The EPA has finalized its enhanced reporting requirement for substances commonly known as “forever chemicals.” Assent’s Cally Edgren digs into the widespread effects for companies that make or sell manufactured goods.
In October, the EPA published its final rule regarding reporting obligations for manufacturers and importers of per- and polyfluoroalkyl substances (PFAS), more commonly referred to as “forever chemicals.” The new rule, under Section 8(a)(7) of the Toxic Substances Control Act (TSCA), requires manufacturers to report the manufacture and/or import of PFAS chemicals to the EPA for each year dating back to 2011.
This includes PFAS in imported “articles,” such as in a surface coating or electrical insulation). These reports must include complex information, including PFAS identity, categories of use and production or import volumes. The EPA estimates that at least 1,462 chemicals are “PFAS,” according to the definition of this rule, half of which are actively used in the U.S. market.
Final reports for most manufacturers and importers must be submitted by May 8, 2025 (small manufacturers may be allowed an additional six months).
This announcement is expected to have far-reaching impacts on industry, and compliance professionals need to prepare accordingly. Because analytical testing for most PFAS chemicals is not possible, the EPA recommends collecting this information from suppliers. Without visibility into PFAS in the materials companies purchase, they could lose customers, experience part shortages and face increased costs.
Why PFAS are being phased out
PFAS have been increasingly scrutinized because they are persistent in the environment and create potential health risks. These substances are resistant to degradation and bioaccumulate in the body. According to national health authorities, about 97% of Americans have PFAS in their bloodstreams.
Research has indicated that exposure to certain PFAS may lead to negative health effects, including increased risk of thyroid disease, higher blood cholesterol levels, decreased vaccine response, reduced fertility in women, heightened risk of high blood pressure and preeclampsia and lower infant birthweight.
Given these potential risks and the durability of PFAS, regulatory bodies worldwide are moving toward stricter control and eventual phase-out of these substances. Increasing regulatory oversight, coupled with growing public awareness and concern, underscores the need for businesses to act quickly — not only to understand and comply with rapidly emerging PFAS regulations but to anticipate increasing business disruptions caused by supply chain shortages, customer demands and investor and insurer scrutiny.
Why this is a ‘scope-proof” issue
The new TSCA Section 8(a)(7) PFAS reporting requirements cover businesses that have manufactured or imported PFAS since Jan. 1, 2011. This includes the importation of PFAS already incorporated into articles, such as those containing PFAS as part of surface coatings or included in electrical equipment. Notably, there are no de minimis exemptions for small-volume importers or small businesses, meaning all in-scope companies must comply regardless of their size or the volume of goods they import.
However, the EPA has streamlined reporting requirements for manufacturers that only import PFAS in articles and for businesses that only produce or use small quantities (under 10 kg) for research purposes. These regulations do not cover waste management activities involving the importation of municipal solid waste streams for disposal or destruction, nor do they extend to certain federal agency activities.
Despite the specific scope of this new rule, it will have wide-reaching impacts for companies and compliance professionals far beyond its immediate purview.
Increased customer PFAS data requests
With the official EPA announcement, expect a surge in customer inquiries about your product’s components and PFAS compliance. Customers that request “no PFAS” declarations will expect to receive them promptly to show their own due diligence. Failure to respond quickly can harm your bottom line as buyers swap out suppliers for those that are faster at proving compliance.
Competition for PFAS-compliant parts & suppliers
Growing PFAS regulations around the globe are triggering a race for both existing stock (before suppliers replace PFAS-containing materials) and PFAS-free stock (as everyone shifts to new sources at the same time), driving competition for parts (as well as costs and delivery times) through the roof. Having detailed information about your PFAS usage and what’s coming from your supply chain is vital to getting a head start on identifying your supply chain risks and securing the materials you need.
Major chemical manufacturers like 3M have already announced they’ll be discontinuing PFAS products due to investor and liability pressures, coupled with decreased demand. PFAS restrictions are also affecting manufacturing processes and facilities. Your maintenance, repair and operations (MRO) may depend on a PFAS product, such as processing chemicals, lubricants or components like o-rings or gaskets, which may need to be swapped out for compliant alternatives. You will need to evaluate whether any MRO-related purchases in your supply chain contain PFAS and validate whether they are subject to new federal or state reporting requirements — including any materials that you are importing. In some cases, you may need to make capital investments to update or even replace entire pieces of equipment that are incompatible with compliant alternatives.
Preparation must begin now
The new EPA reporting rule on PFAS makes it vital for businesses to adopt an aggressive approach to ensure compliance by the reporting deadline. This includes engaging suppliers to collect PFAS data to meet reporting requirements as well as to address customer demands. With other growing global PFAS regulations, you can also expect intensifying competition for PFAS-free parts and suppliers, leading to a scarcity of PFAS-containing materials as major chemical manufacturers discontinue PFAS products. It’s necessary to understand where PFAS are in all of your purchased materials so you not only can meet EPA reporting requirements but develop longer-term compliance plans and supply chain risk management strategies.
In this ever-changing regulatory landscape, preparation must begin right away. PFAS regulations are already affecting market access for many products, as well as manufacturing processes and operations in facilities. With new regulations emerging on a rapidly increasing basis, even manufacturers that haven’t been affected by PFAS usage yet are starting to feel the regulatory, supply chain and customer pressures.
Ensuring compliance with the new TSCA reporting rule, as well as those coming out of other jurisdictions like the state of Maine, requires an in-depth understanding of the PFAS chemicals in your supply chain and a robust system for collecting and managing PFAS data. With the right approach and resources, businesses can successfully navigate these changes and maintain their competitive edge in the market.