EDF Health

FDA agrees to reconsider safety of ortho-phthalates

By Tom Neltner, Senior Director, Safer Chemicals Initiative / 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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Posted in FDA, Food, Health policy, Phthalates, Regulation / Tagged , , , , , , , , , | Authors: / Comments are closed

Missing the forest for the trees? Are we addressing the biggest risks from exposure to phthalates?

By Lindsay McCormick / Published: September 22, 2014

Lindsay McCormick is a Research Analyst.  Richard Denison, Ph.D., is a Lead Senior Scientist. 

A recent study published in Environmental Health Perspectives is the first to demonstrate a link between childhood asthma and prenatal exposure to certain phthalates.  Phthalates are a group of chemical plasticizers used in hundreds of everyday products, including home construction materials, toys, food packaging, medical devices, and synthetic fragrances found in personal care products, cleaning products, cosmetics, and air fresheners.  For the most part, it is impossible for the average consumer to know what products are made with phthalates; however, if you see the word “fragrance” listed on your shampoo or sun screen, it may well contain a phthalate.  

Several studies have suggested that phthalate exposure may have an adverse impact on children’s respiratory health (for example, see here, here, and here).   However, none of these studies has considered the potential role of prenatal exposure – exposures to the fetus in the womb – to phthalates.

The prenatal period is a critical developmental window for lung and respiratory health.  Thus, researchers at the Columbia Center for Children’s Environmental Health (CCCEH) hypothesized that prenatal phthalate exposure would be associated with later development of asthma in childhood.  To investigate this hypothesis, the researchers measured phthalate metabolite levels in the urine of 300 women in the 3rd trimester of pregnancy, and then followed the children of these women to assess the extent to which they developed asthma between the ages of 5 and 11.  Read More »

Posted in Emerging science, Health policy, Health science, Regulation / Tagged , , | Read 2 Responses

“Advanced recycling” is a toxic scam — now the EPA is turning a blind eye to some of the most toxic chemicals it produces

By Maria Doa, PhD, Senior Director, Chemicals Policy and Sara Hull, MPH, Project Manger, Safer Chemicals / Published: August 4, 2025

Advanced recycling is a false solution to the plastic waste crisis

What’s new: Last month, the Environmental Protection Agency (EPA) withdrew a proposed rule covering 18 new chemicals, which would have paused industry efforts to turn toxic oils from plastic waste into fuel until the agency could review their health risks. Companies make these oils through pyrolysis, a controversial process that essentially burns plastic waste—often full of toxic additives like lead, phthalates and PFAS—at high temperatures. Industry has sought for years to re-brand this inefficient and dirty process as “advanced recycling”—a false solution to the plastic waste crisis.

Why it matters: In 2022, the EPA approved the production and use of the 18 chemicals despite significant health risks documented in the agency’s own analysis. These risks include an up-to 1-in-4 lifetime cancer risk—250,000 times greater than what the EPA typically considers acceptable. It was only after residents near the facility in Pascagoula, Mississippi that received the approval learned of these risks and filed a lawsuit that the EPA finally pulled it back.

As damning as the EPA’s 2022 analysis was, it almost certainly underestimated the true risks of the 18 chemicals by failing to consider the known health risks of toxic additives such as lead, PFAS and dioxins commonly found in waste-plastic pyrolysis oils. In response to mounting pressure, the EPA issued the proposed rule in 2023 to address these additional risks. Because it is nearly impossible to make fuels from these oils that are free from toxicants, the rule had an immediate chilling effect on industry investment in “advanced recycling” that’s thawing now that it has been withdrawn.

Our Take: The proposed rule was effective because it would have required companies to notify the EPA before producing and using the new chemicals when they contain toxic plastic additives by designating it as a significant new use. This designation also would have given the agency time to evaluate potential risks to human health and the environment—and mitigate them if necessary.

The proposed rule was also significant because it represents the first time the EPA officially acknowledged that waste plastic-derived pyrolysis oils contain toxic additives “known to cause cancer and harm the reproductive system, among other health effects.” While we believe this rule (and the list of toxic chemicals requiring review) did not go far enough—and submitted comments to the EPA in 2023 explaining why—it was a big step in the right direction.

What’s the problem with so-called “advanced recycling?” Although industry touts “advanced recycling” as a solution to the plastic waste crisis, the process has major flaws. Not only does it fail to recycle anything, but it also rarely results in new plastic products. To make matters worse, the oils it produces are so toxic that their use is highly limited. Continued investments in “advanced recycling” will lock us into burning more polluting fossil fuels that contribute to climate change. Instead of spending its resources propping up this toxic scam, industry could devote them to developing truly innovative and safe solutions.

