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Analysis Finds Fewer Biotech Crops Moving Through Regulatory System
For years, agricultural biotechnology companies and industry analysts predicted that genetic engineering would spawn a cornucopia of heartier crops, more-healthful oils, delayed-ripening fruits, and many other more nutritious and better-tasting foods. However, the number of genetically engineered (GE) crops going through the regulatory review process dropped sharply between the late 1990s and the early 2000s, according to a report issued today by the nonprofit Center for Science in the Public Interest (CSPI). Also, the federal government is taking longer to review GE crops, according to CSPI, even though most of the recent crops have been slight variations of previously approved crops.
CSPI reviewed regulatory records for GE crops at the Food and Drug Administration (FDA) and the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture. CSPI found that the products reviewed in the 2000s have mostly been crops with the same or similar genes as the first generation of GE crops commercialized in the late 1990s, such as insect-resistant or herbicide- tolerant versions of soybean, corn, cotton, and canola.
“The biotech industry is quick to bemoan government regulation, claiming it is too onerous,” said Gregory Jaffe, director of biotechnology policy for CSPI and the author of the report, Withering on the Vine: Will Agricultural Biotech’s Promises Bear Fruit?. “But the fact is that even without strict government regulations, the industry is not innovating, it is stagnating. The industry promised a bounty of beneficial crops, but the biotech cupboard remains pretty bare, except for the few crops that have benefitted grain, oilseed, and cotton farmers.”
Government reviews of GE crops have slowed in the last few years. At the FDA, to which companies submit human-safety data about their GE crops voluntarily, CSPI found that from 1995 to 1999, 47 crops completed the regulatory process, with consultations taking, on average, about seven months from start to finish. From 2000 to 2004, only 15 crops completed the process—a drop-off of two-thirds. And, the FDA took almost twice as long—13.8 months on average—to complete its reviews.
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Fewer products are being submitted for approval by government agencies.
By Philip Brasher
In 2000, biotech companies such as Pioneer Hi-Bred and Monsanto were promising that more healthful foods were just around the corner, thanks to genetically engineered crops.
Instead, the number of biotech crops reviewed by federal regulators has dropped sharply, and the products submitted to the government tend to be variations of traits already on the market, according to a report by the Center for Science in the Public Interest, a consumer advocacy group.
"The promise of additional benefits has not been realized," said the report, titled "Withering on the Vine: Will Agricultural Biotech's Promises Bear Fruit?"
Biotech seeds are popular with soybean, corn and cotton farmers, but the traits that have been engineered into their crops - resistance to insects or herbicides - are of little interest to consumers.
The industry is struggling to overcome consumer opposition to biotech foods in Europe and Japan.
New traits promised by biotech companies include soybeans that taste better or produce more healthful cooking oil.
The Food and Drug Administration, which looks into the safety of the crops, has reviewed 15 since 2000, compared with 47 from 1995 through 1999.
The U.S. Agriculture Department, which reviews the environmental impact of biotech plants, approved nearly four times as many biotech crops from 1994 through 1999 as it has since 2000, said the report.
The decline in USDA approvals is partly because of a restructuring of the agency's biotechnology staff, industry officials say. USDA created a biotechnology regulatory office in 2002 and has since doubled the staff from 25 to about 50.
The department also has imposed new rules for testing and approval of crops engineered for pharmaceutical and industrial uses.
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Dennis Normile*
The developing world's two premier agricultural research organizations have agreed to join forces on selected scientific projects. But the leaders of the International Rice Research Institute (IRRI) in Los Baños, the Philippines, and the International Maize and Wheat Improvement Center (CIMMYT), near Mexico City, rejected an outside recommendation to merge their administrative structures.
"A cynic could say that there is not much new" in this agreement, says Alex McCalla, professor emeritus of agricultural economics at the University of California, Davis, and chair of the CIMMYT board of directors. "Still, this is a set of commitments that goes way beyond anything these two centers have done before."
The two centers are part of a global network of 16 institutions working on agricultural challenges in the developing world. The impetus for closer cooperation comes from recent research showing that the major cereals share many genes. Last year the two centers asked the Rockefeller Foundation to study various organizational options, including a full merger (Science, 27 February 2004, p. 1281). Meeting earlier this month in Shanghai, the centers' two boards of directors accepted the foundation's suggestion to begin four joint research programs immediately and to pool support services related to issues such as intellectual-property rights, biosafety, and scientific publishing.
