EDF Health

10 ways the incoming FDA Commissioner should protect people from toxic chemicals in food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 22, 2021

Tom Neltner, Chemicals Policy Director.

The FDA’s critical role in the COVID-19 pandemic has brought intense interest in whom President Biden will nominate to lead the agency as its new commissioner.

While COVID-19 is the priority, the FDA obviously has many vital other responsibilities. Though it doesn’t get that much attention, one of the important roles of the agency is to protect the public from unsafe chemicals in food. Frankly, their record has been disappointing, but the new administration has an opportunity to fix some key problems that scientists and doctors have been warning us about for years.

Here are ten things the new FDA Commissioner should do to keep unsafe chemicals out of our food. The list ranges from actions on specific chemicals to broader reforms.

  1. Stop letting industry decide for themselves, in secret, whether chemicals are safe and can be added to food. EDF, represented by Earthjustice, and the Center for Food Safety, have sued the agency to close the dangerous “Generally Recognized as Safe” loophole.
  2. Systematically reassess dangerous food chemicals it has allowed to be used in food based on new information. The FDA approved the use of many chemicals in food decades ago, and we now have evidence that some of these are unsafe. A chemical shouldn’t be given a forever approval. There needs to be a systematic process to review the scientific evidence, especially when new risks come to light.
  3. Ban the use of perchlorate, an ingredient in rocket fuel, from use in plastic packaging and equipment that comes into contact with food. Perchlorate gets into food, and exposure is particularly dangerous for pregnant women, infants, and young children, as it has been linked to developmental delays, reduced growth, and impaired learning abilities. We’ve sued the FDA to get this chemical out of food, and the case is pending.
  4. Comply with its 60-year-old Congressional mandate to look at the cumulative effect of chemical exposures people have when deciding whether to approve the use of related chemicals in food. EDF’s investigation of 900 approval decisions found that just one followed this common-sense mandate. The reality is that no one is exposed to just one chemical – so the agency shouldn’t be analyzing chemicals’ safety as if that were the case. FDA must respond to a petition filed by EDF and other organizations demanding that the agency follow the law and assess chemicals as classes.
  5. Drive down levels of heavy metals in food. Over the last decades, evidence has emerged of concerning levels of lead, arsenic, and cadmium in food consumed by children, such as rice, juice, and root crops like sweet potatoes and carrots. The FDA should move quickly and aggressively on its new commitment to set limits on heavy metals in food children eat and should also set limits for other food.
  6. Use modern science when evaluating if a chemical poses a health risk. The FDA is stuck in the past by relying on outdated, less accurate scientific methods and ignoring the evolving information we now know about chemical exposure. You wouldn’t insist on driving a car the Flintstones drove just because that was the first car ever.
  7. Prohibit lead from being added to materials that contact food, such as the tin that lines metal cans, and tighten limits for lead in bottled water. EDF’s analysis of FDA data found lead in 98% of certain canned fruits compared to 3% in fresh or frozen types. We’ve sent a formal petition to FDA requesting it immediately take action to ban these harmful and unnecessary uses of lead. Though it’s not a food safety issue, the FDA should also reject a challenge to its decision to ban lead acetate in hair dye. That challenge has put the FDA decision on hold, meaning that people are literally still putting lead on their head!
  8. Prohibit ortho-phthalates from being added to food packaging and processing equipment. These chemicals are known to disrupt hormones and harm brain development. The FDA is significantly overdue in meeting its legally required deadline to make a decision based on a petition from 2016 by EDF and nine other consumer, public health, and environmental groups to ban these chemicals.
  9. Be more transparent about the decisions it is making on chemicals in food. Information about FDA decisions should be publicly available without a Freedom of Information Act request and a months-long wait to learn more about agency actions on the chemicals in our food supply.
  10. Take aggressive action on harmful PFAS in food packaging and processing equipment. PFAS (Per- and poly-fluorinated alkyl substances) can provide water and grease resistance to paper and paperboard and can also leach into food. Growing evidence links PFAS to a wide range of serious health effects – from developmental problems to cancer. And now we know that many types of PFAS bioaccumulate in the body.
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Two chemicals that remind us why we should exercise caution with the oil industry’s wastewater

By EDF Blogs / Published: October 14, 2020

Cloelle Danforth, Scientist. 

