Low Volume Exemptions Eliminated for PFAS Chemicals

Certain low-volume chemicals, particularly ones manufactured in quantities less than 10,000 kg/year, are exempt from full premanufacture notice (PMN) review under the Toxic Substances Control Act (TSCA). In late April 2021, the U.S. Environmental Protection Agency (EPA) released a statement essentially excluding PFAS (per- and polyfluoroalkyl substances) from low volume exemptions (LVEs). In this blog post, we take a closer look at PFAS and the corresponding policy change.

Per- and Polyfluoroalkyl Substances

PFAS are synthetic chemical compounds characterized by the presence of strong carbon-fluorine bonds. Because of this, these substances are highly resistant to degradation and, as a result, tend to persist in the environment. PFAS are used extensively in many different industries, such as automotive, construction, defense, and more. These chemicals are found frequently in food, drinking water, and many household products. Because of their extensive use and their environmental persistence, human exposure is common.

PFAS can present a variety of risks to human health. While research continues to be conducted to better understand the full spectrum of health effects posed by these substances, a number of studies of humans exposed to PFAS have indicated that these chemicals may result in:

  • a compromising of the body's immune system
  • a disruption of the body's hormonal levels
  • hypercholesterolemia
  • an increased cancer risk

Given the risks associated with them, the manufacture and use of certain PFAS chemicals has been banned in the United States. It is anticipated that this will remain a controversial topic for some time as research on it continues.

A Change in Policy

The policy change regarding LVEs is a reflection of the increased steps the EPA is taking to improve PFAS management and regulation. Aimed at keeping potentially dangerous PFAS chemicals from being introduced onto the market, it is anticipated this will have a significant impact on companies that deal with these chemicals in any capacity. In addition, the Agency is taking an extra step in this regard by asking many companies to voluntarily withdraw previously granted LVEs. Ongoing, the EPA will review new LVE applications on a case-by-case basis. The change in policy is also designed to ensure that for those PFAS chemicals that do enter the market, a thorough review is conducted, and relevant safeguards are implemented.

Accessing Critical Information on PFAS and Other Chemicals

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