FDA agrees to reconsider safety of ortho-phthalates

Tom Neltner, J.D.is Chemicals Policy Director.

Yesterday, the Food and Drug Administration (FDA) agreed to consider withdrawing its approvals of 30 food additives known as ortho-phthalates from use in food packaging and food handling equipment.  The chemicals are in a class of chemically- and pharmacologically-related substances used as plasticizers, binders, coating agents, defoamers, gasket closures, and slimicide agents to process and package food. The agency allows them to be used in cellophane, paper, paperboard, and plastics that come in contact with food. All of the chemicals were approved by the agency before 1985.  Pursuant to 21 U.S.C. 321(s), chemicals that are reasonably expected to get into food from their intentional use in materials contacting food are considered “food additives.”

FDA acted in response to a food additive petition submitted by the Natural Resources Defense Council, Center for Science in the Public Interest, Center for Environmental Health, Center for Food Safety, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids’ Environment, and Learning Disabilities Association of America – groups all concerned by the adverse health effects of ortho-phthalates at the levels typically seen in food.

Academic studies have linked some of these chemicals to various reproductive, developmental and endocrine health problems. In fact, every ortho-phthalate that has been studied for these types of health effects has been found to pose a risk. From lower IQ in young children to malformation of the male genital tract, the evidence of health effects in humans continues to grow. But, with more than half of the 30 chemicals lacking any published safety data, the full extent of the threat remains unclear.

Several reports have found numerous ortho-phthalates in everyday food. While these chemicals are used in many consumer products other than food, the primary source of exposure appears to be food, presumably from their FDA-approved use in food packaging and handling equipment.

What requests did FDA reject?

In a reminder of how arcane the law can be, FDA rejected two requests in the petition because it concluded that:

  • A food additive petition could not be used to ban a chemical’s use as a food additive. A petition must propose “the issuance of a regulation prescribing the conditions under which such additive may be safely used.” (21 U.S.C. 348(b)(1)) In a narrow interpretation of its authority, FDA said that a food additive petition could not be used to ban or a set a “zero tolerance.” As a result, it rejected the request to ban the ortho-phthalates that the Consumer Products Safety Commission has proposed to ban from children’s toys, pacifers, teething rings and other products. Congress had already banned the use of some of these ortho-phthalates in 2008 in these products.
  • Chemical uses “approved” by FDA or the U.S. Department of Agriculture prior to the enactment of the 1958 law are exempt from the definition of food additives. (21 U.S.C. 321(s)) These approvals are known as “prior sanctioned.” I put “approved” in quotes because the agency only needed to issue a letter not objecting to a specific use for it to qualify as exempt. Not objecting is quite different than approving it. As a result of this interpretation, five ortho-phthalates used “as plasticizers when migrating from food packaging material” pursuant to 21 CFR 181.27 are not eligible for review by the agency through a food additive petition. All other FDA-approved uses of these chemicals – and there are many – will be considered as part of the food additive petition.

The agency advised the groups that a citizens petition pursuant to 21 CFR 10.30 was the proper means to make those requests. The petitioners will submit the citizens petition soon.

What happens now?

FDA has 180 days from April 12, 2016 to determine if there is no longer a “reasonable certainty of no harm,” the legal standard of safety for food additives and generally recognized as safe (GRAS) substances, for ortho-phthalates as a class. If there are not adequate research data for a particular chemical in the class, FDA must assume that chemical also has reproductive, developmental and endocrine toxicity based on the precedent set by its January decision removing the agency’s approval of perfluorinated compounds.

The stakes for children’s health are high. If FDA agrees with this new petition, it will issue a final rule that removes its approvals for the class of chemicals. Any food that physically contacted materials using any of the ortho-phthalates affected by decision would be considered adulterated on the day it was published in the Federal Register.  This means it would be illegal to sell them.


For more information, please see the NGO’s food additive petition and FDA’s decision.

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