On October 13, 2022, Earthjustice, on behalf of numerous environmental organizations and community advocates throughout the country, filed a petition with EPA requesting that the Agency revoke the approval of approximately 600 PFAS Low Volume Exemptions (LVEs) and Low-Exposure Exemptions (LoREXs) to the TSCA Premanufacture Notice (PMN) requirement. The petition argues that EPA has a regulatory and statutory duty under 40 C.F.R. § 723.50(h)(2)(i)(A) to review previously granted LVEs and LoREXs to ensure they meet legal standards for exemption under TSCA section 5 (h)(4). (Earthjustice states that 40 C.F.R. § 723.50(h)(2)(i)(A) implicitly requires EPA to notify a manufacturer “at any time after the [initial] review period,” if it determines that a previously granted exemption no longer meets the legal standard, is that EPA must continue to evaluate chemicals’ eligibility for PMN exemptions in light of new information.)
PMN exemptions require that a substance “will not present an unreasonable risk.” The petition argues that this conclusion cannot be scientifically supported for the exposure levels allowed under the LVEs and LoREXes that have been granted. The petition notes that EPA has the authority to revoke a previously granted exception at any time if it no longer meets TSCA’s legal standards. When it issued the LVE rule in 1985, the Agency detailed its revocation authority, explaining that the authority “ensure[s] that eligibility for the exemption will be determined on the basis of the best available information [i.e., scientific evidence], regardless of when the information becomes available.” EPA made a similar statement regarding LoREXes in 1995. The petition noted that this obligation is further stressed in case law that holds that EPA and other federal agencies have a general duty to consider new scientific information that may bear on whether the Agency’s past decisions or standards are health-protective, and to modify past decisions to ensure legal requirements are met.
The petition further argues that EPA’s prior initiatives to address PFAS LVEs do not adequately address health risks. Earthjustice highlights numerous studies related to PFAS and human, animal, and environmental health, as well as EPA’s own statements indicating that it expects that chemicals entering commerce through both LVE and LoREX will result in levels of contaminations that far exceed what are now thought to be safe levels for PFAS.
This petition builds on Earthjustice’s 2021 petition that asked the Agency to amend the regulations that create exemptions from the PMN process—the LVE, the LoREX, the Byproducts Exemption, and the Polymer Exemption—to prohibit their use for PFAS. The Agency has not yet responded to that request. TSCA section 21 permits any person to petition EPA to initiate a proceeding for the issuance, amendment, or repeal of a rule or order under TSCA section 4 (rules or order requiring chemical testing), section 5(d) or (f) (orders affecting new chemical substances) section 6 (rules imposing regulatory controls on chemicals), and section 8 (rules requiring information).