Prescription Rice

In his classic <em>Japanese Cooking: A Simple Art</em>, Shizuo Tsuji sings the praises of one of the world’s staples: “Rice is a beautiful food. It is beautiful when it grows—precision rows of sparkling green stalks shooting up to reach the hot summer sun. It is beautiful when harvested, autumn gold sheaves piled in diked, patchwork paddies. It is beautiful when, once threshed, it enters granary bins like a cataract of tiny seed-pearls. It is beautiful when cooked by a practiced hand, pure white and sweetly fragrant.”
Farmers in California’s flat, hazy rice fields have worked for years to realize this vision, spending millions of dollars and refining standards in an effort to please the demanding Japanese palate and gain a toehold in its lucrative market. And it’s beginning to work: roughly 40 percent of the rice grown in California goes to Japan.  Climate and soil conditions in the Sacramento Valley provide an ideal environment for growing the premium rice desired in Japan, but trade barriers and prejudices against foreign rice have not been easily overcome. Just in the past few years California’s rice has finally earned some respect in Japan and other finicky Asian markets, and last year’s crop could achieve the best return for farmers in the state’s history. But now California farmers worry that the purity of their rice, its hard-won status, and their own livelihood may become casualties of the global debate on genetic modification.
At issue is a new kind of rice—a new kind of farm crop, in fact—that is genetically engineered to produce pharmaceuticals. Using the same recombinant DNA techniques that have created GE foods, biotechnology companies are now making plants like rice, corn, and tobacco into “factories” for producing medically useful compounds. Plants with altered genes are grown like normal crops, in a field or greenhouse, and then are processed and refined after harvesting. The purified products of these novel “pharm” crops can be vaccines, antibodies, or proteins for use in drugs. But critics worry that “pharming” poses the threat of contamination to non-GE food crops, through seed mixing or pollen drift.
Over the past few months, a small Sacramento-based biotechnology company’s aim to expand its experimental crop of pharmaceutical rice has caused a shake-up in the normally hermetic California rice industry. In October of last year, Ventria BioScience petitioned the California Rice Commission (CRC) for permission to grow 120 acres of two varieties of rice engineered to produce artificial versions of two human proteins—lysozyme and lactoferrin—which occur naturally in breast milk and tears. Founded in 1993, Ventria has planted small research plots in Northern California since 1997 with US Department of Agriculture approval, but its bid to expand production brought the company and the Sacramento Valley a flurry of national media attention: this would be the first time in the nation that such crops were grown on a commercial scale. It’s possible that Ventria’s expansion might have passed unnoticed with other crops, but the CRC retains a measure of control over the planting of any new rice variety. Ventria’s plans were subject to state approval, first by a CRC advisory board, then by the state agriculture secretary.
Ventria’s petition set off a review process. Under a 2000 law called the Rice Certification Act, the CRC board is charged with creating growing and processing restrictions for rice varieties of “commercial impact,” but the board cannot stop any specific variety from being grown, no matter how controversial. Eventually the company agreed to plant commercially only in ten Southern California counties, each more than 100 miles from the nearest food rice farm. Some farmers were not appeased.
“One little slip. One slip, that’s all it’s gonna take. If there’s a mistake, the farmer is going to pay—big time,” rice farmer Joe Carrancho told the CRC advisory board as it prepared to vote on Ventria’s protocol in late March. In work boots and dusty blue overalls, Carrancho held up a chart showing 100 percent opposition to GMO wheat from Japanese consumers. “We are fearful,” he said.
Despite the concerns voiced by environmental and advocacy groups, the state-appointed advisory board voted six to five in favor of an emergency approval—speeding up a normal four-month review and public comment process into ten days—so that Ventria might obtain approval in time for spring planting. By this point, news of Ventria’s  intentions had gotten out, and opponents flooded the  California Department of Food and Agriculture (CDFA) with complaints, including a petition signed by 70 farmers. Still, says Greg Massa, one of the rice farmers who led the fight against  Ventria’s plans,  “We were not  optimistic.”
As farmers awaited word on a decision, the Japan Rice Retailers’ Association sent a letter to the CDFA and the CRC that validated many growers’ concerns. “From the viewpoint of the rice wholesalers and retailers in Japan,” it read, “it is certain that the commercialization of GM rice in the US will evoke a distrust of the US rice as a whole among Japanese consumers, since we think it is practically impossible to guarantee no GM rice contamination in non-GM US rice… If the GM rice is actually commercialized in the US, we shall strongly request the Japanese government to take necessary measures not to import any California rice to Japan.”
Soon after the release of the Japanese statement, the CDFA rejected the request for emergency processing, sending Ventria’s proposal back to the CRC for further clarification—much to the relief of farmers and activists. Ventria’s proposal now faces a lengthier review process and further negotiations with the rice commission, and, critically, a stall in the process. As a result of all the legal wrangling, it’s likely that Ventria will miss the seasonal window for planting in California this year.
But the controversy over pharma rice is far from over. Ventria may still gain state approval to grow its crop commercially in the next few months or next year, and as soon as the company obtains a 2004 federal permit, it can continue to sow research plots in undisclosed locations in Northern California. But California’s rice farmers consider themselves lucky: It’s only because of strict government regulation over the California state rice industry that Ventria must vet its plans at the state level at all. Midwestern farmers have little or no chance to comment on pharming that might be happening next door.
“I think it was a victory, but it’s just one step in the whole war,” says Massa. “Farmers need help on this GMO issue because we’re fighting the big battles with some fairly major corporations and they have a lot of money and a lot of power and the only way we can beat them is public outcry.”

