FDA Sued Over Inaction on a Petition to Restrict the Use of Perchlorate in Food Packaging

A lawsuit filed by six nongovernment organizations (NGOs) seeks to require the U.S. Food and Drug Administration (FDA) to issue a final order on a petition concerning the use of perchlorate in food packaging. The petition, filed on December 31, 2014, requested that FDA:  

1. Remove potassium perchlorate as a permitted additive in sealing gaskets for food containers in 21 C.F.R. Part 177.1210;
2. Revoke the 2005 "Threshold of Regulation" (TOR) exemption No. 2005-006, which permits the use of sodium perchlorate monohydrate as a conductivity enhancer in the manufacture of antistatic agents in dry food packaging; and
3. Promulgate a new regulation under 21 C.F.R. Part 189, Subpart D to prohibit the use of perchlorate in antistatic agents for use in food-contact articles.

  The petition cited toxicity concerns and an underestimation of exposure to perchlorate as reasons for the request. (For more information on the petition, see the PackagingLaw.com article, NRDC Petitions FDA to Restrict the Use of Two Chemicals in Food Packaging.) FDA did publish a Federal Register notice on March 16, 2015, (See 80 Fed. Reg. 13508) requesting comments on the petition by May 15, 2015. The lawsuit was filed by the Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Environmental Working Group, and Natural Resources Defense Council on March 31, 2016 in the U.S. Court of Appeals for the Ninth Circuit.