EPA is renewing a program to work cooperatively with companies to voluntarily withdraw all previously granted low volume exemptions (LVEs) for per- and polyfluoroalkyl substances (PFAS). This will build upon a 2016 outreach effort that resulted in companies withdrawing more than half of the 82 long-chain PFAS LVEs targeted for withdrawal at the time. For this 2021 expanded effort, the majority of the LVEs remaining for which EPA will be soliciting voluntary withdrawals are the shorter chain PFAS LVEs. Under this effort, EPA plans to leverage partnerships with trade associations, non-governmental organizations, and direct outreach to companies to develop a workable path forward for all parties involved. EPA intends to provide progress updates to highlight the PFAS LVE withdrawals, as appropriate, of those stakeholders that help to support and deliver on the goal of this PFAS LVE Stewardship Program.
Section 1: The EPA’s Role in Reviewing New Chemicals
Existing Federal law authorizes EPA to review “the safety of the manufacture, importation, or use of any article, or the condition of any article, based on new information which becomes available, and to issue or revoke any written approval or registration, or any other permission.”21 EPA must establish a process for considering, evaluating, and taking action on changes in information about existing information as it relates to the safety of the manufacture, importation, or use of any article.
TSCA and the Importance for Chemical Safety
TSCA has been in place since 1971. It requires companies to test for TSCA-regulated substances in industrial facilities, commercial production facilities, and lab facilities, and to develop methods to eliminate the release of TSCA-regulated substances. Although TSCA was not a requirement of new chemical registrations until 1994, as of July 2018, approximately 140 chemical substances are currently regulated by TSCA, including more than 250,000 compounds. Responsible management of chemical substances is critical for health and safety, due to the risk they pose to the environment and people. TSCA also plays a key role in protecting workers and protecting the public from unexpected and unanticipated releases, both in manufacturing facilities and out of them.
What is the PFAS LVE Stewardship Program?
EPA is requiring that all companies who applied for a long-chain PFAS LVE under the 2015 Update (then known as the PFOS/PFOA Phase 2b) withdraw their applications. In addition, EPA will be reviewing the applications of companies that submitted long-chain PFAS LVEs after the 2015 Update and are seeking to have their LVEs withdrawn. Who can withdraw a LVE? EPA is seeking LVEs for which there are no meaningful alternatives available to EPA. The agency will review those applications and the submission of information demonstrating that there are no acceptable alternatives to these products. EPA has not yet determined the effective date of this expanded program.
Some Background on PFAS
PFAS are synthetic chemicals that have been in use since the 1940s. They are man-made materials that are found in non-stick, stain-resistant, waterproof, and other protective coatings used for everyday use. PFAS can be created in several ways, including the production of fuel and other substances. Although PFAS chemicals have been extensively studied, their human health effects are not well understood, and they have been detected in humans in the drinking water and food supply. They are known to have effects on reproduction, immune function, and the ability to smell, as well as other human health effects, including developmental effects and carcinogenicity. PFAS are often grouped into six major groups based on physical, chemical, and biological properties.
Why Does This Matter?
The use of chemicals in manufacturing is fundamental to modern life. A recent Food and Drug Administration report indicated that all Americans should be concerned about potential exposures from contaminants in consumer products.1EPA’s previous removal program sought to address the lack of access to safer options in chemicals by withdrawing 62 long-chain PFAS LVEs. This work has helped to reduce the exposure of public health for the hundreds of millions of Americans who are exposed to PFAS, through use in commercial food processing, non-stick cookware and stain repellents, flame retardants, medical devices, and carpets and upholstery. EPA identified an emerging public health threat to infants through prenatal exposure to PFAS.
PFAS chemicals in general pose significant health and environmental risks, as there is a clear need for public information about the safe disposal, environmental impact, and best management practices for these chemicals. As EPA reviews and develops proposed cleanup guidelines for specific PFAS chemicals, the Agency will continue to take into consideration best practices established by stakeholders across industries, states, local communities, and tribes. Similar to the approach taken for PFOS/PFOA, EPA is also undertaking a comprehensive study to collect data to assess the potential health impacts of perfluorinated chemicals (PFCs) from drinking water.