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How Safe is Your Food? Don't Ask the FDA.

Linda Greer

Posted November 1, 2013

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I’ve been working on federal chemical regulation in Washington since the 1980’s and have thought for the longest time that nothing holds a candle to TSCA, the Toxic Substances Control Act, for how outdated it is as a legal framework and how poorly it accommodates the demands of modern day science and commerce.  However, reports published in the last three years by The Pew Charitable Trusts Food Additives Project make clear that TSCA’s programs actually pale in comparison to those under the Food Additives Amendment of 1958, directing FDA to ensure the safety of chemicals used in food and packaging.   EPA actually has more authority under TSCA than FDA to obtain information needed to assess the safety of chemicals.  For example, at least industry must notify EPA 90 days before it manufactures a chemical, and give the government the opportunity to review and veto it.  In contrast, an additive manufacturer can make a new additive and determine its use would be “generally recognized as safe,” or GRAS, without ever telling the government.   

Yes, you read that correctly, FDA has interpreted the food additives law to allow industry to determine the safety of substances added to food! Without even obligating companies to inform FDA!  I thought I’d seen pretty much everything in EPA’s struggles with its 35-year old TSCA law, but, I must say, the problems at FDA under the 55 year-old food law, reported by Pew, take the cake.

The provision of central concern in the food additives law is the GRAS exemption.  First envisioned by Congress as an exemption for common food ingredients like oil and vinegar, industry quickly expanded it to become, as Pew described it, a loophole that has swallowed the law.   As a result, FDA is completely unaware of roughly 1,000 substances in our food supply.   One thousand!  FDA doesn’t even know their names.  And it doesn’t take a law degree to recognize the inherent conflict of interest that industry would have in evaluating the safety of its own chemicals. [See Pew’s excellent analysis of this problem in JAMA Internal Medicine article].

What’s worse, once an additive have been cleared, either by industry or the government, there is almost no  looking back. Thousands of chemicals evaluated decades ago are in our food supply on the basis of completely outdated science often with very little actual research on them.  Bisphenol A is one such chemical with which NRDC is quite familiar. It was included in a “wish list” for metal can coatings that industry submitted to FDA in 1963. FDA granted industry’s wishes using “’unwritten’ assumptions” without scientific rigor even by 1960’s standards, and it’s been allowed in food ever since.  

For decades there have been concerns with the FDA food additive program.  In 1969, President Nixon, responding to the public outcry over artificial sweetener cyclamate, ordered the agency to review the safety of all additives it had approved in the 1960s starting with GRAS substances.  Thirteen years later, in 1982, an expert advisory committee re-recommended that FDA should include modern science to test the safety of additives, this time more specifically to include behavioral and hormonal impacts, allergic reactions, the body’s reaction to chemicals, effects on vulnerable populations such as children and pregnant women, and the combined effect of similar substances. FDA followed through with only a few of these suggestions. The Government Accountability Office (GAO) stepped up to the plate in 2010 in response to a request by Representative DeLauro of Connecticut and Senator Harkin of Iowa.  GAO issued a very critical report concluding that “FDA’s oversight process does not help ensure the safety of all new GRAS determinations.”  The Pew team’s comprehensive assessment of FDA’s food additives program goes deeper than any other in illuminating how the program functions and where the problems lie.

Clearly, it is time to take action.  So, I’m happy to let you know that NRDC is expanding its food work to solve these problems.  To launch our expanded work, we welcome Tom Neltner and Maricel Maffini, both of whom led the strong research team at Pew, to the NRDC Health Program staff. Their experience greatly increases the depth of NRDC’s chemical reform bench, and we look forward to having them on our team.

We are up and rolling. Our first action item was to submit comments on a GRAS notice that FDA is currently reviewing. Our analysis showed that McCormick, the company that submitted the GRAS notice, did not follow FDA’s recommendations when estimated how much additives people will consume, ignored that children and teens will consume the most, and “cherry-picked” available exposure data to stay within the acceptable limits of consumption.  The press took notice, and it sent a few shocks to the food industry.

NRDC will use all available means to strengthen food-additive oversight and will reach out to Congress, FDA, state and local governments, consumers and the private sector to ensure that the food reaching your table is safe.

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Ellen StokesNov 1 2013 04:58 PM

While I commend NRDC for wanting to keep consumers safe from potentially harmful substances and additives in the food supply, I can’t agree that the current Generally Recognized as Safe (GRAS) approval system isn’t working and that consumers are in danger. Quite the contrary. As the approval process stands today, most companies use panels of scientific experts to make determinations about an ingredient’s safety, based on scientific data including peer-reviewed studies demonstrating safety -- as well as a history of safe use in the food supply. The data that backs up a GRAS determination is not only publicly available, but also must be provided to the FDA upon request.

As a registered dietitian who works closely with the International Food Additives Council, I see no reason to change the current system based on safety concerns. Further, I fear a major overhaul of the system would be a highly costly misadventure that could ultimately harm consumers more than help them. The government doesn’t have the resources to keep thousands of scientists on staff with the required expertise to be able to determine the safety of so many different food additives. My guess is the government would be hiring the same people who currently serve on these panels -- at a staggering cost to taxpayers.

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