Regulatory Overview

Every week there is another article referencing new proposed regulations regarding gene editing for crops. These are all part of a global effort to harmonize the regulatory requirements for the new breeding innovations such as gene editing in order to make these innovations available to the global farming industry and enable free movement (import/export) of agricultural commodities using these innovations.

Background and Status

The goal of these global efforts to harmonize regulation associated with gene editing is to fix the patchwork of uncertain and complex regulations promulgated to ban or limit GMO’s or the use of foreign DNA in breeding traits. They are addressing a global understanding that the lack of regulatory clarity, including consistent and predictable legislation with clear technical criteria, has stifled innovation and the realization of the full potential of these technologies.

Technology breakthroughs driving these proposed regulatory changes are the new gene editing technologies that mimic the process by which genomic change occurs in nature. Because gene-edited plant traits are indistinguishable from those that take place in nature the proposed regulations would treat these traits on the same basis as traits produced by conventional breeding. The regulations for traits that are developed using conventional breeding are globally harmonized. These new proposed changes would, in essence, have gene-edited traits logically follow those same regulations.

The inherent challenges of global crop production are to enhance yield with less crop protection chemicals and fertilizers, to improve sustainability and to lower agriculture’s carbon footprint. To cope successfully with these challenges, biology-driven approaches such as gene-edited traits and precision plant breeding are a critically important component of the much-needed innovations for global crop farming. The pressing need for innovations to address the challenges of climate change and food security have made evolving these regulations a global priority. Each innovation of this emerging industry improves farming sustainability and reduces the negative environmental impact of current crop production practice including the reduction of its carbon footprint.

Crop protection chemicals have been highly successful in helping farmers manage the yield reducing impacts of disease, insects and weeds. But the gains have come with some environmental costs: harming soil microbes, ground water contamination, increased carbon footprint and air pollution.

Biological approaches to crop protection address these challenges. The new era of innovation for crop protection will come from biological products such as gene-edited traits, not chemistry. The goal is to manage challenges like crop diseases by developing crops with durable resistance to diseases, as opposed to the traditional use of fungicides to combat them.

Agriculture is one of the rare global systems where global regulatory policy can directly address both carbon footprint, and impact on the environment, as well as sustainability, productivity, and profitability of the global food supply. These new innovations from biological crop protection will enable the farmer to better adapt to their rapidly changing environment, to lower their costs and to materially improve their workplace and working conditions. These are the real drivers in the push for a new regulatory environment to enable a new era of growth and innovation in global crop farming practice. As Copa Cogeco, a group that represents 22 million European farmers, put it, “[these technologies] are not a luxury but an urgent necessity for the vitality of the whole EU farming model…”

The map below attempts to show the region-by-region status of regulatory efforts associated with precision gene editing.

Gene-editing: Advances in Global Regulatory Policy

World Map Advances in Global Regulatory Policy

Resources

American Seed Trade Association
Biotechnology Innovation Oragnization
California Chamber of Commerce
US Canola Association
Seeds Canada
European Seed Association
Canada Grains Council