But governance issues proved more difficult. All agree that a complete merger wouldn't work. "Dissolving two existing international institutions and replacing them with a new one raised a host of very difficult legal and procedural problems," says Gary Toenniessen, a Rockefeller Foundation official and coordinator for the working group. The working group and the boards also agreed that the research projects should have a single leader and a unified budget. But the boards balked at putting the two centers under a single director-general and a single board of directors, as the foundation's working group had suggested.
McCalla says both boards felt that having a single director-general "was tantamount to a merger" and, thus, "premature." Instead, the boards decided to set up two committees, one to oversee the joint programs and one to explore common management. They also agreed to have two members sit on both boards. "Depending on the performance of these joint programs, we may take a second step toward greater cooperation," says Keijiro Otsuka, an agricultural economist at the Foundation for Advanced Studies on International Development in Tokyo and chair of the IRRI board.
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By RICHARD SINE
The head of DuPont's crop protection division said Wednesday that he expected to keep sales growing with new generations of cleaner and more effective chemicals for the world's farmers.
DuPont Co. vice president James Collins said he aimed to increase total sales from $2.2 billion to over $3 billion by 2010, a 36 percent gain, even though the worldwide crop protection market is expected to rise 8 percent, to $33 billion, during the same period.
"Our secret to growing has been very detailed segmentation and market analysis," Collins said during a conference call updating investors on the 3,700-employee division based in Wilmington.
Sales have grown 11 percent in the past three years, reversing a three-year decline. Collins said both the growth and the decline in the worldwide market are mostly tied to currency fluctuations.
In fact, the market for agricultural chemicals is nearly flat, he said. That's in part due to the spread of genetically engineered seeds that have weed or insect resistance built in. DuPont's $6.2 billion agriculture and nutrition platform, which includes crop protection, also includes the Pioneer seed company, which produces many such seeds.
But pests eventually build resistance to these seeds as well, Collins said. For example, Roundup Ready, a product from competitor Monsanto, at first hurt sales of a DuPont herbicide. Roundup Ready was initially designed to require use of only one herbicide, Monsanto's Roundup. But some weeds are becoming resistant to Roundup, creating opportunities for other DuPont products.
Some crops require up to 15 applications of insecticide in a single growing season, Collins said. As a result, insects may render a new class of pesticides virtually useless in as little as two years.
New diseases are also opening markets for DuPont chemicals. Collins estimated a $1 billion new market to treat Asian soybean rust, a fungus spreading through the United States and Latin America. DuPont is developing a pesticide, Flusilazole, to treat the fungus.
Seeds with genetic traits that can resist the soybean rust may take several years to develop. "Farmers want something they can use now," Collins said.
Even larger markets should open up as farmers phase out more-toxic pesticides in response to regulatory pressures. Collins said he saw a $4.5 billion opportunity in replacing pesticides that were acutely toxic or polluting groundwater.
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The majority of food retailers and producers in the European Union will not use genetically modified ingredients in their own brands, a new survey by Greenpeace shows.
Of 60 major food retailers and producers surveyed, 49 said they have a non-genetically modified foods policy in their brands in Europe or in countries where they make most of their sales. Another eight said they had the policy in some countries but not all. Only Dutch Royal Ahold said they used genetically modified ingredients in several of its own branded products, Greenpeace said.
Last year, the EU ended its five-year moratorium on genetically modified foods by approving a type of genetically modified canned sweetcorn. The EU also requires strict labeling and improved consumer information about biotech content in all crops and ingredients.
Greenpeace said the results shows that Europeans don't want to buy genetically modified foods and stores don't want to sell them.
However, a Monsanto official said in a published report that it is possible to sell labeled products in Europe, and that the number of products has nearly doubled over the last six months.
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TOKYO (Reuters) - Bad case of hay fever? Eat more rice. Japanese scientists have developed a genetically modified strain of rice they say will help alleviate the symptoms of an affliction that causes misery each year for some 10 percent of Japan's population.
The new strain of rice contains a gene that produces the allergy-causing protein, a Farm Ministry official said on Friday.
"Eating the rice ... helps mute the reaction of the body's immune system," she said, adding that the effect was similar to other allergy treatments where a small amount of allergen is released into the body to allow resistance to build up.
