USDA Backs Production of Rice With Human Genes

By Rick Weiss
Washington Post
March 2, 2007

The Agriculture Department has given a preliminary green light for the first commercial production of a food crop engineered to contain human genes, reigniting fears that biomedically potent substances in high-tech plants could escape and turn up in other foods.

The plan, confirmed yesterday by the California biotechnology company leading the effort, calls for large-scale cultivation in Kansas of rice that produces human immune system proteins in its seeds.

The proteins are to be extracted for use as an anti-diarrhea medicine and might be added to health foods such as yogurt and granola bars.

"We can really help children with diarrhea get better faster. That is the idea," said Scott E. Deeter, president and chief executive of Sacramento-based Ventria Bioscience, emphasizing that a host of protections should keep the engineered plants and their seeds from escaping into surrounding fields.

But critics are assailing the effort, saying gene-altered plants inevitably migrate out of their home plots. In this case, they said, that could result in pharmacologically active proteins showing up in the food of unsuspecting consumers.

Although the proteins are not inherently dangerous, there would be little control over the doses people might get exposed to, and some might be allergic to the proteins, said Jane Rissler of the Union of Concerned Scientists, a science policy advocacy group.

"This is not a product that everyone would want to consume," Rissler said, adding that other companies grow such plants indoors or in vats. "It is unwise to produce drugs in plants outdoors."

Consumer advocacy groups, including Consumers Union and the Washington-based Center for Food Safety, have also opposed Ventria's plans. "We definitely have big concerns," said Joseph Mendelson, the center's legal director.

Ventria has developed three varieties of rice, each endowed with a different human gene that makes the plants produce one of three human proteins. Two of them -- lactoferrin and lysozyme -- are bacteria-fighting compounds found in breast milk and saliva.

A recent company-sponsored study done in Peru concluded that children with severe diarrhea recovered a day and a half faster if the salty fluids they were prescribed were spiked with the proteins.

Deeter said production in plants is far cheaper than other methods, which should help make the therapy affordable in the developing world, where severe diarrhea kills 2 million children each year.

"Plants are phenomenal factories," Deeter said. "Our raw materials are the sun, soil and water."

The company is also talking to the Food and Drug Administration about putting the proteins into health foods. Its third variety of rice makes serum albumin, a blood protein used in medical therapies.

Until now, plants with human genes have been restricted to small test plots. In October, Ventria sought permission to grow its rice commercially on as many as 3,200 acres in Geary County, Kan., starting with 450 acres this spring.

A previous plan to grow the rice in southern Missouri was dropped when beermaker Anheuser-Busch -- the nation's largest rice buyer, which has expressed concern about the safety and consumer acceptance of gene-altered rice -- threatened to stop buying rice from the state if the deal went through.

Because no other rice is grown in Kansas and because rice can only grow in flooded areas, the risk of escape or cross-fertilization with other rice plants is nil there, Deeter said. The company will mill virtually all the seeds on site -- using dedicated equipment -- to minimize the risk of seeds getting mistakenly released or sold.

On Wednesday, the Agriculture Department published its draft environmental assessment, which concluded that the project posed no undue risks. The public can comment until March 30.

Also on Wednesday, the agency revealed that a type of rice seed in Arkansas had become contaminated with a different variety of genetically engineered rice, LL62, that was never released for marketing. The error was discovered in the course of an ongoing investigation into the widespread contamination of U.S. rice by yet another gene-altered variety, LL601, which has seriously disrupted rice exports.

Those problems, along with the previous discovery of unapproved, gene-altered StarLink corn in food and the accidental release of crops that had been engineered to make a vaccine for pig diarrhea, undermine the USDA's credibility, critics said.

"USDA's record is not good," Rissler said, pointing to several recent court judgments against the department and a December 2005 inspector general report that savaged the department for its poor oversight of biotechnology. "We don't think they can enforce even the inadequate system that is in place."

