FDA Agrees to Reconsider Safety of Ortho-phthalates

Decision is in response to a request from 10 environmental, consumer and public health groups

April 13, 2016
Betsy Mullins, (202) 446-6716, betsy@betsymullins.com
Keith Gaby, (202) 572-3336, kgaby@edf.org

The Food and Drug Administration (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.

The decision is in response to a food additive petition from the Environmental Defense Fund, 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. “These chemicals are a serious threat to pregnant woman, their developing fetuses and children,” said Tom Neltner, Chemicals Policy Director at EDF. “But, manufacturers continue to use ortho-phthalates – from farm to fork – even though 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. 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. From lower IQ in young children to malformation of the male genital tract, academic studies have linked some of these chemicals to a variety of reproductive, developmental and endocrine health problems.

“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.

In a reminder of how arcane the law can be, FDA rejected two requests in the petition on technical grounds. First, it rejected the NGO’s request to ban the ortho-phthalates that the Consumer Products Safety Commission has proposed to ban from children’s toys, pacifiers, teething rings and other products. Congress had already banned the use of some of these ortho-phthalates in 2008 in these products.

“It doesn’t make sense to ban some ortho-phthalates from children’s toys, and phase them out of vinyl flooring, but still approve them for contacting food. Ortho-phthalates can cause reproductive and developmental effects,” said Lisa Lefferts, Senior Scientist, Center for Science in the Public Interest.

Second, FDA declined to review five ortho-phthalates that were approved before 1958. In the coming days, petitioners will use another regulatory process – a citizens petition – to request action on these matters.

FDA has six months (180 days) to determine if there is a “reasonable certainty of no harm” for all 30 of these 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.

If FDA’s agrees with the petition, it will issue a rule that removes its approvals for the ortho-phthalates. Once that rule was published in the Federal Register, it would be illegal to sell any foods that contacted packaging or equipment using the ortho-phthalates in question.

For more information please see the original petition and FDA’s letter

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