What role does regulation play in this? Why do we do it? Is it working? As scientists

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1 DR. ANDREW ROBERTS, DEPUTY EXECUTIVE DIRECTOR Introduction to the ILSI Research Foundation Context for agricultural innovation What are we facing in the 21 st century? Why people are interested in agricultural innovation Are we prepared to meet these challenges? What role does regulation play in this? Why do we do it? Is it working? As scientists Any views expressed (deliberately or accidentally) are my own, and not necessarily those of the ILSI Research Foundation A distinct, complementary, non-membership component of the ILSI network Funded through grants and donations from public and private sector sources We use the same global, multi-sectoral approach as ILSI s other entities to advance our mission

2 Bringing scientists together to improve environmental sustainability and human health Previously -Organized into centers and programs -Competing brands, confusion, difficulty in describing work, inconsistency, limitations for growth Looking ahead -Establish the ILSI Research Foundation as the focus -Simplify how our work is described, synchronize communication efforts, leverage resources more efficiently Improved responsiveness and agility to emerging needs Increased flexibility and adaptability of resources and programmatic work More focused scientific expertise More efficient messaging, highlighting our values and impact in a cohesive way A BRIEF HISTORY OF AGRICULTURAL INNOVATION THROUGH THE 20 TH CENTURY

3 For 10 millennia, farmers use selective breeding to produce better performing plant varieties Experimentation is trial and error with farmers saving seed with the hope that it breeds true This is incredibly successful, albeit time consuming Produces many of the crops we have today which are radically different than their ancestors ~1900 Gregor Mendel s work with peas introduces the principles of genetics Greatly facilitates crop breeding Mutation breeding discovered in the 1920 s The first GE plant was produced in a laboratory around 1983 (published in 1984) National Academies of Science Risks posed by GE plants are the same as those posed by non-ge plants with similar traits Conclusion is well accepted by the scientific community By 1986, some governments established regulatory frameworks for the technology At least in part to address public concerns Very few people argued against regulation Using the principles and practices derived from other activities Plant quarantine Pesticide regulation The first GE plants are commercially introduced in the mid-1990s

4 TM For a variety of reasons, the introduction of GE crops has been controversial Some of these stem from at least arguably legitimate concerns However, 20+ years of experience in the field is not being adequately reflected in regulatory reviews* Social and consumer trends are rejecting production efficiency Wealthy consumers are paying for the aesthetics of inefficiency Intensive agriculture is derided as factory farming and assumed to be harmful to the environment and human health Despite all the available evidence suggesting the opposite A BRIEF INTRODUCTION TO CHALLENGES IN FOOD PRODUCTION IN THE 21 ST CENTURY source: Third National Climate Assessment, US Global Change Research Program (2014). source: Third National Climate Assessment, US Global Change Research Program (2014)

5 Maize Soybeans Rice Wheat Sweet Potatoes Pulses Millet Cassava Sugar cane Sorghum Potatoes Impact of Reducing Food Wastage by 30% Global rates of yield gain ( ), based on data available from FAOSTAT Rate Needed to Double Yields by Annual Rate of Yield Gain (%) Livestock Multiple diseases Rice 1 False smut Maize Stem borer Cassava 2 Whitefly Mealybug False smut on rice, Photo credit: IRRI Stem borer on maize, Photo credit: CYMMIT Whitefly on cassava, Photo credit: CIAT January 2007 source: Rockström, et al., Planetary boundaries: exploring the safe operating space for humanity. Ecology and Society 14 (2),

6 ARE WE HELPING OR HURTING OURSELVES? Source: Maplecroft (2014). 21 We need to grow more food* Under increasingly variable climatic conditions Not just produce more calories, but provide access to nutrients In the face of emerging pest and disease pressures We need to do it in such a way that protects our environment from further degradation* On less land With fewer inputs Lower environmental impact This is simply not possible without innovation* Insanity is doing the same thing over and over again expecting different results (Einstein) New techniques and production methods are being developed and used to address production and environmental challenges* No-till Integrated soil fertility management (ISFM) Precision agriculture Organic agriculture Nitrogen use efficiency Water harvesting Drip irrigation Sprinkler irrigation Improved varieties drought resistant Improved varieties heat resistant Crop protection *Food Security in a world of natural resource scarcity: the role of agricultural technologies Rosegrant, et. al

7 *Food Security in a world of natural resource scarcity: the role of agricultural technologies Rosegrant, et. al Does current agricultural policy foster innovation? In particular, plant breeding innovation Are regulations being applied in a way that facilitates the adoption of beneficial technologies while preventing harm to human health and the environment? Are regulators being supported with clear policy decisions on what they need to protect in the environment or what constitutes a hazard in the food supply? Regulatory Burden for non-gmo Regulatory Burden for GMO Level of Regulatory Oversight Potential for harm from an activity

8 GE/GM plants are subject to much more regulation than conventionally bred plants Despite 20 years of experience, regulations are becoming more burdensome There are multiple reasons for this It is very challenging to lightly regulate In most countries, there is no rational link between expected level of risk and burden of regulatory oversight A whole host of new technologies are emerging Site directed mutagenesis Gene Editing Oligonucleotide directed Zinc finger nucleases TALENs CRISPR Cas-9 RNAi Reverse Breeding Something coming tomorrow that I haven t thought of yet Currently global debate centers on whether these technologies are producing GMOs Because the regulatory burden is so much higher for GE Innovative technologies may not be pursued if they are considered GE Public sector institutes and small enterprises can t afford to comply with regulation Regardless of the potential (or lack of potential) risks to the environment or food safety The context of the risks these products do or don t pose is lost The current experience with GE/GM crop regulation is mixed, at best. Stated goals: Allow the introduction of beneficial technologies Reassure the public about safety Regulation has decidedly not reassured the public of the safety of the technology

9 Look for ways to exclude future innovations from GMO regulation Legal definitions Similarity to products of conventional breeding Rationalize the current regulatory approaches Better alignment between likelihood of harm and evidence required to demonstrate safety Both present serious challenges Old Technologies New Technologies Understand the role of science in informing public policy including regulations Science doesn t tell you should do or must do It can tell you what will happen if you do/don t do something Accept that people may reach different conclusions about what to do based on the same facts When engaging in regulatory activities, insist that policy makers do their job Too often scientists are struggling to science their way out of policy uncertainty What are the regulatory endpoints? What is being protected, and what is the standard of that protection? Leave your research interests at home Regulation and research are very different activities Just because something is interesting doesn t mean it is relevant More data is not the solution to every problem Science/Risk communication matters greatly If you hand a policy maker a report that they can t understand you aren t helping Provide the appropriate context (avoid volume bias)

10 We need innovative solutions, without prejudice to the development process* We can t know where the next important breakthrough in plant breeding will occur Conventional breeding Genetic engineering Site specific endonucleases (Gene Editing) Can we afford to exclude potentially useful technologies from plant breeding efforts?*