46 | July 2021
As companies start to phase out PFAS
from their products, they should keep in
mind that assurances by their suppliers that
PFAS are not intentionally used may not
be sufficient. Fluorination of plastic surfaces
generates PFAS that are likely to leach into
the packaging content, but these PFAS are
not intentionally used. Companies should
ask suppliers whether they fluorinate the
plastic containers.
FDA and EPA must address
unanswered questions and
take action
Given the reported range of products us-
ing plastic containers treated with fluorine,
we are pleased to see that EPA and FDA
are actively coordinating in evaluating the
situation and taking the next steps.
We believe that FDA needs to con-
duct two types of safety review. The first
is whether the product's use is so wide-
spread that it constitutes an imminent haz-
ard to public health that warrants a recall.
To do this assessment, FDA should work
with EPA to quickly identify and investigate
container manufacturing facilities that
store significant quantities of fluorine gas
and have had to submit risk management
plans under the Clean Air Act.
The second review needed is evalu-
ating whether there is sufficient evidence
that the fluorine gas treatment approved
by the agency in 1983 for polyethylene
is safe or if the agency should stop its
continued use as a food contact substance.
For this purpose, 21 C.F.R. 170.3(i) defines
safe to mean "there is a reasonable cer-
tainty in the minds of competent scientists
that the substance is not harmful under
the conditions of its intended use" after
considering three factors that include "the
cumulative effect of the substance in the
diet, taking into account any chemically or
pharmacologically related substance or
substances in such diet."
Given the evidence we see from EPA
2021 study and Rand and Mabury's 2011
study, we cannot see how FDA could
maintain the fluorination treatment pro-
cess is safe, and we hope that the agency
will take swift action to ban the practice to
protect public health.
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[1] The regulation uses parts per million.
We converted it to parts per billion in
order to use a consistent set of units.
[2] 7264 µg/kg of food (ppb) = (5000 µg F
/ kg of food) * (1 µmol F / 19 µg F) * (1
µmol PFOA / 15 µmol F) * (414.07 µg
PFOA / µmol PFOA).
[3] Oral Intermediate Minimal Risk Level
(MRL) is 3×10-6 milligrams of PFOA
per kilogram of body weight per day
established by the CDC's Agency for
Toxic Substances and Disease Registry
in May 2021 Toxicological Profile for
Perfluoroalkyls. See Table 1-2 and 1-3.
FDA adopted the MRLs in June 2021.
An Intermediate MRL is based on 15 to
364 days of exposure.
[4] Polypropylene is marketed as a
candidate for direct fluorination https://
www.berlinpackaging.com/fluorination/
[5] Trifluoroacetic acid (C2) and perfluoro-
propanoic acid (C3) comprised 80% of
the total PFAS. We calculated 188 ppb
by multiplying 314 ng/cm
2
times 600
cm
2
for inside surface of 1L bottle times
1000 ng/microgram.
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