So…”what is TSCA”?
The Toxic Substances Control Act (TSCA or TOSCA) was passed by Congress in 1976. It is a law administered by the U.S. Environmental Protection Agency (EPA), that regulates the introduction of new or already existing chemicals. TSCA has three main objectives:
1) to assess and regulate new commercial chemicals before they enter the market
2) to regulate chemicals already existing in 1976 that posed an “unreasonable risk to health or to the environment”, i.e. PCBs, lead, mercury and radon;
3) to regulate these chemicals’ distribution and use.
On January 6, 2021, the U.S. Environmental Protection Agency (EPA)’s Office of Pollution Protection and Toxics (OPPT) published the final rules for Section 6(h) of TSCA. This restricts entities from placing a product containing any of five newly classified toxic substances on the market. Non-compliance under this section, 15 U.S.C. 2615 and Title 18 of the U.S. Code, can lead to civil penalties.
Known as persistent, bioaccumulative, or toxic (PBT) chemicals, this grouping of restricted substances includes:
▹ Phosphate flame retardant and plasticizer2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP)
▹ Brominated flame retardant
▹ Antioxidant, lubricant, and fuel additive
▹ Chlorinated hydraulic, heat transfer, or transformer fluid
▹ Chlorinated plasticizer
Most of the substances will be restricted to a 0% threshold under the EPA’s definition of an “Article,” which is similar to requirements under the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) Regulation. However, these new substances aren’t restricted by the REACH Regulation, so only those companies with full material disclosures (FMDs) for their products will be fully capable of evaluating this particular risk.
The final rules of Section 6(h) were passed on February 5, 2021, and came into full effect on March 6, 2021, for product manufacturers. This all means companies without this data are potentially non-compliant with requirements needed for U.S. market access. Distributors, for some of the products containing the substances, may have until January 6, 2022, or later.
Of the five newly restricted substances, PIP 3:1 may have the greatest industry impact. It may replace older restricted brominated flame retardants in some products. It is also an additive in thermoplastics and resins for compliance with electrical safety standards and rubberized materials (e.g. seals, gaskets) used in fuel and hydraulic applications.
Companies that manufacture and place products containing PIP 3:1 on the market are expected to notify their customers of these restrictions. Also, due to the wide use of these substances, companies in the electronics, industrial equipment, medical, aerospace and defense, and automotive industries should immediately evaluate their product landscape. Fastbolt requires that all procured product either comply with the Toxic Substance Control Act (TCSA) at the time of manufacture (positive certification) or not be subject to TSCA requirements (negative certification).
It would be prudent to engage your supply chain to identify which of your products could contain these five substances over the restricted threshold.