An editorial in Nature Genetics has called for gene-edited crops to be subject to no more regulation than crops developed through conventional breeding. In an accompanying commentary, Chinese, German and US researchers make the case that many applications of gene-editing would lead to crops that would, at least in theory, be possible to produce by conventional methods, since gene-editing does not require insertion of foreign genes. The Obama administration has launched a review of regulation for biotech crops, and both the editorial and commentary call for regulation to be based on the product, not the technology used to make it.
Dr. Jeff Wolt, Professor of Agronomy & Toxicology, Biosafety Institute for Genetically Modified Agricultural Products, Iowa State University (webpage):
Expertise: Biotechnology safety analysis applied to risk management and science policy decision-making.
“In the commentary by Huang et al., and the accompanying editorial in the current issue of Nature Genetics, pragmatic arguments are advanced for the importance and safety of processes for producing genome-edited crops and livestock. These arguments are well supported by the current state of scientific knowledge and emerging regulatory opinion regarding genome-edited products.
“Most critical amongst the points advanced are:
- the need to clearly distinguish between transgenics (GMOs) and genome-edited crops (GECs) and livestock
- the “wisdom of ‘product-based’ versus ‘technology-based’ [process-based] regulation.”
“Of course the devil-is-in-the-details regarding these points, as well as the guiding principles for generating and regulating GECs as proposed by Huang et al. The processes of genome-editing fall along a continuum extending from simple insertions/deletions within the genome which are indistinguishable from natural occurring mutation events, to template insertions which may or may not resemble those expected to arise from spontaneous mutation, to actual transgene insertions.
“In the first instance, simple insertions/deletions warrant limited safety evaluation beyond what is typical of products of traditional breeding. The second instance of genome editing with template additions also warrants little added consideration when, as Huang et al state, these additions are familiar within the species or its close relatives, or when they are expected to arise from spontaneous mutations (though less familiar variations enter somewhat murkier territory and may require closer consideration). Finally, use of genome editing to insert transgenes represents an improvement in transgenic techniques but still falls within the regulatory definitions of GMOs.
“While regulatory processes that consider product over process are clearly needed, we are currently stuck with statutes and approaches throughout much of the world that are process-focused*, either explicitly or in effect . This clearly needs to be avoided in the case of genome-edited crops and animals. The approaches outlined in the commentary are a good step in this direction, as is the call of the editors of Nature Genetics for clarity and transparency in information regarding production of genome-edited crops and livestock.”
*Correction: ‘product-focussed’ was amended to ‘process-focussed’.
Dr. David Stern, Professor and President of the Boyce Thompson Institute for Plant Research (webpage):
Expertise: communication between different sub-cellular compartments within plant cells.
“In my opinion the framework proposed is commonsense and in keeping with the public good. Proposals such as this should be very helpful to the National Academies in their ongoing study of biotechnology regulation. The editorial appropriately raises public perception and transparency as key concerns. Plant breeding is an ancient art, dating back thousands of years, and the scientific community is more or less equating gene-edited crops with traditional plant breeding, which may not be a view shared by people outside the scientific community. So we can expect to continue to hear that scientists are “playing God” whereas conventional breeding is somehow more pure and natural. I think this is a price that must be paid for the many benefits gene-edited crops can bring to the agricultural space.”
Dr. Yinong Yang, Associate Professor at the Department of Plant Pathology and Environmental Microbiology, Pennsylvania State University (webpage):
Expertise: Improving and applying genome editing technology for precision breeding and crop improvement.
“Genome editing technologies, especially the CRISPR/Cas system, greatly enhance our ability to precisely breed agricultural crops for trait improvement and are expected to reshape the landscape of agricultural biotechnology in the near future. In the most recent issue of Nature Genetics, Huang et al proposed a timely and much needed regulatory framework for genome-edited crops (GECs). In my opinion, the four guiding principles recommended by the authors are prudent and sufficient for the regulation of GECs. Currently, crop varieties developed via conventional breeding (e.g., crossbreeding of the same or related species, chemical or radiation mutagenesis, induction of polyploidy or protoplast fusion) are free of government regulation, but many of them, especially those produced by the public sector, are registered and published in the Journal of Plant Registrations. Documentation of research as outlined in the four guiding principles and registration of GECs should promote transparency and reduces potential public skepticism towards GECs.
“As stated in the editorial of Nature Genetics, it is necessary to establish a distinction between GMOs generated through the transgenic introduction of foreign DNA sequence and GECs generated through precise editing of an organism’s native genome. This is particularly important in terms of government regulation and public perception. I agree with the editorial position that other than transparent documentation and registration of GECs, no further regulatory requirements should be imposed upon GECs with small indels or nucleotide variants that exist in the same or related species or may arise via spontaneous mutation.”
Declared interests (see GENeS register of interests policy):
Dr. Jeff Wolt: “I serve as a contributing faculty member to the Iowa State University Crop Bioengineering Consortium which advances the uses of plant genome editing for crop improvement.”
Dr. Yinong Yang: “My research has been supported by federal, state and university research grants. One of my PhD students is supported by Monsanto’s Beachell-Borlaug International Scholars Program which is administrated by Texas A & M University and funded by Monsanto. Currently, my group is improving and applying genome editing technology for precision breeding and crop improvement.”
No further interests declared
- ‘Where genome editing is needed‘ published in Nature Genetics on Wednesday 27 January, 2015.
- ‘A proposed regulatory framework for genome-edited crops‘ by Huang, et al, published in Nature Genetics on Wednesday 27 January 2015.