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USFDA Allows Chemicals in Food Despite Lack of Toxicity Testing

Jennifer Sass

Posted August 14, 2013 in Health and the Environment, U.S. Law and Policy

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Chemicals are added to food to preserve, flavor, thicken, or otherwise alter it in some desirable way. Used this way, the chemicals are called ‘food additives’. In other contexts the same chemicals may be considered industrial chemicals or pesticides.

For example, sulfites were banned by FDA in 1986 for use on fruits and vegetables that are eaten raw, but are still allowed as a preservative in cooked and processed foods, and they occur naturally in wines and beers. They are also approved by EPA as pesticides, to prevent fungus and preserve grape crops. When eaten in foods, they induce allergy-like reactions in many people (FDA estimates that 1 in 100 people are sensitive to sulfites in food). When FDA approved their use as a food additive in the 1970s, sulfites were deemed to be Generally Recognized As Safe (GRAS) and exempted from FDA premarket approval requirements. 

In 1974, the FDA allowed asbestos-contaminated salt produced by one company, United Salt in Houston, to be sold as table salt, as GRAS. FDA had even received comments from the trade group Salt Institute that it had looked at this type of salt – called diaphragm salt - and seen asbestos fibers by optical microscopy. Only in response to public outrage did FDA do a proper analysis of the salt at outside labs, using the more powerful electron microscopy, whereupon tens of millions of asbestos fibers per gram was found and FDA revoked its approval.

asbestos.jpg

The black box of FDA food regulations came under the spot light when technical experts at The Pew Charitable Trusts started working to answer these questions and others about how chemicals in our food are regulated.

Today, Pew released a report in the scientific journal Reproductive Toxicology reporting that less than 38% of over 8,000 FDA-regulated additives (including those added directly to food intentionally, and food contact materials that may contaminate foods) have a published feeding study. (Feeding studies comprise the basic toxicology test – the first test a scientist would do to evaluate the safety of a chemical additive.) For the direct additives (added intentionally to the food) only 21.6% (out of almost 4,000) have the feeding studies necessary to estimate a safe level of exposure, and only 6.7% have reproductive or developmental toxicity data in FDA’s database. 

It appears FDA and companies were often making safety decisions by comparing one chemical to another rather than doing an actual toxicology study.  They were building a house of cards based on assumptions and unsupported extrapolations instead of direct scientific evidence. 

How did our food regulations go so terribly wrong? The Pew team has a few insights:

Once a chemical use is cleared to be added to the food supply, it is seldom re-assessed for ongoing safety. So, the manufacturer has no incentive to support additional toxicity testing. And the FDA doesn’t have the authority to require testing if it has questions about a chemical.

GRAS determinations are permitted to be made by the chemical manufacturer, not FDA (unless the additive affects food color). If the additive is self-determined to be GRAS by the company, then it can choose whether or not to alert the FDA about the new food additive. In other words, even reporting GRAS additives to FDA is voluntary. Had the company selling the asbestos-contaminated table salt opted not to notify FDA, it may have stayed on the market.

In fact, the Pew team believes that about one thousand food additives are in the food supply without FDA’s knowledge. An example is the 2010 debacle with caffeine-alcohol drinks marketed for young people without informing the FDA. The manufacturer had considered the additives to be GRAS, until alcoholic poisonings and blackouts resulted in public outrage and Congressional scrutiny.

A 2010 report by the US Government Accountability Office (GAO), providing Congressional oversight, called the whole messed-up GRAS process into question when it learned that engineered nanomaterials were being deemed GRAS food additives. GAO concluded that, “FDA does not know to what extent, or even whether, companies track evolving scientific information about their GRAS substances. FDA's approach to regulating nanotechnology allows engineered nanomaterials to enter the food supply as GRAS substances without FDA's knowledge.” It is disturbing that nanomaterials are deemed to be GRAS food additives, when the legal definition of GRAS is that there is, “a reasonably certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use”, and there is no scientific consensus on how to even test the toxicity or safety of nanomaterials.

Last week, the Pew team published a report in The Journal of the American Medical Association Internal Medicine showing that “financial conflicts of interest are ubiquitous” in the process leading to determining that a chemical is GRAS. Considering the lack of toxicity data for thousands of chemicals (many of which are designated as GRAS) allowed in food, one wonders 1) who made the decision that they were safe and 2) whether their judgment was influenced by the manufacturer.

A commentary by Dr. Marion Nestle highlights the obvious conflicts of interest as one of the biggest problems with chemical food additive regulations (or lack thereof). She emphasizes the fact that Pew reported that all – that’s 100% - of the members of the expert panels that review food additives to make GRAS determinations have financial relationships with companies that manufacture the food additives being reviewed. Follow the money! (An editorial today in the prestigious journal Nature discusses the Pew study and highlights the problems of financial conflicts)

I’ve extensively documented the problem of chemical manufacturers testing the safety of their own products. It isn’t rocket science to think that a bias and a financial conflict may lead to a misrepresentation of the potential toxicity of a chemical. But, when those chemicals are intentionally added to the food supply, well, things just got a lot more serious!

This past spring, NRDC officially requested a copy of the FDA database of food additives that includes both the names of the chemicals and the basis for the FDA’s approving them for use in food. FDA failed to respond, so we had to file a lawsuit against FDA for this public information. What is FDA hiding from the public? Thanks to the Pew team, the public is starting to learn about failures in the food additives regulatory process.

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Comments

Barry CastlemanAug 14 2013 07:14 AM

The asbestos-contaminated diaphragm salt occurred in the most common process for making chlorine in the country, wherein an electric current is put through concentrated salt solution (brine) and the gases chlorine and hydrogen come out at the electrodes. Meanwhile, the salt solution is converted to lye (NaOH) solution. A submerged asbestos diaphragm insulates the electrodes from each other, and this deteriorates at a known rate and has to be periodically replaced. Not all of the salt in the original mine salt solution is converted to lye, so the unreacted salt is normally recrystallized from the lye solution and recycled. Well some genius got the idea of selling those nicer looking salt crystals for food grade.

The petitioners did not have to even identify themselves but were referred to as companies A, B, C, D, and E. It looked like half of the chlorine industry was involved. I consulted crystallographers I knew at Johns Hopkins who assured me that the microscopic asbestos fibers would make great seedlings for the formations of the salt crystals from the lye solution. I sent a letter to the FDA citing the Salt Institute report and the media picked up the story, "Asbestos in Salt." There was plenty about the lethality of asbestos getting on the media by then.

A few months later, a Dow scientist made a presentation at an industry meeting in New Orleans which found its way to me. He reported there was 3 billion asbestos fibers in the lye solution from which the diaphragm salt was crystallized. Once this was noted in Food Chemical News, the FDA submitted samples of diaphragm salt and was told by Franklin Institute that it had 16 million fibers per gram anbd by Dow labs that it had 80 million fibers per gram. When NRDC lawyer Marcia Cleveland mailed me the Federal Register notice in which the approval was withdrawn, she referred to the stuff as "salted asbestos."

In the end, the petitioner was disclosed and it was just one company, not a chlorine producer, called United Salt in Houston.

Mrs KramerAug 14 2013 08:55 AM

"They were building a house of cards based on assumptions and unsupported extrapolations instead of direct scientific evidence."

This is a huge problem within US government regulatory agencies that establish public health policies. They have been relying upon never vetted science to falsely claim proof of safe levels of many toxins.

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Switchboard is the staff blog of the Natural Resources Defense Council, the nation’s most effective environmental group. For more about our work, including in-depth policy documents, action alerts and ways you can contribute, visit NRDC.org.

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