EDF Health

Selected tag(s): food additive

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

By / Published: June 22, 2022

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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EDF joins court challenge of FDA’s refusal to ban use of perchlorate in food contact materials

By / Published: October 29, 2019

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

Today, EDF, represented by Earthjustice, joined with other public health advocates in filing a lawsuit to overturn the Food and Drug Administration’s (FDA) May 2017 decision, reaffirmed in April 2019 that allows the continued use of perchlorate[1], at concentrations up to 12,000 parts per million, in plastic packaging and processing equipment in contact with dry food. Perchlorate exposure is particularly dangerous for fetuses, infants, and young children, as it has been linked to developmental delays, reduced growth, and impaired learning capabilities. FDA relied on flawed reasoning while entirely ignoring important evidence developed by its own scientists revealing potentially serious risks resulting from ongoing use of perchlorate. We maintain that the intentional and unnecessary use of perchlorate in food contact materials should end.[2]

As with any litigation, we take this action reluctantly. We have long questioned FDA’s decisions that ignore evidence that endocrine disruptors like perchlorate can cause harm at levels the agency systematically dismisses as trivial. We have also pushed back on FDA’s decisions that allow toxic chemicals to be used in packaging and processing equipment that contact food ingredients multiple times from the farm to the grocery store shelf when the exposure estimate is based solely on the amount of the chemical that may migrate into food from the final product packaging. Agency assertions that its estimates are based on worst-case assumptions are misleading when they only consider a single contact. While FDA’s initial decision in November 2005 allowing the use of perchlorate-containing plastic raises all of these problems, the agency’s failure to address its own data and accompanying analysis by its own scientists that was published a decade later has left us with little choice but to act.

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EPA to consider perchlorate risks from degradation of hypochlorite bleach

By / Published: February 3, 2017

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

Virtually all types of food contain measurable amounts of perchlorate. Young children are the most highly exposed, and they consume levels that may be unsafe. Reducing exposure to perchlorate is of public health importance because it presents a risk to children’s brain development

One potentially significant source of the toxic chemical in food is hypochlorite bleach that, when not well managed, degrades to perchlorate. Bleach is used to sanitize food manufacturing equipment or to wash or peel fruits and vegetables. Thanks to a recent decision by Environmental Protection Agency’s (EPA) Office of Pesticide Programs, we will better understand the risk posed by perchlorate-contaminated bleach and whether standards are needed to improve the management of bleach.

Reduce perchlorate exposure by improving bleach management

In 2011, an excellent report by the American Water Works Association (AWWA) and the Water Research Foundation documented that hypochlorite bleach degrades into perchlorate. The report also included guidelines on better management of hypochlorite to preserve its effectiveness for drinking water utilities using it to disinfect water.

Most of AWWA’s recommendations are equally relevant to food manufacturers and anyone using bleach to disinfect food contact surfaces. The key recommendations are:

  • Dilute hypochlorite solutions on delivery. Cutting the concentration in half decreases the degradation rate by a factor of 7.
  • Store hypochlorite solutions at lower temperatures. Reducing temperature by 5oC decreases degradation rate by a factor of 2.
  • Keep pH between 11 and 13 even after dilution.
  • Avoid extended storage times, and use fresh hypochlorite solutions when possible.

The objective is not to reduce the use of bleach. Rather it is to preserve its effectiveness by preventing degradation to perchlorate through careful management.

Bleach: a food additive and a pesticide

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Senator Markey asks: What if people could buy food they know is free of secret ingredients?

By / Published: April 30, 2016

Senator Markey (D-MA) asked FDA if it can require a label to tell consumers when the food they are eating contains chemicals it has not reviewed for safety. In his April 26 letter, he asked the agency to respond by May 17.

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

In May 2015, 36% of consumers said that chemicals in food was their most important food safety issue and 23% of consumer said they changed their purchase habits out of concern with chemicals in their food. Leading food manufacturers responded by reformulating their products to remove artificial flavors and colors.

What if these same consumers knew that chemicals added to their food had not been reviewed for safety by the Food and Drug Administration (FDA)? As the Natural Resources Defense Council made clear two years ago, 56 food additive makers chose to avoid FDA’s scrutiny by taking advantage of a loophole in the law for “Generally Recognized as Safe” (GRAS) substances. They purposely chose not to be transparent by keeping secret the safety evaluation conducted by their employees or consultants. These companies appear to make only a few of the estimated 1000 chemicals that FDA has not checked for safety or is aware they exist.

In February, we learned that 51% of consumers think that safety means not only that a product is free of harmful ingredients but that its labeling is clear and accurate. Forty-seven percent want clear information on ingredients and sourcing. With this in mind, it’s fair to assume that consumers also expect that all food chemicals are safe and known to the FDA. Many consumers would likely not buy products where the labeling failed to disclose that the food they serve their families contained ingredients the FDA has admitted it “cannot vouch for their safety”.

On April 26, Senator Edward Markey (D-MA) put the issue front and center when he asked FDA whether it has “sufficient authority to require a special label on any foods or beverages containing ingredients that have been self-determined to be GRAS without an FDA review?” If FDA had sufficient authority, then “what would the label look like?” Read More »

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FDA agrees to reconsider safety of ortho-phthalates

By / Published: April 13, 2016

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

Yesterday, the Food and Drug Administration (FDA) agreed to consider withdrawing its approvals of 30 food additives known as ortho-phthalates from use in food packaging and food handling equipment.  The chemicals are in a class of chemically- and pharmacologically-related substances used as plasticizers, binders, coating agents, defoamers, gasket closures, and slimicide agents to process and package food. The agency allows them to be used in cellophane, paper, paperboard, and plastics that come in contact with food. All of the chemicals were approved by the agency before 1985.  Pursuant to 21 U.S.C. 321(s), chemicals that are reasonably expected to get into food from their intentional use in materials contacting food are considered “food additives.”

FDA acted in response to a food additive petition submitted by 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, Environmental Defense Fund, 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.

Academic studies have linked some of these chemicals to various reproductive, developmental and endocrine health problems. In fact, every ortho-phthalate that has been studied for these types of health effects has been found to pose a risk. From lower IQ in young children to malformation of the male genital tract, the evidence of health effects in humans continues to grow. But, with more than half of the 30 chemicals lacking any published safety data, the full extent of the threat remains unclear.

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