EDF Health

FDA is dragging its feet while children continue to be exposed to perchlorate in food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: January 11, 2019

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

It has been more than 18 months since EDF and other advocates challenged the Food and Drug Administration’s (FDA) May 2017 decision to continue allowing perchlorate in dry food plastic packaging and food handling equipment.

While Congress gives FDA 180 days to act on food additive petitions, FDA must act “as soon as possible” on a challenge such as ours. However, the agency has yet to complete a review of its May 2017 decision in light of our concerns and evaluate whether to either stand by it, or reverse it. We did not expect FDA would take three times longer to review a decision already made, especially since our objection is largely based on the agency’s own data.

In the meantime, perchlorate in food continues to threaten children’s brains. The chemical, a component of rocket fuel, disrupts the thyroid gland’s normal function and reduces production of the thyroid hormone needed for healthy fetal and child brain development. FDA’s own studies show increased levels of perchlorate in foods such as baby food dry cereal, indicating the chemical’s intentional use in dry food packaging is the likely source of increased exposure for young children.

How FDA got it wrong

In FDA’s May 2017 decision to continue allowing intentional use of perchlorate in contact with dry food, the agency largely relied on flawed science to assess dietary exposure. Its three central errors were:

  1. Ignoring its own data showing significantly increased exposure for children;
  2. Woefully underestimating exposure based on a flawed migration test; and
  3. Unrealistically assuming that perchlorate-laden plastic would only contact food once.

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FDA-approved PFAS: A serious breakdown in assessing food additive safety

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: November 4, 2018

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

This blog is the fourth in a series describing information we discovered in reviewing thousands of pages from the Food and Drug Administration’s (FDA) response to our Freedom of Information Act (FOIA) of the agency’s approval of 31 Food Contact Substance Notifications (FCNs) from 2002 to 2016 submitted by six companies for 19 distinct chemical mixtures of per- and poly-fluorinated substances (PFAS).

In this blog, we identify one company’s serious breach of its obligation to provide FDA with all relevant toxicology data. While hindsight is 20/20, we have reason to believe that if FDA had had all relevant information, it would have demanded more studies potentially revealing risks that are only now coming to light with related chemicals. Though we have not completed a similar review for the other companies, we think this inadequate approach to chemical safety is not unique to a single company, and FDA should reassess all its reviews given what is now known about PFAS chemicals.

Safety assessment requirements for food additives – including food contact substances

When a company seeks FDA’s approval of food additives (including food contact substances), it is required to provide the agency with all relevant chemistry, toxicology and environmental data so it can conduct a safety assessment. While the agency typically conducts a literature search of its own and of public databases, the company that is claiming the chemical’s use is safe is obligated to include any data that is inconsistent with the company’s conclusion.

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FDA reduces maximum daily limit for lead in children’s food by half

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: October 25, 2018

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

On September 27, 2018, the Food and Drug Administration (FDA) reduced the maximum allowed daily intake of lead for children from 6 to 3 micrograms per day (µg/day). It has also set a limit for adults of 12.5 µg/day, to protect against possible fetal exposure in women who are unaware they are pregnant and to reduce infant exposure during nursing. The agency now refers to these limits as the “Interim Reference Level” to match the Centers for Disease Control and Prevention’s (CDC) terminology for elevated blood lead levels that warrant action. FDA reports that the new level for children is the amount of lead in food expected to result in a blood lead level of 5 µg/deciliter, with a 10-fold safety factor to account for differences across the population.

This change is a major step in FDA’s new push to limit heavy metals in food to protect children’s neurological development. In April 2018, FDA explained that its Toxic Elements Working Group is “looking at all the [heavy] metals across all foods rather than one contaminant, one food at a time,” and that “even though the level 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.”

As the agency indicated earlier this year, the next step for the Working Group is to “begin reevaluating the specific lead levels that FDA has set for a variety of foods.”

