FDA refuses request to ban brain-damaging chemical from food packaging

Agency dodges accountability, missing chance to protect kids from the harm of perchlorate

April 23, 2019
Keith Gaby, (202) 572-3336, kgaby@edf.org

 (Washington, D.C. – April 23, 2019) Today, the Food and Drug Administration (FDA) doubled-down on its flawed 2005 and 2017 decisions to allow the hazardous chemical, perchlorate, to be added to dry food packaging. FDA denied a request by Environmental Defense Fund, Natural Resources Defense Council, Breast Cancer Prevention Partners, Center for Environmental Health, Center for Science in the Public Interest, Center for Food Safety, Clean Water Action, Environmental Working Group, and Improving Kids’ Environment for a public hearing to challenge the agency’s conclusions. 

The group’s request had demonstrated both that the agency grossly underestimated the amount of perchlorate that gets into food from packaging and ignored its own studies showing young children’s exposure to the neurotoxin increased after its 2005 decision to allow the chemical’s use in food packaging. By taking almost two years to reaffirm its overly narrow reading of the law, the agency dodged accountability for its flawed science and is allowing exposure to perchlorate – a chemical that harms fetal and infant brain development – to continue. 

Perchlorate is a known endocrine disruptor that impairs the thyroid’s ability to use iodine in the diet to make a hormone essential to brain development. For the estimated 20% of pregnant women who are already iodine-deficient, any exposure to perchlorate can pose a risk to a child’s healthy development.

“It is outrageous that FDA took almost two years to simply reaffirm its flawed interpretation of the law. The agency originally agreed that a 2014 petition to ban perchlorate was properly filed and asked for public comments. FDA then changed its view of the law in its May 2017 denial of the petition,” said Tom Neltner, Chemicals Policy Director at Environmental Defense Fund.  “By denying our challenge today, FDA is avoiding an opportunity to protect kids from the irreversible harm posed by perchlorate exposure.”

Erik D. Olson, Senior Director for Health and Food at the Natural Resources Defense Council, said “pregnant moms shouldn’t have to worry when they sit down for a meal that they may be threatening the health of their babies with a toxic chemical in their food. FDA is falling down on the job. The agency should be protecting kids’ developing brains from the dangers posed by hazardous perchlorate in our food.”

“FDA’s decision to continue allowing this neurotoxic chemical in dry food packaging is a big mistake - babies bear the brunt of the risk and impact,” said Jane Houlihan, Research Director for Healthy Babies Bright Futures. “With FDA’s failure to protect children, it falls on perchlorate maker BASF to do the right thing and withdraw this unnecessary chemical from the food packaging market.”

“FDA’s actions show its callous disregard for the risks perchlorate poses to pregnant women, infants and children, and put process ahead of its mission to keep food safe,” said Lisa Lefferts, Senior Scientist at Center for Science in the Public Interest

“Perchlorate—an ingredient in rocket fuel—harms fetal and infant brain development. It should never be used in food packaging, let alone food packaging for kids products,” said Scott Faber, Vice President for Government Affairs at Environmental Working Group, “It’s unacceptable that FDA is allowing this hazardous substance to continue to be used and won’t even allow a hearing on the science.” 

“The development of the brain is like a one-way street; there is no U-turn to go back and fix the problems perchlorate exposure may have caused,” said Dr. Maricel Maffini. “It is absolutely unnecessary to use this well-known endocrine disrupting chemical in contact with food.”

FDA approved perchlorate for use in plastic packaging for food in 2005 – despite evidence that it harms fetal and infant brain development. In May 2017, the agency rejected a petition to ban the chemical as a food additive – in a decision that EDF has shown relied on flawed science. Advocates responded by challenging the move and requesting a formal evidentiary public hearing in June 2017. 

An FDA report published in 2016 found that virtually all foods sampled had detectable levels of perchlorate. Even more concerning – FDA’s own studies show increased levels of perchlorate in foods such as baby food dry cereal, indicating the chemical’s intentional use in dry food packaging is the likely source of increased exposure for young children. Dry rice cereal—often the first solid food given to a baby—and barley cereal showed the greatest increase from before and after the decision.

The June 2017 objection cited the agency’s refusal to acknowledge evidence that perchlorate exposure increased significantly after its 2005 decision to allow perchlorate in packaging. Additionally, the groups cited evidence that FDA’s initial decision to approve perchlorate grossly underestimated the amount of perchlorate migrating into dry food. By denying those objections today, FDA is once again ignoring these critical details. We will consider our legal options to challenge this decision. 

# # #

Environmental Defense Fund (edf.org), a leading international nonprofit organization, creates transformational solutions to the most serious environmental problems. EDF links science, economics, law and innovative private-sector partnerships. Connect with us on EDF Voices, Twitter and Facebook.