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June 5, 2017 5:00 pm

Comment Deadline: FDA Denial of Food Additive Petition regarding Perchlorates

  • Government
  • Agency
  • Neuroscience

The Food and Drug Administration (FDA) is denying a petition requesting a revocation of the food additive Threshold of Regulation (TOR) exemption for the use of sodium perchlorate monohydrate as a conductivity enhancer in antistatic agents for use in finished articles in contact with dry foods. The petition also requested that FDA issue a new regulation to prohibit the use of perchlorates in antistatic agents for use in food-contact articles; and that the FDA amend the food additive regulations to no longer provide for the use of potassium perchlorate as an additive in closure-sealing gaskets for food containers. Members of the public may submit electronic or written objections and requests for a hearing.

Perchlorate can interfere with the normal functioning of the thyroid gland by competitively inhibiting the transport of iodide into the thyroid. Iodide is an important component of two thyroid hormones, T4 and T3, and the transfer of iodide from the blood into the thyroid is an essential step in the synthesis of these two hormones. Iodide transport into the thyroid is mediated by a protein molecule known as the sodium (Na+)-iodide (I−) symporter (NIS). NIS molecules bind iodide with high affinity, but they also bind other ions that have a similar shape and electric charge, such as perchlorate. The binding of these other ions to the NIS can inhibit iodide transport into the thyroid, which can result in intrathyroidal iodide deficiency and consequently decreased synthesis of T4 and T3 (73 FR 60262, 60266, October 10, 2008). In fetuses, infants, and young children, thyroid hormones are critical for normal growth and development. Id. at 60275. For example, sustained thyroid hormone decrement in a pregnant mother could lead to adverse neurodevelopmental effects in the fetus. Id. at 60266. Research in this area is ongoing.

More information is available via the Federal Register notice.