What’s next? With the rule now out of the way, the EPA is likely to reissue its approval of the 18 chemicals and propose a new set of “rules” that would ignore both the known cancer risks and the additional risks from the highly toxic additives. This would be an unacceptable outcome for public health. The agency must consider the full picture of risk—not just part of it.

With industry actively pushing to develop new facilities across the country—and simultaneously seeking exemptions from other pollution limits for facilities like the one in Pascagoula—the EPA’s reversal opens the door to more pollution and greater harm to both people and the environment. We must hold both the EPA and industry accountable to ensure these plastic waste-derived new chemicals filled with dangerous toxins are not approved—and that any future rules protect people and the environment from unreasonable risk.

To learn more about the health risks of “advanced recycling,” check out this recent Instagram reel by Sarah Vogel, Senior Vice President of Healthy Communities.

Posted in Adverse health effects, BPA, Chemical exposure, Chemical regulation, Contamination, Environmental justice, Frontline communities, Health policy, Industry influence, Phthalates, Risk assessment, TSCA, Vulnerable populations / Authors: , / Comments are closed

Six ways FDA can do better on food safety

By Maria Doa, PhD, Senior Director, Chemicals Policy, Liora Fiksel, Project Manager, Healthy Communities and Maricel Maffini, PhD, Consultant / Published: February 6, 2025

Refrigerated groceriesWhat Happened: 
Bipartisan support is growing for food safety reform as U.S. Food and Drug Administration (FDA) is considering comments on a new process for reassessing chemicals already on the market . On January 21, EDF submitted comments to FDA on how the agency should strengthen its proposal for a process to ensure the safety of existing ingredients in the market. While EDF supports modernizing FDA’s Human Food Program processes and methods, the current proposal falls short on transparency, efficiency, and scientific rigor.  

Why it Matters:
The public deserves a systematic, science-based approach to food chemical safety. FDA’s current process is outdated, opaque, and reactive rather than proactive. Delays in addressing chemical safety are common, with FDA often taking years to act on food additive petitions and chemical reassessments. Many food chemicals were approved decades ago using little or no data and have not been reevaluated since.    

FDA often relies only on its own studies, while ignoring or disregarding findings from other authoritative institutions such as the National Institutes of Health (NIH) and the European Food Safety Authority (EFSA), seemingly unable to acknowledge modernizing science. This failure to consider the full picture and the best available science undermines public health.  

Additionally, the agency fails to consider the cumulative effects of multiple related substances. People aren’t exposed to single chemicals in isolation, yet the FDA continues to evaluate them as if they are.  

While FDA leadership has emphasized that food chemical safety is a top priority for the Human Foods Program, historical lack of action has driven states like California to implement its own food additive regulations. This state-by-state approach creates a patchwork of rules that highlights the urgency for stronger federal leadership to protect all Americans from toxic chemicals. 

Our Take: 
FDA’s proposed process is a step forward but needs significant improvements.  

  1. FDA should set up a true prioritization process

    • FDA’s proposed process doesn’t identify which of the 10,000+ chemicals authorized to be used in food will be reassessed or why. FDA needs to outline specific criteria for prioritizing chemicals (e.g., risks to children’s health, endocrine disruption, biomonitoring data); start with high-priority chemicals identified by authoritative bodies like U.S. Environmental Protection Agency (EPA), International Agency for Research on Cancer (IARC) and the National Toxicology (NTP) Program; and make the process transparent by publishing rankings and methodology. Other agencies such as EPA have done this; FDA could build on their successful approaches.  
  2. Commit to comprehensive assessments 
    • FDA proposes using “focused assessments” based on limited data, skipping peer review and public transparency. FDA should commit to comprehensive assessments that use all available evidence and limit focused assessments to when immediate action is needed. 
  3. Enforce the Delaney Clause 
    • FDA must prioritize removing carcinogens, as mandated by law, without redundant reassessments. 
  4. Embed peer review and public input 
    • FDA should establish a scientific advisory committee, hold public comment periods, and ensure robust, external peer review for influential decisions.
  5. Separate risk assessment from risk management 
    • FDA should create an independent office to ensure unbiased chemical risk reassessments to avoid bias from teams that approve chemicals for market use. 
  6. Consider cumulative effects 
    • FDA often assesses chemicals in isolation, ignoring how we are exposed to multiple chemicals at the same time in real life. FDA should evaluate combined chemicals exposures, as required by law.

