FDA Announces Three-Year Phase-Out of PFAS Used in Food Packaging; FDA Studies Indicate Non-Detectable Levels of PFAS in General Food Supply

Food and Agriculture Law  

August 31, 2020

The United States Food and Drug Administration (FDA) recently announced that several manufacturers of certain short-chain per- and polyfluoroalkyl substances (PFAS) used in food packaging have voluntarily agreed to phase-out the use of such PFAS compounds over the next three years. The specific PFAS compound at issue, 6:2 Fluorotelomer alcohol (6:2 FTOH), is a short-chain polymeric PFAS compound commonly used to help “grease-proof” food packaging such as pizza boxes and cheeseburger wrappers.

The FDA’s announcement comes in the wake of recent studies indicating the potential that 6:2 FTOH may accumulate in humans from chronic dietary exposure. Although the underlying studies evaluating the health effects of 6:2 FTOH were conducted on rodents and at higher doses than would be expected in humans, the FDA concluded that the potential health risks from 6:2 FTOH have been underestimated.

Although the FDA previously authorized the use of these compounds in food packaging, three large manufacturers voluntarily agreed to phase-out their sale of substances containing 6:2 FTOH over the next three years starting in January 2021. A fourth manufacturer previously indicated that it already stopped the sale of substances containing short-chain PFAS compounds in the U.S. marketplace. The FDA indicates it will monitor the progress of this phase-out.

At the same time, the FDA has continued to evaluate the presence of PFAS in the general food supply. So far, the FDA has concluded that essentially no food products contain detectable levels of PFAS. A small handful of tests indicated detectable levels of perfluorooctane sulfonic acid (PFOS)—one of the most common PFAS compounds—in ground turkey and tilapia, but the FDA concluded that the trace levels of PFOS were not a health concern for humans.

These developments are positive news for food producers. These developments may also inform standard setting under the federal and various state drinking water programs. In general, drinking water Maximum Contaminant Levels (MCLs) take into consideration the level of exposure to a contaminant in foods through an adjustment factor knows as the “relative source contribution” or “RSC.” If human exposures occur mostly or exclusively through drinking water, and not through the food supply, that would be expected to result in higher MCL values.