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Challenge to FDA’s GRAS rule moves forward after court rejects request for dismissal

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 14, 2018

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

In a critical ruling for food additive safety, a federal district court ruled on Wednesday that EDF, represented by Earthjustice, has standing in its legal challenge to the Food and Drug Administration’s (FDA) Generally Recognized as Safe (GRAS) rule. This 2016 final rule allows food manufacturers to make secret GRAS safety determinations for chemicals added to food, without notifying FDA or the public, and to use the chemical in food without anyone else’s knowledge. The court was considering a motion to dismiss from FDA arguing that plaintiffs did not have standing to bring the case. The judge found EDF and the Center for Food Safety (CFS) “plausibly allege harm to their members” and therefore “satisfy the injury-in-fact requirement for standing.” Our legal challenge now moves to the substance of our concerns with the flaws in the agency’s GRAS Rule.

The court found that members of EDF and CFS showed a risk of harm consistent with the requirements of the law in alleging that FDA’s “GRAS Rule poses a credible threat to their members.” Specifically the court stated that:

  • Their members “have been and will be exposed to potentially dangerous substances that were introduced into the food supply without FDA oversight, public participation, or the opportunity for judicial review.”
  • They “explicitly identify multiple substances that manufacturers determined to be GRAS and used in food despite concerns raised by FDA about their safety, as well as additional undisputedly dangerous substances that Plaintiffs reasonably anticipate will be introduced into the food supply under the GRAS Rule.”
  • “[T]hese injuries are ongoing and imminent.

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: July 23, 2018

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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FDA-approved PFAS and drinking water – Q&A on textile mills and environmental permits

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 21, 2018

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

In May 2018, we released a blog highlighting paper mills as a potentially significant source of drinking water contamination from 14 Food and Drug Administration (FDA)-approved poly- and per-fluorinated alkyl substances (PFAS) used to greaseproof paper. We showed that wastewater discharge could result in PFAS concentrations in rivers in excess of the Environmental Protection Agency (EPA)’s 70 parts per trillion (ppt) health advisory level for drinking water contamination for PFOA and PFOS, the most studied of the PFASs. We identified 269 paper mills with discharge permits that warrant investigation. Readers of the blog have asked some important questions highlighted below. As with most issues involving PFAS, there are many gaps in what we know. Based on the information provided in response to EDF’s Freedom of Information Act (FOIA) request to FDA, we hope to fill in some of the gaps and highlight key information needed to better understand the risks of PFASs.  

Question 1: Could textile mills also be a source of PFASs in drinking water?

The answer is “probably.” The FDA-approved PFASs can be used in coating paper that contacts food to repel oil, grease, and water. The same or similar FDA-approved PFASs may be used for non-food uses such as coating textiles to resist stains and repel water.

The processes used to coat paper and textiles differ in some aspects that could affect a mill’s environmental releases. For paper, the PFASs are typically added to the wet wood fibers to be made into paper. In contrast, we understand that PFASs are applied to textiles after the water is removed. Therefore, we would suspect that the amount of PFASs, whether as polymers or impurities, released with the wastewater of a textile mill would be lower compared to that of a typical paper mill. However, there is very little data available to assess the potential environmental release of PFASs from textile mills. Unlike with FDA approvals, there is no environmental review of a chemical’s use in non-food consumer products.[1] So, it would be worthwhile to investigate textile mills for use of PFASs in addition to looking at paper mills.

Using an EPA database[2], we identified 66 textile mills (PDF and EXCEL) in the US, two thirds of which are located in North and South Carolina. Based on wastewater flow, the two largest mills are both operated by Milliken. Its largest facility is in Greenville, South Carolina with a water discharge of 72 million gallons per day (MGD). The second largest is in Bacon, Georgia with a water discharge of 15 MGD. DuPont’s Old Hickory facility, near Nashville, Tennessee, had the third greatest flow at 10 MGD. We do not know whether any of the facilities use and discharge FDA-approved PFASs.

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