The Biotechnology Industry's Frankensteinian Creation

The Biotechnology Industry's Frankensteinian Creation

May 01, 2001

Published in Trends in Biotechnology

Published in Trends in Biotechnology

April 2001


The past two decades have been the best and the worst of times for biotechnology applied to agriculture and food production -- stunning scientifically, dismal politically. Especially in Europe, there is widespread public and political opposition to importing gene-spliced or "genetically modified" (GM) seeds, vandalization of field trials, suspension of regulatory approvals, labeling required to identify GM foods, and even their banishment by major supermarket chains.


Big agribusiness has no one to blame but itself.

The cause of much of this adversity is ill-conceived public policy -- in particular, overregulation that singles out and discriminates against a superior new technology. Ironically, the big agribusiness companies, especially Monsanto, have no one to blame but themselves. By insisting for years that their own gene-spliced crop plants and the foods derived from them merited extraordinary government oversight, agricultural biotechnology companies elicited regulations that lessened competition and slowed the flow of products through the development pipeline. (This strategy also played into activists' scare scenarios, discouraging public acceptance of the new products.)


The companies appear not to have learned the "rule of holes," that is when you're in a hole, stop digging. In a major policy speech on November 27, 2000, Hendrik A. Verfaillie, Monsanto's new CEO, neglected to mention overregulation, let alone any (belated) commitment to seeking public policy toward biotechnology that makes scientific and common sense. Instead, he sniveled and crawled to the very radicals whose vandalism and propaganda had lopped $8.6 billion off Monsanto's market value, so weakening the company that it was sold dirt-cheap last year to the Pharmacia Corporation. He went out of his way to endorse a new Food and Drug Administration (FDA) policy that requires a burdensome premarket review of biotechnology foods, an approach that has been roundly censured by the scientific community.


A few companies requested more restrictive regulation.

In the early 1980s, a few major agrochemical-biotechnology companies led by Monsanto approached senior policy makers in the administration of President Ronald Reagan and requested more restrictive regulation, primarily from the Environmental Protection Agency (EPA), than could be justified on scientific grounds. Their motive was clear -- to use regulation as a market entry barrier to competitors, in particular, seed companies and biotechnology start-ups that were less able to bear the high costs of unnecessary regulation than other companies.


They achieved their short-term goal. The US Department of Agriculture (USDA), the FDA, and (especially) the EPA promulgated new policies that focused specifically on and discriminated against plants and microorganisms crafted with gene-splicing techniques. The regulatory policies put federal bureaucrats in the middle of virtually all field trials of GM plants during the past 15 years, spelling disaster for small businesses and especially for academic institutions, whose scientists lack the resources to comply with burdensome, unnecessary regulation. The cost of field-testing GM plants skyrocketed to as much as 20-fold higher than for virtually identical plants crafted with older, less precise genetic techniques. Limited R and D resources were siphoned away from productive research to paperwork and gratuitous field test requirements. Added production costs were a particular disadvantage to products in this competitive, low profit-margin market.


Not many of the 1980s companies still exist.

Seed companies and entrepreneurial biotechnology companies, for the most part, failed to compete successfully on this tilted playing field, and subsequently many were bought at a fraction of their true value by Monsanto, Novartis, and Dupont. During one period of only 18 months, for example, harvesting the fruits of its anticompetitive strategy, Monsanto bought up Agracetus, Ecogen, and Calgene. Few of the agriculture-related biotechnology companies launched in the 1980s exist today, in contrast to biopharmaceutical companies, for which numbers have increased steadily for a quarter century.


However, Monsanto and the few others that remain have won only a Pyrrhic victory. The overregulation that they engineered has fed the antibiotechnology mythology that has poisoned the views of consumers and emboldened regulators, particularly in Europe and Japan.


Consumers view the most regulated technologies to be the least safe.

The industry as a whole must share the blame for this strategy. Its monolithic trade association, the Washington, D.C.-based Biotechnology Industry Organization (BIO), has lobbied tirelessly for overregulation in the US and internationally for more than a decade. For example, in a 1994 letter to the FDA, BIO requested that the agency develop a special notification scheme for GM foods, even though there was no evidence that they posed any health risk, and such foods were already subject to the FDA's routine, rigorous policing of the marketplace. The agency did announce such a requirement, a repudiation of its 20-year-old commitment to regulate biotech-derived food products in a scientifically defensible and risk-based way. When the proposed change in policy was formally published in January 2001, Carl Feldbaum, the president of BIO, praised it: "The increased openness and accountability that will flow from the changes FDA announced today provide renewed grounds for the confidence American consumers have in our food supply and the regulatory system to ensure its safety." Nothing could be further from the truth. As the head of a prominent American consumer group has observed, "For obvious reasons, the consumer views the technologies that are most regulated to be the least safe ones. Heavy involvement by government, no matter how well intended, inevitably sends the wrong signals. Rather than ensuring confidence, it raises suspicion and doubt."


Industry has advocated other unscientific and even bizarre regulatory proposals, including one from the EPA to begin regulating garden and crop plants as pesticides. Under this policy, case by case regulatory review is required for even small-scale field trials of familiar, innocuous, commercially important, GM plants genetically improved to enhance their resistance to pests or disease. This proposed policy has been condemned repeatedly by dozens of scientific associations, representing more than 100,000 scientists and food professionals.


No one will be allowed to grow and test GM plants without approval.

In the international arena, Monsanto and BIO have lobbied for United Nations-based regulation of biotechnology. One result has been the disastrous Cartagena biosafety protocol, finalized in January under the auspices of the 1992 United Nations Convention on Biological Diversity. These regulations introduced a global scheme for regulation of biotechnology products that violates a cardinal principal of regulation -- namely, that the degree of scrutiny should be commensurate with risk. Under this unscientific and Draconian regulatory regime, no biologist, plant breeder, or farmer will be allowed to grow and test a GM crop or garden plant, no matter how small the test-plot, without prior, case by case approval from the UN-sanctioned bio-police. (By contrast, with rare exceptions, plants crafted with more primitive, less precise genetic techniques will continue to be subject to no government scrutiny at all, from the first tests in the field to the consumer's plate.) Paperwork, red tape, and corruption will dog the process from beginning to end, from the first seed to the store shelves, to around the world, and the regulations offer national regulators cover for decisions based solely on protectionist considerations.


Monsanto and BIO have likewise supported and participated in the work of no fewer than three panels of the Codex Alimentarius Commission, the United Nations agency concerned with international food standards. These groups are working toward holding biotechnology-derived food and food ingredients to standards that are unscientific, far beyond those that any other products can or should meet, and that will prevent their competing successfully in the marketplace.


Agricultural biotechnology holds tremendous potential.

Agricultural biotechnology holds tremendous potential benefits for the world's consumers and farmers. Products will continue to emerge in the marketplace but at a disturbingly low rate because of regulatory barriers. Under current circumstances, the commercialization of agricultural-biotechnology products will be limited primarily to commodity crops grown at vast scale, at the expense of opportunities to improve important small-acreage crops. For example, innovation will seldom target improvement of the genetics of environmentally threatened but low-value-added species, such as trees, or of subsistence crops, such as millet, cassava and yams.


The potential market for GM plants and foods derived from them is being undermined and distorted by overregulation and public antagonism. Ironically, both are the industry's own Frankensteinian creation.


Henry I. Miller is a fellow at the Hoover Institution at Stanford University and the Competitive Enterprise Institute.