Perspective: The Interaction Between Ag Innovation and Regulation
In the Perspectives guest blog series, Farm Foundation invites participants from among the varied Farm Foundation programs to share their unique viewpoint on a topic relevant to a Farm Foundation focus area. This guest blog was contributed by Karen Carr, partner at ArentFox Schiff, and Round Table Fellow.
I often claim, honestly, that I am lucky to have the most interesting law practice one could have. Case in point: a few weeks ago, I visited a biology lab where I ogled petri dishes containing plants that have been engineered to produce proteins that are ordinarily derived from animals—a novel source of a key food ingredient that has the potential to revolutionize dairy alternatives. Every day I work with product developers like that one, who are using everything from artificial intelligence to zinc fingers to add to the already incredible toolbox potentially available to our farmers and ranchers, such as salmon that can be farmed in domestic land‐based facilities, soil microbes that can decrease the use of synthetic nitrogen, urban farm facilities, and better‐tasting fruits and vegetables. All have a laudable goal: to improve the way we produce food, fuel, fiber, and other products vital to our lives, both in the United States and globally.
It’s a truly remarkable time to be working in this field. Record amounts of capital are being invested in the agriculture sector—particularly in ventures operating at the intersection of agriculture and technology, sometimes referred to as “AgTech.” One source has estimated that venture capital firms invested $10.5 billion across 751 deals in AgTech startups during 2021, an increase in deal value of more than 58 percent over 2020. This also means there are opportunities to convene with developers, investors, and researchers at conferences and summits, particularly now that we are able to get back to doing some of that convening in person. As we face incredible challenges, the future is bright and full of solutions.
As I practice at the intersection of law and regulation, thinking about the future of our food and agriculture system always leads me to contemplate our regulatory system and the role it plays in advancing innovation. A significant part of my day‐to‐day work is spent working with developers to identify, understand, and secure a regulatory pathway for the newest of these tools so that products can get to market. I also work with trade associations and industry coalitions on ensuring that federal, state, and local policy provides a clear, predictable pathway to market for those new tools while providing consumers with the confidence that new products are safe.
Focusing on Risks, Not Hazards
We are fortunate to live in the United States for many reasons. Innovation flourishes here because of our world‐class education system, thriving public and private research and development programs, and access to capital. We are also fortunate to live in a country whose regulatory system evaluates innovation using the principles of risk assessment.
The goal of risk‐based regulation is to focus regulatory resources in a way that is proportionate to the risks that particular products, or categories of products, pose. Where technological advancements, and our understanding of those advancements, allow a greater understanding of risk, regulatory burdens should be lowered (or enhanced) accordingly. This approach stands in stark contrast to the hazard‐based framework used by some of our most important trading partners, under which technology is avoided or resisted until all risk—irrespective of degree—is ruled out.
Warp‐speed innovation is not without its challenges. In particular, it is a continuing challenge for our regulatory system to keep pace with advances in technology. Indeed, this very question was the subject of a National Academies report a few years ago entitled “Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System.” In it, the authors predicted that advances would increase in scale, scope, complexity, and tempo—simultaneously—and counseled that agencies should prepare. But in order to address this increased volume of product development using new technologies, regulators at all levels of government need to understand the underlying technologies to be able to adequately and efficiently assess risk. Indeed, the study authors advocate for increasing agencies’ scientific capabilities, and for agencies to increase investments in regulatory science, among other recommendations.
The Role of Stakeholders in Promoting Innovation
We all have a role in identifying opportunities to harmonize advancement with the appropriate level of regulatory resources. All stakeholders should take advantage of every opportunity afforded them to communicate with regulators about what challenges they are facing, and what tools are needed to solve them. Product developers—large, small, public, private, and all the rest—should communicate with the agencies that will regulate them about what products are in the pipeline (in a manner that is in balance with the important need to protect valuable IP) and communicate with Congress about where additional resources or capabilities are needed. And Congress and the executive branch should use their existing authorities to ensure that agencies have all the resources they need to work cooperatively with developers to conduct timely and complete reviews.
Karen Carr counsels, advocates, and litigates on behalf of food and agriculture companies and industry groups, with a focus on agricultural technology, food, biotechnology, pesticides and other chemical substances, and environmental law. She co-leads ArentFox Schiff’s AgTech industry group.