Viewpoint: USDA’s ‘zombie’ biotech regulation will not die

This article originally ran at Forbes and has been republished here with permission of the author.

The “corporate culture” at USDA toward the regulation of genetically engineered plants is unscientific, self-interested and inimical to progress in agriculture. For almost 30 years, it has prevented American plant biologists and breeders from creating the Next Big Thing.  And there’s no improvement on the horizon.

The development of a positive “corporate culture” is important, whether the organization is in the private sector or part of the government.  We’ve seen recently that the culture of government organizations such as the IRS, EPA, Department of Justice and National Labor Relations Board–all of which have demonstrated a willingness to become highly politicized–leaves much to be desired.

The creation of a good organizational culture is no accident. The culture of Quicken Loans, which was rated by J.D. Power and Associates highest in customer satisfaction among originators of mortgage for the fifth straight year in 2014, is a case in point.  As CEO Bill Emerson explained about their commitment to customer service in a New York Times interview,

If you don’t create a culture at your company, a culture will create itself. And it won’t be good. I sometimes hear people say, “We don’t have a culture at our company.” They have one. But if it hasn’t been nurtured, if no one has spent on any time on it, you can assume it’s the wrong culture.

Certain regulatory agencies unquestionably have developed the “wrong culture” for their clients–regulated industry and American taxpayers–because they are excessively burdensome, short on competence, and based on principles like, “We’ve always done it this way,” and “How can we protect our perks?” instead of, “This is the way that science, the law and common sense dictate.”

A culture of excess, damn-the-public-interest regulation is anything but small potatoes: According to the “Ten Thousand Commandments” report on regulatory costs from Wayne Crews of the Competitive Enterprise Institute, the aggregate costs for Americans to comply with federal regulations in 2012 were $1.806 trillion, which amounts to $14,678 per family, or 23 percent of the average household income of $63,685.

Regulatory reform could boost the economy in ways that not only don’t require federal spending but actually reduce it, to say nothing of the indirect benefits. With relatively moderate changes in policy we could lighten the drag caused by excessive, unscientific regulation, encourage businesses and investors to get back into the game, and give consumers more disposable income.

The regulation of genetically engineered plants by USDA’s Animal and Plant Health Inspection Service (APHIS) is a case in point.  Its approach is unscientific, unwise, wasteful and anti-competitive, but it survives in part because of APHIS’s culture: Its bureaucrats are not motivated to institute changes that will diminish the agency’s responsibilities or budget, and in any case few have been around long enough to recall the dubious origins of their own regulatory approach.

In fact, USDA’s approach is an anomaly that should never have happened. In 1986 the White House Office of Science and Technology Policy published a policy statement that focused oversight and regulatory triggers on the risk-related characteristics of products, such as plants’ weediness or toxicity, rather than on the process used for genetic modification. This approach was reaffirmed in a 1992 policy statement that set forth the overarching principle for regulation: The degree and intrusiveness of oversight “should be based on the risk posed by the introduction and should not turn on the fact that an organism has been modified by a particular process or technique.”

Thus, it reflected the broad consensus in the scientific community that there is a seamless continuum of methods for genetic modification, and the newest techniques are essentially an extension, or refinement, of older, less precise and less predictable ones.

But intent on building a new (and wholly superfluous) regulatory empire, USDA heeded neither the consensus of the scientific community nor the directives from the White House. The resulting stultifying regulation has inhibited research and development, particularly in public institutions, ever since.

APHIS had long regulated the importation and interstate movement of organisms (plants, bacteria, fungi, viruses, etc.) that are plant pests, which were defined by means of an inclusive list–essentially a “thumbs up or down” approach. A plant that an investigator might wish to introduce into the field is either on the inclusive, prohibited list of plants pests—and therefore requires a permit—or it’s exempt.

This straightforward approach is risk-based, in that the organisms required to undergo case-by-case governmental review are an enhanced-risk group—organisms that can injure or damage plants—compared to organisms not considered to be plant pests. But for more than a quarter-century, this risk-based USDA regulation has had an evil twin–a parallel regime focused exclusively on plants altered or produced with the most precise genetic engineering techniques. USDA tortured the original concept of a plant pest as something known to be harmful and crafted a new, jury-rigged category: a “regulated article,” defined in a way that captures virtually every new genetically engineered plant for case by-case review, regardless of its potential risk.

In order to perform a field trial with a regulated article, a researcher must apply to USDA and submit extensive paperwork before, during and after the field trial. After conducting field trials for a number of years at many sites, the developer then submits a vast amount of data and requests “deregulation” by USDA, which is equivalent to approval for unconditional release. These requirements make genetically engineered plants extraordinarily expensive to develop and test: the cost of discovery, development and regulatory authorization of a new trait introduced between 2008 and 2012 averaged $136 million, according to Wendelyn Jones of DuPont Pioneer.

USDA’s discriminatory treatment of genetically engineered plants makes no sense.  Plants have long been selected by nature and bred by humans or irradiated to create mutants with enhanced resistance or tolerance to external threats–insects, disease organisms, herbicides and environmental stresses–to their survival and productivity. They have also been modified for other qualities. For example, primitive wheat breeders crafted durum (hard) wheat for pasta and softer varieties for cakes. Plant breeders have learned from experience about the need for risk analysis, assessment and management.  New varieties of plants (whichever techniques are used to craft them) that normally harbor relatively high levels of toxins— such as celery, squash and potatoes— are analyzed carefully to make sure that levels of potentially harmful substances are still in the safe range.

