
- Navigate competing jurisdiction with the Consumer Product Safety Commission (CPSC). Many companies are already familiar with the CPSC, which has authority over consumer products, or any product that is manufactured and distributed for consumer end use (not industrial use). If the EPA goes ahead with “articles” regulation, it will regulate many goods over which the CPSC will have concurrent authority. The CPSC and EPA have equal authority to ban chemicals in consumer products. If the EPA issues a final rule banning a chemical, as it has done with PBT chemicals, questions may arise as to whether the presence of the chemical in a consumer product should be immediately interpreted as a “Substantial product hazard” for which the products must be recalled. This could trigger an obligation to recall products already on the market even if the EPA ban does not come into effect for several years in the future. In addition, the EPA’s action in the area of finished products could significantly prevent the CPSC from issuing its own rules for chemicals in consumer products for fear of creating compliance conflicts.
To predict what lies ahead, industry should carefully consider recent EPA actions regarding Persistent, Bioaccumulative, and Toxic Chemicals (PBTs), particularly phenol, PIP (3: 1) and PFAS. In January 2021, the EPA took action to eliminate PBT chemicals from certain products. When stakeholders complained about the burden of this type of compliance, the EPA issued a 6-month postponement of the application of “no-action insurance” and extended the compliance deadline until March 8, 2022. While the EPA may further extend the compliance deadline, the Agency has been very clear that industry should document the “concrete steps” it has taken to comply with these new regulations.