US FDA dismisses request for ban on suspected thyroid disruptor from food packaging

26 Apr 2019 --- The US Food and Drug Administration (FDA) has doubled down on its 2005 and 2017 decisions to allow the potentially hazardous chemical perchlorate to be added to dry food packaging. Perchlorate is present in plastics used to store dry foods – such as oats and rice – but can block the thyroid gland from taking up iodine, which it needs to make thyroid hormone – a hormone that is essential for fetal and infant brain development, as well as normal metabolism in people of all ages.

Perchlorate can occur naturally in soil, but is also manufactured for use in rocket fuel, explosives and for static reduction in carpets and electronic equipment. Since 2005, it has been cleared for use in plastic materials to transport and store dry food ingredients.

However, for the estimated 20 percent of pregnant women who are already iodine-deficient, any exposure to perchlorate can pose a risk to a child’s healthy development, according to the Environmental Defense Fund (EDF).

The authority denied a request by the EDF – which has heavily criticized the “flawed” decision – as well as eight other NGOs including the Center for Science in the Public Interest (CSPI). The group called for a public hearing to challenge the agency’s conclusions. 

This is not the first run-in with controversy that the perchlorate has faced. The chemical was originally approved for use in packaging in 2005, but a group of NGOs requested a ban on the substance in 2014 and then filed a suit in 2016 over the FDA's failure to act on this petition.Exposure to perchlorate can pose a risk to a child’s healthy development, according to the Environmental Defense Fund (EDF).

“It is outrageous that the 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,” says Tom Neltner, Chemicals Policy Director at EDF. “By denying our challenge today, the FDA is avoiding an opportunity to protect kids from the irreversible harm posed by perchlorate exposure.”

The denial of the initial petition prompted Lisa Lefferts, Senior Scientist at the CSPI, to claim that “the Trump administration places the convenience of the food packaging industry over the needs of pregnant women, infants and children.” 

An array of responses have accused the agency of dodging accountability and putting children in harm's way and even calls on the chemical’s manufacturer – BASF – to cease production.

“The FDA’s decision to continue allowing this neurotoxic chemical in dry food packaging is a big mistake as babies bear the brunt of the risk and impact,” says 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.”

PackagingInsights has reached out to BASF to comment on this story.

Mounting evidence?
The petition follows a report released in March by the nonprofit Environmental Working Group (EWG) which found that an estimated 2,000 synthetic substances are permitted in non-organic products, while fewer than 40 synthetic substances are approved for use in organic products. Such substances are used to extend shelf-life and add flavor. Perchlorate was also flagged in the report as an important and hazardous chemical that does not show up on ingredients’ lists – organic or otherwise – because it is part of the packaging material. Still, this does not negate its potential to contaminate food.

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.

According to data shared on the FDA’s website, between 2008 and 2012, the agency collected and tested a total of 5,464 food samples for perchlorate and found no overall change in perchlorate levels across foods compared to 937 samples collected between 2005 and 2006. Further analysis of perchlorate levels per year between 2008 and 2012 also reportedly found no consistent change in perchlorate levels across foods from year to year.

However, the group of NGOs claims that the agency has 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.

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, says the EDF. By denying those objections today, FDA is once again ignoring these critical details. EDF notes that it “will consider legal options to challenge this decision.”

By Laxmi Haigh