Viewpoint: Bureacucracy building or real research and regulatory reform — Can Biden turn a proclamation to spur biotechnology innovation in health, energy and agriculture into actionable projects?


[dropcapP[/dropcap]Resident Biden has published an Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe and Secure American Bioeconomy. The goal is to “coordinate a whole-of-government approach to move biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.”

We’ve seen proclamations like this before, but this one is better than most. This is because it contains more than just instructions to the enforcement authorities: it contains instructions on how to develop specific plans to implement the order, how to report to bodies with budgetary authority, and how to follow up reports to demonstrate compliance. In other words, it bears the handwriting of someone who has been around the block and aaaa noticed all the things bureaucracies can do to delay, disrupt and derail a president’s policies, whether by ineptitude , sloth or malicious intent. Biden saw this film and it looks like he won’t be here for a rerun.

References to “bioeconomy” have skyrocketed over the past two decades. Photo credit: Frisvold et. Al.

As the world moves into the century of biology, the long-term fortunes of the United States will rise or fall to the extent that these policies are successful. But for all the sharp-eyed pragmatism in Biden’s approach, it is not without imperfections. It understandably focuses on the bioeconomy as a whole, with a strong emphasis on the sectors identified within it, for which there is specific guidance. But in naming which sectors to look out for, he leaves to the last thing that should come first: agriculture.

It’s actually quite simple: Agriculture is the prerequisite and basis of civilization. As one scholar remarked, “Civilization was built on genetically engineered crops.” Without the surplus production of storable food, humans would be too busy with the tasks of survival to develop skills at anything else. It was only with the advent of surplus, storable production that cultures were able to pursue a specialization that allowed them to mature into civilizations. But modern agriculture is a victim of its own success, one that is often overlooked and taken for granted as continued improvements in production efficiencies make hunger a thing of the past, at least for many in the developed world. But projected population growth and today’s geopolitical crises mean that farmers will need to produce more food over the next thirty years than they have done from the dawn of man to the present day. This is no small challenge, and it means breaking down the barriers that hamper agricultural innovation. This would bring a lot of low-hanging fruit within reach. How can we achieve this?

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In the last thirty years, agriculture has changed fundamentally as modern methods of genetic improvement have been integrated into plant and animal breeding. Enormous added value has been created, which benefits smallholders in developing countries more than large-scale farms in industrialized nations. However, this happened despite ill-considered measures in most countries aimed at ensuring safety. Experience has shown that the regulations put in place have been excessive and have contributed little or nothing to safety. Hundreds of billions of tons of “GMOs” (“genetically modified organisms”) have been produced and consumed by humans and livestock with unprecedented safety and enormous environmental and economic benefits. Yet despite this unprecedented track record, new plant and animal varieties improved using the most modern methods continue to face far more onerous regulatory hurdles than the fruits of older, less precise technologies with poorer (though still impressive) safety records.’

Bringing new developments to market can cost many times more money to comply with regulations than it does to develop them. Credit: AgbioInvestor 2022 and members of CropLife International

We know what causes disease and death in food and feed: microbial contamination from improper preparation methods or the presence of toxins and food allergens. Genetic enhancement methods do not create or exacerbate these problems, but in fact provide new tools to further reduce them. So why are the fruits of the most advanced genetic enhancement techniques subjected to the most rigorous regulatory scrutiny? That makes no sense.

Biden’s executive order points in the direction of this reality, calling on agencies to “clarify and streamline regulations in the service of a science- and risk-based, predictable, efficient and transparent system to support the safe use of biotechnology products.” That is good, but similar previous exhortations have not borne fruit. The EO’s follow-up mechanisms and deadlines for feedback give hope that things will be better this time, but in the past such instructions have not come to life and in some cases have been actively resisted. Biden needs to deliver more. What should agencies do to fix the problems with existing regulations?

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Credit: AgbioInvestor 2022 and members of CropLife International

The first thing to do is refresh your understanding of the ‘Coordinated Framework’. Promulgated in 1986, before many of today’s regulators were born, the CF codified the outcomes of several years of congressional hearings and deliberations by the National Academies of Science and regulators on how the products of in vitro recombinant DNA research and development should be regulated. The CF noted that despite considerable concern in some quarters about the potential dangers of powerful new biotechnology, no one has been able to identify a plausible new threat. While there may sometimes be dangers associated with a particular application of technology, we are aware of them – we have seen them in older methods of genetic improvement, such as classical plant breeding and animal domestication. We have experience in managing and mitigating risks arising from exposure to such hazards – we have been doing this for millennia. As a result, existing regulations and agencies provided a reasonable starting point, and the CF agencies (USDA, EPA, and FDA) were tasked with applying those agencies to the new products. USDA was the fastest and most successful, followed by FDA and EPA. As a result, agriculture has changed for the better, although food technology applications have not kept pace and microbial applications have not been able to thrive under EPA jurisdiction.

But even under the CF, it takes many years (~13) and millions of dollars (~130) to bring most new agricultural biotech innovations to market. For products that pose no novel hazards, have an unmatched safety record, and have delivered massive economic and environmental benefits, this represents a massive policy failure. This has happened because the USDA, FDA, and EPA have not updated their regulations in a timely manner. They have each made some efforts in this regard, particularly USDA, but they are all lagging far behind. This is because they have lost sight of the principles set out in the 1986 Coordinated Framework. The result is that today there is a gap between current regulatory approaches and those that could be supported on the basis of science and experience.

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Sound risk management must be based on a scientifically sound risk assessment, which in turn requires prior identification of the hazard. If there is no risk, there is no justification for regulation. If agencies applied these first principles, they would immediately take most of the regulatory oversight they currently administer off the books. Remarkably, the FDA instead believes that the use of gene editing in livestock is so dangerous that it must be banned until proven safe, even if used to produce phenotypes identical to those are already present in existing cattle herds. This is madness.

Cattle dehorning is expensive, and gene editing offers a way to prevent it, improve animal welfare and reduce costs. Photo credit: Kent Ward

Good regulations have several characteristics in common: they start with identifying a hazard; they move to a scientifically based risk assessment; and they take action to mitigate or manage the risk that is proportional to the hazards involved and does not go beyond what is necessary to manage exposure to the hazard. No US agency currently has policies that meet these standards. Until they do, they will impede, not enable, the policies that President Biden has set.

Ultimately, what is needed is well captured in an up-to-date tweet:

Photo credit: Twitter

Val Giddings received his Ph.D. in Genetics and Evolutionary Biology from the University of Hawaii. Val is also President/CEO of PrometheusAB, Inc and a senior fellow at the Information Technology and Innovation Foundation. You can follow Val on Twitter @prometheusgreen

A version of this article was published by the Information Technology and Innovation Foundation and is used here with permission. Visit the Information Technology and Innovation Foundation on Twitter @ITIFdc





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