Share

NGOs Request Hearing on FDA’s Denial of Their Perchlorate Food Additive Petition

June 6, 2017

Challenging the U.S. Food and Drug Administration’s (FDA) May 2017 denial of their food additive petition to remove several clearances for perchlorate from food-contact applications, a group of nongovernmental organizations (NGOs) have requested a formal evidentiary public hearing. (Click here to view the request.) This type of hearing, which would be held before an administrative law judge (ALJ), has not happened since the 1970s.

By way of background, the National Resources Defense Council (NRDC) and eight other organizations submitted a food additive petition to FDA in 2014 requesting that the Agency:

  • Revoke its 2005 approval of Threshold of Regulation (TOR) exemption No. 2005–006 allowing as much as 1.2 % sodium perchlorate monohydrate in dry food packaging;
  • Issue a new regulation under Part 189 of Title 21 of the Code of Federal Regulations (C.F.R.) prohibiting the use of perchlorate as a conductivity enhancer in the manufacture of antistatic agents to be used in food contact articles; and
  • Remove the clearance in Section 177.1210 for potassium perchlorate when used as an additive in sealing gaskets for food containers.

FDA’s decision to deny the NGO’s petition was posted in the May 4, 2017, Federal Register, the same day that the Agency also announced that it was removing the clearance for potassium perchlorate as an additive in closure-sealing gaskets for food containers based on abandonment, rather than safety reasons as requested by the NGOs.

With respect to the other two requests, FDA determined that the NGOs did not provide sufficient evidence to support the requested changes. (For more information, see the PackagingLaw.com article, FDA Removes Clearance for Potassium Perchlorate in Sealing Gaskets Based on Abandonment.) FDA also stated that a request to revoke a TOR exemption or issue a new regulation under § 189 fall outside the scope of food additive petitions, and should instead be submitted in the format of a citizen petition.