FDA Revokes Approval of Three Perfluoroalkyl Ethyl Containing Food-Contact Substances
Adding to the continuing regulatory scrutiny of perfluoroalkyl chemicals, the Food and Drug Administration revoked its approval of three perfluoroalkyl ether chemicals used in oil and water repellants for paper and paperboard food packaging on January 4, 2016. The FDA took this action in response to a petition submitted by a number of NGOs, including the Natural Resources Defense Council (“NRDC”) and Breast Cancer Fund, seeking an amended regulation to remove FDA’s approval of these chemicals for use in food packaging under 21 C.F.R. Section 176.170.
The three affected chemicals are:
1. Diethanolamine salts of mono- and bis (1 H, 1 H, 2 H, 2 H perfluoroalkyl) phosphates where the alkyl group is even-numbered in the range C8-C18 and the salts have a fluorine content of 52.4 percent to 54.4 percent as determined on a solids basis;
2. Pentanoic acid, 4,4-bis [(gamma-omega-perfluoro-C8-20-alkyl)thio] derivatives, compounds with diethanolamine (CAS Reg. No. 71608-61-2); and
3. Perfluoroalkyl substituted phosphate ester acids, ammonium salts formed by the reaction of 2,2-bis[([gamma], [omega]-perfluoro C4-20 alkylthio) methyl]-1,3-propanediol, polyphosphoric acid and ammonium hydroxide.
For use in food packaging, these three chemicals are regulated as food additives/food contact substances (“FCSs”) under the Federal Food, Drug and Cosmetic Act. In reviewing — and granting — a petition seeking an amendment to a food additive regulation based on new scientific data, like the petition submitted by the NRDC and the other NGOs, FDA must find that such data must be adequate for the agency to conclude that there is no longer a reasonable certainty of no harm for the intended use of the substance.
In revoking its approval of these three substances, the FDA did make the necessary finding basing its conclusion at least in part on its prior evaluations of perfluoroalkyl chemicals, stating that it has “made a determination that the information provided in the petition and other publicly available relevant data demonstrates that there is no longer a reasonable certainty of no harm for the food contact use of the three FCS.” Significantly, the new scientific data upon which the FDA relied did not pertain to these three specific chemicals but to the more general category of long-chain perfluoroalkyl chemicals:
“Upon review of the available information, FDA has confirmed our 2010 determination that data demonstrating reproductive and developmental toxicity for long-chain perfluorocarboxylic acids and fluorotelomer alcohols are applicable to long-chain PFCs on a general basis [citation omitted]. FDA’s updated review noted that there are no available toxicological studies conducted with the three FCSs that address the endpoints of reproductive or developmental toxicity. As all three FCSs are long-chain PFCs, and in the absence of data specific to the three FCSs to address these endpoints, FDA utilized the available data demonstrating reproductive and developmental toxicity for long-chain perfluorocarboxylic acids and fluorotelomer alcohols to assess the safety of the approved food-contact use of the FCSs….FDA’s review noted that available data demonstrate that long-chain perfluorocarboxylic acids and fluorotelomer alcohols biopersist in animals and that this biopersistence also occurs in humans [citation omitted]. Although available migration information does not allow a quantitative assessment of the safety of exposure to these FCSs, the reproductive and development toxicity of the three FCSs can be qualitatively assessed in the context of biopersistence and the expectation that chronic dietary exposure to these FCSs would result in a systemic exposure to the FCSs or their metabolic by-products at levels higher than their daily dietary exposure [citation omitted].”
The food industry largely abandoned the use of these chemicals in paper and paperboard food packaging before the FDA’s action. Still, this action formalizes an effective legal ban on the use of such chemicals in this application, and reinforces continuing concerns about the biopersistence and toxicity of perfluoroalkyl chemicals.