This article originally ran at Forbes and has been republished here with permission of the author.
Relevant excerpt: Consumers have been shortchanged by the industry-government collusion. They have been prevented from enjoying the full potential—medical, nutritional and economic—of genetic engineering. There is a broad consensus in the scientific community that the new molecular techniques for genetic modification are extensions, or refinements, of earlier, more primitive ones, and that their use should not trigger regulatory review.
Nevertheless, the regulatory burden on the use of the newer techniques is far greater, and the opportunity costs of unnecessary regulatory delays and inflated development expenses are formidable.
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The big agribusiness companies have achieved “regulatory capture” of government agencies–but not in the way that many people think. At the urging of industry, since the 1980s federal agencies have over-regulated genetically engineered plants, animals and microorganisms–at great cost to U.S.-based R&D and, ultimately, to consumers.
It’s no secret that although the Internet has vastly enriched our lives in many respects, it has downsides—less interpersonal interaction, more anonymous snarkiness, online harassment and even cyber-stalking.
The ‘net has also made it difficult to stop or correct the promulgation of misinformation, as I have learned to my dismay: A valid observation I made to a New York Times reporter for a 2001 article on the regulation of genetic engineering has been repeatedly taken out of context and misrepresented by activists. It continues to appear anew—still out of context and misconstrued–13 years later.
Here is the portion of the original article that is often quoted on anti-genetic engineering websites (such as here and here):
Even longtime Washington hands said that the control this nascent [agbiotech] industry exerted over its own regulatory destiny—through the Environmental Protection Agency, the Agriculture Department and ultimately the Food and Drug Administration—was astonishing. “In this area, the U.S. government agencies have done exactly what big agribusiness has asked them to do and told them to do,” said Dr. Henry Miller, a senior research fellow at the Hoover Institution, who was responsible for biotechnology issues at the Food and Drug Administration from 1979 to 1994.
Sounds like a “Eureka!” moment, right? A former senior regulator revealing an egregious example of what economists call “regulatory capture”–agencies that were created to act in the public interest instead advancing the interests of the industry or sector they oversee by implementing too-lenient regulation. (Economics Nobel Laureate George Stigler developed this concept.) That’s what activists—and even some journalists who failed to do their homework—would have you believe.
That excerpt has been misrepresented to imply that companies applying the molecular techniques of genetic engineering to agriculture (the exemplar of which was, and is, Monsanto) wanted, and got, less regulatory scrutiny than was warranted, possibly putting consumers and the environment at risk.
Actually, my statement was intended to convey exactly the opposite, as was clear from verbiage in the article that preceded the passage quoted above:
Although the Reagan administration had been championing deregulation across multiple industries, Monsanto had a different idea: the company wanted its new technology, genetically modified food, to be governed by rules issued in Washington—and wanted the White House to champion the idea. “There were no products at the time,” Leonard Guarraia, a former Monsanto executive who attended the [Vice President George H.W.] Bush meeting, recalled in a recent interview. “But we bugged him for regulation. We told him that we have to be regulated.”
The genetically improved varieties that had been crafted for centuries with older, less precise, less predictable techniques of genetic modification neither needed nor received any government review or imprimatur for field trials or commercialization. But for its new varieties crafted with state-of-the art molecular techniques, the big agribusiness companies wanted sui generis regulatory requirements that would be far in excess of what scientific considerations and the principles of sound regulation dictated. And as the Times article related, “[T]he White House complied, working behind the scenes to help Monsanto—long a political power with deep connections in Washington—get the regulations that it wanted.”
And as described in the Times article, that collusion continued for years: “It was an outcome that would be repeated, again and again, through three administrations. What Monsanto wished for from Washington, Monsanto—and, by extension, the biotechnology industry—got. If the company’s strategy demanded regulations, rules favored by the industry were adopted.”
This was regulatory capture, to be sure, but not the kind that resulted in too little testing by agribusiness companies or in insufficient government oversight, as the screeds on anti-genetic engineering websites would have you believe. In fact, the industry titans with deep pockets demanded an excessively high regulatory bar that would act as a barrier to competition from start-ups.
Consumers have been shortchanged by the industry-government collusion. They have been prevented from enjoying the full potential—medical, nutritional and economic—of genetic engineering. There is a broad consensus in the scientific community that the new molecular techniques for genetic modification are extensions, or refinements, of earlier, more primitive ones, and that their use should not trigger regulatory review.
