FDA Removes Clearance for Potassium Perchlorate in Sealing Gaskets Based on Abandonment
The U.S. Food and Drug Administration (FDA) announced a final rule amending the food additive regulations (21 C.F.R. Part 177.1210) to no longer provide for the use of potassium perchlorate as an additive in closure-sealing gaskets for food containers based on abandonment. (See the May 4 Federal Register.) This action was taken in response to a food additive petition submitted on behalf of PLASTICS (formerly SPI).
On the same day, FDA also announced in the Federal Register that it was denying a petition submitted by a group of nongovernment organizations (NGOs) requesting that the Agency remove the clearance for potassium perchlorate as an additive in closure-sealing gaskets for food containers based on safety since that use had been abandoned. The NGO petition also requested that FDA revoke the Threshold of Regulation (TOR) exemption No. 2005-006 for the use of sodium perchlorate monohydrate as a conductivity enhancer in antistatic agency for use in dry food packaging, and that FDA add potassium perchlorate to 21 C.F.R. Part 189 of the food additive regulations—effectively, a “negative ‘list” of substances prohibited for use in food-contact applications.
The NGOs petition was filed on October 15, 2014. PLASTICS filed comments in opposition to that food additive petition on June 29, 2015, that included the points listed below.
Potassium perchlorate was no longer used by industry.
A safety determination was unnecessary in the absence of actual exposure.
FDA should de-list potassium perchlorate on the basis that it is no longer used.
A “negative listing” would reflect a hazard-based approach (“any and all exposure is harmful”).
This would break with FDA’s longstanding policy of risk-based analysis (“applications should be evaluated on a case-by-case basis, for the intended use”) using scientific procedures.
Subsequently, PLASTICS provided market data in its own food additive petition on April 19, 2016 (officially filed with FDA on May 11, 2016), and provided supplemental comments in response to FDA’s request for additional information. Based on the evidence presented by PLASTICS, FDA has agreed to de-list perchlorate from Section 177.1210, preempting the NGO petition.