EPA Releases New Framework Addressing New PFAS And New Uses Of PFAS In The Market

July 18, 2023

Read the full article by Cliff L. Rothenstein, Dawn M. Lamparello, B. David Naidu, and Julia A. McGowan (K&L Gates)

"On Thursday, 29 June 2023, the US Environmental Protection Agency (EPA) announced a new framework (Framework) that will impact manufacturers across the country. The Framework lays out a new process for reviewing and assessing the potential environmental risks posed by new and new uses of per- and poly-fluoroalkyl substances (PFAS). This PFAS Framework establishes more stringent pre-market screening procedures for certain PFAS chemicals that may be harmful to human health or the environment. Under the Framework, the EPA will review and take appropriate action for new PFAS or significant new uses of existing PFAS through pre-manufacture notices (PMNs) and significant new use notices (SNUNs) through the EPA’s authority under the Toxic Substances Control Act (TSCA).

BACKGROUND

PFAS are a class of fluorinated chemicals used in various consumer products and are commonly known as “forever chemicals” due to their high resistance to degradation. There are thousands of different PFAS, and only a small fraction of them have been well studied. In October 2021, the EPA announced a broad “PFAS Strategic Roadmap” aimed at researching and regulating the presence of PFAS in the environment. According to the EPA, this new PFAS Framework advances the EPA’s Roadmap through the “New Chemicals Program” mandated by TSCA Section 5.

The New Chemicals Program regulates “new chemicals” by requiring anyone who plans to manufacture them to provide the EPA with a PMN at least 90 days prior to manufacture, subject to certain exemptions. Under TSCA, a “new chemical” is any chemical that is not currently on the TSCA inventory, which is a list of chemicals that are already deemed “existing” in US commerce. Therefore, when new chemicals are created, the EPA reviews them under the New Chemicals Program to ensure their entrance into the market will not pose significant health concerns or dangerous environmental releases. Manufacturers are also subject to a 90-day notice requirement if they wish to engage in the use of a chemical that the EPA has deemed a “significant new use” from what had previously been approved by the agency under a prior PMN submission, by way of a SNUN submission."