In a dramatic announcement last week, EPA suggested that if companies import, manufacture, or process a finished good for commercial sale, and that product is not a pesticide, not a firearm, not a tobacco product, and not a food, food additive, drug, cosmetic, or device, they will need to know all chemicals contained in those products. We explain more about this below.
EPA has traditionally declined to extend most of its chemical regulations to finished goods, which are known as “articles” under the Toxic Substances Control Act (TSCA), on the grounds it would be enormously difficult for importers of complex consumer products to determine the chemical identity of each chemical substance in these products. Industry stakeholders have generally supported this approach and have long taken the position that supply chains are too complex to expect finished product manufacturers to be aware of all chemicals in those products.
But Michal Freedhoff, head of the EPA chemicals program, signaled last week that EPA may be shifting course to a new approach for articles. In a bold keynote address at the annual meeting of the Product Stewardship Society, Freedhoff noted that EPA unquestionably has the authority under TSCA to regulate chemicals in manufactured goods and finished products—even if it has not often exercised that authority in the past. She said, “It’s simply not tenable for industry to complain about a rule regulating articles because they don’t know what’s in them.” Freedhoff further emphasized 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 Freedhoff did not announce any new regulatory actions, this potential new direction for EPA has important—and very serious—implications for nearly every company involved in manufacturing, importing, distributing, or selling finished goods.
Recent Regulatory Actions on Articles PIP (3:1) and PFAS May Preview EPA’s New Direction
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. 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.
First, in the January 2021 release of regulations on five persistent, bioaccumulative and toxic (PBT) chemicals, EPA took action to remove these PBT chemicals from certain articles. For one of the five PBT chemicals, PIP (3:1), EPA’s action became a concern for stakeholders who may have PIP (3:1) in their products but were unaware of the EPA rulemaking. In light of the serious compliance difficulties, in March 2021 EPA issued a “No Action Assurance” deferring enforcement of the rule for six months and subsequently extended the compliance deadline to March 8, 2022. EPA intends to further extend the compliance date through rulemaking but has made it clear that it expects industry to provide documentation of “concrete steps taken” to identify substitutes, information on needed updates to specific certifications, and time estimates for this work. In her recent remarks, Freedhoff emphasized that “without this more specific information, EPA will be unlikely to extend the compliance dates again.”
Second, in July 2020, EPA announced in a final rule that it would require reporting and review of articles containing certain PFAS (Significant New Use Rule for Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances, or “PFAS SNUR”). The PFAS SNUR requires that EPA be notified before certain long-chain PFAS are imported into the U.S. for use as a surface coating in an article (so that EPA can conduct a review and approve any of these uses).
Third, in June 2021, EPA proposed a rule that would require reporting from importers of articles containing PFAS. In the proposed rule, EPA asserted authority to regulate articles stating that “TSCA does not define articles, nor does the statute define articles as a category of substances exclusive of chemical substances. EPA, therefore, considers its ability to regulate chemical substances to encompass authority to regulate articles containing such chemical substances.” Although many industry stakeholders have criticized the proposed rule as impractical for articles given that many companies are not privy to processes and chemicals used upstream in the supply chain, Freedhoff’s remarks suggest that EPA may nevertheless require reporting regarding articles.
Current EPA Proposals May Exceed the Scope of European Union (EU) Regulations
In her remarks, Freedhoff implied that extending TSCA regulations to articles may pose less of a burden than claimed because EU regulations already require companies to have some level of knowledge regarding chemicals in products—at least for the EU’s “substances of very high concern” (SVHC). However, it is important to place Freedhoff’s comparison in context. Since June 1, 2007, the EU’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulations have required suppliers of articles to notify consumers when any of the SVHC chemicals are present at levels above 0.1%. Currently, this list contains 219 chemicals. A detailed understanding of these notification obligations can be found here.
Thus, the EU’s REACH notification obligations—broad though they may be—only extend to the 219 chemicals on the SVHC list. Moreover, there is a threshold level triggering reporting and notification obligations in the EU, further limiting companies’ responsibilities. But Freedhoff’s remarks did not suggest that TSCA regulations applicable to articles would be limited to any smaller set of chemicals, and EPA has omitted any threshold reporting level in its proposed PFAS reporting rule—a move that has drawn sharp industry criticism. A commonsense exemption, for example, would be for articles where PFAS may be present only as an impurity or byproduct. If EPA’s final rule requires reporting of PFAS in articles at any level—this would make EPA’s reporting obligations for articles markedly different (and potentially much broader) than the EU’s approach.
Navigating the Increasingly Complex Regulatory Landscape for Finished Goods
In short, it appears all but certain that EPA intends to move toward requiring manufacturers and importers of finished goods to comply with complex chemical regulations, many of which companies will have never before grappled. This is likely to pose serious compliance challenges and will require companies to devote significant resources to understanding regulations and gathering the data needed to comply. Several of these challenges may include:
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. These chemicals are extremely common chemicals and are likely to be found in almost every company’s supply chain. 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.
All indications suggest that product manufacturers and importers must include TSCA as an important component of their ongoing environmental compliance efforts. However, ensuring TSCA compliance will not be an easy or seamless task for many companies, particularly those that are unfamiliar with the law or unaccustomed to complying with EPA’s expanding universe of complex product regulations. Testing every product (and component of a product) may not be technically or economically feasible for many companies and products. Tracing a complex product’s composition down to the level of individual chemical constituents – including those in or on internal product components – may require communicating with suppliers around the world.
For a company that produces or imports a large number of complex consumer goods, this could be an expansive, if not monumental, undertaking. Product manufacturers and importers should begin to take steps now to become familiar with TSCA, monitor EPA’s chemical regulations, and be prepared to adapt and respond when those regulations are poised to impact their products.