Millions of Japanese suffer from hay fever each spring caused by an allergic reaction to pollen from the Japanese cedar tree.
The pollen count this spring is forecast to be 5 to 10 times worse than last year.
Officials gathered on Friday to discuss steps to battle the pollen menace, including the new rice, pollen-free cedar trees and a tea-drink that helps combat symptoms.
"This is becoming quite a social problem," said Yasufumi Tanihashi, a special cabinet minister for science and technology.
Growing the new rice could draw protests from consumers concerned about the safety of genetically modified products.
The official said that if the new rice goes into production it will be the first genetically modified product to be grown in Japan.
Ironically, production of rice, Japan's staple food, has been on a long-term downtrend due to falling consumption.
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Scientists have said a woman who died of bird flu probably contracted the disease from her daughter.
The researchers from the Thai Ministry of Public Health warn it is likely there will be more cases where the virus is passed from human to human.
Professor John Oxford, a leading UK expert, said the virus had broken down the "final door" which prevented it being spread between people.
The study is published in the New England Journal of Medicine.
In 2004, avian flu infected at least 44 people in eight south Asian countries, killing 32.
Until the late 1990s, it had not been thought that the virus strain - H5N1 - could spread to humans.
Once it did, scientists began to fear it could then be spread between people.
In a "worst-case scenario", they suggested the virus could combine with a human flu virus if people were simultaneously infected with both.
If the viruses then exchanged genes, a new, highly infective virus could be created and be passed from person to person.
It is not thought that this happened in the Thai case, but experts say the fact that the evidence strongly suggests human-to-human transmission of the basic virus is worrying.
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Outbreaks that killed 12 in Southeast Asia raise fears of a mutated virus spread by humans.
After smoldering through the summer and fall, avian flu has erupted again in Southeast Asia with 12 confirmed deaths since late December, the latest a 10-year-old Vietnamese girl who died Sunday.
Thailand has reported widespread outbreaks among farm poultry, and Vietnam, where all the fatalities have occurred in the last month, now counts bird or human infections in nearly half of its provinces.
The growing number of cases suggests that the virus may be mutating into a form that is more easily transmitted to and among humans, increasing the possibility of a pandemic.
"The situation in Southeast Asia right now is the most significant setup for a very serious public health crisis that I've seen in my 30 years in this business," said Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. "We're sitting on a time bomb."
Vietnamese officials have struggled to contain the virus, deploying riot police at some checkpoints around Ho Chi Minh City to prevent an influx of infected birds during this month's Lunar New Year celebrations.
The government has destroyed more than 1 million domestic poultry in an effort to control the outbreak. But the virus has become so widespread that the mass slaughter of birds has been abandoned in some infected areas.
Since July, about 1 million birds have died or been culled in Thailand, compared with about 40 million culled during the first few months of last year.
Authorities believe the virus has a natural reservoir in wild fowl, which continually reinfect domesticated flocks.
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By Charles Piller, Times Staff Writer
Vietnamese authorities Wednesday ordered the slaughter or culling of all domesticated ducks in Ho Chi Minh City to stem surging bird flu outbreaks that have killed 13 people since late December.
Vietnam's Health Ministry on Tuesday had confirmed that a Cambodian woman who died Sunday had bird flu, marking the first confirmed Cambodian death from the disease and indicating its possible spread. All the other fatalities since December have been Vietnamese nationals.
The 25-year-old woman was from Kampot province in Cambodia, where she developed symptoms Jan. 21. She sought treatment in Vietnam and died in the Kien Giang provincial hospital.
Influenza experts said the limited culling being undertaken in Ho Chi Minh City probably was a case of too little, too late because the virus had already spread through most of the region.
"These measures are really nonsense," Dutch virologist Jan de Jong of Erasmus University in Rotterdam, one of the leading experts on the virus, said in a telephone interview.
In recent months, authorities in Thailand and Vietnam have culled only in areas immediately around outbreaks, with minimal success.
Last year, a far larger culling — about 100 million birds across the region — also proved ineffective, partly because the virus had become endemic in wild bird populations that infect farms.
De Jong suggested that a near-total culling of the region's poultry and curtailment of poultry farming for several years would be the only ways to stop the outbreaks.
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