54 / SEEDWORLD.COM JUNE 2017 review will focus on scientific aspects to ensure they keep pace with technological change and might result in proposals for inclusion, or exclusion, of techniques or organisms from regulation. At this time, no amendments relating to recent plant breeding methods have been drafted. Although technical changes can be made, the definitions of what is and what is not a GMO in Australia are contained within the gene technology legislation. “There is a general view … that there’s a range of new science and new develop- ment getting caught up in the regulatory system,” says Matthew Cossey, CropLife Australia chief executive. “What’s impor- tant is that you have a system that con- sumers have absolute confidence in. That it has safety but also allows for research to flourish and for new innovations to make it to the farming sector.” U.S. Proposes Non-Regulation The U.S. Department of Agriculture (USDA) determined in April 2016 that it would not regulate a mushroom and a new type of corn genetically modified with the gene-editing tool CRISPR-Cas9. These were the first CRISPR-edited crops to be approved by the U.S. government. Regulated by both the USDA and the Food and Drug Administration (FDA), the federal agencies were asked to review how they handle products derived from biotechnology, as well as recent breeding methods. In January, USDA released its rule- making notice in tandem with FDA, whereby FDA acknowledged in its Request for Information that some appli- cations of gene editing result in plants that could be developed through more traditional breeding methods. USDA proposed a regulatory program in which it first assesses GE organisms to determine if they pose plant pest or noxious weed risks. If the department concludes that a GE organism does not pose a plant pest or noxious weed risk, then it would not require a permit for the importation, interstate movement and environmental release of the GE organ- ism. However, if it is determined, based on risk analysis that controls on movement are needed, the department will work with the requestor to establish appropri- ate permit conditions to manage identi- fied risks to allow safe movement. “We’re pleased that USDA’s proposal recognizes that some applications of gene editing result in plant varieties that are essentially equivalent to varieties that are developed through more traditional breeding methods, and treats these varieties accordingly,” says Andy LaVigne, American Seed Trade Association presi- dent and CEO. Europe: Uncertainty Prevails In October, France recommended the European Court of Justice regulate all organisms created through all methods of mutagenesis. On the flip side, in 2015 Sweden had decided that the technical and legal issues associated with plant breeding innovation favored non-regula- tion and Finland followed suit. But the broader European Parliament (EP) seems to be at a stalemate. In June 2016, the EP voted on an initiative put for- ward by its Committee for Agriculture. The initiative received broad backing from the Agriculture and Rural Develop- ment Committee, but the plenary vote significantly altered the final text by suppressing proposals related to a more supportive and enabling regulatory framework for plant breeding and crop protection innovations. “It is fair to say that we are rather disappointed,” says Garlich von Essen, European Seed Association secretary general. The plenary voted down a number of elements that had called upon the EU to facilitate the development and deployment of innovative plant breeding methods by a supportive and enabling regulatory framework. Von Essen says: “To some extent, the EP has missed the point and an important opportunity.” Pro Innovation Policies Needed The fact is that regulatory policy will determine the methods used across companies and across crops. Policies that place an overly high regulatory burden on new plant breeding innovations will limit use to only the largest companies and only the highest value crops, such as corn and soybeans. While countries around the world chart new territories in determining how plant breeding innovations should be handled, the international seed industry hopes policymakers will create frame- works that give legal certainty to plant breeders and developers, foster innova- tion and ensure safety. “A recent study shows that more than 80 percent of current and future produc- tivity and sustainability gains are derived from plant breeding,” von Essen says. In moving forward, Slutsky says the goal is to adopt a set of consistent criteria for how a product should be evaluated, and thus regulated. ISF, through its Plant Breeding Innovation Working Group, devel- oped a document outlining such criteria. “If we can get the scientific commu- nity to agree on a set of parameters, then we can build a path minimizing political and ‘off science’ disruptions when we approach regulators and policymakers,” Kiekebusch says. That’s why in mid-November, SAA hosted a meeting with academic repre- sentatives from the U.S., Mexico, Paraguay, Colombia, Argentina, Uruguay, Peru, Chile and Brazil to discuss concepts for consist- ent criteria when it comes to how, and if, these innovations should be regulated. “We want to be proactive from both a policy and communications point of view,” Slutsky says, “so at the end of the day, scientists can take advantage of these plant breeding innovations.” These innovations are seen as part of the solution to helping farmers increase crop yields and better manage disease, pest and abiotic pressures in a sustainable manner. SW PLANT BREEDING INNOVATION POLICY “What’s important is that you have a system that consumers have absolute confidence in. That it has safety but also allows for research to flourish ...” — Matthew Cossey