FDA sued for delay in deciding perchlorate food additive petition

Tom Neltner, J.D.is Chemicals Policy Director.

[pullquote]At the end of 2014, FDA agreed to consider a food additive petition from NGOs to ban perchlorate – a chemical that can impair a child’s brain development – as an additive to food packaging. The agency had 180 days to act, but fifteen months later, the petitioners are still waiting for a response. Today, they sued.[/pullquote]

It’s been 15 months since a group of environmental, consumer, and public health advocates petitioned the Food and Drug Administration (FDA) to remove the agency’s approval of perchlorate uses in packaging.

Traditionally, FDA’s food additive petition process has been the exclusive purview of food manufacturers seeking approval to use new chemicals or expand uses of already approved chemicals in food production. However, nothing in the law prohibits the public from using the process to ban or restrict the use of certain chemicals.

The perchlorate food additive petition was one of the first times that the process has been used to seek removal of a risky chemical from the nation’s food supply. Such an innovative approach was shown to be effective when FDA accepted a separate petition submitted by the same organizations to ban long-chain perfluorinated compounds in January 2016. Food additive petitions are a powerful tool in the ongoing effort to remove unsafe chemicals from our food.

By law, the process is supposed to take 180 days – six months. FDA formally agreed to consider the petition on December 31, 2014 – 15 months ago. Today, 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 sued FDA to force action on the petition.

It is disappointing that the petitioning NGOs had to turn to the courts to get an answer on a petition that, if granted, could prevent vulnerable populations such as pregnant women, fetuses and young children from ongoing exposures to perchlorate, a chemical that has high health risks.

Perchlorate can inhibit the thyroid’s ability to use the iodine in the diet. The body needs iodine to make the thyroid hormones that are essential to a fetus’ and child’s brain development. Lower hormone levels could impair a child’s cognitive and developmental skills. Most pregnant women in the United States already have inadequate iodine levels, and unnecessary exposure to perchlorate can increase the risk to a child’s healthy development.

In 2005, FDA granted approval for using perchlorate as an anti-static agent in dry goods plastic packaging. The chemical compound was already approved as an additive in sealing gaskets for food containers. Perchlorate also has other non-FDA regulated uses ranging from rocket fuel and fireworks to road flares and airbags and it is a common contaminant of hypochlorite bleach. When hypochlorite, a common household and industrial disinfectant used in food processing and to peel and wash produce, is not managed carefully, it quickly degrades to perchlorate.

Three years after FDA approved perchlorate as an anti-static agent in dry goods packaging, a separate FDA study of food revealed that 74% of the food types tested had measurable amounts of perchlorate. It may be surprising to note that the food in that study was collected around the same time as the agency was making its decision to expand the use of perchlorate.

Other public health agencies have released additional studies that underscore the breadth of the problem. The Centers for Disease Control and Prevention (CDC) found perchlorate in the urine of every American they tested since 2001. Children have higher levels than adults. Meanwhile, in 2013, EPA’s Science Advisory Board also cautioned that children are disproportionately impacted by the presence of perchlorate.

This is a complicated issue. I can understand that it was going to take FDA longer than six months to complete its review. The agency must, by law, consider the cumulative effect of not only perchlorate but two other chemicals—thiocyanate and nitrates—in the diet that also inhibit the thyroid’s ability to use iodine. In addition, our food supply is extensively contaminated with perchlorate. However, with the agency’s technical scientific review drawing to a close, it is time for FDA to act. Hopefully, the NGOs’ lawsuit will be the impetus needed to get the overdue petition resolved.

Perchlorate is a dangerous chemical. FDA’s 2005 decision was wrong and never should have been made. To protect kids’ brains, the agency needs to reverse its prior approvals and ban the use of perchlorate as an additive.

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