On September 28, 2023, U.S Environmental Protection Agency (EPA) announced an important new rule under the Toxic Substances Control Act (TSCA), requiring manufacturers of per- and polyfluoroalkyl substances (PFAS) to provide more data for better regulation. PFASs are a large class of chemically stable organic fluorides known for their water and stain resistance, as well as good insulation. They find extensive use in various industrial sectors, including food packaging, electronics, leather and apparel, construction and household applications, firefighting, and medical supplies. However, PFASs are persistent and migrate in the environment, making them difficult to degrade. They are also called persistent chemicals and have posed a significant threat to human health and the ecological environment.
The new rule requires anyone who has manufactured (including imported) PFAS or PFAS-containing articles since January 1, 2011 to report certain data to EPA, including PFAS uses, production volumes, disposal, exposures, and hazards. However, PFAS used in pesticides, food, food additives, pharmaceuticals, cosmetics or medical devices are exempt from this rule. This rule will come into effect on November 13, 2023.
According to 40 CFR Part 705 issued by the EPA, PFAS is defined as including at least one of these three structures:
(1) R–(CF2)–CF(R’) R”, where both CF2 and CF moieties are saturated carbons;
(2) R–CF2OCF2–R’, where R and R’ can either be F, O, or saturated carbons; and
(3) CF3C (CF3) R’ R”, where R’ and R” can either be F or saturated carbons;
EPA has determined that at least 1462 PFAS known to have been made or used in the U.S. since 2011 will be subject to the final rule, better capturing the important data the agency needs to protect human health and the environment from these chemicals.
According to the new rule, enterprises have manufactured (including imported) PFAS since 2011 will have 18 months following the effective date of this rule to report PFAS data to EPA. Small enterprises that only report imported PFAS-containing articles will have 24 months from the effective date of this rule to report PFAS to EPA. Enterprises that fail to comply will be subject to civil penalties.
Additionally, on October 20, 2023, the U.S EPA finalized rule to require enhanced PFAS reporting to the Toxics Release Inventory (TRI).
In order to better regulate the persistent chemicals, the U.S. EPA improved reporting on PFAS to the TRI by eliminating an exemption that allowed facilities to avoid reporting information on PFAS when those chemicals were used in small concentrations. Because they are used at low concentrations in many products. This change enables the EPA to acquire more comprehensive PFAS data for better environmental protection and public health preservation.
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