FDA accepting public comments on the safety of ortho-phthalates

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

Today, the Food and Drug Administration (FDA) announced it was accepting public comment on a food additive petition asking the agency to reconsider the safety of 30 toxic chemicals known as ortho-phthalates, which are used as additives in food packaging and handling materials.

The announcement, to be published in tomorrow’s Federal Register, comes shortly after a new study by Dr. Ami Zota published in the journal Environmental Health Perspectives found that individuals who consume large amounts of fast food have higher levels of exposure to two of the most commonly-used phthalates—diethylhexyl phthalate (DEHP) and diisononyl phthtlate (DiNP). Because the study was about fast food, final food packaging is less likely to be a major source than food handling equipment, including gloves.

The Milken Institute School of Public Health at the George Washington University study adds more urgency to the petition filed by EDF and allies which prompted today’s FDA notice.

Ortho-phthalates are a class of chemically- and pharmacologically-related industrial substances; thirty of them have FDA-approved uses as plasticizers, binders, coating agents, defoamers, gasket closures, and slimicide agents in food packaging materials and processing equipment. Found in cellophane, paper and paperboard, and plastics that come in contact with food, they can leach into the food.

Studies have linked ortho-phthalates exposure to a variety of reproductive and developmental problems, and some are known endocrine disruptors.

Previous studies have found that diet is a major source of phthalate exposure. The Milken study, is one of the first to look specifically at the exposure risk of fast food using the National Health and Nutrition Examination Survey (NHANES) data. NHANES is a nationally representative survey. The researchers found that individuals who consumed fast food in the 24 hours leading up to the study had as much as 40% (corrected 5/19/16) more phthalates in their urine than study participants who had not eaten fast food in the previous day. The findings also provide one of the first concrete steps that consumers can take to reduce their exposure—they can eat less fast food.

Public comments on this petition can be submitted until July 19, 2016.

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