EDF Health

FDA finds surprisingly high levels of PFAS in certain foods – including chocolate cake

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

As reported by the Associated Press today, at a conference last week in Helsinki, Finland, the U.S. Food and Drug Administration (FDA) presented the results of three studies it conducted of 16 per- and poly-fluoroalkyl substances (PFAS) in various foods. A friend who attended the conference sent us photos of the poster. The results for samples of meat and chocolate cake purchased by the agency in October 2017 as part of its ongoing Total Diet Study (TDS) jumped out at us as surprisingly high and worth further investigation:

  • 17,640 parts per trillion (ppt) of perfluoro-n-pentanoic acid (PFPeA) in chocolate cake with icing. These levels suggest that the cake was contaminated from the intentional use of the chemical to greaseproof paper that contacted the cake rather than from an environmental source. We cannot find any evidence that FDA ever reviewed the safety of PFPeA as a food contact substance – meaning the manufacturer may have secretly designated it as Generally Recognized as Safe (GRAS). We also found little evidence – good or bad – of the health risks posed by this PFAS. We have reached out to FDA to learn more, but as of this blog posting the agency has not yet responded. This chemical was also found in chocolate milk at 154 ppt.
  • Nearly half (10 of 21) meat samples had quantifiable levels of perfluoroctanesulfonate (PFOS) with concentrations ranging from 134 ppt in a frankfurter to 865 ppt in tilapia. Unlike the chemical in chocolate cake, PFOS has been extensively studied because of widespread environmental contamination, especially around the facilities in Alabama and Minnesota where it was previously produced. It is associated with increased cholesterol, thyroid disease, testicular cancer, and decreased birth weight. While comparisons are complicated, the PFOS levels found in some of these meats were far greater than the 70 ppt health advisory set by the Environmental Protection Agency (EPA) for drinking water in May 2016. Two years later, the Centers for Disease Control and Prevention (CDC) proposed limits that are almost 7 times more protective than EPA’s, partly because more recent studies indicate the chemical may undermine the effectiveness of vaccines. Production of PFOS in the United States reportedly ended in 2002, though it is still made overseas and may have been imported paper. In 2016, FDA removed its approval to greaseproof paper with PFOS.

FDA’s poster also showed testing results from food produced around two PFAS contaminated areas. FDA found most of the 16 PFAS at varying levels measured in produce sold in farmer’s markets downstream of a PFAS production facility in the Eastern U.S. – presumably Chemours’ plant in North Carolina. The highest produce sample had 1,200 ppt and was purchased within 10 miles downstream of the production plant and short-chain PFAS were prevalent.

The other contaminated area was a dairy farm near an air force base in New Mexico. FDA found many of the 16 PFAS in the water and silage used to feed the cows but PFOS was the most prevalent among a few PFAS measured in the milk with levels higher than 5000 ppt. The agency also detected several PFAS in cheese produced by the farm in lower amounts than the milk. Many of the PFAS are likely from aqueous film forming foam (AFFF) used to fight fire and conduct firefighting training at the Air Force base.

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Also posted in Food, GRAS, PFAS, Public Health / Tagged , , , | 2 Responses

Too much cadmium and lead in kids’ food according to estimates by FDA

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

The Food and Drug Administration (FDA) released a study in April estimating young children’s exposure to lead and cadmium from their diets and identifying food groups that are a significant source of these heavy metals. The study used data from the agency’s Total Diet Study (TDS) program for 2014 to 2016 and the Center for Disease Control and Prevention’s (CDC) What We Eat in America (WWEIA) Survey for 2009 to 2014.[1]

The study is a reminder of how pervasive heavy metals are in children’s diets and that, while the levels are relatively low, the cumulative exposure is significant. Based on FDA’s analysis (Table 1 below), we estimate that about 2.2 million children exceeded the agency’s maximum daily intake (MDI) for lead at a given time. The results for cadmium are new and worrisome, with estimated daily intake (EDI) levels that are 3 to 4 times greater than lead. And while FDA has not yet set an MDI limit for cadmium, the average young child exceeds most of the relevant daily exposure limits set by other agencies. Clearly, cadmium warrants greater attention, but note that the evidence of neurotoxicity is still emerging.

Table 1: Young children’s estimated dietary intake (EDI) of lead and cadmium based on FDA’s TDS results for years 2014 to 2016 (based on hybrid method)

Age GroupLead Mean EDI Lead 90th Percentile EDICadmium Mean EDICadmium 90th Percentile EDI
LimitsFDA’s MDI is 3.0No MDL set by FDA. Intake exceeded most limits set by other agencies
1-6 years1.8 µg/day2.9 µg/day6.8 µg/day11.0 µg/day
1-3 years1.7 µg/day2.6 µg/day5.8 µg/day9.7 µg/day
4-6 years2.0 µg/day3.1 µg/day7.8 µg/day12.1 µg/day

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EDF asks judge to rule on legality of FDA rule allowing companies to secretly decide on chemicals in our food

Tom Neltner, J.D.is Chemicals Policy Director

At the end of March, EDF, represented jointly by counsel from Earthjustice and the Center for Food Safety (CFS), asked a federal district court judge to decide as a matter of law that the Food and Drug Administration’s (FDA) Generally Recognized as Safe (GRAS) regulation is unlawful. The GRAS Rule allows food manufacturers to make secret safety determinations for chemicals added to food without notifying FDA or the public and to use such chemicals. If the judge agrees to our request, this would vacate the rule. Two years ago, EDF and others challenged the legality of the GRAS Rule in the Federal District Court for the Southern District of New York. Last September, the court ruled that plaintiffs EDF and the CFS have standing, setting the stage for a decision on the merits of the case.

