The birth of GMO rules

Process-based rules or product-based rules

Trends in acreage planted with GM varieties

Effect of safety regulation on market and research characteristics

(modified from: Nina V. Fedoroff and Nancy Marie Brown - Mendel in the kitchen - The National Academies Press, 2004)

GMO rules and no GMO rules

Any crop modified using molecular techniques—and only those crops—must be scrutinized by government agencies. The crop is evaluated as a potential toxic substance, pesticide, or plant pest, and sometimes as a food additive as well (examples: EN1, EN2, EN3).

In view of humankind’s long history of tinkering with food plants, this state of affairs is very odd. Over the last century breeders have learned to churn up plant genomes in many new ways. They cross plants from different species and even different genera. They use tissue culture, chemicals, and radiation to make mutants—plants that might be more resistant to drought, disease, and pests, or that might provide more or tastier food than the unmutated variety. Their techniques have become increasingly complex, and increasingly invasive.

For example, in 1979 Shivcharan S. Maan of Fargo, North Dakota, received United States Patent No. 4,143,486. “The invention,” wrote Maan, “satisfies the long felt need for a relatively simple, commercially feasible method of producing hybrid wheat seeds.” Maan’s method begins with a single cell from the weed Aegilops squarrosa, or goat grass, one of the ancestors of modern wheat. First the nucleus of the cell is removed and discarded. Then a new nucleus, taken out of a cell of bread wheat, Triticum aestivum, is inserted into the goat grass cell. This alloplasmic wheat cell is grown, using tissue culture techniques, into a mature plant, and the seed is harvested. This seed is then exposed to radiation or soaked in a mutagenic chemical. In the example included in his patent, Maan notes that 500 seeds from plants having A. squarrosa cytoplasm and a T. aestivum nucleus were exposed to a mutagenic chemical for 16 hours before being planted in a greenhouse. The seed spikes of the mature plants were covered with plastic bags so that the plants would self-pollinate. “The 45,000 seeds obtained from self-pollination were harvested and planted in the field.” Maan and his colleagues did not know what types of mutations the chemical treatment might have caused. To learn, they grew the plants to maturity and “visually examined” them for “abnormalities,” choosing the 39 plants that could not make pollen to include in further breeding. The thousands of others they simply plowed under.

No federal agency checked to see if these plants were toxic or allergenic. No federal agency needed to be asked before the plants could leave the greenhouse. No federal agency needed to approve the scale-up of the field tests.

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The birth of GMO rules

The rules for field-testing of GM plants were based on outsized fears that crop plants modified using molecular techniques were somehow new and might be dangerous. Those fears date from the early days of recombinant DNA. By 1972 DNA from almost any source could be cloned in bacterial cells by recombining it with plasmid DNA. Some scientists—among them Paul Berg, who would later receive the Nobel Prize for his pioneering recombinant DNA work—began to worry that, by using these techniques, researchers might unwittingly create a new human pathogen. If it escaped from the laboratory, it could never be recalled. By 1974 Berg and other prominent molecular biologists, wrote a letter to the National Academy of Sciences and published it in Science magazine. It was titled: “Potential biohazards of recombinant DNA molecules.”

This self-organized group of concerned scientists formulated four goals: to institute a moratorium on recombinant DNA research, to address public fears about creating new genes, to consider what would happen if such genes got out of the laboratory, and to ask the director of the National Institutes of Health, Robert Stone, to assemble a committee that would write guidelines, carry out risk assessment, and convene an international group of scientific leaders to discuss the guidelines.

The National Institutes of Health (NIH) established an Office of Recombinant DNA Activities and began converting the Asilomar framework into what would become the NIH Guidelines for Recombinant DNA Research. The first version was issued in June 1976. Fredrickson, director of the NIH, was clear that the guidelines were not regulations. Because they addressed hypothetical, not known, hazards they would evolve as knowledge accumulated and experience grew.

Not unexpectedly, many in the federal government and in communities around the country disagreed. They began to clamor for laws to regulate recombinant DNA research. But laws are difficult to undo. The research might prove quite harmless. If it did, laws would impose unnecessary restrictions, interfering with the development of much-needed new pharmaceutical products, such as human insulin, interferon, tissue plasminogen activator, and hepatitis B vaccine. NIH urged President Gerald Ford to extend the NIH guidelines to all federal and private research. After some delay, the directive was issued in September 1976, and the Federal Interagency Committee on Recombinant DNA Research was formed to look at the regulatory authorities of each agency and to see whether new laws were really necessary. Efforts to pass laws did not stop. Over the next several years, 12 bills to regulate DNA research were introduced in Congress; none was passed.

Until, the first “release into the environment” (the field test) of a GMO (a common bacterium, Pseudomonas syringae) was approved by NIH. The picture of the researcher who was conducting the field test, wearing a full-body white coverall, with helmet and breathing apparatus (because of state regulations) became an icon for protesters against recombinant DNA technology. The NIH was reprimanded by a federal court for approving the release without filing a formal environmental assessment, and in early 1984 a Cabinet Council Working Group was formed to bring the federal agencies’ representatives together to work out the regulatory issues. It proposed a Coordinated Framework for the Regulation of Biotechnology, published in 1986. And today, in USA as in Europe, the GMO creation and production is regulated by laws (for USA: USDA, EPA, FDA; for EU: EN4, ES1, F1, I1; see also: EN5).

