Tom Neltner, J.D., is Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant
Last month, the Food and Drug Administration’s (FDA) scientists published a study showing significant increases in perchlorate contamination in food sampled from 2008 and 2012 compared to levels sampled from 2003 to 2006. The amount of perchlorate infants and toddlers eat went up 34% and 23% respectively. Virtually all types of food had measurable levels of perchlorate, up from 74%. These increases are important because perchlorate threatens fetal and child brain development. As we noted last month, one in five pregnant women are already at great risk from any perchlorate exposure. The FDA study doesn’t explain the increase in perchlorate contamination. Yet, it’s important to note that there is one known factor that did change in this time period: FDA allowed perchlorate to be added to plastic packaging.
Reported perchlorate levels in food varied widely, suggesting that how the food was processed may have made a significant difference. The increase in three foods jumped out to me:
- Bologna: At a shocking 1,557 micrograms of perchlorate per kilogram (µg/kg), this lunchmeat had by far the highest levels. Another sample had the fifth highest levels at 395 µg/kg. Yet a quarter of the other bologna samples had no measurable perchlorate. Previously, FDA reported levels below 10 µg/kg.
- Salami: One sample had 686 µg/kg giving it a third ranking. Other samples showed much lower levels and six of the 20 had no detectable levels of perchlorate. Previously, FDA reported levels below 7 µg/kg.
- Rice Cereal for Babies: Among baby foods, prepared dry rice cereal had the two highest levels with 173 and 98 µg/kg. Yet, 15 of the 20 samples had non-detectable levels of perchlorate. Previously, FDA reported levels less than 1 µg/kg.
The increases are disturbing in light of the threat posed by perchlorate to children’s brain development and the emerging science showing the risk at lower levels is greater than thought a decade ago. The risk is particularly significant for children in those families loyal to those brands with high levels. Unfortunately, FDA’s study does not identify the brand of food tested.
What might explain the increase in perchlorate contamination?
The only action we can document is FDA’s decision in 2005 to allow as much as 12,000 parts per million (ppm) of perchlorate to be added as an anti-static agent to plastic packaging for dry food with no free fat or oil. The packaging can be used for final products or raw materials before or during processing. Even if the final product is a liquid, raw materials such as rice, whey, sugar, starch, or spice may have contacted the perchlorate-laden plastic. The FDA decision was made in late in 2005 and sampling from the first study ended in 2006.
A Freedom of Information Act request by the Natural Resources Defense Council (NRDC) showed that FDA’s decision was based on a flawed and outdated assumption that perchlorate would not migrate into food at significant levels. Tests provided by the manufacturer late in 2015, in response to a food additive petition from NRDC and others, showed that perchlorate did indeed migrate into food, most likely from abrasion as the food flows in and out of the package. The petition asked FDA to reverse its 2005 decision and ban use of perchlorate. When FDA missed the June 2015 statutory deadline for a decision on the petition, NRDC and others sued the agency to force action. The agency told the court that it aims to make a final decision by March 2017.
What does FDA’s analysis say?
For more than 40 years, as part of its Total Diet Study, FDA has collected samples of more than 280 types of food every year from three randomly-selected cities in four regions of the country. It blends the samples from each of the three cities and analyzes the composite sample for various chemicals, such as heavy metals, nutrients, pesticides and other substances. The agency samples more than 50 types of baby food, including three types of infant formula. The agency also tests bottled water but not tap water. The agency does not report the brands sampled.
Periodically, the agency posts the results on its website and publishes studies evaluating its findings. In response to concerns with perchlorate contamination of produce and dairy, FDA published a study in 2008 summarizing the results from samples collected from 2003 to 2006. It provides updates on a webpage dedicated to the chemical.
On December 21, 2016, FDA published its latest article reporting the results for samples collected from 2008 to 2012 and compared them with those collected from 2003 to 2006 using two different statistical methods. The study provides supplementary data that includes the analytical results but does not identify the year or region from which the samples were collected. Neither the article nor the analytical results are yet available on the agency’s webpages dedicated to perchlorate or the Total Diet Study.
FDA estimated dietary intakes for 14 distinct age/sex groups. Infants and toddlers had the highest estimated consumption with 0.36 and 0.43 μg/kg-bw/day respectively. Infants had a 34% increase in perchlorate exposure compared to the foods purchased before and around the time of FDA’s approval to use perchlorate in food packaging. More than half of the infant exposure came from baby food, including infant formula. Two-year old children’s exposure increased 23%. More than half of their exposure came from dairy products.
What should FDA do?
FDA’s compelling data on the significant increase in perchlorate exposure from the food we feed our children since its approval of perchlorate added to packaging should prompt the agency to act now to ban its use in contact with food. This decision cannot come fast enough. FDA must remedy a problem of its own making, and protect what many of us value the most—our children’s health and their ability to learn and thrive to their fullest potential.
Update: On Jan 24, we revised to first paragraph to be clearer that the estimated increases were in the amount of perchlorate infants and toddlers ate.