Preparing for Future Products of Biotechnology: Regulatory Agencies Are More Ready Than They Think

The U.S. National Academies of Sciences, Engineering & Medicine this week released a report titled “Preparing for Future Products of Biotechnology.” The intent was as commendable as it was unusual: “to identify the kinds of products that may be produced with biotechnology in the next 10 years… to provide advice on the scientific capabilities, tools, and expertise that may be necessary to regulate those forthcoming products.” In other words, this is a case of bureaucrats trying to get ahead of the curve, to make sure they are ready to deal with challenges the future is bringing at a breakneck pace. This is a good and rare thing. But the report runs off the rails by assuming all these new products are a cause for alarm, and present new dangers we’ve not seen before. As the report itself found, that doesn’t seem to be the case.

The report provides fascinating reading on multiple levels. On the positive side, given the looming challenges we face to feed, clothe, and shelter a population approaching 9 billion, the report finds that “The scale, scope, complexity, and tempo of biotechnology products are likely to increase in the next 5–10 years.” This is certainly true, and it matters because those challenges cannot be met without innovation. An observation the report takes as a negative, however, is that “Many products will be similar to existing biotechnology products, but they may be created through new processes, and some products may be wholly unlike products that exist today.” The report infers that regulatory agencies lack the tools and staffing to deal with so many new products, and media reports have featured this as a major finding.

On its face, that statement is accurate. Agriculture faces a lot of problems needing solutions, and new tools have a host of candidates in the pipeline. But the statement is also misleading—and in truth the agencies are not as unprepared as the report suggests, though to be fair to its authors, the solution to this problem was specifically placed outside their remit. The reason some observers worry that regulatory agencies stand to be overwhelmed by an avalanche of innovative products (if we’re lucky) is not just that our technological capabilities are exploding—they are—but also that the products will somehow be so different from all other products that have come before that regulators will surely be left scratching their heads, unable to process any of it. This is a fallacy. The Committee that prepared the report apparently didn’t stop to examine the flawed presuppositions that these technologies are inherently risky and their products necessarily require special regulatory scrutiny beyond that which is leveled at innovations produced with older, more familiar technologies like conventional plant breeding. The fact is every competent body that has looked at new biotechnologies has found they are not inherently dangerous, and their products have a track record over three decades demonstrating them to be as safe as, or safer than, older innovations to which we have become so accustomed through use that we’ve forgotten what a drastic departure they are from their own obsolete antecedents. Consider corn. In other words, experience has shown that novelty is not the same as risky. So, how have we dealt with the risks of these new technologies so far?

In a parallel, but distinct bureaucratic exercise to the present study, the White House Office of Science and Technology Policy (OSTP) recently completed a review and update to the regulatory framework that has been in place since 1986 to review and ensure the safety of crops, foods, and other products resulting from (some of) the tools of modern biotechnology. Regulatory agencies were directed by OSTP to update their regulations for products under their legal authorities, and they have published draft proposals for revisions that are presently being commented on by the public. One directly relevant passage in the U.S. Department of Agriculture proposal quantifies the vast experience the agency has accumulated under the current system:

…[The Animal and Plant Health Inspection Service] has issued more than 18,000 authorizations for the environmental release of GE organisms in multiple sites, primarily for research and development of improved crop varieties for agriculture. Additionally, APHIS has issued more than 12,000 authorizations for the importation of GE organisms, and nearly 12,000 authorizations for the interstate movement of GE organisms… APHIS has granted 124 determinations of nonregulated status…

This vast body of experience has led APHIS to conclude, “The Agency’s evaluations to date have provided evidence that most genetic engineering techniques, even those that use a plant pest as a vector, vector agent, or donor, do not result in a GE organism that presents a plant pest risk.” The present report found similarly that “The risk-assessment endpoints for future biotechnology products are not new compared with those that have been identified for existing biotechnology products…” It goes on to say that “the pathways to those endpoints have the potential to be very different in terms of complexity.” But as the Academy found in its first examination of this topic, in 1987, what matters for safety is the endpoint, not the path by which it is reached, but rather the characteristics manifest (the phenotype) at that endpoint. They have reaffirmed this finding in no fewer than 10 subsequent studies, including a mammoth report released last summer.

The present report says “there are many competing interests, risks, and benefits regarding future biotechnology products. The United States and international regulatory systems will need to achieve a balance among these competing aspects when considering how to manage the development and use of new products of biotechnology. Many parts of society have concerns over the safety and ethics of various biotechnologies, while others see prospects for biotechnology to address challenging social and environmental issues. Biotechnology products that are on the horizon are likely to generate substantial public debate.” But U.S. policy is that the role of regulators is to prevent unreasonable risks, to provide a measure of safety in the face of actual risks from genuine hazards. Congress deliberately refrained from delegating the authority in their authorizing statutes to mediate disagreements about ethics, social and other issues, which are commonly left to market and other forces.

It is true that regulatory agencies, as presently deployed, stand to be swamped by a tsunami of innovative products. But this could be filed under the heading of “just desserts.” If the committee had interrogated its contrafactual presumptions that these innovative technologies and their products are inherently unreasonably risky, then they might have realized that most of the innovations we expect, however exciting on their merits, are mundane in their lack of novel hazards and risks. If agencies would set these aside and focus regulatory scrutiny on products with characteristics that are genuinely unfamiliar and likely to present hazards that translate into genuine risks, then experience indicates the looming tsunami suddenly becomes a ripple. From a risk standpoint, the lesson from experience is that the appropriate response to the coming wave of biotech innovation would be perhaps nothing more than a big yawn.