TSCA’s impact on global supply chains

The law is extending its impact beyond the US – North America Managing Editor Kelly Franklin explains why this matters.

Kelly Franklin_

by Kelly Franklin

The Toxic Substances Control Act (TSCA) has been the US federal chemical law since it was first implemented in 1976. It was significantly amended under the Frank R Lautenberg Chemical Safety for the 21st Century Act in 2016. So far, TSCA’s greatest impact has been on companies and suppliers operating inside the US but, as the law develops, that is set to change.

Speaking at the 2023 Chemical Watch Expo, North America Managing Editor Kelly Franklin – an expert on TSCA – shed light on how the law is expanding its impacts beyond the US. In this summary, we share highlights from her presentation and explore the implications for your compliance.


Understanding TSCA’s transformation

The  2016 amendments brought about a significant overhaul of the TSCA statute, prompting a surge of activity over the past few years. The Environmental Protection Agency (EPA) has been working to interpret the law under different US presidential administrations, which has resulted in an unsettled environment for understanding how the law should be understood and applied.

TSCA is fundamentally a different law following the 2016 amendment. Consequently, its impact on global supply chains is expected to continue to grow. Several suppliers have already been caught off guard by new TSCA requirements, highlighting the need for proactive risk management for companies placing products in the US market.


PBTs: a sign of things to come

One area where TSCA has already exerted its influence is on persistent, bioaccumulative, and toxic (PBT) substances. Under TSCA Section 6(h), the EPA was required to take ‘expedited action’ to reduce exposures to five PBT substances identified in 2016.

The EPA proposed risk management rules for this set of substances in 2019, aiming to reduce exposure to the extent practicable. The final rules took effect in January 2021, introducing bans on many uses of these chemicals, with some exceptions and extensions.

Shortly after the final rules took effect, significant concerns arose regarding restrictions on the flame retardant PIP (3:1) after the electronics industry highlighted its widespread use in wire coatings in electronics goods and the potential impact of restrictions on US commerce.

After discussions, the EPA offered an enforcement discretion, giving the electronics industry until 2024 to comply.

A similar scenario unfolded with decaBDE in early 2023. The nuclear energy sector had received a two-year extension to comply with a prohibition on decaBDE in certain articles. The extension was in response to a key supplier requesting additional time to comply.

When that extension expired, the industry alerted the EPA that most of the nuclear energy sector had only recently become aware of the requirement and had not participated in the earlier rulemaking process. The EPA offered a further extension as an enforcement discretion but signalled its frustration with industry’s supply chain communication lapse.

Why does this matter?

The EPA is just getting started issuing risk management rules under TSCA section 6(a). The PBTs were expedited rules that signaled the agency’s approach. Now it has completed its risk evaluations for the first ten chemicals, the EPA is beginning to address high production volume chemicals used in a huge range of applications.

For example, the EPA has already proposed restricting most commercial and all consumer uses of methylene chloride and perchloroethylene. Proposed restrictions for other high-priority chemicals like trichloroethylene and carbon tetrachloride are expected soon, with dozens of others to follow in the coming years.

PFAS reporting rule: a potential compliance challenge

Another significant development in the TSCA program is the proposed PFAS reporting rule under TSCA section 8. Although the rule is still in the proposal stage, it has the potential to create substantial challenges for the industry once adopted.

Under the proposed rule, any entity that manufactured or imported any per- and polyfluoroalkyl substances (PFASs) since 2011 will be required to report detailed information on them. Importantly, the proposed rule does not exempt imported articles. Therefore, if a business has imported any PFAS-containing articles into the US since 2011, it will be subject to this reporting requirement as currently proposed.

It’s likely that businesses involved in the supply chain of PFAS-containing articles imported into the US may start receiving enquiries from customers related to compliance under this rule.

It’s worth noting that the proposed PFAS reporting rule includes a structure-based definition of PFAS. It covers about 1,300 substances, but without specific CAS numbers, adding further complexity to compliance efforts. It is also possible that the definition may be different in the final version of the rule.

The EPA is expected to issue the final PFAS reporting rule later this year, making it essential for companies to proactively prepare. It’s never too soon to start assessing your global supply chains and understanding the PFASs present in products.

An Initial Regulatory Flexibility Analysis (IRFA) released in November estimated the proposed PFAS reporting rule would affect more than 130,000 companies, 99.8% of which are article importers. The estimated compliance cost is nearly $876m, highlighting the significant financial implications for businesses affected.

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