Nevertheless, the regulatory burden on the use of the newer techniques is far greater, and the opportunity costs of unnecessary regulatory delays and inflated development expenses are formidable. Billions of dollars have been squandered by the public and private sectors on complying with superfluous, redundant, unscientific regulatory requirements that have priced public sector and small-company R&D out of the business.
These inflated development costs are the primary reason that more than 99% of genetically engineered crops that are being cultivated are large-scale commodity crops–corn, cotton, canola, soy and sugar beets. Hawaiian papaya is one of the few examples of significant acreage of genetically engineered “specialty crops” such as fruits, nuts or vegetables. The once-promising sector of “biopharming,” which uses genetic engineering techniques to induce crops such as corn, tomatoes and tobacco to produce high concentrations of high-value pharmaceuticals, is moribund because of the extraordinary regulatory burdens. The once-high hopes for genetically engineered “biorational” microbial pesticides and microorganisms to clean up toxic wastes are dead and gone. Not surprisingly, few are willing to invest in the development of badly needed, genetically improved varieties of the subsistence crops grown in the developing world.
As University of California Berkeley agricultural economist David Zilberman and his colleagues observed, “The foregone benefits from these otherwise feasible production technologies are irreversible, both in the sense that past harvests have been lower than they would have been if the technology had been introduced and in the sense that yield growth is a cumulative process of which the onset has been delayed.”
During and since my government service, I have pushed hard against the unscientific policies that represent regulatory capture, arguing instead for risk-based regulation that respects the principle of proportionality, which dictates that the degree of government scrutiny of a product or activity should be proportional to the perceived risk.
Efforts by me and others to ensure that regulation is scientifically defensible and risk-based have been met with scathing personal attacks from both industry and anti-genetic engineering activists. The former resented my interference with their regulatory capture strategy, and ironically the activists call me a shill for industry. This excerpt from NPR science reporter Dan Charles’ book, “Lords of the Harvest: Biotech, Big Money, and the Future of Food,” describes how industry viewed me:
“Henry has more or less called us traitors. He gets very intense,” says [Will Carpenter, Monsanto Government Relations executive]. “He really thought he was helping us. But I told him once that I didn’t think we could stand much more of his help.”
[Monsanto’s] Guarraia is less polite. “Henry Miller,” he says grimly, “did more harm to biotechnology than [anti-science, anti-technology activist] Jeremy Rifkin ever did. He put the government completely at odds with the critics.”
Those critics, a diverse group that included Rifkin, several environmentalist groups, and a few Democratic leaders in Congress, pushed for an entirely new set of regulations for biotechnology.
That was the whole point: The government should be at odds with those who would co-opt regulation for their own benefit at the expense of the public interest.
We didn’t need new regulations; with the exception of wild berries, wild game, wild mushrooms, fish and shellfish, virtually everything in our diets had been genetically improved by one technique or another for decades or even centuries. The agencies that tortured their enabling statutes to concoct regulations specific to the newest, best, most precise and predictable technology—primarily USDA’s Animal and Plant Health Inspection Service and the EPA (as well as international organizations, such as elements of the United Nations)—have created the burdens and imposed the opportunity costs described above.
Ironically, activists seem to be unaware that their demands for more product testing and regulation actually strengthen the oligopoly of the big agribusiness companies they hate.
What are the take-home lessons from this sorry tale? First, it recalls the observation of the 18th century philosopher and economist Adam Smith, “People of the same trade seldom meet together, even for merriment and diversion, but the conversation ends in a conspiracy against the public, or in some contrivance to raise prices.”
Second, in order to counteract such conspiracies and contrivances, government officials should make decisions solely on the basis of what favors the public interest. That is, after all, their obligation in return for lifetime tenure as civil servants.
Third, Congress has failed miserably in its oversight role; it has a responsibility to be alert for and to prevent regulatory capture.
And finally, when it comes to public policy, we are best off when we let science show the way.
Henry I. Miller, a physician, is the Robert Wesson Fellow in Scientific Philosophy & Public Policy at Stanford University’s Hoover Institution. He was the founding director of the FDA’s Office of Biotechnology. Follow him on Twitter @henryimiller.
