EDF Health

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 23, 2020

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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Hurricanes Coming: Protecting Black and Brown Neighborhoods from a “Triple Whammy”

By Elena Craft, PhD / Published: June 17, 2020

Elena Craft, Ph.D., is Senior Director of Climate and Health

This is the first in a series of Global Clean Air blogs on COVID-19 and air pollution. EDF scientists will share data about pollution levels during quarantine from a local and global perspective, and provide recommendations for governments and companies to Rebuild Better.

A black man who lived most of his 88 years in Pleasantville was one of the first Houstonians to die from COVID-19.

James C. Campbell, Source: ABC13.com Houston

His name was James C. Campbell. He raised a family in one of the first neighborhoods in the city planned for black Houstonians, Pleasantville, which has been surrounded in the years since it was founded by congested interstates, salvage yards, metal recyclers, and a sprawling brewery where heavy trucks come and go day and night. Pleasantville residents still share stories about where they were when chemicals in warehouses exploded in the 1990s and forced them to flee their neighborhood for safety.

Just days after Campbell’s funeral in early April, as the coronavirus started to spread across Texas, UT Health researchers mapped neighborhoods across Houston like Pleasantville where residents suffering from underlying health conditions and from years of exposure to air pollution were at increased risk from the worst impacts of a COVID infection. The intention was clear: Data could help local government leaders decide how, and where, to marshal resources to protect the health of those who needed it most.

Disasters do not impact neighborhoods equally, data like that show. It’s clear during the coronavirus pandemic, just as it was clear during past disasters like Hurricane Harvey. In 2017, for example, in the first, and worst days of the storm, 93 percent of all known toxic emissions in all of Harris County were released within a four-mile radius of the predominantly Hispanic neighborhood Manchester — an area that includes Pleasantville — even though it makes up less than 5 percent of the county geographically.

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

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 1, 2020

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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Think PFAS in food packaging are safe simply because FDA accepted their use? Think again.

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: November 13, 2019

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

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PFAS manufacturers’ claims that the agency demands scientific data, including toxicity and exposure, and conducts a rigorous review before allowing the use of the chemicals in contact with food are not accurate.

[/pullquote]Per- and poly-fluorinated alkyl substances (PFAS)—recently dubbed “forever chemicals”—have received a large amount of national attention, mostly due to contamination of drinking water affecting millions of Americans. Since June 2019, when the U.S. Food and Drug Administration (FDA) released its testing results from three studies, questions have arisen about food as a source of PFAS exposure. The main routes by which PFAS enter the food supply are environmental contamination—such as from nearby chemical manufacturing facilities, airports or Department of Defense operations—and from food packaging and processing equipment.

With greater attention on PFAS in food, we’ve noticed several misleading PFAS manufacturers’ talking points asserting that FDA review and acceptance is required for any PFAS to be used in contact with food, and that, due to this review, PFAS that go through this process are safe. However, their claims that the agency demands scientific data, including toxicity and exposure, and conducts a rigorous review before allowing the use of the chemicals in contact with food are not accurate.

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Without a food safety overhaul for additives, the innovative food craze could spiral out of control

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: October 31, 2019

Tom Neltner, J.D., Chemicals Policy Director

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At an FDA-sponsored conference, EDF proposed a new path forward to ensure innovative food ingredients are safe by overhauling how food additives are regulated today.

[/pullquote]Every day brings reports of new ingredients that food innovators around the world have developed to meet consumer demands for a healthier and more sustainable food supply. The innovations range from new ways to extract useful additives from existing sources such as algae to bioengineering to make novel ingredients like sweeteners or proteins that can be grown in a tank instead of on a farm.

At EDF, we encourage innovation that helps communities and the environment thrive, especially in the face of the threats posed by climate change. However, an innovator’s bold claims, especially those involving food safety, must be closely scrutinized before the additive hits the marketplace. Given the potential for harm to consumers, we cannot simply take a company’s assertion of safety at face value – there must be transparency and the Food and Drug Administration (FDA) must provide an independent review.

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Air pollution: E-commerce’s sustainability problem that isn’t the cardboard box

By EDF Blogs / Published: July 22, 2019

Aileen Nowlan, Senior Manager, EDF+Business

This post originally appeared on EDF+Business.

With the click of a button, our groceries, clothes, personal care products, household items – just about anything – could arrive on our doorsteps in a neatly packaged cardboard box. It’s convenience, delivered. But at what cost?

What happens behind-the-scenes to get a package delivered to your door is taking a toll on our planet and our health. Freight is the fastest growing source of greenhouse gases and a major source of local air pollution. The rise in e-commerce is a growing part of increased pollution and poor air quality.

The truth is, “free shipping” isn’t really free. We’re just paying for it in other ways.

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Posted in Air pollution, Hyperlocal mapping, Markets and Retail, Public health / Tagged , , , | Authors: / Comments are closed