Transgenic Research

Clarifying the regulation of genome editing in Australia: situation for food

Foreword

The global need for plant breeding innovation

Regulatory aspects of gene editing in Argentina Abstract Argentina is a world leader in regards to regulation and adoption of genetically modified (GM) crops. As a consequence, the regulatory aspects of gene editing applied to agriculture were considered proactively by the Argentinian regulators, who implemented simple but solid pioneering regulatory criteria for gene edited crops. At present, the Argentine regulatory system is fully able to establish if a gene-edited crop should be classified (and handled) either as a GM crop or a conventional new variety. To this end, the concept of “novel combination of genetic material” derived from the Cartagena Protocol on Biosafety is of decisive importance. After some pilot cases that have been managed under this criteria, now applicants appreciate the ease, speed and predictability of the regulation. Moreover, it has been considered by other countries in the course of developing their own regulations, thus acting also as a harmonization factor for the safe and effective insertion of these technologies in the global market.

Programme OECD conference on genome editing

DNA-free genome editing with preassembled CRISPR/Cas9 ribonucleoproteins in plants Abstracts Processes of traditional trait development in plants depend on genetic variations derived from spontaneous mutation or artificial random mutagenesis. Limited availability of desired traits in crossable relatives or failure to generate the wanted phenotypes by random mutagenesis led to develop innovative breeding methods that are truly cross-species and precise. To this end, we devised novel methods of precise genome engineering that are characterized to use pre-assembled CRISPR/Cas9 ribonucleoprotein (RNP) complex instead of using nucleic ands or Agrobacterium. We found that our methods successfully engineered plant genomes without leaving any foreign DNA footprint in the genomes. To facilitate introduction of RNP into plant nucleus, we first obtained protoplasts after removing the transfection barrier, cell wall. Whole plants were regenerated from the single cell of protoplasts that has been engineered with the RNP. Pending the improved way of protoplast regeneration technology especially in crop plants, our methods should help develop novel traits in crop plants in relatively short time with safe and precise way.

An overview of OECD activities related to modern techniques of biotechnology and genome editing

Innovation and the regulation of products of agricultural biotechnology in the United States of America Abstract The policy of the United States government is to seek regulatory approaches, consistent with applicable laws, that protect health and the environment while reducing unnecessary regulatory burdens and avoiding unjustifiably inhibiting innovation, stigmatizing new technologies, or creating unnecessary trade barriers [Adapted from the National Strategy for Modernizing the Regulatory System for Biotechnology Products, Product of the Emerging Technologies Interagency Policy Coordination Committee’s Biotechnology Working Group (OSTP 2016)]. U.S. agencies are focused on delivering health and environmental protection based on the best available science; establishing transparent, coordinated, predictable, and efficient regulatory practices across agencies; and promoting public confidence in the oversight of the products of biotechnology through clear and transparent public engagement [Adapted from the Task Force on Agriculture and Rural Prosperity Report (USDA 2017)]. U.S. agencies that regulate the products of agricultural biotechnology discuss regulatory approaches presented during the June 2018 OECD Conference on Genome Editing Applications in Agriculture, focusing on plants developed using genome editing.

Agricultural applications of genome editing in farmed animals Abstract Animal husbandry is believed to predate farming of crops, and remains a core component of most agricultural systems. Historic breeding strategies were based largely on visual observation, crossing animals that were perceived to display enhanced merit. Advances in sequencing capacity coupled with reduced costs have allowed genomic selection tools to deliver significant contribution to breeding regimes. The application of genome editors to make specific changes to livestock genomes has the potential to deliver additional benefits.

Canadian regulatory aspects of gene editing technologies Abstract The development of gene editing techniques, capable of producing plants and animals with new and improved traits, is revolutionizing the world of plant and animal breeding and rapidly advancing to commercial reality. However, from a regulatory standpoint the Government of Canada views gene editing as another tool that will join current methods used to develop desirable traits in plants and animals. This is because Canada focusses on the potential risk resulting from the novelty of the trait, or plant or animal product entering the Canadian environment or market place, rather than the process or method by which it was created. The Canadian Food Inspection Agency is responsible for the regulation of the environmental release of plants with novel traits, and novel livestock feeds, while Health Canada is responsible for the regulation of novel foods. Environment and Climate Change Canada, in partnership with Health Canada, regulates modified animals for entry into the environment. In all cases, these novel products may be the result of conventional breeding, mutagenesis, recombinant DNA techniques or other methods of plant or animal breeding such as gene editing. This novelty approach allows the Canadian regulatory system to efficiently adjust to any new developments in the science of plant and animal breeding and allows for risk-appropriate regulatory decisions. This approach encourages innovation while maintaining science-based regulatory expertise. Canadian regulators work cooperatively with proponents to determine if their gene editing-derived product meets the definition of a novel product, and whether it would be subject to a pre-market assessment. Therefore, Canada’s existing regulatory system is well positioned to accommodate any new innovations or technologies in plant or animal breeding, including gene editing.