The debate on plant breeding innovation, the resulting plant varieties and products and whether to regulate these products under current or new regulations or not is not limited to the European continent, but also taking place in many other countries. European Seed sat down with Bernice Slutsky, Senior Vice President of the American Seed Trade Association (ASTA), and also Chairperson of the ISF Working Group Plant Breeding Innovation, to get her take on the topic and on some of the recent policy developments in the US.
European Seed (ES): Bernice, over the past few years, there has been a lot of debate on plant breeding innovation. In your view, what are the pros and cons of the latest methods in general and more specifically for the seed trade?
Bernice Slutsky (BS): Over the last few decades, plant scientists have gained an increased understanding of plant genetics through the capability to sequence plant genomes and the ability to link a specific gene(s) to a specific plant characteristic. The major significance of the more recent innovations in plant breeding methods, such as gene editing, is that these methods now enable breeders to efficiently utilize all of this genetic information and knowledge to improve a plant’s phenotype more precisely. Gene editing methods can be used to very precisely target a change to a specific gene(s) in a plant’s genome to create the desired plant characteristic. They can also be used to identify a gene in a plant’s wild relative and to efficiently recreate that gene and the desired characteristic in an existing, high-performing commercial variety. Because these new methods are efficient and economical, they are accessible to public and commercial plant breeders, small and large, and can be used across all agriculturally important crops, including field, vegetables and specialty crops. To plant breeders and the seed industry, these methods provide tremendous promise with very few, if any, downsides.
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ES: What will be the impact for the global and US seed trade of regulating these new techniques in the same way as GMO’s?
BS: As we know, there is currently a patchwork of national GMO regulations. As an example, the problem of asynchronous approvals has had an impact on agriculture commodity trade. Definitions for ‘GMO’, ‘biotechnology’, ‘genetic engineering’ and ‘bioengineering’ are not consistent across countries. The regulatory burden of these global GMO regulations has meant that only the largest developers are able to afford bringing a GMO variety to market and has limited the use of GMO technology to high value crops such as corn and soybeans.
Ultimately, if the same regulatory system is used for products of gene editing, it will negatively affect research collaborations, hinder the movement of seed globally, cause commodity trade disruption and effectively limit the use of this valuable plant breeding tool.
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ES: At the moment we are seeing a divergence between countries in how they regulate these new techniques. What are the pitfalls of such an approach, and what needs to be done?
BS: In fact, most countries have not yet made decisions on how they will regulate products developed using these new techniques. More specifically, most countries have not yet determined if or how current domestic GMO regulations would apply to these newer products. For those countries that have made decisions on how to interpret current GMO regulations with respect to gene editing, there is more commonality in these policies than divergence. This convergence is particularly true for using gene editing to make deletions and other changes that do not result in a “novel genetic combination”. We are also seeing countries seeing the value of aligning policies and having an understanding of the problems created by divergent policies.
However, much work is left to be done both by the private sector and governments. The goal of the seed industry is consistent, science-based, policies across countries. In working toward this goal, it will be important to encourage opportunities and venues to facilitate government discussions toward this end.
ES: Earlier in 2017, the United States Department of Agriculture (USDA) made a proposal which would revise their current biotech regulations. What triggered this proposal?
BS: USDA has well over 20 years of experience in implementing their current biotech regulations. In addition, all of the regulations that implement the US Coordinated Framework for the Regulation of Biotechnology were meant to evolve along with regulatory experience and the evolution of the science. The proposed rule set out some proposed definitions which essentially set up the initial scope of regulation. In these definitions, some exemptions were defined that would carve out certain applications of gene editing, such as genetic changes that could also occur through traditional mutagenesis and making genetic changes within the sexually compatible plant gene pool. The American Seed Trade Association (ASTA) supported these exemptions. However, these definitions were a small part of the proposed regulatory revisions. The bulk of the proposal focused on revisions to the procedures to be used for those products falling under the scope of the regulations.
ES: In the meantime, in early November 2017, the USDA proposal was withdrawn. What happened?
BS: The United States has very strict requirements for the procedures that regulatory agencies must go through during the rulemaking. Once a proposed rule is published in the US Federal Register asking for public comments, an agency is not allowed to engage stakeholders on the proposed rule, other than through the formal written commenting process. The agency proposing the rule cannot go beyond describing what is in the proposal when speaking with stakeholders. Therefore, USDA decided to withdraw the proposal so that it could more easily engage with stakeholders on additional options, particularly around the procedures for those products falling under the initial scope of the proposal. The withdrawal did not signal a change in course around the definitions/exemptions that defined the regulatory scope of the proposal. Withdrawing the proposal also allows USDA to more easily engage with other governments on concepts in the proposal, something that ASTA and the rest of the US agriculture value has strongly encouraged.
ES: How are you engaging ASTA members in spreading the message about plant breeding innovation? Are you seeing the first effects?
BS: ASTA has a very robust communication effort around plant breeding innovation in general and more specifically around gene editing. It is extremely important that ASTA members have communication tools at their disposal, so they can, in turn, be able to tell the positive story of plant breeding the role that innovation has played in bringing a wide range of new varieties to farmers and ultimately to the consumer. ASTA also recognizes that any communication effort cannot be limited to the US borders and is therefore collaborating with other national and regional seed associations as well as the International Seed Federation and CropLife International on creating these communication tools. For more information, visit www.seedinginnovation.org.
