EDF Health

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FDA’s Failure on Food Chemical Safety Leaves Consumers at Risk of Chronic Diseases

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

Update: FDA published the citizen petition upon receipt on 9/23, and is requesting public comment.

More than 60 years ago, Congress enacted legislation requiring the Food and Drug Administration (FDA) and the food industry to evaluate the cumulative effects of substances in the diet that have related health impacts when assessing the safety of chemical additives. In our decade of analyzing FDA and industry actions, we have been increasingly concerned that both have ignored this requirement. To figure it out, we investigated all safety determinations contained in Generally Recognized as Safe (GRAS) notifications voluntarily submitted by food manufacturers to FDA since the program began in 1997. We looked at GRAS notices because they are publicly available and because FDA rules explicitly require that food manufacturers include in the notice an explanation of how they considered the requirement. If there was an omission, it would be more easily noticeable.

We found that in only one of 877 GRAS notices did a food manufacturer consider the cumulative effect requirement in a meaningful way. And we found no evidence that the agency either recognized this single attempt to follow the law or had objected to the omissions in the 876 other notices. This failure has significant consequences for public health, particularly for communities who already face significant health and socio-economic disparities, and for children, who are uniquely susceptible to dietary exposures to multiple chemicals.

For this reason, EDF joined with other health, environmental, and consumer groups to file a formal petition to demand FDA and food manufacturers start following the law. The petition requests specific changes to rules designed to reinforce the existing requirement and make it easier to verify compliance. Still, given the lack of transparency in agency reviews, success still largely depends on FDA and the food industry taking seriously the mandate and the food safety implications.

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

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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Best practices for reducing cadmium in food: New review from FDA scientists

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 the professionals at the Food and Drug Administration 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.

Two years ago, the Food and Drug Administration (FDA) put cadmium on our radar when the Toxic Elements Working Group included cadmium together with arsenic, lead and mercury as metals affecting children’s neurological development. As part of that effort, FDA committed to look at all four metals across all foods instead of one contaminant, one food at a time. Last year, FDA’s scientists published a peer-reviewed article assessing children’s exposure to lead and cadmium in the diet. They found that spinach, lettuce, sunflower seeds, potato chips and wheat cereal were among the top 10 foods with the highest cadmium concentration.

New review of mitigation strategies

This year, FDA’s scientists published in a peer-reviewed journal a review of mitigation strategies to reduce dietary exposure to cadmium. Because plants uptake cadmium from the soil and “70 to 80% of dietary cadmium intake in humans comes from plant-based food,” the article focuses on methods to “reduce or prevent initial uptake by plants.” The authors explained that cadmium enters the food supply through natural and manmade sources, highlighting that cadmium often is a contaminant in phosphate fertilizers. Cadmium is also a contaminant in zinc used to galvanize steel.

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

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.

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Posted in FDA, Health Policy, Industry Influence, PFAS / Also tagged | Comments are closed

When it comes to testing heavy metals in food, the result is only as good as the lab.

Tom Neltner, J.D., Chemicals Policy Director and Boma Brown-West, Senior Manager.

“Even though the levels of a metal in any particular food is low, our overall
exposure adds up because many of the foods we eat contain them in small amounts.”

 

Dr. Conrad Choiniere, leader of FDA’s Toxic Elements Workgroup on April 20, 2018

Heavy metals such as arsenic, cadmium, and lead are present in most foods, whether conventional or organic, usually as the result of environmental contamination. Because heavy metals pose significant threats even at low levels, the Food and Drug Administration (FDA) has made reducing cumulative exposure a priority. The Baby Food Council – consisting of Beech-Nut Nutrition Company, Happy Family Organics, Earth’s Best, and Gerber Products Company and supported by Healthy Babies Bright Futures (HBBF), Cornell University and EDF – shares this goal and seeks to reduce heavy metals in the companies’ products to as low as reasonably achievable using best-in-class management practices.

Through the Council, EDF is coordinating a proficiency testing program to enable retailers, food manufacturers, ingredient suppliers, and others to identify laboratories that are capable of measuring arsenic, cadmium, and lead at levels in the low parts per billion (ppb). The Council has arranged for FAPAS, a leading proficiency testing provider for the food and water testing industries, to manage the testing program.

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FDA’s updated results for PFAS in food suggest progress but raise questions about its method

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

The Food and Drug Administration (FDA) recently released revised lab results from testing for 16 PFAS in food. Initial results of the testing were announced last June and gained wide attention because the levels of PFAS in certain foods were quite high. Surprisingly, the revised lab results show significantly fewer detections and, in the case of ground turkey and tilapia, concentrations of PFOS that are almost nine times lower than the values initially reported in June. In addition to the revised lab results, the agency also released a validated method for analyzing food for the substances and updated its PFAS webpage.

We were glad to see FDA’s ongoing work on PFAS and have already heard from commercial laboratories who are considering using the validated method as a potential new service to offer their customers. In analyzing the documentation that FDA provided,[1] we have concerns about the agency’s criteria to determine whether a sample had detectable levels of a PFAS. It appears unnecessarily restrictive and effectively underestimates the public’s exposure to PFAS. We are planning to meet with the agency to better understand their rationale for the criteria selection and its implications.

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