Genetically Engineered Proteins Regulated as Food Additives: Another Very Short List

Regulation of most genetically engineered (GE) foods is currently not required by the U.S. Food and Drug Administration (FDA).  However, because many developers of GE foods have voluntarily consulted with the FDA about their products (and records of those consultations can be found on FDA’s web site) one can get a pretty good idea of the kinds of proteins being added to our food through the use of genetic engineering.

During the last 18 years most of the proteins added to food or feed products through genetic engineering confer resistance to pests like corn rootworm or viruses like papaya ringspot or herbicides like 2,4-D.  A few are meant to alter the constitution of edible oils or proteins; Monsanto, for example, has added a gene to corn that increases levels of the amino acid lycine making corn a more “complete” protein for animal feed.  And Pioneer Hi-Bred International added a red fluorescent protein to corn for selection purposes but does not intend for that protein to end up in seeds it sells to farmers.

But whatever the intentions of the developers, or the pros and cons of their products, proteins not previously found in our food have been added to it.  Shouldn’t these proteins be considered food additives and therefore be regulated by the FDA?

The protein added to the first genetically engineered agricultural product to be marketed in the United States was and the FDA did.

A protein that renders cells resistant to the antibiotic kanamycin and is normally found in the bacterium E. coli was present in the GE Flavr Savr™ tomatoes marketed in the United States in the mid-1990′s.  That protein was not normally found in (as part of) the foods we ate before the birth of the ag biotech industry.

And so, in 1994, the FDA regulated it as a food additive. (And Calgene, the developer of the Flavr Savr™ tomato, published the safety studies it submitted to that agency; see photo.)

So why hasn’t the FDA treated the GE proteins added to our food and feed since then as food additives?  Most of them are bacterial or viral proteins and therefore no less innocuous than the kanamycin-resistance protein from E. coli.  And who knows what kind of GE proteins we may be eating in the not too distant future since this powerful technology can be used to add proteins from any organism to our food. (The gene encoding Pioneer Hi-Bred’s red fluorescent protein was isolated from a sea anemone.)

I don’t know why the FDA stopped treating proteins added to foods through genetic engineering as food additives. (Ironically, the agency’s Office of Food Additive Safety carries out the voluntary consultations with developers of GE products.)  But I do think the FDA’s handling of the Flavr Savr™ tomato made a lot of sense.  Foreign proteins are being added to our food and, whether added through genetic engineering or any other process, those proteins–logically anyway–are “food additives.” Shouldn’t they be regulated accordingly as was done in the case of the Flavr Savr™ tomato?

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2 Responses to Genetically Engineered Proteins Regulated as Food Additives: Another Very Short List

  1. Tom Zinnen says:

    Calgene asked the FDA to consider the kanamycin resistance gene and its protein as a food additive, even though the FDA was inclined to give the gene and its protein GRAS (Generally Regarded as Safe) status. Calgene was willing to go through the hurdles to get the FDA approval as a food additive as a way to generate consumer confidence. See http://www.fda.gov/Food/FoodScienceResearch/Biotechnology/Submissions/ucm225043.htm

    • Belinda says:

      Actually, Jim Maryanski et al. at FDA called Calgene in late 1992 and asked the company to re-submit their submission as an FAP. It was an interesting behind-the-scenes moment, a phone call I sat in on and described in my book (p 161). FDA said that Congress would be more comfortable with an FAP; Roger Salquist asked FDA how the change would affect Calgene’s stock price.
      And yes, part of Calgene’s motivation was to generate consumer confidence. That’s one of my main points: Calgene was pretty successful in doing just that and the entire industry since then has not been. Why not follow Calgene’s lead and improve consumer confidence by requiring FDA regulation, using the laws on the books to regulate these new food additives, and being transparent by listing the food additives on consumer food labels?

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