EDF Health

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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How and when will FDA rule on ortho-phthalates in food? It’s anyone’s guess.

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: January 29, 2019

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

The Food and Drug Administration (FDA) has yet to decide three overlapping petitions requesting the agency take action on uses of ortho-phthalates in contact with food. Two of the petitions—a food additive petition and a citizen petition—were submitted by EDF, Earthjustice and nine other public health allies. In those petitions, we requested the revocation of all uses of this class of chemicals in food because the agency can no longer conclude that such use is safe. The law required FDA to make a decision by no later than September 2018; that deadline has long since come and gone, and the agency hasn’t acted.

The third petition was submitted by the Flexible Vinyl Alliance, an industry group. It requested that the agency revoke the food additive uses of 26 ortho-phthalates because, according to FDA’s notice, they had been abandoned. The agency agreed to review the petition in July 2018 and invited public comment on it in November 2018.  Public comments were due on January 14, 2019.

In a press release about its petition, the industry group announced that only four ortho-phthalates “remain relevant in food contact applications”:  di(2-ethylhexyl) phthalate (DEHP), diisononyl phthalate (DINP), dicyclohexyl phthalate (DCHP) and diisodecyl phthalate (DIDP).  It also stated that it confidentially provided the agency with exposure and safety data on these four substances. The agency has made neither the industry’s petition nor the safety data on the four ortho-phthalates publicly available. We submitted a Freedom of Information Act (FOIA) request seeking industry’s “confidential” report and more information on the petition.  We await a response.

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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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