FDA May Revoke Prior Sanction
for PVC Food Packaging

Food Chemical News 18mar74

The Food and Drug Administration is considering a proposal to revoke the "prier sanction" for use of polyvinyl chloride in food packaging because of the possibility of migration of vinyl chloride monomer.

The new proposal to make PVC a "food additive" would replace the pending proposal which would formalize the "prior sanction" for general food packaging under §121.2009, but ban its use far packaging alcoholic beverages.

The agency had previously informed the Society for the Plastics Industry that more data is required on PVC and vinyl chloride monomer migration to food (See FOOD CHEMICAL NEWS, March 4, Page 25), but this was mainly in the context of alcoholic beverages. Industry had previously informed FDA that new processing of PVC would reduce migration of the monomer (See FOOD CHEMICAL NEWS, Oct. 22, Page 26; and Dec. 24, Page 22).

FDA's doubts about PVC packaging, especially for fatty foods, were conveyed to SPI representatives in a recent meeting in Washington.

Agency official. noted that testimony before the Occupational Safety and Health Administration had indicated monomer migration to foods, especially fatty foods. and that FDA has found teat regulatory agencies in other countries have found vinyl chloride in food.

FDA-ers say that the new-process PVC might take care of the problem, but that "trade secret" considerations have prevented the investigations that are needed. It is probable that firms will have to file Food Additive Petitions, in which they will have to demonstrate that vinyl chloride monomer migration meets a specific limit.

A way must be found to limit the amount of vinyl chloride monomer to less than the sensitivity of the most sensitive method available, FDA-ers say. Current methods are sensitive to 50 ppb. Officials indicate that PVC will have to meet both tests for residues and an end-test on the package itself.

There will also have to be toxicological work, FDA-ors say, in order to establish a no-effect level for vinyl chloride.

There are now a number of clearances for PVC as a "food additive" under the Subpart F indirect Food Additive Orders. These probably will be reviewed. FDA-ors say there is information that PVC used in can coatings under §121 .2514 for resinous and polymeric coatings does not result in vinyl, chloride getting into the food.