Perfluorocarboxylates and Perchlorates

A coalition of nine organizations with an interest in protecting children’s health filed two food additive petitions with FDA yesterday. See attached. In the US, chemicals used in food packaging and food handling equipment that may leach into food are considered additives and are regulated by FDA.

Typically, food additive petitions are filed by industry to get FDA approval to use a new chemical. However, the law also allows the public to submit these petitions to restrict or ban chemical uses. The first petition asks FDA to reverse the agency’s 2005 approval that allowed perchlorate in consumer and industrial dry food plastic packaging as an antistatic agent. Ciba Specialty Chemical (purchased by BASF in 2010) made the request for a product sold under the trade name of Irgastat P18 containing up to 1.2% perchlorate. The agency apparently overlooked an 83-fold error in the company’s application that, if caught, would have made the use ineligible for approval.

Compounding the problem, FDA made an additional 3.3-fold error when it announced its decision on its website allowing any company to use as much as 4% perchlorate in the final dry food packaging. The petition cites BASF documents marketing Irgastat P18 for use as an inner liner in bulk dry food packaging in China. Most raw food materials sent overseas are handled in this type of packaging.

FDA acted even though perchlorate was a widely recognized endocrine disruptor that makes it difficult for the thyroid gland to absorb iodine. Iodine is essential to make thyroid hormones. For adults, there hormones regulate the body’s metabolism. For pregnant women, these hormones are essential to fetal brain development, especially in the first two trimesters when the fetus’ thyroid is not fully functioning. For the 30% of pregnant women who don’t get enough iodine already, the fetus is extremely vulnerable to harm from perchlorate. The hormones continue to be essential for infants as their brains grow.

Since 2005, the evidence against perchlorate has only grown more convincing. It is now clear that thiocyanate and nitrates, two other additives, act in a similar manner as perchlorate. The cumulative effect of all three on the thyroid must be considered to ensure children develop to their fullest potential. FDA did not consider the impact of these chemicals in 2005.

The petition also asks FDA to revoke its 1962 approval of perchlorate in food container gaskets. While it is not clear that food manufacturers actually use perchlorate for gaskets, the use is not safe and is unnecessary.

While FDA was evaluating the use of perchlorate as an additive to dry food packaging, it was also accumulating evidence that the chemical was pervasive in the US food supply. Almost 75% of food types had detectable levels with produce leading the way. However, processed food products not associated with produce, such as English muffins sold in the Midwest, also had high levels.

The evidence suggests that perchlorate contamination in bleach used to keep food and water free of pathogens is a likely major source of exposure. The sodium hypochlorite in bleach degrades into perchlorate over time, especially if stored at high concentrations or temperatures. Careful storage and handling of bleach can minimize this problem.

The second petition asks FDA to revoke its 1967 to 1997 approvals of chemicals related to long-chain perfluorcarboxylates as greaseproofing agents in paper and paperboard such as sandwich wrappers, pizza boxes, and frozen food. When these chemicals accumulate in the human body, they can cause harm especially to the developing fetus.

Prodded by the US Environmental Protection Agency and other agencies, US and European manufacturers have shutdown production of these chemicals and most food manufacturers are thought to have stopped using them as well. However, FDA regulations continue to allow their use, and, because of weak post-market monitoring programs, the agency would not know it.

With new production ramping up in China and India, the petition asks FDA to revoke these perfluorocarboxylate approvals to help prevent a relapse should food manufacturers relax their vigilance. FDA has three weeks to accept or reject the petitions for filing. If accepted, then it would post them in the Federal Register for comment 30 days later. The law mandates that the agency make a final decision within 180 days of filing.

For more information, contact Tom Neltner at 317-442-3973 or .

Perchlorate Food Additive PetitionPFC Food Additive Petition