40 | June 2021
T
he Guardian recently published a powerful story by re-
porter 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 re-
sponse to a Freedom of Information Act request by EDF and En-
vironmental Working Group. The analysis showed that two major
PFAS manufacturers, Daikin and DuPont, withheld safety informa-
tion 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 tox-
ic 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 prob-
lems including harm to the reproductive, nervous and immune
systems.
2. When the FDA scientists found out these chemicals accu-
mulate 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 ac-
cepting the industry's offer of five years apparently without ne-
gotiation.
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 ac-
count any chemically or pharmacologically related substance or
substances in such diet."
However, FDA told The Guardian the studies "do not demon-
strate 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 ev-
idence does not need to be concrete or show imminent harm.
Further — the FDA scientists had already rejected an offer to con-
duct 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
PFAS: Chemical Industry's
Hidden Harm By MOMS Clean Air Force
This post was written by Tom Neltner, J.D., Chemicals Policy
Director and Maricel Maffini, Ph.D., Consultant.
It originally posted on EDF Health:
