We Need Smarter Regulation of Food and Agricultural Biotechnology

By John J. Cohrseen and Henry I. Miller

EXECUTIVE SUMMARY

In the early 1970s a group of scientists — none involved in agriculture or food — raised concerns about the hypothetical hazards that might arise from the use of the newly discovered molecular genetic modification techniques (recombinant DNA technology) that could alter the inheritable characteristics of an organism via directed changes in its DNA.

That led to an initial voluntary moratorium on the use of the new recombinant DNA (r-DNA) techniques, and subsequently the creation by the National Institutes of Health of guidelines for the application of these techniques for any purpose. These “process-based” guidelines, which were applicable exclusively to the use of these new techniques, were in addition to the existing “product-focused” regulatory requirements of FDA, USDA and EPA. For example, without regulatory approval the “intentional release” of “recombinant organisms” into the environment or fermentation (in contained fermenters) at volumes greater than ten liters of was prohibited.

No similar blanket restrictions existed for plants or other organisms similarly modified by traditional techniques, such as chemical or irradiation mutagenesis.

Thus, premature and ultimately ill-founded concerns about the risks of r-DNA organisms in agriculture and environmental applications precipitated the regulation of r-DNA organisms triggered simply by the “process,” or technique, for genetic modification, rather than the “product,” i.e., the characteristics of the modified organism.

The regulatory burden on the use of recombinant DNA technology was, and remains, disproportionate to its risk, and the opportunity costs of regulatory delays and expenses are formidable. According to Wendelyn Jones at DuPont Crop Protection, “A survey completed in 2011 found the cost of discovery, development and authorization of a new plant biotechnology trait introduced between 2008 and 2012 was $136 million. On average, about 26 percent of those costs ($35.1 million) were incurred as part of the regulatory testing and registration process.” Thus, given that at least 120 genetically engineered seeds with new traits have been approved by USDA, the public and private sectors have spent billions of dollars on complying with superfluous, redundant regulatory requirements that have priced public sector and small companies’ agricultural research and development (R&D) out of the marketplace.

These inflated development costs are the primary reason that more than 99% of genetically engineered crops that are cultivated today are large-scale commodity crops — corn, cotton, canola, soy, alfalfa and sugar beets. Virus-resistant Hawaiian papaya, bruise- and fungus-resistant potatoes and non-browning apples are among the few examples of genetically engineered “specialty crops,” such as fruits, nuts, or vegetables. Early concerns from the food industry about possible food contamination led to onerous USDA restrictions on the once-promising sector of “biopharming,” which uses genetic engineering techniques to induce crops such as corn, tomatoes, and tobacco to produce high concentrations of high-value pharmaceuticals. Likewise, the once high hopes for genetically engineered “biorational” microbial pesticides and microorganisms to clean up toxic wastes are dead and gone. Not surprisingly, few companies or other entities are willing to invest in the development of badly needed genetically improved varieties of the subsistence crops grown in the developing world.

While multinational corporate crop developers can bear these high regulatory costs for high-value, large-volume commodity grains, excessive regulation disproportionately affects small enterprises and, especially, public research endeavors, such as those at land-grant universities, which lack the necessary resources to comply with burdensome and costly regulatory requirements. Therefore, land grant universities have been put at a substantial competitive disadvantage and are seldom able either to expose their students to state-of-the-art breeding programs or to create important new varieties.

The global regulatory compliance costs associated with a new insect-resistant or herbicide-resistant recombinant DNA-modified variety of corn, for example, which are, as noted above, around $35 million, do not include the resources spent on products that are never approved; the costs borne by growers, shippers and processors associated with segregation, traceability and special labeling; or the opportunity costs of compliance with unnecessary regulation.