FDA Denies Petition to Ban Perchlorate from Food Packaging

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Washington, D.C. — According to the Natural Resources Defense Council (NRDC), the U.S. Food and Drug Administration (FDA) denied a petition filed by the NRDC, together with the Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest and the Environmental Working Group. The petition filed in December of 2014 sought regulation to ban Perchlorate in dry food packaging. In 2005, FDA made the decision to allow the use of as much as 12,000 parts per million (ppm) of perchlorate as an anti-static agent to plastic packaging for dry food with no free fat or oil.

The petitioners contend that Perchlorate impairs hormone production critical to brain development and poses a particular health threat to fetuses, infants and children. They cite a study by FDA which found elevated levels of the additive in foods such as bologna, salami and rice cereal for babies which some samples saw levels up to 173 and 98 µg/kg. While, levels of Perchlorate varied widely across samples, previously reported levels by FDA were less than 1 µg/kg.

“This chemical is all over our food supply,” said Erik Olson, director of the Health Program at NRDC in a press release. “FDA has all the evidence it needs that it’s a public health threat… This decision ignores the science and the law.  It’s an affront to all Americans, who expect that when they buy food, it won’t harm them.  We’re looking at our legal options to challenge this bad decision.”

When the petition was originally filed, the agency missed its deadline to respond by June 2015. As a result, NRDC and the Center for Food Safety, on behalf of these health and environmental organizations sued FDA in March 2016 in order to force the agency to act upon the petition.

In the conclusion of FDA’s formal denial, the agency explained its decision stating:

“We have determined that the dietary exposure to sodium perchlorate monohydrate as a result of the use allowed by the TOR exemption No. 2005-006 does not exceed the TOR exemption criteria in §170.39(a)(2)(i)and that the data and information provided do not support a conclusion that TOR exemption No. 2005-006 is no longer supportable.  With respect to the petition’s second request, we decline to propose a regulation under part 189 prohibiting the use of perchlorates as a food contact substance in antistatic agents because proposing such a regulation would be inconsistent with our conclusion that the data and information provided in the petition do not support a conclusion that TOR exemption No. 2005-006 is no longer supportable. With respect to the petition’s third request, which is the sole request that is the proper subject of a food additive petition, the food additive use of potassium perchlorate has been removed from §177.1210 in a final rule published elsewhere in this issue of the Federal Registerand we decline to address the petitioners’ assertions regarding the safety of the food additive use.Therefore, we are denying all three requests, and we are denying the petition in full.”

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