Related article:  Enlist Duo: Everything you need to know about new dual herbicide resistant crops

Similar things should be regulated similarly, and the degree of oversight should be proportionate to the perceived risk of the genetically engineered plant, which is a function of certain characteristics of the host plant (weediness, toxicity, ability to outcross, etc.) and the introduced gene. It is not the source or the method used to introduce a gene but its function that’s important. But for decades, plants made with the newest, most precise techniques have been subjected to the most regulation, independent of risk.

There are alternatives to this unscientific, process-based regulation that are both more scientific and more logical. One has, in fact, been enshrined in federal regulations for more than two decades: the FDA’s approach to “Foods Derived from New Plant Varieties” foods. Published in 1992, it emphasizes that the agency’s Center for Food Safety and Nutrition does not impose discriminatory regulation based on the use of one technique or another, and that greater scrutiny is applied only when certain safety- or nutrition-related issues are raised.

Another valid, risk-based approach is described in the handbook, Biosafety in Microbiological and Biomedical Laboratories from the National Institutes of Health and the Centers for Disease Control and Prevention. It specifies the procedures and physical containment that are appropriate for research with microorganisms, including the most dangerous pathogens known. These microorganisms were stratified into risk categories by panels of expert scientists. The NIH/CDC approach was adapted to field trials of plants by a group of Stanford University academics (including this author) and described in a 1997 peer-reviewed article in the journal Nature Biotechnology.

Howard Shelanski, President Obama’s regulatory czar (aka the director of OMB’s Office of Information and Regulatory Affairs) said in 2013, “Some regulations that were well crafted when first issued can become unnecessary over time as conditions change—and regulations that aren’t providing real benefits to society need to be streamlined, modified, or repealed.” Well, USDA’s regulation of genetically engineered plants was flawed from the beginning, almost 30 years ago, so it’s way past time for a change. But there is little impetus from any quarter to rationalize APHIS’s flawed paradigm. Industry hasn’t demanded it; few USDA bureaucrats have either the smarts or the institutional memory to appreciate that their approach owes more to politics than science, and that it is detrimental to advances in agriculture; and congressional oversight is effectively nonexistent.

One of the stated goals of a study currently underway by the National Research Council–“review the scientific foundation of current environmental and food safety assessments for GE crops and foods and their accompanying technologies, as well as evidence of the need for and potential value of additional tests”–might have addressed unscientific and technique-based regulation, but the composition of the panel and the mandate are clear indications that “the fix is in”; the probability that this group will address unscientific and excessive regulation is zero.  (This wouldn’t be the first example of NRC malfeasance on this subject.)

Except for the chairman, only one of the members of the panel, Michael Rodemeyer, has significant familiarity with the long history of public policy surrounding genetic engineering in agriculture–and he has a decades-long anti-biotechnology bias. Inexplicably, none of the deeply knowledgeable and eminent members of the National Academy of Sciences who participated in the groundbreaking 1987 and 1989 studies were appointed to this panel.

Let us return to culture: Regulators have a finely honed sense of inertia and also routinely put their own self-interest–more responsibilities, grander bureaucratic empires and bigger budgets–ahead of the public interest. According to a 2007 report by the Government Accountability Office, the congressional research and auditing agency, when bureaucrats conduct reviews, they usually conclude that the current rules should be kept. (That’s hardly a surprise: You might as well try to take a hambone from a pit bull.)

Although USDA bureaucrats are implementing a kind of “zombie regulation”– that was (scientifically) dead-on-arrival since its inception but lives on to inhibit innovation–they do not want regulatory reform and are actually resisting Executive Orders that require it. For example, Executive Order 13563, “Improving Regulation and Regulatory Review,” which was issued in 2011 with great fanfare by the Obama administration, states: “Our regulatory system must protect public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation. It must be based on the best available science. It must allow for public participation and an open exchange of ideas. It must promote predictability and reduce uncertainty.”

Even more relevant is 2012 Executive Order 13610, “Identifying and Reducing Regulatory Burdens,” which directs Federal agencies to “conduct retrospective analyses of existing rules to examine whether they remain justified and whether they should be modified or streamlined in light of changed circumstances, including the availability of new technologies.”

These executive orders provide a basis for reviewing and revising department’s regulation of genetic engineering, especially in light of this qualifier: “Executive Order 13610 directs Federal agencies to give priority, consistent with law, to those initiatives that will produce significant quantifiable monetary savings or significant quantifiable reductions in paperwork burdens while protecting public health, welfare, safety, and the environment.”

But the USDA bureaucrats are leaving nothing to chance. They consistently load their Advisory Committee on Biotechnology and 21st Century Agriculture with dedicated anti-biotechnology ideologues who not only oppose regulatory reform but would prefer to regulate genetic engineering out of existence entirely. Moreover, the government lifers expect to outlast short-term political appointees, and they have become adept at digging in their heels.

Changes for the better in the massive federal bureaucracy are elusive because as columnist George Will put it, “swollen government has a shriveled brain.”

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.

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