FDA Issues Final Rule Amending Food Additive Regulations
On January 4, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule amending its food additive regulations to no longer allow the use of three specific perfluoroalkyl ethyl-containing food contact substances (FCS) as oil and water repellants for paper and paperboard for use in contact with aqueous and fatty foods. All three of the FCSs contain extended perfluorinated alkyl chains greater than or equal to eight carbons in length and as such are long-chain perfluorinated compounds (PFC). These FCSs, regulated as food additives under the Federal Food, Drug, and Cosmetic Act (FFDCA), are:
- Diethanolamine salts of mono- and bis (1H,1H,2H,2H 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;
- Pentanoic acid, 4,4-bis [(gamma-omega-perfluoro-C8-20-alkyl)thio] derivatives, compounds with diethanolamine (CAS Reg. No. 71608-61-2); 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.
FDA’s action is in response to a petition filed in January 2015 proposing that FDA amend its food additive regulations (21 C.F.R. § 176.170) to disallow the use of these FCSs as oil and water repellants for paper and paperboard for use in contact with aqueous and fatty foods. The petition was filed 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, and Improving Kids’ Environment. The petition cites a 2010 FDA comprehensive review memorandum on the available literature for long-chain PFCs and provides the results of an updated comprehensive literature search, which the petition asserts reinforces the concern for reproductive and developmental toxicity for long-chain PFCs.
FDA’s regulations implementing FFDCA at 21 C.F.R. 170.3(i) define safety as “a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.” For FDA to grant a petition that seeks an amendment to a food additive regulation based upon new data concerning the toxicity of the food additive, such data must be adequate for FDA to conclude that there is no longer a reasonable certainty of no harm for the intended use of the substance.
FDA reviewed the data and information in the petition and other available relevant materials to evaluate whether new data are available as to the toxicity of the subject FCSs that justify amendment of § 176.170. FDA’s conclusions were as follows:
- The toxicological profile for long-chain PFCs (chain lengths greater than or equal to eight carbons) demonstrates biopersistence that is applicable to long-chain PFCs on a general basis;
- Available data on long-chain perfluorocarboxylic acids and fluorotelomer alcohols (a sub-set of long-chain PFCs) demonstrate reproductive and developmental toxicity in animal models. These data also raise, according to FDA, significant questions as to the safety of the authorized uses of the three FCSs subject to the petition;
- There is a lack of data specific to the three long-chain PFCs subject to the petition to address the questions of biopersistence, reproductive, and developmental toxicity;
- There is no longer a reasonable certainty of no harm for the food contact use of these FCSs; and
- New data are available as to the toxicity of substances structurally similar to these compounds that demonstrate there is no longer a reasonable certainty of no harm from the food contact use of these FCSs.
These food additive uses are no longer authorized as of January 4, 2016. The petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition are available in Docket Number FDA-2015-F-0714.
FDA’s final rule presents commercial and regulatory challenges that need to be identified and addressed quickly for those entities still relying upon these technologies. Although the news is not good for entities relying upon these authorizations, the decision is not unexpected and many may have transitioned away from these technologies. While FDA has approved additives for some food packaging applications, it is unclear if alternatives in all cases exist. Interested stakeholders may wish to consider carefully this development and be prepared to address its consequences.