USDA OKs Plan to Grow Modified Rice

By Sam Hananel
Associated Press
March 2, 2007

WASHINGTON - The Department of Agriculture has granted preliminary approval for a large-scale plan to grow genetically altered rice in Kansas, prompting some critics to raise safety concerns.

Sacramento, Calif.-based Ventria Bioscience wants to grow rice modified to produce human proteins on more than 3,000 acres of farmland near Junction City, Kan.

The pharmaceutical rice would be harvested and refined for use in medicines to fight diarrhea, dehydration and other illnesses that kill millions of infants and toddlers each year.

While Kansas officials have embraced the project as a boon to the state's emerging biosciences industry, environmentalists and some food groups warn the proteins could find their way into the food chain, causing medical reactions or allergies.

"We're opposed to the production of pharmaceutical and industrial chemicals in food crops grown outdoors because we think there are too many ways contamination of the food supply could occur," said Karen Perry Stillerman, senior analyst at the Union of Concerned Scientists, a science advocacy group.

The USDA released a draft environmental assessment on Wednesday that concluded planting the rice poses virtually no risk. No commercial rice is grown in Kansas and Ventria will use dedicated equipment, storage and processing facilities to prevent seeds from mixing with other crops, the USDA said. The rice will be milled on site.

"We have a product here that can help children get better faster," said Ventria president and CEO Scott Deeter. He said any concerns are "based on perception, not reality" given all the precautions the company is taking.

"It's a dedicated supply chain all throughout the process," Deeter said.

But Stillerman said weather events, like tornadoes, could carry seeds into other fields where contamination could occur. She also cited the possibility of human error in transporting and handling the rice.

Genetically modified crops are regulated by the USDA. State governments can review safety procedures and suggest more stringent regulation of the companies before a permit is issued.

Ventria has faced opposition to growing pharmaceutical rice in other states from farmers and environmental groups. When Ventria tried to grow the crop in southeast Missouri, beer giant Anheuser-Busch Cos. threatened to boycott all rice from the state if the plan was allowed.

The company won approval in 2005 to grow its rice on smaller plots in North Carolina, which also has no commercial rice farming.

USA Rice Federation spokesman David Coia said his group opposed genetically engineered rice in Missouri, but is not taking a position on the Kansas plan.

"Where there would be a threat to commercial rice crops, we certainly would take an interest, but that doesn't appear to be the case in this instance," Coia said.

Kansas Gov. Kathleen Sebelius and other officials have enthusiastically welcomed Ventria to the state. The company plans to spend $6 million to renovate an abandoned grocery distribution center in Junction City and could eventually contract with farmers to grow rice on 30,000 acres.

Rep. Jerry Moran, a Republican whose district includes Junction City and most of western Kansas, said he has heard no complaints from farmers.

The public has until March 30 to submit comments to the USDA. If final approval is granted, Ventria will begin planting rice in April or May, Deeter said.

Sick People Used Like Laboratory Rats in GM Trials

By Geoffrey Lean
The Independent (UK)
March 4, 2007

Genetically modified potatoes developed by Monsanto, the multinational biotech company, have been fed to sick patients in an experiment. Rats that ate similar potatoes in the research suffered reductions in the weight of their hearts and prostate glands.

Dr Michael Antoniou, reader in molecular genetics at Guy's, King's and St Thomas' School of Medicine, said use of humans was "irresponsible and totally unethical, especially when already ill subjects were enrolled. These people truly were guinea pigs." Other scientists said the trials were too short, on too few people, to give meaningful results of long-term effects.

Monsanto said the vegetables were safe, and the researchers conducting the experiment said effects on the rats were within "permissible" limits.

The experiment is described in a hitherto unpublished report by the Nutrition Institute of the Russian Academy of Medical Science, done "by agreement with Monsanto Company" in 1998.

The report says "10 patients suffering from hypertensive disease and ischemic heart disease" were fed a pound of the Russet Burbank potatoes - modified to resist Colorado beetles - every day for three weeks, and monitored.

