Agricultural Biotechnology Regulation

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For conventionally bred plants, regulators rely on plant breeders to conduct appropriate safety testing and to be the first line of defense against genetic alterations that might prove dangerous. They are not subject to any government premarket review, and regulation of conventionally derived food products amounts to little more than monitoring the marketplace for contaminated or misbranded products. Numerous scientific bodies have concluded that there is no scientific reason for holding bioengineered and conventional crops to different regulatory standards. However, despite this long-standing consensus of the scientific community, biotech- derived plants are subject to very strict government oversight in the United States and abroad.

In a 1989 report, the National Research Council (NRC) concluded, “Information about the process used to produce a genetically modified organism is important in understanding the characteristics of the product. However, the nature of the process is not a useful criterion for determining whether the product requires less or more oversight.” Another NRC panel repeated this conclusion in a 2004 report. And an expert committee of the Institute of Food Technologists (IFT) concluded unequivocally that neither existing empirical data nor theoretical considerations support more stringent safety standards than those that apply to conventional foods. According to the IFT, the evaluation of bioengineered organisms and the food derived from them “does not require a fundamental change in established principles of food safety; nor does it require a different standard of safety, even though, in fact, more information and a higher standard of safety are being required.” 

For thousands of years, human hands have used both crude and sophisticated techniques to generate both subtle and gross genetic changes in the food crops on which we rely. All of the known risks of biotechnology are also known to exist in conventional plant breeding methods. In almost all cases, these risks can be managed easily and effectively without any need for government oversight. Consequently, the disproportionate attention paid to biotechnology ignores the lessons of both biology and the history of agriculture. 

In some cases, certain products of conventional or biotech modification might pose substantial risk and therefore could warrant heightened government oversight. However, focusing only on recombinant DNA (deoxyribonucleic acid) techniques, and treating all bioengineered products as if they are uniquely risky, is counterproductive. Instead, regulatory efforts should be redirected to focus oversight on new organisms that express characteristics likely to pose significant risk, regardless of the methods used in their development, while leaving relatively low-risk traits of both conventional and recombinant DNA modification unburdened by costly regulation. 

Introducing any new living organism into the environment or the food supply cannot be said to be risk-free, but assessment of the risks of bioengineered organisms should focus on the nature of the organism and of the environment into which the organism is to be introduced, independent of the breeding method used. Whether an organism is bioengineered, conventionally bred, or unmodified, safety evaluations should be based on three considerations: familiarity, or the sum total of knowledge about the traits of the organism and the new environment; the ability to confine or control the organism; and the likelihood of harmful effects if the organism should escape control or confinement. 

Naturally, with conventional and biotech modification, breeders must be vigilant to ensure that newly introduced plants do not pose human health problems, become invasive, or injure natural biodiversity as a result of intentional or accidental genetic changes. But neither the introduction of one, two, or several genes, judged against the background of tens or hundreds of thousands of the host organism’s own genes, nor the transformation process itself creates any risk that is novel, unique, or in some way difficult to manage. 

How novel is a corn plant, for example, that contains a newly inserted gene for a bacterial protein that is toxic only to certain insect larvae when one considers that every crop plant already has hundreds or thousands of its own natural pest-resistance genes? How novel is a gene-spliced canola plant enhanced to withstand a particular herbicide, given that conventional herbicide-tolerant canola plants have been produced and used commercially for more than two decades? 

Only when an identifiable high-risk trait is involved should formal government oversight be required. Fortunately, recombinant DNA (rDNA) techniques actually make it easier to identify such risky traits.