The most important rate-limiting factor in our ability to harness biological innovations to the challenges of feeding the world, sustaining human and environmental health, and addressing climate change, is the burden imposed by ill-considered regulations. Unless this bottleneck can be unblocked, the enormous potential for transatlantic scientific cooperation will not yield the necessary fruits.
Divergent regulatory paths: Precaution vs openness to innovation
Existing policies, legislation, and regulations do little or nothing to advance human or environmental safety.2 Born out of understandable caution at the dawn of recombinant DNA technologies, today their most obvious impact is to obstruct and discourage research, development, and deployment of innovative solutions to various challenges.3 This is so despite an abundant record of production and consumption of new biotech products with enviable records of improved safety, superior sustainability, and widespread beneficial economic impacts.4 The benefits are so substantial that a pattern has emerged of farmers breaking the law to acquire and plant improved seeds in countries where governments have lagged in allowing access.5
It is one thing to implement policies and regulations ostensibly designed to ensure safety; it is quite another to ignore vast data and decades of experience around the world to maintain obsolete policies and regulations that add nothing to safety or sustainability, but only impede our ability to use the most innovative, precise, and safest tools to address our gravest challenges.6
In terms of regulatory policy and openness to biological innovations, the width of the Atlantic might be measured better in light years than miles or kilometers. As imperfect as regulations for the products of biotechnology are in North America, they are simply indefensible in Europe.7
The United States decided in 1986, after years of study and consultation, that no new laws were required to ensure the safety of crops and foods improved through biotechnology. This was based on the finding that they present no novel hazards, and foreseeable risks of their development and use fall into categories with which humans have considerable experience from millennia of conventional plant and animal breeding.8 The United States therefore decided to regulate these novel products under existing authorities administered by the Department of Agriculture, the Food and Drug Administration, and Environmental Protection Agency.9 While implementation of this policy, the “Coordinated Framework,” has been far from perfect, it has been sufficiently predictable and science-based to enable an explosion of innovation, new product development, and commercial activity. Consequently, the United States has led the world to the present day wherein crops improved through biotechnology are now the global standard for quality seeds, delivering improved yields, safety, sustainability, and economic productivity around the world, with the lion’s share of benefits accruing on behalf of small farmers in developing countries.10 Europe took a different approach.
It is one thing to implement policies and regulations ostensibly designed to ensure safety; it is quite another to ignore vast data and decades of experience around the world to maintain obsolete policies and regulations that add nothing to safety or sustainability.
The European Union decided to regulate seeds improved through biotechnology as a novel class governed under new regulations specifically focused on an arbitrary category known as “GMOs” (for “genetically modified organisms”). The conceit was that because they represented gene combinations produced by mechanisms supposedly “not found in nature” (but actually ubiquitous) they must present novel hazards, even though none has ever been identified. These putatively novel hazards, despite the lack of any concrete manifestations, allegedly required dedicated, specific, “precautionary” regulations. The resulting regulatory regime proved so burdensome it led to the general collapse of agricultural biotechnology in Europe, which had played a leading role in its discovery and invention. Permissions for field trials proved almost impossible to obtain, products could not be developed and brought to market, academic labs abandoned the field, and the industry relocated most of its assets and activities to the Americas. And Europe became the world’s largest importer of commodity foods improved through biotechnology, only recently surpassed by China.
Opportunity for transatlantic cooperation
Many scientists in the EU (and around the world) knew from the beginning that this was the wrong approach, yet the EU pushed its model internationally, with aggressive diplomacy, leading to emulation by many countries in the developing world, with equally unhappy results to those seen in Europe.11 But a growing number of scientists, policymakers, and even “green” NGOs that had originally opposed GMOs, now recognize the counterproductive results of this approach and are working to avoid repeating the same mistakes with gene editing. This shines a spotlight on the most important and potentially fruitful opportunity for transatlantic cooperation in biotechnology: the revival of science-based regulatory regimes in which the degree of regulatory oversight is proportional to the hazards involved, and regulation that enables, rather than discourages the safe development of innovative products. A return to and reaffirmation of these first principles would provide fertile ground for cooperation and coordination globally. Regulatory reform (everywhere, not just in the EU and its emulators, though the need is greatest there) provides fertile ground for transatlantic cooperation and coordination. We have robust models of proven approaches.12 Without such cooperation, other progress in developing and deploying innovative solutions through biotechnology will be impeded or foregone.
As to national security risks, just as with other risks, novelty attributable to biotechnology is elusive. One can do very nasty things with conventional bioweapons, and they are easily magnified with recombinant DNA techniques. At the same time, defensive capacities are also buttressed by biotechnology, as demonstrated by the rapid development of mRNA vaccines against SARS-CoV-2. There has been some good work done in this area, but this topic is worth exploring at greater depth. The OECD has a track record of thoughtful analyses with such topics. One possibility would be to build on that foundation by establishing a joint OECD/NATO working group to serve as a forum.
Further reading
- Robert D. Atkinson, “Sectoral Policies to Drive Productivity Growth” (ITIF, October 12, 2021), https://itif.org/publications/2021/10/12/sectoral-policies-drive-productivity-growth.
- ITIF comments to the White House Office of Science and Technology Policy regarding its Notice of Request for Information for Bioeconomy (84 Federal Register 47561), October 15, 2019, http://www2.itif.org/2019-comments-ostp-bioeconomy.pdf.
- Robert D. Atkinson, “Computer Chips vs. Potato Chips: The Case for a U.S. Strategic-Industry Policy” (ITIF, January 2022), https://itif.org/publications/2022/01/03/computer-chips-vs-potato-chips-case-us-strategic-industry-policy.
- Robert D. Atkinson, “Weaving Strategic-Industry Competitiveness Into the Fabric of U.S. Economic Policy” (ITIF, February 2022), https://itif.org/publications/2022/02/07/weaving-strategic-industry-competitiveness-fabric-us-economic-policy.
- Office of Science and Technology Policy, “National Strategy for Modernizing the Regulatory System for Biotechnology Products,” September, 2016, https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/biotech_national_strategy_final.pdf.
- Jyotsna L. Pandey, “Policy for Bioeconomic Growth,” BioScience, 70(6):459-460 (June 2020), https://doi.org/10.1093/biosci/biaa049.
Val Giddings is a senior fellow at the Information Technology and Innovation Foundation (ITIF). Giddings received his Ph.D. in genetics and evolutionary biology from the University of Hawaii in 1980. Val can be found on Twitter @prometheusgreen
A version of this article was posted on the ITIF and is used here with permission. You can check out ITIF on Twitter @ITIFdc