Regulatory Barriers to the Development of Innovative Agricultural Biotechnology by Small Businesses and Universities

Since the early 1980s, American taxpayers have invested heavily in public, university, and small business developers of crops and foods improved using biotechnology. Yet the return on this investment, in terms of new, improved genetically engineered (GE) crops, is disappointingly thin. Although the U.S. Department of Agriculture, universities, and small businesses have developed dozens of GE crops—with improved traits ranging from healthier and less allergenic to safer and more environmentally sustainable—and carried many through safety and premarket testing, almost all have been denied commercial release mainly because of U.S. regulatory obstacles that disproportionately penalize public, academic, and smaller private breeding entities. In theory, scientifically sound regulations serve the public good by assuring a reasonable degree of product safety while not unduly stifling innovation. In a scientifically rigorous, risk-based safety assessment, the degree of regulatory scrutiny is commensurate with the degree of identified risk posed by the product in question. In reality, however, our current regulations are not based on product risk, but on spurious, undocumented risks posed by the process of genetic engineering. These regulations impose scrutiny well beyond that imposed on non-GE products posing similar risks. As well, the unnecessarily onerous and expensive regulations discourage and stifle innovation, especially in small businesses and universities. This report analyses the current U.S. regulatory system for GE crops, compares it with those of major trading partners, and considers various aspects of agricultural biotechnology regulaDespite foundational contributions requiring considerable public resource commitments for GE crop innovation and development, the academic institutions and small private entities have been almost entirely excluded from the agricultural biotechnology market. (Photo from Lightspring/Shutterstock.) < NO footnote: text to this line tion, including labeling and scientifically sound alternatives to the unnecessarily restrictive current regulatory system to allow the benefits of safe agricultural biotechnology products from small business and universities to accrue to farmers, consumers, and the environment.