More than 80,000 chemicals are produced,
used, and present in the United States. This is one of their stories.

Post updated 8/22/2013.

Are we letting the chemical industry decide what is safe for us to eat?

Toxic substances — how does the government prevent them from getting into the products we buy? If you’ve been reading about the appalling inadequacy of the Toxic Substances Control Act or TSCA (such as here and here), you already know the answer to that question: Not well at all.

Now, TSCA pertains to chemicals in general — the kinds that might be found in your couch (flame retardants) or do-it-yourself foam insulation (diisocyanates) or yard (pesticides). But what about chemicals that appear in your food, the stuff we call food additives? After all, I’m sure most of you would agree that it’s bad enough for a toxic chemical to be in your couch, but it’s a whole other level of bad for a toxic compound to have been added to your food.

Food and the Chemicals in Food

Perhaps in recognition of that fact, Congress has provided for separate regulatory oversight for food additives.

While TSCA is administered by the Environmental Protection Agency, food safety is the purview of the Food and Drug Administration per the Federal Food, Drug, and Cosmetic Act. The act, first passed by Congress in 1938, has been modified and amended a number of times since.

The Food Additives Amendment of 1958 established, as this summary explains, that “any substance intentionally added to food is a food additive and is subject to pre-market approval by FDA.”* But there’s a notable caveat to this definition, which has become arguably the crux of the matter. The caveat is an exemption for additives considered “GRAS” or “generally recognized as safe.” This caveat, as this summary puts it, stipulates that pre-market FDA approval is required “unless the use of the substance is generally recognized as safe … (or otherwise excepted from the definition of food additive – e.g., color additive).” In other words food additives must be pre-approved by FDA unless they are “generally recognized as safe” for their intended use in which case no pre-approval is needed and the manufacturer is essentially free to add the chemical to foodstuffs willy-nilly.

The Devil’s in the Details — and the Interpretation

In principle this proviso could make a lot of sense — why have the FDA spend huge amounts of time approving stuff that everyone knows is safe? Shouldn’t be a problem as long as the term “generally recognized as safe” is carefully defined to assure that whatever gets added to our food is indeed safe. But if it’s interpreted too loosely, the GRAS proviso could open the floodgates for dangerous additives to make their way into our food and our bodies.

And many argue that this is exactly what happened in 1997, when the FDA streamlined the GRAS exemption. (See here, here and here.) With the launch of the GRAS Notification Program, the FDA “replac[ed] the then-existing voluntary but resource-intensive GRAS Affirmation Petition process the agency put in place in the 1970’s, with a more streamlined voluntary GRAS notification process.” Under the notification program, the FDA has essentially ceded the task of assessing the safety of a food additive to the manufacturer that makes and sells the additive. A bit like giving a wolf the job of protecting the sheep, only in this case the sheep are us.

And there’s more. A 2010 reportby the Government Accountability Office found that “Currently, companies may determine a substance is GRAS without FDA’s approval or knowledge.” Some manufacturers don’t even bother to notify the FDA that they are using the GRAS exemption.

On the basis of a review of 451 GRAS notifications that were voluntarily submitted to the FDA between 1997 and 2012, Thomas Neltner of The Pew Charitable Trusts and colleagues concluded that “financial conflicts of interest were ubiquitous in determinations that an additive to food was GRAS. The lack of independent review in GRAS determinations raises concerns about the integrity of the process and whether it ensures the safety of the food supply, particularly in instances where the manufacturer does not notify the FDA of the determination.” Incredibly these authors found that of the 451 notifications they considered, not a single one had been filed by an expert panel selected by an independent party. They were all generated by either employees of the manufacturer (22.4 percent), a consulting firm hired by the manufacturer (13.3 percent), or a panel selected by a consulting firm hired by the manufacturer (63.4 percent).

When you’re shopping in the chemical marketplace, even if you’re buying food the watchword is caveat emptor.

________________

End Notes

* The actual statute reads: “The term ‘food additive’ means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use; except that such term does not include—
(1) a pesticide chemical residue in or on a raw agricultural commodity or processed food; or
(2) a pesticide chemical; or
(3) a color additive; or
(4) any substance used in accordance with a sanction or approval granted prior to September 6, 1958, pursuant to this chapter, the Poultry Products Inspection Act [21U.S.C. 451 et seq.] or the Meat Inspection Act of March 4, 1907, as amended and extended [21 U.S.C. 601 et seq.];
(5) a new animal drug; or
(6) an ingredient described in paragraph (ff) in, or intended for use in, a dietary supplement.”

See also the “Food Additives” section and this edited excerpt of the 1958 amendment.

Post updated 8/22/2013, 7:33 pm because an earlier version of this post was published in error.

Related
The Chemical Marketplace series