FDA Agrees to Petitioners’ Request to Reconsider Safety of Ortho-phthalates

In response to a food additive petition, FDA has agreed to consider withdrawing its approval of 30 toxic chemicals known as ortho-phthalates from use in food packaging and food handling equipment, according to the Environmental Defense Fund (EDF), which petitioned for the withdrawal, along with 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, 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.

EDF stated that the ortho-phthalates are a serious threat to pregnant woman, their developing fetuses and children, but manufacturers continue to use them, although there are alternatives. Ortho-phthalates are a class of chemically and pharmacologically related substances used as plasticizers, binders, coating agents, defoamers, gasket closures, and slimicide agents. They are used in cellophane, paper and paperboard, and plastics that come in contact with food.

Several reports have found numerous ortho-phthalates in everyday food, EDF said. 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, EDF said, adding that academic studies have linked some of these chemicals to a variety of reproductive, developmental and endocrine health problems, from lower IQ in young children to malformation of the male genital tract.

“We’ve known these food packaging chemicals are dangerous for a while, but the food processing industry has not acted. They are not protecting the public from these toxins, so now it’s time for FDA to do so,” said Peter Lehner, senior attorney for the Sustainable Food and Agriculture Program at Earthjustice.

FDA rejected two requests in the petition on technical grounds, including the NGO’s request to ban certain ortho-phthalates from children's toys, pacifiers, teething rings and other products, although Congress banned the use of some of these in 2008 in these products. FDA also declined to review five ortho-phthalates that were approved before 1958. The petitioners plan to use a citizens’ petition to request action on these matters.

FDA has 180 days to determine if there is a “reasonable certainty of no harm” for the 30 ortho-phthalates as a class. If there is not adequate data for a particular chemical in the class, FDA must assume that chemical also has reproductive, developmental and endocrine toxicity based on its precedential decision on long-chain perfluorinated compounds, EDF said.

 If FDA’s agrees with the petition, it will issue a rule that removes its approvals for the ortho-phthalates.  

See the original petition and FDA’s letter for more information.