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Health advocates say FDA ignored law, science on perchlorate

Agency won't ban chemical from food packaging despite evidence it causes infant brain damage

Using the same mechanism that resulted in the banning of cyclamates in 1970, a group of public health watchdog organizations is challenging the FDA’s decision not to ban perchlorate in food packaging.

The consumer advocates say the Food and Drug Administration ignored scientific evidence that shows the chemical disrupts fetal and infant brain development, causing permanent brain damage. The groups contend FDA’s own data shows perchlorate, which is used in rocket fuel, herbicides and explosives, “migrates” from packaging materials into foods.

“FDA approved its use in plastic packaging for food in 2005 — despite evidence that it harms fetal and infant brain development,” according to a news release from the Environmental Defense Fund, one of the groups seeking a formal evidentiary public hearing before an administrative law judge.

feeding baby“An FDA report published in 2016 found that virtually all foods sampled had detectable levels of perchlorate. Even more concerning, the amount of perchlorate in foods infants and toddlers eat increased 36 percent and 24 percent, respectively, from 2008-2012 compared to 2005-2006. 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.

Today’s objection filed with the FDA cites the agency’s refusal to acknowledge evidence that perchlorate exposure increased significantly after its 2005 decision to allow perchlorate in packaging. Additionally, the objection cites evidence that FDA’s initial decision to approve perchlorate grossly underestimated the amount of perchlorate migrating into dry food.”

Contamination of food by perchlorate is specifically referenced as one of the dangers of the chemical by the Environmental Protection Agency, which considers it to be a carcinogen.

Other groups joining in the call for a review of FDA’s decision include:

  • 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;
  • Natural Resources Defense Council; and
  • Improving Kids’ Environment.

Food companies add perchlorate to plastic packaging for dry food such as rice cereal, flour and spices to reduce the buildup of static charges. The consumer advocates say an industry study showed the toxic chemical migrates into the food inside the packages.

“Perchlorate threatens fetal and child brain development by impairing the thyroid’s ability to use iodine in the diet to make the thyroid hormone — T4 — that is essential to brain development,” according to the news release from the public health advocacy groups.

The advocacy groups are requesting the formal evidentiary public hearing in response to FDA’s announcement on May 4 that it would not ban the chemical from dry food packaging.

In their request, the advocacy groups say the FDA made numerous legal and scientific errors during the decision-making process.

“FDA relied on a single study using a test designed for small packaging that was conducted by a company with a vested interest in the outcome,” according to the request for a hearing.

“This migration test bears little relevance to the actual conditions of use of the perchlorate in bulk packaging allowed by FDA. It was not designed to assess the abrasive and compressive forces driving the migration of perchlorate into food from this use. It also was not relevant to the contribution of perchlorate into food from food handling equipment. Despite these serious shortcomings, the company’s test still showed that perchlorate migrates into food.”

Specifically, the groups want:

  • FDA to revoke its 2005 approval of Threshold of Regulation (TOR) exemption No. 2005–006 that allows up to 1.2 percent sodium perchlorate monohydrate in dry food packaging;
  • FDA to issue a new § 189.301 (21 CFR 189.301) prohibiting the use of perchlorate as a conductivity enhancer in the manufacture of antistatic agents to be used in food contact articles; and
  • FDA to remove potassium perchlorate as an allowed additive in sealing gaskets for food containers in existing § 177.1210 (21 CFR 177.1210).

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