This post originally appeared on the EDF Energy Exchange blog.

Over the past few years, we’ve written a lot about the wastewater generated from oil and gas production — specifically, how little is known about what’s in it and the potential risks of exposure.

But as states try to set standards for how to safely treat and dispose of this waste, there are two chemicals in particular that deserve to be among the regulatory priorities.

The first is a class of synthetic chemicals known as per- and polyfluoroalkyl substances — PFAS for short. Members of this class, often referred to as “forever chemicals” because they are highly persistent in the environment, are known to cause adverse health impacts in humans. This can include a range of symptoms, including damage to the immune system, low infant birth weights and cancer.

The second chemical is 1,4-dioxane. Short-term exposure to this carcinogen can cause immediate health impacts, like eye, nose and throat irritation and impaired lung function. Prolonged exposure can lead to liver and kidney damage, as well as cancer.

Read More »

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FDA takes an important step by phasing out paper greaseproofing agents containing a specific PFAS

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: August 4, 2020

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

Last week, the Food and Drug Administration (FDA) announced the phase-out of per- and polyfluorinated alkyl substances (PFAS) used to greaseproof paper and paperboard food packaging made from a specific type of short-chain PFAS known as 6:2 fluorotelomer alcohol (6:2 FTOH).  The action, narrow as it is, is welcome news for efforts to protect public health and the environment from the risks posed by short chain PFAS, known as “forever chemicals” because they do not degrade.

FDA secured voluntary agreements with three companies, Archroma, Asahi Glass, and Daikin, to phase-out products based on 6:2 FTOH. A fourth company, Chemours, asked FDA to suspend the agency’s approvals on its products containing the PFAS one year ago. The action affects 15 food contact substance notifications (FCN) approved by the agency between 2006 and 2016. It does not address 13 FCNs for similar greaseproofing uses made from PFAS other than 6:2 FTOH. And, under the agreement, consumers may still find 6:2 FTOH-laden, carry-out containers until June 2025.

The process FDA took, and the time it took to get there, reveals the significant difficulties the agency has in reversing past actions in the face of mounting evidence of a chemical’s risk:

  • FDA must seek out information because companies have no obligation to affirmatively notify the agency of new studies showing potential problems;
  • When FDA finds the information and identifies potential safety concerns, it appears to act as if it has the burden of proving the use is no longer safe; and
  • FDA continued approving uses of 6:2 FTOH even after it identified problematic data gaps.

These difficulties reinforce the need for actions being taken by states such as Washington, Maine, New York, and California, by Congress, and by retailers to reduce uses of PFAS in their products. When it comes to food packaging, PFAS are dinosaurs and their time is running out.

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Greasing the skids: The Trump EPA is green-lighting dozens of new PFAS under TSCA

By / Published: July 28, 2020

Richard Denison, Ph.D., is a Lead Senior Scientist.

Under an obscure and opaque – and increasingly used – exemption that EPA provides under the Toxic Substances Control Act (TSCA), EPA has been quietly approving companies’ requests to introduce new poly- and per-fluorinated substances (PFAS) onto the market.  And it seems to be ramping up. [pullquote]Under this EPA the “low-volume exemption” (LVE) application process is proving to be very smooth sailing for getting new PFAS onto the market.[/pullquote]

PFAS is a class of chemicals that are showing up as environmental contaminants all over the country.  They are linked to large and growing list of adverse effects on human health.  These concerns have led to increased scrutiny about EPA’s actions to allow new PFAS to enter commerce.  EDF and others have raised concerns about a number of premanufacture notices (PMNs) companies have filed seeking approval to introduce new PFAS into commerce (see here and here); the PMN process is the standard way in which companies are to notify EPA of their intent to start manufacturing a new chemical.

But EPA has created other pathways to quickly get a chemical on the market, whereby companies can apply for an exemption from the PMN process.  As documented in this post, we have identified a whole lot of PFAS coming into EPA’s new chemicals program through exemptions, and most of them are getting quickly approved.  Worse yet, this side process is highly insulated from public scrutiny.  Read More »

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Former chemical industry official Beck, now at Trump White House, again interferes to weaken EPA action on dangerous chemicals: This time it’s PFAS

By / Published: April 20, 2020

Richard Denison, Ph.D., is a Lead Senior Scientist.