Until now, this new generation of GMOs has flown under the public’s radar. The “plant-made pharmaceutical” industry, which has been gathering steam since the early 1990s, has kept out of the spotlight so far partly because pharm crops are still in field- test phase. Field tests generally involve only a few acres at a time—in 2002, the entire biotech industry planted only 130 acres of pharmaceutical crops. As for the products of these crops, none has received approval for human consumption from the US Food and Drug Administration. According to Lisa Dry, a spokesperson for the Biotechnology Industry  Organization, the industry is “in its infancy.”
Each pharm crop requires a yearly federal permit from APHIS (USDA’s Animal and Plant Health Inspection Service). In the application, companies must describe planting and harvesting strategies, explaining how they’ll prevent contamination of the food supply. But most of that information is withheld from the public as “confidential business information,” which can make it difficult for outside experts to review the safety of specific procedures. In Ventria’s case, local rice farmers don’t know where the company’s research plots are, despite the fact that its rice has been grown in the Sacramento Valley since 1997. “They were quite secretive about what they’re doing and where they’re doing it,” says Bryce Lundberg, an organic rice grower .
In the end, it took a band of environmental activists to blow Ventria’s cover. In 2001, a Greenpeace researcher discovered a test field of Ventria’s rice in the Sacramento Valley’s Sutter County. Donning biohazard suits, Greenpeace activists protested the Ventria plots with huge dummy  syringes and banners declaring “This Rice is a Drug.”
Criticism also came from more conservative quarters. In February 2002, the National Academy of Sciences issued a report calling for regulatory reform, suggesting a detailed review of the potential environmental effects of transgenic plants and broader public and scientific involvement in the USDA approval process. In July 2002, the anti-GMO advocacy group Genetically Engineered Food Alert issued a comprehensive report on pharming, which advocated a ban on open-air pharmaceutical crops. The report warned of a StarLink-like contamination of the food supply—a reference to the 2000 incident in which GE corn that had not been approved for human consumption was found in taco shells.
In October 2002, those fears were validated. In a Nebraska field, APHIS inspectors discovered that biotech company ProdiGene had failed to remove volunteer pharma corn plants from a crop of conventionally grown soybeans. In violation of APHIS’ regulations, the company had planted soybeans on land where an experimental plot of corn engineered to produce a pig vaccine grew the year before. When corn seeds remaining in the soil sprouted up among the soy, the field was harvested anyway, despite a directive from APHIS to the contrary, and the beans were sent to storage with the pharma corn mixed in. ProdiGene was fined and forced to buy back more than a half-million bushels of the contaminated soy at a cost of close to $3 million.
After the ProdiGene incident, the USDA tightened the reins on growing conditions for pharmaceutical crops. In January 2004, Agriculture Secretary Ann Veneman announced the Department’s intention to overhaul its biotech regulations and develop a comprehensive environmental impact statement—a process that may take many months. Complicating the regulatory web further, the FDA has not issued any decision on how plant-made pharmaceuticals will be regulated as drugs. “The regulatory system is playing catch-up to an industry that’s moving forward without proper oversight,” says Greg Jaffe of the Center for Science in the Public Interest.
A lot of the debate boils down to whether food and feed crops should be used as pharmaceutical “factories.” A number of mainstream food processing and manufacturing organizations have publicly called for stricter regulation of pharma crops. Even Nature Biotechnology, an industry research journal, criticized biotech companies for not being “sensible” about the use of food crops. The magazine’s  February 2004 editorial suggested a way to prevent an  impending controversy: “Simply don’t use food plants for producing drugs. Why not? Precisely because they are  food plants.”
Ventria officials have kept largely silent on the controversy (calls to the company were not returned), but CEO Scott Deeter gave one explanation for his company’s determination to grow pharmaceuticals in food crops before a USDA advisory committee in June 2003. “We know a lot about the biology of rice,” he said. “Grains have a natural protein storage mechanism,” and are “highly scalable,” making them much more affordable than current fermentation methods of producing pharmaceutical proteins, which can cost hundreds of millions of dollars. The two proteins Ventria is developing could help treat the “more than 3.8 million children under five that die every year due to respiratory infection and diarrheal disease.” Reducing the price tag for those proteins by as much as 90 percent, the company seeks to bring “low-cost solutions” to developing countries. “We’re solving world problems,” says Deeter. “We want to save two million kids a year. That’s what gets us out of bed in the morning.”
But Bill Freese, a research analyst for Friends of the Earth, says there’s no evidence to show that plant-made pharmaceutical proteins are safe, especially for children, who experience higher levels of allergic reactions. Naturally occurring human forms of lactoferrin and lysozyme together can kill bacteria, but the pharma versions, says Freese, “aren’t human proteins.” Critics also question how Ventria’s proteins will be delivered, especially considering that the FDA hasn’t made a decision on how such plant-made drug products will be regulated. Ventria may seek to deliver its product as a “medical food,” another largely unregulated category. Press accounts have also mentioned potential marketing of Ventria’s proteins as nutritional supplements, which undergo far less scrutiny from the FDA than drugs but can’t carry the same health claims on the label.
Deeter has said that he hopes to see his products on the market by 2006, but that doesn’t mean they’ll be grown in California. The state regulatory process has been a challenge, and Deeter told the Sacramento Business Journal that the company is looking elsewhere, even in South America, for permanent production and research facilities.
Should Ventria pack up shop, that may silence some of its California critics, but not all. There is no field for pharma crops far enough away to suit Massa: “Drugs, chemicals, plastics—whatever they come up with—should not be grown in a food crop.”

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