Read the Forbes story by John J. Cohrssen and Henry I. Miller here.
Worries about slow economic growth have shifted the mood of America from “hope and change” eight years ago to “drain the swamp,” which is at least in part a realization that government regulation needs major fixes to spur innovation and job creation.
The economic burden of the accumulating, often inconspicuous mountain of regulatory requirements is almost unimaginable: According to a study earlier this year from the Mercatus Center at George Mason University that used a 22-industry dataset covering the years from 1977 through 2012, by distorting the investment choices that lead to innovation, regulation has created a considerable drag on the economy that amounts to an average reduction in the annual growth rate of the U.S. gross domestic product (GDP) of 0.8 percent. That translates to a U.S. economy that is a whopping $4 trillion smaller than it otherwise would have been.
During the campaign, President-elect Trump questioned whether certain regulations were sensible, and in its transition to power the new administration is poised to refine or eliminate many of them. The costs and benefits of many regulations are alarmingly unbalanced, and reducing the regulatory burden judiciously could be good news not only for consumers, but also for a number of R&D sectors with the capacity to produce the Next Big Thing.
Plant biotechnology, also known as genetic engineering (the production of “GMOs”), is one.
Thirty years ago, the Reagan White House issued a set of rules for the use of the then-new molecular techniques of genetic engineering in agriculture, which were primarily focused on improving crops to increase farming efficiency while reducing the cost of inputs. There was consensus in the scientific community at the time that the new techniques were an extension, or refinement—a clear improvement—compared to the less precise, less predictable, haphazard techniques (which were unregulated) that had been used for decades or longer.
New rules for USDA and EPA oversight of these new products were arguably unnecessary, but they were introduced anyway, dictated by political considerations and activists’ perseveration about conjectural risks, rather than empirical information about known hazards.
For improved or new varieties of plants, risk is a function of certain characteristics of the parental plant (such as weediness, toxicity, or ability to “outcross” with other plants) and the nature of introduced or changed genes. In other words, it is not the source or the method used to change a gene but the resulting changed function that determines the presence and degree of a risk.
Under USDA’s Animal and Plant Health Inspection Service (APHIS), however, plants made with the newest, most precise and predictable techniques have been subjected to the most extensive and burdensome regulation, independent of the risk of the product, while those made with less precise techniques, such as mutagenesis and wide-crosses (in which genes or chromosomes are moved from one species or genus to another) are for the most part subject to no regulation at all. Likewise, EPA imposes special requirements for those plants with enhanced ability to protect themselves from pests—but only if they were developed with the more precise and predictable molecular techniques.
As a result, the cost of discovery, development, and regulatory authorization of a new trait introduced via genetic engineering between 2008 and 2012 averaged $136 million, according to Wendelyn Jones of DuPont Pioneer, a major corporation involved in crop genetics. That is far more than the costs for plants with identical traits but made with inferior genetic techniques.
A fundamental assumption in issuing those rules was that with experience their stringency would be gradually be diminished and rationalized to correspond with the actual demonstrated risk.
Over 30 years, the conjectured hazards have not materialized. The safety record of genetically engineered plants and foods derived from them is extraordinary. After the cultivation worldwide of more than 5 billion acres of genetically engineered crops (by more than 18 million farmers in about three dozen countries) and the consumption of more than 4 trillion servings of food by inhabitants of North America alone, there has not been a single ecosystem disrupted or a single confirmed tummy ache. And in the United States, genetically engineered corn, cotton, canola, soybean, alfalfa, sugar beets and papaya are major success stories.
Nevertheless, the regulatory burdens imposed by the 1986 U.S. Coordinated Framework for the Regulation of Biotechnology have never been reduced to appropriate levels commensurate with the de minimus levels of risk experienced during these 30 years. Worse, biotechnology has spawned a proliferation of technique-focused national and international regulatory regimes that seem to employ more bureaucrats to burden new technology than there are plant scientists working to enhance food security and sustainability.
While a handful of huge agribusiness companies are able to cope with and have benefitted from excessive regulation, agricultural scientists and smaller companies have become discouraged by the excessively burdensome regulatory costs. The result has been a brake on agricultural innovation, which is evident from the fact that the vast majority of acreage of genetically engineered crops is huge-volume commodity crops, while “specialty crops” such as fruits, nuts and vegetables have been largely ignored.
products of molecular genetic engineering. We need to introduce regimes that are scientifically defensible and risk-based rather than focused on the use of certain techniques. Such regimes exist in practice in other arenas and, for genetic engineering, have been described in the scientific literature.
Nevertheless, just this year Obama administration officials, in considering the need to update the 1986 Coordinated Framework, have shown a lack of understanding of the history of genetic engineering and of the regulatory issues, and they have been unwilling to undertake the necessary fundamental changes. Rather, their intention seems to be to expand the regulatory net further, still focusing on the use of newer, superior techniques.
As officials in the Trump administration reduce the regulatory burdens of the Coordinated Framework, they should also address the worldwide proliferation of unscientific regulatory approaches by other countries and international organizations. Making regulation scientifically defensible and risk-based would spur the agricultural progress and innovation needed to achieve greater food safety, security and sustainability.
Such reforms won’t come easily. Regulators develop a sense of entitlement and resist any diminution of their responsibilities, budgets and empires; and industries also often become wedded to the status quo.
But isn’t change is what “change elections” are all about?
John J. Cohrssen is an attorney who has served in a number of government posts in the Executive and Legislative Branches of the federal government, including Associate Director of President George H.W. Bush’s Council on Competitiveness and Counsel for the House Energy and Commerce Committee. Henry I. Miller, a physician, is the Robert Wesson Fellow in Scientific Philosophy and Public Policy at Stanford University’s Hoover Institution. He was the founding director of the Office of Biotechnology at the FDA and is the coauthor of “The Frankenfood Myth: How Protest and Politics Threaten the Biotech Revolution.”