It was only in February that Reveal News’ Elizabeth Shogren exposed the Trump White House’s role in dramatically weakening the Environmental Protection Agency’s (EPA) draft risk evaluation for the solvent trichloroethylene (TCE), which is linked to fetal heart defects at low doses.  The White House’s 11th-hour intervention, led by former chemical industry official Dr. Nancy Beck, forced EPA to rely on a different health effect that would allow 500 times greater exposures to the ubiquitous toxic chemical.

There was every reason to expect this episode was not a one-off, given Beck’s other actions both while at EPA and once arriving at the White House.  Sure enough, last week Ellen Knickmeyer of the Associated Press exposed another such incident, this time involving a group of chemicals collectively known as “perfluoroalkyl and polyfluoroalkyl substances” or PFAS that are showing up as environmental contaminants all over the country.[pullquote]Beck’s first order of business was to compel her former colleagues at EPA to submit the proposed PFAS rule for White House review, which neither the Obama administration nor the Trump administration up to that point had deemed necessary.[/pullquote]

Knickmeyer reported on documents obtained by Senator Tom Carper of Delaware, ranking member of the Senate’s Environment and Public Works Committee, that detail Beck’s largely successful effort to scale back a rule EPA first proposed in 2015.  Called a Significant New Use Rule, or SNUR, it would require companies seeking to import products containing certain PFAS to notify EPA in advance, thereby allowing EPA to determine whether to allow the import and impose needed restrictions.  Sen. Carper made the documents public via a letter he sent to EPA Administrator Andrew Wheeler calling on EPA to finalize the original rule instead of the watered-down re-proposed rule EPA released for public comment in February.  Read More »

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FDA scientists push back on an industry-funded analysis about bioaccumulation and toxicity of short-chain PFAS

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 1, 2020

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

Note to readers: As we all grapple with the grave global health challenge from COVID19, we want to acknowledge the essential services that professionals at the Food and Drug Administration (FDA) and in the food production, processing and retail industries provide in continuing to deliver food. In the meantime, we are continuing to work towards improved health protections – including reducing chemicals in food. We’ll plan to keep sharing developments that may be useful to you. In the meantime, please stay safe and healthy.

Last year, we reported on a sophisticated analysis performed by FDA’s scientists showing that 5:3 acid, a breakdown product of a short-chain PFAS known as 6:2 fluorotelomer (6:2 FTOH) was slow to be eliminated by the body. The authors concluded that the metabolite was an important biomarker for assessment of long-term exposure to 6:2 FTOH and showed potential bioaccumulative (aka biopersistence[1]) properties. The chemical 6:2 FTOH is a common starting substance in the manufacture of many PFAS polymers, including those used to greaseproof paper and paperboard. As a result, it is a major impurity in, and degradation product of, these polymers.

We are now reporting on two recent publications by the same group of FDA scientists (Kabadi et al.[2] and Rice et al.)[3] in which they not only confirmed their initial findings but also produced new evidence on the behavior of short-chain PFAS when they enter the body. The new evidence highlights:

  • Bioaccumulation: 6:2 FTOH is transformed by the body into several metabolites; one of them, called 5:3 acid, bioaccumulates, and the bioaccumulation is greater with lower exposure to 6:2 FTOH.
  • Toxicity: The toxicity of 6:2 FTOH is concerning and its risk to human health may have been significantly underestimated previously. Data on perfluorohexanoic acid (PFHxA), the industry’s proposed reference chemical for the short-chain PFAS class are not appropriate for assessing the potential health effects of 6:2 FTOH.

The FDA’s scientists reached these important conclusions after reviewing “recently received additional data on 6:2 FTOH and 5:3 acid” and more than a dozen reports on oral toxicity studies that “had been conducted and submitted by industry in support for food contact uses” of short-chain PFAS in addition to a study by the National Toxicology Program. They also called out flaws in industry-funded analyses that reached different conclusions.

Read More »

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