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Selected tag(s): phthalates

FDA Acknowledged Ortho-Phthalates Could Be Grouped Into Classes For Safety, Then Punted

Maricel Maffini, consultant and Tom Neltner, Chemicals Policy Director

In May, FDA decided to allow continued use of nine ortho-phthalates in food packaging and processing equipment but punted on deciding whether or not using those phthalates is safe. We’ve written about the petitions that resulted in the decision, along with the agency’s decision to “abandon” the use of 19 other phthalates (here, here, here, and here). We’ve also written about how phthalates that industry and FDA say are no longer on the market are showing up in our food (here and here). Today, however, we focus on whether those nine phthalates are a class of related substances—and the implications for public health if they are.

FDA’s obligation to evaluate related chemicals as a class

FDA’s regulations state that additives “that cause similar or related pharmacological effects will be regarded as a class, and in the absence of evidence to the contrary, as having additive toxic effects.” In denying our petition, FDA acknowledged that some phthalates could be in a class of related substances. For example, FDA described studies showing that seven phthalates reduced testosterone production – an effect called antiandrogenicity – during fetal development. This caused malformation of the male reproductive system (primarily malformed genitals in male infants). The agency balked at declaring all phthalates anti-androgenic because four of them did not show that effect.[1]

But rather than move forward with a safety assessment of the use of the antiandrogenic phthalates as a class of chemicals with similar toxicity, FDA dropped the issue, implicitly sending the message the chemicals are safe. This is contrary to the agency’s obligation. When making a final decision on a food additive petition that allows the use of a substance, FDA must explicitly decide the use is safe after considering the cumulative effect of it and related substances in the diet.[2]

In contrast to FDA’s failure to act, the Consumer Product Safety Commission, responding to safety concerns, took action five years earlier and banned use of antiandrogenic phthalates in children’s products.

A phthalate scorecard: Where we stand on which phthalates can be used and their health effects

The table below provides a scorecard for the nine phthalates that remain in use. Of those substances, studies showed that seven were associated with developmental effects, including four which have antiandrogenic effects. Two phthalates were never studied for developmental effects.

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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. Read More »

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The new FDA Commissioner has a full plate; here are three steps he can take to keep focused on food safety too

Tom Neltner, Senior Director, Safer Chemicals.

The U.S. Senate today voted to return Robert Califf to the role of FDA Commissioner, bringing needed leadership to an agency that plays a vital role in protecting public health. 

While Dr. Califf faces historic challenges in the form of the COVID-19 pandemic and the opioid epidemic, he also has a tremendous opportunity to elevate the agency’s important role in protecting the public from unsafe chemicals in food. 

We put together a list of three things Dr. Califf and the FDA have the authority to do right now to keep problematic chemicals out of our food:  Read More »

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A gap remains in the circular economy conversation: Toxic chemicals in packaging

Boma Brown-West, Senior Manager, Tom Neltner, Chemicals Policy Director, and Michelle Harvey, Consultant.

This is the first blog in a series evaluating the challenges associated with single-use food packaging waste.

This week Walmart joined a growing number of companies that are trying to advance the circular economy for packaging. Like previous commitments from NestleCoca-Cola and McDonald’s, Walmart is stepping up its efforts to use more recyclable packaging, incorporate more recycled content, and accelerate development of collection and recycling infrastructures. EDF has a long history fighting for greater and smarter plastics recycling, so we are pleased to see more companies working to eliminate plastic packaging waste from our environment. However, something is often missing from their statements: commitments for safer packaging free of toxic chemicals.

What defines safer packaging?

There are many facets to sustainable packaging: recyclability, reusability, lower material and energy inputs, and the avoidance of toxic chemicals.  A significant amount of virgin plastic used in packaging currently contains toxic chemical additives such as ortho-phthalates or contaminants such as heavy metals. These chemicals have been linked to diseases and health disorders, such as reproductive problems and impaired brain development. When tainted plastic packaging is reused or recycled, these toxic chemicals persist and may accumulate to worrisome levels until the packaging is retired, posing long-term threats to our health.

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How and when will FDA rule on ortho-phthalates in food? It’s anyone’s guess.

Tom Neltner, J.D.is Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

The Food and Drug Administration (FDA) has yet to decide three overlapping petitions requesting the agency take action on uses of ortho-phthalates in contact with food. Two of the petitions—a food additive petition and a citizen petition—were submitted by EDF, Earthjustice and nine other public health allies. In those petitions, we requested the revocation of all uses of this class of chemicals in food because the agency can no longer conclude that such use is safe. The law required FDA to make a decision by no later than September 2018; that deadline has long since come and gone, and the agency hasn’t acted.

The third petition was submitted by the Flexible Vinyl Alliance, an industry group. It requested that the agency revoke the food additive uses of 26 ortho-phthalates because, according to FDA’s notice, they had been abandoned. The agency agreed to review the petition in July 2018 and invited public comment on it in November 2018.  Public comments were due on January 14, 2019.

In a press release about its petition, the industry group announced that only four ortho-phthalates “remain relevant in food contact applications”:  di(2-ethylhexyl) phthalate (DEHP), diisononyl phthalate (DINP), dicyclohexyl phthalate (DCHP) and diisodecyl phthalate (DIDP).  It also stated that it confidentially provided the agency with exposure and safety data on these four substances. The agency has made neither the industry’s petition nor the safety data on the four ortho-phthalates publicly available. We submitted a Freedom of Information Act (FOIA) request seeking industry’s “confidential” report and more information on the petition.  We await a response.

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American Academy of Pediatrics calls for “urgently needed reforms” to fix broken food additive regulatory system

Tom Neltner, J.D. is Chemicals Policy Director

Today, the American Academy of Pediatrics (AAP) released a “Food Additives and Child Health” policy statement calling for “urgently needed reforms to the current regulatory process at the US Food and Drug Administration (FDA) for food additives.” The policy applies to chemicals deliberately added to food or to food packaging or food processing equipment that get into food. These substances are used to flavor, color, preserve, package, process and store our food, but many never appear among the list of ingredients. AAP’s statement calls specifically for the following:

  • “Greatly strengthening or replacing the GRAS [Generally Recognized as Safe] determination process;
  • Updating the scientific foundation of the FDA’s safety assessment program;
  • Retesting all previously approved chemicals; and
  • Labeling direct additives with limited or no toxicity data.”

EDF applauds AAP’s policy statement and its decision to add its influential voice to the rising call for reform of the process by which FDA and food manufacturers decide additives are safe. AAP, a professional society representing 67,000 pediatricians, develops policy statements regarding federal, state, and community policies that affect children through an extensive, deliberative process that draws on tremendous scientific expertise. As with past policies, such as those concerning lead toxicity and fruit juice consumption, this statement on chemicals in food presents a well-reasoned assessment of the problem and clear recommendations for reform.

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