Regulating Genetically Engineered Crops in the U.S.: Forcing a Square Technology Peg into a Round Regulatory Hole

Despite what you may have read in The New York Times or on Monsanto’s website or in books like some written by former regulatory officials, current regulation of genetically engineered (GE) crops in the United States is not necessarily “burdensome” and not “every biotechnology product has to be submitted to two or more [government agencies] for approval.”   In the first place (and as I mentioned in a post on 11/9/11), one of the three U.S. agencies making up the “coordinated framework” that deals with biotech crops, the Food and Drug Administration (FDA), does not require regulation of most GE foods or feeds at all.

In its 1992 original “Statement  of  Policy: Foods Derived from New Plant Varieties,” the FDA described the “genetic modification techniques” used to traditionally breed crop plants and those used to genetically engineer them as constituting a “continuum.”  Nearly every scientist, representative of the biotech industry, or U.S. federal regulator who has defended or promoted the use of biotechnology in agriculture since then has done so using the same notion: that genetic engineering is an extension of traditional breeding.

And based, at least in part, on the idea of that “continuum” extending from traditional breeding to genetic engineering, the FDA’s policy over the last 20 years has been “to regulate foods produced by new methods, such as recombinant DNA techniques, within the existing statutory and regulatory framework.”  (That decision in 1992 was a reaffirmation of a policy originally described, in conjunction with the Office of Science and Technology Policy in the Executive Office of the President, in the Federal Register of June 26, 1986.)  The U.S. Department of Agriculture (USDA) and the U.S. Environmental Protection Agency (EPA) both followed suit.

But it’s really only happenstance that has made it possible to utilize the “existing statutory and regulatory framework” at USDA and EPA to regulate the GE agricultural products that have been commercialized during the intervening two decades.  And, while FDA could have used its Food Additive Petition (FAP) process to regulate all the commercially available GE foods and feed products that contain foreign proteins, it only did so for the relatively innocuous Flavr Savr™ tomato; no GE food or feed product since has undergone FDA’s FAP process.  In fact, utilizing the “existing statutory and regulatory framework” effectively prevents the FDA from directly dealing with any of the pesticide-producing GE products, like the new Bt sweet corn that Monsanto is currently promoting, at all (although FDA did make recommendations in the case of StarLink™ corn back in 2000, a GE crop which produced a GE protein that behaved like a human allergen) because all pesticidal substances are regulated by the EPA.

As described in a recent issue  of Nature Biotechnology, GE crops have only come under “USDA’s regulatory domain because they were made using ‘plant pests’ such as [Agrobacterium tumefaciens and Cauliflower mosaic virus (CaMV)],” organisms on USDA’s plant pest list.  (A. tumefaciens is a bacterium that inserts its own genes into plants to cause crown gall disease; genetic engineers modify it to eliminate the disease-causing genes and replace them with recombinant genes responsible for GE traits like herbicide tolerance, insect resistance, etc., etc.  And most of the genes genetic engineers have introduced into GE crops are “turned on” in the recipient plants because the “promoter” region from a gene expressed at high levels in CaMV, a gene called the 35S gene, has been spliced onto the genes responsible for those GE traits; the 35S promoter turns on GE genes to high levels in, essentially, every cell at every stage of development in the recipient plant.)

And GE crops only come under EPA’s domain if the engineered gene introduced into the crop produces a pesticidal protein.

So, it was only a matter of time before a GE crop was developed without using A. tumefaciens to insert the GE genes, and without the 35S promoter to “turn on” a GE gene,  and without a GE gene that encodes a pesticidal protein.

But that time has come.

Scotts Miracle-Gro, of Marysville, Ohio, has developed a GE herbicide-tolerant Kentucky bluegrass that is, according to the USDA, outside its regulatory authority.  According to the Nature Biotechnology article, the company has no intention of commercializing this GE crop but if it did, it would not have to follow that agency’s approval route.

And because this GE bluegrass contains no pesticidal proteins, it would not come under EPA regulations either.  And whether or not Kentucky bluegrass is considered a feed product, it would also not be regulated by the FDA as that agency requires no regulation of practically every GE food or feed crop developed thus  far.

Genetic engineering is a powerful technology.  Any gene from any living organism, or genes from extinct organisms, or even genes made de novo in laboratories can all be inserted–using processes that are currently highly mutagenic–into plants grown on millions of acres in this country.  The products of this powerful technology should be carefully regulated on a case-for-case basis, not a hit-or-miss basis as is currently the situation in the United States.

I don’t agree with most of the justifications Dr. Fedoroff gave in her op-ed piece in The New York Times for suggesting that the “three U.S. regulatory agencies need to develop a single set of requirements” for regulating GE crops.  But I do agree that it is time to do away with the concept of regulating the products of agricultural biotechnology using the “existing statutory and regulatory framework” in this country and come up with a new system for evaluating their safety.  It’s time to stop trying to force a square technological peg into a round regulatory hole.

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One Response to Regulating Genetically Engineered Crops in the U.S.: Forcing a Square Technology Peg into a Round Regulatory Hole

  1. Tom says:

    Its interesting to compare the regulatory environment for GE products with that of the financial products that led to the ongoing financial crisis. As with GE, multiple financial regulatory agencies were involved but lacked a clear mandate to regulate some of the most innovative (ie, dangerous) financial products and that didn’t really end very well.

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