Half a century ago, biotechnology became a marketing buzzword for the products and processes that used then-new techniques of genetic modification, such as recombinant DNA technology, or "gene splicing." Today, that term has given way to "the bioeconomy," the economic output from biotechnology, which President Biden's September 12 "Executive Order 14081 on Advancing Biotechnology and Biomanufacturing" seeks to grow with new industrial policy.
With its many bureaucratic requirements and initiatives, the executive order may be counterproductive. Fifty years of experience with biotechnology should have taught us that scientific, technological, and commercial successes benefit from three things: government funding of basic, pre-commercial research beyond the capability of a single company; a stable economic environment conducive to investment; and the avoidance of unreasonable restraints on the private sector pursuing new products and technologies.
The order aims to "coordinate a whole-of-government approach to advance biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security." It builds on the provisions of the CHIPS and Science Act of 2022, signed a month earlier. That act established a National Engineering Biology Research and Development Initiative, which authorized increased financial support, the development of new tools, additional testing facilities, education and training, and other provisions intended to enhance U.S. biotechnology and biomanufacturing competitiveness.
The administration's industrial policy begins with virtue-signaling platitudes, such as its emphasis on "principles of equity, ethics, safety, and security that enable access to technologies, processes, and products in a manner that benefits all Americans." It then drifts toward gratuitous restraints, requiring that the government "launch a Biosafety and Biosecurity Innovation Initiative, which shall seek to reduce biological risks associated with advances in biotechnology, biomanufacturing, and the bioeconomy." This is in addition to the directive in the National Engineering Biology Research and Development Initiative, which states that the National Science Foundation should enter an agreement with the National Academies of Sciences, Engineering, and Medicine to "conduct a review, and make recommendations with respect to, the ethical, legal, environmental, safety, security, and other appropriate societal issues . . . related to engineering biology research and development," because "we must take concrete steps to reduce biological risks associated with advances in biotechnology."
This new focus on issues like risk, safety, ethics, and equity ignores the last half century of public policy on biotechnology. Specifically, it neglects the many exacting analyses of the risks and benefits of biotechnology research and products, the landmark 1986 Coordinated Framework for the Regulation of Biotechnology, and the subsequent refinements that have reduced regulatory stringency as the industry has accumulated experience to allay initial concerns.
As long ago as 1989, a U.S. National Research Council study, reflecting the consensus of the scientific community, concluded that the new molecular genetic-engineering techniques were merely extensions, or refinements, of earlier, less precise, less predictable methods. Despite the reassurance offered by that assessment, U.S. agencies have consistently over-regulated, thereby delaying or preventing the introduction of many innovative products.
The agencies' excessive or unscientific regulation includes: unnecessary USDA permits for plants that are better defined and more predictable than most unregulated ones; stultifying EPA regulation of plants with improved resistance to pests and pathogens; the EPA's classification of a harmless bacterium called "ice-minus" Pseudomonas syringae as a pesticide (supposedly because frost is a pest), making its testing and commercialization too burdensome to pursue and thus resulting in hundreds of millions of dollars in frost damage to crops; and the FDA's stifling oversight of genetically engineered animals, which it has regulated as "new animal drugs."
The current regulation of biotechnology and of the "bioeconomy" imposes substantial and often excessive burdens in time and money before research can be conducted and products sold. These burdens limit the participation of academic and commercial entities in new discoveries.
The prospect of continuing regulatory excesses overshadows the positive aspects of Biden's executive order, but it is not the only concern. The order also creates a bureaucratic maze of new initiatives and an alphabet soup of acronymic federal agencies tasked to create commissions, prepare reports, and, well, you name it: "Within 2 years of the date of this order, agencies at which recommendations are directed in the implementation plan required under subsection (c) of this section shall report to the Director of OMB, the APNSA, the APEP, the APDP, and the Director of OSTP on measures taken and resources allocated." And so on.
Instead of creating a massive make-work project for bureaucrats, the Biden administration should simplify the implementation of the order and put the highest priority on regulatory reforms that would stimulate growth of the bioeconomy.
Henry I. Miller, a physician and molecular biologist, was the founding director of the Food and Drug Administration's Office of Biotechnology. John J. Cohrssen is an attorney who has served in several government posts in both the executive and legislative branches of government, including as legal counsel for the White House Working Group responsible for the Coordinated Framework for the Regulation of Biotechnology.