Abstract
Genome editing for crop improvement lies at the leading edge of disruptive bioengineering technologies that will challenge existing regulatory paradigms for products of biotechnology and which will elicit widespread public interest. Regulation of products of biotechnology through the US Coordinated Framework for Biotechnology is predicated on requiring burden of proof that regulation is warranted. Although driven by considerations of newly emerging processes for product development, regulation has, for the most part, focused on characteristics of the biotechnology product itself and not the process used for its development per se. This standard of evidence and product focus has been maintained to date in regulatory considerations of genome edited crops. Those genome edited crops lacking recombinant DNA (rDNA) in the product intended for environmental release, lacking plant pest or pesticidal activity, or showing no food safety attributes different from those of traditionally bred crops are not deemed subject to regulatory evaluation. Regardless, societal uncertainties regarding genome editing are leading regulators to seek ways whereby these uncertainties may be addressed through redefinition of those products of biotechnology that may be subject to regulatory assessments. Within US law prior statutory history, language and regulatory action have significant influence on decision making; therefore, the administrative law and jurisprudence underlying the current Coordinated Framework strongly inform policy and governance when considering new plant breeding technologies such as genome editing.
Highlights
Society faces a wave of disruptive biotechnology innovation extending from uses of deoxyribonucleic acid (DNA) as an information storage medium to applications of human genome editing and synthetic biology (NASEM, 2017)
Regulators in the US have found no basis in existing regulation to encumber potential entry of genome edited crops into commercial use when the intended product shows no evidence for presence of recombinant DNA (Wolt et al, 2016)
This concern stands in juxtaposition to current-day considerations of products developed through site-directed mutagenesis via genome editing where there are questions as to whether these products are analogous to products of classical mutagenesis, which remain outside of regulatory purview, or whether they are uniquely products of biotechnology that are to be regarded within the existing regulatory frameworks in the US and elsewhere (Sprink et al, 2016; Wolt et al, 2016)
Summary
Society faces a wave of disruptive biotechnology innovation extending from uses of DNA as an information storage medium to applications of human genome editing and synthetic biology (NASEM, 2017). The first commercial uses in 1994 were met perhaps with more public curiosity than concern (Bruening and Lyons, 2000), but there has been a steady decline in public support to the point where in 2015, only 37% of the public viewed genetically engineered (GE) foods as safe as compared to 88% of scientists from a wide range of disciplines (Funk and Rainie, 2015) Against this backdrop, regulators in the US have found no basis in existing regulation to encumber potential entry of genome edited crops into commercial use when the intended product shows no evidence for presence of recombinant DNA (rDNA) (Wolt et al, 2016).
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