FDA decisions leave ortho-phthalates in food and our safety in limbo

Tom Neltner, Senior Director, Safer Chemicals; Maricel Maffini, Ph.D., Consultant

On May 19, the Food and Drug Administration (FDA) announced four incongruous actions in response to petitions submitted by EDF and others asking the agency to ban the use of more than two dozen ortho-phthalates (phthalates) in food packaging and processing equipment. We filed the petitions because we were concerned that these hormone-disrupting chemicals were harming people, especially children, who consume food contaminated by this class of chemicals. Since filing the petitions six years ago, the evidence of harm – and our concern for children’s health – have only grown more compelling.

Despite a statutory duty to decide whether the authorized uses were safe, the agency delayed making a decision and then essentially dodged the safety issue, opting instead to allow nine phthalates it had approved decades ago to be used in plastics, paper, and adhesives that contact food or drinks. FDA only acted in response to a lawsuit filed by Earthjustice for EDF and other health and environmental advocates.

FDA’s decisions allow phthalates to continue to seep into our food and do little to protect the public. As a result, EDF and the other advocates, supported by Earthjustice, filed formal objections to the agency’s decisions on two food additive petitions and petitioned the agency to reconsider its denial of a separate citizen petition. We also demanded an evidentiary public hearing to consider the significant new evidence FDA glossed over.

The groups that took part in one or more of the objections filed with FDA are Earthjustice, EDF, Breast Cancer Prevention Partners, Environmental Protection Network, Environmental Working Group, Healthy Babies Bright Futures, Learning Disabilities Association of America, Center for Food Safety, Center for Environmental Health, Center for Science in the Public Interest, Defend Our Health and Alaska Community Action on Toxics.

Nine phthalates still allowed

FDA denied our 2016 food additive and citizen petitions without actually deciding whether the approved uses are safe. The agency said it was not convinced that the phthalates covered by our petitions should be treated as a class and, therefore, did not get to the critical question of whether they are safe.

Despite acknowledging that some of the chemicals could be grouped into smaller classes, specifically mentioning phthalates known to be anti-androgenic, FDA chose not to proceed with a safety assessment at all. It is worth noting that in 2014, an expert panel for the Consumer Product Safety Commission (CPSC) concluded that eight phthalates should be banned from children’s toys and other children’s articles because they are all anti-androgenic and can interfere with the production and function of male hormones. CPSC later agreed with the panel’s recommendation.

On the same day FDA denied our two petitions, the agency partially granted an industry petition claiming that all but four of the phthalates (see asterisks in list below) were no longer in use in food contact materials and should be considered “abandoned”. On a technicality, it allowed an additional five phthalates to remain approved, despite industry’s claims. In the end, FDA left nine phthalates allowed for use in materials that contact food. They are:

• Di(2-ethylhexyl) phthalate, CAS No. 117-81-7 (DEHP)*
• Dicyclohexyl phthalate, CAS No. 84-61-7 (DCHP)*
• Diisononyl phthalate, CAS No. 28553-12-0 (DINP)*
• Diisodecyl phthalate, CAS No. 26761-40-0 (DIDP)*
• Diallyl phthalate, CAS No. 131-17-9 (DAP)
• Diethyl phthalate, CAS No. 84-66-2 (DEP)
• Butyl phthalyl butyl glycolate, CAS No. 85-70-1 (BPBG)
• Diisooctyl phthalate, CAS No. 27554-26-3 (DIOP)
• Ethyl phthalyl ethyl glycolate, CAS No. 84-72-0 (EPEG)

FDA also took a fourth action in response to the petitions. The agency acknowledged that it had not assessed the safety of phthalates since 1985, and published a separate request for information on the use and safety of eight of the nine phthalates still allowed.

This is a disturbing development that should give us pause. The agency in charge of protecting our health from chemicals in food waited six years to decide whether chemicals – many already deemed unsafe for children’s toys – should be allowed in food, and simultaneously acknowledged it needed more safety data.

If you’re confused at this point, that’s okay. So are we. Unfortunately, this is par for the course for an agency that has all-to-often failed to make timely decisions and meet consumers’ food safety expectations.

Our objections and comments to FDA’s decisions

We raised eight issues in our objection to FDA’s decision denying our 2016 food additive petition:

1. FDA unlawfully placed on petitioners the burden of proving that the approved food-additive uses of phthalates are not safe;
2. FDA unlawfully failed to evaluate the safety of the food-additive uses of phthalates that remain authorized;
3. FDA failed to address new toxicity information that raises significant questions about the safety of the approved food-additive uses of phthalates;
4. FDA applied an erroneous interpretation of “chemically or pharmacologically related” substances for which the Federal Food Drug and Cosmetic Act mandates a cumulative effects analysis;
5. FDA failed to rationally consider whether the nine phthalates that remain approved for food-contact use, and/or any subset(s) of those chemicals, are chemically or pharmacologically related;
6. FDA failed to consider the cumulative effects of all pharmacologically related phthalates in the diet, including those that are from environmental contamination;
7. FDA erred in requiring the petitioners to adduce exposure data and prove that current exposure to the substances at issue exceeds safe levels; and
8. Contrary to FDA’s conclusion, the available exposure information raises serious safety questions and requires a public hearing.

We also filed an objection and comments to FDA’s decision on the industry food additive petition:

1. An objection, saying FDA improperly rejected the abandonment request for DAP and should remove its approved uses;
2. A comment noting that FDA should remove the approvals of prior-sanctioned uses of DEP, DIOP, EPEG, and BPBG as a plasticizer at § 181.27 and
3. Another comment calling on FDA to clearly communicate to food manufacturers and to food packaging and handling equipment manufacturers that the 26 abandoned ortho-phthalates are prohibited for food uses that may result in their migration into food

The law requires that FDA resolve our objections as soon as possible. It must also hold a public hearing to examine the evidence and resolve genuine and substantive questions of fact.

Let’s hope FDA will be timelier on these objections than it was on our original petitions. We will be monitoring the timeframe for FDA’s response closely given the agency’s egregious delays in responding to the underlying petitions. In addition, we will continue to press Congressional leaders and the public to demand action to protect children from ortho-phthalates. And if FDA does not respond, we will be prepared to go back to court.