FDA published a final rule in the Federal Register on the substances used as oil and water repellants for paper and paperboard for use in contact with aqueous and fatty foods.
All of the FCSs contain extended alkyl chains where all of the hydrogens are replaced by fluorine (hence the FCSs are “perfluorinated”).
The substances are 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% to 54.4% as determined on a solids basis.
Pentanoic acid, 4,4-bis [(gamma-omega-perfluoro-C8-20-alkyl)thio] derivatives, compounds with diethanolamine and 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.
The agency said new data on the toxicity of structurally similar substances demonstrates there is ‘no longer a reasonable certainty of no harm’ from their use as food contact substances.
However, it added an updated review noted there are no available toxicological studies with the three FCSs that address the endpoints of reproductive or developmental toxicity.
FDA used available data demonstrating reproductive and developmental toxicity for long-chain perfluorocarboxylic acids and fluorotelomer alcohols to assess safety of the approved food-contact use of the FCSs.
“…in the absence of data specific to the three FCSs to address reproductive and developmental toxicity, adequate migration data to determine dietary exposure to the FCSs from the food-contact use, and sufficient data to account for a consumer's systemic exposure resulting from chronic dietary exposure to these FCSs, we conclude that there is no longer a reasonable certainty of no harm for the food contact use of these FCSs,” said the agency.
It is in response to a petition in 2014 by the Natural Resources Defense Council, the Center for Food Safety, the Breast Cancer Fund, the Center for Environmental Health, Clean Water Action, the Center for Science in the Public Interest, Children's Environmental Health Network, Environmental Working Group (EWG) and Improving Kids' Environment.
Ken Cook, president of EWG, said it has taken the FDA more than 10 years to take action and it’s banning three chemicals that aren't even made any more.
"This is another egregious example of how, all too often, regulatory actions under the nation’s broken chemical laws are too little and too late to protect Americans' health. Congress needs to ensure that chemicals that make their way into food, either as deliberate additives or as contaminants from packaging and other outside sources, are thoroughly investigated.”
Electronic or written objections and requests for a hearing can be submitted by February 3.
No longer manufactured
Commenting on the docket, The Society of the Plastics Industry (SPI) said the three long-chain PFOA-based materials identified are no longer manufactured, and represent an old technology replaced by alternative materials and they are not imported for use in food-contact applications in the US.
SPI member companies said they have no intention of manufacturing the materials for the described use in food-contact applications in the future.
The group said the listings for the PFOA and PFOS-based materials should be removed from the relevant regulation on the basis of abandonment.
SPI also identified two additional substances based on a perfluorooctane sulfonate (PFOS) chemistry, no longer manufactured for the intended use.
One is ammonium bis(N-ethyl-2-perfluoroalkylsulfonamido ethyl) phosphates, containing not more than 15% ammonium mono (N-ethyl-2-perfluoroalkylsulfonamido ethyl) phosphates, where the alkyl group is more than 95% C8 and the salts have a fluorine content of 50.2% to 52.8% as determined on a solids basis.
The other is Perfluoroalkyl acrylate copolymer containing 35 to 40 weight percent fluorine, produced by the copolymerization of ethanaminium, N, N, Ntrimethyl-2-[(2-methyl-1-oxo-2-propenyl)-oxy ]-, chloride; 2-propenoic acid, 2-methyl-, oxiranylmethyl ester; 2-propenoic acid, 2-ethoxyethyl ester; and 2-propenoic acid, 2-(heptadecafluoro-octyl)sulfonyl] methyl amino]ethyl ester.