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Process-based rules or product-based rules

The point is that, with these laws, all the familiar crop plants—corn, wheat, rice, cotton—long subjected to a variety of genetic manipulations came under the regulatory purview of government agencies, but only if the genetic technique used to modify them was molecular.

This process-based definition makes no biological sense. As the Council of the National Academy of Sciences pointed out in a 1987 publication, it sets one kind of genetic modification apart from all those that breeders have used for decades. The Council had asked a small group of experts in molecular techniques, ecology, evolution, and plant pathology to examine the various kinds of environmental and health problems that might arise from modifying plants, animals, and microorganisms by recombinant DNA (R-DNA) techniques. The committee reported that the many thousands of plants that had been made using these methods had not revealed unexpected hazards. Indeed, the problems were familiar ones. They were the same as the problems of plants modified by the many other genetic techniques in use. The committee concluded: “Assessment of the risks of introducing R-DNA-engineered organisms into the environment should be based on the nature of the organism and the environment into which it is introduced, not on the method by which it was produced.”

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Trends in acreage planted with GM varieties

As tracked by the International Service for the Acquisition of Agri-biotech Applications (or ISAAA), the genetically modified food grown in 2002 by more than 5 million farmers on 145 million acres in 16 countries worldwide is the product of five large, multinational corporations: Aventis, BASF, DuPont, Monsanto, and Syngenta. Some 90 percent of the market is Monsanto’s alone (see also: List of Completed Consultations on Bioengineered Foods; for the GMO products authorised in EU: EN6).

The 145 million acres (more than 95 million acres in the U.S.) are planted in varieties of soy, canola, cotton, and corn that can tolerate an herbicide (the list includes the glyphosate in Roundup; the glufosinate in Basta, Challenge, Rely, and Finale; and the sethoxydim in Poast) or that make their own Bt pesticide, a crystalline protein from the bacterium Bacillus thuringiensis. Two crops (cotton and corn) can do both. The world leader, with 62 percent of the area farmed, is herbicide-tolerant soy.

Because of their market predominance, Bt corn and Roundup Ready soy, canola, and cotton, all sold by Monsanto, have come to mean GM or GMO in the minds of most protestors against genetically modified foods. Monsanto has been dubbed “Monsatan” by activists in the United Kingdom and has become a scapegoat for the industry.

Seeds of new GM varieties bought from seed companies cost more than those not modified by molecular techniques. Farmers must agree not to save seeds for replanting the next year. Most farmers do not save seeds of corn, soy, canola, or cotton anyway. The practice hasn’t been common in America since the 1930s, because saved seeds often transmit diseases. But the idea of signing a contract to that effect rubs some farmers the wrong way.

Despite the high costs and the contracts, the acreage planted in GM varieties of corn, soy, canola, and cotton continues to grow. From 2001 to 2002 it increased about 10 percent in the U.S., 12 percent worldwide. The reason, according to one analyst, is that farmers found genetically modified seeds “an attractive commercial option. Farmers planting herbicide-tolerant GM soybeans in the United States, for example, could gain roughly $6 per acre in reduced herbicide costs, despite technology fees and no change in yields.”

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Effect of safety regulation on market and research characteristics

Farmers have not been uniformly satisfied, as with any new technology. Some have run afoul of the intellectual property rules. By saving or selling seed, or even by failing to weed out those seeds that escaped the harvest and sprouted as volunteers the next season, they can bring on Monsanto’s private investigators (clued in via the company’s toll-free tip line by a law-abiding neighbor). As with teenagers nabbed for pirating music over the Internet, the farmers caught tend to expostulate loudly about freedom. Monsanto, like the rock stars who object to their music being “shared” without royalties being paid, comes off looking like a bully.

Protesters have picked up on these intellectual property disagreements between multinational companies and family farmers to argue that genetic engineering will give control of our seed—our food—to heartless corporations. Sometimes the behaviour of these corporations is disinterested: some genetically engineered crops—like the virus-resistant papaya—were designed specifically to solve the problems of small, family farmers. They make no profit for Monsanto, even though Monsanto controls the patent on the coat protein technology; it was donated. The fact that there are so few of these kinds of genetically modified crops is not the result of any failure in the technology. According to many scientists, the reason a handful of companies dominates the market is the cost of complying with federal regulations.

Ingo Potrykus, the creator of the Golden Rice, noted in 2003 that activists have “not completely unjustified concerns that big companies might dominate the seed markets and food production. But this has nothing to do with the technology,” he said. “If following the regulations were easier, small companies could come up with comparable products. I very much dislike this concentration process,” he added, referring to the fact that the vast majority of genetically modified crops being grown were developed by large profit-making companies and not by universities or nonprofit agricultural research institutes. “The opposition is against it, too,” Potrykus continued, “but they are the cause of it. They’re the ones who have made it so expensive.”

To Roger Beachy the regulations are “so impositional that we are really working hard to exclude the public sector, the academic community, from using their skills to improve crops.” Noting that the number of field trials run by universities has greatly decreased since 2000, he said, “It’s not surprising, because the cost of product development is so high that there is little chance that an academic research team can develop new varieties for commercial release.” And it is the universities, the academic researchers, who have historically made a point of breeding local varieties, like the Hawaiian papayas, that are meant to benefit small farms.

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