It goes on: "A certain risk of GM food products for human health does exist, as there can be by-effects of inserted genes besides the designed ones." The report describes the patients as "volunteers" and says they liked the GM potato so much they all "expressed their intention to consume it at home".

After comparing them with 10 other patients fed conventional potatoes, the report concludes: "The genetically modified potato provided by Monsanto did not reveal toxic, mutagenic, immune modulating and allergic effects within the examined parameters of the present experiment".

It recommended the GM potatoes "can be used for human nutrition purposes in further epidemiological research". The report says the rats, tested over six months, suffered "increases of kidneys' absolute weight" when compared to ones fed conventional potatoes but that all changes were "within permissible physiological fluctuation".

But Dr Irina Ermakova, of the Russian Academy of Science, calls the GM potatoes "dangerous" for rats, adding: "On this evidence, they cannot be used in the nourishment of people".

Tony Coombs from Monsanto UK said in a statement: "Potatoes genetically improved to prevent Colorado beetle destroying the crop have already been consumed, as safely as conventional or organic ones, in North America for years."

Key Monsanto Patent Rejected

By Jane Roberts
commercialappeal.com
March 4, 2007

The U.S. Patent and Trademark Office has rejected a key patent in Monsanto's Roundup Ready arsenal, possibly stripping the agribusiness giant of its power to license the technology to farmers.

St. Louis-based Monsanto has the right to appeal the decision or try to reach a compromise by reducing the breadth of the patent. It has 60 days to respond.

"We believe the patent is still valid, and at the end of the process, we believe the patent will still be enforced," said Lee Quarles, company spokesman.

If the patent is revoked, he said Monsanto holds additional patents to protect its intellectual investment.

The patent is one of four Monsanto patents the nonprofit Public Patent Foundation asked the patent office to review last fall, alleging they were granted without merit.

"We think there are several problems. One is the patents don't deserve to exist because Monsanto didn't come up with something new or unobvious," said Dan Ravicher, executive director.

The other issue, he said, is that Monsanto has used the patents to "aggressively try to bankrupt farmers or put them out of business."

The rejection -- while not a revocation -- "casts a substantial cloud of doubt on Monsanto. They will be less successful in their efforts to sue," Ravicher said.

The patents protect seed traits that make cotton and soybean plants immune to glyphosate, the generic name for the active ingredient in the herbicide Roundup.

With the modified seed, farmers can spray glyphosate over the crop, killing the weeds but not the crop.

The practice has revolutionized row crop agriculture because it requires farmers to make fewer passes over their fields, saving time, energy and soil compaction.

Monsanto has had a monopoly on the trait since it introduced it in cotton in 1997. The company requires farmers to sign a licensing agreement saying they will not save the seed for future planting.

It has sued a number of producers in high-profile cases, including several in the Mid-South, for licensing breaches.

"The whole notion that a company can get a utility patent on a plant is new and very controversial," said Bill Freese, science policy analyst at the Center for Food Safety, a nonprofit that focuses on ag biotechnology and supporting organic standards.

"A utility patent is for a mechanical invention. For decades, it didn't apply to plants because they are not inventions."

Seed germplasm contains advancements that have happened through evolution and breeding programs, some conducted in family-farm breeding programs.

Patenting the entire germplasm gives the patent holder control over enhancements that occurred in the public domain, Freese said.

Lisa Dry, spokeswoman for the American Seed Trade Association, said Monsanto is not alone in actively protecting its innovations.

"I know that it may sound odd to refer to a plant as an 'invention,' but patents are granted for all sorts of innovations where 'the hand of man' is involved in making a plant different in some manner.

"By preserving their intellectual property, seed companies and breeders can invest in research and development for new seeds to help farmers produce better yields or to provide solutions to farmers to reduce the impact of factors they cannot control -- temperature, moisture, weather and soil conditions -- to name a few."

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