EDF Health

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: May 7, 2019

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
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
LimitsFDA’s MDI is 3.0No MDL set by FDA. Intake exceeded most limits set by other agencies

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 18, 2019

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.

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 26, 2019

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.

[pullquote]See our list of key chemicals of concern in food packaging.[/pullquote]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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: March 19, 2019

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: February 27, 2019

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 Nestle, Coca-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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FDA seeks expert panel review of neurodevelopmental risk of inorganic arsenic in food

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: February 25, 2019

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

Updated March 27, 2019 to include a link to EDF’s comments and to Project TENDR’s comments.

The United States has asked the Codex Alimentarius (Codex), the international standard setting body for food, to prioritize inorganic arsenic for evaluation of non-cancer effects such as neurodevelopmental, immunological, and cardiovascular effects. The evaluation would be conducted by an expert panel convened by the Joint Food and Agriculture Organization / World Health Organization Expert Committee on Food Additives (JECFA), on which Codex relies for scientific advice.[1]

EDF will submit comments in support of the proposal and encourages others to do the same.[2] However, FDA should not wait for the review to be finished before incorporating this evidence into its long-awaited standards for inorganic arsenic in rice.

Evidence of harm from inorganic arsenic on children’s neurodevelopment has grown more compelling

Inorganic arsenic is a known water and food contaminant. FDA has measured it in many foods included in its Total Diet Study, but it’s mostly known for its presence in baby and infant foods such as rice and fruit juices. The presence of inorganic arsenic in staples of children’s diets is concerning due to its risk of potential lasting health effects. The risks posed by inorganic arsenic on fetal and child brain development has become increasingly clear since the early 2000s as epidemiological studies began to scrutinize more subtle effects such as learning disorders and epigenetic effects. Earlier studies mostly focused on gross measures such as low body weight or increased stillbirths.

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