Expert Interview Series: Dr. Jennifer Kuzma and GE Technology Regulation

 

October 31, 2017

Interviewer: Jessica Brandt

Jennifer Kuzma is the Goodnight-North Carolina GlaxoSmithKline Foundation Distinguished Professor in Social Sciences in the School of Public and International Affairs and Co-Director of Genetic Engineering and Society at North Carolina State University. Her research focuses include synthetic biology, risk-governance policy processes, and the ecological and societal aspects of gene-drive technologies for pest and disease management applications. Dr. Kuzma was previously a National Academy of Sciences study director for genetic engineering and bioterrorism and recently served on the National Academy of Sciences Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System. Her expertise in genetic engineering policy issues has been called upon by news outlets including The New York Times, NPR, Scientific American, and the Washington Post. She earned her Ph.D. in biochemistry from the University of Colorado, Boulder in 1995.

 

Jessica Brandt interviewed Dr. Kuzma earlier this semester as part of our blog series on genetically modified organisms in the regulatory context. This interview follows our recent Rethinking Regulation blog post, “Genetically engineered salmon – coming soon to a US store near you?”, which was published earlier this month. This interview has been edited for clarity.

What do you think is the biggest challenge regulators face with a product like AquAdvantage salmon?

There are a couple of main challenges. First, products like AquaAdvantage salmon do not fit well with the current regulatory structure. For example, the FDA worked under the National Environmental Policy Act (NEPA) to assess environmental impacts which is more of an assessment statute than a legal authority.  For legal authority, they used the New Animal Drug Act provisions, thereby considering the gene a drug, and this is also a poor fit. A second challenge is that there is a lack of scientific data to use in risk assessments of these products. Importantly, there may not be experiments we can use in the pre-market assessment process that can accurately predict what will happen when the product goes to market.

With AquAdvantage, the FDA tested for allergenicity and their results indicated a statistical increase in allergenicity with the diploid population of the GE salmon compared to the non-GE variety, as well as a descriptive increase in allergenicity with the triploid GE population. This result squeezed through the regulatory process without the experiments having to be repeated, as the agency concluded that the levels were still within the range of other fish allergens.  Of course, this raised some questions about risks posed to consumers who eat this product over long periods of time. This introduces yet another challenge – how to deal with scientific uncertainty in regulatory decisions? But this is a value question rather than a scientific question. With the scientific results in hand, policy makers are asked to make a regulatory decision and determine what level of uncertainty is acceptable for that decision. IT is very difficult to determine the potential for long-term, even if low-consequence, effects.  Though setting safety standards involves value-based decisions, it is forced to fit within existing decision processes which privilege natural science information.  In other words, agencies try to “stick to the science” in decision making.  But that is very difficult as safety is a socially constructed concept.

A third challenge stemming from this problem is whether consumers trust how the government deals with scientific uncertainty in the genetically engineered foods context. Consumer environmental groups are serving as watchdogs over these processes and end up filing lawsuits against the FDA for the inadequacy of their risk or environmental assessments.  However, now there is a labeling requirement for such products, we will see how consumer distrust plays out in the market – will consumers avoid purchasing and consuming the GE salmon? What will these decisions reveal about consumer’s values about how they want their food produced?  One option for labeling is a QSR code which has been controversial.

A final challenge, which was discussed in the blog post, is that given the legal infrastructure and focus of FDA’s product review, there was a lack of consideration for indirect and long-term effects of AquAdvantage production on ecosystems (for example, what will it mean for water and land use?).

Should a new regulatory framework be established for products, like AquAdvantage, that are intended for human consumption? If so, what might that look like?

I am not entirely sure where I come down on this question – do we need new laws or do the existing laws need to be more thoughtfully interpreted to fit new product contexts? Many other countries have specific legal frameworks in place for GE products and it might be helpful to see a cross-analysis of these different approaches for GE food regulation.

I will say, though, that regulating this salmon as an animal drug makes very little sense. The things regulators are looking for with animal drug applications are drug safety and efficacy for the animal which will be exposed, not necessarily for people who may be consuming the exposed animal (although FDA does consider it).  Furthermore, the FDA was also the wrong agency for the environmental assessment of the animal product. Environmental agencies, such as EPA, FWS and NOAA-NMFS, have better frameworks for environmental assessments. It might be a different story if we had more efficient and flexible coordinated frameworks through which agencies could work together but we did not see that to be true with the AquAdvantage case. Flexibility could be an asset here, but in addition to that, we need political will and resources to facilitate the process more effectively.

How have your experiences with the National Academy of Sciences influenced your thinking about the role of scientists in society?

My experiences with the National Academy of Sciences made me realize that there are entrenched attitudes about excluding the consideration of values from risk assessment. But what we may not realize is that Academy committee members bring their own values to the process regardless. We select the scientific studies that best fit those values and we bring our own biases to this process. It concerns me that we did not evaluate the inclusion of our own values and biases more thoroughly while I was serving on the NAS Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System. In my opinion, we didn’t thoroughly ask questions like “how would an ecologist, an ethicist, a sociologist think about this risk and the types of data we would need to answer these questions.” These experiences also highlighted the different ways that very knowledgeable experts interpret uncertainty.

I think we also need to better incorporate the decision-making sciences, for example the policy analysis and political sciences, in these processes. The primary goals of the Academy, then, should be to interpret the natural sciences in ways that broader audiences can understand the result. These interpretations could then be used by those who should be deciding what needs to be done and issuing policy recommendations (such as anthropologists, policy scholars, regulatory and legal experts, and stakeholders affected by the issue). I do not think the National Academy of Sciences is the best place for decision or policy making.

What are some of the ongoing debates in GE regulation that scholars interested in regulatory governance should be paying attention to?

People interested in GE product regulation should keep paying attention to the labeling standards that are currently being developed by the USDA. Gene editing is a related and interesting regulation area and there are a lot of questions about how gene edited products will be dealt with by the USDA and FDA. For example, how will we deal with the gene drive issues that arise when certain gene editing approaches allow edited genes to spread through wild populations. The Obama Administration released draft guidances right before leaving office for USDA new rules and FDA guidance to include gene editing, but we have yet to see what will be made of that rule and guidance. I’m particularly curious to see what will come under the scope of GE and how the regulatory definitions will be important.  More generally, we are starting to see some policy scholarship for broadening voices in regulatory decision making.  I am curious how this will apply in the GE context and whether these processes will stay closed to industry and government or will open more.

I also recommend watching for whether President Trump will issue an Executive Order (EO) on regulatory review like most recent presidents have. OIRA currently plays a big role in regulatory product policy. What will President Trump’s potential EO say about cost-benefit analysis (CBA) versus social, distributive justice issues, and ethical values? In the past, every regulatory review policy has called for a different balance of these two aspects; while society values are the most difficult to quantify, they are also the most important to people. As of now, however, they do not fit well into regulatory CBAs.