This post was written by Tom Neltner, JD, Chemicals Policy Director, EDF, and Maricel Maffini, PhD, Consultant. It originally posted on EDF Health:
The Guardian recently published a powerful story by reporter Tom Perkins detailing how chemical manufacturers hid evidence of dangerous health impacts from certain types of PFAS and the Food and Drug Administration (FDA) did not take sufficient and swift action to protect the public.
The story is largely based on data revealed in the FDA’s response to a Freedom of Information Act request by EDF and Environmental Working Group. The analysis showed that two major PFAS manufacturers, Daikin and DuPont, withheld safety information from the agency both by 1) not submitting it when the agency was considering whether the chemical should be on the market, and 2) not alerting the FDA when later analysis revealed a problem.
The companies’ failures are disturbing. What FDA did (or, more precisely, failed to do) after finding out is also disconcerting. While the agency’s scientists have taken strides to more fully understand the harm posed by PFAS, management has failed to adequately translate the science into timely action to protect people from toxic chemicals like these in their food.
Here are three important takeaways from the article:
1. What Daikin and DuPont knew and hid from the FDA is damning. Daikin’s testing found liver and kidney damage in its animal studies. DuPont’s data revealed that its chemicals stay in the body for a long time, a characteristic that means the toxic chemicals can accumulate to levels that can cause health problems including harm to the reproductive, nervous and immune systems.
2. When the FDA scientists found out these chemicals accumulate in the body, its leadership failed to act in a timely and decisive manner. The chemicals are still on the market today and remain allowed to contaminate food until 2025. Even when its scientists thought there wasn’t any time to waste, FDA leadership decided to get the chemicals off the market by accepting the industry’s offer of five years apparently without negotiation.
3. FDA downplayed the health risk and was misleading in public statements. Under the law, an additive is unsafe if there is no longer “a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use” after considering three factors including “[t]he cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in such diet.”
However, FDA told The Guardian the studies “do not demonstrate an imminent health hazard”, and more studies were needed to draw concrete conclusions about its safety, and that of other short chain PFAS. FDA has a responsibility to remove additives from food unless the agency is confident the use is safe. The evidence does not need to be concrete or show imminent harm. Further – the FDA scientists had already rejected an offer to conduct additional studies, which suggests they felt they did not need more evidence.
Instead, the agency appears satisfied to not take a regulatory action while more and more evidence piles up about a chemical’s health impacts, and FDA keeps insisting they need even more to go on. Even after seeing the suppressed test results from Daikin and DuPont, as well as other disturbing research, the FDA told The Guardian that more studies are needed in direct contradiction to its scientists. All the while, people are put in harms’ way.