While developing this process, FDA can take immediate action on priority chemicals. EDF and others have already petitioned the agency to act on harmful phthalates, per- and poly-fluoroalkyl substances (PFAS), cancer-causing solvents (including methylene chloride), and titanium dioxide, BPA and lead. These toxic chemicals do not belong in our food. With growing bipartisan support for stronger food safety regulations, FDA has an obligation to be a leader in this space.  About two-thirds of American adults across political ideologies “strongly or somewhat favor” restricting or reformulating processed foods to remove added sugars and dyes signifying wide support for greater regulation on food additives.  

Next Steps: 
It is critical that FDA reevaluates its processes for determining the safety of chemicals in our food. EDF will continue to pressure FDA to act now on high-priority food chemicals, using the best available science and enforcing laws that effectively protect people’s health.  

Go Deeper:
Read the full version of the comments EDF submitted to FDA here. 

Posted in FDA, Food / Authors: , , / Comments are closed

FDA Says We Are All Made of Chemicals So How Can Any Be Bad For You?

By EDF Blogs / Published: April 11, 2024

By Maria Doa, PhD, Senior Director, Chemicals Policy, Maricel Maffini, PhD, Consultant, and Liora Fiksel, Project Manager, Healthy Communities

 

Woman reading product label in grocery store

What happened

You may have seen news or online content from FDA about chemicals in our foods, including that our food – and everything else in the world – is made up of chemicals.

FDA’s online content also characterizes toxic chemicals such as lead and mercury simply as naturally occurring or naturally present in our environment. It further fails to distinguish the most harmful chemicals by asserting that for all chemicals, it is the amount of the chemical that matters when determining their harm.

Why it matters

It is true that everything, including our food, is made up of chemicals. However, that does not mean that we should treat all chemicals equally.

Highly toxic chemicals such as lead, mercury, PFAS, TCE, methylene chloride, and BPA are examples of substances that should not be in our food. These toxic metals and synthetic chemicals do not have nutritional benefits and are not equivalent to the chemicals that make up the proteins, fats and carbohydrates that are necessary for a healthy diet. We should not be exposed to toxic chemicals at any level.

The suggestion that toxic metals and synthetic chemicals such as PFAS in our food are just chemicals like essential elements such as potassium in bananas is misleading and harmful.

Unfortunately, FDA accomplished just that. In a webpage released earlier last week, the agency tried to address worries about chemicals in food, an issue that consumers have been concerned about for several years. In its attempt to bring confidence about the safety of the food supply, FDA tried to normalize the presence of toxic chemicals, including neurotoxicants, carcinogens and endocrine disruptors, in our food.

Our take

If a toxic chemical such as lead or mercury is naturally occurring, is it OK?

No. While there are very low levels of these metals that are naturally present in our environment the majority of what is now in our environment is not natural background but the result of pollution and other contamination due to human activities. These levels are not “naturally occurring.”

It is also essential to recognize that naturally occurring does not equate with safety. There is no safe level of exposure to lead and mercury which are potent neurotoxicants. They are particularly harmful to infants and small children and exposure to even small amounts can cause harm.

Is there always a safe level of exposure to a chemical?

Treating all chemicals in our food the same way ignores the science. Some chemicals, in addition to lead and mercury, are so toxic that essentially any amount of exposure is of concern:

  • Chemicals like TCE associated with multiple types of cancers and harm pregnant women and infants.
  • Chemicals like PFAS also known as forever chemicals because they are so difficult to destroy that can harm pregnant women, cause cancer and harm the immune system in vanishing small quantities. For two of the PFAS, EPA just declared that there is no safe level of exposure.
  • Chemicals like BPA that harm the immune and reproductive systems, disrupts the normal function of hormones and affects learning and memory at levels 20,000 times lower than previously estimated, and
  • Chemicals like methylene chloride are associated with cancer and liver toxicity.
  • Chemicals like phthalates that also disrupt the normal function of hormones specially during development of the male reproductive tract. These chemicals are strictly limited in children’s toys due to their toxicity.

And being exposed to more than one of these chemicals that cause the same harm, such as cancer, can increase the harmful effects.

Further, Congress also recognized that some chemicals should not be allowed to be added to our food. Period. Congress included a provision known as the Delaney Clause in our food safety laws that states a food additive cannot be deemed “safe if it is found to induce cancer when ingested by man or animal.” Yet unfortunately, some carcinogens continue to be allowed.