In the Motion for Summary Judgment, we identify the following four ways in which FDA violated the law in the GRAS Rule. FDA has until May 28 to respond to our motion.

  1. FDA unlawfully delegated to food manufacturers its authority to determine the safety of chemicals added to our food.

When Congress enacted the Federal Food Drug and Cosmetic Act (FFDCA) of 1938, it gave FDA the responsibility to ensure the nation’s food is safe and free from harmful substances. To implement this responsibility, it provided the agency broad authority to adopt necessary regulations.

Unfortunately, in the GRAS Rule, instead of fulfilling its responsibility to keep food safe, FDA formally and unlawfully outsourced its responsibility to the regulated entities themselves – namely, for-profit additive manufacturers – allowing them to decide for themselves, in secret, whether the chemical substances they have manufactured can be added to food. This unlawful delegation – made without express statutory authorization – makes it all but impossible for FDA to fulfill its obligations under the FFDCA.

As a result, the GRAS Rule impermissibly allows regulated, private companies with obvious conflicts of interest to self-certify the use of their chemical additives as GRAS without notifying FDA. This is not a case where FDA is seeking legitimate outside input to gather factual information or advice and make policy recommendations. Here, FDA retains no oversight over these secret GRAS determinations that directly affect the safety of our food and thus render it impossible for the agency to fulfill its statutory mandate to keep our food safe.

By delegating its authority in the GRAS Rule, the agency violated Constitutional principles, the FFDCA, and the Administrative Procedures Act (APA). The rule effectively insulates the agency from democratic accountability for food safety decisions and denies citizens their right to seek judicial review of decisions about the safety of substances that may be added to food.

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Toxic chemicals can enter food through packaging. We made a list.

Boma Brown-West, Senior Manager, Tom Neltner, Chemicals Policy Director, and Michelle Harvey, Consultant.

This is the second in a series evaluating the challenges in single-use food packaging waste.

See our list of key chemicals of concern in food packaging.

In the late 1980s, the Council of Northeast Governors (CONEG) was concerned that heavy metals in packaging would accumulate in recycled materials to levels that presented serious health concerns. The organization drafted model legislation that prohibited the intentional addition of mercury, lead, cadmium, and hexavalent chromium to any component of packaging, including inks. It also set a 100 parts-per-million limit on the total amount of these four heavy metals. To ensure compliance, companies making packaging materials had to provide certificates of compliance to downstream purchasers and report compliance to the states.

CONEG also established the Toxics in Packaging Clearinghouse to maintain the model legislation, coordinate implementation of state legislation, and serve as a resource for companies seeking compliance information. The Council’s hypothesis: protecting virgin material from contamination will improve the recyclability of post-consumer materials and protect public health.

Over the years, 19 states have adopted a variation of the model legislation.  In 2018, the State of Washington took an unprecedented step of expanding its version of the legislation from heavy metals to include per- and poly-fluorinated alkyl substances (PFAS). PFAS are bioaccumulating, persistent chemicals and are associated with an array of health problems including endocrine disruption and children’s developmental harm. The State was concerned that paper and cardboard food packaging treated with these chemicals may be contaminating composting and paper recycling processes post-consumer.

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Important insight from the organic certification approach to chemical additives in food

Tom Neltner, J.D.is Chemicals Policy Director

Since 2014, chemicals in food[1] have been consumers’ most important food safety issue, reaching a high of 35% in 2018, according to annual industry surveys by the International Food Information Council. For comparison, “foodborne illness from bacteria” was half that percent.

Food companies have responded to this growing consumer alarm by adopting policies banning artificial flavors, colors and other ingredients that sound like chemicals. This approach is unlikely to do more than serve as window dressing for the underlying problems since it’s not science-based – many of these additives may be safe. The Center for Science in the Public Interest called out this practice in its 2017 “Clean Label: Public Relations or Public Health?” report and pointed readers to its Chemical Cuisine system that rates common additives for health and safety.

There are some companies, like Panera Bread, that are taking a more systematic approach to the ingredients used in the food they sell, starting with the question of whether the additives used are essential and whether the ingredients pose health or safety concerns. As a result, the company worked closely with their suppliers and reformulated many of their products.

And now, thanks to a fascinating new report from the Environmental Working Group (EWG), we are learning about another structured approach that addresses health concerns with chemical additives – the Federal organic certification program for processed foods. To be honest, before reading the report, I viewed the organic program as narrowly focused on pesticides and was only vaguely aware of how it dealt with chemical additives. I was missing the bigger picture.

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A gap remains in the circular economy conversation: Toxic chemicals in packaging

Boma Brown-West, Senior Manager, Tom Neltner, Chemicals Policy Director, and Michelle Harvey, Consultant.

This is the first blog in a series evaluating the challenges associated with single-use food packaging waste.

This week Walmart joined a growing number of companies that are trying to advance the circular economy for packaging. Like previous commitments from NestleCoca-Cola and McDonald’s, Walmart is stepping up its efforts to use more recyclable packaging, incorporate more recycled content, and accelerate development of collection and recycling infrastructures. EDF has a long history fighting for greater and smarter plastics recycling, so we are pleased to see more companies working to eliminate plastic packaging waste from our environment. However, something is often missing from their statements: commitments for safer packaging free of toxic chemicals.

What defines safer packaging?

There are many facets to sustainable packaging: recyclability, reusability, lower material and energy inputs, and the avoidance of toxic chemicals.  A significant amount of virgin plastic used in packaging currently contains toxic chemical additives such as ortho-phthalates or contaminants such as heavy metals. These chemicals have been linked to diseases and health disorders, such as reproductive problems and impaired brain development. When tainted plastic packaging is reused or recycled, these toxic chemicals persist and may accumulate to worrisome levels until the packaging is retired, posing long-term threats to our health.

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