How can we be assured of a safe food supply if the agency that is supposed to ensure safety takes the same “it’s the amount that matters” approach to these toxic chemicals as it does to salt?

And how can we have confidence that FDA will fully consider consumers in determining food safety when the agency not only falsely equates toxic chemicals with the chemicals that make up the proteins, fats and carbohydrates in our diet but also takes a patronizing approach to the public by stating that “chemical names may sound complicated but that does not mean they are not safe.”

Next steps

In the last several years, public interest organizations have petitioned FDA to review the safety of chemicals known to pose risk to health.  Many petitions are still unresolved.

FDA should recognize toxic chemicals for what they are – chemicals that can harm our health and well-being – rather than camouflage them just as any other chemical. The science and the law demand that in making decisions about food safety, FDA recognize and act on the most toxic chemicals and fully consider consumers in its decision making.

 

Posted in General interest / Authors: / Read 1 Response

FDA’s squishy definition of adverse health effects of substances in food

By Maricel Maffini, PhD, Consultant and Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 15, 2023

Maricel Maffini, consultant, and Tom Neltner, Senior Director, Safer Chemicals

3 human figures showing stages of becoming ill. First figure is all white and standing up straight. Second figure is bent over and stomach area is red. Third figure is is all red, bent over, and appears to be vomiting.

What Happened

A recent peer-reviewed publication criticized FDA’s criteria for identifying adverse health effects associated with exposure to pathogens, chemicals, or allergens in foods. The authors gave two recent examples of the agency dismissing health concerns: a toxin created in spoiled fish that caused temporary, medically adverse health effects because they were short-term and reversible, and an additive where evidence from animal testing showed harm in only one sex. The authors concluded that the agency’s criteria are “inadequate because they are not science-based.”

Why It Matters

FDA is responsible for protecting food safety and the public’s health. In order to do that, it makes decisions whether a pathogen, chemical, or allergen causes an adverse health effect that must be avoided—so the agency’s definition of an adverse health effect is critically important. Unfortunately, FDA lacks a clear definition of the term, usually approaching it on a case-by-case basis in a manner that lacks transparency and scientific grounding.

Adverse Effects Dismissed by FDA

In 2020, the director of The Pew Charitable Trusts’ food safety project argued that FDA failed to “protect Americans from preventable illnesses” because it considered that the effects caused by the fish toxin were temporary or reversible. FDA described the toxin’s effects, which ranged from facial flushing and sweating, dizziness, nausea and headache to more severe cases of blurred vision, respiratory stress, and swelling of the tongue. The Pew director reasonably added that people may require hospitalization, medical treatment due to cardiac complications, and altered blood pressure–all of which are adverse health effects.

In a 2019 final rule approving the listing of leghemoglobin as a color additive, the Center for Food Safety objected that FDA dismissed statistically significant “changes in blood chemistry, blood clotting ability, and blood globulin values” as potential health effects. In its response to the objection, the agency argued that “statistical differences seen between control animals and treatment animals due to small changes in the value of the parameter are not likely to be of biological or toxicological significance.” FDA further stated that for the color additive to cause the blood changes to be “potentially adverse” it should:

  • Show a “clear dose-response,” described as a direct relationship between the dose given and the effect observed, in other words, the higher the dose, the higher the effect; and
  • Be observed in both sexes of the species in which the substance is tested.

This argument put forth by FDA’s food safety scientists would be summarily dismissed by their colleagues on the drug side because it ignores current scientific principles: dose responses can have different shapes and there are known sex differences in response to exposures from multiple chemicals.

Our Take

This is an ongoing issue. Other organizations have defined “adverse health effects.” For example, EPA’s Integrated Risk Information System (IRIS) defines adverse effect as “[a] biochemical change, functional impairment, or pathologic lesion that affects the performance of the whole organism, or reduces an organism’s ability to respond to an additional environmental challenge.”

FDA’s lack of a practical definition for adverse health effect and how the agency applies it in food safety assessments has likely contributed to inconsistencies in its decision making.

Next Steps

We will continue to press the agency for transparency about what health effects it considers important to prevent and protect the health of American families. FDA should publish clear, rational, science-based criteria for determining adverse effects and periodically review them as our knowledge base advances to better inform regulatory decisions.

Posted in Adverse health effects, FDA, Health hazards, Health policy, Health science, Public health, Regulation / Tagged , , , | Authors: , / Comments are closed